FN Thomson Reuters Web of Science™
VR 1.0
PT J
AU Iarikov, DE
Alexander, J
Nambiar, S
AF Iarikov, Dmitri E.
Alexander, John
Nambiar, Sumathi
TI Hypersensitivity Reactions Associated With Fidaxomicin Use
SO CLINICAL INFECTIOUS DISEASES
LA English
DT Article
DE fidaxomicin; adverse reactions; hypersensitivity
AB We report hypersensitivity reactions associated with fidaxomicin, an antibacterial drug approved for the treatment of Clostridium difficile-associated diarrhea. These reactions are viewed as significant because of severity and unexpected because fidaxomicin is minimally absorbed. The fidaxomicin labeling was revised to include information about the possibility of hypersensitivity reactions.
C1 [Iarikov, Dmitri E.; Alexander, John; Nambiar, Sumathi] US FDA, Div Antiinfect Prod, Silver Spring, MD USA.
RP Iarikov, DE (reprint author), 10903 New Hampshire Ave,Bldg 22,Room 6245, Silver Spring, MD 20993 USA.
EM dmitri.iarikov@fda.hhs.gov
NR 3
TC 2
Z9 2
U1 0
U2 3
PU OXFORD UNIV PRESS INC
PI CARY
PA JOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA
SN 1058-4838
EI 1537-6591
J9 CLIN INFECT DIS
JI Clin. Infect. Dis.
PD FEB 15
PY 2014
VL 58
IS 4
BP 537
EP 539
DI 10.1093/cid/cit719
PG 3
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA AA4WQ
UT WOS:000331097800016
PM 24178248
ER
PT J
AU Jester, ELE
Abraham, A
Wang, YS
El Said, KR
Plakas, SM
AF Jester, Edward L. E.
Abraham, Ann
Wang, Yuesong
El Said, Kathleen R.
Plakas, Steven M.
TI Performance evaluation of commercial ELISA kits for screening of
furazolidone and furaltadone residues in fish
SO FOOD CHEMISTRY
LA English
DT Article
DE ELISA; Furazolidone; Furaltadone
ID CATFISH ICTALURUS-PUNCTATUS; TISSUE-BOUND METABOLITES; CHANNEL CATFISH;
DEPLETION
AB Regulatory monitoring for nitrofuran drug residues in aquaculture products has largely focused on LC-MS/MS. In addition, there is a need for facile and high-throughput screening methods for monitoring programs. We evaluated the performance of Ridascreen (R-Biopharm) ELISA kits for nitrofuran drug residues in fish muscle, with verification by LC-MS/MS. Kits were available for 3-amino-2-oxazolidinone (AOZ) and 3-amino-5-morpholino-methyl-2-oxazolidinone (AMOZ) side-chains of furazolidone and furaltadone, respectively. We found good repeatability in fortified and incurred muscle samples, with RSDs ranging from 1.8% to 7.6%. Recoveries of AOZ and AMOZ from muscle fortified at levels of 0.5-2 ng/g ranged from 98% to 114%. Excellent selectivity was demonstrated. The minimum detection limits (MDLs) for AOZ and AMOZ in muscle were 0.05 and 0.2 ng/g, respectively. ELISA data were highly correlated with those of LC-MS/MS. Results of this study support the use of these kits as screening assays for nitrofuran residues in fish muscle. Published by Elsevier Ltd.
C1 [Jester, Edward L. E.; Abraham, Ann; Wang, Yuesong; El Said, Kathleen R.; Plakas, Steven M.] US FDA, Div Seafood Sci & Technol, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
RP Jester, ELE (reprint author), US FDA, Div Seafood Sci & Technol, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
EM Edward.Jester@fda.hhs.gov
NR 15
TC 9
Z9 11
U1 4
U2 69
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0308-8146
EI 1873-7072
J9 FOOD CHEM
JI Food Chem.
PD FEB 15
PY 2014
VL 145
BP 593
EP 598
DI 10.1016/j.foodchem.2013.08.090
PG 6
WC Chemistry, Applied; Food Science & Technology; Nutrition & Dietetics
SC Chemistry; Food Science & Technology; Nutrition & Dietetics
GA 261SP
UT WOS:000327685200079
PM 24128519
ER
PT J
AU Ouyang, WM
Torigoe, C
Fang, H
Xie, T
Frucht, DM
AF Ouyang, Weiming
Torigoe, Chikako
Fang, Hui
Xie, Tao
Frucht, David M.
TI Anthrax Lethal Toxin Inhibits Translation of Hypoxia-inducible Factor 1
alpha and Causes Decreased Tolerance to Hypoxic Stress
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
DE Bacillus; Bacterial Pathogenesis; Hypoxia; Hypoxia-inducible Factor;
Infectious Diseases; MAP kinases (MAPKs); mTOR; Protein Stability;
Toxins; Translation
ID HIPPEL-LINDAU PROTEIN; SIGNALING PATHWAYS; INNATE IMMUNITY;
BACILLUS-ANTHRACIS; SYSTEMIC ANTHRAX; KEY MEDIATOR; HIF-1-ALPHA;
FACTOR-1-ALPHA; TARGETS; KINASE
AB Background: Hypoxia is proposed as a mediator of anthrax lethal factor (LT)-induced pathology. Results: LT inhibits hypoxia-inducible factor 1 (HIF-1) translation and causes increased cellular toxicity in response to hypoxic stress. Conclusion: LT reduces HIF-1 translation, dysregulating host responses to hypoxia. Significance: Inhibition of HIF-1 translation is a novel mechanism underlying LT-induced pathology.
Hypoxia is considered to be a contributor to the pathology associated with administration of anthrax lethal toxin (LT). However, we report here that serum lactate levels in LT-treated mice are reduced, a finding inconsistent with the anaerobic metabolism expected to occur during hypoxia. Reduced lactate levels are also observed in the culture supernatants of LT-treated cells. LT inhibits the accumulation of hypoxia-inducible factor (HIF)-1, a subunit of HIF-1, the master regulator directing cellular responses to hypoxia. The toxin has no effect on the transcription or protein turnover of HIF-1, but instead it acts to inhibit HIF-1 translation. LT treatment diminishes phosphorylation of eIF4B, eIF4E, and rpS6, critical components of the intracellular machinery required for HIF-1 translation. Moreover, blockade of MKK1/2-ERK1/2, but not p38 or JNK signaling, lowers HIF-1 protein levels in both normoxic and hypoxic conditions, consistent with a role for MKK1 and MKK2 as the major targets of LT responsible for the inhibition of HIF-1 translation. The physiological importance of the LT-induced translation blockade is demonstrated by the finding that LT treatment decreases the survival of hepatocyte cell lines grown in hypoxic conditions, an effect that is overcome by preinduction of HIF-1. Taken together, these data support a role for LT in dysregulating HIF-1 and thereby disrupting homeostatic responses to hypoxia, an environmental characteristic of certain tissues at baseline and/or during disseminated infection with Bacillus anthracis.
C1 [Ouyang, Weiming; Torigoe, Chikako; Fang, Hui; Xie, Tao; Frucht, David M.] US FDA, Div Monoclonal Antibodies, Off Biotechnol Prod, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
RP Frucht, DM (reprint author), US FDA, Div Monoclonal Antibodies, Off Biotechnol Prod, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
EM david.frucht@fda.hhs.gov
FU Food and Drug Administration
FX This work was supported by a Medical Countermeasures Grant from the Food
and Drug Administration.
NR 58
TC 1
Z9 1
U1 0
U2 6
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
EI 1083-351X
J9 J BIOL CHEM
JI J. Biol. Chem.
PD FEB 14
PY 2014
VL 289
IS 7
BP 4180
EP 4190
DI 10.1074/jbc.M113.530006
PG 11
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA AA9HG
UT WOS:000331403800031
PM 24366872
ER
PT J
AU Orza, AI
Mihu, C
Soritau, O
Diudea, M
Florea, A
Matei, H
Balici, S
Mudalige, T
Kanarpardy, GK
Biris, AS
AF Orza, Anamaria I.
Mihu, Carmen
Soritau, Olga
Diudea, Mircea
Florea, Adrian
Matei, Horea
Balici, Stefana
Mudalige, Thilak
Kanarpardy, Ganesh K.
Biris, Alexandru S.
TI Multistructural biomimetic substrates for controlled cellular
differentiation
SO NANOTECHNOLOGY
LA English
DT Article
DE nanomaterials; stem cell differentiation; gold-functionalized
collagen-laminin substrate; extracellular matrix
ID MESENCHYMAL STEM-CELLS; MULTIWALLED CARBON NANOTUBES; TYPE-1
DIABETES-MELLITUS; EXTRACELLULAR-MATRIX; GOLD NANOPARTICLES;
HEPATOCELLULAR-CARCINOMA; NEURAL DIFFERENTIATION; REGENERATIVE MEDICINE;
PARKINSONS-DISEASE; FOCAL ADHESIONS
AB Multidimensional scaffolds are considered to be ideal candidates for regenerative medicine and tissue engineering based on their potential to provide an excellent microenvironment and direct the fate of the cultured cells. More recently, the use of stem cells in medicine has opened a new technological opportunity for controlled tissue formation. However, the mechanism through which the substrate directs the differentiation of stem cells is still rather unclear. Data concerning its specific surface chemistry, topology, and its signaling ability need to be further understood and analyzed. In our study, atomic force microscopy was used to study the stiffness, roughness, and topology of the collagen (Coll) and metallized collagen (MC) substrates, proposed as an excellent substrate for regenerative medicine. The importance of signaling molecules was studied by constructing a new hybrid signaling substrate that contains both collagen and laminin extracellular matrix (ECM) proteins. The cellular response-such as attachment capability, proliferation and cardiac and neuronal phenotype expression on the metallized and non-metallized hybrid substrates (collagen + laminin)-was studied using MTT viability assay and immunohistochemistry studies. Our findings indicate that such hybrid materials could play an important role in the regeneration of complex tissues.
C1 [Orza, Anamaria I.; Diudea, Mircea] Univ Arkansas, Ctr Integrat Nanotechnol Sci, Little Rock, AR 72204 USA.
[Orza, Anamaria I.; Kanarpardy, Ganesh K.; Biris, Alexandru S.] Inst Oncol, Cluj Napoca, Romania.
[Mihu, Carmen] Univ Babes Bolyai, Fac Chem & Chem Engn, R-3400 Cluj Napoca, Romania.
[Soritau, Olga; Florea, Adrian; Matei, Horea; Balici, Stefana] Iuliu Hatieganu Univ Med & Pharm, Dept Cell & Mol Biol, Cluj Napoca 400349, Romania.
[Mudalige, Thilak] US FDA, Arkansas Reg Lab, Jefferson, AR 72079 USA.
RP Orza, AI (reprint author), Univ Arkansas, Ctr Integrat Nanotechnol Sci, 2801 South Univ Ave, Little Rock, AR 72204 USA.
EM anamaria.orza@emory.edu
RI Diudea, Mircea/C-6838-2014
NR 81
TC 6
Z9 6
U1 2
U2 35
PU IOP PUBLISHING LTD
PI BRISTOL
PA TEMPLE CIRCUS, TEMPLE WAY, BRISTOL BS1 6BE, ENGLAND
SN 0957-4484
EI 1361-6528
J9 NANOTECHNOLOGY
JI Nanotechnology
PD FEB 14
PY 2014
VL 25
IS 6
AR 065102
DI 10.1088/0957-4484/25/6/065102
PG 13
WC Nanoscience & Nanotechnology; Materials Science, Multidisciplinary;
Physics, Applied
SC Science & Technology - Other Topics; Materials Science; Physics
GA 296OP
UT WOS:000330194800002
PM 24434767
ER
PT J
AU Dong, JL
Song, LN
Yin, JJ
He, WW
Wu, YH
Gu, N
Zhang, Y
AF Dong, Jinlai
Song, Lina
Yin, Jun-Jie
He, Weiwei
Wu, Yihang
Gu, Ning
Zhang, Yu
TI Co3O4 Nanoparticles with Multi-Enzyme Activities and Their Application
in Immunohistochemical Assay
SO ACS APPLIED MATERIALS & INTERFACES
LA English
DT Article
DE cobalt oxide nanoparticles; multi-enzyme mimetics; high redox potential;
immunohistochemical assay
ID IRON-OXIDE NANOPARTICLES; PEROXIDASE-LIKE ACTIVITY; LITHIUM-ION
BATTERIES; TRANSITION-METALS; HYDROXYL RADICALS; SUPEROXIDE; OXIDATION;
OXYGEN; VEGF; NANOSTRUCTURES
AB Co3O4 nanoparticles (Co3O4 NPs), synthesized by the coprecipitation method, showed intrinsic catalase-like, peroxidase-like, and SOD-like activity. The catalytic activity of Co3O4 NPs was much higher than analogous Fe3O4 NPs. Co3O4's mechanisms of catalytic activity were analyzed in detail using the electron spin resonance (ESR) method, which confirmed that Co3O4 NPs don't follow the classical Fenton reactions with hydrogen peroxide the way Fe3O4 NPs do. The high redox potential of Co3+/Co2+ was supposed to be the leading cause of the differences in both activity and mechanism with Fe3O4. Based on the high, peroxidase-like activity, a new immunohistochemical assay was designed in which the avastin antibody was conjugated onto the surface of Co3O4 NPs. The conjugates obtained were used to detect vascular endothelial growth factor (VEGF) that was overexpressed in tumor tissue. When the experimental and control groups were stained, there were clear distinctions between them. This study showed that there are many opportunities to improve the enzyme-like activities of nanomaterials and also to improve their potential applications for biocatalysis and bioassays, especially in relatively harsh conditions.
C1 [Dong, Jinlai; Song, Lina; Wu, Yihang; Gu, Ning; Zhang, Yu] Southeast Univ, State Key Lab Bioelect, Jiangsu Key Lab Biomat & Devices, Sch Biol Sci & Med Engn, Nanjing 210096, Jiangsu, Peoples R China.
[Yin, Jun-Jie; He, Weiwei] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Gu, N (reprint author), Southeast Univ, State Key Lab Bioelect, Jiangsu Key Lab Biomat & Devices, Sch Biol Sci & Med Engn, Nanjing 210096, Jiangsu, Peoples R China.
EM zhangyu@seu.edu.cn
RI Yin, Jun Jie /E-5619-2014
FU National Basic Research Program of China [2011CB933503, 2013CB733800];
National Natural Science Foundation of China [31170959, 61127002]; Basic
Research Program of Jiangsu Province (Natural Science Foundation)
[BK2011036]; Research Fund for the Doctoral Program of Higher Education
of China [20110092110029]; National Key Technology Research and
Development Program of China [2012BAI23B02]; FDA Nanotechnology CORES
Program; Office of Cosmetics and Colors, CFSAN/FDA
FX We would like to thank Barbara Berman for editorial assistance. This
research was supported by the National Basic Research Program of China
(No. 2011CB933503, 2013CB733800), the National Natural Science
Foundation of China (No. 31170959, 61127002), the Basic Research Program
of Jiangsu Province (Natural Science Foundation, No. BK2011036), the
Research Fund for the Doctoral Program of Higher Education of China
(20110092110029), and the National Key Technology Research and
Development Program of China (2012BAI23B02). It was also partially
supported by a regulatory science grant under the FDA Nanotechnology
CORES Program and by the Office of Cosmetics and Colors, CFSAN/FDA (W.H.
and J.Y.). This article is not an official U.S. Food and Drug
Administration. (FDA) guidance or policy statement. No official support
or endorsement by the U.S. FDA is intended or should be inferred.
NR 47
TC 36
Z9 37
U1 18
U2 108
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 1944-8244
J9 ACS APPL MATER INTER
JI ACS Appl. Mater. Interfaces
PD FEB 12
PY 2014
VL 6
IS 3
BP 1959
EP 1970
DI 10.1021/am405009f
PG 12
WC Nanoscience & Nanotechnology; Materials Science, Multidisciplinary
SC Science & Technology - Other Topics; Materials Science
GA AB0OY
UT WOS:000331493200082
PM 24387092
ER
PT J
AU Khairuzzaman, A
Ahmed, SU
Higuera, A
Bellantone, RA
AF Khairuzzaman, A.
Ahmed, S. U.
Higuera, A.
Bellantone, R. A.
TI Effect of excipient porosity on the melting behavior of imbibed frozen
liquids
SO THERMOCHIMICA ACTA
LA English
DT Article
DE Differential scanning calorimetry; Melting point depression;
Gibbs-Thompson equation; Imbibed liquids
ID DRUG-RELEASE KINETICS; THERMOPOROMETRY; WATER; PARAMETERS; TABLETS;
EROSION; MATRIX
AB The effect of excipient porosity on melting point depression of confined fluids was investigated. Two grades of the pharmaceutical excipient silicon dioxide, Syloid 244 FP and Syloid 74 Regular, were used as model porous excipients. The pore size distribution for each was characterized by nitrogen gas adsorption. The excipient pores were loaded with two liquids, water and cyclohexane, which were allowed to imbibe into the pores. The loaded excipients were then subjected to thermal analysis by cooling then heating, and the melting behavior of the imbibed frozen material was evaluated using differential scanning calorimetry (DSC). A mathematical model for the observed DSC thermograms was developed from the Gibbs-Thompson equation, which was used to relate the melting point depression of materials to the local curvature and the local surface energy per volume of imbibed material inside the pores. In all cases, two distinct melt behaviors were seen. One was a melt peak near the nominal melting temperature, corresponding to frozen fluids outside the pores. The other was a secondary satellite endotherm, which showed a melting point depression that occurred over a broad temperature range that was distinctly below the nominal melting temperature. This satellite endotherm was attributed to melting of the imbibed material in the pores, and the model equations were fit to the experimental DSC data. The local surface energies per volume of imbibed material were calculated for each case. These corresponded to apparent interfacial tensions between the imbibed material and the Syloid pore walls of 58-71 mJ/m(2) for water and 13 mJ/m(2) for cyclohexane. The data show that the excipient porosity can cause remarkable melting point depression, and the results of the modeling suggested that this analytical technique may represent a novel approach to assess the impact of surface area on small particles. (C) 2013 Elsevier B.V. All rights reserved.
C1 [Khairuzzaman, A.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Ahmed, S. U.] Abon Pharmaceut LLC, Northvale, NJ 07647 USA.
[Higuera, A.] OSI Pharmaceut, Farmingdale, NY 11735 USA.
[Bellantone, R. A.] Long Isl Univ, Arnold & Marie Schwartz Coll Pharm & Hlth Sci, Div Pharmaceut Sci, Brooklyn, NY 11201 USA.
RP Bellantone, RA (reprint author), Long Isl Univ, Arnold & Marie Schwartz Coll Pharm & Hlth Sci, Div Pharmaceut Sci, 75 Dekalb Ave, Brooklyn, NY 11201 USA.
EM rbellant@liu.edu
OI Bellantone, Robert/0000-0001-6750-2847
FU Barr Pharmaceuticals (Pomona, New York)
FX This work is based in part on the Ph.D. Dissertation of Akm
Khairuzzaman. The authors would like to express their gratitude to Barr
Pharmaceuticals (Pomona, New York) for its support of this research.
NR 21
TC 1
Z9 1
U1 3
U2 8
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0040-6031
EI 1872-762X
J9 THERMOCHIM ACTA
JI Thermochim. Acta
PD FEB 10
PY 2014
VL 577
BP 53
EP 58
DI 10.1016/j.tca.2013.12.013
PG 6
WC Thermodynamics; Chemistry, Analytical; Chemistry, Physical
SC Thermodynamics; Chemistry
GA AB3JU
UT WOS:000331687900009
ER
PT J
AU Khalaj, M
Abbasi, A
Yamanishi, H
Akiyama, K
Wakitani, S
Kikuchi, S
Hirose, M
Yuzuriha, M
Magari, M
Degheidy, HA
Abe, K
Ogura, A
Hashimoto, H
Kunieda, T
AF Khalaj, Maryam
Abbasi, Abdolrahim
Yamanishi, Hiroshi
Akiyama, Kouyou
Wakitani, Shuso
Kikuchi, Sotaro
Hirose, Michiko
Yuzuriha, Misako
Magari, Masaki
Degheidy, Heba A.
Abe, Kuniya
Ogura, Atsuo
Hashimoto, Hiroshi
Kunieda, Tetsuo
TI A Missense Mutation in Rev7 Disrupts Formation of Pol zeta, Impairing
Mouse Development and Repair of Genotoxic Agent-induced DNA Lesions
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
DE Cell Proliferation; DNA Polymerase; Embryo; Mouse Genetics; Mutant
ID PRIMORDIAL GERM-CELLS; CROSS-LINK REPAIR; POLYMERASE-ZETA;
FANCONI-ANEMIA; EMBRYONIC LETHALITY; CHROMOSOMAL INSTABILITY; GENOMIC
INSTABILITY; CATALYTIC SUBUNIT; MAMMALIAN-CELLS; B-CELLS
AB Background:Rev7 encodes a subunit of Pol for translesion DNA synthesis (TLS). Results: We found a Rev7 mutation in mice that causes developmental defects and increases susceptibility for genotoxicity. Conclusion:Rev7 is essential for mouse development through its function in cell proliferation. Significance: These findings demonstrate a unique function of Pol in development that is absent in other TLS polymerases. Repro22 is a mutant mouse produced via N-ethyl-N-nitrosourea-induced mutagenesis that shows sterility with germ cell depletion caused by defective proliferation of primordial germ cells, decreased body weight, and partial lethality during embryonic development. Using a positional cloning strategy, we identified a missense mutation in Rev7/Mad2l2 (Rev7(C70R)) and confirmed that the mutation is the cause of the defects in repro22 mice through transgenic rescue with normal Rev7. Rev7/Mad2l2 encodes a subunit of DNA polymerase (Pol), 1 of 10 translesion DNA synthesis polymerases known in mammals. The mutant REV7 did not interact with REV3, the catalytic subunit of Pol. Rev7(C70R/C70R) cells showed decreased proliferation, increased apoptosis, and arrest in S phase with extensive H2AX foci in nuclei that indicated accumulation of DNA damage after treatment with the genotoxic agent mitomycin C. The Rev7(C70R) mutation does not affect the mitotic spindle assembly checkpoint. These results demonstrated that Rev7 is essential in resolving the replication stalls caused by DNA damage during S phase. We concluded that Rev7 is required for primordial germ cell proliferation and embryonic viability and development through the translesion DNA synthesis activity of Pol preserving DNA integrity during cell proliferation, which is required in highly proliferating embryonic cells.
C1 [Khalaj, Maryam; Abbasi, Abdolrahim; Yamanishi, Hiroshi; Wakitani, Shuso; Magari, Masaki] Okayama Univ, Grad Sch Nat Sci & Technol, Okayama 7008530, Japan.
[Akiyama, Kouyou; Kunieda, Tetsuo] Okayama Univ, Grad Sch Environm & Life Sci, Okayama 7008530, Japan.
[Khalaj, Maryam; Abbasi, Abdolrahim] NIDDK, Lab Cellular & Dev Biol, NIH, Bethesda, MD 20892 USA.
[Kikuchi, Sotaro; Hashimoto, Hiroshi] Yokohama City Univ, Grad Sch Nanobiosci, Tsurumi Ku, Yokohama, Kanagawa 2300045, Japan.
[Hirose, Michiko; Yuzuriha, Misako; Abe, Kuniya; Ogura, Atsuo] RIKEN Bioresource Ctr, Tsukuba, Ibaraki 3050074, Japan.
[Degheidy, Heba A.] US FDA, Div Biol, Silver Spring, MD 20993 USA.
RP Abbasi, A (reprint author), NIDDK, Lab Cellular & Dev Biol, NIH, Bethesda, MD 20892 USA.
EM abbasiar@mail.nih.gov; tkunieda@cc.okayama-u.ac.jp
RI Ogura, Atsuo/J-3916-2014
OI Ogura, Atsuo/0000-0003-0447-1988
FU Japan Society for the Promotion of Science
FX This work was authored, in whole or in part, by National Institutes of
Health staff. This work was supported in part by grants from the Japan
Society for the Promotion of Science.
NR 60
TC 10
Z9 10
U1 0
U2 5
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
EI 1083-351X
J9 J BIOL CHEM
JI J. Biol. Chem.
PD FEB 7
PY 2014
VL 289
IS 6
BP 3811
EP 3824
DI 10.1074/jbc.M113.514752
PG 14
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA AA8TU
UT WOS:000331368700060
PM 24356953
ER
PT J
AU Mendicino, M
Bailey, AM
Wonnacott, K
Puri, RK
Bauer, SR
AF Mendicino, Michael
Bailey, Alexander M.
Wonnacott, Keith
Puri, Raj K.
Bauer, Steven R.
TI MSC-Based Product Characterization for Clinical Trials: An FDA
Perspective
SO CELL STEM CELL
LA English
DT Editorial Material
ID MESENCHYMAL STROMAL CELLS; POTENCY
AB Proposals submitted to the FDA for MSC-based products are undergoing a rapid expansion that is characterized by increased variability in donor and tissue sources, manufacturing processes, proposed functional mechanisms, and characterization methods. Here we discuss the diversity in MSC-based clinical trial product proposals and highlight potential challenges for clinical translation.
C1 [Mendicino, Michael] OC, ORSI, OCS, Silver Spring, MD 20993 USA.
[Mendicino, Michael; Wonnacott, Keith; Puri, Raj K.; Bauer, Steven R.] CBER, OCTGT, DCGT, Rockville, MD 20852 USA.
[Bailey, Alexander M.] CBER, OCTGT, DCEPT, Rockville, MD 20852 USA.
RP Mendicino, M (reprint author), OC, ORSI, OCS, 10903 New Hampshire Blvd, Silver Spring, MD 20993 USA.
EM m.mendicino.phd@gmail.com; steven.bauer@fda.hhs.gov
NR 10
TC 57
Z9 61
U1 0
U2 11
PU CELL PRESS
PI CAMBRIDGE
PA 600 TECHNOLOGY SQUARE, 5TH FLOOR, CAMBRIDGE, MA 02139 USA
SN 1934-5909
EI 1875-9777
J9 CELL STEM CELL
JI Cell Stem Cell
PD FEB 6
PY 2014
VL 14
IS 2
BP 141
EP +
DI 10.1016/j.stem.2014.01.013
PG 7
WC Cell & Tissue Engineering; Cell Biology
SC Cell Biology
GA AA1DF
UT WOS:000330835800006
PM 24506881
ER
PT J
AU Yih, WK
Lieu, TA
Kulldorff, M
Martin, D
McMahill-Walraven, CN
Platt, R
Selvam, N
Selvan, M
Lee, GM
Nguyen, M
AF Yih, W. Katherine
Lieu, Tracy A.
Kulldorff, Martin
Martin, David
McMahill-Walraven, Cheryl N.
Platt, Richard
Selvam, Nandini
Selvan, Mano
Lee, Grace M.
Nguyen, Michael
TI Intussusception Risk after Rotavirus Vaccination in US Infants
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Article
ID UNITED-STATES; LESS-THAN-5 YEARS; SAFETY; CHILDREN; PROGRAM; MEXICO;
HOSPITALIZATIONS; SURVEILLANCE; IMMUNIZATION; PENTAVALENT
AB BackgroundInternational postlicensure studies have identified an increased risk of intussusception after vaccination with the second-generation rotavirus vaccines RotaTeq (RV5, a pentavalent vaccine) and Rotarix (RV1, a monovalent vaccine). We studied this association among infants in the United States.
MethodsThe study included data from infants 5.0 to 36.9 weeks of age who were enrolled in three U.S. health plans that participate in the Mini-Sentinel program sponsored by the Food and Drug Administration. Potential cases of intussusception and vaccine exposures from 2004 through mid-2011 were identified through procedural and diagnostic codes. Medical records were reviewed to confirm the occurrence of intussusception and the status with respect to rotavirus vaccination. The primary analysis used a self-controlled risk-interval design that included only vaccinated children. The secondary analysis used a cohort design that included exposed and unexposed person-time.
ResultsThe analyses included 507,874 first doses and 1,277,556 total doses of RV5 and 53,638 first doses and 103,098 total doses of RV1. The statistical power for the analysis of RV1 was lower than that for the analysis of RV5. The number of excess cases of intussusception per 100,000 recipients of the first dose of RV5 was significantly elevated, both in the primary analysis (attributable risk, 1.1 [95% confidence interval, 0.3 to 2.7] for the 7-day risk window and 1.5 [95% CI, 0.2 to 3.2] for the 21-day risk window) and in the secondary analysis (attributable risk, 1.2 [95% CI, 0.2 to 3.2] for the 21-day risk window). No significant increase in risk was seen after dose 2 or 3. The results with respect to the primary analysis of RV1 were not significant, but the secondary analysis showed a significant risk after dose 2.
ConclusionsRV5 was associated with approximately 1.5 (95% CI, 0.2 to 3.2) excess cases of intussusception per 100,000 recipients of the first dose. The secondary analysis of RV1 suggested a potential risk, although the study of RV1 was underpowered. These risks must be considered in light of the demonstrated benefits of rotavirus vaccination. (Funded by the Food and Drug Administration.)
Rotavirus vaccination has been associated with a decline in rotavirus-associated illness, but intussusception remains a concern. In this study, the pentavalent rotavirus vaccine was associated with a slight increase in intussusception, as compared with the monovalent vaccine. In 1999, a tetravalent rhesus-human reassortant rotavirus vaccine (RotaShield, Wyeth Lederle) was voluntarily withdrawn from the U.S. market within a year after licensure owing to an association with intussusception. The excess risk of intussusception was estimated at approximately 1 to 2 cases per 10,000 recipients of the vaccine.(1) In 2006 and 2008, respectively, a pentavalent bovine-human reassortant rotavirus vaccine (RV5; RotaTeq, Merck) and a monovalent human rotavirus vaccine (RV1; Rotarix, GlaxoSmithKline) were licensed after evaluation in clinical trials involving more than 60,000 infants, which provided enough statistical power to allow detection of an intussusception risk of a magnitude similar to ...
C1 [Yih, W. Katherine; Lieu, Tracy A.; Kulldorff, Martin; Platt, Richard; Lee, Grace M.] Harvard Univ, Sch Med, Dept Populat Med, Boston, MA 02215 USA.
[Yih, W. Katherine; Lieu, Tracy A.; Kulldorff, Martin; Platt, Richard; Lee, Grace M.] Harvard Pilgrim Hlth Care Inst, Boston, MA 02215 USA.
[Lee, Grace M.] Boston Childrens Hosp, Div Infect Dis, Boston, MA USA.
[Lee, Grace M.] Boston Childrens Hosp, Dept Lab Med, Boston, MA USA.
[Lieu, Tracy A.] Kaiser Permanente No Calif, Div Res, Oakland, CA USA.
[Martin, David; Nguyen, Michael] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[McMahill-Walraven, Cheryl N.] Aetna, Blue Bell, PA USA.
[Selvam, Nandini] HealthCore, Govt & Acad Res, Alexandria, VA USA.
[Selvan, Mano] Humana, Comprehens Hlth Insights, Louisville, KY USA.
RP Yih, WK (reprint author), Harvard Univ, Sch Med, Dept Populat Med, 133 Brookline Ave,6th Fl, Boston, MA 02215 USA.
EM katherine_yih@harvardpilgrim.org
OI Kulldorff, Martin/0000-0002-5284-2993
FU Food and Drug Administration
FX Funded by the Food and Drug Administration.
NR 33
TC 77
Z9 78
U1 2
U2 15
PU MASSACHUSETTS MEDICAL SOC
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
EI 1533-4406
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD FEB 6
PY 2014
VL 370
IS 6
BP 503
EP 512
DI 10.1056/NEJMoa1303164
PG 10
WC Medicine, General & Internal
SC General & Internal Medicine
GA AA4NT
UT WOS:000331073500006
PM 24422676
ER
PT J
AU Mansfield, E
Tyner, KM
Poling, CM
Blacklock, JL
AF Mansfield, Elisabeth
Tyner, Katherine M.
Poling, Christopher M.
Blacklock, Jenifer L.
TI Determination of Nanoparticle Surface Coatings and Nanoparticle Purity
Using Microscale Thermogravimetric Analysis
SO ANALYTICAL CHEMISTRY
LA English
DT Article
ID QUARTZ-CRYSTAL MICROBALANCE; GOLD NANOPARTICLES; TEMPERATURE; CHEMISTRY;
OXIDATION; DENSITY
AB The use of nanoparticles in some applications (i.e., nanomedical, nanofiltration, or nanoelectronic) requires small samples with well-known purities and composition. In addition, when nanoparticles are introduced into complex environments (e.g., biological fluids), the particles may become coated with matter, such as proteins or lipid layers. Many of today's analytical techniques are not able to address small-scale samples of nanoparticles to determine purity and the presence of surface coatings. Through the use of an elevated-temperature quartz crystal microbalance (QCM) method we call microscale thermogravimetric analysis, or mu-TGA, the nanoparticle purity, as well as the presence of any surface coatings of nanomaterials, can be measured. Microscale thermogravimetric analysis is used to determine the presence and amount of surface-bound ligand coverage on gold nanoparticles and confirm the presence of a poly(ethylene glycol) coating on SiO2 nanoparticles. Results are compared to traditional analytical techniques to demonstrate reproducibility and validity of mu-TGA for determining the presence of nanoparticle surface coatings. Carbon nanotube samples are also analyzed and compared to conventional TGA. The results demonstrate mu-TGA is a valid method for quantitative determination of the coatings on nanoparticles, and in some cases, can provide purity and compositional data of the nanoparticles themselves.
C1 [Mansfield, Elisabeth; Poling, Christopher M.; Blacklock, Jenifer L.] NIST, Appl Chem & Mat Div, Boulder, CO 80305 USA.
[Tyner, Katherine M.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Mansfield, E (reprint author), NIST, Appl Chem & Mat Div, Boulder, CO 80305 USA.
EM elisabeth.mansfield@nist.gov
NR 28
TC 10
Z9 10
U1 6
U2 42
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0003-2700
EI 1520-6882
J9 ANAL CHEM
JI Anal. Chem.
PD FEB 4
PY 2014
VL 86
IS 3
BP 1478
EP 1484
DI 10.1021/ac402888v
PG 7
WC Chemistry, Analytical
SC Chemistry
GA AA3TI
UT WOS:000331014800026
PM 24400715
ER
PT J
AU Aryal, B
Jeong, J
Rao, VA
AF Aryal, Baikuntha
Jeong, Jinsook
Rao, V. Ashutosh
TI Doxorubicin-induced carbonylation and degradation of cardiac myosin
binding protein C promote cardiotoxicity
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
DE cancer; ROS; cardioprotection
ID OXIDATIVE STRESS; HYPERTROPHIC CARDIOMYOPATHY; HL-1 CARDIOMYOCYTES;
CATALYZED OXIDATION; MYBP-C; MUSCLE; ACTIN; THERAPY; MICE;
IDENTIFICATION
AB Dose-dependent oxidative stress by the anthracycline doxorubicin (Dox) and other chemotherapeutic agents causes irreversible cardiac damage, restricting their clinical effectiveness. We hypothesized that the resultant protein oxidation could be monitored and correlated with physiological functional impairment. We focused on protein carbonylation as an indicator of severe oxidative damage because it is irreversible and results in proteasomal degradation. We identified and investigated a specific high-molecular weight cardiac protein that showed a significant increase in carbonylation under Dox-induced cardiotoxic conditions in a spontaneously hypertensive rat model. We confirmed carbonylation and degradation of this protein under oxidative stress and prevention of such effect in the presence of the iron chelator dexrazoxane. Using MS, the Dox-induced carbonylated protein was identified as the 140-kDa cardiac myosin binding protein C (MyBPC). We confirmed the carbonylation and degradation of MyBPC using HL-1 cardiomyocytes and a purified recombinant untagged cardiac MyBPC under metal-catalyzed oxidative stress conditions. The carbonylation and degradation of MyBPC were time-and drug concentration-dependent. We demonstrated that carbonylated MyBPC undergoes proteasome-mediated degradation under Dox-induced oxidative stress. Cosedimentation, immunoprecipitation, and actin binding assays were used to study the functional consequences of carbonylated MyBPC. Carbonylation of MyBPC showed significant functional impairment associated with its actin binding properties. The dissociation constant of carbonylated recombinant MyBPC for actin was 7.35 +/- 1.9 mu M compared with 2.7 +/- 0.6 mu M for native MyBPC. Overall, our findings indicate that MyBPC carbonylation serves as a critical determinant of cardiotoxicity and could serve as a mechanistic indicator for Dox-induced cardiotoxicity.
C1 [Aryal, Baikuntha; Jeong, Jinsook; Rao, V. Ashutosh] US FDA, Chem Lab, Div Therapeut Prot, Off Biotechnol Prod,Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
RP Rao, VA (reprint author), US FDA, Chem Lab, Div Therapeut Prot, Off Biotechnol Prod,Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
EM ashutosh.rao@fda.hhs.gov
FU Center for Drug Evaluation and Research Critical Path; Medical
Countermeasures Initiative (MCMi)
FX We acknowledge helpful discussions with Drs. Rodney L. Levine (National
Institutes of Health), Melanie Simpson (National Cancer Institute), and
Eugene H. Herman [Food and Drug Administration (FDA)]. We thank Dr.
Melkamu G. Kebtie (FDA) and Dr. Shen Luo (FDA) for their help with MS.
We acknowledge Prof. William C. Claycomb for kindly providing HL-1
cells. This research was supported by the Center for Drug Evaluation and
Research Critical Path and Medical Countermeasures Initiative (MCMi)
funding. The views expressed in this article are those of the authors
and do not necessarily reflect the official policy or position of the
United States Food and Drug Administration and the Department of Health
and Human Services, nor does mention of trade names, commercial
products, or organizations imply endorsement by the United States
Government.
NR 41
TC 15
Z9 15
U1 1
U2 16
PU NATL ACAD SCIENCES
PI WASHINGTON
PA 2101 CONSTITUTION AVE NW, WASHINGTON, DC 20418 USA
SN 0027-8424
J9 P NATL ACAD SCI USA
JI Proc. Natl. Acad. Sci. U. S. A.
PD FEB 4
PY 2014
VL 111
IS 5
BP 2011
EP 2016
DI 10.1073/pnas.1321783111
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 302FL
UT WOS:000330587600080
PM 24449919
ER
PT J
AU Qiu, YH
Li, X
Duan, JZ
AF Qiu, Yihong
Li, Xia
Duan, John Z.
TI Influence of Drug Property and Product Design on In Vitro-In Vivo
Correlation of Complex Modified-Release Dosage Forms
SO JOURNAL OF PHARMACEUTICAL SCIENCES
LA English
DT Article
DE modified release; bimodal release; dissolution; kinetics; absorption;
disposition; pharmacokinetics; IVIVC; simulation; superposition
ID PHARMACOKINETICS; BIOAVAILABILITY; ACETAMINOPHEN; FORMULATIONS; TRAMADOL
AB The present study examines how drug's inherent properties and product design influence the evaluation and applications of in vitro-in vivo correlation (IVIVC) for modified-release (MR) dosage forms consisting of extended-release (ER) and immediate-release (IR) components with bimodal drug release. Three analgesic drugs were used as model compounds, and simulations of in vivo pharmacokinetic profiles were conducted using different release rates of the ER component and various IR percentages. Plasma concentration-time profiles exhibiting a wide range of t(max) and maximum observed plasma concentration (C-max) were obtained from superposition of the simulated IR and ER profiles based on a linear IVIVC. It was found that depending on the drug and dosage form design, direct use of the superposed IR and ER data for IVIVC modeling and prediction may (1) be acceptable within errors, (2) become unreliable and less meaningful because of the confounding effect from the non-negligible IR contribution to C-max, or (3) be meaningless because of the insensitivity of C-max to release rate change of the ER component. Therefore, understanding the drug, design and drug release characteristics of the product is essential for assessing the validity, accuracy, and reliability of IVIVC of complex MR products obtained via directly modeling of in vivo data. (C) 2013 Wiley Periodicals, Inc.
C1 [Qiu, Yihong] AbbVie Inc, Oral Drug Prod Mfg Sci & Technol, N Chicago, IL 60064 USA.
[Li, Xia; Duan, John Z.] US FDA, Off New Drug Qual Assessment, Silver Spring, MD USA.
RP Qiu, YH (reprint author), AbbVie Inc, Oral Drug Prod Mfg Sci & Technol, N Chicago, IL 60064 USA.
EM qiu.yihong@abbvie.com
NR 26
TC 2
Z9 2
U1 0
U2 0
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0022-3549
EI 1520-6017
J9 J PHARM SCI-US
JI J. Pharm. Sci.
PD FEB
PY 2014
VL 103
IS 2
BP 507
EP 516
DI 10.1002/jps.23804
PG 10
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA AO4LW
UT WOS:000341311100019
PM 24338862
ER
PT J
AU Cantor, SL
Gupta, A
Khan, MA
AF Cantor, Stuart L.
Gupta, Abhay
Khan, Mansoor A.
TI Analytical Methods for the Evaluation of Melamine Contamination
SO JOURNAL OF PHARMACEUTICAL SCIENCES
LA English
DT Article
DE melamine; gelatin; near-infrared spectroscopy (NIRS); chemometrics;
partial least squares; PLS; FTIR; infrared spectroscopy; Raman
spectroscopy; X-ray diffractometry
ID RATS
AB There is an urgent need for the analysis of melamine in the global pharmaceutical supply chain to detect economically motivated adulteration or unintentional contamination using a simple, nondestructive analytical technique that confirms the extent of adulteration in a shorter time period. In this work, different analytical techniques (thermal analysis, X-ray diffraction, Fourier transform infrared (FT-IR), FT-Raman, and near-infrared (NIR) spectroscopy) were evaluated for their ability to detect a range of melamine levels in gelatin. While FT-IR and FT-Raman provided qualitative assessment of melamine contamination or adulteration, powder X-ray diffraction and NIR were able to detect and quantify the presence of melamine at levels as low as 1.0% w/w. Multivariate analysis of the NIR data yielded the most accurate model when three principal components were used. Data were pretreated using standard normal variate transformation to remove multiplicative interferences of scatter and particle size. The model had a root-mean-square error of calibration of 2.4 (R-2 = 0.99) and root-mean square error of prediction of 2.5 (R-2 = 0.96). The value of the paired t test for actual and predicted samples (1%-50% w/w) was 0.448 (p < 0.05), further indicating the robustness of the model. Published 2013.
C1 [Cantor, Stuart L.; Gupta, Abhay; Khan, Mansoor A.] US FDA, Off Pharmaceut Sci, Div Prod Qual Res, Silver Spring, MD 20993 USA.
RP Khan, MA (reprint author), US FDA, Off Pharmaceut Sci, Div Prod Qual Res, Silver Spring, MD 20993 USA.
EM Mansoor.khan@fda.hhs.gov
OI cantor, stuart/0000-0001-6506-1419
FU U.S. Department of Energy; CDER
FX This project was also supported in part by an appointment to the ORISE
Research Participation Program at CDER administered by the Oak Ridge
Institute for Science and Education through an agreement between the
U.S. Department of Energy and CDER.
NR 12
TC 0
Z9 0
U1 2
U2 15
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0022-3549
EI 1520-6017
J9 J PHARM SCI-US
JI J. Pharm. Sci.
PD FEB
PY 2014
VL 103
IS 2
BP 539
EP 544
DI 10.1002/jps.23812
PG 6
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA AO4LW
UT WOS:000341311100022
PM 24327168
ER
PT J
AU Babu, US
Balan, KV
Garthoff, LH
Calvo, MS
AF Babu, Uma S.
Balan, Kannan V.
Garthoff, Larry H.
Calvo, Mona S.
TI Vitamin D-2 from UVB light exposed mushrooms modulates immune response
to LPS in rats
SO MOLECULAR NUTRITION & FOOD RESEARCH
LA English
DT Article
DE Inflammation; Lipopolysaccharide; Mushrooms; NK activity; Vitamin D2
ID SERUM 25-HYDROXYVITAMIN D; WHITE BUTTON MUSHROOMS; AGARICUS-BISPORUS;
DIETARY SUPPLEMENTATION; EDIBLE MUSHROOMS; ULTRAVIOLET-IRRADIATION;
UNITED-STATES; D DEFICIENCY; MICE; CHOLECALCIFEROL
AB Scope: Poor vitamin D (vitD) status is linked to increased risk of infectious diseases, thus there is need for vitD-rich foods. UVB-exposed mushrooms synthesize vitD(2) but knowledge of bioavailability and function in immune response is lacking.
Methods and results: One hundred rats were fed one of five diets-control, 20 IU vitD(3)/day; no vitD(3)/day; 5% unexposed mushroom, 2.4 IU vitD(2)/day; 2.5% UVB mushroom, 300 IU vitD(2)/day; and 5% UVB mushroom, 600 IU vitD(2)/day-for 10 wk and challenged with either saline or the endotoxin LPS. Blood and tissues were collected at 3 h postchallenge. Plasma 25-hydroxyvitamin D (25OHD) levels from UVB-exposed mushroom fed rats were significantly elevated and associated with higher natural killer cell activity and reduced plasma inflammatory response to LPS compared to control diet fed rats. Microarray evaluation of rat spleens for changes in inflammatory gene expression showed significant upregulation of proinflammatory genes after LPS compared to saline controls in all groups. However, compared to control rats, upregulation of the proinflammatory genes was markedly reduced in the groups fed vitD(2)-enriched mushrooms.
Conclusion: Rats fed UVB-exposed mushrooms had significantly higher plasma total 25OHD levels that were associated with increased innate immune response and anti-inflammatory effects.
C1 [Babu, Uma S.; Balan, Kannan V.; Garthoff, Larry H.; Calvo, Mona S.] US FDA, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Calvo, MS (reprint author), US FDA, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, 8301 Muirkirk Rd, Laurel, MD 20708 USA.
EM mona.calvo@fda.hhs.gov
FU Mushroom Council; US Food and Drug Administration Center for Food Safety
and Applied Nutrition; FDA Commissioner's Fellowship Program; Oak Ridge
Institute for Science and Education (ORISE)
FX The authors thank the Mushroom Council and US Food and Drug
Administration Center for Food Safety and Applied Nutrition for support.
Kannan V. Balan was funded by the FDA Commissioner's Fellowship Program
and Oak Ridge Institute for Science and Education (ORISE).
NR 62
TC 4
Z9 4
U1 1
U2 9
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1613-4125
EI 1613-4133
J9 MOL NUTR FOOD RES
JI Mol. Nutr. Food Res.
PD FEB
PY 2014
VL 58
IS 2
BP 318
EP 328
DI 10.1002/mnfr.201300286
PG 11
WC Food Science & Technology
SC Food Science & Technology
GA AJ4GA
UT WOS:000337629700011
PM 24038984
ER
PT J
AU Zhang, J
Knapton, A
Lipshultz, SE
Cochran, TR
Hiraragi, H
Herman, EH
AF Zhang, Jun
Knapton, Alan
Lipshultz, Steven E.
Cochran, Thomas R.
Hiraragi, Hajime
Herman, Eugene H.
TI Sex-related Differences in Mast Cell Activity and Doxorubicin Toxicity:
A Study in Spontaneously Hypertensive Rats
SO TOXICOLOGIC PATHOLOGY
LA English
DT Article
DE doxorubicin; cardiomyopathy; nephropathy; spontaneously hypertensive
rats; ovariectomy; cardiac mast cells; renal mast cells
ID ADRIAMYCIN-INDUCED CARDIOMYOPATHY; CONGESTIVE-HEART-FAILURE; OXIDATIVE
STRESS; OVARIECTOMIZED RATS; INDUCED NEPHROPATHY; FEMALE RATS;
RALOXIFENE TREATMENT; ANTIOXIDANT ENZYMES; DENDRITIC CELLS;
FREE-RADICALS
AB Clinically, girls appear to be more sensitive than boys to the cardiotoxic effects of doxorubicin, whereas the opposite may be true for adults. To identify and characterize potential sex-related differences, adult male and female spontaneously hypertensive rats (SHR; some ovariectomized [OVX]) received 1 mg/kg of doxorubicin or saline iv weekly for 9, 10, or 12 weeks. Weight gain was slower in treated males. Serum concentrations of cholesterol and triglycerides increased and those of albumin decreased in both sexes, but changes were more pronounced in treated males. Treated males had significantly more severe cardiomyopathy scores and higher serum levels of cTnT than females. The increased cardiotoxicity was accompanied by higher numbers of cardiac mast cells (MCs) and percentage of cardiac MCs undergoing degranulation. Doxorubicin-treated OVX animals had significantly increased numbers of cardiac MCs, more severe myocardial lesions, and elevated serum concentrations of cTnT compared to doxorubicin-treated normal female SHR. The severity of cardiac lesions in the OVX female was similar to that observed in doxorubicin-treated males. This study demonstrated the presence of sex-related differences in the cardiotoxic effects elicited by doxorubicin and identified variations in the level of cardiac MC activity as a factor which could possibly contribute to the male-female dissimilarity.
C1 [Zhang, Jun; Knapton, Alan; Herman, Eugene H.] US FDA, Div Drug Safety Res, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Lipshultz, Steven E.; Cochran, Thomas R.] Univ Miami, Leonard M Miller Sch Med, Miami, FL USA.
[Hiraragi, Hajime] Amgen Inc, Seattle, WA USA.
RP Herman, EH (reprint author), US FDA, Div Drug Safety Res HFD 910, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM eugene.herman@fda.hhs.gov
NR 45
TC 10
Z9 10
U1 0
U2 1
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0192-6233
EI 1533-1601
J9 TOXICOL PATHOL
JI Toxicol. Pathol.
PD FEB
PY 2014
VL 42
IS 2
BP 361
EP 375
DI 10.1177/0192623313482778
PG 15
WC Pathology; Toxicology
SC Pathology; Toxicology
GA AJ4ES
UT WOS:000337625300008
PM 23531790
ER
PT J
AU Zhang, LS
Zhang, J
Shea, K
Xu, L
Tobin, G
Knapton, A
Sharron, S
Rouse, R
AF Zhang, Leshuai
Zhang, Jun
Shea, Katherine
Xu, Lin
Tobin, Grainne
Knapton, Alan
Sharron, Stewart
Rouse, Rodney
TI Autophagy in Pancreatic Acinar Cells in Caerulein-treated Mice:
Immunolocalization of Related Proteins and Their Potential as Markers of
Pancreatitis
SO TOXICOLOGIC PATHOLOGY
LA English
DT Article
DE apoptosis; autophagosome; lysosome; necrosis; trypsinogen activation
ID DRUG-INDUCED PANCREATITIS; NITRIC-OXIDE SYNTHASE; CATHEPSIN-B;
TRYPSINOGEN ACTIVATION; LYSOSOMAL CATHEPSINS; EXPERIMENTAL-MODELS;
MEMBRANE-PROTEIN; ACID-PHOSPHATASE; APOPTOTIC DEATH; CANCER-CELLS
AB Drug-induced pancreatitis (DIP) is an underdiagnosed condition that lacks sensitive and specific biomarkers. To better understand the mechanisms of DIP and to identify potential tissue biomarkers, we studied experimental pancreatitis induced in male C57BL/6 mice by intraperitoneal injection of caerulein (10 or 50 mu g/kg) at 1-hr intervals for a total of 7 injections. Pancreata from caerulein-treated mice exhibited consistent acinar cell autophagy and apoptosis with infrequent necrosis. Kinetic assays for serum amylase and lipase also showed a dose-dependent increase. Terminal deoxynucleotidyl transferase-mediated biotin-dNTP nick labeling (TUNEL) detected dose-dependent acinar cell apoptosis. By light microscopy, autophagy was characterized by the formation of autophagosomes and autolysosomes (ALs) within the cytoplasm of acinar cells. Immunohistochemical studies with specific antibodies for proteins related to autophagy and pancreatic stress were conducted to evaluate these proteins as potential biomarkers of pancreatitis. Western blots were used to confirm immunohistochemical results using pancreatic lysates from control and treated animals. Autophagy was identified as a contributing process in caerulein-induced pancreatitis and proteins previously associated with autophagy were upregulated following caerulein treatment. Autophagosomes and ALs were found to be a common pathway, in which cathepsins, lysosome-associated membrane protein 2, vacuole membrane protein 1, microtubule-associated protein 1 light chain 3 (LC3), autophagy-related protein 9, Beclin1, and pancreatitis-associated proteins were simultaneously involved in response to caerulein stimulus. Regenerating islet-derived 3 gamma (Reg3 gamma), a pancreatic acute response protein, was dose-dependently induced in caerulein-treated mice and colocalized with the autophagosomal marker, LC3. This finding supports Reg3 gamma as a candidate biomarker for pancreatic injury.
C1 [Zhang, Leshuai; Zhang, Jun; Shea, Katherine; Xu, Lin; Tobin, Grainne; Knapton, Alan; Sharron, Stewart; Rouse, Rodney] US FDA, Div Drug Safety Res, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Rouse, R (reprint author), US FDA, Div Drug Safety Res, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM rodney.rouse@fda.hhs.gov
RI Zhang, Leshuai/C-8077-2012
NR 91
TC 5
Z9 8
U1 0
U2 6
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0192-6233
EI 1533-1601
J9 TOXICOL PATHOL
JI Toxicol. Pathol.
PD FEB
PY 2014
VL 42
IS 2
BP 435
EP 457
DI 10.1177/0192623313486967
PG 23
WC Pathology; Toxicology
SC Pathology; Toxicology
GA AJ4ES
UT WOS:000337625300014
PM 23640381
ER
PT J
AU Lazorick, S
Crawford, Y
Gilbird, A
Fang, XM
Burr, V
Moore, V
Hardison, GT
AF Lazorick, Suzanne
Crawford, Yancey
Gilbird, Anthony
Fang, Xiangming
Burr, Veronica
Moore, Valeria
Hardison, George T., Jr.
TI Long-Term Obesity Prevention and the Motivating Adolescents with
Technology to CHOOSE Health (TM) Program
SO CHILDHOOD OBESITY
LA English
DT Article
ID CHILDHOOD OBESITY; PHYSICAL-ACTIVITY; PLANET-HEALTH; EDUCATION; POLICY;
CATCH
AB Background: The Motivating Adolescents with Technology to CHOOSE Health (TM) (MATCH) intervention integrates lifestyle behavior change curriculum within academic subjects taught in seventh grade. This study assesses obesity prevention in participants into high school.
Methods: The study compares four-to five-year longitudinal data from a single-site cohort (N = 106, 54% retained from 195 participants at baseline; 82% of those still at the school) pre- and postintervention in a rural middle school with high obesity rates with data from the 2006 Child Survey and 2010 Child and Young Adult Surveys from the National Longitudinal Survey of Youth 1979 (N= 600), which serves as a nationally representative comparison group. Outcome measures include pre- and postchanges in weight category, BMI, BMI z-score, BMI percentile for age and gender, and rates of change per month in BMI measures.
Results: At follow-up, change in percent overweight was significantly different between groups, with the MATCH group decreasing (20-12%) and the comparison group increasing (17-19%). Overall, the MATCH group had significantly higher decrease rates in BMI z-scores (p = 0.002) and BMI percentile (p = 0.01) than the comparison group. Of all adolescents at healthy weight at baseline, 2% from MATCH became overweight after five years, whereas 13% of the comparison group increased to overweight or obese (p = 0.02) after four years.
Conclusions: Despite a small sample size and a high-risk setting, at long-term follow-up, a greater proportion of MATCH participants than in the comparison group decreased from overweight to healthy weight or remained at healthy weight. The MATCH results suggest that some proportion of high-risk adolescents can have their growth trajectory follow a healthier path than expected.
C1 [Lazorick, Suzanne; Crawford, Yancey; Hardison, George T., Jr.] E Carolina Univ, Brody Sch Med, Dept Pediat, Greenville, NC 27834 USA.
[Lazorick, Suzanne] E Carolina Univ, Brody Sch Med, Dept Publ Hlth, Greenville, NC 27834 USA.
[Gilbird, Anthony] E Carolina Univ, Brody Sch Med, Off Human Res Integr, Greenville, NC 27834 USA.
[Fang, Xiangming] E Carolina Univ, Coll Allied Hlth Sci, Dept Biostat, Greenville, NC 27834 USA.
[Burr, Veronica] Veritas Collaborat, Durham, NC USA.
[Moore, Valeria] US FDA, Off Regulatory Affairs, St Louis, MO USA.
RP Lazorick, S (reprint author), E Carolina Univ, Brody Sch Med, 600 Moye Blvd,174 Life Sci Bldg, Greenville, NC 27834 USA.
EM lazoricks@ecu.edu
FU Blue Cross and Blue Shield of North Carolina Foundation; Robert Wood
Johnson Foundation; MATCH; Martin County school
FX This work was supported by funding from the Blue Cross and Blue Shield
of North Carolina Foundation and, in part, by the Robert Wood Johnson
Foundation Physician Faculty Scholar Award Program. An abstract of the
MATCH results included in this article was presented as a poster at The
Obesity Society 30th Annual Scientific Meeting, San Antonio, Texas,
September 20-24, 2012. The authors acknowledge the several Martin County
businesses that contributed a combined total of $6,500 of funding and
supplies for MATCH, as well as backpacks that served as an incentive for
participation in the follow-p measures. The authors also thank the
Martin County school system personnel who supported this work,
particularly administrative leadership during 2006-2008, including
Superintendent Dr. Thomas Daly. Finally, the authors recognize Principal
Clay Wagner, who supported MATCH at the middle school in 2006-2008, and
then greatly facilitated the follow-up study as the high school
principal in 2011-2012.
NR 34
TC 7
Z9 7
U1 2
U2 11
PU MARY ANN LIEBERT, INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 2153-2168
EI 2153-2176
J9 CHILD OBES
JI Child Obes.
PD FEB
PY 2014
VL 10
IS 1
BP 25
EP 33
DI 10.1089/chi.2013.0049
PG 9
WC Pediatrics
SC Pediatrics
GA AI5GC
UT WOS:000336892400005
PM 24325403
ER
PT J
AU Woo, EJ
Winiecki, SK
Ou, AC
AF Woo, Emily Jane
Winiecki, Scott K.
Ou, Alan C.
TI Motor palsies of cranial nerves (excluding VII) after vaccination
Reports to the US Vaccine Adverse Event Reporting System
SO HUMAN VACCINES & IMMUNOTHERAPEUTICS
LA English
DT Article
DE vaccine; cranial nerve palsy; ptosis; disconjugate gaze; adverse event;
postmarketing safety surveillance
ID ATTENUATED INFLUENZA VACCINE; BELLS-PALSY; POSTMARKETING EVALUATION;
UNITED-STATES; SAFETY; H1N1; VAERS; AGE
AB We reviewed cranial nerve palsies, other than VII, that have been reported to the US Vaccine Adverse Event Reporting System (VAERS). We examined patterns for differences in vaccine types, seriousness, age, and clinical characteristics. We identified 68 reports of cranial nerve palsies, most commonly involving the oculomotor (III), trochlear (IV), and abducens (VI) nerves. Isolated cranial nerve palsies, as well as palsies occurring as part of a broader clinical entity, were reported. Forty reports (59%) were classified as serious, suggesting that a cranial nerve palsy may sometimes be the harbinger of a broader and more ominous clinical entity, such as a stroke or encephalomyelitis. There was no conspicuous clustering of live vs. inactivated vaccines. The patient age range spanned the spectrum from infants to the elderly. Independent data may help to clarify whether, when, and to what extent the rates of cranial nerve palsies following particular vaccines may exceed background levels.
C1 [Woo, Emily Jane; Winiecki, Scott K.] US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Ou, Alan C.] NIAID, Div Microbiol & Infect Dis, NIH, Bethesda, MD 20892 USA.
RP Woo, EJ (reprint author), US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
EM jane.woo@fda.hhs.gov
OI Winiecki, Scott/0000-0003-4912-4621
NR 23
TC 2
Z9 2
U1 0
U2 0
PU LANDES BIOSCIENCE
PI AUSTIN
PA 1806 RIO GRANDE ST, AUSTIN, TX 78702 USA
SN 2164-5515
EI 2164-554X
J9 HUM VACC IMMUNOTHER
JI Human Vaccines Immunother.
PD FEB
PY 2014
VL 10
IS 2
BP 301
EP 305
DI 10.4161/hv.27032
PG 5
WC Biotechnology & Applied Microbiology; Immunology
SC Biotechnology & Applied Microbiology; Immunology
GA AI1YV
UT WOS:000336652500014
PM 24231288
ER
PT J
AU Hess, CN
McCoy, LA
Duggirala, HJ
Tavris, DR
O'Callaghan, K
Douglas, PS
Peterson, ED
Wang, TY
AF Hess, Connie N.
McCoy, Lisa A.
Duggirala, Hesha J.
Tavris, Dale R.
O'Callaghan, Kathryn
Douglas, Pamela S.
Peterson, Eric D.
Wang, Tracy Y.
TI Sex-Based Differences in Outcomes After Percutaneous Coronary
Intervention for Acute Myocardial Infarction: A Report From
TRANSLATE-ACS
SO JOURNAL OF THE AMERICAN HEART ASSOCIATION
LA English
DT Article
DE acute myocardial infarction; major adverse cardiac events; percutaneous
coronary intervention; sex-based outcomes
ID ACADEMIC RESEARCH CONSORTIUM; AMERICAN-HEART-ASSOCIATION; RAPID RISK
STRATIFICATION; SUPPRESS ADVERSE OUTCOMES; GENDER-DIFFERENCES; EARLY
IMPLEMENTATION; PRIMARY ANGIOPLASTY; CLINICAL-TRIALS; ARTERY-DISEASE;
REGISTRY
AB Background-Data regarding sex-based outcomes after percutaneous coronary intervention (PCI) for myocardial infarction are mixed. We sought to examine whether sex differences in outcomes exist in contemporary practice.
Methods and Results-We examined acute myocardial infarction patients undergoing PCI between April 2010 and October 2012 at 210 US hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) observational study. Outcomes included 1-year risk of major adverse cardiac events and bleeding according to Global Utilization of Strategies To Open Occluded Arteries (GUSTO) and Bleeding Academic Research Consortium (BARC) definitions. Among 6218 patients, 27.5% (n=1712) were female. Compared with men, women were older, had more comorbidities, and had lower functional status. Use of multivessel PCI and drug-eluting stents was similar between sexes, while women received less prasugrel. Unadjusted cumulative incidence of 1-year major adverse cardiac events was higher for women than for men (15.7% versus 13.6%, P=0.02), but female sex was no longer associated with higher incidence of major adverse cardiac events after multivariable adjustment (hazard ratio 0.98, 95% CI 0.83 to 1.15). Female sex was associated with higher risks of post-PCI GUSTO bleeding (9.1% versus 5.7%, P<0.0001) and postdischarge BARC bleeding (39.6% versus 27.9%, P<0.0001). Differences persisted after adjustment (GUSTO: hazard ratio 1.32, 95% CI 1.06 to 1.64; BARC: incidence rate ratio 1.42, 95% CI 1.27 to 1.56).
Conclusions-Female and male myocardial infarction patients undergoing PCI differ regarding demographic, clinical, and treatment profiles. These differences appear to explain the higher observed major adverse cardiac event rate but not higher adjusted bleeding risk for women versus men.
C1 [Hess, Connie N.; McCoy, Lisa A.; Douglas, Pamela S.; Peterson, Eric D.; Wang, Tracy Y.] Duke Clin Res Inst, Durham, NC USA.
[Duggirala, Hesha J.; Tavris, Dale R.; O'Callaghan, Kathryn] US FDA, Silver Spring, MD USA.
RP Hess, CN (reprint author), Duke Univ, Med Ctr, Duke Clin Res Inst, 2400 Pratt St,Room 0311,Terrace Level, Durham, NC 27705 USA.
EM connie.hess@duke.edu
FU Food and Drug Administration Office of Women's Health; Daiichi Sankyo,
Ltd; Eli Lilly and Company; National Institutes of Health
[5T32HL069749-09]
FX This analysis was sponsored by the Food and Drug Administration Office
of Women's Health. TRANSLATE-ACS was funded by Daiichi Sankyo, Ltd and
Eli Lilly and Company. Hess received support from the National
Institutes of Health (grant 5T32HL069749-09).
NR 39
TC 22
Z9 23
U1 1
U2 4
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 2047-9980
J9 J AM HEART ASSOC
JI J. Am. Heart Assoc.
PD FEB
PY 2014
VL 3
IS 1
AR e000523
DI 10.1161/JAHA.113.000523
PG 10
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA AI3VZ
UT WOS:000336794500017
PM 24510115
ER
PT J
AU Collinger, JL
Kryger, MA
Barbara, R
Betler, T
Bowsher, K
Brown, EHP
Clanton, ST
Degenhart, AD
Foldes, ST
Gaunt, RA
Gyulai, FE
Harchick, EA
Harrington, D
Helder, JB
Hemmes, T
Johannes, MS
Katyal, KD
Ling, GSF
McMorland, AJC
Palko, K
Para, MP
Scheuermann, J
Schwartz, AB
Skidmore, ER
Solzbacher, F
Srikameswaran, AV
Swanson, DP
Swetz, S
Tyler-Kabara, EC
Velliste, M
Wang, W
Weber, DJ
Wodlinger, B
Boninger, ML
AF Collinger, Jennifer L.
Kryger, Michael A.
Barbara, Richard
Betler, Timothy
Bowsher, Kristen
Brown, Elke H. P.
Clanton, Samuel T.
Degenhart, Alan D.
Foldes, Stephen T.
Gaunt, Robert A.
Gyulai, Ferenc E.
Harchick, Elizabeth A.
Harrington, Deborah
Helder, John B.
Hemmes, Timothy
Johannes, Matthew S.
Katyal, Kapil D.
Ling, Geoffrey S. F.
McMorland, Angus J. C.
Palko, Karina
Para, Matthew P.
Scheuermann, Janet
Schwartz, Andrew B.
Skidmore, Elizabeth R.
Solzbacher, Florian
Srikameswaran, Anita V.
Swanson, Dennis P.
Swetz, Scott
Tyler-Kabara, Elizabeth C.
Velliste, Meel
Wang, Wei
Weber, Douglas J.
Wodlinger, Brian
Boninger, Michael L.
TI Collaborative Approach in the Development of High-Performance
Brain-Computer Interfaces for a Neuroprosthetic Arm: Translation from
Animal Models to Human Control
SO CTS-CLINICAL AND TRANSLATIONAL SCIENCE
LA English
DT Article
DE brain; clinical trials; methodology; translational research
ID SPINAL-CORD-INJURY; ELECTROCORTICOGRAPHIC SPECTRAL-ANALYSIS; BLOCK
AUTONOMIC HYPERREFLEXIA; HUMAN SENSORIMOTOR CORTEX; PRIMATE MOTOR
CORTEX; ECOG SIGNALS; TRANSURETHRAL LITHOLAPAXY; MOVEMENT DIRECTION;
CORTICAL CONTROL; PROSTHETIC ARM
AB Our research group recently demonstrated that a person with tetraplegia could use a brain-computer interface (BCI) to control a sophisticated anthropomorphic robotic arm with skill and speed approaching that of an able-bodied person. This multiyear study exemplifies important principles in translating research from foundational theory and animal experiments into a clinical study. We present a roadmap that may serve as an example for other areas of clinical device research as well as an update on study results. Prior to conducting a multiyear clinical trial, years of animal research preceded BCI testing in an epilepsy monitoring unit, and then in a short-term (28 days) clinical investigation. Scientists and engineers developed the necessary robotic and surgical hardware, software environment, data analysis techniques, and training paradigms. Coordination among researchers, funding institutes, and regulatory bodies ensured that the study would provide valuable scientific information in a safe environment for the study participant. Finally, clinicians from neurosurgery, anesthesiology, physiatry, psychology, and occupational therapy all worked in a multidisciplinary team along with the other researchers to conduct a multiyear BCI clinical study. This teamwork and coordination can be used as a model for others attempting to translate basic science into real-world clinical situations.
C1 [Collinger, Jennifer L.; Foldes, Stephen T.; Weber, Douglas J.; Boninger, Michael L.] Dept Vet Affairs Med Ctr, Pittsburgh, PA 15206 USA.
[Collinger, Jennifer L.; Kryger, Michael A.; Barbara, Richard; Brown, Elke H. P.; Clanton, Samuel T.; Foldes, Stephen T.; Gaunt, Robert A.; Harchick, Elizabeth A.; Harrington, Deborah; Schwartz, Andrew B.; Skidmore, Elizabeth R.; Tyler-Kabara, Elizabeth C.; Wang, Wei; Weber, Douglas J.; Wodlinger, Brian; Boninger, Michael L.] Univ Pittsburgh, Dept Phys Med & Rehabil, Pittsburgh, PA USA.
[Collinger, Jennifer L.; Degenhart, Alan D.; Gaunt, Robert A.; Schwartz, Andrew B.; Tyler-Kabara, Elizabeth C.; Wang, Wei; Weber, Douglas J.; Boninger, Michael L.] Univ Pittsburgh, Dept Bioengn, Pittsburgh, PA USA.
[Betler, Timothy; Srikameswaran, Anita V.] Univ Pittsburgh, Sch Hlth Sci Media Relat, Pittsburgh, PA USA.
[Bowsher, Kristen] US FDA, Off Device Evaluat, Silver Spring, MD USA.
[Degenhart, Alan D.; Foldes, Stephen T.; Schwartz, Andrew B.; Wang, Wei; Weber, Douglas J.; Wodlinger, Brian] Carnegie Mellon Univ, Ctr Neural Basis Cognit, Pittsburgh, PA 15213 USA.
[Degenhart, Alan D.; Foldes, Stephen T.; Schwartz, Andrew B.; Wang, Wei; Weber, Douglas J.; Wodlinger, Brian] Univ Pittsburgh, Pittsburgh, PA USA.
[Gyulai, Ferenc E.] Univ Pittsburgh, Dept Anesthesiol, Pittsburgh, PA USA.
[Helder, John B.; Johannes, Matthew S.; Katyal, Kapil D.; Para, Matthew P.; Swetz, Scott] Johns Hopkins Univ, Appl Phys Lab, Laurel, MD USA.
[Ling, Geoffrey S. F.] Def Adv Res Projects Agcy, Arlington, VA USA.
[McMorland, Angus J. C.; Schwartz, Andrew B.; Velliste, Meel] Univ Pittsburgh, Syst Neurosci Inst, Pittsburgh, PA USA.
[McMorland, Angus J. C.; Schwartz, Andrew B.; Velliste, Meel] Univ Pittsburgh, Dept Neurobiol, Pittsburgh, PA USA.
[Schwartz, Andrew B.; Tyler-Kabara, Elizabeth C.; Boninger, Michael L.] Univ Pittsburgh, McGowan Inst Regenerat Med, Pittsburgh, PA USA.
[Skidmore, Elizabeth R.] Univ Pittsburgh, Dept Occupat Therapy, Pittsburgh, PA USA.
[Solzbacher, Florian] Univ Utah, Dept Elect & Comp Engn, Salt Lake City, UT USA.
[Solzbacher, Florian] Univ Utah, Dept Bioengn, Salt Lake City, UT 84112 USA.
[Solzbacher, Florian] Univ Utah, Dept Mat Sci & Engn, Salt Lake City, UT 84112 USA.
[Swanson, Dennis P.] Univ Pittsburgh, Res Conduct & Compliance Off, Pittsburgh, PA USA.
[Tyler-Kabara, Elizabeth C.] Univ Pittsburgh, Dept Neurol Surg, Pittsburgh, PA 15260 USA.
[Wang, Wei] Univ Pittsburgh, Clin & Translat Neurosci Inst, Pittsburgh, PA USA.
RP Boninger, ML (reprint author), Dept Vet Affairs Med Ctr, Pittsburgh, PA 15206 USA.
EM boninger@pitt.edu
RI Tyler-Kabara, Elizabeth/H-4930-2013;
OI Tyler-Kabara, Elizabeth/0000-0003-3286-1094; Gaunt,
Robert/0000-0001-6202-5818; Boninger, Michael/0000-0001-6966-919X
FU Defense Advanced Research Projects Agency (DARPA) Revolutionizing
Prosthetics program [N66001-10-C-4056]; National Institutes of Health
(NIH) [8KL2TR000146-07]; Office of Research and Development,
Rehabilitation Research & Development Service, Department of Veterans
Affairs [B6789C, B7143R, RX720]; UPMC Rehabilitation Institute
FX This material is based upon work supported by the Defense Advanced
Research Projects Agency (DARPA) Revolutionizing Prosthetics program
contract number N66001-10-C-4056, the National Institutes of Health
(NIH) grant 8KL2TR000146-07, the Office of Research and Development,
Rehabilitation Research & Development Service, Department of Veterans
Affairs (Grants # B6789C, B7143R, and RX720), and the UPMC
Rehabilitation Institute. The views expressed herein are those of the
authors and do not reflect the official policy or position of the
Department of Veterans Affairs, Department of Defense, or the United
States government.
NR 64
TC 11
Z9 12
U1 1
U2 31
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1752-8054
EI 1752-8062
J9 CTS-CLIN TRANSL SCI
JI CTS-Clin. Transl. Sci.
PD FEB
PY 2014
VL 7
IS 1
BP 52
EP 59
DI 10.1111/cts.12086
PG 8
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AA9VE
UT WOS:000331440300015
PM 24528900
ER
PT J
AU Miller, HI
AF Miller, Henry I.
TI Investing in Bad Science
SO POLICY REVIEW
LA English
DT Article
C1 [Miller, Henry I.] Stanford Univ, Hoover Inst, Stanford, CA 94305 USA.
[Miller, Henry I.] US FDA, Off Biotechnol, Rockville, MD 20857 USA.
RP Miller, HI (reprint author), Stanford Univ, Hoover Inst, Stanford, CA 94305 USA.
NR 0
TC 0
Z9 0
U1 2
U2 2
PU HOOVER INST
PI STANFORD
PA STANFORD UNIV, STANFORD, CA 94305-601 USA
SN 0146-5945
J9 POLICY REV
JI Policy Rev.
PD FEB-MAR
PY 2014
IS 177
BP 33
EP 42
PG 10
WC Political Science
SC Government & Law
GA AI1UO
UT WOS:000336640800003
ER
PT J
AU Qi, YL
Zhang, YT
Fein, S
Wang, CL
Loyo-Berrios, N
AF Qi, Youlin
Zhang, Yuanting
Fein, Sara
Wang, Cunlin
Loyo-Berrios, Nilsa
TI Maternal and Breast Pump Factors Associated with Breast Pump Problems
and Injuries
SO JOURNAL OF HUMAN LACTATION
LA English
DT Article
DE breast pump injuries; breastfeeding; breast pump; breastfeeding
difficulties; breast pumping; breast pump problems
ID BIRTH-WEIGHT INFANTS; FEEDING PRACTICES; UNITED-STATES; MOTHERS; MILK;
CONTAMINATION; ANXIETY
AB Background: Benefits of using a breast pump are well documented, but pump-related problems and injuries and the associated risk factors have not been reported. Objectives: This study aimed to describe breast pump-related problems and injuries and identify factors associated with these problems and injuries. Methods: Data were from the Infant Feeding Practices Study II; mothers were recruited from a nationally distributed consumer opinion panel. Mothers were asked about breast pump use, problems, and injuries at infant ages 2, 5, and 7 months. Survival analysis was used to identify factors associated with pump-related problems and injuries. Results: The sample included 1844 mothers. About 62% and 15% of mothers reported pump-related problems and injuries, respectively. The most commonly reported problem was that the pump did not extract enough milk and the most commonly reported injury was sore nipples. Using a battery-operated pump and intending to breastfeed less than 12 months were associated with higher risks of pump-related problems and injury. Learning from a friend to use the pump was associated with lower risk of pump-related problems, and using a manual pump and renting a pump were associated with a higher risk of problems. Conclusion: Our results suggest that problems and injuries associated with breast pump use can happen to mothers of all socioeconomic characteristics. Breastfeeding mothers may reduce their risks of problems and injury by not using battery-operated pumps and may reduce breast pump problems by not using manual pumps and by learning breast pump skills from a person rather than following written or video instructions.
C1 [Qi, Youlin; Wang, Cunlin; Loyo-Berrios, Nilsa] US FDA, Silver Spring, MD 20993 USA.
[Zhang, Yuanting; Fein, Sara] US FDA, College Pk, MD USA.
RP Qi, YL (reprint author), US FDA, Ctr Devices & Radiol Hlth, WO66 RM4212,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM youlin.qi@fda.hhs.gov
NR 24
TC 10
Z9 10
U1 0
U2 5
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0890-3344
EI 1552-5732
J9 J HUM LACT
JI J. Hum. Lact.
PD FEB
PY 2014
VL 30
IS 1
BP 62
EP 72
DI 10.1177/0890334413507499
PG 11
WC Nursing; Obstetrics & Gynecology; Pediatrics
SC Nursing; Obstetrics & Gynecology; Pediatrics
GA AH1OP
UT WOS:000335890900010
PM 24166052
ER
PT J
AU Pillai, SK
Chang, A
Murphy, MW
Buzzell, J
Ansari, A
Whitcomb, RC
Miller, C
Jones, R
Saunders, DP
Cavicchia, P
Watkins, SM
Blackmore, C
Williamson, JA
Stephens, M
Morrison, M
McNees, J
Murphree, R
Buchanan, M
Hogan, A
Lando, J
Nambiar, A
Torso, L
Melnic, JM
Yang, L
Lewis, L
AF Pillai, Satish K.
Chang, Arthur
Murphy, Matthew W.
Buzzell, Jennifer
Ansari, Armin
Whitcomb, Robert C., Jr.
Miller, Charles
Jones, Robert
Saunders, David P.
Cavicchia, Philip
Watkins, Sharon M.
Blackmore, Carina
Williamson, John A.
Stephens, Michael
Morrison, Melissa
McNees, James
Murphree, Rendi
Buchanan, Martha
Hogan, Anthony
Lando, James
Nambiar, Atmaram
Torso, Lauren
Melnic, Joseph M.
Yang, Lucie
Lewis, Lauren
TI 2011 Investigation of Internal Contamination with Radioactive Strontium
Following Rubidium Rb 82 Cardiac PET Scan
SO BIOSECURITY AND BIOTERRORISM-BIODEFENSE STRATEGY PRACTICE AND SCIENCE
LA English
DT Article
AB During routine screening in 2011, US Customs and Border Protection (CBP) identified 2 persons with elevated radioactivity. CBP, in collaboration with Los Alamos National Laboratory, informed the Food and Drug Administration (FDA) that these people could have increased radiation exposure as a result of undergoing cardiac Positron Emission Tomography (PET) scans several months earlier with rubidium Rb 82 chloride injection from CardioGen-82. We conducted a multistate investigation to assess the potential extent and magnitude of radioactive strontium overexposure among patients who had undergone Rb 82 PET scans. We selected a convenience sample of clinical sites in 4 states and reviewed records to identify eligible study participants, defined as people who had had an Rb 82 PET scan between February and July 2011. All participants received direct radiation screening using a radioisotope identifier able to detect the gamma energy specific for strontium-85 (514keV) and urine bioassay for excreted radioactive strontium. We referred a subset of participants with direct radiation screening counts above background readings for whole body counting (WBC) using a rank ordering of direct radiation screening. The rank order list, from highest to lowest, was used to contact and offer voluntary enrollment for WBC. Of 308 participants, 292 (95%) had direct radiation screening results indistinguishable from background radiation measurements; 261 of 265 (98%) participants with sufficient urine for analysis had radioactive strontium results below minimum detectable activity. None of the 23 participants who underwent WBC demonstrated elevated strontium activity above levels associated with routine use of the rubidium Rb 82 generator. Among investigation participants, we did not identify evidence of strontium internal contamination above permissible levels. This investigation might serve as a model for future investigations of radioactive internal contamination incidents.
C1 [Pillai, Satish K.; Chang, Arthur] Ctr Dis Control & Prevent, Hlth Studies Branch, Natl Ctr Environm Hlth, Atlanta, GA 30329 USA.
[Murphy, Matthew W.; Ansari, Armin; Miller, Charles; Saunders, David P.] Ctr Dis Control & Prevent, Natl Ctr Environm Hlth, Atlanta, GA 30329 USA.
[Buzzell, Jennifer] Ctr Dis Control & Prevent, Radiat Studies Branch, Div Environm Hazards & Hlth Effects, Natl Ctr Environm Hlth, Atlanta, GA 30329 USA.
[Whitcomb, Robert C., Jr.] Ctr Dis Control & Prevent, Radiat Studies Branch, Natl Ctr Environm Hlth, Atlanta, GA 30329 USA.
[Jones, Robert] Ctr Dis Control & Prevent, Inorgan & Radiat Analyt Toxicol Branch, Div Sci Lab, Natl Ctr Environm Hlth, Atlanta, GA 30329 USA.
[Lewis, Lauren] Ctr Dis Control & Prevent, Hlth Studies Branch, Div Environm Hazards & Hlth Effects, Natl Ctr Environm Hlth, Atlanta, GA 30329 USA.
[Cavicchia, Philip] Florida Dept Hlth, Tallahassee, FL USA.
[Watkins, Sharon M.; Blackmore, Carina] Florida Dept Hlth, Bur Epidemiol, Tallahassee, FL USA.
[Stephens, Michael] Florida Dept Hlth, Florida Bur Radiat Control, Div Emergency Preparedness & Community Support, Tallahassee, FL USA.
[Williamson, John A.] Florida Dept Hlth, Bur Radiat Control, Environm Radiat Programs, Orlando, FL USA.
[Morrison, Melissa] CDC, Off Publ Hlth Preparedness & Response, Alabama Dept Publ Hlth, Ctr Emergency Preparedness, Montgomery, AL USA.
[McNees, James] Alabama Dept Publ Hlth, Off Radiat Control, Montgomery, AL 36102 USA.
[Murphree, Rendi] CDC, Tennessee Dept Hlth, Nashville, TN USA.
[Buchanan, Martha] Knox Cty Hlt Dept, Knoxville, TN USA.
[Hogan, Anthony] Tennessee Dept Environm & Conservat, Div Radiol Hlth, Nashville, TN USA.
[Lando, James] CDC, Off Publ Hlth Preparedness & Response, Pittsburgh, PA USA.
[Nambiar, Atmaram; Torso, Lauren] Dept Hlth, Div Infect Dis Epidemiol, Bur Epidemiol, Harrisburg, PA USA.
[Melnic, Joseph M.] Bur Radiat Protect, Dept Environm Protect, Harrisburg, PA USA.
[Yang, Lucie] US FDA, Div Nonprescript Clin Evaluat, Off New Drugs, Silver Spring, MD USA.
RP Pillai, SK (reprint author), Ctr Dis Control & Prevent, NCEZID Div Preparedness & Emerging Infect, 1600 Clifton Rd,MS C18, Atlanta, GA 30329 USA.
EM vig8@cdc.gov
NR 15
TC 2
Z9 2
U1 1
U2 4
PU MARY ANN LIEBERT, INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1538-7135
EI 1557-850X
J9 BIOSECUR BIOTERROR
JI Biosecur. Bioterror.
PD FEB 1
PY 2014
VL 12
IS 1
BP 42
EP 48
DI 10.1089/bsp.2013.0072
PG 7
WC Public, Environmental & Occupational Health; International Relations
SC Public, Environmental & Occupational Health; International Relations
GA AB0EA
UT WOS:000331463400005
PM 24552361
ER
PT J
AU Ramage, JG
Prentice, KW
Morse, SA
Carter, AJ
Datta, S
Drumgoole, R
Gargis, SR
Griffin-Thomas, L
Hastings, R
Masri, HP
Reed, MS
Sharma, SK
Singh, AK
Swaney, E
Swanson, T
Gauthier, C
Toney, D
Pohl, J
Shakamuri, P
Stuchlik, O
Elder, IA
Estacio, PL
Garber, EAE
Hojvat, S
Kellogg, RB
Kovacs, G
Stanker, L
Weigel, L
Hodge, DR
Pillai, SP
AF Ramage, Jason G.
Prentice, Kristin Willner
Morse, Stephen A.
Carter, Andrew J.
Datta, Shomik
Drumgoole, Rahsaan
Gargis, Shaw R.
Griffin-Thomas, LaToya
Hastings, Rebecca
Masri, Heather P.
Reed, Matthew S.
Sharma, Shashi K.
Singh, Ajay K.
Swaney, Erin
Swanson, Tanya
Gauthier, Cheryl
Toney, Denise
Pohl, Jan
Shakamuri, Priyanka
Stuchlik, Olga
Elder, Ian A.
Estacio, Peter L.
Garber, Eric A. E.
Hojvat, Sally
Kellogg, Richard B.
Kovacs, Gerald
Stanker, Larry
Weigel, Linda
Hodge, David R.
Pillai, Segaran P.
TI Comprehensive Laboratory Evaluation of a Specific Lateral Flow Assay for
the Presumptive Identification of Abrin in Suspicious White Powders and
Environmental Samples
SO BIOSECURITY AND BIOTERRORISM-BIODEFENSE STRATEGY PRACTICE AND SCIENCE
LA English
DT Article
ID RIBOSOME-INACTIVATING PROTEINS; LINKED-IMMUNOSORBENT-ASSAY;
SITE-DIRECTED MUTAGENESIS; A A-CHAIN; ABRUS-PRECATORIUS; IN-VITRO;
RICIN; AGGLUTININ; EXPRESSION; TOXICITY
AB Abrin is a heterodimeric toxin present in the seeds of the Abrus precatorius plant. The easily obtainable seeds can yield a highly toxic product that can be used in various types of biocrimes and terrorism-related activities, including "white-powder" letters. Although the vast majority of these threats are hoaxes, the lack of rapid and reliable detection assays for abrin, such as lateral flow assays (LFAs), can be an impediment to accurate and rapid hazard assessment. One of the complicating factors associated with LFAs is the use of antibodies of poor affinity and specificity that cross-react with near neighbors or that bind to plant lectins, which are capable of nonspecifically cross-linking the capture and detector antibodies. Because of the critical need to promote public safety and public health, we conducted a comprehensive laboratory evaluation of a commercial LFA for the rapid detection of abrin. This study was conducted using comprehensive inclusivity and exclusivity panels of abrin and near-neighbor plant materials, along with panels of lectins, related proteins, white powders, and environmental background material, to determine the sensitivity, specificity, limit of detection, dynamic range, and repeatability of the assay for the specific intended use of evaluating suspicious white powders and environmental samples for the presumptive presence of abrin.
C1 [Ramage, Jason G.; Prentice, Kristin Willner] Booz Allen Hamilton Inc, Mclean, VA USA.
[Hodge, David R.; Pillai, Segaran P.] US Dept Homeland Secur, Chem & Biol Def Div, Sci & Technol Directorate, Washington, DC 20528 USA.
[Morse, Stephen A.; Carter, Andrew J.] Ctr Dis Control & Prevent, Div Foodborne Waterborne & Environm Dis, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA USA.
[Datta, Shomik; Sharma, Shashi K.; Singh, Ajay K.; Garber, Eric A. E.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
[Drumgoole, Rahsaan; Swaney, Erin] Texas Dept State Hlth Serv, Emergency Preparedness Branch, Austin, TX USA.
[Gargis, Shaw R.] CDC, Div Select Agents & Toxins, Atlanta, GA 30333 USA.
[Griffin-Thomas, LaToya; Masri, Heather P.; Toney, Denise] Div Consolidated Lab Serv, Richmond, VA USA.
[Hastings, Rebecca; Swanson, Tanya; Gauthier, Cheryl] Massachusetts Dept Publ Hlth, State Lab Inst, Bioterrorism Response Lab, Jamaica Plain, MA USA.
[Reed, Matthew S.; Shakamuri, Priyanka] CDC, Div Sci Resources, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA.
[Pohl, Jan] CDC, Biotechnol Core Facil Branch, Div Sci Resources, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA.
[Elder, Ian A.] US Dept Homeland Secur, Washington, DC USA.
[Estacio, Peter L.] Lawrence Livermore Natl Lab, Livermore, CA USA.
[Hojvat, Sally] US FDA, Div Microbiol Devices, Silver Spring, MD USA.
[Kellogg, Richard B.; Weigel, Linda] CDC, Lab Preparedness & Response Branch, Div Preparedness & Emerging Infect, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA.
[Kovacs, Gerald] ABL Inc, Rockville, MD USA.
[Stanker, Larry] USDA ARS, Foodborne Toxin Detect & Control Res Unit, Albany, CA USA.
RP Pillai, SP (reprint author), US Dept Homeland Secur, Chem & Biol Def Div, Sci & Technol Directorate, Washington, DC 20528 USA.
EM Segaran.Pillai@HQ.DHS.GOV
NR 33
TC 6
Z9 6
U1 1
U2 9
PU MARY ANN LIEBERT, INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1538-7135
EI 1557-850X
J9 BIOSECUR BIOTERROR
JI Biosecur. Bioterror.
PD FEB 1
PY 2014
VL 12
IS 1
BP 49
EP 62
DI 10.1089/bsp.2013.0080
PG 14
WC Public, Environmental & Occupational Health; International Relations
SC Public, Environmental & Occupational Health; International Relations
GA AB0EA
UT WOS:000331463400006
PM 24552362
ER
PT J
AU Alsante, KM
Huynh-Ba, KC
Baertschi, SW
Reed, RA
Landis, MS
Furness, S
Olsen, B
Mowery, M
Russo, K
Iser, R
Stephenson, GA
Jansen, P
AF Alsante, Karen M.
Huynh-Ba, Kim C.
Baertschi, Steven W.
Reed, Robert A.
Landis, Margaret S.
Furness, Scott
Olsen, Bernard
Mowery, Mark
Russo, Karen
Iser, Robert
Stephenson, Gregory A.
Jansen, Patrick
TI Recent Trends in Product Development and Regulatory Issues on Impurities
in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2:
Safety Considerations of Impurities in Pharmaceutical Products and
Surveying the Impurity Landscape
SO AAPS PHARMSCITECH
LA English
DT Article
ID SOLID-STATE; DEGRADATION; PHOTOSTABILITY; REACTIVITY; IDENTIFICATION;
HYDROCHLORIDE; ACETONITRILE; AUTOXIDATION; FORMULATION; SUBSTANCES
C1 [Alsante, Karen M.; Landis, Margaret S.] Pfizer Global Res & Dev, Groton, CT 06340 USA.
[Huynh-Ba, Kim C.] Pharmalytik Newark, Newark, DE USA.
[Baertschi, Steven W.; Stephenson, Gregory A.; Jansen, Patrick] Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46285 USA.
[Reed, Robert A.] Celsion Corp, Lawrenceville, NJ USA.
[Furness, Scott; Iser, Robert] US FDA, Washington, DC 20204 USA.
[Olsen, Bernard] Olsen Pharmaceut Consulting LLC, W Lafayette, IN USA.
[Mowery, Mark] Merck & Co Inc, West Point, PA USA.
[Russo, Karen] US Pharmacopeial Convent Inc, Rockville, MD USA.
RP Landis, MS (reprint author), Pfizer Global Res & Dev, Groton, CT 06340 USA.
EM margaret.s.landis@pfizer.com
NR 75
TC 3
Z9 3
U1 0
U2 6
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1530-9932
J9 AAPS PHARMSCITECH
JI AAPS PharmSciTech
PD FEB
PY 2014
VL 15
IS 1
BP 237
EP 251
DI 10.1208/s12249-013-0061-z
PG 15
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA AE5TW
UT WOS:000334053200025
PM 24363207
ER
PT J
AU Zhou, WL
Wang, PG
AF Zhou, Wanlong
Wang, Perry G.
TI Cosmetic bioanalysis using LC-MS: challenges and future outlook
SO BIOANALYSIS
LA English
DT Editorial Material
DE carryover; cosmetics; LC-MS; matrix effects; weighting factor
ID MASS-SPECTROMETRY; LIQUID-CHROMATOGRAPHY; HEXAPEPTIDES
C1 [Zhou, Wanlong; Wang, Perry G.] US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, College Pk, MD 20740 USA.
RP Wang, PG (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM perry.wang@fda.hhs.gov
NR 10
TC 0
Z9 0
U1 2
U2 7
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PD FEB
PY 2014
VL 6
IS 4
BP 437
EP 440
DI 10.4155/bio.13.246
PG 4
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA AC6IY
UT WOS:000332626700008
PM 24568347
ER
PT J
AU Williamson, LN
Conner, DP
Stier, EM
Davit, BM
AF Williamson, Leah N.
Conner, Dale P.
Stier, Ethan M.
Davit, Barbara M.
TI Common bioanalytical deficiencies with bioequivalence submissions in
Abbreviated New Drug Applications
SO BIOANALYSIS
LA English
DT Article
AB Background: The US FDA published A Guidance for Industry: Bioanalytical Method Validation in May 2001. Despite the publication of the guidance, companies continue to submit bioequivalence studies with bioanalytical deficiencies that preclude Abbreviated New Drug Application approval. The Divisions of Bioequivalence in the FDA's Office of Generic Drugs conducted a survey of the bioequivalence submissions over a 10-year period (2001-2011) to identify the most commonly occurring bioanalytical deficiencies. Results: Data from a total of 4028 Abbreviated New Drug Application submissions were collected to identify bioanalytical deficiencies. Of the three categories of bioanalytical deficiencies (method, validation and report), the majority of the deficiencies were from the bioanalytical method validation section. Globally, the percentage of bioanalytical method validation deficiencies was 62%. Conclusions: The approval of generic drugs would be accelerated if these deficiencies were avoided by generic companies by adhering to the guidance and therefore submitting a more complete application.
C1 [Williamson, Leah N.; Conner, Dale P.; Stier, Ethan M.] US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Rockville, MD 20852 USA.
[Davit, Barbara M.] Merck Res Labs, Rahway, NJ 07065 USA.
RP Williamson, LN (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, 11919 Rockville Pike, Rockville, MD 20852 USA.
EM leah.williamson@fda.hhs.gov
NR 1
TC 0
Z9 0
U1 2
U2 6
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PD FEB
PY 2014
VL 6
IS 4
BP 441
EP 445
DI 10.4155/bio.13.329
PG 5
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA AC6IY
UT WOS:000332626700009
PM 24568348
ER
PT J
AU Yu, CW
Bashaw, ED
AF Yu, Chongwoo
Bashaw, Edward D.
TI Regulatory perspective of bioana-lysis from a clinical pharmacology
reviewer standpoint: do you see what I see?
SO BIOANALYSIS
LA English
DT Article
ID TESTOSTERONE
AB Clinical pharmacology plays an important role in drug development, including the evaluation of the drugs pharmacokinetics, pharmacodynamics, drug-interaction potential, exposure-response relationship and safety considerations when being used in specific populations. Clinical pharmacology data is pivotal in ensuring the delivery of the right drug, in the right dose, at the right time, to each particular patient and it has significantly influenced the risk/benefit assessment and labeling recommendations. Consequently, the reliability of the bioanalytical methods and data are of considerable importance, and the solid footing in drug development. Documentation of bioanalytical data from method validation or clinical trials is a critical element supporting regulatory submissions such as new drug applications or biologics license applications. Case examples are presented to highlight the utility and importance of bioanalysis in drug development to ensure that drug products are safe, efficacious, and given at the right dose.
C1 [Yu, Chongwoo; Bashaw, Edward D.] US FDA, Div Clin Pharmacol 3, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Yu, CW (reprint author), US FDA, Div Clin Pharmacol 3, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM chongwoo.yu@fda.hhs.gov
NR 8
TC 1
Z9 1
U1 0
U2 3
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PD FEB
PY 2014
VL 6
IS 4
BP 505
EP 510
DI 10.4155/bio.13.334
PG 6
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA AC6IY
UT WOS:000332626700015
PM 24568353
ER
PT J
AU Toro, M
Cao, GJ
Ju, WT
Allard, M
Barrangou, R
Zhao, SH
Brown, E
Meng, JH
AF Toro, Magaly
Cao, Guojie
Ju, Wenting
Allard, Marc
Barrangou, Rodolphe
Zhao, Shaohua
Brown, Eric
Meng, Jianghong
TI Association of Clustered Regularly Interspaced Short Palindromic Repeat
(CRISPR) Elements with Specific Serotypes and Virulence Potential of
Shiga Toxin-Producing Escherichia coli
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID REAL-TIME PCR; CAS SYSTEMS; STREPTOCOCCUS-THERMOPHILUS; ANTIVIRAL
DEFENSE; IMMUNE-SYSTEM; EVOLUTION; RESISTANCE; INTERFERENCE;
PROKARYOTES; STRAINS
AB Shiga toxin-producing Escherichia coli (STEC) strains (n = 194) representing 43 serotypes and E. coli K-12 were examined for clustered regularly interspaced short palindromic repeat (CRISPR) arrays to study genetic relatedness among STEC serotypes. A subset of the strains (n = 81) was further analyzed for subtype I-E cas and virulence genes to determine a possible association of CRISPR elements with potential virulence. Four types of CRISPR arrays were identified. CRISPR1 and CRISPR2 were present in all strains tested; 1 strain also had both CRISPR3 and CRISPR4, whereas 193 strains displayed a short, combined array, CRISPR3-4. A total of 3,353 spacers were identified, representing 528 distinct spacers. The average length of a spacer was 32 bp. Approximately one-half of the spacers (54%) were unique and found mostly in strains of less common serotypes. Overall, CRISPR spacer contents correlated well with STEC serotypes, and identical arrays were shared between strains with the same H type (O26:H11, O103:H11, and O111:H11). There was no association identified between the presence of subtype I-E cas and virulence genes, but the total number of spacers had a negative correlation with potential pathogenicity (P < 0.05). Fewer spacers were found in strains that had a greater probability of causing outbreaks and disease than in those with lower virulence potential (P < 0.05). The relationship between the CRISPR-cas system and potential virulence needs to be determined on a broader scale, and the biological link will need to be established.
C1 [Toro, Magaly; Cao, Guojie; Ju, Wenting; Meng, Jianghong] Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
[Toro, Magaly; Cao, Guojie; Meng, Jianghong] Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
[Allard, Marc; Brown, Eric] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
[Barrangou, Rodolphe] N Carolina State Univ, Dept Food Bioproc & Nutr Sci, Raleigh, NC 27695 USA.
[Zhao, Shaohua] US FDA, Ctr Vet Med, Laurel, MD USA.
RP Meng, JH (reprint author), Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
EM jmeng@umd.edu
RI Toro, Magaly/F-6525-2011; Barrangou, Rodolphe/I-2878-2014
OI Toro, Magaly/0000-0002-6280-2215; Barrangou,
Rodolphe/0000-0002-0648-3504
NR 45
TC 16
Z9 16
U1 0
U2 19
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
EI 1098-5336
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD FEB
PY 2014
VL 80
IS 4
BP 1411
EP 1420
DI 10.1128/AEM.03018-13
PG 10
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA AB2LV
UT WOS:000331625100021
PM 24334663
ER
PT J
AU Napier, ID
Simon, L
Perry, D
Cooke, PS
Stocco, DM
Sepehr, E
Doerge, DR
Kemppainen, BW
Morrison, EE
Akingbemi, BT
AF Napier, India D.
Simon, Liz
Perry, Devin
Cooke, Paul S.
Stocco, Douglas M.
Sepehr, Estatira
Doerge, Daniel R.
Kemppainen, Barbara W.
Morrison, Edward E.
Akingbemi, Benson T.
TI Testicular Development in Male Rats Is Sensitive to a Soy-Based Diet in
the Neonatal Period
SO BIOLOGY OF REPRODUCTION
LA English
DT Article
DE androgen; androgens/androgen receptor; daidzein; endocrine disruptors;
genistein; Leydig cells; phytoestrogen; sex steroids; testis; toxicology
ID SPRAGUE-DAWLEY RATS; ANTI-MULLERIAN HORMONE; LEYDIG-CELLS; TESTOSTERONE
LEVELS; BISPHENOL-A; STEROIDOGENIC ENZYMES; LACTATIONAL TRANSFER;
LUTEINIZING-HORMONE; INFANT FORMULA; DEFICIENT MICE
AB Approximately 30% of infants in the United States are exposed to high doses of isoflavones resulting from soy infant formula consumption. Soybeans contain the isoflavones genistin and daidzin, which are hydrolyzed in the gastrointestinal tract to their genistein and daidzein aglycones. Both aglycones possess hormonal activity and may interfere with male reproductive development. Testosterone, which supports male fertility, is mainly produced by testicular Leydig cells. Our previous studies indicated that perinatal exposure of male rats to isoflavones induced proliferative activity in Leydig cells and increased testosterone concentrations into adulthood. However, the relevance of the neonatal period as part of the perinatal window of isoflavone exposure remains to be established. The present study examined the effects of exposure to isoflavones on male offspring of dams maintained on a casein-based control or whole soybean diet in the neonatal period, that is, Days 2 to 21 postpartum. The results showed that the soybean diet stimulated proliferative activity in developing Leydig cells while suppressing their steroidogenic capacity in adulthood. In addition, isoflavone exposure decreased production of anti-Mullerian hormone by Sertoli cells. Similar to our previous in vitro studies of genistein action in Leydig cells, daidzein induced proliferation and interfered with signaling pathways to suppress steroidogenic activity. Overall, the data showed that the neonatal period is a sensitive window of exposure to isoflavones and support the view that both genistein and daidzein are responsible for biological effects associated with soy-based diets.
C1 [Napier, India D.; Perry, Devin; Kemppainen, Barbara W.; Morrison, Edward E.; Akingbemi, Benson T.] Auburn Univ, Dept Anat Physiol & Pharmacol, Auburn, AL 36849 USA.
[Simon, Liz] Louisiana State Univ, Hlth Sci Ctr, Dept Physiol, New Orleans, LA USA.
[Cooke, Paul S.] Univ Florida, Dept Physiol Sci, Gainesville, FL 32610 USA.
[Stocco, Douglas M.] Texas Tech Univ, Hlth Sci Ctr, Dept Cell Biol & Biochem, Lubbock, TX 79409 USA.
[Sepehr, Estatira; Doerge, Daniel R.] Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Akingbemi, BT (reprint author), Auburn Univ, Dept Anat Physiol & Pharmacol, Auburn, AL 36849 USA.
EM akingbt@auburn.edu
FU National Institutes of Health [ES 15886]; Oak Ridge Institute for
Science and Education, administered through an interagency agreement
between the U.S. Department of Energy; U.S. Food and Drug Administration
FX Supported in part by National Institutes of Health grant ES 15886 to
B.T.A. E.S. was supported by a fellowship from the Oak Ridge Institute
for Science and Education, administered through an interagency agreement
between the U.S. Department of Energy and the U.S. Food and Drug
Administration. The views presented in this article do not necessarily
reflect those of the U.S. Food and Drug Administration. Data were
presented in preliminary form at the 46th Annual Meeting of the Society
for the Study of Reproduction, July 31-August 4, 2011, Portland OR.
NR 56
TC 4
Z9 5
U1 2
U2 17
PU SOC STUDY REPRODUCTION
PI MADISON
PA 1691 MONROE ST,SUITE # 3, MADISON, WI 53711-2021 USA
SN 0006-3363
EI 1529-7268
J9 BIOL REPROD
JI Biol. Reprod.
PD FEB
PY 2014
VL 90
IS 2
DI 10.1095/biolreprod.113.113787
PG 12
WC Reproductive Biology
SC Reproductive Biology
GA AC6HO
UT WOS:000332622400008
PM 24451983
ER
PT J
AU Baxi, J
Calhoun, W
Sepah, YJ
Hammer, DX
Ilev, I
Pfefer, TJ
Nguyen, QD
Agrawal, A
AF Baxi, Jigesh
Calhoun, William
Sepah, Yasir Jamal
Hammer, Daniel X.
Ilev, Ilko
Pfefer, T. Joshua
Quan Dong Nguyen
Agrawal, Anant
TI Retina-simulating phantom for optical coherence tomography
SO JOURNAL OF BIOMEDICAL OPTICS
LA English
DT Article
DE phantoms; optical coherence tomography; tissue-mimicking phantoms;
optical coherence tomography measurements
ID OCT DEVICES; MODEL EYE; THICKNESS; PERFORMANCE
AB Optical coherence tomography (OCT) is a rapidly growing imaging modality, particularly in the field of ophthalmology. Accurate early diagnosis of diseases requires consistent and validated imaging performance. In contrast to more well-established medical imaging modalities, no standardized test methods currently exist for OCT quality assurance. We developed a retinal phantom which mimics the thickness and near-infrared optical properties of each anatomical retinal layer as well as the surface topography of the foveal pit. The fabrication process involves layer-by-layer spin coating of nanoparticle-embedded silicone films followed by laser micro-etching to modify the surface topography. The thickness of each layer and dimensions of the foveal pit are measured with high precision. The phantom is embedded into a commercially available, water-filled model eye to simulate ocular dispersion and emmetropic refraction, and for ease of use with clinical OCT systems. The phantom was imaged with research and clinical OCT systems to assess image quality and software accuracy. Our results indicate that this phantom may serve as a useful tool to evaluate and standardize OCT performance. (C) The Authors.
C1 [Baxi, Jigesh; Calhoun, William; Hammer, Daniel X.; Ilev, Ilko; Pfefer, T. Joshua; Agrawal, Anant] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20933 USA.
[Sepah, Yasir Jamal; Quan Dong Nguyen] Johns Hopkins Univ, Sch Med, Wilmer Eye Inst, Retinal Imaging Res & Reading Ctr, Baltimore, MD 21287 USA.
[Sepah, Yasir Jamal; Quan Dong Nguyen] Univ Nebraska Med Ctr, Stanley M Truhlsen Eye Inst, Omaha, NE 68131 USA.
RP Baxi, J (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20933 USA.
EM Jigesh.Baxi@fda.hhs.gov
FU US Food and Drug Administration's Critical Path Initiative
FX The research in this publication was supported by the US Food and Drug
Administration's Critical Path Initiative. The mention of commercial
products, their sources, or their use in connection with material
reported herein is not to be construed as either an actual or implied
endorsement of such products by the Department of Health and Human
Services.
NR 28
TC 14
Z9 15
U1 5
U2 64
PU SPIE-SOC PHOTO-OPTICAL INSTRUMENTATION ENGINEERS
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98225 USA
SN 1083-3668
EI 1560-2281
J9 J BIOMED OPT
JI J. Biomed. Opt.
PD FEB
PY 2014
VL 19
IS 2
AR 021106
DI 10.1117/1.JBO.19.2.021106
PG 8
WC Biochemical Research Methods; Optics; Radiology, Nuclear Medicine &
Medical Imaging
SC Biochemistry & Molecular Biology; Optics; Radiology, Nuclear Medicine &
Medical Imaging
GA AC9CE
UT WOS:000332830900008
PM 24042445
ER
PT J
AU Yu, Y
Fuscoe, JC
Zhao, C
Guo, C
Jia, MW
Qing, T
Bannon, DI
Lancashire, L
Bao, WJ
Du, TT
Luo, H
Su, ZQ
Jones, WD
Moland, CL
Branham, WS
Qian, F
Ning, BT
Li, Y
Hong, HX
Guo, L
Mei, N
Shi, TL
Wang, KY
Wolfinger, RD
Nikolsky, Y
Walker, SJ
Duerksen-Hughes, P
Mason, CE
Tong, WD
Thierry-Mieg, J
Thierry-Mieg, D
Shi, LM
Wang, C
AF Yu, Ying
Fuscoe, James C.
Zhao, Chen
Guo, Chao
Jia, Meiwen
Qing, Tao
Bannon, Desmond I.
Lancashire, Lee
Bao, Wenjun
Du, Tingting
Luo, Heng
Su, Zhenqiang
Jones, Wendell D.
Moland, Carrie L.
Branham, William S.
Qian, Feng
Ning, Baitang
Li, Yan
Hong, Huixiao
Guo, Lei
Mei, Nan
Shi, Tieliu
Wang, Kevin Y.
Wolfinger, Russell D.
Nikolsky, Yuri
Walker, Stephen J.
Duerksen-Hughes, Penelope
Mason, Christopher E.
Tong, Weida
Thierry-Mieg, Jean
Thierry-Mieg, Danielle
Shi, Leming
Wang, Charles
TI A rat RNA-Seq transcriptomic BodyMap across 11 organs and 4
developmental stages
SO NATURE COMMUNICATIONS
LA English
DT Article
ID MOUSE GENE-EXPRESSION; GENOME; LIVER; IDENTIFICATION; INFORMATION;
LANDSCAPE; MODENCODE; ELEMENTS; DATABASE; DISEASE
AB The rat has been used extensively as a model for evaluating chemical toxicities and for understanding drug mechanisms. However, its transcriptome across multiple organs, or developmental stages, has not yet been reported. Here we show, as part of the SEQC consortium efforts, a comprehensive rat transcriptomic BodyMap created by performing RNA-Seq on 320 samples from 11 organs of both sexes of juvenile, adolescent, adult and aged Fischer 344 rats. We catalogue the expression profiles of 40,064 genes, 65,167 transcripts, 31,909 alternatively spliced transcript variants and 2,367 non-coding genes/non-coding RNAs (ncRNAs) annotated in AceView. We find that organ-enriched, differentially expressed genes reflect the known organ-specific biological activities. A large number of transcripts show organ-specific, age-dependent or sex-specific differential expression patterns. We create a web-based, open-access rat BodyMap database of expression profiles with crosslinks to other widely used databases, anticipating that it will serve as a primary resource for biomedical research using the rat model.
C1 [Yu, Ying; Zhao, Chen; Jia, Meiwen; Qing, Tao; Du, Tingting; Luo, Heng; Shi, Leming] Fudan Univ, Sch Life Sci & Pharm, Ctr Pharmacogen, State Key Lab Genet Engn, Shanghai 201203, Peoples R China.
[Yu, Ying; Zhao, Chen; Jia, Meiwen; Qing, Tao; Du, Tingting; Luo, Heng; Shi, Leming] Fudan Univ, Sch Life Sci & Pharm, MOE Key Lab Contemporary Anthropol, Shanghai 201203, Peoples R China.
[Fuscoe, James C.; Su, Zhenqiang; Moland, Carrie L.; Branham, William S.; Qian, Feng; Ning, Baitang; Li, Yan; Hong, Huixiao; Guo, Lei; Mei, Nan; Tong, Weida; Shi, Leming] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 92079 USA.
[Bannon, Desmond I.] Army Inst Publ Hlth, US Army Publ Hlth Command, Aberdeen Proving Ground, MD 21010 USA.
[Lancashire, Lee] IP & Sci Thomson Reuters, London EC1N 8JS, England.
[Bao, Wenjun; Wolfinger, Russell D.] SAS Inst Inc, Cary, NC 27513 USA.
[Jones, Wendell D.] Express Anal Inc, Durham, NC 27713 USA.
[Shi, Tieliu] Coll Life Sci, Ctr Bioinformat, Shanghai 200241, Peoples R China.
[Shi, Tieliu] Coll Life Sci, Inst Biomed Sci, Shanghai 200241, Peoples R China.
[Wang, Kevin Y.] Johns Hopkins Univ, Sch Med, Baltimore, MD 21205 USA.
[Walker, Stephen J.] Wake Forest Univ Hlth Sci, Wake Forest Inst Regenerat Med, Winston Salem, NC 27157 USA.
[Duerksen-Hughes, Penelope] Loma Linda Univ, Sch Med, Dept Basic Sci, Loma Linda, CA 92350 USA.
[Mason, Christopher E.] Cornell Univ, Dept Physiol & Biophys, New York, NY 10021 USA.
[Mason, Christopher E.] Cornell Univ, Inst Computat Biomed, New York, NY 10021 USA.
[Thierry-Mieg, Jean; Thierry-Mieg, Danielle] Natl Inst Hlth, Natl Ctr Biotechnol Informat, Bethesda, MD 20894 USA.
[Shi, Leming] Fudan Zhangjiang Ctr Clin Genom, Shanghai 201203, Peoples R China.
[Shi, Leming] Zhangjiang Ctr Translat Med, Shanghai 201203, Peoples R China.
[Wang, Charles] Loma Linda Univ, Sch Med, Ctr Genom & Div Microbiol Mol Genet, Loma Linda, CA 92350 USA.
RP Wang, C (reprint author), Loma Linda Univ, Sch Med, Ctr Genom & Div Microbiol Mol Genet, Loma Linda, CA 92350 USA.
EM leming.shi@gmail.com; oxwang@gmail.com
RI Guo, Chao/B-2647-2010; mei, nan/E-8915-2011; Luo, Heng/D-3616-2016;
THIERRY-MIEG, Jean/F-1975-2017
OI Guo, Chao/0000-0002-6673-0933; mei, nan/0000-0002-3501-9014; Luo,
Heng/0000-0001-5192-8878; THIERRY-MIEG, Jean/0000-0002-0396-6789
FU US Food and Drug Administrative Agency (FDA); FDA Office of Women's
Health, China's Program of Global Experts; National Institutes of
Health's (NIH) Intramural Research Program; National 973 Key Basic
Research Program of China [2010CB945401]; National Natural Science
Foundation of China [31240038, 31071162]; Science and Technology
Commission of Shanghai Municipality [11DZ2260300]; China's National
Super-computing Center of Tianjin; NIH/NCBI's Supercomputing Center; USA
FDA's Supercomputing Center
FX The views presented in this article do not necessarily reflect current
or future opinion or policy of the US Food and Drug Administration. Any
mention of commercial products is for clarification and not intended as
an endorsement. This work was supported in part by the US Food and Drug
Administrative Agency (FDA), the FDA Office of Women's Health, China's
Program of Global Experts, the National Institutes of Health's (NIH)
Intramural Research Program, the National 973 Key Basic Research Program
of China (2010CB945401), the National Natural Science Foundation of
China (31240038 and 31071162) and the Science and Technology Commission
of Shanghai Municipality (11DZ2260300). We gratefully acknowledge
support by the China's National Super-computing Center of Tianjin, the
NIH/NCBI's Supercomputing Center and the USA FDA's Supercomputing
Center. We also thank Drs. Keely Walker, David Klein, Marina Bessarabova
and Donna Mendrick for critical review of an earlier version of the
manuscript.
NR 43
TC 50
Z9 52
U1 1
U2 39
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 2041-1723
J9 NAT COMMUN
JI Nat. Commun.
PD FEB
PY 2014
VL 5
AR 3230
DI 10.1038/ncomms4230
PG 11
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA AC6WG
UT WOS:000332665700005
PM 24510058
ER
PT J
AU Alam, MM
Bufano, MK
Xu, P
Kalsy, A
Yu, Y
Freeman, YW
Sultana, T
Rashu, MR
Desai, I
Eckhoff, G
Leung, DT
Charles, RC
LaRocque, RC
Harris, JB
Clements, JD
Calderwood, SB
Qadri, F
Vann, WF
Kovac, P
Ryan, ET
AF Alam, Mohammad Murshid
Bufano, Megan Kelly
Xu, Peng
Kalsy, Anuj
Yu, Y.
Freeman, Y. Wu
Sultana, Tania
Rashu, Md. Rasheduzzaman
Desai, Ishaan
Eckhoff, Grace
Leung, Daniel T.
Charles, Richelle C.
LaRocque, Regina C.
Harris, Jason B.
Clements, John D.
Calderwood, Stephen B.
Qadri, Firdausi
Vann, W. F.
Kovac, Pavol
Ryan, Edward T.
TI Evaluation in Mice of a Conjugate Vaccine for Cholera Made from Vibrio
cholerae O1 (Ogawa) O-Specific Polysaccharide
SO PLOS NEGLECTED TROPICAL DISEASES
LA English
DT Article
ID MEMORY B-CELL; INFECTION-DERIVED IMMUNITY; ORAL KILLED CHOLERA; FREE
MOUSE MODEL; ANTIBODY-RESPONSES; SEROTYPE OGAWA; DETOXIFIED
LIPOPOLYSACCHARIDE; TRANSCUTANEOUS IMMUNIZATION; PROTECTIVE IMMUNITY;
HOUSEHOLD CONTACTS
AB Background Protective immunity against cholera is serogroup specific. Serogroup specificity in Vibrio cholerae is determined by the O-specific polysaccharide (OSP) of lipopolysaccharide (LPS). Generally, polysaccharides are poorly immunogenic, especially in young children.
Methodology Here we report the evaluation in mice of a conjugate vaccine for cholera (OSP:TThc) made from V. cholerae O1 Ogawa O-Specific Polysaccharide-core (OSP) and recombinant tetanus toxoid heavy chain fragment (TThc). We immunized mice intramuscularly on days 0, 21, and 42 with OSP:TThc or OSP only, with or without dmLT, a non-toxigenic immunoadjuvant derived from heat labile toxin of Escherichia coli.
Principal Findings We detected significant serum IgG antibody responses targeting OSP following a single immunization in mice receiving OSP:TThc with or without adjuvant. Anti-LPS IgG responses were detected following a second immunization in these cohorts. No anti-OSP or anti-LPS IgG responses were detected at any time in animals receiving un-conjugated OSP with or without immunoadjuvant, and in animals receiving immunoadjuvant alone. Responses were highest following immunization with adjuvant. Serum anti-OSP IgM responses were detected in mice receiving OSP:TThc with or without immunoadjuvant, and in mice receiving unconjugated OSP. Serum anti-LPS IgM and vibriocidal responses were detected in all vaccine cohorts except in mice receiving immunoadjuvant alone. No significant IgA anti-OSP or anti-LPS responses developed in any group. Administration of OSP:TThc and adjuvant also induced memory B cell responses targeting OSP and resulted in 95% protective efficacy in a mouse lethality cholera challenge model.
Conclusion We describe a protectively immunogenic cholera conjugate in mice. Development of a cholera conjugate vaccine could assist in inducing long-term protective immunity, especially in young children who respond poorly to polysaccharide antigens.
Author Summary Cholera is a severe dehydrating diarrheal illness of humans caused by organisms Vibrio cholerae serogroups O1 or O139 serogroup organisms. Protective immunity against cholera is serogroup specific. Serogroup specificity in V. cholerae is determined by the O-specific polysaccharide (OSP) of lipopolysaccharide (LPS). Generally, polysaccharides are poorly immunogenic, especially in young children. Unfortunately, children bear a large burden of cholera globally. Here we describe a novel cholera conjugate vaccine and show that it induces immune responses in mice, including memory responses, to OSP, the T cell-independent antigen that probably is the target of protective immunity to cholera. These responses were highest following immunization of the vaccine with a novel immunoadjuvant, dmLT. We also show that immunization of mice with this conjugate vaccine protects against challenge with wild-type V. cholerae. A protectively immunogenic cholera conjugate vaccine that induces long-term memory responses could have particular utility in young children who are most at risk of cholera.
C1 [Alam, Mohammad Murshid; Bufano, Megan Kelly; Kalsy, Anuj; Yu, Y.; Freeman, Y. Wu; Sultana, Tania; Rashu, Md. Rasheduzzaman; Desai, Ishaan; Eckhoff, Grace; Leung, Daniel T.; Charles, Richelle C.; LaRocque, Regina C.; Harris, Jason B.; Calderwood, Stephen B.; Ryan, Edward T.] Massachusetts Gen Hosp, Div Infect Dis, Boston, MA 02114 USA.
[Alam, Mohammad Murshid; Sultana, Tania; Rashu, Md. Rasheduzzaman; Leung, Daniel T.; Qadri, Firdausi] ICDDR B, Dhaka, Bangladesh.
[Xu, Peng; Kovac, Pavol] NIDDK, LBC, NIH, Bethesda, MD 20892 USA.
[Leung, Daniel T.; Charles, Richelle C.; LaRocque, Regina C.; Calderwood, Stephen B.; Ryan, Edward T.] Harvard Univ, Sch Med, Dept Med, Boston, MA USA.
[Harris, Jason B.] Harvard Univ, Sch Med, Dept Pediat, Boston, MA 02115 USA.
[Clements, John D.] Tulane Univ, Sch Med, New Orleans, LA 70112 USA.
[Calderwood, Stephen B.] Harvard Univ, Sch Med, Dept Microbiol & Immunol, Boston, MA USA.
[Vann, W. F.] US FDA, CBER, Lab Bacterial Toxins, Bethesda, MD 20014 USA.
[Ryan, Edward T.] Harvard Univ, Sch Publ Hlth, Dept Immunol & Infect Dis, Boston, MA 02115 USA.
RP Alam, MM (reprint author), Massachusetts Gen Hosp, Div Infect Dis, Boston, MA 02114 USA.
EM etryan@partners.org
RI Kovac, Pavol/B-8813-2008; Xu, Peng/K-7036-2012;
OI Kovac, Pavol/0000-0001-5044-3449; leung, daniel/0000-0001-8401-0801
FU icddr,b; Intramural Research Program of the National Institutes of
Health; NIDDK; National Institutes of Health; National Institute of
Allergy & Infectious Diseases [AI077883, AI106878, AI058935]; career
development awards [K08 AI089721, K08 AI100923]; Fogarty International
Center Training Grant in Vaccine Development and Public Health
[TW005572]; FIC Career Development Awards [K01 TW07409, TW07144];
Swedish International Development Cooperation Agency; Howard Hughes
Medical Institute; American Society for Tropical Medicine & Hygiene -
Burroughs Wellcome Fund
FX This research was supported by the icddr,b, by the Intramural Research
Program of the National Institutes of Health, NIDDK, and extramural
grants from the National Institutes of Health, including the National
Institute of Allergy & Infectious Diseases (AI077883, AI106878, AI058935
[SBC, ETR, and FQ], and career development awards K08 AI089721 [RCC] and
K08 AI100923 [DTL]), a Fogarty International Center Training Grant in
Vaccine Development and Public Health (TW005572 [MMA, TS, MRR and FQ]),
FIC Career Development Awards (K01 TW07409 [JBH], TW07144 [RCL]), as
well as by the Swedish International Development Cooperation Agency
(FQ), a Physician Scientist Early Career Award from the Howard Hughes
Medical Institute (RCL), and a Postdoctoral Fellowship in Tropical
Infectious Diseases from the American Society for Tropical Medicine &
Hygiene - Burroughs Wellcome Fund (DTL). The funders had no role in
study design, data collection and analysis, decision to publish, or
preparation of the manuscript.
NR 62
TC 5
Z9 5
U1 1
U2 7
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1935-2735
J9 PLOS NEGLECT TROP D
JI Plos Neglect. Trop. Dis.
PD FEB
PY 2014
VL 8
IS 2
AR e2683
DI 10.1371/journal.pntd.0002683
PG 8
WC Infectious Diseases; Parasitology; Tropical Medicine
SC Infectious Diseases; Parasitology; Tropical Medicine
GA AB8CK
UT WOS:000332017500019
PM 24516685
ER
PT J
AU Gannavaram, S
Davey, S
Lakhal-Naouar, I
Duncan, R
Nakhasi, HL
AF Gannavaram, Sreenivas
Davey, Sonya
Lakhal-Naouar, Ines
Duncan, Robert
Nakhasi, Hira L.
TI Deletion of Ubiquitin Fold Modifier Protein Ufm1 Processing Peptidase
Ufsp in L. donovani Abolishes Ufm1 Processing and Alters Pathogenesis
SO PLOS NEGLECTED TROPICAL DISEASES
LA English
DT Article
ID LEISHMANIA-DONOVANI; PLASMODIUM-FALCIPARUM; VISCERAL LEISHMANIASIS;
TRYPANOSOMA-BRUCEI; IDENTIFICATION; SYSTEM; AMASTIGOTES; NUCLEASE;
ENZYME
AB Previously, we showed Leishmania donovani Ufm1 has a Gly residue conserved at the C-terminal region with a unique 17 amino acid residue extension that must be processed prior to conjugation to target proteins. In this report, we describe for the first time the isolation and characterization of the Leishmania Ufm1-specific protease Ufsp. Biochemical analysis of L. donovani Ufsp showed that this protein possesses the Ufm1 processing activity using sensitive FRET based activity probes. The Ufm1 cleavage activity was absent in a mutant Ufsp in which the active site cysteine is altered to a serine. To examine the effects of abolition of Ufm1 processing activity, we generated a L. donovani null mutant of Ufsp (LdUfsp(-/-)). Ufm1 processing activity was abolished in LdUfsp(-/-) mutant, and the processing defect was reversed by re-expression of wild type but not the cys>ser mutant in the LdUfsp(-/-) parasites. Further LdUfsp(-/-) mutants showed reduced survival as amastigotes in infected human macrophages but not as promastigotes. This growth defect in the amastigotes was reversed by re-expression of wild type but not the cys>ser mutant in the Ufsp(-/-) indicating the essential nature of this protease for Leishmania pathogenesis. Further, mouse infection experiments showed deletion of Ufsp results in reduced virulence of the parasites. Additionally, Ufsp activity was inhibited by an anti-leishmanial drug Amphotericin B. These studies provide an opportunity to test LdUfsp(-/-) parasites as drug and vaccine targets.
Author Summary Ubiquitin and ubiquitin like proteins (Ubls) and the enzymes that mediate the conjugation/deconjugation reactions have not been well studied in protozoan parasites despite their widely recognized importance in a broad range of cellular functions in eukaryotes. We have previously reported that Ufm1 has distinct protein targets and cellular localization in the human parasite Leishmania donovani and deletion of Ufm1 in L. donovani adversely impacts the pathogenesis suggesting that Ufm1 associated enzymes could be exploited as drug targets. Using sensitive FRET based activity probes we identified the Ufm1 processing peptidase Ufsp in L. donovani. In addition, we show that deletion of Ufsp specifically reduces the survival of amastigotes, the parasite stage that is present in the humans thus altering the pathogenesis. Studies showing inhibition of Ufsp activity by anti-leishmanial drug further suggests that Leishmania Ufsp can serve as a novel target for pharmacological intervention for this parasite that causes deadly disease.
C1 [Gannavaram, Sreenivas; Davey, Sonya; Lakhal-Naouar, Ines; Duncan, Robert; Nakhasi, Hira L.] US FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Gannavaram, S (reprint author), US FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
EM sreenivas.gannavaram@fda.hhs.gov; hira.nakhasi@fda.hhs.gov
NR 37
TC 5
Z9 6
U1 0
U2 5
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1935-2735
J9 PLOS NEGLECT TROP D
JI Plos Neglect. Trop. Dis.
PD FEB
PY 2014
VL 8
IS 2
AR e2707
DI 10.1371/journal.pntd.0002707
PG 12
WC Infectious Diseases; Parasitology; Tropical Medicine
SC Infectious Diseases; Parasitology; Tropical Medicine
GA AB8CK
UT WOS:000332017500008
PM 24587462
ER
PT J
AU Chamani, A
Mehta, HP
McDermott, MK
Djeffal, M
Nayyar, G
Patwardhan, DV
Attaluri, A
Topoleski, LDT
Zhu, L
AF Chamani, Alireza
Mehta, Hitesh P.
McDermott, Martin K.
Djeffal, Manel
Nayyar, Gaurav
Patwardhan, Dinesh V.
Attaluri, Anilchandra
Topoleski, L. D. Timmie
Zhu, Liang
TI Theoretical Simulation of Temperature Elevations in a Joint Wear
Simulator During Rotations
SO JOURNAL OF BIOMECHANICAL ENGINEERING-TRANSACTIONS OF THE ASME
LA English
DT Article
DE bioheat transfer; joint simulator; temperature elevations; simulation
ID CROSS-LINKED POLYETHYLENE; TOTAL HIP IMPLANTS; BEARING MATERIALS;
HEAT-GENERATION; FINITE-ELEMENT; LUBRICANT; CUPS; REPLACEMENTS;
ZIRCONIA; BEHAVIOR
AB The objective of this study is to develop a theoretical model to simulate temperature fields in a joint simulator for various bearing conditions using finite element analyses. The frictional heat generation rate at the interface between a moving pin and a stationary base is modeled as a boundary heat source. Both the heat source and the pin are rotating on the base. We are able to conduct a theoretical study to show the feasibility of using the COMSOL software package to simulate heat transfer in a domain with moving components and a moving boundary source term. The finite element model for temperature changes agrees in general trends with experimental data. Heat conduction occurs primarily in the highly conductive base component, and high temperature elevation is confined to the vicinity of the interface in the pin. Thirty rotations of a polyethylene pin on a cobalt-chrome base for 60 s generate more than 2.26 degrees C in the temperature elevation from its initial temperature of 25 degrees C at the interface in a baseline model with a rotation frequency of 0.5 Hz. A higher heat generation rate is the direct result of a faster rotation frequency associated with intensity of exercise, and it results in doubling the temperature elevations when the frequency is increased by100%. Temperature elevations of more than 7.5 degrees C occur at the interface when the friction force is tripled from that in the baseline model. The theoretical modeling approach developed in this study can be used in the future to test different materials, different material compositions, and different heat generation rates at the interface under various body and environmental conditions.
C1 [Chamani, Alireza; Topoleski, L. D. Timmie; Zhu, Liang] Univ Maryland Baltimore Cty, Dept Mech Engn, Baltimore, MD 21250 USA.
[Mehta, Hitesh P.; McDermott, Martin K.; Djeffal, Manel; Nayyar, Gaurav; Patwardhan, Dinesh V.] US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Chem & Mat Sci, Silver Spring, MD 20993 USA.
[Attaluri, Anilchandra] Johns Hopkins Univ, Baltimore, MD 21205 USA.
RP Zhu, L (reprint author), Univ Maryland Baltimore Cty, Dept Mech Engn, Baltimore, MD 21250 USA.
EM zliang@umbc.edu
RI Mehta, Hitesh/I-1393-2013
FU University of Maryland Baltimore County
FX This work was supported by the University of Maryland Baltimore County.
NR 29
TC 0
Z9 0
U1 0
U2 9
PU ASME
PI NEW YORK
PA TWO PARK AVE, NEW YORK, NY 10016-5990 USA
SN 0148-0731
EI 1528-8951
J9 J BIOMECH ENG-T ASME
JI J. Biomech. Eng.-Trans. ASME
PD FEB
PY 2014
VL 136
IS 2
SI SI
AR 021027
DI 10.1115/1.4026158
PG 6
WC Biophysics; Engineering, Biomedical
SC Biophysics; Engineering
GA AC4IE
UT WOS:000332483700027
PM 24317017
ER
PT J
AU Borgert, CJ
Stuchal, LD
Mihaich, EM
Becker, RA
Bentley, KS
Brausch, JM
Coady, K
Geter, DR
Gordon, E
Guiney, PD
Hess, F
Holmes, CM
LeBaron, MJ
Levine, S
Marty, S
Mukhi, S
Neal, BH
Ortego, LS
Saltmiras, DA
Snajdr, S
Staveley, J
Tobia, A
AF Borgert, Christopher J.
Stuchal, Leah D.
Mihaich, Ellen M.
Becker, Richard A.
Bentley, Karin S.
Brausch, John M.
Coady, Katie
Geter, David R.
Gordon, Elliot
Guiney, Patrick D.
Hess, Frederick
Holmes, Catherine M.
LeBaron, Matthew J.
Levine, Steve
Marty, Sue
Mukhi, Sandeep
Neal, Barbara H.
Ortego, Lisa S.
Saltmiras, David A.
Snajdr, Suzanne
Staveley, Jane
Tobia, Abraham
TI Relevance Weighting of Tier 1 Endocrine Screening Endpoints by Rank
Order
SO BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY
LA English
DT Review
DE endocrine disrupters; weight of evidence; endocrine screening;
regulatory toxicology; Endocrine Disruptor Screening Program
ID MINNOW PIMEPHALES-PROMELAS; RAT UTEROTROPHIC BIOASSAY;
STEROID-BIOSYNTHESIS INHIBITORS; AMPHIBIAN METAMORPHOSIS ASSAY;
THYROID-HORMONE ACTION; SPRAGUE-DAWLEY RATS; PLASMA SEX STEROIDS; MYKISS
LIVER-CELLS; FATHEAD MINNOW; IN-VIVO
AB Weight of evidence (WoE) approaches are recommended for interpreting various toxicological data, but few systematic and transparent procedures exist. A hypothesis-based WoE framework was recently published focusing on the U.S. EPA's Tier 1 Endocrine Screening Battery (ESB) as an example. The framework recommends weighting each experimental endpoint according to its relevance for deciding eight hypotheses addressed by the ESB. Here we present detailed rationale for weighting the ESB endpoints according to three rank ordered categories and an interpretive process for using the rankings to reach WoE determinations. Rank 1 was assigned to in vivo endpoints that characterize the fundamental physiological actions for androgen, estrogen, and thyroid activities. Rank 1 endpoints are specific and sensitive for the hypothesis, interpretable without ancillary data, and rarely confounded by artifacts or nonspecific activity. Rank 2 endpoints are specific and interpretable for the hypothesis but less informative than Rank 1, often due to oversensitivity, inclusion of narrowly context-dependent components of the hormonal system (e.g., in vitro endpoints), or confounding by nonspecific activity. Rank 3 endpoints are relevant for the hypothesis but only corroborative of Ranks 1 and 2 endpoints. Rank 3 includes many apical in vivo endpoints that can be affected by systemic toxicity and nonhormonal activity. Although these relevance weight rankings (W-REL) necessarily involve professional judgment, their a priori derivation enhances transparency and renders WoE determinations amenable to methodological scrutiny according to basic scientific premises, characteristics that cannot be assured by processes in which the rationale for decisions is provided post hoc. (C) 2014 Wiley Periodicals, Inc.
C1 [Borgert, Christopher J.] Appl Pharmacol & Toxicol Inc, Gainesville, FL USA.
[Stuchal, Leah D.] Univ Florida, Dept Physiol Sci, CEHT, Gainesville, FL 32610 USA.
[Mihaich, Ellen M.] Environm & Regulatory Resources ER2, Durham, NC USA.
[Becker, Richard A.] Amer Chem Council, Washington, DC USA.
[Bentley, Karin S.; Snajdr, Suzanne] EI Pont Nemours, Wilmington, DE USA.
[Brausch, John M.; Hess, Frederick; Holmes, Catherine M.] BASF Corp, Res Triangle Pk, NC USA.
[Coady, Katie; LeBaron, Matthew J.; Marty, Sue] Dow Chem Co USA, Midland, MI 48674 USA.
[Geter, David R.; Ortego, Lisa S.] Bayer CropSci LP, Res Triangle Pk, NC USA.
[Gordon, Elliot] E Gordon Consulting LLC, Princeton Jct, NJ USA.
[Guiney, Patrick D.] SC Johnson & Son Inc, Racine, WI USA.
[Levine, Steve; Saltmiras, David A.] Monsanto Co, St Louis, MO USA.
[Mukhi, Sandeep] FMC Agr Prod, Ewing, NJ USA.
[Neal, Barbara H.] Exponent, Alexandria, VA USA.
[Staveley, Jane] Exponent, Cary, NC USA.
[Tobia, Abraham] US FDA, Silver Spring, MD USA.
RP Borgert, CJ (reprint author), 2250 NW 24th Ave, Gainesville, FL 32605 USA.
EM cjborgert@apt-pharmatox.com
FU Endocrine Policy Forum
FX Some substances under EPA EDSP Test Orders for endocrine screening are
produced by the authors' employers. This article has been reviewed in
accordance with the peer- and administrative-review policies of the
authors' organizations. The views expressed here are those of the
authors and do not necessarily reflect the opinions and/or policies of
their employers. There are no contractual relations or proprietary
considerations that restrict dissemination of the research findings of
the authors. C.J. Borgert, E. M. Mihaich, and L. D. Stuchal are
independent scientists/consultants who received financial support for
portions of this project from the Endocrine Policy Forum. Time spent by
other co-authors was supported by their respective employers or a
personal contribution.
NR 131
TC 9
Z9 9
U1 4
U2 17
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1542-9733
EI 1542-9741
J9 BIRTH DEFECTS RES B
JI Birth Defects Res. Part B-Dev. Reprod. Toxicol.
PD FEB
PY 2014
VL 101
IS 1
SI SI
BP 90
EP 113
DI 10.1002/bdrb.21096
PG 24
WC Oncology; Genetics & Heredity; Toxicology
SC Oncology; Genetics & Heredity; Toxicology
GA AA8TO
UT WOS:000331368100008
PM 24510745
ER
PT J
AU Fox, WF
Luna, L
Schaur, G
AF Fox, William F.
Luna, LeAnn
Schaur, Georg
TI Destination taxation and evasion: Evidence from US inter-state commodity
flows
SO JOURNAL OF ACCOUNTING & ECONOMICS
LA English
DT Article
DE Taxation; Evasion; Multijurisdictional
ID TAX COMPETITION; BORDER
AB Tax evasion has been an important issue in the accounting literature for several decades. but the focus has been on corporate income taxes. We develop a new way to examine tax evasion that focuses on corporate transactions, rather than corporate profits. Specifically, we examine how commodity flows respond to destination sales taxes, allowing for tax evasion as a function of distance between trade partners. After accounting for transportation costs, we find that the effect of taxes decreases as distance increases. This is consistent with the notion that longer distances between trade partners hinder government oversight and increase the likelihood of successful tax evasion. Our results are robust with respect to outliers, strategic neighbor effects, information sharing agreements and other re-specifications. These results are important to policymakers because they evidence the difficulty of enforcing destination taxation in open economies such as U.S. states and the European Union. (C) 2013 Elsevier B.V. All rights reserved.
C1 [Fox, William F.] Univ Tennessee, Dept Econ, Knoxville, TN 37996 USA.
[Fox, William F.; Luna, LeAnn] 715 Stokely Management Ctr, CBER, Knoxville, TN 37996 USA.
[Luna, LeAnn] Univ Tennessee, Dept Accounting, Knoxville, TN 37996 USA.
[Schaur, Georg] Univ Tennessee, Dept Econ, Stokely Management Center 505A, Knoxville, TN 37996 USA.
RP Luna, L (reprint author), Univ Tennessee, Dept Accounting, Knoxville, TN 37996 USA.
EM billfox@utk.edu; leann@utk.edu; gschaur@utk.edu
NR 26
TC 4
Z9 4
U1 4
U2 30
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0165-4101
EI 1879-1980
J9 J ACCOUNT ECON
JI J. Account. Econ.
PD FEB
PY 2014
VL 57
IS 1
BP 43
EP 57
DI 10.1016/j.jacceco.2013.12.001
PG 15
WC Business, Finance; Economics
SC Business & Economics
GA AC2QQ
UT WOS:000332349400003
ER
PT J
AU Chagas, AC
Oliveira, F
Debrabant, A
Valenzuela, JG
Ribeiro, JMC
Calvo, E
AF Chagas, Andrezza C.
Oliveira, Fabiano
Debrabant, Alain
Valenzuela, Jesus G.
Ribeiro, Jose M. C.
Calvo, Eric
TI Lundep, a Sand Fly Salivary Endonuclease Increases Leishmania Parasite
Survival in Neutrophils and Inhibits XIIa Contact Activation in Human
Plasma
SO PLOS PATHOGENS
LA English
DT Article
ID LUTZOMYIA-LONGIPALPIS; EXTRACELLULAR TRAPS; INFECTION; FLIES; VECTOR;
STREPTOCOCCUS; PROTECTION; MECHANISM; PROTEIN; GLANDS
AB Neutrophils are the host's first line of defense against infections, and their extracellular traps (NET) were recently shown to kill Leishmania parasites. Here we report a NET-destroying molecule (Lundep) from the salivary glands of Lutzomyia longipalpis. Previous analysis of the sialotranscriptome of Lu. longipalpis showed the potential presence of an endonuclease. Indeed, not only was the cloned cDNA (Lundep) shown to encode a highly active ss- and dsDNAse, but also the same activity was demonstrated to be secreted by salivary glands of female Lu. longipalpis. Lundep hydrolyzes both ss- and dsDNA with little sequence specificity with a calculated DNase activity of 300000 Kunitz units per mg of protein. Disruption of PMA (phorbol 12 myristate 13 acetate)- or parasite-induced NETs by treatment with recombinant Lundep or salivary gland homogenates increases parasite survival in neutrophils. Furthermore, co-injection of recombinant Lundep with metacyclic promastigotes significantly exacerbates Leishmania infection in mice when compared with PBS alone or inactive (mutagenized) Lundep. We hypothesize that Lundep helps the parasite to establish an infection by allowing it to escape from the leishmanicidal activity of NETs early after inoculation. Lundep may also assist blood meal intake by lowering the local viscosity caused by the release of host DNA and as an anticoagulant by inhibiting the intrinsic pathway of coagulation.
Author Summary Salivary components from disease vectors help the arthropod to acquire blood. Here we show that an arthropod vector salivary enzyme affects the innate immune system of the hostmainly the destruction of neutrophil trapsallowing the Leishmania parasite to evade the host immune response and to cause an infection. This work highlights the relevance of vector salivary components in parasite transmission and further suggests the inclusion of these proteins as components for an anti-Leishmania vaccine. Importantly, because salivary proteins are always present at the site of natural transmission, this work further encourages the testing of vaccine candidates using the natural route of transmissionthe bites of an arthropod vectorinstead of current practices based solely on needle injection of parasites.
C1 [Chagas, Andrezza C.; Oliveira, Fabiano; Valenzuela, Jesus G.; Ribeiro, Jose M. C.; Calvo, Eric] NIAID, Lab Malaria & Vector Res, NIH, Rockville, MD 20852 USA.
[Debrabant, Alain] US FDA, Ctr Biol Evaluat & Res, Lab Emerging Pathogens, Bethesda, MD USA.
RP Chagas, AC (reprint author), NIAID, Lab Malaria & Vector Res, NIH, Rockville, MD 20852 USA.
EM ecalvo@niaid.nih.gov
RI Oliveira, Fabiano/B-4251-2009; Ribeiro, Jose/J-7011-2015;
OI Oliveira, Fabiano/0000-0002-7924-8038; Calvo, Eric/0000-0001-7880-2730;
Ribeiro, Jose/0000-0002-9107-0818
FU Division of Intramural Research, NIAID, National Institutes of Health
FX This work was funded by the Division of Intramural Research, NIAID,
National Institutes of Health. The funders had no role in study design,
data collection and analysis, decision to publish, or preparation of the
manuscript.
NR 37
TC 17
Z9 17
U1 0
U2 3
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1553-7374
J9 PLOS PATHOG
JI PLoS Pathog.
PD FEB
PY 2014
VL 10
IS 2
AR e1003923
DI 10.1371/journal.ppat.1003923
PG 12
WC Microbiology; Parasitology; Virology
SC Microbiology; Parasitology; Virology
GA AB9CC
UT WOS:000332085900031
PM 24516388
ER
PT J
AU Buxbaum, NP
Farthing, DE
Treadwell, S
Bare, C
Kapoor, V
Telford, W
Gress, R
AF Buxbaum, Nataliya Prokopenko
Farthing, Donald Eugene
Treadwell, Shirin
Bare, Catherine
Kapoor, Veena
Telford, William
Gress, Ronald
TI In Vivo T Regulatory Cell Kinetics Are Altered in a Pre-Clinical Model
of Chronic Graft-Versus-Host Disease
SO BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
LA English
DT Meeting Abstract
CT BMT Tandem Meetings
CY FEB 26-MAR 02, 2014
CL Grapevine, TX
C1 [Buxbaum, Nataliya Prokopenko; Farthing, Donald Eugene; Bare, Catherine; Kapoor, Veena; Telford, William] NCI, ETIB, NIH, Bethesda, MD 20892 USA.
[Treadwell, Shirin] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Gress, Ronald] NCI, Expt Transplantat & Immunol Branch, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1083-8791
EI 1523-6536
J9 BIOL BLOOD MARROW TR
JI Biol. Blood Marrow Transplant.
PD FEB
PY 2014
VL 20
IS 2
SU 1
MA 45
BP S50
EP S51
PG 2
WC Hematology; Immunology; Transplantation
SC Hematology; Immunology; Transplantation
GA AA5QT
UT WOS:000331155400050
ER
PT J
AU Bowyer, JF
Tranter, KM
Sarkar, S
Raymick, J
Hanig, JP
Schmued, LC
AF Bowyer, John F.
Tranter, Karen M.
Sarkar, Sumit
Raymick, James
Hanig, Joseph P.
Schmued, Larry C.
TI Systemic Administration of Fluoro-Gold for the Histological Assessment
of Vascular Structure, Integrity and Damage
SO CURRENT NEUROVASCULAR RESEARCH
LA English
DT Article
DE Fluoro-Gold; Blood-brain barrier; Vascular elements; Hemorrhage;
Kainate; Amphetamine
ID BLOOD-BRAIN-BARRIER; ALZHEIMERS-DISEASE; LONG-TERM; DIABETIC-RATS;
METHAMPHETAMINE; TRACER; COMPLICATIONS; DEGENERATION; MICROVESSELS;
HYPERTHERMIA
AB Fluoro-Gold (F-G) has been used extensively as a fluorescent retrograde neuronal-track tracer in the past. We now report that intraperitoneal administration of 10 to 30 mg/kg of F-G from 30 min to 7 days prior to sacrifice labels vascular endothelial cells of the brain, choroid plexus and meninges and can be used to assess vascular integrity and damage. F-G vascular labeling co-localized with rat endothelial cell antigen (RECA-1) in the membrane. F-G also intensely labeled the nuclei of the endothelial cells, and co-localized with propidium iodide staining of these nuclei. As well, the administration of F-G during neurotoxic insults produced by amphetamine, kainic acid or "penetrating" wound to the brain can detect where vascular leakage/hemorrhage has occurred. Histological methods to detect F-G labeled brain vasculature were performed in the same manner as that used for fluorescent visualization of neuronal elements labeled with F-G after perfusion fixation and coronal sectioning (15 to 40 mu m) of the brain. This in vivo F-G labeling of endothelial cells and their nuclei yields a clear picture of the integrity of the vasculature and can be used to detect changes in structure. Vascular leaks after "penetrating" wounds through the cortex and striatum, hyperthermic amphetamine exposure or excitotoxic kainate exposure were detected by F-G in the extracellular space and via parenchymal F-G subsequently labeling the terminals and neurons adjacent to the lesioned or damaged vasculature. Further studies are necessary to determine the extent of the leakage necessary to detect vasculature damage. Visualization of the F-G labeling of vasculature structure and leakage is compatible with standard fluorescent immuno-labeling methods used to detect the presence and distribution of a protein in histological sections. This method should be directly applicable to studying brain vascular damage that occurs in the progression of Alzheimer's disease, diabetes and for monitoring the brain vascular changes during development.
C1 [Bowyer, John F.; Sarkar, Sumit; Schmued, Larry C.] US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
[Tranter, Karen M.; Raymick, James] Toxicol Pathol Associates, Jefferson, AR 72079 USA.
[Hanig, Joseph P.] FDA Silver Spring, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Bowyer, JF (reprint author), US FDA, Natl Ctr Toxicol Res, 3900 NCTR Rd,HFT 132, Jefferson, AR 72079 USA.
EM john.bowyer@fda.hhs.gov
FU FDA [E7295, E7312, E7519]
FX This study was supported by FDA protocol E7295, E# E7312 and E7519.
NR 30
TC 3
Z9 3
U1 1
U2 7
PU BENTHAM SCIENCE PUBL LTD
PI SHARJAH
PA EXECUTIVE STE Y-2, PO BOX 7917, SAIF ZONE, 1200 BR SHARJAH, U ARAB
EMIRATES
SN 1567-2026
EI 1875-5739
J9 CURR NEUROVASC RES
JI Curr. Neurovasc. Res.
PD FEB
PY 2014
VL 11
IS 1
BP 31
EP 47
DI 10.2174/1567202610666131124235011
PG 17
WC Clinical Neurology; Neurosciences
SC Neurosciences & Neurology
GA AA8XI
UT WOS:000331377900006
PM 24274907
ER
PT J
AU Sarkar, S
Raymick, J
Mann, D
Bowyer, JF
Hanig, JP
Schmued, LC
Paule, MG
Chigurupati, S
AF Sarkar, Sumit
Raymick, James
Mann, Dushyant
Bowyer, John F.
Hanig, Joseph P.
Schmued, Larry C.
Paule, Merle G.
Chigurupati, Srinivasulu
TI Neurovascular Changes in Acute, sub-Acute and Chronic Mouse Models of
Parkinson's Disease
SO CURRENT NEUROVASCULAR RESEARCH
LA English
DT Article
DE Blood-brain barrier; Blood vessel; Endothelial cells; FT-gel; GFAP;
MPTP; NeuN; Parkinson's disease; TH
ID BLOOD-BRAIN-BARRIER; CORTICAL GLUCOSE-METABOLISM; VASCULAR
BASEMENT-MEMBRANE; FLUORO-JADE-C; ALZHEIMERS-DISEASE; OXIDATIVE STRESS;
DOPAMINERGIC NEUROTOXICITY; NEUROTROPHIC FACTOR; ENDOTHELIAL-CELLS;
HIGH-RESOLUTION
AB Although selective neurodegeneration of nigro-striatal dopaminergic neurons is widely accepted as a cause of Parkinson's disease (PD), the role of vascular components in the brain in PD pathology is not well understood. However, the neurodegeneration seen in PD is known to be associated with neuroinflammatory-like changes that can affect or be associated with brain vascular function. Thus, dysfunction of the capillary endothelial cell component of neurovascular units present in the brain may contribute to the damage to dopaminergic neurons that occurs in PD. An animal model of PD employing acute, sub-acute and chronic exposures of mice to methyl-phenyl-tetrahydropyridine (MPTP) was used to determine the extent to which brain vasculature may be damaged in PD. Fluoro-Turquoise gelatin labeling of microvessels and endothelial cells was used to determine the extent of vascular damage produced by MPTP. In addition, tyrosine hydroxylase (TH) and NeuN were employed to detect and quantify dopaminergic neuron damage in the striatum (CPu) and substantia nigra (SNc). Gliosis was evaluated through GFAP immunohistochemistry. MPTP treatment drastically reduced TH immunoreactive neurons in the SNc (20.68+2.83 in acute; 22.98+2.14 in sub-acute; 10.20+2.24 in chronic vs 34.88+/-2.91in controls; p<0.001). Similarly, TH immunoreactive terminals were dramatically reduced in the CPu of MPTP treated mice. Additionally, all three MPTP exposures resulted in a decrease in the intensity, length, and number of vessels in both CPu and SNc. Degenerative vascular changes such as endothelial cell 'clusters' were also observed after MPTP suggesting that vasculature damage may be modifying the availability of nutrients and exposing blood cells and/or toxic substances to neurons and glia. In summary, vascular damage and degeneration could be an additional exacerbating factor in the progression of PD, and therapeutics that protect and insure vascular integrity may be novel treatments for PD.
C1 [Sarkar, Sumit; Bowyer, John F.; Schmued, Larry C.; Paule, Merle G.; Chigurupati, Srinivasulu] US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
Toxicol Pathol Associates, Jefferson, AR 72079 USA.
[Mann, Dushyant] Wayne State Univ, Sch Med, Detroit, MI 48201 USA.
[Hanig, Joseph P.] US FDA, CDER, Off Testing & Res, White Oak, MD 20993 USA.
RP Sarkar, S (reprint author), US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Bldg 53D,HFT 32, Jefferson, AR 72079 USA.
EM Sumit.Sarkar@FDA.hhs.gov
FU National Center for Toxicological Research/FDA [E0751201]
FX This study was supported by the National Center for Toxicological
Research/FDA (E0751201).
NR 80
TC 8
Z9 8
U1 0
U2 6
PU BENTHAM SCIENCE PUBL LTD
PI SHARJAH
PA EXECUTIVE STE Y-2, PO BOX 7917, SAIF ZONE, 1200 BR SHARJAH, U ARAB
EMIRATES
SN 1567-2026
EI 1875-5739
J9 CURR NEUROVASC RES
JI Curr. Neurovasc. Res.
PD FEB
PY 2014
VL 11
IS 1
BP 48
EP 61
DI 10.2174/1567202610666131124234506
PG 14
WC Clinical Neurology; Neurosciences
SC Neurosciences & Neurology
GA AA8XI
UT WOS:000331377900007
PM 24274908
ER
PT J
AU Laughon, MM
Avant, D
Tripathi, N
Hornik, CP
Cohen-Wolkowiez, M
Clark, RH
Smith, B
Rodriguez, W
AF Laughon, Matthew M.
Avant, Debbie
Tripathi, Nidhi
Hornik, Christoph P.
Cohen-Wolkowiez, Michael
Clark, Reese H.
Smith, Brian
Rodriguez, William
TI Drug Labeling and Exposure in Neonates
SO JAMA PEDIATRICS
LA English
DT Article
ID INHALED NITRIC-OXIDE; INTENSIVE-CARE-UNIT; VENTRICULAR TACHYARRHYTHMIA;
GASTROESOPHAGEAL-REFLUX; RANDOMIZED MULTICENTER; PEDIATRIC POPULATION;
PREGNANT-WOMEN; OFF-LABEL; INFANTS; PHARMACOKINETICS
AB IMPORTANCE Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. Neonatal information in labeling is even scarcer because neonates comprise a vulnerable subpopulation for which end-point development is lagging and studies are more challenging.
OBJECTIVE To quantify progress made in neonatal studies and neonatal information in product labeling as a result of recent legislation.
DESIGN, SETTING, AND PARTICIPANTS We identified a cohort of drug studies between 1997 and 2010 that included neonates as a result of pediatric legislation using information available on the FDA website. We determined what studies were published in the medical literature, the legislation responsible for the studies, and the resulting neonatal labeling changes. We then examined the use of these drugs in a cohort of neonates admitted to 290 neonatal intensive care units (NICUs) (the Pediatrix Data Warehouse) in the United States from 2005 to 2010.
EXPOSURE Infants exposed to a drug studied in neonates as identified by the FDA website.
MAIN OUTCOMES AND MEASURES Number of drug studies with neonates and rate of exposure per 1000 admissions among infants admitted to an NICU.
RESULTS In a review of the FDA databases, we identified 28 drugs studied in neonates and 24 related labeling changes. Forty-one studies encompassed the 28 drugs, and 31 (76%) of these were published. Eleven (46%) of the 24 neonatal labeling changes established safety and effectiveness. In a review of a cohort of 446 335 hospitalized infants, we identified 399 drugs used and 1 525 739 drug exposures in the first 28 postnatal days. Thirteen (46%) of the 28 drugs studied in neonates were not used in NICUs; 8 (29%) were used in fewer than 60 neonates. Of the drugs studied, ranitidine was used most often (15 627 neonates, 35 exposures per 1000 admissions).
CONCLUSIONS AND RELEVANCE Few drug labeling changes made under pediatric legislation include neonates. Most drugs studied are either not used or rarely used in US NICUs. Strategies to increase the study of safe and effective drugs for neonates are needed.
C1 [Laughon, Matthew M.] Univ N Carolina, Dept Pediat, Chapel Hill, NC USA.
[Avant, Debbie; Rodriguez, William] Food & Drug Adm, Rockville, MD USA.
[Tripathi, Nidhi; Hornik, Christoph P.; Cohen-Wolkowiez, Michael; Smith, Brian] Duke Clin Res Inst, Durham, NC USA.
[Tripathi, Nidhi; Hornik, Christoph P.; Cohen-Wolkowiez, Michael; Smith, Brian] Duke Univ, Med Ctr, Durham, NC USA.
[Clark, Reese H.] Pediatrix Ctr Res & Educ Sunrise, Sunrise, FL USA.
RP Laughon, MM (reprint author), UNC Hosp, 101 Manning Dr,CB 7596,4th Floor, Chapel Hill, NC 27599 USA.
EM matt_laughon@med.unc.edu
RI Smith, Phillip/I-5565-2014
FU National Institutes of Health [5UL-1RR024128-01, 1K23HD064814]; US
government [HHSN267200700051C]; Eunice Kennedy Shriver National
Institute of Child Health and Human Development [1K23HL092225-01];
Thrasher Research Fund; US Department of Health and Human Services
(Eunice Kennedy Shriver National Institute of Child Health and Human
Development) [1K23HD060040-01]; US Department of Health and Human
Services (Department of Health and Human Services) [1R18AE000028-01]; US
Department of Health and Human Services [HHSN267200700051C]
FX This study used Clinical and Translational Science Award biostatistical
services through the Division of Pediatric Quantitative Sciences
(National Institutes of Health grant 5UL-1RR024128-01). Dr Laughon
receives support from the US government for his work in pediatric and
neonatal clinical pharmacology (government contract HHSN267200700051C,
principal investigator D. K. Benjamin, Jr, MD, PhD, MPH, under the Best
Pharmaceuticals for Children Act) and from Eunice Kennedy Shriver
National Institute of Child Health and Human Development grant
1K23HL092225-01. Dr Cohen-Wolkowiez receives support for research from
National Institutes of Health grant 1K23HD064814 and the nonprofit
organization Thrasher Research Fund (www.thrasherresearch.org). Dr Smith
receives salary support for research from the National Institutes of
Health and the US Department of Health and Human Services (Eunice
Kennedy Shriver National Institute of Child Health and Human Development
grant 1K23HD060040-01, Department of Health and Human Services grant
1R18AE000028-01, and government contract HHSN267200700051C).
NR 43
TC 33
Z9 33
U1 0
U2 6
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 330 N WABASH AVE, STE 39300, CHICAGO, IL 60611-5885 USA
SN 2168-6203
EI 2168-6211
J9 JAMA PEDIATR
JI JAMA Pediatr.
PD FEB
PY 2014
VL 168
IS 2
BP 130
EP 136
DI 10.1001/jamapediatrics.2013.4208
PG 7
WC Pediatrics
SC Pediatrics
GA AA8TD
UT WOS:000331366900010
PM 24322269
ER
PT J
AU Samala, RK
Chan, HP
Lu, Y
Hadjiiski, L
Wei, J
Sahiner, B
Helvie, MA
AF Samala, Ravi K.
Chan, Heang-Ping
Lu, Yao
Hadjiiski, Lubomir
Wei, Jun
Sahiner, Berkman
Helvie, Mark A.
TI Computer-aided detection of clustered microcalcifications in multiscale
bilateral filtering regularized reconstructed digital breast
tomosynthesis volume
SO MEDICAL PHYSICS
LA English
DT Article
DE digital breast tomosynthesis; computer-aided detection;
microcalcification; multiscale enhancement; regularized reconstruction
ID INITIAL-EXPERIENCE; MAMMOGRAPHY; CLASSIFICATION; PERFORMANCE; OBSERVER;
CALCIFICATIONS; POPULATION; VISIBILITY; PARAMETERS; PARADIGM
AB Purpose: Develop a computer-aided detection (CADe) system for clustered microcalcifications in digital breast tomosynthesis (DBT) volume enhanced with multiscale bilateral filtering (MSBF) regularization.
Methods: With Institutional Review Board approval and written informed consent, two-view DBT of 154 breasts, of which 116 had biopsy-proven microcalcification (MC) clusters and 38 were free of MCs, was imaged with a General Electric GEN2 prototype DBT system. The DBT volumes were reconstructed with MSBF-regularized simultaneous algebraic reconstruction technique (SART) that was designed to enhance MCs and reduce background noise while preserving the quality of other tissue structures. The contrast-to-noise ratio (CNR) of MCs was further improved with enhancement-modulated calcification response (EMCR) preprocessing, which combined multiscale Hessian response to enhance MCs by shape and bandpass filtering to remove the low-frequency structured background. MC candidates were then located in the EMCR volume using iterative thresholding and segmented by adaptive region growing. Two sets of potential MC objects, cluster centroid objects and MC seed objects, were generated and the CNR of each object was calculated. The number of candidates in each set was controlled based on the breast volume. Dynamic clustering around the centroid objects grouped the MC candidates to form clusters. Adaptive criteria were designed to reduce false positive (FP) clusters based on the size, CNR values and the number of MCs in the cluster, cluster shape, and cluster based maximum intensity projection. Free-response receiver operating characteristic (FROC) and jackknife alternative FROC (JAFROC) analyses were used to assess the performance and compare with that of a previous study.
Results: Unpaired two-tailed t-test showed a significant increase (p < 0.0001) in the ratio of CNRs for MCs with and without MSBF regularization compared to similar ratios for FPs. For view-based detection, a sensitivity of 85% was achieved at an FP rate of 2.16 per DBT volume. For case-based detection, a sensitivity of 85% was achieved at an FP rate of 0.85 per DBT volume. JAFROC analysis showed a significant improvement in the performance of the current CADe system compared to that of our previous system (p = 0.003).
Conclusions: MBSF regularized SART reconstruction enhances MCs. The enhancement in the signals, in combination with properly designed adaptive threshold criteria, effective MC feature analysis, and false positive reduction techniques, leads to a significant improvement in the detection of clustered MCs in DBT. (C) 2014 American Association of Physicists in Medicine.
C1 [Samala, Ravi K.; Chan, Heang-Ping; Lu, Yao; Hadjiiski, Lubomir; Wei, Jun; Helvie, Mark A.] Univ Michigan, Dept Radiol, Ann Arbor, MI 48109 USA.
[Sahiner, Berkman] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Samala, RK (reprint author), Univ Michigan, Dept Radiol, Ann Arbor, MI 48109 USA.
EM rsamala@umich.edu
OI Samala, Ravi/0000-0002-6661-4801
FU USPHS [RO1 CA151443]; University of Michigan investigators, through the
Biomedical Research Partnership (USPHS) [CA91713]
FX This work is supported by USPHS Grant No. RO1 CA151443. The digital
breast tomosynthesis system was developed by the GE Global Research
Group, with input and some revisions from the University of Michigan
investigators, through the Biomedical Research Partnership (USPHS Grant
No. CA91713, PI: Paul Carson, Ph.D.) collaboration. The content of this
paper does not necessarily reflect the position of the funding agencies
and no official endorsement of any equipment and product of any
companies mentioned should be inferred.
NR 31
TC 16
Z9 16
U1 2
U2 11
PU AMER ASSOC PHYSICISTS MEDICINE AMER INST PHYSICS
PI MELVILLE
PA STE 1 NO 1, 2 HUNTINGTON QUADRANGLE, MELVILLE, NY 11747-4502 USA
SN 0094-2405
J9 MED PHYS
JI Med. Phys.
PD FEB
PY 2014
VL 41
IS 2
AR 021901
DI 10.1118/1.4860955
PG 14
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA AA6MV
UT WOS:000331213300034
PM 24506622
ER
PT J
AU Kim, IW
Han, N
Burckart, GJ
Oh, JM
AF Kim, In-Wha
Han, Nayoung
Burckart, Gilbert J.
Oh, Jung Mi
TI Epigenetic Changes in Gene Expression for Drug-Metabolizing Enzymes and
Transporters
SO PHARMACOTHERAPY
LA English
DT Article
DE pharmacoepigenetics; personalized medicine; drug metabolism; DNA
methylation; histone modification
ID TUMOR-SPECIFIC EXPRESSION; ACUTE MYELOID-LEUKEMIA; HUMAN
PROSTATE-CANCER; PREGNANE X RECEPTOR; DNA METHYLATION; PROMOTER REGION;
MULTIDRUG-RESISTANCE; MESSENGER-RNA; INTERINDIVIDUAL DIFFERENCES; ABCG2
EXPRESSION
AB Individual differences in drug response can be caused by genetic and epigenetic variability and disease determinants. Pharmacoepigenetics is a new field that studies the expression changes in pharmacogenes without changes in DNA sequences. Epigenetic control mechanisms are associated with DNA methylation, histone modification, small noncoding RNAs, and nucleosome remodeling. Researchers are actively attempting to identify epigenetic mechanisms for controlling the expression of enzymes and transporters affecting the metabolism and disposition of drugs. Current evidence suggests that epigenetic changes play a major role in cytochrome P450 enzyme expression, major transporter function, and in interactions with nuclear receptors. A thorough understanding of pharmacoepigenetics provides insight into new approaches to drug discovery and development, provides an understanding of previously observed actions of older drugs, and provides a pathway by which epigenetics can be harnessed to provide better patient-specific therapy.
C1 [Kim, In-Wha; Han, Nayoung; Oh, Jung Mi] Seoul Natl Univ, Coll Pharm, Seoul 151742, South Korea.
[Kim, In-Wha; Han, Nayoung; Oh, Jung Mi] Seoul Natl Univ, Pharmaceut Sci Res Inst, Seoul 151742, South Korea.
[Burckart, Gilbert J.] US FDA, Ctr Drug Evaluat & Res, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD USA.
RP Oh, JM (reprint author), Seoul Natl Univ, Coll Pharm, 1 Gwanak Ro, Seoul 151742, South Korea.
EM jmoh@snu.ac.kr
FU National Research Foundation of Korea; Korean government Ministry of
Science, ICT, and Future Planning [NRF-2009-00081414]
FX inferred. This work was supported by the National Research Foundation of
Korea grant, funded by the Korean government Ministry of Science, ICT,
and Future Planning (no. NRF-2009-00081414).
NR 79
TC 14
Z9 15
U1 0
U2 22
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0277-0008
EI 1875-9114
J9 PHARMACOTHERAPY
JI Pharmacotherapy
PD FEB
PY 2014
VL 34
IS 2
BP 140
EP 150
DI 10.1002/phar.1362
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA AA6HH
UT WOS:000331198900008
PM 24166985
ER
PT J
AU Mustonen, PSJ
Oelbermann, M
Kass, DCL
AF Mustonen, P. S. Jorge
Oelbermann, M.
Kass, D. C. L.
TI Response of the common bean (Phaseolus vulgaris L.) to Tithonia
diversifolia (Hamsl.) Gray biomass retention or removal in a slash and
mulch agroforestry system
SO AGROFORESTRY SYSTEMS
LA English
DT Article
DE Chirripo Rojo; Mycorrhiza; Negro Huasteco; Phosphorus; Root
characteristics; Shoot characteristics
ID SOIL CHEMICAL-PROPERTIES; PHOSPHORUS ACQUISITION; FALLOW SYSTEMS; GREEN
MANURES; WESTERN KENYA; FERTILITY; MAIZE; PLANT; ROOT; CAPACITY
AB The addition of mulch biomass from Tithonia diversifolia (Hemsl.) Gray prior to seeding may improve bean production. We evaluated the response of two Costa Rican bean cultivars (Chirripo Rojo, Negro Huasetco) to the retention or removal of T. diversifolia biomass with respect to soil chemical characteristics, and bean biomass, nutrient content, root architecture, and fungal structures. There were no significant differences (p < 0.05) between bean cultivars and their influence on soil characteristics. Soil pH, Ca and Mg were significantly lower (p < 0.05) at bean harvest in both biomass removal and retention treatments compared to those at the time of bean sowing, whereas exchangeable acidity was significantly greater (p < 0.05) at bean harvest. Bean shoot nutrient concentration differed significantly between cultivars but not between biomass retention or removal treatments except for Mg. Pod, leaf and stem biomass, root characteristics, and the number of root fungal structures (entry points, vesicles, arbuscules) were significantly different (p < 0.05) between bean cultivars and mulch biomass treatments. Results showed that T. diversifolia biomass positively influenced bean shoot and root characteristics, and suggested that the addition of mulch may have added relatively large quantities of P and K to the soil and stimulated the uptake of these nutrients.
C1 [Mustonen, P. S. Jorge] Jorge & Mustonen SRL, Dept Agron, Santo Domingo, Dominican Rep.
[Oelbermann, M.] Univ Waterloo, Dept Environm & Resource Studies, Waterloo, ON N2L 3G1, Canada.
[Kass, D. C. L.] US FDA, Northeast Reg Lab, Jamaica, NY USA.
RP Oelbermann, M (reprint author), Univ Waterloo, Dept Environm & Resource Studies, Waterloo, ON N2L 3G1, Canada.
EM compay1_rd@hotmail.com; moelbermann@uwaterloo.ca; dclk9@hotmail.com
OI Oelbermann, Maren/0000-0003-0996-4140
NR 37
TC 1
Z9 2
U1 2
U2 27
PU SPRINGER
PI DORDRECHT
PA VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS
SN 0167-4366
EI 1572-9680
J9 AGROFOREST SYST
JI Agrofor. Syst.
PD FEB
PY 2014
VL 88
IS 1
BP 1
EP 10
DI 10.1007/s10457-013-9650-9
PG 10
WC Agronomy; Forestry
SC Agriculture; Forestry
GA AA0FW
UT WOS:000330772000001
ER
PT J
AU Major, JM
Sargent, JD
Graubard, BI
Carlos, HA
Hollenbeck, AR
Altekruse, SF
Freedman, ND
McGlynn, KA
AF Major, Jacqueline M.
Sargent, James D.
Graubard, Barry I.
Carlos, Heather A.
Hollenbeck, Albert R.
Altekruse, Sean F.
Freedman, Neal D.
McGlynn, Katherine A.
TI Local geographic variation in chronic liver disease and hepatocellular
carcinoma: contributions of socioeconomic deprivation, alcohol retail
outlets, and lifestyle
SO ANNALS OF EPIDEMIOLOGY
LA English
DT Article
DE Neighborhood; Socioeconomic disparities; Health care; Liver cancer;
Liver disease; Cohort; Kernel density estimation; Multilevel; Census
ID UNITED-STATES; RACIAL DISPARITY; SURVIVAL; ASSOCIATION; MORTALITY;
HEALTH; RISK
AB Purpose: Hepatocellular carcinoma (HCC) incidence rates continue to increase in the United States. Geographic variation in rates suggests a potential contribution of area-based factors, such as neighborhood socioeconomic deprivation, retail alcohol availability, and access to health care.
Methods: Using the National Institutes of Health-American Association of Retired Persons Diet and Health Study, we prospectively examined area socioeconomic variations in HCC incidence (n = 434 cases) and chronic liver disease (CLD) mortality (n = 805 deaths) and assessed contribution of alcohol outlet density, health care infrastructure, diabetes, obesity, and health behaviors. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated from hierarchical Cox regression models.
Results: Area socioeconomic deprivation was associated with increased risk of HCC incidence and CLD mortality (HR, 1.48; 95% CI, 1.03-2.14 and HR, 2.36; 95% CI, 1.79-3.11, respectively) after accounting for age, sex, and race. After additionally accounting for educational attainment and health risk factors, associations for HCC incidence were no longer significant; associations for CLD mortality remained significant (HR, 1.78; 95% CI, 1.34-2.36). Socioeconomic status differences in alcohol outlet density and health behaviors explained the largest proportion of socioeconomic status-CLD mortality association, 10% and 29%, respectively. No associations with health care infrastructure were observed.
Conclusions: Our results suggest a greater effect of area-based factors for CLD than HCC. Personal risk factors accounted for the largest proportion of variance for HCC but not for CLD mortality. Published by Elsevier Inc.
C1 [Major, Jacqueline M.; Graubard, Barry I.; Freedman, Neal D.; McGlynn, Katherine A.] NCI, Div Canc Epidemiol & Genet, Bethesda, MD 20892 USA.
[Major, Jacqueline M.] US FDA, Off Surveillance & Epidemiol, Silver Spring, MD 20993 USA.
[Sargent, James D.; Carlos, Heather A.] Dartmouth Coll, Norris Cotton Canc Ctr, Canc Control Res Program, Lebanon, NH 03756 USA.
[Hollenbeck, Albert R.] AARP, Washington, DC USA.
[Altekruse, Sean F.] NCI, Div Canc Control & Populat Sci, Bethesda, MD 20892 USA.
RP Major, JM (reprint author), US FDA, Div Epidemiol, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM jacqueline.major@fda.hhs.gov
RI Freedman, Neal/B-9741-2015
OI Freedman, Neal/0000-0003-0074-1098
FU Intramural Research Program of the National Institutes of Health,
National Cancer Institute
FX This research was supported in part by the Intramural Research Program
of the National Institutes of Health, National Cancer Institute. Cancer
incidence data from the Atlanta metropolitan area were collected by the
Georgia Center for Cancer Statistics, Department of Epidemiology,
Rollins School of Public Health, Emory University. Cancer incidence data
from California were collected by the California Department of Health
Services, Cancer Surveillance Section. Cancer incidence data from the
Detroit metropolitan area were collected by the Michigan Cancer
Surveillance Program, Community Health Administration, State of
Michigan. The Florida cancer incidence data used in this report were
collected by the Florida Cancer Data System under contract with the
Florida Department of Health. The views expressed herein are solely
those of the authors and do not necessarily reflect those of the Florida
Cancer Data System or Florida Department of Health. Cancer incidence
data from Louisiana were collected by the Louisiana Tumor Registry,
Louisiana State University Medical Center in New Orleans. Cancer
incidence data from New Jersey were collected by the New Jersey State
Cancer Registry, Cancer Epidemiology Services, New Jersey State
Department of Health and Senior Services. Cancer incidence data from
North Carolina were collected by the North Carolina Central Cancer
Registry. Cancer incidence data from Pennsylvania were supplied by the
Division of Health Statistics and Research, Pennsylvania Department of
Health, Harrisburg, Pennsylvania. The Pennsylvania Department of Health
specifically disclaims responsibility for any analyses, interpretations,
or conclusions. Cancer incidence data from Arizona were collected by the
Arizona Cancer Registry, Division of Public Health Services, Arizona
Department of Health Services. Cancer incidence data from Texas were
collected by the Texas Cancer Registry, Cancer Epidemiology and
Surveillance Branch, Texas Department of State Health Services. Cancer
incidence data from Nevada were collected by the Nevada Central Cancer
Registry, Center for Health Data and Research, Bureau of Health Planning
and Statistics, State Health Division, State of Nevada Department of
Health and Human Services. We are indebted to the participants in the
NIH-AARP Diet and Health Study for their outstanding cooperation. The
views expressed in this manuscript do not necessarily represent those of
the Department of Health and Human Services or the U.S. Food and Drug
Administration.
NR 33
TC 8
Z9 8
U1 1
U2 8
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1047-2797
EI 1873-2585
J9 ANN EPIDEMIOL
JI Ann. Epidemiol.
PD FEB
PY 2014
VL 24
IS 2
BP 104
EP 110
DI 10.1016/j.annepidem.2013.11.006
PG 7
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA AA2GO
UT WOS:000330913300004
PM 24332863
ER
PT J
AU Hong, HX
Tong, WD
AF Hong, Huixiao
Tong, Weida
TI Emerging efforts for discovering new biomarkers of liver disease and
hepatotoxicity
SO BIOMARKERS IN MEDICINE
LA English
DT Editorial Material
DE biomarkers; discovery; hepatotoxicity; liver disease
ID MICRORNAS; INJURY; CANCER
C1 [Hong, Huixiao; Tong, Weida] US FDA, Natl Ctr Toxicol Res, Div Bioinformat & Biostat, Jefferson, AR 72079 USA.
RP Hong, HX (reprint author), US FDA, Natl Ctr Toxicol Res, Div Bioinformat & Biostat, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM huixiao.hong@fda.hhs.gov; weida.tong@fda.hhs.gov
NR 17
TC 7
Z9 7
U1 0
U2 2
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1752-0363
EI 1752-0371
J9 BIOMARK MED
JI Biomark. Med.
PD FEB
PY 2014
VL 8
IS 2
BP 143
EP 146
DI 10.2217/bmm.13.156
PG 4
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AA6MM
UT WOS:000331212400001
PM 24521010
ER
PT J
AU Bhattacharyya, S
Yan, K
Pence, L
Simpson, PM
Gill, P
Letzig, LG
Beger, RD
Sullivan, JE
Kearns, GL
Reed, MD
Marshall, JD
Van Den Anker, JN
James, LP
AF Bhattacharyya, Sudeepa
Yan, Ke
Pence, Lisa
Simpson, Pippa M.
Gill, Pritmohinder
Letzig, Lynda G.
Beger, Richard D.
Sullivan, Janice E.
Kearns, Gregory L.
Reed, Michael D.
Marshall, James D.
Van Den Anker, John N.
James, Laura P.
TI Targeted liquid chromatography-mass spectrometry analysis of serum
acylcarnitines in acetaminophen toxicity in children
SO BIOMARKERS IN MEDICINE
LA English
DT Article
DE -oxidation; acetaminophen; acylcarnitine; biomarker; clinical; hepatic;
toxicity
ID ACUTE LIVER-FAILURE; INDUCED HEPATIC-NECROSIS; PROTEIN ADDUCTS; INDUCED
HEPATOTOXICITY; MICE; CLOFIBRATE; METABOLISM; OVERDOSE; METABOLOMICS;
MULTICENTER
AB Aim: Long-chain acylcarnitines have been postulated to be sensitive biomarkers of acetaminophen (APAP)-induced hepatotoxicity in mouse models. In the following study, the relationship of acylcarnitines with other known indicators of APAP toxicity was examined in children receiving low-dose (therapeutic) and high-dose (overdose' or toxic ingestion) exposure to APAP. Materials & methods: The study included three subject groups: group A (therapeutic dose, n = 187); group B (healthy controls, n = 23); and group C (overdose, n = 62). Demographic, clinical and laboratory data were collected for each subject. Serum samples were used for measurement of APAP protein adducts, a biomarker of the oxidative metabolism of APAP and for targeted metabolomics analysis of serum acylcarnitines using ultra performance liquid chromatography-triple-quadrupole mass spectrometry. Results: Significant increases in oleoyl- and palmitoyl-carnitines were observed with APAP exposure (low dose and overdose) compared with controls. Significant increases in serum ALT, APAP protein adducts and acylcarnitines were observed in overdose children that received delayed treatment (time to treatment from overdose >24 h) with the antidote N-acetylcysteine. Time to peak APAP protein adducts in serum was shorter than that of the acylcarnitines and serum ALT. Conclusion: Perturbations in long-chain acylcarnitines in children with APAP toxicity suggest that mitochrondrial injury and associated impairment in the -oxidation of fatty acids are clinically relevant as biomarkers of APAP toxicity.
C1 [Bhattacharyya, Sudeepa; Gill, Pritmohinder; Letzig, Lynda G.; James, Laura P.] Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR 72202 USA.
[Bhattacharyya, Sudeepa; Gill, Pritmohinder; Letzig, Lynda G.; James, Laura P.] Arkansas Childrens Hosp, Res Inst, Little Rock, AR 72202 USA.
[Yan, Ke; Simpson, Pippa M.] Med Coll Wisconsin, Milwaukee, WI 53226 USA.
[Pence, Lisa; Beger, Richard D.] US FDA, Natl Ctr Toxicol Res, Div Syst Biol, Jefferson, AR 72079 USA.
[Sullivan, Janice E.] Univ Louisville, Kosair Char Pediat Clin Res Unit, Dept Pediat, Louisville, KY 40202 USA.
[Sullivan, Janice E.] Univ Louisville, Kosair Char Pediat Clin Res Unit, Dept Pharmacol & Toxicol, Louisville, KY 40202 USA.
[Sullivan, Janice E.] Kosair Childrens Hosp, Louisville, KY 40202 USA.
[Kearns, Gregory L.] Childrens Mercy Hosp, Div Pediat Pharmacol Med Toxicol & Therapeut Inno, Kansas City, MO 64108 USA.
[Reed, Michael D.] Northeast Ohio Med Univ, Dept Pediat, Div Clin Pharmacol & Toxicol, Akron, OH 44038 USA.
[Reed, Michael D.] Akron Childrens Hosp, Rebecca D Considine Res Inst, Akron, OH 44308 USA.
[Marshall, James D.] Childrens Hlth Care Syst, Ft Worth, TX 76104 USA.
[Van Den Anker, John N.] Childrens Natl Med Ctr, Div Pediat Clin Pharmacol, Washington, DC 20010 USA.
[James, Laura P.] Univ Arkansas Med Sci, Dept Pharmacol, Little Rock, AR 72205 USA.
[James, Laura P.] Univ Arkansas Med Sci, Dept Toxicol, Little Rock, AR 72205 USA.
RP James, LP (reprint author), Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR 72202 USA.
EM jameslaurap@uams.edu
FU National Institutes of Diabetes, Digestive and Kidney Diseases [R01
DK75936]; Arkansas Biosciences Institute; Arkansas Tobacco Settlement
Funds
FX This work was funded in part by a grant (R01 DK75936 to LP James) from
the National Institutes of Diabetes, Digestive and Kidney Diseases and
the Arkansas Biosciences Institute, which is funded by Arkansas Tobacco
Settlement Funds. LP James is part owner of Acetaminophen Toxicity
Diagnostics, LLC and has a patent pending for the development of a
commercial assay for measurement of acetaminophen protein adducts. The
authors have no other relevant affiliations or financial involvement
with any organization or entity with a financial interest in or
financial conflict with the subject matter or materials discussed in the
manuscript apart from those disclosed.
NR 32
TC 13
Z9 13
U1 1
U2 18
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1752-0363
EI 1752-0371
J9 BIOMARK MED
JI Biomark. Med.
PD FEB
PY 2014
VL 8
IS 2
BP 147
EP 159
DI 10.2217/bmm.13.150
PG 13
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AA6MM
UT WOS:000331212400002
PM 24521011
ER
PT J
AU Wang, YP
Chen, T
Tong, WD
AF Wang, Yuping
Chen, Tao
Tong, Weida
TI miRNAs and their application in drug-induced liver injury
SO BIOMARKERS IN MEDICINE
LA English
DT Review
DE drug-induced liver injury; microRNA; translational biomarkers
ID MAMMALIAN MICRORNA TARGETS; CIRCULATING MICRORNAS; HUMAN-DISEASE;
GENE-EXPRESSION; KIDNEY-DISEASE; BREAST-CANCER; BODY-FLUIDS; BIOMARKERS;
PLASMA; RNA
AB The complex miRNA regulatory network plays an important role in diverse biological activities of physiopathological processes. In addition to the discovery of and research on the extracellular miRNAs detected in multiple biofluids, the properties of tissue specificity and high stability underlie the great potential of these small miRNAs to serve as translational biomarkers for various diseases in the clinical setting, including in drug-induced liver injury. In this review, we describe the major technologies currently used and challenges in miRNA measurement and provide information on major bioinformatics resources available for current miRNA research. We also discuss novel findings in liver disease and highlight the potential of miRNAs for clinical and basic research as translational biomarkers for drug-induced liver injury.
C1 [Wang, Yuping; Tong, Weida] US FDA, Natl Ctr Toxicol Res, Div Bioinformat & Biostat, Jefferson, AR 72079 USA.
[Chen, Tao] US FDA, Natl Ctr Toxicol Res, Div Genet & Mol Toxicol, Jefferson, AR 72079 USA.
RP Tong, WD (reprint author), US FDA, Natl Ctr Toxicol Res, Div Bioinformat & Biostat, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM weida.tong@fda.hhs.gov
NR 102
TC 9
Z9 9
U1 0
U2 13
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1752-0363
EI 1752-0371
J9 BIOMARK MED
JI Biomark. Med.
PD FEB
PY 2014
VL 8
IS 2
BP 161
EP 172
DI 10.2217/bmm.13.147
PG 12
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AA6MM
UT WOS:000331212400003
PM 24521012
ER
PT J
AU Chen, MJ
Bisgin, H
Tong, L
Hong, HX
Fang, H
Borlak, J
Tong, WD
AF Chen, Minjun
Bisgin, Halil
Tong, Lillian
Hong, Huixiao
Fang, Hong
Borlak, Juergen
Tong, Weida
TI Toward predictive models for drug-induced liver injury in humans: are we
there yet?
SO BIOMARKERS IN MEDICINE
LA English
DT Article
DE biomarker; drug label; drug safety; drug-induced liver injury;
predictive model
ID IN-SILICO MODELS; HUMAN HEPATOTOXICITY; HUMAN PHARMACOKINETICS;
TOXICITY; ASSAY; QSAR; TOXICOGENOMICS; CLASSIFICATION; DISCOVERY; SAFETY
AB Drug-induced liver injury (DILI) is a frequent cause for the termination of drug development programs and a leading reason of drug withdrawal from the marketplace. Unfortunately, the current preclinical testing strategies, including the regulatory-required animal toxicity studies or simple in vitro tests, are insufficiently powered to predict DILI in patients reliably. Notably, the limited predictive power of such testing strategies is mostly attributed to the complex nature of DILI, a poor understanding of its mechanism, a scarcity of human hepatotoxicity data and inadequate bioinformatics capabilities. With the advent of high-content screening assays, toxicogenomics and bioinformatics, multiple end points can be studied simultaneously to improve prediction of clinically relevant DILIs. This review focuses on the current state of efforts in developing predictive models from diverse data sources for potential use in detecting human hepatotoxicity, and also aims to provide perspectives on how to further improve DILI prediction.
C1 [Chen, Minjun; Bisgin, Halil; Tong, Lillian; Hong, Huixiao; Tong, Weida] US FDA, Natl Ctr Toxicol Res, Div Bioinformat & Biostat, Jefferson, AR 72079 USA.
[Tong, Lillian] CALTECH, Div Biol & Biol Engn, Pasadena, CA 91125 USA.
[Fang, Hong] US FDA, Natl Ctr Toxicol Res, Off Sci Coordinat, Jefferson, AR 72079 USA.
[Borlak, Juergen] Hannover Med Sch, Ctr Pharmacol & Toxicol, Hannover, Germany.
RP Tong, WD (reprint author), US FDA, Natl Ctr Toxicol Res, Div Bioinformat & Biostat, Jefferson, AR 72079 USA.
EM weida.tong@fda.hhs.gov
FU German Federal Ministry of Education and Research as part of the Virtual
Liver Network initiative [031 6154]; ORISE of the US FDA
FX J Borlak receives funding from the German Federal Ministry of Education
and Research as part of the Virtual Liver Network initiative (grant
number 031 6154). J Borlak is recipient of an ORISE stipend of the US
FDA, which is gratefully acknowledged. The authors have no other
relevant affiliations or financial involvement with any organization or
entity with a financial interest in or financial conflict with the
subject matter or materials discussed in the manuscript apart from those
disclosed.
NR 92
TC 33
Z9 36
U1 4
U2 17
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1752-0363
EI 1752-0371
J9 BIOMARK MED
JI Biomark. Med.
PD FEB
PY 2014
VL 8
IS 2
BP 201
EP 213
DI 10.2217/bmm.13.146
PG 13
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AA6MM
UT WOS:000331212400006
PM 24521015
ER
PT J
AU Kugelman, JR
Johnston, SC
Mulembakani, PM
Kisalu, N
Lee, MS
Koroleva, G
McCarthy, SE
Gestole, MC
Wolfe, ND
Fair, JN
Schneider, BS
Wright, LL
Huggins, J
Whitehouse, CA
Wemakoy, EO
Muyembe-Tamfum, JJ
Hensley, LE
Palacios, GF
Rimoin, AW
AF Kugelman, Jeffrey R.
Johnston, Sara C.
Mulembakani, Prime M.
Kisalu, Neville
Lee, Michael S.
Koroleva, Galina
McCarthy, Sarah E.
Gestole, Marie C.
Wolfe, Nathan D.
Fair, Joseph N.
Schneider, Bradley S.
Wright, Linda L.
Huggins, John
Whitehouse, Chris A.
Wemakoy, Emile Okitolonda
Muyembe-Tamfum, Jean Jacques
Hensley, Lisa E.
Palacios, Gustavo F.
Rimoin, Anne W.
TI Genomic Variability of Monkeypox Virus among Humans, Democratic Republic
of the Congo
SO EMERGING INFECTIOUS DISEASES
LA English
DT Article
ID ROCHE LIGHTCYCLER; SMALLPOX; INFECTION; TRANSMISSION; POXVIRUSES;
SQUIRRELS; EVOLUTION; OUTBREAK; SEQUENCE; ECOLOGY
AB Monkeypox virus is a zoonotic virus endemic to Central Africa. Although active disease surveillance has assessed monkeypox disease prevalence and geographic range, information about virus diversity is lacking. We therefore assessed genome diversity of viruses in 60 samples obtained from humans with primary and secondary cases of infection from 2005 through 2007. We detected 4 distinct lineages and a deletion that resulted in gene loss in 10 (16.7%) samples and that seemed to correlate with human-to-human transmission (p = 0.0544). The data suggest a high frequency of spillover events from the pool of viruses in nonhuman animals, active selection through genomic destabilization and gene loss, and increased disease transmissibility and severity. The potential for accelerated adaptation to humans should be monitored through improved surveillance.
C1 [Kugelman, Jeffrey R.] US Army Med Res Inst Infect Dis, Ctr Genome Sci, Ft Detrick, MD USA.
[Johnston, Sara C.; Lee, Michael S.; Koroleva, Galina; McCarthy, Sarah E.; Gestole, Marie C.; Huggins, John; Whitehouse, Chris A.; Palacios, Gustavo F.] US Army Med Res Inst Infect Dis, Ft Detrick, MD USA.
[Mulembakani, Prime M.; Wemakoy, Emile Okitolonda] Kinshasa Sch Publ Hlth, Kinshasa, Zaire.
[Kisalu, Neville; Rimoin, Anne W.] Univ Calif Los Angeles, Los Angeles, CA 90024 USA.
[Wolfe, Nathan D.; Fair, Joseph N.; Schneider, Bradley S.] Global Viral Forecasting, San Francisco, CA USA.
[Wright, Linda L.] Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, Bethesda, MD USA.
[Muyembe-Tamfum, Jean Jacques] Natl Inst Biomed Res, Kinshasa, Zaire.
[Hensley, Lisa E.] US FDA, Silver Spring, MD USA.
RP Rimoin, AW (reprint author), Univ Calif Los Angeles, Fielding Sch Publ Hlth, Dept Epidemiol, 640 Charles E Young Dr S, Los Angeles, CA 90024 USA.
EM gustavo.f.palacios.ctr@us.army.mil; arimoin@ucla.edu
RI Palacios, Gustavo/I-7773-2015;
OI Palacios, Gustavo/0000-0001-5062-1938; Schneider, Bradley
S/0000-0001-7642-0018
FU Defense Threat Reduction Agency [1881290]; Metabiota; US Department of
Defense Armed Forces Health Surveillance Center, Division of Global
Emerging Infections, Surveillance Operations; Henry M. Jackson
Foundation for the Advancement of Military Medicine; Defense Threat
Reduction Agency Cooperative Biological Engagement Program; Google.org;
Skoll Foundation; US Agency for International Development Emerging
Pandemic Threats Program, PREDICT project [GHN-A-OO-09-00010-00]
FX This work was funded by the Defense Threat Reduction Agency Project no.
1881290. The sample collection and epidemiologic study was partially
financed by Metabiota, whose contribution was supported by the US
Department of Defense Armed Forces Health Surveillance Center, Division
of Global Emerging Infections, Surveillance Operations; the Henry M.
Jackson Foundation for the Advancement of Military Medicine; the Defense
Threat Reduction Agency Cooperative Biological Engagement Program;
Google.org; the Skoll Foundation; and the US Agency for International
Development Emerging Pandemic Threats Program, PREDICT project, under
the terms of cooperative agreement no. GHN-A-OO-09-00010-00.
NR 40
TC 9
Z9 9
U1 1
U2 10
PU CENTERS DISEASE CONTROL
PI ATLANTA
PA 1600 CLIFTON RD, ATLANTA, GA 30333 USA
SN 1080-6040
EI 1080-6059
J9 EMERG INFECT DIS
JI Emerg. Infect. Dis
PD FEB
PY 2014
VL 20
IS 2
BP 232
EP 239
DI 10.3201/eid2002.130118
PG 8
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 301TA
UT WOS:000330553800008
PM 24457084
ER
PT J
AU Muindi, KM
McCarthy, PC
Wang, T
Vionnet, J
Battistel, M
Jankowska, E
Vann, WF
AF Muindi, Karen M.
McCarthy, Pumtiwitt C.
Wang, Theresa
Vionnet, Justine
Battistel, Marcos
Jankowska, Ewa
Vann, Willie F.
TI Characterization of the meningococcal serogroup X capsule
N-acetylglucosamine-1-phosphotransferase
SO GLYCOBIOLOGY
LA English
DT Article
ID CONJUGATE VACCINE; MENINGITIDIS; POLYSIALYLTRANSFERASE; PURIFICATION;
TRANSFERASE; ANTIGENS; SUBUNIT; DISEASE; MOTIFS
AB Neisseria meningitidis serogroups A, B, C, Y, W135 and X are responsible for most cases of meningococcal meningitis. Neisseria meningitidis serogroup X has recently emerged as a contributor to outbreaks of disease in Africa, but there is currently no vaccine against serogroup X. Understanding of the biosynthesis of the serogroup X capsular polysaccharide would provide useful tools for vaccine production. The serogroup X polysaccharide is a homopolymer of (alpha 1 -> 4)-linked N-acetylglucosamine (GlcNAc)-1-phosphate. It has been shown that the gene cluster xcbABC encodes synthesis of this polysaccharide. The xcbA gene product has significant homology with sacB, which is responsible for synthesis of the Neisseria serogroup A capsular polysaccharide, an (alpha 1 -> 6)-N-acetylmannosamine-1-phosphate homopolymer. The xcbA protein also shares homology with the catalytic domain of human N-acetylglucosamine-1-phosphoryltransferase, a key enzyme in the mannose-6-phosphate receptor pathway. In this study, we show that xcbA in the appropriate background is sufficient for the synthesis of N. meningitidis serogroup X polysaccharide. By ELISA we detected polysaccharide in fractions of Escherichia coli expressing the xcbA gene. We isolated polysaccharide from an E. coli strain expressing XcbA and demonstrated that this polysaccharide has a C-13-NMR spectrum identical to that of polysaccharide isolated from N. meningitidis Group X. We also demonstrate that the purified XcbA protein is an N-acetylglucosamine-1-phosphotransferase that transfers N-acetylglucosamine-1-phosphate from UDP-GlcNAc to the 4-hydroxyl of an N-acetylglucosamine-1-phosphate oligosaccharide. Oligosaccharides fluorescently labeled at the aglycon are extended by XcbA only after the 4-phosphate occupying the non-reducing GlcNAc has been removed. The minimum size of fluorescent acceptors is a trisaccharide.
C1 [Muindi, Karen M.; McCarthy, Pumtiwitt C.; Wang, Theresa; Vionnet, Justine; Battistel, Marcos; Jankowska, Ewa; Vann, Willie F.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Vann, WF (reprint author), US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM willie.vann@fda.hhs.gov
FU CRADA
FX This work was partially supported by a CRADA between the Food and Drug
Administration and the Program for Appropriate Technology in
Health-PATH.
NR 28
TC 4
Z9 4
U1 2
U2 11
PU OXFORD UNIV PRESS INC
PI CARY
PA JOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA
SN 0959-6658
EI 1460-2423
J9 GLYCOBIOLOGY
JI Glycobiology
PD FEB
PY 2014
VL 24
IS 2
BP 139
EP 149
DI 10.1093/glycob/cwt091
PG 11
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA AA1EM
UT WOS:000330839300003
PM 24134880
ER
PT J
AU Harris, M
Bhuvaneshwar, K
Natarajan, T
Sheahan, L
Wang, DF
Tadesse, MG
Shoulson, I
Filice, R
Steadman, K
Pishvaian, MJ
Madhavan, S
Deeken, J
AF Harris, Michael
Bhuvaneshwar, Krithika
Natarajan, Thanemozhi
Sheahan, Laura
Wang, Difei
Tadesse, Mahlet G.
Shoulson, Ira
Filice, Ross
Steadman, Kenneth
Pishvaian, Michael J.
Madhavan, Subha
Deeken, John
TI Pharmacogenomic characterization of gemcitabine response - a framework
for data integration to enable personalized medicine
SO PHARMACOGENETICS AND GENOMICS
LA English
DT Article
DE DMET; gemcitabine; NCI-60; pancreatic cancer; probabilistic networks
ID SINGLE-NUCLEOTIDE POLYMORPHISMS; GENOME-WIDE ASSOCIATION; PREGNANE-X
RECEPTOR; PANCREATIC-CANCER; BAYESIAN NETWORKS; GENE-EXPRESSION;
FUNCTIONAL-ANALYSIS; CYTIDINE DEAMINASE; HUMAN HEPATOCYTES; TARGET GENES
AB ObjectivesResponse to the oncology drug gemcitabine may be variable in part due to genetic differences in the enzymes and transporters responsible for its metabolism and disposition. The aim of our in-silico study was to identify gene variants significantly associated with gemcitabine response that may help to personalize treatment in the clinic.MethodsWe analyzed two independent data sets: (a) genotype data from NCI-60 cell lines using the Affymetrix DMET 1.0 platform combined with gemcitabine cytotoxicity data in those cell lines, and (b) genome-wide association studies (GWAS) data from 351 pancreatic cancer patients treated on an NCI-sponsored phase III clinical trial. We also performed a subset analysis on the GWAS data set for 135 patients who were given gemcitabine+placebo. Statistical and systems biology analyses were performed on each individual data set to identify biomarkers significantly associated with gemcitabine response.ResultsGenetic variants in the ABC transporters (ABCC1, ABCC4) and the CYP4 family members CYP4F8 and CYP4F12, CHST3, and PPARD were found to be significant in both the NCI-60 and GWAS data sets. We report significant association between drug response and variants within members of the chondroitin sulfotransferase family (CHST) whose role in gemcitabine response is yet to be delineated.ConclusionBiomarkers identified in this integrative analysis may contribute insights into gemcitabine response variability. As genotype data become more readily available, similar studies can be conducted to gain insights into drug response mechanisms and to facilitate clinical trial design and regulatory reviews. (C) 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.
C1 [Harris, Michael; Bhuvaneshwar, Krithika; Natarajan, Thanemozhi; Sheahan, Laura; Wang, Difei; Madhavan, Subha] Georgetown Univ, Med Ctr, Innovat Ctr Biomed Informat, Washington, DC 20007 USA.
[Harris, Michael; Steadman, Kenneth; Pishvaian, Michael J.; Madhavan, Subha; Deeken, John] Georgetown Univ, Med Ctr, Dev Therapeut Program, Lombardi Comprehens Canc Ctr, Washington, DC 20007 USA.
[Shoulson, Ira] Georgetown Univ, Med Ctr, Dept Neurol, Washington, DC 20007 USA.
[Tadesse, Mahlet G.] Georgetown Univ, Dept Math & Stat, Washington, DC 20007 USA.
[Sheahan, Laura] ESAC Inc, Rockville, MD USA.
[Filice, Ross] US FDA, Silver Spring, MD USA.
RP Madhavan, S (reprint author), Georgetown Univ, Med Ctr, Innovat Ctr Biomed Informat, 2115 Wisconsin Ave NW,Suite 110, Washington, DC 20007 USA.
EM sm696@georgetown.edu
RI Wang, Difei/E-7066-2010
FU FDA Centers of Excellence in Regulatory Science and Innovation (CER-SI)
[FDA U01 FD004319]; National Cancer Institute [P30CA051008]
FX This work was supported, in part, by the FDA Centers of Excellence in
Regulatory Science and Innovation (CER-SI) (FDA U01 FD004319), and by
the National Cancer Institute (P30CA051008). The content is solely the
responsibility of the authors and does not necessarily represent the
official views of the FDA, the National Cancer Institute, or the
National Institutes of Health. Support for research computing resources
was provided by the Amazon Corporation.
NR 77
TC 4
Z9 6
U1 0
U2 7
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1744-6872
EI 1744-6880
J9 PHARMACOGENET GENOM
JI Pharmacogenet. Genomics
PD FEB
PY 2014
VL 24
IS 2
BP 81
EP 93
DI 10.1097/FPC.0000000000000015
PG 13
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Pharmacology
& Pharmacy
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Pharmacology
& Pharmacy
GA AA1TT
UT WOS:000330879300001
PM 24401833
ER
PT J
AU Chen, S
Xuan, JK
Wan, LQ
Lin, HX
Couch, L
Mei, N
Dobrovolsky, VN
Guo, L
AF Chen, Si
Xuan, Jiekun
Wan, Liqing
Lin, Haixia
Couch, Letha
Mei, Nan
Dobrovolsky, Vasily N.
Guo, Lei
TI Sertraline, an Antidepressant, Induces Apoptosis in Hepatic Cells
Through the Mitogen-Activated Protein Kinase Pathway
SO TOXICOLOGICAL SCIENCES
LA English
DT Article
DE sertraline; liver toxicity; mitochondrial dysfunction; apoptosis; cell
death; MAPK pathway
ID SEROTONIN REUPTAKE INHIBITORS; GENE-EXPRESSION CHANGES; LIVER HEPG2
CELLS; OF-THE-LITERATURE; C-JUN; MAP KINASE; MITOCHONDRIAL DYSFUNCTION;
TRICYCLIC ANTIDEPRESSANTS; INDUCED CYTOTOXICITY; CASPASE-3 PATHWAYS
AB Sertraline is generally used for the treatment of depression and is also approved for the treatment of panic, obsessive-compulsive, and posttraumatic stress disorders. Previously, using rat primary hepatocytes and isolated mitochondria, we demonstrated that sertraline caused hepatic cytotoxicity and mitochondrial impairment. In the current study, we investigated and characterized molecular mechanisms of sertraline toxicity in human hepatoma HepG2 cells. Sertraline decreased cell viability and induced apoptosis in a dose- and time-dependent manner. Sertraline activated the intrinsic checkpoint protein caspase-9 and caused the release of cytochrome c from mitochondria to cytosol; this process was Bcl-2 family dependent because antiapoptotic Bcl-2 family proteins were decreased. Pretreatment of the HepG2 cells with caspase-3, caspase-8, and caspase-9 inhibitors partially but significantly reduced the release of lactate dehydrogenase, indicating that sertraline-induced apoptosis is mediated by both intrinsic and extrinsic apoptotic pathways. Moreover, sertraline markedly increased the expression of tumor necrosis factor (TNF) and the phosphorylation of JNK, extracellular signal-regulated kinase (ERK1/2), and p38. In sertraline-treated cells, the induction of apoptosis and cell death was shown to be the result of activation of JNK, but not ERK1/2 or p38 in the mitogen-activated protein kinase (MAPK) pathway. Furthermore, silencing MAP4K4, the upstream kinase of JNK, attenuated both apoptosis and cell death caused by sertraline. Taken together, our findings suggest that sertraline induced apoptosis in HepG2 cells at least partially via activation of the TNF-MAP4K4-JNK cascade signaling pathway.
C1 [Chen, Si; Xuan, Jiekun; Wan, Liqing; Couch, Letha; Guo, Lei] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Wan, Liqing] Shanghai Inst Food & Drug Control, Shanghai 201203, Peoples R China.
[Lin, Haixia; Mei, Nan; Dobrovolsky, Vasily N.] US FDA, Div Genet & Mol Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Guo, L (reprint author), US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, 3900 NCTR Rd,HFT-110, Jefferson, AR 72079 USA.
EM lei.guo@fda.hhs.gov
RI mei, nan/E-8915-2011; Lin, Haixia /J-4772-2015
OI mei, nan/0000-0002-3501-9014;
FU U.S. FDA's International Scientist Exchange Program
FX S.C., J.X., and H.L. were supported by appointments to the Postgraduate
Research Program at the National Center for Toxicological Research
administered by the Oak Ridge Institute for Science Education through an
interagency agreement between the U.S. Department of Energy and the U.S.
FDA. L.W. was supported by the U.S. FDA's International Scientist
Exchange Program.
NR 62
TC 14
Z9 14
U1 0
U2 7
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1096-6080
EI 1096-0929
J9 TOXICOL SCI
JI Toxicol. Sci.
PD FEB
PY 2014
VL 137
IS 2
BP 404
EP 415
DI 10.1093/toxsci/kft254
PG 12
WC Toxicology
SC Toxicology
GA AA2RU
UT WOS:000330942600011
PM 24194395
ER
PT J
AU Menis, M
Anderson, SA
Forshee, RA
McKean, S
Johnson, C
Holness, L
Warnock, R
Gondalia, R
Worrall, CM
Kelman, JA
Ball, R
Izurieta, HS
AF Menis, M.
Anderson, S. A.
Forshee, R. A.
McKean, S.
Johnson, C.
Holness, L.
Warnock, R.
Gondalia, R.
Worrall, C. M.
Kelman, J. A.
Ball, R.
Izurieta, H. S.
TI Transfusion-associated circulatory overload (TACO) and potential risk
factors among the inpatient US elderly as recorded in Medicare
administrative databases during 2011
SO VOX SANGUINIS
LA English
DT Article
DE Transfusion-Associated Circulatory Overload; risk factors; inpatient
elderly; Medicare administrative databases
ID ACUTE LUNG INJURY; PULMONARY-EDEMA
AB Background and Objectives Transfusion-associated circulatory overload (TACO) is a serious transfusion complication resulting in respiratory distress. The study's objective was to assess TACO occurrence and potential risk factors among elderly Medicare beneficiaries (ages 65 and older) in the inpatient setting during 2011.
Materials and Methods This retrospective claims-based study utilized Medicare administrative databases in coordination with Centers for Medicare & Medicaid Services. Transfusions were identified by recorded procedure and revenue centre codes, while TACO was ascertained via ICD-9-CM diagnosis code. We evaluated TACO diagnosis code rates overall and by age, gender, race, number of units and blood components transfused. Multivariate logistic regression analyses were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs).
Results Among 2147038 inpatient transfusion stays for elderly in 2011, 1340 had TACO diagnosis code, overall rate of 624 per 100000 stays. TACO rates increased significantly with age and units transfused (P<00001). After adjustment for confounding, significantly higher odds of TACO were found for women vs. men (OR=140, 95% CI 126-160), White people vs. non-White people (OR=138, 95% CI 120-162) and persons with congestive heart failure (OR=161, 95% CI 144-188), chronic pulmonary disease (OR=119, 95% CI 108-132) and different anaemias.
Conclusion Our study identified largest number of potential TACO cases to date and showed a substantial increase in TACO occurrence with age and number of units transfused. The study suggested increased TACO risk in elderly with congestive heart failure, chronic pulmonary disease and anaemias. Overall, study shows importance of large administrative databases as an additional epidemiological tool.
C1 [Menis, M.; Anderson, S. A.; Forshee, R. A.; Holness, L.; Ball, R.; Izurieta, H. S.] US FDA, Rockville, MD 20852 USA.
[McKean, S.; Johnson, C.; Warnock, R.; Gondalia, R.] Acumen LLC, Burlingame, CA USA.
[Worrall, C. M.; Kelman, J. A.] Ctr Medicare & Medicaid Serv, Baltimore, MD USA.
RP Menis, M (reprint author), US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, 1401 Rockville Pike,HFM 225, Rockville, MD 20852 USA.
EM mikhail.menis@fda.hhs.gov
FU US Food and Drug Administration, Center for Biologics Evaluation and
Research
FX This study was funded by the US Food and Drug Administration, Center for
Biologics Evaluation and Research. We thank Garner Kropp and Emily Wang
for their contribution during the initial stages of study analyses. All
authors made substantial contributions to research design, or the
acquisition, analysis or interpretation of data and were involved in
drafting of the paper or revising it critically. The manuscript has been
approved by all authors.
NR 27
TC 13
Z9 13
U1 0
U2 0
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0042-9007
EI 1423-0410
J9 VOX SANG
JI Vox Sang.
PD FEB
PY 2014
VL 106
IS 2
BP 144
EP 152
DI 10.1111/vox.12070
PG 9
WC Hematology
SC Hematology
GA AA4SL
UT WOS:000331086300007
PM 23848234
ER
PT J
AU Clarke, IC
Lazennec, JY
Brusson, A
Savisaar, C
Bowsher, JG
Burgett, M
Donaldson, TK
AF Clarke, Ian C.
Lazennec, Jean-Yves
Brusson, Adrien
Savisaar, Christina
Bowsher, John G.
Burgett, Michelle
Donaldson, Thomas K.
TI Risk of Impingement and Third-body Abrasion With 28-mm Metal-on-metal
Bearings
SO CLINICAL ORTHOPAEDICS AND RELATED RESEARCH
LA English
DT Article; Proceedings Paper
CT Open Scientific Meeting of the Hip-Society in Conjunction with the
Annual Meeting of the American-Academy-of-Orthopaedic-Surgeons (AAOS)
CY 2013
CL Chicago, IL
SP Hip Soc, Amer Acad Orthopaed Surg
ID TOTAL HIP-REPLACEMENT; CERAMIC FEMORAL HEADS; LONG-TERM WEAR; ACETABULAR
COMPONENT; ARTICULAR SURFACE; LINER IMPINGEMENT; EARLY OSTEOLYSIS; EARLY
FAILURE; ION LEVELS; ALUMINA
AB Concerns have been raised about the sequelae of metal-on-metal (MoM) bearings in total hip arthroplasty (THA). However, retrieval studies, which offer the best insight into the clinically relevant mechanisms of MoM wear, have followed predictable trends to date such as indicting cobalt-chromium (CoCr) metallurgy, cup design, high conformity between the head and cup, "steep cups," "microseparation," and "edge wear."
We wished to evaluate a set of retrieved 28-mm MoM THA for signs of (1) cup-to-stem impingement; (2) normal wear pattern and concomitant stripe damage on femoral heads that would signify adverse wear mechanics; and (3) well-defined evidence of third-body scratches on bearings that would indicate large abrasive particles had circulated the joint space.
Ten 28-mm MOM retrievals were selected on the basis that femoral stems were included. Revision surgeries at 3 to 8 years were for pain, osteolysis, and cup loosening. CoCr stems and the MoM bearings were produced by one vendor and Ti6Al4V stems by a second vendor. All but two cases had been fixed with bone cement. We looked for patterns of normal wear and impingement signs on femoral necks and cup rims. We looked for adverse wear defined as stripe damage that was visually apparent on each bearing. Wear patterns were examined microscopically to determine the nature of abrasions and signs of metal transfer. Graphical models recreated femoral neck and cup designs to precisely correlate impingement sites on femoral necks to cup positions and head stripe patterns.
The evidence revealed that all CoCr cup liners had impinged on either anterior or posterior facets of femoral necks. Liner impingement at the most proximal neck notch occurred with the head well located and impingement at the distal notch occurred with the head rotated 5 mm out of the cup. The hip gained 20A degrees motion by such a subluxation maneuver with this THA design. All heads had stripe wear, the basal and polar stripes coinciding with cup impingement sites. Analysis of stripe damage revealed 40 to 100-mu m wide scratches created by large particles ploughing across bearing surfaces. The association of stripe wear with evidence of neck notching implicated impingement as the root cause, the outcome being the aggressive third-body wear.
We found consistent evidence of impingement, abnormal stripe damage, and evidence of third-body abrasive wear in a small sample of one type of 28-mm MoM design. Impingement models demonstrated that 28-mm heads could lever 20A degrees out of the liners. Although other studies continue to show good success with 28-mm MoM bearings, their use has been discontinued at La Pitie Hospital.
Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
C1 [Clarke, Ian C.] Loma Linda Univ, Dept Orthopaed, Loma Linda, CA 92350 USA.
[Clarke, Ian C.; Burgett, Michelle] DARF Ctr, Colton, CA 92324 USA.
[Lazennec, Jean-Yves; Brusson, Adrien] UPMC Univ, Dept Orthopaed, La Pitie Hosp, Paris, France.
[Savisaar, Christina; Bowsher, John G.] US FDA, Silver Spring, MD USA.
[Donaldson, Thomas K.] Empire Orthoped, Colton, CA USA.
RP Clarke, IC (reprint author), DARF Ctr, 900E Washington St 200, Colton, CA 92324 USA.
EM hipgeek5@yahoo.com
NR 80
TC 5
Z9 5
U1 0
U2 5
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 0009-921X
EI 1528-1132
J9 CLIN ORTHOP RELAT R
JI Clin. Orthop. Rel. Res.
PD FEB
PY 2014
VL 472
IS 2
BP 497
EP 508
DI 10.1007/s11999-013-3399-3
PG 12
WC Orthopedics; Surgery
SC Orthopedics; Surgery
GA 302EP
UT WOS:000330585000017
PM 24297107
ER
PT J
AU Thompson, KE
Zeng, K
Wilson, CM
Gaber, MW
Miller, DD
Yates, CR
AF Thompson, Karin E.
Zeng, Kui
Wilson, Christy M.
Gaber, Mostafa W.
Miller, Duane D.
Yates, Charles R.
TI Quinic Acid Derivative KZ-41 Exhibits Radiomitigating Activity in
Preclinical Models of Radiation Injury
SO DRUG DEVELOPMENT RESEARCH
LA English
DT Article
DE total body irradiation; wound healing; radiomitigant; vascular injury;
radiation combined injury
ID UNCARIA-TOMENTOSA; AQUEOUS EXTRACT; REPERFUSION; MANAGEMENT; AGENTS
AB Acute radiation syndrome is induced when a significant portion of the body receives highdose, as well as highdose rate, radiation. We have previously identified a quinic acidbased derivative, KZ-41, that protects from radiation injury. Further preclinical efficacy studies were conducted to determine the radiomitigating activity of KZ-41. C57BL/6 mice received total body irradiation (TBI-LD80/30, Cs-137; a?1/42min) followed by either normal saline or KZ-41 (100mg/kg sc a?1/426h postTBI). KZ-41 increased 30day survival by approximately 45% compared with vehicle controls (P<0.05). To further investigate the potential radiomodulating mechanisms of KZ-41, we developed a combined radiation and vascular injury model. C57BL/6 mice surgically fixed with dorsal windows for dermal vasculature imaging received either sham or TBI (Cs-137; 6 Gray). Postcapillary venule injury was induced (24, 48, 72, and 96h postTBI) followed by imaging at 5min and 24h to assess clot formation and blood flow. Impairment in flow (P<0.05) and clot formation (P<0.05) were observed as early as 48 and 72h, respectively. Thus, vascular injury 72h postTBI was used to evaluate intervention (KZ-41; 100mg/kg i.p. at 12, 36, and 60h postTBI) on radiationinduced changes in both flow and clot formation. KZ-41, although not improving flow, increased clot formation (P<0.05). Platelet counts were lower in both irradiated groups compared with sham controls (P<0.05). In summary, KZ-41 exerts radiomitigating activity in lethally irradiated mice. Imaging results suggest KZ-41 exerts radiomitigating activity through mechanisms involving promotion of initial clot formation and vascular flow restoration. The imaging model described herein is useful for further examination of radiationinduced vascular injury repair mechanisms. (C) 2013 Wiley Periodicals, Inc.(C)2013 Wiley Periodicals, Inc.
C1 [Thompson, Karin E.; Miller, Duane D.; Yates, Charles R.] Univ Tennessee, Ctr Hlth Sci, Dept Pharmaceut Sci, Memphis, TN 38163 USA.
[Zeng, Kui] US FDA, Div Pharmaceut Anal, St Louis, MO 63101 USA.
[Wilson, Christy M.] Duke Univ, Durham, NC 27708 USA.
[Gaber, Mostafa W.] Baylor Coll Med, Houston, TX 77030 USA.
RP Yates, CR (reprint author), Univ Tennessee, Ctr Hlth Sci, Dept Pharmaceut Sci, 881 Madison Ave,Pharm Bldg Room 446, Memphis, TN 38163 USA.
EM cyates4@uthsc.edu
FU National Institute of Allergy and Infectious Disease [5R21AI080534];
University of Tennessee College of Pharmacy; RxBio Inc.; ED Labs, Inc.
FX This research was supported by National Institute of Allergy and
Infectious Disease grant number 5R21AI080534, The University of
Tennessee College of Pharmacy, RxBio Inc., and ED Labs, Inc. This
technology is patent pending and is owned by The University of Tennessee
Research Foundation.
NR 22
TC 1
Z9 1
U1 0
U2 4
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0272-4391
EI 1098-2299
J9 DRUG DEVELOP RES
JI Drug Dev. Res.
PD FEB
PY 2014
VL 75
IS 1
SI SI
BP 29
EP 36
DI 10.1002/ddr.21164
PG 8
WC Chemistry, Medicinal; Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA AA0ND
UT WOS:000330791000005
PM 24648047
ER
PT J
AU Liu, P
Zafar, F
Badano, A
AF Liu, Peter
Zafar, Fahad
Badano, Aldo
TI The Effect of Ambient Illumination on Handheld Display Image Quality
SO JOURNAL OF DIGITAL IMAGING
LA English
DT Article
DE Clinical image viewing; Data display; Diagnostic display monitors;
Diagnostic image quality; Digital display; Display device;
Human-computer interaction; Human visual system; Image display; Liquid
crystal display (LCD); Medical displays; Personal digital assistant
(PDA); Visual perception
ID MOBILE DISPLAY
AB Handheld devices such as smartphones and tablets are becoming useful in the medical field, as they allow physicians, radiologists, and researchers to analyze images with the benefit of mobile accessibility. However, for handheld devices to be effective, the display must be able to perform well in a wide range of ambient illumination conditions. We conducted visual experiments to quantify user performance for testing the image quality of two current-generation devices in different ambient illumination conditions while measuring ambient light levels with a real-time illuminance meter. We found and quantified that due to the high reflectivity of handheld devices, performance deteriorates as the user moves from dark areas into environments of greater ambient illumination. The quantitative analysis suggests that differences in display reflection coefficients do not affect the low illumination performance of the device but rather the performance at higher levels of illumination.
C1 [Badano, Aldo] US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol, Silver Spring, MD 20993 USA.
[Liu, Peter] Univ Maryland, Dept Comp Sci, College Pk, MD 20742 USA.
[Zafar, Fahad] Univ Maryland Baltimore Cty, Dept Elect & Comp Engn, Baltimore, MD 21228 USA.
RP Badano, A (reprint author), US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM aldo.badano@fda.hhs.gov
OI badano, aldo/0000-0003-3712-6670
FU Research Participation Program
FX The authors acknowledge support from the Research Participation Program
administered by ORISE through an interagency agreement between DOE and
FDA. The mention of commercial products herein is not to be construed as
either an actual or implied endorsement of such products by the
Department of Health and Human Services. This is a contribution of the
Food and Drug Administration and is not subject to copyright. We thank
the volunteers who participated in the experiments.
NR 9
TC 5
Z9 6
U1 0
U2 15
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 0897-1889
EI 1618-727X
J9 J DIGIT IMAGING
JI J. Digit. Imaging
PD FEB
PY 2014
VL 27
IS 1
BP 12
EP 18
DI 10.1007/s10278-013-9636-1
PG 7
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 304FY
UT WOS:000330733700003
PM 24113844
ER
PT J
AU Murbach, M
Neufeld, E
Kainz, W
Pruessmann, KP
Kuster, N
AF Murbach, Manuel
Neufeld, Esra
Kainz, Wolfgang
Pruessmann, Klaas P.
Kuster, Niels
TI Whole-Body and Local RF Absorption in Human Models as a Function of
Anatomy and Position within 1.5T MR Body Coil
SO MAGNETIC RESONANCE IN MEDICINE
LA English
DT Article
DE local field enhancement; specific absorption rate; large-scale
anatomical property; safety
ID CHILDREN
AB PurposeRadiofrequency energy deposition in magnetic resonance imaging must be limited to prevent excessive heating of the patient. Correlations of radiofrequency absorption with large-scale anatomical features (e.g., height) are investigated in this article.
Theory and MethodsThe specific absorption rate (SAR), as the pivotal parameter for quantifying absorbed radiofrequency, increases with the radial dimension of the patient and therefore with the large-scale anatomical properties. The absorbed energy in six human models has been modeled in different Z-positions (head to knees) within a 1.5T bodycoil.
ResultsFor a fixed B1+ incident field, the whole-body SAR can be up to 2.5 times higher (local SAR up to seven times) in obese adult models compared to children. If the exposure is normalized to 4 W/kg whole-body SAR, the local SAR can well-exceed the limits for local transmit coils and shows intersubject variations of up to a factor of three.
ConclusionsThe correlations between anatomy and induced local SAR are weak for normalized exposure, but strong for a fixed B1+ field, suggesting that anatomical properties could be used for fast SAR predictions. This study demonstrates that a representative virtual human population is indispensable for the investigation of local SAR levels. Magn Reson Med 71:839-845, 2014. (c) 2013 Wiley Periodicals, Inc.
C1 [Murbach, Manuel; Neufeld, Esra; Kuster, Niels] ITIS Fdn, CH-8004 Zurich, Switzerland.
[Murbach, Manuel; Pruessmann, Klaas P.] Univ Zurich, Inst Biomed Engn, Zurich, Switzerland.
[Murbach, Manuel; Pruessmann, Klaas P.] ETH, Zurich, Switzerland.
[Kainz, Wolfgang] US FDA, CDRH, Silver Spring, MD USA.
[Kuster, Niels] Swiss Fed Inst Technol, Zurich, Switzerland.
RP Murbach, M (reprint author), ITIS Fdn, Zeughausstr 43, CH-8004 Zurich, Switzerland.
EM murbach@itis.ethz.ch
FU EUREKA [E!4144]; CTI [9193.1]
FX Grant sponsor: EUREKA; Grant number: E!4144. Grant sponsor: CTI; Grant
number: 9193.1 (project MRI+).
NR 10
TC 11
Z9 11
U1 0
U2 4
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0740-3194
EI 1522-2594
J9 MAGN RESON MED
JI Magn. Reson. Med.
PD FEB
PY 2014
VL 71
IS 2
BP 839
EP 845
DI 10.1002/mrm.24690
PG 7
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA AA0FA
UT WOS:000330769700041
PM 23440667
ER
PT J
AU Khurana, T
Collison, M
Slater, JE
AF Khurana, Taruna
Collison, Maggie
Slater, Jay E.
TI Simultaneous Measurement Of Multiple Proteins In Blattella Germanica
Extract Using Antibody-Based Multiplex Assay
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Meeting Abstract
CT Annual Meeting of the American-Academy-of-Allergy-Asthma-and-Immunology
(AAAAI)
CY FEB 28-MAR 04, 2014
CL San Diego, CA
SP Amer Acad Allergy Asthma & Immunol
C1 [Khurana, Taruna; Collison, Maggie] CBER FDA, Rockville, MD USA.
[Slater, Jay E.] FDA CBER OVRR DBPAP, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0091-6749
EI 1097-6825
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2014
VL 133
IS 2
SU S
MA 761
BP AB220
EP AB220
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 297FO
UT WOS:000330241301077
ER
PT J
AU Mueller, G
Ankney, J
Pedersen, L
Khurana, T
Slater, JE
Glesner, J
Pomes, A
London, R
AF Mueller, Geoffrey
Ankney, John
Pedersen, Lars
Khurana, Taruna
Slater, Jay E.
Glesner, Jill
Pomes, Anna
London, Robert
TI Epitope Mapping Of An Anti-Bla g 1 ScFv Used For Cockroach Allergen
Quantitation
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Meeting Abstract
CT Annual Meeting of the American-Academy-of-Allergy-Asthma-and-Immunology
(AAAAI)
CY FEB 28-MAR 04, 2014
CL San Diego, CA
SP Amer Acad Allergy Asthma & Immunol
C1 [Mueller, Geoffrey; Ankney, John; Pedersen, Lars; London, Robert] NIEHS, NIH, Res Triangle Pk, NC 27709 USA.
[Khurana, Taruna] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Slater, Jay E.] US FDA, CBER, OVRR, DBPAP, Rockville, MD 20857 USA.
[Glesner, Jill; Pomes, Anna] Indoor Biotechnol Inc, Charlottesville, VA USA.
NR 0
TC 0
Z9 0
U1 0
U2 4
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0091-6749
EI 1097-6825
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2014
VL 133
IS 2
SU S
MA 348
BP AB100
EP AB100
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 297FO
UT WOS:000330241300346
ER
PT J
AU Oladipo, TM
Luccioli, S
AF Oladipo, Taiye M.
Luccioli, Stefano
TI Prevalence and Characteristics of Consumer-Reported Food Allergic and
Anaphylactic Events in CAERS, 2007-2011
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Meeting Abstract
CT Annual Meeting of the American-Academy-of-Allergy-Asthma-and-Immunology
(AAAAI)
CY FEB 28-MAR 04, 2014
CL San Diego, CA
SP Amer Acad Allergy Asthma & Immunol
C1 [Oladipo, Taiye M.; Luccioli, Stefano] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0091-6749
EI 1097-6825
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2014
VL 133
IS 2
SU S
MA 718
BP AB207
EP AB207
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 297FO
UT WOS:000330241301034
ER
PT J
AU Slater, JE
Zoch, A
Newman-Gerhardt, S
Khurana, T
AF Slater, Jay E.
Zoch, Allison
Newman-Gerhardt, Shoshana
Khurana, Taruna
TI Comparison Of Total Protein Profile Of Alternaria Alternata Extract
Obtained From Various US Allergenic Extract Manufacturers
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Meeting Abstract
CT Annual Meeting of the American-Academy-of-Allergy-Asthma-and-Immunology
(AAAAI)
CY FEB 28-MAR 04, 2014
CL San Diego, CA
SP Amer Acad Allergy Asthma & Immunol
C1 [Slater, Jay E.] US FDA, CBER, OVRR, DBPAP, Rockville, MD 20857 USA.
[Zoch, Allison; Newman-Gerhardt, Shoshana] US FDA, CBER, Rockville, MD 20857 USA.
[Khurana, Taruna] CBER FDA, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0091-6749
EI 1097-6825
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2014
VL 133
IS 2
SU S
MA 346
BP AB100
EP AB100
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 297FO
UT WOS:000330241300344
ER
PT J
AU Denne, JS
Pennello, G
Zhao, LP
Chang, SC
Althouse, S
AF Denne, Jonathan S.
Pennello, Gene
Zhao, Luping
Chang, Shao-Chun
Althouse, Sandra
TI Identifying a Subpopulation for a Tailored Therapy: Bridging Clinical
Efficacy From a Laboratory-Developed Assay to a Validated In Vitro
Diagnostic Test Kit
SO STATISTICS IN BIOPHARMACEUTICAL RESEARCH
LA English
DT Article
DE Agreement; Companion diagnostic; Concordance; Oncology;
Pharmacogenomics; Predictive biomarker
ID MISSING DATA; TRIALS; CHALLENGES; IMPUTATION
AB In the United States, regulatory approval of a therapy that is tailored to a subpopulation may require the coapproval of a companion in vitro diagnostic (IVD) tool for identifying that subpopulation. Unfortunately, for many reasons, development of the companion IVD may lag such that it is unavailable during a pivotal clinical trial of the therapy. Instead, a laboratory-developed test (LDT) may be used on clinical trial specimens to identify the subpopulation on whom to evaluate the therapy. However, remaining specimen material is saved so that when the companion IVD is ready for market, the specimens can be retested, in an effort to "bridge" from the LDT to the IVD. Unfortunately, retest results can be missing or invalid because some subjects lack remaining specimen material or because what remains is unevaluable (e.g., due to insufficient specimen material, inadequate specimen quality). We frame the bridging analysis problem as one of estimating drug efficacy in the IVD-defined subpopulation. We develop a closed-form approach, as well as approaches based on multiple imputation and bootstrapping to address the missing data problem. We discuss this in the context of a case study involving a recent submission and approval in the United States of a drug and IVD in oncology.
C1 [Denne, Jonathan S.; Zhao, Luping; Chang, Shao-Chun] Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA.
[Pennello, Gene] US FDA, Diagnost Devices Branch, Div Biostat, OSB,CDRH, Silver Spring, MD 20993 USA.
[Althouse, Sandra] IUPUI, Dept Biostat, Indianapolis, IN 46202 USA.
RP Denne, JS (reprint author), Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA.
EM jon_denne@lilly.com; gene.pennello@fda.hhs.gov; zhao_luping@lilly.com;
chang_shao-chun@lilly.com; salhous@iupui.edu
NR 22
TC 5
Z9 5
U1 1
U2 5
PU AMER STATISTICAL ASSOC
PI ALEXANDRIA
PA 732 N WASHINGTON ST, ALEXANDRIA, VA 22314-1943 USA
SN 1946-6315
J9 STAT BIOPHARM RES
JI Stat. Biopharm. Res.
PD FEB
PY 2014
VL 6
IS 1
BP 78
EP 88
DI 10.1080/19466315.2013.852618
PG 11
WC Mathematical & Computational Biology; Statistics & Probability
SC Mathematical & Computational Biology; Mathematics
GA 299YJ
UT WOS:000330431300008
ER
PT J
AU Uribarri, J
Calvo, MS
AF Uribarri, Jaime
Calvo, Mona S.
TI Dietary phosphorus intake and health
SO AMERICAN JOURNAL OF CLINICAL NUTRITION
LA English
DT Editorial Material
ID DISEASE
C1 [Uribarri, Jaime] Mt Sinai Sch Med, New York, NY USA.
[Calvo, Mona S.] US FDA, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, US Dept HHS, Laurel, MD USA.
RP Uribarri, J (reprint author), 1 Gustave Levy Pl, New York, NY 10029 USA.
EM jaime.uribarri@mssm.edu
NR 10
TC 3
Z9 3
U1 0
U2 8
PU AMER SOC NUTRITION-ASN
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0002-9165
EI 1938-3207
J9 AM J CLIN NUTR
JI Am. J. Clin. Nutr.
PD FEB
PY 2014
VL 99
IS 2
BP 247
EP 248
DI 10.3945/ajcn.113.080259
PG 2
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 295XR
UT WOS:000330150200002
PM 24381089
ER
PT J
AU Khurana, T
Collison, M
Chew, FT
Slater, JE
AF Khurana, Taruna
Collison, Maggie
Chew, Fook Tim
Slater, Jay E.
TI Bla g 3: a novel allergen of German cockroach identified using
cockroach-specific avian single-chain variable fragment antibody
SO ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY
LA English
DT Article
ID INNER-CITY CHILDREN; BLATTELLA-GERMANICA; RISK-FACTORS; ASTHMA;
EXTRACTS; EXPOSURE; IGE; SENSITIZATION; PROTEINS; HYPERSENSITIVITY
AB Background: The IgE response to cockroach allergens is thought to be associated with asthma. German cockroach (GCr) allergen extract is a complex mixture of allergens, and the identification and characterization of immunodominant allergens is important for the effective diagnosis and treatment of GCr-induced asthma.
Objective: To characterize a novel GCr allergen homologous to the American cockroach allergen Per a 3.
Methods: GCr-specific avian monoclonal antibodies were used for direct immunoprecipitation of specific targets from whole-body GCr extract. Precipitated protein was identified by mass spectrometry and sequence analysis. Putative recombinant protein also was expressed, purified, and used for determination of allergenicity, determined by IgE enzyme-linked immunosorbent assay with serum from 61 GCr-allergic patients. The identified target also was analyzed for heat stability using a bead-based assay.
Results: The immunoprecipitated target of monoclonal antibody 2A1 was identified as a novel allergen of GCr homologous to American cockroach allergen Per a 3. This homolog, designated Bla g 3, has an apparent mass of 78 kDa, can be measured in GCr extract using antibody 2A1, and is a heat-stable protein. Screening of 61 serum samples from GCr-allergic patients showed a 22% prevalence of Bla g 3-specific IgE.
Conclusion: Bla g 3 is a GCr allergen with structural homology to American cockroach allergen Per a 3. (C) 2014 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
C1 [Khurana, Taruna; Collison, Maggie; Slater, Jay E.] US FDA, Lab Immunobiochem, Div Bacterial Parasit & Allergen Prod, Bethesda, MD 20014 USA.
[Chew, Fook Tim] Natl Univ Singapore, Dept Biol Sci, Allergy & Mol Immunol Lab, Singapore 117548, Singapore.
RP Slater, JE (reprint author), FDA CBER, 1401 Rockville Pike HFM-422, Rockville, MD 20850 USA.
EM jay.slater@fda.hhs.gov
RI Chew, Fook Tim/E-7259-2010
OI Chew, Fook Tim/0000-0003-1337-5146
FU Center for Biologics Evaluation and Research, US Food and Drug
Administration
FX This work was supported by intramural funding from Center for Biologics
Evaluation and Research, US Food and Drug Administration.
NR 34
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Z9 9
U1 2
U2 6
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1081-1206
EI 1534-4436
J9 ANN ALLERG ASTHMA IM
JI Ann. Allergy Asthma Immunol.
PD FEB
PY 2014
VL 112
IS 2
BP 140
EP +
DI 10.1016/j.anai.2013.11.007
PG 7
WC Allergy; Immunology
SC Allergy; Immunology
GA 296HI
UT WOS:000330175500012
PM 24468254
ER
PT J
AU Selker, HP
Oye, KA
Eichler, HG
Stockbridge, NL
Mehta, CR
Kaitin, KI
McElwee, NE
Honig, PK
Erban, JK
D'Agostino, RB
AF Selker, H. P.
Oye, K. A.
Eichler, H-G
Stockbridge, N. L.
Mehta, C. R.
Kaitin, K. I.
McElwee, N. E.
Honig, P. K.
Erban, J. K.
D'Agostino, R. B.
TI A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical
Trials
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Article
ID ACUTE MYOCARDIAL-INFARCTION; THROMBOLYTIC PREDICTIVE INSTRUMENT;
TISSUE-PLASMINOGEN ACTIVATOR; BREAST-CANCER; CORONARY ANGIOPLASTY;
THERAPY; STREPTOKINASE; CHEMOTHERAPY; TRASTUZUMAB; BENEFIT
AB We propose an "efficacy-to-effectiveness" (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the efficacy trial. Efficacy trials use inclusion/exclusion criteria to produce relatively homogeneous samples of participants with the target condition, conducted in settings that foster adherence to rigorous clinical protocols. Effectiveness trials use inclusion/exclusion criteria that generate heterogeneous samples that are more similar to the general patient spectrum, conducted in more varied settings, with protocols that approximate typical clinical care. in E2E trials, results from the efficacy trial component would be used to design the effectiveness trial component, to confirm and/or discern associations between clinical characteristics and treatment effects in typical care, and potentially to test new hypotheses. An E2E approach may improve the evidentiary basis for selecting treatments, expand understanding of the effectiveness of treatments in subgroups with particular clinical features, and foster incorporation of effectiveness information into regulatory processes.
C1 [Selker, H. P.; Kaitin, K. I.; Erban, J. K.] Tufts Univ, Tufts Clin & Translat Sci Inst, Boston, MA 02111 USA.
[Selker, H. P.] Tufts Med Ctr, Inst Clin Res & Hlth Policy Studies, Boston, MA USA.
[Oye, K. A.] Massachusetts Inst Technol Polit Sci & Engn Syst, Cambridge, MA USA.
[Eichler, H-G] European Med Agcy, London, England.
[Stockbridge, N. L.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Mehta, C. R.] Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA.
[Kaitin, K. I.] Tufts Ctr Study Drug Dev, Boston, MA USA.
[McElwee, N. E.] Merck & Co Inc, Whitehouse Stn, NJ USA.
[Erban, J. K.] Tufts Canc Ctr, Boston, MA USA.
[D'Agostino, R. B.] Boston Univ, Dept Math & Stat, Boston, MA 02215 USA.
[D'Agostino, R. B.] Harvard Clin Res Inst, Boston, MA USA.
RP Selker, HP (reprint author), Tufts Univ, Tufts Clin & Translat Sci Inst, Boston, MA 02111 USA.
EM hselker@tuftsmedicalcenter.org
FU National Center for Research Resources of the National Institutes of
Health [UL1 RR025752]; National Center for Advancing Translational
Sciences [UL1 TR000073]
FX The authors thank Aaron Kirby for facilitating and managing this
investigation and report, Abdmoain Abudabrh for very helpful background
research for this project, and Muriel Powers for expert manuscript
preparation. The project was supported by the National Center for
Research Resources of the National Institutes of Health under grant UL1
RR025752 and the National Center for Advancing Translational Sciences
under grant UL1 TR000073. The content is solely the responsibility of
the authors and does not necessarily represent the official views of the
European Medicines Agency, the US Food and Drug Administration, or the
National Institutes of Health.
NR 23
TC 8
Z9 9
U1 0
U2 9
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
EI 1532-6535
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2014
VL 95
IS 2
BP 147
EP 153
DI 10.1038/clpt.2013.177
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 295YA
UT WOS:000330151100019
PM 24060819
ER
PT J
AU Einolfl, HJ
Chen, L
Fahmi, OA
Gibson, CR
Obach, RS
Shebley, M
Silva, J
Sinz, MW
Unadkat, JD
Zhang, L
Zhao, P
AF Einolfl, H. J.
Chen, L.
Fahmi, O. A.
Gibson, C. R.
Obach, R. S.
Shebley, M.
Silva, J.
Sinz, M. W.
Unadkat, J. D.
Zhang, L.
Zhao, P.
TI Evaluation of Various Static and Dynamic Modeling Methods to Predict
Clinical CYP3A Induction Using In Vitro CYP3A4 mRNA Induction Data
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Article
ID DRUG-DRUG INTERACTIONS; CYTOCHROME-P450 3A ACTIVITY; ORAL MIDAZOLAM;
NIFEDIPINE PHARMACOKINETICS; PLASMA-CONCENTRATIONS; HUMAN HEPATOCYTES;
ENZYME-INDUCTION; VIVO; HUMANS; RIFAMPIN
AB Several drug-drug interaction (DDI) prediction models were evaluated for their ability to identify drugs with cytochrome P450 (CYP)3A induction liability based on in vitro mRNA data. The drug interaction magnitudes of CYP3A substrates from 28 clinical trials were predicted using (i) correlation approaches (ratio of the in vivo peak plasma concentration (C-max) to in vitro half-maximal effective concentration (EC50); and relative induction score), (ii) a basic static model (calculated R-3 value), (iii) a mechanistic static model (net effect), and (iv) mechanistic dynamic (physiologically based pharmacokinetic) modeling. All models performed with high fidelity and predicted few false negatives or false positives. The correlation approaches and basic static model resulted in no false negatives when total C-max was incorporated; these models may be sufficient to conservatively identify clinical CYP3A induction liability. Mechanistic models that include CYP inactivation in addition to induction resulted in DDI predictions with less accuracy, likely due to an overprediction of the inactivation effect.
C1 [Einolfl, H. J.] Novartis, E Hanover, NJ USA.
[Chen, L.] GlaxoSmithKline, King Of Prussia, PA USA.
[Fahmi, O. A.; Obach, R. S.] Pfizer Inc, Groton, CT 06340 USA.
[Gibson, C. R.] Merck Res Labs, West Point, PA USA.
[Shebley, M.] AbbVie Inc, N Chicago, IL USA.
[Silva, J.] Johnson &Johnson Pharmaceut Res Inst, Raritan, NJ USA.
[Sinz, M. W.] Bristol Myers Squibb Co, Wallingford, CT 06492 USA.
[Unadkat, J. D.] Univ Washington, Seattle, WA 98195 USA.
[Zhang, L.; Zhao, P.] US FDA, Silver Spring, MD USA.
RP Einolfl, HJ (reprint author), Novartis, E Hanover, NJ USA.
EM heidi.einolf@novartis.com; Odette.a.fahmi@pfizer.com
RI Shebley, Mohamad/G-1368-2016
OI Shebley, Mohamad/0000-0002-0147-8933
NR 36
TC 24
Z9 24
U1 0
U2 7
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
EI 1532-6535
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2014
VL 95
IS 2
BP 179
EP 188
DI 10.1038/clpt.2013.170
PG 10
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 295YA
UT WOS:000330151100022
PM 23995268
ER
PT J
AU Vieiral, MLT
Kirby, B
Ragueneau-Majlessi, I
Galetin, A
Chien, JYL
Einolf, HJ
Fahmi, OA
Fischer, V
Fretland, A
Grime, K
Hall, SD
Higgs, R
Plowchalk, D
Riley, R
Seibert, E
Skordos, K
Snoeys, J
Venkatakrishnan, K
Waterhouse, T
Obach, RS
Berglund, EG
Zhang, L
Zhao, P
Reynolds, KS
Huang, SM
AF Vieiral, Md L. T.
Kirby, B.
Ragueneau-Majlessi, I.
Galetin, A.
Chien, J. Y. L.
Einolf, H. J.
Fahmi, O. A.
Fischer, V.
Fretland, A.
Grime, K.
Hall, S. D.
Higgs, R.
Plowchalk, D.
Riley, R.
Seibert, E.
Skordos, K.
Snoeys, J.
Venkatakrishnan, K.
Waterhouse, T.
Obach, R. S.
Berglund, E. G.
Zhang, L.
Zhao, P.
Reynolds, K. S.
Huang, S-M
TI Evaluation of Various Static In Vitro-In Vivo Extrapolation Models for
Risk Assessment of the CYP3A Inhibition Potential of an Investigational
Drug
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Article
ID CYTOCHROME-P450 INHIBITION; PARALLEL PATHWAYS; PREDICTION; INACTIVATION;
ELIMINATION; IMPACT; METABOLISM; ALGORITHMS; ENZYMES
AB Nine static models (seven basic and two mechanistic) and their respective cutoff values used for predicting cytochrome P450 3A (CYP3A) inhibition, as recommended by the US Food and Drug Administration and the European Medicines Agency, were evaluated using data from 119 clinical studies with orally administered midazolam as a substrate. Positive predictive error (PPE) and negative predictive error (NPE) rates were used to assess model performance, based on a cutoff of 1.25-fold change in midazolam area under the curve (AUC) by inhibitor. For reversible inhibition, basic models using total or unbound systemic inhibitor concentration [I] had high NPE rates (46-47%), whereas those using intestinal luminal ([I](gut)) values had no NPE but a higher PPE. All basic models for time-dependent inhibition had no NPE and reasonable PPE rates (15-18%). Mechanistic static models that incorporate all interaction mechanisms and organ specific [I] values (enterocyte and hepatic inlet) provided a higher predictive precision, a slightly increased NPE, and a reasonable PPE. Various cutoffs for predicting the likelihood of CYP3A inhibition were evaluated for mechanistic models, and a cutoff of 1.25-fold change in midazolam AUC appears appropriate.
C1 [Vieiral, Md L. T.; Zhang, L.; Zhao, P.; Reynolds, K. S.; Huang, S-M] US FDA, Silver Spring, MD USA.
[Kirby, B.; Ragueneau-Majlessi, I.] Univ Washington, Seattle, WA 98195 USA.
[Galetin, A.] Univ Manchester, Manchester, England.
[Chien, J. Y. L.; Fretland, A.; Hall, S. D.; Higgs, R.; Waterhouse, T.] Eli Lilly & Co, Indianapolis, IN 46285 USA.
[Einolf, H. J.] Novartis, E Hanover, NJ USA.
[Fahmi, O. A.; Plowchalk, D.; Obach, R. S.] Pfizer Inc, Groton, CT 06340 USA.
[Fischer, V.] AbbVie, N Chicago, IL USA.
[Grime, K.] AstraZeneca Res & Dev, Molndal, Sweden.
[Riley, R.] AstraZeneca Res & Dev, Alderley Pk, England.
[Seibert, E.] Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT 06877 USA.
[Skordos, K.] GlaxoSmithKline, Res Triangle Pk, NC USA.
[Snoeys, J.] Janssen Pharmaceut Co Johnson &Johnson, Beerse, Belgium.
[Venkatakrishnan, K.] Millennium Pharmaceut Inc, Cambridge, MA USA.
[Berglund, E. G.] Med Prod Agcy, Uppsala, Sweden.
RP Zhao, P (reprint author), US FDA, Silver Spring, MD USA.
EM chien_jenny_yuehling@lilly.com; heidi.einolf@novartis.com;
ping.zhao@fda.hhs.gov; ShiewMei.Huang@fda.hhs.gov
OI Galetin, Aleksandra/0000-0002-3933-5217
FU CAPES/Full:night program; US Food and Drug Administration (FDA) Critical
Path Initiative Project "Development of an Internal Drug Interaction
Database"; Research Participation Program at the Center for Drug
Evaluation and Research
FX We acknowledge the CAPES/Full:night program for the doctoral scholarship
of M.d.L.T.V. and the US Food and Drug Administration (FDA) Critical
Path Initiative Project "Development of an Internal Drug Interaction
Database." This work was supported in part by an appointment to the
Research Participation Program at the Center for Drug Evaluation and
Research administered by the Oak Ridge Institute for Science and
Education through an interagency agreement between the US Department of
Energy and the FDA. We acknowledge Tim Waterhouse and Richard Higgs, of
Eli Lilly and Company, for providing expert support for the error rate
analyses. No official support or endorsement by the Medical Products
Agency is intended or should be inferred.
NR 33
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U1 0
U2 9
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
EI 1532-6535
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2014
VL 95
IS 2
BP 189
EP 198
DI 10.1038/clpt.2013.187
PG 10
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 295YA
UT WOS:000330151100023
PM 24048277
ER
PT J
AU Jarow, JP
Lerner, SP
Kluetz, PG
Liu, K
Sridhara, R
Bajorin, D
Chang, S
Dinney, CPN
Groshen, S
Morton, RA
O'Donnell, M
Quale, DZ
Schoenberg, M
Seigne, J
Vikram, B
AF Jarow, Jonathan P.
Lerner, Seth P.
Kluetz, Paul G.
Liu, Ke
Sridhara, Rajeshwari
Bajorin, Dean
Chang, Sam
Dinney, Colin P. N.
Groshen, Susan
Morton, Ronald A.
O'Donnell, Michael
Quale, Diane Zipursky
Schoenberg, Mark
Seigne, John
Vikram, Bhadrasain
TI Clinical Trial Design for the Development of New Therapies for
Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug
Administration and American Urological Association Public Workshop
SO UROLOGY
LA English
DT Article
ID CARCINOMA IN-SITU; HEXAMINOLEVULINATE FLUORESCENCE CYSTOSCOPY; GUERIN
PLUS INTERFERON; WHITE-LIGHT CYSTOSCOPY; INTRAVESICAL THERAPY;
UROTHELIAL CARCINOMA; PHASE-III; MULTICENTER; CYSTECTOMY; RECURRENCE
AB OBJECTIVE To summarize the discussion at a public workshop, cosponsored by the U.S. Food and Drug Administration (FDA) and the American Urological Association, reviewing potential trial designs for the development of new therapies for non-muscle-invasive bladder cancer (NMIBC). There have been only 3 drug approvals for NMIBC in the last 30 years, and product development for this disease has been stymied by difficulties in trial design and patient accrual.
METHODS A workshop evaluating potential trial design for the development of therapies for NMIBC was held in San Diego, CA, in May 2013. Invited experts representing all stakeholders, including urology, medical oncology, radiation oncology, industry, and patient advocates, discussed development of products for all risk strata of NMIBC.
RESULTS The panel responded to specific questions from the FDA, discussing eligibility criteria, efficacy endpoints, and trial design for patients with a mix of high-grade papillary disease and carcinoma in situ, Bacillus Calmette-Guerin (BCG)-refractory disease, and intermediate-risk disease. Panel members also addressed the magnitude of response that would be clinically meaningful for various disease strata and trial design options for perioperative intravesical chemotherapy instillation at the time of resection of bladder tumors.
CONCLUSION Expert commentary provided by panel members will inform a planned FDA guidance on pathways for drug and biologic development for NMIBC and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee. FDA intends to develop a set of principles that can be used to promote the development of new products for this disease. Published by Elsevier Inc.
C1 [Jarow, Jonathan P.] US FDA, Off Hematol & Oncol Prod, Silver Spring, MD 20993 USA.
Baylor Coll Med, Scott Dept Urol, Med Ctr, Houston, TX 77030 USA.
US FDA, Off Cellular Tissue & Gene Therapies, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA.
US FDA, Div Biometr 5, Off Biostat, CDER, Silver Spring, MD 20993 USA.
Weill Cornell Med Coll, Mem Sloan Kettering Canc Ctr, New York, NY USA.
Vanderbilt Univ, Med Ctr, Dept Urol Surg, Nashville, TN USA.
Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA.
USC Keck Sch Med, USC Norris Comprehens Canc Ctr, Dept Prevent Med, Los Angeles, CA USA.
Amer Med Syst, Minnetonka, MN USA.
Univ Iowa, Iowa City, IA USA.
Bladder Canc Advocacy Network, Bethesda, MD USA.
Johns Hopkins Univ, Sch Med, Baltimore, MD USA.
Dartmouth Hitchcock Med Ctr, Lebanon, NH 03766 USA.
Norris Cotton Canc Ctr, Lebanon, NH USA.
NCI, Bethesda, MD 20892 USA.
RP Jarow, JP (reprint author), US FDA, Off Hematol & Oncol Prod, Silver Spring, MD 20993 USA.
EM Jonathan.jarow@fda.hhs.gov
FU NCI NIH HHS [P30 CA016672]
NR 14
TC 8
Z9 8
U1 1
U2 3
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0090-4295
EI 1527-9995
J9 UROLOGY
JI Urology
PD FEB
PY 2014
VL 83
IS 2
BP 262
EP 264
DI 10.1016/j.urology.2013.10.030
PG 3
WC Urology & Nephrology
SC Urology & Nephrology
GA 296ZF
UT WOS:000330223600002
PM 24332121
ER
PT J
AU Liang, XY
Pfeiffer, RM
Li, WQ
Brossard, M
Burke, LS
Wheeler, W
Calista, D
Fargnoli, MC
Ghiorzo, P
Peris, K
Bianchi-Scarra, G
Chaudru, V
Zelenika, D
Maederl, D
Burdette, L
Yeager, M
Chanock, S
Landi, MT
Demenais, F
Tucker, MA
Goldstein, AM
Yang, XHR
AF Liang, Xueying
Pfeiffer, Ruth M.
Li, Wen-Qing
Brossard, Myriam
Burke, Laura S.
Wheeler, William
Calista, Donato
Fargnoli, Maria Concetta
Ghiorzo, Paola
Peris, Ketty
Bianchi-Scarra, Giovanna
Chaudru, Valerie
Zelenika, Diana
Maederl, Dennis
Burdette, Laurie
Yeager, Meredith
Chanock, Stephen
Landi, Maria Teresa
Demenais, Florence
Tucker, Margaret A.
Goldstein, Alisa M.
Yang, Xiaohong R.
TI Association of Genetic Variants in CDK6 and XRCC1 with the Risk of
Dysplastic Nevi in Melanoma-Prone Families
SO JOURNAL OF INVESTIGATIVE DERMATOLOGY
LA English
DT Article
ID DNA-REPAIR; MEDITERRANEAN POPULATION; CUTANEOUS MELANOMA; CDKN2A
MUTATIONS; POLYMORPHISMS; MC1R; CANCER; PENETRANCE; ASIP
AB Dysplastic nevi (DN) is a strong risk factor for cutaneous malignant melanoma (CMM), and it frequently occurs in melanoma-prone families. To identify genetic variants for DN, we genotyped 677 tagSNPs in 38 melanoma candidate genes that are involved in pigmentation, DNA repair, cell cycle control, and melanocyte proliferation pathways in a total of 504 individuals (310 with DN, 194 without DN) from 53 melanoma-prone families (23 CDKN2A mutation positive and 30 negative). Conditional logistic regression, conditioning on families, was used to estimate the association between DN and each single-nucleotide polymorphism (SNP) separately, adjusted for age, sex, CMM, and CDKN2A status. P-values for SNPs in the same gene were combined to yield gene-specific P-values. Two genes, CDK6 (cyclin-dependent kinase 6) and XRCC1, were significantly associated with DN after Bonferroni correction for multiple testing (P=0.0001 and 0.00025, respectively), whereas neither gene was significantly associated with CMM. Associations for CDK6 SNPs were stronger in CDKN2A mutation-positive families (rs2079147, P-interaction = 0.0033), whereas XRCC1 SNPs had similar effects in mutation-positive and -negative families. The association for one of the associated SNPs in XRCC1 (rs25487) was replicated in two independent data sets (random-effect meta-analysis: P<0.0001). Our findings suggest that some genetic variants may contribute to DN risk independently of their association with CMM in melanoma-prone families.
C1 [Liang, Xueying; Pfeiffer, Ruth M.; Li, Wen-Qing; Burke, Laura S.; Maederl, Dennis; Burdette, Laurie; Yeager, Meredith; Chanock, Stephen; Landi, Maria Teresa; Tucker, Margaret A.; Goldstein, Alisa M.; Yang, Xiaohong R.] NCI, Div Canc Epidemiol & Genet, NIH, Bethesda, MD 20892 USA.
[Liang, Xueying] US FDA, Off In Vitro Diagnost & Radiol Hlth, CDRH, Silver Spring, MD USA.
[Brossard, Myriam; Chaudru, Valerie; Demenais, Florence] INSERM, UMR 946, Genet Variat & Human Dis Unit, Paris, France.
[Brossard, Myriam; Chaudru, Valerie; Demenais, Florence] Univ Paris Diderot, Sorbonne Paris Cite, Inst Univ Hematol, Paris, France.
[Brossard, Myriam] Univ Paris Sud, F-94275 Le Kremlin Bicetre, France.
[Wheeler, William] Informat Management Serivces Inc, Rockville, MD USA.
[Calista, Donato] Osped Gen Provinciale M Bufalini, Dept Dermatol, Cesena, Italy.
[Fargnoli, Maria Concetta; Peris, Ketty] Univ Aquila, Dept Dermatol, I-67100 Laquila, Italy.
[Ghiorzo, Paola; Bianchi-Scarra, Giovanna] Univ Genoa, Dept Internal Med, I-16126 Genoa, Italy.
[Ghiorzo, Paola; Bianchi-Scarra, Giovanna] IRCCS AOU San Martino IST, Lab Genet Rare Hereditary Canc, Genoa, Italy.
[Chaudru, Valerie] Univ Evry Val dEssone, Evry, France.
[Zelenika, Diana] CEA, Inst Genom, Ctr Natl Genotypage, Evry, France.
RP Yang, XHR (reprint author), NCI, Div Canc Epidemiol & Genet, NIH, Bethesda, MD 20892 USA.
EM Royang@mail.nih.gov
RI Demenais, Florence/G-3298-2013; Li, Wenqing/N-2293-2014; Tucker,
Margaret/B-4297-2015;
OI Demenais, Florence/0000-0001-8361-0936; Li, Wenqing/0000-0002-1283-4091;
Peris, Ketty/0000-0002-5237-0463; Fargnoli, Maria
Concetta/0000-0002-7249-2556
FU National Institutes of Health (NIH), National Cancer Institute (NCI);
Division of Cancer Epidemiology and Genetics (DCEG); Ligue Nationale
Contre le Cancer [PRE O5/FD, PRE 09/FD]; NIH, NCI, DCEG; NIH [CA
5558-01A2]
FX We are indebted to the participating families, whose generosity and
cooperation have made this study possible. We also acknowledge the
contributions to this work that were made by Virginia Pichler, Deborah
Zametkin, and Mary Fraser. This research was supported by the Intramural
Research Program of the National Institutes of Health (NIH), National
Cancer Institute (NCI), and Division of Cancer Epidemiology and Genetics
(DCEG). The French study was partly funded by Ligue Nationale Contre le
Cancer (PRE O5/FD and PRE 09/FD to FD and Doctoral fellowship to MB). We
thank the French NEVRISK study group that includes clinicians from
Hopital Saint-Louis, Fondation Rothschild, and Institut Gustave Roussy
for their contribution to patient recruitment and data collection. The
Italian studies were supported by the Intramural Research Program of
NIH, NCI, DCEG, and by R01 grant (CA 5558-01A2) from the NIH to MTL.
NR 25
TC 4
Z9 4
U1 1
U2 9
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0022-202X
EI 1523-1747
J9 J INVEST DERMATOL
JI J. Invest. Dermatol.
PD FEB
PY 2014
VL 134
IS 2
BP 481
EP 487
DI 10.1038/jid.2013.316
PG 7
WC Dermatology
SC Dermatology
GA 292IS
UT WOS:000329896000027
PM 23892592
ER
PT J
AU Myers, MB
McKim, KL
Parsons, BL
AF Myers, Meagan B.
McKim, Karen L.
Parsons, Barbara L.
TI A Subset of Papillary Thyroid Carcinomas Contain KRAS Mutant
Subpopulations at Levels Above Normal Thyroid
SO MOLECULAR CARCINOGENESIS
LA English
DT Article
DE ACB-PCR; cancer biomarkers; cancer genetics; mutation; oncogenes
ID ACB-PCR QUANTIFICATION; RAF INHIBITORS; BRAF MUTATIONS; CANCER; TUMOR;
PATHWAY; GROWTH; ACTIVATION; EXPOSURE; FRACTION
AB The molecular pathogenesis of papillary thyroid carcinoma (PTC) is largely attributed to chromosomal rearrangements and point mutations in genes within the MAPK pathway (i.e., BRAF and RAS). Despite KRAS being the 6th most frequently mutated gene for all cancers, the reported frequency in thyroid cancer is only 2%. This may be due, in part, to the use of insensitive mutation detection methods such as DNA sequencing. Therefore, using the sensitive and quantitative ACB-PCR approach, we quantified KRAS codon 12 GGTGAT and GGTGTT mutant fraction (MF) in 20 normal thyroid tissues, 17 primary PTC, 2 metastatic PTC, and 1 anaplastic thyroid carcinoma. We observed measurable levels of KRAS codon 12 GAT or GTT mutation in all normal thyroid tissues. For PTCs, 29.4% and 35.3% had KRAS codon 12 GAT and GTT MF above the 95% upper confidence interval for the corresponding MFs in normal thyroid. The highest observed KRAS codon 12 GTT MFs were associated with tumors with follicular characteristics and relatively high levels of tumor necrosis. The results indicate KRAS mutant subpopulations are present in a large number of thyroid tumors, a fact previously unrecognized. The presence of KRAS mutation may indicate a tumor with an aggressive phenotype, thus directing the course of clinical treatment. (c) 2012 Wiley Periodicals, Inc.
C1 [Myers, Meagan B.; McKim, Karen L.; Parsons, Barbara L.] US FDA, Div Genet & Mol Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Myers, MB (reprint author), Div Genet & Mol Toxicol, HFT 120,3900,NCTR Rd, Jefferson, AR 72079 USA.
FU NIH [5 U42 RR006042]; National Center for Toxicological Research; U.S.
Food & Drug Administration
FX The authors thank Drs. James Fuscoe and Deborah Hanson for their
critical review of this manuscript. Tissue samples were provided by the
Cooperative Human Tissue Network, a National Cancer Institute supported
resource. Other investigators may have received samples from these same
tissue specimens. We acknowledge use of tissues procured by the National
Disease Research Interchange (NDRI; with support from NIH grant 5 U42
RR006042). The contents of this manuscript do not necessarily reflect
the views or policies of the U.S. Food & Drug Administration, nor does
the mention of trade names or commercial products constitute endorsement
or recommendation for use. This study was supported by National Center
for Toxicological Research and U.S. Food & Drug Administration.
NR 35
TC 11
Z9 11
U1 1
U2 7
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0899-1987
EI 1098-2744
J9 MOL CARCINOGEN
JI Mol. Carcinog.
PD FEB
PY 2014
VL 53
IS 2
BP 159
EP 167
DI 10.1002/mc.21953
PG 9
WC Biochemistry & Molecular Biology; Oncology
SC Biochemistry & Molecular Biology; Oncology
GA 292UB
UT WOS:000329926900008
PM 22930660
ER
PT J
AU Wysowski, DK
AF Wysowski, Diane K.
TI Reply to: Effect of pharmacological treatment of osteoporosis in the
prevention of pathological vertebral fractures
SO BONE
LA English
DT Letter
C1 US FDA, Off Surveillance & Epidemiol, Silver Spring, MD 20993 USA.
RP Wysowski, DK (reprint author), US FDA, Off Surveillance & Epidemiol, Silver Spring, MD 20993 USA.
NR 5
TC 0
Z9 0
U1 0
U2 4
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 8756-3282
EI 1873-2763
J9 BONE
JI Bone
PD FEB
PY 2014
VL 59
BP 150
EP 150
DI 10.1016/j.bone.2013.11.003
PG 1
WC Endocrinology & Metabolism
SC Endocrinology & Metabolism
GA 287QZ
UT WOS:000329558600020
PM 24252522
ER
PT J
AU Prabhakar, S
Asuthkar, S
Lee, W
Chigurupati, S
Zakharian, E
Tsung, AJ
Velpula, KK
AF Prabhakar, Sheila
Asuthkar, Swapna
Lee, William
Chigurupati, Srinivasulu
Zakharian, Eleonora
Tsung, Andrew J.
Velpula, Kiran Kumar
TI Targeting DUSPs in glioblastomas - wielding a double-edged sword?
SO CELL BIOLOGY INTERNATIONAL
LA English
DT Article
DE brain; nervous system; cancer; tumor suppressor
ID PROTEIN-KINASE PHOSPHATASE-1; DUAL-SPECIFICITY PHOSPHATASES; DIRECT
TRANSCRIPTIONAL TARGET; CANDIDATE TUMOR-SUPPRESSOR; CELL-ACTIVE
INHIBITOR; HUMAN BREAST-CANCER; MAP-KINASE; TYROSINE PHOSPHATASES;
PANCREATIC-CANCER; DOWN-REGULATION
AB Several dual-specificity phosphatases (DUSPs) that play key roles in the direct or indirect inactivation of different MAP kinases (MAPKs) have been implicated in human cancers over the past decade. This has led to a growing interest in identifying DUSPs and their specific inhibitors for further testing and validation as therapeutic targets in human cancers. However, the lack of understanding of the complex regulatory mechanisms and cross-talks between MAPK signaling pathways, combined with the fact that DUSPs can act as a double-edged sword in cancer progression, calls for a more careful and thorough investigation. Among the various types of brain cancer, glioblastoma multiforme (GBM) is notorious for its aggressiveness and resistance to current treatment modalities. This has led to the search for new molecular targets, particularly those involving various signaling pathways. DUSPs appear to be a promising target, but much more information on DUSP targets and their effects on GBM is needed before potential therapies can be developed, tested, and validated. This review identifies and summarize the specific roles of DUSP1, DUSP4, DUSP6 and DUSP26 that have been implicated in GBM.
C1 [Asuthkar, Swapna; Lee, William; Zakharian, Eleonora; Tsung, Andrew J.; Velpula, Kiran Kumar] Univ Illinois, Coll Med Peoria, Dept Canc Biol & Pharmacol, Peoria, IL 61605 USA.
[Prabhakar, Sheila] Southeastern Univ, Dept Nat & Hlth Sci, Lakeland, FL 33801 USA.
[Chigurupati, Srinivasulu] US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Velpula, KK (reprint author), Univ Illinois, Coll Med Peoria, Dept Canc Biol & Pharmacol, 1 Illini Dr, Peoria, IL 61605 USA.
EM velpula@uic.edu
NR 80
TC 6
Z9 6
U1 1
U2 19
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1065-6995
EI 1095-8355
J9 CELL BIOL INT
JI Cell Biol. Int.
PD FEB
PY 2014
VL 38
IS 2
BP 145
EP 153
DI 10.1002/cbin.10201
PG 9
WC Cell Biology
SC Cell Biology
GA 288DB
UT WOS:000329591100001
PM 24155099
ER
PT J
AU Martinez, MN
AF Martinez, M. N.
TI Bioequivalence accomplishments, ongoing initiatives, and remaining
challenges
SO JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS
LA English
DT Review
ID HIGHLY VARIABLE DRUGS; PRODUCT BIOEQUIVALENCE; RELEASE FORMULATIONS;
DISSOLUTION; BIOAVAILABILITY; CLASSIFICATION; SOLUBILITY; ABSORPTION;
MODELS
AB Although bioequivalence (BE) concepts date back to the late 1960s, there has been a steady evolution in the tools applied to the assessment of product comparability. Despite these advancements, we continue to face a multitude of unresolved challenges. Several of these challenges are unique to veterinary medicine due to issues such as multiple species approvals, unique dosage forms (e.g., intramammary infusion and medicated premixes), physiological challenges (e.g., limitations in blood volume and stress reactions), and the need to evaluate product equivalence for products intended to release drug over a duration of months. Thus, while in some instances, we can adopt advancements implemented by our human health counterparts but in other situations, we need to pioneer our own method for resolving these challenges. The purpose of this manuscript is to provide an update on recent advances, achievements, and ongoing initiatives associated with the assessment of product BE in veterinary medicine. This review reflects the highlights of a presentation given at the 2012 meeting of the European Association for Veterinary Pharmacology and Toxicology.
C1 US FDA, Ctr Vet Med, Rockville, MD 20855 USA.
RP Martinez, MN (reprint author), US FDA, Ctr Vet Med, HFV 100, Rockville, MD 20855 USA.
EM marilyn.martinez@fda.hhs.gov
NR 37
TC 3
Z9 3
U1 0
U2 7
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0140-7783
EI 1365-2885
J9 J VET PHARMACOL THER
JI J. Vet. Pharmacol. Ther.
PD FEB
PY 2014
VL 37
IS 1
BP 2
EP 12
DI 10.1111/jvp.12063
PG 11
WC Pharmacology & Pharmacy; Veterinary Sciences
SC Pharmacology & Pharmacy; Veterinary Sciences
GA 286WG
UT WOS:000329499400003
PM 23841644
ER
PT J
AU Martinez, M
Blondeau, J
Cerniglia, CE
Fink-Gremmels, J
Guenther, S
Hunter, RP
Li, XZ
Papich, M
Silley, P
Soback, S
Toutain, PL
Zhang, Q
AF Martinez, M.
Blondeau, J.
Cerniglia, C. E.
Fink-Gremmels, J.
Guenther, S.
Hunter, R. P.
Li, X. -Z.
Papich, M.
Silley, P.
Soback, S.
Toutain, P. -L.
Zhang, Q.
TI Workshop report: The 2012 Antimicrobial Agents in Veterinary Medicine:
exploring the consequences of antimicrobial drug use: a 3-D approach
SO JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS
LA English
DT Article
ID MUTANT PREVENTION CONCENTRATIONS; RESISTANT STAPHYLOCOCCUS-AUREUS; HUMAN
INTESTINAL MICROFLORA; ESCHERICHIA-COLI; SUBINHIBITORY CONCENTRATIONS;
STREPTOCOCCUS-PNEUMONIAE; BIOFILM FORMATION; SELECTION WINDOW;
ANTIBIOTICS; IMPACT
AB Antimicrobial resistance is a global challenge that impacts both human and veterinary health care. The resilience of microbes is reflected in their ability to adapt and survive in spite of our best efforts to constrain their infectious capabilities. As science advances, many of the mechanisms for microbial survival and resistance element transfer have been identified. During the 2012 meeting of Antimicrobial Agents in Veterinary Medicine (AAVM), experts provided insights on such issues as use vs. resistance, the available tools for supporting appropriate drug use, the importance of meeting the therapeutic needs within the domestic animal health care, and the requirements associated with food safety and food security. This report aims to provide a summary of the presentations and discussions occurring during the 2012 AAVM with the goal of stimulating future discussions and enhancing the opportunity to establish creative and sustainable solutions that will guarantee the availability of an effective therapeutic arsenal for veterinary species.
C1 [Martinez, M.] US FDA, Ctr Vet Med, Rockville, MD 20857 USA.
[Blondeau, J.] Univ Saskatchewan, Saskatoon, SK, Canada.
[Cerniglia, C. E.] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR USA.
[Fink-Gremmels, J.] Univ Utrecht, Div Pharmacol, Inst Risk Assessment Sci, Utrecht, Netherlands.
[Guenther, S.] Free Univ Berlin, Inst Microbiol & Epizoot, Fac Vet, Berlin, Germany.
[Hunter, R. P.] Elanco Anim Hlth, Greenfield, IN USA.
[Li, X. -Z.] Hlth Canada, Vet Drugs Directorate, Ottawa, ON K1A 0L2, Canada.
[Papich, M.] N Carolina State Univ, Coll Vet Med, Raleigh, NC USA.
[Silley, P.] Univ Bradford, MB Consult Ltd, Bradford BD7 1DP, W Yorkshire, England.
[Soback, S.] Minist Agr, Kimron Vet Inst, Natl Residue Control Lab, Bet Dagan, Israel.
[Toutain, P. -L.] Ecole Natl Vet Toulouse, INRA, UMR1331, Toulouse, France.
[Zhang, Q.] Iowa State Univ, Coll Vet Med, Ames, IA USA.
RP Martinez, M (reprint author), US FDA, Ctr Vet Med, Off New Anim Drug Evaluat HFV 100, Rockville, MD 20855 USA.
EM Marilyn.Martinez@fda.hhs.gov
RI Toutain, Pierre-Louis/G-4540-2011; Guenther, Sebastian/O-5005-2014;
Hunter, Robert/A-2306-2008
OI Toutain, Pierre-Louis/0000-0002-8846-8892; Guenther,
Sebastian/0000-0003-0173-7314; Hunter, Robert/0000-0003-1224-2376
NR 76
TC 3
Z9 3
U1 2
U2 20
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0140-7783
EI 1365-2885
J9 J VET PHARMACOL THER
JI J. Vet. Pharmacol. Ther.
PD FEB
PY 2014
VL 37
IS 1
BP E1
EP E16
DI 10.1111/jvp.12104
PG 16
WC Pharmacology & Pharmacy; Veterinary Sciences
SC Pharmacology & Pharmacy; Veterinary Sciences
GA 286WG
UT WOS:000329499400002
PM 24387782
ER
PT J
AU Horton, J
Degheidy, H
Bauer, S
Robey, P
Holmbeck, K
AF Horton, Jason
Degheidy, Heba
Bauer, Steven
Robey, Pamela
Holmbeck, Kenn
TI Regulation of skeletal stem cell multipotency by MT1-MMP.
SO JOURNAL OF BONE AND MINERAL RESEARCH
LA English
DT Meeting Abstract
CT Annual Meeting of the American-Society-for-Bone-and-Mineral-Research
CY SEP 12-15, 2014
CL Houston, TX
SP Amer Soc Bone & Mineral Res
C1 [Horton, Jason] NCI, NIH, Bethesda, MD 20892 USA.
[Degheidy, Heba; Bauer, Steven] US FDA, Lab Stem Cell Biol, Div Cell & Gene Therapies, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Robey, Pamela; Holmbeck, Kenn] Natl Inst Dent & Craniofacial Res, New York, NY USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0884-0431
EI 1523-4681
J9 J BONE MINER RES
JI J. Bone Miner. Res.
PD FEB
PY 2014
VL 29
SU 1
MA SA0249
BP S169
EP S169
PG 1
WC Endocrinology & Metabolism
SC Endocrinology & Metabolism
GA CK9ZS
UT WOS:000356598701201
ER
PT J
AU Rosenfeld, CS
Ferguson, SA
AF Rosenfeld, Cheryl S.
Ferguson, Sherry A.
TI Barnes Maze Testing Strategies with Small and Large Rodent Models
SO Jove-Journal of Visualized Experiments
LA English
DT Article
DE Behavior; Issue 84; spatial navigation; rats; Peromyscus; mice; intra-
and extra-maze cues; learning; memory; latency; search strategy; escape
motivation
ID MICE PEROMYSCUS-MANICULATUS; AGE-RELATED DEFECTS; SPATIAL MEMORY;
ALZHEIMERS-DISEASE; MOUSE MODEL; BISPHENOL-A; WATER-MAZE; HIPPOCAMPAL
NEUROGENESIS; DEVELOPMENTAL EXPOSURE; COGNITIVE IMPAIRMENT
AB Spatial learning and memory of laboratory rodents is often assessed via navigational ability in mazes, most popular of which are the water and dry-land (Barnes) mazes. Improved performance over sessions or trials is thought to reflect learning and memory of the escape cage/platform location. Considered less stressful than water mazes, the Barnes maze is a relatively simple design of a circular platform top with several holes equally spaced around the perimeter edge. All but one of the holes are false-bottomed or blind-ending, while one leads to an escape cage. Mildly aversive stimuli (e.g. bright overhead lights) provide motivation to locate the escape cage. Latency to locate the escape cage can be measured during the session; however, additional endpoints typically require video recording. From those video recordings, use of automated tracking software can generate a variety of endpoints that are similar to those produced in water mazes (e.g. distance traveled, velocity/speed, time spent in the correct quadrant, time spent moving/resting, and confirmation of latency). Type of search strategy (i.e. random, serial, or direct) can be categorized as well. Barnes maze construction and testing methodologies can differ for small rodents, such as mice, and large rodents, such as rats. For example, while extra-maze cues are effective for rats, smaller wild rodents may require intra-maze cues with a visual barrier around the maze. Appropriate stimuli must be identified which motivate the rodent to locate the escape cage. Both Barnes and water mazes can be time consuming as 4-7 test trials are typically required to detect improved learning and memory performance (e.g. shorter latencies or path lengths to locate the escape platform or cage) and/or differences between experimental groups. Even so, the Barnes maze is a widely employed behavioral assessment measuring spatial navigational abilities and their potential disruption by genetic, neurobehavioral manipulations, or drug/toxicant exposure.
C1 [Rosenfeld, Cheryl S.] Univ Missouri, Biomed Sci & Bond Life Sci Ctr, Columbia, MO 65211 USA.
[Ferguson, Sherry A.] US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
RP Rosenfeld, CS (reprint author), Univ Missouri, Biomed Sci & Bond Life Sci Ctr, Columbia, MO 65211 USA.
EM rosenfeldc@missouri.edu; Sherry.Ferguson@fda.hhs.gov
FU NIH [RC1 ES018195]; University of Missouri College of Veterinary
Medicine; National Center for Toxicological Research/FDA [E7318]; Mizzou
Advantage Grant
FX The authors acknowledge Mr. Eldin Jasarevic, Mr. Scott Williams, Mr.
Roger W. Meissen, Sarah A. Johnson, Dr. R. Michael Roberts, Dr. Mark R.
Ellersieck, and Dr. David C. Geary at the University of Missouri, and
Mr. C. Delbert Law and the animal care staff at the National Center for
Toxicological Research/FDA. This work was supported by an NIH Challenge
Grant to Grant to CSR (RC1 ES018195), a Mizzou Advantage Grant to (CSR
and DCG), a University of Missouri College of Veterinary Medicine
faculty award (CSR), and protocol E7318 at the National Center for
Toxicological Research/FDA.
NR 64
TC 4
Z9 4
U1 3
U2 15
PU JOURNAL OF VISUALIZED EXPERIMENTS
PI CAMBRIDGE
PA 1 ALEWIFE CENTER, STE 200, CAMBRIDGE, MA 02140 USA
SN 1940-087X
J9 JOVE-J VIS EXP
JI J. Vis. Exp.
PD FEB
PY 2014
IS 84
AR e51194
DI 10.3791/51194
PG 15
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA CA0JL
UT WOS:000348604100049
PM 24637673
ER
PT J
AU Baeva, LF
Lyle, DB
Rios, M
Langone, JJ
Lightfoote, MM
AF Baeva, Larissa F.
Lyle, Daniel B.
Rios, Maria
Langone, John J.
Lightfoote, Marilyn M.
TI Different molecular weight hyaluronic acid effects on human macrophage
interleukin 1 beta production
SO JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART A
LA English
DT Article
DE biomaterials; interleukin 1; inflammation; macrophage; hyaluronic acid
ID NITRIC-OXIDE PRODUCTION; ALVEOLAR MACROPHAGES; DENDRITIC CELLS; DERMAL
FILLERS; DANGER SIGNAL; IN-VITRO; OLIGOSACCHARIDES; GROWTH;
LIPOPOLYSACCHARIDE; FRAGMENTS
AB This study examined the effect of hyaluronan (HA) molecular weight on immune response. HA with molecular weights ranging from the unitary disaccharide unit (400 Da) up to 1.7 x 10(6) Da and with very low endotoxin contamination level (less than 0.03 EU/mg) was used. Primary human monocyte/macrophage cultures were assayed for IL-1 production under a variety of inflammatory conditions with or without HA. Under the highest inflammatory states, production of interleukin 1 (IL-1) was suppressed in the presence of high molecular weight hyaluronan (HMW-HA) and in the presence of low molecular weight hyaluronan (LMW-HA) at mg/mL concentrations. There was variability in the sensitivity of the response to HA fragments with MW below 5000 Da at micromolar concentrations. There was variability in IL-1 cytokine productions from donor to donor in unstimulated human cell cultures. This study supplements our previous published study that investigated the immunogenic effect of HA molecular weights using murine cell line RAW264.6, rat splenocytes, and rat adherent differentiated primary macrophages. These data support the hypothesis that if the amount of endotoxin is reduced to an extremely low level, LMW-HA may not directly provoke normal tissue macrophage-mediated inflammatory reactions. (c) 2013 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 102A: 305-314, 2014.
C1 [Baeva, Larissa F.; Lyle, Daniel B.; Langone, John J.; Lightfoote, Marilyn M.] US FDA, Div Biol, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Rios, Maria] US FDA, Lab Emerging Pathogens, Div Emerging & Transfus, Off Blood Res & Review,Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Baeva, LF (reprint author), US FDA, Div Biol, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Larissa.Baeva@fda.hhs.gov
NR 43
TC 15
Z9 15
U1 2
U2 30
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1549-3296
EI 1552-4965
J9 J BIOMED MATER RES A
JI J. Biomed. Mater. Res. Part A
PD FEB
PY 2014
VL 102
IS 2
BP 305
EP 314
DI 10.1002/jbm.a.34704
PG 10
WC Engineering, Biomedical; Materials Science, Biomaterials
SC Engineering; Materials Science
GA 269MT
UT WOS:000328246100001
PM 23533059
ER
PT J
AU Zhu, JQ
Fan, XH
Cheng, YY
Agarwal, R
Moore, CMV
Chen, ST
Tong, WD
AF Zhu, Jieqiang
Fan, Xiaohui
Cheng, Yiyu
Agarwal, Rajiv
Moore, Christine M. V.
Chen, Shaw T.
Tong, Weida
TI Chemometric Analysis for Identification of Botanical Raw Materials for
Pharmaceutical Use: A Case Study Using Panax notoginseng
SO PLOS ONE
LA English
DT Article
ID CHROMATOGRAPHIC FINGERPRINTS; QUALITY-CONTROL; DISCRIMINATION; SAPONINS;
ROOTS
AB The overall control of the quality of botanical drugs starts from the botanical raw material, continues through preparation of the botanical drug substance and culminates with the botanical drug product. Chromatographic and spectroscopic fingerprinting has been widely used as a tool for the quality control of herbal/botanical medicines. However, discussions are still on-going on whether a single technique provides adequate information to control the quality of botanical drugs. In this study, high performance liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC), capillary electrophoresis (CE) and near infrared spectroscopy (NIR) were used to generate fingerprints of different plant parts of Panax notoginseng. The power of these chromatographic and spectroscopic techniques to evaluate the identity of botanical raw materials were further compared and investigated in light of the capability to distinguishing different parts of Panax notoginseng. Principal component analysis (PCA) and clustering results showed that samples were classified better when UPLC- and HPLC-based fingerprints were employed, which suggested that UPLC- and HPLC-based fingerprinting are superior to CE- and NIR-based fingerprinting. The UPLC- and HPLC-based fingerprinting with PCA were able to correctly distinguish between samples sourced from rhizomes and main root. Using chemometrics and its ability to distinguish between different plant parts could be a powerful tool to help assure the identity and quality of the botanical raw materials and to support the safety and efficacy of the botanical drug products.
C1 [Zhu, Jieqiang; Fan, Xiaohui; Cheng, Yiyu] Zhejiang Univ, Coll Pharmaceut Sci, Pharmaceut Informat Inst, Hangzhou 310003, Zhejiang, Peoples R China.
[Agarwal, Rajiv; Moore, Christine M. V.] US FDA, Off New Drug Qual Assessment, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Chen, Shaw T.] US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Tong, Weida] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Fan, XH (reprint author), Zhejiang Univ, Coll Pharmaceut Sci, Pharmaceut Informat Inst, Hangzhou 310003, Zhejiang, Peoples R China.
EM fanxh@zju.edu.cn; rajiv.agarwal@fda.hhs.gov; weida.tong@fda.hhs.gov
FU US FDA; National Basic Research Program of China [2012CB518405]
FX The authors thank US FDA for financial assistance given under CDER's
Regulatory Science and Review Enhancement (RSR) Program to RA.
Participants from Zhejiang University were partially supported by the
National Basic Research Program of China (No. 2012CB518405). The funders
had no role in study design, data collection and analysis, decision to
publish, or preparation of the manuscript.
NR 26
TC 13
Z9 16
U1 7
U2 61
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 31
PY 2014
VL 9
IS 1
AR e87462
DI 10.1371/journal.pone.0087462
PG 10
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 302RF
UT WOS:000330621900115
PM 24498109
ER
PT J
AU Vaclavik, L
Krynitsky, AJ
Rader, JI
AF Vaclavik, Lukas
Krynitsky, Alexander J.
Rader, Jeanne I.
TI Targeted analysis of multiple pharmaceuticals, plant toxins and other
secondary metabolites in herbal dietary supplements by ultra-high
performance liquid chromatography quadrupole-orbital ion trap mass
spectrometry
SO ANALYTICA CHIMICA ACTA
LA English
DT Article
DE Dietary supplements; Pharmaceuticals; Plant toxins; Ultra-high
performance liquid chromatography; Quadrupole-orbitrap mass spectrometer
ID TRADITIONAL CHINESE MEDICINES; SYNTHETIC DRUGS; ADULTERATION;
IDENTIFICATION; FOOD; FEED; MS; EXTRACTION; PESTICIDES; FIBROSIS
AB In this study, an ultra-high performance liquid chromatography-quadrupole-orbital ion trap mass spectrometry (UHPLC-Q-orbitrap MS) method was developed and validated for simultaneous determination of 96 pharmaceuticals, plant toxins, and other plant secondary metabolites in herbal dietary supplements. Target analytes were extracted from samples using the QuEChERS (quick easy cheap effective rugged safe) procedure. The instrument was operated in full MS-data dependent tandem mass spectrometry (full MS-dd-MS/MS) acquisition mode which enabled collection of quantitative high resolution (HR) full mass spectral data and confirmatory HR MS/MS data in a single run. The method provided excellent selectivity in both full MS and dd-MS/MS mode. Under optimized collision energy settings, product ion spectra containing both precursor and two or more product ions were obtained for most of the analytes. Limits of detection (LODs) and limits of quantification (LOQs) for the method differed significantly for the examined matrices. LODs <= 10 mu g kg(-1) and LOQs <= 50 mu g kg(-1) were obtained for 48 to 81% of target compounds across five different matrices. With the exception of highly polar analytes, the optimized QuEChERS extraction procedure provided acceptable recoveries in the range 70%-120%. The precision of the method, characterized as the relative standard deviation (RSD, n=5), was <= 25% and <= 18% at spiking concentrations of 50 mu g kg(-1) and 500 mu g kg(-1), respectively. Because of variations in matrix effects in extracts of herbal dietary supplements that differed in composition, the method of standard additions and an approach based on dilution of matrix components followed by quantification using solvent standards were applied for quantification. The procedure was used to examine commercial dietary supplements for the 96 analytes of interest. To the best of our knowledge, this is the first report of an integrated analysis and quantification of this wide range of compounds. Published by Elsevier B.V.
C1 [Vaclavik, Lukas; Krynitsky, Alexander J.; Rader, Jeanne I.] US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, College Pk, MD 20740 USA.
RP Vaclavik, L (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, 5100 Paint Branch Pkwy,HFS 717, College Pk, MD 20740 USA.
EM Lukas.Vaclavik@fda.hhs.gov
NR 40
TC 32
Z9 34
U1 8
U2 96
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0003-2670
EI 1873-4324
J9 ANAL CHIM ACTA
JI Anal. Chim. Acta
PD JAN 31
PY 2014
VL 810
BP 45
EP 60
DI 10.1016/j.aca.2013.12.006
PG 16
WC Chemistry, Analytical
SC Chemistry
GA 291PO
UT WOS:000329841100008
PM 24439505
ER
PT J
AU Ting, HY
Li, Q
Yang, H
Jin, ML
Zhang, MJ
Ye, LJ
Li, J
Huang, QS
Yin, DC
AF Ting Huyan
Li, Qi
Yang, Hui
Jin, Ming-Liang
Zhang, Ming-Jie
Ye, Lin-Jie
Li, Ji
Huang, Qing-Sheng
Yin, Da-Chuan
TI Protective effect of polysaccharides on simulated microgravity-induced
functional inhibition of human NK cells
SO CARBOHYDRATE POLYMERS
LA English
DT Article
DE Polysaccharide; Human natural killer (NK) cell; Cytotoxicity; Simulated
microgravity (SMG)
ID NATURAL-KILLER-CELLS; SPACE-FLIGHT; CYTOKINE PRODUCTION;
GRIFOLA-FRONDOSA; D-FRACTION; RECEPTOR; TOLL; TLR4; GENE; CYTOTOXICITY
AB Polysaccharides are believed to be strong immunostimulants that can promote the proliferation and activity of T cells, B cells, macrophages and natural killer (NK) cells. This study aimed to investigate the effects of five polysaccharides (Grifola frondosa polysaccharide (GFP), lentinan (LNT), G. lucidum polysaccharide (GLP), Lycium barbarum polysaccharide (LBP) and yeast glucan (YG)) on primary human NK cells under normal or simulated microgravity (SMG) conditions. Our results demonstrated that polysaccharides markedly promoted the cytotoxicity of NK cells by enhancing IFN-gamma and perforin secretion and increasing the expression of the activating receptor NKp30 under normal conditions. Meanwhile polysaccharides can enhance NK cell function under SMG conditions by restoring the expression of the activating receptor NKG2D and reducing the early apoptosis and late apoptosis/necrosis. Moreover, the antibody neutralization test showed that CR3 may be the critical receptor involved in polysaccharides induced NK cells activation. These findings indicated that polysaccharides may be used as immune regulators to promote the health of the public and astronauts during space missions. (C) 2013 Elsevier Ltd. All rights reserved.
C1 [Ting Huyan; Li, Qi; Yang, Hui; Jin, Ming-Liang; Zhang, Ming-Jie; Ye, Lin-Jie; Li, Ji; Huang, Qing-Sheng; Yin, Da-Chuan] Northwestern Polytech Univ, Sch Life Sci, Key Lab Space Biosci & Space Biotechnol, Xian 710072, Shaanxi, Peoples R China.
[Ting Huyan; Yin, Da-Chuan] Northwestern Polytech Univ, Sch Mat Sci & Engn, Xian 710072, Shaanxi, Peoples R China.
[Zhang, Ming-Jie] US FDA, Mol Virol Lab, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
RP Yin, DC (reprint author), Northwestern Polytech Univ, Sch Life Sci, 127 Youyi Xilu, Xian 710072, Shaanxi, Peoples R China.
EM qingshengh@yahoo.com.cn; yindc@nwpu.edu.cn
FU Doctorate Foundation of Northwestern Polytechnical University
[CX201023]; National Natural Science Foundation of China (NSFC)
[31170816, 30971425]
FX We gratefully acknowledge financial support from the Doctorate
Foundation of Northwestern Polytechnical University (CX201023), the
National Natural Science Foundation of China (NSFC, Grant No. 31170816)
and the National Natural Science Foundation of China (NSFC, Grant No.
30971425).
NR 45
TC 1
Z9 1
U1 4
U2 26
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0144-8617
EI 1879-1344
J9 CARBOHYD POLYM
JI Carbohydr. Polym.
PD JAN 30
PY 2014
VL 101
BP 819
EP 827
DI 10.1016/j.carbpol.2013.10.021
PG 9
WC Chemistry, Applied; Chemistry, Organic; Polymer Science
SC Chemistry; Polymer Science
GA 300WN
UT WOS:000330494800103
ER
PT J
AU Wu, HQ
White, M
Berendt, R
Foringer, RD
Khan, M
AF Wu, Huiquan
White, Maury
Berendt, Robert
Foringer, Ryan D.
Khan, Mansoor
TI Integrated Process Analytical Technology Approach for Nucleation
Induction Time Measurement and Nucleation Mechanism Assessment for a
Dynamic Multicomponent Pharmaceutical Antisolvent Crystallization System
SO INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH
LA English
DT Article
ID PRECIPITATION; TEMPERATURE; NAPROXEN; SUPERSATURATION; SPECTROSCOPY;
GROWTH; METASTABILITY; PARACETAMOL; MORPHOLOGY; SULFATE
AB A comprehensive, real-time PAT process monitoring scheme of using near-infrared (NIR) spectroscopy, focused beam reflectance measurement (FBRM), and particle vision microscopy (PVM) was established for process characterization and process understanding of a model dynamic multicomponent pharmaceutical antisolvent crystallization system. The NIR spectra were subjected to principal component analysis (PCA) to construct the process trajectory; and the final products were characterized by X-ray powder diffraction (XRPD), raman spectrometry, and microscopy. Regardless of the PAT technique (i.e., the NIR-PCA method, the FBRM method, and the PVM method) used, this study shows that the nucleation induction time (t(ind)) increases with temperature. In addition, correlations were observed with R-2 of 0.70-0.98 between PVM method and FBRM method and of 0.58-0.84 between NIR-PCA method and FBRM method. Accounting for the dynamic nature of the experiments and changes in the liquid volume (V) as a function of time, a simplified classical nucleation theory model was derived to reveal the relationship between ln(t(ind)V) and (ln S)(-2) (S is the supersaturation ratio). Regions of very strong and very weak dependence on (ln S)(-2) were identified. Final product characterization and in-process observations of particle morphology at t = t(ind) collectively support that heterogeneous- and homogeneous-nucleation mechanisms are responsible for low S and high S regions, respectively. Therefore, the utility of an integrated-PAT approach for understanding a dynamic multicomponent antisolvent crystallization process and elucidating the nucleation mechanism was demonstrated.
C1 [Wu, Huiquan; White, Maury; Berendt, Robert; Foringer, Ryan D.; Khan, Mansoor] US FDA, DPQR, OTR, OPS,CDER, Silver Spring, MD 20993 USA.
RP Wu, HQ (reprint author), US FDA, DPQR, OTR, OPS,CDER, HFD 940,Life Sci Bldg 64,FDA White Oak Campus, Silver Spring, MD 20993 USA.
EM Huiquan.wu@fda.hhs.gov
FU FDA CDER [RSR12-42, RSR13-32]
FX We would like to acknowledge Dr. San Kiang at BMS (New Brunswick, NJ),
Dr. Vincent L. Vilker (currently retired), and Mr. John Casamento at
FDA, Dr. Thomas Wheelock at Iowa State University, Ms. Vaso Vlachos, Mr.
Jack Shu, Mr. Ben Smith, and Mr. Paul Scholl at Mettler-Toledo
(Columbia, MD), and Mr. Steve Ware and Mr. Brendan Simon from Chemglass
Life Science (Vineland, NJ) for their assistances. This work was
partially supported by FDA CDER Regulatory Science and Review (RSR)
Funding RSR12-42 and RSR13-32.
NR 53
TC 7
Z9 7
U1 0
U2 16
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0888-5885
J9 IND ENG CHEM RES
JI Ind. Eng. Chem. Res.
PD JAN 29
PY 2014
VL 53
IS 4
BP 1688
EP 1701
DI 10.1021/ie4036466
PG 14
WC Engineering, Chemical
SC Engineering
GA 302IT
UT WOS:000330598800043
ER
PT J
AU Heckman, CA
Weber, J
Urban, JM
Cayer, ML
Boudreau, NS
AF Heckman, Carol A.
Weber, Jessie
Urban, Jason M.
Cayer, Marilyn L.
Boudreau, Nancy S.
TI Protein Kinase C - Its Role in Protrusion Regulation
SO BIOPHYSICAL JOURNAL
LA English
DT Meeting Abstract
CT 58th Annual Meeting of the Biophysical-Society
CY FEB 15-19, 2014
CL San Francisco, CA
SP Biophys Soc
C1 [Heckman, Carol A.; Weber, Jessie; Cayer, Marilyn L.; Boudreau, Nancy S.] Bowling Green State Univ, Bowling Green, OH 43403 USA.
[Urban, Jason M.] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU CELL PRESS
PI CAMBRIDGE
PA 600 TECHNOLOGY SQUARE, 5TH FLOOR, CAMBRIDGE, MA 02139 USA
SN 0006-3495
EI 1542-0086
J9 BIOPHYS J
JI Biophys. J.
PD JAN 28
PY 2014
VL 106
IS 2
SU 1
BP 169A
EP 170A
PG 2
WC Biophysics
SC Biophysics
GA AI6QE
UT WOS:000337000400840
ER
PT J
AU Pogribny, IP
Rusyn, I
AF Pogribny, Igor P.
Rusyn, Ivan
TI Role of epigenetic aberrations in the development and progression of
human hepatocellular carcinoma
SO CANCER LETTERS
LA English
DT Review
DE Hepatocellular carcinoma; DNA methylation; Histone modifications;
MicroRNAs
ID ACTIVE DNA DEMETHYLATION; PERICENTROMERIC SATELLITE REGIONS; ABERRANT
PROMOTER METHYLATION; GENOME-WIDE HYPOMETHYLATION; HUMAN HEPATOCARCINOMA
CELLS; TUMOR-SUPPRESSOR GENES; HUMAN LIVER-CANCER; MESSENGER-RNA;
HEPATITIS-C; METHIONINE ADENOSYLTRANSFERASE
AB Hepatocellular carcinoma (HCC) is one of the most lethal and prevalent cancers in humans. The molecular mechanisms leading to the development of HCC are extremely complicated and consist of prominent genetic, genomic, and epigenetic alterations. This review summarizes the current knowledge of the role of epigenetic aberrations, including changes in DNA methylation, histone modifications, and expression of microRNAs in the pathogenesis of HCC. It also emphasizes that identification of the underlying epigenetic alterations that drive cell transformation and promote development and progression of HCC is crucially important for understanding mechanisms of hepatocarcinogenesis, its detection, therapeutic intervention, and prevention. Published by Elsevier Ireland Ltd.
C1 [Pogribny, Igor P.] NCTR, Div Biochem Toxicol, Jefferson, AR 72079 USA.
[Rusyn, Ivan] Univ N Carolina, Dept Environm Sci & Engn, Chapel Hill, NC 27599 USA.
RP Pogribny, IP (reprint author), NCTR, Div Biochem Toxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM igor.pogribny@fda.hhs.gov; iir@unc.edu
RI Rusyn, Ivan/S-2426-2016
FU NIH [R01 ES015241, P42 ES005948]
FX This work was supported, in part, by Grants from NIH (R01 ES015241 and
P42 ES005948).
NR 174
TC 51
Z9 57
U1 3
U2 45
PU ELSEVIER IRELAND LTD
PI CLARE
PA ELSEVIER HOUSE, BROOKVALE PLAZA, EAST PARK SHANNON, CO, CLARE, 00000,
IRELAND
SN 0304-3835
EI 1872-7980
J9 CANCER LETT
JI Cancer Lett.
PD JAN 28
PY 2014
VL 342
IS 2
SI SI
BP 223
EP 230
DI 10.1016/j.canlet.2012.01.038
PG 8
WC Oncology
SC Oncology
GA 278ZJ
UT WOS:000328928100008
PM 22306342
ER
PT J
AU Cole, C
Krampis, K
Karagiannis, K
Almeida, JS
Faison, WJ
Motwani, M
Wan, Q
Golikov, A
Pan, Y
Simonyan, V
Mazumder, R
AF Cole, Charles
Krampis, Konstantinos
Karagiannis, Konstantinos
Almeida, Jonas S.
Faison, William J.
Motwani, Mona
Wan, Quan
Golikov, Anton
Pan, Yang
Simonyan, Vahan
Mazumder, Raja
TI Non-synonymous variations in cancer and their effects on the human
proteome: workflow for NGS data biocuration and proteome-wide analysis
of TCGA data
SO BMC BIOINFORMATICS
LA English
DT Article
DE SRA; TCGA; nsSNV; SNV; SNP; Next-gen; NGS; Phylogenetics; Cancer
ID CONVERTING-ENZYME GENE; RHO-FAMILY GTPASES; BREAST-CANCER; HUMAN GENOME;
CLASSIFICATION-SYSTEM; SEQUENCING DATA; CELL-CELL; INFORMATION;
MUTATIONS; RESOURCE
AB Background: Next-generation sequencing (NGS) technologies have resulted in petabytes of scattered data, decentralized in archives, databases and sometimes in isolated hard-disks which are inaccessible for browsing and analysis. It is expected that curated secondary databases will help organize some of this Big Data thereby allowing users better navigate, search and compute on it.
Results: To address the above challenge, we have implemented a NGS biocuration workflow and are analyzing short read sequences and associated metadata from cancer patients to better understand the human variome. Curation of variation and other related information from control (normal tissue) and case (tumor) samples will provide comprehensive background information that can be used in genomic medicine research and application studies. Our approach includes a CloudBioLinux Virtual Machine which is used upstream of an integrated High-performance Integrated Virtual Environment (HIVE) that encapsulates Curated Short Read archive (CSR) and a proteome-wide variation effect analysis tool (SNVDis). As a proof-of-concept, we have curated and analyzed control and case breast cancer datasets from the NCI cancer genomics program - The Cancer Genome Atlas (TCGA). Our efforts include reviewing and recording in CSR available clinical information on patients, mapping of the reads to the reference followed by identification of non-synonymous Single Nucleotide Variations (nsSNVs) and integrating the data with tools that allow analysis of effect nsSNVs on the human proteome. Furthermore, we have also developed a novel phylogenetic analysis algorithm that uses SNV positions and can be used to classify the patient population. The workflow described here lays the foundation for analysis of short read sequence data to identify rare and novel SNVs that are not present in dbSNP and therefore provides a more comprehensive understanding of the human variome. Variation results for single genes as well as the entire study are available from the CSR website (http://hive.biochemistry.gwu.edu/dna.cgi?cmd=csr).
Conclusions: Availability of thousands of sequenced samples from patients provides a rich repository of sequence information that can be utilized to identify individual level SNVs and their effect on the human proteome beyond what the dbSNP database provides.
C1 [Cole, Charles; Karagiannis, Konstantinos; Faison, William J.; Motwani, Mona; Wan, Quan; Pan, Yang; Mazumder, Raja] George Washington Univ, Med Ctr, Dept Biochem & Mol Med, Washington, DC 20037 USA.
[Krampis, Konstantinos] J Craig Venter Inst, Rockville, MD 20850 USA.
[Almeida, Jonas S.] Univ Alabama Birmingham, Dept Pathol, Div Informat, Birmingham, AL 35294 USA.
[Golikov, Anton; Simonyan, Vahan] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Mazumder, Raja] George Washington Univ, McCormick Genom & Prote Ctr, Washington, DC 20037 USA.
RP Mazumder, R (reprint author), George Washington Univ, Med Ctr, Dept Biochem & Mol Med, Washington, DC 20037 USA.
EM mazumder@gwu.edu
OI Wan, Quan/0000-0003-4289-3487; Pan, Yang/0000-0003-3487-7233
FU Research Participation Program at the Center for Biologics Evaluation
[U01 CA168926]
FX We want to thank P Satti and JH Yu for help with database and interface
development. We thank the TCGA tumor-specific groups for providing the
data. We also thank Robert Foreman and Garrett Fields for providing HIVE
system support. All computations were performed at High-performance
Integrated Virtual Environment (HIVE) located at The George Washington
University and implemented/co-developed by Drs. Raja Mazumder and Vahan
Simonyan. This project is supported in part by U01 CA168926 and Research
Participation Program at the Center for Biologics Evaluation and
Research administered by the Oak Ridge Institute for Science and
Education through an interagency agreement between the U.S. Department
of Energy and the U.S. Food and Drug Administration.
NR 88
TC 7
Z9 7
U1 2
U2 12
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1471-2105
J9 BMC BIOINFORMATICS
JI BMC Bioinformatics
PD JAN 27
PY 2014
VL 15
AR 28
DI 10.1186/1471-2105-15-28
PG 18
WC Biochemical Research Methods; Biotechnology & Applied Microbiology;
Mathematical & Computational Biology
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Mathematical & Computational Biology
GA AF1GY
UT WOS:000334463600001
PM 24467687
ER
PT J
AU Yang, AX
Chong, NJ
Jiang, YF
Catalano, J
Puri, RK
Khleif, SN
AF Yang, Amy X.
Chong, Numju
Jiang, Yufei
Catalano, Jennifer
Puri, Raj K.
Khleif, Samir N.
TI Molecular Characterization of Antigen-Peptide Pulsed Dendritic Cells:
Immature Dendritic Cells Develop a Distinct Molecular Profile when
Pulsed with Antigen Peptide
SO PLOS ONE
LA English
DT Article
ID NECROSIS-FACTOR-ALPHA; OLIGONUCLEOTIDE MICROARRAYS; INTERFERON-GAMMA;
GENE-EXPRESSION; CERVICAL-CANCER; TUMOR-ANTIGEN; IN-VITRO; MATURATION;
INDUCTION; IMMUNITY
AB As dendritic cells (DCs) are the most potent professional antigen-presenting cells, they are being tested as cancer vaccines for immunotherapy of established cancers. Although numerous studies have characterized DCs by their phenotype and function, few have identified potential molecular markers of antigen presentation prior to vaccination of host. In this study we generated pre-immature DC (piDC), immature DC (iDC), and mature DC (mDC) from human peripheral blood monocytes (PBMC) obtained from HLA-A2 healthy donors, and pulsed them with human papillomavirus E7 peptide (p11-20), a class I HLA-A2 binding antigen. We then characterized DCs for cell surface phenotype and gene expression profile by microarray technology. We identified a set of 59 genes that distinguished three differentiation stages of DCs (piDC, iDC and mDC). When piDC, iDC and mDC were pulsed with E7 peptide for 2 hrs, the surface phenotype did not change, however, iDCs rather than mDCs showed transcriptional response by up-regulation of a set of genes. A total of 52 genes were modulated in iDC upon antigen pulsing. Elongation of pulse time for iDCs to 10 and 24 hrs did not significantly bring further changes in gene expression. The E7 peptide up-modulated immune response (KPNA7, IGSF6, NCR3, TREM2, TUBAL3, IL8, NFKBIA), pro-apoptosis (BTG1, SEMA6A, IGFBP3 and SRGN), anti-apoptosis (NFKBIA), DNA repair (MRPS11, RAD21, TXNRD1), and cell adhesion and cell migration genes (EPHA1, PGF, IL8 and CYR61) in iDCs. We confirmed our results by Q-PCR analysis. The E7 peptide but not control peptide (PADRE) induced up-regulation of NFKB1A gene only in HLA-A2 positive iDCs and not in HLA-A2 negative iDCs. These results suggest that E7 up-regulation of genes is specific and HLA restricted and that these genes may represent markers of antigen presentation and help rapidly assess the quality of dendritic cells prior to administration to the host.
C1 [Yang, Amy X.; Catalano, Jennifer; Puri, Raj K.] US FDA, Tumor Vaccines & Biotechnol Branch, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[Chong, Numju; Jiang, Yufei; Khleif, Samir N.] NCI, Vaccine Branch, Bethesda, MD 20892 USA.
[Khleif, Samir N.] Georgia Regent Univ, Ctr Canc, Augusta, GA USA.
RP Puri, RK (reprint author), US FDA, Tumor Vaccines & Biotechnol Branch, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
EM raj.puri@fda.hhs.gov
NR 26
TC 2
Z9 2
U1 1
U2 6
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 27
PY 2014
VL 9
IS 1
AR e86306
DI 10.1371/journal.pone.0086306
PG 11
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 301BI
UT WOS:000330507300052
PM 24475103
ER
PT J
AU Song, FH
Monroe, D
El-Demerdash, A
Palmer, C
AF Song, Fenhong
Monroe, Douglas
El-Demerdash, Aref
Palmer, Cynthia
TI Screening for multiple weight loss and related drugs in dietary
supplement materials by flow injection tandem mass spectrometry and
their confirmation by liquid chromatography tandem mass spectrometry
SO JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
LA English
DT Article
DE Weight loss drugs; Dietary supplement; Sibutramine; Flow injection;
LC-MS/MS
ID SLIMMING FUNCTIONAL FOODS; SIBUTRAMINE; MS; ADULTERANTS;
DESMETHYLSIBUTRAMINE; TADALAFIL; ANALOGS; HEALTH
AB A new method has been developed using flow injection tandem mass spectrometry to semi-quantitatively screen for weight loss drugs, including sibutramine, N-desmethylsibutramine, N-didesmethylsibutramine, and phenolphthalein in dietary supplements. Positive identification of these drugs in samples was further confirmed and quantified by liquid chromatography tandem mass spectrometry. The degradation products of sibutramine were observed and identified by LC-MS/MS which include N-desmethylsibutramine, N-didesmethylsibutramine, N-formyldesmethylsibutramine, and N-formyldidesmethylsibutramine. Published by Elsevier B.V.
C1 [Song, Fenhong; Monroe, Douglas; El-Demerdash, Aref] US FDA, Method Dev & Total Diet Res Ctr, Lenexa, KS 66214 USA.
[Palmer, Cynthia] US FDA, Philadelphia Lab, Philadelphia, PA 19106 USA.
RP Song, FH (reprint author), US FDA, Method Dev & Total Diet Res Ctr, 11630 W 80th St, Lenexa, KS 66214 USA.
EM fenhong.song@fda.hhs.gov
NR 20
TC 15
Z9 16
U1 1
U2 26
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0731-7085
EI 1873-264X
J9 J PHARMACEUT BIOMED
JI J. Pharm. Biomed. Anal.
PD JAN 25
PY 2014
VL 88
BP 136
EP 143
DI 10.1016/j.jpba.2013.08.031
PG 8
WC Chemistry, Analytical; Pharmacology & Pharmacy
SC Chemistry; Pharmacology & Pharmacy
GA 287HN
UT WOS:000329532800019
PM 24055849
ER
PT J
AU Avula, B
Wang, YH
Wang, M
Avonto, C
Zhao, JP
Smillie, TJ
Rua, DG
Khan, IA
AF Avula, Bharathi
Wang, Yan-Hong
Wang, Mei
Avonto, Cristina
Zhao, Jianping
Smillie, Troy J.
Rua, Diego
Khan, Ikhlas A.
TI Quantitative determination of phenolic compounds by UHPLC-UV-MS and use
of partial least-square discriminant analysis to differentiate
chemo-types of Chamomile/Chrysanthemum flower heads
SO JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
LA English
DT Article
DE Chamomiles; Chrysanthemum morifolium; Asteraceae; UHPLC-UV-QTOF/MS;
Phenolic compounds
ID CHRYSANTHEMUM-MORIFOLIUM EXTRACT; RECUTITA L. RAUSCHERT;
MATRICARIA-CHAMOMILLA; CHAMAEMELUM-NOBILE; APIGENIN; ACIDS; HPLC;
IDENTIFICATION; DERIVATIVES; COUMARINS
AB A new rapid UHPLC-UV-QTOF/MS method has been developed for the simultaneous analysis of nine phenolic compounds [(Z)-2-beta-D-glucopyranosyloxy-4-methoxycinnamic acid (cis-GMCA), chlorogenic acid, (E)-2-beta-D-glucopyranosyloxy-4-methoxycinnamic acid (trans-GMCA), quercetagetin-7-O-beta-D-glucopyranoside, luteolin-7-O-beta-D-glucoside, apigenin-7-O-beta-D-glucoside, chamaemeloside, apigenin 7-O-(6 ''-O-acetyl-beta-D-glucopyranoside), apigenin] and one polyacetylene (tonghaosu) from the flower heads of Chamomile/Chrysanthemum samples. The chromatographic separation was achieved using a reversed phase C-18 column with a mobile phase of water and acetonitrile, both containing 0.05% formic acid. The ten compounds were completely separated within 15 min at a flow rate of 0.25 mL/min with a 2 mu L injection volume. The different chemo-types of Chamomiles/Chrysanthemum displayed variations in the presence of chemical constituents. German Chamomile samples confirmed the presence of cis-GMCA, trans-GMCA, apigenin-7-O-beta-D-glucoside and tonghaosu as major constituents whereas Roman chamomile samples confirmed the presence of chamamaeloside and apigenin as major compounds. The Chrysanthemum monfolium samples showed the presence of luteolin-7-O-beta-D-glucose as the major compound. The method was applied for the analysis of various commercial products including capsules, tea bags, body and hair care products. LC-mass spectrometry with electrospray ionization (ESI) interface method is described for the evaluation of ten compounds in plant samples and commercial products. This method involved the detection of [M+Na](+) and [M+H](+) ions in the positive mode. Partial least squares discriminant analysis (PLS-DA) was used to visualize commercial samples quality and may be of value for discriminating between chamomile types and Chrysanthemum with regards to the relative content of individual constituents. The results indicated that the method is suitable as a quality control test for various Chamomile/Chrysanthemum samples and market products. (C) 2013 Elsevier B.V. All rights reserved.
C1 [Avula, Bharathi; Wang, Yan-Hong; Wang, Mei; Avonto, Cristina; Zhao, Jianping; Smillie, Troy J.; Khan, Ikhlas A.] Univ Mississippi, Pharmaceut Sci Res Inst, Natl Ctr Nat Prod Res, University, MS 38677 USA.
[Khan, Ikhlas A.] Univ Mississippi, Sch Pharm, Dept Pharmacognosy, University, MS 38677 USA.
[Rua, Diego] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Avula, B (reprint author), Univ Mississippi, Pharmaceut Sci Res Inst, Natl Ctr Nat Prod Res, University, MS 38677 USA.
EM bavula@olemiss.edu; ikhan@olemiss.edu
OI Avonto, Cristina/0000-0002-8209-6813
FU Science Based Authentication of Dietary Supplements; Food and Drug
Administration [5U01FD004246]; United States Department of Agriculture,
Agricultural Research Service [58-6408-02-1-612]
FX This research is supported in part by "Science Based Authentication of
Dietary Supplements" funded by the Food and Drug Administration Grant
Number 5U01FD004246, the United States Department of Agriculture,
Agricultural Research Service, Specific Cooperative Agreement No.
58-6408-02-1-612, and the authors would like to thank Annette Ford for
the extractions of plant samples. The authors also would like to thank
Dr. Feng Wei for collecting Chrysanthemum samples.
NR 30
TC 21
Z9 23
U1 5
U2 94
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0731-7085
EI 1873-264X
J9 J PHARMACEUT BIOMED
JI J. Pharm. Biomed. Anal.
PD JAN 25
PY 2014
VL 88
BP 278
EP 288
DI 10.1016/j.jpba.2013.08.037
PG 11
WC Chemistry, Analytical; Pharmacology & Pharmacy
SC Chemistry; Pharmacology & Pharmacy
GA 287HN
UT WOS:000329532800038
PM 24095803
ER
PT J
AU Pawar, RS
Grundel, E
Fardin-Kia, AR
Rader, JI
AF Pawar, Rahul S.
Grundel, Erich
Fardin-Kia, Ali Reza
Rader, Jeanne I.
TI Determination of selected biogenic amines in Acacia rigidula plant
materials and dietary supplements using LC-MS/MS methods
SO JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
LA English
DT Article
DE Acacia rigidula; Biogenic amines; Dietary supplement;
beta-Methylphenethylamine; Amphetamine
ID LABELED INTERNAL STANDARD; MASS-SPECTROMETRY; TOXIC AMINES; ALKALOIDS;
PHENYLETHYLAMINE; AMPHETAMINE; BERLANDIERI; ISOMERS; IDENTIFICATION;
DERIVATIVES
AB Extracts of Acacia rigidula leaves are used in weight-loss products sold in vitamin shops and over the internet with little or no published data about their potential biological effects. In our chemical investigations on authenticated A. rigidula plant material, we established a rapid and sensitive LC-MS/MS method for the quantitative determination of several phenethylamine, tyramine and tryptamine derivatives. Stable isotopically labeled compounds were used as internal standards for quantitative analysis. We found total calculated contents of 6 biogenic amines in A. rigidula leaf of 18.6 and 32.9 mu g/g. The content of selected amines in 21 dietary supplements labeled as containing A. rigidula was determined by a second LC-MS/MS method. Our study revealed significant differences in the amine profiles of authenticated plant materials and dietary supplements. beta-Methylphenethylamine, a non-natural compound, was found in 9 of the 21 dietary supplement products. p-Methylphenethylamine was found at levels of 960-60,500 mu g/g while phenethylamine was found at levels of 710-171,620 mu g/g. beta-methylphenethylamine is a positional isomer of amphetamine and our results showed that it can be misidentified as amphetamine during LC-MS analysis. An independent GC-MS analysis was used to confirm the presence of beta-methylphenethylamine and the absence of amphetamine in dietary supplements labeled as containing A. rigidula. This study demonstrates that confirmations by independent analytical methods are essential to verify findings of unusual or unexpected compounds in dietary supplements. Published by Elsevier B.V.
C1 [Pawar, Rahul S.; Grundel, Erich; Fardin-Kia, Ali Reza; Rader, Jeanne I.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Pawar, RS (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM Rahul.Pawar@fda.hhs.gov
NR 28
TC 20
Z9 20
U1 5
U2 38
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0731-7085
EI 1873-264X
J9 J PHARMACEUT BIOMED
JI J. Pharm. Biomed. Anal.
PD JAN 25
PY 2014
VL 88
BP 457
EP 466
DI 10.1016/j.jpba.2013.09.012
PG 10
WC Chemistry, Analytical; Pharmacology & Pharmacy
SC Chemistry; Pharmacology & Pharmacy
GA 287HN
UT WOS:000329532800060
PM 24176750
ER
PT J
AU Sacks, LV
Shamsuddin, HH
Yasinskaya, YI
Bouri, K
Lanthier, ML
Sherman, RE
AF Sacks, Leonard V.
Shamsuddin, Hala H.
Yasinskaya, Yuliya I.
Bouri, Khaled
Lanthier, Michael L.
Sherman, Rachel E.
TI Scientific and Regulatory Reasons for Delay and Denial of FDA Approval
of Initial Applications for New Drugs, 2000-2012
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Article
ID SURROGATE END-POINTS; CLINICAL-TRIALS; PHASE-III; DISEASE; CANCER; RATES
AB IMPORTANCE Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients.
OBJECTIVE To identify the reasons that FDA marketing approval for new drugs was delayed or denied.
DESIGN, SETTING, AND PARTICIPANTS A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval.
MAIN OUTCOMES AND MEASURES Reasons for delayed FDA approval or nonapproval of NME applications.
RESULTS Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals (61 of 80 never approved [76.3%] vs 28 of 71 eventually approved [39.4%]; difference, 36.9% [95% CI, 20.25% to 50.86%]; P < .001).
CONCLUSIONS AND RELEVANCE Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable study end points, accounted for significant delays in the approval of new drugs. Understanding the reasons for previous failures is helpful to improve the efficiency of clinical development for new drugs.
C1 [Sacks, Leonard V.; Sherman, Rachel E.] US FDA, Off Med Policy, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Shamsuddin, Hala H.; Yasinskaya, Yuliya I.] US FDA, Off Antimicrobial Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Bouri, Khaled] US FDA, Off Crit Path Programs, Off Commissioner, Silver Spring, MD 20993 USA.
[Lanthier, Michael L.] US FDA, Off Commissioner, Silver Spring, MD 20993 USA.
RP Sacks, LV (reprint author), US FDA, Off Med Policy, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Room 6342, Silver Spring, MD 20993 USA.
EM leonard.sacks@fda.hhs.gov
NR 25
TC 30
Z9 30
U1 2
U2 17
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60654-0946 USA
SN 0098-7484
EI 1538-3598
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD JAN 22
PY 2014
VL 311
IS 4
BP 378
EP 384
DI 10.1001/jama.2013.282542
PG 7
WC Medicine, General & Internal
SC General & Internal Medicine
GA 292YT
UT WOS:000329939300023
PM 24449316
ER
PT J
AU Qu, FL
Zhang, Y
Rasooly, A
Yang, MH
AF Qu, Fengli
Zhang, Yi
Rasooly, Avraham
Yang, Minghui
TI Electrochemical Biosensing Platform Using Hydrogel Prepared from
Ferrocene Modified Amino Acid as Highly Efficient Immobilization Matrix
SO ANALYTICAL CHEMISTRY
LA English
DT Article
ID GLUCOSE-OXIDASE; AMPEROMETRIC DETERMINATION; ELECTRODE; HYBRID; LAYER;
CONSTRUCTION; PERFORMANCE; FABRICATION; MULTILAYER; MONOLAYER
AB To increase the loading of glucose oxidase (GOx) and simplify glucose biosensor fabrication, hydrogel prepared from ferrocene (Fc) modified amino acid phenylalanine (Phe, F) was utilized for the incorporation of GOx. The synthesized hydrogel displays good biocompatibility and contains a significant number of Fc moieties, which can be considered as an ideal matrix to immobilize enzymes for the preparation of mediator-based biosensors. The hydrogel was studied by scanning electron microscopy, which indicated that it was composed of nanofibers with a diameter of around 50-100 nm and length extended to 1 mm. With the addition of GOx into the hydrogel and by directly dropping the resulting biocomposite onto the electrode surface, a glucose biosensor, that displays good performance due to improved enzyme loading and efficient electron transfer, can be simply constructed. The favorable network structure and good biocompatibility of the hydrogel could effectively avoid enzyme leakage and maintain the bioactivity of the enzymes, which resulted in good stability of the biosensor. The biosensor was utilized for the detection of glucose in blood samples with results comparable to those obtained from the hospital. The hydrogel as a functional component of an amperometric biosensor has implications for future development of biosensors and for clinical applications.
C1 [Qu, Fengli; Zhang, Yi; Yang, Minghui] Cent S Univ, Coll Chem & Chem Engn, Minist Educ, Key Lab Resources Chem Nonferrous Met, Changsha 410083, Hunan, Peoples R China.
[Qu, Fengli] Qufu Normal Univ, Coll Chem & Chem Engn, Qufu 273165, Shandong, Peoples R China.
[Rasooly, Avraham] FDA, Off Sci & Engn, Div Biol, Silver Spring, MD 20993 USA.
RP Yang, MH (reprint author), Cent S Univ, Coll Chem & Chem Engn, Minist Educ, Key Lab Resources Chem Nonferrous Met, Changsha 410083, Hunan, Peoples R China.
EM yangminghui@csu.edu.cn
FU National Natural Science Foundation of China [21105128, 21375076,
20973201, 91127024]; National Key Basic Research Program of China
[2014CB744502]
FX We are grateful for the support of the National Natural Science
Foundation of China (21105128, 21375076, 20973201, and 91127024) and the
National Key Basic Research Program of China (2014CB744502). The authors
acknowledge Dr. Rodney Priestley from Princeton University for editorial
assistance.
NR 38
TC 32
Z9 32
U1 9
U2 100
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0003-2700
EI 1520-6882
J9 ANAL CHEM
JI Anal. Chem.
PD JAN 21
PY 2014
VL 86
IS 2
BP 973
EP 976
DI 10.1021/ac403478z
PG 4
WC Chemistry, Analytical
SC Chemistry
GA 296SA
UT WOS:000330204500002
PM 24383679
ER
PT J
AU Walker, BN
James, RH
Calogero, D
Ilev, IK
AF Walker, Bennett N.
James, Robert H.
Calogero, Don
Ilev, Ilko K.
TI Impact of environmental temperature on optical power properties of
intraocular lenses
SO APPLIED OPTICS
LA English
DT Article
AB Optical power properties of lenses and materials in general can be influenced by thermal changes of the material and surrounding medium. In the case of an intraocular lens (IOL) implant, the spherical power (SP), cylinder power, (CP), astigmatism, and spherical aberration are the critical fundamental properties that can significantly impact its efficacy. Directly evaluating how changes in temperature can affect these optical properties may show the importance of considering temperature when evaluating IOL optical characteristics. In this paper, we present a quantitative study on evaluating the impact of environmental temperature changes on IOL fundamental optical properties by testing IOL samples with different materials (e.g., hydrophobic and hydrophilic) and designs (e.g., monofocal and toric) to better encompass types of IOLs in conventional use today. The results from this study demonstrate that significant changes are observed as temperatures are changed from room temperature (20 degrees C) to slightly above body temperature (40 degrees C). Findings indicate that evaluating optical properties at arbitrary temperatures could significantly affect the characterization of IOLs that are already near the tolerance thresholds. (C) 2014 Optical Society of America
C1 [Walker, Bennett N.; James, Robert H.; Ilev, Ilko K.] US FDA, Opt Therapeut & Med Nanophoton Lab, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
[Calogero, Don] US FDA, Off Device Evaluat, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Walker, BN (reprint author), US FDA, Opt Therapeut & Med Nanophoton Lab, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
EM bennett.walker@fda.hhs.gov
OI WALKER, BENNETT/0000-0003-0221-1904
FU Oak Ridge Institute for Science and Education (ORISE)
FX The authors wish to thank Lumetrics Incorporation for all of their
support with the commercial aberrometer. This work was also supported by
Oak Ridge Institute for Science and Education (ORISE). In addition, the
laboratory assistance from students Aurin Chakravarty and Samuel Song
significantly helped facilitate the project. The mention of commercial
products, their sources, or their use in connection with material
reported herein is not to be construed as either an actual or implied
endorsement of such products by the Department of Health and Human
Services.
NR 8
TC 4
Z9 4
U1 0
U2 6
PU OPTICAL SOC AMER
PI WASHINGTON
PA 2010 MASSACHUSETTS AVE NW, WASHINGTON, DC 20036 USA
SN 1559-128X
EI 2155-3165
J9 APPL OPTICS
JI Appl. Optics
PD JAN 20
PY 2014
VL 53
IS 3
BP 453
EP 457
DI 10.1364/AO.53.000453
PG 5
WC Optics
SC Optics
GA 296GD
UT WOS:000330172300019
PM 24514132
ER
PT J
AU Weng, ZQ
Zhou, P
Salminen, WF
Yang, X
Harrill, AH
Cao, ZJ
Mattes, WB
Mendrick, DL
Shi, Q
AF Weng, Zuquan
Zhou, Peng
Salminen, William F.
Yang, Xi
Harrill, Alison H.
Cao, Zhijun
Mattes, William B.
Mendrick, Donna L.
Shi, Qiang
TI Green tea epigallocatechin gallate binds to and inhibits respiratory
complexes in swelling but not normal rat hepatic mitochondria
SO BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS
LA English
DT Article
DE Green tea; Epigallocatechin gallate; Mitochondria; Respiratory chain
complexes; Rat; Liver
ID PERMEABILITY TRANSITION PORE; INDUCED LIVER-INJURY; CELL-DEATH;
ACETAMINOPHEN HEPATOTOXICITY; POLYPHENON-E; MECHANISMS; MOUSE;
HEPATOCYTES; APOPTOSIS; CATECHINS
AB Epigallocatechin gallate (EGCG), the major flavonoid in green tea, is consumed via tea products and dietary supplements, and has been tested in clinical trials. However, EGCG can cause hepatotoxicity in humans and animals by unknown mechanisms. Here EGCG effects on rat liver mitochondria were examined. EGCG showed negligible effects on oxidative phosphorylation at 7.5-100 mu M in normal mitochondria. However, respiratory chain complexes (RCCs) were profoundly inhibited by EGCG in mitochondria undergoing Ca2+ overload-induced mitochondrial permeability transition (MPT). As RCCs are located in mitochondrial inner membranes (IM) and matrix, it was reasoned that EGCG could not readily pass through IM to affect RCCs in normal mitochondria but may do so when IM integrity is compromised. This speculation was substantiated in three ways. (1) Purified EGCG-bound proteins were barely detectable in normal mitochondria and contained no RCCs as determined by Western blotting, but swelling mitochondria contained about 1.5-fold more EGCG-bound proteins which included four RCC subunits together with cyclophilin D that locates in mitochondrial matrix. (2) Swelling mitochondria consumed more EGCG than normal ones. (3) The MPT blocker cyclosporine A diminished the above-mentioned difference. Among four subunits of RCC II, only SDHA and SDHB which locate in mitochondrial matrix, but not SDHC or SDHD which insert into the IM, were found to be EGCG targets. Interestingly, EGCG promoted Ca2+ overload-induced MPT only when moderate MPT already commenced. This study identified hepatic RCCs as targets for EGCG in swelling but not normal mitochondria, suggesting EGCG may trigger hepatotoxicity by worsening pre-existing mitochondria abnormalities. Published by Elsevier Inc.
C1 [Weng, Zuquan; Zhou, Peng; Salminen, William F.; Yang, Xi; Cao, Zhijun; Mendrick, Donna L.; Shi, Qiang] US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Harrill, Alison H.] Univ Arkansas Med Sci, Dept Occupat & Environm Hlth, Little Rock, AR 72205 USA.
[Mattes, William B.] PharmPoint Consulting, Poolesville, MD 20837 USA.
RP Shi, Q (reprint author), US FDA, Div Syst Biol, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM Qiang.Shi@fda.hhs.gov
FU National Center for Toxicological Research
FX Drs. Zuquan Weng and Peng Zhou are supported by the Research
Participation Program at the National Center for Toxicological Research
administrated by the Oak Ridge Institute for Science and Education
through an interagency agreement between the U.S. Department of Energy
and the U.S. Food and Drug Administration. Dr. William Mattes is a
contractor with the FDA NCTR.
NR 29
TC 7
Z9 7
U1 0
U2 11
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0006-291X
EI 1090-2104
J9 BIOCHEM BIOPH RES CO
JI Biochem. Biophys. Res. Commun.
PD JAN 17
PY 2014
VL 443
IS 3
BP 1097
EP 1104
DI 10.1016/j.bbrc.2013.12.110
PG 8
WC Biochemistry & Molecular Biology; Biophysics
SC Biochemistry & Molecular Biology; Biophysics
GA AA9LM
UT WOS:000331415000052
PM 24384371
ER
PT J
AU Gu, Q
Yu, LR
AF Gu, Qiang
Yu, Li-Rong
TI Proteomics quality and standard: From a regulatory perspective
SO JOURNAL OF PROTEOMICS
LA English
DT Review
DE Proteomics; Mass spectrometry; Quality control; Standards; Biomarker
qualification; Regulatory decision
ID TANDEM MASS-SPECTROMETRY; COMPLEX PROTEIN MIXTURES; QUANTITATIVE
PROTEOMICS; MINIMUM INFORMATION; GEL-ELECTROPHORESIS; GUIDELINES;
QUANTIFICATION; CHROMATOGRAPHY; PERFORMANCE; REAGENTS
AB Proteomics has emerged as a rapidly expanding field dealing with large-scale protein analyses. It is anticipated that proteomics data will be increasingly submitted to the U.S. Food and Drug Administration (FDA) for biomarker qualification or in conjunction with applications for the approval of drugs, medical devices, and other FDA-regulated consumer products. To date, however, no established guideline has been available regarding the generation, submission and assessment of the quality of proteomics data that will be reviewed by regulatory agencies for decision making. Therefore, this commentary is aimed at provoking some thoughts and debates towards developing a framework which can guide future proteomics data submission. The ultimate goal is to establish quality control standards for proteomics data generation and evaluation, and to prepare government agencies such as the FDA to meet future obligations utilizing proteomics data to support regulatory decision. Published by Elsevier B.V.
C1 [Gu, Qiang; Yu, Li-Rong] US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Yu, LR (reprint author), US FDA, Biomarkers & Alternat Models Branch, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM Lirong.Yu@fda.hhs.gov
FU FDA Commissioner's Fellowship Program
FX The mass spectrometry proteomics data have been deposited to the
ProteomeXchange Consortium (http://proteomecentral. proteomexchange.org)
via the PRIDE partner repository [53] with the dataset identifier
PXDO00334. This work was supported in part by FDA Commissioner's
Fellowship Program and by an appointment to the Reiearch Participation
Program at the National Center for Toxicological Research administered
by the Oak Ridge Institute for Science and Education through an
interagency agreement between the U.S. Department of Energy and the U.S.
Food and Drug Administration. We wish to thank Yuan Gao, Ricky Holland,
Xiaoqing Guo, Nan Mei, Reagan Kelly, Joshua Xu, and Hong Fang for
providing various levels of help and assistance throughout this study.
The views expressed here are those of the authors and not necessarily of
the U.S. Food and Drug Administration, nor does mention of trade names,
commercial products, or organizations imply endorsement by the U.S.
Government.
NR 52
TC 5
Z9 5
U1 2
U2 13
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1874-3919
EI 1876-7737
J9 J PROTEOMICS
JI J. Proteomics
PD JAN 16
PY 2014
VL 96
BP 353
EP 359
DI 10.1016/j.jprot.2013.11.024
PG 7
WC Biochemical Research Methods
SC Biochemistry & Molecular Biology
GA AB6RD
UT WOS:000331916300028
PM 24316359
ER
PT J
AU Belcher, JD
Chen, CS
Nguyen, J
Milbauer, LM
Abdulla, F
Alayash, AI
Smith, A
Nath, KA
Hebbel, RP
Vercellotti, GM
AF Belcher, John D.
Chen, Chunsheng
Julia Nguyen
Milbauer, Liming
Abdulla, Fuad
Alayash, Abdu I.
Smith, Ann
Nath, Karl A.
Hebbel, Robert P.
Vercellotti, Gregory M.
TI Heme triggers TLR4 signaling leading to endothelial cell activation and
vaso-occlusion in murine sickle cell disease
SO BLOOD
LA English
DT Article
ID OXYGEN SPECIES GENERATION; TRANSGENIC MICE; P-SELECTIN; HEMOLYTIC
DISEASES; VASCULAR OCCLUSION; NITRIC-OXIDE; KAPPA-B; HEMOGLOBIN;
HEMOPEXIN; RECEPTOR
AB Treatment of sickle cell disease (SCD) is hampered by incomplete understanding of pathways linking hemolysis to vaso-occlusion. We investigated these pathways in transgenic sickle mice. Infusion of hemoglobin or heme triggered vaso-occlusion in sickle, but not normal, mice. Methemoglobin, but not heme-stabilized cyanomethemoglobin, induced vaso-occlusion, indicating heme liberation is necessary. In corroboration, hemoglobin-induced vaso-occlusion was blocked by the methemoglobin reducing agent methylene blue, haptoglobin, or the heme-binding protein hemopexin. Untreated HbSS mice, but not HbAA mice, exhibited similar to 10% vaso-occlusion in steady state that was inhibited by haptoglobin or hemopexin infusion. Antibody blockade of adhesion molecules P-selectin, von Willebrand factor (VWF), E-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule 1, platelet endothelial cell (EC) adhesion molecule 1, alpha 4 beta 1, or alpha V beta 3 integrin prevented vaso-occlusion. Heme rapidly (5 minutes) mobilized Weibel-Palade body (WPB) P-selectin and VWF onto EC and vessel wall surfaces and activated EC nuclear factor kappa B (NF-kappa B). This was mediated by TLR4 as TAK-242 blocked WPB degranulation, NF-kappa B activation, vaso-occlusion, leukocyte rolling/adhesion, and heme lethality. TLR4(-/-) mice transplanted with TLR4(+/+) sickle bone marrow exhibited no heme-induced vaso-occlusion. The TLR4 agonist lipopolysaccharide (LPS) activated ECs and triggered vaso-occlusion that was inhibited by TAK-242, linking hemolysis-and infection-induced vaso-occlusive crises to TLR4 signaling. Heme and LPS failed to activate VWF and NF-kappa B in TLR4(-/-) ECs. Anti-LPS immunoglobulin G blocked LPS-induced, but not heme-induced, vaso-occlusion, illustrating LPS-independent TLR4 signaling by heme. Inhibition of protein kinase C, NADPH oxidase, or antioxidant treatment blocked heme-mediated stasis, WPB degranulation, and oxidant production. We conclude that intravascular hemolysis in SCD releases heme that activates endothelial TLR4 signaling leading to WPB degranulation, NF-kappa B activation, and vaso-occlusion.
C1 [Belcher, John D.; Chen, Chunsheng; Julia Nguyen; Milbauer, Liming; Abdulla, Fuad; Hebbel, Robert P.; Vercellotti, Gregory M.] Univ Minnesota, Vasc Biol Ctr, Div Hematol Oncol & Transplantat, Minneapolis, MN 55455 USA.
[Alayash, Abdu I.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Smith, Ann] Univ Missouri, Div Mol Biol & Biochem, Sch Biol Sci, Kansas City, MO 64110 USA.
[Nath, Karl A.] Mayo Clin Fdn, Nephrol Res Unit, Rochester, MN USA.
RP Belcher, JD (reprint author), Univ Minnesota, 420 Delaware St SE,MMC 480, Minneapolis, MN 55455 USA.
EM belcher@umn.edu
RI Abdulla, Fuad/A-3337-2015
FU National Institutes of Health, National Heart, Lung, and Blood Institute
[P01HL55552, HL115467-01, HL1109000-01A1]; Sangart; University of
Missouri Research Board; School of Biological Sciences at University of
Missouri-Kansas City Research Incentive Funds; National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney Diseases
[DK47060]
FX This work was supported by grants from the National Institutes of
Health, National Heart, Lung, and Blood Institute This work was
supported by grants from the National Institutes of Health, National
Heart, Lung, and Blood Institute (P01HL55552; R.P.H. and G.M.V.),
(HL115467-01; G.M.V. and J.D.B.), (HL1109000-01A1; A.I.A.), and by a
research grant award from Sangart (G.M.V. and J.D.B.). Dr Ann Smith
thanks the University of Missouri Research Board and School of
Biological Sciences at University of Missouri-Kansas City Research
Incentive Funds for support. K.A.N. received support from the National
Institutes of Health, National Institute of Diabetes and Digestive and
Kidney Diseases (DK47060). We would like to thank Graham Brown for
preparation of metHb and cyanometHb, Dr Heather Bechtel for assistance
with the graphics in Figure 7, Dr Mark Young and Ashok Malavalli at
Sangart for the preparation and generous gift of stroma-free Hb, Bio
Products Laboratory for the preparation and generous donation of human
haptoglobin, and Bo Hedlund for the generous gift of S-DFO. Michael J.
Franklin read the manuscript and was extremely helpful in making
editorial suggestions.
NR 55
TC 100
Z9 101
U1 4
U2 13
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 2021 L ST NW, SUITE 900, WASHINGTON, DC 20036 USA
SN 0006-4971
EI 1528-0020
J9 BLOOD
JI Blood
PD JAN 16
PY 2014
VL 123
IS 3
BP 377
EP 390
DI 10.1182/blood-2013-04-495887
PG 14
WC Hematology
SC Hematology
GA 290IP
UT WOS:000329748700017
PM 24277079
ER
PT J
AU He, WW
Kim, HK
Warner, WG
Melka, D
Callahan, JH
Yin, JJ
AF He, Weiwei
Kim, Hyun-Kyung
Warner, Wayne G.
Melka, David
Callahan, John H.
Yin, Jun-Jie
TI Photogenerated Charge Carriers and Reactive Oxygen Species in ZnO/Au
Hybrid Nanostructures with Enhanced Photocatalytic and Antibacterial
Activity
SO JOURNAL OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Article
ID ELECTRON-SPIN RESONANCE; AU NANOPARTICLES; TIO2; SEMICONDUCTOR;
TITANIUM; GOLD; DECOMPOSITION; SPECTROSCOPY; CHEMISTRY; MECHANISM
AB Semiconductor nanostructures with photocatalytic activity have the potential for many applications including remediation of environmental pollutants and use in antibacterial products. An effective way for promoting photocatalytic activity is depositing noble metal nanoparticles (NPs) on a semiconductor. In this paper, we demonstrated the successful deposition of Au NPs, having sizes smaller than 3 nm, onto ZnO NPs. ZnO/Au hybrid nanostructures having different molar ratios of Au to ZnO were synthesized. It was found that Au nanocomponents even at a very low Au/ZnO molar ratio of 0.2% can greatly enhance the photocatalytic and antibacterial activity of ZnO. Electron spin resonance spectroscopy with spin trapping and spin labeling was used to investigate the enhancing effect of Au NPs on the generation of reactive oxygen species and photoinduced charge carriers. Deposition of Au NPs onto ZnO resulted in a dramatic increase in light-induced generation of hydroxyl radical, superoxide and singlet oxygen, and production of holes and electrons. The enhancing effect of Au was dependent on the molar ratio of Au present in the ZnO/Au nanostructures. Consistent with these results from ESR measurements, ZnO/Au nanostructures also exhibited enhanced photocatalytic and antibacterial activity. These results unveiled the enhanced mechanism of Au on ZnO and these materials have great potential for use in water purification and antibacterial products.
C1 [He, Weiwei] Xuchang Univ, Inst Surface Micro & Nano Mat, Key Lab Micronano Mat Energy Storage & Convers He, Xuchang 461000, Henan, Peoples R China.
[He, Weiwei; Kim, Hyun-Kyung; Warner, Wayne G.; Melka, David; Callahan, John H.; Yin, Jun-Jie] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Kim, Hyun-Kyung] Minist Food & Drug Safety, Food Safety Bur, Cheongwon 363700, South Korea.
RP Yin, JJ (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM junjie.yin@fda.hhs.gov
RI Yin, Jun Jie /E-5619-2014
FU National Natural Science Foundation of China [21303153, 61204009];
Research Project of Basic and Advanced Technology of Henan Province
[112300410106]; Korean Government; FDA Nanotechnology CORES Program;
Office of Cosmetics and Colors, CFSAN/FDA
FX W. He thanks the National Natural Science Foundation of China (Grant No.
21303153 and 61204009) and the Research Project of Basic and Advanced
Technology of Henan Province (Grant No. 112300410106) for support. H. K.
Kim thanks the support from the Korean Government Scholarship Program.
This work was supported by a regulatory science grant under the FDA
Nanotechnology CORES Program and by the Office of Cosmetics and Colors,
CFSAN/FDA. The authors appreciate Dr. Yongbin Zhang in NCTR/ORA
Nanotechnology Core Facility for his assistance with BET measurements
and Prof. Zhi Zheng from Xuchang University for his kind discussions.
NR 43
TC 120
Z9 123
U1 43
U2 300
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0002-7863
J9 J AM CHEM SOC
JI J. Am. Chem. Soc.
PD JAN 15
PY 2014
VL 136
IS 2
BP 750
EP 757
DI 10.1021/ja410800y
PG 8
WC Chemistry, Multidisciplinary
SC Chemistry
GA 294BY
UT WOS:000330018600040
PM 24354568
ER
PT J
AU Fung, KL
Pan, J
Ohnuma, S
Lund, PE
Pixley, JN
Kimchi-Sarfaty, C
Ambudkar, SV
Gottesman, MM
AF Fung, King Leung
Pan, James
Ohnuma, Shinobu
Lund, Paul E.
Pixley, Jessica N.
Kimchi-Sarfaty, Chava
Ambudkar, Suresh V.
Gottesman, Michael M.
TI MDR1 Synonymous Polymorphisms Alter Transporter Specificity and Protein
Stability in a Stable Epithelial Monolayer
SO CANCER RESEARCH
LA English
DT Article
ID MULTIDRUG-RESISTANCE GENE; P-GLYCOPROTEIN ABCB1; HAPLOTYPE PROFILES; ATP
HYDROLYSIS; CELL-LINES; EXPRESSION; BINDING; DRUGS; VARIANT; DISPOSITION
AB The drug efflux function of P-glycoprotein (P-gp) encoded by MDR1 can be influenced by genetic polymorphisms, including two synonymous changes in the coding region of MDR1. Here we report that the conformation of P-gp and its drug efflux activity can be altered by synonymous polymorphisms in stable epithelial monolayers expressing P-gp. Several cell lines with similar MDR1 DNA copy number were developed and termed LLC-MDR1-WT (expresses wild-type P-gp), LLC-MDR1-3H (expresses common haplotype P-gp), and LLC-MDR1-3HA (a mutant that carries a different valine codon in position 3435). These cell lines express similar levels of recombinant mRNA and protein. P-gp in each case is localized on the apical surface of polarized cells. However, the haplotype and its mutant P-gps fold differently from the wild-type, as determined by UIC2 antibody shift assays and limited proteolysis assays. Surface biotinylation experiments suggest that the non-wild-type P-gps have longer recycling times. Drug transport assays show that wild-type and haplotype P-gp respond differently to P-gp inhibitors that block efflux of rhodamine 123 or mitoxantrone. In addition, cytotoxicity assays show that the LLC-MDR1-3H cells are more resistant to mitoxantrone than the LLC-MDR1-WT cells after being treated with a P-gp inhibitor. Expression of polymorphic P-gp, however, does not affect the host cell's morphology, growth rate, or monolayer formation. Also, ATPase activity assays indicate that neither basal nor drug-stimulated ATPase activities are affected in the variant P-gps. Taken together, our findings indicate that "silent" polymorphisms significantly change P-gp function, which would be expected to affect interindividual drug disposition and response. (C)2013 AACR.
C1 [Fung, King Leung; Pan, James; Ohnuma, Shinobu; Lund, Paul E.; Pixley, Jessica N.; Ambudkar, Suresh V.; Gottesman, Michael M.] NCI, Lab Cell Biol, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Kimchi-Sarfaty, Chava] US FDA, Ctr Biol Evaluat & Res, Div Hematol, Bethesda, MD 20892 USA.
RP Gottesman, MM (reprint author), NCI, Lab Cell Biol, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
EM mgottesman@nih.gov
FU Intramural Research Program of the NIH, National Cancer Institute
FX This research was supported by the Intramural Research Program of the
NIH, National Cancer Institute.
NR 48
TC 36
Z9 38
U1 1
U2 6
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 0008-5472
EI 1538-7445
J9 CANCER RES
JI Cancer Res.
PD JAN 15
PY 2014
VL 74
IS 2
BP 598
EP 608
DI 10.1158/0008-5472.CAN-13-2064
PG 11
WC Oncology
SC Oncology
GA 294HB
UT WOS:000330034200019
PM 24305879
ER
PT J
AU Balsam, J
Rasooly, R
Bruck, HA
Rasooly, A
AF Balsam, Joshua
Rasooly, Reuven
Bruck, Hugh Alan
Rasooly, Avraham
TI Thousand-fold fluorescent signal amplification for mHealth diagnostics
SO BIOSENSORS & BIOELECTRONICS
LA English
DT Article
DE Lab-on-a-chip; mHealth; Capillary; Fluorescence; Image stacking; Mobile
phone
ID CELL-PHONE; BIOSENSOR; IMMUNOSENSOR; IMMUNOASSAY; PLATFORM; HEALTH;
SENSOR; POINT
AB The low sensitivity of Mobile Health (mHealth) optical detectors, such as those found on mobile phones, is a limiting factor for many mHealth clinical applications. To improve sensitivity, we have combined two approaches for optical signal amplification: (1) a computational approach based on an image stacking algorithm to decrease the image noise and enhance weak signals, and (2) an optical signal amplifier utilizing a capillary tube array. These approaches were used in a detection system which includes multi-wavelength LEDs capable of exciting many fluorophores in multiple wavelengths, a mobile phone or a webcam as a detector, and capillary tube array configured with 36 capillary tubes for signal enhancement.
The capillary array enables a similar to 100 x increase in signal sensitivity for fluorescein, reducing the limit of detection (LOD) for mobile phones and webcams from 1000 nM to 10 nM. Computational image stacking enables another similar to 10 x increase in signal sensitivity, further reducing the LOD for webcam from 10 nM to 1 nM.
To demonstrate the feasibility of the device for the detection of disease-related biomarkers, adenovirus DNA labeled with SYBR green or fluorescein was analyzed by both our capillary array and a commercial plate reader. The LOD for the capillary array was 5 ug/mL, and that of the plate reader was 1 ug/mL. Similar results were obtained using DNA stained with fluorescein.
The combination of the two signal amplification approaches enables a similar to 1000 x increase in LOD for the webcam platform. This brings it into the range of a conventional plate reader while using a smaller sample volume (10 ul) than the plate reader requires (100 ul). This suggests that such a device could be suitable for biosensing applications where up to 10 fold smaller sample sizes are needed.
The simple optical configuration for mHealth described in this paper employing the combined capillary and image processing signal amplification is capable of measuring weak fluorescent signals without the need of dedicated laboratories. It has the potential to be used to increase sensitivity of other optically based mHealth technologies, and may increase mHealth's clinical utility, especially for telemedicine and for resource-poor settings and global health applications. Published by Elsevier B.V.
C1 [Balsam, Joshua; Rasooly, Avraham] FDA, Div Biol, Off Sci & Engn, Silver Spring, MD 20993 USA.
[Balsam, Joshua; Bruck, Hugh Alan] Univ Maryland, College Pk, MD 20742 USA.
[Rasooly, Reuven] ARS, Western Reg Res Ctr, USDA, Albany, CA 94710 USA.
[Rasooly, Avraham] NCI, Div Canc Biol, Bethesda, MD 20892 USA.
RP Rasooly, A (reprint author), FDA, Div Biol, Off Sci & Engn, Silver Spring, MD 20993 USA.
EM rasoolya@mail.nih.gov
FU FDA's Center for Devices and Radiological Health, Division of Biology;
National Cancer Institute
FX This work was supported by the FDA's Center for Devices and Radiological
Health, Division of Biology and the National Cancer Institute. The views
expressed are those of the authors and do not represent those of the
U.S. Government.
NR 35
TC 9
Z9 9
U1 5
U2 84
PU ELSEVIER ADVANCED TECHNOLOGY
PI OXFORD
PA OXFORD FULFILLMENT CENTRE THE BOULEVARD, LANGFORD LANE, KIDLINGTON,
OXFORD OX5 1GB, OXON, ENGLAND
SN 0956-5663
EI 1873-4235
J9 BIOSENS BIOELECTRON
JI Biosens. Bioelectron.
PD JAN 15
PY 2014
VL 51
BP 1
EP 7
DI 10.1016/j.bios.2013.06.053
PG 7
WC Biophysics; Biotechnology & Applied Microbiology; Chemistry, Analytical;
Electrochemistry; Nanoscience & Nanotechnology
SC Biophysics; Biotechnology & Applied Microbiology; Chemistry;
Electrochemistry; Science & Technology - Other Topics
GA 251CN
UT WOS:000326905500001
PM 23928092
ER
PT J
AU Warfel, JM
Zimmerman, LI
Merkel, TJ
AF Warfel, Jason M.
Zimmerman, Lindsey I.
Merkel, Tod J.
TI Acellular pertussis vaccines protect against disease but fail to prevent
infection and transmission in a nonhuman primate model
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
DE whooping cough; T-cell memory; animal models; adaptive immunity; IL-17
ID BORDETELLA-PERTUSSIS; WHOLE-CELL; CONTROLLED TRIAL; IMMUNITY;
VACCINATION; CHILDREN; RESURGENCE; DIPHTHERIA; RESPONSES; INFANTS
AB Pertussis is a highly contagious respiratory illness caused by the bacterial pathogen Bordetella pertussis. Pertussis rates in the United States have been rising and reached a 50-y high of 42,000 cases in 2012. Although pertussis resurgence is not completely understood, we hypothesize that current acellular pertussis (aP) vaccines fail to prevent colonization and transmission. To test our hypothesis, infant baboons were vaccinated at 2, 4, and 6 mo of age with aP or whole-cell pertussis (wP) vaccines and challenged with B. pertussis at 7 mo. Infection was followed by quantifying colonization in nasopharyngeal washes and monitoring leukocytosis and symptoms. Baboons vaccinated with aP were protected from severe pertussis-associated symptoms but not from colonization, did not clear the infection faster than naive animals, and readily transmitted B. pertussis to unvaccinated contacts. Vaccination with wP induced a more rapid clearance compared with naive and aP-vaccinated animals. By comparison, previously infected animals were not colonized upon secondary infection. Although all vaccinated and previously infected animals had robust serum antibody responses, we found key differences in T-cell immunity. Previously infected animals and wP-vaccinated animals possess strong B. pertussis-specific T helper 17 (Th17) memory and Th1 memory, whereas aP vaccination induced a Th1/Th2 response instead. The observation that aP, which induces an immune response mismatched to that induced by natural infection, fails to prevent colonization or transmission provides a plausible explanation for the resurgence of pertussis and suggests that optimal control of pertussis will require the development of improved vaccines.
C1 [Warfel, Jason M.; Zimmerman, Lindsey I.; Merkel, Tod J.] US EPA, Div Bacterial Parasit & Allergen Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Merkel, TJ (reprint author), US EPA, Div Bacterial Parasit & Allergen Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM tod.merkel@fda.hhs.gov
RI Chiang, Vincent, Ming-Hsien/D-4312-2016
OI Chiang, Vincent, Ming-Hsien/0000-0002-2029-7863
FU Food and Drug Administration; National Institutes of Health/National
Institute of Allergy and Infectious Diseases [Y1-AI-1727-01]; National
Institutes of Health National Center for Research Resources
[P40RR012317, 5R24RR016556-10]
FX We thank Dr. John Dennis, Dr. Jill Ascher, Lewis Shankle, Perry Altland,
and Ernest Madison for technical assistance. We thank Dr. Gary White,
Dr. Roman Wolf, and Dr. James Papin for technical assistance and
critical discussions. We thank Dr. Drusilla Burns and Dr. Scott Stibitz
for critical reading of the manuscript. This work was funded by the Food
and Drug Administration and National Institutes of Health/National
Institute of Allergy and Infectious Diseases through Interagency
Agreement Y1-AI-1727-01. Baboons were obtained from the Oklahoma Baboon
Research Resource. The Oklahoma Baboon Research Resource was supported
by Grants P40RR012317 and 5R24RR016556-10 from the National Institutes
of Health National Center for Research Resources.
NR 54
TC 136
Z9 137
U1 2
U2 21
PU NATL ACAD SCIENCES
PI WASHINGTON
PA 2101 CONSTITUTION AVE NW, WASHINGTON, DC 20418 USA
SN 0027-8424
J9 P NATL ACAD SCI USA
JI Proc. Natl. Acad. Sci. U. S. A.
PD JAN 14
PY 2014
VL 111
IS 2
BP 787
EP 792
DI 10.1073/pnas.1314688110
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 288LW
UT WOS:000329614500054
PM 24277828
ER
PT J
AU Ramirez-Lee, MA
Rosas-Hernandez, H
Salazar-Garcia, S
Gutierrez-Hernandez, JM
Espinosa-Tanguma, R
Gonzalez, FJ
Ali, SF
Gonzalez, C
AF Ramirez-Lee, Manuel A.
Rosas-Hernandez, Hector
Salazar-Garcia, Samuel
Manuel Gutierrez-Hernandez, Jose
Espinosa-Tanguma, Ricardo
Gonzalez, Francisco J.
Ali, Syed F.
Gonzalez, Carmen
TI Silver nanoparticles induce anti-proliferative effects on airway smooth
muscle cells. Role of nitric oxide and muscarinic receptor signaling
pathway
SO TOXICOLOGY LETTERS
LA English
DT Article
DE Nitric oxide; Muscarinic receptor; Silver nanoparticles; Airway;
Proliferation; Apoptosis
ID ALVEOLAR EPITHELIAL-CELLS; SPRAGUE-DAWLEY RATS; INHALATION TOXICITY;
OXIDATIVE STRESS; LUNG-FUNCTION; ASTHMA; INFLAMMATION; ACTIVATION;
INHIBITION; PATHOPHYSIOLOGY
AB Silver nanoparticles (AgNPs) are used to manufacture materials with new properties and functions. However, little is known about their toxic or beneficial effects on human health, especially in the respiratory system, where its smooth muscle (ASM) regulates the airway contractility by different mediators, such as acetylcholine (ACh) and nitric oxide (NO). The aim of this study was to evaluate the effects of AgNPs on ASM cells. Exposure to AgNPs induced ACh-independent expression of the inducible nitric oxide synthase (iNOS) at 100 mu g/mL, associated with excessive production of NO. AgNPs induced the muscarinic receptor activation, since its blockage with atropine and blockage of its downstream signaling pathway inhibited the NO production. AgNPs at 10 and 100 mu g/mL induced ACh-independent prolonged cytotoxicity and decreased cellular proliferation mediated by the muscarinic receptor-iNOS pathway. However, the concentration of 100 mu g/mL of AgNPs induced muscarinic receptor-independent apoptosis, suggesting the activation of multiple pathways. These data indicate that AgNPs induce prolonged cytotoxic and anti-proliferative effects on ASM cells, suggesting an activation of the muscarinic receptor-iNOS pathway. Further investigation is required to understand the full mechanisms of action of AgNPs on ASM under specific biological conditions. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
C1 [Ramirez-Lee, Manuel A.; Rosas-Hernandez, Hector; Salazar-Garcia, Samuel; Gonzalez, Carmen] Univ Autonoma San Luis Potosi, Fac Ciencias Quim, San Luis Potosi 78210, Mexico.
[Espinosa-Tanguma, Ricardo] Univ Autonoma San Luis Potosi, Fac Med, San Luis Potosi 78210, Mexico.
[Manuel Gutierrez-Hernandez, Jose; Gonzalez, Francisco J.] Univ Autonoma San Luis Potosi, San Luis Potosi 78210, Mexico.
[Rosas-Hernandez, Hector; Ali, Syed F.; Gonzalez, Carmen] US FDA, Neurochem Lab, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Gonzalez, C (reprint author), Univ Autonoma San Luis Potosi, Fac Ciencias Quim, Av Manuel Nava 6, San Luis Potosi 78210, Mexico.
EM cgonzalez.uaslp@gmail.com
RI Hector, Rosas-Hernandez/J-5130-2015;
OI Rosas-Hernandez, Hector/0000-0002-2736-8302
FU Integral Program for Institutional Support [C10-PIFI-03.02.02]; National
Council of Science and Technology of Mexico [407087]
FX We want to thank to Mr. Daniel Alberto Maldonado Ortega for technical
assistance. This work was supported by Integral Program for
Institutional Support Grant C10-PIFI-03.02.02 and National Council of
Science and Technology of Mexico Fellowship for Manuel Alejandro Ramirez
Lee (407087).
NR 77
TC 9
Z9 9
U1 0
U2 11
PU ELSEVIER IRELAND LTD
PI CLARE
PA ELSEVIER HOUSE, BROOKVALE PLAZA, EAST PARK SHANNON, CO, CLARE, 00000,
IRELAND
SN 0378-4274
EI 1879-3169
J9 TOXICOL LETT
JI Toxicol. Lett.
PD JAN 13
PY 2014
VL 224
IS 2
BP 246
EP 256
DI 10.1016/j.toxlet.2013.10.027
PG 11
WC Toxicology
SC Toxicology
GA 264OV
UT WOS:000327889300011
PM 24188929
ER
PT J
AU Jitian, S
White, SR
Yang, HHW
Weisz, A
AF Jitian, Simion
White, Samuel R.
Yang, H. -H. Wendy
Weisz, Adrian
TI Conventional high-performance liquid chromatography versus derivative
spectrophotometry for the determination of 1,3,6-pyrenetrisulfonic acid
trisodium salt and 1,3,6,8-pyrenetetrasulfonic acid tetrasodium salt in
the color additive D&C Green No. 8 (Pyranine)
SO JOURNAL OF CHROMATOGRAPHY A
LA English
DT Article; Proceedings Paper
CT 244th National Fall Meeting of the American-Chemical-Society (ACS)
CY AUG 19-23, 2012
CL Philadelphia, PA
SP Amer Chem Soc, Div Hist Chem, Amer Chem Soc, Amer Chem Soc, Div Chem Educ
DE D&C Green No. 8; Pyranine; 1,3,6-Pyrenetrisulfonic acid sodium salt;
1,3,6,8-Pyrenetetrasulfonic acid sodium salt; HPLC; Derivative
spectrophotometry
ID SUBSIDIARY COLORS; PHLOXINE-B; PRODUCTS; IDENTIFICATION; HPLC
AB Specifications in the U.S. Code of Federal Regulations for the color additive D&C Green No. 8 (Colour Index No. 59040) limit the levels of the subsidiary colors 1,3,6-pyrenetrisulfonic acid trisodium salt (P3S) and 1,3,6,8-pyrenetetrasulfonic acid tetrasodium salt (P4S). The present paper describes a comparative study of two possible methods to replace the currently used multi-step TLC/spectrophotometry method of separating and quantifying the minor components P3S and P4S in G8. One of the new approaches uses conventional high-performance liquid chromatography (HPLC) and the other, derivative spectrophotometry. While the derivative spectrophotometric method was shown to be inadequate for the analysis of minor components overwhelmed by components of much higher concentration, the HPLC method was proven highly effective. The closely related, very polar compounds P3S and P4S were separated by the new HPLC method in less than 4 min using a conventional HPLC instrument. P3S and P4S were quantified by using five-point calibration curves with data points that ranged from 0.45 to 7.63% and from 0.13 to 1.82%, by weight, for P3S and P4S, respectively. The HPLC method was applied to the analysis of test portions from 20 batches of D&C Green No. 8 submitted to the U.S. Food and Drug Administration for certification. Published by Elsevier B.V.
C1 [Jitian, Simion] Politehn Univ Timisoara, Fac Engn Hunedoara, Timisoara, Romania.
[White, Samuel R.; Yang, H. -H. Wendy; Weisz, Adrian] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Weisz, A (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM adrian.weisz@fda.hhs.gov
NR 19
TC 1
Z9 1
U1 2
U2 16
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0021-9673
EI 1873-3778
J9 J CHROMATOGR A
JI J. Chromatogr. A
PD JAN 10
PY 2014
VL 1324
BP 238
EP 241
DI 10.1016/j.chroma.2013.11.033
PG 4
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 297LE
UT WOS:000330256100031
PM 24315677
ER
PT J
AU Jin, TC
Wang, Y
Chen, YW
Fu, TJ
Kothary, MH
McHugh, TH
Zhang, YZ
AF Jin, Tengchuan
Wang, Yang
Chen, Yu-Wei
Fu, Tong-Jen
Kothary, Mahendra H.
McHugh, Tara H.
Zhang, Yuzhu
TI Crystal Structure of Korean Pine (Pinus koraiensis) 7S Seed Storage
Protein with Copper Ligands
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE 7S vicilin; pine nut; allergen; X-ray crystallography; copper protein
ID MAJOR PEANUT ALLERGEN; ARA H 1; TREE NUT ALLERGENS;
CHEMICAL-COMPOSITION; MOLECULAR GRAPHICS; FOOD ALLERGY; PROGRAM;
VICILIN; CRYSTALLIZATION; PURIFICATION
AB The prevalence of food allergy has increased in recent years, and Korean pine vicilin is a potential food allergen. We have previously reported the crystallization of Korean pine vicilin purified from raw pine nut. Here we report the isolation of vicilin mRNA and the crystal structure of Korean pine vicilin at 2.40 angstrom resolution. The overall structure of pine nut vicilin is similar to the structures of other 7S seed storage proteins and consists of an N-terminal domain and a C-terminal domain. Each assumes a cupin fold, and they are symmetrically related about a pseudodyad axis. Three vicilin molecules form a doughnut-shaped trimer through head-to-tail association. Structure characterization of Korean pine nut vicilin unexpectedly showed that, in its native trimeric state, the vicilin has three copper ligands. Sequence alignments suggested that the copper-coordinating residues were conserved in winter squash, sesame, tomato, and several tree nuts, while they were not conserved in a number of legumes, including peanut and soybean. Additional studies are needed to assess whether the copper-coordinating property of vicilins has a biological function in the relevant plants. The nutritional value of this copper-coordinating protein in tree nuts and other edible seeds may be worth further investigations.
C1 [Jin, Tengchuan; Wang, Yang; Chen, Yu-Wei] IIT, Dept Biol, Chicago, IL 60616 USA.
[Fu, Tong-Jen] US FDA, Ctr Food Safety & Appl Nutr, Bedford Pk, IL 60501 USA.
[Kothary, Mahendra H.] US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
[McHugh, Tara H.; Zhang, Yuzhu] ARS, Western Reg Res Ctr, USDA, Albany, CA 94710 USA.
RP Jin, TC (reprint author), NIAID, Struct Immunobiol Unit, Immunol Lab, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
EM tengchuan@gmail.com; yuzhu.zhang@ars.usda.gov
RI Jin, Tengchuan/B-5883-2014;
OI Jin, Tengchuan/0000-0002-1395-188X; Zhang, Yuzhu/0000-0001-7882-5692
FU U.S. Department of Energy, Office of Science, Office of Basic Energy
Sciences [W-31-109-Eng-38]; Illinois Institute of Technology; U.S. Food
and Drug Administration [5U01FD003801]; Institute for Food Safety and
Health, Illinois Institute of Technology [5U01FD003801]
FX Use of the APS was supported by the U.S. Department of Energy, Office of
Science, Office of Basic Energy Sciences, under Contract
W-31-109-Eng-38. This work was partially supported by a fund from the
Illinois Institute of Technology and by Cooperative Agreement
5U01FD003801 between the U.S. Food and Drug Administration and Institute
for Food Safety and Health, Illinois Institute of Technology.
NR 55
TC 7
Z9 7
U1 3
U2 27
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
EI 1520-5118
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD JAN 8
PY 2014
VL 62
IS 1
BP 222
EP 228
DI 10.1021/jf4039887
PG 7
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 288BK
UT WOS:000329586800028
PM 24328105
ER
PT J
AU Zhao, Z
Zhong, LL
Elrod, E
Struble, E
Ma, L
Yan, HL
Harman, C
Deng, L
Virata-Theimer, ML
Liu, P
Alter, H
Grakoui, A
Zhang, P
AF Zhao, Zhong
Zhong, Lilin
Elrod, Elizabeth
Struble, Evi
Ma, Li
Yan, Hailing
Harman, Christine
Deng, Lu
Virata-Theimer, Maria Luisa
Liu, Peter
Alter, Harvey
Grakoui, Arash
Zhang, Pei
TI A Neutralization Epitope in the Hepatitis C Virus E2 Glycoprotein
Interacts with Host Entry Factor CD81
SO PLOS ONE
LA English
DT Article
ID ENVELOPE GLYCOPROTEIN; VIRAL ENTRY; ANTIBODIES; BINDING; PARTICLES;
INFECTION; PLASMA; GENOTYPES; RECEPTOR; PROGRESS
AB The identification of a specific immunogenic candidate that will effectively activate the appropriate pathway for neutralizing antibody production is fundamental for vaccine design. By using a monoclonal antibody (1H8) that neutralizes HCV in vitro, we have demonstrated here that 1H8 recognized an epitope mapped between residues A524 and W529 of the E2 protein. We also found that the epitope residues A524, P525, Y527 and W529 were crucial for antibody binding, while the residues T526, Y527 and W529 within the same epitope engaged in the interaction with the host entry factor CD81. Furthermore, we detected "1H8-like" antibodies, defined as those with amino acid-specificity similar to 1H8, in the plasma of patients with chronic HCV infection. The time course study of plasma samples from Patient H, a well-characterized case of post-transfusion hepatitis C, showed that "1H8-like" antibodies could be detected in a sample collected almost two years after the initial infection, thus confirming the immunogenicity of this epitope in vivo. The characterization of this neutralization epitope with a function in host entry factor CD81 interaction should enhance our understanding of antibody-mediated neutralization of HCV infections.
C1 [Zhao, Zhong; Zhong, Lilin; Struble, Evi; Ma, Li; Yan, Hailing; Harman, Christine; Deng, Lu; Virata-Theimer, Maria Luisa; Liu, Peter; Zhang, Pei] US FDA, Ctr Biol Evaluat & Res, Div Hematol, Off Blood Res & Review, Bethesda, MD 20892 USA.
[Elrod, Elizabeth; Grakoui, Arash] Emory Univ, Emory Vaccine Ctr, Atlanta, GA 30322 USA.
[Alter, Harvey] NIH, Warren Grant Magnuson Clin Ctr, Dept Transfus Med, Bethesda, MD 20892 USA.
RP Zhang, P (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Hematol, Off Blood Res & Review, Bethesda, MD 20892 USA.
EM pei.zhang@fda.hhs.gov
FU Modernizing Science Funds of the Food and Drug Administration
FX This study was supported by the Modernizing Science Funds of the Food
and Drug Administration. The funders had no role in study design, data
collection and analysis, decision to publish, or preparation of the
manuscript.
NR 35
TC 4
Z9 4
U1 0
U2 9
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 6
PY 2014
VL 9
IS 1
AR e84346
DI 10.1371/journal.pone.0084346
PG 9
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 286IW
UT WOS:000329462700018
PM 24400084
ER
PT J
AU Wang, SJ
Dmitrienko, A
AF Wang, Sue-Jane
Dmitrienko, Alex
TI GUEST EDITORS' NOTE: SPECIAL ISSUE ON SUBGROUP ANALYSIS IN CLINICAL
TRIALS
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Editorial Material
C1 [Wang, Sue-Jane] US FDA, Silver Spring, MD 20993 USA.
[Dmitrienko, Alex] Quintiles, Durham, NC USA.
RP Wang, SJ (reprint author), US FDA, Silver Spring, MD 20993 USA.
NR 2
TC 0
Z9 0
U1 0
U2 1
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 520 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PD JAN 2
PY 2014
VL 24
IS 1
SI SI
BP 1
EP 3
DI 10.1080/10543406.2014.858958
PG 3
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AH2EB
UT WOS:000335932400001
PM 24392974
ER
PT J
AU Wang, SJ
Hung, HMJ
AF Wang, Sue-Jane
Hung, H. M. James
TI A REGULATORY PERSPECTIVE ON ESSENTIAL CONSIDERATIONS IN DESIGN AND
ANALYSIS OF SUBGROUPS WHEN CORRECTLY CLASSIFIED
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Biomarker; Formation of subgroup; Interaction-to-overall effects ratio;
Predictive of treatment effect; Subgroup-specific treatment effect
hypothesis
ID RANDOMIZED CLINICAL-TRIALS; CHALLENGES; STRATEGIES; ONCOLOGY
AB This regulatory research provides possible approaches for improvement to conventional subgroup analysis in a fixed design setting. The interaction-to-overall effects ratio is recommended in the planning stage for potential predictors whose prevalence is at most 50% and its observed ratio is recommended in the analysis stage for proper subgroup interpretation if sample size is only planned to target the overall effect size. We illustrate using regulatory examples and underscore the importance of striving for balance between safety and efficacy when considering a regulatory recommendation of a label restricted to a subgroup. A set of decision rules gives guidance for rigorous subgroup-specific conclusions.
C1 [Wang, Sue-Jane] US FDA, Off Biostat, OTS, CDER, Silver Spring, MD 20993 USA.
[Hung, H. M. James] US FDA, Div Biometr 1, OB, OTS,CDER, Silver Spring, MD 20993 USA.
RP Wang, SJ (reprint author), US FDA, Off Biostat, OTS, CDER, 10903 New Hampshire Ave,Bldg 21,HFD 710, Silver Spring, MD 20993 USA.
EM suejane.wang@fda.hhs.gov
FU RSR funds provided by the Center for Drug Evaluation and Research of the
U.S. Food and Drug Administration [05-02, 05-14]
FX The regulatory research work presented here was supported by the RSR
funds 05-02 and 05-14, provided by the Center for Drug Evaluation and
Research of the U.S. Food and Drug Administration. This article reflects
the views of the authors and should not be construed to represent the
views or policies of the U.S. Food and Drug Administration.
NR 35
TC 6
Z9 6
U1 1
U2 5
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 520 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PD JAN 2
PY 2014
VL 24
IS 1
SI SI
BP 19
EP 41
DI 10.1080/10543406.2013.856022
PG 23
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AH2EB
UT WOS:000335932400003
PM 24392976
ER
PT J
AU Varadhan, R
Wang, SJ
AF Varadhan, Ravi
Wang, Sue-Jane
TI STANDARDIZATION FOR SUBGROUP ANALYSIS IN RANDOMIZED CONTROLLED TRIALS
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Confounding; Consistency of treatment effect; Forest plot; Heterogeneity
of treatment effects; Interaction; Marginal structural model
ID MARGINAL STRUCTURAL MODELS
AB Randomized controlled trials (RCTs) emphasize the average or overall effect of a treatment (ATE) on the primary endpoint. Even though the ATE provides the best summary of treatment efficacy, it is of critical importance to know whether the treatment is similarly efficacious in important, predefined subgroups. This is why the RCTs, in addition to the ATE, also present the results of subgroup analysis for preestablished subgroups. Typically, these are marginal subgroup analysis in the sense that treatment effects are estimated in mutually exclusive subgroups defined by only one baseline characteristic at a time (e.g., men versus women, young versus old). Forest plot is a popular graphical approach for displaying the results of subgroup analysis. These plots were originally used in meta-analysis for displaying the treatment effects from independent studies. Treatment effect estimates of different marginal subgroups are, however, not independent. Correlation between the subgrouping variables should be addressed for proper interpretation of forest plots, especially in large effectiveness trials where one of the goals is to address concerns about the generalizability of findings to various populations. Failure to account for the correlation between the subgrouping variables can result in misleading (confounded) interpretations of subgroup effects. Here we present an approach called standardization, a commonly used technique in epidemiology, that allows for valid comparison of subgroup effects depicted in a forest plot. We present simulations results and a subgroup analysis from parallel-group, placebo-controlled randomized trials of antibiotics for acute otitis media.
C1 [Varadhan, Ravi] Johns Hopkins Univ, Sch Med, Div Geriatr Med & Gerontol, Ctr Aging & Hlth, Baltimore, MD USA.
[Varadhan, Ravi] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Biostat, Baltimore, MD USA.
[Wang, Sue-Jane] US FDA, Off Biostat, Off Translat Serv, Ctr Drug Evaluat & Res, Washington, DC 20204 USA.
[Wang, Sue-Jane] Johns Hopkins Univ, Engn Program Profess, Baltimore, MD USA.
[Wang, Sue-Jane] Johns Hopkins Univ, Appl Sci Program Profess, Baltimore, MD USA.
RP Varadhan, R (reprint author), Suite 2-700,2024 E Monument St, Baltimore, MD 21205 USA.
EM rvaradhan@jhmi.edu
FU Food and Drug Administration, Department of Health and Human Services
[HHSF2232010000072C]; RSR grant awarded by the Center for Drug
Evaluation and Research, US Food and Drug Administration [08-48]
FX The analyses upon which this publication is based were performed under
contract HHSF2232010000072C, entitled "Partnership in Applied
Comparative Effectiveness Science," sponsored by the Food and Drug
Administration, Department of Health and Human Services. This research
was also supported by the RSR grant 08-48 awarded by the Center for Drug
Evaluation and Research, US Food and Drug Administration. Ravi Varadhan
is a Brookdale Leadership in Aging Fellow at the Johns Hopkins
University.
NR 6
TC 4
Z9 4
U1 0
U2 3
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 520 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PD JAN 2
PY 2014
VL 24
IS 1
SI SI
BP 154
EP 167
DI 10.1080/10543406.2013.856023
PG 14
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AH2EB
UT WOS:000335932400010
PM 24392983
ER
PT J
AU Chen, S
Melchior, WB
Guo, L
AF Chen, Si
Melchior, William B., Jr.
Guo, Lei
TI Endoplasmic Reticulum Stress in Drug- and Environmental Toxicant-Induced
Liver Toxicity
SO JOURNAL OF ENVIRONMENTAL SCIENCE AND HEALTH PART C-ENVIRONMENTAL
CARCINOGENESIS & ECOTOXICOLOGY REVIEWS
LA English
DT Review
DE signaling pathways; Endoplasmic reticulum (ER) stress; liver toxicity
ID UNFOLDED PROTEIN RESPONSE; HUMAN HEPATIC CELLS; ACETAMINOPHEN-INDUCED
HEPATOTOXICITY; TRANSCRIPTION FACTOR XBP-1; OF-THE-LITERATURE; ER
STRESS; GENE-EXPRESSION; ALZHEIMERS-DISEASE; OXIDATIVE STRESS;
MESSENGER-RNA
AB Liver injury resulting from exposure to drugs and environmental chemicals is a major health problem. Endoplasmic reticulum stress (ER stress) is considered to be an important factor in a wide range of diseases, such as cancer, neurological and cardiovascular disease, diabetes, and inflammatory diseases. The role of ER stress in drug-induced and environmental toxicant-induced liver toxicity has been underestimated in the past; emerging evidence indicates that ER stress makes a substantial contribution to the pathogenesis of drug-induced liver toxicity. In this review, we summarize current knowledge on drugs and environmental toxicants that trigger ER stress in liver and on the underlying molecular mechanisms. We also discuss experimental approaches for ER stress studies.
C1 [Chen, Si; Melchior, William B., Jr.; Guo, Lei] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Guo, L (reprint author), 3900 NCTR Rd HFT-110, Jefferson, AR 72079 USA.
EM Lei.Guo@fda.hhs.gov
FU US Department of Energy; US FDA
FX SC was supported by appointments to the Postgraduate Research Program at
the National Center for Toxicological Research administered by the Oak
Ridge Institute for Science Education through an interagency agreement
between the US Department of Energy and the US FDA.
NR 150
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Z9 11
U1 0
U2 13
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 520 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1059-0501
EI 1532-4095
J9 J ENVIRON SCI HEAL C
JI J. Environ. Sci. Health Pt. C-Environ. Carcinog. Ecotoxicol. Rev.
PD JAN 2
PY 2014
VL 32
IS 1
BP 83
EP 104
DI 10.1080/10590501.2014.881648
PG 22
WC Oncology; Environmental Sciences; Toxicology
SC Oncology; Environmental Sciences & Ecology; Toxicology
GA AC1QE
UT WOS:000332270300003
PM 24598041
ER
PT J
AU Zhou, C
Wang, JW
Sun, N
Tian, J
Wang, J
Lv, YS
Wang, P
Huang, KL
Che, HL
AF Zhou, Cui
Wang, Jianwu
Sun, Na
Tian, Jing
Wang, Jing
Lv, Yingshuang
Wang, Peng
Huang, Kunlun
Che, Huilian
TI Allergenicity of recombinant human lactoferrin to an animal model Brown
Norway rats
SO FOOD AND AGRICULTURAL IMMUNOLOGY
LA English
DT Article
DE recombinant human lactoferrin; BN rat; allergenicity
ID GENETICALLY-MODIFIED CROPS; ORAL SENSITIZATION; ANTIBODY-RESPONSES;
PROTEIN ALLERGENICITY; FOOD PROTEINS; ALLERGIC INFLAMMATION; DIETARY
CONTROL; MAST-CELLS; T-CELLS; MICE
AB The assessment of allergenicity of recombinant human lactoferrin (rhLF) using an animal model for its extensive use. In this study, 32 Brown Norway (BN) rats were divided into four groups that were exposed to ovalbumin (OVA) (positive control), rhLF, bovine lactoferrin (bLF) and saline (negative control), respectively, with daily intragastric administration for 42 days. The level of specific antibody (IgE, IgG and IgG2a), blood cell counts, blood pressure and pathology of important organs were measured and compared among the groups. OVA stimulated significant higher levels of specific-IgE and eosinophil (EO) counts (p <0.05), lower blood pressure (p<0.05) and more serious lesion in the lung of BN rats compared to the other groups. And the animals did not show obvious humeral, cell-mediated and local allergic response to rhLF and bLF. The results demonstrate a weak allergenicity of rhLF on the animal and reveal its potential value for further identified study.
C1 [Zhou, Cui; Sun, Na; Wang, Jing; Huang, Kunlun; Che, Huilian] China Agr Univ, Coll Food Sci & Nutr Engn, Beijing 100094, Peoples R China.
[Wang, Jianwu] Chinese Acad Sci, Inst Zool, Beijing, Peoples R China.
[Wang, Jianwu] China Agr Univ, State Key Lab AgroBiotechnol, Beijing 100094, Peoples R China.
[Tian, Jing] Herbin Med Univ, Dept Dermatol, Affiliated Hosp 1, Harbin, Peoples R China.
[Lv, Yingshuang; Wang, Peng] US FDA, Inst Food Safety & Hlth, Summi Argo, IL USA.
[Lv, Yingshuang; Wang, Peng] IIT, Summi Argo, IL USA.
[Huang, Kunlun; Che, Huilian] Minist Agr, Supervis Inspect & Testing Ctr Genetically Modifi, Beijing, Peoples R China.
RP Che, HL (reprint author), China Agr Univ, Coll Food Sci & Nutr Engn, Beijing 100094, Peoples R China.
EM chehuilian@cau.edu.cn
FU Key Program of National Natural Science Funds of China [81072305]
FX This work was supported by a grant from the Key Program of National
Natural Science Funds of China (No.81072305). We acknowledge all
colleagues who contributed to the LF project and participated in the
allergenicity assessment of rhLF.
NR 51
TC 0
Z9 1
U1 0
U2 8
PU TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXON, ENGLAND
SN 0954-0105
EI 1465-3443
J9 FOOD AGR IMMUNOL
JI Food Agric. Immunol.
PD JAN 2
PY 2014
VL 25
IS 1
BP 34
EP 48
DI 10.1080/09540105.2012.733352
PG 15
WC Chemistry, Applied; Food Science & Technology; Immunology; Toxicology
SC Chemistry; Food Science & Technology; Immunology; Toxicology
GA 287MM
UT WOS:000329545900004
ER
PT B
AU Almuti, K
Rahman, S
Acosta, D
AF Almuti, Khalid
Rahman, Shahid
Acosta, Daniel, Jr.
BE Hayes, AW
Kruger, CL
TI Pathophysiology and Toxicology of the Heart
SO HAYES' PRINCIPLES AND METHODS OF TOXICOLOGY, 6TH EDITION
LA English
DT Article; Book Chapter
DE Arrhythmia; Cardiomyopathy; Torsades de Pointes (TdP); Ischemia;
Ethanol; Cocaine; Anthracyclines; Myocardial infarction
ID SOCIETY-OF-CARDIOLOGY; EUROPEAN-SOCIETY; ALCOHOLIC CARDIOMYOPATHY;
ANTIARRHYTHMIC DRUGS; ATRIAL TACHYCARDIA; QT-INTERVAL; APOPTOSIS;
ARRHYTHMIAS; METALLOTHIONEIN; MECHANISMS
C1 [Almuti, Khalid] Univ Cincinnati, Hlth Phys Off, Cincinnati, OH 45220 USA.
[Rahman, Shahid] Univ Cincinnati, Div Cardiovasc Dis, Cincinnati, OH USA.
[Acosta, Daniel, Jr.] US FDA, Res Off, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Almuti, K (reprint author), Univ Cincinnati, Hlth Phys Off, Cincinnati, OH 45220 USA.
NR 49
TC 0
Z9 0
U1 0
U2 0
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-84214-537-1; 978-1-84214-536-4
PY 2014
BP 1567
EP 1577
D2 10.1201/b17359
PG 11
WC Toxicology
SC Toxicology
GA BD7FA
UT WOS:000362973800033
ER
PT B
AU Volpe, DA
Shen, H
Balimane, PV
AF Volpe, Donna A.
Shen, Hong
Balimane, Praveen V.
BE Wang, J
Urban, L
TI EVALUATION OF THE COLLECTIVE IMPACT OF PASSIVE PERMEABILITY AND ACTIVE
TRANSPORT ON IN VIVO BLOOD-BRAIN BARRIER AND GASTROINTESTINAL DRUG
ABSORPTION
SO PREDICTIVE ADMET: INTEGRATIVE APPROACHES IN DRUG DISCOVERY AND
DEVELOPMENT
LA English
DT Article; Book Chapter
ID GLYCOPROTEIN-MEDIATED TRANSPORT; HUMAN INTESTINAL-ABSORPTION; CANCER
RESISTANCE PROTEIN; MDR1A P-GLYCOPROTEIN; CACO-2 CELL-CULTURE;
ARTIFICIAL MEMBRANE; CEREBROSPINAL-FLUID; UNBOUND CONCENTRATION;
ENDOTHELIAL-CELLS; ORAL ABSORPTION
C1 [Volpe, Donna A.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Shen, Hong; Balimane, Praveen V.] Bristol Myers Squibb Co, Princeton, NJ USA.
RP Volpe, DA (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
NR 108
TC 0
Z9 0
U1 1
U2 1
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
BN 978-1-118-78330-6; 978-1-118-29992-0
PY 2014
BP 263
EP 290
D2 10.1002/9781118783344
PG 28
WC Chemistry, Medicinal; Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA BD7FW
UT WOS:000363025900014
ER
PT B
AU Makris, SL
Harrouk, W
AF Makris, Susan L.
Harrouk, Wafa
BE Hoyer, PB
TI Assessing Ovarian Toxicity in Human Health Risk Assessment for
Environmental Chemicals and Pharmaceuticals
SO OVARIAN TOXICOLOGY, 2ND EDITION
LA English
DT Article; Book Chapter
ID HORMONE REPLACEMENT THERAPY; FEMALE REPRODUCTIVE-SYSTEM; COLLABORATIVE
WORK; 4-VINYLCYCLOHEXENE DIEPOXIDE; DI-(2-ETHYLHEXYL) PHTHALATE;
PUBERTAL DEVELOPMENT; FOLLICLE COUNTS; POSITION PAPER; WISTAR RATS;
FERTILITY
C1 [Makris, Susan L.] US EPA, Natl Ctr Environm Assessment, Washington, DC 20460 USA.
[Harrouk, Wafa] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Makris, SL (reprint author), US EPA, Natl Ctr Environm Assessment, Washington, DC 20460 USA.
NR 129
TC 0
Z9 0
U1 0
U2 0
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4665-0407-3; 978-1-4665-0406-6
PY 2014
BP 335
EP 361
PG 27
WC Obstetrics & Gynecology; Toxicology
SC Obstetrics & Gynecology; Toxicology
GA BD6DH
UT WOS:000362091400016
ER
PT B
AU Chen, Y
Son, I
AF Chen, Yi
Son, Insook
BE Oyarzabal, OA
Kathariou, S
TI Polymerase Chain Reaction-Based Subtyping Methods
SO DNA METHODS IN FOOD SAFETY: MOLECULAR TYPING OF FOODBORNE AND WATERBORNE
BACTERIAL PATHOGENS
LA English
DT Article; Book Chapter
ID FRAGMENT-LENGTH-POLYMORPHISM; FIELD GEL-ELECTROPHORESIS; TANDEM-REPEAT
ANALYSIS; LOCUS VARIABLE-NUMBER; SEQUENCE-BASED PCR; RESISTANT
STAPHYLOCOCCUS-AUREUS; LISTERIA-MONOCYTOGENES STRAINS; MOLECULAR TYPING
METHODS; ESCHERICHIA-COLI O157; COMMERCIAL SOFTWARE PACKAGES
C1 [Chen, Yi; Son, Insook] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Chen, Y (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 102
TC 1
Z9 1
U1 0
U2 0
PU WILEY-BLACKWELL
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, WEST SUSSEX PO19 8SQ, ENGLAND
BN 978-1-118-27866-6; 978-1-118-27867-3
PY 2014
BP 3
EP 26
D2 10.1002/9781118278666
PG 24
WC Biochemical Research Methods; Food Science & Technology; Microbiology
SC Biochemistry & Molecular Biology; Food Science & Technology;
Microbiology
GA BD8IU
UT WOS:000363969200002
ER
PT B
AU Gopinath, G
Hari, K
Jain, R
Kothary, MH
Jarvis, KG
Franco, AA
Grim, CJ
Sathyamoorthy, V
Mammel, MK
Datta, AR
McCardell, BA
Solomotis, MD
Tall, BD
AF Gopinath, G.
Hari, K.
Jain, R.
Kothary, M. H.
Jarvis, K. G.
Franco, A. A.
Grim, C. J.
Sathyamoorthy, V.
Mammel, M. K.
Datta, A. R.
McCardell, B. A.
Solomotis, M. D.
Tall, Ben D.
BE Oyarzabal, OA
Kathariou, S
TI Databases and Internet Applications
SO DNA METHODS IN FOOD SAFETY: MOLECULAR TYPING OF FOODBORNE AND WATERBORNE
BACTERIAL PATHOGENS
LA English
DT Article; Book Chapter
ID UNITED-STATES; BIOINFORMATICS RESOURCE; FOODBORNE ILLNESS; PULSENET;
DISEASES; SURVEILLANCE; INFORMATION; COLLECTION; PATHOGENS; INSTITUTE
C1 [Gopinath, G.; Kothary, M. H.; Jarvis, K. G.; Franco, A. A.; Grim, C. J.; Sathyamoorthy, V.; Mammel, M. K.; Datta, A. R.; McCardell, B. A.; Solomotis, M. D.; Tall, Ben D.] US FDA, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
[Hari, K.; Jain, R.] CBio Inc, Fremont, CA USA.
RP Gopinath, G (reprint author), US FDA, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
OI Tall, Ben/0000-0003-0399-3629
NR 41
TC 0
Z9 0
U1 0
U2 0
PU WILEY-BLACKWELL
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, WEST SUSSEX PO19 8SQ, ENGLAND
BN 978-1-118-27866-6; 978-1-118-27867-3
PY 2014
BP 113
EP 132
D2 10.1002/9781118278666
PG 20
WC Biochemical Research Methods; Food Science & Technology; Microbiology
SC Biochemistry & Molecular Biology; Food Science & Technology;
Microbiology
GA BD8IU
UT WOS:000363969200007
ER
PT B
AU Lynne, AM
Han, J
Foley, SL
AF Lynne, Aaron M.
Han, Jing
Foley, Steven L.
BE Oyarzabal, OA
Kathariou, S
TI Salmonella
SO DNA METHODS IN FOOD SAFETY: MOLECULAR TYPING OF FOODBORNE AND WATERBORNE
BACTERIAL PATHOGENS
LA English
DT Article; Book Chapter
ID FIELD GEL-ELECTROPHORESIS; FRAGMENT-LENGTH-POLYMORPHISM; ENTERICA SUBSP
ENTERICA; TANDEM REPEAT ANALYSIS; RESTRICTION-SITE PCR; SEQUENCE-BASED
PCR; ESCHERICHIA-COLI; VARIABLE-NUMBER; RESISTANT SALMONELLA; SEROTYPE
ENTERITIDIS
C1 [Lynne, Aaron M.] Sam Houston State Univ, Dept Biol Sci, Huntsville, TX 77340 USA.
[Han, Jing; Foley, Steven L.] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Lynne, AM (reprint author), Sam Houston State Univ, Dept Biol Sci, Huntsville, TX 77340 USA.
NR 96
TC 0
Z9 0
U1 0
U2 0
PU WILEY-BLACKWELL
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, WEST SUSSEX PO19 8SQ, ENGLAND
BN 978-1-118-27866-6; 978-1-118-27867-3
PY 2014
BP 337
EP 357
D2 10.1002/9781118278666
PG 21
WC Biochemical Research Methods; Food Science & Technology; Microbiology
SC Biochemistry & Molecular Biology; Food Science & Technology;
Microbiology
GA BD8IU
UT WOS:000363969200015
ER
PT S
AU Zhou, WL
Chang, EY
Wang, PG
AF Zhou, Wanlong
Chang, Eugene Y.
Wang, Perry G.
BE Wang, PG
Vitha, MF
Kay, JF
TI INTRODUCTION: BASIC PRINCIPLES OF ASSAYS TO BE COVERED, SAMPLE HANDLING,
AND SAMPLE PROCESSING
SO HIGH-THROUGHPUT ANALYSIS FOR FOOD SAFETY
SE Chemical Analysis-A Series of Monographs on Analytical Chemistry and Its
Applications
LA English
DT Editorial Material; Book Chapter
ID CHROMATOGRAPHY-MASS SPECTROMETRY; PRESSURIZED LIQUID EXTRACTION;
PESTICIDE-RESIDUES; FOOD ANALYSIS; MICROEXTRACTION; MATRICES; MELAMINE;
SAFETY; MS
C1 [Zhou, Wanlong; Wang, Perry G.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Chang, Eugene Y.] US FDA, Pacific Reg Lab Southwest, Irvine, CA USA.
RP Zhou, WL (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 45
TC 0
Z9 0
U1 0
U2 0
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0069-2883
BN 978-1-118-90792-4; 978-1-118-39630-8
J9 CHEM ANAL SERIES MON
PY 2014
VL 179
BP 1
EP 14
D2 10.1002/9781118907924
PG 14
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BD5EU
UT WOS:000361370700002
ER
PT S
AU Wang, PG
Vitha, M
Kay, J
AF Wang, Perry G.
Vitha, Mark
Kay, Jack
BE Wang, PG
Vitha, MF
Kay, JF
TI CHEMICAL ANALYSIS A SERIES OF MONOGRAPHS ON ANALYTICAL CHEMISTRY AND ITS
APPLICATIONS PREFACE
SO HIGH-THROUGHPUT ANALYSIS FOR FOOD SAFETY
SE Chemical Analysis-A Series of Monographs on Analytical Chemistry and Its
Applications
LA English
DT Editorial Material; Book Chapter
C1 [Wang, Perry G.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Vitha, Mark] Drake Univ, Des Moines, IA 50311 USA.
[Kay, Jack] Univ Strathclyde, Glasgow, Lanark, Scotland.
RP Wang, PG (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0069-2883
BN 978-1-118-90792-4; 978-1-118-39630-8
J9 CHEM ANAL SERIES MON
PY 2014
VL 179
BP XI
EP XII
D2 10.1002/9781118907924
PG 2
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BD5EU
UT WOS:000361370700001
ER
PT S
AU Vaclavik, L
Cajka, T
Zhou, WL
Wang, PG
AF Vaclavik, Lukas
Cajka, Tomas
Zhou, Wanlong
Wang, Perry G.
BE Wang, PG
Vitha, MF
Kay, JF
TI SURVEY OF MASS SPECTROMETRY-BASED HIGH-THROUGHPUT METHODS IN FOOD
ANALYSIS
SO HIGH-THROUGHPUT ANALYSIS FOR FOOD SAFETY
SE Chemical Analysis-A Series of Monographs on Analytical Chemistry and Its
Applications
LA English
DT Article; Book Chapter
ID TIME-OF-FLIGHT; DESORPTION ELECTROSPRAY-IONIZATION; FAST
GAS-CHROMATOGRAPHY; ATMOSPHERIC-PRESSURE PHOTOIONIZATION; SOLID-PHASE
MICROEXTRACTION; MULTIPLE PESTICIDE-RESIDUES; HYDROPHILIC-INTERACTION
CHROMATOGRAPHY; PERFORMANCE LIQUID-CHROMATOGRAPHY; POLYBROMINATED
DIPHENYL ETHERS; EMPLOYING DIRECT ANALYSIS
C1 [Vaclavik, Lukas; Zhou, Wanlong; Wang, Perry G.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Cajka, Tomas] Univ Calif Davis, UC Davis Genome Ctr Metabol, Davis, CA 95616 USA.
RP Vaclavik, L (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RI Cajka, Tomas/A-8914-2008
OI Cajka, Tomas/0000-0002-9728-3355
NR 146
TC 1
Z9 1
U1 0
U2 1
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0069-2883
BN 978-1-118-90792-4; 978-1-118-39630-8
J9 CHEM ANAL SERIES MON
PY 2014
VL 179
BP 15
EP 72
D2 10.1002/9781118907924
PG 58
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BD5EU
UT WOS:000361370700003
ER
PT S
AU Vaclavikova, M
Vaclavik, L
Cajka, T
AF Vaclavikova, Marta
Vaclavik, Lukas
Cajka, Tomas
BE Wang, PG
Vitha, MF
Kay, JF
TI HIGH-THROUGHPUT ANALYSIS OF MYCOTOXINS
SO HIGH-THROUGHPUT ANALYSIS FOR FOOD SAFETY
SE Chemical Analysis-A Series of Monographs on Analytical Chemistry and Its
Applications
LA English
DT Article; Book Chapter
ID TANDEM MASS-SPECTROMETRY; ION-MOBILITY SPECTROMETRY; SURFACE-PLASMON
RESONANCE; LATERAL FLOW IMMUNOASSAY; MULTIPLE MYCOTOXINS; MASKED
MYCOTOXINS; LC-MS/MS; EXTRACTION PROCEDURE; BIOLOGICAL MATRICES;
MULTIANALYTE METHOD
C1 [Vaclavikova, Marta; Vaclavik, Lukas] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Cajka, Tomas] Univ Calif Davis, UC Davis Genome Ctr Metabol, Davis, CA 95616 USA.
RP Vaclavikova, M (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RI Cajka, Tomas/A-8914-2008
OI Cajka, Tomas/0000-0002-9728-3355
NR 96
TC 0
Z9 0
U1 0
U2 1
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0069-2883
BN 978-1-118-90792-4; 978-1-118-39630-8
J9 CHEM ANAL SERIES MON
PY 2014
VL 179
BP 231
EP 266
D2 10.1002/9781118907924
PG 36
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BD5EU
UT WOS:000361370700009
ER
PT B
AU Setty, MKHG
Hewlett, IK
AF Setty, Mohan Kumar Haleyur Giri
Hewlett, Indira K.
BE Liu, D
TI Human Immunodeficiency Virus
SO MANUAL OF SECURITY SENSITIVE MICROBES AND TOXINS
LA English
DT Article; Book Chapter
ID REVERSE-TRANSCRIPTASE INHIBITORS; COLONY-STIMULATING FACTOR; DEFICIENCY
SYNDROME AIDS; HIV-INFECTED PATIENTS; COMBINED P24 ANTIGEN; TYPE-1
GROUP-O; IN-VITRO; PREEXPOSURE PROPHYLAXIS; ANTIBODY-ASSAYS; NUCLEAR
IMPORT
C1 [Setty, Mohan Kumar Haleyur Giri; Hewlett, Indira K.] US FDA, Mol Virol Lab, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Setty, MKHG (reprint author), US FDA, Mol Virol Lab, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
NR 122
TC 0
Z9 0
U1 0
U2 0
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4665-5398-9; 978-1-4665-5396-5
PY 2014
BP 107
EP 122
D2 10.1201/b16752
PG 16
WC Infectious Diseases; Microbiology; Toxicology
SC Infectious Diseases; Microbiology; Toxicology
GA BD7GW
UT WOS:000363061700011
ER
PT B
AU Schneider, KR
Fatica, MK
Lampel, KA
Warren, BR
AF Schneider, K. R.
Fatica, M. K.
Lampel, K. A.
Warren, B. R.
BE Liu, D
TI Shigella
SO MANUAL OF SECURITY SENSITIVE MICROBES AND TOXINS
LA English
DT Article; Book Chapter
ID ACTIN-BASED MOTILITY; ENTEROINVASIVE ESCHERICHIA-COLI;
LINKED-IMMUNOSORBENT-ASSAY; SHIGA TOXIN; FLEXNERI 2A; UNIPOLAR
LOCALIZATION; SONNEI INFECTION; UNITED-STATES; FOODBORNE OUTBREAK;
AEROBACTIN GENES
C1 [Schneider, K. R.; Fatica, M. K.] Univ Florida, Dept Food Sci & Human Nutr, Gainesville, FL 32611 USA.
[Lampel, K. A.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
[Warren, B. R.] Land OLakes Inc, Arden Hills, MN USA.
RP Schneider, KR (reprint author), Univ Florida, Dept Food Sci & Human Nutr, Gainesville, FL 32611 USA.
NR 135
TC 0
Z9 0
U1 1
U2 1
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4665-5398-9; 978-1-4665-5396-5
PY 2014
BP 385
EP 396
D2 10.1201/b16752
PG 12
WC Infectious Diseases; Microbiology; Toxicology
SC Infectious Diseases; Microbiology; Toxicology
GA BD7GW
UT WOS:000363061700035
ER
PT B
AU Liu, DY
Garber, EAE
AF Liu, Dongyou
Garber, Eric A. E.
BE Liu, D
TI Abrin
SO MANUAL OF SECURITY SENSITIVE MICROBES AND TOXINS
LA English
DT Article; Book Chapter
ID TOXIC LECTINS ABRIN; ACUTE DEMYELINATING ENCEPHALITIS;
RIBOSOME-INACTIVATING PROTEIN; ABRUS-PRECATORIUS AGGLUTININ;
LINKED-IMMUNOSORBENT-ASSAY; LEUKEMIC-CELL LINES; A-CHAIN;
ESCHERICHIA-COLI; IN-VITRO; X-RAY
C1 [Liu, Dongyou] Royal Coll Pathologists Australasia, Biosecur Qual Assurance Program, St Leonards, NSW, Australia.
[Garber, Eric A. E.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Liu, DY (reprint author), Royal Coll Pathologists Australasia, Biosecur Qual Assurance Program, St Leonards, NSW, Australia.
NR 93
TC 0
Z9 0
U1 0
U2 0
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4665-5398-9; 978-1-4665-5396-5
PY 2014
BP 443
EP 450
D2 10.1201/b16752
PG 8
WC Infectious Diseases; Microbiology; Toxicology
SC Infectious Diseases; Microbiology; Toxicology
GA BD7GW
UT WOS:000363061700040
ER
PT S
AU Chakravarty, AG
AF Chakravarty, Aloka G.
BE Carini, C
Menon, S
Chang, M
TI Regulatory Issues in Use of Biomarkers in Drug Development
SO CLINICAL AND STATISTICAL CONSIDERATIONS IN PERSONALIZED MEDICINE
SE Chapman & Hall-CRC Biostatistics Series
LA English
DT Article; Book Chapter
ID CLINICAL-TRIALS; SURROGATE ENDPOINTS; ONCOLOGY TRIALS; END-POINTS;
CRITERIA; MARKERS
C1 US FDA, Div Biometr 7, Off Biostat, CDER, Silver Spring, MD 20993 USA.
RP Chakravarty, AG (reprint author), US FDA, Div Biometr 7, Off Biostat, CDER, Silver Spring, MD 20993 USA.
NR 19
TC 2
Z9 2
U1 0
U2 0
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
SN 2154-4298
BN 978-1-4665-9387-9
J9 CH CRC BIOSTAT SER
JI Chapman & Hall-CRC Biostat. Ser.
PY 2014
BP 313
EP 331
PG 19
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA BD6GP
UT WOS:000362204000012
ER
PT B
AU Lee, SC
Zhang, L
Huang, SM
AF Lee, Sue-Chih
Zhang, Lei
Huang, Shiew-Mei
BE You, G
Morris, ME
TI REGULATORY SCIENCE PERSPECTIVES ON TRANSPORTER STUDIES IN DRUG
DEVELOPMENT
SO DRUG TRANSPORTERS: MOLECULAR CHARACTERIZATION AND ROLE IN DRUG
DISPOSITION, 2ND EDITION
SE Wiley Series in Drug Discovery and Development
LA English
DT Article; Book Chapter
ID SALT EXPORT PUMP; ORGANIC CATION TRANSPORTERS; PHARMACOKINETIC
INTERACTION; CLINICAL PHARMACOKINETICS; INTRAHEPATIC CHOLESTASIS; EFFLUX
TRANSPORTERS; HEALTHY-VOLUNTEERS; TUBULAR SECRETION; RENAL CLEARANCE;
LIVER-INJURY
C1 [Lee, Sue-Chih; Zhang, Lei; Huang, Shiew-Mei] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Lee, SC (reprint author), US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
NR 89
TC 3
Z9 3
U1 0
U2 0
PU JOHN WILEY & SONS
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, W SUSSEX PO 19 8SQ, ENGLAND
BN 978-1-118-70530-8; 978-1-118-48993-2
J9 WILEY SER DRUG DISC
PY 2014
BP 473
EP 490
D2 10.1002/9781118705308
PG 18
WC Chemistry, Medicinal; Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA BD6BR
UT WOS:000362007500025
ER
PT S
AU Rahman, Z
Siddiqui, A
Gupta, A
Khan, M
AF Rahman, Ziyaur
Siddiqui, Akhtar
Gupta, Abhay
Khan, Mansoor
BE Shah, N
Sandhu, H
Choi, DS
Chokshi, H
Malick, AW
TI Regulatory Considerations in Development of Amorphous Solid Dispersions
SO AMORPHOUS SOLID DISPERSIONS: THEORY AND PRACTICE
SE Advances in Delivery Science and Technology
LA English
DT Article; Book Chapter
ID GLASS-TRANSITION TEMPERATURE; WATER-SOLUBLE DRUGS; HOT-MELT EXTRUSION;
PHYSICAL STABILITY; PHARMACEUTICAL SOLIDS; SOLVENT EVAPORATION;
DIFFERENT POLYMERS; DISSOLUTION RATE; BINARY-SYSTEMS; PART I
C1 [Rahman, Ziyaur; Siddiqui, Akhtar; Gupta, Abhay; Khan, Mansoor] US FDA, Div Prod Qual & Res, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Khan, M (reprint author), US FDA, Div Prod Qual & Res, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
EM Mansoor.Khan@fda.hhs.gov
OI Rahman, Ziyaur/0000-0002-0402-825X
NR 92
TC 2
Z9 2
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2192-6204
BN 978-1-4939-1598-9; 978-1-4939-1597-2
J9 ADV DEL SCI TECHNOL
PY 2014
BP 545
EP 563
DI 10.1007/978-1-4939-1598-9_17
D2 10.1007/978-1-4939-1598-9
PG 19
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA BD2LH
UT WOS:000358864000018
ER
PT B
AU Dibaji, SAR
Myers, MR
Soneson, JE
Banerjee, RK
AF Dibaji, Seyed Ahmad Reza
Myers, Matthew R.
Soneson, Joshua E.
Banerjee, Rupak K.
GP ASME
TI NONLINEAR DERATING OF HIGH-INTENSITY THERAPEUTIC ULTRASOUND BEAMS USING
GAUSSIAN MODAL SUMS
SO PROCEEDINGS OF THE ASME SUMMER BIOENGINEERING CONFERENCE - 2013, PT A
LA English
DT Proceedings Paper
CT 15th American-Society-Mechanical-Engineering Summer Bioengineering
Conference (SBC2013)
CY JUN 26-29, 2013
CL Sunriver, OR
SP Amer Soc Mech Engn, Bioengineer Div
C1 [Dibaji, Seyed Ahmad Reza; Banerjee, Rupak K.] Univ Cincinnati, Sch Dynam Syst, Mech Engn Program, Cincinnati, OH 45221 USA.
[Myers, Matthew R.; Soneson, Joshua E.] US FDA, Ctr Devices & Radiol Hlth, Div Solid & Fluid Mech, Silver Spring, MD USA.
RP Dibaji, SAR (reprint author), Univ Cincinnati, Sch Dynam Syst, Mech Engn Program, Cincinnati, OH 45221 USA.
NR 3
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC MECHANICAL ENGINEERS
PI NEW YORK
PA THREE PARK AVENUE, NEW YORK, NY 10016-5990 USA
BN 978-0-7918-5560-7
PY 2014
AR V01AT07A014
PG 2
WC Biophysics; Engineering, Biomedical
SC Biophysics; Engineering
GA BD2YH
UT WOS:000359389200093
ER
PT B
AU Vesnovsky, O
Topoleski, LDT
Grossman, LW
Casamento, JP
Zhu, L
AF Vesnovsky, Oleg
Topoleski, L. D. Timmie
Grossman, Laurence W.
Casamento, Jon P.
Zhu, Liang
GP ASME
TI EVALUATION OF TEMPERATURE TRANSIENTS AT VARIOUS BODY TEMPERATURE
MEASURING SITES USING A FAST RESPONSE THERMISTOR BEAD SENSOR
SO PROCEEDINGS OF THE ASME SUMMER BIOENGINEERING CONFERENCE - 2013, PT A
LA English
DT Proceedings Paper
CT 15th American-Society-Mechanical-Engineering Summer Bioengineering
Conference (SBC2013)
CY JUN 26-29, 2013
CL Sunriver, OR
SP Amer Soc Mech Engn, Bioengineer Div
ID THERMOMETER; ACCURACY
C1 [Vesnovsky, Oleg; Topoleski, L. D. Timmie; Grossman, Laurence W.; Casamento, Jon P.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Topoleski, L. D. Timmie; Zhu, Liang] Univ Maryland Baltimore Cty, Dept Mech Engn, Baltimore, MD 21250 USA.
RP Vesnovsky, O (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
NR 4
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC MECHANICAL ENGINEERS
PI NEW YORK
PA THREE PARK AVENUE, NEW YORK, NY 10016-5990 USA
BN 978-0-7918-5560-7
PY 2014
AR V01AT07A003
PG 2
WC Biophysics; Engineering, Biomedical
SC Biophysics; Engineering
GA BD2YH
UT WOS:000359389200082
ER
PT B
AU Walsh, D
Stephen, B
Duraiswamy, N
Vesnovsky, O
Topoleski, LDT
AF Walsh, Donna
Stephen, Beth
Duraiswamy, Nandini
Vesnovsky, Oleg
Topoleski, L. D. Timmie
GP ASME
TI PARAMETERS INFLUENCING DISTAL TIP LOADING OF PACEMAKER AND DEFIBRILLATOR
LEADS
SO PROCEEDINGS OF THE ASME SUMMER BIOENGINEERING CONFERENCE - 2013, PT A
LA English
DT Proceedings Paper
CT 15th American-Society-Mechanical-Engineering Summer Bioengineering
Conference (SBC2013)
CY JUN 26-29, 2013
CL Sunriver, OR
SP Amer Soc Mech Engn, Bioengineer Div
C1 [Walsh, Donna; Stephen, Beth; Duraiswamy, Nandini; Vesnovsky, Oleg; Topoleski, L. D. Timmie] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Topoleski, L. D. Timmie] Univ Maryland, Dept Mech Engn, Baltimore, MD 21250 USA.
RP Walsh, D (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
NR 8
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC MECHANICAL ENGINEERS
PI NEW YORK
PA THREE PARK AVENUE, NEW YORK, NY 10016-5990 USA
BN 978-0-7918-5560-7
PY 2014
AR V01AT20A008
PG 2
WC Biophysics; Engineering, Biomedical
SC Biophysics; Engineering
GA BD2YH
UT WOS:000359389200252
ER
PT B
AU Myers, MR
Hariharan, P
Banerjee, RK
AF Myers, Matthew R.
Hariharan, Prasanna
Banerjee, Rupak K.
GP ASME
TI TRANSLATIONAL RESEARCH IN HIGH-INTENSITY THERAPEUTIC ULTRASOUND: NOVEL
TECHNIQUES FOR PRE-CLINICAL TESTING
SO PROCEEDINGS OF THE ASME SUMMER BIOENGINEERING CONFERENCE - 2013, PT B
LA English
DT Proceedings Paper
CT 15th American-Society-Mechanical-Engineering Summer Bioengineering
Conference (SBC2013)
CY JUN 26-29, 2013
CL Sunriver, OR
SP Amer Soc Mech Engn, Bioengineer Div
ID INFRARED THERMOGRAPHY
C1 [Myers, Matthew R.; Hariharan, Prasanna] US FDA, Ctr Devices & Radiol Hlth, Div Solid & Fluid Mech, Silver Spring, MD 20993 USA.
[Banerjee, Rupak K.] Univ Cincinnati, Dept Mech Engn, Cincinnati, OH 45221 USA.
[Banerjee, Rupak K.] Univ Cincinnati, Biomed Engn Dept, Cincinnati, OH 45221 USA.
RP Myers, MR (reprint author), US FDA, Ctr Devices & Radiol Hlth, Div Solid & Fluid Mech, Silver Spring, MD 20993 USA.
NR 4
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC MECHANICAL ENGINEERS
PI NEW YORK
PA THREE PARK AVENUE, NEW YORK, NY 10016-5990 USA
BN 978-0-7918-5561-4
PY 2014
AR V01BT53A003
PG 2
WC Biophysics; Engineering, Biomedical
SC Biophysics; Engineering
GA BD2YI
UT WOS:000359389300181
ER
PT B
AU Sahu, SC
Casciano, DA
AF Sahu, Saura C.
Casciano, Daniel A.
BE Sahu, SC
Casciano, DA
TI Handbook of Nanotoxicology, Nanomedicine and Stem Cell Use in Toxicology
Preface
SO HANDBOOK OF NANOTOXICOLOGY, NANOMEDICINE AND STEM CELL USE IN TOXICOLOGY
LA English
DT Editorial Material; Book Chapter
C1 [Sahu, Saura C.] US FDA, Laurel, MD 20993 USA.
[Casciano, Daniel A.] Univ Arkansas, Little Rock, AR 72204 USA.
RP Sahu, SC (reprint author), US FDA, Laurel, MD 20993 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU JOHN WILEY & SONS
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, W SUSSEX PO 19 8SQ, ENGLAND
BN 978-1-118-85604-8; 978-1-118-43926-5
PY 2014
BP XI
EP XI
D2 10.1002/9781118856017
PG 1
WC Cell Biology; Nanoscience & Nanotechnology; Toxicology
SC Cell Biology; Science & Technology - Other Topics; Toxicology
GA BD0PW
UT WOS:000357535600001
ER
PT B
AU Keene, AM
Bancos, S
Tyner, KM
AF Keene, Athena M.
Bancos, Simona
Tyner, Katherine M.
BE Sahu, SC
Casciano, DA
TI Considerations for In Vitro Nanotoxicity Testing
SO HANDBOOK OF NANOTOXICOLOGY, NANOMEDICINE AND STEM CELL USE IN TOXICOLOGY
LA English
DT Article; Book Chapter
ID WALLED CARBON NANOTUBES; SOLID LIPID NANOPARTICLES; A549 LUNG-CELLS;
GOLD NANOPARTICLES; SILICA NANOPARTICLES; ENGINEERED NANOMATERIALS;
TOXICITY ASSESSMENT; VIABILITY ASSAYS; VIBRIO-FISCHERI; CELLULAR UPTAKE
C1 [Keene, Athena M.] Afton Chem Corp, Richmond, VA 23219 USA.
[Bancos, Simona; Tyner, Katherine M.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Keene, AM (reprint author), Afton Chem Corp, Richmond, VA 23219 USA.
NR 113
TC 2
Z9 2
U1 0
U2 0
PU JOHN WILEY & SONS
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, W SUSSEX PO 19 8SQ, ENGLAND
BN 978-1-118-85604-8; 978-1-118-43926-5
PY 2014
BP 35
EP 63
D2 10.1002/9781118856017
PG 29
WC Cell Biology; Nanoscience & Nanotechnology; Toxicology
SC Cell Biology; Science & Technology - Other Topics; Toxicology
GA BD0PW
UT WOS:000357535600003
ER
PT B
AU Li, Y
Chen, T
AF Li, Yan
Chen, Tao
BE Sahu, SC
Casciano, DA
TI Genotoxicity of Silver Nanoparticles
SO HANDBOOK OF NANOTOXICOLOGY, NANOMEDICINE AND STEM CELL USE IN TOXICOLOGY
LA English
DT Article; Book Chapter
ID IN-VITRO; OXIDATIVE STRESS; DNA-DAMAGE; DEPENDENT GENERATION;
NEREIS-DIVERSICOLOR; CELLULAR TOXICITY; NANO-SILVER; CELLS;
NANOMATERIALS; CYTOTOXICITY
C1 [Li, Yan; Chen, Tao] US FDA, Div Genet & Mol Toxicol, NCTR, Jefferson, AR 72079 USA.
RP Li, Y (reprint author), US FDA, Div Genet & Mol Toxicol, NCTR, Jefferson, AR 72079 USA.
NR 74
TC 1
Z9 1
U1 0
U2 1
PU JOHN WILEY & SONS
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, W SUSSEX PO 19 8SQ, ENGLAND
BN 978-1-118-85604-8; 978-1-118-43926-5
PY 2014
BP 87
EP 98
D2 10.1002/9781118856017
PG 12
WC Cell Biology; Nanoscience & Nanotechnology; Toxicology
SC Cell Biology; Science & Technology - Other Topics; Toxicology
GA BD0PW
UT WOS:000357535600005
ER
PT B
AU Inselman, AL
Wang, C
Liu, F
Hansen, DK
AF Inselman, Amy L.
Wang, Cheng
Liu, Fang
Hansen, Deborah K.
BE Sahu, SC
Casciano, DA
TI Stem Cells in Toxicity Testing
SO HANDBOOK OF NANOTOXICOLOGY, NANOMEDICINE AND STEM CELL USE IN TOXICOLOGY
LA English
DT Article; Book Chapter
ID VITRO EMBRYOTOXICITY TESTS; WHOLE-EMBRYO CULTURE; END-POINT ANALYSIS;
IN-VITRO; DEVELOPMENTAL TOXICITY; GENE-EXPRESSION; MOLECULAR MARKERS;
TEST EST; NEURAL DIFFERENTIATION; RESPONSE EVALUATION
C1 [Inselman, Amy L.; Hansen, Deborah K.] US FDA, Div Syst Biol, NCTR, Jefferson, AR 72079 USA.
[Wang, Cheng; Liu, Fang] US FDA, Div Neurotoxicol, NCTR, Jefferson, AR USA.
RP Inselman, AL (reprint author), US FDA, Div Syst Biol, NCTR, Jefferson, AR 72079 USA.
NR 94
TC 0
Z9 0
U1 0
U2 0
PU JOHN WILEY & SONS
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER, W SUSSEX PO 19 8SQ, ENGLAND
BN 978-1-118-85604-8; 978-1-118-43926-5
PY 2014
BP 251
EP 265
D2 10.1002/9781118856017
PG 15
WC Cell Biology; Nanoscience & Nanotechnology; Toxicology
SC Cell Biology; Science & Technology - Other Topics; Toxicology
GA BD0PW
UT WOS:000357535600015
ER
PT B
AU Young, RR
Powley, M
Lawlor, TE
Aardema, MJ
AF Young, Robert R.
Powley, Mark
Lawlor, Timothy E.
Aardema, Marilyn J.
BE Brock, WJ
TI GENETIC TOXICOLOGY STUDIES
SO ROLE OF THE STUDY DIRECTOR IN NONCLINICAL STUDIES: PHARMACEUTICALS,
CHEMICALS, MEDICAL DEVICES, AND PESTICIDES
LA English
DT Article; Book Chapter
ID CHINESE-HAMSTER OVARY; MOUSE LYMPHOMA-CELLS; ERYTHROCYTE MICRONUCLEUS
ASSAY; FLOW-CYTOMETRIC ANALYSIS; THYMIDINE KINASE GENE; DNA-REPAIR
ASSAY; IN-VITRO; COMET ASSAY; MUTATION ASSAY; PIG-A
C1 [Young, Robert R.; Lawlor, Timothy E.] BioReliance Corp, Rockville, MD 20850 USA.
[Powley, Mark] US FDA, CDER, Silver Spring, MD USA.
[Aardema, Marilyn J.] Marilyn Aardema Consulting LLC, Fairfield, OH USA.
[Aardema, Marilyn J.] BioReliance Corp, Fairfield, OH USA.
RP Young, RR (reprint author), BioReliance Corp, Rockville, MD 20850 USA.
NR 94
TC 0
Z9 0
U1 0
U2 2
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
BN 978-1-118-87390-8; 978-1-118-37039-1
PY 2014
BP 333
EP 354
D2 10.1002/9781118873922
PG 22
WC Chemistry, Medicinal; Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA BC7LO
UT WOS:000354987000021
ER
PT B
AU Taylor, DR
AF Taylor, Deborah R.
BE Fox, JG
Marini, RP
TI The Ferret in Viral Respiratory Disease Research
SO BIOLOGY AND DISEASES OF THE FERRET, 3RD EDITION
LA English
DT Article; Book Chapter
ID ANTIBODY-DEPENDENT ENHANCEMENT; FELINE INFECTIOUS PERITONITIS;
INFLUENZA-A VIRUS; SYNDROME CORONAVIRUS; PANDEMIC INFLUENZA; LYMPHOCYTE
SUBSETS; SYNCYTIAL VIRUS; H5N1 VIRUSES; SARS; TRANSMISSION
C1 CBER FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Off Blood Res & Review, Bethesda, MD 20993 USA.
RP Taylor, DR (reprint author), CBER FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Off Blood Res & Review, Bethesda, MD 20993 USA.
NR 62
TC 0
Z9 0
U1 0
U2 0
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
BN 978-1-118-78269-9; 978-0-470-96045-5
PY 2014
BP 629
EP 639
D2 10.1002/9781118782699
PG 11
WC Veterinary Sciences
SC Veterinary Sciences
GA BC7IT
UT WOS:000354901200026
ER
PT B
AU Rabin, RL
Slater, JE
AF Rabin, Ronald L.
Slater, Jay E.
BE Lockey, RF
Ledford, DK
TI Standardized Allergen Vaccines in the United States
SO ALLERGENS AND ALLERGEN IMMUNOTHERAPY: SUBCUTANEOUS, SUBLINGUAL,AND ORAL,
5TH EDITION
LA English
DT Article; Book Chapter
ID COMPOSITIONAL DIFFERENCES CD; CAT EXTRACTS SCE; POTENCY; ASSIGNMENT;
STABILITY; PRODUCTS; GERMAN; AU
C1 [Rabin, Ronald L.] US FDA, Div Bacterial Parasit & Allergen Prod, Off Vaccines Res & Review, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[Slater, Jay E.] US FDA, Lab Immunobiochem, Div Bacterial Parasit & Allergen Prod, Off Vaccines Res & Review,Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Rabin, RL (reprint author), US FDA, Div Bacterial Parasit & Allergen Prod, Off Vaccines Res & Review, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
NR 33
TC 3
Z9 3
U1 1
U2 1
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-84214-574-6; 978-1-84214-573-9
PY 2014
BP 281
EP 287
PG 7
WC Allergy; Immunology
SC Allergy; Immunology
GA BC3RG
UT WOS:000351872300021
ER
PT S
AU Barrett, HH
Myers, KJ
Caucci, L
AF Barrett, Harrison H.
Myers, Kyle J.
Caucci, Luca
BE Gregory, GG
Davis, AJ
TI RADIANCE AND PHOTON NOISE: Imaging in geometrical optics, physical
optics, quantum optics and radiology
SO NOVEL OPTICAL SYSTEMS DESIGN AND OPTIMIZATION XVII
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT 17th Conference of Novel Optical Systems Design and Optimization
CY AUG 17-19, 2014
CL San Diego, CA
SP SPIE
DE Radiance; geometrical optics; physical optics; quantum imaging;
radiology; point processes; image; quality
ID NEUMANN-SERIES APPROACH; LIST-MODE LIKELIHOOD; OBJECTIVE ASSESSMENT;
QUALITY; RADIOMETRY; COHERENCE; DETECTORS; TRANSPORT; ALGORITHM; MEDIA
AB A fundamental way of describing a photon-limited imaging system is in terms of a Poisson random process in spatial, angular and wavelength variables. The mean of this random process is the spectral radiance. The principle of conservation of radiance then allows a full characterization of the noise in the image (conditional on viewing a specified object). To elucidate these connections, we first review the definitions and basic properties of radiance as defined in terms of geometrical optics, radiology, physical optics and quantum optics. The propagation and conservation laws for radiance in each of these domains are reviewed. Then we distinguish four categories of imaging detectors that all respond in some way to the incident radiance, including the new category of photon-processing detectors. The relation between the radiance and the statistical properties of the detector output is discussed and related to task-based measures of image quality and the information content of a single detected photon.
C1 [Barrett, Harrison H.] Univ Arizona, Coll Opt Sci, Tucson, AZ 85721 USA.
[Barrett, Harrison H.; Caucci, Luca] Ctr Gamma Ray Imaging, Dept Med Imaging, Tucson, AZ 85724 USA.
[Myers, Kyle J.] US FDA, Ctr Devices & Radiol Hlth, Div Imaging & Appl Math, Silver Spring, MD 20993 USA.
RP Barrett, HH (reprint author), Arizona Hlth Sci Ctr, Ctr Gamma Ray Imaging, Radiol Res Lab, Tucson, AZ 85724 USA.
EM barrett@radiology.arizona.edu
NR 25
TC 2
Z9 2
U1 0
U2 1
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-1-62841-220-8
J9 PROC SPIE
PY 2014
VL 9193
AR 919302
DI 10.1117/12.2066715
PG 17
WC Engineering, Electrical & Electronic; Optics; Physics, Applied
SC Engineering; Optics; Physics
GA BC6PX
UT WOS:000354367700001
ER
PT S
AU Pillai, KV
Hunt, PR
Duncan, TV
AF Pillai, Karthik V.
Hunt, Piper R.
Duncan, Timothy V.
BE Snedeker, SM
TI Nanoparticles in Polymer Nanocomposite Food Contact Materials: Uses,
Potential Release, and Emerging Toxicological Concerns
SO TOXICANTS IN FOOD PACKAGING AND HOUSEHOLD PLASTICS: EXPOSURE AND HEALTH
RISKS TO CONSUMERS
SE Molecular and Integrative Toxicology
LA English
DT Article; Book Chapter
DE Engineered nanomaterials; Food packaging; Polymer nanocomposites;
Migration; Nanotoxicity; Nanoparticle toxicity; Safety of nanotechnology
ID ZINC-OXIDE NANOPARTICLES; SPRAGUE-DAWLEY RATS; SILVER NANOPARTICLES;
ORAL TOXICITY; ENGINEERED NANOMATERIALS; DIOXIDE NANOPARTICLES;
TITANIUM-DIOXIDE; HIGH-PRESSURE; IN-VITRO; MIGRATION
AB Several types of nanotechnology-enabled plastics intended for the storage and transport of foods are close to commercialization. For food contact applications, nanocomposite plastics offer many advantages over traditional polymers. However, while the unique properties of engineered nanomaterials (ENMs) may be harnessed for many positive ends, there are concerns about whether ENMs pose risks to human health. The primary areas of interest for assessing safety of nanocomposite food contact materials (FCM) are the potential for migration of ENMs into food and the potential toxicity of such released ENMs. This chapter offers a review of theoretical and experimental methods to assess the likelihood of ENM release from nanotechnology-enabled materials into liquid media, as well as a brief overview of the potential toxicological considerations of ENMs likely to be used in FCMs. Because the use of nanotechnology in food contact applications is a developing field, this chapter also provides background information on some of the food-related applications of nanocomposites currently in development, and a discussion of current methods being used to assess the release of non-nanoscale food packaging additives or contaminants. The goal of this work is to provide readers with an appreciation for current activity in this field as well as an understanding of data gaps that may need to be addressed in order to ensure the safety of this emerging technology.
C1 [Pillai, Karthik V.; Duncan, Timothy V.] US FDA, Div Food Proc Sci & Technol, Off Food Safety, Ctr Food Safety & Appl Nutr, Bedford Pk, IL 60501 USA.
[Hunt, Piper R.] US FDA, Div Toxicol, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD USA.
RP Duncan, TV (reprint author), US FDA, Div Food Proc Sci & Technol, Off Food Safety, Ctr Food Safety & Appl Nutr, Bedford Pk, IL 60501 USA.
EM Karthik.Pillai@fda.hhs.gov; Piper.Hunt@fda.hhs.gov;
timothy.duncan@fda.hhs.gov
RI Hunt, Piper/G-1555-2012
OI Hunt, Piper/0000-0003-0538-7606
NR 86
TC 1
Z9 1
U1 3
U2 11
PU SPRINGER-VERLAG LONDON LTD
PI GODALMING
PA SWEETAPPLE HOUSE CATTESHALL RD FARNCOMBE, GODALMING GU7 1NH, SURREY,
ENGLAND
SN 2168-4219
BN 978-1-4471-6500-2; 978-1-4471-6499-9
J9 MOLEC INTEGR TOXICOL
PY 2014
BP 95
EP 123
DI 10.1007/978-1-4471-6500-2_4
D2 10.1007/978-1-4471-6500-2
PG 29
WC Environmental Sciences; Food Science & Technology; Toxicology
SC Environmental Sciences & Ecology; Food Science & Technology; Toxicology
GA BC6BJ
UT WOS:000353720200005
ER
PT S
AU Rice, PA
Bandele, OJ
Honigfort, P
AF Rice, Penelope A.
Bandele, Omari J.
Honigfort, Paul
BE Snedeker, SM
TI Perfluorinated Compounds in Food Contact Materials
SO TOXICANTS IN FOOD PACKAGING AND HOUSEHOLD PLASTICS: EXPOSURE AND HEALTH
RISKS TO CONSUMERS
SE Molecular and Integrative Toxicology
LA English
DT Article; Book Chapter
DE Perfluorinated; Fluorotelomer; PFOA; Perfluoroalkyl; Perfluorooctanoic;
Perfluorononanoic; Perfluorodecanoic; Perfluorododecanoic;
Perfluorooctylethanol; FTOH; Perfluorocarboxylates; Food packaging
ID ACTIVATED RECEPTOR-ALPHA; PERFLUOROOCTANE SULFONATE PFOS; MAMMARY-GLAND
DEVELOPMENT; 8-2 FLUOROTELOMER ALCOHOL; HUMAN SEMEN QUALITY;
FLUOROCHEMICAL PRODUCTION WORKERS; RESTRICTED GESTATIONAL EXPOSURES;
PEROXISOMAL BETA-OXIDATION; NATIONAL BIRTH COHORT; SPRAGUE-DAWLEY RATS
AB Perfluorinated compounds (PFCs) exhibit unique physical characteristics including hydrophobic and oleophobic properties as well as thermal and chemical stability. Due to these characteristics, PFCs are used in a wide variety of industrial and consumer applications, including automotive, electrical, clothing, and household products. PFCs are ubiquitous in the environment and PFCs greater than seven carbons in length have been found to bioaccumulate in wildlife and humans. Furthermore, laboratory animal studies have raised concerns as to the safety of human exposure to these compounds. Although their use in the manufacture of food contact substances (FCSs) constitutes a small segment of the use of PFCs, their use in food packaging and migration to foodstuffs does represent a potential source of oral exposure to humans. This chapter focuses on aspects of human exposure, and potential health risks associated with two types of long-chain PFCs that historically have been found in food packaging: perfluorinated carboxylic acids (PFCAs) and fluorinated telomer alcohols (FTOHs).
C1 [Rice, Penelope A.; Bandele, Omari J.; Honigfort, Paul] US FDA, Div Food Contact Notificat, Off Food Addit Safety, Ctr Food Safety & Appl Nutr, College Pk, MD 20993 USA.
RP Rice, PA (reprint author), US FDA, Div Food Contact Notificat, Off Food Addit Safety, Ctr Food Safety & Appl Nutr, College Pk, MD 20993 USA.
EM Penelope.Rice@fda.hhs.gov; Omari.Bandele@fda.hhs.gov;
Paul.Honigfort@fda.hhs.gov
NR 164
TC 0
Z9 0
U1 2
U2 10
PU SPRINGER-VERLAG LONDON LTD
PI GODALMING
PA SWEETAPPLE HOUSE CATTESHALL RD FARNCOMBE, GODALMING GU7 1NH, SURREY,
ENGLAND
SN 2168-4219
BN 978-1-4471-6500-2; 978-1-4471-6499-9
J9 MOLEC INTEGR TOXICOL
PY 2014
BP 177
EP 203
DI 10.1007/978-1-4471-6500-2_7
D2 10.1007/978-1-4471-6500-2
PG 27
WC Environmental Sciences; Food Science & Technology; Toxicology
SC Environmental Sciences & Ecology; Food Science & Technology; Toxicology
GA BC6BJ
UT WOS:000353720200008
ER
PT J
AU Wear, K
Nagatani, Y
Mizuno, K
Matsukawa, M
AF Wear, Keith
Nagatani, Yoshiki
Mizuno, Katsunori
Matsukawa, Mami
GP IEEE
TI Temporal Evolution of Fast and Slow Waves During Propagation Through
Bovine Cancellous Bone In Vitro
SO 2014 IEEE INTERNATIONAL ULTRASONICS SYMPOSIUM (IUS)
LA English
DT Proceedings Paper
CT IEEE International Ultrasonics Symposium (IUS)
CY SEP 03-06, 2014
CL Chicago, IL
SP IEEE
DE fast and slow waves; cancellous bone
ID BAND ULTRASOUND ATTENUATION; PHASE CANCELLATION; TRABECULAR BONE;
STRUCTURAL ANISOTROPY; GROUP-VELOCITY; SIMULATION; DISPERSION; PHANTOM;
FEMUR; SPEED
AB Fast and slow waves were detected in a bovine cancellous bone sample for thicknesses ranging from 7 to 12 mm using bandlimited deconvolution and the modified least-squares Prony's method with curve fitting (MLSP+CF). Bandlimited deconvolution consistently isolated two waves with linear-with-frequency attenuation coefficients, as evidenced by high correlation coefficients between attenuation coefficient and frequency: 0.997 +/- 0.002 (fast wave) and 0.986 +/- 0.013 (slow wave) (mean +/- standard deviation). Average root-mean-squared (RMS) differences between the two algorithms for phase velocities were 5 m/s (fast wave, 350 kHz) and 13 m/s (slow wave, 750 kHz). Average RMS differences for signal loss were 1.6 dB (fast wave, 350 kHz) and 0.4 dB (slow wave, 750 kHz). Phase velocities for thickness = 10 mm were 1726 m/s (fast wave, 350 kHz) and 1455 m/s (slow wave, 750 kHz). Results show support for the model of two waves with linear-with frequency attenuation, successful isolation of fast and slow waves, good agreement between bandlimited deconvolution and MLSP+CF as well as with a Bayesian algorithm, and potential variations of fast and/or slow wave properties with bone sample thickness.
C1 [Wear, Keith] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Nagatani, Yoshiki] Kobe City Coll Technol, Dept Elect, Kobe, Hyogo, Japan.
[Mizuno, Katsunori] Univ Tokyo, Inst Ind Sci, Underwater Technol Collaborat Res Ctr, Tokyo, Japan.
[Matsukawa, Mami] Doshisha Univ, Fac Sci & Engn, Lab Ultrason Elect, Kyoto 602, Japan.
RP Wear, K (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
NR 25
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
BN 978-1-4799-7049-0
PY 2014
BP 927
EP 930
DI 10.1109/ULTSYM.2014.0227
PG 4
WC Acoustics; Engineering, Electrical & Electronic
SC Acoustics; Engineering
GA BC4NN
UT WOS:000352792500226
ER
PT J
AU Wear, KA
Maruvada, S
Liu, YB
Harris, GR
Gammell, P
AF Wear, Keith A.
Maruvada, Subha
Liu, Yunbo
Harris, Gerald R.
Gammell, Paul
GP IEEE
TI Suppression of Pressure Measurement Artifacts from Fiber Optic
Hydrophones Using Complex Deconvolution of Sensitivity
SO 2014 IEEE INTERNATIONAL ULTRASONICS SYMPOSIUM (IUS)
LA English
DT Proceedings Paper
CT IEEE International Ultrasonics Symposium (IUS)
CY SEP 03-06, 2014
CL Chicago, IL
SP IEEE
DE hydrophones; acoustic output; fiber optic
AB Nonlinear acoustic signals contain significant energy at many harmonic frequencies. For many applications, the sensitivity (frequency response) of a hydrophone will not be uniform over such a broad spectrum. In a continuation of a previous investigation involving deconvolution methodology, deconvolution (implemented in the frequency domain as an inverse filter computed from frequency-dependent hydrophone sensitivity) was investigated for improvement of accuracy and precision of nonlinear acoustic output measurements. Time delay spectrometry (TDS) was used to measure complex sensitivities for six fiber-optic hydrophones. The hydrophones were then used to measure a pressure wave with rich harmonic content. Spectral asymmetry between compressional and rarefactional segments was exploited in order to design filters used in conjunction with deconvolution. Complex deconvolution reduced mean bias (for 6 fiber-optic hydrophones) and mean coefficient of variation (COV) for peak compressional pressure (p+), peak rarefactional pressure (p-), and pulse intensity integral (PII). Deconvolution based on sensitivity magnitude or the minimum phase model also resulted in significant reductions in mean bias and COY of acoustic output parameters but was less effective than direct complex deconvolution for p+ and P-. Therefore, deconvolution with appropriate filtering facilitates reliable nonlinear acoustic output measurements using hydrophones with frequency-dependent sensitivity.
C1 [Wear, Keith A.; Maruvada, Subha; Liu, Yunbo; Harris, Gerald R.] US FDA, Silver Spring, MD 20993 USA.
[Gammell, Paul] Gammell Appl Technol, Exmore, VA USA.
RP Wear, KA (reprint author), US FDA, Silver Spring, MD 20993 USA.
NR 6
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
BN 978-1-4799-7049-0
PY 2014
BP 1172
EP 1174
DI 10.1109/ULTSYM.2014.0288
PG 3
WC Acoustics; Engineering, Electrical & Electronic
SC Acoustics; Engineering
GA BC4NN
UT WOS:000352792500287
ER
PT S
AU Yu, A
Sun, DX
Li, BV
Yu, LX
AF Yu, Alex
Sun, Duxin
Li, Bing V.
Yu, Lawrence X.
BE Yu, LX
Li, BV
TI Bioequivalence History
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID DISPOSITION CLASSIFICATION-SYSTEM; HIGHLY VARIABLE DRUGS; INDIVIDUAL
BIOEQUIVALENCE; PHYSIOLOGIC AVAILABILITY; TETRACYCLINE PRODUCTS;
BIOLOGIC AVAILABILITY; RELEASE FORMULATIONS; INHALER DEVICES; PARTIAL
AUC; IN-VITRO
C1 [Yu, Alex; Sun, Duxin] Univ Michigan, Coll Pharm, Ann Arbor, MI 48109 USA.
[Li, Bing V.; Yu, Lawrence X.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Yu, LX (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire, Silver Spring, MD 20993 USA.
EM alexmyu@med.umich.edu; duxins@med.umich.edu; bing.li@fda.hhs.gov;
Lawrence.Yu@fda.hhs.gov
NR 93
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 1
EP 27
DI 10.1007/978-1-4939-1252-0_1
D2 10.1007/978-1-4939-1252-0
PG 27
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100003
ER
PT S
AU Yu, LX
Li, BV
AF Yu, Lawrence X.
Li, Bing V.
BE Yu, LX
Li, BV
TI FDA Bioequivalence Standards Preface
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Editorial Material; Book Chapter
C1 [Yu, Lawrence X.] US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Li, Bing V.] US FDA, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Yu, LX (reprint author), US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP VII
EP VIII
D2 10.1007/978-1-4939-1252-0
PG 2
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100002
ER
PT S
AU Chen, ML
AF Chen, Mei-Ling
BE Yu, LX
Li, BV
TI Fundamentals of Bioequivalence
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID RELEASE FORMULATIONS; CLINICAL PHARMACOKINETICS; LINEAR
PHARMACOKINETICS; IBUPROFEN ENANTIOMERS; SORBITOL INTOLERANCE; DRUG
PRODUCTS; METABOLITES; HUMANS; PHARMACODYNAMICS; EQUIVALENCE
C1 US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Chen, ML (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM meiling.chen@fda.hhs.gov
NR 61
TC 1
Z9 1
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 29
EP 53
DI 10.1007/978-1-4939-1252-0_2
D2 10.1007/978-1-4939-1252-0
PG 25
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100004
ER
PT S
AU Makhlouf, FT
Grosser, SC
Schuirmann, DJ
AF Makhlouf, Fairouz T.
Grosser, Stella C.
Schuirmann, Donald J.
BE Yu, LX
Li, BV
TI Basic Statistical Considerations
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID INDIVIDUAL BIOEQUIVALENCE; CONFIDENCE-INTERVALS; BIOAVAILABILITY;
EQUIVALENCE; DESIGN
C1 [Makhlouf, Fairouz T.; Grosser, Stella C.; Schuirmann, Donald J.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Makhlouf, FT (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Fairouz.Makhlouf@fda.hhs.gov
NR 19
TC 0
Z9 0
U1 1
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 55
EP 93
DI 10.1007/978-1-4939-1252-0_3
D2 10.1007/978-1-4939-1252-0
PG 39
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100005
ER
PT S
AU DeHaven, WI
Conner, DP
AF DeHaven, Wayne I.
Conner, Dale P.
BE Yu, LX
Li, BV
TI The Effects of Food on Drug Bioavailability and Bioequivalence
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID GASTROINTESTINAL-TRACT; RELEASE FORMULATIONS; 1ST-PASS METABOLISM;
ABSORPTION; PHARMACOKINETICS; TABLETS; PH; DISSOLUTION; NIFEDIPINE;
HEALTHY
C1 [DeHaven, Wayne I.; Conner, Dale P.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP DeHaven, WI (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Wayne.Dehaven@fda.hhs.gov
NR 66
TC 0
Z9 0
U1 0
U2 5
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 95
EP 118
DI 10.1007/978-1-4939-1252-0_4
D2 10.1007/978-1-4939-1252-0
PG 24
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100006
ER
PT S
AU Uppoor, RS
Vaidyanathan, J
Mehta, M
Yu, LX
AF Uppoor, Ramana S.
Vaidyanathan, Jayabharathi
Mehta, Mehul
Yu, Lawrence X.
BE Yu, LX
Li, BV
TI Biowaiver and Biopharmaceutics Classification System
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID ORAL-DRUG ABSORPTION; CLASS-III DRUGS; GASTROINTESTINAL TRANSIT;
INTESTINAL TRANSIT; DOSAGE FORMS; BIOAVAILABILITY; BCS; BIOEQUIVALENCE;
PERMEABILITY; DISSOLUTION
C1 [Uppoor, Ramana S.; Vaidyanathan, Jayabharathi; Mehta, Mehul; Yu, Lawrence X.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Uppoor, RS (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Ramana.Uppoor@fda.hhs.gov
NR 41
TC 1
Z9 1
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 119
EP 137
DI 10.1007/978-1-4939-1252-0_5
D2 10.1007/978-1-4939-1252-0
PG 19
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100007
ER
PT S
AU Davit, BM
Patel, DT
AF Davit, Barbara M.
Patel, Devvrat T.
BE Yu, LX
Li, BV
TI Bioequivalence of Highly Variable Drugs
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID SCALED AVERAGE BIOEQUIVALENCE; SIDED TESTS PROCEDURE; PRODUCTS;
BIOAVAILABILITY; POWER; FDA
C1 [Davit, Barbara M.] Merck Sharp & Dohme Corp, Clin Res, Biopharmaceut, Whitehouse Stn, NJ 08889 USA.
[Patel, Devvrat T.] US FDA, Off Gener Drugs, Ctr Drug Evaluat & Res, Rockville, MD 20855 USA.
RP Davit, BM (reprint author), Merck Sharp & Dohme Corp, Clin Res, Biopharmaceut, One Merck Dr,POB 100, Whitehouse Stn, NJ 08889 USA.
EM Barbara.Davit@merck.com
NR 40
TC 0
Z9 1
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 139
EP 164
DI 10.1007/978-1-4939-1252-0_6
D2 10.1007/978-1-4939-1252-0
PG 26
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100008
ER
PT S
AU Zhu, H
Uppoor, RS
Mehta, M
Yu, LX
AF Zhu, Hao
Uppoor, Ramana S.
Mehta, Mehul
Yu, Lawrence X.
BE Yu, LX
Li, BV
TI Partial Area Under the Curve: An Additional Pharmacokinetic Metric for
Bioavailability and Bioequivalence Assessments
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID EXTENDED-RELEASE FORMULATIONS; THERAPEUTIC EQUIVALENCE; DRUG ABSORPTION;
REGULATORY STANDARDS; PARTIAL AUC; PRODUCTS; OPPORTUNITIES; CHALLENGES;
INHIBITOR; EXPOSURE
C1 [Zhu, Hao; Uppoor, Ramana S.; Mehta, Mehul; Yu, Lawrence X.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Zhu, H (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Hao.Zhu@fda.hhs.gov
NR 49
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 165
EP 190
DI 10.1007/978-1-4939-1252-0_7
D2 10.1007/978-1-4939-1252-0
PG 26
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100009
ER
PT S
AU Jiang, WL
Yu, LX
AF Jiang, Wenlei
Yu, Lawrence X.
BE Yu, LX
Li, BV
TI Bioequivalence for Narrow Therapeutic Index Drugs
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID HIGHLY VARIABLE DRUGS; DOSAGE ADJUSTMENT; PRODUCTS
C1 [Jiang, Wenlei; Yu, Lawrence X.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Jiang, WL (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Wenlei.Jiang@fda.hhs.gov
NR 35
TC 1
Z9 1
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 191
EP 216
DI 10.1007/978-1-4939-1252-0_8
D2 10.1007/978-1-4939-1252-0
PG 26
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100010
ER
PT S
AU Zou, P
Yu, LX
AF Zou, Peng
Yu, Lawrence X.
BE Yu, LX
Li, BV
TI Pharmacodynamic Endpoint Bioequivalence Studies
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID DERMATOLOGICAL DRUG PRODUCTS; BIOAVAILABILITY; INFLAMMATION;
FORMULATIONS; BUDESONIDE; ASTHMA; ASSAY
C1 [Zou, Peng; Yu, Lawrence X.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Zou, P (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Peng.Zou@fda.hhs.gov
NR 47
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 217
EP 241
DI 10.1007/978-1-4939-1252-0_9
D2 10.1007/978-1-4939-1252-0
PG 25
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100011
ER
PT S
AU Peters, JR
AF Peters, John R.
BE Yu, LX
Li, BV
TI Clinical Endpoint Bioequivalence Study
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID HEPATIC-ENCEPHALOPATHY; CARDIOVASCULAR-DISEASE; TRAVELERS DIARRHEA;
MEDICAL-EDUCATION; DRUG DEVELOPMENT; FLEXNER REPORT; RIFAXIMIN;
BIOMARKERS; QUANTIFICATION; DISCOVERY
C1 US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Peters, JR (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Johnr.Peters@fda.hhs.gov
NR 38
TC 0
Z9 0
U1 1
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 243
EP 274
DI 10.1007/978-1-4939-1252-0_10
D2 10.1007/978-1-4939-1252-0
PG 32
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100012
ER
PT S
AU Zheng, N
Jiang, WL
Lionberger, R
Yu, LX
AF Zheng, Nan
Jiang, Wenlei
Lionberger, Robert
Yu, Lawrence X.
BE Yu, LX
Li, BV
TI Bioequivalence for Liposomal Drug Products
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID ACCELERATED BLOOD CLEARANCE; IN-VITRO; SOLID TUMORS; DOXORUBICIN
FORMULATIONS; THERAPEUTIC ACTIVITY; REPEATED INJECTION; LIPOPHILIC
DRUGS; DELIVERY SYSTEMS; SURFACE-CHARGE; AMPHOTERICIN-B
C1 [Zheng, Nan; Jiang, Wenlei; Lionberger, Robert; Yu, Lawrence X.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Zheng, N (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM nan.zheng@fda.hhs.gov; wenlei.jiang@fda.hhs.gov;
robert.lionberger@fda.hhs.gov; lawrence.yu@fda.hhs.gov
NR 74
TC 2
Z9 2
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 275
EP 296
DI 10.1007/978-1-4939-1252-0_11
D2 10.1007/978-1-4939-1252-0
PG 22
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100013
ER
PT S
AU Jiang, XJ
Yang, YS
Stier, E
AF Jiang, Xiaojian
Yang, Yongsheng
Stier, Ethan
BE Yu, LX
Li, BV
TI Bioequivalence for Drug Products Acting Locally Within Gastrointestinal
Tract
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID CHRONIC-RENAL-FAILURE; TYPE-2 DIABETES-MELLITUS; BINDER LANTHANUM
CARBONATE; CHRONIC KIDNEY-DISEASE; COLESEVELAM HYDROCHLORIDE; IN-VITRO;
PHOSPHATE BINDER; HEALTHY-VOLUNTEERS; ULCERATIVE-COLITIS; DOSAGE FORMS
C1 [Jiang, Xiaojian; Yang, Yongsheng; Stier, Ethan] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Jiang, XJ (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Xiaojian.Jiang@fda.hhs.gov
NR 109
TC 1
Z9 1
U1 1
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 297
EP 334
DI 10.1007/978-1-4939-1252-0_12
D2 10.1007/978-1-4939-1252-0
PG 38
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100014
ER
PT S
AU Braddy, AC
Conner, DP
AF Braddy, April C.
Conner, Dale P.
BE Yu, LX
Li, BV
TI Bioequivalence for Topical Drug Products
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID IN-VIVO; PERCUTANEOUS-ABSORPTION; HUMAN SKIN; DERMATOLOGICAL PRODUCTS;
GENERIC DEVELOPMENT; DERMAL ABSORPTION; MICRODIALYSIS; DELIVERY; VITRO;
BIOAVAILABILITY
C1 [Braddy, April C.; Conner, Dale P.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Braddy, AC (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM April.Braddy@fda.hhs.gov
NR 61
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 335
EP 367
DI 10.1007/978-1-4939-1252-0_13
D2 10.1007/978-1-4939-1252-0
PG 33
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100015
ER
PT S
AU Saluja, B
Li, BV
Lee, SL
AF Saluja, Bhawana
Li, Bing V.
Lee, Sau L.
BE Yu, LX
Li, BV
TI Bioequivalence for Orally Inhaled and Nasal Drug Products
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID METERED-DOSE INHALERS; ASTHMATIC-PATIENTS; DELIVERY-SYSTEMS;
NITRIC-OXIDE; FORMULATION; PERFORMANCE; METHACHOLINE; SALMETEROL;
DEPOSITION; HISTAMINE
C1 [Saluja, Bhawana; Li, Bing V.; Lee, Sau L.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Lee, SL (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM sau.lee@fda.hhs.gov
NR 44
TC 1
Z9 1
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 369
EP 394
DI 10.1007/978-1-4939-1252-0_14
D2 10.1007/978-1-4939-1252-0
PG 26
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100016
ER
PT S
AU Zhang, XY
AF Zhang, Xinyuan
BE Yu, LX
Li, BV
TI Bioequivalence: Modeling and Simulation
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID ORAL-DRUG ABSORPTION; MONTE-CARLO SIMULATIONS; CONCENTRATION-TIME
PROFILES; HIGHLY VARIABLE DRUGS; BIOPHARMACEUTICS CLASSIFICATION-SYSTEM;
DETAILED PHYSIOLOGICAL MODEL; PARTICLE-SIZE DISTRIBUTION; IN-VITRO
CORRELATION; SOLID DOSAGE FORMS; MIXING-TANK MODEL
C1 US FDA, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Zhang, XY (reprint author), US FDA, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM Xinyuan.Zhang@fda.hhs.gov
NR 112
TC 0
Z9 0
U1 6
U2 7
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 395
EP 417
DI 10.1007/978-1-4939-1252-0_15
D2 10.1007/978-1-4939-1252-0
PG 23
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100017
ER
PT S
AU Subramaniam, S
AF Subramaniam, Sriram
BE Yu, LX
Li, BV
TI Bioanalysis
SO FDA BIOEQUIVALENCE STANDARDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID CHROMATOGRAPHY-MASS SPECTROMETRY; LIGAND-BINDING ASSAYS; LC-MS;
LIQUID-CHROMATOGRAPHY; INCURRED SAMPLE; RECENT ISSUES; METHOD
VALIDATION; HUMAN PLASMA; WHITE PAPER; REGULATED BIOANALYSIS
C1 US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Subramaniam, S (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Sriram.Subramaniam@fda.hhs.gov
NR 58
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4939-1252-0; 978-1-4939-1251-3
J9 AAPS ADV PHARM SCI
PY 2014
BP 419
EP 458
DI 10.1007/978-1-4939-1252-0_16
D2 10.1007/978-1-4939-1252-0
PG 40
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BC1TO
UT WOS:000350418100018
ER
PT S
AU Iacono, MI
Neufeld, E
Bonmassar, G
Akinnagbe, E
Jakab, A
Cohen, E
Kuster, N
Kainz, W
Angelone, LM
AF Iacono, Maria I.
Neufeld, Esra
Bonmassar, Giorgio
Akinnagbe, Esther
Jakab, Andras
Cohen, Ethan
Kuster, Niels
Kainz, Wolfgang
Angelone, Leonardo M.
GP IEEE
TI A Computational Model for Bipolar Deep Brain Stimulation of the
Subthalamic Nucleus
SO 2014 36TH ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN
MEDICINE AND BIOLOGY SOCIETY (EMBC)
SE IEEE Engineering in Medicine and Biology Society Conference Proceedings
LA English
DT Proceedings Paper
CT 36th Annual International Conference of the
IEEE-Engineering-in-Medicine-and-Biology-Society (EMBC)
CY AUG 26-30, 2014
CL Chicago, IL
SP IEEE Engn Medicine & Biol Soc
AB Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has been shown to reduce some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. However, the precise mechanism of the therapeutic action of DBS is still unclear. Stimulation-induced side effects are not uncommon and require electrical "dose" adjustments. Quantitative methods are needed to fully characterize the electric field in the deep brain region that surrounds the electrodes in order to help with adjustments and maximize the efficacy of the device.
Herein we report a magnetic resonance imaging (MRI)-based head model proposed for analysis of fields generated by deep brain stimulation (DBS). The model was derived from multimodal image data at 0.5mm isotropic spatial resolution and distinguishes 142 anatomical structures, including the basal ganglia and 38 nuclei of the thalamus. Six bipolar electrode configurations (1-2, 1-3, 1-4, 2-3, 2-4, 3-4) were modeled in order to assess the effects of the inter-electrode distance of the electric field. Increasing the distance between the electrodes results in an attenuated stimulation, with up to 25% reduction in electric field amplitude delivered (2-3 vs. 1-4). The map of the deep brain structures provided a highly precise anatomical detail which is useful for the quantitative assessment of current spread around the electrode and a better evaluation of the stimulation setting for the treatment optimization.
C1 [Iacono, Maria I.; Akinnagbe, Esther; Cohen, Ethan; Kainz, Wolfgang; Angelone, Leonardo M.] US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Div Phys, Silver Spring, MD 20993 USA.
[Neufeld, Esra; Kuster, Niels] Fdn Res Informat Technol Soc IT IS, CH-8004 Zurich, Switzerland.
[Jakab, Andras] Med Univ Vienna, Computat Image Anal & Radiol Lab, A-1090 Vienna, Austria.
[Bonmassar, Giorgio] MGH, AA Martinos Ctr Biomed Imaging, Dept Radiol, Charlestown, MA USA.
RP Iacono, MI (reprint author), US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Div Phys, Silver Spring, MD 20993 USA.
EM Maria.Iacono@fda.hhs.gov
NR 17
TC 1
Z9 1
U1 0
U2 1
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 1557-170X
BN 978-1-4244-7929-0
J9 IEEE ENG MED BIO
PY 2014
BP 6258
EP 6261
PG 4
WC Engineering, Biomedical; Engineering, Electrical & Electronic
SC Engineering
GA BC1EL
UT WOS:000350044706063
ER
PT J
AU Kish-Doto, J
Scales, M
Eguino-Medina, P
Fitzgerald, T
Tzeng, JP
McCormack, LA
O'Donoghue, A
Oguntimein, O
West, SL
AF Kish-Doto, Julia
Scales, Monica
Eguino-Medina, Paula
Fitzgerald, Tania
Tzeng, Janice P.
McCormack, Lauren A.
O'Donoghue, Amie
Oguntimein, Oluwamurewa
West, Suzanne L.
TI Preferences for Patient Medication Information: What Do Patients Want?
SO JOURNAL OF HEALTH COMMUNICATION
LA English
DT Article
ID RHEUMATIC CONDITIONS; UNITED-STATES; ORGANIZATIONAL SIGNALS; ARTHRITIS;
RECALL; TEXT; PREVALENCE; WOMEN; MEN
AB This study investigated respondent preferences on how best to display patient medication information (PMI) that accompanies prescription medications to promote comprehension and appropriate usage. The authors identified 30 individuals diagnosed with select immune disorders, 30 with other chronic diseases, and 30 from the general public and had them review one of two PMI handouts that varied by format, organization, and content. The authors explored preferences for the PMI handout using one-on-one interviews. The authors analyzed the qualitative data to identify relevant themes and patterns using NVivo9 qualitative software. The majority of respondents noted that the formats of the two PMI handouts were more informative than those they currently receive from the pharmacist, with a preference for the 2-column, segmented design. However, respondent PMI preferences varied by age, education, and health status. Patients need simpler and more concise drug information to make better decisions about their health. Current PMI handouts are dense and complex, which can be confusing and not reader friendly. To improve PMI understandability and usefulness, the U.S. Food and Drug Administration is working with stakeholders, consumer advocates, and academics. Findings from this study may help inform future development of more user-friendly PMI.
C1 [Kish-Doto, Julia] RTI Int, Rockville, MD 20852 USA.
[Scales, Monica; Fitzgerald, Tania; Tzeng, Janice P.; McCormack, Lauren A.; West, Suzanne L.] RTI Int, Res Triangle Pk, NC USA.
[Eguino-Medina, Paula] RTI Int, Washington, DC USA.
[O'Donoghue, Amie; Oguntimein, Oluwamurewa] US FDA, Silver Spring, MD USA.
RP Kish-Doto, J (reprint author), RTI Int, 6110 Execut Blvd,Suite 902, Rockville, MD 20852 USA.
EM jkdoto@rti.org
NR 27
TC 3
Z9 3
U1 0
U2 2
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 WALNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1081-0730
EI 1087-0415
J9 J HEALTH COMMUN
JI J. Health Commun.
PY 2014
VL 19
SU 2
SI SI
BP 77
EP 88
DI 10.1080/10810730.2014.946114
PG 12
WC Communication; Information Science & Library Science
SC Communication; Information Science & Library Science
GA CE5OI
UT WOS:000351884600010
PM 25315585
ER
PT S
AU Mattes, W
Yang, X
Orr, MS
Richter, P
Mendrick, DL
AF Mattes, William
Yang, Xi
Orr, Michael S.
Richter, Patricia
Mendrick, Donna L.
BE Makowski, GS
TI Biomarkers of Tobacco Smoke Exposure
SO ADVANCES IN CLINICAL CHEMISTRY, VOL 67
SE Advances in Clinical Chemistry
LA English
DT Review; Book Chapter
ID SURROGATE END-POINTS; LUNG-CANCER RISK; OPERATING CHARACTERISTIC CURVE;
GENE-ENVIRONMENT INTERACTION; TANDEM MASS-SPECTROMETRY; HUMAN SALIVARY
DNA; CIGARETTE SMOKERS; DRUG DEVELOPMENT; BRONCHIAL EPITHELIUM;
CARDIOVASCULAR-DISEASE
AB Diseases and death caused by exposure to tobacco smoke have become the single most serious preventable public health concern. Thus, biomarkers that can monitor tobacco exposure and health effects can play a critical role in tobacco product regulation and public health policy. Biomarkers of exposure to tobacco toxicants are well established and have been used in population studies to establish public policy regarding exposure to second-hand smoke, an example being the nicotine metabolite cotinine, which can be measured in urine. Biomarkers of biological response to tobacco smoking range from those indicative of inflammation to mRNA and microRNA patterns related to tobacco use and/or disease state. Biomarkers identifying individuals with an increased risk for a pathological response to tobacco have also been described. The challenge for any novel technology or biomarker is its translation to clinical and/or regulatory application, a process that requires first technical validation of the assay and then careful consideration of the context the biomarker assay may be used in the regulatory setting. Nonetheless, the current efforts to investigate new biomarker of tobacco smoke exposure promise to offer powerful new tools in addressing the health hazards of tobacco product use. This review will examine such biomarkers, albeit with a focus on those related to cigarette smoking.
C1 [Mattes, William; Yang, Xi; Mendrick, Donna L.] US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Off Sci, Ctr Tobacco Prod, Rockville, MD 20857 USA.
RP Mattes, W (reprint author), US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM william.mattes@fda.hhs.gov
NR 207
TC 6
Z9 6
U1 2
U2 15
PU ELSEVIER ACADEMIC PRESS INC
PI SAN DIEGO
PA 525 B STREET, SUITE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0065-2423
BN 978-0-12-802267-2
J9 ADV CLIN CHEM
JI Advan. Clin. Chem.
PY 2014
VL 67
BP 1
EP 45
DI 10.1016/bs.acc.2014.09.001
PG 45
WC Medical Laboratory Technology
SC Medical Laboratory Technology
GA BC1AD
UT WOS:000349890400002
PM 25735858
ER
PT S
AU Brorson, K
Kendrick, B
AF Brorson, Kurt
Kendrick, Brent
BE Schiel, JE
Davis, DL
Borisov, OV
TI Perspectives on Well-Characterized Biological Proteins
SO STATE-OF-THE-ART AND EMERGING TECHNOLOGIES FOR THERAPEUTIC MONOCLONAL
ANTIBODY CHARACTERIZATION, VOL 1 - MONOCLONAL ANTIBODY THERAPEUTICS:
STRUCTURE, FUNCTION, AND REGULATORY SPACE
SE ACS Symposium Series
LA English
DT Article; Book Chapter
ID MONOCLONAL-ANTIBODIES; LYSINE; HEAVY; ACID
AB The public expects medicines, including biopharmaceuticals, to be pure, of high quality, and consistent between doses. A critical component of achieving this goal is establishment and control of the critical quality attributes (CQAs) of both the bulk protein drug substance and the final unit dosage form that is administered to the patient. A well-characterized biological protein is one where there is confidence that all features important for product safety and potency have been identified. In this chapter, an industry and a regulatory authority representative discuss perspectives on achieving the shared goal of making high-quality biopharmaceuticals available to the public.
C1 [Brorson, Kurt] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20903 USA.
[Kendrick, Brent] Amgen Inc, Longmont, CO 80503 USA.
RP Brorson, K (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20903 USA.
EM kurt.brorson@fda.hhs.gov
NR 23
TC 0
Z9 0
U1 1
U2 1
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-3026-2
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1176
BP 99
EP 116
D2 10.1021/bk-2014-1176
PG 18
WC Biochemistry & Molecular Biology; Immunology; Pharmacology & Pharmacy
SC Biochemistry & Molecular Biology; Immunology; Pharmacology & Pharmacy
GA BC0ZH
UT WOS:000349873500005
ER
PT S
AU Freedberg, DI
Selenko, P
AF Freedberg, Daron I.
Selenko, Philipp
BE Dill, KA
TI Live Cell NMR
SO ANNUAL REVIEW OF BIOPHYSICS, VOL 43
SE Annual Review of Biophysics
LA English
DT Review; Book Chapter
DE in-cell NMR; on-cell NMR; in-cell EPR; macromolecular crowding; excluded
volume; soft interactions
ID SOLID-STATE NMR; DYNAMIC NUCLEAR-POLARIZATION; XENOPUS-LAEVIS OOCYTES;
ANGLE-SPINNING NMR; MAGNETIC-RESONANCE-SPECTROSCOPY; PROTEIN-PROTEIN
INTERACTIONS; LIVING MAMMALIAN-CELLS; IN-CELL; ESCHERICHIA-COLI; F-19
NMR
AB Ever since scientists realized that cells are the basic building blocks of all life, they have been developing tools to look inside them to reveal the architectures and mechanisms that define their biological functions. Whereas "looking into cells" is typically said in reference to optical microscopy, high-resolution in-cell and on-cell nuclear magnetic resonance (NMR) spectroscopy is a powerful method that offers exciting new possibilities for structural and functional studies in and on live cells. In contrast to conventional imaging techniques, in-and on-cell NMR methods do not provide spatial information on cellular biomolecules. Instead, they enable atomic-resolution insights into the native cell states of proteins, nucleic acids, glycans, and lipids. Here we review recent advances and developments in both fields and discuss emerging concepts that have been delineated with these methods.
C1 [Freedberg, Daron I.] USDA, Lab Bacterial Polysaccharides, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Selenko, Philipp] Leibniz Inst Mol Pharmacol FMP Berlin, Dept NMR Supported Struct Biol, In Cell NMR Lab, D-13125 Berlin, Germany.
RP Freedberg, DI (reprint author), USDA, Lab Bacterial Polysaccharides, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
EM daron.freedberg@fda.hhs.gov; selenko@fmp-berlin.de
NR 109
TC 28
Z9 28
U1 17
U2 80
PU ANNUAL REVIEWS
PI PALO ALTO
PA 4139 EL CAMINO WAY, PO BOX 10139, PALO ALTO, CA 94303-0897 USA
SN 1936-122X
BN 978-0-8243-1843-7
J9 ANNU REV BIOPHYS
JI Annu. Rev. Biophys.
PY 2014
VL 43
BP 171
EP 192
DI 10.1146/annurev-biophys-051013-023136
PG 22
WC Biophysics
SC Biophysics
GA BB9LG
UT WOS:000348434000008
PM 24895852
ER
PT S
AU Finley, JW
Finley, JW
Ellwood, K
Hoadley, J
AF Finley, John Weldon
Finley, John Wescott
Ellwood, Kathleen
Hoadley, James
BE Cousins, RJ
TI Launching a New Food Product or Dietary Supplement in the United States:
Industrial, Regulatory, and Nutritional Considerations
SO ANNUAL REVIEW OF NUTRITION, VOL 34
SE Annual Review of Nutrition
LA English
DT Review; Book Chapter
DE nutrition; food science; Food and Drug Administration; label claims;
food product development; regulations
ID PERCENT POLYMERIC COLOR; MONOMERIC ANTHOCYANINS; ANTIOXIDANT CAPACITY;
CANCER PREVENTION; HEALTH-BENEFITS; BITTER TASTE; AMINO-ACIDS; SELENIUM;
CRANBERRIES; CRITERIA
AB Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. Newfoods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.
C1 [Finley, John Weldon] ARS, USDA, Beltsville, MD 20705 USA.
[Finley, John Wescott] Louisiana State Univ, Sch Nutr & Food Sci, Baton Rouge, LA 70803 USA.
[Ellwood, Kathleen; Hoadley, James] US FDA, College Pk, MD 20740 USA.
RP Finley, JW (reprint author), ARS, USDA, Beltsville, MD 20705 USA.
EM john.finley@ars.usda.gov; jfinley@agcenter.lsu.edu; kellwood@csmd.edu;
jhoadley@easconsultinggroup.com
NR 92
TC 3
Z9 3
U1 1
U2 20
PU ANNUAL REVIEWS
PI PALO ALTO
PA 4139 EL CAMINO WAY, PO BOX 10139, PALO ALTO, CA 94303-0897 USA
SN 0199-9885
BN 978-0-8243-2834-4
J9 ANNU REV NUTR
JI Annu. Rev. Nutr.
PY 2014
VL 34
BP 421
EP 447
DI 10.1146/annurev-nutr-071813-105817
PG 27
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA BB9MA
UT WOS:000348455800018
PM 24850389
ER
PT J
AU Dufield, D
Neubert, H
Garofolo, F
Kirkovsky, L
Stevenson, L
Dumont, I
Kaur, S
Xu, KY
Alley, SC
Szapacs, M
Arnold, M
Bansal, S
Haidar, S
Welink, J
Le Blaye, O
Wakelin-Smith, J
Whale, E
Ishii-Watabe, A
Bustard, M
Katori, N
Amaravadi, L
Aubry, AF
Beaver, C
Bergeron, A
Cai, XY
Cojocaru, L
DeSilva, B
Duggan, J
Fluhler, E
Gorovits, B
Gupta, S
Hayes, R
Ho, S
Ingelse, B
King, L
Levesque, A
Lowes, S
Ma, M
Musuku, A
Myler, H
Olah, T
Patel, S
Rose, M
Schultz, G
Smeraglia, J
Swanson, S
Torri, A
Vazvaei, F
Wilson, A
Woolf, E
Xue, L
Yang, TY
AF Dufield, Dawn
Neubert, Hendrik
Garofolo, Fabio
Kirkovsky, Leo
Stevenson, Lauren
Dumont, Isabelle
Kaur, Surinder
Xu, Keyang
Alley, Stephen C.
Szapacs, Matthew
Arnold, Mark
Bansal, Surendra
Haidar, Sam
Welink, Jan
Le Blaye, Olivier
Wakelin-Smith, Jason
Whale, Emma
Ishii-Watabe, Akiko
Bustard, Mark
Katori, Noriko
Amaravadi, Lakshmi
Aubry, Anne-Francoise
Beaver, Chris
Bergeron, Annik
Cai, Xiao-Yan
Cojocaru, Laura
DeSilva, Binodh
Duggan, Jeff
Fluhler, Eric
Gorovits, Boris
Gupta, Swati
Hayes, Roger
Ho, Stacy
Ingelse, Benno
King, Lindsay
Levesque, Ann
Lowes, Steve
Ma, Mark
Musuku, Adrien
Myler, Heather
Olah, Timothy
Patel, Shefali
Rose, Mark
Schultz, Gary
Smeraglia, John
Swanson, Steven
Torri, Albert
Vazvaei, Faye
Wilson, Amanda
Woolf, Eric
Xue, Li
Yang, Tong-Yuan
TI 2014 White Paper on recent issues in bioanalysis: a full immersion in
bioanalysis (Part 2-hybrid LBA/LCMS, ELN & regulatory agencies' input)
SO BIOANALYSIS
LA English
DT Article
ID VALIDATION GROUP WORKSHOP; CALIBRATION
AB The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).
C1 [Dufield, Dawn; Neubert, Hendrik; Gorovits, Boris; Xue, Li] Pfizer, Andover, MA USA.
[Garofolo, Fabio; Dumont, Isabelle; Bergeron, Annik] Algorithme Pharma Inc, Montreal, PQ H7V 4B3, Canada.
[Kirkovsky, Leo] Pfizer, San Diego, CA USA.
[Stevenson, Lauren; Amaravadi, Lakshmi] Biogen Idec Inc, Cambridge, MA USA.
[Kaur, Surinder; Xu, Keyang] Genentech Inc, San Francisco, CA 94080 USA.
[Alley, Stephen C.] Seattle Genet Inc, Bothell, WA USA.
[Szapacs, Matthew] GlaxoSmithKline, King Of Prussia, PA USA.
[Alley, Stephen C.; Arnold, Mark; Aubry, Anne-Francoise; DeSilva, Binodh; Myler, Heather; Olah, Timothy] Bristol Myers Squibb Co, Princeton, NJ USA.
[Bansal, Surendra; Vazvaei, Faye] Roche Innovat Ctr, New York, NY USA.
[Haidar, Sam] US FDA, Silver Spring, MD USA.
[Welink, Jan] Dutch MEB, Utrecht, Netherlands.
[Le Blaye, Olivier] France ANSM, St Denis, France.
[Wakelin-Smith, Jason; Whale, Emma] UK MHRA, London, England.
[Ishii-Watabe, Akiko; Katori, Noriko] Japan MHLW NIHS, Tokyo, Japan.
[Bustard, Mark] Hlth Canada, Ottawa, ON K1A 0L2, Canada.
[Beaver, Chris] InVentiv Hlth Clin, Montreal, PQ, Canada.
[Cai, Xiao-Yan] Merck, Kenilworth, NJ USA.
[Cojocaru, Laura] Tandem Labs, West Trenton, NJ USA.
[Duggan, Jeff] Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT 06877 USA.
[Fluhler, Eric] Pfizer, Pearl River, NY USA.
[Gupta, Swati] Allergan Pharmaceut Inc, Irvine, CA USA.
[Hayes, Roger] MPI Res, Mattawan, MI USA.
[Ho, Stacy] Sanofi, Waltham, MA USA.
[Ingelse, Benno] Merck, Oss, Netherlands.
[King, Lindsay] Pfizer, Groton, CT USA.
[Levesque, Ann] InVentiv Hlth Clin, Quebec City, PQ, Canada.
[Lowes, Steve; Schultz, Gary] Quintiles, Ithaca, NY USA.
[Ma, Mark; Rose, Mark; Swanson, Steven] Amgen Inc, Thousand Oaks, CA 91320 USA.
[Musuku, Adrien] Pharmascience, Montreal, PQ, Canada.
[Patel, Shefali; Yang, Tong-Yuan] Janssen Res & Dev, Spring House, PA USA.
[Smeraglia, John] UCB Pharma, Braine Lalleud, Belgium.
[Torri, Albert] Regeneron Pharmaceut, Tarrytown, NY USA.
[Wilson, Amanda] AstraZeneca, Macclesfield, Cheshire, England.
[Woolf, Eric] Merck Res Labs, West Point, PA USA.
RP Garofolo, F (reprint author), Algorithme Pharma Inc, 575 Armand Frappier Blvd, Montreal, PQ H7V 4B3, Canada.
EM fgarofolo@algopharm.com
NR 12
TC 14
Z9 14
U1 1
U2 4
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PY 2014
VL 6
IS 23
SI SI
BP 3237
EP 3249
DI 10.4155/bio.14.279
PG 13
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA CA8QP
UT WOS:000349186300017
PM 25529890
ER
PT J
AU Subramaniam, S
Stier, E
Davit, BM
AF Subramaniam, Sriram
Stier, Ethan
Davit, Barbara M.
TI Incurred sample reanalysis in bioequivalence studies for abbreviated new
drug applications
SO BIOANALYSIS
LA English
DT Article
DE abbreviated new drug applications; bioanalysis; bioequivalence studies;
incurred sample reanalysis
ID RECENT ISSUES; WHITE PAPER; HPLC-MS/MS; BIOANALYSIS; VALIDATION
C1 [Subramaniam, Sriram; Stier, Ethan] US FDA, Div Bioequivalence 2, Off Gener Drugs, Silver Spring, MD 20993 USA.
[Davit, Barbara M.] Merck Sharp & Dohme Corp, Whitehouse Stn, NJ USA.
[Davit, Barbara M.] US FDA, Silver Spring, MD 20993 USA.
RP Subramaniam, S (reprint author), US FDA, Div Bioequivalence 2, Off Gener Drugs, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM sriram.subramaniam@fda.hhs.gov
NR 14
TC 0
Z9 0
U1 1
U2 2
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PY 2014
VL 6
IS 24
BP 3349
EP 3354
DI 10.4155/bio.14.232
PG 6
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA CA8QW
UT WOS:000349187000009
PM 25534791
ER
PT J
AU Stevenson, L
Amaravadi, L
Myler, H
Salazar-Fontana, L
Gorovits, B
Kirshner, S
Xue, L
Garofolo, F
Alley, SC
Thway, T
Joyce, A
Bansal, S
Beaver, C
Bergeron, A
Cai, XY
Cojocaru, L
DeSilva, B
Dumont, I
Fluhler, E
Fraser, S
Gouty, D
Gupta, S
Haidar, S
Hayes, R
Ingelse, B
Ishii-Watabe, A
Kaur, S
King, L
Laterza, O
Leung, S
Levesque, A
Ma, M
Petit-Frere, C
Pillutla, R
Rose, M
Schultz, G
Smeraglia, J
Swanson, S
Torri, A
Vazvaei, F
Wakelin-Smith, J
Wilson, A
Woolf, E
Yang, TY
AF Stevenson, Lauren
Amaravadi, Lakshmi
Myler, Heather
Salazar-Fontana, Laura
Gorovits, Boris
Kirshner, Susan
Xue, Li
Garofolo, Fabio
Alley, Stephen C.
Thway, Theingi
Joyce, Alison
Bansal, Surendra
Beaver, Chris
Bergeron, Annik
Cai, Xiao-Yan
Cojocaru, Laura
DeSilva, Binodh
Dumont, Isabelle
Fluhler, Eric
Fraser, Stephanie
Gouty, Dominique
Gupta, Swati
Haidar, Sam
Hayes, Roger
Ingelse, Benno
Ishii-Watabe, Akiko
Kaur, Surinder
King, Lindsay
Laterza, Omar
Leung, Sheldon
Levesque, Ann
Ma, Mark
Petit-Frere, Corinne
Pillutla, Renuka
Rose, Mark
Schultz, Gary
Smeraglia, John
Swanson, Steven
Torri, Albert
Vazvaei, Faye
Wakelin-Smith, Jason
Wilson, Amanda
Woolf, Eric
Yang, Tong-Yuan
TI 2014 White Paper on recent issues in bioanalysis: a full immersion in
bioanalysis (Part 3-LBA and immunogenicity)
SO BIOANALYSIS
LA English
DT Article
ID VALIDATION GROUP WORKSHOP; POLYETHYLENE-GLYCOL; REGULATED BIOANALYSIS;
GLOBAL HARMONIZATION; REFRACTORY GOUT; ANTIBODY; RECOMMENDATIONS;
IMPACT; PEG; BIOTHERAPEUTICS
AB The 2014 8th Workshop on Recent Issues in Bioanalysis (8thWRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three partsfor editorial reasons. This publication (Part 3) covers the recommendations for Large molecules bioanalysis using LBA and Immunogenicity. Part 1 (Small molecules bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input) were published in the Bioanalysis issues 6(22) and 6(23), respectively.
C1 [Stevenson, Lauren; Amaravadi, Lakshmi] Biogen Idec Inc, Cambridge, MA USA.
[Myler, Heather; DeSilva, Binodh; Pillutla, Renuka] Bristol Myers Squibb Co, Princeton, NJ USA.
[Salazar-Fontana, Laura; Kirshner, Susan; Haidar, Sam] US FDA, Silver Spring, MD USA.
[Gorovits, Boris; Xue, Li; Joyce, Alison; Leung, Sheldon] Pfizer, Andover, MA USA.
[Garofolo, Fabio; Bergeron, Annik; Dumont, Isabelle] Algorithme Pharma Inc, Montreal, PQ H7V 4B3, Canada.
[Alley, Stephen C.] Seattle Genet Inc, Bothell, WA USA.
[Thway, Theingi; Ma, Mark; Rose, Mark; Swanson, Steven] Amgen Inc, Thousand Oaks, CA 91320 USA.
[Bansal, Surendra; Vazvaei, Faye] Roche Innovat Ctr, New York, NY USA.
[Beaver, Chris] InVentiv Hlth Clin, Montreal, PQ, Canada.
[Cai, Xiao-Yan] Merck, Kenilworth, NJ USA.
[Cojocaru, Laura] Tandem Labs, West Trenton, NJ USA.
[Fluhler, Eric] Pfizer, Pearl River, NY USA.
[Fraser, Stephanie; King, Lindsay] Pfizer, Groton, CT USA.
[Gouty, Dominique] Intertek, San Diego, CA USA.
[Gupta, Swati] Allergan Pharmaceut Inc, Irvine, CA USA.
[Hayes, Roger] MPI Res, Mattawan, MI USA.
[Ingelse, Benno] Merck, Oss, Netherlands.
[Ishii-Watabe, Akiko] Japan MHLW NIHS, Tokyo, Japan.
[Kaur, Surinder] Genentech Inc, San Francisco, CA 94080 USA.
[Laterza, Omar] Merck, Whitehouse Stn, NJ USA.
[Levesque, Ann] InVentiv Hlth Clin, Quebec City, PQ, Canada.
[Petit-Frere, Corinne] Roche Innovat Ctr, Basel, Switzerland.
[Schultz, Gary] Quintiles, Ithaca, NY USA.
[Smeraglia, John] UCB Pharma, Braine Lalleud, Belgium.
[Torri, Albert] Regeneron Pharmaceut, Tarrytown, NY USA.
[Wakelin-Smith, Jason] UK MHRA, London, England.
[Wilson, Amanda] AstraZeneca, Macclesfield, Cheshire, England.
[Woolf, Eric] Merck Res Labs, West Point, PA USA.
[Yang, Tong-Yuan] Janssen Res & Dev, Spring House, PA USA.
RP Garofolo, F (reprint author), Algorithme Pharma Inc, 575 Armand Frappier Blvd, Montreal, PQ H7V 4B3, Canada.
EM fgarofolo@algopharm.com
FU US FDA; Europe EMA; Health Canada; France ANSM; The Netherlands MEB;
Austria AGES; Germany BfArM; Japan MHWL; UK MHRA
FX The authors would like to acknowledge the US FDA, Europe EMA, Health
Canada, France ANSM, The Netherlands MEB, Austria AGES, Germany BfArM,
Japan MHWL and UK MHRA for supporting this workshop. L Stevenson (Biogen
Idec), L Amaravadi (Biogen Idec), H Myler (Bristol-Myers Squibb), D
Dufield (Pfizer), L Salazar-Fontana (FDA), H Neubert (Pfizer), L
Kirkovsky (Pfizer), F Garofolo (Algorithme Pharma), I Dumont (Algorithme
Pharma), B Gorovits (Pfizer), E Fluhler (Pfizer), R Hayes (MPI
Research), K Xu (Genentech), M Arnold (Bristol-Myers Squibb), S Bansal
(Roche), T Verhaeghe (Janssen), A Bergeron (Algorithme Pharma), O
Laterza (Merck), SC Alley (Seattle Genetics), M Szapacs
(GlaxoSmithKline), A Wilson (AstraZeneca), S Kaur (Genentech) and A
Joyce (Pfizer), for their major contribution in this White Paper. E
Fluhler (Pfizer), O Le Blaye (France ANSM), D Dufield (Pfizer), L
Amaravadi (Biogen Idec), L Stevenson (Biogen Idec) and F Garofolo
(Algorithme Pharma) for chairing the workshop. E Fluhler (Pfizer), D
Dufield (Pfizer), L Amaravadi (Biogen Idec) and L Stevenson (Biogen
Idec) for chairing the White Paper discussions. All the workshop
attendees and members of the bioanalytical community who have sent
comments and suggestions to complete this White Paper. W Garofolo, L Lu,
X Wang, E Petrova, M Losauro and B Felcyn for the logistic assistance of
the event. Future Science Group as a trusted partner.
NR 31
TC 10
Z9 10
U1 0
U2 0
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PY 2014
VL 6
IS 24
BP 3355
EP 3368
DI 10.4155/bio.14.283
PG 14
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA CA8QW
UT WOS:000349187000010
PM 25534792
ER
PT J
AU Dorr, H
Lamkowski, A
Graessle, DH
Bennett, A
Shapiro, A
Farese, AM
Garofalo, M
MacVittie, TJ
Meineke, V
AF Doerr, Harald
Lamkowski, Andreas
Graessle, Dieter H.
Bennett, Alexander
Shapiro, Alla
Farese, Ann M.
Garofalo, Michael
MacVittie, Thomas J.
Meineke, Viktor
TI LINKING THE HUMAN RESPONSE TO UNPLANNED RADIATION AND TREATMENT TO THE
NONHUMAN PRIMATE RESPONSE TO CONTROLLED RADIATION AND TREATMENT
SO HEALTH PHYSICS
LA English
DT Article
DE blood; gastrointestinal tract; health effects; radiation effects
ID MANAGEMENT; MODEL
AB A key difficulty in developing countermeasures against radiation-induced health impairments is the clear lack of controlled clinical studies, due to the relatively low number of radiation victims worldwide. Instead, established and accepted animal models, as well as the recommendations of national and international expert panels and committees, are the main sources of information. Therefore, the development of countermeasures requires comparison of data from many sources and accumulation of information consistent with the U.S. Food and Drug Administration's "Animal Rule.'' A new approach is the comparative analysis of human data from the SEARCH (System for Evaluation and Archiving of Radiation Accidents based on Case Histories) database and data from nonhuman primate (NHP) animal model studies. The SEARCH database contains 824 clinical cases from 81 radiation accidents in 19 countries. This exceptional collection of clinical data from accidentally radiation-exposed persons is analyzed regarding clinical signs and symptoms of radiation-induced health impairments. To analyze the time course of radiation syndromes, clinical parameters common to the SEARCH and NHP databases have to be assigned into comparable categories of clinical severity for each species. The goal is to establish a method for comparison of human and NHP data, validate the NHP data as a surrogate for human efficacy/clinical studies, and open away for the extraction of diagnostic and treatment methods for humans after radiation exposure according to relevant regulations.
C1 [Doerr, Harald; Lamkowski, Andreas; Graessle, Dieter H.; Meineke, Viktor] Univ Ulm, Bundeswehr Inst Radiobiol, D-80937 Munich, Germany.
[Bennett, Alexander; Farese, Ann M.; Garofalo, Michael; MacVittie, Thomas J.] Univ Maryland, Sch Med, Dept Radiat Oncol, Baltimore, MD 21201 USA.
[Shapiro, Alla] US FDA, Silver Spring, MD USA.
RP Dorr, H (reprint author), Univ Ulm, Bundeswehr Inst Radiobiol, Neuherbergstr 11, D-80937 Munich, Germany.
EM haralddoerr@bundeswehr.org
FU National Institute of Allergy and Infectious Diseases (NIAID)
[HHSN272201000046C]
FX Contract Nr: HHSN272201000046C awarded to the University of Maryland,
Baltimore (UMB) by National Institute of Allergy and Infectious Diseases
(NIAID) for the project, "Radiation/Nuclear Medical Countermeasure
Product Development Support Services."
NR 7
TC 4
Z9 4
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, PA 19103 USA
SN 0017-9078
EI 1538-5159
J9 HEALTH PHYS
JI Health Phys.
PD JAN
PY 2014
VL 106
IS 1
BP 129
EP 134
DI 10.1097/HP.0b013e3182a12de0
PG 6
WC Environmental Sciences; Public, Environmental & Occupational Health;
Nuclear Science & Technology; Radiology, Nuclear Medicine & Medical
Imaging
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Nuclear Science & Technology; Radiology, Nuclear Medicine &
Medical Imaging
GA AZ9YW
UT WOS:000348571700012
PM 24276556
ER
PT J
AU Lohne, JJ
Agelarakis, AP
AF Lohne, Jack J.
Agelarakis, Anagnostis P.
TI MULTIELEMENTAL ICP-MS ANALYSIS OF CLASSICAL PERIOD ARCHAEOLOGICAL
CREMATED BONE AND SEDIMENT SAMPLES FROM DEMOSION SEMA POLYANDRIA OF
SALAMINOS 35 SITE IN KERAMEIKOS, ATHENS, GREECE
SO MEDITERRANEAN ARCHAEOLOGY & ARCHAEOMETRY
LA English
DT Article
ID DIFFERENT HISTORICAL EPOCHS; HEAVY-METALS; ELEMENTAL ANALYSIS;
TRACE-ELEMENTS; DIAGENESIS; JORDAN
AB Cremated human bone fragments excavated at the monumental burial site at Salaminos 35 Street in Kerameikos of Athens, Greece, dated to the range of the 8th decade of the 5th century BC were the subject of anthropological study. A number of bone fragments included surface stains of various discolorations. The purpose of this interdisciplinary study combining a forensic anthropology-chemistry substrate was to determine which metal(s), if any, and under what circumstances may have caused the staining on the bone surfaces. To determine this, a Collision/Reaction Cell Inductively Coupled Plasma- Mass Spectrometry (CRC ICP-MS) method with microwave accelerated sample digestion was developed and validated for the quantification of metals in bone. The concentrations of Na, Mg, Al, K, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Ga, As, Rb, Sr, Sn, Ba, Pb and U in the stained bone samples were compared to concentrations in unstained bone fragments and sediment samples from the same contextual archaeological association. The sample analyses and comparisons showed that 14 of the 15 stained bone samples analyzed contained significantly higher concentrations of various metals. Of the seven metals readily available during Classical antiquity (Au, Cu, Ag, Pb, Sri, Fe and Hg), four were detected at significantly high concentrations (Cu, Sn, Fe and Pb) in some samples, Ag was tested for but not detected in any sample while Au and Hg were not tested for. The metals that occurred most often at significantly high concentrations were Cu, Pb, Zn, As, Mg and Fe.
C1 [Lohne, Jack J.] US FDA, ADRC, Lakewood, CO 80225 USA.
[Agelarakis, Anagnostis P.] Adelphi Univ, Dept Anthropol, Garden City, NY 11530 USA.
RP Agelarakis, AP (reprint author), Adelphi Univ, Dept Anthropol, Garden City, NY 11530 USA.
EM agelarakis@adelphi.edu
NR 38
TC 0
Z9 0
U1 2
U2 5
PU UNIV AGEAN, DEPT MEDITERRANEAN STUD
PI RHODES
PA 1 DEMOKRATIAS AV, RHODES, 85100, GREECE
SN 1108-9628
J9 MEDITERR ARCHAEOL AR
JI Mediterr. Archaeol. Archaeom.
PY 2014
VL 14
IS 2
BP 243
EP 257
PG 15
WC Archaeology
SC Archaeology
GA AZ5ML
UT WOS:000348264900017
ER
PT J
AU Guha, S
Hariharan, P
Myers, MR
AF Guha, Suvajyoti
Hariharan, Prasanna
Myers, Matthew R.
TI Enhancement of ICRP's Lung Deposition Model for Pathogenic Bioaerosols
SO AEROSOL SCIENCE AND TECHNOLOGY
LA English
DT Article
ID DIFFERENTIAL MOBILITY ANALYSIS; PUBLIC-HEALTH MANAGEMENT;
RESPIRATORY-TRACT; PARTICLE DEPOSITION; AEROSOL DEPOSITION; INHALATIONAL
ANTHRAX; RELATIVE-HUMIDITY; BIOLOGICAL WEAPON; INFLUENZA-VIRUS;
RISK-ASSESSMENT
AB Terrorist attacks using pathogenic bioaerosols pose a significant public-health threat. Modeling the risk associated with such attacks is valuable from the standpoint of disaster preparedness. To attain greater flexibility in bioterrorism risk modeling, we have developed an open-source lung deposition code based on the International Committee for Radiological Protection (ICRP) Publication 66 (ICRP 1994). This article describes modifications to ICRP's lung deposition model to fit the bioaerosol context and discusses the impact of exposure from a few monodisperse pathogenic toxins such as botulinum toxin, influenza virus, and Bacillus anthracis to infants and adults. As most existing commercial lung deposition codes are not open-source, this code provides users a platform template that can be modified to meet their needs.
C1 [Guha, Suvajyoti; Hariharan, Prasanna; Myers, Matthew R.] US FDA, Div Appl Mech, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Guha, S (reprint author), US FDA, Div Appl Mech, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave,WO62,Room 2233, Silver Spring, MD 20993 USA.
EM Suvajyoti.Guha@fda.hhs.gov
FU Medical Countermeasures Initiative team [MCM2DXXXXX20511,
MCM2JXXXXX270HT]
FX The authors would like to thank the Medical Countermeasures Initiative
team for funding this project (MCM2DXXXXX20511, MCM2JXXXXX270HT).
NR 66
TC 4
Z9 4
U1 3
U2 16
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 WALNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 0278-6826
EI 1521-7388
J9 AEROSOL SCI TECH
JI Aerosol Sci. Technol.
PY 2014
VL 48
IS 12
BP 1226
EP 1235
DI 10.1080/02786826.2014.975334
PG 10
WC Engineering, Chemical; Engineering, Mechanical; Environmental Sciences;
Meteorology & Atmospheric Sciences
SC Engineering; Environmental Sciences & Ecology; Meteorology & Atmospheric
Sciences
GA AW6OH
UT WOS:000346388200005
ER
PT J
AU Fluhler, E
Hayes, R
Garofolo, F
Dumont, I
Le Blaye, O
Arnold, M
Bansal, S
Verhaeghe, T
Wilson, A
Stevenson, L
Myler, H
Bauer, R
Bergeron, A
Bustard, M
Cai, XY
Carbone, M
Cojocaru, L
Desai-Krieger, D
Duggan, J
Haidar, S
Ho, S
Ingelse, B
Katori, N
Levesque, A
Lowes, S
Ma, M
Mettke, K
Michon, J
Musuku, A
Olah, T
Patel, S
Rose, M
Schultz, G
Smeraglia, J
Spooner, N
Stouffer, B
Vazvaei, F
Wakelin-Smith, J
Wang, J
Welink, J
Whale, E
Woolf, E
Xue, L
Yang, TY
AF Fluhler, Eric
Hayes, Roger
Garofolo, Fabio
Dumont, Isabelle
Le Blaye, Olivier
Arnold, Mark
Bansal, Surendra
Verhaeghe, Tom
Wilson, Amanda
Stevenson, Lauren
Myler, Heather
Bauer, Ronald
Bergeron, Annik
Bustard, Mark
Cai, Xiao-Yan
Carbone, Mary
Cojocaru, Laura
Desai-Krieger, Daksha
Duggan, Jeff
Haidar, Sam
Ho, Stacy
Ingelse, Benno
Katori, Noriko
Levesque, Ann
Lowes, Steve
Ma, Mark
Mettke, Katalina
Michon, Josee
Musuku, Adrien
Olah, Timothy
Patel, Shefali
Rose, Mark
Schultz, Gary
Smeraglia, John
Spooner, Neil
Stouffer, Bruce
Vazvaei, Faye
Wakelin-Smith, Jason
Wang, Jian
Welink, Jan
Whale, Emma
Woolf, Eric
Xue, Li
Yang, Tong-Yuan
TI 2014 White Paper on recent issues in bioanalysis: a full immersion in
bioanalysis (Part 1-small molecules by LCMS)
SO BIOANALYSIS
LA English
DT Article
ID VALIDATION GROUP WORKSHOP; GLOBAL CRO COUNCIL; REGULATED BIOANALYSIS;
RECOMMENDATIONS; CALIBRATION; STABILITY
AB The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for small molecule bioanalysis using LCMS. Part 2 (Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' input) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the upcoming issues of Bioanalysis.
C1 [Fluhler, Eric] Pfizer, Pearl River, NY USA.
[Hayes, Roger] MPI Res, Mattawan, MI USA.
[Garofolo, Fabio; Dumont, Isabelle; Bergeron, Annik; Carbone, Mary] Algorithme Pharma Inc, Laval, PQ H7V 4B3, Canada.
[Le Blaye, Olivier] France ANSM, St Denis, France.
[Arnold, Mark; Myler, Heather; Olah, Timothy; Stouffer, Bruce; Wang, Jian] Bristol Myers Squibb Co, Princeton, NJ USA.
[Bansal, Surendra; Vazvaei, Faye] Roche Innovat Ctr, New York, NY USA.
[Verhaeghe, Tom] Janssen Res Dev, Beerse, Belgium.
[Wilson, Amanda] AstraZeneca, Macclesfield, Cheshire, England.
[Stevenson, Lauren] Biogen Idec Inc, Cambridge, MA USA.
[Bauer, Ronald] Austria AGES, Vienna, Austria.
[Bustard, Mark] Hlth Canada, Ottawa, ON K1A 0L2, Canada.
[Cai, Xiao-Yan] Merck, Kenilworth, NJ USA.
[Cojocaru, Laura] Tandem Labs, West Trenton, NJ USA.
[Desai-Krieger, Daksha] Forest Labs Inc, Farmingdale, NY USA.
[Haidar, Sam] Boehringer Ingelheim GmbH & Co KG, Ridgefield, CT USA.
US FDA, Silver Spring, MD USA.
[Ho, Stacy] Sanofi, Waltham, MA USA.
[Ingelse, Benno] Merck, Oss, Netherlands.
[Katori, Noriko] Japan MHLW NIHS, Tokyo, Japan.
[Levesque, Ann] InVent Hlth Clin, Quebec City, PQ, Canada.
[Lowes, Steve; Schultz, Gary] Quintiles, Ithaca, NY USA.
[Ma, Mark; Rose, Mark] Amgen Inc, Thousand Oaks, CA 91320 USA.
[Mettke, Katalina] Germany BfArM, Bonn, Germany.
[Michon, Josee] Pharmascience, Montreal, PQ, Canada.
[Musuku, Adrien; Patel, Shefali; Yang, Tong-Yuan] Janssen Res & Dev, Spring House, PA USA.
[Smeraglia, John] UCB Pharma, Braine Lalleud, Belgium.
[Spooner, Neil] GlaxoSmithKline, Ware, Herts, England.
[Wakelin-Smith, Jason; Whale, Emma] UK MHRA, London, England.
[Welink, Jan] Dutch MEB, Utrecht, Netherlands.
[Duggan, Jeff; Woolf, Eric] Merck Res Labs, West Point, PA USA.
[Xue, Li] Pfizer, Andover, MA USA.
RP Garofolo, F (reprint author), Algorithme Pharma Inc, 575 Armand Frappier Blvd, Laval, PQ H7V 4B3, Canada.
EM fgarofolo@algopharm.com
FU US FDA; Europe EMA; Health Canada; France ANSM; Netherlands MEB; Austria
AGES; Germany BfArM; Japan MHWL; UK MHRA
FX The authors would like to acknowledge the US FDA, Europe EMA, Health
Canada, France ANSM, The Netherlands MEB, Austria AGES, Germany BfArM,
Japan MHWL and UK MHRA for supporting this workshop. L Stevenson (Biogen
Idec), L Amaravadi (Biogen Idec), H Myler (Bristol-Myers Squibb), D
Dufield (Pfizer), L Salazar-Fontana (FDA), H Neubert (Pfizer), L
Kirkovsky (Pfizer), F Garofolo (Algorithme Pharma), I Dumont (Algorithme
Pharma), B Gorovits (Pfizer), E Fluhler (Pfizer), R Hayes (MPI
Research), K Xu (Genentech), M Arnold (Bristol-Myers Squibb), S Bansal
(Roche), T Verhaeghe (Janssen), A Bergeron (Algorithme Pharma), O
Laterza (Merck), SC Alley (Seattle Genetics), M Szapacs
(GlaxoSmithKline), A Wilson (AstraZeneca), S Kaur (Genentech) and A
Joyce (Pfizer), for their major contribution in this White Paper. E
Fluhler (Pfizer), O Le Blaye (France ANSM), D Dufield (Pfizer), L
Amaravadi (Biogen Idec), L Stevenson (Biogen Idec) and F Garofolo
(Algorithme Pharma) for chairing the workshop. E Fluhler (Pfizer), D
Dufield (Pfizer), L Amaravadi (Biogen Idec) and L Stevenson (Biogen
Idec) for chairing the White Paper discussions. All the workshop
attendees and members of the bioanalytical community who have sent
comments and suggestions to complete this White Paper. W Garofolo, L Lu,
X Wang, E Petrova, M Losauro and B Felcyn for the logistic assistance of
the event. Future Science Group as a trusted partner.
NR 13
TC 7
Z9 7
U1 1
U2 4
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PY 2014
VL 6
IS 22
BP 3039
EP 3049
DI 10.4155/bio.14.265
PG 11
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA AW4HR
UT WOS:000346242300009
PM 25496256
ER
PT J
AU Khorasani, AA
Weaver, JL
Salvador-Morales, C
AF Khorasani, Ali A.
Weaver, James L.
Salvador-Morales, Carolina
TI Closing the gap: accelerating the translational process in nanomedicine
by proposing standardized characterization techniques
SO INTERNATIONAL JOURNAL OF NANOMEDICINE
LA English
DT Review
DE physicochemical characterization; poly(ethylene glycol); protein
adsorption; regulatory issues
ID PLASMA-PROTEIN ADSORPTION; ELECTRON-MICROSCOPY TOMOGRAPHY; PEG
CHAIN-LENGTH; X-RAY-SCATTERING; DRUG-DELIVERY; RAMAN-SPECTROSCOPY;
COMPLEMENT ACTIVATION; CARBON NANOTUBES; SURFACE FUNCTIONALIZATION;
ENGINEERED NANOMATERIALS
AB On the cusp of widespread permeation of nanomedicine, academia, industry, and government have invested substantial financial resources in developing new ways to better treat diseases. Materials have unique physical and chemical properties at the nanoscale compared with their bulk or small-molecule analogs. These unique properties have been greatly advantageous in providing innovative solutions for medical treatments at the bench level. However, nanomedicine research has not yet fully permeated the clinical setting because of several limitations. Among these limitations are the lack of universal standards for characterizing nanomaterials and the limited knowledge that we possess regarding the interactions between nanomaterials and biological entities such as proteins. In this review, we report on recent developments in the characterization of nanomaterials as well as the newest information about the interactions between nanomaterials and proteins in the human body. We propose a standard set of techniques for universal characterization of nanomaterials. We also address relevant regulatory issues involved in the translational process for the development of drug molecules and drug delivery systems. Adherence and refinement of a universal standard in nanomaterial characterization as well as the acquisition of a deeper understanding of nanomaterials and proteins will likely accelerate the use of nanomedicine in common practice to a great extent.
C1 [Khorasani, Ali A.] George Mason Univ, Dept Chem & Biochem, Fairfax, VA 22030 USA.
[Khorasani, Ali A.; Salvador-Morales, Carolina] George Mason Univ, Dept Bioengn, Fairfax, VA 22030 USA.
[Khorasani, Ali A.; Salvador-Morales, Carolina] George Mason Univ, Krasnow Inst Adv Study, Fairfax, VA 22030 USA.
[Weaver, James L.] Food & Drug Adm, Ctr Drug Evaluat & Res, Div Appl Regulatory Sci, Silver Spring, MD USA.
RP Salvador-Morales, C (reprint author), George Mason Univ, Dept Bioengn, 4400 Univ Dr MS 1G5, Fairfax, VA 22030 USA.
EM csalvado@gmu.edu
FU CSM (Carolina Salvador-Morales) startup fund [162904]; George Mason
University Graduate Research Assistantship from the CSM startup fund
FX This work was supported by the CSM (Carolina Salvador-Morales) startup
fund (162904). AAK is supported by a George Mason University Graduate
Research Assistantship from the CSM startup fund.
NR 127
TC 6
Z9 6
U1 1
U2 15
PU DOVE MEDICAL PRESS LTD
PI ALBANY
PA PO BOX 300-008, ALBANY, AUCKLAND 0752, NEW ZEALAND
SN 1178-2013
J9 INT J NANOMED
JI Int. J. Nanomed.
PY 2014
VL 9
BP 5729
EP 5751
DI 10.2147/IJN.S72479
PG 23
WC Nanoscience & Nanotechnology; Pharmacology & Pharmacy
SC Science & Technology - Other Topics; Pharmacology & Pharmacy
GA AU8CI
UT WOS:000345823800001
PM 25525356
ER
PT J
AU Willett, C
Rae, JC
Goyak, KO
Minsavage, G
Westmoreland, C
Andersen, M
Avigan, M
Duche, D
Harris, G
Hartung, T
Jaeschke, H
Kleensang, A
Landesmann, B
Martos, S
Matevia, M
Toole, C
Rowan, A
Schultz, T
Seed, J
Senior, J
Shah, I
Subramanian, K
Vinken, M
Watkins, P
AF Willett, Catherine
Rae, Jessica Caverly
Goyak, Katy O.
Minsavage, Gary
Westmoreland, Carl
Andersen, Melvin
Avigan, Mark
Duche, Daniel
Harris, Georgina
Hartung, Thomas
Jaeschke, Hartmut
Kleensang, Andre
Landesmann, Brigitte
Martos, Suzanne
Matevia, Marilyn
Toole, Colleen
Rowan, Andrew
Schultz, Terry
Seed, Jennifer
Senior, John
Shah, Imran
Subramanian, Kalyanasundaram
Vinken, Mathieu
Watkins, Paul
TI Building Shared Experience to Advance Practical Application of
Pathway-Based Toxicology: Liver Toxicity Mode-of-Action
SO ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
LA English
DT Article
DE systems toxicology; pathways of toxicity; adverse outcome pathways; in
vitro toxicology; liver toxicity
ID PRIMARY HUMAN HEPATOCYTES; ADVERSE OUTCOME PATHWAY; ACETAMINOPHEN
HEPATOTOXICITY; RISK-ASSESSMENT; IPCS FRAMEWORK; 21ST-CENTURY; VISION;
INHIBITION; MECHANISMS; RELEVANCE
AB A workshop sponsored by the Human Toxicology Project Consortium (HTPC), "Building Shared Experience to Advance Practical Application of Pathway-Based Toxicology: Liver Toxicity Mode-of-Action" brought together experts from a wide range of perspectives to inform the process of pathway development and to advance two prototype pathways initially developed by the European Commission Joint Research Center (JRC): liver-specific fibrosis and steatosis. The first half of the workshop focused on the theory and practice of pathway development; the second on liver disease and the two prototype pathways. Participants agreed pathway development is extremely useful for organizing information and found that focusing the theoretical discussion on a specific AOP is helpful. It is important to include several perspectives during pathway development, including information specialists, pathologists, human health and environmental risk assessors, and chemical and product manufacturers, to ensure the biology is well captured and end use is considered.
C1 [Willett, Catherine; Matevia, Marilyn; Rowan, Andrew] Humane Soc United States, Washington, DC 20037 USA.
[Rae, Jessica Caverly] DuPont Haskell Global Ctr Hlth & Environm Sci, Newark, DE USA.
[Goyak, Katy O.; Minsavage, Gary] ExxonMobil Biomed Sci Inc, Annandale, NJ USA.
[Westmoreland, Carl] Unilever Res Labs, Safety & Environm Assurance Ctr, Sharnbrook, Beds, England.
[Andersen, Melvin] Hamner Inst Hlth Sci, Res Triangle Pk, NC USA.
[Avigan, Mark; Senior, John] Ctr Drug Evaluat & Res Food & Drug Adm, Silver Spring, MD USA.
[Duche, Daniel] LOreal Res & Innovat, Aulnay Sous Bois, France.
[Harris, Georgina; Hartung, Thomas; Kleensang, Andre; Martos, Suzanne] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, CAAT, Baltimore, MD USA.
[Harris, Georgina; Hartung, Thomas; Kleensang, Andre; Martos, Suzanne] Univ Konstanz, CAAT Europe, Constance, Germany.
[Jaeschke, Hartmut] Univ Kansas, Med Ctr, Kansas City, KS 66103 USA.
[Landesmann, Brigitte] European Commiss, Inst Hlth & Consumer Protect, Joint Res Ctr, Ispra, Italy.
[Toole, Colleen] CeeTox Inc, Kalamazoo, MI USA.
[Schultz, Terry] Univ Tennessee, Knoxville, TN USA.
[Schultz, Terry] OECD Secretariat, Paris, France.
[Seed, Jennifer] Environm Protect Agcy, Off Pollut Prevent & Tox, Risk Assessment Div, Washington, DC USA.
[Shah, Imran] Environm Protect Agcy, Natl Ctr Computat Toxicol, Res Triangle Pk, NC USA.
[Subramanian, Kalyanasundaram] Strand Life Sci, Bangalore, Karnataka, India.
[Vinken, Mathieu] Vrije Univ Brussel, Brussels, Belgium.
[Watkins, Paul] Hamner Inst Hlth Sci, Res Triangle Pk, NC USA.
[Watkins, Paul] Univ N Carolina, Inst Drug Safety Sci, Chapel Hill, NC USA.
RP Willett, C (reprint author), Humane Soc United States, 2100 L St NW, Washington, DC 20037 USA.
EM kwillett@humanesociety.org
RI Vinken, Mathieu/H-7513-2013;
OI Vinken, Mathieu/0000-0001-5115-8893; Kleensang,
Andre/0000-0002-4564-7399
FU NIEHS NIH HHS [T32 ES007141]
NR 37
TC 8
Z9 8
U1 2
U2 6
PU SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH
PI HEILDEBERG
PA TIERGARTENSTRASSE 17, HEILDEBERG, 69121, GERMANY
SN 1868-596X
EI 1868-8551
J9 ALTEX-ALTERN ANIM EX
JI ALTEX-Altern. Anim. Exp.
PY 2014
VL 31
IS 4
BP 500
EP 519
PG 20
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AU0JU
UT WOS:000345310000011
PM 24535319
ER
PT S
AU Grosu, R
Cherry, E
Clarke, EM
Cleaveland, R
Dixit, S
Fenton, FH
Gao, SC
Glimm, J
Gray, RA
Mangharam, R
Ray, A
Smolka, SA
AF Grosu, Radu
Cherry, Elizabeth
Clarke, Edmund M.
Cleaveland, Rance
Dixit, Sanjay
Fenton, Flavio H.
Gao, Sicun
Glimm, James
Gray, Richard A.
Mangharam, Rahul
Ray, Arnab
Smolka, Scott A.
BE Margaria, T
Steffen, B
TI Compositional, Approximate, and Quantitative Reasoning for Medical
Cyber-Physical Systems with Application to Patient-Specific Cardiac
Dynamics and Devices
SO LEVERAGING APPLICATIONS OF FORMAL METHODS, VERIFICATION AND VALIDATION:
SPECIALIZED TECHNIQUES AND APPLICATIONS, PT II
SE Lecture Notes in Computer Science
LA English
DT Proceedings Paper
CT 6th International Symposium on Leveraging Applications of Formal
Methods, Verification and Validation (ISoLA)
CY OCT 08-11, 2014
CL Imperial, GREECE
AB The design of bug-free and safe medical device software is challenging, especially in complex implantable devices that control and actuate organs who's response is not fully understood. Safety recalls of pacemakers and implantable cardioverter defibrillators between 1990 and 2000 affected over 600,000 devices. Of these, 200,000 or 41%, were due to firmware issues that continue to increase in frequency. According to the FDA, software failures resulted in 24% of all medical device recalls in 2011. There is currently no formal methodology or open experimental platform to test and verify the correct operation of medical-device software within the closed-loop context of the patient.
The goal of this effort is to develop the foundations of modeling, synthesis and development of verified medical device software and systems from verified closed-loop models of the device and organ(s). Our research spans both implantable medical devices such as cardiac pacemakers and physiological control systems such as drug infusion pumps which have multiple networked medical systems. These devices are physically connected to the body and exert direct control over the physiology and safety of the patient. The focus of this effort is on (a) Extending current binary safety properties to quantitative verification; (b) Development of patient-specific models and therapies; (c) Multi-scale modeling of complex physiological phenomena and compositional reasoning across a range of model abstractions and refinements; and (d) Bridging the formal reasoning and automated generation of safe and effective software for future medical devices.
C1 [Grosu, Radu; Glimm, James; Smolka, Scott A.] SUNY Stony Brook, Stony Brook, NY 11794 USA.
[Cherry, Elizabeth] Rochester Inst Technol, Rochester, NY USA.
[Clarke, Edmund M.; Gao, Sicun] Carnegie Mellon Univ, Pittsburgh, PA USA.
[Cleaveland, Rance] Univ Maryland, College Pk, MD USA.
[Dixit, Sanjay; Mangharam, Rahul] Univ Pennsylvania, Philadelphia, PA USA.
[Fenton, Flavio H.] Georgia Inst Technol, Atlanta, GA USA.
[Gray, Richard A.] US FDA, Silver Spring, MD USA.
[Ray, Arnab] Fraunhofer USA Ctr Expt Software Engn, E Lansing, MI USA.
RP Grosu, R (reprint author), SUNY Stony Brook, Stony Brook, NY 11794 USA.
NR 19
TC 0
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U1 0
U2 0
PU SPRINGER-VERLAG BERLIN
PI BERLIN
PA HEIDELBERGER PLATZ 3, D-14197 BERLIN, GERMANY
SN 0302-9743
BN 978-3-662-45231-8; 978-3-662-45230-1
J9 LECT NOTES COMPUT SC
PY 2014
VL 8803
BP 356
EP 364
PG 9
WC Computer Science, Artificial Intelligence; Computer Science, Software
Engineering; Computer Science, Theory & Methods
SC Computer Science
GA BB7GD
UT WOS:000345509600026
ER
PT J
AU Gavrielides, MA
Conway, C
O'Flaherty, N
Gallas, BD
Hewitt, SM
AF Gavrielides, Marios A.
Conway, Catherine
O'Flaherty, Neil
Gallas, Brandon D.
Hewitt, Stephen M.
TI Observer Performance in the Use of Digital and Optical Microscopy for
the Interpretation of Tissue-Based Biomarkers
SO ANALYTICAL CELLULAR PATHOLOGY
LA English
DT Article
ID CELLULAR IMAGING-SYSTEM; IN-SITU HYBRIDIZATION; BREAST-CANCER; VIRTUAL
MICROSCOPY; SURGICAL PATHOLOGY; QUANTITATIVE IMMUNOHISTOCHEMISTRY;
MULTISITE PERFORMANCE; HER2/NEU EXPRESSION; PROTEIN EXPRESSION;
HER-2/NEU STATUS
AB Background. We conducted a validation study of digital pathology for the quantitative assessment of tissue-based biomarkers with immunohistochemistry. Objective. To examine observer agreement as a function of viewing modality (digital versus optical microscopy), whole slide versus tissue microarray (TMA) review, biomarker type (HER2 incorporating membranous staining and Ki-67 with nuclear staining), and data type (continuous and categorical). Methods. Eight pathologists reviewed 50 breast cancer whole slides (25 stained with HER2 and 25 with Ki-67) and 2 TMAs (1 stained with HER2, 1 with Ki-67, each containing 97 cores), using digital and optical microscopy. Results. Results showed relatively high overall interobserver and intermodality agreement, with different patterns specific to biomarker type. For HER2, there was better interobserver agreement for optical compared to digital microscopy for whole slides as well as better interobserver and intermodality agreement for TMAs. For Ki-67, those patterns were not observed. Conclusions. The differences in agreement patterns when examining different biomarkers and different scoring methods and reviewing whole slides compared to TMA stress the need for validation studies focused on specific pathology tasks to eliminate sources of variability that might dilute findings. The statistical uncertainty observed in our analyses calls for adequate sampling for each individual task rather than pooling cases.
C1 [Gavrielides, Marios A.; O'Flaherty, Neil; Gallas, Brandon D.] US FDA, Div Imaging Diagnost & Software Reliabil, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Conway, Catherine; Hewitt, Stephen M.] NCI, Pathol Lab, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Conway, Catherine] Leica Biosyst, Vista, CA 92081 USA.
RP Gavrielides, MA (reprint author), US FDA, Div Imaging Diagnost & Software Reliabil, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM marios.gavrielides@fda.hhs.gov
OI Hewitt, Stephen/0000-0001-8283-1788
FU Food and Drug Administration's Office of Women's Health (OWH)
FX The authors are grateful for the pathologists who participated in this
study: Meghna Alimchandani, M. D., David Kleiner, M. D., Ph.D., Alina
Nicolae, M. D., Tan Ngyuen, M. D., Stephen Hewitt M. D., Ph.D., Gregory
Riedlinger, M. D., Ph.D., Jackie Wieneke, M. D., and Avi Rosenberg, M.
D., Ph.D. The study would not be possible without their time and effort.
The authors would also like to thank Wei-Chung Cheng, Ph.D., and Hugo
Caseres for their assistance and expertise regarding monitor color
calibration. This work was supported by the Food and Drug
Administration's Office of Women's Health (OWH) through a research grant
to Marios Gavrielides and Nicholas Petrick. The mention of commercial
products, their sources, or their use in connection with material
reported herein is not to be construed as either an actual or implied
endorsement of such products by the Department of Health and Human
Services.
NR 54
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U1 0
U2 2
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 2210-7177
EI 2210-7185
J9 ANAL CELL PATHOL
JI Anal. Cell. Pathol.
PY 2014
AR 157308
DI 10.1155/2014/157308
PG 10
WC Oncology; Cell Biology; Pathology
SC Oncology; Cell Biology; Pathology
GA AU1ZW
UT WOS:000345416900001
ER
PT S
AU Hoinka, J
Berezhnoy, A
Sauna, ZE
Gilboa, E
Przytycka, TM
AF Hoinka, Jan
Berezhnoy, Alexey
Sauna, Zuben E.
Gilboa, Eli
Przytycka, Teresa M.
BE Sharan, R
TI AptaCluster - A Method to Cluster HT-SELEX Aptamer Pools and Lessons
from Its Application
SO RESEARCH IN COMPUTATIONAL MOLECULAR BIOLOGY, RECOMB2014
SE Lecture Notes in Bioinformatics
LA English
DT Proceedings Paper
CT 18th Annual International Conference on Research in Computational
Molecular Biology (RECOMB)
CY APR 02-05, 2014
CL Carnegie Mellon Univ, Pittsburgh, PA
SP Univ Pittsburgh, Dept Computat & Syst Biol, Int Soc Computat Biol, US Natl Sci Fdn, Biomed Cent GigaScience, Carnegie Mellons Lane Ctr Computat Biol
HO Carnegie Mellon Univ
ID IL-10
AB Systematic Evolution of Ligands by EXponential Enrichment (SELEX) is a well established experimental procedure to identify aptamers - synthetic single-stranded (ribo) nucleic molecules that bind to a given molecular target. Recently, new sequencing technologies have revolutionized the SELEX protocol by allowing for deep sequencing of the selection pools after each cycle. The emergence of High Throughput SELEX (HT-SELEX) has opened the field to new computational opportunities and challenges that are yet to be addressed. To aid the analysis of the results of HT-SELEX and to advance the understanding of the selection process itself, we developed AptaCluster. This algorithm allows for an efficient clustering of whole HT-SELEX aptamer pools; a task that could not be accomplished with traditional clustering algorithms due to the enormous size of such datasets. We performed HT-SELEX with Interleukin 10 receptor alpha chain (IL-10RA) as the target molecule and used AptaCluster to analyze the resulting sequences. AptaCluster allowed for the first survey of the relationships between sequences in different selection rounds and revealed previously not appreciated properties of the SELEX protocol. As the first tool of this kind, AptaCluster enables novel ways to analyze and to optimize the HT-SELEX procedure. Our AptaCluster algorithm is available as a very fast multiprocessor implementation upon request.
C1 [Hoinka, Jan; Przytycka, Teresa M.] NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20892 USA.
[Berezhnoy, Alexey; Gilboa, Eli] Univ Miami, Sch Med, Dept Microbiol & Immunol, Miami, FL 33101 USA.
[Sauna, Zuben E.] Food & Drug Adm, Ctr Biol Evaluat & Res, Lab Hemostasis, Div Hematol, Bethlehem, PA USA.
RP Gilboa, E (reprint author), Univ Miami, Miller Sch Med, Dept Microbiol & Immunol, Miami, FL 33101 USA.
EM EGilboa@med.miami.edu; przytyck@ncbi.nlm.nih.gov
FU Intramural Research Program of the NIH; National Library of Medicine
(JH, TMP); Laboratory of Hemostasis and the Center for Biologics
Evaluation and Research; Food and Drug Administration's Modernization of
Science program (ZES); Dodson estate and the Sylvester Comprehensive
Cancer Center, Medical School, University of Miami ( AB and EG)
FX This work was supported in part by the Intramural Research Program of
the NIH, National Library of Medicine (JH, TMP), in part funds from the
Laboratory of Hemostasis and the Center for Biologics Evaluation and
Research, Food and Drug Administration's Modernization of Science
program (ZES), and in part by bequest from the Dodson estate and the
Sylvester Comprehensive Cancer Center, Medical School, University of
Miami ( AB and EG). The funders had no role in study design, data
collection and analysis, decision to publish, or preparation of the
manuscript. The findings and conclusions in this article have not been
formally disseminated by the Food and Drug Administration and should not
be construed to represent any Agency determination or policy.
NR 19
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Z9 3
U1 1
U2 4
PU SPRINGER INT PUBLISHING AG
PI CHAM
PA GEWERBESTRASSE 11, CHAM, CH-6330, SWITZERLAND
SN 0302-9743
BN 978-3-319-05269-4; 978-3-319-05268-7
J9 LECT N BIOINFORMAT
JI Lect. Notes Bioinforma.
PY 2014
VL 8394
BP 115
EP 128
PG 14
WC Biochemical Research Methods; Computer Science, Information Systems;
Mathematical & Computational Biology
SC Biochemistry & Molecular Biology; Computer Science; Mathematical &
Computational Biology
GA BB6XX
UT WOS:000345119100009
ER
PT S
AU Vogt, WC
Jia, CX
Garra, BS
Pfefer, TJ
AF Vogt, William C.
Jia, Congxian
Garra, Brian S.
Pfefer, T. Joshua
BE Cullum, BM
McLamore, ES
TI Characterization of Tissue-Simulating Polymers for Photoacoustic
Vascular Imaging
SO SMART BIOMEDICAL AND PHYSIOLOGICAL SENSOR TECHNOLOGY XI
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Smart Biomedical and Physiological Sensor Technology XI
CY MAY 07-09, 2014
CL Baltimore, MD
SP SPIE
DE phantom; ultrasound; polyvinyl chloride; plastisol; optical properties;
acoustic properties
ID OPTICAL-PROPERTIES; MIMICKING PHANTOMS; HUMAN SKIN; TOMOGRAPHY;
MAMMOGRAPHY; THICKNESS; INDEX; NM
AB Photoacoustic tomography (PAT) is a maturing imaging technique which combines optical excitation and acoustic detection to enable deep tissue sensing for biomedical applications. Optical absorption provides biochemical specificity and high optical contrast while ultrasonic detection provides high spatial resolution and penetration depth. These characteristics make PAT highly suitable as an approach for vascular imaging. However, standard testing methods are needed in order to characterize and compare the performance of these systems. Tissue-mimicking phantoms are commonly used as standard test samples for imaging system development and evaluation due to their repeatable fabrication and tunable properties. The multi-domain mechanism behind PAT necessitates development of phantoms that accurately mimic both acoustic and optical properties of tissues. While a wide variety of materials have been used in the literature, from gelatin and agar hydrogels to silicone, published data indicates that poly(vinyl chloride) plastisol (PVCP) is a promising candidate material for simulating tissue optical and acoustic properties while also providing superior longevity and stability. Critical acoustic properties of PVCP phantoms, including sound velocity and attenuation, were measured using acoustic transmission measurements at multiple frequencies relevant to typical PAT systems. Optical absorption and scattering coefficients of PVCP gels with and without biologically relevant absorbers and scatterers were measured over wavelengths from 500 to 1100 nm. A custom PAT system was developed to assess image contrast in PVCP phantoms containing fluid channels filled with absorbing dye. PVCP demonstrates strong potential as the basis of high-fidelity polymer phantoms for developing and evaluating PAT systems for vascular imaging applications.
C1 [Vogt, William C.; Jia, Congxian; Garra, Brian S.; Pfefer, T. Joshua] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Vogt, WC (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
NR 31
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U1 2
U2 9
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-1-62841-044-0
J9 PROC SPIE
PY 2014
VL 9107
AR 910719
DI 10.1117/12.2053583
PG 11
WC Engineering, Biomedical; Instruments & Instrumentation; Optics
SC Engineering; Instruments & Instrumentation; Optics
GA BB6WC
UT WOS:000345067200028
ER
PT S
AU Woolsey, N
Wang, HW
Agrawal, A
Wang, JT
Liang, CP
Chen, Y
Pfefer, J
AF Woolsey, Nicholas
Wang, Hsing-Wen
Agrawal, Anant
Wang, Jianting
Liang, Chia-Pin
Chen, Yu
Pfefer, Joshua
BE Cullum, BM
McLamore, ES
TI Quantitative Analysis of Low Contrast Detectability in Optical Coherence
Tomography
SO SMART BIOMEDICAL AND PHYSIOLOGICAL SENSOR TECHNOLOGY XI
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Smart Biomedical and Physiological Sensor Technology XI
CY MAY 07-09, 2014
CL Baltimore, MD
SP SPIE
DE phantom; optical coherence tomography; contrast; detectability
ID RESOLUTION; OCT; FEASIBILITY; ESOPHAGUS; PHANTOMS; CANCER; IMAGES
AB Optical coherence tomography (OCT) is a high resolution imaging technology that is rapidly being adopted as the standard of care for medical applications such as ocular and intravascular imaging. However, clinical translation has been hampered by the lack of standardized test methods for performance evaluation as well as consensus standards analogous to those that have been developed for established medical imaging modalities (e. g., ultrasound). In this study, we address low contrast detectability, specifically, the ability of systems to differentiate between regions exhibiting small differences in scattering coefficient. Based on standard test methods for established medical imaging modalities, we have developed layered phantoms with well-characterized scattering properties in a biologically relevant range. The phantoms consisted of polydimethylsiloxane (PDMS) doped with varying concentrations of BaSO4 microparticles. Microfabrication processes were used to create layered and channel schemes. Two spectral domain OCT systems - a Fourier domain system at 855 nm and a swept-source device at 1310 nm - were then used to image the phantoms. The detectability of regions with different scattering levels was evaluated for each system by measuring pixel intensity differences. Confounding factors such as the inherent attenuation of the phantoms, signal intensity decay due to focusing and system roll-off were also encountered and addressed. Significant differences between systems were noted. The minimum differences in scattering coefficient that the Fourier domain and swept source systems could differentiate was 1.50 and 0.46 mm(-1) respectively. Overall, this approach to evaluating low contrast detectability represents a key step towards the development of standard test methods to facilitate clinical translation of novel OCT systems.
C1 [Woolsey, Nicholas; Wang, Hsing-Wen; Wang, Jianting; Liang, Chia-Pin; Chen, Yu] Univ Maryland, Fischell Dept Engn, College Pk, MD 20742 USA.
[Woolsey, Nicholas; Wang, Hsing-Wen; Agrawal, Anant; Wang, Jianting; Pfefer, Joshua] Food & Drug Adm, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Woolsey, N (reprint author), Univ Maryland, Fischell Dept Engn, College Pk, MD 20742 USA.
FU NSF, CBET [1135514]
FX The authors gratefully acknowledge support from the National Science
Foundation's FDA Scholar-in-Residence program (NSF, CBET 1135514) for
this project. The mention of commercial products, their sources, or
their use in connection with material reported herein is not to be
construed as either an actual or implied endorsement of such products by
the Department of Health and Human Services.
NR 19
TC 0
Z9 0
U1 0
U2 0
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-1-62841-044-0
J9 PROC SPIE
PY 2014
VL 9107
AR UNSP 91070C
DI 10.1117/12.2053721
PG 8
WC Engineering, Biomedical; Instruments & Instrumentation; Optics
SC Engineering; Instruments & Instrumentation; Optics
GA BB6WC
UT WOS:000345067200006
ER
PT S
AU Mosley, SL
AF Mosley, S. L.
BE Komolprasert, V
Turowski, P
TI Framework for FDA's Review of Food Additives, Color Additives, GRAS
Substances, and Food Contact Substances
SO FOOD ADDITIVES AND PACKAGING
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symposium on Food Additives and Packaging / 245th
American-Chemical-Society National Meeting and Exposiiton
CY APR 07-11, 2013
CL New Orleans, LA
SP Amer Chem Soc, Div Agr & Food Chem Inc
AB The 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) defined the term food additive and required producers to demonstrate to FDA the safety of a food additive under the intended conditions of use before it enters the market. In enacting this amendment, Congress recognized that many substances intentionally added to food would not require premarket approval to assure their safety because they were generally recognized as safe by experts qualified by scientific training and experience to evaluate their safety. Thus, the intended use of such substances was excluded from the definition of a food additive, and was termed generally recognized as safe (GRAS). Also, in 1960, Congress amended the FD&C Act again to establish premarket review for color additives. Lastly, in 1997, Congress amended the FD&C Act to establish a mandatory pre-market notification process for food contact substances, formerly known as indirect food additives. This chapter will discuss how the agency uses its authorities to ensure that substances and packaging materials in the food supply are safe.
C1 US FDA, Ctr Food Safety & Appl Nutr, Off Food Addit Safety, Div Biotechnol & GRAS Notice Review, College Pk, MD 20740 USA.
RP Mosley, SL (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Food Addit Safety, Div Biotechnol & GRAS Notice Review, 5100 Paint Branch Pkwy,HFS-255, College Pk, MD 20740 USA.
EM Sylvester.Mosley@fda.hhs.gov
NR 0
TC 0
Z9 0
U1 2
U2 5
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-3024-8
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1162
BP 27
EP 34
PG 8
WC Chemistry, Multidisciplinary; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BB6EC
UT WOS:000344714000003
ER
PT S
AU Barrows, JN
Lipman, AL
Belai, N
AF Barrows, Julie N.
Lipman, Arthur L.
Belai, Nebebech
BE Komolprasert, V
Turowski, P
TI History of US Regulation of Color Additives and Colorants
SO FOOD ADDITIVES AND PACKAGING
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symposium on Food Additives and Packaging / 245th
American-Chemical-Society National Meeting and Exposiiton
CY APR 07-11, 2013
CL New Orleans, LA
SP Amer Chem Soc, Div Agr & Food Chem Inc
ID FOOD; ANILINE; DYE
AB Color additives are dyes, pigments, or other substances that impart color to foods, drugs, cosmetics, and certain medical devices. Colorants are similar substances that impart color to food contact materials such as packaging. The U.S. Food and Drug Administration has the responsibility for regulating color additives and colorants, and both have premarket approval requirements. Federal oversight began in the late 19th Century and continued with the 1906 Food and Drugs Act, 1938 Federal Food, Drug, and Cosmetic Act, and multiple amendments. This chapter combines the history of U.S. regulation of color additives and colorants.
C1 [Barrows, Julie N.; Lipman, Arthur L.; Belai, Nebebech] US FDA, College Pk, MD 20740 USA.
RP Barrows, JN (reprint author), US FDA, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM julie.barrows@fda.hhs.gov
NR 39
TC 0
Z9 0
U1 3
U2 4
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-3024-8
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1162
BP 57
EP 71
PG 15
WC Chemistry, Multidisciplinary; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BB6EC
UT WOS:000344714000006
ER
PT S
AU Thurmond, TS
AF Thurmond, T. S.
BE Komolprasert, V
Turowski, P
TI U. S. Food and Drug Administration's (FDA) Safety Assessment of Food
Ingredients
SO FOOD ADDITIVES AND PACKAGING
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symposium on Food Additives and Packaging / 245th
American-Chemical-Society National Meeting and Exposiiton
CY APR 07-11, 2013
CL New Orleans, LA
SP Amer Chem Soc, Div Agr & Food Chem Inc
AB The FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine have regulatory responsibility for approximately 80% of foods and food-related products consumed in the United States. The safety assessment of ingredients added directly to foods meant for human consumption is an important component of this responsibility. Before food ingredients such as certified colors, colors derived from natural sources, artificial sweeteners, leavening agents, etc., can be introduced into the food supply they require a safety decision that they present "... a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use." This section will present a brief summary of the safety assessment process conducted for chemicals added to our food supply as food additives or color additives. It will also briefly discuss the current FDA draft regulatory guidance for the use of food-related products developed using nanotechnology, as well as some of the issues associated with toxicology testing of food ingredients developed using this technology. Lastly, it will discuss the potential for the incorporation of alternative in vitro and in vivo toxicity testing methods into the overall safety assessment paradigm.
C1 US FDA, Ctr Food Safety & Appl Nutr, Off Food Addit Safety, College Pk, MD 20740 USA.
RP Thurmond, TS (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Food Addit Safety, 5100 Paint Branch Pkwy,HFS-265, College Pk, MD 20740 USA.
EM Scott.Thurmond@fda.hhs.gov
NR 6
TC 1
Z9 1
U1 5
U2 10
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-3024-8
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1162
BP 91
EP 95
PG 5
WC Chemistry, Multidisciplinary; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BB6EC
UT WOS:000344714000009
ER
PT S
AU Proffitt, LD
AF Proffitt, Leah D.
BE Komolprasert, V
Turowski, P
TI Environmental Review of Food Additive Submissions
SO FOOD ADDITIVES AND PACKAGING
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symposium on Food Additives and Packaging / 245th
American-Chemical-Society National Meeting and Exposiiton
CY APR 07-11, 2013
CL New Orleans, LA
SP Amer Chem Soc, Div Agr & Food Chem Inc
AB Under the National Environmental Policy Act (NEPA) of 1969, federal agencies are required to consider environmental factors in their decision-making, and examine the environmental impacts of major, final actions. At FDA, these actions include but are not limited to petitions, (food- and color-additive, and citizen petitions), Threshold of Regulation (TOR) detemiinations, and allowing a Food Contact Notification (FCN) to become effective. Under FDA's NEPA implementing regulations, each of these submission types is required, to include an environmental component in the form of either a claim of categorical exclusion or an environmental assessment (EA). NEPA does not supplement or replace FDA's enabling statute, the Federal Food, Drug and Cosmetic Act (FFDCA). Categorical exclusions apply to actions that the agency has found do not individually or cumulatively affect the environment. Thus, categorical exclusions are very narrowly defined and precisely worded to fit very specific actions. EAs are required for any action for which there is no categorical exclusion, or where a categorical exclusion exists, but there are extraordinary circumstances that require further examination in an EA. The agency has developed guidance for what information to include in an EA to ensure that it provides the agency with sufficient information to determine whether an Environmental Impact Statement (EIS) or a Findings of No Significant Impact (FONSI) is appropriate.
C1 US FDA, College Pk, MD 20740 USA.
RP Proffitt, LD (reprint author), US FDA, 5100 Paint Branch Pkwy HFS-255, College Pk, MD 20740 USA.
EM leah.proffitt@fda.hhs.gov
NR 0
TC 0
Z9 0
U1 2
U2 3
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-3024-8
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1162
BP 97
EP 103
PG 7
WC Chemistry, Multidisciplinary; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BB6EC
UT WOS:000344714000010
ER
PT S
AU Komolprasert, V
AF Komolprasert, Vanee
BE Komolprasert, V
Turowski, P
TI Evaluating Packaging Materials for Use during the Irradiation of
Prepackaged Food
SO FOOD ADDITIVES AND PACKAGING
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symposium on Food Additives and Packaging / 245th
American-Chemical-Society National Meeting and Exposiiton
CY APR 07-11, 2013
CL New Orleans, LA
SP Amer Chem Soc, Div Agr & Food Chem Inc
AB Irradiation is an effective means for controlling foodborne pathogens and has gained much interest from the food industry in the past two decades. Irradiation of prepackaged food is a reasonable and practical method to avoid the post-irradiation contamination of food, and additionally, the irradiated foods are ready for shipping to the market immediately after irradiation. Irradiation can induce chemical changes to the packaging materials resulting in the formation of breakdown products that may readily migrate into foods. Therefore, the packaging materials holding food being irradiated are required to undergo premarket authorization prior to use. This chapter addresses the interpretation of the food irradiation regulations, the effects of various types of radiation on food packaging materials, challenges for analyzing breakdown products, and some approaches for use in evaluating packaging materials for use during the irradiation of prepackaged food.
C1 US FDA, Div Food Contact Notificat, Off Food Addit Safety, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Komolprasert, V (reprint author), US FDA, Div Food Contact Notificat, Off Food Addit Safety, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM Vanee.Komolprasert@fda.hhs.gov
NR 3
TC 1
Z9 1
U1 1
U2 4
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-3024-8
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1162
BP 119
EP 126
PG 8
WC Chemistry, Multidisciplinary; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BB6EC
UT WOS:000344714000012
ER
PT S
AU Song, YS
AF Song, Yoon S.
BE Komolprasert, V
Turowski, P
TI Effect of High Pressure Processing on Migration Characteristics in
Polymer Films
SO FOOD ADDITIVES AND PACKAGING
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symposium on Food Additives and Packaging / 245th
American-Chemical-Society National Meeting and Exposiiton
CY APR 07-11, 2013
CL New Orleans, LA
SP Amer Chem Soc, Div Agr & Food Chem Inc
ID HIGH HYDROSTATIC-PRESSURE; MASS-TRANSFER PROPERTIES; PACKAGING
MATERIALS; GLASS-TRANSITION; ISOTACTIC POLYPROPYLENE; FOOD-PRODUCTS;
COOLING RATE; CRYSTALLIZATION; STERILIZATION; BARRIER
AB The use of polymer-based flexible packaging materials has allowed application of high pressure processing (HPP) to pre-packaged food products. Many of these materials have been shown to withstand different HPP conditions without significant loss of physical and mechanical properties. There are, however, still substantial gaps in scientific information surrounding the effect of pressure on food and packaging interactions. If HPP promotes migration of additives and other residual contaminants into foods in direct contact with the materials, it could possibly become a concern to public health. This chapter reviews the results of published research concerning (1) changes in morphological properties of the polymeric packaging materials under high pressure conditions and (2) HPP effects upon chemical migration from packaging materials and sorption of food constituents (flavor scalping) into packaging.
C1 US FDA, Div Food Proc Sci & Technol HFS 450, Inst Food Safety & Hlth, Bedford Pk, IL 60501 USA.
RP Song, YS (reprint author), US FDA, Div Food Proc Sci & Technol HFS 450, Inst Food Safety & Hlth, 6502 South Archer Rd, Bedford Pk, IL 60501 USA.
EM yoon.song@fda.hhs.gov
NR 49
TC 0
Z9 0
U1 1
U2 8
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-3024-8
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1162
BP 139
EP 154
PG 16
WC Chemistry, Multidisciplinary; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BB6EC
UT WOS:000344714000014
ER
PT J
AU Echevarria, D
Gutfraind, A
Boodram, B
Major, ME
Cotler, S
Dahari, H
AF Echevarria, Desarae
Gutfraind, Alexander
Boodram, Basmattee
Major, Marian E.
Cotler, Scott
Dahari, Harel
TI Modeling treatment scale up effect on hepatitis C prevalence among
persons who inject drugs in metropolitan Chicago
SO HEPATOLOGY
LA English
DT Meeting Abstract
CT 65th Annual Meeting of the
American-Association-for-the-Study-of-Liver-Diseases
CY NOV 07-11, 2014
CL Boston, MA
SP Amer Assoc Study Liver Dis
C1 [Echevarria, Desarae; Gutfraind, Alexander; Cotler, Scott; Dahari, Harel] Loyola Univ, Med Ctr, Dept Med, Program Expt & Theoret Modeling,Div Hepatol, Maywood, IL 60153 USA.
[Gutfraind, Alexander; Boodram, Basmattee] Univ Illinois, Sch Publ Hlth, Chicago, IL USA.
[Major, Marian E.] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[Dahari, Harel] Los Alamos Natl Lab, Los Alamos, NM USA.
NR 0
TC 0
Z9 0
U1 0
U2 3
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0270-9139
EI 1527-3350
J9 HEPATOLOGY
JI Hepatology
PY 2014
VL 60
SU 1
SI SI
MA 974
BP 671A
EP 672A
PG 2
WC Gastroenterology & Hepatology
SC Gastroenterology & Hepatology
GA AS8EW
UT WOS:000344483803023
ER
PT S
AU Lunn, G
AF Lunn, George
BE Town, WG
Currano, JN
TI Analytical Procedures and the Regulation of New Drug Development
SO SCIENCE AND THE LAW: ANALYTICAL DATA IN SUPPORT OF REGULATION IN HEALTH,
FOOD, AND THE ENVIRONMENT
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symp on Science and the Law: Analytical Data in Support of Regulation in
Health, Food, and the Environment / 244th Amer-Chem-Soc National Meeting
and Exposition
CY AUG 19-23, 2012
CL Philadelphia, PA
SP Amer Chem Soc, Div Chem Informat
AB Within the United States Food and Drug Administration, the Center for Drug Evaluation and Research is responsible for the regulation of pharmaceuticals that are intended for marketing. In the broadest sense, the type of information that should be submitted to the Food and Drug Administration by the applicant is set by statute and the Code of Federal Regulations, along with various Guidance documents. The recommendations become more specific as we move from the statute to Guidance. The amount of information that should be supplied is determined by the stage of development. Generally, lesser amounts of information are supplied in the early stages and submissions become larger and more detailed as development proceeds. These principles are illustrated by the example of analytical procedures.
C1 US FDA, Off New Drug Qual Assessment, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Lunn, G (reprint author), US FDA, Off New Drug Qual Assessment, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM George.lunn@fda.hhs.gov
NR 6
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-2947-1
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1147
BP 71
EP 80
PG 10
WC Chemistry, Multidisciplinary; Environmental Sciences
SC Chemistry; Environmental Sciences & Ecology
GA BB6EE
UT WOS:000344714200005
ER
PT S
AU Rodriguez, JD
Gryniewicz-Ruzicka, CM
Arzhantsev, S
Kauffman, JF
Buhse, LF
AF Rodriguez, Jason D.
Gryniewicz-Ruzicka, Connie M.
Arzhantsev, Sergey
Kauffman, John F.
Buhse, Lucinda F.
BE Town, WG
Currano, JN
TI Rapid Screening Methods for Pharmaceutical Surveillance
SO SCIENCE AND THE LAW: ANALYTICAL DATA IN SUPPORT OF REGULATION IN HEALTH,
FOOD, AND THE ENVIRONMENT
SE ACS Symposium Series
LA English
DT Proceedings Paper
CT Symp on Science and the Law: Analytical Data in Support of Regulation in
Health, Food, and the Environment / 244th Amer-Chem-Soc National Meeting
and Exposition
CY AUG 19-23, 2012
CL Philadelphia, PA
SP Amer Chem Soc, Div Chem Informat
ID ION MOBILITY SPECTROMETRY; DIETARY-SUPPLEMENTS; WEIGHT-LOSS; CALCIUM
SUPPLEMENTS; RAMAN-SPECTROSCOPY; SYNTHETIC ADULTERANTS;
MASS-SPECTROMETRY; LEAD CONTENT; ESI-MS; SIBUTRAMINE
AB Over the past few years, the United States Food and Drug Administration has developed rapid spectroscopic screening methods for the surveillance of pharmaceutical materials in the field. The main objective of this program is to enhance public safety and ensure that drug products and ingredients are safe and effective. This chapter presents a broad overview of the technologies that are used in the rapid screening program and highlights their use in improving public safety by increasing the number of regulated products that can be screened before reaching consumers.
C1 [Rodriguez, Jason D.; Gryniewicz-Ruzicka, Connie M.; Arzhantsev, Sergey; Kauffman, John F.; Buhse, Lucinda F.] US FDA, Div Pharmaceut Anal, Ctr Drug Evaluat & Res, St Louis, MO 63110 USA.
RP Rodriguez, JD (reprint author), US FDA, Div Pharmaceut Anal, Ctr Drug Evaluat & Res, 645 S Newstead Ave, St Louis, MO 63110 USA.
EM Jason.Rodriguez@fda.hhs.gov
NR 63
TC 2
Z9 2
U1 1
U2 3
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-2947-1
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1147
BP 149
EP 168
PG 20
WC Chemistry, Multidisciplinary; Environmental Sciences
SC Chemistry; Environmental Sciences & Ecology
GA BB6EE
UT WOS:000344714200011
ER
PT J
AU Li, XF
Chen, S
Sun, TC
Xu, YX
Chen, YA
Liu, YH
Xiang, R
Li, N
AF Li, Xuefei
Chen, Si
Sun, Tongchao
Xu, Yingxi
Chen, Yanan
Liu, Yanhua
Xiang, Rong
Li, Na
TI The Transcriptional Regulation of SOX2 on FOXA1 Gene and its Application
in Diagnosis of Human Breast and Lung Cancers
SO CLINICAL LABORATORY
LA English
DT Article
DE SOX2; FOXA1; breast cancer; lung cancer; tumor diagnosis
ID EMBRYONAL CARCINOMA-CELLS; PROSTATE-CANCER; RECEPTOR FUNCTION;
EXPRESSION; DIFFERENTIATION; ASSOCIATION; FIBROBLASTS; INHIBITOR;
REPRESSES; PROGNOSIS
AB Background: Recent study demonstrated the important contribution of SOX2 to tumorigenesis and metastasis properties of various types of cancers and strongly supported the concept that SOX2 can be used as an effective marker for diagnosis and predicting prognosis of cancer patients. However, our previous RNA-Seq results from human lung cancer cell line A549 showed that some oncogenes, including FOXA1 are negatively regulated by SOX2.
Methods: To further verify the transcriptional regulation effect of SOX2 on FOXA1 and elucidate its application in the diagnosis of human lung and breast cancer, we performed real-time RT-PCR and Western blotting to test the regulation effect of SOX2 on the expression of FOXA1 gene. OncoPrint analysis was used to reveal the alteration of SOX2 and FOXA1 genes in breast invasive carcinoma cases and lung squamous cell carcinoma cases from the Cancer Genome Atlas (TCGA) data portal. Immunohistochemistry staining was performed to test the expression of SOX2 and FOXA1 in human breast and lung carcinoma.
Results: The results showed that there is an inhibitory effect of SOX2 on the expression of FOXA1 gene. In addition, these two genes are altered in 5.8% of 484 breast invasive carcinoma cases and 46.4% of 179 lung squamous cell carcinoma cases from the Cancer Genome Atlas (TCGA) data portal, which showed an increased percentage of carcinoma cases when compared with single gene alteration. Immunohistochemistry staining of SOX2 and FOXA1 in human breast and lung carcinoma further revealed the mutual complementary effect of these two proteins in the diagnosis of carcinoma.
Conclusions: Our study revealed SOX2 as a negative upstream regulator for FOXA1 gene and demonstrated SOX2 and FOXA1 as effective dual markers in improving the diagnosis efficiency for human lung and breast tumor.
C1 [Li, Xuefei; Chen, Si; Sun, Tongchao; Xu, Yingxi; Chen, Yanan; Liu, Yanhua; Xiang, Rong; Li, Na] Nankai Univ, Sch Med, Tianjin 300071, Peoples R China.
[Li, Xuefei] Beijing Hlth Vocat Coll, Beijing 100053, Peoples R China.
[Chen, Si] US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
[Xiang, Rong; Li, Na] Tianjin Key Lab Tumor Microenvironm & Neurovasc R, Tianjin 300071, Peoples R China.
RP Li, N (reprint author), Nankai Univ, Sch Med, 94 Weijin Rd, Tianjin 300071, Peoples R China.
EM lina08@nankai.edu.cn
FU NSFC [31000616, 81372308]; China International Cooperation Research
Program [2012DFA10650]
FX This work was funded by: NSFC (31000616 and 81372308 to N. Li), China
International Cooperation Research Program 2012DFA10650 (to R. Xiang).
The funders had no role in study design, data collection and analysis,
decision to publish, or preparation of the manuscript.
NR 37
TC 6
Z9 6
U1 0
U2 5
PU CLIN LAB PUBL
PI HEIDELBERG
PA IM BREITSPIEL 15, HEIDELBERG, D-69126, GERMANY
SN 1433-6510
J9 CLIN LAB
JI Clin. Lab.
PY 2014
VL 60
IS 6
BP 909
EP 918
DI 10.7754/Clin.Lab.2013.130437
PG 10
WC Medical Laboratory Technology
SC Medical Laboratory Technology
GA AQ5OD
UT WOS:000342857600005
PM 25016694
ER
PT J
AU Liu, Y
Wu, HH
Li, M
Yin, JJ
Nie, ZH
AF Liu, Yi
Wu, Haohao
Li, Meng
Yin, Jun-Jie
Nie, Zhihong
TI pH dependent catalytic activities of platinum nanoparticles with respect
to the decomposition of hydrogen peroxide and scavenging of superoxide
and singlet oxygen
SO NANOSCALE
LA English
DT Article
ID RESONANCE SPECTROSCOPY; OXIDE NANOPARTICLES; FUEL-CELLS; ZINC-OXIDE;
GENERATION; CYTOTOXICITY; MECHANISMS; TOXICITY; RADICALS; CANCER
AB Recently, platinum (Pt) nanoparticles (NPs) have received increasing attention in the field of catalysis and medicine due to their excellent catalytic activity. To rationally design Pt NPs for these applications, it is crucial to understand the mechanisms underlying their catalytic and biological activities. This article describes a systematic study on the Pt NP-catalyzed decomposition of hydrogen peroxide (H2O2) and scavenging of superoxide (O(2)c(sic)) and singlet oxygen (O-1(2)) over a physiologically relevant pH range of 1.12-10.96. We demonstrated that the catalytic activities of Pt NPs can be modulated by the pH value of the environment. Our results suggest that Pt NPs possess peroxidase-like activity of decomposing H2O2 into cOH under acidic conditions, but catalase-like activity of producing H2O and O-2 under neutral and alkaline conditions. In addition, Pt NPs exhibit significant superoxide dismutase-like activity of scavenging O-2(sic) under neutral conditions, but not under acidic conditions. The O-1(2) scavenging ability of Pt NPs increases with the increase in the pH of the environment. The study will provide useful guidance for designing Pt NPs with desired catalytic and biological properties.
C1 [Liu, Yi; Nie, Zhihong] Univ Maryland, Dept Chem & Biochem, College Pk, MD 20742 USA.
[Liu, Yi; Wu, Haohao; Li, Meng; Yin, Jun-Jie] US FDA, Div Analyt Chem, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Yin, JJ (reprint author), US FDA, Div Analyt Chem, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM junjie.yin@fda.hhs.gov; znie@umd.edu
RI Yin, Jun Jie /E-5619-2014; Nie, Zhihong/D-7495-2011;
OI Nie, Zhihong/0000-0001-9639-905X; Wu, Haohao/0000-0003-3852-2608
FU FDA HHS [5U01FD001418]
NR 35
TC 19
Z9 20
U1 9
U2 64
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 2040-3364
EI 2040-3372
J9 NANOSCALE
JI Nanoscale
PY 2014
VL 6
IS 20
BP 11904
EP 11910
DI 10.1039/c4nr03848g
PG 7
WC Chemistry, Multidisciplinary; Nanoscience & Nanotechnology; Materials
Science, Multidisciplinary; Physics, Applied
SC Chemistry; Science & Technology - Other Topics; Materials Science;
Physics
GA AQ7MB
UT WOS:000343000800040
PM 25175625
ER
PT S
AU Masci, P
Zhang, Y
Jones, P
Oladimeji, P
D'Urso, E
Bernardeschi, C
Curzon, P
Thimbleby, H
AF Masci, Paolo
Zhang, Yi
Jones, Paul
Oladimeji, Patrick
D'Urso, Enrico
Bernardeschi, Cinzia
Curzon, Paul
Thimbleby, Harold
BE Badger, JM
Rozier, KY
TI Combining PVSio with Stateflow
SO NASA FORMAL METHODS, NFM 2014
SE Lecture Notes in Computer Science
LA English
DT Proceedings Paper
CT 6th NASA Formal Methods Symposium (NFM)
CY APR 29-MAY 01, 2014
CL NASA Johnson Space Ctr, Houston, TX
HO NASA Johnson Space Ctr
DE Simulation; PVSio; Stateflow
AB An approach to integrating PVS executable specifications and Stateflow models is presented that uses web services to enable a seamless exchange of simulation events and data between PVS and Stateflow. Thus, it allows the wide range of applications developed in Stateflow to benefit from the rigor of PVS verification. The effectiveness of the approach is demonstrated on a medical device prototype, which consists of a user interface developed in PVS and a software controller implemented in Stateflow. Simulation on the prototype shows that simulation data produced is exchanged smoothly between in PVSio and Stateflow.
C1 [Masci, Paolo; Curzon, Paul] Queen Mary Univ London, Sch Elect Engn & Comp Sci, London, England.
[Zhang, Yi; Jones, Paul] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Oladimeji, Patrick; Thimbleby, Harold] Swansea Univ, FITLab, Swansea SA2 8PP, W Glam, Wales.
[D'Urso, Enrico; Bernardeschi, Cinzia] Univ Pisa, Dipartimento Ingn Informaz, Pisa, Italy.
RP Masci, P (reprint author), Queen Mary Univ London, Sch Elect Engn & Comp Sci, London, England.
EM p.m.masci@qmul.ac.uk; yi.zhang2@fda.hhs.gov; paul.jones@fda.hhs.gov;
p.oladimeji@swansea.ac.uk; e.durso@studenti.unipi.it;
c.bernardeschi@unipi.it; p.curzon@qmul.ac.uk; h.thimbleby@swansea.ac.uk
OI Bernardeschi, Cinzia/0000-0003-1604-4465; Masci,
Paolo/0000-0002-0667-7763
FU CHI+ MED (EPSRC) [EP/ G059063/ 1]
FX This work is part of CHI+ MED (EPSRC grant EP/ G059063/ 1).
NR 9
TC 2
Z9 2
U1 0
U2 0
PU SPRINGER-VERLAG BERLIN
PI BERLIN
PA HEIDELBERGER PLATZ 3, D-14197 BERLIN, GERMANY
SN 0302-9743
BN 978-3-319-06200-6; 978-3-319-06199-3
J9 LECT NOTES COMPUT SC
PY 2014
VL 8430
BP 209
EP 214
PG 6
WC Computer Science, Software Engineering; Computer Science, Theory &
Methods
SC Computer Science
GA BB3IX
UT WOS:000342810300016
ER
PT S
AU Smith, RE
Tran, K
Richards, KM
AF Smith, Robert E.
Tran, Kevin
Richards, Kristy M.
BE AttaUrRahman, FRS
TI Bioactive Annonaceous Acetogenins
SO STUDIES IN NATURAL PRODUCTS CHEMISTRY, VOL 41
SE Studies in Natural Products Chemistry
LA English
DT Article; Book Chapter
ID MITOCHONDRIAL COMPLEX-I; NADH-UBIQUINONE OXIDOREDUCTASE; TETRAHYDROFURAN
RING ACETOGENINS; TANDEM MASS-SPECTROMETRY; ATYPICAL PARKINSONISM;
FAMILY ANNONACEAE; DYNAMIC FUNCTION; RECENT PROGRESS; SQUAMOSA SEEDS;
PAW PAW
C1 [Smith, Robert E.; Tran, Kevin; Richards, Kristy M.] US FDA, Lenexa, KS 66215 USA.
[Smith, Robert E.] Pk Univ, Dept Sci, Parkville, MO USA.
RP Smith, RE (reprint author), US FDA, Lenexa, KS 66215 USA.
NR 92
TC 9
Z9 9
U1 0
U2 3
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1572-5995
BN 978-0-444-63295-1; 978-0-444-63294-4
J9 STUD NAT PROD CHEM
JI Stud. Nat. Prod. Chem.
PY 2014
VL 41
BP 95
EP 117
DI 10.1016/B978-0-444-63294-4.00004-8
PG 23
WC Chemistry, Medicinal; Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA BB2YX
UT WOS:000342571400005
ER
PT S
AU Snellman, E
AF Snellman, E.
BE Hoorfar, J
TI Guidelines and protocols for safe practice in fresh produce production:
FDA legislation
SO GLOBAL SAFETY OF FRESH PRODUCE: A HANDBOOK OF BEST PRACTICE, INNOVATIVE
COMMERCIAL SOLUTIONS AND CASE STUDIES
SE Woodhead Publishing Series in Food Science Technology and Nutrition
LA English
DT Article; Book Chapter
DE FDA; produce safety; good agricultural practices (GAPs); Coordinated
Outbreak Response & Evaluation (CORE); Food Safety Modernizaton Act
(FSMA)
ID GREEN ONIONS; OUTBREAK
AB As fresh produce consumption by US consumers increased, so too did outbreaks of illness related to consumption of those commodities. In response, the US Food and Drug Administration (FDA), together with the US Department of Agriculture (USDA), developed guidance setting out good agricultural practices (GAPs) to minimize contamination of produce, and began working with food safety partners to promote their adoption. In implementing GAPs, lessons learned during key outbreaks have led to enhanced efforts to minimize illness related to consumption of fresh produce through prevention, response, education and research. The Agency is now working to establish on-farm preventive controls that will be mandatory for many produce growers and packers.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Snellman, E (reprint author), US FDA, Ctr Food Safety & Appl Nutr, HFS 317,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM Erick.Snellman@fda.hhs.gov
NR 28
TC 0
Z9 0
U1 1
U2 3
PU WOODHEAD PUBL LTD
PI CAMBRIDGE
PA ABINGTON HALL ABINGTON, CAMBRIDGE CB1 6AH, CAMBS, ENGLAND
SN 2042-8049
BN 978-1-78242-027-9; 978-1-78242-018-7
J9 WOODHEAD PUBL FOOD S
JI Woodhead Publ. Food Sci. Technol. Nutr.
PY 2014
IS 260
BP 22
EP 32
DI 10.1533/9781782420279.1.22
PG 11
WC Agronomy; Food Science & Technology
SC Agriculture; Food Science & Technology
GA BB2HQ
UT WOS:000341779200005
ER
PT S
AU Feng, P
AF Feng, Peter
BE Hoorfar, J
TI Global safety of fresh produce A handbook of best practice, innovative
commercial solutions and case studies Foreword
SO GLOBAL SAFETY OF FRESH PRODUCE: A HANDBOOK OF BEST PRACTICE, INNOVATIVE
COMMERCIAL SOLUTIONS AND CASE STUDIES
SE Woodhead Publishing Series in Food Science Technology and Nutrition
LA English
DT Editorial Material; Book Chapter
C1 US FDA, College Pk, MD 20740 USA.
RP Feng, P (reprint author), US FDA, HFS 711,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM Peter.Feng@fda.hhs.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WOODHEAD PUBL LTD
PI CAMBRIDGE
PA ABINGTON HALL ABINGTON, CAMBRIDGE CB1 6AH, CAMBS, ENGLAND
SN 2042-8049
BN 978-1-78242-027-9; 978-1-78242-018-7
J9 WOODHEAD PUBL FOOD S
JI Woodhead Publ. Food Sci. Technol. Nutr.
PY 2014
IS 260
BP XXXV
EP XXXVI
PG 2
WC Agronomy; Food Science & Technology
SC Agriculture; Food Science & Technology
GA BB2HQ
UT WOS:000341779200002
ER
PT S
AU Luo, Y
Ingram, DT
Khurana, K
AF Luo, Y.
Ingram, D. T.
Khurana, K.
BE Hoorfar, J
TI Preventing cross-contamination during produce wash operations
SO GLOBAL SAFETY OF FRESH PRODUCE: A HANDBOOK OF BEST PRACTICE, INNOVATIVE
COMMERCIAL SOLUTIONS AND CASE STUDIES
SE Woodhead Publishing Series in Food Science Technology and Nutrition
LA English
DT Article; Book Chapter
DE post-harvest; produce; wash water; sanitizers; foodborne pathogens
ID ESCHERICHIA-COLI O157-H7; FRESH-CUT LETTUCE; CHLORINE INACTIVATION;
WATER; DISINFECTION; VEGETABLES; SURVIVAL; EFFICACY; GROWTH
AB Produce washing is a common commercial practice intended to enhance product quality and shelf-life, and improve food safety through the removal of foreign materials, plant tissue exudates and the inactivation of both human pathogens and spoilage microorganisms. However, in the absence of sufficient sanitizer presence, washing also has the potential to allow pathogen survival and spread to uncontaminated produce in the wash water. Maintenance of effective sanitizer concentrations in the wash water is a critical control point to reduce risk by preventing wash water itself from becoming a major source of pathogen cross-contamination.
C1 [Luo, Y.] ARS, USDA, Environm Microbial & Food Safety Lab, Beltsville, MD 20705 USA.
[Ingram, D. T.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Khurana, K.] Pulse Instruments, Camarillo, CA 93012 USA.
RP Luo, Y (reprint author), ARS, USDA, Environm Microbial & Food Safety Lab, Beltsville, MD 20705 USA.
EM Yaguang.Luo@ars.usda.gov; David.Ingram@fda.hhs.gov
NR 22
TC 3
Z9 3
U1 0
U2 4
PU WOODHEAD PUBL LTD
PI CAMBRIDGE
PA ABINGTON HALL ABINGTON, CAMBRIDGE CB1 6AH, CAMBS, ENGLAND
SN 2042-8049
BN 978-1-78242-027-9; 978-1-78242-018-7
J9 WOODHEAD PUBL FOOD S
JI Woodhead Publ. Food Sci. Technol. Nutr.
PY 2014
IS 260
BP 103
EP 111
DI 10.1533/9781782420279.2.103
PG 9
WC Agronomy; Food Science & Technology
SC Agriculture; Food Science & Technology
GA BB2HQ
UT WOS:000341779200009
ER
PT S
AU Hoorfar, J
Feng, P
Duffy, G
Malorny, B
Binet, R
AF Hoorfar, J.
Feng, P.
Duffy, G.
Malorny, B.
Binet, R.
BE Hoorfar, J
TI Bottlenecks and limitations in testing for pathogens in fresh produce
SO GLOBAL SAFETY OF FRESH PRODUCE: A HANDBOOK OF BEST PRACTICE, INNOVATIVE
COMMERCIAL SOLUTIONS AND CASE STUDIES
SE Woodhead Publishing Series in Food Science Technology and Nutrition
LA English
DT Article; Book Chapter
DE sampling; sample preparation; cultivation; PCR; sequencing
ID ESCHERICHIA-COLI; SHIGELLA-FLEXNERI; ALFALFA SEEDS; RISK-FACTOR;
SALMONELLA; OUTBREAK; SURVIVAL; FOODS; INFECTIONS; VEGETABLES
AB Microbial content of produce can be impacted by sanitary conditions of the production region, use of composted manure, type and quality of irrigation water and many other factors, which can introduce risk factors. Furthermore, the types of produce, uneven distribution of contamination and heterogeneity of samples all pose challenges to obtaining representative samples. Other variables to consider when testing for pathogens in produce include method sensitivity, specificity, applicability, etc. These statistical and analytical uncertainties can have a significant impact as the data are used to infer the health risk of larger product lots, which are broadly sold and are often ready-to-eat.
C1 [Hoorfar, J.] Tech Univ Denmark, DK-2860 Soborg, Denmark.
[Feng, P.; Binet, R.] US FDA, College Pk, MD 20740 USA.
[Duffy, G.] TEAGASC, Food Res Ctr, Dublin 15, Ireland.
[Malorny, B.] BfR, Berlin, Germany.
RP Feng, P (reprint author), US FDA, HFS 711,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM jhoo@food.dtu.dk; Peter.Feng@fda.hhs.gov; geraldine.duffy@teagasc.ie;
burkhard.malorny@bfr.bund.de; rachel.binet@fda.hms.gov
NR 47
TC 0
Z9 0
U1 0
U2 1
PU WOODHEAD PUBL LTD
PI CAMBRIDGE
PA ABINGTON HALL ABINGTON, CAMBRIDGE CB1 6AH, CAMBS, ENGLAND
SN 2042-8049
BN 978-1-78242-027-9; 978-1-78242-018-7
J9 WOODHEAD PUBL FOOD S
JI Woodhead Publ. Food Sci. Technol. Nutr.
PY 2014
IS 260
BP 274
EP 291
DI 10.1533/9781782420279.4.274
PG 18
WC Agronomy; Food Science & Technology
SC Agriculture; Food Science & Technology
GA BB2HQ
UT WOS:000341779200022
ER
PT S
AU Smith, MA
AF Smith, M. A.
BE Hoorfar, J
TI Sprout-associated outbreaks and development of preventive controls
SO GLOBAL SAFETY OF FRESH PRODUCE: A HANDBOOK OF BEST PRACTICE, INNOVATIVE
COMMERCIAL SOLUTIONS AND CASE STUDIES
SE Woodhead Publishing Series in Food Science Technology and Nutrition
LA English
DT Article; Book Chapter
DE sprouts; sprouted seed; pathogens; outbreaks; preventive controls
AB Fresh produce is an important part of a healthy diet. However, produce is susceptible to contamination. Produce is often consumed raw, or only lightly cooked, which may allow pathogens to survive and cause illness. Sprouts are especially problematic because the conditions that encourage seeds to sprout are also ideal for growth of pathogens, if present. The steps of sprout production do not include processes to eliminate pathogens. This chapter describes an iterative process to better understand hazards associated with sprouted seeds and beans, to identify preventive controls for these hazards and to monitor and promote adoption of effective preventive controls.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Smith, MA (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy,HFS 317, College Pk, MD 20740 USA.
EM michelle.smith@fda.hhs.gov
NR 18
TC 0
Z9 0
U1 1
U2 1
PU WOODHEAD PUBL LTD
PI CAMBRIDGE
PA ABINGTON HALL ABINGTON, CAMBRIDGE CB1 6AH, CAMBS, ENGLAND
SN 2042-8049
BN 978-1-78242-027-9; 978-1-78242-018-7
J9 WOODHEAD PUBL FOOD S
JI Woodhead Publ. Food Sci. Technol. Nutr.
PY 2014
IS 260
BP 327
EP 339
DI 10.1533/9781782420279.5.327
PG 13
WC Agronomy; Food Science & Technology
SC Agriculture; Food Science & Technology
GA BB2HQ
UT WOS:000341779200025
ER
PT J
AU Kanungo, J
Cuevas, E
Ali, SF
Paule, MG
AF Kanungo, Jyotshna
Cuevas, Elvis
Ali, Syed F.
Paule, Merle G.
TI Zebrafish Model in Drug Safety Assessment
SO CURRENT PHARMACEUTICAL DESIGN
LA English
DT Article
DE Zebrafish; drug; toxicity screening; high throughput assay;
neurotoxicity; hepatotoxicity; cardiotoxicity
ID EMBRYO TERATOGENESIS ASSAY; DANIO-RERIO EMBRYOS; METABOLIC-ACTIVATION
SYSTEM; BLOOD-RETINAL BARRIER; HAIR CELL-DEATH; IN-VIVO MODEL;
DEVELOPMENTAL TOXICITY; LATERAL-LINE; ETHANOL EXPOSURE; LARVAL ZEBRAFISH
AB Over the past decade, zebrafish are being increasingly used in assessing the effects of chemical compounds. Especially, the embryos and larvae, due to their microscopically small size and optical transparency, are compatible with multi-well microtiter plates for high throughput screening. Being transparent, they allow for non-invasive visualization of internal organs during early development. The organization of the genome, the genetic pathways controlling signal transduction and the developmental pattern appear to be significantly conserved between zebrafish and humans. Major organ systems including the nervous, cardiovascular, digestive and visual systems of zebrafish are also similar to their mammalian counterparts at the anatomical, physiological and molecular levels. Therefore, zebrafish assays are ideal for evaluating multiple organ toxicities simultaneously that contrast in vitro assays performed on cultured cells or tissue explants and organ slices. Although research on zebrafish as a model system began a few decades ago, later studies on zebrafish developmental biology and developmental genetics resulted in the characterization of a large number of genes involved in vertebrate development and biological pathways thus establishing zebrafish as a relevant human disease model for research. Recently, zebrafish have become an attractive vertebrate model for pharmaceutical and toxicological studies. We have outlined in this review some of the toxicological screens and tools that used zebrafish early life stages, and the efforts made to validate zebrafish assays against mammalian drug screens.
C1 [Kanungo, Jyotshna; Cuevas, Elvis; Ali, Syed F.; Paule, Merle G.] US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Kanungo, J (reprint author), US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM jyotshnabala.kanungo@fda.hhs.gov
FU National Center for Toxicological Research (NCTR)/U.S. Food and Drug
Administration (FDA)
FX This work was supported by the National Center for Toxicological
Research (NCTR)/U.S. Food and Drug Administration (FDA).
NR 268
TC 10
Z9 10
U1 9
U2 37
PU BENTHAM SCIENCE PUBL LTD
PI SHARJAH
PA EXECUTIVE STE Y-2, PO BOX 7917, SAIF ZONE, 1200 BR SHARJAH, U ARAB
EMIRATES
SN 1381-6128
EI 1873-4286
J9 CURR PHARM DESIGN
JI Curr. Pharm. Design
PY 2014
VL 20
IS 34
BP 5416
EP 5429
PG 14
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA AP3UV
UT WOS:000342004400006
PM 24502596
ER
PT J
AU Forrey, C
Saylor, DM
Silverstein, JS
Douglas, JF
Davis, EM
Elabd, YA
AF Forrey, Christopher
Saylor, David M.
Silverstein, Joshua S.
Douglas, Jack F.
Davis, Eric M.
Elabd, Yossef A.
TI Prediction and validation of diffusion coefficients in a model drug
delivery system using microsecond atomistic molecular dynamics
simulation and vapour sorption analysis
SO SOFT MATTER
LA English
DT Article
ID SPIN-ECHO NMR; SMALL-PENETRANT DIFFUSION; GLASS-FORMING LIQUIDS;
FREE-VOLUME THEORY; SELF-DIFFUSION; AMORPHOUS POLYMERS; PROBE DIFFUSION;
GAS-DIFFUSION; HYDROCARBON POLYMERS; COMPUTER-SIMULATION
AB Diffusion of small to medium sized molecules in polymeric medical device materials underlies a broad range of public health concerns related to unintended leaching from or uptake into implantable medical devices. However, obtaining accurate diffusion coefficients for such systems at physiological temperature represents a formidable challenge, both experimentally and computationally. While molecular dynamics simulation has been used to accurately predict the diffusion coefficients, D, of a handful of gases in various polymers, this success has not been extended to molecules larger than gases, e.g., condensable vapours, liquids, and drugs. We present atomistic molecular dynamics simulation predictions of diffusion in a model drug eluting system that represent a dramatic improvement in accuracy compared to previous simulation predictions for comparable systems. We find that, for simulations of insufficient duration, sub-diffusive dynamics can lead to dramatic over-prediction of D. We present useful metrics for monitoring the extent of sub-diffusive dynamics and explore how these metrics correlate to error in D. We also identify a relationship between diffusion and fast dynamics in our system, which may serve as a means to more rapidly predict diffusion in slowly diffusing systems. Our work provides important precedent and essential insights for utilizing atomistic molecular dynamics simulations to predict diffusion coefficients of small to medium sized molecules in condensed soft matter systems.
C1 [Forrey, Christopher; Saylor, David M.; Silverstein, Joshua S.] US FDA, Div Chem & Mat Sci, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
[Douglas, Jack F.; Davis, Eric M.] NIST, Mat Sci & Engn Div, Mat Measurement Lab, Gaithersburg, MD USA.
[Elabd, Yossef A.] Drexel Univ, Dept Chem & Biol Engn, Philadelphia, PA 19104 USA.
RP Forrey, C (reprint author), US FDA, Div Chem & Mat Sci, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
EM christopher.forrey@fda.hhs.gov
RI Elabd, Yossef/G-9866-2014
OI Elabd, Yossef/0000-0002-7790-9445
FU National Science Foundation through the NSF/FDA Scholar-in-Residence
Program at the FDA [CBET-1041361]
FX Simulations were made possible by access to high performance
computational facilities through both the Division of Imaging and
Applied Mathematics (DIAM) and the Division of Electrical and So. ware
Engineering (DESE) at the FDA. The authors acknowledge the financial
support of the National Science Foundation (CBET-1041361) through the
NSF/FDA Scholar-in-Residence Program at the FDA that provided support
for E. M. Davis and Y. A. Elabd.
NR 99
TC 4
Z9 4
U1 6
U2 40
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1744-683X
EI 1744-6848
J9 SOFT MATTER
JI Soft Matter
PY 2014
VL 10
IS 38
BP 7480
EP 7494
DI 10.1039/c4sm01297f
PG 15
WC Chemistry, Physical; Materials Science, Multidisciplinary; Physics,
Multidisciplinary; Polymer Science
SC Chemistry; Materials Science; Physics; Polymer Science
GA AP4VS
UT WOS:000342077900006
PM 25115846
ER
PT S
AU Tatavarthy, A
Luna, VA
Amuso, PT
AF Tatavarthy, Aparna
Luna, Vicki A.
Amuso, Philip T.
BE Bush, K
TI How multidrug resistance in typhoid fever affects treatment options
SO ANTIMICROBIAL THERAPEUTICS REVIEWS: INFECTIOUS DISEASES OF CURRENT AND
EMERGING CONCERN
SE Annals of the New York Academy of Sciences
LA English
DT Article; Book Chapter
DE Salmonella Typhi; typhoid fever; antibiotic resistance; fluoroquinolones
ID ENTERICA SEROVAR-TYPHI; MEDIATED QUINOLONE RESISTANCE; DECREASED
CIPROFLOXACIN SUSCEPTIBILITY; MULTIRESISTANT SALMONELLA-TYPHI; FIELD
GEL-ELECTROPHORESIS; SEROTYPE TYPHI; CHLORAMPHENICOL RESISTANCE;
MOLECULAR ANALYSIS; DRUG-RESISTANCE; UNITED-STATES
AB Salmonella enterica serotype Typhi (S. Typhi) is an enteric pathogen that causes typhoid fever. The infection can be severe, with significant morbidity and mortality, requiring antimicrobial therapy. Cases of S. Typhi infection in the United States and other developed countries are often associated with travel to endemic regions. The empirical use of first-line drugs for therapy, including ampicillin, chloramphenicol, and trimethoprim/sulfamethoxazole, has resulted in transmissible multidrug resistance. With the global increase in multidrug-resistant S. Typhi, use of ciprofloxacin, with excellent oral absorption, few side effects, and cost-effectiveness, has become popular for treatment. However, decreased ciprofloxacin susceptibility due to point mutations in the S. Typhi genes gyrA and/or parC has caused treatment failures, necessitating alternative therapeutic options. S. Typhi is typically genetically homogenous, with phylogenetic and epidemiological studies showing that identical clones and diverse S. Typhi types often coexist in the same geographic region. Studies investigating point mutations have demonstrated that selective pressure from empirical use of first-line drugs and fluoroquinolones has led to the global emergence of haplotype H-58. Antibiotic resistance is subject to high selective pressure in S. Typhi and thus demands careful use of antimicrobials.
C1 [Tatavarthy, Aparna; Luna, Vicki A.] Univ S Florida, Coll Publ Hlth, Ctr Biol Def, Tampa, FL USA.
[Amuso, Philip T.] Florida Dept Hlth, Bur Publ Hlth Labs, Tampa, FL USA.
[Amuso, Philip T.] Univ S Florida, Morsani Coll Med, Tampa, FL USA.
RP Tatavarthy, A (reprint author), US FDA, Dept Hlth & Human Serv HHS, CFSAN, ORS, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM Aparna.Tatavarthy@fda.hhs.gov
NR 100
TC 3
Z9 4
U1 1
U2 5
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
SN 0077-8923
J9 ANN NY ACAD SCI
JI Ann.NY Acad.Sci.
PY 2014
VL 1323
BP 76
EP 90
DI 10.1111/nyas.12490
PG 15
WC Infectious Diseases; Microbiology; Pharmacology & Pharmacy
SC Infectious Diseases; Microbiology; Pharmacology & Pharmacy
GA BB1PH
UT WOS:000341250600007
PM 25069595
ER
PT B
AU Yang, X
Schnackenberg, LK
Shi, Q
Salminen, WF
AF Yang, Xi
Schnackenberg, Laura K.
Shi, Qiang
Salminen, William F.
BE Gupta, RC
TI Hepatic toxicity biomarkers
SO BIOMARKERS IN TOXICOLOGY
LA English
DT Article; Book Chapter
ID INDUCED LIVER-INJURY; ACETAMINOPHEN-INDUCED HEPATOTOXICITY;
MITOCHONDRIAL PERMEABILITY TRANSITION; PERFORMANCE
LIQUID-CHROMATOGRAPHY; GAMMA-GLUTAMYL-TRANSPEPTIDASE; GLUTATHIONE
S-TRANSFERASE; CIRCULATING MICRORNAS; QUANTITATIVE-ANALYSIS;
METABOLIC-ACTIVATION; SERUM BIOMARKERS
C1 [Yang, Xi; Schnackenberg, Laura K.; Shi, Qiang] US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Salminen, William F.] PAREXEL, Sarasota, FL USA.
RP Yang, X (reprint author), US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 164
TC 1
Z9 1
U1 0
U2 2
PU ACADEMIC PRESS LTD-ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL ROAD, LONDON NW1 7DX, ENGLAND
BN 978-0-12-404649-8; 978-0-12-404630-6
PY 2014
BP 241
EP 259
DI 10.1016/B978-0-12-404630-6.00013-0
PG 19
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BB1MX
UT WOS:000341214100014
ER
PT B
AU Hilmas, CJ
Fabricant, DS
AF Hilmas, Corey J.
Fabricant, Daniel S.
BE Gupta, RC
TI Biomarkers of toxicity for dietary ingredients contained in dietary
supplements
SO BIOMARKERS IN TOXICOLOGY
LA English
DT Article; Book Chapter
ID CHINESE HERBS NEPHROPATHY; ARISTOLOCHIC ACID NEPHROPATHY; USNIC-ACID;
RENAL-FAILURE; THYROTOXICOSIS; OUTBREAK; HEPATOTOXICITY; RATS;
IDENTIFICATION; METABOLITES
C1 [Hilmas, Corey J.] US FDA, Dietary Supplements Regulat Implementat Branch, Div Dietary Supplement Programs, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Fabricant, Daniel S.] US FDA, Div Dietary Supplement Programs, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Hilmas, CJ (reprint author), US FDA, Dietary Supplements Regulat Implementat Branch, Div Dietary Supplement Programs, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 69
TC 0
Z9 0
U1 0
U2 0
PU ACADEMIC PRESS LTD-ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL ROAD, LONDON NW1 7DX, ENGLAND
BN 978-0-12-404649-8; 978-0-12-404630-6
PY 2014
BP 609
EP 627
DI 10.1016/B978-0-12-404630-6.00035-X
PG 19
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BB1MX
UT WOS:000341214100036
ER
PT B
AU Chen, JJ
Lin, WJ
Lu, TP
AF Chen, James J.
Lin, Wei-Jiun
Lu, Tzu-Pin
BE Gupta, RC
TI Biomarkers of susceptibility Pharmacogenomics and toxicogenomics
SO BIOMARKERS IN TOXICOLOGY
LA English
DT Article; Book Chapter
ID HIGH-DIMENSIONAL DATA; GENE-EXPRESSION DATA; MOLECULAR NUTRITION;
MICROARRAY DATA; BREAST-CANCER; CLASSIFICATION; CLASSIFIERS; SELECTION;
TOXICITY; LIMITATIONS
C1 [Chen, James J.] US FDA, Biostat Branch, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Lin, Wei-Jiun] Feng Chia Univ, Dept Appl Math, Taipei, Taiwan.
[Lu, Tzu-Pin] US FDA, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Chen, JJ (reprint author), US FDA, Biostat Branch, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
OI LU, TZU-PIN/0000-0003-3697-0386
NR 33
TC 0
Z9 1
U1 0
U2 0
PU ACADEMIC PRESS LTD-ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL ROAD, LONDON NW1 7DX, ENGLAND
BN 978-0-12-404649-8; 978-0-12-404630-6
PY 2014
BP 975
EP 982
DI 10.1016/B978-0-12-404630-6.00058-0
PG 8
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BB1MX
UT WOS:000341214100059
ER
PT B
AU Farrar, JA
Guzewich, J
AF Farrar, Jeffrey A.
Guzewich, Jack
BE Matthews, KR
Sapers, GM
Gerba, CP
TI Identification of the Source of Contamination
SO PRODUCE CONTAMINATION PROBLEM: CAUSES AND SOLUTIONS, 2ND EDITION
SE Food Science and Technology-International Series
LA English
DT Article; Book Chapter
C1 [Farrar, Jeffrey A.; Guzewich, Jack] US FDA, Ctr Food Safety & Appl Nutr, Rockville, MD 20857 USA.
RP Farrar, JA (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Rockville, MD 20857 USA.
NR 4
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER ACADEMIC PRESS INC
PI SAN DIEGO
PA 525 B STREET, SUITE 1900, SAN DIEGO, CA 92101-4495 USA
BN 978-0-12-404686-3; 978-0-12-404611-5
J9 FOOD SCI TECH-INT SE
PY 2014
BP 59
EP 83
DI 10.1016/B978-0-12-404611-5.00003-8
PG 25
WC Food Science & Technology
SC Food Science & Technology
GA BB1KM
UT WOS:000341162000004
ER
PT B
AU Keller, SE
AF Keller, Susanne E.
BE Matthews, KR
Sapers, GM
Gerba, CP
TI Tree Fruits and Nuts: Outbreaks, Contamination Sources, Prevention, and
Remediation
SO PRODUCE CONTAMINATION PROBLEM: CAUSES AND SOLUTIONS, 2ND EDITION
SE Food Science and Technology-International Series
LA English
DT Article; Book Chapter
ID ESCHERICHIA-COLI O157-H7; UNPASTEURIZED APPLE CIDER; GOLDEN-DELICIOUS
APPLES; SALMONELLA-TYPHIMURIUM DT104; ENTERITIDIS PHAGE TYPE-30;
LISTERIA-MONOCYTOGENES; FRESH PRODUCE; UNITED-STATES; ACID TOLERANCE;
ORANGE JUICE
C1 FDA, CFSAN, Inst Food Safety & Hlth, Bedford Pk, IL 60501 USA.
RP Keller, SE (reprint author), FDA, CFSAN, Inst Food Safety & Hlth, Bedford Pk, IL 60501 USA.
NR 152
TC 2
Z9 2
U1 1
U2 6
PU ELSEVIER ACADEMIC PRESS INC
PI SAN DIEGO
PA 525 B STREET, SUITE 1900, SAN DIEGO, CA 92101-4495 USA
BN 978-0-12-404686-3; 978-0-12-404611-5
J9 FOOD SCI TECH-INT SE
PY 2014
BP 291
EP 312
DI 10.1016/B978-0-12-404611-5.00013-0
PG 22
WC Food Science & Technology
SC Food Science & Technology
GA BB1KM
UT WOS:000341162000014
ER
PT B
AU Prestin, A
Chou, WYS
AF Prestin, Abby
Chou, Wen-ying Sylvia
BE Hamilton, HE
Chou, WYS
TI Web 2.0 and the changing health communication environment
SO ROUTLEDGE HANDBOOK OF LANGUAGE AND HEALTH COMMUNICATION
SE Routledge Handbooks in Applied Linguistics
LA English
DT Article; Book Chapter
ID NATIONAL TRENDS SURVEY; DIGITAL DIVIDE; BREAST-CANCER; SUPPORT GROUP;
SOCIAL MEDIA; INFORMATION; INTERNET; ONLINE; FACEBOOK; YOUTUBE
C1 [Prestin, Abby] US FDA, Ctr Tobacco Prod, Rockville, MD 20857 USA.
[Chou, Wen-ying Sylvia] NCI, Hlth Commun & Informat Res Branch, Bethesda, MD 20892 USA.
RP Prestin, A (reprint author), US FDA, Ctr Tobacco Prod, Rockville, MD 20857 USA.
NR 61
TC 1
Z9 1
U1 1
U2 1
PU ROUTLEDGE
PI ABINGDON
PA 2 PARK SQ, MILTON PARK, ABINGDON OX14 4RN, OXFORD, ENGLAND
BN 978-1-315-85697-1; 978-0-415-67043-2
J9 ROUT HANDB APPL
PY 2014
BP 184
EP 197
PG 14
WC Health Policy & Services; Linguistics
SC Health Care Sciences & Services; Linguistics
GA BB1JD
UT WOS:000341147600013
ER
PT J
AU Binkowitz, B
Yue, LQ
AF Binkowitz, Bruce
Yue, Lilly Q.
TI SPECIAL ISSUE ASSOCIATED WITH THE 2013 ASA BIOPHARMACEUTICAL
FDA/INDUSTRY STATISTICS WORKSHOP
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Editorial Material
C1 [Binkowitz, Bruce] Merck & Co Inc, Rahway, NJ 07065 USA.
[Yue, Lilly Q.] US FDA, Silver Spring, MD USA.
RP Binkowitz, B (reprint author), Merck & Co Inc, Rahway, NJ 07065 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2014
VL 24
IS 5
SI SI
BP 965
EP 967
DI 10.1080/10543406.2014.942425
PG 3
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AN2MF
UT WOS:000340418700001
PM 25014118
ER
PT J
AU Yue, LQ
Lu, N
Xu, YL
AF Yue, Lilly Q.
Lu, Nelson
Xu, Yunling
TI DESIGNING PREMARKET OBSERVATIONAL COMPARATIVE STUDIES USING EXISTING
DATA AS CONTROLS: CHALLENGES AND OPPORTUNITIES
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Observational comparative studies; Propensity score; Study design; Use
of existing data
ID PROPENSITY SCORES; CAUSAL INFERENCE; BIAS
AB Due to the special nature of medical device clinical studies, observational (nonrandomized) comparative studies play important roles in the premarket safety/effectiveness evaluation of medical devices. While historical data collected in earlier investigational device exemption studies of a previously approved medical device have been used to form control groups in comparative studies, high-quality registry data are emerging to provide opportunities for the premarket evaluation of new devices. However, in such studies, various biases could be introduced in every stage and aspect of study and may compromise the objectivity of study design and validity of study results. In this article, challenges and opportunities in the design of such studies using propensity score methodology are discussed from regulatory perspectives.
C1 [Yue, Lilly Q.; Lu, Nelson; Xu, Yunling] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Yue, LQ (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM lilly.yue@fda.hhs.gov
NR 19
TC 3
Z9 3
U1 1
U2 1
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2014
VL 24
IS 5
SI SI
BP 994
EP 1010
DI 10.1080/10543406.2014.926367
PG 17
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AN2MF
UT WOS:000340418700004
PM 25013971
ER
PT J
AU Hung, HMJ
Wang, SJ
Yang, PL
AF Hung, H. M. James
Wang, Sue-Jane
Yang, Peiling
TI SOME CHALLENGES WITH STATISTICAL INFERENCE IN ADAPTIVE DESIGNS
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Adaptive selection; Adaptive statistical information; Biomarker; Marker;
Unweighted Z statistic; Weighted Z statistic
ID GROUP SEQUENTIAL DESIGNS; CLINICAL-TRIAL DESIGN; SAMPLE-SIZE;
CONDITIONAL POWER; I ERROR; ENRICHMENT; INFORMATION; ADAPTATION;
STRATEGIES; SELECTION
AB Adaptive designs have generated a great deal of attention to clinical trial communities. The literature contains many statistical methods to deal with added statistical uncertainties concerning the adaptations. Increasingly encountered in regulatory applications are adaptive statistical information designs that allow modification of sample size or related statistical information and adaptive selection designs that allow selection of doses or patient populations during the course of a clinical trial. For adaptive statistical information designs, a few statistical testing methods are mathematically equivalent, as a number of articles have stipulated, but arguably there are large differences in their practical ramifications. We pinpoint some undesirable features of these methods in this work. For adaptive selection designs, the selection based on biomarker data for testing the correlated clinical endpoints may increase statistical uncertainty in terms of type I error probability, and most importantly the increased statistical uncertainty may be impossible to assess.
C1 [Hung, H. M. James; Yang, Peiling] US FDA, Div Biometr 1, Off Biostat, Off Translat Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Wang, Sue-Jane] US FDA, Off Biostat, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Hung, HMJ (reprint author), US FDA, Div Biometr 1, Off Biostat, Off Translat Sci,Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 21,Room 4616, Silver Spring, MD 20993 USA.
EM hsienming.hung@fda.hhs.gov
FU RSR fund by Center for Drug Evaluation and Research of the U.S. Food and
Drug Administration [05-02]
FX The research work presented in this article was supported by the RSR
fund number 05-02, provided by Center for Drug Evaluation and Research
of the U.S. Food and Drug Administration.
NR 37
TC 5
Z9 5
U1 0
U2 5
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2014
VL 24
IS 5
SI SI
BP 1059
EP 1072
DI 10.1080/10543406.2014.925911
PG 14
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AN2MF
UT WOS:000340418700008
PM 24915027
ER
PT J
AU Chen, Y
Luo, S
Chu, HT
Su, X
Nie, L
AF Chen, Yong
Luo, Sheng
Chu, Haitao
Su, Xiao
Nie, Lei
TI An Empirical Bayes Method for Multivariate Meta-analysis with an
Application in Clinical Trials
SO COMMUNICATIONS IN STATISTICS-THEORY AND METHODS
LA English
DT Article
DE Bivariate beta-binomial model; Exact method; Hypergeometric function;
Meta-analysis; Relative risk; Sarmanov family
ID BIVARIATE DISTRIBUTIONS; DIABETES-MELLITUS; SARMANOV FAMILY; WOMEN;
MODEL; RISK; SPECIFICITY; SENSITIVITY; PREVALENCE
AB We propose an empirical Bayes method for evaluating overall and study-specific treatment effects in multivariate meta-analysis with binary outcome. Instead of modeling transformed proportions or risks via commonly used multivariate general or generalized linear models, we directly model the risks without any transformation. The exact posterior distribution of the study-specific relative risk is derived. The hyperparameters in the posterior distribution can be inferred through an empirical Bayes procedure. As our method does not rely on the choice of transformation, it provides a flexible alternative to the existing methods and in addition, the correlation parameter can be intuitively interpreted as the correlation coefficient between risks.
C1 [Chen, Yong; Luo, Sheng; Su, Xiao] Univ Texas Hlth Sci Ctr Houston, Div Biostat, Houston, TX 77030 USA.
[Chu, Haitao] Univ Minnesota, Sch Publ Hlth, Div Biostat, Minneapolis, MN 55455 USA.
[Nie, Lei] US FDA, Div Biometr 4, Off Biometr, OTS,CDER, Silver Spring, MD USA.
RP Chen, Y (reprint author), Univ Texas Hlth Sci Ctr Houston, Div Biostat, 1200 Herman Pressler, Houston, TX 77030 USA.
EM yong.chen@uth.tmc.edu
FU Agency for Healthcare Research and Quality [R03HS022900]; National
Institutes of Health/National Center for Advancing Translational
Sciences [KL2 TR000370]; U.S. Department of Health and Human Services
Agency for Healthcare Research and Quality Grant from the U.S. National
Cancer Institute [R03HS020666, P01CA142538]
FX Yong Chen was supported by grant number R03HS022900 from the Agency for
Healthcare Research and Quality. The content is solely the
responsibility of the authors and does not necessarily represent the
official views of the Agency for Healthcare Research and Quality. Sheng
Luo's research was supported in part by National Institutes of
Health/National Center for Advancing Translational Sciences grant KL2
TR000370. Haitao Chu was supported in part by the U.S. Department of
Health and Human Services Agency for Healthcare Research and Quality
Grant R03HS020666 and P01CA142538 from the U.S. National Cancer
Institute".
NR 35
TC 0
Z9 0
U1 0
U2 4
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 0361-0926
EI 1532-415X
J9 COMMUN STAT-THEOR M
JI Commun. Stat.-Theory Methods
PY 2014
VL 43
IS 16
BP 3536
EP 3551
DI 10.1080/03610926.2012.700379
PG 16
WC Statistics & Probability
SC Mathematics
GA AN0LW
UT WOS:000340277100012
PM 25089070
ER
PT J
AU Andersen, ME
Betts, K
Dragan, Y
Fitzpatrick, S
Goodman, JL
Hartung, T
Himmelfarb, J
Ingber, DE
Jacobs, A
Kavlock, R
Kolaja, K
Stevens, JL
Tagle, D
Taylor, DL
Throckmorton, D
AF Andersen, Melvin E.
Betts, Kellyn
Dragan, Yvonne
Fitzpatrick, Suzanne
Goodman, Jesse L.
Hartung, Thomas
Himmelfarb, Jonathan
Ingber, Donald E.
Jacobs, Abigail
Kavlock, Robert
Kolaja, Kyle
Stevens, James L.
Tagle, Dan
Taylor, D. Lansing
Throckmorton, Douglas
TI Developing Microphysiological Systems for Use as Regulatory Tools -
Challenges and Opportunities
SO ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
LA English
DT Editorial Material
ID CHIP
C1 [Andersen, Melvin E.] Hamner Inst Hlth Sci, Res Triangle Pk, NC USA.
[Dragan, Yvonne] AstraZeneca, Waltham, MA USA.
[Fitzpatrick, Suzanne] US FDA, Ctr Food Safety & Appl Nutr, Silver Spring, MD USA.
[Goodman, Jesse L.] US FDA, Silver Spring, MD USA.
[Hartung, Thomas] Johns Hopkins Univ, Ctr Alternat Anim Testing, Baltimore, MD USA.
[Himmelfarb, Jonathan] Univ Washington, Kidney Res Inst, Seattle, WA USA.
[Ingber, Donald E.] Harvard Univ, Wyss Inst Biol Inspired Engn, Cambridge, MA 02138 USA.
[Jacobs, Abigail; Throckmorton, Douglas] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Kavlock, Robert] US EPA, Res Triangle Pk, NC USA.
[Kolaja, Kyle] Cellular Dynamics Int Inc, Madison, WI USA.
[Stevens, James L.] Lilly Res Labs, Greenfield, IN 46140 USA.
[Tagle, Dan] Natl Ctr Adv Translat Sci, NIH, Bethesda, MD USA.
[Taylor, D. Lansing] Univ Pittsburgh, Drug Discovery Inst, Pittsburgh, PA USA.
RP Betts, K (reprint author), 8023 Glenside Dr, Takoma Pk, MD USA.
EM k_betts@nasw.org
OI Andersen, Melvin/0000-0002-3894-4811
FU NCATS NIH HHS [U18 TR000547, UH3 TR000504, UH2 TR000504]
NR 6
TC 10
Z9 10
U1 2
U2 5
PU SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH
PI HEILDEBERG
PA TIERGARTENSTRASSE 17, HEILDEBERG, 69121, GERMANY
SN 1868-596X
EI 1868-8551
J9 ALTEX-ALTERN ANIM EX
JI ALTEX-Altern. Anim. Exp.
PY 2014
VL 31
IS 3
BP 364
EP 367
PG 4
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AL9NU
UT WOS:000339468800012
PM 25061900
ER
PT J
AU Shukla, C
Bashaw, ED
Stagni, G
Benfeldt, E
AF Shukla, C.
Bashaw, E. D.
Stagni, G.
Benfeldt, E.
TI Applications of dermal microdialysis: a review
SO JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
LA English
DT Review
DE Sampling; Kinetics; Flow rate; Dialysate; Permeation
ID IN-VIVO MICRODIALYSIS; ATOPIC-DERMATITIS PATIENTS; SUCTION BLISTER
TECHNIQUE; ZERO-NET-FLUX; CUTANEOUS MICRODIALYSIS; TRANSDERMAL DELIVERY;
HUMAN SKIN; IONTOPHORETIC ADMINISTRATIONS; DERMATOPHARMACOKINETIC
METHOD; SUBCUTANEOUS MICRODIALYSIS
AB Microdialysis (MD) is a sampling technique used to assess tissue concentrations of analytes producing a real-time dynamic drug profile. It's been almost 25 years since MD saw application in sampling and measuring skin concentrations following topical and transdermal applications. The purpose of this review is to provide a technical overview of MD and summarize the widespread applications that are explored with dermal or cutaneous MD ranging from a potential tool to establish topical bioequivalence to unraveling the mechanisms of inflammatory skin disorders. This review also includes current regulatory perspectives in order to benefit scientists and/or clinicians who are novices in this area.
C1 [Shukla, C.; Bashaw, E. D.] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Stagni, G.] Long Isl Univ, Arnold & Marie Schwartz Coll Pharm & Hlth Sci, Div Pharmaceut Sci, Brooklyn, NY 11201 USA.
[Benfeldt, E.] Univ Copenhagen, Roskilde Hosp, Dept Dermatol, Roskilde, Denmark.
RP Shukla, C (reprint author), US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Chinmay.Shukla@fda.hhs.gov
NR 122
TC 0
Z9 0
U1 3
U2 11
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1773-2247
J9 J DRUG DELIV SCI TEC
JI J. Drug Deliv. Sci. Technol.
PY 2014
VL 24
IS 3
BP 259
EP 269
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA AM5VK
UT WOS:000339928900004
ER
PT S
AU Sandbulte, MR
Eichelberger, MC
AF Sandbulte, Matthew R.
Eichelberger, Maryna C.
BE Spackman, E
TI Analyzing Swine Sera for Functional Antibody Titers Against Influenza A
Neuraminidase Proteins Using an Enzyme-Linked Lectin Assay (ELLA)
SO ANIMAL INFLUENZA VIRUS, SECOND EDITION
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Swine influenza A virus; Neuraminidase; Neuraminidase inhibition;
Antibody titration
ID DIVALENT-CATION REQUIREMENTS; VIRUS INFECTION; HEMAGGLUTININ; EVOLUTION;
ANTIGENS; VACCINE; H1N1; MICE
AB Neuraminidase (NA) is an envelope glycoprotein of influenza viruses, including swine-lineage influenza A viruses. NA possesses sialidase activity, which is functionally important at multiple points in viral replication, counter-balancing the sialic acid receptor binding activity of the hemagglutinin (HA), the other major envelope glycoprotein. The NA proteins of influenza A viruses have been classified into nine serological subtypes, and they undergo antigenic drift variation similar to that of HA. Antibodies to NA are analyzed much less often than antibodies to HA. The conventional assay for NA inhibition (NI) antibody titration, established decades ago, is widely considered unwieldy and inefficient for routine use. In recent years, a few new formats have been developed which still measure inhibition of NA enzymatic function, but more efficiently and with less chemical waste produced. Described here is the enzyme-linked lectin assay (ELLA), which is performed in 96-well plates and analyzed on a spectrophotometric plate reader. An important factor in adoption of the ELLA technique for animal studies, such as swine, is the choice of NA antigen, which may be purified protein or whole virus containing an antigenically irrelevant HA protein. This NI assay, in conjunction with the hemagglutination inhibiting (HI) antibody assay, offers a practical way to characterize viral isolates more fully and to quantify antibodies induced by infection or vaccination.
C1 [Sandbulte, Matthew R.] Iowa State Univ, Coll Vet Med, Dept Vet Microbiol & Prevent Med, Ames, IA 50011 USA.
[Eichelberger, Maryna C.] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Sandbulte, MR (reprint author), Iowa State Univ, Coll Vet Med, Dept Vet Microbiol & Prevent Med, Ames, IA 50011 USA.
NR 18
TC 3
Z9 3
U1 0
U2 0
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-4939-0758-8; 978-1-4939-0757-1
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2014
VL 1161
BP 337
EP 345
DI 10.1007/978-1-4939-0758-8_28
D2 10.1007/978-1-4939-0758-8
PG 9
WC Agriculture, Dairy & Animal Science; Biochemical Research Methods;
Biochemistry & Molecular Biology
SC Agriculture; Biochemistry & Molecular Biology
GA BA8RU
UT WOS:000338513600029
PM 24899442
ER
PT B
AU Brar, SS
Gobburu, J
AF Brar, Satjit S.
Gobburu, Joga
BE Figg, WD
McLeod, HL
TI Pharmacometrics
SO HANDBOOK OF ANTICANCER PHARMACOKINETICS AND PHARMACODYNAMICS, 2ND
EDITION
SE Cancer Drug Discovery and Development
LA English
DT Article; Book Chapter
DE Pharmacokinetics; Pharmacodynamics; Regulatory; Drug development;
Clinical pharmacology
ID CLINICAL-TRIAL DESIGN; LUNG-CANCER PATIENTS; DRUG DEVELOPMENT;
PHARMACODYNAMIC PRINCIPLES; MYCOPHENOLATE-MOFETIL; DISEASE PROGRESSION;
LABELING DECISIONS; PREDICTIVE CHECK; DOSE SELECTION; TIME-COURSE
AB Pharmacometrics is the science of quantifying disease, drug, and trial characteristics with the goal of influencing drug development and regulatory and therapeutic decisions. Techniques employing pharmacometric principles are increasingly being used, allowing for efficient utilization of prior experimental information and ultimately streamlining drug development. Using mathematical and statistical models, modeling and simulation allows a simplification of complex systems under investigation and may be able to predict the effects of various treatment options, and the corresponding consequence, on the future course of the disease process. The summation of information can be used to develop more efficient, and hopefully successful, clinical trials. This chapter summarizes the basic theory and application of pharmacometric techniques. Examples of where such pharmacometric principles have been successfully employed in oncology drug development are presented.
C1 [Brar, Satjit S.; Gobburu, Joga] US FDA, Off Clin Pharmacol, Div Pharmacometr, Silver Spring, MD 20993 USA.
[Gobburu, Joga] Univ Maryland, Sch Pharm, Baltimore, MD 21201 USA.
[Gobburu, Joga] US FDA, Silver Spring, MD USA.
RP Gobburu, J (reprint author), US FDA, Off Clin Pharmacol, Div Pharmacometr, Silver Spring, MD 20993 USA.
EM Satjit.Brar@fda.hhs.gov; jgobburu@rx.umaryland.edu
NR 50
TC 1
Z9 1
U1 1
U2 2
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
BN 978-1-4614-9135-4; 978-1-4614-9134-7
J9 CANCER DRUG DISCOV D
JI Canc. Drug. Disc. Dev.
PY 2014
BP 173
EP 192
DI 10.1007/978-1-4614-9135-4_11
D2 10.1007/978-1-4614-9135-4
PG 20
WC Oncology; Pharmacology & Pharmacy
SC Oncology; Pharmacology & Pharmacy
GA BA6CE
UT WOS:000337095300011
ER
PT B
AU Rahman, A
AF Rahman, Atiqur
BE Figg, WD
McLeod, HL
TI Exposure-Response Relationships of Anticancer Agents: Application in
Drug Development and Drug Label
SO HANDBOOK OF ANTICANCER PHARMACOKINETICS AND PHARMACODYNAMICS, 2ND
EDITION
SE Cancer Drug Discovery and Development
LA English
DT Article; Book Chapter
DE Biomarkers; Exposure; Oncology; Pharmacokinetics; Pharmacodynamics;
Response; Surrogates
ID PROSTATE-SPECIFIC ANTIGEN; CHRONIC MYELOID-LEUKEMIA;
FLUORO-BETA-ALANINE; DOSE-RANGING TRIAL; CELL LUNG-CANCER; PHASE-I;
BREAST-CANCER; TYROSINE KINASE; ZOLEDRONIC ACID; BCR-ABL
AB The understanding of exposure-response relationship (ER) is critical in oncology drug development and drug approval. The ER relationship not only helps in selecting the optimum dose and regimen for testing in the pivotal clinical trial for approval, but allows recommending dose adjustment for patients with special conditions. The exposure variables are mostly area under the concentration-time profile (AUC) and/or plasma or serum concentration, while the response variable ranges from biomarkers to clinical endpoints. Application of ER assessment in oncology drug development is illustrated using approved cancer drugs, such as busulfan, zolandronic acid, imatinib, docetaxel, carboplatin, vandetanib, everolimus, and ipilimumab. The FDA guidance on ER relationships elaborates on the regulatory applications, study design, and data analysis aspects of the clinical trials that should be conducted during drug development. The results of the clinical trials exploring ER relationships are usually described in the "Clinical Pharmacology" section of the drug's package inserts; however, the impact and interpretation of the results of these trials reflecting in dose modifications, therapeutic drug monitoring, and safety are included in "Highlights," " Dosage and Administration," and "Warnings and Precautions" sections of the label.
C1 US FDA, Div Clin Pharmacol 5, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Rahman, A (reprint author), US FDA, Div Clin Pharmacol 5, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, Bldg 51,Room 2188,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM namatiqur.rahman@fda.hhs.gov
NR 57
TC 0
Z9 0
U1 0
U2 1
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
BN 978-1-4614-9135-4; 978-1-4614-9134-7
J9 CANCER DRUG DISCOV D
JI Canc. Drug. Disc. Dev.
PY 2014
BP 747
EP 762
DI 10.1007/978-1-4614-9135-4_37
D2 10.1007/978-1-4614-9135-4
PG 16
WC Oncology; Pharmacology & Pharmacy
SC Oncology; Pharmacology & Pharmacy
GA BA6CE
UT WOS:000337095300037
ER
PT J
AU Kaplan, GG
Konduru, K
Manangeeswaran, M
Jacques, J
Amharref, N
Nakamura, S
AF Kaplan, Gerardo G.
Konduru, Krishnamurthy
Manangeeswaran, Mohanraj
Jacques, Jerome
Amharref, Nadia
Nakamura, Siham
BE Thomas, HC
Lok, ASF
Locarnini, SA
Zuckerman, AJ
TI Structure, molecular virology, natural history, and experimental models
SO VIRAL HEPATITIS, 4TH EDITION
LA English
DT Article; Book Chapter
ID HEPATITIS-A-VIRUS; MONKEY KIDNEY-CELLS; CAP-INDEPENDENT TRANSLATION;
IRES-DEPENDENT TRANSLATION; HAVCR1 GENE HAPLOTYPES;
TRACT-BINDING-PROTEIN; SUBVIRAL PARTICLES; VIRAL-RNA;
GLYCERALDEHYDE-3-PHOSPHATE DEHYDROGENASE; MONOCLONAL-ANTIBODIES
AB Hepatitis A virus (HAV), a small, naked, single-stranded, positive RNA virus that belongs to the Picornaviridae, causes acute hepatitis in humans and nonhuman primates. HAV infection typically does not induce cytopathic effect in cell culture, and disease results from an immunopathogenic process that clears the virus without leaving chronic sequelae. HAV is transmitted through the oral-fecal route, but it is unknown how it reaches the liver. The pathogenic process of HAV is poorly understood. However, recent advances in the understanding of the effects of the interaction of HAV with its cellular receptor 1 (HAVCR1), which blocks the activation of T cell receptors and shuts off regulatory T cell (Treg) functions, help explain how HAV modulates the immune response to evade detection during its long incubation period and is cleared with limited liver damage. The shut-off of Treg functions may also explain the protective effect of HAV infection in the development of atopy and autoimmunity.
C1 [Kaplan, Gerardo G.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Konduru, Krishnamurthy] US FDA, Ctr Biol Evaluat & Res, Lab Emerging Pathogens, Bethesda, MD USA.
[Manangeeswaran, Mohanraj; Jacques, Jerome; Amharref, Nadia; Nakamura, Siham] US FDA, Ctr Biol Evaluat & Res, ORISE, Res Participat Program, Bethesda, MD USA.
RP Kaplan, GG (reprint author), US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
NR 99
TC 0
Z9 0
U1 1
U2 5
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
BN 978-0-470-67295-2
PY 2014
BP 29
EP 42
PG 14
WC Gastroenterology & Hepatology; Infectious Diseases; Virology
SC Gastroenterology & Hepatology; Infectious Diseases; Virology
GA BA5VL
UT WOS:000337034100004
ER
PT S
AU Jia, YP
Pereira, CP
Buehler, PW
AF Jia, Yiping
Pereira, Claudia P.
Buehler, Paul W.
BE Ferreira, GC
Kadish, KM
Smith, KM
Guilard, R
TI Hemoglobin and Hemoglobin-based Oxygen Carriers: A Biochemical,
Pharmacological, and Toxicological Perspective
SO HANDBOOK OF PORPHYRIN SCIENCE WITH APPLICATIONS TO CHEMISTRY, PHYSICS,
MATERIALS SCIENCE, ENGINEERING, BIOLOGY AND MEDICINE, VOL 27:
ERYTHROPOIESIS, HEME AND APPLICATIONS TO BIOMEDICINE
SE Handbook of Porphyrin Science
LA English
DT Article; Book Chapter
ID CROSS-LINKED HEMOGLOBIN; TRAUMATIC BRAIN-INJURY; CLAM LUCINA-PECTINATA;
CELL-FREE HEMOGLOBIN; RED-BLOOD-CELLS; STROMA-FREE HEMOGLOBIN;
SPERM-WHALE MYOGLOBIN; NITRIC-OXIDE BINDING; CHEMICALLY-MODIFIED
HEMOGLOBINS; EMBRYONIC CHICKEN HEMOGLOBINS
C1 [Jia, Yiping; Pereira, Claudia P.; Buehler, Paul W.] Ctr Biol Evaluat & Res, Lab Biochem & Vasc Biol, Div Hematol, Bethesda, MD 20892 USA.
RP Jia, YP (reprint author), Ctr Biol Evaluat & Res, Lab Biochem & Vasc Biol, Div Hematol, Bethesda, MD 20892 USA.
EM paul.buehler@fda.hhs.gov
NR 250
TC 0
Z9 0
U1 0
U2 3
PU WORLD SCIENTIFIC PUBL CO PTE LTD
PI SINGAPORE
PA PO BOX 128 FARRER RD, SINGAPORE 9128, SINGAPORE
SN 1793-9518
BN 978-981-4407-78-6
J9 HANDB PORPHYR SCI
PY 2014
VL 27
BP 117
EP 165
PG 49
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA BA5QY
UT WOS:000336962200006
ER
PT S
AU Gavrielides, MA
Li, Q
Zeng, RP
Myers, KJ
Sahiner, B
Petrick, N
AF Gavrielides, Marios A.
Li, Qin
Zeng, Rongping
Myers, Kyle J.
Sahiner, Berkman
Petrick, Nicholas
BE Whiting, BR
Hoeschen, C
Kontos, D
TI Volume estimation of multi-density nodules with thoracic CT
SO MEDICAL IMAGING 2014: PHYSICS OF MEDICAL IMAGING
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Medical Imaging - Physics of Medical Imaging
CY FEB 17-20, 2014
CL San Diego, CA
SP Soc Photo Opt Instrumentat Engn, Modus Med Devices Inc, XIFIN Inc, Ventana Med Syst Inc, Intrace Med, Caresteam, GE Healthcare
DE volume estimation; multi-density nodules; thoracic computed tomography;
phantom study
ID PULMONARY NODULES; LUNG; PHANTOM
AB The purpose of this work was to quantify the effect of surrounding density on the volumetric assessment of lung nodules in a phantom CT study. Eight synthetic multi-density nodules were manufactured by enclosing spherical cores in larger spheres of double the diameter and with a different uniform density. Different combinations of outer/inner diameters (20/10mm, 10/5mm) and densities (100HU/-630H1J, 10HU/-630HU, -630HU/100HU, -630HU/-10HU) were created. The nodules were placed within an anthropomorphic phantom and scanned with a 16-detector row CT scanner. Ten repeat scans were acquired using exposures of 20, 100, and 200mAs, slice collimations of 16x0.75mm and 16x1.5mm, and pitch of 1.2, and were reconstructed with varying slice thicknesses (three for each collimation) using two reconstruction filters (medium and standard). The volumes of the inner nodule cores were estimated from the reconstructed CT data using a matched-filter approach with templates modeling the characteristics of the multi-density objects. Volume estimation of the inner nodule was assessed using percent bias (PB) and the standard deviation of percent error (SPE). The true volumes of the inner nodules were measured using micro CT imaging. Results show PB values ranging from -12.4 to 2.3% and SPE values ranging from 1.8 to 12.8%. This study indicates that the volume of multi-density nodules can be measured with relatively small percent bias (on the order of +/- 12% or less) when accounting for the properties of surrounding densities. These findings can provide valuable information for understanding bias and variability in clinical measurements of nodules that also include local biological changes such as inflammation and necrosis.
C1 [Gavrielides, Marios A.; Li, Qin; Zeng, Rongping; Myers, Kyle J.; Sahiner, Berkman; Petrick, Nicholas] US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Gavrielides, MA (reprint author), US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
NR 12
TC 1
Z9 1
U1 0
U2 0
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9826-7
J9 PROC SPIE
PY 2014
VL 9033
AR 903331
DI 10.1117/12.2043833
PG 10
WC Optics; Physics, Applied; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Physics; Radiology, Nuclear Medicine & Medical Imaging
GA BA8VD
UT WOS:000338775800104
ER
PT S
AU Ghammraoui, B
Peng, R
Suarez, I
Bettolo, C
Badal, A
AF Ghammraoui, B.
Peng, R.
Suarez, I
Bettolo, C.
Badal, A.
BE Whiting, BR
Hoeschen, C
Kontos, D
TI Including the effect of molecular interference in the coherent x-ray
scattering modeling in MC-GPU and PENELOPE for the study of novel breast
imaging modalities
SO MEDICAL IMAGING 2014: PHYSICS OF MEDICAL IMAGING
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Medical Imaging - Physics of Medical Imaging
CY FEB 17-20, 2014
CL San Diego, CA
SP Soc Photo Opt Instrumentat Engn, Modus Med Devices Inc, XIFIN Inc, Ventana Med Systems Inc, Intrace Med, Caresteam, GE Healthcare
DE Coherent-scatter; X-ray scattering; Monte Carlo simulation; Breast
cancer; Energy Dispersive X-Ray Diffraction
ID TISSUE; DIFFRACTION
AB Purpose: To present upgraded versions of MC-GPU and PenEASY_Imaging, two open-source Monte Carlo codes for the simulation of radiographic projections and CT. The codes have been extended with the aim of studying breast imaging modalities that rely on the accurate modeling of coherent x-ray scatter.
Methods: The simulation codes were extended to account for the effect of molecular interference in coherent scattering using experimentally measured molecular interference functions. The validity of the new model was tested experimentally using the Energy Dispersive X-Ray Diffraction (EDXRD) technique with a polychromatic x-ray source and an energy-resolved Germanium detector at a fixed scattering angle. Experiments and simulations of a full field digital mammography system with and without a ID focused antiscatter grid were conducted for additional validation. The modified MC-GPU code was also used to examine the possibility of characterizing breast cancer within a mathematical breast phantom using the EDXRD technique.
Results: The measured EDXRD spectra were correctly reproduced by the simulation with the modified code while the previous code using the Independent Atomic Approximation led to large errors in the predicted diffraction spectra. There was good agreement between the simulated and measured rejection factor for the ID focused antiscatter grid with both models. The simulation study in a whole breast showed that the x-ray scattering profiles of adipose, fibrosis, cancer and benign tissues are differentiable.
Conclusion: MC-GPU and PENELOPE were successfully extended and validated for accurate modeling of coherent x-ray scatter. The EDXRD technique with pencil-cone geometry in a whole breast was investigated by a simulation study and it was concluded that this technique has potential to characterize breast cancer lesions.
C1 [Ghammraoui, B.; Peng, R.; Suarez, I; Bettolo, C.; Badal, A.] US FDA, Div Imaging & Appl Math, OSEL, CDRH, Silver Spring, MD 20993 USA.
RP Ghammraoui, B (reprint author), US FDA, Div Imaging & Appl Math, OSEL, CDRH, Silver Spring, MD 20993 USA.
EM bahaa.ghammraoui@fda.hhs.gov
NR 13
TC 1
Z9 1
U1 0
U2 2
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9826-7
J9 PROC SPIE
PY 2014
VL 9033
AR 90334N
DI 10.1117/12.2042799
PG 8
WC Optics; Physics, Applied; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Physics; Radiology, Nuclear Medicine & Medical Imaging
GA BA8VD
UT WOS:000338775800159
ER
PT S
AU Kontson, K
Jennings, RJ
AF Kontson, Kimberly
Jennings, Robert J.
BE Whiting, BR
Hoeschen, C
Kontos, D
TI X-ray scatter characterization in dedicated breast CT with bowtie
filters
SO MEDICAL IMAGING 2014: PHYSICS OF MEDICAL IMAGING
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Medical Imaging - Physics of Medical Imaging
CY FEB 17-20, 2014
CL San Diego, CA
SP Soc Photo Opt Instrumentat Engn, Modus Med Devices Inc, XIFIN Inc, Ventana Med Systems Inc, Intrace Med, Caresteam, GE Healthcare
DE bowtie filter; breast CT; scatter-to-primary ratio
ID MONTE-CARLO-SIMULATION; IMAGE QUALITY; RADIATION; DESIGN; CBCT
AB The scatter contamination of projection images in cone-beam computed tomography (CT) degrades image quality. The use of bowtie filters in dedicated breast CT can decrease this scatter contribution. Three bowtie filter designs that compensate for one or more aspects of the beam-modifying effects due to the differences in path length in a projection have been studied. The first produces the same beam-hardening effect as breast tissue with a single-material design. The second produces the same beam quality and intensity at the detector with a two-material design and the third eliminates the beam-hardening effect by adjusting the bowtie filter thickness such that the same effective attenuation is produced at the detector. We have selected aluminum, boron carbide/beryllium oxide, and PM MA as the materials for the previously described designs, respectively. These designs have been investigated in terms of their ability to reduce the scatter contamination in projection images acquired in a dedicated breast CT geometry. The magnitude of the scatter was measured as the scatter-to-primary ratio using experimental and Monte Carlo techniques. The distribution of the scatter was also measured at different locations in the scatter image to produce scatter distribution maps for all three bowtie filter designs. The results of this study will be useful in designing scatter correction methods and understanding the benefits of bowtie filters in dedicated breast CT.
C1 [Kontson, Kimberly; Jennings, Robert J.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Kontson, K (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
OI KONTSON, KIMBERLY/0000-0002-4978-6011
NR 14
TC 1
Z9 1
U1 0
U2 0
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9826-7
J9 PROC SPIE
PY 2014
VL 9033
AR 903343
DI 10.1117/12.2043051
PG 12
WC Optics; Physics, Applied; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Physics; Radiology, Nuclear Medicine & Medical Imaging
GA BA8VD
UT WOS:000338775800141
ER
PT J
AU Shabalina, SA
Ogurtsov, AY
Spiridonov, NA
Koonin, EV
AF Shabalina, Svetlana A.
Ogurtsov, Aleksey Y.
Spiridonov, Nikolay A.
Koonin, Eugene V.
TI Evolution at protein ends: major contribution of alternative
transcription initiation and termination to the transcriptome and
proteome diversity in mammals
SO NUCLEIC ACIDS RESEARCH
LA English
DT Article
ID INTRINSICALLY DISORDERED REGIONS; EUKARYOTIC MESSENGER-RNAS; GENOME
BROWSER DATABASE; SPLICE-SITE CHOICE; SELECTION PRESSURE; UNTRANSLATED
REGIONS; FUNCTIONAL DIVERSITY; INTERACTION NETWORKS; SECONDARY
STRUCTURE; INTERGENIC REGIONS
AB Alternative splicing (AS), alternative transcription initiation (ATI) and alternative transcription termination (ATT) create the extraordinary complexity of transcriptomes and make key contributions to the structural and functional diversity of mammalian proteomes. Analysis of mammalian genomic and transcriptomic data shows that contrary to the traditional view, the joint contribution of ATI and ATT to the transcriptome and proteome diversity is quantitatively greater than the contribution of AS. Although the mean numbers of protein-coding constitutive and alternative nucleotides in gene loci are nearly identical, their distribution along the transcripts is highly non-uniform. On average, coding exons in the variable 5' and 3' transcript ends that are created by ATI and ATT contain approximately four times more alternative nucleotides than core protein-coding regions that diversify exclusively via AS. Short upstream exons that encompass alternative 5'-untranslated regions and N-termini of proteins evolve under strong nucleotide-level selection whereas in 3'-terminal exons that encode protein C-termini, protein-level selection is significantly stronger. The groups of genes that are subject to ATI and ATT show major differences in biological roles, expression and selection patterns.
C1 [Shabalina, Svetlana A.; Ogurtsov, Aleksey Y.; Koonin, Eugene V.] NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20984 USA.
[Spiridonov, Nikolay A.] US FDA, Div Therapeut Prot, Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
RP Koonin, EV (reprint author), NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20984 USA.
EM shabalin@ncbi.nlm.nih.gov; koonin@ncbi.nlm.nih.gov
FU Department of Health and Human Services (DHHS) (National Institutes of
Health, National Library of Medicine)
FX Department of Health and Human Services (DHHS) (National Institutes of
Health, National Library of Medicine) intramural funds. Funding for open
access charge: DHHS (National Institutes of Health, National Library of
Medicine) intramural funds.
NR 78
TC 11
Z9 11
U1 0
U2 8
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0305-1048
EI 1362-4962
J9 NUCLEIC ACIDS RES
JI Nucleic Acids Res.
PY 2014
VL 42
IS 11
BP 7132
EP 7144
DI 10.1093/nar/gku342
PG 13
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA AK9TG
UT WOS:000338769400035
PM 24792168
ER
PT S
AU Selen, A
AF Selen, Arzu
BE BarShalom, D
Rose, K
TI Pediatric Formulations and Dosage Forms and Future Opportunities: Impact
of Regulations in the USA and Implementation of Quality by Design
SO PEDIATRIC FORMULATIONS: A ROADMAP
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID SHRIVER NATIONAL INSTITUTE; CHILD HEALTH; THERAPEUTIC ORPHAN; MEDICATION
ERRORS; ETHICAL CONDUCT; CLINICAL-TRIALS; EVALUATE DRUGS; INFORMATION;
GUIDELINES; MEDICINES
AB The advances in pharmaceutical sciences and technology have been so significant that Peter Drucker's quote that "the future has already happened" applies readily for medicines developed for adults. For pediatric patients, the future is about to happen. The continuation of focused partnerships and knowledge sharing and leveraging are critical to ensure that pediatric patients have timely access to high quality drug products that were developed with pediatric patients in mind. An overview of regulatory efforts, regulations and legislation to address the challenges for pediatric drug development are discussed. The implementation of regulatory incentives, the Pediatric Rule, Best Pharmaceuticals for Children Act, and Pediatric Research Equity Act, is having an impact and has led to incorporation of information for dosing of approximately 500 drug products since 1998 starting with implementation of the Pediatric Rule. There are significant accomplishments and a lot more work ahead for the pediatric community. The labeling information is usually for older pediatric patients and the need for information for safe and effective dosing of patients of 6 years old or younger remains. Some of the study outcomes are inconclusive with respect to safety and efficacy, and support the hypotheses that better understanding of drug delivery to pediatric patients is needed for determining and delivering the right dose to the pediatric patients. The 2012 Food and Drug Administration Safety and Innovation Act and implementation of Quality by Design paradigm focusing on drug product design and manufacturing process are expected to have a synergistic effect for continuing to advance development of pediatric dosage forms and formulations for the benefit of the pediatric patients.
C1 US FDA, Off New Drug Qual Assessment, CDER, Silver Spring, MD 20993 USA.
RP Selen, A (reprint author), US FDA, Off New Drug Qual Assessment, CDER, 10903 New Hampshire Ave,Bldg 21,Room 1604, Silver Spring, MD 20993 USA.
EM Arzu.Selen@fda.hhs.gov
NR 65
TC 0
Z9 0
U1 2
U2 4
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4899-8011-3; 978-1-4899-8010-6
J9 AAPS ADV PHARM SCI
PY 2014
VL 11
BP 377
EP 393
DI 10.1007/978-1-4899-8011-3_26
D2 10.1007/978-1-4899-8011-3
PG 17
WC Pediatrics; Pharmacology & Pharmacy
SC Pediatrics; Pharmacology & Pharmacy
GA BA6BB
UT WOS:000337084700027
ER
PT B
AU Seeff, LB
Ghany, MG
AF Seeff, Leonard B.
Ghany, Marc G.
BE Thompson, G
TI HARVEY ALTER AND MICHAEL HOUGHTON: THE DISCOVERY OF HEPATITIS C AND THE
INTRODUCTION OF SCREENING TO PREVENT ITS TRANSMISSION IN TRANSFUSED
BLOOD
SO PIONEERS OF MEDICINE WITHOUT A NOBEL PRIZE
LA English
DT Article; Book Chapter
ID NON-B-HEPATITIS; NON-A-HEPATITIS; UNITED-STATES; POSTTRANSFUSION
HEPATITIS; AUSTRALIA ANTIGEN; NATURAL-HISTORY; VIRUS; JAUNDICE;
SEQUENCE; ANTIBODY
C1 [Seeff, Leonard B.] Hill Grp, Bethesda, MD 20817 USA.
[Seeff, Leonard B.] US FDA, Silver Spring, MD USA.
[Ghany, Marc G.] NIDDK, Liver Dis Branch, NIH, Bethesda, MD USA.
RP Seeff, LB (reprint author), Hill Grp, Bethesda, MD 20817 USA.
NR 39
TC 0
Z9 0
U1 1
U2 2
PU IMPERIAL COLL PRESS
PI COVENT GARDEN
PA 57 SHELTON STREET, COVENT GARDEN WC2H 9HE, ENGLAND
BN 978-1-78326-384-4; 978-1-78326-385-1; 978-1-78326-383-7
PY 2014
BP 197
EP 214
D2 10.1142/p922
PG 18
WC History & Philosophy Of Science
SC History & Philosophy of Science
GA BA6ZY
UT WOS:000337341800014
ER
PT J
AU Chien, CY
Chang, CW
Tsai, CA
Chen, JJ
AF Chien, Chih-Yi
Chang, Ching-Wei
Tsai, Chen-An
Chen, James J.
TI MAVTgsa: An R Package for Gene Set (Enrichment) Analysis
SO BIOMED RESEARCH INTERNATIONAL
LA English
DT Article
ID MULTIPLE END-POINTS; EXPRESSION DATA; GLOBAL TEST; CANCER; KNOWLEDGE;
PATHWAYS
AB Gene set analysis methods aim to determine whether an a priori defined set of genes shows statistically significant difference in expression on either categorical or continuous outcomes. Although many methods for gene set analysis have been proposed, a systematic analysis tool for identification of different types of gene set significance modules has not been developed previously. This work presents an R package, called MAVTgsa, which includes three different methods for integrated gene set enrichment analysis. (1) The one-sided OLS (ordinary least squares) test detects coordinated changes of genes in gene set in one direction, either up- or downregulation. (2) The two-sided MANOVA (multivariate analysis variance) detects changes both up-and downregulation for studying two or more experimental conditions. (3) A random forests-based procedure is to identify gene sets that can accurately predict samples from different experimental conditions or are associated with the continuous phenotypes. MAVTgsa computes the.. values and FDR (false discovery rate) q-value for all gene sets in the study. Furthermore, MAVTgsa provides several visualization outputs to support and interpret the enrichment results. This package is available online.
C1 [Chien, Chih-Yi] Keelung Chang Gung Mem Hosp, Community Med Res Ctr, Keelung 204, Taiwan.
[Chang, Ching-Wei; Chen, James J.] Natl Ctr Toxicol Res, Div Bioinformat & Biostat, Jefferson, AR 72079 USA.
[Tsai, Chen-An] Natl Taiwan Univ, Dept Agron, Taipei 106, Taiwan.
[Chen, James J.] China Med Univ, Grad Inst Biostat, Taichung, Taiwan.
[Chen, James J.] China Med Univ, Ctr Biostat, Taichung, Taiwan.
RP Tsai, CA (reprint author), Natl Taiwan Univ, Dept Agron, 1,Sect 4,Roosevelt Rd, Taipei 106, Taiwan.
EM catsai@ntu.edu.tw; jamesj.chen@fda.hhs.gov
OI Tsai, Chen-An/0000-0002-7490-4331
FU Post-doctoral Fellowship Program at the NCTR
FX Chih-Yi's research was supported by the Post-doctoral Fellowship Program
at the NCTR administered by the Oak Ridge Institute for Science and
Education through an interagency agreement between USDOE and USFDA.
NR 31
TC 1
Z9 1
U1 1
U2 4
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 2314-6133
EI 2314-6141
J9 BIOMED RES INT
JI Biomed Res. Int.
PY 2014
AR 346074
DI 10.1155/2014/346074
PG 11
WC Biotechnology & Applied Microbiology; Medicine, Research & Experimental
SC Biotechnology & Applied Microbiology; Research & Experimental Medicine
GA AL1BJ
UT WOS:000338860500001
ER
PT J
AU Chalbot, MCG
Brown, J
Chitranshi, P
da Costa, GG
Pollock, ED
Kavouras, IG
AF Chalbot, M. -C. G.
Brown, J.
Chitranshi, P.
da Costa, G. Gamboa
Pollock, E. D.
Kavouras, I. G.
TI Functional characterization of the water-soluble organic carbon of
size-fractionated aerosol in the southern Mississippi Valley
SO ATMOSPHERIC CHEMISTRY AND PHYSICS
LA English
DT Article
ID MAGNETIC-RESONANCE-SPECTROSCOPY; BIOMASS BURNING AEROSOLS; LOS-ANGELES
BASIN; PARTICULATE MATTER; ATMOSPHERIC AEROSOLS; DICARBOXYLIC-ACIDS;
ISOTOPIC COMPOSITIONS; SOURCE APPORTIONMENT; SEASONAL-VARIATION;
ALIPHATIC-AMINES
AB The chemical content of water-soluble organic carbon (WSOC) as a function of particle size was characterized in Little Rock, Arkansas in winter and spring 2013. The objectives of this study were to (i) compare the functional characteristics of coarse, fine and ultrafine WSOC and (ii) reconcile the sources of WSOC for periods when carbonaceous aerosol was the most abundant particulate component. The WSOC accounted for 5% of particle mass for particles with d(p) > 0.96 mu m and 10% of particle mass for particles with d(p) < 0.96 mu m. Non-exchangeable aliphatic (H-C), unsaturated aliphatic (H-C-C=), oxygenated saturated aliphatic (H-C-O), acetalic (O-CH-O) and aromatic (Ar-H) protons were determined by proton nuclear magnetic resonance (H-1-NMR). The total non-exchangeable organic hydrogen concentrations varied from 4.1 +/- 0.1 nmol m(-3) for particles with 1.5 < d(p) < 3.0 mu m to 73.9 +/- 12.3 nmol m(-3) for particles with d(p) < 0.49 mu m. The molar H / C ratios varied from 0.48 +/- 0.05 to 0.92 +/- 0.09, which were comparable to those observed for combustion-related organic aerosol. The R-H was the most abundant group, representing about 45% of measured total non-exchangeable organic hydrogen concentrations, followed by H-C-O (27%) and H-C-C= (26%). Levoglucosan, amines, ammonium and methanesulfonate were identified in NMR fingerprints of fine particles. Sucrose, fructose, glucose, formate and acetate were associated with coarse particles. These qualitative differences of H-1-NMR profiles for different particle sizes indicated the possible contribution of biological aerosols and a mixture of aliphatic and oxygenated compounds from biomass burning and traffic exhausts. The concurrent presence of ammonium and amines also suggested the presence of ammonium/aminium nitrate and sulfate secondary aerosol. The size-dependent origin of WSOC was further corroborated by the increasing delta C-13 abundance from -26.81 +/- 0.18 parts per thousand for the smallest particles to -25.93 +/- 0.31 parts per thousand for the largest particles and the relative distribution of the functional groups as compared to those previously observed for marine, biomass burning and secondary organic aerosol. The latter also allowed for the differentiation of urban combustion-related aerosol and biological particles. The five types of organic hydrogen accounted for the majority of WSOC for particles with d(p) > 3.0 mu m and d(p) < 0.96 mu m.
C1 [Chalbot, M. -C. G.; Brown, J.; Kavouras, I. G.] Univ Arkansas Med Sci, Little Rock, AR 72205 USA.
[Chitranshi, P.; da Costa, G. Gamboa] Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Pollock, E. D.] Univ Arkansas, Stable Isotope Lab, Fayetteville, AR 72701 USA.
RP Kavouras, IG (reprint author), Univ Arkansas Med Sci, Little Rock, AR 72205 USA.
EM ikavouras@uams.edu
RI Kavouras, Ilias/H-7056-2012
OI pollock, erik/0000-0002-2834-4935; Kavouras, Ilias/0000-0003-0342-5306;
Kavouras, Ilias/0000-0003-0436-3784
FU Intramural FDA HHS [FD999999]
NR 75
TC 11
Z9 11
U1 1
U2 36
PU COPERNICUS GESELLSCHAFT MBH
PI GOTTINGEN
PA BAHNHOFSALLEE 1E, GOTTINGEN, 37081, GERMANY
SN 1680-7316
EI 1680-7324
J9 ATMOS CHEM PHYS
JI Atmos. Chem. Phys.
PY 2014
VL 14
IS 12
BP 6075
EP 6088
DI 10.5194/acp-14-6075-2014
PG 14
WC Meteorology & Atmospheric Sciences
SC Meteorology & Atmospheric Sciences
GA AK5BH
UT WOS:000338438300014
PM 27471518
ER
PT J
AU Tworkoski, E
Dorris, E
Shin, D
Phillips, KS
AF Tworkoski, Ellen
Dorris, Eric
Shin, Daniel
Phillips, K. Scott
TI A high-throughput method for testing biofouling and cleaning of polymer
hydrogel materials used in medical devices
SO ANALYTICAL METHODS
LA English
DT Article
ID CONTACT-LENSES; SURFACES; PROTEIN; CONTAMINATION; FLUORESCENCE;
INSTRUMENTS; RESPONSES; ADHESION; RELEASE
AB A miniaturized, high-throughput method is developed to measure biofouling and cleaning processes of transparent silicone-and hydroxyethylmethacrylate-based polymer hydrogel materials used in medical devices. Protein biofouling and cleaning effectiveness were measured in 384-well microtiter plates using 3 mm biopsy punches from hydrogel materials soaked in a simulated protein soil fluid (PSF). Fluorescence detection of labeled protein components enabled highly sensitive quantification of biofouling and cleaning endpoints. The sample volume to soaking volume ratio and surface area to soaking volume ratio are similar to those used for full-sized analysis. The method showed minimal perturbation from sample height variations up to hundreds of micrometers. A calibration curve constructed by testing samples soaked in eight different concentrations (0-1.25 mg mL(-1)) of fluorescent protein showed a broad dynamic range, but fluorescence quenching occurred above 0.75 mg mL(-1) protein in highly absorbing hydrogels. The method was found to have 1 : 1 linear correlation with measurements obtained by 2D fluorescence imaging using biofouled/ cleaned miniature punches, and 3D confocal fluorescence profiling using full-sized samples soaked in PSF. A comparison of protein biofouling on two types of hydrogel materials revealed that the slope of protein concentration-response curves for high water materials was 100-fold higher than for low water materials. To demonstrate simultaneous measurement of biofouling by multiple soil components, lipid and protein sorption were also tested and found to be correlated. The characterization and results obtained here show the potential of this method for exploring mechanistic details of biofouling and cleaning processes. The method greatly decreases the time and cost associated with the large number of unique samples required, making it possible to study the roles of the numerous material, solution and soil variables at the biointerface of medical devices.
C1 [Tworkoski, Ellen; Dorris, Eric; Shin, Daniel; Phillips, K. Scott] US FDA, Off Med Prod & Tobacco, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs,Div Chem & Mat Sci, Silver Spring, MD 20993 USA.
RP Phillips, KS (reprint author), US FDA, Off Med Prod & Tobacco, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs,Div Chem & Mat Sci, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM kenneth.phillips@fda.hhs.gov
RI Phillips, Kenneth/A-2156-2013; phillips, kenneth/F-7560-2014
OI Phillips, Kenneth/0000-0002-6552-0694; phillips,
kenneth/0000-0002-6552-0694
NR 38
TC 4
Z9 4
U1 2
U2 13
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1759-9660
EI 1759-9679
J9 ANAL METHODS-UK
JI Anal. Methods
PY 2014
VL 6
IS 13
BP 4521
EP 4529
DI 10.1039/c3ay40501j
PG 9
WC Chemistry, Analytical; Food Science & Technology; Spectroscopy
SC Chemistry; Food Science & Technology; Spectroscopy
GA AJ5XI
UT WOS:000337763200008
ER
PT J
AU Zhai, XZ
Jia, HM
Zhang, YE
Lei, Y
Wei, J
Gao, YH
Chu, JH
He, WW
Yin, JJ
Zheng, Z
AF Zhai, Xuezhen
Jia, Huimin
Zhang, Yange
Lei, Yan
Wei, Jie
Gao, Yuanhao
Chu, Junhao
He, Weiwei
Yin, Jun-Jie
Zheng, Zhi
TI In situ fabrication of Cu2ZnSnS4 nanoflake thin films on both rigid and
flexible substrates
SO CRYSTENGCOMM
LA English
DT Article
ID SOLAR-CELLS; NANOCRYSTALS; GROWTH; PRECURSORS; EFFICIENCY
AB Cu2ZnSnS4 (CZTS) thin film, a highly promising and low-cost absorber layer material for solar cells, has been in situ fabricated on stainless steel and FTO glass substrates for the first time, using a one-step solvothermal treatment of CuZnSn-alloyed film with sulphur or selenium powder. The resulting products were characterized by X-ray diffractometry (XRD), scanning electron microscopy (SEM), transmission electron microscopy (TEM), and UV-vis-NIR spectroscopy. Raman spectroscopy was used to characterize and confirm the formation of CZTS. The effects of temperature, reaction time, the ratio of Cu/Zn/Sn, and non-elemental reactants on the formation of CZTS nanocrystal films were assessed, and we found that the reaction temperature was a key factor in determining the properties of the final products. Pure CZTS phase forms at a temperature of 250 degrees C or higher. Our method produces CZTS thin films at 250 degrees C, the lowest reaction temperature that can be used in the process and the lowest temperature of any current fabrication system. We also found that flexible substrates promote the growth of CZTS nanocrystals. Using flexible substrates in the in situ fabrication of nanocrystalline thin films may make it possible to use CZTS for industrial applications.
C1 [Zhai, Xuezhen; Jia, Huimin; Zhang, Yange; Lei, Yan; Wei, Jie; Gao, Yuanhao; He, Weiwei; Zheng, Zhi] Xuchang Univ, Inst Surface Micro & Nano Mat, Key Lab Micronano Energy Storage & Convers Mat He, Xuchang 461000, Henan, Peoples R China.
[Zhai, Xuezhen; Wei, Jie; Chu, Junhao] E China Normal Univ, Dept Elect, Minist Educ, Key Lab Polar Mat & Devices, Shanghai 200241, Peoples R China.
[He, Weiwei; Yin, Jun-Jie] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Zhai, XZ (reprint author), Xuchang Univ, Inst Surface Micro & Nano Mat, Key Lab Micronano Energy Storage & Convers Mat He, Xuchang 461000, Henan, Peoples R China.
EM zhengzhi99999@gmail.com
RI Yin, Jun Jie /E-5619-2014
FU National Natural Science Foundation of China [21273192, 61204009];
Innovation Scientists and Technicians Troop Construction Projects of
Henan Province [144200510014]; Program for Science & Technology
Innovation Teams in the Universities of Henan Province [2012
IRTSTHN021]; Innovation Scientists and Technicians Team Projects of
Henan Province Program for Basic and Advanced Technology of Henan
Province [112300410106, 124300510055]; Science and Technology of Henan
Province [12A150022]
FX We thank Barbara Berman from U.S. FDA for her kind and scientific
editing. This work was supported by the National Natural Science
Foundation of China (grant no. 21273192, 61204009), the Innovation
Scientists and Technicians Troop Construction Projects of Henan Province
(grant no. 144200510014), the Program for Science & Technology
Innovation Teams in the Universities of Henan Province (2012
IRTSTHN021), the Innovation Scientists and Technicians Team Projects of
Henan Province Program for Basic and Advanced Technology of Henan
Province (grant no. 112300410106, 124300510055), and the Research Key
Projects of Science and Technology of Henan Province (grant no.
12A150022).
NR 27
TC 12
Z9 12
U1 9
U2 50
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1466-8033
J9 CRYSTENGCOMM
JI Crystengcomm
PY 2014
VL 16
IS 27
BP 6244
EP 6249
DI 10.1039/c4ce00174e
PG 6
WC Chemistry, Multidisciplinary; Crystallography
SC Chemistry; Crystallography
GA AJ9MV
UT WOS:000338036400034
ER
PT J
AU Weisz, A
Krantz, ZB
AF Weisz, Adrian
Krantz, Zoe B.
TI Determination of synthetic by-products and an intermediate in the colour
additives D&C Red Nos 27 and 28 (phloxine B) and their lakes using
conventional HPLC
SO FOOD ADDITIVES AND CONTAMINANTS PART A-CHEMISTRY ANALYSIS CONTROL
EXPOSURE & RISK ASSESSMENT
LA English
DT Article
DE D&C Red No. 27; D&C Red No. 28; phloxine B; 2,3,4,5-tetrachloro-6-(3 ',5
'-dibromo-2 ',4 '-dihydroxybenzoyl) benzoic acid; brominated
resorcinols; 3,4,5,6-tetrachlorophthalic acid; HPLC
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; ETHERS
AB Specifications in the US Code of Federal Regulations (CFR) for the colour additives D&C Red No. 27 (R27) and D&C Red No. 28 (R28) limit the levels of the synthetic by-products 2,3,4,5-tetrachloro-6-(3',5'-dibromo-2',4'-dihydroxybenzoyl) benzoic acid (SBBA) and "brominated resorcinol" and of the intermediate 3,4,5,6-tetrachlorophthalic acid (TCPA). The present study reports the development and application of a conventional HPLC method for the quantitative determination of these impurities in R27, R28 and their lakes. Because the CFR-listed "brominated resorcinol" refers to a group of synthetic by-products, six variously brominated resorcinols were examined as possible impurities. Due to their rapid decomposition in the presence of the dye, the existence of any brominated resorcinols in R27 and R28 is highly unlikely, and this supposition is supported by the results obtained in this study. SBBA, 2,4,6-tribromoresorcinol (Br3R, the brominated resorcinol most likely to be found as an impurity) and TCPA were quantified by using five-point calibration curves with data points (w/w) that ranged from 0.066% to 0.820% for SBBA, from 0.050% to 0.499% for Br3R, and from 0.061% to 1.410% for TCPA. The HPLC method was applied to the analysis of test portions from batches of R27, R28 and their lakes submitted to the USFDA for certification by domestic and foreign manufacturers.
C1 [Weisz, Adrian; Krantz, Zoe B.] US FDA, Ctr Food Safety & Appl Nutr, Off Cosmet & Colors, College Pk, MD 20740 USA.
RP Weisz, A (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Cosmet & Colors, College Pk, MD 20740 USA.
EM adrian.weisz@fda.hhs.gov
NR 14
TC 1
Z9 1
U1 2
U2 3
PU TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXON, ENGLAND
SN 1944-0049
EI 1944-0057
J9 FOOD ADDIT CONTAM A
JI Food Addit. Contam. Part A-Chem.
PY 2014
VL 31
IS 6
BP 979
EP 984
DI 10.1080/19440049.2014.905714
PG 6
WC Chemistry, Applied; Food Science & Technology; Toxicology
SC Chemistry; Food Science & Technology; Toxicology
GA AJ9IT
UT WOS:000338023300002
PM 24646430
ER
PT S
AU Pezeshk, A
Sahiner, B
Zeng, RP
Wunderlich, A
Chen, WJ
Petrick, N
AF Pezeshk, Aria
Sahiner, Berkman
Zeng, Rongping
Wunderlich, Adam
Chen, Weijie
Petrick, Nicholas
BE Aylward, S
Hadjiiski, LM
TI Seamless Insertion of Real Pulmonary Nodules in Chest CT Exams
SO MEDICAL IMAGING 2014: COMPUTER-AIDED DIAGNOSIS
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging - Computer-Aided Diagnosis
CY FEB 18-20, 2014
CL San Diego, CA
SP SPIE, Modus Med Devices Inc, XIFIN, Inc, Ventana Med Syst Inc, Intrace Med
DE Reference library creation; Lesion insertion; Chest CT; Poisson image
editing
ID COMPUTER-AIDED DIAGNOSIS; FINITE-SAMPLE SIZE; LUNG NODULES; SIMULATION;
PERFORMANCE; LESIONS
AB The availability of large medical image datasets is critical in many applications such as training and testing of computer aided diagnosis (CAD) systems, evaluation of segmentation algorithms, and conducting perceptual studies. However, collection of large repositories of clinical images is hindered by the high cost and difficulties associated with both the accumulation of data and establishment of the ground truth. To address this problem, we are developing an image blending tool that allows users to modify or supplement existing datasets by seamlessly inserting a real lesion extracted from a source image into a different location on a target image. In this study we focus on the application of this tool to pulmonary nodules in chest CT exams. We minimize the impact of user skill on the perceived quality of the blended image by limiting user involvement to two simple steps: the user first draws a casual boundary around the nodule of interest in the source, and then selects the center of desired insertion area in the target. We demonstrate examples of the performance of the proposed system on samples taken from the Lung Image Database Consortium (LIDC) dataset, and compare the noise power spectrum (NPS) of blended nodules versus that of native nodules in simulated phantoms.
C1 [Pezeshk, Aria; Sahiner, Berkman; Zeng, Rongping; Wunderlich, Adam; Chen, Weijie; Petrick, Nicholas] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
RP Pezeshk, A (reprint author), WO62-4110,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM aria.pezeshk@fda.hhs.gov
NR 21
TC 0
Z9 0
U1 0
U2 1
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9828-1
J9 PROC SPIE
PY 2014
VL 9035
AR 90351K
DI 10.1117/12.2043786
PG 10
WC Engineering, Electrical & Electronic; Optics; Radiology, Nuclear
Medicine & Medical Imaging
SC Engineering; Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA7XB
UT WOS:000337842400052
ER
PT J
AU Nagarkatti, R
de Araujo, FF
Gupta, C
Debrabant, A
AF Nagarkatti, Rana
de Araujo, Fernanda Fortes
Gupta, Charu
Debrabant, Alain
TI Aptamer Based, Non-PCR, Non-Serological Detection of Chagas Disease
Biomarkers in Trypanosoma cruzi Infected Mice
SO PLOS NEGLECTED TROPICAL DISEASES
LA English
DT Article
ID EXCRETED-SECRETED ANTIGENS; DISCOVERY; SERUM; ANTIBODIES;
IDENTIFICATION; SERODIAGNOSIS; DIAGNOSIS; SELECTION; EFFICACY; TOOLS
AB Chagas disease affects about 5 million people across the world. The etiological agent, the intracellular parasite Trypanosoma cruzi (T. cruzi), can be diagnosed using microscopy, serology or PCR based assays. However, each of these methods has their limitations regarding sensitivity and specificity, and thus to complement these existing diagnostic methods, alternate assays need to be developed. It is well documented that several parasite proteins called T. cruzi Excreted Secreted Antigens (TESA), are released into the blood of an infected host. These circulating parasite antigens could thus be used as highly specific biomarkers of T. cruzi infection. In this study, we have demonstrated that, using a SELEx based approach, parasite specific ligands called aptamers, can be used to detect TESA in the plasma of T. cruzi infected mice. An Enzyme Linked Aptamer (ELA) assay, similar to ELISA, was developed using biotinylated aptamers to demonstrate that these RNA ligands could interact with parasite targets. Aptamer L44 (Apt-L44) showed significant and specific binding to TESA as well as T. cruzi trypomastigote extract and not to host proteins or proteins of Leishmania donovani, a related trypanosomatid parasite. Our result also demonstrated that the target of Apt-L44 is conserved in three different strains of T. cruzi. In mice infected with T. cruzi, Apt-L44 demonstrated a significantly higher level of binding compared to non-infected mice suggesting that it could detect a biomarker of T. cruzi infection. Additionally, Apt-L44 could detect these circulating biomarkers in both the acute phase, from 7 to 28 days post infection, and in the chronic phase, from 55 to 230 days post infection. Our results show that Apt-L44 could thus be used in a qualitative ELA assay to detect biomarkers of Chagas disease.
C1 [Nagarkatti, Rana; de Araujo, Fernanda Fortes; Gupta, Charu; Debrabant, Alain] US FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Nagarkatti, R (reprint author), US FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
EM alain.debrabant@fda.hhs.gov
OI Gupta, Charu/0000-0002-7437-6559
FU Food and Drug Administration
FX The funding for this study was obtained via intramural grants from the
Food and Drug Administration. The funders had no role in study design,
data collection and analysis, decision to publish, or preparation of the
manuscript.
NR 44
TC 8
Z9 8
U1 0
U2 15
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1935-2735
J9 PLOS NEGLECT TROP D
JI Plos Neglect. Trop. Dis.
PD JAN
PY 2014
VL 8
IS 1
AR e2650
DI 10.1371/journal.pntd.0002650
PG 10
WC Infectious Diseases; Parasitology; Tropical Medicine
SC Infectious Diseases; Parasitology; Tropical Medicine
GA AJ8SI
UT WOS:000337977300043
PM 24454974
ER
PT J
AU Bai, JPF
Fontana, RJ
Price, ND
Sangar, V
AF Bai, Jane P. F.
Fontana, Robert J.
Price, Nathan D.
Sangar, Vineet
TI Systems pharmacology modeling: an approach to improving drug safety
SO BIOPHARMACEUTICS & DRUG DISPOSITION
LA English
DT Review
DE systems biology; molecular pathways; molecular networks; mitochondria;
gene drug interaction; biomarkers; clinical phenotype; organ injury;
cellular phenotype
ID MITOCHONDRIAL PROTEIN-SYNTHESIS; HIV-INFECTED PATIENTS; FATTY-ACID
OXIDATION; INDUCED LIVER-INJURY; GROWTH-FACTOR-BETA; SKELETAL-MUSCLE;
VALPROIC ACID; GLOBAL RECONSTRUCTION; HEPATIC STEATOSIS; LACTIC-ACIDOSIS
AB Advances in systems biology in conjunction with the expansion in knowledge of drug effects and diseases present an unprecedented opportunity to extend traditional pharmacokinetic and pharmacodynamic modeling/analysis to conduct systems pharmacology modeling. Many drugs that cause liver injury and myopathies have been studied extensively. Mitochondrion-centric systems pharmacology modeling is important since drug toxicity across a large number of pharmacological classes converges to mitochondrial injury and death. Approaches to systems pharmacology modeling of drug effects need to consider drug exposure, organelle and cellular phenotypes across all key cell types of human organs, organ-specific clinical biomarkers/phenotypes, gene-drug interaction and immune responses. Systems modeling approaches, that leverage the knowledge base constructed from curating a selected list of drugs across a wide range of pharmacological classes, will provide a critically needed blueprint for making informed decisions to reduce the rate of attrition for drugs in development and increase the number of drugs with an acceptable benefit/risk ratio. Copyright (c) 2013 John Wiley & Sons, Ltd.
C1 [Bai, Jane P. F.] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Fontana, Robert J.] Univ Michigan, Dept Internal Med, Sch Med, Ann Arbor, MI 48109 USA.
[Price, Nathan D.; Sangar, Vineet] Inst Syst Biol, Seattle, WA 98109 USA.
RP Bai, JPF (reprint author), US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM jane.bai@fda.hhs.gov
NR 80
TC 9
Z9 9
U1 2
U2 11
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0142-2782
EI 1099-081X
J9 BIOPHARM DRUG DISPOS
JI Biopharm. Drug Dispos.
PD JAN
PY 2014
VL 35
IS 1
SI SI
BP 1
EP 14
DI 10.1002/bdd.1871
PG 14
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA AJ2WR
UT WOS:000337525700001
PM 24136298
ER
PT J
AU Kempic, A
AF Kempic, Annamarie
TI Inaugural Eric M. Blumberg Memorial Lecture
SO FOOD AND DRUG LAW JOURNAL
LA English
DT Article
C1 [Kempic, Annamarie] US FDA, Rockville, MD 20857 USA.
RP Kempic, A (reprint author), US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FOOD DRUG LAW INST
PI WASHINGTON
PA 1000 VERMONT AVE NW, SUITE 1200, WASHINGTON, DC 20005-4903 USA
SN 1064-590X
J9 FOOD DRUG LAW J
JI Food Drug Law J.
PY 2014
VL 69
IS 2
BP 137
EP 142
PG 6
WC Food Science & Technology; Law; Nutrition & Dietetics; Pharmacology &
Pharmacy
SC Food Science & Technology; Government & Law; Nutrition & Dietetics;
Pharmacology & Pharmacy
GA AJ2NX
UT WOS:000337495700001
PM 25163208
ER
PT J
AU Ning, BT
Su, ZQ
Mei, N
Hong, HX
Deng, HL
Shi, LM
Fuscoe, JC
Tolleson, WH
AF Ning, Baitang
Su, Zhenqiang
Mei, Nan
Hong, Huixiao
Deng, Helen
Shi, Leming
Fuscoe, James C.
Tolleson, William H.
TI Toxicogenomics and Cancer Susceptibility: Advances with Next-Generation
Sequencing
SO JOURNAL OF ENVIRONMENTAL SCIENCE AND HEALTH PART C-ENVIRONMENTAL
CARCINOGENESIS & ECOTOXICOLOGY REVIEWS
LA English
DT Review
DE Cancer; carcinogenesis; genomics; toxicogenomics; environmental
exposure; next generation sequencing
ID METASTATIC COLORECTAL-CANCER; CELL LUNG-CANCER;
METHYLENETETRAHYDROFOLATE REDUCTASE POLYMORPHISM; FAMILIAL ADENOMATOUS
POLYPOSIS; GENE-ENVIRONMENT INTERACTIONS; AFFECT DNA METHYLATION; ACUTE
MYELOID-LEUKEMIA; NIS-TRANSFORMED CELLS; BREAST-CANCER; HUMAN
TRANSCRIPTOME
AB The aim of this review is to comprehensively summarize the recent achievements in the field of toxicogenomics and cancer research regarding genetic-environmental interactions in carcinogenesis and detection of genetic aberrations in cancer genomes by next-generation sequencing technology. Cancer is primarily a genetic disease in which genetic factors and environmental stimuli interact to cause genetic and epigenetic aberrations in human cells. Mutations in the germline act as either high-penetrance alleles that strongly increase the risk of cancer development, or as low-penetrance alleles that mildly change an individual's susceptibility to cancer. Somatic mutations, resulting from either DNA damage induced by exposure to environmental mutagens or from spontaneous errors in DNA replication or repair are involved in the development or progression of the cancer. Induced or spontaneous changes in the epigenome may also drive carcinogenesis. Advances in next-generation sequencing technology provide us opportunities to accurately, economically, and rapidly identify genetic variants, somatic mutations, gene expression profiles, and epigenetic alterations with single-base resolution. Whole genome sequencing, whole exome sequencing, and RNA sequencing of paired cancer and adjacent normal tissue present a comprehensive picture of the cancer genome. These new findings should benefit public health by providing insights in understanding cancer biology, and in improving cancer diagnosis and therapy.
C1 [Ning, Baitang; Su, Zhenqiang; Mei, Nan; Hong, Huixiao; Shi, Leming; Fuscoe, James C.; Tolleson, William H.] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Deng, Helen] Arkansas Dept Hlth & Human Serv, Little Rock, AR USA.
[Shi, Leming] Fudan Univ, Sch Pharm, Ctr Pharmacogen, Shanghai 200433, Peoples R China.
RP Ning, BT (reprint author), Natl Ctr Toxicol Res, 3900 NCTR Rd,HFT100, Jefferson, AR 72079 USA.
EM baitang.ning@fda.hhs.gov
RI mei, nan/E-8915-2011
OI mei, nan/0000-0002-3501-9014
NR 224
TC 8
Z9 11
U1 2
U2 27
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 WALNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1059-0501
EI 1532-4095
J9 J ENVIRON SCI HEAL C
JI J. Environ. Sci. Health Pt. C-Environ. Carcinog. Ecotoxicol. Rev.
PY 2014
VL 32
IS 2
BP 121
EP 158
DI 10.1080/10590501.2014.907460
PG 38
WC Oncology; Environmental Sciences; Toxicology
SC Oncology; Environmental Sciences & Ecology; Toxicology
GA AJ4AB
UT WOS:000337610000002
PM 24875441
ER
PT J
AU He, WW
Wamer, W
Xia, QS
Yin, JJ
Fu, PP
AF He, Weiwei
Wamer, Wayne
Xia, Qingsu
Yin, Jun-jie
Fu, Peter P.
TI Enzyme-Like Activity of Nanomaterials
SO JOURNAL OF ENVIRONMENTAL SCIENCE AND HEALTH PART C-ENVIRONMENTAL
CARCINOGENESIS & ECOTOXICOLOGY REVIEWS
LA English
DT Review
DE Nanomaterial; peroxidase-like activity; oxidase-like activity;
catalase-like activity; superoxide dismutase-like activity; electron
spin resonance
ID PEROXIDASE-LIKE ACTIVITY; STABILIZED AU NANOCLUSTERS; IRON-OXIDE
NANOPARTICLES; CATALYTIC-ACTIVITY; HYDROGEN-PEROXIDE; COLORIMETRIC
DETECTION; GOLD NANOPARTICLES; LIPID-PEROXIDATION; GLUCOSE DETECTION;
PLATINUM NANOPARTICLES
AB Due to possessing an extremely small size and a large surface area per unit of volume, nanomaterials have specific characteristic physical, chemical, photochemical, and biological properties that are very useful in many new applications. Nanoparticles' catalytic activity and intrinsic ability in generating or scavenging reactive oxygen species in general can be used to mimic the catalytic activity of natural enzymes. Many nanoparticles with enzyme-like activities have been found, potentially capable of being applied for commercial uses, such as in biosensors, pharmaceutical processes, and the food industry. To date, a variety of nanoparticles, especially those formed from noble metals, have been determined to possess oxidase-like, peroxidase-like, catalase-like, and/or superoxide dismutase-like activity. The ability of nanoparticles to mimic enzymatic activity, especially peroxidase mimics, can be used in a variety of applications, such as detection of glucose in biological samples and waste water treatment. To study the enzyme-like activity of nanoparticles, the electron spin resonance method represents a critically important and convenient analytical approach for zero-time detection of the reactive substrates and products as well as for mechanism determination.
C1 [He, Weiwei] Xuchang Univ, Inst Surface Micro & Nano Mat, Key Lab Micronano Mat Energy Storage & Convers He, Xuchang, Henan, Peoples R China.
[He, Weiwei; Wamer, Wayne; Yin, Jun-jie] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Xia, Qingsu; Fu, Peter P.] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Yin, JJ (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM junjie.yin@fda.hhs.gov
RI Yin, Jun Jie /E-5619-2014
FU National Natural Science Foundation of China [201303153]
FX W. He thanks the National Natural Science Foundation of China (Grant No.
201303153) for support.
NR 99
TC 17
Z9 17
U1 20
U2 114
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 WALNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1059-0501
EI 1532-4095
J9 J ENVIRON SCI HEAL C
JI J. Environ. Sci. Health Pt. C-Environ. Carcinog. Ecotoxicol. Rev.
PY 2014
VL 32
IS 2
BP 186
EP 211
DI 10.1080/10590501.2014.907462
PG 26
WC Oncology; Environmental Sciences; Toxicology
SC Oncology; Environmental Sciences & Ecology; Toxicology
GA AJ4AB
UT WOS:000337610000004
PM 24875443
ER
PT J
AU Dankmeyer, JL
Fast, RL
Cote, CK
Worsham, PL
Fritz, D
Fisher, D
Kern, SJ
Merkel, T
Kirschning, CJ
Amemiya, K
AF Dankmeyer, Jennifer L.
Fast, Randy L.
Cote, Christopher K.
Worsham, Patricia L.
Fritz, David
Fisher, Diana
Kern, Steven J.
Merkel, Tod
Kirschning, Carsten J.
Amemiya, Kei
TI Multiple Roles of Myd88 in the Immune Response to the Plague F1-V
Vaccine and in Protection against an Aerosol Challenge of Yersinia
pestis CO92 in Mice
SO JOURNAL OF IMMUNOLOGY RESEARCH
LA English
DT Article
ID FUSION PROTEIN VACCINE; RECOMBINANT V-ANTIGEN; TOLL-LIKE RECEPTOR-2;
PNEUMONIC PLAGUE; LEGIONELLA-PNEUMOPHILA; NALP3 INFLAMMASOME; CUTTING
EDGE; MONOCLONAL-ANTIBODIES; PHAGOSOME MATURATION; ACTIVE IMMUNIZATION
AB The current candidate vaccine against Yersinia pestis infection consists of two subunit proteins: the capsule protein or F1 protein and the low calcium response V protein or V-antigen. Little is known of the recognition of the vaccine by the host's innate immune system and how it affects the acquired immune response to the vaccine. Thus, we vaccinated Toll-like receptor (Tlr) 2, 4, and 2/4-double deficient, as well as signal adaptor protein Myd88-deficient mice. We found that Tlr4 and Myd88 appeared to be required for an optimal immune response to the F1-V vaccine but not Tlr2 when compared to wild-type mice. However, there was a difference between the requirement for Tlr4 and MyD88 in vaccinated animals. When F1-V vaccinated Tlr4 mutant (lipopolysaccharide tolerant) and Myd88-deficient mice were challenged by aerosol with Y. pestis CO92, all but one Tlr4 mutant mice survived the challenge, but no vaccinated Myd88-deficient mice survived the challenge. Spleens from these latter nonsurviving mice showed that Y. pestis was not cleared from the infected mice. Our results suggest that MyD88 appears to be important for both an optimal immune response to F1-V and in protection against a lethal challenge of Y. pestis CO92 in F1-V vaccinated mice.
C1 [Dankmeyer, Jennifer L.; Fast, Randy L.; Cote, Christopher K.; Worsham, Patricia L.; Fritz, David; Fisher, Diana; Kern, Steven J.; Amemiya, Kei] US Army, Med Res Inst Infect Dis, Frederick, MD 21703 USA.
[Merkel, Tod] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Kirschning, Carsten J.] Univ Duisburg Essen, Inst Med Microbiol, Essen, Germany.
RP Amemiya, K (reprint author), US Army, Med Res Inst Infect Dis, Frederick, MD 21703 USA.
EM kei.amemiya@us.army.mil
FU Joint Science and TechnologyOffice/Defense Threat Reduction Agency
[1.1A0018 07_RD_B]
FX The authors thank Steven Tobery and Anthony Bassett for their excellent
technical assistance throughout this study. The authors thank Sarah
Cohen for technical assistance in photomicroscopy. We also thank Stephen
Little for critical reading of this paper. The authors thank the Joint
Science and TechnologyOffice/Defense Threat Reduction Agency for support
for this research (Project no. 1.1A0018 07_RD_B). Opinions,
interpretations, conclusions, and recommendations are those of the
authors and are not necessarily endorsed by the U.S. Army.
NR 61
TC 0
Z9 0
U1 0
U2 4
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 2314-8861
EI 2314-7156
J9 J IMMUNOL RES
JI J Immunol. Res.
PY 2014
AR 341820
DI 10.1155/2014/341820
PG 13
WC Immunology
SC Immunology
GA AJ1SS
UT WOS:000337436600001
ER
PT S
AU Gallas, BD
Cheng, WC
Gavrielides, MA
Ivansky, A
Keay, T
Wunderlich, A
Hipp, J
Hewitt, SM
AF Gallas, Brandon D.
Cheng, Wei-Chung
Gavrielides, Marios A.
Ivansky, Adam
Keay, Tyler
Wunderlich, Adam
Hipp, Jason
Hewitt, Stephen M.
BE MelloThoms, CR
Kupinski, MA
TI eeDAP: An Evaluation Environment for Digital and Analog Pathology
SO MEDICAL IMAGING 2014: IMAGE PERCEPTION, OBSERVER PERFORMANCE, AND
TECHNOLOGY ASSESSMENT
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging - Image Perception, Observer Performance,
and Technology Assessment
CY FEB 16-17, 2014
CL San Diego, CA
SP SPIE, Modus Med Devices Inc, XIFIN Inc, Ventana Med Syst Inc, Intrace Med
DE Digital Pathology; Whole Slide Imaging; Reader Studies; Technology
Evaluation
AB Purpose: The purpose of this work is to present a platform for designing and executing studies that compare pathologists interpreting histopathology of whole slide images (WSI) on a computer display to pathologists interpreting glass slides on an optical microscope.
Methods: Here we present eeDAP, an evaluation environment for digital and analog pathology. The key element in eeDAP is the registration of the WSI to the glass slide. Registration is accomplished through computer control of the microscope stage and a camera mounted on the microscope that acquires images of the real time microscope view. Registration allows for the evaluation of the same regions of interest (ROIs) in both domains. This can reduce or eliminate disagreements that arise from pathologists interpreting different areas and focuses the comparison on image quality.
Results: We reduced the pathologist interpretation area from an entire glass slide (approximate to 10-30 mm)(2) to small ROIs < (50 um)(2). We also made possible the evaluation of individual cells.
Conclusions: We summarize eeDAP's software and hardware and provide calculations and corresponding images of the microscope field of view and the ROIs extracted from the WSIs. These calculations help provide a sense of eeDAP's functionality and operating principles, while the images provide a sense of the look and feel of studies that can be conducted in the digital and analog domains. The eeDAP software can be downloaded from code. google.com (project: eeDAP) as Matlab source or as a precompiled stand-alone license-free application.
C1 [Gallas, Brandon D.; Cheng, Wei-Chung; Gavrielides, Marios A.; Ivansky, Adam; Keay, Tyler; Wunderlich, Adam] US FDA, Div Imaging & Appl Math, OSEL, CDRH, Silver Spring, MD 20993 USA.
[Hipp, Jason; Hewitt, Stephen M.] Natl Inst Hlth, Natl Canc Inst, Ctr Canc Res, Pathol Lab, Bethesda, MD USA.
RP Gallas, BD (reprint author), US FDA, Div Imaging & Appl Math, OSEL, CDRH, Silver Spring, MD 20993 USA.
EM brandon.gallas@fda.hhs.gov
OI Gallas, Brandon/0000-0001-7332-1620; Hewitt, Stephen/0000-0001-8283-1788
FU U. S. Food and Drug Administration (FDA/ CDRH)
FX This research project was partially funded through a Critical Path grant
from the U. S. Food and Drug Administration (FDA/ CDRH). We would like
to acknowledge Catherine Conway, formerly at the NIH, for her active
involvement in the project, including the preparation and annotation of
slides and training materials.; .
NR 9
TC 0
Z9 0
U1 0
U2 2
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9830-4
J9 PROC SPIE
PY 2014
VL 9037
AR UNSP 903709
DI 10.1117/12.2044443
PG 12
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA7IZ
UT WOS:000337585600008
ER
PT S
AU He, X
Samuelson, F
Zeng, RP
Sahiner, B
AF He, Xin
Samuelson, Frank
Zeng, Rongping
Sahiner, Berkman
BE MelloThoms, CR
Kupinski, MA
TI Discover Common Properties of Human Observers' Visual Search and
Mathematical Observers' Scanning PART I. Theory and Conjecture
SO MEDICAL IMAGING 2014: IMAGE PERCEPTION, OBSERVER PERFORMANCE, AND
TECHNOLOGY ASSESSMENT
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging - Image Perception, Observer Performance,
and Technology Assessment
CY FEB 16-17, 2014
CL San Diego, CA
SP SPIE, Modus Med Devices Inc, XIFIN Inc, Ventana Med Syst Inc, Intrace Med
DE visual search; effective set size; ROC curve; search performance;
power-law-shaped ROC curve; uncertainty model; decision theory;
normative approach; equivalent ideal observer; rational observer
ID SIGNAL-DETECTION; LUMINANCE INCREMENT; SET-SIZE; MODEL; DETECTABILITY;
UNCERTAINTY; BACKGROUNDS; ATTENTION; STIMULUS; PERFORMANCE
AB There is a lack of consensus in measuring observer performance in search tasks. To pursue a consensus, we set our goal as to obtain metrics that are practical, meaningful and objective. We consider a metric practical if it can be implemented to measure human and computer observers' performance. To be meaningful, we propose to discover metrics that reflect the intrinsic properties of search observers. Thus, the meaningfulness of the metrics is ensured by the discovered properties being intrinsic. We set our success criteria as that the discovered properties can make verifiable predications. Thus the objectivity of the metrics is ensured by their prediction ability. The goal of this work is to present a theory and a conjecture toward two intrinsic properties of search observers: rationality in classification as measured by the location-known-exactly ROC curve and location uncertainty as measured by the effective set size. These two properties are used to develop search models in both single-response and free-response search tasks. To confirm whether these properties are "intrinsic", in a companion paper, we investigate their ability in predicting search performance of both human and scanning channelized Hotelling observers.
C1 [He, Xin; Samuelson, Frank; Zeng, Rongping; Sahiner, Berkman] US FDA, Rockville, MD 20857 USA.
RP He, X (reprint author), US FDA, Rockville, MD 20857 USA.
NR 38
TC 0
Z9 0
U1 0
U2 2
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9830-4
J9 PROC SPIE
PY 2014
VL 9037
AR 903712
DI 10.1117/12.2043318
PG 11
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA7IZ
UT WOS:000337585600036
ER
PT S
AU He, X
Samuelson, F
Sahiner, B
AF He, Xin
Samuelson, Frank
Sahiner, Berkman
BE MelloThoms, CR
Kupinski, MA
TI Discover Common Properties of Human Observers' Visual Search and
Mathematical Observers' Scanning PART II. Empirical studies using human
and model Observers
SO MEDICAL IMAGING 2014: IMAGE PERCEPTION, OBSERVER PERFORMANCE, AND
TECHNOLOGY ASSESSMENT
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging - Image Perception, Observer Performance,
and Technology Assessment
CY FEB 16-17, 2014
CL San Diego, CA
SP SPIE, Modus Med Devices Inc, XIFIN Inc, Ventana Med Syst Inc, Intrace Med
DE search; search performance; power-law-shaped ROC curve; uncertainty
model of visual detection; decision theory; normative approach;
equivalent ideal observer; rational observer; science as falsification
AB In a companion paper, we proposed the well-delineated-object conjecture to describe a rational observer's behavior in a search task. We discovered two intrinsic properties to describe the performance of rational search observers: rationality in classification and location uncertainty. We proposed to use the location-known-exactly (LKE) ROC curve and the effective number of well-delineated objects or effective set size (M*) to quantify these two properties. The purpose of this paper is to develop an experimental framework to test the conjecture that was put forward in the companion paper. In particular, for each observer, we designed experiments to measure LIKE ROC curve and M*, which were then used to predict the same observer's performance in other search tasks. The predictions were then compared to the experimentally measured observer performance. Our results indicate that modeling the search performance using the LIKE ROC curve and M* leads to successful predictions in most cases.
C1 [He, Xin; Samuelson, Frank; Sahiner, Berkman] US FDA, Rockville, MD 20857 USA.
RP He, X (reprint author), US FDA, Rockville, MD 20857 USA.
NR 5
TC 0
Z9 0
U1 0
U2 0
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9830-4
J9 PROC SPIE
PY 2014
VL 9037
AR 903713
DI 10.1117/12.2043319
PG 10
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA7IZ
UT WOS:000337585600037
ER
PT S
AU Park, S
Zhang, GZ
Zeng, RP
Myers, KJ
AF Park, Subok
Zhang, George Z.
Zeng, Rongping
Myers, Kyle J.
BE MelloThoms, CR
Kupinski, MA
TI Comparing observer models and feature selection methods for a task-based
statistical assessment of digital breast tomsynthesis in reconstruction
space
SO MEDICAL IMAGING 2014: IMAGE PERCEPTION, OBSERVER PERFORMANCE, AND
TECHNOLOGY ASSESSMENT
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging - Image Perception, Observer Performance,
and Technology Assessment
CY FEB 16-17, 2014
CL San Diego, CA
SP SPIE, Modus Med Devices Inc, XIFIN Inc, Ventana Med Syst Inc, Intrace Med
DE model observer; technology assessment; channelized Hotelling observer;
partial least squares; Laguerre Gauss; digital breast tomosynthesis;
task-based assessment of image quality
ID TOMOSYNTHESIS; PERFORMANCE; PROJECTION
AB A task-based assessment of image quality(1) for digital breast tomosynthesis (DBT) can be done in either the projected or reconstructed data space. As the choice of observer models and feature selection methods can vary depending on the type of task and data statistics, we previously investigated the performance of two channelized-Hotelling observer models in conjunction with 2D Laguerre-Gauss (LG) and two implementations of partial least squares (PLS) channels along with that of the Hotelling observer in binary detection tasks involving DBT projections.(2, 3) The difference in these observers lies in how the spatial correlation in DBT angular projections is incorporated in the observer's strategy to perform the given task. In the current work, we extend our method to the reconstructed data space of DBT. We investigate how various model observers including the aforementioned compare for performing the binary detection of a spherical signal embedded in structured breast phantoms with the use of DBT slices reconstructed via filtered back projection. We explore how well the model observers incorporate the spatial correlation between different numbers of reconstructed DBT slices while varying the number of projections. For this, relatively small and large scan angles (24 degrees and 96 degrees) are used for comparison. Our results indicate that 1) given a particular scan angle, the number of projections needed to achieve the best performance for each observer is similar across all observer/channel combinations, i.e., N-p = 25 for scan angle 96 degrees and N-p = 13 for scan angle 24 degrees, and 2) given these sufficient numbers of projections, the number of slices for each observer to achieve the best performance differs depending on the channel/observer types, which is more pronounced in the narrow scan angle case.
C1 [Park, Subok; Zhang, George Z.; Zeng, Rongping; Myers, Kyle J.] OSEL, CDRH, Div Imaging & Appl Math, 10903 New Hampshire Ave,Bldg 62,Rm 3109, Silver Spring, MD 20993 USA.
RP Park, S (reprint author), OSEL, CDRH, Div Imaging & Appl Math, 10903 New Hampshire Ave,Bldg 62,Rm 3109, Silver Spring, MD 20993 USA.
EM subok.park@fda.hhs.gov
NR 18
TC 3
Z9 3
U1 0
U2 3
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9830-4
J9 PROC SPIE
PY 2014
VL 9037
AR UNSP 90370M
DI 10.1117/12.2043598
PG 11
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA7IZ
UT WOS:000337585600020
ER
PT S
AU Wunderlich, A
Goossens, B
AF Wunderlich, Adam
Goossens, Bart
BE MelloThoms, CR
Kupinski, MA
TI Nonparametric EROC analysis for observer performance evaluation on joint
detection and estimation tasks
SO MEDICAL IMAGING 2014: IMAGE PERCEPTION, OBSERVER PERFORMANCE, AND
TECHNOLOGY ASSESSMENT
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging - Image Perception, Observer Performance,
and Technology Assessment
CY FEB 16-17, 2014
CL San Diego, CA
SP SPIE, Modus Med Devices Inc, XIFIN Inc, Ventana Med Syst Inc, Intrace Med
ID CURVES; AREAS
AB The majority of the literature on task-based image quality assessment has focused on lesion detection tasks, using the receiver operating characteristic (ROC) curve, or related variants, to measure performance. However, since many clinical image evaluation tasks involve both detection and estimation (e. g., estimation of kidney stone composition, estimation of tumor size), there is a growing interest in performance evaluation for joint detection and estimation tasks. To evaluate observer performance on such tasks, Clarkson introduced the estimation ROC (EROC) curve, and the area under the EROC curve as a summary figure of merit. In the present work, we propose nonparametric estimators for practical EROC analysis from experimental data, including estimators for the area under the EROC curve and its variance. The estimators are illustrated with a practical example comparing MRI images reconstructed from different k-space sampling trajectories.
C1 [Wunderlich, Adam] US FDA, Div Imaging & Appl Math, OSEL, CDRH, Rockville, MD 20857 USA.
[Goossens, Bart] Univ Ghent, TELIN IPI iMinds, Dept Telecomm & Inform Proc, B-9000 Ghent, Belgium.
RP Wunderlich, A (reprint author), US FDA, Div Imaging & Appl Math, OSEL, CDRH, Rockville, MD 20857 USA.
EM adam.wunderlich@fda.hhs.gov; bart.goossens@telin.ugent.be
NR 11
TC 0
Z9 0
U1 0
U2 1
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9830-4
J9 PROC SPIE
PY 2014
VL 9037
AR UNSP 90370F
DI 10.1117/12.2043105
PG 7
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA7IZ
UT WOS:000337585600013
ER
PT S
AU Hammer, DX
Lozzi, A
Abliz, E
Greenbaum, N
Turner, KP
Pfefer, TJ
Agrawal, A
Krauthamer, V
Welle, CG
AF Hammer, Daniel X.
Lozzi, Andrea
Abliz, Erkinay
Greenbaum, Noah
Turner, Kevin P.
Pfefer, T. Joshua
Agrawal, Anant
Krauthamer, Victor
Welle, Cristin G.
BE Hirschberg, H
Madsen, SJ
Jansen, ED
Luo, Q
Mohanty, SK
Thakor, NV
TI Optical coherence microscopy of mouse cortical vasculature surrounding
implanted electrodes
SO OPTICAL TECHNIQUES IN NEUROSURGERY, NEUROPHOTONICS, AND OPTOGENETICS
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Optical Techniques in Neurosurgery, Neurophotonics, and
Optogenetics
CY FEB 01-04, 2014
CL San Francisco, CA
SP SPIE
DE Optical coherence tomography; angiography; microscopy; neural electrode;
mouse; vasculature
ID ANGIOGRAPHY; TETRAPLEGIA; TOMOGRAPHY; HUMANS; CORTEX
AB Optical coherence microscopy (OCM) provides real-time, in-vivo, three-dimensional, isotropic micron-resolution structural and functional characterization of tissue, cells, and other biological targets. Optical coherence angiography (OCA) also provides visualization and quantification of vascular flow via speckle-based or phase-resolved techniques. Performance assessment of neuroprosthetic systems, which allow direct thought control of limb prostheses, may be aided by OCA. In particular, there is a need to examine the underlying mechanisms of chronic functional degradation of implanted electrodes. Angiogenesis, capillary network remodeling, and changes in flow velocity are potential indicators of tissue changes that may be associated with waning electrode performance. The overall goal of this investigation is to quantify longitudinal changes in vascular morphology and capillary flow around neural electrodes chronically implanted in mice. We built a 1315-nm OCM system to image vessels in neocortical tissue in a cohort of mice. An optical window was implanted on the skull over the primary motor cortex above a penetrating shank-style microelectrode array. The mice were imaged bi-weekly to generate vascular maps of the region surrounding the implanted microelectrode array. Acute effects of window and electrode implantation included vessel dilation and profusion of vessels in the superficial layer of the cortex (0-200 mu m). In deeper layers surrounding the electrode, no qualitative differences were seen in this early phase. These measurements establish a baseline vascular tissue response from the cortical window preparation and lay the ground work for future longitudinal studies to test the hypothesis that vascular changes will be associated with chronic electrode degradation.
C1 [Hammer, Daniel X.; Lozzi, Andrea; Abliz, Erkinay; Greenbaum, Noah; Turner, Kevin P.; Pfefer, T. Joshua; Agrawal, Anant; Krauthamer, Victor; Welle, Cristin G.] US FDA, Div Phys, Off Sci & Engn Lab, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Hammer, DX (reprint author), US FDA, Div Phys, Off Sci & Engn Lab, Ctr Devices & Radiol Hlth, 10913 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM daniel.hammer@fda.hhs.gov
OI Welle, Cristin/0000-0001-8735-0983
NR 18
TC 0
Z9 0
U1 0
U2 3
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9841-0
J9 PROC SPIE
PY 2014
VL 8928
AR 892804
DI 10.1117/12.2040972
PG 9
WC Microscopy; Optics; Radiology, Nuclear Medicine & Medical Imaging;
Spectroscopy
SC Microscopy; Optics; Radiology, Nuclear Medicine & Medical Imaging;
Spectroscopy
GA BA7IR
UT WOS:000337576500001
ER
PT J
AU Zhang, Q
Davis, KJ
Hoffmann, D
Vaidya, VS
Brown, RP
Goering, PL
AF Zhang, Qin
Davis, Kelly J.
Hoffmann, Dana
Vaidya, Vishal S.
Brown, Ronald P.
Goering, Peter L.
TI Urinary biomarkers track the progression of nephropathy in hypertensive
and obese rats
SO BIOMARKERS IN MEDICINE
LA English
DT Article
DE chronic kidney disease; hypertension; obesity; urine biomarker
ID ACUTE KIDNEY INJURY; CARDIAC-SURGERY; RENAL-DISEASE; KOLETSKY RAT;
CYSTATIN C; NEPHROTOXICITY; ASSOCIATION; MOLECULE-1; EXCRETION; RECOVERY
AB Aims:To determine whether urinary biomarkers of acute kidney injury can be used to monitor the progression of chronic kidney injury in a rat model of hypertension and obesity. Materials & methods: A suite of novel urinary biomarkers were used to track the progression of kidney damage in SHROB and SHR-lean rats. Results: Urinary albumin, NAG, clusterin, osteopontin, RPA-1 and fibrinogen levels were significantly elevated over time and were closely associated with the severity of histopathologically determined nephropathy in both SHROB and SHR-lean rats. Conclusion: Urinary biomarkers, such as albumin, fibrinogen, NAG, clusterin, RPA-1 and osteopontin, may serve as useful tools to track the progression of chronic kidney disease associated with hypertension and obesity.
C1 [Zhang, Qin; Brown, Ronald P.; Goering, Peter L.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Davis, Kelly J.] US FDA, Natl Ctr Toxicol Res, Toxicol Pathol Associates, Jefferson, AR 72079 USA.
[Hoffmann, Dana; Vaidya, Vishal S.] Brigham & Womens Hosp, Dept Med, Boston, MA 02115 USA.
[Hoffmann, Dana; Vaidya, Vishal S.] Harvard Univ, Sch Med, Boston, MA 02115 USA.
RP Goering, PL (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM peter.goering@fda.hhs.gov
FU Office of Chief Scientist Challenge Grant
FX This work was supported by funds provided by an Office of Chief
Scientist Challenge Grant, a program administered by the US FDA, Office
of the Commissioner. The authors have no other relevant affiliations or
financial involvement with any organization or entity with a financial
interest in or financial conflict with the subject matter or materials
discussed in the manuscript apart from those disclosed.
NR 36
TC 12
Z9 12
U1 1
U2 4
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1752-0363
EI 1752-0371
J9 BIOMARK MED
JI Biomark. Med.
PD JAN
PY 2014
VL 8
IS 1
BP 85
EP 94
DI 10.2217/bmm.13.106
PG 10
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA AI9BF
UT WOS:000337220700020
PM 24325231
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI The History of Intraocular Lenses
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 9
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 3
EP 6
PG 4
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800001
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI The Materials
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID METHACRYLATE) INTRAOCULAR LENSES
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 6
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 7
EP 13
PG 7
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800002
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Rigid Intraocular Lenses of the Past
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 15
EP 16
PG 2
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800003
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Soft Intraocular Lenses of the Past
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 5
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 17
EP 22
PG 6
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800004
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Currently Used Lenses
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID SILICONE INTRAOCULAR LENSES; YAG LASER PHOTODISRUPTION; NEODYMIUM
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 5
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 23
EP 26
PG 4
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800005
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Monofocal Intraocular Lenses
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID HIGHER-ORDER ABERRATIONS; CORNEAL; DECENTRATION
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 9
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 27
EP 38
PG 12
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800006
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Toric Intraocular Lenses
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID CORNEAL INCISION; ASTIGMATISM; PHACOEMULSIFICATION; LOCATION
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 10
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 39
EP 52
PG 14
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800007
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Multifocal Intraocular Lenses
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID AGE-RELATED MACULOPATHY; CONTRAST SENSITIVITY; VISUAL-ACUITY;
BLUE-LIGHT; MACULAR DEGENERATION; SPHERICAL-ABERRATION;
CATARACT-SURGERY; RETINAL DISEASE; SEE PROJECT; LOW-VISION
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 45
TC 0
Z9 0
U1 1
U2 1
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 53
EP 72
PG 20
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800008
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Accommodative Intraocular Lenses
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] US FDA, LASIK Study, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 6
TC 0
Z9 0
U1 0
U2 1
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 73
EP 78
PG 6
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800009
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Mix and Match
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Tulane Univ, Sch Med, New Orleans, LA 70112 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 2
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 79
EP 81
PG 3
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800010
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Refractive Cataract Surgery
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
Tulane Univ, Sch Med, New Orleans, LA 70112 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 7
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 83
EP 89
PG 7
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800011
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Intraocular Lens Exchange
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
Tulane Univ, Sch Med, New Orleans, LA 70112 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 3
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 91
EP 94
PG 4
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800012
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Correction of Astigmatism
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID TORIC INTRAOCULAR-LENS; CATARACT-SURGERY; CORNEAL ASTIGMATISM;
IMPLANTATION; OUTCOMES
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 7
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 95
EP 97
PG 3
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800013
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Vision Quality
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID MULTIFOCAL INTRAOCULAR LENSES; CONTRAST SENSITIVITY;
SPHERICAL-ABERRATION; CATARACT-SURGERY; VISUAL-ACUITY; GLAUCOMA; EYES;
ANISEIKONIA; POSITION; DISEASE
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 32
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 99
EP 118
PG 20
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800014
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Viscoelastic Substances
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID RETENTION; HEALON
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 7
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 119
EP 124
PG 6
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800015
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Instruments Used for Intraocular Lens Insertion
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 125
EP 133
PG 9
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800016
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Injectors and Implantation of Foldable Intraocular Lenses
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 2
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 135
EP 153
PG 19
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800017
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Implantation of an Intraocular Lens With Capsular Rupture
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 6
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 155
EP 159
PG 5
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800018
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Tear or Damage of the Intraocular Lens
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 2
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 161
EP 162
PG 2
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800019
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Irrigation/Aspiration Post Implantation
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 4
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 163
EP 166
PG 4
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800020
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Closure of the Incision
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 167
EP 170
PG 4
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800021
ER
PT B
AU Buratto, L
Brint, SF
Boccuzzi, D
AF Buratto, Lucio
Brint, Stephen F.
Boccuzzi, Domenico
BA Buratto, L
Brint, SF
Boccuzzi, D
BF Buratto, L
Brint, SF
Boccuzzi, D
TI Drugs and Fluids for Intraocular Use
SO CATARACT SURGERY AND INTRAOCULAR LENSES
LA English
DT Article; Book Chapter
ID RANDOMIZED CLINICAL-TRIAL; BALANCED SALT-SOLUTION; BLOOD-AQUEOUS
BARRIER; CATARACT-SURGERY; IRRIGATING SOLUTIONS; CORNEAL ENDOTHELIUM;
POSTOPERATIVE ENDOPHTHALMITIS; PROPHYLAXIS; GLUTATHIONE; ESCRS
C1 [Buratto, Lucio] US FDA, Rockville, MD 20857 USA.
[Brint, Stephen F.] Amer Coll Surg, Chicago, IL USA.
[Boccuzzi, Domenico] Clin Mediterranea, Naples, Italy.
[Boccuzzi, Domenico] Comboni Ctr, Sogakope, Ghana.
NR 19
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-604-9
PY 2014
BP 171
EP 173
PG 3
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BA3PP
UT WOS:000334564800022
ER
PT J
AU Hoffmann, M
Zhao, SH
Pettengill, J
Luo, Y
Monday, SR
Abbott, J
Ayers, SL
Cinar, HN
Muruvanda, T
Li, C
Allard, MW
Whichard, J
Meng, JH
Brown, EW
McDermott, PF
AF Hoffmann, Maria
Zhao, Shaohua
Pettengill, James
Luo, Yan
Monday, Steven R.
Abbott, Jason
Ayers, Sherry L.
Cinar, Hediye N.
Muruvanda, Tim
Li, Cong
Allard, Marc W.
Whichard, Jean
Meng, Jianghong
Brown, Eric W.
McDermott, Patrick F.
TI Comparative Genomic Analysis and Virulence Differences in Closely
Related Salmonella enterica Serotype Heidelberg Isolates from Humans,
Retail Meats, and Animals
SO GENOME BIOLOGY AND EVOLUTION
LA English
DT Article
DE outbreak; antimicrobial resistance; plasmid; SNP analysis; trace-back
ID IV SECRETION SYSTEMS; MULTILOCUS GENOTYPE DATA; SEROVAR HEIDELBERG;
ESCHERICHIA-COLI; UNITED-STATES; POPULATION-STRUCTURE;
CAENORHABDITIS-ELEGANS; PLASMID; DIVERSITY; EVOLUTION
AB Salmonella enterica subsp. enterica serovar Heidelberg (S. Heidelberg) is one of the top serovars causing human salmonellosis. Recently, an antibiotic-resistant strain of this serovar was implicated in a large 2011 multistate outbreak resulting from consumption of contaminated ground turkey that involved 136 confirmed cases, with one death. In this study, we assessed the evolutionary diversity of 44 S. Heidelberg isolates using whole-genome sequencing (WGS) generated by the 454 GS FLX (Roche) platform. The isolates, including 30 with nearly indistinguishable (one band difference) Xbal pulsed-field gel electrophoresis patterns (JF6X01.0032, JF6X01.0058), were collected from various sources between 1982 and 2011 and included nine isolates associated with the 2011 outbreak. Additionally, we determined the complete sequence for the chromosome and three plasmids from a clinical isolate associated with the 2011 outbreak using the Pacific Biosciences (PacBio) system. Using single-nucleotide polymorphism (SNP) analyses, we were able to distinguish highly clonal isolates, including strains isolated at different times in the same year. The isolates from the recent 2011 outbreak clustered together with a mean SNP variation of only 17 SNPs. The S. Heidelberg isolates carried a variety of phages, such as prophage P22, P4, lambda-like prophage Gifsy-2, and the P2-like phage which carries the sopE1 gene, virulence genes including 62 pathogenicity, and 13 fimbrial markers and resistance plasmids of the incompatibility (Inc)I1, IncA/C, and IncHI2 groups. Twenty-one strains contained an IncX plasmid carrying a type IV secretion system. On the basis of the recent and historical isolates used in this study, our results demonstrated that, in addition to providing detailed genetic information for the isolates, WGS can identify SNP targets that can be utilized for differentiating highly clonal S. Heidelberg isolates.
C1 [Hoffmann, Maria; Zhao, Shaohua; Abbott, Jason; Ayers, Sherry L.; Li, Cong; McDermott, Patrick F.] US FDA, Div Anim & Food Microbiol, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
[Hoffmann, Maria; Meng, Jianghong] Univ Maryland, Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
[Pettengill, James; Luo, Yan] US FDA, Div Publ Hlth & Biostat, Off Food Def Commun & Emergency Response, Ctr Food Safety & Nutr, College Pk, MD USA.
[Monday, Steven R.; Muruvanda, Tim; Allard, Marc W.; Brown, Eric W.] US FDA, Div Microbiol, Off Regulatory Sci, Ctr Food Safety & Nutr, College Pk, MD USA.
[Cinar, Hediye N.] US FDA, Div Virulence Assessment, Off Appl Res & Safety Assessment, Ctr Food Safety & Nutr, Laurel, MD USA.
[Whichard, Jean] Ctr Dis Control & Prevent, Div Foodborne Waterborne & Environm Dis, Atlanta, GA USA.
RP Hoffmann, M (reprint author), US FDA, Div Anim & Food Microbiol, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
EM maria.hoffman@fda.hhs.gov; Patrick.McDermott@fda.hhs.gov
FU Center for Veterinary Medicine; Center for Food Safety and Applied
Nutrition at the US Food and Drug Administration; Joint Institute for
Food Safety and Applied Nutrition (JIFSAN), University of Maryland,
College Park, MD
FX The authors thank Ruth Timme for submission of the draft genomes to NCBI
and the NCBI rapid annotation pipeline team, Bill Klimke, Dmitry
Dernovoy, Stacy Ciufo, Kathleen O'Neill, Azat Badretdin, and Tatiana
Tatusova, for key genome annotation service. Further they thank Yuansha
Chen for sharing the CVM/DAFM database of antimicrobial resistance
genes. No human subjects or animals were used in this study. All authors
have read the manuscript and agreed to its contents, subject matter, and
author line order. These data are novel and have not been previously
published elsewhere. Disclosure forms provided by the authors will be
available with the full text of this article. This work was supported by
the Center for Veterinary Medicine and the Center for Food Safety and
Applied Nutrition at the US Food and Drug Administration and by an
appointment of MH by the Joint Institute for Food Safety and Applied
Nutrition (JIFSAN), University of Maryland, College Park, MD.
NR 64
TC 22
Z9 22
U1 0
U2 28
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1759-6653
J9 GENOME BIOL EVOL
JI Genome Biol. Evol.
PY 2014
VL 6
IS 5
BP 1046
EP 1068
DI 10.1093/gbe/evu079
PG 23
WC Evolutionary Biology; Genetics & Heredity
SC Evolutionary Biology; Genetics & Heredity
GA AI7BY
UT WOS:000337037100002
PM 24732280
ER
PT B
AU Goren, MJ
Plaut, VC
AF Goren, Matt J.
Plaut, Victoria C.
BE Thomas, KM
Plaut, VC
Tran, NM
TI Racial Identity Denial and its Discontents Implications for Individuals
and Organizations
SO DIVERSITY IDEOLOGIES IN ORGANIZATIONS
SE Series in Applied Psychology
LA English
DT Article; Book Chapter
ID DOMINANT-GROUP IDENTITY; COLOR-BLINDNESS; WHITE PRIVILEGE; INTERGROUP
RELATIONS; GROUP IDENTIFICATION; ETHNIC-IDENTITY; SELF-ESTEEM;
DIVERSITY; ATTITUDES; PREJUDICE
C1 [Goren, Matt J.] Univ Calif Berkeley, Social Personal Psychol Program, Berkeley, CA 94720 USA.
[Goren, Matt J.] US FDA, Rockville, MD 20857 USA.
[Plaut, Victoria C.] Berkeley Sch Law, Berkeley, CA USA.
[Plaut, Victoria C.] Berkeley Sch Law, Culture Divers & Intergrp Relat Lab, Berkeley, CA USA.
[Plaut, Victoria C.] Univ Calif Berkeley, Dept Psychol, Berkeley, CA 94720 USA.
RP Goren, MJ (reprint author), Univ Calif Berkeley, Social Personal Psychol Program, Berkeley, CA 94720 USA.
NR 111
TC 0
Z9 0
U1 1
U2 2
PU ROUTLEDGE
PI LONDON
PA 11 NEW FETTER LANE, LONDON EC4P 4EE, ENGLAND
BN 978-1-84872-966-7; 978-1-315-85218-8; 978-1-84872-965-0
J9 SER APPL PSYCHOL
PY 2014
BP 43
EP 66
PG 24
WC Industrial Relations & Labor; Psychology, Applied
SC Business & Economics; Psychology
GA BA2HW
UT WOS:000333423200005
ER
PT S
AU Dobrovolsky, VN
Cao, XF
Bhalli, JA
Heflich, RH
AF Dobrovolsky, Vasily N.
Cao, Xuefei
Bhalli, Javed A.
Heflich, Robert H.
BE Keohavong, P
Grant, SG
TI Detection of Pig-a Mutant Erythrocytes in the Peripheral Blood of Rats
and Mice
SO MOLECULAR TOXICOLOGY PROTOCOLS, 2ND EDITION
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Gene mutation; Glycosyl phosphatidyl inositol; Flow cytometry;
Reticulocytes; CD59 surface marker; CD24 surface marker; Antibodies
ID FLOW-CYTOMETRIC DETECTION; IN-VIVO GENOTOXICITY; MUTATION ASSAY;
TRANSGENIC MICE; SHUTTLE VECTORS; CELLS; GENE; MODEL; TOXICOLOGY;
SELECTION
AB The endogenous X-linked phosphatidyl inositol glycan class A gene (Pig-a) can be used as a reporter of in vivo somatic cell mutation in rats and mice. Pig-a mutant cells are deficient in specific protein surface markers and can be identified and quantified by immunofluorescent staining followed by high-throughput flow cytometry. Pig-a mutation detection is commonly performed with red blood cells (RBCs) because (1) the low volumes of blood required for determining mutant frequencies in RBCs allow multiple samplings on small laboratory animals over extended periods of time; (2) the execution of the RBC assay is easy and the interpretation of the results is straightforward; and (3) RBC Pig-a mutant frequencies are known within hours of sample collection. Two endpoints are determined in the assay: the frequency of mutant total RBCs and the frequency of mutant reticulocytes. When Pig-a mutation is used to assess the in vivo mutagenic potential of suspect hazards, the frequency of mutant reticulocytes is an early indicator of mutagenic potential, while the mutant frequency in total RBCs can be measured more rapidly and with greater precision.
C1 [Dobrovolsky, Vasily N.; Cao, Xuefei; Bhalli, Javed A.; Heflich, Robert H.] Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
RP Dobrovolsky, VN (reprint author), Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
NR 22
TC 3
Z9 4
U1 0
U2 1
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-62703-739-6; 978-1-62703-738-9
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2014
VL 1105
BP 205
EP 221
DI 10.1007/978-1-62703-739-6_17
D2 10.1007/978-1-62703-739-6
PG 17
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Pharmacology & Pharmacy; Toxicology
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy; Toxicology
GA BA2SX
UT WOS:000333851000018
PM 24623231
ER
PT S
AU Dobrovolsky, VN
Shaddock, JG
Heflich, RH
AF Dobrovolsky, Vasily N.
Shaddock, Joseph G.
Heflich, Robert H.
BE Keohavong, P
Grant, SG
TI Analysis of In Vivo Mutation in the Hprt and Tk Genes of Mouse
Lymphocytes
SO MOLECULAR TOXICOLOGY PROTOCOLS, 2ND EDITION
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Hypoxanthine-guanine phosphoribosyltransferase (Hprt); Thymidine kinase
(Tk); alamarBlue (TM); Mutation; Loss of heterozygosity (LOH)
ID CHINESE-HAMSTER CELLS; TRANSGENIC MICE; ADENINE
PHOSPHORIBOSYLTRANSFERASE; SOMATIC MUTATION; LOCUS; HETEROZYGOSITY;
INVIVO; ASSAY; SYSTEM; RECOMBINATION
AB Assays measuring mutant frequencies in endogenous reporter genes are used for identifying potentially genotoxic environmental agents and discovering phenotypes prone to genomic instability and diseases, such as cancer. Here, we describe methods for identifying mouse spleen lymphocytes with mutations in the endogenous X-linked hypoxanthine guanine phosphoribosyl transferase (Hprt) gene and the endogenous autosomal thymidine kinase (Tk) gene. The selective clonal expansion of mutant lymphocytes is based upon the phenotypic properties of HPRT-and TK-deficient cells. The same procedure can be utilized for quantifying Hprt mutations in most strains of mice (and, with minor changes, in other mammalian species), while mutations in the Tk gene can be determined only in transgenic mice that are heterozygous for inactivation of this gene. Expanded mutant clones can be further analyzed to classify the types of mutations in the Tk gene (small intragenic mutations vs. large chromosomal mutations) and to determine the nature of intragenic mutation in both the Hprt and Tk genes.
C1 [Dobrovolsky, Vasily N.; Shaddock, Joseph G.; Heflich, Robert H.] Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
RP Dobrovolsky, VN (reprint author), Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
NR 39
TC 1
Z9 1
U1 0
U2 2
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-62703-739-6; 978-1-62703-738-9
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2014
VL 1105
BP 255
EP 270
DI 10.1007/978-1-62703-739-6_20
D2 10.1007/978-1-62703-739-6
PG 16
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Pharmacology & Pharmacy; Toxicology
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy; Toxicology
GA BA2SX
UT WOS:000333851000021
PM 24623234
ER
PT S
AU Fuscoe, JC
AF Fuscoe, James C.
BE Keohavong, P
Grant, SG
TI Simultaneous Quantification of t(14;18) and HPRT Exon 2/3 Deletions in
Human Lymphocytes
SO MOLECULAR TOXICOLOGY PROTOCOLS, 2ND EDITION
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Translocation; Deletion; Lymphocytes; V(D) J recombination; Illegitimate
V(D) J recombination; HPRT deletions; t(14;18) translocation;
Quantitative PCR assay Poisson statistics; Human; Cancer; Biomarker
ID ILLEGITIMATE V(D)J RECOMBINATION; MEDIATED MUTATIONS; SEQUENCE-ANALYSIS;
T-LYMPHOCYTES; ADULT HUMANS; DNA; ETOPOSIDE; LYMPHOMA; T(14-18); CELLS
AB Specific recurring chromosomal translocations and deletions are found in a variety of cancers. In hematopoietic malignancies, many of these chromosomal aberrations result from mistakes involving V(D)J recombination. V(D)J recombination is required for the formation of functional T-cell receptor genes in T-cells and antibody genes in B-cells. This is an inherently dangerous process, however, because double-strand breaks are introduced into the chromosomes. Molecular evidence indicates that failure of the fidelity of this process results in the activation of proto-oncogenes or the inactivation of tumor-suppressor genes. Here we describe sensitive, quantitative PCR assays for the measurement of such events in human lymphocytes. One assay measures the frequency of t(14; 18) translocations that result in the dysfunctional regulation of the anti-apoptotic gene BCL-2. The other assay measures the frequency of a deletion caused by illegitimate V(D)J recombination in the X-linked HPRT gene. The findings and conclusions presented in this article are the author's and do not necessarily reflect those of the Food and Drug Administration.
C1 US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Fuscoe, JC (reprint author), US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 19
TC 0
Z9 0
U1 0
U2 0
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-62703-739-6; 978-1-62703-738-9
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2014
VL 1105
BP 303
EP 311
DI 10.1007/978-1-62703-739-6_24
D2 10.1007/978-1-62703-739-6
PG 9
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Pharmacology & Pharmacy; Toxicology
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy; Toxicology
GA BA2SX
UT WOS:000333851000025
PM 24623238
ER
PT S
AU Myers, MB
McKinzie, PB
Wang, YY
Meng, FX
Parsons, BL
AF Myers, Meagan B.
McKinzie, Page B.
Wang, Yiying
Meng, Fanxue
Parsons, Barbara L.
BE Keohavong, P
Grant, SG
TI ACB-PCR Quantification of Somatic Oncomutation
SO MOLECULAR TOXICOLOGY PROTOCOLS, 2ND EDITION
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Allele-specific competitive blocker-polymerase chain reaction (ACB-PCR);
Oncomutation; Point mutation; Allele-specific PCR; Mutation detection;
Base substitution; KRAS
ID COMPETITIVE BLOCKER PCR; RAS CODON 61; MUTANT FRACTION; TUMOR; MUTATION;
CANCER; TISSUE
AB Allele-specific competitive blocker-polymerase chain reaction (ACB-PCR) is a sensitive approach for the selective amplification of an allele. Using the ACB-PCR technique, hotspot point mutations in oncogenes and tumor-suppressor genes (oncomutations) are being developed as quantitative biomarkers of cancer risk. ACB-PCR employs a mutant specific primer (with a 3'-penultimate mismatch relative to the mutant DNA sequence, but a double 3'-terminal mismatch relative to the wild-type DNA sequence) to selectively amplify rare mutant DNA molecules. A blocker primer (having a non-extendable 3'-end and with a 3'-penultimate mismatch relative to the wild-type DNA sequence, but a double 3'-terminal mismatch relative to the mutant DNA sequence) is included in ACB-PCR to selectively repress amplification from the abundant wild-type molecules. Consequently, ACB-PCR is capable of quantifying the level of a single basepair substitution mutation in a DNA population when present at a mutant: wild type ratio of 10(-5) or greater. Quantification of rare mutant alleles is achieved by parallel analysis of unknown samples and mutant fraction (MF) standards (defined mixtures of mutant and wild-type DNA sequences). The ability to quantify specific mutations with known association to cancer has several important applications, including evaluating the carcinogenic potential of chemical exposures in rodent models and in the diagnosis and treatment of cancer. This chapter provides a step-by-step description of the ACB-PCR methodology as it has been used to measure human KRAS codon 12 GGT to GAT mutation.
C1 [Myers, Meagan B.] Natl Ctr Toxicol Res, Div Genet & Mol Toxicol, Jefferson, AR 72079 USA.
[McKinzie, Page B.; Wang, Yiying; Meng, Fanxue; Parsons, Barbara L.] Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
RP Myers, MB (reprint author), Natl Ctr Toxicol Res, Div Genet & Mol Toxicol, Jefferson, AR 72079 USA.
NR 24
TC 2
Z9 2
U1 0
U2 6
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-62703-739-6; 978-1-62703-738-9
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2014
VL 1105
BP 345
EP 363
DI 10.1007/978-1-62703-739-6_27
D2 10.1007/978-1-62703-739-6
PG 19
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Pharmacology & Pharmacy; Toxicology
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy; Toxicology
GA BA2SX
UT WOS:000333851000028
PM 24623241
ER
PT J
AU Robertson, A
Garcia, AC
Quintana, HAF
Smith, TB
Castillo, BF
Reale-Munroe, K
Gulli, JA
Olsen, DA
Hooe-Rollman, JI
Jester, ELE
Klimek, BJ
Plakas, SM
AF Robertson, Alison
Garcia, Ana C.
Quintana, Harold A. Flores
Smith, Tyler B.
Castillo, Bernard F., II
Reale-Munroe, Kynoch
Gulli, Joseph A.
Olsen, David A.
Hooe-Rollman, Jennifer I.
Jester, Edward L. E.
Klimek, Brian J.
Plakas, Steven M.
TI Invasive Lionfish (Pterois volitans): A Potential Human Health Threat
for Ciguatera Fish Poisoning in Tropical Waters
SO MARINE DRUGS
LA English
DT Article
DE ciguatera fish poisoning; Caribbean ciguatoxins; lionfish; Caribbean;
mass spectrometry
ID CIGUATOXIN; CHANNEL; TOXINS; BREVETOXINS; ATLANTIC
AB Invasive Indo-Pacific lionfish (Pterois volitans) have rapidly expanded in the Western Atlantic over the past decade and have had a significant negative impact on reef fish biodiversity, habitat, and community structure, with lionfish out-competing native predators for resources. In an effort to reduce this population explosion, lionfish have been promoted for human consumption in the greater Caribbean region. This study examined whether the geographical expansion of the lionfish into a known ciguatera-endemic region can pose a human health threat for ciguatera fish poisoning (CFP). More than 180 lionfish were collected from waters surrounding the US Virgin Islands throughout 2010 and 2011. Ciguatoxin testing included an in vitro neuroblastoma cytotoxicity assay for composite toxicity assessment of sodium-channel toxins combined with confirmatory liquid chromatography tandem mass spectrometry. A 12% prevalence rate of ciguatoxic lionfish exceeding the FDA guidance level of 0.1 mu g/kg C-CTX-1 equivalents was identified in fish from the U. S. Virgin Islands, highlighting a potential consumption risk in this region. This study presents the first evidence that the invasive lionfish, pose a direct human health risk for CFP and highlights the need for awareness and research on this food safety hazard in known endemic areas.
C1 [Robertson, Alison; Garcia, Ana C.; Quintana, Harold A. Flores; Hooe-Rollman, Jennifer I.; Jester, Edward L. E.; Klimek, Brian J.; Plakas, Steven M.] US FDA, Div Seafood Sci & Technol, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
[Robertson, Alison; Klimek, Brian J.] Univ S Alabama, Dept Marine Sci, Mobile, AL 36688 USA.
[Smith, Tyler B.] Univ Virgin Islands, Ctr Marine & Environm Studies, St Thomas, VI 00802 USA.
[Castillo, Bernard F., II; Reale-Munroe, Kynoch] Univ,Virgin Islands, Coll Sci & Math, Kingshill, VI 00850 USA.
[Gulli, Joseph A.] Caribbean Ocean Restorat & Educ CORE Fdn, Christiansted, VI 00824 USA.
[Olsen, David A.] St Thomas Fishermens Assoc, St Thomas, VI 00803 USA.
RP Robertson, A (reprint author), US FDA, Div Seafood Sci & Technol, Gulf Coast Seafood Lab, 1 Iberville Dr, Dauphin Isl, AL 36528 USA.
EM alisonrobertson@southalabama.edu; agarci3@gmail.com;
Harold.FloresQuintana@fda.hhs.gov; tsmith@live.uvi.edu;
bcastil@live.uvi.edu; kynoch_reale@yahoo.com; nolionfish@yahoo.com;
Olsen41@aol.com; Jennifer.Hooe-Rollman@fda.hhs.gov;
Edward.Jester@fda.hhs.gov; bklimek15@gmail.com;
Steven.Plakas@fda.hhs.gov
FU Centers for Disease Control and Prevention, National Center for
Environmental Health [U01EH000421]; Ecology and Oceanography of Harmful
Algal Blooms (ECOHAB) program through the National Oceanic and
Atmospheric Administration (NOAA) [NA11NOS4780028, NA11NOS4780062]
FX We are grateful for the assistance of the many volunteer divers and
fishermen who assisted with collection of lionfish specimens during this
study. Lionfish photographs were kindly provided by one of our volunteer
divers, Robert Georgopul and used with permission. We are thankful to
Jared Loader (FDA-ORISE) for helpful discussions and input on the
chemistry of CTXs and to Elizabeth Kadison for sample co-ordination in
St. Thomas. Jessica Hill and Elise Koob assisted with sample
preparation. The Dauphin Island Sea Laboratory-FDA co-operative program
provided internships to Jessica Hill, Elise Koob, and co-author Brian
Klimek. This work was supported in part by funding from the Centers for
Disease Control and Prevention, National Center for Environmental Health
grant U01EH000421, and by the Ecology and Oceanography of Harmful Algal
Blooms (ECOHAB) program through the National Oceanic and Atmospheric
Administration (NOAA) grants NA11NOS4780028 and NA11NOS4780062. This is
ECOHAB contribution no. 766.
NR 21
TC 9
Z9 11
U1 2
U2 38
PU MDPI AG
PI BASEL
PA POSTFACH, CH-4005 BASEL, SWITZERLAND
SN 1660-3397
J9 MAR DRUGS
JI Mar. Drugs
PD JAN
PY 2014
VL 12
IS 1
BP 88
EP 97
DI 10.3390/md12010088
PG 10
WC Chemistry, Medicinal
SC Pharmacology & Pharmacy
GA AH4HH
UT WOS:000336087500006
PM 24378919
ER
PT S
AU Benvenuto, MA
Ahuja, S
Duncan, T
Noonan, GO
Roberts-Kirchhoff, E
AF Benvenuto, M. A.
Ahuja, S.
Duncan, T.
Noonan, G. O.
Roberts-Kirchhoff, E.
BE Benvenuto, MA
Ahuja, S
Duncan, TV
Noonan, GO
RobertsKirchhoff, ES
TI Overview
SO CHEMISTRY OF FOOD, FOOD SUPPLEMENTS, AND FOOD CONTACT MATERIALS: FROM
PRODUCTION TO PLATE
SE ACS Symposium Series
LA English
DT Editorial Material; Book Chapter
AB Ensuring the safety of food requires a complex and ever-changing set of interactions between producers, distrbutors, consumers and regulators. As advances are made in packaging and food additives, as food distributions systems evolve to meet consumer needs, or as these respond to environmental and population changes, adjustments to regulatory systems may become neceesary. Analytical, environmental and materials chemistry can often play important roles in responding to these changes and in continuing to help with the improvement of food safety and security. This chapter gives a breif overview of the chapters, produced from seminars presented at three symposia held at the 245th ACS National Convention in New Orleans, Louisiana in the spring of 2013.
C1 [Benvenuto, M. A.; Roberts-Kirchhoff, E.] Univ Detroit Mercy, Detroit, MI 48221 USA.
[Ahuja, S.] UNC Wilmington, Ahuja Acad Water Qual, Wilmington, NC USA.
[Duncan, T.] US FDA, Bedford Pk, IL 60516 USA.
[Noonan, G. O.] US FDA, College Pk, MD 20740 USA.
RP Benvenuto, MA (reprint author), Univ Detroit Mercy, 4001 W McNichols Rd, Detroit, MI 48221 USA.
EM Gregory.Noonan@fda.hhs.gov
NR 13
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-2952-5
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1159
BP 1
EP 4
D2 10.1021/bk-2014-1159
PG 4
WC Food Science & Technology
SC Food Science & Technology
GA BA4MI
UT WOS:000336002500001
ER
PT S
AU Croce, TA
AF Croce, Teresa A.
BE Benvenuto, MA
Ahuja, S
Duncan, TV
Noonan, GO
RobertsKirchhoff, ES
TI FDA's Regulation of Nanotechnology in Food Ingredients
SO CHEMISTRY OF FOOD, FOOD SUPPLEMENTS, AND FOOD CONTACT MATERIALS: FROM
PRODUCTION TO PLATE
SE ACS Symposium Series
LA English
DT Article; Book Chapter
AB Nanotechnology has the potential to impact many FDA-regulated product areas, including food ingredients. The agency issued draft guidance in 2011 to address its current thinking on nanotechnology and has extended that overarching guidance through the publication of a subsequent draft guidance document in 2012 specific to food ingredients, including food contact substances and food ingredients that are color additives. The 2012 document examines how significant changes in manufacturing process, including the integration of nanotechnology, may impact the safety and regulatory status of the food ingredient.
C1 US FDA, Div Petit Review, Off Food Addit Safety, College Pk, MD 20740 USA.
RP Croce, TA (reprint author), US FDA, Div Petit Review, Off Food Addit Safety, 5100 Paint Branch Pkwy,HFS 265, College Pk, MD 20740 USA.
EM Teresa.Croce@fda.hhs.gov
NR 6
TC 0
Z9 0
U1 0
U2 2
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 978-0-8412-2952-5
J9 ACS SYM SER
JI ACS Symp. Ser.
PY 2014
VL 1159
BP 41
EP 50
D2 10.1021/bk-2014-1159
PG 10
WC Food Science & Technology
SC Food Science & Technology
GA BA4MI
UT WOS:000336002500004
ER
PT J
AU Pang, L
Word, B
Xu, JS
Wang, HG
Hammons, G
Huang, SM
Lyn-Cook, B
AF Pang, Li
Word, Beverly
Xu, Joshua
Wang, Honggang
Hammons, George
Huang, Shiew-Mei
Lyn-Cook, Beverly
TI ATP-Binding Cassette Genes Genotype and Expression: A Potential
Association with Pancreatic Cancer Development and Chemoresistance?
SO GASTROENTEROLOGY RESEARCH AND PRACTICE
LA English
DT Article
ID MULTIDRUG-RESISTANCE; P-GLYCOPROTEIN; CELL-LINES; MDR1 GENE;
POLYMORPHISMS; TRANSPORTERS; SUSCEPTIBILITY; CHEMOTHERAPY; LOCALIZATION;
GEMCITABINE
AB Genetic polymorphisms in ABC (ATP-binding cassette) transporter genes are associated with differential responses to chemotherapy in various cancers including pancreatic cancer. In this study, four SNPs in the ABCB1, ABCC1, and ABCG2 genes were investigated in normal and pancreatic cancerous specimens. The expression of the three transporters was also analyzed. The TT genotypes of G2677T and C3435T in ABCB1 gene were associated with lower risk of developing pancreatic cancer (P = 0.013, OR = 0.35 and P = 0.015, OR = 0.29, resp.). To our knowledge, this is the first report of the common polymorphisms in the ABCB1 gene affecting the genetic risk of developing pancreatic cancer. Moreover, the expression of ABCB1 in 2677TT and 3435TT carriers was lower compared to the wild-type homozygotes and heterozygotes. A cell viability assay, using standard pancreatic cancer cell lines, revealed that the ABCB1 2677TT-3455TT haplotype was more sensitive than the other haplotypes to gemcitabine. Conclusion. Polymorphisms in ABCB1 G2677T and G3435T were associated with differential susceptibility to pancreatic cancer and may predict responses to chemotherapy.
C1 [Pang, Li; Word, Beverly; Wang, Honggang; Hammons, George; Lyn-Cook, Beverly] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Xu, Joshua] US FDA, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Huang, Shiew-Mei] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat Res, Silver Spring, MD 20993 USA.
RP Lyn-Cook, B (reprint author), US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM beverly.lyn-cook@fda.hhs.gov
OI Xu, Joshua/0000-0001-5313-5847
NR 28
TC 3
Z9 3
U1 1
U2 4
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 1687-6121
EI 1687-630X
J9 GASTROENT RES PRACT
JI Gastroenterol. Res. Pract.
PY 2014
AR 414931
DI 10.1155/2014/414931
PG 9
WC Gastroenterology & Hepatology
SC Gastroenterology & Hepatology
GA AH5DW
UT WOS:000336149700001
ER
PT J
AU Zhang, MH
Feng, L
Gu, JF
Ma, L
Qin, D
Wu, C
Jia, XB
AF Zhang, Minghua
Feng, Liang
Gu, Junfei
Ma, Liang
Qin, Dong
Wu, Chan
Jia, Xiaobin
TI The Attenuation of Moutan Cortex on Oxidative Stress for Renal Injury in
AGEs-Induced Mesangial Cell Dysfunction and Streptozotocin-Induced
Diabetic Nephropathy Rats
SO OXIDATIVE MEDICINE AND CELLULAR LONGEVITY
LA English
DT Article
ID GLYCATION END-PRODUCTS; KIDNEY-DISEASE; ANTIOXIDANT ACTIVITY;
GENE-EXPRESSION; HIGH-GLUCOSE; RECEPTOR; COMPLICATIONS; INFLAMMATION;
RAGE; PATHOGENESIS
AB Oxidative stress (OS) has been regarded as one of themajor pathogeneses of diabetic nephropathy (DN) through damaging kidney which is associated with renal cells dysfunction. The aim of this study was to investigate whether Moutan Cortex (MC) could protect kidney function against oxidative stress in vitro or in vivo. The compounds in MC extract were analyzed by HPLC-ESI-MS. High-glucose-fat diet and STZ (30 mg kg(-1)) were used to induce DN rats model, while 200 mu g mL(-1) AGEs were for HBZY-1 mesangial cell damage. The treatment with MC could significantly increase the activity of SOD, glutathione peroxidase (GSH-PX), and catalase (CAT). However, lipid peroxidation malondialdehyde (MDA) was reduced markedly in vitro or in vivo. Furthermore, MC decreased markedly the levels of blood glucose, serum creatinine, and urine protein in DN rats. Immunohistochemical assay showed that MC down regulated significantly transforming growth factor beta 2 (TGF-beta 2) protein expression in renal tissue. Our data provided evidence to support this fact that MC attenuated OS in AGEs-induced mesangial cell dysfunction and also in high-glucose-fat diet and STZ-induced DN rats.
C1 [Zhang, Minghua; Feng, Liang; Gu, Junfei; Ma, Liang; Qin, Dong; Wu, Chan; Jia, Xiaobin] Jiangsu Prov Acad Chinese Med, Key Lab New Drug Delivery Syst Chinese Mat Med, Nanjing 210028, Jiangsu, Peoples R China.
[Zhang, Minghua; Qin, Dong; Jia, Xiaobin] Jiangsu Univ, Dept Pharm, Zhenjiang 212013, Jiangsu, Peoples R China.
[Gu, Junfei; Wu, Chan; Jia, Xiaobin] Nanjing Univ Chinese Med, Coll Pharm, Nanjing 210046, Jiangsu, Peoples R China.
[Ma, Liang] Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Feng, L (reprint author), Jiangsu Prov Acad Chinese Med, Key Lab New Drug Delivery Syst Chinese Mat Med, Nanjing 210028, Jiangsu, Peoples R China.
EM wenmoxiushi@163.com; jxiaobin2005@hotmail.com
FU National Natural Science of China [81202906]; Natural Science Foundation
of Jiangsu Province [BK2012491]
FX The authors sincerely acknowledge the financial support of National
Natural Science of China (no. 81202906) and Natural Science Foundation
of Jiangsu Province (BK2012491).
NR 49
TC 1
Z9 1
U1 3
U2 9
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 1942-0900
EI 1942-0994
J9 OXID MED CELL LONGEV
JI Oxidative Med. Cell. Longev.
PY 2014
AR 463815
DI 10.1155/2014/463815
PG 13
WC Cell Biology
SC Cell Biology
GA AG9JL
UT WOS:000335735300001
ER
PT J
AU Scott, J
Botsis, T
Ball, R
AF Scott, J.
Botsis, T.
Ball, R.
TI Simulating adverse event spontaneous reporting systems as preferential
attachment networks
SO APPLIED CLINICAL INFORMATICS
LA English
DT Article
DE Simulation; data mining; vaccines; safety; network analysis
ID SIGNAL GENERATION; US VACCINE; PHARMACOVIGILANCE; INTUSSUSCEPTION; VAERS
AB Background: Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases. Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limitations.
Objective: We sought to develop a novel SRS simulation strategy based on plausible mechanisms for the growth of databases over time.
Methods: We developed a simulation strategy based on the network principle of preferential attachment. We demonstrated how this strategy can be used to create simulations based on specific databases of interest, and provided an example of using such simulations to compare signal detection thresholds for a popular data mining algorithm.
Results: The preferential attachment simulations were generally structurally similar to our targeted SRS database, although they had fewer nodes of very high degree. The approach was able to generate signal-free SRS simulations, as well as mimicking specific known true signals. Explorations of different reporting thresholds for the FDA Vaccine Adverse Event Reporting System suggested that using proportional reporting ratio [PRR] > 3.0 may yield better signal detection operating characteristics than the more commonly used PRR > 2.0 threshold.
Discussion: The network analytic approach to SRS simulation based on the principle of preferential attachment provides an attractive framework for exploring the performance of safety signal detection algorithms. This approach is potentially more principled and versatile than existing simulation approaches.
Conclusion: The utility of network-based SRS simulations needs to be further explored by evaluating other types of simulated signals with a broader range of data mining approaches, and comparing network-based simulations with other simulation strategies where applicable.
C1 [Scott, J.; Botsis, T.; Ball, R.] US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Botsis, T.] Univ Tromso, Dept Comp Sci, Tromso, Norway.
RP Scott, J (reprint author), US FDA, Off Biostat & Epidemiol, CBER, 1401 Rockville Pike,HFM 215, Rockville, MD 20852 USA.
EM john.scott@fda.hhs.gov
NR 16
TC 4
Z9 4
U1 0
U2 2
PU SCHATTAUER GMBH-VERLAG MEDIZIN NATURWISSENSCHAFTEN
PI STUTTGART
PA HOLDERLINSTRASSE 3, D-70174 STUTTGART, GERMANY
SN 1869-0327
J9 APPL CLIN INFORM
JI Appl. Clin. Inform.
PY 2014
VL 5
IS 1
BP 206
EP 218
DI 10.4338/ACI-2013-11-RA-0097
PG 13
WC Medical Informatics
SC Medical Informatics
GA AG6XG
UT WOS:000335561700003
PM 24734134
ER
PT J
AU Sharma, K
Goehe, R
Beckta, JM
Valerie, K
Gewirtz, DA
AF Sharma, Khushboo
Goehe, Rachel
Beckta, Jason M.
Valerie, Kristoffer
Gewirtz, David A.
TI AUTOPHAGY AND RADIOSENSITIZATION IN CANCER
SO EXCLI JOURNAL
LA English
DT Review
DE Autophagy; ATM; DNA damage response; lung cancer; glioblastomas; breast
cancer; radiosensitization
ID CELL LUNG-CANCER; MALIGNANT GLIOMA-CELLS; GROWTH-FACTOR RECEPTOR;
UNFOLDED PROTEIN RESPONSE; DNA-DAMAGE RESPONSE; BREAST-TUMOR CELLS;
IONIZING-RADIATION; CYTOTOXIC AUTOPHAGY; SIGNALING PATHWAYS; MAMMALIAN
TARGET
AB Autophagy is a natural self-degradative process by which cells eliminate misfolded proteins and damaged organelles. Autophagy has been shown to have multiple functions in tumor cells that may be dependent on the tumor type and the treatment conditions. Autophagy can have a cytoprotective role and be thought of as a survival mechanism or be cytotoxic in nature and mediate cell death. Radiation, one of the primary treatments for many different types of cancer, almost uniformly promotes autophagy in tumor cells. While autophagy produced in response to radiation is often considered to be cytoprotective, radiation-induced autophagy has also been shown to mediate susceptibility to radiation. This review addresses the complexity of autophagy in response to radiation treatment in three different cancer models, specifically lung cancer, breast cancer and glioblastoma. A deeper understanding of the different roles played by autophagy in response to radiation should facilitate the development of approaches for enhancing the therapeutic utility of radiation by providing strategies for combination treatment with unique radiosensitizers as well as preventing the initiation of strategies which are likely to attenuate the effectiveness of radiation therapy.
C1 [Sharma, Khushboo; Gewirtz, David A.] Virginia Commonwealth Univ, Dept Pharmacol, Richmond, VA 23298 USA.
[Sharma, Khushboo; Gewirtz, David A.] Virginia Commonwealth Univ, Dept Toxicol, Richmond, VA 23298 USA.
[Beckta, Jason M.; Valerie, Kristoffer] Virginia Commonwealth Univ, Dept Radiat Oncol, Richmond, VA 23298 USA.
[Gewirtz, David A.] Virginia Commonwealth Univ, Dept Med, Richmond, VA 23298 USA.
[Valerie, Kristoffer; Gewirtz, David A.] Virginia Commonwealth Univ, Massey Canc Ctr, Richmond, VA 23298 USA.
[Goehe, Rachel] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Gewirtz, DA (reprint author), Virginia Commonwealth Univ, Massey Canc Ctr, 401 Coll St, Richmond, VA 23298 USA.
EM gewirtz@vcu.edu
FU NIH [R01NS064593, R21ES016636, F30 CA171893]; CTSA from the National
Center for Advancing Translational Sciences [UL1TR000058]
FX Supported in part by NIH R01NS064593 (K.V.), R21ES016636 (K.V.), F30
CA171893 (J.M.B.) and CTSA award No. UL1TR000058 from the National
Center for Advancing Translational Sciences (D.A.G).
NR 75
TC 5
Z9 5
U1 0
U2 4
PU EXCLI JOURNAL MANAGING OFFICE
PI DORTMUND
PA LEIBNIZ RESEARCH CENTRE WORKING ENVIRONMENT & HUMAN FACTORS EXCLI
JOURNAL, ARDEYSTR 67, DORTMUND, D-44139, GERMANY
SN 1611-2156
J9 EXCLI J
JI EXCLI J.
PY 2014
VL 13
BP 178
EP 191
PG 14
WC Biology
SC Life Sciences & Biomedicine - Other Topics
GA AG6HK
UT WOS:000335519500014
PM 26417252
ER
PT S
AU Le, HND
Hitchins, VM
Ilev, IK
Kim, DH
AF Le, Hanh N. D.
Hitchins, Victoria M.
Ilev, Ilko K.
Kim, Do-Hyun
BE Gannot, I
TI Monitoring Biofilm Attachment on Medical Device Surfaces Using
Hyperspectral Imaging
SO OPTICAL FIBERS AND SENSORS FOR MEDICAL DIAGNOSTICS AND TREATMENT
APPLICATIONS XIV
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Optical Fibers and Sensors for Medical Diagnostics and
Treatment Applications XIV
CY FEB 01-02, 2014
CL San Francisco, CA
SP SPIE
DE Biofilm attachment; Hyperspectral Imaging; Dot Product Method
ID INFECTION; ADHERENCE
AB Microbial biofilm is a colony of single bacteria cells (planktonic) that attach to surfaces, attract other microorganisms to attach and grow, and together build an extracellular matrix composed of polysaccharides, protein, and DNA. Furthermore, some cells may detach and spread to other surface. Biofilm on medical devices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral Imaging was utilized for distinguishing a wide area of biofilm coverage on various materials and on different textures of stainless steel test coupons. In addition to biofilm coverage, the shear stress of biofilm on attached surfaces is also important. The present study investigates the effect of shear stress on the adhesion of biofilms on common medical device surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Pseudomonas aeruginosa and growth was monitored after 24 and 48 hours at 37 degrees C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral Images were taken. We hypothesize that stronger attachment on rough surface withstands greater shear stress compared to smooth surface. The results have verified our hypothesis with more biofilm persists on brushed surface such as stainless steel than on un-brushed surface like mirror-like or glass.
C1 [Le, Hanh N. D.; Hitchins, Victoria M.; Ilev, Ilko K.; Kim, Do-Hyun] US FDA, Silver Spring, MD 20993 USA.
RP Le, HND (reprint author), US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Do-Hyun.Kim@fda.hhs.gov
NR 11
TC 1
Z9 1
U1 0
U2 7
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9851-9
J9 PROC SPIE
PY 2014
VL 8938
AR 893809
DI 10.1117/12.2047867
PG 10
WC Remote Sensing; Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Remote Sensing; Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA3CA
UT WOS:000334100600005
ER
PT S
AU Gould, T
Wang, QZ
Pfefer, TJ
AF Gould, Taylor
Wang, Quanzeng
Pfefer, T. Joshua
BE Raghavachari, R
Liang, R
TI Optical-thermal light-tissue interactions during photoacoustic imaging
SO DESIGN AND QUALITY FOR BIOMEDICAL TECHNOLOGIES VII
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Design and Quality for Biomedical Technologies VII
CY FEB 01-02, 2014
CL San Francisco, CA
SP SPIE
DE Photoacoustics; Monte Carlo modeling; laser-tissue interactions; laser
safety
ID PORT-WINE STAINS; OXYGEN-SATURATION; LASER TREATMENT; HUMAN SKIN;
IN-VIVO; BREAST; TOMOGRAPHY; RECONSTRUCTION; SPECTROSCOPY; IRRADIATION
AB Photoacoustic imaging (PAI) has grown rapidly as a biomedical imaging technique in recent years, with key applications in cancer diagnosis and oximetry. In spite of these advances, the literature provides little insight into thermal tissue interactions involved in PAI. To elucidate these basic phenomena, we have developed, validated, and implemented a three-dimensional numerical model of tissue photothermal (PT) response to repetitive laser pulses. The model calculates energy deposition, fluence distributions, transient temperature and damage profiles in breast tissue with blood vessels and generalized perfusion. A parametric evaluation of these outputs vs. vessel diameter and depth, optical beam diameter, wavelength, and irradiance, was performed. For a constant radiant exposure level, increasing beam diameter led to a significant increase in subsurface heat generation rate. Increasing vessel diameter resulted in two competing effects - reduced mean energy deposition in the vessel due to light attenuation and greater thermal superpositioning due to reduced thermal relaxation. Maximum temperatures occurred either at the surface or in subsurface regions of the dermis, depending on vessel geometry and position. Results are discussed in terms of established exposure limits and levels used in prior studies. While additional experimental and numerical study is needed, numerical modeling represents a powerful tool for elucidating the effect of PA imaging devices on biological tissue.
C1 [Gould, Taylor; Wang, Quanzeng; Pfefer, T. Joshua] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Pfefer, TJ (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM Joshua.pfefer@fda.hhs.gov
NR 40
TC 0
Z9 0
U1 0
U2 3
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9849-6
J9 PROC SPIE
PY 2014
VL 8936
AR 893603
DI 10.1117/12.2044379
PG 8
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA3BX
UT WOS:000334099600002
ER
PT S
AU Wang, JT
Coburn, J
Woolsey, N
Liang, CP
Ramella-Roman, J
Chen, Y
Pfefer, J
AF Wang, Jianting
Coburn, James
Woolsey, Nicholas
Liang, Chia-Pin
Ramella-Roman, Jessica
Chen, Yu
Pfefer, Joshua
BE Raghavachari, R
Liang, R
TI Quantitative Assessment of Biophotonic Imaging System Performance with
Phantoms Fabricated by Rapid Prototyping
SO DESIGN AND QUALITY FOR BIOMEDICAL TECHNOLOGIES VII
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Design and Quality for Biomedical Technologies VII
CY FEB 01-02, 2014
CL San Francisco, CA
SP SPIE
DE 3D printing; rapid proto-typing; geometric phantoms; biophotonic
imaging; hyperspectral reflectance imaging
ID OPTICAL-PROPERTIES; IN-VITRO; TISSUES
AB In biophotonic imaging, turbid phantoms that are low-cost, biologically-relevant, and durable are desired for standardized performance assessment. Such phantoms often contain inclusions of varying depths and sizes in order to quantify key image quality characteristics such as penetration depth, sensitivity and contrast detectability. The emerging technique of rapid prototyping with three-dimensional (3D) printers provides a potentially revolutionary way to fabricate these structures. Towards this goal, we have characterized the optical properties and morphology of phantoms fabricated by two 3D printing approaches: thermosoftening and photopolymerization. Material optical properties were measured by spectrophotometry while the morphology of phantoms incorporating 0.2-1.0 mm diameter channels was studied by mu CT, optical coherence tomography (OCT) and optical microscopy. A near-infrared absorbing dye and nanorods at several concentrations were injected into channels to evaluate detectability with a near-infrared hyperspectral reflectance imaging (HRI) system (650-1100 nm). Phantoms exhibited biologically-relevant scattering and low absorption across visible and near-infrared wavelengths. Although limitations in resolution were noted, channels with diameters of 0.4 mm or more could be reliably fabricated. The most significant problem noted was the porosity of phantoms generated with the thermosoftening-based printer. The aforementioned three imaging methods provided a valuable mix of insights into phantom morphology and may also be useful for detailed structural inspection of medical devices fabricated by rapid prototyping, such as customized implants. Overall, our findings indicate that 3D printing has significant potential as a method for fabricating well-characterized, standard phantoms for medical imaging modalities such as HRI.
C1 [Wang, Jianting; Woolsey, Nicholas; Liang, Chia-Pin; Chen, Yu] Univ Maryland, College Pk, MD 20742 USA.
[Wang, Jianting; Coburn, James; Woolsey, Nicholas; Chen, Yu; Pfefer, Joshua] Food & Drug Adm, Silver Spring, MD 10903 USA.
[Ramella-Roman, Jessica] Florida Int Univ, Dept Biomed Engn, Miami, FL 33174 USA.
RP Wang, JT (reprint author), Univ Maryland, College Pk, MD 20742 USA.
FU National Science Foundation's FDA [CBET-1238407]; University of
Maryland; Center for Excellence in Regulatory Science and Innovation
(CERSI)
FX The authors acknowledge support from the National Science Foundation's
FDA Scholar-in-Residence program (NSF, CBET-1238407) and the University
of Maryland Center for Excellence in Regulatory Science and Innovation
(CERSI). The authors would also like to thank Dr. Maureen Dreher for her
help with mu CT imaging.
NR 14
TC 0
Z9 0
U1 0
U2 1
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-8194-9849-6
J9 PROC SPIE
PY 2014
VL 8936
AR UNSP 89360M
DI 10.1117/12.2044089
PG 8
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BA3BX
UT WOS:000334099600012
ER
PT J
AU Hamburg, MA
AF Hamburg, Margaret A.
TI A Key Port of the FDA Mission: Driving Innovation
SO MANUFACTURING ENGINEERING
LA English
DT Editorial Material
C1 US FDA, Washington, DC 20204 USA.
RP Hamburg, MA (reprint author), US FDA, Washington, DC 20204 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SOC MANUFACTURING ENGINEERS
PI DEARBORN
PA ONE SME DRIVE, PO BOX 930, DEARBORN, MI 48121-0930 USA
SN 0361-0853
J9 MANUF ENG
JI Manuf. Eng.
PY 2014
SU S
BP 19
EP 19
PG 1
WC Engineering, Manufacturing
SC Engineering
GA AE4EV
UT WOS:000333936500003
ER
PT J
AU Neese, SL
Pisani, SL
Doerge, DR
Helferich, WG
Sepehr, E
Chittiboyina, AG
Rotte, SCK
Smillie, TJ
Khan, IA
Korol, DL
Schantz, SL
AF Neese, Steven L.
Pisani, Samantha L.
Doerge, Daniel R.
Helferich, William G.
Sepehr, Estatira
Chittiboyina, Amar G.
Rotte, Sateesh Chandra Kumar
Smillie, Troy J.
Khan, Ikhlas A.
Korol, Donna L.
Schantz, Susan L.
TI The effects of dietary treatment with S-equol on learning and memory
processes in middle-aged ovariectomized rats
SO NEUROTOXICOLOGY AND TERATOLOGY
LA English
DT Article
DE Equol; Phytoestrogens; Aging; Executive function; Place teaming
ID ESTROGEN-RECEPTOR-ALPHA; ADULT FEMALE RATS; POSTMENOPAUSAL WOMEN;
SPATIAL MEMORY; COGNITIVE FUNCTION; SOY PHYTOESTROGENS; DEVELOPMENTAL
NEUROTOXICITY; DIFFERENTIAL REINFORCEMENT; ISOFLAVONE SUPPLEMENTS;
DELAYED ALTERNATION
AB The use of over-the-counter botanical estrogens containing isolated soy isoflavones, including genistein and daidzein, has become a popular alternative to traditional hormone therapies. Menopausal women use these products as an aide in healthy aging, including for the maintenance of cognitive function. The safety and efficacy of many of these commercial preparations remain unknown. Previous research in our lab found that treatment of ovariectomized (OVX) female Long-Evans rats with genistein impaired working memory in an operant delayed spatial alternation (DSA) task and response learning in a plus-maze, but enhanced place learning assessed in the plus-maze. The present study further examined the effects of isolated isoflavones on working memory and place learning by treating middle-aged (12-13 month old) OVX female Long-Evans rats with S-equol, the exclusive enantiomer produced by metabolism of daidzein in the mammalian gut. S-equol binds selectively to ERI3 with an affinity similar to that of genistein but has low transcriptional potency. For DSA testing, S-equol at 1.94, 0.97 mg, or 0 mg (sucrose control) was orally administered to animals daily, 30 min before behavioral testing, and again both 4 and 8 hours after the first treatment Rats were tested on the DSA task following the first, morning dose. For place learning, rats received 0.97 mg S-equol every 4 hours during the light portion of the cycle beginning 48 hours prior to behavioral testing (total exposure 8.7 mg S-equol). S-equol treatment was largely without effect on the DSA and place learning tasks. This is the first study to test the behavioral effects of isolated S-equol in OVX rodents, and shows that, unlike genistein or estradiol, repeated daily treatment with this isoflavone metabolite does not alter learning and memory processes in middle-aged OVX rats. (c) 2013 Elsevier Inc All rights reserved.
C1 [Neese, Steven L.; Schantz, Susan L.] Univ Illinois, Dept Comparat Biosci, Urbana, IL 61802 USA.
[Neese, Steven L.; Pisani, Samantha L.; Korol, Donna L.; Schantz, Susan L.] Univ Illinois, Neurosci Program, Urbana, IL 61801 USA.
[Neese, Steven L.] Baldwin Wallace Univ, Dept Psychol & Neurosci, Berea, OH 44017 USA.
[Doerge, Daniel R.; Sepehr, Estatira] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Helferich, William G.] Univ Illinois, Dept Food Sci & Human Nutr, Urbana, IL 61801 USA.
[Chittiboyina, Amar G.; Rotte, Sateesh Chandra Kumar; Smillie, Troy J.; Khan, Ikhlas A.] Univ Mississippi, Natl Ctr Nat Prod Res, Thad Cochran Res Ctr 3011, University, MS 38677 USA.
[Korol, Donna L.] Syracuse Univ, Dept Biol, Syracuse, NY 13244 USA.
RP Neese, SL (reprint author), Baldwin Wallace Univ, Dept Psychol & Neurosci, 275 Eastland Rd, Berea, OH 44017 USA.
EM stlneese@illinois.edu; spisan2@illinois.edu; daniel.doerge@fda.hhs.org;
helferic@illinois.edu; estatira.sepehr@fda.hhs.gov; amar@olemiss.edu;
sckumarr@olemiss.edu; tsmillie@olemiss.edu; ikhan@olemiss.edu;
dlkorol@syr.edu; schantz@illinois.edu
FU ODS [P50 AT006268]; NCAAM; NCI; National Institute of Environmental
Health Sciences [T32 ES007326]
FX The authors would like to thank Mindy Howe and Suren Bandara for their
help with OVX surgeries and daily animal care and John Katzenellebogen
for reviewing this manuscript. This research was supported by the P50
AT006268 from ODS, NCAAM, and NCI (DLK, SLS, DRD, WGH). Steven Neese
also received support from the National Institute of Environmental
Health Sciences Grant T32 ES007326.
NR 82
TC 4
Z9 4
U1 2
U2 5
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0892-0362
EI 1872-9738
J9 NEUROTOXICOL TERATOL
JI Neurotoxicol. Teratol.
PD JAN-FEB
PY 2014
VL 41
BP 80
EP 88
DI 10.1016/j.ntt.2013.12.004
PG 9
WC Neurosciences; Toxicology
SC Neurosciences & Neurology; Toxicology
GA AE4IW
UT WOS:000333947100012
PM 24368316
ER
PT J
AU Fine, AJ
Sorbello, A
Kortepeter, C
Scarazzini, L
AF Fine, Andrew J.
Sorbello, Alfred
Kortepeter, Cindy
Scarazzini, Linda
TI Progressive Multifocal Leukoencephalopathy after Natalizumab
Discontinuation
SO ANNALS OF NEUROLOGY
LA English
DT Article
ID MULTIPLE-SCLEROSIS; PATIENT; RISK
AB Objective: To identify cases of laboratory-or biopsy-confirmed progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS) who previously discontinued natalizumab (NTZ) for reasons unrelated to suspected or proven PML and assess PML risk factors in these cases.
Methods: We searched the US Food and Drug Administration Adverse Event Reporting System and MEDLINE for reports submitted from 2006 to 2012 of laboratory-confirmed PML with symptom onset >= 30 days following NTZ withdrawal. We only analyzed cases where NTZ discontinuation was unrelated to suspected PML.
Results: Seventeen patients discontinued NTZ for reasons unrelated to PML but were subsequently diagnosed with the disease. The median NTZ duration was 47 monthly doses (range = 9-59 doses). All patients presented with compatible clinical symptoms within 6 months following withdrawal, and PML was confirmed by brain biopsy or by identifying JC virus in the cerebrospinal fluid by polymerase chain reaction. Immune reconstitution inflammatory syndrome (IRIS) was reported in 11 patients. Eleven patients (65%) received new MS treatments between NTZ discontinuation and PML confirmation. No deaths were reported. At NTZ withdrawal, 16 patients (94%) had >= 1 PML risk factor, including NTZ duration >= 2 years (n = 13), prior immunosuppressive agents (n = 8), and reported anti-JC virus seropositivity (n = 13).
Interpretation: NTZ-treated patients presenting clinically with PML within 6 months after NTZ withdrawal frequently have pre-existing PML risk factors. Clinicians need heightened awareness for new onset PML, IRIS, and MS relapse in evaluating neurological decline following NTZ discontinuation.
C1 [Fine, Andrew J.; Sorbello, Alfred; Kortepeter, Cindy] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Fine, AJ (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Andrew.Fine@fda.hhs.gov
NR 18
TC 23
Z9 23
U1 0
U2 5
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0364-5134
EI 1531-8249
J9 ANN NEUROL
JI Ann. Neurol.
PD JAN
PY 2014
VL 75
IS 1
BP 108
EP 115
DI 10.1002/ana.24051
PG 8
WC Clinical Neurology; Neurosciences
SC Neurosciences & Neurology
GA AA3WQ
UT WOS:000331026300012
PM 24242357
ER
PT J
AU Miesegaes, GR
Lute, SC
Read, EK
Brorson, KA
AF Miesegaes, G. R.
Lute, S. C.
Read, E. K.
Brorson, K. A.
TI Viral Clearance by Flow-Through Mode Ion Exchange Columns and Membrane
Adsorbers
SO BIOTECHNOLOGY PROGRESS
LA English
DT Article
DE monoclonal antibodies; viral clearance; anion exchange chromatography;
membrane adsorbers; downstream purification; design-of-experiments; DoE
ID VIRUS REMOVAL; CHROMATOGRAPHY; PURIFICATION; PROTEIN; ANTIBODIES;
ROBUST; MEDIA; DNA
AB Anion exchange (AEX) is a common downstream purification operation for biotechnology products manufactured in cell culture such as therapeutic monoclonal antibodies (mAbs) and Fc-fusion proteins. We present a head-to-head comparison of the viral clearance efficiency of AEX adsorbers and column chromatography using the same process fluids and comparable run conditions. We also present overall trends from the CDER viral clearance database. In our comparison of multiple brands of resins and adsorbers, clearance of three model viruses (PPV, X-MuLV, and PR772) was largely comparable, with some exceptions which may reflect run conditions that had not been optimized on a resin/membrane specific basis. (c) 2013 American Institute of Chemical Engineers Biotechnol. Prog., 30:124-131, 2014
C1 [Miesegaes, G. R.; Lute, S. C.; Read, E. K.; Brorson, K. A.] CDER FDA, Off Biotechnol Prod, Silver Spring, MD 20903 USA.
RP Brorson, KA (reprint author), CDER FDA, Off Biotechnol Prod, 10903 New Hampshire Ave, Silver Spring, MD 20903 USA.
EM kurt.brorson@fda.hhs.gov
FU CDER Regulatory Science and Research project [11-64]
FX The authors thank Michele Dougherty and Audey Jia for careful review of
this manuscript. Funding was provided by the CDER Regulatory Science and
Research project grant 11-64.
NR 31
TC 3
Z9 3
U1 2
U2 14
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 8756-7938
EI 1520-6033
J9 BIOTECHNOL PROGR
JI Biotechnol. Prog.
PD JAN
PY 2014
VL 30
IS 1
BP 124
EP 131
DI 10.1002/btpr.1832
PG 8
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA AA9AJ
UT WOS:000331385800013
PM 24167103
ER
PT J
AU Bento, JC
Lane, KD
Read, EK
Cerca, N
Christie, GE
AF Bento, Joana C.
Lane, Kristin D.
Read, Erik K.
Cerca, Nuno
Christie, Gail E.
TI Sequence determinants for DNA packaging specificity in the S-aureus
pathogenicity island SaPI1
SO PLASMID
LA English
DT Article
DE Pathogenicity island; SaPI; Terminase; DNA packaging; Helper phage; Pac
site
ID CAPSID SIZE DETERMINATION; GRAM-POSITIVE BACTERIA; HELPER PHAGE;
PROTEINS; SITE; BACTERIOPHAGES; INTERFERENCE; REPLICATION; RECOGNITION;
INITIATION
AB The SaPIs and their relatives are a family of genomic islands that exploit helper phages for high frequency horizontal transfer. One of the mechanisms used by SaPIs to accomplish this molecular piracy is the redirection of the helper phage DNA packaging machinery. SaPls encode a small terminase subunit that can be substituted for that of the phage. In this study we have determined the initial packaging cleavage sites for helper phage 80a, which uses the phage-encoded small terminase subunit, and for SaPI1, which uses the SaPI-encoded small terminase subunit. We have identified a 19 nt SaPI1 sequence that is necessary and sufficient to allow high frequency 80a transduction of a plasmid by a terminase carrying the SaPI1-encoded small subunit. We also show that the hybrid enzyme with the SaPI1 small terminase subunit is capable of generalized transduction. (C) 2014 Elsevier Inc. All rights reserved.
C1 [Bento, Joana C.; Lane, Kristin D.; Christie, Gail E.] Virginia Commonwealth Univ, Sch Med, Dept Microbiol & Immunol, Richmond, VA 23298 USA.
[Read, Erik K.] Food & Drug Adm, Ctr Drug Evaluat & Res, Div Monoclonal Antibodies, Silver Spring, MD 20993 USA.
[Bento, Joana C.; Cerca, Nuno] Univ Minho, Ctr Biol Engn, IBB, P-4710057 Braga, Portugal.
RP Christie, GE (reprint author), Virginia Commonwealth Univ, Sch Med, Dept Microbiol & Immunol, POB 980678, Richmond, VA 23298 USA.
EM jcbento@vcu.edu; lanekd@vcu.edu; Erik.Read@fda.hhs.gov;
nunocerca@ceb.uminho.pt; christie@vcu.edu
OI Cerca, Nuno/0000-0003-3365-3537
FU FDA's Medical Countermeasures Initiative [HHSF2232010000521]; NIH [1R56
AI081837]; Portuguese Institute Fundacao para a Ciencia e Tecnologia
(FCT); PhD Fellowship [SFRH/BD/66250/2009]; National Academies National
Research Council; NIAID/NIFI [HHSN272200700055C]
FX This work was performed in part under FDA's Medical Countermeasures
Initiative, Contract #HHSF2232010000521 and NIH 1R56 AI081837 (to GEC).
JCB was supported by the Portuguese Institute Fundacao para a Ciencia e
Tecnologia (FCT), PhD Fellowship SFRH/BD/66250/2009. E.K.R. was
supported by the National Academies National Research Council; his
contribution to this study was carried out at NICHHD, NIH, Bethesda, MD,
in the laboratory of the late Robert A. Weisberg. Plasmid pCN51 (in
strain NRS613) and strain RN4282 (NRS145) were obtained through the
Network of Antimicrobial Resistance in Staphylococcus aureus (NARSA)
program supported under NIAID/NIFI contract #HHSN272200700055C.
NR 36
TC 5
Z9 5
U1 0
U2 3
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0147-619X
EI 1095-9890
J9 PLASMID
JI Plasmid
PD JAN
PY 2014
VL 71
BP 8
EP 15
PG 8
WC Genetics & Heredity; Microbiology
SC Genetics & Heredity; Microbiology
GA AC0MG
UT WOS:000332188800002
PM 24365721
ER
PT J
AU Vorvolakos, K
Coburn, JC
Saylork, DM
AF Vorvolakos, Katherine
Coburn, James C.
Saylork, David M.
TI Dynamic interfacial behavior of viscoelastic aqueous hyaluronic acid:
effects of molecular weight, concentration and interfacial velocity
SO SOFT MATTER
LA English
DT Article
ID PRIMARY CILIARY DYSKINESIA; NAKED MOLE-RAT; MECHANICAL-PROPERTIES;
PERICELLULAR MATRIX; CONTACT INHIBITION; CANCER RESISTANCE;
CELL-MIGRATION; HYDROGELS; ADHESION; MOTION
AB An aqueous hyaluronic acid (HA((aq))) pericellular coat, when mediating the tactile aspect of cellular contact inhibition, has three tasks: interface formation, mechanical signal transmission and interface separation. To quantify the interfacial adhesive behavior of HA((aq)), we induce simultaneous interface formation and separation between HA((aq)) and a model hydrophobic, hysteretic Si-SAM surface. While surface tension gamma remains essentially constant, interface formation and separation depend greatly on concentration (5 <= C <= 30 mg mL(-1)), molecular weight (6 <= MW <= 2000 kDa) and interfacial velocity (0 <= V <= 3 mm s-1), each of which affect shear elastic and loss moduli G' and G '', respectively. Viscoelasticity dictates the mode of interfacial motion: wetting-dewetting, capillary necking, or rolling. Wetting-dewetting is quantified using advancing and receding contact angles theta(A) and theta(R), and the hysteresis between them, yielding data landscapes for each C above the [MW, V] plane. The landscape sizes, shapes, and curvatures disclose the interplay, between surface tension and viscoelasticity, which governs interfacial dynamics. Gel point coordinates modulus G and angular frequency omega appear to predict wetting-dewetting (G < 75 omega(0.2)), capillary necking (75 omega(0.2) < G < 200 omega(0.075)) or rolling (G > 200 omega(0.075)). Dominantly dissipative HA((aq)) sticks to itself and distorts irreversibly before separating, while dominantly elastic HA((aq)) makes contact and separates with only minor, reversible distortion. We propose the dimensionless number (G'V)/(omega,gamma), varying from similar to 10(-5) to similar to 10(3) in this work, as a tool to predict the mode of interface formation-separation by relating interfacial kinetics with bulk viscoelasticity. Cellular contact inhibition may be thus aided or compromised by physiological or interventional shifts in [C, MW, V], and thus in (G'V)/(omega,gamma), which affect both mechanotransduction and interfacial dynamics. These observations, understood in terms of physical properties, may be broadened to probe interfacial dynamics of other viscoelastic aqueous biopolymers.
C1 [Vorvolakos, Katherine; Saylork, David M.] US FDA, Div Chem & Mat Sci, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
RP Vorvolakos, K (reprint author), US FDA, Div Chem & Mat Sci, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
EM katherine.vorvolakos@fda.hhs.gov
FU Medical Device Fellowship Program of the Center for Devices and
Radiological Health in United States Food and Drug Administration;
Division of Chemistry and Material Science in the Office of Science and
Engineering Laboratories, of the Center for Devices and Radiological
Health in the United States Food and Drug Administration
FX This work was supported by the Medical Device Fellowship Program, and by
the Division of Chemistry and Material Science in the Office of Science
and Engineering Laboratories, of the Center for Devices and Radiological
Health in the United States Food and Drug Administration. We thank
Professor Srinivasa R. Raghavan of the University of Maryland Department
of Chemical and Biomolecular Engineering for guidance on rheometry. We
also thank Dr Steven Pollack, Dr Peter Nemes and Dr Charles Durfor for
helpful discussions.
NR 52
TC 2
Z9 2
U1 1
U2 27
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1744-683X
EI 1744-6848
J9 SOFT MATTER
JI Soft Matter
PY 2014
VL 10
IS 13
BP 2304
EP 2312
DI 10.1039/c3sm52372a
PG 9
WC Chemistry, Physical; Materials Science, Multidisciplinary; Physics,
Multidisciplinary; Polymer Science
SC Chemistry; Materials Science; Physics; Polymer Science
GA AC4GJ
UT WOS:000332478800022
PM 24795963
ER
PT J
AU Lin, BH
Guthrie, J
Rahkovsky, I
Lin, CT
Lee, JY
AF Lin, Biing-Hwan
Guthrie, Joanne
Rahkovsky, Ilya
Lin, Chung-Tung
Lee, Jonq-Ying
TI Simulating the Potential Effects of a Shelf-Tag Nutrition Information
Program and Pricing on Diet Quality Associated with Ready-to-Eat Cereals
SO INTERNATIONAL FOOD AND AGRIBUSINESS MANAGEMENT REVIEW
LA English
DT Article
DE breakfast cereals; Guiding Stars Program; pricing intervention; dietary
outcomes
ID FOOD-PRICES; PURCHASES; DEMAND; POLICY
AB Previous research has shown that the Guiding Stars Program (TM) (GSP), a shelf-tag nutrition information system used in some supermarkets in the United States (US), increases consumer demand for ready-to-eat (RTE) breakfast cereals that the program considers more nutritious. Further, consumer demand for cereals is found to respond to price. Here we simulate potential changes in RTE cereal consumption predicted by estimated demand if a GSP or a 10% price manipulation were in effect nationwide in the US, and measure the impact on intakes of whole grains, added sugars, sodium, and calories. We find small effects for the GSP and somewhat larger ones for a 10% price intervention.
C1 [Lin, Biing-Hwan; Guthrie, Joanne; Rahkovsky, Ilya] Econ Res Serv USDA, Washington, DC 20024 USA.
[Lin, Chung-Tung] Ctr Food Safety & Appl Nutr FDA, College Pk, MD 20740 USA.
[Lee, Jonq-Ying] Univ Florida, Dept Food & Resource Econ, Gainesville, FL 32611 USA.
RP Lin, BH (reprint author), Econ Res Serv USDA, 355 E St SW, Washington, DC 20024 USA.
EM blin@ers.usda.gov; jguthrie@ers.usda.gov; irahkovsky@ers.usda.gov;
chung-tung.lin@fda.hhs.gov; jonqying@ufl.edu
NR 33
TC 0
Z9 0
U1 0
U2 7
PU INT FOOD & AGRIBUSINESS MANAGEMENT REVIEW
PI COLLEGE STATION
PA 333 BLOCKER BUILDING, 2124 TAMU, COLLEGE STATION, TX 77843-2124 USA
SN 1559-2448
J9 INT FOOD AGRIBUS MAN
JI Int. Food Agribus. Manag. Rev.
PY 2014
VL 17
IS A
SI SI
BP 7
EP 23
PG 17
WC Agricultural Economics & Policy
SC Agriculture
GA AB7VD
UT WOS:000331998100002
ER
PT J
AU Darpo, B
Sarapa, N
Garnett, C
Benson, C
Dota, C
Ferber, G
Jarugula, V
Johannesen, L
Keirns, J
Krudys, K
Ortemann-Renon, C
Riley, S
Rogers-Subramaniam, D
Stockbridge, N
AF Darpo, Borje
Sarapa, Nenad
Garnett, Christine
Benson, Charles
Dota, Corina
Ferber, Georg
Jarugula, Venkateswar
Johannesen, Lars
Keirns, James
Krudys, Kevin
Ortemann-Renon, Catherine
Riley, Steve
Rogers-Subramaniam, Danise
Stockbridge, Norman
TI The IQ-CSRC Prospective Clinical Phase 1 Study: "Can Early QT Assessment
Using Exposure Response Analysis Replace the Thorough QT Study?"
SO ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
LA English
DT Article
DE Thorough QT; QTc study; QTc interval; healthy volunteers;
single-ascending-dose
ID HEALTHY-SUBJECTS; DE-POINTES; QT/QTC; PROLONGATION; INTERVAL; DATABASE;
DRUGS
AB A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac Safety Research Consortium has been formed to design a clinical study in healthy subjects demonstrating that the thorough QT (TQT) study can be replaced by robust ECG monitoring and exposure-response (ER) analysis of data generated from First-in-Man single ascending dose (SAD) studies. Six marketed drugs with well-characterized QTc effects were identified in discussions with FDA; five have caused QT prolongation above the threshold of regulatory concern. Twenty healthy subjects will be enrolled in a randomized, placebo-controlled study designed with the intent to have similar power to exclude small QTc effects as a SAD study. Two doses (low and high) of each drug will be given on separate, consecutive days to 9 subjects. Six subjects will receive placebo. Data will be analyzed using linear mixed-effects ER models. Criteria for QT-positive drugs will be the demonstration of an upper bound (UB) of the 2-sided 90% confidence interval (CI) of the projected QTc effect at the peak plasma level of the lower dose above the threshold of regulatory concern (currently 10 ms) and a positive slope of ER relationship. The criterion for QT-negative drug will be an UB of the CI of the projected QTc effect of the higher dose <10 ms. It is expected that a successful outcome in this study will provide evidence supporting replacement of the TQT study with ECG assessments in standard early clinical development studies for a new chemical entity.
C1 [Darpo, Borje] Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Div Cardiovasc Med, Stockholm, Sweden.
[Darpo, Borje] iCardiac Technol, Rochester, NY USA.
[Sarapa, Nenad] Bayer Healthcare Inc, Clin Sci, Whippany, NJ USA.
[Garnett, Christine] Certara, St Louis, MO USA.
[Benson, Charles; Rogers-Subramaniam, Danise] Eli Lilly & Co, Lilly Corp Ctr, Indianapolis, IN 46285 USA.
[Dota, Corina] AstraZeneca R&D, Molndal, Sweden.
[Ferber, Georg] Stat Georg Ferber GmbH, CH-4125 Riehen, Switzerland.
[Jarugula, Venkateswar] Novartis Inst Biomed Res, Drug Metab & Pharmacokinet, E Hanover, NJ USA.
[Johannesen, Lars; Krudys, Kevin] US FDA, Div Pharmacometr, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Johannesen, Lars] Karolinska Univ Hosp, Karolinska Inst, Dept Clin Physiol, Stockholm, Sweden.
[Keirns, James] Astellas Pharma Global Dev Inc, Global Clin Pharmacol & Exploratory Dev, Northbrook, IL USA.
[Ortemann-Renon, Catherine] Clin & Exploratory Pharmacol, Bridgewater, MA USA.
[Riley, Steve] Pfizer Inc, Specialty Care Business Unit, Clin Pharmacol, Groton, CT 06340 USA.
[Stockbridge, Norman] US FDA, Ctr Drug Evaluat & Res, Div Cardiovasc & Renal Prod, Silver Spring, MD USA.
RP Darpo, B (reprint author), Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Div Cardiovasc Med, Stockholm, Sweden.
EM borje.darpo@telia.com
NR 21
TC 35
Z9 36
U1 0
U2 1
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1082-720X
EI 1542-474X
J9 ANN NONINVAS ELECTRO
JI Ann. Noninvasive Electrocardiol.
PD JAN
PY 2014
VL 19
IS 1
BP 70
EP 81
DI 10.1111/anec.12128
PG 12
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA AA5OC
UT WOS:000331148300010
PM 24372708
ER
PT S
AU Ke, AB
Rostami-Hodjegan, A
Zhao, P
Unadkat, JD
AF Ke, Alice Ban
Rostami-Hodjegan, Amin
Zhao, Ping
Unadkat, Jashvant D.
BE Insel, PA
TI Pharmacometrics in Pregnancy: An Unmet Need
SO ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 54
SE Annual Review of Pharmacology and Toxicology
LA English
DT Review; Book Chapter
DE modeling; simulation; PBPK; CYP; POP-PK
ID INTERINDIVIDUAL VARIABILITY; PHARMACOKINETIC MODEL; FALCIPARUM-MALARIA;
CLINICAL-TRIALS; DRUG TRIALS; WOMEN; FETAL; PRESCRIPTION; DISPOSITION;
METABOLISM
AB Pregnant women and their fetuses are orphan populations with respect to the safety and efficacy of drugs. Physiological and absorption, distribution, metabolism, and excretion (ADME) changes during pregnancy can significantly affect drug pharmacokinetics (PK) and may necessitate dose adjustment. Here, the specific aspects related to the design, execution, and analysis of clinical studies in pregnant women are discussed, underlining the unmet need for top-down pharmacometrics analyses and bottom-up modeling approaches. The modeling tools that support data analysis for the pregnancy population are reviewed, with a focus on physiologically based pharmacokinetics (PBPK) and population pharmacokinetics (POP-PK). By integrating physiological data, preclinical data, and clinical data (e.g., via POP-PK) to quantify anticipated changes in the PK of drugs during pregnancy, the PBPK approach allows extrapolation beyond the previously studied model drugs to other drugs with well-characterized ADME characteristics. Such a systems pharmacology approach can identify drugs whose PK may be altered during pregnancy, guide rational PK study design, and support dose adjustment for pregnant women.
C1 [Ke, Alice Ban] Lilly Res Labs, Drug Disposit, Indianapolis, IN 46285 USA.
[Rostami-Hodjegan, Amin] Univ Manchester, Sch Pharm & Pharmaceut Sci, Manchester M13 9PT, Lancs, England.
[Rostami-Hodjegan, Amin] Simcyp Ltd, Sheffield S2 4SU, S Yorkshire, England.
[Zhao, Ping] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Unadkat, Jashvant D.] Univ Washington, Dept Pharmaceut, Seattle, WA 98195 USA.
RP Ke, AB (reprint author), Lilly Res Labs, Drug Disposit, Indianapolis, IN 46285 USA.
EM zamek_ban_alice@lilly.com; amin.rostami@manchester.ac.uk;
Ping.Zhao@fda.hhs.gov; jash@u.washington.edu
NR 55
TC 15
Z9 15
U1 0
U2 13
PU ANNUAL REVIEWS
PI PALO ALTO
PA 4139 EL CAMINO WAY, PO BOX 10139, PALO ALTO, CA 94303-0897 USA
SN 0362-1642
BN 978-0-8243-0454-6
J9 ANNU REV PHARMACOL
JI Annu. Rev. Pharmacol. Toxicol.
PY 2014
VL 54
BP 53
EP 69
DI 10.1146/annurev-pharmtox-011613-140009
PG 17
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA BJR57
UT WOS:000329822200004
PM 24392692
ER
PT J
AU Natanegara, F
Neuenschwander, B
Seaman, JW
Kinnersley, N
Heilmann, CR
Ohlssen, D
Rochester, G
AF Natanegara, Fanni
Neuenschwander, Beat
Seaman, John W., Jr.
Kinnersley, Nelson
Heilmann, Cory R.
Ohlssen, David
Rochester, George
TI The current state of Bayesian methods in medical product development:
survey results and recommendations from the DIA Bayesian Scientific
Working Group
SO PHARMACEUTICAL STATISTICS
LA English
DT Article
ID CLINICAL-TRIALS; P-VALUES; STATISTICS; MODELS; ELICITATION; INFERENCE;
BELIEFS; IDEAS
C1 [Natanegara, Fanni; Heilmann, Cory R.] Eli Lilly & Co, Indianapolis, IN 46285 USA.
[Neuenschwander, Beat] Novartis Pharma AG, Basel, Switzerland.
[Seaman, John W., Jr.] Baylor Univ, Dept Stat Sci, Waco, TX 76798 USA.
[Kinnersley, Nelson] Roche Prod Ltd, Welwyn Garden City AL7 3AY, Herts, England.
[Ohlssen, David] Novartis Pharmaceut, E Hanover, NJ USA.
[Rochester, George] US FDA, Ctr Tobacco Prod, Silver Sprint, MD USA.
RP Natanegara, F (reprint author), Eli Lilly & Co, Indianapolis, IN 46285 USA.
EM natanegara_fanni@lilly.com
NR 49
TC 2
Z9 2
U1 0
U2 3
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1539-1604
EI 1539-1612
J9 PHARM STAT
JI Pharm. Stat.
PD JAN
PY 2014
VL 13
IS 1
SI SI
BP 3
EP 12
PG 10
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AA3NW
UT WOS:000331000400002
PM 24027093
ER
PT J
AU Price, KL
Xia, HA
Lakshminarayanan, M
Madigan, D
Manner, D
Scott, J
Stamey, JD
Thompson, L
AF Price, Karen L.
Xia, H. Amy
Lakshminarayanan, Mani
Madigan, David
Manner, David
Scott, John
Stamey, James D.
Thompson, Laura
TI Bayesian methods for design and analysis of safety trials
SO PHARMACEUTICAL STATISTICS
LA English
DT Article
ID SAMPLE-SIZE DETERMINATION; CLINICAL-TRIALS; CARDIOVASCULAR RISK; EVENT
TIMES; FACTOR-VIII; METAANALYSIS; DISTRIBUTIONS; MODELS; CHOICE
C1 [Price, Karen L.; Manner, David] Eli Lilly & Co, Indianapolis, IN 46285 USA.
[Xia, H. Amy] Amgen Inc, Thousand Oaks, CA 91320 USA.
[Lakshminarayanan, Mani] Merck Res Labs, N Wales, PA USA.
[Madigan, David] Columbia Univ, Dept Stat, New York, NY USA.
[Scott, John] US FDA, Ctr Biol Evaluat & Res, Off Biostatist & Epidemiol, Silver Spring, MD USA.
[Stamey, James D.] Baylor Univ, Dept Stat, Waco, TX 76798 USA.
[Thompson, Laura] US FDA, Ctr Devices & Radiol Hlth, Off Surveillance & Biometr, Silver Spring, MD USA.
RP Price, KL (reprint author), Eli Lilly & Co, Lilly Corp Ctr, Global Stat Sci & Adv Analyt, Indianapolis, IN 46285 USA.
EM price_k@lilly.com
OI Stamey, James/0000-0002-3787-6490
NR 65
TC 5
Z9 5
U1 0
U2 5
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1539-1604
EI 1539-1612
J9 PHARM STAT
JI Pharm. Stat.
PD JAN
PY 2014
VL 13
IS 1
SI SI
BP 13
EP 24
PG 12
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AA3NW
UT WOS:000331000400003
PM 23897858
ER
PT J
AU Gamalo, MA
Tiwari, RC
LaVange, LM
AF Gamalo, Meg A.
Tiwari, Ram C.
LaVange, Lisa M.
TI Bayesian approach to the design and analysis of non-inferiority trials
for anti-infective products
SO PHARMACEUTICAL STATISTICS
LA English
DT Article
ID VENTILATOR-ASSOCIATED PNEUMONIA; HOSPITAL-ACQUIRED PNEUMONIA;
INFECTIOUS-DISEASES SOCIETY; POWER PRIOR DISTRIBUTIONS; CLINICAL-TRIALS;
PHARMACOKINETICS-PHARMACODYNAMICS; NONPARAMETRIC PROBLEMS; ANTIBACTERIAL
AGENTS; NOSOCOMIAL PNEUMONIA; PREDICTIVE APPROACH
C1 [Gamalo, Meg A.; Tiwari, Ram C.; LaVange, Lisa M.] US FDA, Off Biostat, Silver Spring, MD 20993 USA.
RP Gamalo, MA (reprint author), US FDA, Off Biostat, Silver Spring, MD 20993 USA.
EM margaret.gamalo@fda.hhs.gov
NR 53
TC 12
Z9 12
U1 3
U2 14
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1539-1604
EI 1539-1612
J9 PHARM STAT
JI Pharm. Stat.
PD JAN
PY 2014
VL 13
IS 1
SI SI
BP 25
EP 40
PG 16
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AA3NW
UT WOS:000331000400004
PM 23913880
ER
PT J
AU Viele, K
Berry, S
Neuenschwander, B
Amzal, B
Chen, F
Enas, N
Hobbs, B
Ibrahim, JG
Kinnersley, N
Lindborg, S
Micallef, S
Roychoudhury, S
Thompson, L
AF Viele, Kert
Berry, Scott
Neuenschwander, Beat
Amzal, Billy
Chen, Fang
Enas, Nathan
Hobbs, Brian
Ibrahim, Joseph G.
Kinnersley, Nelson
Lindborg, Stacy
Micallef, Sandrine
Roychoudhury, Satrajit
Thompson, Laura
TI Use of historical control data for assessing treatment effects in
clinical trials
SO PHARMACEUTICAL STATISTICS
LA English
DT Article
ID POWER PRIOR DISTRIBUTIONS; SAMPLE-SIZE; MODELS; INFORMATION
C1 [Viele, Kert; Berry, Scott] Berry Consultants, Austin, TX 78746 USA.
[Neuenschwander, Beat] Novartis Pharmaceut, CIS, Basel, Switzerland.
[Amzal, Billy] LA SER Analyt, London, England.
[Chen, Fang] SAS, Cary, NC USA.
[Enas, Nathan] Eli Lilly & Co, Indianapolis, IN 46285 USA.
[Hobbs, Brian] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA.
[Ibrahim, Joseph G.] Univ N Carolina, Chapel Hill, NC USA.
[Kinnersley, Nelson] F Hoffmann La Roche & Cie AG, Welwyn Garden City, Herts, England.
[Lindborg, Stacy] Biogen Idec Inc, Cambridge, MA USA.
[Micallef, Sandrine] Sanofi Aventis R&D, Paris, France.
[Roychoudhury, Satrajit] Novartis, E Hanover, NJ USA.
[Thompson, Laura] US FDA, Rockville, MD 20857 USA.
RP Viele, K (reprint author), Berry Consultants, Austin, TX 78746 USA.
EM kert@berryconsultants.net
FU NCI NIH HHS [P01 CA142538, P30 CA016672]
NR 25
TC 23
Z9 24
U1 1
U2 16
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1539-1604
EI 1539-1612
J9 PHARM STAT
JI Pharm. Stat.
PD JAN
PY 2014
VL 13
IS 1
SI SI
BP 41
EP 54
PG 14
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA AA3NW
UT WOS:000331000400005
PM 23913901
ER
PT J
AU Kleensang, A
Maertens, A
Rosenberg, M
Fitzpatrick, S
Lamb, J
Auerbach, S
Brennan, R
Crofton, KM
Gordon, B
Fornace, AJ
Gaido, K
Gerhold, D
Haw, R
Henney, A
Ma'ayan, A
McBride, M
Monti, S
Ochs, MF
Pandey, A
Sharan, R
Stierum, R
Tugendreich, S
Willett, C
Wittwehr, C
Xia, JG
Patton, GW
Arvidson, K
Bouhifd, M
Hogberg, HT
Luechtefeld, T
Smirnova, L
Zhao, L
Adeleye, Y
Kanehisa, M
Carmichael, P
Andersen, ME
Hartung, T
AF Kleensang, Andre
Maertens, Alexandra
Rosenberg, Michael
Fitzpatrick, Suzanne
Lamb, Justin
Auerbach, Scott
Brennan, Richard
Crofton, Kevin M.
Gordon, Ben
Fornace, Albert J., Jr.
Gaido, Kevin
Gerhold, David
Haw, Robin
Henney, Adrian
Ma'ayan, Avi
McBride, Mary
Monti, Stefano
Ochs, Michael F.
Pandey, Akhilesh
Sharan, Roded
Stierum, Rob
Tugendreich, Stuart
Willett, Catherine
Wittwehr, Clemens
Xia, Jianguo
Patton, Geoffrey W.
Arvidson, Kirk
Bouhifd, Mounir
Hogberg, Helena T.
Luechtefeld, Thomas
Smirnova, Lena
Zhao, Liang
Adeleye, Yeyejide
Kanehisa, Minoru
Carmichael, Paul
Andersen, Melvin E.
Hartung, Thomas
TI Pathways of Toxicity
SO ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
LA English
DT Article
DE systems toxicology; pathways of toxicity; adverse outcome pathways; in
vitro toxicology; human toxome
ID BIOLOGICAL NETWORKS; SYSTEMS TOXICOLOGY; 21ST-CENTURY; THOUGHT; FOOD;
VALIDATION; TOXICOGENOMICS; PERSPECTIVES; TECHNOLOGIES; INTEGRATION
AB Despite wide-spread consensus on the need to transform toxicology and risk assessment in order to keep pace with technological and computational changes that have revolutionized the life sciences, there remains much work to be done to achieve the vision of toxicology based on a mechanistic foundation. A workshop was organized to explore one key aspect of this transformation the development of Pathways of Toxicity (PoT) as a key tool for hazard identification based on systems biology. Several issues were discussed in depth in the workshop: The first was the challenge of formally defining the concept of a PoT as distinct from, but complementary to, other toxicological pathway concepts such as mode of action (MoA). The workshop came up with a preliminary definition of PoT as "A molecular definition of cellular processes shown to mediate adverse outcomes of toxicants". It is further recognized that normal physiological pathways exist that maintain homeostasis and these, sufficiently perturbed, can become PoT. Second, the workshop sought to define the adequate public and commercial resources for PoT information, including data, visualization, analyses, tools, and use-cases, as well as the kinds of efforts that will be necessary to enable the creation of such a resource. Third, the workshop explored ways in which systems biology approaches could inform pathway annotation, and which resources are needed and available that can provide relevant PoT information to the diverse user communities.
C1 [Kleensang, Andre; Maertens, Alexandra; Bouhifd, Mounir; Hogberg, Helena T.; Luechtefeld, Thomas; Smirnova, Lena; Zhao, Liang; Hartung, Thomas] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Ctr Alternat Anim Testing, Baltimore, MD USA.
[Rosenberg, Michael; McBride, Mary] Agilent Technol, Santa Clara, CA USA.
[Fitzpatrick, Suzanne; Gaido, Kevin] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
[Lamb, Justin] Genometry Inc, Cambridge, MA USA.
[Auerbach, Scott] NIEHS, Div Natl Toxicol Program, NIH, Res Triangle Pk, NC 27709 USA.
[Brennan, Richard] Thomson Reuters Inc, Carlsbad, CA USA.
[Crofton, Kevin M.] US EPA, Off Res & Dev, Natl Ctr Computat Toxicol, Res Triangle Pk, NC 27711 USA.
[Gordon, Ben] MIT, Dept Biol Engn, Cambridge, MA 02139 USA.
[Fornace, Albert J., Jr.] Georgetown Univ, Dept Biochem & Mol & Cellular Biol, Washington, DC USA.
[Fornace, Albert J., Jr.] Georgetown Univ, Lombardi Comprehens Canc Ctr, Washington, DC USA.
[Gerhold, David] NIH, Natl Ctr Adv Translat Sci, Rockville, MD USA.
[Haw, Robin] Ontario Inst Canc Res, Reactome, Toronto, ON, Canada.
[Henney, Adrian] Heidelberg Univ, German Virtual Liver Network, Heidelberg, Germany.
[Ma'ayan, Avi] Icahn Sch Med Mt Sinai, Dept Pharmacol & Syst Therapeut, New York, NY USA.
[Monti, Stefano] Boston Univ, Sch Med, Sect Computat Biomed, Boston, MA 02118 USA.
[Ochs, Michael F.] Johns Hopkins Univ, Sch Med, Ctr Oncol, Baltimore, MD 21205 USA.
[Pandey, Akhilesh] Johns Hopkins Univ, Sch Med, Inst Med Genet, Baltimore, MD USA.
[Pandey, Akhilesh] Johns Hopkins Univ, Sch Med, Dept Biol Chem, Baltimore, MD 21205 USA.
[Pandey, Akhilesh] Johns Hopkins Univ, Sch Med, Dept Oncol, Baltimore, MD 21205 USA.
[Pandey, Akhilesh] Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD 21205 USA.
[Sharan, Roded] Tel Aviv Univ, Blavatnik Sch Comp Sci, IL-69978 Tel Aviv, Israel.
[Stierum, Rob] TNO Hlth Living Microbiol & Syst Biol, Zeist, Netherlands.
[Tugendreich, Stuart] Ingenu Syst Inc, Redwood City, CA USA.
[Willett, Catherine] Humane Soc United States, Washington, DC USA.
[Wittwehr, Clemens] Commiss European Communities, Joint Res Ctr, Syst Toxicol Unit, I-21020 Ispra, Italy.
[Xia, Jianguo] Univ British Columbia, Dept Microbiol & Immunol, Vancouver, BC V5Z 1M9, Canada.
[Patton, Geoffrey W.; Arvidson, Kirk] US FDA, Ctr Food Safety & Appl Nutr, Off Food Addit Safety, College Pk, MD USA.
[Adeleye, Yeyejide; Carmichael, Paul] Unilever, Safety & Environm Assurance Ctr, Sharnbrook, Beds, England.
[Kanehisa, Minoru] Kyoto Univ, Inst Chem Res, Kyoto 606, Japan.
[Andersen, Melvin E.] Hamner Inst Hlth Sci, Res Triangle Pk, NC USA.
[Hartung, Thomas] Univ Konstanz, CAAT Europe, Constance, Germany.
RP Hartung, T (reprint author), Johns Hopkins Bloomberg Sch Publ Hlth, Ctr Alternat Anim Testing, 615 North Wolfe St,W7032, Baltimore, MD 21205 USA.
EM thartung@jhsph.edu
RI Crofton, Kevin/J-4798-2015; Zhao, Liang/I-4777-2015;
OI Crofton, Kevin/0000-0003-1749-9971; Zhao, Liang/0000-0002-2126-6778;
Kleensang, Andre/0000-0002-4564-7399
FU Unilever; NIH transformative research project on "Mapping the Human
Toxome by Systems Toxicology" [R01ES020750]; FDA grant "DNTox-21c
Identification of pathways of developmental neurotoxicity for high
throughput testing by metabolomics" [U01FD004230]
FX This CAAT workshop on Pathways of Toxicity was made possible by support
from Unilever and the extensive discussions and experiences of the NIH
transformative research project on "Mapping the Human Toxome by Systems
Toxicology" (R01ES020750) and FDA grant "DNTox-21c Identification of
pathways of developmental neurotoxicity for high throughput testing by
metabolomics" (U01FD004230).
NR 58
TC 38
Z9 39
U1 1
U2 14
PU SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH
PI HEILDEBERG
PA TIERGARTENSTRASSE 17, HEILDEBERG, 69121, GERMANY
SN 1868-596X
EI 1868-8551
J9 ALTEX-ALTERN ANIM EX
JI ALTEX-Altern. Anim. Exp.
PY 2014
VL 31
IS 1
BP 53
EP 61
PG 9
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA 304MF
UT WOS:000330750300007
PM 24127042
ER
PT J
AU Bale, AS
Kenyon, E
Flynn, TJ
Lipscomb, JC
Mendrick, DL
Hartung, T
Patton, GW
AF Bale, Ambuja S.
Kenyon, Elaina
Flynn, Thomas J.
Lipscomb, John C.
Mendrick, Donna L.
Hartung, Thomas
Patton, Geoffrey W.
TI Correlating In Vitro Data to In Vivo Findings for Risk Assessment
SO ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
LA English
DT Editorial Material
DE risk assessment; in vitro-to-in vivo correlation; biomarkers; toxome
ID HUMAN MICROSOMAL PROTEIN; METABOLIC-CLEARANCE; HEPATIC MICROSOMES;
SCALING FACTORS; LIVER; MODELS; EXTRAPOLATION; FOOD; HEPATOTOXICITY;
TOXICOLOGY
AB A special session at the Toxicology and Risk Assessment Conference in Cincinnati, OH, USA in May, 2012 presented approaches to expand current uses of in vitro toxicity data for risk assessment. Evaluation of xenobiotics through use of in vitro study methods is increasing exponentially and these methodologies offer a relatively fast and considerably cheaper way to determine toxicities in comparison to traditional animal-based approaches. One of the challenges with in vitro data is to effectively use this information for risk assessment purposes. Currently, in vitro studies are used as supportive information for hazard characterization and to identify mechanisms associated with toxicity. Being able to effectively correlate in vitro effects with in vivo observations represents a major challenge for risk assessors. The presentations in this special session provided innovative approaches toward effectively using in vitro data for the human health risk assessment process
C1 [Bale, Ambuja S.] US EPA, Off Res & Dev, Natl Ctr Environm Assessment, Washington, DC 20460 USA.
[Kenyon, Elaina] US EPA, Natl Hlth & Environm Effects Res Lab, Res Triangle Pk, NC 27711 USA.
[Flynn, Thomas J.] US FDA, Neurotoxicol & In Vitro Toxicol Branch, Div Toxicol, Off Appl Res & Safety Assessment,Ctr Food Safety, Laurel, MD USA.
[Lipscomb, John C.] US EPA, Natl Ctr Environm Assessment, Cincinnati, OH 45268 USA.
[Mendrick, Donna L.] US FDA, Natl Ctr Toxicol Res, Div Syst Biol, Jefferson, AR 72079 USA.
[Hartung, Thomas] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, CAAT, Baltimore, MD USA.
[Hartung, Thomas] Univ Konstanz, CAAT Europe, Constance, Germany.
[Patton, Geoffrey W.] US FDA, Div Food Contact Notificat, Off Food Addit Safety, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Bale, AS (reprint author), US EPA, Off Res & Dev, Natl Ctr Environm Assessment, 1200 Penn Ave NW, Washington, DC 20460 USA.
EM ambujabale@gmail.com
NR 34
TC 2
Z9 2
U1 0
U2 4
PU SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH
PI HEILDEBERG
PA TIERGARTENSTRASSE 17, HEILDEBERG, 69121, GERMANY
SN 1868-596X
EI 1868-8551
J9 ALTEX-ALTERN ANIM EX
JI ALTEX-Altern. Anim. Exp.
PY 2014
VL 31
IS 1
BP 79
EP 90
PG 12
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA 304MF
UT WOS:000330750300009
PM 24248035
ER
PT J
AU Calvo, MS
Moshfegh, AJ
Tucker, KL
AF Calvo, Mona S.
Moshfegh, Alanna J.
Tucker, Katherine L.
TI Assessing the Health Impact of Phosphorus in the Food Supply: Issues and
Considerations
SO ADVANCES IN NUTRITION
LA English
DT Article
ID SERUM PARATHYROID-HORMONE; CHRONIC KIDNEY-DISEASE;
CARDIOVASCULAR-DISEASE; HEMODIALYSIS-PATIENTS; CALCIUM HOMEOSTASIS;
PHOSPHATE ADDITIVES; DIETARY PHOSPHORUS; MINERAL METABOLISM; NUTRIENT
DATABASES; MORTALITY RISK
AB The Western dietary pattern of intake common to many Americans is high in fat, refined carbohydrates, sodium, and phosphorus, all of which are associated with processed food consumption and higher risk of life-threatening chronic diseases. In this review, we focus on the available information on current phosphorus intake with this Western dietary pattern, and new knowledge of how the disruption of phosphorus homeostasis can occur when intake of phosphorus far exceeds nutrient needs and calcium intake is limited. Elevation of extracellular phosphorus, even when phosphorus intake is seemingly modest, but excessive relative to need and calcium intake, may disrupt the endocrine regulation of phosphorus balance in healthy individuals, as it is known to do in renal disease. This elevation in serum phosphate, whether episodic or chronically sustained, may trigger the secretion of regulatory hormones, whose actions can damage tissue, leading to the development of cardiovascular disease, renal impairment, and bone loss. Therefore, we assessed the health impact of excess phosphorus intake in the context of specific issues that reflect changes over time in the U.S. food supply and patterns of intake. Important issues include food processing and food preferences, the need to evaluate phosphorus intake in relation to calcium intake and phosphorus bioavailability, the accuracy of various approaches used to assess phosphorus intake, and the difficulties encountered in evaluating the relations of phosphorus intake to chronic disease markers or incident disease.
C1 [Calvo, Mona S.] US FDA, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
[Moshfegh, Alanna J.] ARS, Food Surveys Res Grp, USDA, Beltsville, MD USA.
[Tucker, Katherine L.] Univ Massachusetts Lowell, Dept Clin Lab & Nutr Sci, Lowell, MA USA.
RP Calvo, MS (reprint author), US FDA, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
FU American Society for Nutrition; American Society for Nephrology
FX Presented at the symposium "Dietary Phosphorus Excess: A Risk Factor in
Chronic Bone, Kidney, and Cardiovascular Disease" held at the 2013
American Society for Nutrition Scientific Sessions and Annual Meeting at
Experimental Biology, 24 April 2013 in Boston, MA. The symposium was
sponsored by the American Society for Nutrition and supported in part by
the American Society for Nephrology. A summary of this was published in
the September 2013 issue of Advances in Nutrition.
NR 49
TC 14
Z9 14
U1 3
U2 34
PU AMER SOC NUTRITION-ASN
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 2161-8313
EI 2156-5376
J9 ADV NUTR
JI Adv. Nutr.
PD JAN
PY 2014
VL 5
IS 1
BP 104
EP 113
DI 10.3945/an.113004861
PG 10
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 301UP
UT WOS:000330557900016
PM 24425729
ER
PT J
AU Alvandi, F
Kwitkowski, VE
Ko, CW
Rothmann, MD
Ricci, S
Saber, H
Ghosh, D
Brown, J
Pfeiler, E
Chikhale, E
Grillo, J
Bullock, J
Kane, R
Kaminskas, E
Farrell, AT
Pazdur, R
AF Alvandi, Firoozeh
Kwitkowski, Virginia E.
Ko, Chia-Wen
Rothmann, Mark D.
Ricci, Stacey
Saber, Haleh
Ghosh, Debasis
Brown, Janice
Pfeiler, Erika
Chikhale, Elsbeth
Grillo, Joseph
Bullock, Julie
Kane, Robert
Kaminskas, Edvardas
Farrell, Ann T.
Pazdur, Richard
TI US Food and Drug Administration Approval Summary: Omacetaxine
Mepesuccinate as Treatment for Chronic Myeloid Leukemia
SO ONCOLOGIST
LA English
DT Article
DE FDA; Omacetaxine mepesuccinate; CML; Chronic myeloid leukemia
AB On October 26, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate (Synribo; Teva Pharmaceuticals USA, Inc., North Wales, PA, http:// www. tevausa. com) for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/ or intolerance to two or more tyrosine kinase inhibitors (TKIs). The approvalwas basedontheFDAreviewofdata from111 patients withCML inCPor inAPwhohadreceivedtwoormorepriorTKIs, including imatinib. Major cytogenetic responsewas achieved in 18% ofpatientswithCP, withamedianresponsedurationof12.5 months. Major hematologic response was achieved in 14% of patients with AP, with a median response duration of 4.7 months. TheFDAsafetyevaluationwasbasedonsubmitteddata from 163 patients with CP or AP CML who had received at least one dose of omacetaxine mepesuccinate. The safety evaluationwas limited by the single-arm design of the clinical trials as conducted in a small number of previously treated patients. The mostcommon ($ 20%) adverse reactions of any grade in enrolled patients included thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, and infection. The FDA concluded that omacetaxine mepesuccinate has shown activity and a favorable benefit-to-risk profile for the studied population of adult patients with CML (CP or AP) with resistance and/ or intolerance to two or more TKIs. Further evidence of response durability to verify clinical benefit is pending.
C1 [Alvandi, Firoozeh; Kwitkowski, Virginia E.; Ricci, Stacey; Saber, Haleh; Kane, Robert; Kaminskas, Edvardas; Farrell, Ann T.; Pazdur, Richard] US FDA, Off Hematol & Oncol Prod, Off New Drugs, Silver Spring, MD 20993 USA.
[Ko, Chia-Wen; Rothmann, Mark D.] US FDA, Off Biostat, Silver Spring, MD 20993 USA.
[Ghosh, Debasis; Brown, Janice; Pfeiler, Erika; Chikhale, Elsbeth] US FDA, Off Pharmaceut Sci, Silver Spring, MD 20993 USA.
[Grillo, Joseph; Bullock, Julie] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Kwitkowski, VE (reprint author), US FDA, Div Hematol Prod, 10903 New Hampshire Ave,Room 2161, Silver Spring, MD 20993 USA.
EM virginia.kwitkowski@fda.hhs.gov
NR 5
TC 12
Z9 13
U1 0
U2 4
PU ALPHAMED PRESS
PI DURHAM
PA 318 BLACKWELL ST, STE 260, DURHAM, NC 27701-2884 USA
SN 1083-7159
EI 1549-490X
J9 ONCOLOGIST
JI Oncologist
PD JAN
PY 2014
VL 19
IS 1
BP 94
EP 99
DI 10.1634/theoncologist.2013-0077
PG 6
WC Oncology
SC Oncology
GA 297YP
UT WOS:000330291300013
PM 24309980
ER
PT J
AU McClenahan, SD
Uhlenhaut, C
Krause, PR
AF McClenahan, Shasta D.
Uhlenhaut, Christine
Krause, Philip R.
TI Optimization of virus detection in cells using massively parallel
sequencing
SO BIOLOGICALS
LA English
DT Article
DE Virus detection; Massively parallel sequencing (MPS); Non-specific PCR
ID PORCINE CIRCOVIRUS; KAPOSIS-SARCOMA; SAMPLES; LINES; IDENTIFICATION;
PARVOVIRUS; CHILDREN; DISEASES; ASSAY; SV40
AB Massively parallel sequencing (MPS)-based virus detection has potential regulatory applications. We studied the ability of one of these approaches, based on degenerate oligonucleotide primer (DOP)-polymerase chain reaction (PCR), to detect viral sequences in cell lines known to express viral genes or particles. DOP-PCR was highly sensitive for the detection of small quantities of isolated viral sequences. Detected viral sequences included nodavirus, bracovirus, and endogenous retroviruses in High Five cells, porcine circovirus type 1 and porcine endogenous retrovirus in P1(15 cells, human T-cell leukemia virus 1 in M.) cells, human papillomavirus 18 in HeLa cells, human herpesvirus 8 in BCBL-1 cells, and Epstein Barr Virus in Raji cells. Illumina sequencing (for which primers were most efficiently added using PCR) provided greater sensitivity for virus detection than Roche 454 sequencing. Analyzing nucleic acids extracted both directly from samples and from capsid-enriched preparations provided useful information. Although there are limitations of these methods, these results indicate significant promise for the combination of nonspecific PCR and MPS in identifying contaminants in clinical and biological samples, including cell lines and reagents used to produce vaccines and therapeutic products. (C) 2013 Published by Elsevier Ltd on behalf of The International Alliance for Biological Standardization.
C1 [McClenahan, Shasta D.; Krause, Philip R.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Uhlenhaut, Christine] Robert Koch Inst, Ctr Biol Threats & Special Pathogens, Highly Pathogen Viruses ZBS1, D-13353 Berlin, Germany.
RP Krause, PR (reprint author), US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM philip.krause@fda.hhs.gov
OI Krause, Philip/0000-0002-1045-7536
NR 38
TC 7
Z9 7
U1 0
U2 8
PU ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 1045-1056
EI 1095-8320
J9 BIOLOGICALS
JI Biologicals
PD JAN
PY 2014
VL 42
IS 1
BP 34
EP 41
DI 10.1016/j.biologicals.2013.11.002
PG 8
WC Biochemical Research Methods; Biotechnology & Applied Microbiology;
Pharmacology & Pharmacy
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Pharmacology & Pharmacy
GA 298OS
UT WOS:000330334500005
PM 24309095
ER
PT J
AU Komatsu, TE
Pikis, A
Naeger, LK
Harrington, PR
AF Komatsu, Takashi E.
Pikis, Andreas
Naeger, Lisa K.
Harrington, Patrick R.
TI Resistance of human cytomegalovirus to ganciclovir/valganciclovir: A
comprehensive review of putative resistance pathways
SO ANTIVIRAL RESEARCH
LA English
DT Review
DE Cytomegalovirus; Ganciclovir; Valganciclovir; Resistance; Cidofovir;
Foscarnet
ID DNA-POLYMERASE MUTATIONS; ORGAN TRANSPLANT RECIPIENTS; STEM-CELL
TRANSPLANTATION; ACQUIRED-IMMUNODEFICIENCY-SYNDROME; OPEN READING FRAME;
ANTICYTOMEGALOVIRUS COMPOUND AIC246; CONFERRING FOSCARNET RESISTANCE;
PLAQUE REDUCTION ASSAY; GANCICLOVIR-RESISTANT; DRUG-RESISTANCE
AB Human cytomegalovirus (HCMV) is a pathogen that can be life-threatening in immunocompromised individuals. Valganciclovir and its parent drug ganciclovir are currently the principle drugs used for the treatment or prevention of HCMV disease. The development of HCMV resistance to ganciclovir/valganciclovir has been documented in treated patients and is associated with the emergence of amino acid substitutions in the viral proteins pUL97, pUL54 or both. Generally, single amino acid substitutions associated with clinical resistance that alone do not confer decreased ganciclovir susceptibility in cell culture have been disregarded as causative or clinically significant. This review focuses on the analysis and mechanisms of antiviral drug resistance to HCMV. We also conducted a review of publicly available clinical and nonclinical data to construct a comprehensive list of pUL97 and pUL54 amino acid substitutions that are associated with a poor clinical response to the first line therapies ganciclovir and valganciclovir, or associated with reduced HCMV ganciclovir susceptibility in cell culture. Over 40 putative ganciclovir/valganciclovir resistance-associated substitutions were identified in this analysis. These include the commonly reported substitutions M460I/V and C592G in pUL97. There were additional substitutions that are not widely considered as ganciclovir/valganciclovir resistance-associated substitutions, including V466M in pUL97 and E315D in pUL54. Some of these ganciclovir/valganciclovir resistance-associated substitutions may confer cross-resistance to other HCMV therapies, such as cidofovir and foscarnet. Based on this review, we propose that there are more potential HCMV ganciclovir/valganciclovir resistance pathways than generally appreciated. The resulting comprehensive list of putative ganciclovir/valganciclovir resistance-associated substitutions provides a foundation for future investigations to characterize the role of specific substitutions or combinations of substitutions, which will enhance our understanding of HCMV mechanisms of ganciclovir/valganciclovir resistance and also provide insight regarding the potential for cross-resistance to other HCMV therapies. Published by Elsevier B.V.
C1 [Komatsu, Takashi E.; Pikis, Andreas; Naeger, Lisa K.; Harrington, Patrick R.] US FDA, Div Antiviral Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Pikis, Andreas] NIDCR, Microbial Biochem & Genet Sect, Lab Cell & Dev Biol, NIH, Bethesda, MD 20892 USA.
RP Komatsu, TE (reprint author), US FDA, Div Antiviral Prod, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 22 Room 6323, Silver Spring, MD 20993 USA.
EM Takashi.Komatsu@fda.hhs.gov
FU Intramural Research Program of the National Institute of Dental and
Craniofacial Research, National Institutes of Health, Department of
Health and Human Services, Bethesda, Maryland
FX We thank Debra Birnkrant, Mike Bray, Edward Cox, Jeffrey Murray, Jules
O'Rear, and Kuate Seraphin for helpful manuscript suggestions and
discussion. A.P. is supported in part by the Intramural Research Program
of the National Institute of Dental and Craniofacial Research, National
Institutes of Health, Department of Health and Human Services, Bethesda,
Maryland.
NR 191
TC 21
Z9 23
U1 0
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0166-3542
EI 1872-9096
J9 ANTIVIR RES
JI Antiviral Res.
PD JAN
PY 2014
VL 101
BP 12
EP 25
DI 10.1016/j.antiviral.2013.10.011
PG 14
WC Pharmacology & Pharmacy; Virology
SC Pharmacology & Pharmacy; Virology
GA 290QF
UT WOS:000329772700002
PM 24184129
ER
PT J
AU Dreher, ML
Nagaraja, S
Bui, H
Hong, D
AF Dreher, Maureen L.
Nagaraja, Srinidhi
Bui, Hieu
Hong, Danny
TI Characterization of load dependent creep behavior in medically relevant
absorbable polymers
SO JOURNAL OF THE MECHANICAL BEHAVIOR OF BIOMEDICAL MATERIALS
LA English
DT Article
DE Creep; Absorbable; PLLA; PLGA; Crystallinity; Viscoelasticity
ID IN-VITRO DEGRADATION; MECHANICAL-PROPERTIES; BIODEGRADABLE POLYMERS;
POLY(L-LACTIC ACID); FAILURE; FIXATION; POLYLACTIDES; SCAFFOLDS;
DEVICES; FORCES
AB While synthetic absorbable polymers have a substantial history of use in medical devices, their use is expanding and becoming more prevalent for devices where long term loading and structural support is required. In addition, there is evidence that current absorbable medical devices may experience permanent deformations, warping (out of plane twisting), and geometric changes in vivo. For clinical indications with long term loading or structural support requirements, understanding the material's viscoelastic properties becomes increasingly important whereas these properties have not been used historically as preclinical indications of performance or design considerations. In this study we measured the static creep, creep recovery and cyclic creep responses of common medically relevant absorbable materials (i.e., poly(L-lactide, PLLA) and poly(1-co-glycolide, PLGA) over a range of physiologically relevant loading magnitudes. The results indicate that both PLLA and PLGA exhibit creep behavior and failure at loads significantly less than the yield or ultimate properties of the material and that significant material specific responses to loading exist. In addition, we identified a strong correlation between the extent of creep in the material and its crystallinity. Results of the study provide new information on the creep behavior of PLLA and PLGA and support the use of viscoelastic properties of absorbable polymers as part of the material selection process. Published by Elsevier Ltd.
C1 [Dreher, Maureen L.; Nagaraja, Srinidhi] US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Solid & Fluid Mech, Silver Spring, MD 20993 USA.
[Bui, Hieu; Hong, Danny] CDRH Med Device Fellowship Program, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Solid & Fluid Mech, Silver Spring, MD 20993 USA.
RP Dreher, ML (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Solid & Fluid Mech, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Maureen.dreher@fda.hhs.gov
RI Bui, Hieu/J-4408-2014
OI Bui, Hieu/0000-0002-0038-8266
FU CDRH's Medical Device Fellowship Program; FDA's Office of the Critical
Path Initiative
FX We gratefully acknowledge FDA's Office of the Critical Path Initiative
for funding the study and CDRH's Medical Device Fellowship Program for
student funding. We also gratefully acknowledge Dr. Scott Miller for
assistance with statistical analyses.
NR 39
TC 5
Z9 5
U1 5
U2 13
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1751-6161
EI 1878-0180
J9 J MECH BEHAV BIOMED
JI J. Mech. Behav. Biomed. Mater.
PD JAN
PY 2014
VL 29
SI SI
BP 470
EP 479
DI 10.1016/j.jmbbm.2013.10.005
PG 10
WC Engineering, Biomedical; Materials Science, Biomaterials
SC Engineering; Materials Science
GA 294ZF
UT WOS:000330085700043
PM 24211356
ER
PT J
AU Zhang, L
AF Zhang, Lei
TI SCIENTIFIC AND REGULATORY PERSPECTIVES ON DRUG INTERACTION EVALUATION
DURING DRUG DEVELOPMENT
SO DRUG METABOLISM REVIEWS
LA English
DT Meeting Abstract
CT 10th International Meeting of the
International-Society-for-the-Study-of-Xenobiotics (ISSX)
CY SEP 29-OCT 03, 2013
CL Toronto, CANADA
SP Int Soc Study Xenobiot
C1 [Zhang, Lei] US FDA, Off Clin Pharmacol, Off Translat Sci, CDER, Silver Spring, MD USA.
NR 2
TC 0
Z9 0
U1 0
U2 2
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 0360-2532
EI 1097-9883
J9 DRUG METAB REV
JI Drug Metab. Rev.
PD JAN
PY 2014
VL 45
SU 1
BP 18
EP 18
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 286DO
UT WOS:000329445700042
ER
PT J
AU Mulgaonkar, A
Ragueneau-Majlessi, I
Chung, S
Zhang, L
Zhao, P
AF Mulgaonkar, Aditi
Ragueneau-Majlessi, Isabelle
Chung, Sophie
Zhang, Lei
Zhao, Ping
TI ANALYSIS OF METABOLISM AND TRANSPORT DRUG INTERACTION DATA IN 2012 NEW
DRUG APPLICATIONS
SO DRUG METABOLISM REVIEWS
LA English
DT Meeting Abstract
CT 10th International Meeting of the
International-Society-for-the-Study-of-Xenobiotics (ISSX)
CY SEP 29-OCT 03, 2013
CL Toronto, CANADA
SP Int Soc Study Xenobiot
C1 [Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle; Chung, Sophie] Univ Washington, Dept Pharmaceut, Seattle, WA 98195 USA.
[Zhang, Lei] US FDA, Off Clin Pharmacol, Off Translat Sci, CDER, Silver Spring, MD USA.
[Zhao, Ping] US FDA, Off Clin Pharmacol, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 1
U2 2
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 0360-2532
EI 1097-9883
J9 DRUG METAB REV
JI Drug Metab. Rev.
PD JAN
PY 2014
VL 45
SU 1
BP 117
EP 118
PG 2
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 286DO
UT WOS:000329445700237
ER
PT J
AU Chaudhry, AS
Yang, X
Lee, SJ
Burckart, GJ
Fan, YP
Guengerich, FP
Strom, SC
Thummel, K
Schuetz, EG
AF Chaudhry, Amarjit S.
Yang, Xia
Lee, Su-Jun
Burckart, Gilbert J.
Fan, Yiping
Guengerich, F. Peter
Strom, Stephen C.
Thummel, Kenneth
Schuetz, Erin G.
TI FUNCTIONAL SIGNIFICANCE OF SNPS ON CYP3A4 EXPRESSION AND ACTIVITY IN
CAUCASIAN LIVERS
SO DRUG METABOLISM REVIEWS
LA English
DT Meeting Abstract
CT 10th International Meeting of the
International-Society-for-the-Study-of-Xenobiotics (ISSX)
CY SEP 29-OCT 03, 2013
CL Toronto, CANADA
SP Int Soc Study Xenobiot
C1 [Chaudhry, Amarjit S.; Schuetz, Erin G.] St Jude Childrens Res Hosp, Dept Pharmaceut Sci, Memphis, TN 38105 USA.
[Yang, Xia] Univ Calif Los Angeles, Dept Integrat Biol & Physiol, Los Angeles, CA USA.
[Lee, Su-Jun] Inje Univ, Coll Med, Dept Pharmacol, Pusan, South Korea.
[Lee, Su-Jun] Inje Univ, Coll Med, PharmacoGen Res Ctr, Pusan, South Korea.
[Burckart, Gilbert J.] US FDA, Off Clin Pharmacol, Silver Spring, MD USA.
[Fan, Yiping] St Jude Childrens Res Hosp, Dept Computat Biol, Memphis, TN 38105 USA.
[Guengerich, F. Peter] Vanderbilt Univ, Sch Med, Dept Biochem, Nashville, TN 37212 USA.
[Strom, Stephen C.] Karolinska Hosp & Inst, Dept Lab Med, Stockholm, Sweden.
[Thummel, Kenneth] Univ Washington, Seattle, WA 98195 USA.
NR 0
TC 0
Z9 0
U1 0
U2 3
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 0360-2532
EI 1097-9883
J9 DRUG METAB REV
JI Drug Metab. Rev.
PD JAN
PY 2014
VL 45
SU 1
BP 214
EP 214
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 286DO
UT WOS:000329445700429
ER
PT J
AU Warren, M
Jahic, M
Huang, J
Shi, Q
Salminen, W
Huang, Y
AF Warren, Mark
Jahic, Mirza
Huang, Jane
Shi, Qiang
Salminen, William
Huang, Yong
TI TRANSPORTER INHIBITION BY HERBAL SUPPLEMENTS - POTENTIAL DRUG-DIETARY
SUPPLEMENT INTERACTIONS
SO DRUG METABOLISM REVIEWS
LA English
DT Meeting Abstract
CT 10th International Meeting of the
International-Society-for-the-Study-of-Xenobiotics (ISSX)
CY SEP 29-OCT 03, 2013
CL Toronto, CANADA
SP Int Soc Study Xenobiot
C1 [Warren, Mark; Jahic, Mirza; Huang, Jane; Huang, Yong] Optivia Biotechnol Inc, Menlo Pk, CA USA.
[Shi, Qiang] US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR USA.
[Salminen, William] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 1
U2 2
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 0360-2532
EI 1097-9883
J9 DRUG METAB REV
JI Drug Metab. Rev.
PD JAN
PY 2014
VL 45
SU 1
BP 256
EP 256
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 286DO
UT WOS:000329445700511
ER
PT J
AU Dal Pan, G
AF Dal Pan, Gerald J.
TI Ongoing Challenges in Pharmacovigilance
SO DRUG SAFETY
LA English
DT Article
ID ADVERSE DRUG-REACTIONS; APPROVED MEDICATION GUIDES; HEALTH-CARE
UTILIZATION; EVENT REPORTING SYSTEM; SIGNAL-DETECTION; CONTAMINATED
HEPARIN; OFF-LABEL; SAFETY; FDA; INFORMATION
AB While pharmacovigilance systems have made substantial progress in the past several decades, all pharmacovigilance systems face a common set of ongoing challenges in drug safety surveillance in five principal interrelated areas: engaging the public, collaboration and partnerships, incorporating informatics, adopting a global approach, and assessing the impact of efforts. In broad terms, these challenges are not new. Rather, advances in science and technology, along with more demanding societal expectations, have changed the nature of these challenges and provided new opportunities to move the field forward. Differences in organization and levels of development, as well as regional differences, necessarily imply that a single approach is not suitable for all regions, though sharing of best practices can help each region.
C1 US FDA, Silver Spring, MD 20993 USA.
RP Dal Pan, G (reprint author), US FDA, 10903 New Hampshire Ave,Bldg 22,Room 4304, Silver Spring, MD 20993 USA.
EM gerald.dalpan@fda.hhs.gov
NR 75
TC 6
Z9 6
U1 1
U2 4
PU ADIS INT LTD
PI AUCKLAND
PA 41 CENTORIAN DR, PRIVATE BAG 65901, MAIRANGI BAY, AUCKLAND 1311, NEW
ZEALAND
SN 0114-5916
EI 1179-1942
J9 DRUG SAFETY
JI Drug Saf.
PD JAN
PY 2014
VL 37
IS 1
BP 1
EP 8
DI 10.1007/s40264-013-0123-x
PG 8
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
GA 288PT
UT WOS:000329624800001
PM 24264884
ER
PT J
AU Partyka, ML
Bond, RF
Farrar, J
Falco, A
Cassens, B
Cruse, A
Atwill, ER
AF Partyka, Melissa L.
Bond, Ronald F.
Farrar, Jeff
Falco, Andy
Cassens, Barbara
Cruse, Alonza
Atwill, Edward R.
TI Quantifying the Sensitivity of Scent Detection Dogs To Identify Fecal
Contamination on Raw Produce
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID OLFACTORY DETECTION; CRYPTOSPORIDIUM-PARVUM; CANIS-FAMILIARIS; FRESH
PRODUCE; OUTBREAKS; ACCURACY; IDENTIFICATION; CALIFORNIA; PRINCIPLE;
DIAGNOSIS
AB Consumption of raw produce commodities has been associated with foodborne outbreaks in the United States. In a recent Centers for Disease Control and Prevention report outlining the incidence of food-related outbreaks from 1998 to 2008, produce of all kinds were implicated in 46% of illnesses and 23% of deaths. Methods that quickly identify fecal contamination of foods, including produce, will allow prioritization of samples for testing during investigations and perhaps decrease the time required to identify specific brands or lots. We conducted a series of trials to characterize the sensitivity and specificity of scent detection dogs to accurately identify fecal contamination on raw agricultural commodities (romaine lettuce, spinach, cilantro, and roma tomatoes). Both indirect and direct methods of detection were evaluated. For the indirect detection method, two dogs were trained to detect contamination on gauze pads previously exposed to produce contaminated with feces. For the direct detection method, two dogs were trained to identify fecal contamination on fresh produce. The indirect method did not result in acceptable levels of sensitivity except for the highest levels of fecal contamination (25 g of feces). Each dog had more difficulty detecting fecal contamination on cilantro and spinach than on roma tomatoes. For the direct detection method, the dogs exhibited >75% sensitivity for detecting >= 0.25 g of feces on leafy greens (cilantro, romaine lettuce, and spinach) and roma tomatoes, with sensitivity declining as the amount of feces dropped below 0.025 g. We determined that use of a scent detection dog to screen samples for testing can increase the probability of detecting >= 0.025 g of fecal contamination by 500 to 3,000% when samples with fecal contamination are rare (<= 1%)
C1 [Partyka, Melissa L.; Bond, Ronald F.; Atwill, Edward R.] Univ Calif Davis, Sch Vet Med, Western Inst Food Safety & Secur, Davis, CA 95616 USA.
[Farrar, Jeff] US FDA, Off Food & Vet Med, Silver Spring, MD 20993 USA.
[Falco, Andy] Falco K9 Acad, Brea, CA 92821 USA.
[Cassens, Barbara] US FDA, Off Partnerships, Rockville, MD 20857 USA.
[Cruse, Alonza] US FDA, Off Regulatory Affairs, Los Angeles Dist Off, Irvine, CA 92620 USA.
RP Atwill, ER (reprint author), Univ Calif Davis, Sch Vet Med, Western Inst Food Safety & Secur, 1089 Vet Med Dr, Davis, CA 95616 USA.
EM ratwill@ucdavis.edu
FU California Department of Food and Agriculture, Specialty Crop Block
Grant Program; U.S. Food and Drug Administration [U01-003-572]
FX The authors extend our appreciation to Andrew Gordus (California
Department of Fish and Wildlife) and Thomas McCoy (T.J. McCoy and
Associates, Kansas City, MO) for their invaluable assistance. The
authors also thank Dr. Lisa Lit (Department of Animal Sciences,
University of California, Davis) for her valuable feedback and advice
and Dr. Brenda McCowan (Population Health and Reproduction, University
of California, Davis) for continual support and guidance. This work was
funded by a grant from the California Department of Food and
Agriculture, Specialty Crop Block Grant Program, with additional funding
from the U.S. Food and Drug Administration (project U01-003-572).
NR 36
TC 2
Z9 2
U1 0
U2 15
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
EI 1944-9097
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2014
VL 77
IS 1
BP 6
EP 14
DI 10.4315/0362-028X.JFP-13-249
PG 9
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 288DX
UT WOS:000329593300001
PM 24405993
ER
PT J
AU Li, HP
Fu, XW
Bima, YG
Koontz, J
Megalis, C
Yang, F
Fleischman, G
Tortorello, ML
AF Li, Haiping
Fu, Xiaowen
Bima, Yige
Koontz, John
Megalis, Christina
Yang, Fei
Fleischman, Gregory
Tortorello, Mary Lou
TI Effect of the Local Microenvironment on Survival and Thermal
Inactivation of Salmonella in Low- and Intermediate-Moisture
Multi-Ingredient Foods
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID PEANUT BUTTER; INTERNATIONAL OUTBREAK; CONTAMINATED CHOCOLATE;
TYPHIMURIUM; ORANIENBURG; EASTBOURNE; RESISTANCE
AB Multi-ingredient foods having low- or intermediate-moisture characteristics may pose a special challenge to process design and validation. Ingredients of these foods can create local microenvironments that may have a distinct impact on pathogen survival and processing requirements. In this study, two model systems, each consisting of 80% commercial peanut butter (P) and 20% nonfat dry milk powder (M), were formulated to be identical in composition, but different in the source of the Salmonella contamination as originating in either the ingredient P or M. Immediately after inoculation, Salmonella showed a 2.0-log reduction when M was the contaminated ingredient compared with a 0.6-log reduction when P was the contaminated ingredient. This pattern of survival was consistent with the single-ingredient control containing only M (2.5-log reduction) or only P (0.7-log reduction), suggesting that the immediate proximity of cells is determined by the contaminated ingredient in the model system. After 5 weeks of storage, the survival rates of Salmonella in the two systems remained different, i.e. a 4- and 2-log reduction resulted in the system with M or P as the contaminated ingredient, respectively. Furthermore, thermal inactivation efficacies also differed significantly between the two systems. Fourier transform infrared spectroscopy demonstrated the nonhomogeneous distribution of water, lipid, and protein, indicating that varied local microenvironments were present and likely affected the behavior of the pathogen. The impact of the microenvironment on inactivation and survival of Salmonella was further confirmed in a butter cookie formulation in which Salmonella was inoculated via four different ingredients. This study shows that the local microenvironment in low- and intermediate-moisture foods affects Salmonella survival and thermal inactivation. The ingredient source of the contamination should be taken into account for process design and validation to ensure the safety of the product.
C1 [Li, Haiping; Koontz, John; Megalis, Christina; Fleischman, Gregory; Tortorello, Mary Lou] US FDA, Div Food Proc Sci & Technol, Bedford Pk, IL 60501 USA.
[Fu, Xiaowen; Bima, Yige; Yang, Fei] IIT, Inst Food Safety & Hlth, Bedford Pk, IL 60501 USA.
RP Li, HP (reprint author), US FDA, Div Food Proc Sci & Technol, 6502 South Archer Rd, Bedford Pk, IL 60501 USA.
EM haiping.li@fda.hhs.gov
FU U.S. Food and Drug Administration
FX The authors are very grateful for the insightful critical reviews
provided by Jenny Scott and John Larkin. This work was supported in part
by a grant from the U.S. Food and Drug Administration to the Institute
for Food Safety and Health, Illinois Institute of Technology.
NR 20
TC 8
Z9 8
U1 0
U2 40
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
EI 1944-9097
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2014
VL 77
IS 1
BP 67
EP 74
DI 10.4315/0362-028X.JFP-13-277
PG 8
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 288DX
UT WOS:000329593300008
PM 24406000
ER
PT J
AU Holzgrefe, H
Ferber, G
Champeroux, P
Gill, M
Honda, M
Greiter-Wilke, A
Baird, T
Meyer, O
Saulnier, M
AF Holzgrefe, Henry
Ferber, Georg
Champeroux, Pascal
Gill, Michael
Honda, Masaki
Greiter-Wilke, Andrea
Baird, Theodore
Meyer, Olivier
Saulnier, Muriel
TI Preclinical QT safety assessment: Cross-species comparisons and human
translation from an industry consortium
SO JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS
LA English
DT Article
DE Biomarker; Cynomolgus monkey; Dog; Guinea pig; Marmoset; Methods;
Minipig; Moxifloxacin; Preclinical-clinical concordance; QT
rate-correction
ID HEART-RATE CORRECTION; GUINEA-PIG HEART; TORSADES-DE-POINTES;
TELEMETERED CYNOMOLGUS MONKEYS; MARMOSETS CALLITHRIX-JACCHUS; I-KR
BLOCKADE; INTERVAL PROLONGATION; COMMON MARMOSETS; BEAGLE DOGS;
CONSCIOUS DOG
AB Introduction: In vivo models have been required to demonstrate relative cardiac safety, but model sensitivity has not been systematically investigated. Cross-species and human translation of repolarization delay, assessed as QT/QTc prolongation, has not been compared employing common methodologies across multiple species and sites. Therefore, the accurate translation of repolarization results within and between preclinical species, and to man, remains problematic. Methods: Six pharmaceutical companies entered into an informal consortium designed to collect high-resolution telemetered data in multiple species (dog; n = 34, cynomolgus; n = 37, minipig; n = 12, marmoset; n = 14, guinea pig; n = 5, and man; n = 57). All animals received vehicle and varying doses of moxifloxacin (3-100 mg/kg, p.o.) with telemetered ECGs (>= 500 Hz) obtained for 20-24 h post-dose. Individual probabilistic QT-RR relationships were derived for each subject. The rate-correction efficacies of the individual (QTca) and generic correction formulae (Bazett, Fridericia, and Van de Water) were objectively assessed as the mean squared slopes of the QTc-RR relationships. Normalized moxifloxacin QTca responses (Veh Delta%/mu M) were derived for 1 h centered on the moxifloxacin Tmax. Results: All QT-RR ranges demonstrated probabilistic uncertainty; slopes varied distinctly by species where dog and human exhibited the lowest QT rate-dependence, which was much steeper in the cynomolgus and guinea pig. Incorporating probabilistic uncertainty, the normalized QTca-moxifloxacin responses were similarly conserved across all species, including man. Discussion: The current results provide the first unambiguous evidence that all preclinical in vivo repolarization assays, when accurately modeled and evaluated, yield results that are consistent with the conservation of moxifloxacin-induced QT prolongation across all common preclinical species. Furthermore, these outcomes are directly transferable across all species including man. The consortium results indicate that the implementation of standardized QTc data presentation, QTc reference cycle lengths, and rate-correction coefficients can markedly improve the concordance of preclinical and clinical outcomes in most preclinical species. (C) 2013 Elsevier Inc. All rights reserved.
C1 [Gill, Michael] Bristol Myers Squibb Co, Discovery Toxicol, Princeton, NJ 08543 USA.
[Champeroux, Pascal] CERB, Ctr Rech Biol, F-18800 Baugy, France.
[Holzgrefe, Henry] Charles River Labs, Reno, NV 89511 USA.
[Honda, Masaki] Chugai Pharmaceut Co Ltd, Div Res, Gotemba, Shizuoka 4128513, Japan.
[Greiter-Wilke, Andrea; Meyer, Olivier] F Hoffmann La Roche Ltd, CH-4070 Basel, Switzerland.
[Baird, Theodore] MPI Res Inc, Mattawan, MI 49071 USA.
[Saulnier, Muriel] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Ferber, Georg] Stat Georg Ferber GmbH, CH-4125 Riehen, Switzerland.
RP Holzgrefe, H (reprint author), Charles River Labs, Dept Toxicol, 6995 Longley Lane, Reno, NV 89511 USA.
EM Henry.holzgrefe@crl.com; Statistik.Georg.Ferber@bluewin.ch;
pascal.champeroux@cerb.fr; Michael.gill@bms.com;
hondamsk@chugai-pharm.co.jp; andrea.greiter-wilke@roche.com;
Theodore.Baird@mpiresearch.com; olivier-meyer@hotmail.com;
Muriel.saulnier@fda.hhs.gov
NR 149
TC 19
Z9 19
U1 2
U2 5
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1056-8719
EI 1873-488X
J9 J PHARMACOL TOX MET
JI J. Pharmacol. Toxicol. Methods
PD JAN-FEB
PY 2014
VL 69
IS 1
BP 61
EP 101
DI 10.1016/j.vascn.2013.05.004
PG 41
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 291OA
UT WOS:000329836800008
PM 23689033
ER
PT J
AU Viner, K
Perella, D
Lopez, A
Bialek, S
Nguyen, M
Spells, N
Watson, B
AF Viner, Kendra
Perella, Dana
Lopez, Adriana
Bialek, Stephanie
Nguyen, Michael
Spells, Niya
Watson, Barbara
TI Comparing Active and Passive Varicella Surveillance in Philadelphia,
2005-2010: Recommendations for the Transition to Nationwide Passive
Varicella Disease Surveillance
SO PUBLIC HEALTH REPORTS
LA English
DT Article
AB Objective. The Philadelphia Department of Public Health (PDPH) conducts active surveillance for varicella in West Philadelphia. For its approximately 300 active surveillance sites, PDPH mandates biweekly reports of varicella (including zero cases) and performs intensive case investigations. Elsewhere in Philadelphia, surveillance sites passively report varicella cases, and abbreviated investigations are conducted. We used active varicella surveillance program data to inform the transition to nationwide passive varicella surveillance.
Methods. We compared classification of reported cases, varicella disease incidence, and reporting completeness for active and passive surveillance areas for 2005-2010. We assessed reporting completeness using capture-recapture analysis of 2- to 18-year-old cases reported by schools/daycare centers and health-care providers.
Results. From 2005 to 2010, PDPH received 3,280 passive and 969 active surveillance varicella case reports. Most passive surveillance reports were classified as probable cases (18% confirmed, 56% probable, and 26% excluded), whereas nearly all of the active surveillance reports were either confirmed or excluded (36% confirmed, 11% probable, and 53% excluded). Overall incidence rates calculated using confirmed/probable cases were similar in the active and passive surveillance areas. Detection of laboratory-confirmed, breakthrough, and moderate-to-severe cases was equivalent for both surveillance areas.
Conclusions. Although active surveillance for varicella results in better classified cases, passive surveillance provides comparable data for monitoring disease trends in breakthrough and moderate-to-severe varicella. To further improve passive surveillance in the two-dose-varicella vaccine era, jurisdictions should consider conducting periodic enhanced surveillance, encouraging laboratory testing, and collecting additional varicella-specific variables for passive surveillance.
C1 [Viner, Kendra; Perella, Dana; Spells, Niya; Watson, Barbara] Philadelphia Dept Publ Hlth, Philadelphia, PA 19146 USA.
[Lopez, Adriana; Bialek, Stephanie] Ctr Dis Control & Prevent, Atlanta, GA USA.
[Nguyen, Michael] US FDA, Rockville, MD 20857 USA.
RP Viner, K (reprint author), Philadelphia Dept Publ Hlth, Div Dis Control, 500 S Broad St, Philadelphia, PA 19146 USA.
EM kendra.viner@phila.gov
NR 15
TC 0
Z9 0
U1 0
U2 0
PU ASSOC SCHOOLS PUBLIC HEALTH
PI WASHINGTON
PA 1900 M ST NW, STE 710, WASHINGTON, DC 20036 USA
SN 0033-3549
J9 PUBLIC HEALTH REP
JI Public Health Rep.
PD JAN-FEB
PY 2014
VL 129
IS 1
BP 47
EP 54
PG 8
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA 288BL
UT WOS:000329586900007
PM 24381359
ER
PT J
AU Bird, ST
Crentsil, V
Temple, R
Pinheiro, S
Demczar, D
Stone, M
AF Bird, Steven T.
Crentsil, Victor
Temple, Robert
Pinheiro, Simone
Demczar, Dorothy
Stone, Marc
TI Cardiac Safety Concerns Remain for Citalopram at Dosages Above 40 mg/Day
SO AMERICAN JOURNAL OF PSYCHIATRY
LA English
DT Editorial Material
ID QT INTERVAL
C1 [Stone, Marc] US FDA, Div Epidemiol, Off Pharmacovigilance & Epidemiol, Off Surveillance & Epidemiol,Ctr Drug Evaluat & R, Silver Spring, MD 20993 USA.
FDA, Div Psychiat Prod, Silver Spring, MD USA.
FDA, Off Drug Evaluat 1, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Stone, M (reprint author), US FDA, Div Epidemiol, Off Pharmacovigilance & Epidemiol, Off Surveillance & Epidemiol,Ctr Drug Evaluat & R, Silver Spring, MD 20993 USA.
EM marc.stone@fda.hhs.gov
NR 10
TC 5
Z9 7
U1 0
U2 3
PU AMER PSYCHIATRIC PUBLISHING, INC
PI ARLINGTON
PA 1000 WILSON BOULEVARD, STE 1825, ARLINGTON, VA 22209-3901 USA
SN 0002-953X
EI 1535-7228
J9 AM J PSYCHIAT
JI Am. J. Psychiat.
PD JAN
PY 2014
VL 171
IS 1
BP 17
EP 19
DI 10.1176/appi.ajp.2013.13070905
PG 3
WC Psychiatry
SC Psychiatry
GA 286OO
UT WOS:000329478800005
PM 24399423
ER
PT J
AU Kluetz, PG
Pierce, W
Maher, VE
Zhang, H
Tang, SH
Song, PF
Liu, Q
Haber, MT
Leutzinger, EE
Al-Hakim, A
Chen, W
Palmby, T
Alebachew, E
Sridhara, R
Ibrahim, A
Justice, R
Pazdur, R
AF Kluetz, Paul G.
Pierce, William
Maher, V. Ellen
Zhang, Hui
Tang, Shenghui
Song, Pengfei
Liu, Qi
Haber, Martin T.
Leutzinger, Eldon E.
Al-Hakim, Ali
Chen, Wei
Palmby, Todd
Alebachew, Elleni
Sridhara, Rajeshwari
Ibrahim, Amna
Justice, Robert
Pazdur, Richard
TI Radium Ra 223 Dichloride Injection: US Food and Drug Administration Drug
Approval Summary
SO CLINICAL CANCER RESEARCH
LA English
DT Article
ID METASTATIC PROSTATE-CANCER; INCREASED SURVIVAL; MITOXANTRONE;
PREDNISONE; DOCETAXEL; TRIAL; CHEMOTHERAPY; ABIRATERONE
AB On May 15, 2013, the U. S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Ra-223; Xofigo injection; Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The FDA review was based on clinical trial BC1-06, which randomly allocated patients (2: 1) to either Ra-223 plus best standard of care (BSoC) or placebo plus BSoC. The primary endpoint was overall survival (OS) with a key secondary endpoint of time to first symptomatic skeletal event (SSE). A statistically significant improvement in OS was demonstrated [HR, 0.70; 95% confidence interval, 0.55-0.88, P = 0.0019]. At the prespecified interim analysis, the median OS durations were 14.0 and 11.2 months in the Ra-223 and placebo arms, respectively. The improvement in OS was supported by a delay in time to first SSE favoring the Ra-223 arm. The most common (> 10%) adverse reactions in patients receiving Ra-223 were nausea, diarrhea, vomiting, and peripheral edema. The most common (> 10%) hematologic laboratory abnormalities were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia. Ra-223 is the first a-emitting radiotherapeutic and the first radiopharmaceutical to demonstrate an OS advantage in metastatic prostate cancer. (C) 2013 AACR.
C1 [Kluetz, Paul G.; Pierce, William; Maher, V. Ellen; Chen, Wei; Palmby, Todd; Alebachew, Elleni; Ibrahim, Amna; Justice, Robert; Pazdur, Richard] US FDA, Off Hematol & Oncol Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Zhang, Hui; Tang, Shenghui; Sridhara, Rajeshwari] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Song, Pengfei; Liu, Qi] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Haber, Martin T.; Leutzinger, Eldon E.; Al-Hakim, Ali] US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Off New Drug Qual Assessment, Silver Spring, MD 20993 USA.
RP Kluetz, PG (reprint author), US FDA, Off Hematol & Oncol Prod, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 22,2359, Silver Spring, MD 20993 USA.
EM Paul.Kluetz@fda.hhs.gov
NR 15
TC 22
Z9 27
U1 0
U2 6
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
EI 1557-3265
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD JAN 1
PY 2014
VL 20
IS 1
BP 9
EP 14
DI 10.1158/1078-0432.CCR-13-2665
PG 6
WC Oncology
SC Oncology
GA 284GC
UT WOS:000329303100003
PM 24190979
ER
PT J
AU Wear, KA
Gammell, PM
Maruvada, S
Liu, YB
Harris, GR
AF Wear, Keith A.
Gammell, Paul M.
Maruvada, Subha
Liu, Yunbo
Harris, Gerald R.
TI Improved Measurement of Acoustic Output Using Complex Deconvolution of
Hydrophone Sensitivity
SO IEEE TRANSACTIONS ON ULTRASONICS FERROELECTRICS AND FREQUENCY CONTROL
LA English
DT Article
ID TIME-DELAY SPECTROMETRY; FOCUSED ULTRASOUND FIELDS; PHASE CALIBRATION;
FREQUENCY-RESPONSE; MODEL; AMPLITUDE; PRESSURE; SENSOR; MHZ
AB The traditional method for calculating acoustic pressure amplitude is to divide a hydrophone output voltage measurement by the hydrophone sensitivity at the acoustic working frequency, but this approach neglects frequency dependence of hydrophone sensitivity. Another method is to perform a complex deconvolution between the hydrophone output waveform and the hydrophone impulse response (the inverse Fourier transform of the sensitivity). In this paper, the effects of deconvolution on measurements of peak compressional pressure (p(+)), peak rarefactional pressure (p(-)), and pulse intensity integral (PII) are studied. Time-delay spectrometry (TDS) was used to measure complex sensitivities from 1 to 40 MHz for 8 hydrophones used in medical ultrasound exposimetry. These included polyvinylidene fluoride (PVDF) spot-poled membrane, needle, capsule, and fiber-optic designs. Subsequently, the 8 hydrophones were used to measure a 4-cycle, 3 MHz pressure waveform mimicking a pulsed Doppler waveform. Acoustic parameters were measured for the 8 hydrophones using the traditional approach and deconvolution. Average measurements (across all 8 hydrophones) of acoustic parameters from deconvolved waveforms were 4.8 MPa (p(+)), 2.4 MPa (p(-)), and 0.21 mJ/cm(2) (PII). Compared with the traditional method, deconvolution reduced the coefficient of variation (ratio of standard deviation to mean across all 8 hydrophones) from 29% to 8% (p(+)), 39% to 13% (p(-)), and 58% to 10% (PII).
C1 [Wear, Keith A.; Maruvada, Subha; Liu, Yunbo; Harris, Gerald R.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Gammell, Paul M.] Gammell Appl Technol LLC, Exmore, VA USA.
RP Wear, KA (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM keith.wear@fda.hhs.gov
NR 29
TC 7
Z9 7
U1 0
U2 24
PU IEEE-INST ELECTRICAL ELECTRONICS ENGINEERS INC
PI PISCATAWAY
PA 445 HOES LANE, PISCATAWAY, NJ 08855-4141 USA
SN 0885-3010
EI 1525-8955
J9 IEEE T ULTRASON FERR
JI IEEE Trans. Ultrason. Ferroelectr. Freq. Control
PD JAN
PY 2014
VL 61
IS 1
BP 62
EP 75
DI 10.1109/TUFFC.2014.2879
PG 14
WC Acoustics; Engineering, Electrical & Electronic
SC Acoustics; Engineering
GA 287EA
UT WOS:000329522400006
PM 24402896
ER
PT J
AU Sun, HH
Lee, JJ
Papadopoulos, EJ
Lee, CS
Nelson, RM
Sachs, HC
Rodriguez, WJ
Mulberg, AE
AF Sun, Haihao
Lee, Jessica J.
Papadopoulos, Elektra J.
Lee, Catherine S.
Nelson, Robert M.
Sachs, Hari C.
Rodriguez, William J.
Mulberg, Andrew E.
TI Alternate Endpoints and Clinical Outcome Assessments in Pediatric
Ulcerative Colitis Registration Trials
SO JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION
LA English
DT Article
DE clinical outcome measure; disease activity index; pediatric specific
endpoints; pediatric ulcerative colitis
ID ORAL MESALAMINE; PRO INSTRUMENTS; ACTIVITY INDEX; THERAPY; MODERATE;
MULTICENTER; INDUCTION; REMISSION; EFFICACY; CHILDREN
AB Objectives:Presently, there is no consensus on endpoint measures to assess clinical outcomes for pediatric ulcerative colitis (UC). This study reviewed the endpoints used in the registration trials of approved drugs for pediatric UC.Methods:The primary efficacy endpoints of all registration trials completed from 1950 to 2008 that led to Food and Drug Administration approval for indications in pediatric and adult UC were reviewed.Results:Colazal and Remicade have been approved for pediatric UC indication, and clinical response was used as a primary endpoint in these registration trials. The clinical response in the adult Colazal trials was defined as a reduction of rectal bleeding and improvement in at least one of the other assessed symptoms (stool frequency, patient functional assessment, abdominal pain, sigmoidoscopic grade, and physician's global assessment) assessed by the Sutherland UC Activity Index. The pediatric Colazal trial defined clinical response using the Modified Sutherland UC Activity Index, which excluded abdominal pain and functional assessment. Both adult and pediatric Remicade trials used clinical response defined by the Mayo score as the primary endpoint. The Pediatric Ulcerative Colitis Activity Index was used to measure various secondary endpoints in the pediatric Remicade trial.Conclusions:Pediatric-specific endpoints were used, but outcome measures and definition of clinical response were not consistent in pediatric UC trials. Consensus on the definition of successful treatment outcome (clinical response and/or remission) and collaboration in the development of well-defined and reliable measures of signs and symptoms for use in conjunction with endoscopic parameters of mucosal healing will facilitate pediatric drug development.
C1 [Sun, Haihao; Lee, Catherine S.; Nelson, Robert M.; Rodriguez, William J.] US FDA, Off Pediat Therapeut, Off Commissioner, Ctr Drug Res & Evaluat, Silver Spring, MD 20993 USA.
[Lee, Jessica J.; Mulberg, Andrew E.] US FDA, Div Gastroenterol & Inborn Errors Prod, Ctr Drug Res & Evaluat, Silver Spring, MD 20993 USA.
[Papadopoulos, Elektra J.] US FDA, Study Endpoint & Labeling Dev SEALD, Ctr Drug Res & Evaluat, Silver Spring, MD 20993 USA.
[Sachs, Hari C.] US FDA, Pediat & Maternal Hlth Staff, Off New Drug, Ctr Drug Res & Evaluat, Silver Spring, MD 20993 USA.
RP Mulberg, AE (reprint author), US FDA, Div Gastroenterol & Inborn Errors Prod, Off New Drug, Ctr Drug Res & Evaluat, 10903 New Hampshire Ave,Bldg 22,Room 5120, Silver Spring, MD 20993 USA.
EM Andrew.Mulberg@fda.hhs.gov
NR 19
TC 2
Z9 2
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0277-2116
EI 1536-4801
J9 J PEDIATR GASTR NUTR
JI J. Pediatr. Gastroenterol. Nutr.
PD JAN
PY 2014
VL 58
IS 1
BP 12
EP 17
DI 10.1097/MPG.0000000000000186
PG 6
WC Gastroenterology & Hepatology; Nutrition & Dietetics; Pediatrics
SC Gastroenterology & Hepatology; Nutrition & Dietetics; Pediatrics
GA 282QR
UT WOS:000329188000016
PM 24121142
ER
PT J
AU Avalos, LA
Chen, H
Yang, CM
Andrade, SE
Cooper, WO
Cheetham, CT
Davis, RL
Dublin, S
Hammad, TA
Kaplan, S
Pawloski, PA
Raebel, MA
Scott, PE
Smith, DH
Toh, S
Li, DK
AF Avalos, Lyndsay A.
Chen, Hong
Yang, Chunmei
Andrade, Susan E.
Cooper, William O.
Cheetham, Craig T.
Davis, Robert L.
Dublin, Sascha
Hammad, Tarek A.
Kaplan, Sigal
Pawloski, Pamala A.
Raebel, Marsha A.
Scott, Pamela E.
Smith, David H.
Toh, Sengwee
Li, De-Kun
TI The Prevalence and Trends of Antiviral Medication Use During Pregnancy
in the US: A Population-Based Study of 664,297 Deliveries in 2001-2007
SO MATERNAL AND CHILD HEALTH JOURNAL
LA English
DT Article
DE Antiviral medication; Exposure during pregnancy; Prevalence
ID HEPATITIS-B-VIRUS; ACYCLOVIR EXPOSURE; BIRTH-DEFECTS; INFECTION; RISK;
DATE
AB To evaluate the prevalence, trends, timing and duration of exposure to antiviral medications during pregnancy within a US cohort of pregnant women and to evaluate the proportion of deliveries with a viral infection diagnosis among women given antiviral medication during pregnancy. Live-born deliveries between 2001 and 2007, to women aged 15-45 years, were included from the Medication Exposure in Pregnancy Risk Evaluation Program, a collaborative research program between the U.S. Food and Drug Administration and eleven health plans. They were evaluated for prevalence, timing, duration, and temporal trends of exposure to antiviral medications during pregnancy. We also calculated the proportion of deliveries with a viral infection diagnosis among those exposed to antiviral medications. Among 664,297 live births, the overall prevalence of antiviral exposure during pregnancy was 4 % (n = 25,155). Between 2001 and 2007, antiviral medication exposure during pregnancy doubled from 2.5 to 5 %. The most commonly used antiviral medication was acyclovir, with 3 % of the deliveries being exposed and most of the exposure occurring after the 1st trimester. Most deliveries exposed to antiviral medications were exposed for less than 30 days (2 % of all live births). Forty percent of the women delivering an infant exposed to antiviral medications had a herpes diagnosis. Our findings highlight the increased prevalence of women delivering an infant exposed to antiviral medications over time. These findings support the need for large, well-designed studies to assess the safety and effectiveness of these medications during pregnancy.
C1 [Avalos, Lyndsay A.; Chen, Hong; Yang, Chunmei; Li, De-Kun] Kaiser Permanente No Calif, Div Res, Oakland, CA 94612 USA.
[Andrade, Susan E.] Meyers Primary Care Inst, Worcester, MA USA.
[Andrade, Susan E.] Univ Massachusetts, Sch Med, Worcester, MA USA.
[Cooper, William O.] Vanderbilt Univ, Sch Med, Dept Pediat & Prevent Med, Nashville, TN 37212 USA.
[Cheetham, Craig T.] Kaiser Permanente So Calif, Dept Res & Evaluat, Pasadena, CA 91101 USA.
[Davis, Robert L.] Kaiser Permanente Georgia, Ctr Hlth Res, Atlanta, GA USA.
[Dublin, Sascha] Grp Hlth Res Inst, Seattle, WA USA.
[Hammad, Tarek A.; Kaplan, Sigal; Scott, Pamela E.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Pawloski, Pamala A.] HealthPartners Res Fdn, Minneapolis, MN USA.
[Raebel, Marsha A.] Kaiser Permanente Colorado, Inst Hlth Res, Denver, CO USA.
[Smith, David H.] Kaiser Permanente Northwest, Ctr Hlth Res, Portland, OR USA.
[Toh, Sengwee] Harvard Univ, Sch Med, Dept Populat Med, Boston, MA USA.
[Toh, Sengwee] Harvard Pilgrim Hlth Care Inst, Boston, MA USA.
[Li, De-Kun] Stanford Univ, Sch Med, Dept Hlth Res & Policy, Palo Alto, CA 94304 USA.
RP Avalos, LA (reprint author), Kaiser Permanente No Calif, Div Res, 2000 Broadway, Oakland, CA 94612 USA.
EM Lyndsay.A.Avalos@kp.org
RI Toh, Sengwee/D-7567-2017
OI Toh, Sengwee/0000-0002-5160-0810
FU NCATS NIH HHS [UL1 TR001082]; NIA NIH HHS [K23 AG028954, K23AG028954];
NICHD NIH HHS [K12 HD052163, K12HD052163]
NR 21
TC 2
Z9 2
U1 0
U2 7
PU SPRINGER/PLENUM PUBLISHERS
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1092-7875
EI 1573-6628
J9 MATERN CHILD HLTH J
JI Matern. Child Health J.
PD JAN
PY 2014
VL 18
IS 1
BP 64
EP 72
DI 10.1007/s10995-013-1234-9
PG 9
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA 283MG
UT WOS:000329249600009
PM 23420306
ER
PT J
AU Fang, Y
Karim, KS
Badano, A
AF Fang, Yuan
Karim, Karim S.
Badano, Aldo
TI Effect of burst and recombination models for Monte Carlo transport of
interacting carriers in a-Se x-ray detectors on Swank noise
SO MEDICAL PHYSICS
LA English
DT Article
DE Swank noise; semiconductor detector; Monte Carlo; amorphous Selenium
ID AMORPHOUS SELENIUM; PHOTOGENERATION; IONS
AB Purpose: The authors describe the modification to a previously developed Monte Carlo model of semiconductor direct x-ray detector required for studying the effect of burst and recombination algorithms on detector performance. This work provides insight into the effect of different charge generation models for a-Se detectors on Swank noise and recombination fraction.
Methods: The proposed burst and recombination models are implemented in the Monte Carlo simulation package, ARTEMIS, developed by Fang et al. ["Spatiotemporal Monte Carlo transport methods in x-ray semiconductor detectors: Application to pulse-height spectroscopy in a-Se," Med. Phys. 39(1), 308-319 (2012)]. The burst model generates a cloud of electron-hole pairs based on electron velocity, energy deposition, and material parameters distributed within a spherical uniform volume (SUV) or on a spherical surface area (SSA). A simple first-hit (FH) and a more detailed but computationally expensive nearest-neighbor (NN) recombination algorithms are also described and compared.
Results: Simulated recombination fractions for a single electron-hole pair show good agreement with Onsager model for a wide range of electric field, thermalization distance, and temperature. The recombination fraction and Swank noise exhibit a dependence on the burst model for generation of many electron-hole pairs from a single x ray. The Swank noise decreased for the SSA compared to the SUV model at 4 V/mu m, while the recombination fraction decreased for SSA compared to the SUV model at 30 V/mu m. The NN and FH recombination results were comparable.
Conclusions: Results obtained with the ARTEMIS Monte Carlo transport model incorporating drift and diffusion are validated with the Onsager model for a single electron-hole pair as a function of electric field, thermalization distance, and temperature. For x-ray interactions, the authors demonstrate that the choice of burst model can affect the simulation results for the generation of many electron-hole pairs. The SSA model is more sensitive to the effect of electric field compared to the SUV model and that the NN and FH recombination algorithms did not significantly affect simulation results. (C) 2014 American Association of Physicists in Medicine.
C1 [Fang, Yuan; Badano, Aldo] US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Fang, Yuan; Karim, Karim S.] Univ Waterloo, Dept Elect & Comp Engn, Waterloo, ON N2L 3G1, Canada.
RP Fang, Y (reprint author), US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM yuan.fang@fda.hhs.gov
OI badano, aldo/0000-0003-3712-6670
FU Natural Sciences and Engineering Research Council of Canada (NSERC);
Research Participation Program at the Center for Device and Radiological
Health
FX The author (Y.F.) would like to acknowledge funding by an appointment to
the Research Participation Program at the Center for Device and
Radiological Health administered by the Oak Ridge Institute for Science
and Education through an interagency agreement between the (U.S.)
Department of Energy (DOE) and U.S. Food and Drug Administration. This
work was also financially supported in part by the Natural Sciences and
Engineering Research Council of Canada (NSERC). The mention of
commercial products herein is not to be construed as either an actual or
implied endorsement of such products by the Department of Health and
Human Services. This is a contribution of the U.S. Food and Drug
Administration and is not subject to copyright.
NR 22
TC 0
Z9 0
U1 0
U2 3
PU AMER ASSOC PHYSICISTS MEDICINE AMER INST PHYSICS
PI MELVILLE
PA STE 1 NO 1, 2 HUNTINGTON QUADRANGLE, MELVILLE, NY 11747-4502 USA
SN 0094-2405
J9 MED PHYS
JI Med. Phys.
PD JAN
PY 2014
VL 41
IS 1
AR 011904
DI 10.1118/1.4842435
PG 5
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 282OT
UT WOS:000329182200025
PM 24387512
ER
PT J
AU Du, DY
Wagoner, A
Barone, SB
Zinderman, CE
Kelman, JA
MaCurdy, TE
Forshee, RA
Worrall, CM
Izurieta, HS
AF Du, Dongyi (Tony)
Wagoner, Austin
Barone, Samuel B.
Zinderman, Craig E.
Kelman, Jeffrey A.
MaCurdy, Thomas E.
Forshee, Richard A.
Worrall, Chris M.
Izurieta, Hector S.
TI Incidence of Endophthalmitis after Corneal Transplant or Cataract
Surgery in a Medicare Population
SO OPHTHALMOLOGY
LA English
DT Article
ID ONSET POSTOPERATIVE ENDOPHTHALMITIS; VISUAL-ACUITY OUTCOMES; PENETRATING
KERATOPLASTY; FUNGAL ENDOPHTHALMITIS; NATIONAL OUTCOMES;
RETINAL-DETACHMENT; EXTRACTION; KERATITIS; BACTERIAL
AB Objective: To estimate the incidence of infectious endophthalmitis after corneal transplant or cataract surgery, to evaluate the trend of endophthalmitis during the study period, and to assess demographic risk factors for endophthalmitis after surgeries.
Design: A retrospective population-based cohort study.
Participants and Controls: Study cohorts were derived from the Medicare claims databases, 2006 to 2011. Patients were continuously enrolled in Medicare Part A, Part B, and Part D. Patients undergoing corneal transplant or cataract surgery were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes.
Methods: Endophthalmitis was defined in 3 different ways: (1) using ICD-9-CM codes (sensitive definition), (2) combining ICD-9-CM codes with Current Procedural Terminology, Fourth Edition (CPT-4) codes (specific definition), or (3) combining ICD-9-CM codes with antifungal prescriptions for endophthalmitis caused by fungal infection. Demographic risk factors for endophthalmitis were examined using multivariate Cox models.
Main Outcome Measures: Incidence rates of endophthalmitis were calculated and compared for each definition of endophthalmitis at 6-week and 6-month intervals after corneal transplant or cataract surgery.
Results: The infectious endophthalmitis incidence rates ranged from 0.11% to 1.05% in the corneal transplant cohort, 0.06% to 0.20% in the cataract surgery cohort, and 0.16% to 0.68% in the concurrent surgery cohort, depending on the definition and time interval after surgery. Compared with the cataract surgery cohort, the corneal transplant cohort had a higher adjusted hazard ratio (HR) of endophthalmitis within the 6-week postoperative interval (HR, 2.744; 95% confidence interval [CI], 1.544-4.880 in the sensitive definition and HR, 2.792; 95% CI, 1.146-6.802 in the specific definition) and within the 6-month postoperative interval (HR, 4.607; 95% CI, 3.144-6.752 for the sensitive definition and HR, 4.385; 95% CI, 2.245-8.566 for the specific definition).
Conclusions: It is possible to monitor the trend of infectious endophthalmitis after corneal transplant or cataract surgery through examining Medicare claims databases as long as a consistent definition of endophthalmitis is used. The annual incidence of endophthalmitis was stable over time during the study period for both corneal transplant and cataract surgery procedures; however, there was a wider year-to-year variation for the corneal transplant cohort. (C) 2014 by the American Academy of Ophthalmology.
C1 [Du, Dongyi (Tony); Zinderman, Craig E.; Forshee, Richard A.; Izurieta, Hector S.] US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Wagoner, Austin] Acumen LLC, Berkeley, CA USA.
[Barone, Samuel B.] US FDA, Off Cellular Tissue & Gene Therapies, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Kelman, Jeffrey A.; Worrall, Chris M.] Ctr Medicare & Medicaid Serv, Baltimore, MD USA.
[MaCurdy, Thomas E.] Stanford Univ, Dept Econ, Stanford, CA 94305 USA.
RP Du, DY (reprint author), US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, WOC1 RM343N HFM 222,1401 Rockville Pike, Rockville, MD 20852 USA.
EM dongyi.du@fda.hhs.gov
NR 25
TC 16
Z9 16
U1 0
U2 4
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0161-6420
EI 1549-4713
J9 OPHTHALMOLOGY
JI Ophthalmology
PD JAN
PY 2014
VL 121
IS 1
BP 290
EP 298
DI 10.1016/j.ophtha.2013.07.016
PG 9
WC Ophthalmology
SC Ophthalmology
GA 282KG
UT WOS:000329169500047
PM 23993357
ER
PT J
AU McClure, DL
Raebel, MA
Yih, WK
Shoaibi, A
Mullersman, JE
Anderson-Smits, C
Glanz, JM
AF McClure, David L.
Raebel, Marsha A.
Yih, W. Katherine
Shoaibi, Azadeh
Mullersman, Jerald E.
Anderson-Smits, Colin
Glanz, Jason M.
TI Mini-Sentinel methods: framework for assessment of positive results from
signal refinement
SO PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
LA English
DT Editorial Material
ID VACCINE SAFETY; FOOD; SURVEILLANCE; DATALINK
C1 [McClure, David L.] Marshfield Clin Res Fdn, Marshfield Epidemiol Res Ctr, Marshfield, WI 54449 USA.
[Raebel, Marsha A.; Glanz, Jason M.] Kaiser Permanente Colorado, Inst Hlth Res, Denver, CO USA.
[Raebel, Marsha A.] Univ Colorado, Skaggs Sch Pharm & Pharmaceut Sci, Aurora, CO USA.
[Yih, W. Katherine] Harvard Univ, Sch Med, Dept Populat Med, Boston, MA USA.
[Yih, W. Katherine] Harvard Pilgrim Hlth Care Inst, Boston, MA USA.
[Shoaibi, Azadeh] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Mullersman, Jerald E.] US FDA, Ctr Biol Evaluat & Res, Silver Spring, MD USA.
[Mullersman, Jerald E.] E Tennessee State Univ, Quillen Coll Med, Dept Pathol, Johnson City, TN 37614 USA.
[Anderson-Smits, Colin] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Glanz, Jason M.] Colorado Sch Publ Hlth, Dept Epidemiol, Aurora, CO USA.
RP McClure, DL (reprint author), Marshfield Clin Res Fdn, Epidemiol Res Ctr ML2, 1000 North Oak Ave, Marshfield, WI 54449 USA.
EM mcclure.david@marshfieldclinic.org
FU PHS HHS [HHSF223200910006I]
NR 24
TC 3
Z9 3
U1 1
U2 1
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1053-8569
EI 1099-1557
J9 PHARMACOEPIDEM DR S
JI Pharmacoepidemiol. Drug Saf.
PD JAN
PY 2014
VL 23
IS 1
BP 3
EP 8
DI 10.1002/pds.3547
PG 6
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
GA 282ND
UT WOS:000329177700002
PM 24395545
ER
PT J
AU Briesacher, BA
Soumerai, SB
Zhang, F
Toh, S
Andrade, SE
Wagner, JL
Shoaibi, A
Gurwitz, JH
AF Briesacher, Becky A.
Soumerai, Stephen B.
Zhang, Fang
Toh, Sengwee
Andrade, Susan E.
Wagner, Joann L.
Shoaibi, Azadeh
Gurwitz, Jerry H.
TI Critically reviewing impact of regulatory actions, not just FDA's
Response
SO PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
LA English
DT Letter
C1 [Briesacher, Becky A.; Andrade, Susan E.; Gurwitz, Jerry H.] Univ Massachusetts, Sch Med, Div Geriatr Med, Worcester, MA 01605 USA.
[Briesacher, Becky A.; Andrade, Susan E.; Wagner, Joann L.; Gurwitz, Jerry H.] Meyers Primary Care Inst, Worcester, MA USA.
[Briesacher, Becky A.; Andrade, Susan E.; Wagner, Joann L.; Gurwitz, Jerry H.] Univ Massachusetts, Sch Med, Worcester, MA 01605 USA.
[Soumerai, Stephen B.; Zhang, Fang; Toh, Sengwee] Harvard Univ, Sch Med, Dept Populat Med, Boston, MA USA.
[Soumerai, Stephen B.; Zhang, Fang; Toh, Sengwee] Harvard Pilgrim Hlth Care Inst, Boston, MA USA.
[Shoaibi, Azadeh] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Briesacher, BA (reprint author), Univ Massachusetts, Sch Med, Div Geriatr Med, Biotech 4,Suite 315,377 Plantat St, Worcester, MA 01605 USA.
EM Becky.Briesacher@umassmed.edu
RI Toh, Sengwee/D-7567-2017
OI Toh, Sengwee/0000-0002-5160-0810
FU PHS HHS [HHSF223200910006I]
NR 1
TC 0
Z9 0
U1 0
U2 0
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1053-8569
EI 1099-1557
J9 PHARMACOEPIDEM DR S
JI Pharmacoepidemiol. Drug Saf.
PD JAN
PY 2014
VL 23
IS 1
BP 106
EP 106
DI 10.1002/pds.3519
PG 1
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
GA 282ND
UT WOS:000329177700015
PM 24395548
ER
PT J
AU Iyasu, S
Staffa, J
Graham, D
Shoaibi, A
Levenson, M
Chakravarty, A
Hammad, TA
AF Iyasu, Solomon
Staffa, Judy
Graham, Dave
Shoaibi, Azadeh
Levenson, Mark
Chakravarty, Aloka
Hammad, Tarek A.
TI Drug risk assessment and data reuse
SO PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
LA English
DT Letter
C1 [Iyasu, Solomon; Graham, Dave] US FDA, Off Pharmacovigilance & Epidemiol, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Staffa, Judy] US FDA, Div Epidemiol 2, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Shoaibi, Azadeh] US FDA, Off Med Policy, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Levenson, Mark; Chakravarty, Aloka] US FDA, Div Biometr 7, Off Biostat, Off Translat Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Hammad, Tarek A.] Merck & Co Inc, Epidemiol, Merck Res Labs, Whitehouse Stn, NJ 08889 USA.
RP Iyasu, S (reprint author), US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM Solomon.iyasu@fda.hhs.gov
NR 2
TC 0
Z9 0
U1 0
U2 4
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1053-8569
EI 1099-1557
J9 PHARMACOEPIDEM DR S
JI Pharmacoepidemiol. Drug Saf.
PD JAN
PY 2014
VL 23
IS 1
BP 107
EP 108
DI 10.1002/pds.3518
PG 2
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
GA 282ND
UT WOS:000329177700016
PM 24395549
ER
PT J
AU Chi, X
Zhi, L
Vostal, JG
AF Chi, Xuan
Zhi, Li
Vostal, Jaroslav G.
TI Human platelets pathogen reduced with riboflavin and ultraviolet light
do not cause acute lung injury in a two-event SCID mouse model
SO TRANSFUSION
LA English
DT Article
ID APHERESIS PLATELETS; AMOTOSALEN HCL; A LIGHT; TRANSFUSION; MICE;
INACTIVATION; MACROPHAGES; NEUTROPHILS; ACTIVATION; REDUCTION
AB BackgroundPathogen reduction technologies (PRTs) can induce platelet (PLT) lesions that reduce PLT survival and recovery from circulation and may be associated with acute lung injury (ALI).
Study Design and MethodsHuman PLTs (hPLTs) in plasma with or without single or multiple Mirasol PRT treatments were assessed in vitro by aggregation and percentage of P-selectin expression. In vivo studies included PLT recovery in SCID mice and assessment of ALI in a two-event mouse model in which the sensitizing event was lipopolysaccharide injection and the second event was infusion of Mirasol-treated hPLTs.
ResultsA single-dose Mirasol treatment (5J/cm(2)) did not induce any change in aggregation in response to adenosine 5-diphosphate (ADP) while a five-times-repeat Mirasol treatment (5x) increased aggregation response to low concentration of ADP. Mirasol PLTs (1x-5x) had increased percentage of P-selectin-positive PLTs after treatment and decreased aggregation with TRAP as the agonist. In vivo recovery in SCID mice was reduced extensively with Mirasol treatments (1x and 5x). In the two-event model of ALI, only the 5x Mirasol PLTs accumulated in the lung and this was not accompanied by changes in lung histology or increases in MIP-2 levels in bronchoalveolar lavage fluid.
ConclusionsMirasol PRT treatment induced PLT activation and reduced in vivo recovery in a SCID mouse model of transfusion. In our two-event mouse model of ALI, the 5x Mirasol hPLTs accumulated in the lung, but did not cause signs of ALI. The 1x Mirasol treatment did not lead to PLT lung accumulation or ALI in this model.
C1 [Chi, Xuan; Zhi, Li; Vostal, Jaroslav G.] US FDA, Lab Cellular Hematol, Div Hematol, OBRR,Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
RP Vostal, JG (reprint author), US FDA, Lab Cellular Hematol, Div Hematol, OBRR,Ctr Biol Evaluat & Res, Bldg 29,Room 321,HFM 335,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM jaroslav.vostal@fda.hhs.gov
NR 28
TC 4
Z9 4
U1 0
U2 0
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0041-1132
EI 1537-2995
J9 TRANSFUSION
JI Transfusion
PD JAN
PY 2014
VL 54
IS 1
BP 74
EP 85
DI 10.1111/trf.12242
PG 12
WC Hematology
SC Hematology
GA 285TU
UT WOS:000329418700014
PM 23656563
ER
PT J
AU Volpe, DA
Hamed, SS
Zhang, LK
AF Volpe, Donna A.
Hamed, Salaheldin S.
Zhang, Lei K.
TI Use of Different Parameters and Equations for Calculation of IC50 Values
in Efflux Assays: Potential Sources of Variability in IC50 Determination
SO AAPS JOURNAL
LA English
DT Article
DE Caco-2; drug interaction; IC50; inhibition; P-glycoprotein
ID P-GLYCOPROTEIN INHIBITION; DRUG-DRUG INTERACTIONS; IN-VIVO PREDICTION;
CACO-2 CELLS; GP INHIBITION; DIGOXIN-INTERACTIONS; PDE5 INHIBITORS; MDCK
CELLS; VITRO; TRANSPORT
AB Drug interactions due to efflux transporters may result in one drug increasing or decreasing the systemic exposure of a second drug. The potential for in vivo drug interactions is estimated through in vitro cell assays. Variability in in vitro parameter determination (e. g., IC50 values) among laboratories may lead to different conclusions in in vivo interaction predictions. The objective of this study was to investigate variability in in vitro inhibition potency determination that may be due to calculation methods. In a Caco-2 cell assay, the absorptive and secretive permeability of digoxin was measured in the presence of spironolactone, itraconazole and vardenafil. From the permeability data, the efflux ratio and net secretory flux where calculated for each inhibitor. IC50 values were then calculated using a variety of equations and software programs. All three drugs decreased the secretory transport of digoxin in a concentration-dependent manner while increasing digoxin's absorption to a lesser extent. The resulting IC50 values varied according to the parameter evaluated, whether percent inhibition or percent control was applied, and the computational IC50 equation. This study has shown that multiple methods used to quantitate the inhibition of drug efflux in a cell assay can result in different IC50 values. The variability in the results in this study points to a need to standardize any transporter assay and calculation methods within a laboratory and to validate the assay with a set of known inhibitors and non-inhibitors against a clinically relevant substrate.
C1 [Volpe, Donna A.; Hamed, Salaheldin S.; Zhang, Lei K.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Volpe, DA (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM donna.volpe@fda.hhs.gov
NR 57
TC 6
Z9 6
U1 0
U2 9
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1550-7416
J9 AAPS J
JI AAPS J.
PD JAN
PY 2014
VL 16
IS 1
BP 172
EP 180
DI 10.1208/s12248-013-9554-7
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 282IX
UT WOS:000329165600019
PM 24338112
ER
PT J
AU Petrick, N
Kim, HJG
Clunie, D
Borradaile, K
Ford, R
Zeng, RP
Gavrielides, MA
McNitt-Gray, MF
Lu, ZQJ
Fenimore, C
Zhao, BS
Buckler, AJ
AF Petrick, Nicholas
Kim, Hyun J. Grace
Clunie, David
Borradaile, Kristin
Ford, Robert
Zeng, Rongping
Gavrielides, Marios A.
McNitt-Gray, Michael F.
Lu, Z. Q. John
Fenimore, Charles
Zhao, Binsheng
Buckler, Andrew J.
TI Comparison of 1D, 2D, and 3D Nodule Sizing Methods by Radiologists for
Spherical and Complex Nodules on Thoracic CT Phantom Images
SO ACADEMIC RADIOLOGY
LA English
DT Article
DE Computer tomography; lung nodules; phantom study; volumetric tumor
measurement
ID LUNG-CANCER; PULMONARY NODULES; COMPUTED-TOMOGRAPHY; TREATMENT RESPONSE;
TUMOR RESPONSE; 7TH EDITION; VOLUME; SEGMENTATION; BIOMARKER; SCANS
AB Rationale and Objectives: To estimate and statistically compare the bias and variance of radiologists measuring the size of spherical and complex synthetic nodules.
Materials and Methods: This study did not require the institutional review board approval. Six radiologists estimated the size of 10 synthetic nodules embedded within an anthropomorphic thorax phantom from computed tomography scans at 0.8- and 5-mm slice thicknesses. The readers measured the nodule size using unidimensional (1D) longest in-slice dimension, bidimensional (2D) area from longest in-slice and longest perpendicular dimension, and three-dimensional pp) semiautomated volume. lntercomparisons of bias (difference between average and true size) and variance among methods were performed after converting the 2D and 3D estimates to a compatible 1D scale.
Results: The relative biases of radiologists with the 3D tool were -1.8%, -0.4%, -0.7%, -0.4%, and -1.6% for 10-mm spherical, 20-mm spherical, 20-mm elliptical, 10-mm lobulated, and 10-mm spiculated nodules compared to 1.4%, -0.1%, -26.5%, -7.8%, and -39.8% for 1D. The three-dimensional measurements were significantly less biased than 1D for elliptical, lobulated, and spiculated nodules. The relative standard deviations for 3D were 7.5%, 3.9%, 3.6%, 9.7%, and 8.3% compared to 5.7%, 2.6%, 20.3%, 5.3%, and 16.4% for 1D. Unidimensional sizing was significantly less variable than 3D for the lobulated nodule and significantly more variable for the ellipsoid and spiculated nodules. Three-dimensional bias and variability were smaller for thin 0.8-mm slice data compared to thick 5.0-mm data.
Conclusions: The study shows that radiologist-controlled 3D volumetric lesion sizing can not only achieve smaller bias but also achieve similar or smaller variability compared to 1D sizing, especially for complex lesion shapes.
C1 [Petrick, Nicholas; Zeng, Rongping; Gavrielides, Marios A.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Kim, Hyun J. Grace; McNitt-Gray, Michael F.] Univ Calif Los Angeles, David Geffen Sch Med, Dept Radiol Sci, Los Angeles, CA 90095 USA.
[Kim, Hyun J. Grace] Univ Calif Los Angeles, Fielding Sch Publ Hlth, Dept Biostat, Los Angeles, CA USA.
[Clunie, David; Borradaile, Kristin] CoreLab Partners Inc, Princeton, NJ USA.
[Ford, Robert] Clin Trials Imaging Consulting LLC, Belle Mead, NJ USA.
[Lu, Z. Q. John; Fenimore, Charles] NIST, Gaithersburg, MD 20899 USA.
[Zhao, Binsheng] Columbia Univ, Med Ctr, Dept Radiol, New York, NY USA.
[Buckler, Andrew J.] Elucid Bioimaging Inc, Wenham, MA USA.
RP Petrick, N (reprint author), US FDA, Ctr Devices & Radiol Hlth, WO62-4118,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM nicholas.petrick@fda.hhs.gov
RI Clunie, David/Q-2777-2015;
OI Clunie, David/0000-0002-2406-1145; Buckler, Andrew/0000-0002-0786-4835;
McNItt-Gray, Michael/0000-0003-3004-4613
FU U.S. Food and Drug Administration (FDA); National Institute of
Biomedical Imaging and Bioengineering; National Cancer Institute through
IAG [224-07-6030]; Center for Interventional Oncology at the National
Institutes of Health (NIH); NIH; FDA
FX The phantom data collection was funded though a Critical Path grant from
the U.S. Food and Drug Administration (FDA). The intramural research
program of the National Institute of Biomedical Imaging and
Bioengineering, the National Cancer Institute through IAG no.
224-07-6030, the Center for Interventional Oncology at the National
Institutes of Health (NIH) and an Interagency Agreement between the NIH
and the FDA also provided partial support for this project.
NR 26
TC 17
Z9 17
U1 0
U2 7
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1076-6332
EI 1878-4046
J9 ACAD RADIOL
JI Acad. Radiol.
PD JAN
PY 2014
VL 21
IS 1
BP 30
EP 40
DI 10.1016/j.acra.2013.09.020
PG 11
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 280HI
UT WOS:000329018900005
PM 24331262
ER
PT J
AU Xiong, HS
Yu, LX
Qu, HB
AF Xiong, Haoshu
Yu, Lawrence X.
Qu, Haibin
TI A weighting approach for chromatographic fingerprinting to ensure the
quality consistency of botanical drug products
SO ANALYTICAL METHODS
LA English
DT Article
ID DANSHEN INJECTION; HERBAL MEDICINES; SIMILARITY
AB The batch-to-batch quality consistency needs to be controlled to ensure the efficacy and safety of botanical drug products. Chromatographic fingerprinting is a powerful tool for characterizing complex chemical systems such as botanical drugs. This paper presented the combined use of a proposed weighting algorithm and multivariate statistical analysis on fingerprint data to achieve quality consistency evaluation of botanical drug products. A set of fingerprint data following multivariate normal distribution was simulated based on the real fingerprint data of a botanical drug product, Danshen injection. The weight of each peak was set based on its batch-to-batch peak variation. A principal component analysis (PCA) model was established, and the Hotelling T-2 and DModX statistics were applied to evaluate quality consistency. The effect of weighting on the monitoring capability of the two statistics was evaluated through monitoring simulated peak area variations. The results showed that both the two statistics were more sensitive to the characteristic peaks with smaller batch-to-batch peak variations. Hence the peaks with larger variability will be permitted to have a wider tolerance range of variation, while a more narrow range of variation was seen for the peaks with smaller variability among batches. Peak weighting combined with multivariate statistical analysis has overcome some drawbacks of the fingerprint similarity analysis method, and is worthy of application and recommendation for the quality consistency evaluation of botanical drug products.
C1 [Xiong, Haoshu; Qu, Haibin] Zhejiang Univ, Coll Pharmaceut Sci, Pharmaceut Informat Inst, Hangzhou 310058, Zhejiang, Peoples R China.
[Yu, Lawrence X.] US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Qu, HB (reprint author), Zhejiang Univ, Coll Pharmaceut Sci, Pharmaceut Informat Inst, Hangzhou 310058, Zhejiang, Peoples R China.
EM quhb@zju.edu.cn
FU China International Science and Technology Cooperation Project
[2010DFB33630]
FX This work was financially supported by the China International Science
and Technology Cooperation Project (no. 2010DFB33630).
NR 24
TC 0
Z9 0
U1 4
U2 13
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1759-9660
EI 1759-9679
J9 ANAL METHODS-UK
JI Anal. Methods
PY 2014
VL 6
IS 2
BP 476
EP 481
DI 10.1039/c3ay41728j
PG 6
WC Chemistry, Analytical; Food Science & Technology; Spectroscopy
SC Chemistry; Food Science & Technology; Spectroscopy
GA 281AP
UT WOS:000329072200021
ER
PT J
AU Corton, JC
Cunningham, ML
Hummer, BT
Lau, C
Meek, B
Peters, JM
Popp, JA
Rhomberg, L
Seed, J
Klaunig, JE
AF Corton, J. Christopher
Cunningham, Michael L.
Hummer, B. Timothy
Lau, Christopher
Meek, Bette
Peters, Jeffrey M.
Popp, James A.
Rhomberg, Lorenz
Seed, Jennifer
Klaunig, James E.
TI Mode of action framework analysis for receptor-mediated toxicity: The
peroxisome proliferator-activated receptor alpha (PPAR alpha) as a case
study
SO CRITICAL REVIEWS IN TOXICOLOGY
LA English
DT Review
DE Di(2-ethylhexyl) phthalate (DEHP); human relevancy framework; key
events; liver cancer; mode of action; NF-kB; oxidative stress;
peroxisome proliferator-activated receptor alpha (PPAR alpha)
ID NF-KAPPA-B; ACYL-COA OXIDASE; TUMOR-NECROSIS-FACTOR; JUNCTIONAL
INTERCELLULAR COMMUNICATION; CONSTITUTIVE ANDROSTANE RECEPTOR;
<4-CHLORO-6-(2,3-XYLIDINO)-2-PYRIMIDINYLTHIO>ACETIC ACID WY-14,643;
CIPROFIBRATE-INDUCED HEPATOCARCINOGENESIS; CORONARY-HEART-DISEASE;
RETINOID-X-RECEPTOR; TRANSFERASE TRANSPEPTIDASE ACTIVITY
AB Several therapeutic agents and industrial chemicals induce liver tumors in rodents through the activation of the peroxisome proliferator-activated receptor alpha (PPAR alpha). The cellular and molecular events by which PPAR alpha activators induce rodent hepatocarcinogenesis has been extensively studied and elucidated. This review summarizes the weight of evidence relevant to the hypothesized mode of action (MOA) for PPAR alpha activator-induced rodent hepatocarcinogenesis and identifies gaps in our knowledge of this MOA. Chemical-specific and mechanistic data support concordance of temporal and dose-response relationships for the key events associated with many PPAR alpha activators including a phthalate ester plasticizer di(2-ethylhexyl) phthalate (DEHP) and the drug gemfibrozil. While biologically plausible in humans, the hypothesized key events in the rodent MOA, for PPAR alpha activators, are unlikely to induce liver tumors in humans because of toxicodynamic and biological differences in responses. This conclusion is based on minimal or no effects observed on growth pathways, hepatocellular proliferation and liver tumors in humans and/or species (including hamsters, guinea pigs and cynomolgous monkeys) that are more appropriate human surrogates than mice and rats at overlapping dose levels. Overall, the panel concluded that significant quantitative differences in PPAR alpha activator-induced effects related to liver cancer formation exist between rodents and humans. On the basis of these quantitative differences, most of the workgroup felt that the rodent MOA is "not relevant to humans'' with the remaining members concluding that the MOA is "unlikely to be relevant to humans''. The two groups differed in their level of confidence based on perceived limitations of the quantitative and mechanistic knowledge of the species differences, which for some panel members strongly supports but cannot preclude the absence of effects under unlikely exposure scenarios.
C1 [Corton, J. Christopher; Lau, Christopher; Seed, Jennifer] US EPA, Res Triangle Pk, NC 27711 USA.
[Cunningham, Michael L.] NIEHS, Natl Toxicol Program, Res Triangle Pk, NC 27709 USA.
[Hummer, B. Timothy] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Meek, Bette] Univ Ottawa, McLaughlin Ctr Populat Hlth Risk Assessment, Ottawa, ON, Canada.
[Peters, Jeffrey M.] Penn State Univ, Ctr Mol Toxicol & Carcinogenesis, University Pk, PA 16802 USA.
[Popp, James A.] Stratoxon LLC, Lancaster, PA USA.
[Rhomberg, Lorenz] Gradient Corp, Cambridge, MA 02138 USA.
[Klaunig, James E.] Indiana Univ, Dept Environm Hlth, Indianapolis, IN 46204 USA.
RP Corton, JC (reprint author), US EPA, Natl Hlth & Environm Effects Res Lab, 109 TW Alexander Dr,MD B105-03, Res Triangle Pk, NC 27711 USA.
EM corton.chris@epa.gov; jklauni@indiana.edu
FU Alliance for Risk Assessment (ARA); American Chemistry Council (ACC)
Center for Advancing Risk Assessment; CropLife America; CXR Biosciences;
Dow Chemical Company; DuPont; Hamner Institute for Health; Indiana
University Department of Environmental Health; Society for Risk Analysis
(SRA); Society of Toxicology (SOT); 3M Company; Toxicology Excellence
for Risk Assessment (TERA); U.S. EPA National Health and Environmental
Effects Research Laboratory (NHEERL); U.S. EPA Office of Chemical Safety
and Pollution Prevention (OCSPP); U.S. EPA Office of Water (OW); TERA
FX The employment affiliations of the authors are shown on the cover page.
However, this manuscript, including all analyses, interpretations and
opinions expressed are exclusively the work product of the authors and
are not necessarily those of their employers or respective institutions.
Funding and/or in-kind support for the workshop and this manuscript (but
not to the coauthors) were provided by the Alliance for Risk Assessment
(ARA), American Chemistry Council (ACC) Center for Advancing Risk
Assessment, CropLife America, CXR Biosciences, The Dow Chemical Company,
DuPont, The Hamner Institute for Health, Indiana University Department
of Environmental Health, Society for Risk Analysis (SRA), Society of
Toxicology (SOT), 3M Company, Toxicology Excellence for Risk Assessment
(TERA), U.S. EPA National Health and Environmental Effects Research
Laboratory (NHEERL), U.S. EPA Office of Chemical Safety and Pollution
Prevention (OCSPP) and U.S. EPA Office of Water (OW). The National
Institute of Environmental Health Sciences (NIEHS) provided the workshop
venue. Several of the manuscript authors are employed by the
institutions that provided funding for the workshop. Some of the authors
of this manuscript have consulted for government and industry on
receptor-specific related projects, have been or are funded through
grants and by organizations mentioned earlier and/or have served as
reviewers or on committees for related topics. Toxicology Excellence for
Risk Assessment (TERA) was provided funding to organize and run the
workshop. Some case study panel members were offered funding for travel
and lodging associated with the workshop; some of the members accepted
this funding. Funding was also utilized by TERA to coordinate and draft
workshop manuscripts. Additional funding was supplied by The Dow
Chemical Company, 3M Company and DuPont to finalize and submit the
manuscripts. There was no input or review of the manuscripts by these
sponsors. This manuscript was reviewed by the National Health and
Environmental Effects Research Laboratory, U. S. Environmental
Protection Agency and the NIEHS prior to submission, as a matter of
protocol; however, none of those internal reviews altered the scientific
conclusions
NR 381
TC 34
Z9 34
U1 3
U2 38
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 1040-8444
EI 1547-6898
J9 CRIT REV TOXICOL
JI Crit. Rev. Toxicol.
PD JAN
PY 2014
VL 44
IS 1
BP 1
EP 49
DI 10.3109/10408444.2013.835784
PG 49
WC Toxicology
SC Toxicology
GA 281XG
UT WOS:000329133700001
PM 24180432
ER
PT J
AU Mahmood, I
AF Mahmood, I.
TI Designing first-in-human dose of coagulation factors: application of
pharmacokinetic allometric scaling
SO HAEMOPHILIA
LA English
DT Article
DE clearance; coagulation factors; first-in-human dose; interspecies
scaling; pharmacokinetics; rule of exponent
ID FC FUSION PROTEIN; HEMOPHILIA-B PATIENTS; RECOMBINANT FACTOR-IX;
ACTIVATED FACTOR-VII; PROLONGED HALF-LIFE; RIX-FP; HUMANS; SAFETY;
CLEARANCE; TRIAL
AB The objectives of this study were to (i) evaluate the predictive performance of pharmacokinetic interspecies scaling of coagulation factors to predict clearance (CL) and (ii) project first-in-human dose based on the predicted human CL. Human CL of nine coagulation factors was predicted using two or three animal species using two methods: (i) CL vs. body weight (simple allometry) and where applicable (ii) the product of CL and brain weight vs. body weight. Based on the predicted human CL, four methods were used to project the first-in-human dose. The predicted pharmacokinetic parameters and the estimated first-in-human dose of coagulation factors were compared with the observed human values obtained from clinical trials. The results of the study indicated that the CL of coagulation factors can be predicted with reasonable accuracy in humans and a good estimate of first-in-human dose can be obtained from the predicted human CL. The suggested methods in this study are not only time and cost-effective but also provide rational alternatives to the somewhat arbitrary dose selection process for coagulation factors often used.
C1 [Mahmood, I.] US FDA, Off Blood Review & Res OBRR, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
RP Mahmood, I (reprint author), US FDA, Off Blood Review & Res OBRR, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
EM iftekhar.mahmood@fda.hhs.gov
NR 30
TC 1
Z9 1
U1 1
U2 5
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1351-8216
EI 1365-2516
J9 HAEMOPHILIA
JI Haemophilia
PD JAN
PY 2014
VL 20
IS 1
BP 32
EP 38
DI 10.1111/hae.12231
PG 7
WC Hematology
SC Hematology
GA 276FG
UT WOS:000328733300009
PM 23855969
ER
PT J
AU Ponce, RA
Gelzleichter, T
Haggerty, HG
Heidel, S
Holdren, MS
Lebrec, H
Mellon, RD
Pallardy, M
AF Ponce, Rafael A.
Gelzleichter, Thomas
Haggerty, Helen G.
Heidel, Shawn
Holdren, Matthew S.
Lebrec, Herve
Mellon, R. Daniel
Pallardy, Marc
TI Immunomodulation and lymphoma in humans
SO JOURNAL OF IMMUNOTOXICOLOGY
LA English
DT Review
DE Human; immune modulation; lymphoma
ID EPSTEIN-BARR-VIRUS; SYSTEMIC-LUPUS-ERYTHEMATOSUS;
HUMAN-IMMUNODEFICIENCY-VIRUS; CLASS-SWITCH RECOMBINATION;
NON-HODGKINS-LYMPHOMA; NECROSIS FACTOR THERAPY; CENTER B-CELLS; COMMON
VARIABLE IMMUNODEFICIENCY; CANCER-RELATED INFLAMMATION; GERMINAL CENTER
REACTION
AB Observational and clinical studies have associated increased cancer risks with primary or acquired immunodeficiencies, autoimmunity, and use of immunotherapies to treat chronic inflammation (e.g. autoimmunity) or support organ engraftment. Understanding of the relationship between immune status and cancer risk is generally grounded in two juxtaposing paradigms: that the immune system protects the host via surveillance of tumors and oncogenic viruses (e.g. immunosurveillance model) and that chronic inflammation can augment tumor growth and metastasis (inflammation model). Whereas these models support a role of immune status in many cancers, they are insufficient to explain the disproportionate increase in B-cell lymphoma risk observed across patient populations with either chronic immunosuppression or inflammation. Evaluation for the presence of Epstein-Barr virus (EBV) in lymphomas obtained from various populations demonstrates a variable role for the virus in lymphomagenesis across patient populations. An evaluation of the DNA alterations found in lymphomas and an understanding of B-cell ontogeny help to provide insight into the unique susceptibility of lymphocytes, primarily B-cells, to oncogenic transformation. EBV-independent B-cell oncogenic transformation is driven by chronic antigenic stimulation due to either inflammation (as seen in patients with autoimmune disease or a tissue allograft) or to unresolved infection (as seen in immunosuppressed patients), and the transformation arises as a result of DNA damage from genomic recombination and mutation during class switching and somatic hypermutation. This model explains the increased background rate of lymphoma in some patients with autoimmunity, and highlights the challenge of resolving the confounding that occurs between disease severity and use of targeted immunotherapies to treat chronic inflammation. The ability to distinguish between disease-and treatment-related risk of lymphoma and an appreciation of the etiology of B-cell transformation is central to an improved risk assessment by scientists, clinicians and regulators, including the approval, labeling, and chronic use of immunotherapies.
C1 [Ponce, Rafael A.; Lebrec, Herve] Amgen Inc, Seattle, WA 98119 USA.
[Gelzleichter, Thomas] Genentech Inc, Brisbane, CA USA.
[Haggerty, Helen G.] Bristol Myers Squibb Co, New Brunswick, NJ USA.
[Heidel, Shawn] Covance Labs Inc, Greenfield, IN USA.
[Holdren, Matthew S.] Bristol Myers Squibb Co, Mt Vernon, IA USA.
[Mellon, R. Daniel] US FDA, DAAAP, Off Drug Evaluat 2, Off New Drugs,Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Pallardy, Marc] Univ Paris, Fac Pharm, Paris, France.
RP Ponce, RA (reprint author), Amgen Inc, 1201 Amgen Court West,AW1 J3120, Seattle, WA 98119 USA.
EM rponce@amgen.com
NR 141
TC 6
Z9 6
U1 0
U2 7
PU INFORMA HEALTHCARE
PI NEW YORK
PA 52 VANDERBILT AVE, NEW YORK, NY 10017 USA
SN 1547-691X
EI 1547-6901
J9 J IMMUNOTOXICOL
JI J. Immunotoxicol.
PD JAN-MAR
PY 2014
VL 11
IS 1
BP 1
EP 12
DI 10.3109/1547691X.2013.798388
PG 12
WC Toxicology
SC Toxicology
GA 279FH
UT WOS:000328945300001
PM 23746314
ER
PT J
AU Prater, SN
Banugaria, SG
Morgan, C
Sung, CC
Rosenberg, AS
Kishnani, PS
AF Prater, Sean N.
Banugaria, Suhrad G.
Morgan, Claire
Sung, Crystal C.
Rosenberg, Amy S.
Kishnani, Priya S.
TI Letter to the Editors: Concerning "CRIM-negative Pompe disease patients
with satisfactory clinical outcomes on enzyme replacement therapy" by Al
Khallaf et al
SO JOURNAL OF INHERITED METABOLIC DISEASE
LA English
DT Letter
C1 [Prater, Sean N.; Banugaria, Suhrad G.; Kishnani, Priya S.] Duke Univ, Med Ctr, Dept Pediat, Div Med Genet, Durham, NC 27710 USA.
[Morgan, Claire; Sung, Crystal C.] Genzyme Corp, Boston, MA USA.
[Rosenberg, Amy S.] US FDA, Div Therapeut Prot, Off Biotechnol Prod, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
RP Kishnani, PS (reprint author), Duke Univ, Med Ctr, Dept Pediat, Div Med Genet, Durham, NC 27710 USA.
EM kishn001@mc.duke.edu
FU NINDS NIH HHS [U54 NS065768, U54NS065768]
NR 7
TC 2
Z9 2
U1 0
U2 1
PU SPRINGER
PI DORDRECHT
PA VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS
SN 0141-8955
EI 1573-2665
J9 J INHERIT METAB DIS
JI J. Inherit. Metab. Dis.
PD JAN
PY 2014
VL 37
IS 1
BP 141
EP 143
DI 10.1007/s10545-013-9637-8
PG 3
WC Endocrinology & Metabolism; Genetics & Heredity; Medicine, Research &
Experimental
SC Endocrinology & Metabolism; Genetics & Heredity; Research & Experimental
Medicine
GA 281KN
UT WOS:000329100200019
PM 23887636
ER
PT J
AU Grigorenko, E
Fisher, C
Patel, S
Chancey, C
Rios, M
Nakhasi, HL
Duncan, RC
AF Grigorenko, Elena
Fisher, Carolyn
Patel, Sunali
Chancey, Caren
Rios, Maria
Nakhasi, Hira L.
Duncan, Robert C.
TI Multiplex Screening for Blood-Borne Viral, Bacterial, and Protozoan
Parasites using an Open Array Platform
SO JOURNAL OF MOLECULAR DIAGNOSTICS
LA English
DT Article
ID WEST-NILE-VIRUS; REAL-TIME PCR; HEPATITIS-C-VIRUS; INTERNATIONAL
STANDARD; WORKING REAGENTS; RNA; ASSAY; DNA; LEISHMANIA; HIV-1
AB The use of nucleic acid tests for detection of pathogens has improved the safety of blood products. However, ongoing pathogen emergence demonstrates a need for development of devices testing for multiple pathogens simultaneously. One approach combines two proven technologies: Taqman chemistry for target identification and quantification and the OpenArray nanofluidic real-time PCR platform for spatial multiplexing of assays. A panel of Taqman assays was developed to detect nine blood-borne pathogens (BBPs): four viral, two bacterial, and three protozoan parasites. The custom BBP OpenArray plate with 18 assays was tested for specificity and analytical sensitivity for nucleic acid from each purified pathogen and with pathogen-spiked human blood and plasma samples. For most targets, the Limits of detection (10 to 10,000 copies/mL) were comparable with existing real-time platforms. The testing of the BBP OpenArray with pathogen-spiked coded human plasma or blood samples and negative control specimens demonstrated no false-positive results among the samples tested and correctly identified pathogens with the lowest concentration detected ranging from 10 cells/mL (Trypanosoma cruzi) to 10,000 cells/mL (Escherichia coli). These results represent a proof of concept that indicated the BBP OpenArray platform in combination with Taqman chemistry may provide a multiplex real-time PCR pathogen detection method that pints the way for a next-generation platform for infectious disease testing in blood.
C1 [Grigorenko, Elena; Patel, Sunali] Life Technol Corp, San Francisco, CA USA.
[Fisher, Carolyn; Chancey, Caren; Rios, Maria; Nakhasi, Hira L.; Duncan, Robert C.] US FDA, Ctr Biol Evaluat & Res, Div Emerging & Transfus Transmitted Dis, Bethesda, MD USA.
RP Duncan, RC (reprint author), 1401 Rockville Pike,HFM310, Rockville, MD 20852 USA.
EM robert.duncan@fda.hhs.gov
RI Duncan, Robert/I-8168-2015
OI Duncan, Robert/0000-0001-8409-2501
FU internal FDA grant under the Modernizing Science Program
FX Supported in part by an internal FDA grant under the Modernizing Science
Program.
NR 34
TC 10
Z9 10
U1 1
U2 11
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1525-1578
EI 1943-7811
J9 J MOL DIAGN
JI J. Mol. Diagn.
PD JAN
PY 2014
VL 16
IS 1
BP 136
EP 144
DI 10.1016/j.jmoldx.2013.08.002
PG 9
WC Pathology
SC Pathology
GA 278YT
UT WOS:000328926500015
PM 24184228
ER
PT J
AU Lucas, CL
Kuehn, HS
Zhao, F
Niemel, JE
Deenick, EK
Palendira, U
Avery, DT
Moens, L
Cannons, JL
Lanai, MB
Stoddard, J
Ouyane, W
Frucht, DM
Rao, VK
Atkinson, TP
Agharahimi, A
Hussey, AA
Folioll, LR
Olivier, KN
Fleisher, TA
Pittaluga, S
Holland, SM
Cohen, JI
Oliveira, JB
Tangye, SG
Schwartzberg, PL
Lenardol, MJ
Uzel, G
AF Lucas, Carrie L.
Kuehn, Hye Sun
Zhao, Fang
Niemel, Julie E.
Deenick, Elissa K.
Palendira, Umaimainthan
Avery, Danielle T.
Moens, Leen
Cannons, Jennifer L.
Lanai, Matthew Bianca
Stoddard, Jennifer
Ouyane, Weiming
Frucht, David M.
Rao, V. Koneti
Atkinson, T. Prescott
Agharahimi, Anahita
Hussey, Ashleigh A.
Folioll, Les R.
Olivier, Kenneth N.
Fleisher, Thomas A.
Pittaluga, Stefania
Holland, Steven M.
Cohen, Jeffrey I.
Oliveira, Joao B.
Tangye, Stuart G.
Schwartzberg, Pamela L.
Lenardol, Michael J.
Uzel, Gulbu
TI Dominant-activating germline mutations in the gene encoding the PI(3)K
catalytic subunit p110 delta result in T cell senescence and human
immunodeficiency
SO NATURE IMMUNOLOGY
LA English
DT Article
ID IMPAIRED B-CELL; PHOSPHOINOSITIDE 3-KINASE; P85-ALPHA SUBUNIT; CLASS
IPI3K; P110 DELTA; MTOR; MEMORY; DIFFERENTIATION; KINASE; METABOLISM
AB The p110 delta subunit of phosphatidylinositol-3-OH kinase (PI(3)K) is selectively expressed in leukocytes and is critical for lymphocyte biology. Here we report fourteen patients from seven families who were heterozygous for three different germline, gain-of-function mutations in PIK3CD (which encodes p110 delta). These patients presented with sinopulmonary infections, lymphadenopathy, nodular lymphoid hyperplasia and viremia due to cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV). Strikingly, they had a substantial deficiency in naive T cells but an over-representation of senescent effector T cells. In vitro, T cells from patients exhibited increased phosphorylation of the kinase Akt and hyperactivation of the metabolic checkpoint kinase mTOR, enhanced glucose uptake and terminal effector differentiation. Notably, treatment with rapamycin to inhibit mTOR activity in vivo partially restored the abundance of naive T cells, largely 'rescued' the in vitro T cell defects and improved the clinical course.
C1 [Lucas, Carrie L.; Lanai, Matthew Bianca; Lenardol, Michael J.] NIAID, Immunol Lab, NIH, Mol Dev Immune Syst Sect, Bethesda, MD 20892 USA.
[Kuehn, Hye Sun; Niemel, Julie E.; Stoddard, Jennifer; Fleisher, Thomas A.] NIH, Ctr Clin, Dept Lab Med, Bethesda, MD USA.
[Zhao, Fang; Cannons, Jennifer L.; Schwartzberg, Pamela L.] NHGRI, NIH, Genet Dis Res Branch, Cell Signaling Sect, Bethesda, MD 20892 USA.
[Zhao, Fang] Univ Chicago, Pritzker Sch Med, Chicago, IL 60637 USA.
[Deenick, Elissa K.; Palendira, Umaimainthan; Avery, Danielle T.; Moens, Leen] Garvan Inst Med Res, Immunol & Immunodeficiency Grp, Program Immunol, Sydney, NSW, Australia.
[Deenick, Elissa K.; Palendira, Umaimainthan] Univ New S Wales, Fac Med, St Vincents Clin Sch, Sydney, NSW, Australia.
[Ouyane, Weiming; Frucht, David M.] United States Food & Drug Adm, Ctr Drug Evaluat & Res, Off Biotechnol Prod, Div Monoclonal Antibodies,Lab Cell Biol, Bethesda, MD USA.
[Atkinson, T. Prescott] Univ Alabama Birmingham, Dept Pediat, Div Allergy & Immunol, Birmingham, AL USA.
[Olivier, Kenneth N.; Holland, Steven M.] Frederick Natl Lab Clin Res, Sci Applicatidns Int Corp Frederick, Clin Monitoring Res Program, Clin Res Directorate,Lab Clin Infect Dis, Frederick, MD USA.
[Agharahimi, Anahita] NIH, Ctr Clin, Bethesda, MD USA.
[Folioll, Les R.] Natl Canc Inst, NIH, Pathol Lab, Bethesda, MD USA.
[Pittaluga, Stefania] Natl Inst Allergy & Infect Dis, Natl Inst Hlth, Lab Infect Dis, Bethesda, MD USA.
[Cohen, Jeffrey I.] Inst Med Integral Prof Fernando Figue, Recife Pernambuco, Brazil.
RP Uzel, G (reprint author), NIAID, Lab Clin Infect Dis, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
EM guzel@niaid.nih.gov
RI Tangye, Stuart/H-4023-2014;
OI Biancalana, Matthew/0000-0002-1078-1838; Oliveira,
Joao/0000-0001-9388-8173; Ouyang, Wenjun/0000-0002-1811-5864; Niemela,
Julie/0000-0003-4197-3792
FU Division of Intramural Research, National Institute of Allergy and
Infectious Diseases, Clinical Center of the US National Institutes of
Health; National Human Genome Research Institute of the US National
Institutes of Health; Frederick National Laboratory for Cancer Research
of the US National Institutes of Health [HHSN261200800001E]; National
Health and Medical Research Council of Australia; Cancer Council NSW;
Cancer Institute NSW; Research Foundation-Flanders, Belgium; National
Institute of General Medical Sciences
FX We thank the referring physicians, as well as the patients and families.
Supported by the Division of Intramural Research, National Institute of
Allergy and Infectious Diseases, Clinical Center of the US National
Institutes of Health (C.L.L., H.S.K., J.E.N., M.B., J.S., WO., V.K.R.,
A.A., A.A.H., K.N.O., T.A.F., S.P., S.M.H., J.I.C., M.J.L., G.U.), the
National Human Genome Research Institute of the US National Institutes
of Health (F.Z., J.L.C., P.L.S.), the Frederick National Laboratory for
Cancer Research of the US National Institutes of Health
(HHSN261200800001E), the National Health and Medical Research Council of
Australia (E.K.D., UP., S.G.T.), Cancer Council NSW (S.G.T.), the Cancer
Institute NSW (U.P.), the Research Foundation-Flanders, Belgium (L.M.)
and the National Institute of General Medical Sciences (C.L.L. and
R.Z.). The content of this publication does not necessarily reflect the
views or policies of the US Department of Health and Human Services, nor
does mention of trade names, commercial products or organizations imply
endorsement by the US Government.
NR 48
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U1 2
U2 28
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 1529-2908
EI 1529-2916
J9 NAT IMMUNOL
JI Nat. Immunol.
PD JAN
PY 2014
VL 15
IS 1
BP 88
EP 97
DI 10.1038/ni.2771
PG 10
WC Immunology
SC Immunology
GA 277DZ
UT WOS:000328800500016
PM 24165795
ER
PT J
AU LaVange, LM
AF LaVange, Lisa M.
TI The Role of Statistics in Regulatory Decision Making
SO THERAPEUTIC INNOVATION & REGULATORY SCIENCE
LA English
DT Article
DE statistical reviews; regulatory guidance; data quality; sensitivity
analysis; meta-analysis; missing data; adaptive design
AB The number of statistical challenges facing regulators remains high, as does the importance of statistical thinking in the regulatory decision-making process. Statisticians in the Office of Biostatistics at the US Food and Drug Administration review hundreds of new drug and therapeutic biologic applications each year and advise sponsors on protocols numbering in the thousands. In addition to remaining up to date on the newest statistical methods, statisticians are often called upon for innovative approaches to difficult regulatory problems. This article presents the author's view of the important role that statisticians play in regulatory decision making, beginning with a broad overview of current office initiatives, including the development of guidance documents and a recent push for open and transparent collaboration with industry on methods development. Several recent examples are provided to illustrate the impact that statisticians can have on regulatory decisions through the use of strategic quantitative thinking. Also discussed are areas where it is believed that innovative statistical solutions or greater clarity on existing approaches is still needed.
C1 US FDA, Off Biostat, OTS, CDER, Silver Spring, MD 20933 USA.
RP LaVange, LM (reprint author), US FDA, Off Biostat, OTS, CDER, Bldg 21,Room 3554,10903 New Hampshire Ave, Silver Spring, MD 20933 USA.
EM lisa.lavange@fda.hhs.gov
FU US Food and Drug Administration (FDA)
FX This study had no external funding source; it was funded entirely by the
US Food and Drug Administration (FDA). The author is employed by the
FDA.
NR 36
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Z9 4
U1 2
U2 8
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 2168-4790
EI 2168-4804
J9 THER INNOV REGUL SCI
JI Ther. Innov. Regul. Sci.
PD JAN
PY 2014
VL 48
IS 1
BP 10
EP 19
DI 10.1177/2168479013514418
PG 10
WC Medical Informatics; Pharmacology & Pharmacy
SC Medical Informatics; Pharmacology & Pharmacy
GA 282II
UT WOS:000329164100002
ER
PT J
AU Wang, SJ
Hung, HMJ
AF Wang, Sue-Jane
Hung, H. M. James
TI A Conditional Adaptive Weighted Test Method for Confirmatory Trials
SO THERAPEUTIC INNOVATION & REGULATORY SCIENCE
LA English
DT Article
DE adaptive statistical information design; consistency of treatment
effects; down weighting at individual level; efficiency loss; firewalls
for trial logistics
ID SAMPLE-SIZE; CLINICAL-TRIALS
AB The authors consider a statistically valid method that has little concern caused by down weighting in stage 2 or slight loss in efficiency and possibly improves power performance for a trial design that allows for adaptation of statistical information. In addition to the need for a priori sound data-based planning that accounts for limited uncertainty, the criteria for statistical information adaptation are scientifically sound and can foster transparent trial logistics that are necessary for such adaptation in confirmatory trials. A major rationale of the proposed conditional adaptive weighted test method is to increase the probability of success of an adequate and well-controlled confirmatory trial that may otherwise fall short of statistical significance despite initial rigorous planning for statistical information.
C1 [Wang, Sue-Jane] US FDA, Off Biostat, OTS, CDER, Silver Spring, MD 20993 USA.
[Hung, H. M. James] US FDA, Div Biometr 1, OB, OTS,CDER, Silver Spring, MD 20993 USA.
RP Wang, SJ (reprint author), US FDA, Off Biostat, OTS, CDER, 10903 New Hampshire Ave,Bldg 21, Silver Spring, MD 20993 USA.
EM suejane.wang@fda.hhs.gov
FU RSR [06-14, 05-02, 05-12]; Center for Drug Evaluation and Research of
the US Food and Drug Administration.
FX The author(s) disclosed receipt of the following financial support for
the research, authorship, and/or publication of this article: The
research work presented in this article was supported by the RSR funds #
06-14, # 05-02, and # 05-12, awarded by the Center for Drug Evaluation
and Research of the US Food and Drug Administration.
NR 9
TC 2
Z9 2
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 2168-4790
EI 2168-4804
J9 THER INNOV REGUL SCI
JI Ther. Innov. Regul. Sci.
PD JAN
PY 2014
VL 48
IS 1
BP 51
EP 55
DI 10.1177/2168479013513891
PG 5
WC Medical Informatics; Pharmacology & Pharmacy
SC Medical Informatics; Pharmacology & Pharmacy
GA 282II
UT WOS:000329164100006
ER
PT J
AU Huang, L
Guo, T
Zalkikar, JN
Tiwari, RC
AF Huang, Lan
Guo, Ted
Zalkikar, Jyoti N.
Tiwari, Ram C.
TI A Review of Statistical Methods for Safety Surveillance
SO THERAPEUTIC INNOVATION & REGULATORY SCIENCE
LA English
DT Article
DE passive surveillance; disproportional signal; postmarket safety
database; FDA Sentinel Initiative
ID SIGNAL-DETECTION; RATIO TEST; REPORTING SYSTEM; DRUG; PHARMACOVIGILANCE;
DATABASE; GENERATION; DISCOVERY; EVENTS; VAERS
AB The data-mining statistical methods used for disproportionality analysis of drug-adverse event combinations from large drug safety databases such as the FDA's Adverse Event Reporting System (FAERS), consisting of spontaneous reports on adverse events for postmarket drugs, are called passive surveillance methods. However, the statistical signal detection methods for longitudinal data, as the data accrue in time, are called active surveillance methods. A review of the most commonly used passive surveillance statistical methods and the relationships among them is presented with unified notations. These methods are applied to the 2006-2012 FAERS data; the number of drug signals of disproportionate rates (SDRs) detected by each of these methods with the common SDRs from all of these methods, for the adverse event myocardial infarction, are given. Finally, there is a brief discussion on the recently developed active surveillance methods.
C1 [Huang, Lan; Zalkikar, Jyoti N.] US FDA, Div Biostat 5, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Guo, Ted; Tiwari, Ram C.] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Huang, L (reprint author), US FDA, Div Biostat 5, Off Biostat, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,White Oak Bldg 21,Room 46, Silver Spring, MD 20993 USA.
EM lan.huang@fda.hhs.gov
NR 36
TC 4
Z9 4
U1 1
U2 7
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 2168-4790
EI 2168-4804
J9 THER INNOV REGUL SCI
JI Ther. Innov. Regul. Sci.
PD JAN
PY 2014
VL 48
IS 1
BP 98
EP 108
DI 10.1177/2168479013514236
PG 11
WC Medical Informatics; Pharmacology & Pharmacy
SC Medical Informatics; Pharmacology & Pharmacy
GA 282II
UT WOS:000329164100012
ER
PT J
AU Wang, YMC
Jawa, V
Ma, M
AF Wang, Yow-Ming C.
Jawa, Vibha
Ma, Mark
TI Immunogenicity and PK/PD evaluation in biotherapeutic drug development:
scientific considerations for bioanalytical methods and data analysis
SO BIOANALYSIS
LA English
DT Review
ID PHARMACOKINETIC ASSESSMENT; BIOTECHNOLOGY PRODUCTS;
MONOCLONAL-ANTIBODIES; IN-VIVO; IMPACT; PHARMACODYNAMICS; IMMUNOASSAY;
ASSAYS; OPTIMIZATION; DISPOSITION
AB With the advent of novel technologies, considerable advances have been made in the evaluation of the relationship between PK and PD. Ligand-binding assays have been the primary assay format supporting PK and immunogenicity assessments. Critical and in-depth characterizations of the ligand-binding assay of interest can provide valuable understanding of the limitations, for interpreting PK/PD and immunogenicity results. This review illustrates key challenges with regard to understanding the relationship between anti-drug antibody and PK/PD, including confounding factors associated with the development and validation of ligand-binding assays, mechanisms by which anti-drug antibody impacts PK/PD, factors to consider during data analyses and interpretation, and a perspective on integrating immunogenicity data into the well-established quantitative modeling approach. Through recognizing these challenges, we propose some opportunities for improvements in the development and validation of fit-for-purpose bioanalytical methods.
C1 [Wang, Yow-Ming C.] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Jawa, Vibha] Amgen Inc, Dept Clin Immunol, Thousand Oaks, CA 91320 USA.
[Ma, Mark] Amgen Inc, Dept Pharmacokinet & Drug Metab, Thousand Oaks, CA 91320 USA.
RP Ma, M (reprint author), Amgen Inc, Dept Pharmacokinet & Drug Metab, 1 Amgen Ctr Dr, Thousand Oaks, CA 91320 USA.
EM mark.ma@amgen.com
NR 43
TC 7
Z9 7
U1 1
U2 9
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PD JAN
PY 2014
VL 6
IS 1
BP 79
EP 87
DI 10.4155/BIO.13.302
PG 9
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 273ZG
UT WOS:000328574200012
PM 24341496
ER
PT J
AU Mohan, KVK
Rao, SS
Gao, Y
Atreya, CD
AF Mohan, K. V. K.
Rao, S. Sainath
Gao, Y.
Atreya, C. D.
TI Enhanced antimicrobial activity of peptide-cocktails against common
bacterial contaminants of ex vivo stored platelets
SO CLINICAL MICROBIOLOGY AND INFECTION
LA English
DT Article
DE Antimicrobial peptides; bactericidal; colony-forming units; pathogen
reduction; platelet-derived peptides
ID IN-VITRO ACTIVITIES; MICROBICIDAL PROTEINS; STAPHYLOCOCCUS-AUREUS;
EXPERIMENTAL ENDOCARDITIS; INNATE IMMUNITY; ARGININE-RICH;
SUSCEPTIBILITY; COMBINATION; MECHANISMS; RESISTANCE
AB Bacterial contamination of blood components such as ex vivo-stored platelets is a major safety risk in transfusion medicine. We have recently shown that synthetic antimicrobial peptides named PD1-PD4 derived from the thrombin-induced human platelet-derived antimicrobial proteins, and repeats of Arg-Trp (RW1-RW5) demonstrate microbicidal activity against selected bacteria and viruses. In the present study, we selected PD3, PD4, RW2, RW3 and RW4 and evaluated each individual peptide and their various combinations to see whether the cocktail regimen enhances the antimicrobial activity above and over the individual peptides. Stored platelet or plasma samples spiked with known titres of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae and Bacillus cereus were treated with either individual peptides or with peptides in various combinations. Analyses revealed that individual peptides show moderate microbicidal activity (10- to 100-fold reduction) against the tested bacteria relative to their combined regimen. The peptide combinations (RW2+RW4, RW2+RW3+RW4 and PD4+RW3+RW4) on the other hand enhanced the microbicidal activity (c.10000-fold reduction) and revealed a minimal inhibitory concentration of 5M. Time-kill kinetics indicated that these three peptide combinations exhibited enhanced antimicrobial activity bringing about a 100-fold reduction of bacterial titres within 20min of incubation. The present study therefore demonstrates the synergistic effect of antimicrobial peptides when used in combinations and provides a proof-of-concept of its potential application as a molecular tool towards pathogen reduction and further extends the possibility of using peptide combinatorial therapeutics as broad-spectrum antibiotics or as alternatives to combat drug-resistant bacteria.
C1 [Mohan, K. V. K.; Rao, S. Sainath; Atreya, C. D.] US FDA, Sect Cell Biol, Lab Cellular Hematol, Bethesda, MD 20014 USA.
[Gao, Y.] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Mohan, KVK (reprint author), Bldg 29A,Room 2C-15,NIH Campus,8800 Rockville Pik, Bethesda, MD 20892 USA.
EM krishna.ketha@fda.hhs.gov
FU Center for Biologics Evaluation and Research (CBER); US Department of
Energy; US Food and Drug Administration
FX SSR is a recipient of a postdoctoral fellowship at the Center for
Biologics Evaluation and Research (CBER) administered by the Oak Ridge
Institute for Science and Education through an intra-agency agreement
between the US Department of Energy and the US Food and Drug
Administration. Review of the manuscript by Drs Salim Haddad and
Vladimir Lugovstev, of CBER, is highly appreciated.
NR 30
TC 1
Z9 1
U1 1
U2 9
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1198-743X
EI 1469-0691
J9 CLIN MICROBIOL INFEC
JI Clin. Microbiol. Infect.
PD JAN
PY 2014
VL 20
IS 1
BP O39
EP O46
DI 10.1111/1469-0691.12326
PG 8
WC Infectious Diseases; Microbiology
SC Infectious Diseases; Microbiology
GA 273JK
UT WOS:000328530900017
PM 23926880
ER
PT J
AU Manjanatha, MG
Bishop, ME
Pearce, MG
Kulkarni, R
Lyn-Cook, LE
Ding, W
AF Manjanatha, Mugimane G.
Bishop, Michelle E.
Pearce, Mason G.
Kulkarni, Rohan
Lyn-Cook, Lascelles E.
Ding, Wei
TI Genotoxicity of Doxorubicin in F344 Rats by Combining the Comet Assay,
Flow-Cytometric Peripheral Blood Micronucleus Test, and Pathway-Focused
Gene Expression Profiling
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Article
DE doxorubicin; comet assay; micronucleus assay; gene expression
ID SPONTANEOUSLY HYPERTENSIVE-RATS; CONGESTIVE-HEART-FAILURE; CELL
GEL-ELECTROPHORESIS; DNA-DAMAGE; IN-VITRO; INDUCED CARDIOTOXICITY; RENAL
TOXICITY; ANTHRACYCLINE CARDIOTOXICITY; CHILDHOOD-CANCER; MULTIPLE
ORGANS
AB Doxorubicin (DOX) is an antineoplastic drug effective against many human malignancies. DOX's clinical efficacy is greatly limited because of severe cardiotoxicity. To evaluate if DOX is genotoxic in the heart, similar to 7-week-old, male F344 rats were administered intravenously 1, 2, and 3 mg/kg bw DOX at 0, 24, 48, and 69 hr and the Comet assays in heart, liver, kidney, and testis and micronucleus (MN) assay in the peripheral blood (PB) erythrocytes using flow cytometry were conducted. Rats were euthanized at 72 hr and PB was removed for the MN assay and single cells were isolated from multiple tissues for the Comet assays. None of the doses of DOX induced a significant DNA damage in any of the tissues examined by the alkaline Comet assay. Contrastingly, the glycosylase enzymes-modified Comet assay showed a significant dose dependent increase in the oxidative DNA damage in the cardiac tissue (P 0.05). In the liver, only the top dose induced significant increase in the oxidative DNA damage (P 0.05). The histopathology showed no severe cardiotoxicity but non-neoplastic lesions were present in both untreated and treated samples. A severe toxicity likely occurred in the bone marrow because no viable reticulocytes could be screened for the MN assay. Gene expression profiling of the heart tissues showed a significant alteration in the expression of 11 DNA damage and repair genes. These results suggest that DOX is genotoxic in the heart and the DNA damage may be induced primarily via the production of reactive oxygen species. Environ. Mol. Mutagen. 55:24-34, 2014. (c) 2013 Wiley Periodicals, Inc.(dagger 99.9%, Positive Predictive Value of 99.7%, and an overall score (average of sensitivity and Positive Predictive Value) of 99.8% when applied to the training set. The best overall performance on the test sets were: 88.9%, 76.3% and 84.4% for phases I, II and Ill, respectively. We developed a robust heart beat detector that fuses annotations from multiple individual detectors. The algorithm improves the training results compared to ECG detections alone, and performs well on the test sets. Data fusion approaches like this one can improve patient monitoring and reduce false alarms.
C1 [Johannesen, Lars; Vicente, Jose; Scully, Christopher G.; Galeotti, Loriano; Strauss, David G.] US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Johannesen, Lars] Karolinska Inst, Dept Clin Physiol, S-10401 Stockholm, Sweden.
[Johannesen, Lars] Karolinska Univ Hosp, Stockholm, Sweden.
[Johannesen, Lars] Univ Zaragoza, IIS Aragon, BSICoS Grp, Aragon Inst Engn Res I3A, Zaragoza, Aragon, Spain.
RP Johannesen, L (reprint author), Bldg 62,RM 1125C,10993 New Hampshire Ave, Silver Spring, MD 20910 USA.
EM Lars.johannesen@fda.hhs.gov
NR 8
TC 1
Z9 1
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2325-887X
BN 978-1-4799-4346-3
J9 COMPUT CARDIOL CONF
PY 2014
VL 41
BP 277
EP 280
PG 4
WC Cardiac & Cardiovascular Systems; Computer Science, Interdisciplinary
Applications; Mathematical & Computational Biology
SC Cardiovascular System & Cardiology; Computer Science; Mathematical &
Computational Biology
GA BE2TW
UT WOS:000370068300071
ER
PT S
AU Scully, CG
Kramer, GC
Strauss, DG
AF Scully, Christopher G.
Kramer, George C.
Strauss, David G.
BE Murray, A
TI Dynamics of Arterial Pressure Components in a Sheep Model of Hemorrhage
SO 2014 COMPUTING IN CARDIOLOGY CONFERENCE (CINC), VOL 41
SE Computing in Cardiology Conference
LA English
DT Proceedings Paper
CT 41st Computing in Cardiology Conference (CinC)
CY SEP 07-10, 2014
CL Cambridge, MA
SP Massachusetts Inst Technol, European Soc Cardiol, IEEE EMBS, Mortara, PhysioNet, Philips, Mindray, IBM, Zoll, Mitsubishi Elect, lOP Publishing, IMES, CSAIL, Medtronic, Boston Sci, Samsung, GE
ID HEART-RATE RESPONSE
AB There is a need for accurate monitors that can track blood loss and report a patient's current physiological response. We explored phase coherence between components of the arterial blood pressure waveform for this purpose.
Adult conscious sheep underwent 25 mL/kgBody-weight hemorrhages over 15 minutes (14 total hemorrhage experiments) while continuous arterial blood pressure measurements were made. Phase coherence from a single arterial pressure monitor was assessed between all combinations of the pulse-pulse interval, systolic blood pressure, and pulse pressure sequences as a measure of the synchronization between the component dynamics.
Phase coherence measures were compared during baseline, the peak compensatory response and a decompensation phase. Phase coherence in the range of 0.06 - 0.15 Hz between the pulse-pulse interval and systolic blood pressure sequences as well as the systolic blood pressure and pulse pressure sequences was elevated during the peak compensation period Analytical techniques to assess the relationship between signals recorded during hemorrhage can be explored for their potential predictive capabilities.
C1 [Scully, Christopher G.; Strauss, David G.] US FDA, Div Biomed Phys, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Kramer, George C.] Univ Texas Med Branch, Dept Anesthesiol, Galveston, TX 77555 USA.
RP Scully, CG (reprint author), 10903 New Hampshire Ave Bldg 62 RM 1202C, Silver Spring, MD 20993 USA.
EM christopher.scully@fda.hhs.gov
NR 9
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2325-887X
BN 978-1-4799-4346-3
J9 COMPUT CARDIOL CONF
PY 2014
VL 41
BP 305
EP 308
PG 4
WC Cardiac & Cardiovascular Systems; Computer Science, Interdisciplinary
Applications; Mathematical & Computational Biology
SC Cardiovascular System & Cardiology; Computer Science; Mathematical &
Computational Biology
GA BE2TW
UT WOS:000370068300078
ER
PT S
AU Sassi, R
Sparagino, L
Stockbridge, NL
Guadiana, JM
Badilini, F
AF Sassi, Roberto
Sparagino, Luca
Stockbridge, Norman L.
Guadiana, Juan M.
Badilini, Fabio
BE Murray, A
TI Proof of Concept for an International Long-Time Preservation ECG Format
SO 2014 COMPUTING IN CARDIOLOGY CONFERENCE (CINC), VOL 41
SE Computing in Cardiology Conference
LA English
DT Proceedings Paper
CT 41st Computing in Cardiology Conference (CinC)
CY SEP 07-10, 2014
CL Cambridge, MA
SP Massachusetts Inst Technol, European Soc Cardiol, IEEE EMBS, Mortara, PhysioNet, Philips, Mindray, IBM, Zoll, Mitsubishi Elect, lOP Publishing, IMES, CSAIL, Medtronic, Boston Sci, Samsung, GE
AB We present a proof-of-concept of a medical data format for storing and retrieving 12-lead, 10-second standard electrocardiograms (ECG). The new format combines a digital ECG record into a standard graphical report (PDF).
Using the very recent PDF/A-3 standard (ISO 19005-3: 2012), we designed a long-term preservation graphic report (such as a standard 3 x4 or 6x2 ECG printout) in which the original ECG digital data (using the aECG ANSI/HL7 R1-2004 format) is embedded as a compressed attachment. The proposal also includes two ways of ensuring conformity between the ECG vector images and the digital data. First, a digital signature is added to guarantee that the document was not modified after creation. Second, specific metadata are inserted to allow a direct digital comparison between the vector ECG printout and the data.
To prove the feasibility of the approach, 93 aECGs, selected from different device manufacturers, resolutions and sample rates, were converted into the new format and then validated. Differences between digital data and vector graphics were always smaller than 0.02 mu V, significantly below the typical AID converter resolution.
C1 [Sassi, Roberto; Sparagino, Luca] Univ Milan, Dipartimento Informat, Via Bramante 65, I-26013 Crema, CR, Italy.
[Stockbridge, Norman L.] US FDA, Div Cardiovasc & Renal Prod, CDER, Silver Spring, MD USA.
[Guadiana, Juan M.] FAA, Las Cruces, NM USA.
[Badilini, Fabio] AMPS LLC, New York, NY USA.
RP Sassi, R (reprint author), Univ Milan, Dipartimento Informat, Via Bramante 65, I-26013 Crema, CR, Italy.
EM roberto.sassi@unimi.it
RI Sassi, Roberto/B-8136-2008; Spargino, Luca/M-4435-2015
OI Sassi, Roberto/0000-0001-9729-2641; Spargino, Luca/0000-0003-4572-9252
NR 7
TC 1
Z9 1
U1 0
U2 1
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2325-887X
BN 978-1-4799-4346-3
J9 COMPUT CARDIOL CONF
PY 2014
VL 41
BP 461
EP 464
PG 4
WC Cardiac & Cardiovascular Systems; Computer Science, Interdisciplinary
Applications; Mathematical & Computational Biology
SC Cardiovascular System & Cardiology; Computer Science; Mathematical &
Computational Biology
GA BE2TW
UT WOS:000370068300117
ER
PT S
AU Chen, DD
Gray, RA
Fenton, FH
AF Chen, Diandian Diana
Gray, Richard A.
Fenton, Flavio H.
BE Murray, A
TI Modelling the Take-off Voltage of the Action Potential during Fast
Pacing
SO 2014 COMPUTING IN CARDIOLOGY CONFERENCE (CINC), VOL 41
SE Computing in Cardiology Conference
LA English
DT Proceedings Paper
CT 41st Computing in Cardiology Conference (CinC)
CY SEP 07-10, 2014
CL Cambridge, MA
SP Massachusetts Inst Technol, European Soc Cardiol, IEEE EMBS, Mortara, PhysioNet, Philips, Mindray, IBM, Zoll, Mitsubishi Elect, lOP Publishing, IMES, CSAIL, Medtronic, Boston Sci, Samsung, GE
ID VENTRICULAR-FIBRILLATION
AB To date over 50 models for cardiac action potential have been developed, and while they vary widely in their complexity and the physiological characteristics that they reproduce, most fail to accurately replicate the takeoff potential during fast pacing and fibrillation. A specific aspect we focus is on the takeoff potential for an S2 stimulation following a steady S1 action potential. In microelectrodes and optical mapping experiment, the take-off voltage of an S2 action potential has been shown to be relatively high while most cardiac cell models do not reflect this feature, as the voltage needs to return close to the resting membrane potential before it can be reactivated. Since this difference can have great effects in electrical waves and their dynamics during tachycardia and fibrillation, we developed a framework that can be incorporated into the models to reproduce. the experimentally observed higher take off potential.
Recovery of inactivation in the Sodium current is the key to the activation from an S2 stimulus. Therefore, we focused on the sodium inactivation gates h and j. We hypothesized that the j gate is the source of the low take off potential because it recovers during AP final repolarization. Our procedure is to model the dynamics of both gates via a single one with an adjustable time constant tau. We model tau with an asymmetric equation. Using this equation form, we can manipulate the width, height, and asymptotic values of tau. The features that change the takeoff potential significantly are the midpoint and asymptotic valuers) of tau. By shifting the midpoint value of tau to a higher value, the takeoff potential increase, while rest of the sodium dynamics remains unaltered.
C1 [Chen, Diandian Diana; Fenton, Flavio H.] Georgia Inst Technol, Sch Phys, 837 State St, Atlanta, GA 30332 USA.
[Gray, Richard A.] US FDA, Silver Spring, MD USA.
RP Chen, DD (reprint author), Georgia Inst Technol, Sch Phys, 837 State St, Atlanta, GA 30332 USA.
EM dchen87@gatech.edu
NR 12
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2325-887X
BN 978-1-4799-4346-3
J9 COMPUT CARDIOL CONF
PY 2014
VL 41
BP 685
EP 688
PG 4
WC Cardiac & Cardiovascular Systems; Computer Science, Interdisciplinary
Applications; Mathematical & Computational Biology
SC Cardiovascular System & Cardiology; Computer Science; Mathematical &
Computational Biology
GA BE2TW
UT WOS:000370068300173
ER
PT S
AU Calhoun, WR
Ilev, I
AF Calhoun, William R., III
Ilev, Ilko
GP IEEE
TI Effect of Femtosecond Laser Pulse Energy and Repetition Rate on Laser
Induced Second and Third Harmonic Generation in Corneal Tissue
SO 2014 CONFERENCE ON LASERS AND ELECTRO-OPTICS (CLEO)
SE Conference on Lasers and Electro-Optics
LA English
DT Proceedings Paper
CT Conference on Lasers and Electro-Optics (CLEO)
CY JUN 08-13, 2014
CL San Jose, CA
ID LIGHT; SURGERY; RETINA
AB We present a quantitative study on the effect of femtosecond laser pulse energy and repetition rate on the intensity and duration of the laser induced second and third harmonic generation in fresh corneal tissue.
C1 [Calhoun, William R., III; Ilev, Ilko] US FDA, Opt Therapeut & Med Nanophoton Lab, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Calhoun, WR (reprint author), US FDA, Opt Therapeut & Med Nanophoton Lab, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM William.Calhoun@fda.hhs.gov
NR 7
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2160-9020
J9 CONF LASER ELECTR
PY 2014
PG 2
WC Engineering, Electrical & Electronic; Optics; Physics, Applied
SC Engineering; Optics; Physics
GA BE2RC
UT WOS:000369908600073
ER
PT S
AU Hassan, M
Gaitan, B
Ilev, I
AF Hassan, Moinuddin
Gaitan, Brandon
Ilev, Ilko
GP IEEE
TI Decontamination of Medical Device Surface Using Ultrashort Pulsed Laser
Irradiation
SO 2014 CONFERENCE ON LASERS AND ELECTRO-OPTICS (CLEO)
SE Conference on Lasers and Electro-Optics
LA English
DT Proceedings Paper
CT Conference on Lasers and Electro-Optics (CLEO)
CY JUN 08-13, 2014
CL San Jose, CA
ID DISINFECTION
AB We present a novel approach for non-contact, rapid and chemical-free decontamination of medical device surfaces using near-infrared ultrashort (nano-to femtosecond) pulse lasers. A proof-of-principal experimental platform is validated through multivariable comparison studies.
C1 [Hassan, Moinuddin; Gaitan, Brandon; Ilev, Ilko] US FDA, Opt Therapeut & Med Nanophoton Lab, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Hassan, M (reprint author), US FDA, Opt Therapeut & Med Nanophoton Lab, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM moinuddin.hassan@fda.hhs.gov
NR 4
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2160-9020
J9 CONF LASER ELECTR
PY 2014
PG 2
WC Engineering, Electrical & Electronic; Optics; Physics, Applied
SC Engineering; Optics; Physics
GA BE2RC
UT WOS:000369908600080
ER
PT S
AU Li, DW
Zheng, JF
Liu, Y
Chen, J
Pan, CW
Kainz, W
AF Li, Dawei
Zheng, Jianfeng
Liu, Yan
Chen, Ji
Pan, Changwan
Kainz, Wolfgang
GP IEEE
TI Using Scaling Approach to Estimate MRI RF Field Induced Heating for
Small Medical Implant
SO 2014 IEEE INTERNATIONAL SYMPOSIUM ON ELECTROMAGNETIC COMPATIBILITY (EMC)
SE IEEE International Symposium on Electromagnetic Compatibility
LA English
DT Proceedings Paper
CT IEEE International Symposium on Electromagnetic Compatibility (EMC)
CY AUG 03-08, 2014
CL Raleigh, NC
SP IEEE, EMC Soc, ANDRO, ARRL, FEKO, GAUSS INSTRUMENTS, INFIELD Sci Inc, RETLIF TESTING LABS, ETS LINDGREN, ENR Seven Mountains Sci Inc, Evaluat Engn, IEEE Antennas & Propagat Magazine, IEEE Microwave Magazine, ATER, In Compliance Same Page Publishing Inc, ITEM Interference Technol, Microwave Journal, Safety & EMC Magazine, Webcom Commun Corp, Wireless Design & Dev, ECN
DE RF induced heating; MRI safety; scaling approach; medical implants
AB In this paper, a quick and efficient approach is proposed to estimate the in-vivo RF induced heating of small medical implants under MRI procedure. The method is based on scaling the in-vivo incident electric fields. Numerical and experimental studies demonstrate the efficiency and accuracy of the proposed method.
C1 [Li, Dawei; Zheng, Jianfeng; Liu, Yan; Chen, Ji] Univ Houston, Dept Elect & Comp Engn, Houston, TX 77004 USA.
[Pan, Changwan] Microtech Co Ltd, Nanjing, Jiangsu, Peoples R China.
[Kainz, Wolfgang] US FDA, Rockville, MD 20857 USA.
RP Li, DW (reprint author), Univ Houston, Dept Elect & Comp Engn, Houston, TX 77004 USA.
EM dli15@central.uh.edu; jzheng3@central.uh.edu; jchen18@central.uh.edu;
wolfgang.kainz@fda.hhs.gov
NR 7
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2158-110X
BN 978-1-4799-5545-9
J9 IEEE INT SYMP ELEC
PY 2014
BP 109
EP 112
PG 4
WC Engineering, Electrical & Electronic
SC Engineering
GA BG9OA
UT WOS:000393471300020
ER
PT S
AU Huang, X
Zheng, JF
Chen, J
Wu, X
Kono, M
Hozono, H
Kainz, W
AF Huang, Xin
Zheng, Jianfeng
Chen, Ji
Wu, Xin
Kono, Mari
Hozono, Hideki
Kainz, Wolfgang
GP IEEE
TI MRI Heating Reduction for External Fixation Devices Using Absorption
Material
SO 2014 IEEE INTERNATIONAL SYMPOSIUM ON ELECTROMAGNETIC COMPATIBILITY (EMC)
SE IEEE International Symposium on Electromagnetic Compatibility
LA English
DT Proceedings Paper
CT IEEE International Symposium on Electromagnetic Compatibility (EMC)
CY AUG 03-08, 2014
CL Raleigh, NC
SP IEEE, EMC Soc, ANDRO, ARRL, FEKO, GAUSS INSTRUMENTS, INFIELD Sci Inc, RETLIF TESTING LABS, ETS LINDGREN, ENR Seven Mountains Sci Inc, Evaluat Engn, IEEE Antennas & Propagat Magazine, IEEE Microwave Magazine, ATER, In Compliance Same Page Publishing Inc, ITEM Interference Technol, Microwave Journal, Safety & EMC Magazine, Webcom Commun Corp, Wireless Design & Dev, ECN
DE absorption material; RF heating reduction; external fixation
AB Using absorption materials to reduce RF heating during MRI procedure is studied in this paper. Materials with different electromagnetic absorption characteristics are used to alter the EM and current distributions on the device. Consequently, the RF induced heating behaviors of external fixation devices can be reduced. Numerical and experimental studies are provided to demonstrate the potentials of reducing the RF heating for external fixation devices of using lossy materials.
C1 [Huang, Xin; Zheng, Jianfeng; Chen, Ji] Univ Houston, ECE Dept, Houston, TX 77004 USA.
[Wu, Xin; Kono, Mari; Hozono, Hideki] Molex Inc, Lisle, IL USA.
[Kainz, Wolfgang] US FDA, Silver Spring, MD USA.
RP Huang, X (reprint author), Univ Houston, ECE Dept, Houston, TX 77004 USA.
EM xhuang12@uh.edu; jchen18@uh.edu; wolfgang.kainz@fda.hhs.gov
NR 5
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2158-110X
BN 978-1-4799-5545-9
J9 IEEE INT SYMP ELEC
PY 2014
BP 113
EP 117
PG 5
WC Engineering, Electrical & Electronic
SC Engineering
GA BG9OA
UT WOS:000393471300021
ER
PT S
AU Li, DW
Huang, X
Chen, J
Kainz, W
AF Li, Dawei
Huang, Xin
Chen, Ji
Kainz, Wolfgang
GP IEEE
TI A Study of Antenna Efficiency and MRI Compatibility of Cardiac Stent
SO 2014 IEEE INTERNATIONAL SYMPOSIUM ON ELECTROMAGNETIC COMPATIBILITY (EMC)
SE IEEE International Symposium on Electromagnetic Compatibility
LA English
DT Proceedings Paper
CT IEEE International Symposium on Electromagnetic Compatibility (EMC)
CY AUG 03-08, 2014
CL Raleigh, NC
SP IEEE, EMC Soc, ANDRO, ARRL, FEKO, GAUSS INSTRUMENTS, INFIELD Sci Inc, RETLIF TESTING LABS, ETS LINDGREN, ENR Seven Mountains Sci Inc, Evaluat Engn, IEEE Antennas & Propagat Magazine, IEEE Microwave Magazine, ATER, In Compliance Same Page Publishing Inc, ITEM Interference Technol, Microwave Journal, Safety & EMC Magazine, Webcom Commun Corp, Wireless Design & Dev, ECN
DE Implantable stent implants; Radiation efficiency; Biomedical wireless
communication; MRI Compatibility
AB Implantable stents can be used as radiation antennas for wireless communication of cardiovascular health monitoring data. However, such stent can also lead to RF induced heating during MRI procedure. In this paper, we investigate the effect of different stent size on the antenna radiation performance as well as its RF induced heating during MRI procedure. Preliminary investigations show that longer stent typically yields to better radiation efficiency but suffers from higher temperature rises.
C1 [Li, Dawei] Univ Houston, Dept Elect & Comp Engn, Houston, TX 77004 USA.
[Kainz, Wolfgang] US FDA, Rockville, MD 20857 USA.
RP Li, DW (reprint author), Univ Houston, Dept Elect & Comp Engn, Houston, TX 77004 USA.
EM dli15@central.uh.edu; xhuang12@central.uh.edu; jchen18@central.uh.edu;
wolfgang.kainz@fda.hhs.gov
NR 9
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2158-110X
BN 978-1-4799-5545-9
J9 IEEE INT SYMP ELEC
PY 2014
BP 165
EP 170
PG 6
WC Engineering, Electrical & Electronic
SC Engineering
GA BG9OA
UT WOS:000393471300031
ER
PT S
AU Krauthamer, V
AF Krauthamer, Victor
GP IEEE
TI Neuromodulation with Subthreshold Electrical Stimulation: Mechanisms,
Safety, and Seeking Proof of Effectiveness
SO 2014 IEEE SIGNAL PROCESSING IN MEDICINE AND BIOLOGY SYMPOSIUM (SPMB)
SE IEEE Signal Processing in Medicine and Biology Symposium
LA English
DT Proceedings Paper
CT IEEE Signal Processing in Medicine and Biology Symposium
CY DEC 13-13, 2014
CL Philadelphia, PA
SP Neural Engineering Data Consortium, The Inst of Elect and Elect Engineers (Region 2), Signal Proc Soc (Philadelphia Sect)
C1 [Krauthamer, Victor] US FDA, Off Sci & Engn Labs, Div Biomed Phys, Rockville, MD 20857 USA.
RP Krauthamer, V (reprint author), US FDA, Off Sci & Engn Labs, Div Biomed Phys, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 2372-7241
BN 978-1-4799-8184-7
J9 IEEE SIG PROC MED
PY 2014
PG 1
WC Engineering, Electrical & Electronic
SC Engineering
GA BF2IS
UT WOS:000380471200002
ER
PT J
AU Neufeld, E
Iacono, MI
Akinnagbe, E
Wolf, J
Oikonomidis, IV
Sharma, D
Wilm, B
Wyss, M
Jakab, A
Cohen, E
Kuster, N
Kainz, W
Angelone, LM
AF Neufeld, Esra
Iacono, Maria I.
Akinnagbe, Esther
Wolf, Johanna
Oikonomidis, Ioannis V.
Sharma, Deepika
Wilm, Bertram
Wyss, Michael
Jakab, Andras
Cohen, Ethan
Kuster, Niels
Kainz, Wolfgang
Angelone, Leonardo M.
GP IEEE
TI Computational Platform Combining Detailed and Precise Functionalized
Anatomical Phantoms with EM-Neuron Interaction Modeling
SO 2014 XXXITH URSI GENERAL ASSEMBLY AND SCIENTIFIC SYMPOSIUM (URSI GASS)
LA English
DT Proceedings Paper
CT 29th URSI General Assembly and Scientific Symposium (URSI GASS)
CY AUG 16-23, 2014
CL Beijing, PEOPLES R CHINA
SP URSI
AB A computational framework including functionalized anatomical phantoms able to simulate electromagnetic (EM)-neuron interactions in complex tissue-structure environments was developed. The anatomic head model distinguishes a large number of structures, particularly in regions relevant to EM-neuron interactions (i.e., ear, eye, deep brain structures). Multimodal Magnetic Resonance (MR) images were acquired together with Diffusion Tensor Imaging (DTI) data to guide neuron model placement and inform about tissue anisotropy. A dedicated EM solver was implemented and coupled with dynamic models of neuronal activity. The topologically conforming, non-self-intersecting, high-element-quality surfaces are suitable for a wide range of numerical methods and solvers, as demonstrated in an application derived from transcranial alternating current stimulation. The platform was validated against literature data, e.g., on the SENN [1] model which was further extended to account for local thermal effects. Additionally, the EM-neuron coupling simulation platform was also applied to investigate MRI gradient coil switching induced nerve stimulation.
C1 [Neufeld, Esra; Oikonomidis, Ioannis V.; Sharma, Deepika; Kuster, Niels] Fdn Res Informat Technol Soc ITIS, CH-8004 Zurich, Switzerland.
[Iacono, Maria I.; Akinnagbe, Esther; Cohen, Ethan; Kainz, Wolfgang; Angelone, Leonardo M.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Wolf, Johanna; Oikonomidis, Ioannis V.; Sharma, Deepika; Kuster, Niels] ETH, Swiss Fed Inst Technol, CH-8092 Zurich, Switzerland.
[Wilm, Bertram; Wyss, Michael] Univ Zurich, Inst Biomed Engn, CH-8006 Zurich, Switzerland.
[Wilm, Bertram; Wyss, Michael] Swiss Fed Inst Technol, Zurich, Switzerland.
[Jakab, Andras] Med Univ Vienna, Computat Image Anal & Radiol Lab, A-1090 Vienna, Austria.
RP Neufeld, E (reprint author), Fdn Res Informat Technol Soc ITIS, CH-8004 Zurich, Switzerland.
EM neufeld@itis.ethz.ch; maria.iacono@gmail.com; akinnesther@gmail.com;
wolf@itis.ethz.ch; ioannis@itis.ethz.ch; sharma@itis.ethz.ch;
wilm@biomed.ee.ethz.ch; wyss@biomed.ee.ethz.ch;
andras.jakab@meduniwien.ac.at; ethan.cohen@fda.hhs.gov;
kuster@itis.ethz.ch; wolfgang.kainz@fda.hhs.gov;
leonardo.angelone@fda.hhs.gov
NR 7
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
BN 978-1-4673-5225-3
PY 2014
PG 4
WC Engineering, Electrical & Electronic; Physics, Applied
SC Engineering; Physics
GA BE0QU
UT WOS:000366628703301
ER
PT J
AU Ghosh, T
AF Ghosh, T.
BE Chilcott, R
Brain, K
TI SYSTEMIC TOPICAL DRUG DELIVERY: US REGULATORY PERSPECTIVES ON PRODUCT
DEVELOPMENT, BIOPHARMACEUTICALS AND CLINICAL PHARMACOLOGY
SO ADVANCES IN DERMATOLOGICAL SCIENCES
SE Issues in Toxicology
LA English
DT Article; Book Chapter
C1 [Ghosh, T.] US FDA, Off New Drugs & Qual Assessment, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Ghosh, T (reprint author), US FDA, Off New Drugs & Qual Assessment, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
NR 3
TC 0
Z9 0
U1 0
U2 0
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, CAMBRIDGE CB4 4WF, CAMBS, ENGLAND
BN 978-1-84973-463-9
J9 ISSUES TOXICOL
PY 2014
VL 20
BP 287
EP 307
PG 21
WC Dermatology; Toxicology
SC Dermatology; Toxicology
GA BG3WO
UT WOS:000388324400025
ER
PT J
AU Glindmeyer, HW
Harry, A
AF Glindmeyer, H. W.
Harry, A.
TI Fda's Current Approach To Premarket Notification SuBMIssions (510(k)s)
For Continuous Positive Pressure Ventilators
SO AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
LA English
DT Meeting Abstract
C1 [Glindmeyer, H. W.] US FDA, Silver Spring, MD USA.
[Glindmeyer, H. W.; Harry, A.] US FDA, White Oak, DC USA.
EM henry.glindmeyer@fda.hhs.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER THORACIC SOC
PI NEW YORK
PA 25 BROADWAY, 18 FL, NEW YORK, NY 10004 USA
SN 1073-449X
EI 1535-4970
J9 AM J RESP CRIT CARE
JI Am. J. Respir. Crit. Care Med.
PY 2014
VL 189
MA A4578
PG 1
WC Critical Care Medicine; Respiratory System
SC General & Internal Medicine; Respiratory System
GA V45TF
UT WOS:000209838204072
ER
PT J
AU Wang, Y
Pereira, C
Scott, DE
Brantly, M
Rouhani, F
Reed, JL
AF Wang, Y.
Pereira, C.
Scott, D. E.
Brantly, M.
Rouhani, F.
Reed, J. L.
TI Cytosolic Alpha-1 Proteinase Inhibitor Regulates Mitochondrial
Superoxide Generation And Inflammasome Signaling In Monocytes: Role Of
Autophagy
SO AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
LA English
DT Meeting Abstract
C1 [Wang, Y.; Pereira, C.; Scott, D. E.; Reed, J. L.] US FDA, Bethesda, MD 20014 USA.
[Brantly, M.; Rouhani, F.] Univ Florida, Gainesville, FL USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER THORACIC SOC
PI NEW YORK
PA 25 BROADWAY, 18 FL, NEW YORK, NY 10004 USA
SN 1073-449X
EI 1535-4970
J9 AM J RESP CRIT CARE
JI Am. J. Respir. Crit. Care Med.
PY 2014
VL 189
MA A4942
PG 1
WC Critical Care Medicine; Respiratory System
SC General & Internal Medicine; Respiratory System
GA V45TF
UT WOS:000209838204434
ER
PT J
AU Wang, MY
Misakian, M
He, HJ
Bajcsy, P
Abbasi, F
Davis, JM
Cole, KD
Turko, IV
Wang, LL
AF Wang, Meiyao
Misakian, Martin
He, Hua-Jun
Bajcsy, Peter
Abbasi, Fatima
Davis, Jeffrey M.
Cole, Kenneth D.
Turko, Illarion V.
Wang, Lili
TI Quantifying CD4 receptor protein in two human CD4+lymphocyte
preparations for quantitative flow cytometry
SO CLINICAL PROTEOMICS
LA English
DT Article
DE Cryopreserved peripheral blood mononuclear cells (PBMC); Lyophilized
Cyto-Trol (TM); CD4 receptor density; Flow cytometry; Multiple reaction
monitoring (MRM) mass spectrometry (MS); Scanning electron microscopy
(SEM); Microvilli; Cell surface area
AB Background: In our previous study that characterized different human CD4+ lymphocyte preparations, it was found that both commercially available cryopreserved peripheral blood mononuclear cells (PBMC) and a commercially available lyophilized PBMC (Cyto-Trol T) preparation fulfilled a set of criteria for serving as biological calibrators for quantitative flow cytometry. However, the biomarker CD4 protein expression level measured for T helper cells from Cyto-Trol was about 16% lower than those for cryopreserved PBMC and fresh whole blood using flow cytometry and mass cytometry. A primary reason was hypothesized to be due to steric interference in anti-CD4 antibody binding to the smaller sized lyophilized control cells.
Method: Targeted multiple reaction monitoring (MRM) mass spectrometry (MS) is used to quantify the copy number of CD4 receptor protein per CD4+ lymphocyte. Scanning electron microscopy (SEM) is utilized to assist searching the underlying reasons for the observed difference in CD4 receptor copy number per cell determined by MRM MS and CD4 expression measured previously by flow cytometry.
Results: The copy number of CD4 receptor proteins on the surface of the CD4+ lymphocyte in cryopreserved PBMCs and in lyophilized control cells is determined to be (1.45 +/- 0.09) x 10(5) and (0.85 +/- 0.11) x 10(5), respectively, averaged over four signature peptides using MRM MS. In comparison with cryopreserved PBMCs, there are more variations in the CD4 copy number in lyophilized control cells determined based on each signature peptide. SEM images of CD4+ lymphocytes from lyophilized control cells are very different when compared to the CD4+ T cells from whole blood and cryopreserved PBMC.
Conclusion: Because of the lyophilization process applied to Cyto-Trol control cells, a lower CD4 density value, defined as the copy number of CD4 receptors per CD4+ lymphocyte, averaged over three different production lots is most likely explained by the loss of the CD4 receptors on damaged and/or broken microvilli where CD4 receptors reside. Steric hindrance of antibody binding and the association of CD4 receptors with other biomolecules likely contribute significantly to the nearly 50% lower CD4 receptor density value for cryopreserved PBMC determined from flow cytometry compared to the value obtained from MRM MS.
C1 [Wang, Meiyao; Turko, Illarion V.] Univ Maryland, Inst Biosci & Biotechnol Res, 9600 Gudelsky Dr, Rockville, MD 20850 USA.
[Wang, Meiyao; Turko, Illarion V.] NIST, Biomol Measurement Div, Gaithersburg, MD 20899 USA.
[Misakian, Martin] NIST, Quantum Measurements Div, Gaithersburg, MD 20899 USA.
[He, Hua-Jun; Cole, Kenneth D.; Wang, Lili] NIST, Biosyst & Biomat Div, Gaithersburg, MD 20899 USA.
[Bajcsy, Peter] NIST, Software & Syst Div, Gaithersburg, MD 20899 USA.
[Abbasi, Fatima] CBER FDA, Lab Stem Cell Biol, Cellular & Tissue Therapy Branch, Div Cell & Gene Therapies, Bethesda, MD 20892 USA.
[Davis, Jeffrey M.] NIST, Mat Measurement Sci Div, Gaithersburg, MD 20899 USA.
RP Wang, MY (reprint author), Univ Maryland, Inst Biosci & Biotechnol Res, 9600 Gudelsky Dr, Rockville, MD 20850 USA.
EM meiyaow@umd.edu; lili.wang@nist.gov
NR 23
TC 2
Z9 2
U1 1
U2 1
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1542-6416
EI 1559-0275
J9 CLIN PROTEOM
JI Clin. Proteom.
PY 2014
VL 11
AR 43
DI 10.1186/1559-0275-11-43
PG 10
WC Biochemical Research Methods
SC Biochemistry & Molecular Biology
GA V42YR
UT WOS:000209649600038
PM 25593565
ER
PT S
AU Delmonte, P
Fardin-Kia, AR
Aldai, N
Mossoba, MM
Kramer, JKG
AF Delmonte, Pierluigi
Fardin-Kia, Ali Reza
Aldai, Noelia
Mossoba, Magdi M.
Kramer, John K. G.
BE Sels, B
Philippaerts, A
TI Analysis of Conjugated and Other Fatty Acids
SO CONJUGATED LINOLEIC ACIDS AND CONJUGATED VEGETABLE OILS
SE RSC Catalysis Series
LA English
DT Article; Book Chapter
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; TRANS-PALMITOLEIC ACID;
ALPHA-ELEOSTEARIC ACID; SILVER-ION HPLC; LINOLEIC-ACID; MILK-FAT;
GAS-CHROMATOGRAPHY; CLA ISOMERS; OCTADECADIENOIC ACID; STATIONARY PHASES
C1 [Delmonte, Pierluigi; Fardin-Kia, Ali Reza; Mossoba, Magdi M.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
[Aldai, Noelia] Univ Basque Country UPV EHU, Fac Pharm, Dept Pharm & Food Sci, Vitoria 01006, Spain.
[Kramer, John K. G.] Agr & Agri Food Canada, Guelph Food Res Ctr, Guelph, ON, Canada.
RP Delmonte, P (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM Pierluigi.Delmonte@fda.hhs.gov; jkgkramer@rogers.com
NR 117
TC 0
Z9 0
U1 0
U2 0
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, CAMBRIDGE CB4 4WF, CAMBS, ENGLAND
SN 1757-6725
BN 978-1-78262-021-1; 978-1-84973-900-9
J9 RSC CATAL SER
PY 2014
IS 19
BP 172
EP 231
D2 10.1039/9781782620211
PG 60
WC Chemistry, Applied; Food Science & Technology
SC Chemistry; Food Science & Technology
GA BG3PG
UT WOS:000388104100009
ER
PT S
AU Weaver, JD
Gupta, S
Woods, TO
AF Weaver, Jason D.
Gupta, Shikha
Woods, Terry O.
BE Mitchell, MR
Smith, SW
Woods, T
Berg, BT
TI The Effects of Test Speed on Fatigue Life of Nitinol Wire in Rotary Bend
SO FATIGUE AND FRACTURE OF MEDICAL METALLIC MATERIALS AND DEVICES: 3RD
VOLUME
SE American Society for Testing and Materials Special Technical
Publications
LA English
DT Proceedings Paper
CT Symposium on Fatigue and Fracture of Medical Metallic Materials and
Devices
CY NOV 14, 2012
CL Atlanta, GA
SP ASTM Int Comm E08 Fatigue & Fracture, ASTM Subcommittee E08 05 Cycl Deformat & Fatigue Crack Format
DE fatigue; nitinol; speed; frequency; rotary bend; wire
ID SHAPE-MEMORY WIRES; FRACTURE; PREVALENCE; ROTATION; STENTS
AB In order to acquire durability data for medical devices in a reasonable amount of time, manufacturers often perform fatigue testing at an accelerated rate. However, the effects of increasing test frequency on the fatigue life of nitinol devices have not been thoroughly investigated. In order to better understand how test speed affects nitinol fatigue, superelastic nitinol wire was tested in body-temperature water in a free (unguided) rotary bend fatigue apparatus. Alternating strains of 0.9 %, 1.0 %, 1.1 %, 1.5 %, or 2.0 % were applied at rotational test speeds of 0.6, 6, or 60 Hz. Except for the highest strain level, results trended toward increased fatigue life at higher test frequencies. Fatigue life at 6 and 60 Hz was significantly greater (p< 0.05) than fatigue life at the slowest test speed for alternating strains of 1.0 %, 1.1 %, and 1.5 %. High-speed video of 1.0 % and 1.1 % alternating strain tests at 60 Hz revealed small vibrations that manifested as side-to-side rocking motion of the wire. Because of the unexpected vibrations seen in nitinol wire tests, supplementary testing of cobalt-chromium wire was conducted. Highspeed video of cobalt-chromium wire at 0.5 % alternating strain and 333 Hz test speed showed a vertical bouncing motion that appeared to be a second vibration mode. To constrain motion and reduce vibration effects, wire guides were constructed and used in additional testing. Guided tests of cobalt-chromium wire showed reduced vibration, resulting in a lowered fatigue life that was nearer to values expected based on literature. Although further testing is needed, vibrations appear to artificially increase fatigue life by altering the imposed radius of curvature and reducing the amount of strain wires undergo in each cycle. Rotary bend wire fatigue testing remains a relatively simple and useful test; however, caution is recommended when the test is conducted without wire guides, as vibrations may affect fatigue life.
C1 [Weaver, Jason D.; Gupta, Shikha; Woods, Terry O.] US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Weaver, JD (reprint author), US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM jason.weaver@fda.hhs.gov
NR 15
TC 0
Z9 0
U1 0
U2 0
PU ASTM INTERNATIONAL
PI WEST CONSHOHOCKEN
PA 100 BARR HARBOR DRIVE, PO BOX C700, WEST CONSHOHOCKEN, PA 19428-2959 USA
SN 0066-0558
BN 978-0-8031-7545-7
J9 AM SOC TEST MATER
PY 2014
VL 1559
BP 1
EP 17
DI 10.1520/STP155920120213
PG 17
WC Materials Science, Biomaterials; Materials Science, Characterization &
Testing
SC Materials Science
GA BE3OB
UT WOS:000371052500002
ER
PT J
AU Liu, SL
Paule, MG
Zhang, X
Newport, GD
Patterson, TA
Apana, SM
Berridge, MS
Maisha, MP
Slikker, W
Wang, C
AF Liu, Shuliang
Paule, Merle G.
Zhang, Xuan
Newport, Glenn D.
Patterson, Tucker A.
Apana, Scott M.
Berridge, Marc S.
Maisha, Mackean P.
Slikker, William, Jr.
Wang, Cheng
TI Positron emission tomography with [F-18]FLT revealed sevoflurane-induced
inhibition of neural progenitor cell expansion in vivo
SO FRONTIERS IN NEUROLOGY
LA English
DT Article
DE neural progenitor cell; positron emission tomography; [F-18]FLT;
sevoflurane; proliferation
AB Neural progenitor cell expansion is critical for normal brain development and an appropriate response to injury. During the brain growth spurt, exposures to general anesthetics, which either block the N-methyl-D-aspartate receptor or enhance the gamma-aminobutyric acid receptor type A can disturb neuronal transduction. This effect can be detrimental to brain development. Until now, the effects of anesthetic exposure on neural progenitor cell expansion in vivo had seldom been reported. Here, minimally invasive micro positron emission tomography (microPET) coupled with 3'-deoxy-3' [F-18] fluoro-l-thymidine ([F-18]FLT) was utilized to assess the effects of sevoflurane exposure on neural progenitor cell proliferation. ELT, a thymidine analog, is taken up by proliferating cells and phosphorylated in the cytoplasm, leading to its intracellular trapping. Intracellular retention of [F-18]FLT, thus, represents an observable in vivo marker of cell proliferation. Here, postnatal day 7 rats (n = 11/group) were exposed to 2.5% sevoflurane or room air for 9 h. For up to 2 weeks following the exposure, standard uptake values (SUVs) for [F-18]-FLT in the hippocampal formation were significantly attenuated in the sevoflurane-exposed rats (p < 0.0001), suggesting decreased uptake and retention of [F-18]FLT (decreased proliferation) in these regions. Four weeks following exposure, SUVs for [F-18]FLT were comparable in the sevoflurane-exposed rats and in controls. Co-administration of 7-nitroindazole (30 mg/kg, n= 5), a selective inhibitor of neuronal nitric oxide synthase, significantly attenuated the SUVs for [F-18]FLT in both the air-exposed (p = 0.00006) and sevoflurane-exposed rats (p = 0.0427) in the first week following the exposure. These findings suggested that microPET in couple with [F-18]FLT as cell proliferation marker could be used as a non-invasive modality to monitor the sevoflurane-induced inhibition of neural progenitor cell proliferation in vivo.
C1 [Liu, Shuliang; Paule, Merle G.; Zhang, Xuan; Newport, Glenn D.; Patterson, Tucker A.; Slikker, William, Jr.; Wang, Cheng] US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
[Apana, Scott M.; Berridge, Marc S.] 3D Imaging LLC, Little Rock, AR USA.
[Maisha, Mackean P.] US FDA, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Wang, C (reprint author), US FDA, Natl Ctr Toxicol Res, HFT-132,3900 NCTR Rd, Jefferson, AR 72079 USA.
EM Cheng.wang@fda.hhs.gov
NR 65
TC 1
Z9 1
U1 0
U2 1
PU FRONTIERS MEDIA SA
PI LAUSANNE
PA PO BOX 110, EPFL INNOVATION PARK, BUILDING I, LAUSANNE, 1015,
SWITZERLAND
SN 1664-2295
J9 FRONT NEUROL
JI Front. Neurol.
PY 2014
VL 5
AR 234
DI 10.3389/fneur.2014.00234
PG 7
WC Clinical Neurology; Neurosciences
SC Neurosciences & Neurology
GA V42QW
UT WOS:000209629300220
PM 25452743
ER
PT J
AU McCune, SK
Mulugeta, YA
AF McCune, Susan K.
Mulugeta, Yeruk Ager
TI Regulatory science needs for neonates: a call for neonatal community
collaboration and innovation
SO FRONTIERS IN PEDIATRICS
LA English
DT Editorial Material
DE neonatal; regulatory science; drugs; trials; collaboration
C1 [McCune, Susan K.; Mulugeta, Yeruk Ager] US FDA, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Mulugeta, Yeruk Ager] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP McCune, SK (reprint author), US FDA, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM susan.mccune@fda.hhs.gov
NR 16
TC 4
Z9 5
U1 0
U2 0
PU FRONTIERS MEDIA SA
PI LAUSANNE
PA PO BOX 110, EPFL INNOVATION PARK, BUILDING I, LAUSANNE, 1015,
SWITZERLAND
SN 2296-2360
J9 FRONT PEDIATR
JI Front. Pediatr.
PY 2014
VL 2
AR 135
DI 10.3389/fped.2014.00135
PG 3
WC Pediatrics
SC Pediatrics
GA V46PX
UT WOS:000209897200133
PM 25520945
ER
PT J
AU Su, ZQ
Fang, H
Hong, HX
Shi, LM
Zhang, WQ
Zhang, WW
Zhang, YY
Dong, ZR
Lancashire, LJ
Bessarabova, M
Yang, X
Ning, BT
Gong, BS
Meehan, J
Xu, J
Ge, WG
Perkins, R
Fischer, M
Tong, W
AF Su, Zhenqiang
Fang, Hong
Hong, Huixiao
Shi, Leming
Zhang, Wenqian
Zhang, Wenwei
Zhang, Yanyan
Dong, Zirui
Lancashire, Lee J.
Bessarabova, Marina
Yang, Xi
Ning, Baitang
Gong, Binsheng
Meehan, Joe
Xu, Joshua
Ge, Weigong
Perkins, Roger
Fischer, Matthias
Tong, Weida
TI An investigation of biomarkers derived from legacy microarray data for
their utility in the RNA-seq era
SO GENOME BIOLOGY
LA English
DT Article
ID GENE-EXPRESSION SIGNATURE; MULTIPLE-MYELOMA; CONNECTIVITY MAP;
REPRODUCIBILITY; CONSISTENCY; PLATFORMS; MODELS
AB Background:
Gene expression microarray has been the primary biomarker platform ubiquitously applied in biomedical research, resulting in enormous data, predictive models, and biomarkers accrued. Recently, RNA-seq has looked likely to replace microarrays, but there will be a period where both technologies co-exist. This raises two important questions: Can microarray-based models and biomarkers be directly applied to RNA-seq data? Can future
RNA-seq-based predictive models and biomarkers be applied to microarray data to leverage past investment?
Results:
We systematically evaluated the transferability of predictive models and signature genes between microarray and RNA-seq using two large clinical data sets. The complexity of cross-platform sequence correspondence was considered in the analysis and examined using three human and two rat data sets, and three levels of mapping
complexity were revealed. Three algorithms representing different modeling complexity were applied to the three levels of mappings for each of the eight binary endpoints and Cox regression was used to model survival times with expression data. In total, 240,096 predictive models were examined.
Conclusions:
Signature genes of predictive models are reciprocally transferable between microarray and RNA-seq data for model development, and microarray-based models can accurately predict RNA-seq-profiled samples; while
RNA-seq-based models are less accurate in predicting microarray-profiled samples and are affected both by the
choice of modeling algorithm and the gene mapping complexity. The results suggest continued usefulness of legacy
microarray data and established microarray biomarkers and predictive models in the forthcoming RNA-seq era.
C1 [Su, Zhenqiang; Fang, Hong; Hong, Huixiao; Zhang, Wenqian; Yang, Xi; Ning, Baitang; Gong, Binsheng; Meehan, Joe; Xu, Joshua; Ge, Weigong; Perkins, Roger; Tong, Weida] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Su, Zhenqiang; Bessarabova, Marina] Thomson Reuters, IP & Sci, Boston, MA 02210 USA.
[Shi, Leming; Lancashire, Lee J.] Fudan Univ, Sch Life Sci & Pharm, State Key Lab Genet Engn, Shanghai 201203, Peoples R China.
[Shi, Leming] Fudan Univ, Sch Life Sci & Pharm, MOE Key Lab Contemporary Anthropol, Shanghai 201203, Peoples R China.
[Shi, Leming] Fudan Zhangjiang Ctr Clin Genom, Shanghai 201203, Peoples R China.
[Shi, Leming; Zhang, Wenwei] Zhanjiang Ctr Translat Med, Shanghai 201203, Peoples R China.
[Zhang, Wenwei; Zhang, Yanyan; Dong, Zirui] BGI Shenzhen, Guangdong 518083, Peoples R China.
[Dong, Zirui; Fischer, Matthias] Univ Childrens Hosp Cologne, Dept Pediat Oncol & Hematol, D-50924 Cologne, Germany.
[Fischer, Matthias] Univ Childrens Hosp Cologne, Ctr Mol Med CMMC, D-50924 Cologne, Germany.
RP Su, ZQ (reprint author), US FDA, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM zhenqiangsu@gmail.com; matthias.fischer@uk-koeln.de;
weida.tong@fda.hhs.gov
RI Gong, Binsheng/E-2306-2015
OI Gong, Binsheng/0000-0002-8724-5435
FU National Science Foundation of China [31471239]; National High
Technology Research and Development Program of China [2015AA020104]
FX The authors gratefully acknowledge the contribution of Drs Jean
Thierry-Mieg,Danielle Thierry-Mieg, Stan Gaj, Marc o Chierici, and their
co-workers for processing the RNA-Seq data in the FDA SEQC Toxicogenomic
data set using their respective data analysis pipelines. This work was
supported in part by the National High Technology Research and
Development Program of China (2015AA020104, to LS) and the National
Science Foundation of China (31471239, to LS).
NR 30
TC 8
Z9 8
U1 0
U2 3
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1474-760X
J9 GENOME BIOL
JI Genome Biol.
PY 2014
VL 15
IS 12
AR 523
DI 10.1186/s13059-014-0523-y
PG 26
WC Biotechnology & Applied Microbiology; Genetics & Heredity
SC Biotechnology & Applied Microbiology; Genetics & Heredity
GA AW9XX
UT WOS:000346609500034
PM 25633159
ER
PT J
AU Gong, BS
Wang, C
Su, ZQ
Hong, HX
Thierry-Mieg, J
Thierry-Mieg, D
Shi, LM
Auerbach, SS
Tong, WD
Xu, J
AF Gong, Binsheng
Wang, Charles
Su, Zhenqiang
Hong, Huixiao
Thierry-Mieg, Jean
Thierry-Mieg, Danielle
Shi, Leming
Auerbach, Scott S.
Tong, Weida
Xu, Joshua
TI Transcriptomic profiling of rat liver samples in a comprehensive study
design by RNA-Seq
SO SCIENTIFIC DATA
LA English
DT Article
AB RNA-Seq provides the capability to characterize the entire transcriptome in multiple levels including gene expression, allele specific expression, alternative splicing, fusion gene detection, and etc. The US FDA-led SEQC (i.e., MAQC-III) project conducted a comprehensive study focused on the transcriptome profiling of rat liver samples treated with 27 chemicals to evaluate the utility of RNA-Seq in safety assessment and toxicity mechanism elucidation. The chemicals represented multiple chemogenomic modes of action (MOA) and exhibited varying degrees of transcriptional response. The paired-end 100 bp sequencing data were generated using Illumina HiScanSQ and/or HiSeq 2000. In addition to the core study, six animals (i.e., three aflatoxin B1 treated rats and three vehicle control rats) were sequenced three times, with two separate library preparations on two sequencing machines. This large toxicogenomics dataset can serve as a resource to characterize various aspects of transcriptomic changes (e.g., alternative splicing) that are byproduct of chemical perturbation.
C1 [Gong, Binsheng; Su, Zhenqiang; Hong, Huixiao; Shi, Leming; Tong, Weida; Xu, Joshua] US FDA, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Wang, Charles] Loma Linda Univ, Sch Med, Ctr Genom, Loma Linda, CA 92350 USA.
[Wang, Charles] Loma Linda Univ, Sch Med, Div Microbiol & Mol Genet, Loma Linda, CA 92350 USA.
[Thierry-Mieg, Jean; Thierry-Mieg, Danielle] NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20814 USA.
[Shi, Leming] Fudan Univ, State Key Lab Genet Engn, Shanghai 201203, Peoples R China.
[Shi, Leming] Fudan Univ, MOE Key Lab Contemporary Anthropol, Sch Life Sci, Shanghai 201203, Peoples R China.
[Shi, Leming] Fudan Univ, MOE Key Lab Contemporary Anthropol, Sch Pharm, Shanghai 201203, Peoples R China.
[Auerbach, Scott S.] NIEHS, Biomol Screening Branch, Div Natl Toxicol Program, POB 12233, Res Triangle Pk, NC 27709 USA.
RP Auerbach, SS (reprint author), NIEHS, Biomol Screening Branch, Div Natl Toxicol Program, POB 12233, Res Triangle Pk, NC 27709 USA.
EM auerbachs@niehs.nih.gov; weida.tong@fda.hhs.gov; zhihua.xu@fda.hhs.gov
RI THIERRY-MIEG, Jean/F-1975-2017
OI THIERRY-MIEG, Jean/0000-0002-0396-6789
FU Intramural Research Program of the NIH, National Library of Medicine
FX This dataset was generated for the SEQC toxicogenomics study and the
related research manuscript8. The authors would like to thank
Philippe Rocca-Serra for his guidance and assistance in sample metadata
collection and coding with ISA-TAB. This research was supported in part
by the Intramural Research Program of the NIH, National Library of
Medicine. The views presented in this article do not necessarily reflect
current or future opinion or policy of the US Food and Drug
Administration. Any mention of commercial products is for clarification
and not intended as an endorsement.
NR 24
TC 3
Z9 3
U1 0
U2 0
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 2052-4463
J9 SCI DATA
JI Sci. Data
PY 2014
VL 1
AR 140021
DI 10.1038/sdata.2014.21
PG 10
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA V45VG
UT WOS:000209843500014
ER
PT J
AU Harpaz, R
Odgers, D
Gaskin, G
DuMouchel, W
Winnenburg, R
Bodenreider, O
Ripple, A
Szarfman, A
Sorbello, A
Horvitz, E
White, RW
Shah, NH
AF Harpaz, Rave
Odgers, David
Gaskin, Greg
DuMouchel, William
Winnenburg, Rainer
Bodenreider, Olivier
Ripple, Anna
Szarfman, Ana
Sorbello, Alfred
Horvitz, Eric
White, Ryen W.
Shah, Nigam H.
TI A time-indexed reference standard of adverse drug reactions
SO SCIENTIFIC DATA
LA English
DT Article
AB Undetected adverse drug reactions (ADRs) pose a major burden on the health system. Data mining methodologies designed to identify signals of novel ADRs are of deep importance for drug safety surveillance. The development and evaluation of these methodologies requires proper reference benchmarks. While progress has recently been made in developing such benchmarks, our understanding of the performance characteristics of the data mining methodologies is limited because existing benchmarks do not support prospective performance evaluations. We address this shortcoming by providing a reference standard to support prospective performance evaluations. The reference standard was systematically curated from drug labeling revisions, such as new warnings, which were issued and communicated by the US Food and Drug Administration in 2013. The reference standard includes 62 positive test cases and 75 negative controls, and covers 44 drugs and 38 events. We provide usage guidance and empirical support for the reference standard by applying it to analyze two data sources commonly mined for drug safety surveillance.
C1 [Harpaz, Rave; Odgers, David; Gaskin, Greg; Shah, Nigam H.] Stanford Univ, Ctr Biomed Informat Res, Stanford, CA 94305 USA.
[DuMouchel, William] Oracle Hlth Sci, Bedford, MA 01730 USA.
[Winnenburg, Rainer; Bodenreider, Olivier; Ripple, Anna] NIH, Natl Lib Med, Bethesda, MD 20894 USA.
[Szarfman, Ana; Sorbello, Alfred] US FDA, Silver Spring, MD 20993 USA.
[Horvitz, Eric; White, Ryen W.] Microsoft Res, Redmond, WA 98052 USA.
RP Harpaz, R (reprint author), Stanford Univ, Ctr Biomed Informat Res, Stanford, CA 94305 USA.
EM rharpaz@stanford.edu
FU NIH [U54-HG004028]; NIGMS [GM101430- 01A1]; Med Scholars fellowship from
the Stanford School of Medicine; Intramural Research Program of the NIH,
National Library of Medicine; Microsoft Research
FX R.H. and N.H.S. acknowledge support by NIH grant U54-HG004028 for the
National Center for Biomedical Ontology and by NIGMS grant GM101430-
01A1. D.O. acknowledges support by NIGMS grant GM101430- 01A1. G.G. is
supported by a Med Scholars fellowship from the Stanford School of
Medicine. This work was supported in part by the Intramural Research
Program of the NIH, National Library of Medicine, and Microsoft
Research.
NR 29
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Z9 6
U1 0
U2 0
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 2052-4463
J9 SCI DATA
JI Sci. Data
PY 2014
VL 1
AR 140043
DI 10.1038/sdata.2014.43
PG 10
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA V45VG
UT WOS:000209843500039
ER
PT J
AU Xu, J
Su, ZQ
Hong, HX
Thierry-Mieg, J
Thierry-Mieg, D
Kreil, DP
Mason, CE
Tong, WD
Shi, LM
AF Xu, Joshua
Su, Zhenqiang
Hong, Huixiao
Thierry-Mieg, Jean
Thierry-Mieg, Danielle
Kreil, David P.
Mason, Christopher E.
Tong, Weida
Shi, Leming
TI Cross-platform ultradeep transcriptomic profiling of human reference RNA
samples by RNA-Seq
SO SCIENTIFIC DATA
LA English
DT Article
AB Whole-transcriptome sequencing ('RNA-Seq') has been drastically changing the scale and scope of genomic research. In order to fully understand the power and limitations of this technology, the US Food and Drug Administration (FDA) launched the third phase of the MicroArray Quality Control (MAQC-III) project, also known as the SEquencing Quality Control (SEQC) project. Using two well-established human reference RNA samples from the first phase of the MAQC project, three sequencing platforms were tested across more than ten sites with built-in truths including spike-in of external RNA controls (ERCC), titration data and qPCR verification. The SEQC project generated over 30 billion sequence reads representing the largest RNA-Seq data ever generated by a single project on individual RNA samples. This extraordinarily ultradeep transcriptomic data set and the known truths built into the study design provide many opportunities for further research and development to advance the improvement and application of RNA-Seq.
C1 [Xu, Joshua; Su, Zhenqiang; Hong, Huixiao; Tong, Weida; Shi, Leming] US FDA, Div Bioinformat cs & Biostat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Thierry-Mieg, Jean; Thierry-Mieg, Danielle] NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20814 USA.
[Kreil, David P.] Boku Univ Vienna, Chair Bioinformat Res Grp, Vienna, Austria.
[Kreil, David P.] Univ Warwick, Coventry CV4 7AL, W Midlands, England.
[Mason, Christopher E.] Weill Cornell Med Coll, Dept Physiol & Biophys, New York, NY 10021 USA.
[Mason, Christopher E.] Weill Cornell Med Coll, Inst Computat Biomed, New York, NY 10021 USA.
[Shi, Leming] Fudan Univ, State Key Lab Genet Engn, Shanghai 201203, Peoples R China.
[Shi, Leming] Fudan Univ, MOE Key Lab Contemporary Anthropol, Sch Life Sci, Shanghai 201203, Peoples R China.
[Shi, Leming] Fudan Univ, MOE Key Lab Contemporary Anthropol, Sch Pharm, Shanghai 201203, Peoples R China.
RP Tong, W (reprint author), US FDA, Div Bioinformat cs & Biostat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM leming.shi@gmail.com
RI THIERRY-MIEG, Jean/F-1975-2017
OI THIERRY-MIEG, Jean/0000-0002-0396-6789
FU Intramural Research Program of the NIH, National Library of Medicine
FX The authors would like to acknowledge all the participants of the SEQC
project, particularly the sequencing sites for generating the
high-quality data set. This research was supported in part by the
Intramural Research Program of the NIH, National Library of Medicine.
The views presented in this article do not necessarily reflect current
or future opinion or policy of the US Food and Drug Administration. Any
mention of commercial products is for clarification and not intended as
an endorsement.
NR 22
TC 1
Z9 1
U1 0
U2 0
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 2052-4463
J9 SCI DATA
JI Sci. Data
PY 2014
VL 1
AR 140020
DI 10.1038/sdata.2014.20
PG 8
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA V45VG
UT WOS:000209843500013
ER
PT J
AU Yu, Y
Zhao, C
Su, ZQ
Wang, C
Fuscoe, JC
Tong, WD
Shi, LM
AF Yu, Ying
Zhao, Chen
Su, Zhenqiang
Wang, Charles
Fuscoe, James C.
Tong, Weida
Shi, Leming
TI Comprehensive RNA-Seq transcriptomic profiling across 11 organs, 4 ages,
and 2 sexes of Fischer 344 rats
SO SCIENTIFIC DATA
LA English
DT Article
AB The rat is used extensively by the pharmaceutical, regulatory, and academic communities for safety assessment of drugs and chemicals and for studying human diseases; however, its transcriptome has not been well studied. As part of the SEQC (i.e., MAQC-III) consortium efforts, a comprehensive RNA-Seq data set was constructed using 320 RNA samples isolated from 10 organs (adrenal gland, brain, heart, kidney, liver, lung, muscle, spleen, thymus, and testes or uterus) from both sexes of Fischer 344 rats across four ages (2-, 6-, 21-, and 104-week-old) with four biological replicates for each of the 80 sample groups (organ-sex- age). With the Ribo-Zero rRNA removal and Illumina RNA-Seq protocols, 41 million 50 bp single-end reads were generated per sample, yielding a total of 13.4 billion reads. This data set could be used to identify and validate new rat genes and transcripts, develop a more comprehensive rat transcriptome annotation system, identify novel gene regulatory networks related to tissue specific gene expression and development, and discover genes responsible for disease and drug toxicity and efficacy.
C1 [Yu, Ying; Zhao, Chen; Shi, Leming] Fudan Univ, Ctr Pharmacogen, State Key Lab Genet Engn, Shanghai 201203, Peoples R China.
[Yu, Ying; Zhao, Chen; Shi, Leming] Fudan Univ, MOE Key Lab Contemporary Anthropol, Sch Life Sci, Shanghai 201203, Peoples R China.
[Yu, Ying; Zhao, Chen; Shi, Leming] Fudan Univ, MOE Key Lab Contemporary Anthropol, Sch Pharm, Shanghai 201203, Peoples R China.
[Su, Zhenqiang; Fuscoe, James C.; Tong, Weida; Shi, Leming] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Wang, Charles] Loma Linda Univ, Sch Med, Ctr Genom, Loma Linda, CA 92350 USA.
[Wang, Charles] Loma Linda Univ, Sch Med, Div Microbiol & Mol Genet, Loma Linda, CA 92350 USA.
[Shi, Leming] Fudan Zhangjiang Ctr Clin Genom, Shanghai 201203, Peoples R China.
[Shi, Leming] Zhanjiang Ctr Translat Med, Shanghai 201203, Peoples R China.
RP Shi, LM (reprint author), Fudan Univ, Ctr Pharmacogen, State Key Lab Genet Engn, Shanghai 201203, Peoples R China.
EM leming.shi@gmail.com
FU China's Program of Global Experts; China's National Supercomputing
Center of Tianjin; FDA Office of Women's Health
FX The authors gratefully acknowledge experimental support of many
collaborators who were listed as coauthors of the paper8 on
the initial analysis of the data set described in this manuscript. This
work was supported in part by China's Program of Global Experts, China's
National Supercomputing Center of Tianjin, and the FDA Office of Women's
Health. The views presented in this article do not necessarily reflect
current or future opinion or policy of the US Food and Drug
Administration. Any mention of commercial products is for clarification
and not intended as an endorsement.
NR 20
TC 1
Z9 1
U1 0
U2 0
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 2052-4463
J9 SCI DATA
JI Sci. Data
PY 2014
VL 1
AR 140013
DI 10.1038/sdata.2014.13
PG 8
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA V45VG
UT WOS:000209843500005
ER
PT B
AU Abraham, A
Plakas, SM
Dickey, RW
AF Abraham, Ann
Plakas, Steven M.
Dickey, Robert W.
BE Rossini, GP
TI Chemistry of Brevetoxins
SO TOXINS AND BIOLOGICALLY ACTIVE COMPOUNDS FROM MICROALGAE, VOL 1: ORIGIN,
CHEMISTRY AND DETECTION
LA English
DT Article; Book Chapter
ID OYSTER CRASSOSTREA-VIRGINICA; MUSSELS PERNA-CANALICULUS; TANDEM
MASS-SPECTROMETRY; KARENIA-BREVIS CULTURES; NEW-ZEALAND; RED TIDE;
AUSTROVENUS-STUTCHBURYI; PTYCHODISCUS-BREVIS; GREENSHELL MUSSELS;
GYMNODINIUM-BREVE
C1 [Abraham, Ann; Plakas, Steven M.; Dickey, Robert W.] US FDA, Div Seafood Sci & Technol, 1 Iberville Dr, Dauphin Isl, AL 36528 USA.
RP Abraham, A (reprint author), US FDA, Div Seafood Sci & Technol, 1 Iberville Dr, Dauphin Isl, AL 36528 USA.
EM ann.abraham@fda.hhs.gov; steven.plakas@fda.hhs.gov;
robert.dickey@fda.hhs.gov
NR 49
TC 0
Z9 0
U1 0
U2 0
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4822-1069-9; 978-1-4822-1068-2
PY 2014
BP 153
EP 175
PG 23
WC Plant Sciences; Toxicology
SC Plant Sciences; Toxicology
GA BF7MJ
UT WOS:000384234600007
ER
PT B
AU Hungerford, JM
AF Hungerford, James M.
BE Rossini, GP
TI Marine Toxin Detection Methods in Regulation-From Validation to
Implementation
SO TOXINS AND BIOLOGICALLY ACTIVE COMPOUNDS FROM MICROALGAE, VOL 1: ORIGIN,
CHEMISTRY AND DETECTION
LA English
DT Article; Book Chapter
ID PARALYTIC SHELLFISH TOXINS; SINGLE-LABORATORY VALIDATION;
LIQUID-CHROMATOGRAPHY; POISONING TOXINS; PRECHROMATOGRAPHIC OXIDATION;
QUANTITATIVE-DETERMINATION; FLUORESCENCE DETECTION; MOUSE BIOASSAY; PSP
TOXINS; OYSTERS
C1 [Hungerford, James M.] US FDA, ATC, PRL NW, AOAC Marine & Freshwater Toxins Task Force, 22201 23rd Dr SE, Bothell, WA 98021 USA.
RP Hungerford, JM (reprint author), US FDA, ATC, PRL NW, AOAC Marine & Freshwater Toxins Task Force, 22201 23rd Dr SE, Bothell, WA 98021 USA.
EM James.Hungerford@fda.gov
NR 47
TC 0
Z9 0
U1 0
U2 0
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4822-1069-9; 978-1-4822-1068-2
PY 2014
BP 487
EP 502
PG 16
WC Plant Sciences; Toxicology
SC Plant Sciences; Toxicology
GA BF7MJ
UT WOS:000384234600016
ER
PT B
AU Deeds, JR
AF Deeds, Jonathan R.
BE Rossini, GP
TI Toxicity of Palytoxins: From Cellular to Organism Level Responses
SO TOXINS AND BIOLOGICALLY ACTIVE COMPOUNDS FROM MICROALGAE VOL 2:
BIOLOGICAL EFFECTS AND RISK MANAGEMENT
LA English
DT Article; Book Chapter
ID DINOFLAGELLATE OSTREOPSIS-SIAMENSIS; FRENCH MEDITERRANEAN COAST;
OF-THE-ART; HAFF-DISEASE; PUTATIVE PALYTOXIN; MARINE TOXIN; OVATOXIN-A;
STRUCTURE ELUCIDATION; RIBOTOXIC STRESS; 1ST EVIDENCE
C1 [Deeds, Jonathan R.] US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
RP Deeds, JR (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM jonathan.deeds@fda.hhs.gov
NR 96
TC 0
Z9 0
U1 1
U2 1
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4822-3147-2; 978-1-4822-3146-5
PY 2014
BP 351
EP 378
PG 28
WC Plant Sciences; Toxicology
SC Plant Sciences; Toxicology
GA BF7MH
UT WOS:000384234100014
ER
PT B
AU Byrnes, AP
Huang, Y
Shannon, K
AF Byrnes, Andrew P.
Huang, Ying
Shannon, Kevin
BE Lattime, EC
Gerson, SL
TI The FDA Review Process for Cancer Gene Therapy
SO GENE THERAPY OF CANCER: TRANSLATIONAL APPROACHES FROM PRECLINICAL
STUDIES TO CLINICAL IMPLEMENTATION, 3RD EDITION
LA English
DT Article; Book Chapter
DE FDA; CBER; cancer gene therapy; regulatory review; CMC;
pharmacology/toxicology; clinical; drug development
ID EXPRESSION; MODELS; CELLS; ANGIOGENESIS; MELANOMA; VECTOR
AB This chapter provides an overview of the U. S. Food and Drug Administration (FDA) review process for cancer gene therapy products. Cancer gene therapy products are reviewed within FDA's Center for Biologics Evaluation and Research (CBER). Although there are currently no FDA-approved gene therapies, CBER works with academic and industry sponsors during all stages of product development. CBER's roles range from giving scientific advice to providing regulatory oversight to ensure the appropriate and safe treatment of human subjects. CBER teams composed of experts in various disciplines (chemistry/manufacturing/controls, pharmacology/toxicology, clinical, biostatistics, and regulatory project managers) review product and manufacturing issues, preclinical assessment, and clinical trial design at all stages of product development. This chapter summarizes CBER's functions and highlights some issues that are of particular importance for sponsors of cancer gene therapy trials. References with further regulatory guidance and information are provided.
C1 [Byrnes, Andrew P.; Huang, Ying; Shannon, Kevin] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
RP Byrnes, AP (reprint author), US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
NR 45
TC 0
Z9 0
U1 1
U2 5
PU ELSEVIER ACADEMIC PRESS INC
PI SAN DIEGO
PA 525 B STREET, SUITE 1900, SAN DIEGO, CA 92101-4495 USA
BN 978-0-12-394632-4; 978-0-12-394295-1
PY 2014
BP 503
EP 515
DI 10.1016/B978-0-12-394295-1.00035-4
PG 13
WC Biotechnology & Applied Microbiology; Oncology; Genetics & Heredity;
Medicine, Research & Experimental
SC Biotechnology & Applied Microbiology; Oncology; Genetics & Heredity;
Research & Experimental Medicine
GA BIE16
UT WOS:000327801200041
ER
PT J
AU Srivaths, PR
Goldstein, SL
Krishnamurthy, R
Silverstein, DM
AF Srivaths, Poyyapakkam R.
Goldstein, Stuart L.
Krishnamurthy, Rajesh
Silverstein, Douglas M.
TI High serum phosphorus and FGF 23 levels are associated with progression
of coronary calcifications
SO PEDIATRIC NEPHROLOGY
LA English
DT Article
DE Hemodialysis; Pediatric; Children
ID CHRONIC-KIDNEY-DISEASE; STAGE RENAL-DISEASE; LEFT-VENTRICULAR
HYPERTROPHY; HEMODIALYSIS-PATIENTS; VASCULAR CALCIFICATION; ARTERY
CALCIFICATION; CARDIOVASCULAR-DISEASE; YOUNG-ADULTS; DIALYSIS; CHILDREN
AB Coronary calcifications (CC) portend increased mortality in adults receiving hemodialysis (HD), however the risk factors associated with CC progression are not well known in pediatric patients. Our previous cross-sectional studies demonstrated high CC prevalence (31 %) in pediatric patients, which were significantly associated with high serum phosphorus (P), fibroblast growth factor 23 (FGF) levels, dialysis vintage, and low cholesterol. The current study was undertaken to determine and elucidate CC progression in pediatric HD patients.
A 1-year prospective longitudinal study of 16 pediatric patients (ten male; mean age, 16.9 +/- 3 years; range, 10.1-20.4 years) receiving chronic HD was conducted.
CC were observed in five of 16 (31.3 %) patients on baseline computed tomogram (CT) scan; 14/16 patients underwent 1-year CT. All patients with initial CC who completed CT at 1 year (3/5) progressed; one patient had new CC and none of the patients had resolved CC. Mean Agatston score increased from 23.4 +/- 18.06 HU (baseline) to 169 +/- 298.9 HU. Patients with CC progression had higher mean serum P (8.6 +/- 1.8 mg/dl vs. 6.3 +/- 1.1 mg/dl, p = 0.015) and FGF 23 levels (3,994 +/- 860.5 pg/ml vs. 2,327 +/- 1,206.4 pg/ml, p = 0.028). Serum P and FGF 23 levels were positively correlated with final Agatston scores (R = 0.65, p = 0.01 for serum P and R = 0.54, p = 0.045 for FGF 23) and change in Agatston scores (R = 0.65, p = 0.01 for serum P and R = 0.52, p = 0.048 for FGF 23).
Our study shows that CC is progressive in pediatric patients receiving HD and that increased serum P and FGF 23 levels are associated with this progression.
C1 [Srivaths, Poyyapakkam R.] Baylor Coll Med, Texas Childrens Hosp Pediat Nephrol, Houston, TX 77030 USA.
[Goldstein, Stuart L.] Cincinnati Childrens Hosp, Sect Pediat Nephrol, Cincinnati, OH USA.
[Krishnamurthy, Rajesh] Baylor Coll Med, Texas Childrens Hosp Radiol, Houston, TX 77030 USA.
[Silverstein, Douglas M.] US FDA, Renal Devices Branch, Silver Spring, MD USA.
RP Srivaths, PR (reprint author), Baylor Coll Med, Texas Childrens Hosp Pediat Nephrol, 6621 Fannin St,MC 3-2482, Houston, TX 77030 USA.
EM srivaths@bcm.edu
NR 37
TC 3
Z9 4
U1 0
U2 5
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 0931-041X
EI 1432-198X
J9 PEDIATR NEPHROL
JI Pediatr. Nephrol.
PD JAN
PY 2014
VL 29
IS 1
BP 103
EP 109
DI 10.1007/s00467-013-2575-8
PG 7
WC Pediatrics; Urology & Nephrology
SC Pediatrics; Urology & Nephrology
GA 264LB
UT WOS:000327877600012
PM 23921492
ER
PT B
AU Kahook, MY
AF Kahook, Malik Y.
BE Kahook, MY
TI MIGS Advances in Glaucoma Surgery INTRODUCTION
SO MIGS: ADVANCES IN GLAUCOMA SURGERY
LA English
DT Editorial Material; Book Chapter
C1 [Kahook, Malik Y.] Univ Colorado, Sch Med, Denver, CO 80202 USA.
[Kahook, Malik Y.] Univ Colorado, Ctr Eye, Denver, CO 80202 USA.
[Kahook, Malik Y.] Univ Colorado, Ctr Eye, Glaucoma Serv, Denver, CO 80202 USA.
[Kahook, Malik Y.] US FDA, Ophthalm Device Div, Rockville, MD 20857 USA.
[Kahook, Malik Y.] Univ Colorado, Rocky Mt Lions Eye Inst, Denver, CO 80202 USA.
RP Kahook, MY (reprint author), Univ Colorado, Sch Med, Denver, CO 80202 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-600-1
PY 2014
BP XV
EP XV
PG 1
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BHN74
UT WOS:000326000800001
ER
PT B
AU SooHoo, JR
Kahook, MY
Seibold, LK
AF SooHoo, Jeffrey R.
Kahook, Malik Y.
Seibold, Leonard K.
BE Kahook, MY
TI Basic Anatomy and Wound-Healing Considerations for MIGS
SO MIGS: ADVANCES IN GLAUCOMA SURGERY
LA English
DT Article; Book Chapter
ID AQUEOUS OUTFLOW; GLAUCOMA; CYCLOPHOTOCOAGULATION; NEODYMIUM; EYE
C1 [SooHoo, Jeffrey R.] Univ Colorado, Sch Med, Dept Ophthalmol, Aurora, CO 80045 USA.
[Kahook, Malik Y.] Univ Colorado, Sch Med, Denver, CO USA.
[Kahook, Malik Y.] Univ Colorado, Ctr Eye, Denver, CO 80202 USA.
[Kahook, Malik Y.] Univ Colorado, Ctr Eye, Glaucoma Serv, Denver, CO 80202 USA.
[Kahook, Malik Y.] US FDA, Ophthalm Device Div, Rockville, MD 20857 USA.
[Kahook, Malik Y.] Univ Colorado, Rocky Mt Lions Eye Inst, Denver, CO 80202 USA.
[Seibold, Leonard K.] Univ Colorado, Sch Med, Dept Ophthalmol, Boulder, CO 80309 USA.
RP SooHoo, JR (reprint author), Univ Colorado, Sch Med, Dept Ophthalmol, Aurora, CO 80045 USA.
NR 18
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-600-1
PY 2014
BP 17
EP 25
PG 9
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BHN74
UT WOS:000326000800004
ER
PT B
AU Ittoop, SM
Kahook, MY
Seibold, LK
AF Ittoop, Sabita M.
Kahook, Malik Y.
Seibold, Leonard K.
BE Kahook, MY
TI Trabecular Meshwork Bypass Devices
SO MIGS: ADVANCES IN GLAUCOMA SURGERY
LA English
DT Article; Book Chapter
ID OPEN-ANGLE GLAUCOMA; STENT IMPLANTATION; CATARACT-SURGERY;
PHACOEMULSIFICATION
C1 [Ittoop, Sabita M.] Univ Colorado Denver, Dept Ophthalmol, Aurora, CO 80045 USA.
[Kahook, Malik Y.] Univ Colorado, Sch Med, Denver, CO USA.
[Kahook, Malik Y.] Univ Colorado, Ctr Eye, Denver, CO 80202 USA.
[Kahook, Malik Y.] Univ Colorado, Ctr Eye, Glaucoma Serv, Denver, CO 80202 USA.
[Kahook, Malik Y.] US FDA, Ophthalm Device Div, Rockville, MD 20857 USA.
[Kahook, Malik Y.] Univ Colorado, Rocky Mt Lions Eye Inst, Denver, CO 80202 USA.
[Seibold, Leonard K.] Univ Colorado, Sch Med, Dept Ophthalmol, Denver, CO USA.
RP Ittoop, SM (reprint author), Univ Colorado Denver, Dept Ophthalmol, Aurora, CO 80045 USA.
NR 19
TC 0
Z9 0
U1 0
U2 0
PU SLACK INC
PI THOROFARE
PA 6900 GROVE ROAD, THOROFARE, NJ 08086-9447 USA
BN 978-1-61711-600-1
PY 2014
BP 27
EP 35
PG 9
WC Ophthalmology; Surgery
SC Ophthalmology; Surgery
GA BHN74
UT WOS:000326000800005
ER
PT J
AU Baker, MA
Nguyen, M
Cole, DV
Lee, GM
Lieu, TA
AF Baker, Meghan A.
Michael Nguyen
Cole, David V.
Lee, Grace M.
Lieu, Tracy A.
TI Post-licensure rapid immunization safety monitoring program (PRISM) data
characterization
SO VACCINE
LA English
DT Article
DE Mini-Sentinel; PRISM; Vaccine; Health outcome; Data characterization;
Surveillance
ID GUILLAIN-BARRE-SYNDROME; EVENT REPORTING SYSTEM; ACUTE DISSEMINATED
ENCEPHALOMYELITIS; INTRANASAL INFLUENZA VACCINE; HENOCH-SCHONLEIN
PURPURA; REAL-TIME SURVEILLANCE; RHEUMATOID-ARTHRITIS; FEBRILE SEIZURES;
ADVERSE EVENTS; UNITED-STATES
AB Background: The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of this large claims-based distributed database for vaccine safety surveillance by characterizing the underlying data.
Methods: We characterized data available on vaccine exposures in PRISM, estimated how much additional data was gained by matching with select state and local immunization registries, and compared vaccination coverage estimates based on PRISM data with other available data sources. We generated rates of computerized codes representing potential health outcomes relevant to vaccine safety monitoring. Standardized algorithms including ICD-9 codes, number of codes required, exclusion criteria and location of the encounter were used to obtain the background rates.
Results: The majority of the vaccines routinely administered to infants, children, adolescents and adults were well captured by claims data Immunization registry data in up to seven states comprised between 5% and 9% of data for all vaccine categories with the exception of 10% for hepatitis B and 3% and 4% for rotavirus and zoster respectively. Vaccination coverage estimates based on PRISM's computerized data were similar to but lower than coverage estimates from the National Immunization Survey and Healthcare Effectiveness Data and Information Set. For the 25 health outcomes of interest studied, the rates of potential outcomes based on ICD-9 codes were generally higher than rates described in the literature, which are typically clinically confirmed cases.
Conclusion: PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring. (C) 2013 Elsevier Ltd. All rights reserved.
C1 [Baker, Meghan A.; Cole, David V.; Lee, Grace M.; Lieu, Tracy A.] Harvard Pilgrim Hlth Care Inst, Dept Populat Med, Boston, MA USA.
[Baker, Meghan A.; Cole, David V.; Lee, Grace M.; Lieu, Tracy A.] Harvard Univ, Sch Med, Boston, MA USA.
[Baker, Meghan A.] Brigham & Womens Hosp, Dept Med, Div Infect Dis, Boston, MA 02115 USA.
[Michael Nguyen] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Lee, Grace M.] Boston Childrens Hosp, Dept Med, Div Infect Dis, Boston, MA USA.
RP Baker, MA (reprint author), Harvard Pilgrim Hlth Care Inst, Dept Populat Med, Boston, MA USA.
EM meghan_baker@harvardpilgrim.org; Michael.Nguyen@fda.hhs.gov;
david_cole@harvardpilgrim.org; Grace.Lee@childrens.harvard.edu;
tracy.lieu@kp.org
FU Food and Drug Administration (FDA) through Department of Health and
Human Services (HHS) [HHSF223200910006I]; Mini-Sentinel program
FX Mini-Sentinel is funded by the Food and Drug Administration (FDA)
through Department of Health and Human Services (HHS) Contract Number
HHSF223200910006I. The views expressed in this document do not
necessarily reflect the official policies of the Department of Health
and Human Services, nor does mention of trade names, commercial
practices, or organizations imply endorsement by the U.S. government.;
We thank Richard Platt, M.D., M.Sc., Jeffrey Brown, Ph.D., and Nicolas
Beaulieu, M.A., for their support via the leadership of the
Mini-Sentinel program and its distributed database and Robert Rosofsky,
M.A. for his work on the de-duplication of vaccine and immunization
registry data. We also thank Sunali Goonesekera, M.Sc. for her help with
references. Finally, we greatly appreciate the input of the PRISM team
on vaccine and health outcome codes and algorithms.
NR 80
TC 4
Z9 4
U1 0
U2 7
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
EI 1873-2518
J9 VACCINE
JI Vaccine
PD DEC 30
PY 2013
VL 31
SU 10
BP K98
EP K112
DI 10.1016/j.vaccine.2013.04.088
PG 15
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 289LS
UT WOS:000329684600012
PM 24331080
ER
PT J
AU Chung, CP
Rohan, P
Krishnaswami, S
McPheeters, ML
AF Chung, Cecilia P.
Rohan, Patricia
Krishnaswami, Shanthi
McPheeters, Melissa L.
TI A systematic review of validated methods for identifying patients with
rheumatoid arthritis using administrative or claims data
SO VACCINE
LA English
DT Review
DE Rheumatoid arthritis; Validation; Administrative database; ICD-9;
Positive predictive value; Algorithm
ID MODIFYING ANTIRHEUMATIC DRUGS; POPULATION-BASED COHORT; FACTOR-ALPHA
ANTAGONISTS; HEALTH-CARE UTILIZATION; ACUTE MYOCARDIAL-INFARCTION;
INFLAMMATORY-BOWEL-DISEASE; SAFETY MONITORING PROGRAM;
CONGESTIVE-HEART-FAILURE; UNITED-STATES; AUTOIMMUNE-DISEASES
AB Purpose: To review the evidence supporting the validity of billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify patients with rheumatoid arthritis (RA) in administrative and claim databases.
Methods: We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to RA and reference lists of included studies were searched. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria and extracted the data. Data collected included participant and algorithm characteristics.
Results: Nine studies reported validation of computer algorithms based on International Classification of Diseases (ICD) codes with or without free-text, medication use, laboratory data and the need for a diagnosis by a rheumatologist. These studies yielded positive predictive values (PPV) ranging from 34 to 97% to identify patients with RA. Higher PPVs were obtained with the use of at least two ICD and/or procedure codes (ICD-9 code 714 and others), the requirement of a prescription of a medication used to treat RA, or requirement of participation of a rheumatologist in patient care. For example, the PPV increased from 66 to 97% when the use of disease-modifying antirheumatic drugs and the presence of a positive rheumatoid factor were required.
Conclusions: There have been substantial efforts to propose and validate algorithms to identify patients with RA in automated databases. Algorithms that include more than one code and incorporate medications or laboratory data and/or required a diagnosis by a rheumatologist may increase the PPV. (C) 2013 Elsevier Ltd. All rights reserved.
C1 [Chung, Cecilia P.] Vanderbilt Univ, Sch Med, Med Ctr N, Div Rheumatol, Nashville, TN 37232 USA.
[Rohan, Patricia] US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Rockville, MD 20852 USA.
[Krishnaswami, Shanthi; McPheeters, Melissa L.] Vanderbilt Univ, Med Ctr, Vanderbilt Evidence Based Practice Ctr, Nashville, TN 37203 USA.
[McPheeters, Melissa L.] Vanderbilt Univ, Med Ctr, Dept Obstet & Gynecol, Nashville, TN 37203 USA.
RP Chung, CP (reprint author), Vanderbilt Univ, Sch Med, Med Ctr N, Div Rheumatol, 1161 21st Ave South,D-3100, Nashville, TN 37232 USA.
EM c.chung@vanderbilt.edu; shanthi.krishnaswami@vanderbilt.edu;
melissa.mcpheeters@vanderbilt.edu
FU Food and Drug Administration (FDA) through Department of Health and
Human Services (HHS) [HHSF223200910006I]; Vanderbilt Physician Scientist
Development Award
FX Mini-Sentinel is funded by the Food and Drug Administration (FDA)
through Department of Health and Human Services (HHS) Contract Number
HHSF223200910006I. The views expressed in this document do not
necessarily reflect the official policies of the Department of Health
and Human Services, nor does mention of trade names, commercial
practices, or organizations imply endorsement by the U.S. government.
CPC was funded by the Vanderbilt Physician Scientist Development Award.
NR 117
TC 18
Z9 18
U1 0
U2 4
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
EI 1873-2518
J9 VACCINE
JI Vaccine
PD DEC 30
PY 2013
VL 31
SU 10
BP K41
EP K61
DI 10.1016/j.vaccine.2013.03.075
PG 21
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 289LS
UT WOS:000329684600007
PM 24331074
ER
PT J
AU Lu, TP
Chuang, EY
Chen, JJ
AF Lu, Tzu-Pin
Chuang, Eric Y.
Chen, James J.
TI Identification of reproducible gene expression signatures in lung
adenocarcinoma
SO BMC BIOINFORMATICS
LA English
DT Article
DE Lung adenocarcinoma; Microarray; Pathway analysis; Prognostic biomarker;
Predictive biomarker
ID THERAPEUTIC TARGET; PREDICT SURVIVAL; CANCER; CELL; PATHWAYS;
CHEMOTHERAPY; METAANALYSIS; ASSOCIATION; SENSITIVITY; VANDETANIB
AB Background: Lung cancer is the leading cause of cancer-related death worldwide. Tremendous research efforts have been devoted to improving treatment procedures, but the average five-year overall survival rates are still less than 20%. Many biomarkers have been identified for predicting survival; challenges arise, however, in translating the findings into clinical practice due to their inconsistency and irreproducibility. In this study, we proposed an approach by identifying predictive genes through pathways.
Results: The microarrays from Shedden et al. were used as the training set, and the log-rank test was performed to select potential signature genes. We focused on 24 cancer-related pathways from 4 biological databases. A scoring scheme was developed by the Cox hazard regression model, and patients were divided into two groups based on the medians. Subsequently, their predictability and generalizability were evaluated by the 2-fold cross-validation and a resampling test in 4 independent datasets, respectively. A set of 16 genes related to apoptosis execution was demonstrated to have good predictability as well as generalizability in more than 700 lung adenocarcinoma patients and was reproducible in 4 independent datasets. This signature set was shown to have superior performances compared to 6 other published signatures. Furthermore, the corresponding risk scores derived from the set were found to associate with the efficacy of the anti-cancer drug ZD-6474 targeting EGFR.
Conclusions: In summary, we presented a new approach to identify reproducible survival predictors for lung adenocarcinoma, and the identified genes may serve as both prognostic and predictive biomarkers in the future.
C1 [Lu, Tzu-Pin; Chen, James J.] US FDA, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Little Rock, AR USA.
[Lu, Tzu-Pin; Chuang, Eric Y.] Natl Taiwan Univ, YongLin Biomed Engn Ctr, Taipei 10764, Taiwan.
[Chuang, Eric Y.] Natl Taiwan Univ, Grad Inst Biomed Engn & Bioinformat, Taipei 10764, Taiwan.
[Chen, James J.] China Med Univ, Grad Inst Biostat, Taichung, Taiwan.
[Chen, James J.] China Med Univ, Ctr Biostat, Taichung, Taiwan.
RP Chen, JJ (reprint author), US FDA, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Little Rock, AR USA.
EM jamesj.chen@fda.hhs.gov
OI LU, TZU-PIN/0000-0003-3697-0386
NR 48
TC 4
Z9 4
U1 0
U2 6
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1471-2105
J9 BMC BIOINFORMATICS
JI BMC Bioinformatics
PD DEC 26
PY 2013
VL 14
AR UNSP 371
DI 10.1186/1471-2105-14-371
PG 10
WC Biochemical Research Methods; Biotechnology & Applied Microbiology;
Mathematical & Computational Biology
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Mathematical & Computational Biology
GA 292MU
UT WOS:000329906800001
PM 24369726
ER
PT J
AU Gomberg-Maitland, M
Bull, TM
Saggar, R
Barst, RJ
Elgazayerly, A
Fleming, TR
Grimminger, F
Rainisio, M
Stewart, DJ
Stockbridge, N
Ventura, C
Ghofrani, AH
Rubin, LJ
AF Gomberg-Maitland, Mardi
Bull, Todd M.
Saggar, Rajeev
Barst, Robyn J.
Elgazayerly, Amany
Fleming, Thomas R.
Grimminger, Friedrich
Rainisio, Maurizio
Stewart, Duncan J.
Stockbridge, Norman
Ventura, Carlo
Ghofrani, Ardeschir H.
Rubin, Lewis J.
TI New Trial Designs and Potential Therapies for Pulmonary Artery
Hypertension
SO JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
LA English
DT Review
DE ethics; pulmonary arterial hypertension; therapeutics; trial designs
ID EXTRACORPOREAL MEMBRANE-OXYGENATION; VASOACTIVE-INTESTINAL-PEPTIDE;
SMOOTH-MUSCLE-CELLS; RIGHT-VENTRICULAR HYPERTROPHY; TYROSINE KINASE
INHIBITOR; OUTCOMES PRO INSTRUMENTS; SURROGATE END-POINTS; INHALED
NITRIC-OXIDE; IMATINIB MESYLATE; HEART-FAILURE
AB A greater understanding of the epidemiology, pathogenesis, and pathophysiology of pulmonary artery hypertension (PAH) has led to significant advances, but the disease remains fatal. Treatment options are neither universally available nor always effective, underscoring the need for development of novel therapies and therapeutic strategies. Clinical trials to date have provided evidence of efficacy, but were limited in evaluating the scope and duration of treatment effects. Numerous potential targets in varied stages of drug development exist, in addition to novel uses of familiar therapies. The pursuit of gene and cell-based therapy continues, and device use to help acute deterioration and chronic management is emerging. This rapid surge of drug development has led to multicenter pivotal clinical trials and has resulted in novel ethical and global clinical trial concerns. This paper will provide an overview of the opportunities and challenges that await the development of novel treatments for PAH. (C) 2013 by the American College of Cardiology Foundation
C1 [Gomberg-Maitland, Mardi] Univ Chicago, Dept Med, Cardiol Sect, Chicago, IL 60637 USA.
[Bull, Todd M.] Univ Colorado, Dept Med, Sect Pulm & Crit Care, Aurora, CO USA.
[Saggar, Rajeev] Heart & Lung Inst, Phoenix, AZ USA.
[Barst, Robyn J.] Columbia Univ, New York, NY USA.
[Elgazayerly, Amany] European Med Agcy, London, England.
[Fleming, Thomas R.] Univ Washington, Dept Biostat, Seattle, WA 98195 USA.
[Grimminger, Friedrich; Ghofrani, Ardeschir H.] Univ Hosp Giessen, Dept Med Oncol, Dept Med, Sect Pulm, Giessen, Germany.
[Rainisio, Maurizio] AbaNovus, San Remo, Italy.
[Stewart, Duncan J.] Ottawa Hosp Res Inst, Dept Med, Sect Cardiol, Ottawa, ON, Canada.
[Stockbridge, Norman] US FDA, White Oak, MD USA.
[Ventura, Carlo] Univ Bologna, Dept Med, Sect Cardiol, Bologna, Italy.
[Rubin, Lewis J.] Univ Calif San Diego, Dept Med, Sect Pulm & Crit Care, San Diego, CA 92103 USA.
RP Gomberg-Maitland, M (reprint author), Univ Chicago, Pulm Hypertens Program, Dept Med, Cardiol Sect, 5841 South Maryland Ave,MC5403, Chicago, IL 60611 USA.
EM mgomberg@bsd.uchicago.edu
FU Actelion; Gilead; Medtronic; Novartis; United Therapeutics; Bayer
Schering; Pfizer; Ergonex; Encysive; GlaxoSmithKline
FX Dr. Saggar contributed to the manuscript until September 1, 2013, when
he became an employee of United Therapeutics. Dr. Barst is deceased. The
opinions expressed herein might not reflect the official opinions of the
Food and Drug Administration or the European Medical Agencies. Dr.
Gomberg-Maitland has received institutional grant support from Actelion,
Gilead, Medtronic and Novartis as principal investigator through the
University of Chicago; and has served as a consultant to and/or on
steering committees, scientific advisory boards, or data safety
monitoring for Actelion, Gilead, Medtronic, Merck, and Ikaria. Dr. Bull
has received an investigator initiated grant from United Therapeutics;
and has served on the advisory board of Actelion. Dr. Saggar has a
relationship with EvoLung LLC; has served on the advisory board of
Gilead; and is a United Therapeutics employee as of September 1, 2013.
Dr. Fleming has served as a consultant to Actelion and Pfizer. Dr.
Grimminger has received research grants from Bayer Schering, Pfizer,
Ergonex, and Encysive; has received honoraria payments from Bayer
Schering, Pfizer, Actelion, Encysive, and Novartis Pharmaceuticals; and
has a consultancy and/or advisory board relationship with Nycomed
(Altana Pharma). Dr. Stewart has had relationships with Northern
Therapeutics and United Therapeutics. Dr. Ghofrani has relationships
with Actelion, Bayer, GlaxoSmithKline, Merck, Novartis, and Pfizer. Dr.
Rubin has relationships with United Therapeutics, Bayer, GeNO, the
National Heart, and Blood Institute, the U. S. Food and Drug
Administration, Actelion, Lung LLC, Gilead, Reata Pharmaceuticals, Arena
Pharmaceuticals, and Aires Pharmaceuticals; and has served as a
consultant for Aires Pharmaceuticals and GeNO. All other authors have
reported that they have no relationships relevant to the contents of
this paper to disclose.
NR 103
TC 49
Z9 49
U1 1
U2 22
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0735-1097
EI 1558-3597
J9 J AM COLL CARDIOL
JI J. Am. Coll. Cardiol.
PD DEC 24
PY 2013
VL 62
IS 25
SU S
BP D82
EP D91
DI 10.1016/j.jacc.2013.10.026
PG 10
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 286HW
UT WOS:000329459400010
PM 24355645
ER
PT J
AU Lamart, S
Imran, R
Simon, SL
Doi, K
Morton, LM
Curtis, RE
Lee, C
Drozdovitch, V
Maass-Moreno, R
Chen, CC
Whatley, M
Miller, DL
Pacak, K
Lee, C
AF Lamart, Stephanie
Imran, Rebecca
Simon, Steven L.
Doi, Kazutaka
Morton, Lindsay M.
Curtis, Rochelle E.
Lee, Choonik
Drozdovitch, Vladimir
Maass-Moreno, Roberto
Chen, Clara C.
Whatley, Millie
Miller, Donald L.
Pacak, Karel
Lee, Choonsik
TI Prediction of the location and size of the stomach using patient
characteristics for retrospective radiation dose estimation following
radiotherapy
SO PHYSICS IN MEDICINE AND BIOLOGY
LA English
DT Article
ID POSITION; THERAPY; CANCER
AB Following cancer radiotherapy, reconstruction of doses to organs, other than the target organ, is of interest for retrospective health risk studies. Reliable estimation of doses to organs that may be partially within or fully outside the treatment field requires reliable knowledge of the location and size of the organs, e.g., the stomach, which is at risk from abdominal irradiation. The stomach location and size are known to be highly variable between individuals, but have been little studied. Moreover, for treatments conducted years ago, medical images of patients are usually not available in medical records to locate the stomach. In light of the poor information available to locate the stomach in historical dose reconstructions, the purpose of this work was to investigate the variability of stomach location and size among adult male patients and to develop prediction models for the stomach location and size using predictor variables generally available in medical records of radiotherapy patients treated in the past. To collect data on stomach size and position, we segmented the contours of the stomach and of the skeleton on contemporary computed tomography (CT) images for 30 male patients in supine position. The location and size of the stomach was found to depend on body mass index (BMI), ponderal index (PI), and age. For example, the anteroposterior dimension of the stomach was found to increase with increasing BMI (approximate to 0.25 cm kg(-1) m(2)) whereas its craniocaudal dimension decreased with increasing PI (approximate to-3.3 cm kg(-1) m(3)) and its transverse dimension increased with increasing PI (approximate to 2.5 cm kg(-1) m(3)). Using the prediction models, we generated three-dimensional computational stomach models from a deformable hybrid phantom for three patients of different BMI. Based on a typical radiotherapy treatment, we simulated radiotherapy treatments on the predicted stomach models and on the CT images of the corresponding patients. Those dose calculations demonstrated good agreement between predicted and actual stomachs compared with doses derived from a reference model of the body that might be used in the absence of individual CT scan data.
C1 [Lamart, Stephanie; Imran, Rebecca; Simon, Steven L.; Doi, Kazutaka; Morton, Lindsay M.; Curtis, Rochelle E.; Drozdovitch, Vladimir; Lee, Choonsik] NCI, Div Canc Epidemiol & Genet, NIH, Bethesda, MD 20892 USA.
[Lee, Choonik] Univ Michigan Hosp, Dept Radiat Oncol, Ann Arbor, MI 48109 USA.
[Maass-Moreno, Roberto; Chen, Clara C.; Miller, Donald L.] NIH, Dept Radiol & Imaging Sci, Ctr Clin, Bethesda, MD 20892 USA.
[Whatley, Millie] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Pacak, Karel] Eunice Kennedy Shriver Natl Inst Child Hlth & Dev, NIH, Bethesda, MD USA.
RP Lamart, S (reprint author), NCI, Div Canc Epidemiol & Genet, NIH, Bethesda, MD 20892 USA.
EM leechoonsik@mail.nih.gov
RI Morton, Lindsay/B-5234-2015; Lee, Choonsik/C-9023-2015
OI Morton, Lindsay/0000-0001-9767-2310; Lee, Choonsik/0000-0003-4289-9870
FU National Cancer Institute
FX This study utilized the high-performance computational capabilities of
the Biowulf Linux cluster at the National Institutes of Health,
Bethesda, MD (http://biowulf.nih.gov). This work was supported by the
National Cancer Institute's intramural research program.
NR 16
TC 4
Z9 4
U1 0
U2 1
PU IOP PUBLISHING LTD
PI BRISTOL
PA TEMPLE CIRCUS, TEMPLE WAY, BRISTOL BS1 6BE, ENGLAND
SN 0031-9155
EI 1361-6560
J9 PHYS MED BIOL
JI Phys. Med. Biol.
PD DEC 21
PY 2013
VL 58
IS 24
BP 8739
EP 8753
DI 10.1088/0031-9155/58/24/8739
PG 15
WC Engineering, Biomedical; Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Radiology, Nuclear Medicine & Medical Imaging
GA 266SG
UT WOS:000328043400011
PM 24301086
ER
PT J
AU Foley, C
Harvey, E
Bidol, SA
Henderson, T
Njord, R
DeSalvo, T
Haupt, T
Mba-Jonas, A
Bailey, C
Bopp, C
Bosch, SA
Gerner-Smidt, P
Mody, RK
Nguyen, TA
Strockbine, N
Tauxe, RV
AF Foley, Catherine
Harvey, Emily
Bidol, Sally A.
Henderson, Tiffany
Njord, Rebecca
DeSalvo, Traci
Haupt, Thomas
Mba-Jonas, Adamma
Bailey, Chris
Bopp, Cheryl
Bosch, Stacey A.
Gerner-Smidt, Peter
Mody, Rajal K.
Thai-An Nguyen
Strockbine, Nancy
Tauxe, Robert V.
TI Outbreak of Escherichia coli O104:H4 Infections Associated with Sprout
Consumption - Europe and North America, May-July 2011
SO MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
LA English
DT Article
C1 [Harvey, Emily] Massachusetts Dept Publ Hlth, Boston, MA 02111 USA.
[Mba-Jonas, Adamma] US FDA, Dept Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Bailey, Chris; Bopp, Cheryl; Bosch, Stacey A.; Gerner-Smidt, Peter; Mody, Rajal K.; Thai-An Nguyen; Strockbine, Nancy; Tauxe, Robert V.] CDC, Div Foodborne Waterborne & Environm Dis, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA.
RP Mba-Jonas, A (reprint author), US FDA, Dept Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
EM adamma.mba-jonas@fda.hhs.gov
NR 10
TC 11
Z9 11
U1 0
U2 5
PU CENTER DISEASE CONTROL & PREVENTION
PI ATLANTA
PA MAILSTOP E-90, ATLANTA, GA 30333 USA
SN 0149-2195
EI 1545-861X
J9 MMWR-MORBID MORTAL W
JI MMWR-Morb. Mortal. Wkly. Rep.
PD DEC 20
PY 2013
VL 62
IS 50
BP 1029
EP 1031
PG 3
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA 278AX
UT WOS:000328861500003
ER
PT J
AU Collins, FS
Hamburg, MA
AF Collins, Francis S.
Hamburg, Margaret A.
TI First FDA Authorization for Next-Generation Sequencer
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Editorial Material
AB The FDA has granted marketing authorization for a high-throughput genomic sequencer, Illumina's MiSeqDx, which will allow the development of innumerable new genome-based tests. Access to genomic data may transform research, clinical care, and patient engagement. This year marks 60 years since James Watson and Francis Crick described the structure of DNA and 10 years since the complete sequencing of the human genome. Fittingly, today the Food and Drug Administration (FDA) has granted marketing authorization for the first high-throughput (next-generation) genomic sequencer, Illumina's MiSeqDx, which will allow the development and use of innumerable new genome-based tests. When a global team of researchers sequenced that first human genome, it took more than a decade and cost hundreds of millions of dollars. Today, because of federal and private investment, sequencing technologies have advanced dramatically, and a human genome ...
C1 [Collins, Francis S.] NIH, Off Director, Bethesda, MD 20892 USA.
[Hamburg, Margaret A.] US Dept HHS, US FDA, Off Commissioner, Silver Spring, MD USA.
RP Collins, FS (reprint author), NIH, Off Director, Bldg 10, Bethesda, MD 20892 USA.
NR 5
TC 86
Z9 91
U1 2
U2 6
PU MASSACHUSETTS MEDICAL SOC
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
EI 1533-4406
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD DEC 19
PY 2013
VL 369
IS 25
BP 2369
EP 2371
DI 10.1056/NEJMp1314561
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 274DQ
UT WOS:000328586000003
PM 24251383
ER
PT J
AU Lo, SC
Li, BJ
Hung, GC
Lei, HY
Li, TW
Zhang, J
Nagamine, K
Tsai, SE
Zucker, MJ
Olesnicky, L
AF Lo, Shyh-Ching
Li, Bingjie
Hung, Guo-Chiuan
Lei, Haiyan
Li, Tianwei
Zhang, Jing
Nagamine, Kenjiro
Tsai, Shien
Zucker, Mark J.
Olesnicky, Ludmilla
TI Isolation and Characterization of Two Novel Bacteria Afipia cberi and
Mesorhizobium hominis from Blood of a Patient Afflicted with Fatal
Pulmonary Illness
SO PLOS ONE
LA English
DT Article
ID SP-NOV; ALPHA-PROTEOBACTERIA; SEQUENCE; INFECTIONS; STRAIN; STABILITY;
CULTURE; FELIS
AB We recently isolated and discovered new Bradyrhizobiaceae microbes from the cryopreserved culture broth of blood samples from 3 patients with poorly defined illnesses using modified SP4 media and culture conditions coupled with genomic sequencing. Using a similar protocol, we studied a previously cryopreserved culture broth of blood sample from a patient who had succumbed to an acute onset of fulminant pulmonary illness. We report that two phases of microbial growth were observed in the re-initiated culture. Biochemical and genomic characterization revealed microbes isolated from the first phase of growth were new Afipia species of Bradyrhizobiaceae, tentatively named A. cberi with a similar to 5 MB chromosome that was different from those of all previously known Afipia microbes including the newly discovered A. septicemium. The microbes isolated from the second phase of growth were prominent sugar assimilators, novel Phyllobacteriaceae, phylogenetically most closely related to Mesorhizobium and tentatively named M. hominis with a similar to 5.5 MB chromosome. All A. cberi isolates carry a circular similar to 140 KB plasmid. Some M. hominis isolates possess a circular similar to 412 KB plasmid that can be lost in prolonged culture or passage. No antibiotics resistant genes could be identified in both of the A. cberi and M. hominis plasmids. Antibiotic susceptibility studies using broth culture systems revealed isolates of A. cberi could be sensitive to some antibiotics, but all isolates of M. hominis were resistant to essentially all tested antibiotics. However, the cell-free antibiotics susceptibility test results may not be applicable to clinical treatment against the microbes that are known to be capable of intracellular growth. It remains to be determined if the 2 previously unknown Rhizobiales were indeed pathogenic and played a role in the pulmonary disease process in this patient. Specific probes and methods will be developed to re-examine the diseased lungs from patient's autopsy.
C1 [Lo, Shyh-Ching; Li, Bingjie; Hung, Guo-Chiuan; Lei, Haiyan; Li, Tianwei; Zhang, Jing; Nagamine, Kenjiro; Tsai, Shien] US FDA, Tissue Microbiol Lab, Div Cellular & Gene Therapies, Off Cellular Tissue & Gene Therapies,Ctr Biol Eva, Bethesda, MD 20014 USA.
[Zucker, Mark J.] Newark Beth Israel Med Ctr, Dept Med, Newark, NJ USA.
[Olesnicky, Ludmilla] Newark Beth Israel Med Ctr, Dept Pathol, Newark, NJ USA.
RP Lo, SC (reprint author), US FDA, Tissue Microbiol Lab, Div Cellular & Gene Therapies, Off Cellular Tissue & Gene Therapies,Ctr Biol Eva, Bethesda, MD 20014 USA.
EM shyhching.lo@fda.hhs.gov
FU FDA Modernizing Science Intramural Grant
FX The study was supported in part by FDA Modernizing Science Intramural
Grant entitled "A new approach of detection and/or discovery of
previously unknown pathogens". The funders had no role in study design,
data collection and analysis, decision to publish, or preparation of the
manuscript. No additional external funding was received for this study.
NR 30
TC 5
Z9 5
U1 0
U2 13
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD DEC 18
PY 2013
VL 8
IS 12
AR e82673
DI 10.1371/journal.pone.0082673
PG 17
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 276HL
UT WOS:000328740300054
PM 24367538
ER
PT J
AU Krause, PR
Bialek, SR
Boppana, SB
Griffiths, PD
Laughlin, CA
Ljungman, P
Mocarski, ES
Pass, RF
Read, JS
Schleiss, MR
Plotkin, SA
AF Krause, Philip R.
Bialek, Stephanie R.
Boppana, Suresh B.
Griffiths, Paul D.
Laughlin, Catherine A.
Ljungman, Per
Mocarski, Edward S.
Pass, Robert F.
Read, Jennifer S.
Schleiss, Mark R.
Plotkin, Stanley A.
TI Priorities for CMV vaccine development
SO VACCINE
LA English
DT Review
DE Cytomegalovirus; Congenital CMV; Viruses; Clinical trial endpoints;
Meeting report
ID CONGENITAL CYTOMEGALOVIRUS-INFECTION; ORGAN TRANSPLANT RECIPIENTS;
BONE-MARROW-TRANSPLANTATION; STEM-CELL TRANSPLANTATION; GLYCOPROTEIN-B
VACCINE; DOUBLE-BLIND; ADVISORY-COMMITTEE; HEARING-LOSS; DISEASE;
IMMUNIZATION
AB A multidisciplinary meeting addressed priorities related to development of vaccines against cytomegalovirus (CMV), the cause of congenital CMV (cCMV) disease and of serious disease in the immunocompromised. Participants discussed optimal uses of a CMV vaccine, aspects of clinical study design, and the value of additional research. A universal childhood CMV vaccine could potentially rapidly reduce cCMV disease, as infected children are sources of viral transmission to seronegative and seropositive mothers. A vaccine administered to adolescents or adult women could also reduce cCMV disease by making them immune prior to pregnancy. Clinical trials of CMV vaccines in women should evaluate protection against cCMV infection, an essential precursor of cCMV disease, which is a more practical and acceptable endpoint for assessing vaccine effects on maternal-fetal transmission. Clinical trials of vaccines to evaluate prevention of CMV disease in stem cell transplant recipients could use CMV viremia at a level triggering pre-emptive antiviral therapy as an endpoint, because widespread use of pre-emptive and prophylactic antivirals has rendered CMV-induced disease too rare to be a practical endpoint for clinical trials. In solid organ transplant patients, CMV-associated disease is sufficiently common for use as a primary endpoint. Additional research to advance CMV vaccine development should include identifying factors that predict fetal loss due to CMV, determining age-specific incidence and transmission rates, defining the mechanism and relative contributions of maternal reactivation and reinfection to cCMV disease, developing assays that can distinguish between reactivation and re-infection in seropositive vaccinees, further defining predictors of sequelae from cCMV infection, and identifying clinically relevant immune response parameters to CMV (including developing validated assays that could assess CMV antibody avidity) that could lead to the establishment of immune correlates of protection. Published by Elsevier Ltd.
C1 [Krause, Philip R.] US FDA, Off Vaccines Res & Review, CBER, Bethesda, MD 20014 USA.
[Bialek, Stephanie R.] Ctr Dis Control & Prevent, Atlanta, GA USA.
[Boppana, Suresh B.; Pass, Robert F.] Univ Alabama Birmingham, Birmingham, AL USA.
[Griffiths, Paul D.] UCL, London WC1E 6BT, England.
[Laughlin, Catherine A.] NIAID, NIH, Bethesda, MD USA.
[Ljungman, Per] Karolinska Inst, Stockholm, Sweden.
[Mocarski, Edward S.] Emory Univ, Atlanta, GA 30322 USA.
[Read, Jennifer S.] Natl Vaccine Program Off, Washington, DC USA.
[Schleiss, Mark R.] Univ Minnesota, Minneapolis, MN USA.
[Plotkin, Stanley A.] Univ Penn, Philadelphia, PA 19104 USA.
RP Krause, PR (reprint author), US FDA, Off Vaccines Res & Review, CBER, 29 Lincoln Dr, Bethesda, MD 20014 USA.
EM philip.krause@fda.hhs.gov; zqg7@cdc.gov; sboppana@peds.uab.edu;
p.griffiths@ucl.ac.uk; CLaughlin@niaid.nih.gov; Per.Ljungman@ki.se;
mocarski@emory.edu; RPass@peds.uab.edu; Jennifer.Read@fda.hhs.gov;
schleiss@umn.edu; stanley.plotkin@vaxconsult.com
OI Krause, Philip/0000-0002-1045-7536
FU Food and Drug Administration; National Institutes of Health; Centers for
Disease Control and Prevention; National Vaccine Program Office
FX We acknowledge the Food and Drug Administration, the National Institutes
of Health, the Centers for Disease Control and Prevention, and the
National Vaccine Program Office for sponsorship of the CMV Vaccine
Workshop, held in Bethesda, MD on the NIH Campus on January 11-12, 2012.
We also thank the presenters and participants at the meeting for
excellent discussions that enabled a highly productive meeting.
NR 55
TC 36
Z9 37
U1 0
U2 7
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
EI 1873-2518
J9 VACCINE
JI Vaccine
PD DEC 17
PY 2013
VL 32
IS 1
BP 4
EP 10
DI 10.1016/j.vaccine.2013.09.042
PG 7
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 289LT
UT WOS:000329684700003
PM 24129123
ER
PT J
AU Pope, CR
De Feo, CJ
Unger, VM
AF Pope, Christopher R.
De Feo, Christopher J.
Unger, Vinzenz M.
TI Cellular distribution of copper to superoxide dismutase involves
scaffolding by membranes
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
DE membrane scaffold; copper homeostasis; copper transfer; copper uptake
ID AMYOTROPHIC-LATERAL-SCLEROSIS; SACCHAROMYCES-CEREVISIAE; 2-DIMENSIONAL
CRYSTALLIZATION; NEURODEGENERATIVE DISEASES; CHAPERONE CCS; YEAST;
GLUTATHIONE; OXYGEN; SOD1; DIMERIZATION
AB Efficient delivery of copper ions to specific intracellular targets requires copper chaperones that acquire metal cargo through unknown mechanisms. Here we demonstrate that the human and yeast copper chaperones (CCS) for superoxide dismutase 1 (SOD1), long thought to exclusively reside in the cytosol and mitochondrial intermembrane space, can engage negatively charged bilayers through a positively charged lipid-binding interface. The significance of this membrane-binding interface is established through SOD1 activity and genetic complementation studies in Saccharomyces cerevisiae, showing that recruitment of CCS to the membrane is required for activation of SOD1. Moreover, we show that a CCS: SOD1 complex binds to bilayers in vitro and that CCS can interact with human high affinity copper transporter 1. Shifting current paradigms, we propose that CCS-dependent copper acquisition and distribution largely occur at membrane interfaces and that this emerging role of the bilayer may reflect a general mechanistic aspect of cellular transition metal ion acquisition.
C1 [Pope, Christopher R.; Unger, Vinzenz M.] Northwestern Univ, Dept Mol Biosci, Evanston, IL 60208 USA.
[Pope, Christopher R.; Unger, Vinzenz M.] Northwestern Univ, Chem Life Proc Inst, Evanston, IL 60208 USA.
[De Feo, Christopher J.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Unger, VM (reprint author), Northwestern Univ, Dept Mol Biosci, Evanston, IL 60208 USA.
EM v-unger@northwestern.edu
FU [F31 NS076213]; [F31 NS56825]; [GM094479]
FX We thank Valeria Culotta and coworkers for the S. cerevisiae reagents
and guidance with the in vivo complementation studies. We thank Dennis
Winge for many helpful discussions and critical suggestions. We also
thank Krasimir Spasov and Jose Olvera for construct preparation and
experimental advice throughout the course of this project. This work was
supported by predoctoral fellowships F31 NS076213 (to C. R. P.), F31
NS56825 (to C.J.D.F.), and GM094479 (to V.M.U.).
NR 41
TC 18
Z9 18
U1 1
U2 9
PU NATL ACAD SCIENCES
PI WASHINGTON
PA 2101 CONSTITUTION AVE NW, WASHINGTON, DC 20418 USA
SN 0027-8424
J9 P NATL ACAD SCI USA
JI Proc. Natl. Acad. Sci. U. S. A.
PD DEC 17
PY 2013
VL 110
IS 51
BP 20491
EP 20496
DI 10.1073/pnas.1309820110
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 273PR
UT WOS:000328548600042
PM 24297923
ER
PT J
AU Kluetz, PG
Ning, YM
Maher, VE
Zhang, LJ
Tang, SH
Ghosh, D
Aziz, R
Palmby, T
Pfuma, E
Zirkelbach, JF
Mehrotra, N
Tilley, A
Sridhara, R
Ibrahim, A
Justice, R
Pazdur, R
AF Kluetz, Paul G.
Ning, Yang-Min
Maher, V. Ellen
Zhang, Lijun
Tang, Shenghui
Ghosh, Debasis
Aziz, Robeena
Palmby, Todd
Pfuma, Elimika
Zirkelbach, Jeanne Fourie
Mehrotra, Nitin
Tilley, Amy
Sridhara, Rajeshwari
Ibrahim, Amna
Justice, Robert
Pazdur, Richard
TI Abiraterone Acetate in Combination with Prednisone for the Treatment of
Patients with Metastatic Castration-Resistant Prostate Cancer: US Food
and Drug Administration Drug Approval Summary
SO CLINICAL CANCER RESEARCH
LA English
DT Article
ID CLINICAL-TRIALS; WORKING GROUP; END-POINTS; PHASE-II; DOCETAXEL;
MITOXANTRONE; RECOMMENDATIONS; SURVIVAL
AB On December 10, 2012, the U. S. Food and Drug Administration granted full approval for a modified indication for abiraterone acetate (Zytiga tablets; Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The approval was based on clinical trial COU-AA-302, which randomly allocated asymptomatic or mildly symptomatic patients with chemotherapy-naive mCRPC and no visceral metastases to either abiraterone acetate plus prednisone (N = 546) or placebo plus prednisone (N 542). The coprimary endpoints were radiographic progression-free survival (rPFS) and overall survival (OS). The median rPFS was 8.3 months in the placebo arm and had not yet been reached in the abiraterone acetate arm {HR, 0.43 [95% confidence interval (CI) 0.35-0.52]; P < 0.0001}. A prespecified interim analysis demonstrated an improvement in OS favoring the abiraterone acetate arm [HR, 0.79 (95% CI, 0.66-0.96)] but did not cross the O'Brien-Fleming boundary for statistical significance. Safety data confirmed the known adverse reaction profile of abiraterone acetate. Full approval was granted on the basis of a large magnitude of effect on rPFS, a favorable trend in OS, and internal consistency across multiple secondary endpoints and exploratory patient-reported pain data. This is the first drug approval for mCRPC to use rPFS as the primary endpoint. Importantly, this approval was granted in the context of a prior statistically significant OS benefit that formed the basis of the original April 28, 2011, approval of abiraterone acetate for patients with mCRPC who had received prior chemotherapy containing docetaxel. (C) 2013 AACR.
C1 [Kluetz, Paul G.; Ning, Yang-Min; Maher, V. Ellen; Aziz, Robeena; Palmby, Todd; Tilley, Amy; Ibrahim, Amna; Justice, Robert; Pazdur, Richard] US FDA, Ctr Drug Evaluat & Res, Off Hematol & Oncol Prod, Off NewDrugs, Silver Spring, MD 20993 USA.
[Zhang, Lijun; Tang, Shenghui; Sridhara, Rajeshwari] US FDA, Ctr Drug Evaluat & Res, Off Biostat, Silver Spring, MD 20993 USA.
[Pfuma, Elimika; Zirkelbach, Jeanne Fourie; Mehrotra, Nitin] US FDA, Ctr Drug Evaluat & Res, Off Clin Pharmacol, Silver Spring, MD 20993 USA.
[Ghosh, Debasis] US FDA, Ctr Drug Evaluat & Res, Off New Drug Qual Assessment, Silver Spring, MD 20993 USA.
RP Kluetz, PG (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Hematol & Oncol Prod, 10903 New Hampshire Ave,Bldg 22,2223, Silver Spring, MD 20993 USA.
EM kluetzpa@cder.fda.gov; ningy@cder.fda.gov
NR 18
TC 22
Z9 23
U1 1
U2 8
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
EI 1557-3265
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD DEC 15
PY 2013
VL 19
IS 24
BP 6650
EP 6656
DI 10.1158/1078-0432.CCR-13-2134
PG 7
WC Oncology
SC Oncology
GA 279CY
UT WOS:000328938700002
PM 24150234
ER
PT J
AU Vaclavikova, M
MacMahon, S
Zhang, K
Begley, TH
AF Vaclavikova, Marta
MacMahon, Shaun
Zhang, Kai
Begley, Timothy H.
TI Application of single immunoaffinity clean-up for simultaneous
determination of regulated mycotoxins in cereals and nuts
SO TALANTA
LA English
DT Article
DE Mycotoxins; Multi-target analysis; Immunoaffinity clean-up; Nuts;
Cereals; UHPLC-MS/MS
ID MASS-SPECTROMETRY; FOOD
AB A rapid and sensitive analytical strategy for the simultaneous determination of twelve mycotoxins (aflatoxins, fumonisins, zearalenon, deoxynivalenol, ochratoxin A, T-2 and HT-2 toxins) using ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UHPLC-MS/MS) was developed and validated. The method was validated for peanuts, barley and maize-breakfast cereals; selected as they represent the matrices most often contaminated by mycotoxins. The method is designed for fast and reliable analyses of mycotoxins in regulatory, industrial and private laboratories. Multi-target immunoaffinity columns containing antibodies for all mycotoxins studied herein were used for sample clean-up. Method optimization was predominantly focused on the simplification of extraction and cleanup procedure recommended by column producers. This newly developed and simplified procedure decreased both the sample preparation time and the solvent volumes used for their processing. The analysis of all regulated mycotoxins was conducted by a newly developed UHPLC-MS/MS method with a sample run time of only ten minutes. The method trueness was tested with analytical spikes and certified reference materials, with recoveries ranging from 71% to 112% for all of the examined mycotoxins. Published by Elsevier B.V.
C1 [Vaclavikova, Marta; MacMahon, Shaun; Zhang, Kai; Begley, Timothy H.] US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, College Pk, MD 20740 USA.
RP Vaclavikova, M (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, 5100 Paint Branch Pkwy,HFS-706, College Pk, MD 20740 USA.
EM Marta.Vaclavikova@fda.hhs.gov
FU appointment to the Research Participation Program at the Center for Food
Safety and the Applied Nutrition
FX MV acknowledges the support by an appointment to the Research
Participation Program at the Center for Food Safety and the Applied
Nutrition administered by the Oak Ridge Institute for Science and
Education through an interagency agreement between the U.S. Department
of Energy and the U.S. Food and Drug Administration.
NR 14
TC 13
Z9 15
U1 4
U2 64
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0039-9140
EI 1873-3573
J9 TALANTA
JI Talanta
PD DEC 15
PY 2013
VL 117
BP 345
EP 351
DI 10.1016/j.talanta.2013.09.007
PG 7
WC Chemistry, Analytical
SC Chemistry
GA 277EI
UT WOS:000328801400051
PM 24209351
ER
PT J
AU Valencia, A
Prous, J
Mora, O
Sadrieh, N
Valerio, LG
AF Valencia, Antoni
Prous, Josep
Mora, Oscar
Sadrieh, Nakissa
Valerio, Luis G., Jr.
TI A novel QSAR model of Salmonella mutagenicity and its application in the
safety assessment of drug impurities
SO TOXICOLOGY AND APPLIED PHARMACOLOGY
LA English
DT Article
DE Safety; Mutagenicity; QSAR; Modeling; Binned algorithms; Computational
toxicology
ID CARCINOGENICITY; PREDICTION; VALIDATION; GENOTOXICITY; AGREEMENT;
SUPPORT
AB As indicated in ICH M7 draft guidance, in silico predictive tools including statistically-based QSARs and expert analysis may be used as a computational assessment for bacterial mutagenicity for the qualification of impurities in pharmaceuticals. To address this need, we developed and validated a QSAR model to predict Salmonella t. mutagenicity (Ames assay outcome) of pharmaceutical impurities using Prous Institute's Symmetry(SM), a new in silico solution for drug discovery and toxicity screening, and the Mold2 molecular descriptor package (FDA/NCTR). Data was sourced from public benchmark databases with known Ames assay mutagenicity outcomes for 7300 chemicals (57% mutagens). Of these data, 90% was used to train the model and the remaining 10% was set aside as a holdout set for validation. The model's applicability to drug impurities was tested using a FDA/CDER database of 951 structures, of which 94% were found within the model's applicability domain. The predictive performance of the model is acceptable for supporting regulatory decision-making with 84 +/- 1% sensitivity, 81 +/- 1% specificity, 83 +/- 1% concordance and 79 +/- 1% negative predictivity based on internal cross-validation, while the holdout dataset yielded 83% sensitivity, 77% specificity, 80% concordance and 78% negative predictivity. Given the importance of having confidence in negative predictions, an additional external validation of the model was also carried out, using marketed drugs known to be Ames-negative, and obtained 98% coverage and 81% specificity. Additionally, Ames mutagenicity data from FDA/CFSAN was used to create another data set of 1535 chemicals for external validation of the model, yielding 98% coverage, 73% sensitivity, 86% specificity, 81% concordance and 84% negative predictivity. Published by Elsevier Inc.
C1 [Valencia, Antoni; Prous, Josep; Mora, Oscar] Prous Inst Biomed Res, Barcelona 08008, Spain.
[Sadrieh, Nakissa; Valerio, Luis G., Jr.] US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Valerio, LG (reprint author), US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, White Oak 51 Room 4150,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM luis.valerio@fda.hhs.gov
NR 30
TC 6
Z9 6
U1 2
U2 25
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0041-008X
EI 1096-0333
J9 TOXICOL APPL PHARM
JI Toxicol. Appl. Pharmacol.
PD DEC 15
PY 2013
VL 273
IS 3
BP 427
EP 434
DI 10.1016/j.taap.2013.09.015
PG 8
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 275XC
UT WOS:000328711700001
PM 24090816
ER
PT J
AU Grundy, HH
Read, WA
Macarthur, R
Dickinson, M
Charlton, AJ
Dusek, M
Breidbach, A
Scholl, PF
Newsome, GA
Bell, D
Alewijn, M
AF Grundy, H. H.
Read, W. A.
Macarthur, R.
Dickinson, M.
Charlton, A. J.
Dusek, M.
Breidbach, A.
Scholl, P. F.
Newsome, G. A.
Bell, D.
Alewijn, M.
TI Selected reaction monitoring method to determine the species origin of
blood-based binding agents in meats: A collaborative study
SO FOOD CHEMISTRY
LA English
DT Article
DE Thrombin; Binding agent; Bovine and porcine blood; Food authenticity;
Selected reaction monitoring; Collaborative trial; LC-MS/MS
ID QUADRUPOLE MASS-SPECTROMETRY; LIQUID-CHROMATOGRAPHY; PRODUCTS;
VALIDATION
AB Binding products or food 'glues' are used throughout the food industry to increase the meat use rate or to augment economic efficiency. Some of these binders contain thrombin from bovine and porcine blood. The European parliament has recently banned thrombin-based additives and labelling legislation governs their use in the US. A mass spectrometry screening method is available to detect the addition of thrombin agents to foods as there is a need to protect consumers and to avoid misleading trade practices. We report the details of an inter-laboratory trial to determine the transferability of this method to operators in various food testing laboratories, each using a different triple quadrupole mass spectrometer design. The trial was successful with the species origin of the binding agent contained in each of the 43 test materials being correctly reported by the participants. This is consistent with a false positive and false negative rate of 0%. This is the first collaborative study, as far as we are aware, which involves a liquid chromatography mass spectrometry (LC-MS/MS) application to approach a food authenticity issue. Crown Copyright (c) 2013 Published by Elsevier Ltd. All rights reserved.
C1 [Grundy, H. H.; Read, W. A.; Macarthur, R.; Dickinson, M.; Charlton, A. J.] Food & Environm Res Agcy, York YO41 1LZ, N Yorkshire, England.
[Dusek, M.] Czech Agr & Food Inspect Author, Prague 150005, Czech Republic.
[Breidbach, A.] European Commiss, Joint Res Ctr, Inst Reference Mat & Measurements, B-2440 Geel, Belgium.
[Newsome, G. A.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Bell, D.] Lab Govt Chemist, Teddington TW11 0LY, Middx, England.
[Alewijn, M.] Rikilt Inst Food Safety, NL-6708 WB Wageningen, Netherlands.
RP Grundy, HH (reprint author), Food & Environm Res Agcy, York YO41 1LZ, N Yorkshire, England.
EM helen.grundy@fera.gsi.gov.uk
RI Newsome, G. Asher/J-8970-2012;
OI Newsome, G. Asher/0000-0003-1683-2197; Scholl, Peter/0000-0002-8870-3266
FU Evidence and Knowledge Base Science Team at the Department for
Environment, Food and Rural Affairs (Defra) [FA0107]; Authenticity
Programme at the Food Standards Agency [Q01093]
FX We gratefully acknowledge funding from the Evidence and Knowledge Base
Science Team at the Department for Environment, Food and Rural Affairs
(Defra, Project FA0107) for funding this collaborative study. We also
thank the Authenticity Programme at the Food Standards Agency for
funding earlier work to develop the method used during this trial (Grant
number Q01093). We would also like to thank Mark Sykes of FAPAS (R) for
proof reading this manuscript.
NR 12
TC 1
Z9 1
U1 2
U2 40
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0308-8146
EI 1873-7072
J9 FOOD CHEM
JI Food Chem.
PD DEC 15
PY 2013
VL 141
IS 4
BP 3531
EP 3536
DI 10.1016/j.foodchem.2013.06.063
PG 6
WC Chemistry, Applied; Food Science & Technology; Nutrition & Dietetics
SC Chemistry; Food Science & Technology; Nutrition & Dietetics
GA 223YI
UT WOS:000324848000034
PM 23993517
ER
PT J
AU Zineh, I
Pacanowski, M
Woodcock, J
AF Zineh, Issam
Pacanowski, Michael
Woodcock, Janet
TI Pharmacogenetics and Coumarin Dosing - Recalibrating Expectations
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Editorial Material
ID EFFICACY
C1 [Zineh, Issam; Pacanowski, Michael; Woodcock, Janet] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Zineh, I (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
NR 4
TC 30
Z9 31
U1 0
U2 4
PU MASSACHUSETTS MEDICAL SOC
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
EI 1533-4406
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD DEC 12
PY 2013
VL 369
IS 24
BP 2273
EP 2275
DI 10.1056/NEJMp1314529
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 268FV
UT WOS:000328156300002
PM 24328463
ER
PT J
AU Chen, XR
Zhang, YB
Yan, J
Sadiq, R
Chen, T
AF Chen, Xinrong
Zhang, Yongbin
Yan, Jian
Sadiq, Rakhshinda
Chen, Tao
TI miR-34a suppresses mutagenesis by inducing apoptosis in human
lymphoblastoid TK6 cells
SO MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS
LA English
DT Article
DE miR-34a; Mutagenesis; Apoptosis
ID IN-VITRO MICRONUCLEUS; DIPLOID HUMAN-LYMPHOBLASTS; TARGET
MESSENGER-RNAS; SMALL INTERFERING RNA; TUMOR-SUPPRESSOR; DNA-DAMAGE;
MUTATION ASSAY; NBS1 KNOCKDOWN; WORKING GROUP; RAT-LIVER
AB miR-34a, a tumor suppressor miRNA, has been identified as a direct transcriptional target of P53. miRNA precursors and inhibitors have been used to modulate the expression of their targeted mRNA and thereby study miRNA functions. We indicated in our previous work that X-ray induces miR-34a expression in a time and dose dependent manner. The objective of this study was to elucidate the role of miR-34a in X-ray-induced mutations in human lymphoblast TK6 cells. Neither over-expression of miR-34a by lipid transfection of miR-34a precursor nor down regulation of endogenous miR-34a by miR-34a inhibitor had any effect on X-ray-induced micronucleus frequency in TK6 cells. Over-expression of miR-34a in TK6 cells significantly reduced X-ray induced mutant frequency (MF) in the Thymidine Kinase (TK) locus while suppression of endogenous miR-34a can increase the background level MF in TK6 cells. Furthermore, over-expression of miR-34a promoted and down-regulation of miR-34a inhibited background and Xray-induced apoptosis in TK6 cells. Our study suggests miR-34a is an important negative regulator of mutagenesis and the mechanism is possibly mediated through apoptosis. Published by Elsevier B.V.
C1 [Chen, Xinrong; Yan, Jian; Sadiq, Rakhshinda; Chen, Tao] Natl Ctr Toxicol Res, Div Genet & Mol Toxicol, Food & Drug Adm, Jefferson, AR 72079 USA.
[Zhang, Yongbin] Natl Ctr Toxicol Res, Off Sci Coordinat, Food & Drug Adm, Jefferson, AR 72079 USA.
RP Chen, T (reprint author), NCTR, HFT 130,3900 NCTR Rd, Jefferson, AR 72079 USA.
EM xinrong.Chen@fda.hhs.gov; yongbin.Zhang@fda.hhs.gov;
Jian.yan@fda.hhs.gov; rakhshinda.Sadiq@fda.hhs.gov; tao.chen@fda.hhs.gov
FU U.S. Food and Drug Administration
FX This work was supported by the commissioner's fellowship program in U.S.
Food and Drug Administration.
NR 45
TC 0
Z9 0
U1 1
U2 5
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1383-5718
EI 1879-3592
J9 MUTAT RES-GEN TOX EN
JI Mutat. Res. Genet. Toxicol. Environ. Mutagen.
PD DEC 12
PY 2013
VL 758
IS 1-2
BP 35
EP 40
DI 10.1016/j.mrgentox.2013.08.010
PG 6
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 276CB
UT WOS:000328724600007
PM 24025418
ER
PT J
AU Kashoki, M
Lee, C
Jenkins, J
AF Kashoki, Mwango
Lee, Cathryn
Jenkins, John
TI Drug Postmarketing Studies
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Letter
C1 [Kashoki, Mwango; Lee, Cathryn; Jenkins, John] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Kashoki, M (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,WO 22,Room 6464, Silver Spring, MD 20993 USA.
EM mwango.kashoki@fda.hhs.gov
NR 3
TC 0
Z9 0
U1 0
U2 0
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 330 N WABASH AVE, STE 39300, CHICAGO, IL 60611-5885 USA
SN 0098-7484
EI 1538-3598
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD DEC 11
PY 2013
VL 310
IS 22
BP 2459
EP 2459
DI 10.1001/jama.2013.278901
PG 1
WC Medicine, General & Internal
SC General & Internal Medicine
GA 266NN
UT WOS:000328030900032
PM 24327044
ER
PT J
AU Sharma, GM
Khuda, SE
Pereira, M
Slate, A
Jackson, LS
Pardo, C
Williams, KM
Whitaker, TB
AF Sharma, Girdhari M.
Khuda, Sefat E.
Pereira, Marion
Slate, Andrew
Jackson, Lauren S.
Pardo, Christopher
Williams, Kristina M.
Whitaker, Thomas B.
TI Development of an Incurred Cornbread Model for Gluten Detection by
Immunoassays
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE Gluten; ELISA; immunoassay; incurred food; thermal processing
ID IMMUNOCHEMICAL ANALYTICAL METHODS; MULTIPLE ALLERGENS; PEANUT PROTEINS;
ELISA DETECTION; CELIAC-DISEASE; WHEAT; FOODS; MATRIX; PREVALENCE;
RECOVERY
AB Gluten that is present in food as a result of cross-contact or misbranding can cause severe health concerns to wheat-allergic and celiac patients. Immunoassays, such as enzyme-linked immunosorbent assay (ELISA) and lateral flow device (LFD), are commonly used to detect gluten traces in foods. However, the performance of immunoassays can be affected by non-assay-related factors, such as food matrix and processing conditions. Gluten (0-500 ppm) and wheat flour (20-1000 ppm) incurred cornbread was prepared at different incurred levels and baking conditions (204.4 degrees C for 20, 27, and 34 min) to study the accuracy and precision of gluten measurement by seven immunoassay kits (three LFD and four ELISA kits). The stability and immunoreactivity of gluten proteins, as measured by western blot using three different antibodies, were not adversely affected by the baking conditions. However, the gluten recovery varied depending upon the ELISA kit and the gluten source used to make the incurred cornbread, affecting the accuracy of gluten quantification (BioKits, 9-77%; Morinaga, 91-137%; R-Biopharm, 61 -108%; and Romer Labs, 113-190%). Gluten recovery was reduced with increased baking time for most ELISA kits analyzed. Both the sampling and analytical variance increased with an increase in the gluten incurred level. The predicted analytical coefficient of variation associated with all ELISA kits was below 12% for all incurred levels, indicative of good analytical precision.
C1 [Sharma, Girdhari M.; Khuda, Sefat E.; Pereira, Marion; Williams, Kristina M.] US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
[Slate, Andrew; Whitaker, Thomas B.] N Carolina State Univ, Dept Biol & Agr Engn, Raleigh, NC 27695 USA.
[Jackson, Lauren S.; Pardo, Christopher] US FDA, Ctr Food Safety & Appl Nutr, Bedford Pk, IL 60501 USA.
RP Sharma, GM (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 8301 Muirkirk Rd, Laurel, MD 20708 USA.
EM girdhari.sharma@fda.hhs.gov
NR 26
TC 8
Z9 8
U1 2
U2 18
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
EI 1520-5118
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD DEC 11
PY 2013
VL 61
IS 49
BP 12146
EP 12154
DI 10.1021/jf404072x
PG 9
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 272DE
UT WOS:000328439700034
PM 24245605
ER
PT J
AU Chen, ZC
Fischer, ER
Kouiavskaia, D
Hansen, BT
Ludtke, SJ
Bidzhieva, B
Makiya, M
Agulto, L
Purcell, RH
Chumakov, K
AF Chen, Zhaochun
Fischer, Elizabeth R.
Kouiavskaia, Diana
Hansen, Bryan T.
Ludtke, Steven J.
Bidzhieva, Bella
Makiya, Michelle
Agulto, Liane
Purcell, Robert H.
Chumakov, Konstantin
TI Cross-neutralizing human anti-poliovirus antibodies bind the recognition
site for cellular receptor
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
DE phage display; passive immunization; antiviral therapy; broadly reactive
antibodies
ID ELECTRON-MICROSCOPY; ANTIGENIC STRUCTURE; MONOCLONAL-ANTIBODIES;
COMPLEXES; ERADICATION; MUTANTS; VIRUS; CD155; RNA
AB Most structural information about poliovirus interaction with neutralizing antibodies was obtained in the 1980s in studies of mouse monoclonal antibodies. Recently we have isolated a number of human/chimpanzee anti-poliovirus antibodies and demonstrated that one of them, MAb A12, could neutralize polioviruses of both serotypes 1 and 2. This communication presents data on isolation of an additional cross-neutralizing antibody (F12) and identification of a previously unknown epitope on the surface of poliovirus virions. Epitope mapping was performed by sequencing of antibody-resistant mutants and by cryo-EM of complexes of virions with Fab fragments. The results have demonstrated that both cross-neutralizing antibodies bind the site located at the bottom of the canyon surrounding the fivefold axis of symmetry that was previously shown to interact with cellular poliovirus receptor CD155. However, the same antibody binds to serotypes 1 and 2 through different specific interactions. It was also shown to interact with type 3 poliovirus, albeit with about 10-fold lower affinity, insufficient for effective neutralization. Antibody interaction with the binding site of the cellular receptor may explain its broad reactivity and suggest that further screening or antibody engineering could lead to a universal antibody capable of neutralizing all three serotypes of poliovirus.
C1 [Chen, Zhaochun; Makiya, Michelle; Agulto, Liane; Purcell, Robert H.] NIAID, Infect Dis Lab, NIH, Bethesda, MD 20892 USA.
[Fischer, Elizabeth R.; Hansen, Bryan T.] NIAID, Electron Microscopy Unit, Res Technol Branch, Rocky Mt Labs, Hamilton, MT 59840 USA.
[Kouiavskaia, Diana; Bidzhieva, Bella; Chumakov, Konstantin] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Ludtke, Steven J.] Baylor Coll Med, Verna & Marrs McLean Dept Biochem & Mol Biol, Natl Ctr Macromol Imaging, Houston, TX 77030 USA.
RP Purcell, RH (reprint author), NIAID, Infect Dis Lab, NIH, Bethesda, MD 20892 USA.
EM robert.purcell@nih.gov; konstantin.chumakov@fda.hhs.gov
FU National Institute of Allergy and Infectious Diseases, National
Institutes of Health; Food and Drug Administration Center for Biologics
Evaluation and Research; NIH [R01-GM080139]
FX This work was supported in part by the Intramural Research Program of
the National Institute of Allergy and Infectious Diseases, National
Institutes of Health, the Food and Drug Administration Center for
Biologics Evaluation and Research, and NIH Grant R01-GM080139 (to S.L.).
NR 31
TC 16
Z9 16
U1 1
U2 10
PU NATL ACAD SCIENCES
PI WASHINGTON
PA 2101 CONSTITUTION AVE NW, WASHINGTON, DC 20418 USA
SN 0027-8424
J9 P NATL ACAD SCI USA
JI Proc. Natl. Acad. Sci. U. S. A.
PD DEC 10
PY 2013
VL 110
IS 50
BP 20242
EP 20247
DI 10.1073/pnas.1320041110
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 266YY
UT WOS:000328061700066
PM 24277851
ER
PT J
AU Ali, MM
Minor, T
Amialchuk, A
AF Ali, Mir M.
Minor, Travis
Amialchuk, Aliaksandr
TI Estimating the Biases Associated with Self-Perceived, Self-Reported, and
Measured BMI on Mental Health
SO PLOS ONE
LA English
DT Article
ID BODY-MASS INDEX; OBESITY; ADOLESCENTS; WEIGHT; DEPRESSION; RISK
AB Purpose: The purpose of the study is to explore the relationship between individuals' perceptions of their weight-status, self-reported height and weight, and measured weight status.
Methods: A national survey of 9,248 adolescents (47% male) between the ages of 11 and 27 is analyzed to determine whether inaccuracies in reporting are caused by misperception or conscious intent, and whether there tends to be a systematic bias in how individuals self-report. Self-esteem was used as an example of an important outcome variable in order to illustrate the magnitudes of the biases that may arise when using different measures of body size.
Results: Our results indicate that measured obesity status is associated with the reduction in Rosenberg Self-Esteem (RSE) of 0.30 points (p-value 0.005) among adolescents and 0.20 points (p-value 0.002) among young adults; in addition, using self-reported height and weight as opposed to measured height and weight does not result in a statistically detectable difference in the estimates.
Conclusions: Individuals' self-reports of height and weight are not as unreliable as we might have expected. Although estimates from measured height and weight are preferred, in the absence of such measures, self-reported measures would likely be a reliable alternative. The differences in self-perception of weight status, however, imply that it is not comparable to measured weight categories.
C1 [Ali, Mir M.] Subst Abuse & Mental Hlth Serv Adm, Anal & Serv Res Branch, Rockville, MD USA.
[Minor, Travis] US FDA, Off Regulat Policy & Social Sci, College Pk, MD USA.
[Amialchuk, Aliaksandr] Univ Toledo, Dept Econ, Toledo, OH 43606 USA.
RP Ali, MM (reprint author), Subst Abuse & Mental Hlth Serv Adm, Anal & Serv Res Branch, Rockville, MD USA.
EM mir.ali@samhsa.hhs.gov
OI Minor, Travis/0000-0002-5297-7695
FU National Institute of Child Health and Human Development [P01-HD31921]
FX The views expressed here are those of the authors and do not necessarily
reflect the views of the Substance Abuse & Mental Health Services
Administration or the Food & Drug Administration. This research uses
data from Add Health, a program project designed by J. Richard Udry
Peter S. Bearman, and Kathleen Mullan Harris, and funded by a grant
P01-HD31921 from the National Institute of Child Health and Human
Development, with cooperative funding from 17 other agencies. Special
acknowledgment is due Ronald R. Rindfuss and Barbara Entwisle for
assistance in the original design. Persons interested in obtaining data
files from Add Health should contact Add Health, Carolina Population
Center, 123 W. Franklin Street, Chapel Hill, NC 27516-2524
(addhealth@unc.edu).
NR 17
TC 3
Z9 3
U1 1
U2 19
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD DEC 4
PY 2013
VL 8
IS 12
AR e81021
DI 10.1371/journal.pone.0081021
PG 5
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 265KD
UT WOS:000327949300067
PM 24324658
ER
PT J
AU Revollo, JR
Oakley, RH
Lu, NZ
Kadmiel, M
Gandhavadi, M
Cidlowski, JA
AF Revollo, Javier R.
Oakley, Robert H.
Lu, Nick Z.
Kadmiel, Mahita
Gandhavadi, Maheer
Cidlowski, John A.
TI HES1 Is a Master Regulator of Glucocorticoid Receptor-Dependent Gene
Expression
SO SCIENCE SIGNALING
LA English
DT Article
ID HELIX FACTOR HES-1; NEURONAL DIFFERENTIATION; FUNCTIONAL-ANALYSIS;
TRANSGENIC MICE; LOOP; MECHANISMS; PROMOTER; INSULIN; NOTCH; RESISTANCE
AB Hairy and enhancer of split-1 (HES1) is a basic helix-loop-helix transcription factor that is a key regulator of development and organogenesis. However, little is known about the role of HES1 after birth. Glucocorticoids, primary stress hormones that are essential for life, regulate numerous homeostatic processes that permit vertebrates to cope with physiological challenges. The molecular actions of glucocorticoids are mediated by glucocorticoid receptor-dependent regulation of nearly 25% of the genome. Here, we established a genome-wide molecular link between HES1 and glucocorticoid receptors that controls the ability of cells and animals to respond to stress. Glucocorticoid signaling rapidly and robustly silenced HES1 expression. This glucocorticoid-dependent repression of HES1 was necessary for the glucocorticoid receptor to regulate many of its target genes. Mice with conditional knockout of HES1 in the liver exhibited an expanded glucocorticoid receptor signaling profile and aberrant metabolic phenotype. Our results indicate that HES1 acts as a master repressor, the silencing of which is required for proper glucocorticoid signaling.
C1 [Revollo, Javier R.; Oakley, Robert H.; Lu, Nick Z.; Kadmiel, Mahita; Gandhavadi, Maheer; Cidlowski, John A.] NIEHS, Lab Signal Transduct, NIH, Dept Hlth & Human Serv, Res Triangle Pk, NC 27709 USA.
[Revollo, Javier R.] US FDA, Div Genet & Mol Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Lu, Nick Z.] Northwestern Univ, Feinberg Sch Med, Dept Med, Div Allergy Immunol, Chicago, IL 60611 USA.
RP Cidlowski, JA (reprint author), NIEHS, Lab Signal Transduct, NIH, Dept Hlth & Human Serv, Res Triangle Pk, NC 27709 USA.
EM cidlows1@niehs.nih.gov
FU Intramural Research Program of the NIH, NIEHS
FX Funding: This research was supported by the Intramural Research Program
of the NIH, NIEHS. Author contributions: J.R.R. designed and performed
the experiments, analyzed the data, and wrote the manuscript. R.H.O.
designed the experiments, analyzed the data, and wrote the manuscript.
N.Z.L. designed and performed the experiments. M. K. designed and
performed the experiments and analyzed the data. M. G. performed the
experiments. J.A.C. designed the experiments, analyzed the data, and
wrote the manuscript.
NR 30
TC 10
Z9 10
U1 0
U2 8
PU AMER ASSOC ADVANCEMENT SCIENCE
PI WASHINGTON
PA 1200 NEW YORK AVE, NW, WASHINGTON, DC 20005 USA
SN 1945-0877
EI 1937-9145
J9 SCI SIGNAL
JI Sci. Signal.
PD DEC 3
PY 2013
VL 6
IS 304
AR ra103
DI 10.1126/scisignal.2004389
PG 13
WC Biochemistry & Molecular Biology; Cell Biology
SC Biochemistry & Molecular Biology; Cell Biology
GA 265HO
UT WOS:000327941400001
PM 24300895
ER
PT J
AU Adedinsewo, DA
Noory, L
Bednarczyk, RA
Steinhoff, MC
Davis, R
Ogbuanu, C
Omer, SB
AF Adedinsewo, Demilade A.
Noory, Laila
Bednarczyk, Robert A.
Steinhoff, Mark C.
Davis, Robert
Ogbuanu, Chinelo
Omer, Saad B.
TI Impact of maternal characteristics on the effect of maternal influenza
vaccination on fetal outcomes
SO VACCINE
LA English
DT Article
DE Influenza; Pregnancy; PRAMS; Preterm birth; Small for gestational age;
Vaccine
ID PROPENSITY SCORE; PREGNANCY; DIFFERENCE; WOMEN; MATCH; PROPORTIONS;
COHORT; BIAS; US
AB Background: Maternal infections during pregnancy have been associated with adverse fetal and infant health outcomes, and vaccination against influenza is the most effective tool to prevent morbidity and mortality due to seasonal and pandemic influenza. We evaluated the association between receipt of the inactivated seasonal influenza vaccine on preterm and small for gestational age (SGA) births, with the aim to assess racial and socioeconomic variations in vaccine effect.
Methods: We conducted a retrospective analysis of state-wide surveillance data from Georgia for the most recent four years available at the beginning of the study, a total of 8393 live births in Georgia from January 1, 2005 through December 31, 2008. We constructed multivariable logistic regression models and calculated odds ratios (OR) estimates with corresponding 95% confidence intervals (CI) to evaluate the effect of maternal influenza vaccination on SGA (birth weight <10th percentile for gestational age) and preterm (gestational age at birth <37 weeks) births while controlling for potential confounders.
Results: Among all women, we found significant strong associations between maternal influenza vaccination and reduced odds of a preterm birth during the widespread influenza activity period [OR=0.39, 95% CI: 0.18, 0.83]. In this period, vaccination was protective against SGA births among women at higher risk for influenza related morbidity - women enrolled in the Women, Infant and Child (WIC) program [OR=0.20, 95% CI: 0.04, 0.98] and Black women [OR=0.15 95% CI: 0.02, 0.94]; maternal influenza vaccination was associated with reduced odds of a preterm birth among white women [OR=0.34, 95% CI: 0.12, 0.91] and women of higher socio-economic status [OR=0.30, 95% CI: 0.12, 0.74].
Conclusion: Influenza vaccination during pregnancy was significantly associated with reduced odds of small for gestational age and preterm births during the widespread influenza activity period. Vaccination effects varied by socio-demographic characteristics. (C) 2013 Elsevier Ltd. All rights reserved.
C1 [Adedinsewo, Demilade A.] Emory Univ, Rollins Sch Publ Hlth, Dept Epidemiol, Atlanta, GA 30322 USA.
[Noory, Laila] US FDA, Ctr Tobacco Prod, Off Sci, Washington, DC 20204 USA.
[Bednarczyk, Robert A.; Omer, Saad B.] Emory Univ, Rollins Sch Publ Hlth, Hubert Dept Global Hlth, Atlanta, GA 30322 USA.
[Steinhoff, Mark C.] Cincinnati Childrens Hosp Med Ctr, Childrens Global Hlth Ctr, Cincinnati, OH 45229 USA.
[Bednarczyk, Robert A.; Davis, Robert; Omer, Saad B.] Kaiser Permanente Ctr Hlth Res, Atlanta, GA USA.
[Omer, Saad B.] Emory Vaccine Ctr, Atlanta, GA USA.
[Omer, Saad B.] Emory Univ, Sch Med & Childrens Healthcare Atlanta, Dept Pediat, Atlanta, GA 30322 USA.
RP Omer, SB (reprint author), Emory Univ, Sch Publ Hlth, 1518 Clifton Rd, Atlanta, GA 30322 USA.
EM demi.adedinsewo@gmail.com; lailasara@gmail.com;
robert.a.bednarczyk@emory.edu; mark.steinhoff@cchmc.org;
robert.l.davis@kp.org; chogbuanu@dhr.state.ga.us; somer@emory.edu
OI Bednarczyk, Robert/0000-0002-6812-0928; Adedinsewo,
Demilade/0000-0002-8629-2029
FU Kaiser Permanente Georgia community benefits grant
FX Funding: The study was partially funded by a Kaiser Permanente Georgia
community benefits grant.
NR 38
TC 15
Z9 15
U1 0
U2 3
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
EI 1873-2518
J9 VACCINE
JI Vaccine
PD DEC 2
PY 2013
VL 31
IS 49
BP 5827
EP 5833
DI 10.1016/j.vaccine.2013.09.071
PG 7
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 274GW
UT WOS:000328595800007
PM 24120677
ER
PT J
AU Ruano-Rossil, JM
AF Ruano-Rossil, Jorge M.
TI The Unrecognized Role of the FDA Microanalytical Analyst
SO MILITARY MEDICINE
LA English
DT Editorial Material
C1 US FDA, Pacific Reg Lab South West, Irvine, CA 92612 USA.
RP Ruano-Rossil, JM (reprint author), US FDA, Pacific Reg Lab South West, 19701 Fairchild, Irvine, CA 92612 USA.
NR 6
TC 0
Z9 0
U1 0
U2 1
PU ASSOC MILITARY SURG US
PI BETHESDA
PA 9320 OLD GEORGETOWN RD, BETHESDA, MD 20814 USA
SN 0026-4075
EI 1930-613X
J9 MIL MED
JI Milit. Med.
PD DEC
PY 2013
VL 178
IS 12
BP 1281
EP 1284
DI 10.7205/MILMED-D-13-00267
PG 4
WC Medicine, General & Internal
SC General & Internal Medicine
GA AN7UF
UT WOS:000340805800002
PM 24306008
ER
PT J
AU Ellingsen, AB
Olsen, JS
Granum, PE
Rorvik, LM
Gonzalez-Escalona, N
AF Ellingsen, Anette B.
Olsen, Jaran S.
Granum, Per E.
Rorvik, Liv M.
Gonzalez-Escalona, Narjol
TI Genetic characterization of trh positive Vibrio spp. isolated from
Norway
SO FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY
LA English
DT Article
DE tdh; trh; V. parahaemolyticus; V. alginolyticus; MLST; urease; Vibrio;
PCR
ID THERMOSTABLE DIRECT HEMOLYSIN; PARAHAEMOLYTICUS PANDEMIC STRAINS;
MULTIPLEX PCR; ALGINOLYTICUS STRAIN; PATHOGENIC VIBRIOS; ALASKAN
OYSTERS; URE GENES; SEQUENCE; O3-K6; CHOLERAE
AB The thermostable direct hemolysin (TDH) and/or TDH-related hemolysin (TRH) genes are carried by most virulent Vibrio parahaemolyticus serovars. In Norway, trh+ V parahaemolyncus constitute 4.4 and 4.5% of the total number of V. parahaemolyncus isolated from blue mussel (Mytilus edulis) and water, respectively. The trh gene is located in a region close to the gene cluster for urease production (ure). This region was characterized in V. parahaemolyticus strain TH3996 and it was found that a nickel transport operon (nik) was located between the first gene (ureR) and the rest of the ure cluster genes. The organization of the trh-ureR-nik-ure gene cluster in the Norwegian trh+ isolates was unknown. In this study, we explore the gene organization within the trh-ureR-nik-ure cluster for these isolates. PCR analyses revealed that the genes within the trh-ureR-nik-ure gene cluster of Norwegian trh+ isolates were organized in a similar fashion as reported previously for TH33996. Additionally, the phylogenetic relationship among these trh+ isolates was investigated using Multilocus Sequence Typing (MLST). Analysis by MLST or ureR-trh sequences generated two different phylogenetic trees for the same strains analyzed, suggesting that ureR-trh genes have been acquired at different times in Norwegian V. parahaemolyticus isolates. MLST results revealed that some pathogenic and non-pathogenic V. parahaemolyticus isolates in Norway appear to be highly genetically related.
C1 [Ellingsen, Anette B.; Granum, Per E.; Rorvik, Liv M.] Norwegian Sch Vet Sci, Dept Food Safety & Infect Biol, Oslo, Norway.
[Olsen, Jaran S.] Norwegian Def Res Estab, N-2007 Kjeller, Norway.
[Gonzalez-Escalona, Narjol] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Gonzalez-Escalona, N (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy HFS 712, College Pk, MD 20740 USA.
EM narjol.gonzalez-escalona@fda.hhs.gov
OI Gonzalez-Escalona, Narjol/0000-0003-4568-0022
NR 55
TC 8
Z9 8
U1 2
U2 6
PU FRONTIERS RESEARCH FOUNDATION
PI LAUSANNE
PA PO BOX 110, LAUSANNE, 1015, SWITZERLAND
SN 2235-2988
J9 FRONT CELL INFECT MI
JI Front. Cell. Infect. Microbiol.
PD DEC
PY 2013
VL 3
AR 107
DI 10.3389/fcimb.2013.00107
PG 10
WC Immunology; Microbiology
SC Immunology; Microbiology
GA AC0SS
UT WOS:000332205700020
PM 24400227
ER
PT J
AU Rice, SB
Chan, C
Brown, SC
Eschbach, P
Han, L
Ensor, DS
Stefaniak, AB
Bonevich, J
Vladar, AE
Walker, ARH
Zheng, JW
Starnes, C
Stromberg, A
Ye, J
Grulke, EA
AF Rice, Stephen B.
Chan, Christopher
Brown, Scott C.
Eschbach, Peter
Han, Li
Ensor, David S.
Stefaniak, Aleksandr B.
Bonevich, John
Vladar, Andras E.
Walker, Angela R. Hight
Zheng, Jiwen
Starnes, Catherine
Stromberg, Arnold
Ye, Jia
Grulke, Eric A.
TI Particle size distributions by transmission electron microscopy: an
interlaboratory comparison case study
SO METROLOGIA
LA English
DT Article
AB This paper reports an interlaboratory comparison that evaluated a protocol for measuring and analysing the particle size distribution of discrete, metallic, spheroidal nanoparticles using transmission electron microscopy (TEM). The study was focused on automated image capture and automated particle analysis. NIST RM8012 gold nanoparticles (30 nm nominal diameter) were measured for area-equivalent diameter distributions by eight laboratories. Statistical analysis was used to (1) assess the data quality without using size distribution reference models, (2) determine reference model parameters for different size distribution reference models and non-linear regression fitting methods and (3) assess the measurement uncertainty of a size distribution parameter by using its coefficient of variation. The interlaboratory area-equivalent diameter mean, 27.6 nm +/- 2.4 nm (computed based on a normal distribution), was quite similar to the area-equivalent diameter, 27.6 nm, assigned to NIST RM8012. The lognormal reference model was the preferred choice for these particle size distributions as, for all laboratories, its parameters had lower relative standard errors (RSEs) than the other size distribution reference models tested (normal, Weibull and Rosin-Rammler-Bennett). The RSEs for the fitted standard deviations were two orders of magnitude higher than those for the fitted means, suggesting that most of the parameter estimate errors were associated with estimating the breadth of the distributions. The coefficients of variation for the interlaboratory statistics also confirmed the lognormal reference model as the preferred choice. From quasi-linear plots, the typical range for good fits between the model and cumulative number-based distributions was 1.9 fitted standard deviations less than the mean to 2.3 fitted standard deviations above the mean. Automated image capture, automated particle analysis and statistical evaluation of the data and fitting coefficients provide a framework for assessing nanoparticle size distributions using TEM for image acquisition.
C1 [Rice, Stephen B.] Cabot Corp, Billerica, MA 01821 USA.
[Chan, Christopher; Brown, Scott C.] Dupont Cent Res & Dev, Wilmington, DE 19880 USA.
[Eschbach, Peter] Hewlett Packard Corp, Corvallis, OR USA.
[Han, Li; Ensor, David S.] RTI Int, Nanotechnol Engn Technol Unit, Res Triangle Pk, NC 27709 USA.
[Stefaniak, Aleksandr B.] NIOSH, Morgantown, WV 26505 USA.
[Bonevich, John; Vladar, Andras E.; Walker, Angela R. Hight] NIST, Gaithersburg, MD 20899 USA.
[Zheng, Jiwen] US FDA, Div Chem & Mat Sci, Silver Spring, MD 20993 USA.
[Starnes, Catherine; Stromberg, Arnold] Univ Kentucky, Dept Stat, Lexington, KY 40506 USA.
[Starnes, Catherine; Stromberg, Arnold] Univ Kentucky, Appl Stat Lab, Lexington, KY 40506 USA.
[Ye, Jia; Grulke, Eric A.] Univ Kentucky, Lexington, KY 40506 USA.
RP Rice, SB (reprint author), Cabot Corp, 157 Concord Rd, Billerica, MA 01821 USA.
EM eric.grulke@uky.edu
RI Hight Walker, Angela/C-3373-2009; Brown, Scott/A-7254-2008
OI Hight Walker, Angela/0000-0003-1385-0672; Brown,
Scott/0000-0003-0138-474X
FU Intramural CDC HHS [CC999999]
NR 34
TC 10
Z9 10
U1 4
U2 29
PU IOP PUBLISHING LTD
PI BRISTOL
PA TEMPLE CIRCUS, TEMPLE WAY, BRISTOL BS1 6BE, ENGLAND
SN 0026-1394
EI 1681-7575
J9 METROLOGIA
JI Metrologia
PD DEC
PY 2013
VL 50
IS 6
BP 663
EP 678
DI 10.1088/0026-1394/50/6/663
PG 16
WC Instruments & Instrumentation; Physics, Applied
SC Instruments & Instrumentation; Physics
GA AA1BP
UT WOS:000330831600012
PM 26361398
ER
PT J
AU Frush, D
Denham, CR
Goske, MJ
Brink, JA
Morin, RL
Mills, TT
Butler, PF
McCollough, C
Miller, DL
AF Frush, Donald
Denham, Charles R.
Goske, Marilyn J.
Brink, James A.
Morin, Richard L.
Mills, Thalia T.
Butler, Priscilla F.
McCollough, Cynthia
Miller, Donald L.
TI Radiation Protection and Dose Monitoring in Medical Imaging: A Journey
From Awareness, Through Accountability, Ability and Action ... But Where
Will We Arrive?
SO JOURNAL OF PATIENT SAFETY
LA English
DT Review
DE CT scan; radiation dose; image gently; computed tomography; children;
radiation risk; radiation protection
ID CANCER-RISK ESTIMATION; COMPUTED-TOMOGRAPHY; CT; EXPOSURE; CAMPAIGN
AB Radiation awareness and protection of patients have been the fundamental responsibilities in diagnostic imaging since the discovery of x-rays late in 1895 and the first reports of radiation injury in 1896. In the ensuing years, there have been significant advancements in equipment that uses either x-rays to form images, such as fluoroscopy or computed tomography (CT), or the types of radiation emitted during nuclear imaging procedures (e.g., positron emission tomography [PET]). These advancements have allowed detailed and indispensable evaluation of a vast array of disorders. In fact, in 2001, CT and MRI were cited by physicians as the most significant medical innovations in the previous 3 decades. Rapid technological advancements in the last decade with CT, especially, have required imaging professionals to keep pace with increasingly complex technology to derive the maximum benefits of improved image acquisition and display techniques, in essence, the improved quality of the examination. It has also been challenging to fulfill the fundamental responsibilities of safety during this period of rapid growth (e.g., radiation protection, management of the risk of additional interventions driven by incidental findings, performing studies that were not indicated). The purpose of this paper is to define critical issues pertinent to ensuring patient safety through the appropriate assessment, recording, monitoring, and reporting of the radiation dose from CT.
C1 [Frush, Donald] Duke Univ, Med Ctr, Dept Radiol, Durham, NC 27710 USA.
[Denham, Charles R.] TMIT, Austin, TX USA.
[Goske, Marilyn J.] Childrens Hosp Med Ctr, Cincinnati, OH USA.
[Brink, James A.] Massachusetts Gen Hosp, Dept Diagnost Radiol, Boston, MA 02114 USA.
[Morin, Richard L.] Mayo Clin Jacksonville, Dept Radiol, Jacksonville, FL 32224 USA.
[Mills, Thalia T.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Butler, Priscilla F.] Amer Coll Radiol, Dept Qual & Safety, Reston, VA USA.
[Miller, Donald L.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
RP Frush, D (reprint author), Duke Univ, Med Ctr, McGovern Davison Childrens Hlth Ctr 1905, Div Pediat Radiol, Erwin Rd, Durham, NC 27710 USA.
EM donald.frush@duke.edu
NR 58
TC 7
Z9 8
U1 1
U2 8
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1549-8417
EI 1549-8425
J9 J PATIENT SAF
JI J. Patient Saf.
PD DEC
PY 2013
VL 9
IS 4
BP 232
EP 238
PG 7
WC Health Care Sciences & Services; Health Policy & Services
SC Health Care Sciences & Services
GA 300GA
UT WOS:000330451200008
PM 24257067
ER
PT J
AU Wong, KS
Nguyen, JN
White, T
Menefee, SA
Walter, AJ
Krulewitch, CJ
Anderson-Smits, CT
Jakus-Waldman, SM
AF Wong, Keri S.
Nguyen, John N.
White, Terry
Menefee, Shawn A.
Walter, Andrew J.
Krulewitch, Cara J.
Anderson-Smits, Colin T.
Jakus-Waldman, Sharon M.
TI Adverse Events Associated With Pelvic Organ Prolapse Surgeries That Use
Implants
SO OBSTETRICS AND GYNECOLOGY
LA English
DT Article
ID RANDOMIZED-CONTROLLED-TRIAL; ABDOMINAL RECONSTRUCTIVE SURGERY;
SACROSPINOUS LIGAMENT SUSPENSION; ANTERIOR VAGINAL PROLAPSE; TERM
OUTCOME EVALUATION; SUPPORT DEFECTS; TRANSVAGINAL MESH; RISK-FACTORS;
SURGICAL REPAIR; SEXUAL FUNCTION
AB OBJECTIVE: To estimate the rate of vaginal implant exposure associated with biologic grafts and permanent mesh used for pelvic organ prolapse (POP) surgery, to describe treatments used for these complications, and to estimate response rates to these treatments. The secondary aims were to describe the operative and perioperative complications.
METHODS: This was a retrospective analysis of female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent POP surgeries with biologic grafts and permanent mesh between September 2008 and May 2010. Inpatient and outpatient electronic medical records were reviewed for postoperative adverse events.
RESULTS: During the 21-month period, 1,282 women, mean age of 62 years (+/- 10 standard deviation), median parity of 3 (interquartile range 2-4), and median body mass index of 28 (interquartile range 24-30) underwent prolapse repairs with 1,484 implants with a mean follow-up time of 358 days (+/- 276 standard deviation). Vaginal exposures occurred more often with permanent mesh (53/847 [6%]) than biologic grafts (10/637 [1.6%]) (P<.001). Resolution of vaginal exposure after the first treatment occurred in 24 of 63 (38%), whereas 39 of 63 (62%) required multiple treatments. Surgical excision was performed in 20 of 63 (32%) exposures. Permanent mesh exposures were more likely to require surgical excision (20/53 [38%]) than biologic graft exposures (zero of 10) (P=.02).
CONCLUSION: Vaginal exposure occurred more frequently with permanent mesh than biologic graft, may require multiple treatments, and occasionally require surgical excision.
C1 Kaiser Permanente, Dept Obstet & Gynecol, Downey, CA USA.
Kaiser Permanente, Dept Obstet & Gynecol, Roseville, CA USA.
Kaiser Permanente, Dept Obstet & Gynecol, Honolulu, HI USA.
US FDA, Div Epidemiol, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
RP Nguyen, JN (reprint author), Kaiser Fdn Hosp, Dept Obstet & Gynecol, So Calif Permanente Med Grp, 9449 E Imperial Highway,Suite C327, Downey, CA 90242 USA.
EM John.N.Nguyen@kp.org
FU U.S. Food and Drug Administration
FX Funding provided by the U.S. Food and Drug Administration.
NR 23
TC 2
Z9 3
U1 0
U2 1
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0029-7844
EI 1873-233X
J9 OBSTET GYNECOL
JI Obstet. Gynecol.
PD DEC
PY 2013
VL 122
IS 6
BP 1239
EP 1245
DI 10.1097/AOG.0000000000000008
PG 7
WC Obstetrics & Gynecology
SC Obstetrics & Gynecology
GA 300FV
UT WOS:000330450700014
PM 24201675
ER
PT J
AU Moro, PL
Museru, OI
Broder, K
Cragan, J
Zheteyeva, Y
Tepper, N
Revzina, N
Lewis, P
Arana, J
Barash, F
Kissin, D
Vellozzi, C
AF Moro, Pedro L.
Museru, Oidda I.
Broder, Karen
Cragan, Janet
Zheteyeva, Yenlik
Tepper, Naomi
Revzina, Natalia
Lewis, Paige
Arana, Jorge
Barash, Faith
Kissin, Dmitry
Vellozzi, Claudia
TI Safety of Influenza A (H1N1) 2009 Live Attenuated Monovalent Vaccine in
Pregnant Women
SO OBSTETRICS AND GYNECOLOGY
LA English
DT Article
ID IMMUNIZATION PRACTICES ACIP; ADVISORY-COMMITTEE; UNITED-STATES;
FETAL-DEATH; RECOMMENDATIONS; PREVENTION; COHORT; RISK
AB OBJECTIVE: To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events.
METHODS: We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 2009 to June 2010. We reviewed the initial reports and obtained pregnancy outcome and infant data through 6 months of age from medical records. We reviewed the numbers and characteristics of pregnancy complications and infant outcomes including major birth defects and medically important infant conditions. Rates of spontaneous abortion, preterm birth, and major birth defects and their 95% confidence intervals were calculated.
RESULTS: The Vaccine Adverse Event Reporting System received 113 reports stating receipt of live H1N1 vaccine during pregnancy with no adverse events reported. We obtained follow-up maternal records on 95 of the 113 (84%) live H1N1 reports (40.2% were vaccinated in the first trimester) and found: 87 live births (two twin pregnancies) and no maternal deaths occurred. Number and rates of pregnancy-specific adverse events included: 10 (10.5%, 5.8-18.3) spontaneous abortions; four (4.7%, 1.8-11.4) preterm deliveries at 35-36 weeks of gestation; three (3.4%, 1.2-9.7) infants had one or more major birth defects noted at birth: one cleft palate, one cleft lip, and one microtia (underdeveloped or absent external ear). Seven neonates and infants were hospitalized for medically important conditions. One infant death occurred in a 2.5-month-old boy as a result of pertussis.
CONCLUSION: Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified.
C1 Ctr Dis Control & Prevent, Immunizat Safety Off,Natl Ctr Birth Defects & Dev, Div Healthcare Qual Promot,Div Birth Defects & De, Natl Ctr Emerging & Zoonot Infect Dis,Birth Defec, Atlanta, GA 30333 USA.
Ctr Dis Control & Prevent, Womens Hlth & Fertil Branch, Div Reprod Hlth, Natl Ctr Chron Dis Prevent & Hlth Promot, Atlanta, GA 30333 USA.
Emory Sch Med, Dept Pediat, Atlanta, GA USA.
US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Silver Spring, MD USA.
RP Moro, PL (reprint author), Ctr Dis Control & Prevent, Immunizat Safety Off, Div Healthcare Qual Promot, 1600 Clifton Rd,MS D26, Atlanta, GA 30333 USA.
EM pmoro@cdc.gov
FU Centers for Disease Control and Prevention; U.S. Food and Drug
Administration
FX Funded by the Centers for Disease Control and Prevention and the U.S.
Food and Drug Administration.
NR 30
TC 18
Z9 18
U1 0
U2 6
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0029-7844
EI 1873-233X
J9 OBSTET GYNECOL
JI Obstet. Gynecol.
PD DEC
PY 2013
VL 122
IS 6
BP 1271
EP 1278
DI 10.1097/AOG.0000000000000010
PG 8
WC Obstetrics & Gynecology
SC Obstetrics & Gynecology
GA 300FV
UT WOS:000330450700018
PM 24201689
ER
PT J
AU Hampp, C
Kang, EM
Borders-Hemphill, V
AF Hampp, Christian
Kang, Elizabeth M.
Borders-Hemphill, Vicky
TI Use of Prescription Antiobesity Drugs in the United States
SO PHARMACOTHERAPY
LA English
DT Article
DE antiobesity drugs; utilization; duration; phentermine; orlistat;
sibutramine
ID OBESITY; TRENDS
AB STUDY OBJECTIVE To examine national trends in prescription antiobesity drug use in the United States.
DESIGN Data analysis.
DATA SOURCE The IMS Health Vector One National and Total Patient Tracker and Encuity Research Treatment Answers databases, the Source Healthcare Analytics Source Lx database, and IMS LifeLink database.
MEASUREMENTS AND MAIN RESULTS National drug use estimates from 1991-2011 were extracted from the IMS Health Vector One National database, and patient characteristics from 2008-2011 were extracted from the Vector One Total Patient Tracker and Encuity Research Treatment Answers databases. The Source Healthcare Analytics Source Lx database was used to examine duration of antiobesity drug use from 2002-2011, with a sensitivity analysis performed using the IMS LifeLink database. In 2011, approximately 2.74 million patients used antiobesity drugs, predominantly phentermine (2.43 million patients). The use of prescription orlistat and sibutramine was relatively uncommon. Eighty-five percent of antiobesity drug users were female, 62% were aged 17-44 years, and 4.5% had a body mass index of <= 24.9 kg/m(2). Duration of use was generally short and most patients only had one episode of antiobesity drug use during the observation period. The longest episode of use was 30 days or less in 47-58% of patients. Approximately one quarter of the patients used antiobesity drugs for longer than 90 days, including phentermine and other amphetamine congeners whose labels recommend short-term use, not exceeding "a few weeks." Only 1.3-4.2% of antiobesity drug users used them for longer than 1 year. Concomitant use of two or more prescription weight-loss drugs was generally uncommon, although phentermine was dispensed during 13-16% of benzphetamine, diethylpropion, or phendimetrazine episodes of use.
CONCLUSION Phentermine dominated the prescription weight-loss market. Despite the indication of short-term use for amphetamine congeners, duration of use was similar to other antiobesity drugs. Nevertheless, the reasons for and implications of the limited duration of use observed with all prescription antiobesity drugs deserve further investigation.
C1 [Hampp, Christian; Kang, Elizabeth M.] US FDA, Div Epidemiol 1, Off Pharmacovigilance & Epidemiol, Off Surveillance & Epidemiol,Ctr Drug Evaluat & R, Silver Spring, MD 20993 USA.
[Borders-Hemphill, Vicky] US FDA, Div Medicat Error Prevent & Anal, Off Medicat Error Prevent & Risk Management, Off Surveillance & Epidemiol,Ctr Drug Evaluat & R, Silver Spring, MD 20993 USA.
RP Hampp, C (reprint author), US FDA, Div Epidemiol 1, Off Pharmacovigilance & Epidemiol, Off Surveillance & Epidemiol,Ctr Drug Evaluat & R, Silver Spring, MD 20993 USA.
EM Christian.hampp@fda.hhs.gov
FU Intramural FDA HHS [FD999999]
NR 14
TC 25
Z9 25
U1 2
U2 8
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0277-0008
EI 1875-9114
J9 PHARMACOTHERAPY
JI Pharmacotherapy
PD DEC
PY 2013
VL 33
IS 12
BP 1299
EP 1307
DI 10.1002/phar.1342
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 297HQ
UT WOS:000330246900011
PM 24019195
ER
PT J
AU Zhang, GD
Thau, E
Brown, EW
Hammack, TS
AF Zhang, Guodong
Thau, Eve
Brown, Eric W.
Hammack, Thomas S.
TI Comparison of a novel strategy for the detection and isolation of
Salmonella in shell eggs with the Food and Drug Administration
Bacteriological Analytical Manual method
SO POULTRY SCIENCE
LA English
DT Article
DE Salmonella; broth; detection; isolation; egg
ID REAL-TIME PCR; RAPPAPORT-VASSILIADIS MEDIUM; LOW MICROBIAL LOAD; RAPID
DETECTION; ENTERITIDIS; RECOVERY; SPP.; GROWTH; SYSTEM; POOLS
AB The current FDA Bacteriological Analytical Manual (BAM) method for the detection of Salmonella in eggs requires 2 wk to complete. The objective of this project was to improve the BAM method for the detection and isolation of Salmonella in whole shell eggs. A novel protocol, using 1,000 g of liquid eggs for direct preenrichment with 2 L of tryptic soy broth (TSB) followed by enrichment using Rappaport-Vassiliadis and Tetrathionate broths, was compared with the standard BAM method, which requires 96 h room temperature incubation of whole shell egg samples followed by preenrichment in TSB supplemented with FeSO4. Four Salmonella ser. Enteritidis (4 phage types) and one Salmonella ser. Heidelberg isolates were used in the study. Bulk inoculated pooled liquid eggs, weighing 52 or 56 kg (approximately 1,100 eggs) were used in each trial. Twenty 1,000-g test portions were withdrawn from the pooled eggs for both the alternative and the reference methods. Test portions were inoculated with Salmonella at 1 to 5 cfu/1,000 g eggs. Two replicates were performed for each isolate. In the 8 trials conducted with Salmonella ser. Enteritidis, the alternative method was significantly (P < 0.05) more productive than the reference method in 3 trials, and significantly (P < 0.05) less productive than the reference method in 1 trial. There were no significant (P < 0.05) differences between the 2 methods for the other 4 trials. For Salmonella ser. Heidelberg, combined data from 2 trials showed the alternative method was significantly (P < 0.05) more efficient than the BAM method. We have concluded that the alternative method, described herein, has the potential to replace the current BAM culture method for detection and isolation of Salmonella from shell eggs based on the following factors: 1) the alternative method is 4 d shorter than the reference method; 2) it uses regular TSB instead of the more complicated TSB supplemented with FeSO4; and 3) it was equivalent or superior to the reference method in 9 out of 10 trials for the detection of Salmonella in shell eggs.
C1 [Zhang, Guodong; Thau, Eve; Brown, Eric W.; Hammack, Thomas S.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Zhang, GD (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM Guodong.Zhang@fda.hhs.gov
NR 39
TC 0
Z9 0
U1 1
U2 11
PU POULTRY SCIENCE ASSOC INC
PI SAVOY
PA 1111 N DUNLAP AVE, SAVOY, IL 61874-9604 USA
SN 0032-5791
EI 1525-3171
J9 POULTRY SCI
JI Poult. Sci.
PD DEC
PY 2013
VL 92
IS 12
BP 3266
EP 3274
DI 10.3382/ps.2013-03380
PG 9
WC Agriculture, Dairy & Animal Science
SC Agriculture
GA 301IR
UT WOS:000330526500025
PM 24235238
ER
PT J
AU Lu, YH
Sun, JC
Petrova, K
Yang, X
Greenhaw, J
Salminen, WF
Beger, RD
Schnackenberg, LK
AF Lu, Yihong
Sun, Jinchun
Petrova, Katya
Yang, Xi
Greenhaw, James
Salminen, William F.
Beger, Richard D.
Schnackenberg, Laura K.
TI Metabolomics evaluation of the effects of green tea extract on
acetaminophen-induced hepatotoxicity in mice
SO FOOD AND CHEMICAL TOXICOLOGY
LA English
DT Article
DE Green tea extract; Acetaminophen; Hepatotoxicity; Metabolic profiling;
Metabolomics
ID MITOCHONDRIAL PERMEABILITY TRANSITION; CHROMATOGRAPHY-MASS SPECTROMETRY;
DIETARY-SUPPLEMENT HEPATOTOXICITY; NITRIC-OXIDE; OXIDATIVE STRESS;
BILE-ACIDS; UNITED-STATES; CELL-DEATH; URIC-ACID; RAT-LIVER
AB Green tea has been purported to have beneficial health effects including protective effects against oxidative stress. Acetaminophen (APAP) is a widely used analgesic drug that can cause acute liver injury in overdose situations. These studies explored the effects of green tea extract (GTE) on APAP-induced hepatotoxicity in liver tissue extracts using ultra performance liquid chromatography/quadrupole time-of-flight mass spectrometry and nuclear magnetic resonance spectroscopy. Mice were orally administered GTE, APAP or GTE and APAP under three scenarios. APAP alone caused a high degree of hepatocyte necrosis associated with increases in serum transaminases and alterations in multiple metabolic pathways. The time of GTE oral administration relative to APAP either protected against or potentiated the APAP-induced hepatotoxicity. Dose dependent decreases in histopathology scores and serum transaminases were noted when GTE was administered prior to APAP; whereas, the opposite occurred when GTE was administered after APAP. Similarly, metabolites altered by APAP alone were less changed when GTE was given prior to APAP. Significantly altered pathways included fatty acid metabolism, glycerophospholipid metabolism, glutathione metabolism, and energy pathways. These studies demonstrate the complex interaction between GTE and APAP and the need to employ novel analytical strategies to understand the effects of dietary supplements on pharmaceutical compounds. Published by Elsevier Ltd.
C1 [Lu, Yihong; Sun, Jinchun; Petrova, Katya; Yang, Xi; Greenhaw, James; Salminen, William F.; Beger, Richard D.; Schnackenberg, Laura K.] US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Schnackenberg, LK (reprint author), US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson Labs, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM Laura.Schnackenberg@fda.hhs.gov
NR 70
TC 12
Z9 17
U1 8
U2 44
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0278-6915
EI 1873-6351
J9 FOOD CHEM TOXICOL
JI Food Chem. Toxicol.
PD DEC
PY 2013
VL 62
BP 707
EP 721
DI 10.1016/j.fct.2013.09.025
PG 15
WC Food Science & Technology; Toxicology
SC Food Science & Technology; Toxicology
GA 293GW
UT WOS:000329960400090
PM 24080264
ER
PT J
AU Teeguarden, J
Hanson-Drury, S
Fisher, JW
Doerge, DR
AF Teeguarden, Justin
Hanson-Drury, Sesha
Fisher, Jeffrey W.
Doerge, Daniel R.
TI Are typical human serum BPA concentrations measurable and sufficient to
be estrogenic in the general population?
SO FOOD AND CHEMICAL TOXICOLOGY
LA English
DT Review
DE BPA; Epidemiology; Toxicity; Estrogenic; Biomonitoring
ID BISPHENOL-A CONCENTRATIONS; SPRAGUE-DAWLEY RATS; ENDOCRINE-DISRUPTING
CHEMICALS; TANDEM MASS-SPECTROMETRY; PERFORMANCE LIQUID-CHROMATOGRAPHY;
IN-VITRO FERTILIZATION; HUMAN URINE; RHESUS-MONKEYS; REPRODUCTIVE
TOXICITY; BIOLOGICAL SAMPLES
AB Mammalian estrogen receptors modulate many physiological processes. Chemicals with structural features similar to estrogens can interact with estrogen receptors to produce biological effects similar to those caused by endogenous estrogens in the body. Bisphenol A (BPA) is a structural analogue of estrogen that binds to estrogen receptors. Exposure to BPA in humans is virtually ubiquitous in industrialized societies, but BPA is rapidly detoxified by metabolism and does not accumulate in the body. Whether or not serum concentrations of BPA in humans are sufficiently high to disrupt normal estrogen-related biology is the subject of intense political and scientific debate. Here we show a convergence of robust methods for measuring or calculating serum concentrations of BPA in humans from 93 published studies of more than 30,000 individuals in 19 countries across all life stages. Typical serum BPA concentrations are orders of magnitude lower than levels measurable by modern analytical methods and below concentrations required to occupy more than 0.0009% of Type II Estrogen Binding Sites, GPR30, ER alpha or ER beta receptors. Occupancies would be higher, but <= 0.04%, for the highest affinity receptor, ERR gamma. Our results show limited or no potential for estrogenicity in humans, and question reports of measurable BPA in human serum. (C) 2013 Elsevier Ltd. All rights reserved.
C1 [Teeguarden, Justin; Hanson-Drury, Sesha] Pacific Norwest Natl Lab, Richland, WA 99352 USA.
[Fisher, Jeffrey W.; Doerge, Daniel R.] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Teeguarden, J (reprint author), 902 Battelle Blvd, Richland, WA 99352 USA.
EM jt@pnl.gov
OI Teeguarden, Justin/0000-0003-3817-4391
FU U.S. EPA [R83386701]
FX The authors would like to thank the U.S. EPA for providing funding for
this work under the STAR program, grant R83386701. The authors would
also like to thank Dr. Daniel Naiman, Department of Applied Mathematics
and Statistics, Johns Hopkins University, Baltimore, MD for providing
the exposure data for women of child-bearing age derived from NHANES
data. The authors are also grateful for the graphics support provided by
Mr. Cortland Johnson of the Pacific Northwest National Laboratory. The
views expressed in this article do not necessarily reflect those of the
U.S. Food and Drug Administration.
NR 117
TC 33
Z9 33
U1 4
U2 37
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0278-6915
EI 1873-6351
J9 FOOD CHEM TOXICOL
JI Food Chem. Toxicol.
PD DEC
PY 2013
VL 62
BP 949
EP 963
DI 10.1016/j.fct.2013.08.001
PG 15
WC Food Science & Technology; Toxicology
SC Food Science & Technology; Toxicology
GA 293GW
UT WOS:000329960400118
PM 23959105
ER
PT J
AU Rahkovsky, I
Lin, BH
Lin, CTJ
Lee, JY
AF Rahkovsky, Ilya
Lin, Biing-Hwan
Lin, Chung-Tung Jordan
Lee, Jonq-Ying
TI Effects of the Guiding Stars Program on purchases of ready-to-eat
cereals with different nutritional attributes
SO FOOD POLICY
LA English
DT Article
DE Nutrition information; Front-of-package nutrition labeling; Cereal
demand; Guiding Stars Program
ID FOOD LABELS; INFORMATION; CONSUMERS; SPACE
AB Over the past decade, the food industry has increased its use of front-of-package and shelf-tag nutrition labeling designed to present key nutritional aspects and characteristics of food products. One such system is the Guiding Stars Program (TM) (GSP), which uses an algorithm to score the nutritional values of food products from one to three stars, where more stars mean more nutritious. We studied how the introduction of the GSP in one supermarket chain affected the demand for ready-to-eat cereals. We estimated the demand for cereals and measured the effect using a treatment-control approach. We found that the GSP significantly increased the demand for cereals that GSP considers more nutritious at the expense of cereals that GSP considers less nutritious. Published by Elsevier Ltd.
C1 [Rahkovsky, Ilya; Lin, Biing-Hwan] USDA, Econ Res Serv, Washington, DC USA.
[Lin, Chung-Tung Jordan] US FDA, Ctr Food Safety & Appl Nutr, Rockville, MD 20857 USA.
[Lee, Jonq-Ying] Univ Florida, Gainesville, FL 32611 USA.
RP Rahkovsky, I (reprint author), 355 E St SW, Washington, DC 20024 USA.
EM irahkovsky@ers.usda.gov
NR 33
TC 11
Z9 11
U1 1
U2 16
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0306-9192
EI 1873-5657
J9 FOOD POLICY
JI Food Policy
PD DEC
PY 2013
VL 43
BP 100
EP 107
DI 10.1016/j.foodpol.2013.08.013
PG 8
WC Agricultural Economics & Policy; Economics; Food Science & Technology;
Nutrition & Dietetics
SC Agriculture; Business & Economics; Food Science & Technology; Nutrition
& Dietetics
GA 285SA
UT WOS:000329414100010
ER
PT J
AU Winterstein, AG
Knox, CA
Kubilis, P
Hampp, C
AF Winterstein, Almut G.
Knox, Caitlin A.
Kubilis, Paul
Hampp, Christian
TI Appropriateness of Age Thresholds for Respiratory Syncytial Virus
Immunoprophylaxis in Moderate-Preterm Infants A Cohort Study
SO JAMA PEDIATRICS
LA English
DT Article
ID WEEKS GESTATIONAL-AGE; INFECTION REQUIRING HOSPITALIZATION;
INTENSIVE-CARE-UNIT; PREMATURE-INFANTS; RISK-FACTORS; PREDICT
HOSPITALIZATION; COMPLETED WEEKS; BORN; CHILDREN; BRONCHIOLITIS
AB IMPORTANCE Recommendations concerning the appropriate age threshold for respiratory syncytial virus (RSV) prophylaxis in moderate-preterm infants are highly debated.
OBJECTIVE To determine the age at which moderate-preterm infants' risk of RSV hospitalization has decreased to the risk observed in low-risk term infants.
DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of Florida and Texas Medicaid fee-for-service billing records matched to birth certificates from Medicaid beneficiaries aged 0 to 12 months with a sibling younger than 5 years and without other indications for RSV prophylaxis between January 1, 1999, and December 31, 2004.
EXPOSURES For each state, we used discrete time survival analysis to develop age trend models for RSV hospitalizations for 2 groups: moderate-preterm infants (32-34 weeks' gestational age) and term infants (37-41 weeks' gestational age).
MAIN OUTCOMES AND MEASURES Age at which preterm infants' risk of RSV hospitalization equaled the risk for term infants at age 1 month. RESULTS Our cohort included 247 566 eligible infants with 5322 RSV hospitalizations. Preterm status doubled the risk for RSV hospitalization in both Florida (odds ratio = 2.41; 95% CI, 1.85-3.12) and Texas (odds ratio = 1.94; 95% CI, 1.64-2.30). Preterm infants' risk of RSV hospitalization was similar to that for 1-month-old term infants at ages 4.2 months (95% CI, 2.5-5.7) in Florida and 4.5 months (95% CI, 2.8-6.4) in Texas.
CONCLUSIONS AND RELEVANCE The age at which moderate-preterm infants showed RSV hospitalization risk similar to their healthy term counterparts supports the more restrictive age thresholds in RSV immunoprophylaxis recommendations. Further studies are warranted to investigate the age-dependent risk of RSV hospitalization in other RSV risk groups.
C1 [Winterstein, Almut G.] Univ Florida, Dept Epidemiol, Gainesville, FL 32610 USA.
[Winterstein, Almut G.; Knox, Caitlin A.; Kubilis, Paul] Univ Florida, Dept Pharmaceut Outcomes & Policy, Gainesville, FL 32610 USA.
[Hampp, Christian] US FDA, Div Epidemiol, Off Pharmacovigilance & Epidemiol, Off Surveillance & Epidemiol,Ctr Drug Evaluat & R, Silver Spring, MD USA.
RP Winterstein, AG (reprint author), Univ Florida, Coll Pharm, Dept Pharmaceut Outcomes & Policy, HPNP Bldg,1225 Ctr Dr,POB 100496, Gainesville, FL 32610 USA.
EM almut@ufl.edu
RI winterstein, Almut/A-3017-2014
OI winterstein, Almut/0000-0002-6518-5961
FU Florida Agency of Healthcare Administration; American Foundation for
Pharmaceutical Education fellowship
FX This study was supported in part by a grant from the Florida Agency of
Healthcare Administration and was conducted in collaboration with the
Florida Center for Medicaid and the Uninsured, University of Florida. Ms
Knox was supported by an American Foundation for Pharmaceutical
Education fellowship and the Mary K. Owens Fellowship for Healthcare
Innovation from the University of Florida.
NR 49
TC 20
Z9 20
U1 0
U2 2
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60654-0946 USA
SN 2168-6203
EI 2168-6211
J9 JAMA PEDIATR
JI JAMA Pediatr.
PD DEC
PY 2013
VL 167
IS 12
BP 1118
EP 1124
DI 10.1001/jamapediatrics.2013.2636
PG 7
WC Pediatrics
SC Pediatrics
GA 291QY
UT WOS:000329845300010
PM 24126903
ER
PT J
AU Minor, T
AF Minor, Travis
TI An investigation into the effect of type I and type II diabetes duration
on employment and wages
SO ECONOMICS & HUMAN BIOLOGY
LA English
DT Article
DE Diabetes; Labor supply; Wages; Panel data
ID WORK PRODUCTIVITY; HEALTH; IMPACT; PREVALENCE; RISK
AB Using data from the National Longitudinal Survey of Youth 1979, the current study examines the effect of type I and type II diabetes on employment status and wages. The results suggest that both the probability of employment and wages are negatively related to the number of years since the initial diagnosis of diabetes. Moreover, the effect of diabetes duration on the probability of employment appears to be nonlinear, peaking around 16 years for females and 10 years for males. A similar negative effect on wages is found only in male diabetics. Finally, the results suggest that failure to distinguish between type I and type II diabetics may lead to some counterintuitive results. Published by Elsevier B.V.
C1 [Minor, Travis] US FDA, Ctr Food Safety & Appl Nutr, Rockville, MD 20857 USA.
RP Minor, T (reprint author), FDA CFSAN, CPK1 HFS 020,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM Travis.Minor@fda.hhs.gov
OI Minor, Travis/0000-0002-5297-7695
NR 21
TC 6
Z9 6
U1 1
U2 14
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1570-677X
EI 1873-6130
J9 ECON HUM BIOL
JI Econ. Hum. Biol.
PD DEC
PY 2013
VL 11
IS 4
BP 534
EP 544
DI 10.1016/j.ehb.2013.04.004
PG 11
WC Economics; Public, Environmental & Occupational Health
SC Business & Economics; Public, Environmental & Occupational Health
GA 283RR
UT WOS:000329265200013
PM 23659822
ER
PT J
AU Guettier, JM
Lungu, A
Goodling, A
Cochran, C
Gorden, P
AF Guettier, Jean-Marc
Lungu, Andreea
Goodling, Anne
Cochran, Craig
Gorden, Phillip
TI The Role of Proinsulin and Insulin in the Diagnosis of Insulinoma: A
Critical Evaluation of the Endocrine Society Clinical Practice Guideline
SO JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
LA English
DT Article
ID ISLET CELL TUMORS; CIRCULATING INSULIN; PLASMA PROINSULIN; COMPONENT
AB Context: An end of fast insulin >= 3 mu IU/mL and a proinsulin concentration >= 5 pmol/L have been suggested as useful cutoffs for the diagnosis of insulinoma.
Objective: The main objective was to evaluate the diagnostic performance of an end of fast insulin concentration >= 3 mu IU/mL and an end of fast proinsulin concentration >= 5 pmol/L.
Design: The design was a case-control series.
Setting: The setting was a tertiary-care center.
Patients: Fifty-six subjects with a positive 48-hour supervised fast had an insulinoma between June 2000 and April 2011. During this same time period, a diagnosis of insulinoma was excluded in 29 subjects who underwent a supervised fast.
Intervention: 48-hour supervised fast.
Main Outcome Measure: The main outcome measures were serum insulin concentration and plasma proinsulin concentration.
Results: Ninety-one percent of the patients with an insulinoma had a measured insulin concentration >= 5 mu IU/mL at the end of fast. The sensitivity increased to 98% if the threshold to define inadequate insulin suppression was lowered to >= 3 mu IU/mL. The median (interquartile range) end of fast proinsulin was 100 (53-270) pmol/L for cases and 6.8 (4.2-12.0) pmol/L for controls. An end of fast proinsulin value of >5 pmol/L could not distinguish cases from controls (59% false positive rate). All patients with an insulinoma (sensitivity 100%) and none of the control subject (specificity 100%) had end of fast proinsulin concentration >= 27 pmol/L.
Conclusions: Using a current insulin assay 9% of insulinoma cases end the supervised fast with an insulin concentration below 5 mu IU/mL. Inadequate insulin suppression defined using a threshold of >= 3 mu IU/mL increases the sensitivity of the test. The value of the proinsulin test lies in its unique ability to distinguish cases from controls. A proinsulin concentration of >= 22 pmol/L best discriminates cases from controls. Reliance on an end of fast proinsulin cutoff value of 5 pmol/L does not augment sensitivity but greatly reduces specificity of the test.
C1 [Guettier, Jean-Marc; Lungu, Andreea; Goodling, Anne; Cochran, Craig; Gorden, Phillip] NIDDK, NIH, Bethesda, MD 20892 USA.
[Guettier, Jean-Marc] US FDA, Div Metab & Endocrinol Prod, Silver Spring, MD 20903 USA.
RP Guettier, JM (reprint author), Bldg 10 CRC,Room 6-5952,10 Ctr Dr, Bethesda, MD 20892 USA.
EM Jean-Marc.Guettier@fda.hhs.gov
FU National Institute of Diabetes and Digestive and Kidney Diseases at the
National Institutes of Health
FX This work was supported by the Intramural Research Program of the
National Institute of Diabetes and Digestive and Kidney Diseases at the
National Institutes of Health.
NR 16
TC 14
Z9 15
U1 0
U2 3
PU ENDOCRINE SOC
PI CHEVY CHASE
PA 8401 CONNECTICUT AVE, SUITE 900, CHEVY CHASE, MD 20815-5817 USA
SN 0021-972X
EI 1945-7197
J9 J CLIN ENDOCR METAB
JI J. Clin. Endocrinol. Metab.
PD DEC
PY 2013
VL 98
IS 12
BP 4752
EP 4758
DI 10.1210/jc.2013-2182
PG 7
WC Endocrinology & Metabolism
SC Endocrinology & Metabolism
GA 272RF
UT WOS:000328477200047
PM 24081736
ER
PT J
AU Li, BG
Chen, JQ
AF Li, Baoguang
Chen, Jin-Qiang
TI Development of a sensitive and specific qPCR assay in conjunction with
propidium monoazide for enhanced detection of live Salmonella spp. in
food
SO BMC MICROBIOLOGY
LA English
DT Article
DE Salmonella; qPCR; Propidium monoazide; Live cells; invA gene
ID REAL-TIME PCR; POLYMERASE-CHAIN-REACTION; UNITED-STATES; SELECTIVE
DETECTION; REFERENCE COLLECTION; FOODBORNE ILLNESS; QUANTITATIVE PCR;
AMPLICON LENGTH; RAPID DETECTION; AMPLIFICATION
AB Background: Although a variety of methodologies are available for detection of Salmonella, sensitive, specific, and efficient methods are urgently needed for differentiation of live Salmonella cells from dead cells in food and environmental samples. Propidium monoazide (PMA) can preferentially penetrate the compromised membranes of dead cells and inhibit their DNA amplification, however, such inhibition has been reported to be incomplete by some studies. In the present study, we report an efficient qPCR assay targeting a conserved region of the invA gene of Salmonella in conjunction with PMA treatment for detection of DNA from live Salmonella cells in food samples.
Results: We investigated the relationship between amplicon length and inhibitory effect of PMA treatment to prevent DNA amplification from dead cells while allowing for DNA amplification from live cells, and found that the two factors are well correlated with each other. An amplicon that is 130 bp in length was determined to be optimal for PMA treatment and was selected for further PMA-qPCR assay development. A PMA-qPCR assay was established by utilizing this amplicon and adopting a modified PMA-treatment procedure. The PMA-qPCR assay provided excellent inhibition of DNA amplification from dead cells (a 17-C-T-value, or 128,000-fold reduction) while only a slight DNA amplification difference (0.5 C-T value) was noted between the PMA-treated and untreated live cells. This assay has been validated through stringent inclusivity and exclusivity studies using a large number of (n = 167) Salmonella, including all strains of SARA and SARB collections, and non-Salmonella strains (n = 36). This PMA-qPCR assay is capable of detecting live Salmonella cells in live/dead cell mixtures, or 30 CFU/g live Salmonella cells from enriched spiked spinach samples as early as 4 h.
Conclusions: A 130-bp amplicon in invA gene was demonstrated to be optimal for PMA treatment for selective detection of live Salmonella cells by PCR. This PMA-qPCR assay provides a sensitive, specific, and efficient method for detecting live Salmonella cells in foods and environmental samples and may have an impact on the accurate microbiological monitoring of Salmonella in foods and environment samples.
C1 [Li, Baoguang; Chen, Jin-Qiang] US FDA, Div Mol Biol, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Li, BG (reprint author), US FDA, Div Mol Biol, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
EM baoguang.li@fda.hhs.gov
NR 45
TC 13
Z9 13
U1 2
U2 22
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1471-2180
J9 BMC MICROBIOL
JI BMC Microbiol.
PD DEC 1
PY 2013
VL 13
AR 273
DI 10.1186/1471-2180-13-273
PG 13
WC Microbiology
SC Microbiology
GA 277ZJ
UT WOS:000328857500001
PM 24289661
ER
PT J
AU Stevenson, L
Garofolo, F
DeSilva, B
Dumont, I
Martinez, S
Rocci, M
Amaravadi, L
Brudny-Kloeppel, M
Musuku, A
Booth, B
Dicaire, C
Wright, L
Mayrand-Provencher, L
Losauro, M
Gouty, D
Arnold, M
Bansal, S
Dudal, S
Dufield, D
Duggan, J
Evans, C
Fluhler, E
Fraser, S
Gorovits, B
Haidar, S
Hayes, R
Ho, S
Houghton, R
Islam, R
Jenkins, R
Katori, N
Kaur, S
Kelley, M
Knutsson, M
Lee, J
Liu, HL
Lowes, S
Ma, M
Mikulskis, A
Myler, H
Nicholson, B
Olah, T
Ormsby, E
Patel, S
Pucci, V
Ray, C
Schultz, G
Shih, J
Shoup, R
Simon, C
Song, A
Neto, JT
Theobald, V
Thway, T
Wakelin-Smith, J
Wang, J
Wang, LX
Welink, J
Whale, E
Woolf, E
Xu, R
AF Stevenson, Lauren
Garofolo, Fabio
DeSilva, Binodh
Dumont, Isabelle
Martinez, Suzanne
Rocci, Mario
Amaravadi, Lakshmi
Brudny-Kloeppel, Margarete
Musuku, Adrien
Booth, Brian
Dicaire, Catherine
Wright, Laura
Mayrand-Provencher, Laurence
Losauro, Mike
Gouty, Dominique
Arnold, Mark
Bansal, Surendra
Dudal, Sherri
Dufield, Dawn
Duggan, Jeff
Evans, Christopher
Fluhler, Eric
Fraser, Stephanie
Gorovits, Boris
Haidar, Sam
Hayes, Roger
Ho, Stacy
Houghton, Richard
Islam, Rafiqul
Jenkins, Rand
Katori, Noriko
Kaur, Surinder
Kelley, Marian
Knutsson, Magnus
Lee, Jean
Liu, Hanlan
Lowes, Steve
Ma, Mark
Mikulskis, Alvydas
Myler, Heather
Nicholson, Bob
Olah, Timothy
Ormsby, Eric
Patel, Shefali
Pucci, Vincenzo
Ray, Chad
Schultz, Gary
Shih, Judy
Shoup, Ronald
Simon, Craig
Song, An
Neto, Joao Tavares
Theobald, Valerie
Thway, Theingi
Wakelin-Smith, Jason
Wang, Jian
Wang, Laixin
Welink, Jan
Whale, Emma
Woolf, Eric
Xu, Raymond
TI 2013 White Paper on recent issues in bioanalysis: 'hybrid' - the best of
LBA and LCMS
SO BIOANALYSIS
LA English
DT Article
ID VALIDATION GROUP WORKSHOP; GLOBAL CRO COUNCIL; REGULATED BIOANALYSIS;
Q-TOF; RECOMMENDATIONS; ASSAYS; BIOTHERAPEUTICS; QUANTIFICATION;
CALIBRATION; CHALLENGES
AB The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis.
C1 [Stevenson, Lauren; Amaravadi, Lakshmi; Mikulskis, Alvydas] Biogen Idec Inc, Cambridge, MA USA.
[Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Dicaire, Catherine; Mayrand-Provencher, Laurence] Algorithme Pharma Inc, Montreal, PQ H7V 4B3, Canada.
[DeSilva, Binodh; Arnold, Mark; Myler, Heather; Olah, Timothy; Wang, Jian] Bristol Myers Squibb Co, Princeton, NJ USA.
[Rocci, Mario] ICON Dev Solut, Whitesboro, NY USA.
[Brudny-Kloeppel, Margarete] Bayer Pharma AG, Berlin, Germany.
[Musuku, Adrien] Pharmascience, Montreal, PQ, Canada.
[Booth, Brian; Haidar, Sam] US FDA, CDER, Silver Spring, MD USA.
[Wright, Laura; Losauro, Mike; Gouty, Dominique] Intertek, San Diego, CA USA.
[Bansal, Surendra] Hoffmann La Roche, Nutley, NJ USA.
[Dudal, Sherri] Hoffmann La Roche AG, Basel, Switzerland.
[Dufield, Dawn; Gorovits, Boris] Pfizer, Andover, MA USA.
[Duggan, Jeff] Boehringer Ingelheim GmbH & Co KG, Ridgefield, CT USA.
[Evans, Christopher] GlaxoSmithKline, King Of Prussia, PA USA.
[Fluhler, Eric] Pfizer, Pearl River, NY USA.
[Fraser, Stephanie] Pfizer, Groton, CT USA.
[Hayes, Roger] MPI Res, Mattawan, MI USA.
[Ho, Stacy; Liu, Hanlan] Sanofi, Waltham, MA USA.
[Houghton, Richard] Quotient Biores, Fordham, England.
[Islam, Rafiqul] Celerion, Lincoln, NE USA.
[Jenkins, Rand; Nicholson, Bob] PPD, Richmond, VA USA.
[Katori, Noriko] Japan MHLW NIHS, Tokyo, Japan.
[Kaur, Surinder; Song, An] Genentech Inc, San Francisco, CA USA.
[Kelley, Marian] MKelley Consulting LLC, W Chester, PA USA.
[Knutsson, Magnus] Ferring Pharmaceut, Copenhagen, Denmark.
[Lee, Jean; Ma, Mark; Shih, Judy; Thway, Theingi] Amgen Inc, Thousand Oaks, CA 91320 USA.
[Lowes, Steve; Schultz, Gary] Quintiles Bioanalyt & ADME Labs, Ithaca, NY USA.
[Ormsby, Eric; Simon, Craig] Hlth Canada TPD, Ottawa, ON, Canada.
[Patel, Shefali] Janssen R&D, Spring House, PA USA.
[Pucci, Vincenzo] Merck Res Labs, Boston, MA USA.
[Ray, Chad] Pfizer, San Diego, CA USA.
[Shoup, Ronald] AIT Biosci, Indianapolis, IN USA.
[Neto, Joao Tavares] ANVISA, Brasilia, DF, Brazil.
[Theobald, Valerie] Sanofi, Framingham, MA USA.
[Wakelin-Smith, Jason; Whale, Emma] UK Med & Healthcare Prod Regulatory Agcy MHRA, Welwyn Garden City, Herts, England.
[Wang, Laixin] Tandem Labs, Salt Lake City, UT USA.
[Welink, Jan] Dutch Med Evaluat Board, Utrecht, Netherlands.
[Woolf, Eric] Merck Res Labs, West Point, PA USA.
[Xu, Raymond] AbbVie, N Chicago, IL USA.
RP Garofolo, F (reprint author), Algorithme Pharma Inc, 575 Armand Frappier Blvd, Montreal, PQ H7V 4B3, Canada.
EM fgarofolo@algopharm.com
FU US FDA; Europe EMA; Health Canada; Netherlands MEB; Brazil ANVISA; Japan
MHLW; UK MHRA
FX The authors would like to acknowledge the US FDA, Europe EMA, Health
Canada, The Netherlands MEB, Brazil ANVISA, Japan MHLW and UK MHRA for
supporting this workshop. L Stevenson (Biogen Idec Inc.) for her major
contribution in coordinating this White Paper for the biotherapeutics
part. B DeSilva (Bristol-Myers Squibb), L Amaravadi (Biogen Idec Inc.),
M Brudny-Kloeppel (Bayer Pharma AG), A Musuku, (Pharmascience) and F
Garofolo (Algorithme Pharma Inc.) for chairing the workshop. L Stevenson
(Biogen Idec Inc.) and M Rocci (ICON Development Solutions) for chairing
the White Paper discussions. All the workshop attendees and members of
the bioanalytical community who have sent comments and suggestions to
complete this White Paper. I Dumont, S Martinez, C Dicaire, L Wright, L
Mayrand-Provencher, M Losauro for collecting the workshop minutes and
preparing the first draft of this White Paper. W Garofolo (Meeting
Coordinator) for the logistic organization of the event. Future Science
Group as a trusted partner.
NR 27
TC 24
Z9 24
U1 0
U2 7
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
EI 1757-6199
J9 BIOANALYSIS
JI Bioanalysis
PD DEC
PY 2013
VL 5
IS 23
BP 2903
EP 2918
DI 10.4155/bio.13.238
PG 16
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 272ZI
UT WOS:000328501700012
PM 24107004
ER
PT J
AU Xu, ZZ
Kalbfleisch, JD
AF Xu, Zhenzhen
Kalbfleisch, John D.
TI Repeated Randomization and Matching in Multi-Arm Trials
SO BIOMETRICS
LA English
DT Article
DE BMW design; Clustered randomized trial; Experimental design; Optimal
matching; Propensity score matching; Randomization tests; Repeated
randomization
ID RADIATION; EXPOSURE; DESIGN
AB Cluster randomized trials with relatively few clusters have been widely used in recent years for evaluation of health-care strategies. The balance match weighted (BMW) design, introduced in Xu and Kalbfleisch (2010, Biometrics66, 813-823), applies the optimal full matching with constraints technique to a prospective randomized design with the aim of minimizing the mean squared error (MSE) of the treatment effect estimator. This is accomplished through consideration of M independent randomizations of the experimental units and then selecting the one which provides the most balance evaluated by matching on the estimated propensity scores. Often in practice, clinical trials may involve more than two treatment arms and multiple treatment options need to be evaluated. Therefore, we consider extensions of the BMW propensity score matching method to allow for studies with three or more arms. In this article, we propose three approaches to extend the BMW design to clinical trials with more than two arms and evaluate the property of the extended design in simulation studies.
C1 [Xu, Zhenzhen] US FDA, CBER, Rockville, MD 20852 USA.
[Kalbfleisch, John D.] Univ Michigan, Dept Biostat, Ann Arbor, MI 48109 USA.
RP Xu, ZZ (reprint author), US FDA, CBER, Rockville, MD 20852 USA.
EM zhenzhen.xu@fda.hhs.gov
FU National Institute of Neurological Disorders and Stroke [RO1 NS050372];
University of Michigan Kidney Epidemiology and Cost Center
FX The authors would like to thank Professors Ben Hansen, Douglas Schaubel
and Thomas Braun for helpful discussions and Professor Phillip Scott for
introducing them to the stroke studies that motivated this work. This
work was supported in part by grant (RO1 NS050372) from the National
Institute of Neurological Disorders and Stroke and by the University of
Michigan Kidney Epidemiology and Cost Center.
NR 22
TC 3
Z9 3
U1 0
U2 5
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0006-341X
EI 1541-0420
J9 BIOMETRICS
JI Biometrics
PD DEC
PY 2013
VL 69
IS 4
BP 949
EP 959
DI 10.1111/biom.12077
PG 11
WC Biology; Mathematical & Computational Biology; Statistics & Probability
SC Life Sciences & Biomedicine - Other Topics; Mathematical & Computational
Biology; Mathematics
GA 271WT
UT WOS:000328423000015
PM 24134592
ER
PT J
AU Hodge, DR
Prentice, KW
Ramage, JG
Prezioso, S
Gauthier, C
Swanson, T
Hastings, R
Basavanna, U
Datta, S
Sharma, SK
Garber, EAE
Staab, A
Pettit, D
Drumgoole, R
Swaney, E
Estacio, PL
Elder, IA
Kovacs, G
Morse, BS
Kellogg, RB
Stanker, L
Morse, SA
Pillai, SP
AF Hodge, David R.
Prentice, Kristin Willner
Ramage, Jason G.
Prezioso, Samantha
Gauthier, Cheryl
Swanson, Tanya
Hastings, Rebecca
Basavanna, Uma
Datta, Shomik
Sharma, Shashi K.
Garber, Eric A. E.
Staab, Andrea
Pettit, Denise
Drumgoole, Rahsaan
Swaney, Erin
Estacio, Peter L.
Elder, Ian A.
Kovacs, Gerald
Morse, Brenda S.
Kellogg, Richard B.
Stanker, Larry
Morse, Stephen A.
Pillai, Segaran P.
TI COMPREHENSIVE LABORATORY EVALUATION OF A HIGHLY SPECIFIC LATERAL FLOW
ASSAY FOR THE PRESUMPTIVE IDENTIFICATION OF RICIN IN SUSPICIOUS WHITE
POWDERS AND ENVIRONMENTAL SAMPLES
SO BIOSECURITY AND BIOTERRORISM-BIODEFENSE STRATEGY PRACTICE AND SCIENCE
LA English
DT Article
ID RIBOSOME-INACTIVATING PROTEINS; COMMUNIS AGGLUTININ; CASTOR BEANS;
TOXINS; GENE; SEQUENCE; AGENTS; CHAIN; ELECTROCHEMILUMINESCENCE;
CYTOTOXICITY
AB Ricin, a heterodimeric toxin that is present in the seeds of the Ricinus communis plant, is the biothreat agent most frequently encountered by law enforcement agencies in the United States. Even in untrained hands, the easily obtainable seeds can yield a highly toxic product that has been used in various types of threats, including white-powder letters. Although the vast majority of these threats are hoaxes, an impediment to accurate hazard assessments by first responders is the unreliability of rapid detection assays for ricin, such as lateral flow assays (LFAs). One of the complicating factors associated with LFAs is the incorporation of antibodies of poor specificity that cross-react with near-neighbors or with plant lectins that are capable of nonspecifically cross-linking the capture and detector antibodies. Because of the compelling and critical need to promote the interests of public safety and public health, the Department of Homeland Security conducted a comprehensive laboratory evaluation study of a commercial LFA for the rapid detection of ricin. This study was conducted using comprehensive inclusivity and exclusivity panels of ricin and near-neighbor plant materials, along with panels of lectins and white-powders, to determine the specificity, sensitivity, limits of detection, dynamic range, and repeatability of the assay for the specific intended use of evaluating suspicious white powders and environmental samples in the field.
C1 [Hodge, David R.; Prentice, Kristin Willner] Booz Allen & Hamilton Inc, Mclean, VA 22102 USA.
[Ramage, Jason G.; Pillai, Segaran P.] US Dept Homeland Secur, Sci & Technol Directorate, Chem & Biol Def Div, Washington, DC USA.
[Prezioso, Samantha] Ctr Dis Control & Prevent, Natl Ctr Emerging & Zoonot Infect Dis, Div Foodborne Waterborne & Environm Dis, Atlanta, GA USA.
[Gauthier, Cheryl; Swanson, Tanya; Hastings, Rebecca] Massachusetts Dept Publ Hlth, Bioterrorism Response Lab, State Lab Inst, Jamaica Plain, MA USA.
[Basavanna, Uma] USAMRIID, Ft Detrick, MD USA.
[Datta, Shomik; Sharma, Shashi K.; Garber, Eric A. E.] Food & Drug Adm, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, College Pk, MD USA.
[Pettit, Denise] NC Dept Hlth & Human Serv, North Carolina State Lab Publ Hlth, Raleigh, NC USA.
[Drumgoole, Rahsaan; Swaney, Erin] Texas Dept State Hlth Serv, Emergency Preparedness Branch, Austin, TX USA.
[Estacio, Peter L.] Lawrence Livermore Natl Lab, Environm Hlth & Qual Assurance, Livermore, CA USA.
[Elder, Ian A.] US Dept Homeland Secur, Washington, DC USA.
[Morse, Brenda S.; Kellogg, Richard B.] CDC, Natl Ctr Emerging & Zoonot Infect Dis, Div Preparedness & Emerging Infect, Lab Preparedness & Response Branch, Atlanta, GA 30333 USA.
[Stanker, Larry] USDA ARS, Foodborne Toxin Detect & Prevent Res Unit, Albany, CA USA.
[Morse, Stephen A.] CDC, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA.
RP Hodge, DR (reprint author), Dept Homeland Secur, S&T BOD STOP 0201,245 Murray Lane, Washington, DC 20528 USA.
EM David.Hodge@hq.dhs.gov
NR 52
TC 13
Z9 13
U1 1
U2 12
PU MARY ANN LIEBERT, INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1538-7135
EI 1557-850X
J9 BIOSECUR BIOTERROR
JI Biosecur. Bioterror.
PD DEC 1
PY 2013
VL 11
IS 4
BP 237
EP 250
DI 10.1089/bsp.2013.0053
PG 14
WC Public, Environmental & Occupational Health; International Relations
SC Public, Environmental & Occupational Health; International Relations
GA 276KT
UT WOS:000328749900003
PM 24320219
ER
PT J
AU Strauss, DG
Mewton, N
Verrier, RL
Nearing, BD
Marchlinski, FE
Killian, T
Moxley, J
Tereshchenko, LG
Wu, KC
Winslow, R
Cox, C
Spooner, PM
Lima, JAC
AF Strauss, David G.
Mewton, Nathan
Verrier, Richard L.
Nearing, Bruce D.
Marchlinski, Francis E.
Killian, Tony
Moxley, John
Tereshchenko, Larisa G.
Wu, Katherine C.
Winslow, Raimond
Cox, Christopher
Spooner, Peter M.
Lima, Joao A. C.
TI Screening Entire Health System ECG Databases to Identify Patients at
Increased Risk of Death
SO CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY
LA English
DT Article
DE arrhythmias; cardiac; death; electrocardiography; fibrosis; mass
screening
ID SUDDEN CARDIAC DEATH; INFARCT TISSUE HETEROGENEITY;
CORONARY-ARTERY-DISEASE; CHRONIC KIDNEY-DISEASE; MAGNETIC-RESONANCE;
STRATIFICATION; ARRHYTHMIA; MORTALITY; CARDIOMYOPATHY; EPIDEMIOLOGY
AB Background Current methods to identify patients at higher risk for sudden cardiac death, primarily left ventricular ejection fraction 35%, miss approximate to 80% of patients who die suddenly. We tested the hypothesis that patients with elevated QRS-scores (index of myocardial scar) and wide QRS-T angles (index abnormal depolarization-repolarization relationship) have high 1-year all-cause mortality and could be further risk stratified with clinical characteristics.
Methods and Results We screened all 12-lead ECGs over 6 months at 2 large hospital systems and analyzed clinical characteristics and 1-year mortality. Patients with ECGs obtained in hospital areas with known high mortality rates were excluded. At the first hospital, QRS-score 5 and QRS-T angle 105 degrees identified 8.0% of patients and was associated with an odds ratio of 2.79 (95% confidence interval, 2.10-3.69) for 1-year mortality compared with patients below both ECG thresholds (13.9% versus 5.5% death rate). Left ventricular ejection fraction was >35% in 82% of the former group of patients, and addition of ECG measures to left ventricular ejection fraction increased the discrimination of death risk (P<0.0001). At the second hospital, the odds ratio was 2.42 (1.95-3.01) for 1-year mortality (8.8% versus 3.8%). Adjustment for patient characteristics eliminated interhospital differences. Multivariable adjusted odds ratio combining data from both hospitals was 1.53 (1.28-1.83). Increasing heart rate and chronic renal impairment further predicted mortality.
Conclusions Screening hospital ECG databases with QRS-scoring and QRS-T angle analysis identifies patients with high 1-year all-cause mortality and predominantly preserved left ventricular ejection fraction. This approach may represent a widely available method to identify patients at increased risk of death.
C1 [Strauss, David G.] US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Mewton, Nathan; Moxley, John; Tereshchenko, Larisa G.; Wu, Katherine C.; Spooner, Peter M.; Lima, Joao A. C.] Johns Hopkins Med Inst, Dept Med, Div Cardiol, Baltimore, MD 21205 USA.
[Verrier, Richard L.; Nearing, Bruce D.] Harvard Univ, Beth Israel Deaconess Med Ctr, Sch Med, Dept Med, Boston, MA 02215 USA.
[Marchlinski, Francis E.; Killian, Tony] Hosp Univ Penn, Div Cardiol, Dept Med, Philadelphia, PA 19104 USA.
[Winslow, Raimond] Johns Hopkins Univ, Dept Biomed Engn, Inst Computat Med, Baltimore, MD USA.
[Cox, Christopher] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA.
RP Lima, JAC (reprint author), Johns Hopkins Univ Hosp, 600 N Wolfe St Blalock 524, Baltimore, MD 21287 USA.
EM jlima@jhmi.edu
OI Tereshchenko, Larisa/0000-0002-6976-1313
FU National Institutes of Health/National Heart, Lung, and Blood Institute
[P20HL101397, R24HL085343]; Leducq Foundation; French Federation of
Cardiology
FX This research was supported in part by grants P20HL101397 and
R24HL085343 from the National Institutes of Health/National Heart, Lung,
and Blood Institute, the Leducq Foundation, and the French Federation of
Cardiology. Johns Hopkins University has a research agreement with GE
Healthcare, Inc, which provided technical support only to this project.
NR 24
TC 10
Z9 10
U1 0
U2 4
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1941-3149
EI 1941-3084
J9 CIRC-ARRHYTHMIA ELEC
JI Circ.-Arrhythmia Electrophysiol.
PD DEC
PY 2013
VL 6
IS 6
BP 1156
EP 1162
DI 10.1161/CIRCEP.113.000411
PG 7
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 273HN
UT WOS:000328526000026
PM 24122522
ER
PT J
AU MacMahon, S
Begley, TH
Diachenko, GW
AF MacMahon, Shaun
Begley, Timothy H.
Diachenko, Gregory W.
TI Occurrence of 3-MCPD and glycidyl esters in edible oils in the United
States
SO FOOD ADDITIVES AND CONTAMINANTS PART A-CHEMISTRY ANALYSIS CONTROL
EXPOSURE & RISK ASSESSMENT
LA English
DT Article
DE 3-MCPD; glycidol; glycidyl esters; oils; processing contaminants
ID FATTY-ACID ESTERS; ELAEIS-GUINEENSIS OIL; MASS-SPECTROMETRY;
3-CHLORO-1,2-PROPANEDIOL 3-MCPD; 3-MONOCHLOROPROPANE-1,2-DIOL;
MONOCHLOROPROPANEDIOL; CONTAMINANTS; CELLS; RATS
AB Fatty acid esters of 3-monochloropropanediol (3-MCPD) and glycidol are processing contaminants found in a wide range of edible oils. While both 3 MCPD and glycidol have toxicological properties that at present has concerns for food safety, the published occurrence data are limited. Occurrence information is presented for the concentrations of 3-MCPD and glycidyl esters in 116 retail and/or industrial edible oils and fats using LC-MS/MS analysis of intact esters. The concentrations for bound 3-MCPD ranged from below the limit of quantitation ( 0.05) in the prevalence was found between wet markets and supermarkets or between whole chickens and chopped chickens. The prevalence of ESBL-producing Salmonella differed significantly (P < 0.05) among different seasons, being higher in autumn than in spring and winter. Overall, ESBL-producing Salmonella varied significantly (P<0.05) among 12 detected Salmonella serotypes: Abony (1 [33.33%] of 3), Indiana (28 [28.57%] of 98), Edinburg (6 [24.00%] of 25), Shubra (2 [20.00%] of 10), Uppsala (1 [16.67%] of 6), Thompson (8 [14.81%] of 54), Haardt (1 [12.50%] of 8), Agona (3 [9.68%] of 31), Gueuletapee (1 [6.25%] of 16), Typhimurium (4 [5.56%] of 72), Heidelberg (1 [4.55%] of 22), and Enteritidis (4 [3.17%] of 126). This study revealed that ESBL-producing Salmonella do exist in retail chicken in the People's Republic of China and that the potential risk of their presence in foods needs further exploration.
C1 [Wu, Haiyun; Xia, Xiaodong; Cui, Yue; Hu, Yuanyuan; Xi, Meili; Wang, Xin; Meng, Jianghong; Yang, Baowei] Northwest A&F Univ, Coll Food Sci, Yangling 712100, Peoples R China.
[Shi, Xianming; Wang, Dapeng] Shanghai Jiao Tong Univ, Shanghai 200240, Peoples R China.
[Meng, Jianghong] Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
[Meng, Jianghong] Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
RP Yang, BW (reprint author), Northwest A&F Univ, Coll Food Sci, Yangling 712100, Peoples R China.
EM ybwsheng@163.com
FU "Fundamental Research Funds for the Central Universities" of Northwest
A&F University, the People's Republic of China; "National High
Technology Research and Development Program of China" (863 Program)
[2012AA101601]
FX This research was supported in part by the "Fundamental Research Funds
for the Central Universities" of Northwest A&F University, the People's
Republic of China, and the "National High Technology Research and
Development Program of China" (863 Program) (no. 2012AA101601).
NR 29
TC 9
Z9 9
U1 1
U2 22
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
EI 1944-9097
J9 J FOOD PROTECT
JI J. Food Prot.
PD DEC
PY 2013
VL 76
IS 12
BP 2040
EP 2044
DI 10.4315/0362-028X.JFP-13-224
PG 5
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 270EH
UT WOS:000328301200007
PM 24290679
ER
PT J
AU Skates, SJ
Gillette, MA
LaBaer, J
Carr, SA
Anderson, L
Liebler, DC
Ransohoff, D
Rifai, N
Kondratovich, M
Tezak, Z
Mansfield, E
Oberg, AL
Wright, I
Barnes, G
Gail, M
Mesri, M
Kinsinger, CR
Rodriguez, H
Boja, ES
AF Skates, Steven J.
Gillette, Michael A.
LaBaer, Joshua
Carr, Steven A.
Anderson, Leigh
Liebler, Daniel C.
Ransohoff, David
Rifai, Nader
Kondratovich, Marina
Tezak, Zivana
Mansfield, Elizabeth
Oberg, Ann L.
Wright, Ian
Barnes, Grady
Gail, Mitchell
Mesri, Mehdi
Kinsinger, Christopher R.
Rodriguez, Henry
Boja, Emily S.
TI Statistical Design for Biospecimen Cohort Size in Proteomics-based
Biomarker Discovery and Verification Studies
SO JOURNAL OF PROTEOME RESEARCH
LA English
DT Article
DE statistical experiment design; biomarker; proteomics; unbiasedness;
power calculation
ID MONITORING MASS-SPECTROMETRY; CARDIOVASCULAR-DISEASE; PROTEIN
BIOMARKERS; MULTIPLEX ASSAYS; PIPELINE; PLASMA; ASSOCIATION;
DIAGNOSTICS; VALIDATION; MARKERS
AB Protein biomarkers are needed to deepen our understanding of cancer biology and to improve our ability to diagnose, monitor, and treat cancers. Important analytical and clinical hurdles must be overcome to allow the most promising protein biomarker candidates to advance into clinical validation studies. Although contemporary proteomics technologies support the measurement of large numbers of proteins in individual clinical specimens, sample throughput remains comparatively low. This problem is amplified in typical clinical proteomics research studies, which routinely suffer from a lack of proper experimental design, resulting in analysis of too few biospecimens to achieve adequate statistical power at each stage of a biomarker pipeline. To address this critical shortcoming, a joint workshop was held by the National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), and American Association for Clinical Chemistry (AACC) with participation from the U.S. Food and Drug Administration (FDA). An important output from the workshop was a statistical framework for the design of biomarker discovery and verification studies. Herein, we describe the use of quantitative clinical judgments to set statistical criteria for clinical relevance and the development of an approach to calculate biospecimen sample size for proteomic studies in discovery and verification stages prior to clinical validation stage. This represents a first step toward building a consensus on quantitative criteria for statistical design of proteomics biomarker discovery and verification research.
C1 [Skates, Steven J.] Massachusetts Gen Hosp, Ctr Canc, Ctr Biostat, Boston, MA 02114 USA.
[Gillette, Michael A.; Carr, Steven A.] Broad Inst Massachusetts Inst Technol & Harvard, Prote Platform, Cambridge, MA 02142 USA.
[LaBaer, Joshua] Arizona State Univ, Biodesign Inst, Tempe, AZ 85287 USA.
[Anderson, Leigh] Plasma Proteome Inst, Washington, DC 20009 USA.
[Anderson, Leigh; Wright, Ian] SISCAPA Technol Inc, Washington, DC 20009 USA.
[Liebler, Daniel C.] Vanderbilt Univ, Sch Med, Jim Ayers Inst Precanc Detect & Diag, Nashville, TN 37232 USA.
[Liebler, Daniel C.] Vanderbilt Univ, Sch Med, Dept Biochem, Nashville, TN 37232 USA.
[Ransohoff, David] Univ N Carolina, Dept Med, Div Gastroenterol & Hepatol, Chapel Hill, NC 27514 USA.
[Rifai, Nader] Childrens Hosp, Dept Lab Med, Boston, MA 02115 USA.
[Rifai, Nader] Harvard Univ, Sch Med, Dept Pathol, Boston, MA 02115 USA.
[Rifai, Nader] King Abdulaziz Univ, Jeddah 22254, Saudi Arabia.
[Kondratovich, Marina; Tezak, Zivana; Mansfield, Elizabeth] US FDA, Off In Vitro Diagnost & Radiol Hlth, Ctr Devices & Radiol Hlth, Dept Hlth & Human Serv, Silver Spring, MD 20993 USA.
[Oberg, Ann L.] Mayo Clin, Dept Hlth Sci Res, Div Biomed Stat & Informat, Rochester, MN 55905 USA.
[Barnes, Grady] Fujirebio Diagnost Inc, Malvern, PA 19355 USA.
[Gail, Mitchell] NCI, Div Canc Epidemiol & Genet, NIH, Dept Hlth & Human Serv, Bethesda, MD 20892 USA.
[Mesri, Mehdi; Kinsinger, Christopher R.; Rodriguez, Henry; Boja, Emily S.] NCI, Off Canc Clin Prote Res, Ctr Strateg Sci Initiat, NIH,Dept Hlth & Human Serv, Bethesda, MD 20892 USA.
RP Skates, SJ (reprint author), Massachusetts Gen Hosp, 50 Staniford St,Suite 560, Boston, MA 02114 USA.
EM sskates@partners.org; bojae@mail.nih.gov
OI Liebler, Daniel/0000-0002-7873-3031
FU National Cancer Institute of the National Institutes of Health through
the Clinical Proteomic Tumor Analysis Consortium (CPTAC) [10XS136,
U24CA160034]; Early Detection Research Network [U01CAI52990]; Mayo
Clinic Specialized Program in Research Excellence [P50CA136393]
FX Research reported in this publication was supported by the National
Cancer Institute of the National Institutes of Health under grants and
contracts through the Clinical Proteomic Tumor Analysis Consortium
(CPTAC) program (10XS136 SJS, U24CA160034 SAC, MAG), the Early Detection
Research Network (U01CAI52990 SJS), and Mayo Clinic Specialized Program
in Research Excellence grant (P50CA136393 AO).
NR 29
TC 32
Z9 32
U1 2
U2 18
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 1535-3893
EI 1535-3907
J9 J PROTEOME RES
JI J. Proteome Res.
PD DEC
PY 2013
VL 12
IS 12
BP 5383
EP 5394
DI 10.1021/pr400132j
PG 12
WC Biochemical Research Methods
SC Biochemistry & Molecular Biology
GA 269HD
UT WOS:000328231300004
PM 24063748
ER
PT J
AU de las Heras, H
Minniti, R
Wilson, S
Mitchell, C
Skopec, M
Brunner, CC
Chakrabarti, K
AF de las Heras, Hugo
Minniti, Ronaldo
Wilson, Sean
Mitchell, Chad
Skopec, Marlene
Brunner, Claudia C.
Chakrabarti, Kish
TI Experimental estimates of peak skin dose and its relationship to the CT
dose index using the CTDI head phantom
SO RADIATION PROTECTION DOSIMETRY
LA English
DT Article
ID PERFUSION COMPUTED-TOMOGRAPHY; RADIOCHROMIC FILM; CORONARY-ANGIOGRAPHY;
ENERGY-DEPENDENCE; DOSIMETRY; SIMULATIONS; SCANNER; PATIENT
AB A straightforward method is presented to estimate peak skin doses (PSDs) delivered by computed tomography (CT) scanners. The measured PSD values are related to the well-known volume CT dose index (CTDIvol), displayed on the console of CT scanners. PSD measurement estimates were obtained, in four CT units, by placing radiochromic film on the surface of a CTDI head phantom. Six different X-ray tube currents including the maximum allowed value were used to irradiate the phantom. PSD and CTDIvol were independently measured and later related to the CTDIvol value displayed on the console. A scanner-specific relationship was found between the measured PSD and the associated CTDIvol displayed on the console. The measured PSD values varied between 27 and 136 mGy among all scanners when the routine head scan parameters were used. The results of this work allow relating the widely used CTDIvol to an actual radiation dose delivered to the skin of a patient.
C1 [de las Heras, Hugo; Brunner, Claudia C.; Chakrabarti, Kish] US FDA, Silver Spring, MD 20993 USA.
[Minniti, Ronaldo] NIST, Gaithersburg, MD 20899 USA.
[Wilson, Sean; Mitchell, Chad] Walter Reed Natl Mil Med Ctr, Bethesda, MD 20889 USA.
[Skopec, Marlene] NIH, Bethesda, MD 20892 USA.
RP de las Heras, H (reprint author), US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM hugo.heras@daad-alumni.de
OI de las Heras, Hugo/0000-0003-3227-0032
FU Critical Path Project of FDA
FX Kish Chakrabarti acknowledges funding from Critical Path Project of FDA,
which enabled him to fund H.H. and C.B. for this work.
NR 40
TC 0
Z9 0
U1 0
U2 3
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0144-8420
EI 1742-3406
J9 RADIAT PROT DOSIM
JI Radiat. Prot. Dosim.
PD DEC
PY 2013
VL 157
IS 4
BP 536
EP 542
DI 10.1093/rpd/nct171
PG 7
WC Environmental Sciences; Public, Environmental & Occupational Health;
Nuclear Science & Technology; Radiology, Nuclear Medicine & Medical
Imaging
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Nuclear Science & Technology; Radiology, Nuclear Medicine &
Medical Imaging
GA 271FI
UT WOS:000328376600008
PM 23864642
ER
PT J
AU Menis, M
Sridhar, G
Selvam, N
Ovanesov, MV
Divan, HA
Liang, YD
Scott, D
Golding, B
Forshee, R
Ball, R
Anderson, SA
Izurieta, HS
AF Menis, Mikhail
Sridhar, Gayathri
Selvam, Nandini
Ovanesov, Mikhail V.
Divan, Hozefa A.
Liang, Yideng
Scott, Dorothy
Golding, Basil
Forshee, Richard
Ball, Robert
Anderson, Steven A.
Izurieta, Hector S.
TI Hyperimmune globulins and same-day thrombotic adverse events as recorded
in a large healthcare database during 2008-2011
SO AMERICAN JOURNAL OF HEMATOLOGY
LA English
DT Article
ID FACTOR-VIII GENE; SENSITIVE GEL-ELECTROPHORESIS; SEVERE HEMOPHILIA-A;
LABORATORY NETWORK; MOLECULAR ANALYSIS; FACTOR-IX; MUTATION; POPULATION;
INHIBITOR; MLPA
AB Thrombotic events (TEs) are rare serious complications following administration of hyperimmune globulin (HIG) products. Our retrospective claims-based study assessed occurrence of same-day TEs following administration of HIGs during 2008-2011 and examined potential risk factors using HealthCore's Integrated Research Database (HIRDSM) and laboratory testing of products' procoagulant Factor XIa activity by U. S. Food and Drug Administration. Multivariable regression was used to estimate same-day TE risk for different products. Of 101,956 individuals exposed to 23 different HIG product groups, 86 (0.84 per 1,000 persons) had a TE diagnosis code (DC) recorded on the same day as HIG administration. Unadjusted same-day TE DC rates (per 1,000 persons) ranged from 0.4 to 148.9 for different products. GamaSTAN S/D IG > 10 cc had statistically significantly higher same-day TE DC risk compared to Tetanus IG (OR=57.57; 95% CI=19.72-168.10). Increased TE risk was also observed with older age (>= 45 years), prior thrombotic events, and hypercoagulable state(s). Laboratory investigation identified elevated Factor XIa activity for GamaSTAN S/D, HepaGam B, HyperHep B S/D, WinRho SDF, HyperRHO S/D full dose, and HyperTET S/D. Our study, for the first time, identified increase in the same-day TE DC risk with GamaSTAN S/D IG > 10 cc and suggests potentially elevated TE risk with other HIGs. Am. J. Hematol. 88: 1035-1040, 2013. (C) 2013 Wiley Periodicals, Inc.
C1 [Menis, Mikhail; Ovanesov, Mikhail V.; Liang, Yideng; Scott, Dorothy; Golding, Basil; Forshee, Richard; Ball, Robert; Anderson, Steven A.; Izurieta, Hector S.] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Sridhar, Gayathri; Selvam, Nandini; Divan, Hozefa A.] HealthCore Inc, Alexandria, VA 22311 USA.
RP Sridhar, G (reprint author), HealthCore Inc, 2001 N Beauregard St,Suite 500, Alexandria, VA 22311 USA.
EM gsridhar@healthcore.com
FU U.S. Food and Drug Administration, Center for Biologics Evaluation and
Research
FX Contract grant sponsor: U.S. Food and Drug Administration, Center for
Biologics Evaluation and Research.
NR 31
TC 12
Z9 12
U1 0
U2 0
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0361-8609
EI 1096-8652
J9 AM J HEMATOL
JI Am. J. Hematol.
PD DEC
PY 2013
VL 88
IS 12
BP 1035
EP 1040
DI 10.1002/ajh.23559
PG 6
WC Hematology
SC Hematology
GA 255FE
UT WOS:000327224000131
PM 23907744
ER
PT J
AU Xiao, R
Perveen, Z
Rouse, RL
Le Donne, V
Paulsen, DB
Ambalavanan, N
Penn, AL
AF Xiao, Rui
Perveen, Zakia
Rouse, Rodney L.
Le Donne, Viviana
Paulsen, Daniel B.
Ambalavanan, Namasivayam
Penn, Arthur L.
TI In Utero Exposure to Second-Hand Smoke Aggravates the Response to
Ovalbumin in Adult Mice
SO AMERICAN JOURNAL OF RESPIRATORY CELL AND MOLECULAR BIOLOGY
LA English
DT Article
DE second-hand smoke; in utero exposure; mouse asthma model; inflammation;
gene regulation
ID CIGARETTE-SMOKE; ALLERGIC-ASTHMA; AIRWAY RESPONSIVENESS; PRENATAL
EXPOSURE; MOUSE MODELS; INFLAMMATION; EXPRESSION; DISEASE; LUNG;
PLETHYSMOGRAPHY
AB Second-hand smoke (SHS) exposure in utero exacerbates adult responses to environmental irritants. We tested the hypothesis that effects of in utero SHS exposure on modulating physiological and transcriptome responses in BALB/c mouse lungs after ovalbumin (OVA) challenge extend well into adulthood, and that the responses show a sex bias. We exposed BALB/c mice in utero to SHS or filtered air (AIR), then sensitized and challenged all offspring with OVA from 19 to 23 weeks of age. At the end of the adult OVA challenge, we evaluated pulmonary function, examined histopathology, analyzed bronchoalveolar lavage fluid (BALF), and assessed gene expression changes in the lung samples. All groups exhibited lung inflammation and inflammatory cell infiltration. Pulmonary function testing (airway hyperresponsiveness [AHR], breathing frequency [f]) and BALF (cell differentials, Th1/Th2 cytokines) assessments showed significantly more pronounced lung responses in the SHS-OVA groups than in AIR-OVA groups (AHR, f; eosinophils, neutrophils; IFN-gamma, IL-1 beta, IL-4, IL-5, IL-10, IL-13, KC/CXCL1, TNF-alpha), with the majority of responses being more pronounced in males than in females. SHS exposure in utero also significantly altered lung gene expression profiles, primarily of genes associated with inflammatory responses and respiratory diseases, including lung cancer and lung fibrosis. Altered expression profiles of chemokines (Cxcl2, Cxcl5, Ccl8, Ccl24), cytokines (Il1b, Il6, Il13) and acute phase response genes (Saa1, Saa3) were confirmed by qRT-PCR. In conclusion, in utero exposure to SHS exacerbates adult lung responses to OVA challenge and promotes a pro-asthmatic milieu in adult lungs; further, males are generally more affected by SHS-OVA than are females.
C1 [Xiao, Rui; Perveen, Zakia; Penn, Arthur L.] Louisiana State Univ, Sch Vet Med, Dept Comparat Biomed Sci, Baton Rouge, LA 70803 USA.
[Le Donne, Viviana; Paulsen, Daniel B.] Louisiana State Univ, Sch Vet Med, Dept Pathobiol Sci, Baton Rouge, LA 70803 USA.
[Rouse, Rodney L.] US FDA, Silver Spring, MD USA.
[Ambalavanan, Namasivayam] Univ Alabama Birmingham, Dept Pediat, Birmingham, AL USA.
RP Penn, AL (reprint author), Room 2425 LSU SVM,Skip Bertman Dr, Baton Rouge, LA 70803 USA.
EM apenn@vetmed.lsu.edu
OI Xiao, Rui/0000-0001-8679-9551; Ambalavanan,
Namasivayam/0000-0003-0731-9092
FU Louisiana Governor's Biotechnology Initiative; National Institutes of
Health [HL092906]
FX This research was supported by the Louisiana Governor's Biotechnology
Initiative (A.L.P.) and National Institutes of Health grant HL092906
(N.A.).
NR 37
TC 1
Z9 1
U1 0
U2 8
PU AMER THORACIC SOC
PI NEW YORK
PA 61 BROADWAY, FL 4, NEW YORK, NY 10006 USA
SN 1044-1549
EI 1535-4989
J9 AM J RESP CELL MOL
JI Am. J. Respir. Cell Mol. Biol.
PD DEC
PY 2013
VL 49
IS 6
BP 1102
EP 1109
DI 10.1165/rcmb.2013-0164OC
PG 8
WC Biochemistry & Molecular Biology; Cell Biology; Respiratory System
SC Biochemistry & Molecular Biology; Cell Biology; Respiratory System
GA 269SI
UT WOS:000328261800025
PM 23898987
ER
PT J
AU Ramachandran, P
Lacher, DW
Pfeiler, EA
Elkins, CA
AF Ramachandran, Padmini
Lacher, David W.
Pfeiler, Erika A.
Elkins, Christopher A.
TI Development of a Tiered Multilocus Sequence Typing Scheme for Members of
the Lactobacillus acidophilus Complex
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID FRAGMENT LENGTH POLYMORPHISM; ET-AL 1980; PROBIOTIC LACTOBACILLI;
SPECIES IDENTIFICATION; GENOME SEQUENCE; RAPD-PCR; SP-NOV; STRAIN;
JOHNSONII; RECOMBINATION
AB Members of the Lactobacillus acidophilus complex are associated with functional foods and dietary supplements because of purported health benefits they impart to the consumer. Many characteristics of these microorganisms are reported to be strain specific. Therefore, proper strain typing is essential for safety assessment and product labeling, and also for monitoring strain integrity for industrial production purposes. Fifty-two strains of the L. acidophilus complex (L. acidophilus, L. amylovorus, L. crispatus, L. gallinarum, L. gasseri, and L. johnsonii) were genotyped using two established methods and compared to a novel multilocus sequence typing (MLST) scheme. PCR restriction fragment length polymorphism (PCR-RFLP) analysis of the hsp60 gene with AluI and TaqI successfully clustered 51 of the 52 strains into the six species examined, but it lacked strain-level discrimination. Random amplified polymorphic DNA PCR (RAPD-PCR) targeting the M13 sequence resulted in highly discriminatory profiles but lacked reproducibility. In this study, an MLST scheme was developed using the conserved housekeeping genes fusA, gpmA, gyrA, gyrB, lepA, pyrG, and recA, which identified 40 sequence types that successfully clustered all of the strains into the six species. Analysis of the observed alleles suggests that nucleotide substitutions within five of the seven MLST loci have reached saturation, a finding that emphasizes the highly diverse nature of the L. acidophilus complex and our unconventional application of a typically intraspecies molecular typing tool. Our MLST results indicate that this method could be useful for characterization and strain discrimination of a multispecies complex, with the potential for taxonomic expansion to a broader collection of Lactobacillus species.
C1 [Ramachandran, Padmini; Lacher, David W.; Pfeiler, Erika A.; Elkins, Christopher A.] US FDA, Div Mol Biol, CFSAN, Laurel, MD 20708 USA.
RP Elkins, CA (reprint author), US FDA, Div Mol Biol, CFSAN, Laurel, MD 20708 USA.
EM chris.elkins@fda.hhs.gov
FU Food Safety and Applied Nutrition; FDA Commissioner's Fellowship
Program; Oak Ridge Institute for Science and Education
FX This study was funded by the Center for Food Safety and Applied
Nutrition. Additional support for this project was provided by the FDA
Commissioner's Fellowship Program and the Oak Ridge Institute for
Science and Education.
NR 33
TC 5
Z9 5
U1 0
U2 13
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
EI 1098-5336
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD DEC
PY 2013
VL 79
IS 23
BP 7220
EP 7228
DI 10.1128/AEM.02257-13
PG 9
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 259RT
UT WOS:000327544700012
PM 24038697
ER
PT J
AU Smith, SM
Wang, AT
Pereira, A
Chang, RD
McKeown, A
Greene, K
Rowbotham, MC
Burke, LB
Coplan, P
Gilron, I
Hertz, SH
Katz, NP
Lin, AH
McDermott, MP
Papadopoulos, EJ
Rappaport, BA
Sweeney, M
Turk, DC
Dworkin, RH
AF Smith, Shannon M.
Wang, Anthony T.
Pereira, Anthony
Chang, R. Daniel
McKeown, Andrew
Greene, Kaitlin
Rowbotham, Michael C.
Burke, Laurie B.
Coplan, Paul
Gilron, Ian
Hertz, Sharon H.
Katz, Nathaniel P.
Lin, Allison H.
McDermott, Michael P.
Papadopoulos, Elektra J.
Rappaport, Bob A.
Sweeney, Michael
Turk, Dennis C.
Dworkin, Robert H.
TI Discrepancies between registered and published primary outcome
specifications in analgesic trials: ACTTION systematic review and
recommendations
SO PAIN
LA English
DT Review
DE Analgesic medications; Clinical trials; Primary outcomes; Registry;
Systematic review
ID CLINICAL-TRIALS; REPORTING BIAS; DRUG TRIALS; EMPIRICAL-EVIDENCE;
RANDOMIZED-TRIALS; CHRONIC PAIN; PUBLICATION; CLINICALTRIALS.GOV;
REGISTRATION; PROTOCOLS
AB The National Institutes of Health released the trial registry Clinical Trials. gov in 2000 to increase public reporting and clinical trial transparency. This systematic review examined whether registered primary outcome specifications (POS; ie, definitions, timing, and analytic plans) in analgesic treatment trials correspond with published POS. Trials with accompanying publications (n = 87) were selected from the Repository of Registered Analgesic Clinical Trials (RReACT) database of all postherpetic neuralgia, diabetic peripheral neuropathy, and fibromyalgia clinical trials registered at Clinical Trials. gov as of December 1, 2011. POS never matched precisely; discrepancies occurred in 79% of the registry-publication pairs (21% failed to register or publish primary outcomes [PO]). These percentages did not differ significantly between industry and non-industry-sponsored trials. Thirty percent of the trials contained unambiguous POS discrepancies (eg, omitting a registered PO from the publication, "demoting'' a registered PO to a published secondary outcome), with a statistically significantly higher percentage of non-industry-sponsored than industry-sponsored trials containing unambiguous POS discrepancies. POS discrepancies due to ambiguous reporting included vaguely worded PO registration; or failing to report the timing of PO assessment, statistical analysis used for the PO, or method to address missing PO data. At best, POS discrepancies may be attributable to insufficient registry requirements, carelessness (eg, failing to report PO assessment timing), or difficulty uploading registry information. At worst, discrepancies could indicate investigator impropriety (eg, registering imprecise PO ["pain''], then publishing whichever pain assessment produced statistically significant results). Improvements in PO registration, as well as journal policies requiring consistency between registered and published PO descriptions, are needed. (C) 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
C1 [Smith, Shannon M.; Pereira, Anthony; Chang, R. Daniel; McKeown, Andrew] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Rochester, NY 14627 USA.
[Wang, Anthony T.] Case Western Reserve Univ, Sch Med, Cleveland, OH USA.
[Greene, Kaitlin; Rowbotham, Michael C.] Calif Pacific Med Ctr, Res Inst, San Francisco, CA USA.
[Burke, Laurie B.; Hertz, Sharon H.; Lin, Allison H.; Papadopoulos, Elektra J.; Rappaport, Bob A.] US FDA, Silver Spring, MD USA.
[Coplan, Paul] Purdue Pharma LP, Stamford, CT USA.
[Coplan, Paul] Univ Penn, Philadelphia, PA 19104 USA.
[Gilron, Ian] Queens Univ, Dept Anesthesiol & Perioperat Med, Kingston, ON, Canada.
[Gilron, Ian] Queens Univ, Dept Biomed & Mol Sci, Kingston, ON, Canada.
[Katz, Nathaniel P.] Analges Solut, Natick, MA USA.
[Katz, Nathaniel P.] Tufts Univ, Boston, MA 02111 USA.
[McDermott, Michael P.] Univ Rochester, Sch Med & Dent, Dept Biostat & Computat Biol, Rochester, NY USA.
[McDermott, Michael P.; Dworkin, Robert H.] Univ Rochester, Sch Med & Dent, Dept Neurol, Rochester, NY 14642 USA.
[Sweeney, Michael] Depomed, Newark, CA USA.
[Turk, Dennis C.] Univ Washington, Dept Anesthesiol & Pain Med, Seattle, WA 98195 USA.
[Dworkin, Robert H.] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Rochester, NY USA.
[Dworkin, Robert H.] Univ Rochester, Sch Med & Dent, Ctr Human Expt Therapeut, Rochester, NY USA.
RP Smith, SM (reprint author), Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Rochester, NY 14627 USA.
EM shannon1_smith@urmc.rochester.edu
OI Coplan, Paul/0000-0002-7078-7780
FU ACTTION; FDA; Astellas; Bristol-Myers Squibb; Collegium; Depomed; Eli
Lilly; Horizon; Jazz; Johnson Johnson; Mallinckrodt; Pfizer; Purdue;
Zalicus
FX The authors report no conflict of interest. The views expressed in this
article are those of the authors and no official endorsement by the U.S.
Food and Drug Administration (FDA) or the pharmaceutical companies that
provided unrestricted grants to support the activities of the ACTTION
public-private partnership should be inferred. Financial support for
this project was provided by the ACTTION public-private partnership,
which has received research contracts, grants, or other revenue from the
FDA, Astellas, Bristol-Myers Squibb, Collegium, Depomed, Eli Lilly,
Horizon, Jazz, Johnson & Johnson, Mallinckrodt, Pfizer, Purdue, Zalicus,
and other sources.
NR 40
TC 11
Z9 11
U1 0
U2 4
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0304-3959
EI 1872-6623
J9 PAIN
JI Pain
PD DEC
PY 2013
VL 154
IS 12
BP 2769
EP 2774
DI 10.1016/j.pain.2013.08.011
PG 6
WC Anesthesiology; Clinical Neurology; Neurosciences
SC Anesthesiology; Neurosciences & Neurology
GA 260LK
UT WOS:000327596200028
PM 23962590
ER
PT J
AU Rubin, C
Myers, T
Stokes, W
Dunham, B
Harris, S
Lautner, B
Annelli, J
AF Rubin, Carol
Myers, Tanya
Stokes, William
Dunham, Bernadette
Harris, Stic
Lautner, Beth
Annelli, Joseph
TI Review of Institute of Medicine and National Research Council
Recommendations for One Health Initiative
SO EMERGING INFECTIOUS DISEASES
LA English
DT Article
AB Human health is inextricably linked to the health of animals and the viability of ecosystems; this is a concept commonly known as One Health. Over the last 2 decades, the Institute of Medicine (IOM) and the National Research Council (NRC) have published consensus reports and workshop summaries addressing a variety of threats to animal, human, and ecosystem health. We reviewed a selection of these publications and identified recommendations from NRC and IOM/NRC consensus reports and from opinions expressed in workshop summaries that are relevant to implementation of the One Health paradigm shift. We grouped these recommendations and opinions into thematic categories to determine if sufficient attention has been given to various aspects of One Health. We conclude that although One Health themes have been included throughout numerous IOM and NRC publications, identified gaps remain that may warrant targeted studies related to the One Health approach.
C1 [Rubin, Carol; Myers, Tanya] Ctr Dis Control & Prevent, Atlanta, GA 30333 USA.
[Stokes, William] NIEHS, Res Triangle Pk, NC 27709 USA.
[Dunham, Bernadette] US FDA, Rockville, MD 20857 USA.
[Harris, Stic] Dept Homeland Secur, Washington, DC USA.
[Lautner, Beth] USDA, Des Moines, IA USA.
[Annelli, Joseph] USDA, Riverdale, MD USA.
RP Rubin, C (reprint author), Ctr Dis Control & Prevent, 1600 Clifton Rd NE,Mailstop A30, Atlanta, GA 30333 USA.
EM crubin@cdc.gov
NR 29
TC 6
Z9 6
U1 1
U2 10
PU CENTERS DISEASE CONTROL
PI ATLANTA
PA 1600 CLIFTON RD, ATLANTA, GA 30333 USA
SN 1080-6040
EI 1080-6059
J9 EMERG INFECT DIS
JI Emerg. Infect. Dis
PD DEC
PY 2013
VL 19
IS 12
BP 1913
EP 1917
DI 10.3201/eid1912.121659
PG 5
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 263RV
UT WOS:000327826600001
PM 24274461
ER
PT J
AU Galeotti, L
van Dam, PM
Loring, Z
Chan, D
Strauss, DG
AF Galeotti, Loriano
van Dam, Peter M.
Loring, Zak
Chan, Dulciana
Strauss, David G.
TI Evaluating strict and conventional left bundle branch block criteria
using electrocardiographic simulations
SO EUROPACE
LA English
DT Article
DE Left bundle branch block; Cardiac resynchronization therapy;
Electrocardiography; Simulations
ID CARDIAC RESYNCHRONIZATION THERAPY; HEART RHYTHM SOCIETY; CONDUCTION
DISTURBANCES; VENTRICULAR ACTIVATION; CLINICAL-CARDIOLOGY;
OF-CARDIOLOGY; QRS DURATION; FAILURE; REPOLARIZATION; PREDICT
AB Left bundle branch block (LBBB) is a critical predictor of patient benefit from cardiac resynchronization therapy (CRT), but recent studies suggest that one-third of patients diagnosed with LBBB by conventional electrocardiographic (ECG) criteria may have a false-positive diagnosis. In this study, we tested the hypothesis that recently proposed strict LBBB ECG criteria improve specificity in cases of left ventricular hypertrophy (LVH) /dilatation and incomplete LBBB.
We developed five heart models based on a healthy male with increasing degrees of LV hypertrophy and/or dilation. With each model, we simulated six conduction types: normal conduction, four increments of delayed initiation of LV activation (incomplete LBBB), and complete LBBB. Simulated ECGs were evaluated for the presence of LBBB by conventional (LV conduction delay and QRSd 120 ms) and strict ECG criteria (LV conduction delay, QRSd 140 ms men or 130 ms women, and mid-QRS notching in at least two of the leads I, aVL, V1, V2, V5, and/or V6). Both conventional and strict LBBB criteria had 100 sensitivity. However, conventional criteria falsely diagnosed LBBB in cases with LVH LV dilated 10 mm, LVH or LV dilated 10 mm combined with LV initiation 6 ms after the right ventricle (RV), and with LV dilated 5 mm combined with LV initiation 12 ms after RV (48 specificity). Strict LBBB criteria resulted in no false positives (100 specificity).
New strict LBBB criteria increase the specificity of complete LBBB diagnosis in the presence of LV hypertrophy/dilatation and incomplete LBBB, which is critical for selecting CRT patients.
C1 [Galeotti, Loriano; Loring, Zak; Chan, Dulciana; Strauss, David G.] US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[van Dam, Peter M.] Radboud Univ Nijmegen, Med Ctr, NL-6525 EZ Nijmegen, Netherlands.
[Loring, Zak] Duke Univ, Sch Med, Durham, NC 27710 USA.
RP Strauss, DG (reprint author), 10903 New Hampshire Ave,WO62 1126, Silver Spring, MD 20993 USA.
EM David.Strauss@fda.hhs.gov
RI GALEOTTI, LORIANO/N-4240-2014
OI GALEOTTI, LORIANO/0000-0002-3200-9080
FU FDA Critical Path Initiative Grant; U.S. Department of Energy; U.S. Food
and Drug Administration
FX This work was supported by an FDA Critical Path Initiative Grant and in
part by an appointment to the Research Participation Program at the
Center for Devices and Radiological Health administered by the Oak Ridge
Institute for Science and Education through an interagency agreement
between the U.S. Department of Energy and the U.S. Food and Drug
Administration.
NR 36
TC 13
Z9 15
U1 3
U2 10
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1099-5129
EI 1532-2092
J9 EUROPACE
JI Europace
PD DEC
PY 2013
VL 15
IS 12
BP 1816
EP 1821
DI 10.1093/europace/eut132
PG 6
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 262KK
UT WOS:000327733700027
PM 23703366
ER
PT J
AU El Fiky, A
Perreault, R
McGinnis, GJ
Rabin, RL
AF El Fiky, Ashraf
Perreault, Roger
McGinnis, Gwendolyn J.
Rabin, Ronald L.
TI Attenuated expression of interferon-beta and interferon-lambda l by
human alternatively activated macrophages
SO HUMAN IMMUNOLOGY
LA English
DT Article
ID DENGUE VIRUS-INFECTION; LEUKEMIA-CELL LINE; ASTHMA EXACERBATIONS;
SIGNAL-TRANSDUCTION; IFN-ALPHA; DIFFERENTIATION; RHINOVIRUS; DEFICIENT;
THP-1; IL-4R-ALPHA
AB Macrophages can be polarized into classically (CAM) or alternatively (MM) activated macrophages with IFN-gamma or IL-4, respectively. CAM are associated with type 1 immune responses and are implicated in autoimmunity; AAM are associated with type 2 responses and are implicated in allergic diseases. An impediment in investigating macrophage biology using primary human monocyte derived macrophages is the wide inter-donor heterogeneity and the limited quantity of cells that survive in vitro polarization. To overcome this impediment, we established a protocol to generate CAM and AAM cultures derived from the THP-1 human promonocytic cell line. In this report, we demonstrate that THP-CAM and -AMM express gene and protein markers that define their primary human monocyte derived counterparts, such as IL-1 beta, CXCL10, and CXCL11 for CAM, and MRC1, IL-4 and CCL22 for AMM. In addition, we demonstrate that STAT6 is selectively activated in THP-AMM which, upon LPS stimulation, have an attenuated or delayed expression of IFN-beta, IFN-lambda 1, and IFN alpha/beta pathway genes compared to their CAM counterparts. Taken together, these findings may help further investigate human diseases associated with the alternatively activated macrophage phenotype using this reproducible in vitro macrophage model. (C) 2013 Published by Elsevier Inc. on behalf of American Society for Histocompatibility and Immunogenetics.
C1 [El Fiky, Ashraf; Perreault, Roger; McGinnis, Gwendolyn J.; Rabin, Ronald L.] US FDA, Ctr Biol Evaluat & Res, Lab Immunobiochem, Div Bacterial Parasit & Allergen Prod,Off Vaccine, Bethesda, MD 20892 USA.
RP Rabin, RL (reprint author), US FDA, Ctr Biol Evaluat & Res, Lab Immunobiochem, Div Bacterial Parasit & Allergen Prod,Off Vaccine, Bldg 29,Room 203A,29 Lincoln Dr MSC 4555, Bethesda, MD 20892 USA.
EM ronald.rabin@fda.hhs.gov
FU Oak Ridge Institute for Science and Education (ORISE); FDA medical
countermeasure initiative (McMi)
FX This work was supported by funding from the Oak Ridge Institute for
Science and Education (ORISE) and the FDA medical countermeasure
initiative (McMi). We thank Jennifer Reed for critical review of this
manuscript.
NR 33
TC 5
Z9 5
U1 1
U2 10
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0198-8859
EI 1879-1166
J9 HUM IMMUNOL
JI Hum. Immunol.
PD DEC
PY 2013
VL 74
IS 12
BP 1524
EP 1530
DI 10.1016/j.humimm.2013.08.267
PG 7
WC Immunology
SC Immunology
GA 266HN
UT WOS:000328014800005
PM 23993990
ER
PT J
AU Foley, SL
Johnson, TJ
Ricke, SC
Nayak, R
Danzeisen, J
AF Foley, Steven L.
Johnson, Timothy J.
Ricke, Steven C.
Nayak, Rajesh
Danzeisen, Jessica
TI Salmonella Pathogenicity and Host Adaptation in Chicken-Associated
Serovars
SO MICROBIOLOGY AND MOLECULAR BIOLOGY REVIEWS
LA English
DT Review
ID CHAIN FATTY-ACIDS; ENTERICA SEROTYPE TYPHIMURIUM; III SECRETION SYSTEM;
INTESTINAL EPITHELIAL-CELLS; GENOMIC ISLAND 1; ANTIBIOTIC-RESISTANCE
REGION; GRADIENT GEL-ELECTROPHORESIS; COMPLETE NUCLEOTIDE-SEQUENCE;
FIBRONECTIN-BINDING PROTEIN; INTRACELLULAR GROWTH-RATE
AB Enteric pathogens such as Salmonella enterica cause significant morbidity and mortality. S. enterica serovars are a diverse group of pathogens that have evolved to survive in a wide range of environments and across multiple hosts. S. enterica serovars such as S. Typhi, S. Dublin, and S. Gallinarum have a restricted host range, in which they are typically associated with one or a few host species, while S. Enteritidis and S. Typhimurium have broad host ranges. This review examines how S. enterica has evolved through adaptation to different host environments, especially as related to the chicken host, and continues to be an important human pathogen. Several factors impact host range, and these include the acquisition of genes via horizontal gene transfer with plasmids, transposons, and phages, which can potentially expand host range, and the loss of genes or their function, which would reduce the range of hosts that the organism can infect. S. Gallinarum, with a limited host range, has a large number of pseudogenes in its genome compared to broader-host-range serovars. S. enterica serovars such as S. Kentucky and S. Heidelberg also often have plasmids that may help them colonize poultry more efficiently. The ability to colonize different hosts also involves interactions with the host's immune system and commensal organisms that are present. Thus, the factors that impact the ability of Salmonella to colonize a particular host species, such as chickens, are complex and multifactorial, involving the host, the pathogen, and extrinsic pressures. It is the interplay of these factors which leads to the differences in host ranges that we observe today.
C1 [Foley, Steven L.; Nayak, Rajesh] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR USA.
[Johnson, Timothy J.; Danzeisen, Jessica] Univ Minnesota, Dept Vet & Biomed Sci, St Paul, MN 55108 USA.
[Ricke, Steven C.] Univ Arkansas, Ctr Food Safety & Dept Food Sci, Fayetteville, AR 72701 USA.
RP Foley, SL (reprint author), US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR USA.
EM steven.foley@fda.hhs.gov
NR 403
TC 24
Z9 27
U1 7
U2 48
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 1092-2172
EI 1098-5557
J9 MICROBIOL MOL BIOL R
JI Microbiol. Mol. Biol. Rev.
PD DEC
PY 2013
VL 77
IS 4
BP 582
EP 607
DI 10.1128/MMBR.00015-13
PG 26
WC Microbiology
SC Microbiology
GA 265IR
UT WOS:000327945100004
PM 24296573
ER
PT J
AU Kachko, A
Loesgen, S
Shahzad-ul-Hussan, S
Tan, W
Zubkova, I
Takeda, K
Wells, F
Rubin, S
Bewley, CA
Major, ME
AF Kachko, Alla
Loesgen, Sandra
Shahzad-ul-Hussan, Syed
Tan, Wendy
Zubkova, Iryna
Takeda, Kazuyo
Wells, Frances
Rubin, Steven
Bewley, Carole A.
Major, Marian E.
TI Inhibition of Hepatitis C Virus by the Cyanobacterial Protein
Microcystis viridis Lectin: Mechanistic Differences between the
High-Mannose Specific Lectins MVL, CV-N, and GNA
SO MOLECULAR PHARMACEUTICS
LA English
DT Article
DE hepatitis C; antiviral lectin; HCV entry inhibitor; cyanovirin-N (CV-N);
HCVcc; biolayer interferometry
ID HUMAN-IMMUNODEFICIENCY-VIRUS; CARBOHYDRATE-BINDING AGENTS; REVEALS
EXTENDED MICROHETEROGENEITY; HIGH-AFFINITY BINDING; ANTI-HIV ACTIVITY;
CYANOVIRIN-N; ENVELOPE GLYCOPROTEINS; GALANTHUS-NIVALIS;
IMMUNE-RESPONSES; STRUCTURAL BASIS
AB Plant or microbial lectins are known to exhibit potent antiviral activities against viruses with glycosylated surface proteins, yet the mechanism(s) by which these carbohydrate-binding proteins exert their antiviral activities is not fully understood. Hepatitis C virus (HCV) is known to possess glycosylated envelope proteins (gpE1E2) and to be potently inhibited by lectins. Here, we tested in detail the antiviral properties of the newly discovered Microcystis viridis lectin (MVL) along with cyanovirin-N (CV-N) and Galanthus nivalis agglutinin (GNA) against cell culture HCV, as well as their binding properties toward viral particles, target cells, and recombinant HCV glycoproteins. Using infectivity assays, CV-N, MVL, and GNA inhibited HCV with IC50 values of 0.6 nM, 30.4 nM, and 11.1 nM, respectively. Biolayer interferometry analysis demonstrated a higher affinity of GNA to immobilized recombinant HCV glycoproteins compared to CV-N and MVL. Complementary studies, including fluorescence-activated cell sorting (FACS) analysis, confocal microscopy, and pre- and post-virus binding assays, showed a complex mechanism of inhibition for CV-N and MVL that includes both viral and cell association, while GNA functions by binding directly to the viral particle. Combinations of GNA with CV-N or MVL in HCV infection studies revealed synergistic inhibitory effects, which can be explained by different glycan recognition profiles of the mainly high-mannoside specific lectins, and supports the hypothesis that these lectins inhibit through different and complex modes of action. Our findings provide important insights into the mechanisms by which lectins inhibit HCV infection. Overall, the data suggest MVL and CV-N have the potential for toxicity due to interactions with cellular proteins while GNA may be a better therapeutic agent due to specificity for the HCV gpE1E2.
C1 [Kachko, Alla; Tan, Wendy; Zubkova, Iryna; Wells, Frances; Major, Marian E.] US FDA, Ctr Biol Evaluat & Res, Lab Hepatitis Viruses, Div Viral Prod, Bethesda, MD 20892 USA.
[Takeda, Kazuyo] US FDA, Ctr Biol Evaluat & Res, Microscopy & Imaging Core Facil, Bethesda, MD 20892 USA.
[Rubin, Steven] US FDA, Ctr Biol Evaluat & Res, Lab Method Dev, Div Viral Prod, Bethesda, MD 20892 USA.
[Loesgen, Sandra; Shahzad-ul-Hussan, Syed; Bewley, Carole A.] NIAID, Bioorgan Chem Lab, Natl Inst Diabet & Digest & Kidney Dis, NIH, Bethesda, MD 20892 USA.
[Shahzad-ul-Hussan, Syed] NIAID, Vaccine Res Ctr, NIH, Bethesda, MD 20892 USA.
RP Major, ME (reprint author), US FDA, Ctr Biol Evaluat & Res, Lab Hepatitis Viruses, Div Viral Prod, Bethesda, MD 20892 USA.
EM Marian.Major@fda.hhs.gov
FU Food and Drug Administration Intramural Research Program; Intramural
Research Program, National Institutes of Health (NIDDK); Intramural AIDS
Targeted Antiviral Program, Office of the Director (CAB)
FX The authors thank Drs. Alain Debrabant and Rana Nagatkatti, Center for
Biologics Evaluation and Research, FDA, for the usage of their Octet red
96 system. This work was supported by Food and Drug Administration
Intramural Research Program, the Intramural Research Program, National
Institutes of Health (NIDDK), and the Intramural AIDS Targeted Antiviral
Program, Office of the Director (CAB).
NR 57
TC 6
Z9 6
U1 0
U2 4
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 1543-8384
J9 MOL PHARMACEUT
JI Mol. Pharm.
PD DEC
PY 2013
VL 10
IS 12
BP 4590
EP 4602
DI 10.1021/mp400399b
PG 13
WC Medicine, Research & Experimental; Pharmacology & Pharmacy
SC Research & Experimental Medicine; Pharmacology & Pharmacy
GA 263TS
UT WOS:000327831500019
PM 24152340
ER
PT J
AU Chalbot, MCG
da Costa, GG
Kavouras, IG
AF Chalbot, Marie-Cecile G.
da Costa, Goncalo Gamboa
Kavouras, Ilias G.
TI NMR Analysis of the Water-Soluble Fraction of Airborne Pollen Particles
SO APPLIED MAGNETIC RESONANCE
LA English
DT Article
ID MAGNETIC-RESONANCE-SPECTROSCOPY; ORGANIC AEROSOL; MATTER; SIMILARITY;
MIXTURES; H-1-NMR; IMAGES; FOREST; MODEL; GENE
AB The analysis of ambient organic aerosols by nuclear magnetic resonance (NMR) spectroscopy is limited because of the large number of organic compounds present at low concentrations. Here, we demonstrate the integrative analysis of NMR spectra of airborne pollen particles using reference spectra, spectral similarity metrics, principal components analysis (PCA), and a chemical mass balance model to determine the predominant types of organic compounds. Strong associations among glucose, fucose, specific amino acids, and airborne pollen particles were observed by spectral similarity metrics and PCA. Carbohydrates accounted for about 51 % of the airborne pollen particles in the spectrum followed by amino acids (42 %) and other compounds (7 %). Overall, our investigations showed that analysis of NMR spectral data of mixtures of environmental organic compounds with pattern recognition methods may generate information on the chemical characteristics of the mixture.
C1 [Chalbot, Marie-Cecile G.; Kavouras, Ilias G.] Univ Arkansas Med Sci, Dept Environm & Occupat Hlth, Little Rock, AR 72205 USA.
[da Costa, Goncalo Gamboa] US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Chalbot, MCG (reprint author), Univ Arkansas Med Sci, Dept Environm & Occupat Hlth, Little Rock, AR 72205 USA.
EM mchalbot@uams.edu
RI Kavouras, Ilias/H-7056-2012;
OI Kavouras, Ilias/0000-0003-0436-3784; Kavouras, Ilias/0000-0003-0342-5306
NR 38
TC 5
Z9 5
U1 1
U2 15
PU SPRINGER WIEN
PI WIEN
PA SACHSENPLATZ 4-6, PO BOX 89, A-1201 WIEN, AUSTRIA
SN 0937-9347
EI 1613-7507
J9 APPL MAGN RESON
JI Appl. Magn. Reson.
PD DEC
PY 2013
VL 44
IS 12
BP 1347
EP 1358
DI 10.1007/s00723-013-0492-4
PG 12
WC Physics, Atomic, Molecular & Chemical; Spectroscopy
SC Physics; Spectroscopy
GA 257QX
UT WOS:000327402000001
ER
PT J
AU Brinker, AD
Lyndly, J
Tonning, J
Moeny, D
Levine, JG
Avigan, MI
AF Brinker, Allen D.
Lyndly, Jenna
Tonning, Joseph
Moeny, David
Levine, Jonathan G.
Avigan, Mark I.
TI Profiling Cumulative Proportional Reporting Ratios of Drug-Induced Liver
Injury in the FDA Adverse Event Reporting System (FAERS) Database
SO DRUG SAFETY
LA English
DT Article
ID SEVERE HEPATOTOXICITY; HEPATIC-FAILURE; SAFETY; TRANSPLANTATION;
TELITHROMYCIN; CRITERIA
AB Background Early prediction and accurate characterization of risk for serious liver injury associated with newly marketed drugs remains an important challenge for clinicians, the pharmaceutical industry, and regulators. To date, a biomarker that specifically indicates exposure to a drug as the etiologic cause of liver injury has not been identified.
Objectives Using cumulative proportional reporting ratios (PRRs), we investigated 'real-time' profiles of a set of pharmaceuticals, over the first 3 years of US marketing, for the signaling of clinically serious drug-induced liver injury (DILI) in a large spontaneous-reporting database.
Methods Using report counts of hepatic failure or clinically serious liver injury obtained from the FDA Adverse Events Reporting System (FAERS) database, PRRs of adverse drug event terms were calculated by division of counts of domestic reports of these events by counts of all serious adverse events for each of 13 selected drugs associated with a broad range of hepatotoxic risk (including three linked to only rare instances of clinically apparent liver injury) with reference to all other drugs in the database. Drug-specific cumulative PRRs were measured at successive intervals (calendar quarters) using cumulative tallies of FAERS reports to generate time-based profiles over the initial 3 years of US marketing.
Results In the set of drugs analyzed, those with no known hepatotoxic risk demonstrated time-based cumulative PRR profiles that approximate the background rates of hepatic failure and serious liver injury reported in the entire FAERS database. In contrast, those that were removed from marketing or subjected to marketing restrictions due to their potential to cause liver injury were associated with profiles of rapidly rising cumulative PRRs that were greater than 5 within the first 10 million domestic prescriptions or the first four quarters of US marketing. The systematic tracking and identification of rising PRRs for DILI associated with newly marketed pharmaceutical and biological agents is a valuable tool for identification of safety signals within the FAERS database.
Limitations Disproportionality profiling of spontaneous reports in FAERS (e.g., cumulative PRR measurements), which signals an association between a recently marketed drug and liver injury, is not a method to quantitatively measure drug-related risk. Regulatory actions in response to emerging drug safety concerns often depend on an accurate assessment of risks using multiple sources of data and the consideration of overall benefits and risks of the agent. Causality must be determined through analysis of individual cases to exclude other etiologies of liver injury.
Conclusion The FAERS database can be used to advance empiric hepatotoxicity time-trending reporting levels for newly marketed agents in order to rapidly identify recently launched potential hepatotoxic agents and initiate further evaluation.
C1 [Brinker, Allen D.; Lyndly, Jenna; Tonning, Joseph; Moeny, David; Levine, Jonathan G.; Avigan, Mark I.] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Brinker, AD (reprint author), US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM allen.brinker@fda.hhs.gov; jenna.lyndly@fda.hhs.gov;
joseph.tonning@fda.hhs.gov; david.moeny@fda.hhs.gov;
jonathan.levine@fda.hhs.gov; mark.avigan@fda.hhs.gov
NR 45
TC 6
Z9 9
U1 0
U2 8
PU ADIS INT LTD
PI AUCKLAND
PA 41 CENTORIAN DR, PRIVATE BAG 65901, MAIRANGI BAY, AUCKLAND 1311, NEW
ZEALAND
SN 0114-5916
EI 1179-1942
J9 DRUG SAFETY
JI Drug Saf.
PD DEC
PY 2013
VL 36
IS 12
BP 1169
EP 1178
DI 10.1007/s40264-013-0116-9
PG 10
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
GA 257NF
UT WOS:000327390800004
PM 24178291
ER
PT J
AU Han, J
Gokulan, K
Barnette, D
Khare, S
Rooney, AW
Deck, J
Nayak, R
Stefanova, R
Hart, ME
Foley, SL
AF Han, Jing
Gokulan, Kuppan
Barnette, Dustyn
Khare, Sangeeta
Rooney, Anthony W.
Deck, Joanna
Nayak, Rajesh
Stefanova, Rossina
Hart, Mark E.
Foley, Steven L.
TI Evaluation of Virulence and Antimicrobial Resistance in Salmonella
enterica Serovar Enteritidis Isolates from Humans and Chicken- and
Egg-Associated Sources
SO FOODBORNE PATHOGENS AND DISEASE
LA English
DT Article
ID FIELD GEL-ELECTROPHORESIS; GENE PROFILES; TYPHIMURIUM; GENOME; FOOD;
DIVERSITY; INFECTION; INTEGRONS; POULTRY; BRAZIL
AB Salmonella enterica serovar Enteritidis is a leading cause of salmonellosis throughout the world and is most commonly associated with the consumption of contaminated poultry and egg products. Salmonella Enteritidis has enhanced ability to colonize and persist in extraintestinal sites within chickens. In this study, 54 Salmonella Enteritidis isolates from human patients (n=28), retail chicken (n=9), broiler farms (n=9), and egg production facilities (n=8) were characterized by antimicrobial susceptibility testing, plasmid analysis, genetic relatedness using XbaI and AvrII pulsed-field gel electrophoresis (PFGE), and the presence of putative virulence genes. Nine isolates were evaluated for their abilities to invade and survive in intestinal epithelial and macrophage cell lines. Overall, 56% (n=30) of isolates were resistant to at least one antimicrobial agent tested, yet no isolates showed resistance to more than three antimicrobials. All isolates carried a common approximate to 55-kb plasmid, with some strains containing additional plasmids ranging from 3 to 50kb. PFGE analysis revealed five XbaI and AvrII clusters. There were significant overlaps in the PFGE patterns of the isolates from human, chicken, and egg houses. All isolates tested PCR positive for iacP, purR, ttrB, spi4H, rmbA, sopE, invA, sopB, spvB, pagC, msgA, spaN, orgA, tolC, and sifA, and negative for iss, virB4, and sipB. Of the isolates selected for virulence testing, those containing the iron acquisition genes, iutA, sitA, and iucA, and approximate to 50-kb plasmids demonstrated among the highest levels of macrophage and epithelial cell invasion, which may indicate their importance in pathogenesis.
C1 [Han, Jing; Gokulan, Kuppan; Barnette, Dustyn; Khare, Sangeeta; Rooney, Anthony W.; Deck, Joanna; Nayak, Rajesh; Hart, Mark E.; Foley, Steven L.] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Barnette, Dustyn] Ouachita Baptist Univ, Dept Biol, Arkadelphia, AR USA.
[Rooney, Anthony W.] Univ Minnesota, Dept Chem, Morris, MN 56267 USA.
[Stefanova, Rossina] Arkansas Dept Hlth, Arkansas Publ Hlth Labs, Little Rock, AR 72205 USA.
RP Foley, SL (reprint author), US FDA, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM steven.foley@fda.hhs.gov
FU FDA Commissioner Fellowship Program; Oak Ridge Institute for Science and
Education
FX The authors would like to thank Drs. Carl Cerniglia, Huizhong Chen, and
Mohamed Nawaz for their critical reviewing of the manuscript. Dr. Jing
Han, Dustyn Barnette, and Anthony Rooney are supported through the Oak
Ridge Institute for Science and Education. Dr. Kuppan Gokulan is
supported by an FDA Commissioner Fellowship Program and by Oak Ridge
Institute for Science and Education.
NR 39
TC 10
Z9 11
U1 0
U2 16
PU MARY ANN LIEBERT, INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1535-3141
EI 1556-7125
J9 FOODBORNE PATHOG DIS
JI Foodborne Pathog. Dis.
PD DEC 1
PY 2013
VL 10
IS 12
BP 1008
EP 1015
DI 10.1089/fpd.2013.1518
PG 8
WC Food Science & Technology
SC Food Science & Technology
GA 255DR
UT WOS:000327220100003
PM 24102082
ER
PT J
AU Fan, Y
Ji, P
Leonard-Segal, A
Sahajwalla, CG
AF Fan, Ying
Ji, Ping
Leonard-Segal, Andrea
Sahajwalla, Chandrahas G.
TI An Overview of the Pediatric Medications for the Symptomatic Treatment
of Allergic Rhinitis, Cough, and Cold
SO JOURNAL OF PHARMACEUTICAL SCIENCES
LA English
DT Review
DE Allergic rhinitis; Cough and cold; Clinical pharmacology; Pediatrics;
Pharmacokinetics; Clinical Pharmacokinetics; Population
Pharmacokinetics; Pharmacodynamics
ID AQUEOUS NASAL SPRAY; DOUBLE-BLIND; CHILDREN; SAFETY; IBUPROFEN;
EFFICACY; ASTHMA; MANAGEMENT
AB Upper respiratory infections and allergic rhinitis are common diseases in children. In recent years, U.S. Food and Drug Administration has been promoting pediatric drug development with marketing exclusivity incentives and requirements. The assessment of clinical pharmacology, efficacy, and safety data has facilitated pediatric drug development and provided appropriate labeling for pediatric use. Regulatory decision making involves multiple evaluation processes, including drug exposure comparison between adult and pediatric population, formulation bridging, dose selection, and evaluation of efficacy and safety in pediatric patients. This article reviews the pediatric drugs indicated for cough, cold, and allergic rhinitis, focusing on the utility of clinical pharmacology, safety, and efficacy data in determining the pediatric dosing regimen and the approaches taken for regulatory decision making. (c) 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:4213-4229, 2013
C1 [Fan, Ying; Ji, Ping; Sahajwalla, Chandrahas G.] US FDA, Off Clin Pharmacol, Div Clin Pharmacol 2, Silver Spring, MD 20993 USA.
[Leonard-Segal, Andrea] US FDA, Off New Drugs, Div Nonprescript Clin Evaluat, Silver Spring, MD 20993 USA.
RP Sahajwalla, CG (reprint author), US FDA, Off Clin Pharmacol, Div Clin Pharmacol 2, Silver Spring, MD 20993 USA.
EM chandrahas.sahajwalla@fda.hhs.gov
NR 77
TC 4
Z9 4
U1 0
U2 7
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0022-3549
EI 1520-6017
J9 J PHARM SCI-US
JI J. Pharm. Sci.
PD DEC
PY 2013
VL 102
IS 12
BP 4213
EP 4229
DI 10.1002/jps.23720
PG 17
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA 254UM
UT WOS:000327193300001
PM 24185951
ER
PT J
AU Rahman, Z
Siddiqui, A
Khan, MA
AF Rahman, Ziyaur
Siddiqui, Akhtar
Khan, Mansoor A.
TI Characterization of a Nonribosomal Peptide Antibiotic Solid Dispersion
Formulation by Process Analytical Technologies Sensors
SO JOURNAL OF PHARMACEUTICAL SCIENCES
LA English
DT Article
DE solid dispersion; chemometrics; crystal defects; dissolution;
multivariate analysis; powder X-ray diffration; fourier infrared
spectroscopy; principle component analysis; partial least square
analysis
ID RAY-POWDER DIFFRACTION; NEAR-INFRARED SPECTROSCOPY; PHYSICAL STABILITY;
DRUGS; QUANTITATION; VALIDATION; REGRESSION; RELEASE; SPECTRA; SYSTEMS
AB The focus of present investigation was to characterize and evaluate the variability of solid dispersion (SD) of amorphous vancomycin (VCM), utilizing crystalline polyethylene glycol (PEG-6000) as a carrier and subsequently, determining their percentage composition by nondestructive method of process analytical technology (PAT) sensors. The SD were prepared by heat fusion method and characterized for physicochemical and spectral properties. Enhanced dissolution was shown by the SD formulations. Decreased crystallinity of PEG-6000 was observed indicating that the drug was present as solution and dispersed form within the polymer. The SD formulations were homogenous as shown by near infrared (NIR) chemical imaging data. Principal component analysis (PCA) and partial least square (PLS) method were applied to NIR and PXRD (powder X-ray diffraction) data to develop model for quantification of drug and carrier. PLS of both data showed correlation coefficient >0.9934 with good prediction capability as revealed by smaller value of root mean square and standard error. The model based on NIR and PXRD were two folds more accurate in estimating PEG-6000 than VCM. In conclusion, the drug dissolution from the SD increased by decreasing crystallinity of PEG-6000, and the chemometric models showed usefulness of PAT sensor in estimating percentage of both VCM and PEG-600 simultaneously. (c) 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:4337-4346, 2013
C1 [Rahman, Ziyaur; Siddiqui, Akhtar; Khan, Mansoor A.] US FDA, Ctr Drug Evaluat & Res, Div Prod Qual & Res, Rockville, MD 20857 USA.
RP Khan, MA (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Prod Qual & Res, Rockville, MD 20857 USA.
EM Mansoor.Khan@fda.hhs.gov
OI Rahman, Ziyaur/0000-0002-0402-825X
NR 44
TC 5
Z9 5
U1 1
U2 12
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0022-3549
EI 1520-6017
J9 J PHARM SCI-US
JI J. Pharm. Sci.
PD DEC
PY 2013
VL 102
IS 12
BP 4337
EP 4346
DI 10.1002/jps.23740
PG 10
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA 254UM
UT WOS:000327193300013
PM 24114944
ER
PT J
AU Kakhi, M
Chittenden, J
AF Kakhi, Maziar
Chittenden, Jason
TI Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution
SO JOURNAL OF PHARMACEUTICAL SCIENCES
LA English
DT Article
DE absorption; mathematical models; in silico modeling; simulations;
population pharmacokinetics; in vitro; in vivo correlation (IVIVC);
stochastic deconvolution; nonlinear mixed effects (NLME) modeling
ID IN-VITRO CORRELATION; DIFFERENTIAL-EQUATIONS; IMPLEMENTATION; LEVEL
AB In environments where complete mechanistic knowledge of the system dynamics is not available, a synergy of first-principle concepts, stochastic methodsand statistical approaches can provide an efficient, accurate, and insightful strategy for model development. In this work, a system of ordinary differential equations describing system pharmacokinetics (PK) was coupled to a Wiener process for tracking the absorption rate coefficient, and was embedded in a nonlinear mixed effects population PK formalism. The procedure is referred to as stochastic deconvolution and itis proposed as a diagnostic tool to inform on a mapping function between the fraction of the drug absorbed and the fraction of the drug dissolved when applying one-stage methods to in vitro-in vivo correlation modeling. The goal of this work was to show that stochastic deconvolution can infer an a priori specified absorption profile given dense observational (simulated) data. The results demonstrate that the mathematical model is able to accurately reproduce the simulated data in scenarios where solution strategies for linear, time-invariant systems would assuredly fail. To this end, PK systems that are representative of Michaelis-Menten kinetics and enterohepatic circulation were investigated. Furthermore, the solution times are manageable using a modest computer hardware platform. (c) 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:4433-4443, 2013
C1 [Kakhi, Maziar] US FDA, Silver Spring, MD 20993 USA.
[Chittenden, Jason] Pharsight Corp, Cary, NC 27518 USA.
RP Kakhi, M (reprint author), US FDA, Silver Spring, MD 20993 USA.
EM maziar.kakhi@fda.hhs.gov
NR 21
TC 4
Z9 4
U1 1
U2 7
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0022-3549
EI 1520-6017
J9 J PHARM SCI-US
JI J. Pharm. Sci.
PD DEC
PY 2013
VL 102
IS 12
BP 4433
EP 4443
DI 10.1002/jps.23752
PG 11
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA 254UM
UT WOS:000327193300023
PM 24174399
ER
PT J
AU Fardin-Kia, AR
Delmonte, P
Kramer, JKG
Jahreis, G
Kuhnt, K
Santercole, V
Rader, JI
AF Fardin-Kia, Ali Reza
Delmonte, Pierluigi
Kramer, John K. G.
Jahreis, Gerhard
Kuhnt, Katrin
Santercole, Viviana
Rader, Jeanne I.
TI Separation of the Fatty Acids in Menhaden Oil as Methyl Esters with a
Highly Polar Ionic Liquid Gas Chromatographic Column and Identification
by Time of Flight Mass spectrometry
SO LIPIDS
LA English
DT Article
DE Ionic liquid; SLB-IL111; GC; Gas chromatography; Menhaden oil; Marine
oil; PUFA; GC-TOF/MS
ID CP-SIL 88; FISH-OIL; CLA ISOMERS; DOCOSAHEXAENOIC ACID; WHALE OILS;
MILK-FAT; GC; CHAIN; TRANS; CIS
AB The fatty acids contained in marine oils or products are traditionally analyzed by gas chromatography using capillary columns coated with polyethylene glycol phases. Recent reports indicate that 100 % cyanopropyl siloxane phases should also be used when the analyzed samples contain trans fatty acids. We investigated the separation of the fatty acid methyl esters prepared from menhaden oil using the more polar SLB-IL111 (200 m x 0.25 mm) ionic liquid capillary column and the chromatographic conditions previously optimized for the separation of the complex mixture of fatty acid methyl esters prepared from milk fat. Identifications of fatty acids were achieved by applying Ag+-HPLC fractionation and GC-TOF/MS analysis in CI+ mode with isobutane as the ionization reagent. Calculation of equivalent chain lengths confirmed the assignment of double bond positions. This methodology allowed the identification of 125 fatty acids in menhaden oil, including isoprenoid and furanoid fatty acids, and the novel 7-methyl-6-hexadecenoic and 7-methyl-6-octadecenoic fatty acids. The chromatographic conditions applied in this study showed the potential of separating in a single 90-min analysis, among others, the short chain and trans fatty acids contained in dairy products, and the polyunsaturated fatty acids contained in marine products.
C1 [Fardin-Kia, Ali Reza; Delmonte, Pierluigi; Rader, Jeanne I.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Kramer, John K. G.] Agr & Agri Food Canada, Guelph Food Res Ctr, Guelph, ON, Canada.
[Jahreis, Gerhard; Kuhnt, Katrin] Univ Jena, Inst Nutr, Jena, Germany.
[Santercole, Viviana] Univ Sassari, Fac Vet Med, I-07100 Sassari, Italy.
RP Fardin-Kia, AR (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, HFS-717,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM alireza.fardinkia@fda.hhs.gov
NR 46
TC 12
Z9 12
U1 2
U2 47
PU SPRINGER HEIDELBERG
PI HEIDELBERG
PA TIERGARTENSTRASSE 17, D-69121 HEIDELBERG, GERMANY
SN 0024-4201
EI 1558-9307
J9 LIPIDS
JI Lipids
PD DEC
PY 2013
VL 48
IS 12
BP 1279
EP 1295
DI 10.1007/s11745-013-3830-2
PG 17
WC Biochemistry & Molecular Biology; Nutrition & Dietetics
SC Biochemistry & Molecular Biology; Nutrition & Dietetics
GA 257TA
UT WOS:000327408300010
PM 24043585
ER
PT J
AU Tembhare, PR
Marti, G
Wiestner, A
Degheidy, H
Farooqui, M
Kreitman, RJ
Jasper, GA
Yuan, CM
Liewehr, D
Venzon, D
Stetler-Stevenson, M
AF Tembhare, Prashant R.
Marti, Gerald
Wiestner, Adrian
Degheidy, Heba
Farooqui, Mohammed
Kreitman, Robert J.
Jasper, Gregory A.
Yuan, Constance M.
Liewehr, David
Venzon, David
Stetler-Stevenson, Maryalice
TI Quantification of Expression of Antigens Targeted by Antibody-Based
Therapy in Chronic Lymphocytic Leukemia
SO AMERICAN JOURNAL OF CLINICAL PATHOLOGY
LA English
DT Article
DE Chronic lymphocytic leukemia; Antibody therapy; Rituximab; Alemtuzumab;
Quantitative flow cytometry
ID QUANTITATIVE FLOW-CYTOMETRY; IMMUNOTOXIN RFB4(DSFV)-PE38 BL22; B-CELL
LEUKEMIAS; PHASE-I TRIAL; CD20 EXPRESSION; LYMPHOPROLIFERATIVE
DISORDERS; ALEMTUZUMAB CAMPATH-1H; RESIDUAL DISEASE; RITUXIMAB;
FLUDARABINE
AB Objectives: Anti-CD20 (rituximab), anti-CD52 (alemtuzumab), anti-CD22 (BL22, HA22), and anti-CD25 (Oncotac) are therapeutic options that are the mainstay or in preclinical development for the treatment of chronic lymphocytic leukemia (CLL). Studies suggest that levels of surface antigen expression may affect response to monoclonal antibody-based therapy.
Methods: Using the flow cytometric Quantibrite method (BD Biosciences, San Jose, CA) to determine antibodies bound per cell, we quantified the levels of surface expression of CD20, CD22, CD25, and CD52 in CLL cells from 28 untreated patients.
Results: The CLL cells in all cases expressed CD20, CD22, and CD52 but 4 (14%) cases were negative for CD25. Although the ranking of levels of expression from highest to lowest was CD52, CD20, CD22, and CD25, the level of antigen expression on any specific case could not be accurately predicted.
Conclusions: Quantification of antigens might be useful in evaluating new antigens to target for therapy and may provide a systematic approach to selecting individualized therapy in CLL. (C) American Society for Clinical Pathology
C1 [Tembhare, Prashant R.; Jasper, Gregory A.; Yuan, Constance M.; Stetler-Stevenson, Maryalice] NCI, Flow Cytometry Unit, Pathol Lab, Ctr Canc Res,NIH, Bethesda, MD 20892 USA.
[Kreitman, Robert J.] NCI, Lab Mol Biol, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Liewehr, David; Venzon, David] NCI, Biostat & Data Management Sect, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Marti, Gerald; Degheidy, Heba] US FDA, Ctr Biol Evaluat & Res, Silver Spring, MD USA.
[Wiestner, Adrian; Farooqui, Mohammed] NHLBI, Hematol Branch, NIH, Bethesda, MD 20892 USA.
RP Stetler-Stevenson, M (reprint author), NCI, Flow Cytometry Unit, Pathol Lab, Ctr Canc Res,NIH, 10 Ctr Dr, Bethesda, MD 20892 USA.
EM stetler@mail.nih.gov
FU Intramural NIH HHS [Z01 BC011104-01]
NR 31
TC 6
Z9 7
U1 0
U2 6
PU AMER SOC CLINICAL PATHOLOGY
PI CHICAGO
PA 2100 W HARRISON ST, CHICAGO, IL 60612 USA
SN 0002-9173
EI 1943-7722
J9 AM J CLIN PATHOL
JI Am. J. Clin. Pathol.
PD DEC
PY 2013
VL 140
IS 6
BP 813
EP 818
DI 10.1309/AJCPYFQ4XMGJD6TI
PG 6
WC Pathology
SC Pathology
GA 255ZX
UT WOS:000327280400007
PM 24225748
ER
PT J
AU Simon, D
Ware, T
Marcotte, R
Lund, BR
Smith, DW
Di Prima, M
Rennaker, RL
Voit, W
AF Simon, Dustin
Ware, Taylor
Marcotte, Ryan
Lund, Benjamin R.
Smith, Dennis W., Jr.
Di Prima, Matthew
Rennaker, Robert L.
Voit, Walter
TI A comparison of polymer substrates for photolithographic processing of
flexible bioelectronics
SO BIOMEDICAL MICRODEVICES
LA English
DT Article
DE Flexible electronics; Smart polymers; Neural interfaces
ID SHAPE-MEMORY POLYMERS; BIOMEDICAL APPLICATIONS; MECHANICAL-PROPERTIES;
NEURAL INTERFACES; IN-VIVO; ELECTRODES; POLYIMIDE; FILMS; DENSITY;
SYSTEMS
AB Flexible bioelectronics encompass a new generation of sensing devices, in which controlled interactions with tissue enhance understanding of biological processes in vivo. However, the fabrication of such thin film electronics with photolithographic processes remains a challenge for many biocompatible polymers. Recently, two shape memory polymer (SMP) systems, based on acrylate and thiol-ene/acrylate networks, were designed as substrates for softening neural interfaces with glass transitions above body temperature (37 A degrees C) such that the materials are stiff for insertion into soft tissue and soften through low moisture absorption in physiological conditions. These two substrates, acrylate and thiol-ene/acrylate SMPs, are compared to polyethylene naphthalate, polycarbonate, polyimide, and polydimethylsiloxane, which have been widely used in flexible electronics research and industry. These six substrates are compared via dynamic mechanical analysis (DMA), thermogravimetric analysis (TGA), and swelling studies. The integrity of gold and chromium/gold thin films on SMP substrates are evaluated with optical profilometry and electrical measurements as a function of processing temperature above, below and through the glass transition temperature. The effects of crosslink density, adhesion and cure stress are shown to play a critical role in the stability of these thin film materials, and a guide for the future design of responsive polymeric materials suitable for neural interfaces is proposed. Finally, neural interfaces fabricated on thiol-ene/acrylate substrates demonstrate long-term fidelity through both in vitro impedance spectroscopy and the recording of driven local field potentials for 8 weeks in the auditory cortex of laboratory rats.
C1 [Simon, Dustin; Ware, Taylor; Di Prima, Matthew; Voit, Walter] Univ Texas Dallas, Dept Mat Sci & Engn, Richardson, TX 75080 USA.
[Voit, Walter] Univ Texas Dallas, Dept Mech Engn, Richardson, TX 75080 USA.
[Marcotte, Ryan] Univ Texas Dallas, Dept Elect Engn, Richardson, TX 75080 USA.
[Lund, Benjamin R.; Smith, Dennis W., Jr.] Univ Texas Dallas, Dept Chem, Richardson, TX 75080 USA.
[Rennaker, Robert L.] Univ Texas Dallas, Sch Brain & Behav Sci, Richardson, TX 75080 USA.
[Di Prima, Matthew] Food & Drug Adm, CDRH OSEL DSFM, Silver Spring, MD 20993 USA.
RP Voit, W (reprint author), Univ Texas Dallas, Dept Mat Sci & Engn, 800 West Campbell RD,Mailstop RL 10, Richardson, TX 75080 USA.
EM walter.voit@utdallas.edu
RI Ware, Taylor/A-7130-2017;
OI Ware, Taylor/0000-0001-7996-7393; Di Prima, Matthew/0000-0003-1623-1324
FU National Institutes of Neurological Disorders and Stroke [5R01DC008982];
National Science Foundation [1147385]; State of Texas
FX The authors would like to thank the FDA for the use of the Bruker
Contour GT-K1 3D Optical Microscope. The opinions and/or conclusions
expressed are solely those of the authors and in no way imply a policy
or position of the Food and Drug Administration. This material is based
partially based upon work supported from several sources: the National
Institutes of Neurological Disorders and Stroke 5R01DC008982; the
National Science Foundation Partnerships for Innovation and Graduate
Research Fellowship under Grant No. 1147385; FUSION support from the
State of Texas.
NR 56
TC 12
Z9 12
U1 8
U2 78
PU SPRINGER
PI DORDRECHT
PA VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS
SN 1387-2176
EI 1572-8781
J9 BIOMED MICRODEVICES
JI Biomed. Microdevices
PD DEC
PY 2013
VL 15
IS 6
BP 925
EP 939
DI 10.1007/s10544-013-9782-8
PG 15
WC Engineering, Biomedical; Nanoscience & Nanotechnology
SC Engineering; Science & Technology - Other Topics
GA 253JM
UT WOS:000327081100003
PM 23852172
ER
PT J
AU Lo Surdo, JL
Millis, BA
Bauer, SR
AF Lo Surdo, Jessica L.
Millis, Bryan A.
Bauer, Steven R.
TI Automated microscopy as a quantitative method to measure differences in
adipogenic differentiation in preparations of human mesenchymal stromal
cells
SO CYTOTHERAPY
LA English
DT Article
DE adipogenesis; bone marrow stromal cell; mesenchymal stromal cell;
microscopy
ID HUMAN BONE-MARROW; ADULT STEM-CELLS; IN-VITRO; OSTEOGENIC
DIFFERENTIATION; ADIPOSE-TISSUE; PROGENITOR CELLS; EXPANSION;
POPULATIONS; PRECURSORS; CULTURES
AB Background aims. Multipotent stromal cells, also called mesenchymal stromal cells (MSCs), are potentially valuable as a cellular therapy because of their differentiation and immunosuppressive properties. As the result of extensive heterogeneity of MSCs, quantitative approaches to measure differentiation capacity between donors and passages on a per-cell basis are needed. Methods. Human bone marrow-derived MSCs were expanded to passages P3, P5 and P7 from eight different donors and were analyzed for colony-forming unit capacity (CPU), cell size, surface marker expression and forward/side-scatter analysis by flow cytometry. Adipogenic differentiation potential was quantified with the use of automated microscopy. Percentage of adipogenesis was determined by quantifying nuclei and Nile red positive adipocytes after automated image acquisition. Results. MSCs varied in expansion capacity and increased in average cell diameter with passage. CFU capacity decreased with passage and varied among cell lines within the same passage. The number of adipogenic precursors varied between cell lines, ranging from 0.5% to 13.6% differentiation at P3. Adipogenic capacity decreased significantly with increasing passage. MSC cell surface marker analysis revealed no changes caused by passaging or donor differences. Conclusions. We measured adipogenic differentiation on a per-cell basis with high precision and accuracy with the use of automated fluorescence microscopy. We correlated these findings with other quantitative bioassays to better understand the role of donor variability and passaging on CPU, cell size and adipogenic differentiation capacity in vitro. These quantitative approaches provide valuable tools to measure MSC quality and measure functional biological differences between donors and cell passages that are not revealed by conventional MSC cell surface marker analysis.
C1 [Lo Surdo, Jessica L.; Bauer, Steven R.] Off Cellular Tissue & Gene Therapies, Div Cellular & Gene Therapies, FDA Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Millis, Bryan A.] NIDCD, NIH, Sect Struct Cell Biol, Bethesda, MD USA.
RP Bauer, SR (reprint author), US FDA, Ctr Biol Evaluat & Res, NIH Bldg 29B HFM 740,Room 2NN10, Bethesda, MD 20892 USA.
EM steven.bauer@fda.hhs.gov
OI Bauer, Steven/0000-0003-2831-846X
FU Jessica Lo Surdo's appointment to the Research Participation Program at
the Center for Biologics Evaluation and Research; US Food and Drug
Administration; Food and Drug Administration Modernizing Science grant
program; Biomedical Advanced Research and Development Authority grant;
Medical Countermeasures Initiative; Division of Cell and Gene Therapies
FX The authors would like to acknowledge Eva Rudikoff for her assistance in
growing the MSCs and Drs Brenton McCright, Deborah Hursh and Patrick
Lynch for reviewing the manuscript. This project was supported in part
by Jessica Lo Surdo's appointment to the Research Participation Program
at the Center for Biologics Evaluation and Research administered by the
Oak Ridge Institute for Science and Education through US Department of
Education and US Food and Drug Administration. This work was also
supported in part by the Food and Drug Administration Modernizing
Science grant program, a Biomedical Advanced Research and Development
Authority grant, a grant from the Medical Countermeasures Initiative and
research funds from the Division of Cell and Gene Therapies.
NR 62
TC 16
Z9 17
U1 0
U2 6
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 1465-3249
EI 1477-2566
J9 CYTOTHERAPY
JI Cytotherapy
PD DEC
PY 2013
VL 15
IS 12
BP 1527
EP 1540
DI 10.1016/j.jcyt.2013.04.010
PG 14
WC Cell & Tissue Engineering; Biotechnology & Applied Microbiology; Cell
Biology; Hematology; Medicine, Research & Experimental
SC Cell Biology; Biotechnology & Applied Microbiology; Hematology; Research
& Experimental Medicine
GA 254ME
UT WOS:000327169000010
PM 23992827
ER
PT J
AU Kaur, P
Chaurasia, CS
Davit, BM
Conner, DP
AF Kaur, Paramjeet
Chaurasia, Chandra S.
Davit, Barbara M.
Conner, Dale P.
TI Bioequivalence Study Designs for Generic Solid Oral Anticancer Drug
Products: Scientific and Regulatory Considerations
SO JOURNAL OF CLINICAL PHARMACOLOGY
LA English
DT Article
DE anticancer; bioequivalence; generics; guidances; pharmacokinetics
ID 6-MERCAPTOPURINE; METHOTREXATE; BEXAROTENE
AB The demonstration of bioequivalence (BE) between the test and reference products is an integral part of generic drug approval process. A sound BE study design is pivotal to the successful demonstration of BE of generic drugs to their corresponding reference listed drug product. Generally, BE of systemically acting oral dosage forms is demonstrated in a crossover, single-dose in vivo study in healthy subjects. The determination of BE of solid oral anticancer drug products is associated with its own unique challenges due to the serious safety risks involved. Unlike typical BE study in healthy subjects, the safety issues often necessitate conducting BE studies in cancer patients. Such BE studies of an anticancer drug should be conducted without disturbing the patients' therapeutic dosing regimen. Attributes such as drug permeability and solubility, pharmacokinetics, dosing regimen, and approved therapeutic indication(s) are considered in the BE study design of solid anticancer drug products. To streamline the drug approval process, the Division of Bioequivalence posts the Bioequivalence Recommendations for Specific Products guidances on the FDA public website. The objective of this article is to illustrate the scientific and regulatory considerations in the design of BE studies for generic solid oral anticancer drug products through examples.
C1 [Kaur, Paramjeet; Chaurasia, Chandra S.; Davit, Barbara M.; Conner, Dale P.] US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Div Bioequivalence, Rockville, MD 20852 USA.
RP Kaur, P (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Div Bioequivalence, Rockville, MD 20852 USA.
EM paramjeet.kaur@fda.hhs.gov
FU FDA Commissioner's Fellowship; ORISE Research Participation Program at
the Center for Drug Evaluation and Research
FX This project was supported in part by FDA Commissioner's Fellowship and
also in part by an appointment to the ORISE Research Participation
Program at the Center for Drug Evaluation and Research administered by
the Oak Ridge Institute for Science and Education through an agreement
between the U. S. Department of Energy and CDER. The authors would also
like to thank Hoainhon T. Nguyen, M. S. (Deputy Director, Division of
Bioequivalence I) and Ethan Stier, Ph.D. (Deputy Director, Division of
Bioequivalence II) for their suggestions during the development of
Bioequivalence Recommendations for Specific Products guidances. Support
provided by LCDR Duong Nhu, Pharm. D., Project Manager, DB II in
preparation of this manuscript is also gratefully acknowledged.
NR 28
TC 2
Z9 2
U1 1
U2 4
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1552-4604
J9 J CLIN PHARMACOL
JI J. Clin. Pharmacol.
PD DEC
PY 2013
VL 53
IS 12
BP 1252
EP 1260
DI 10.1002/jcph.163
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 252OB
UT WOS:000327015000004
PM 23996908
ER
PT J
AU Park, M
Sutherland, JB
Kim, JN
Rafii, F
AF Park, Miseon
Sutherland, John B.
Kim, Jong Nam
Rafii, Fatemeh
TI Effect of Fluoroquinolone Resistance Selection on the Fitness of Three
Strains of Clostridium perfringens
SO MICROBIAL DRUG RESISTANCE
LA English
DT Article
ID CAMPYLOBACTER-JEJUNI; COST; QUINOLONES; MUTATIONS; MUTANTS; DISEASE;
GYRASE; TOXIN; COLI
AB Selection of bacterial strains for resistance to antimicrobial agents may affect fitness; and fluoroquinolone resistance has been shown to affect fitness of aerobic and facultative bacteria. The impact on bacterial fitness of resistance selection to three fluoroquinolones was examined in three wild-type strains of Clostridium perfringens: ATCC 13124, ATCC 3626, and NCTR. Selection for resistance to norfloxacin, ciprofloxacin, and gatifloxacin affected the fitness of nine mutant strains differently. In a series of pure cultures grown in the absence of drugs, the growth of each of the mutants was comparable to that of the corresponding wild type. In competition experiments between mutants and isogenic wild types, however, some of the mutants were less fit. The fitness of ciprofloxacin-resistant mutants was comparable for all three strains, but two gatifloxacin-resistant mutants and one norfloxacin-resistant mutant were significantly less fit than the corresponding wild types. We conclude that both the genetic background of the strain and the fluoroquinolone which induced resistance affected the fitness of the resistant mutants. This is the first time that the effect on fitness of resistance to antimicrobial agents has been measured for C. perfringens.
C1 [Park, Miseon; Sutherland, John B.; Kim, Jong Nam; Rafii, Fatemeh] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Rafii, F (reprint author), US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM fatemeh.rafii@fda.hhs.gov
NR 30
TC 2
Z9 2
U1 2
U2 8
PU MARY ANN LIEBERT, INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1076-6294
EI 1931-8448
J9 MICROB DRUG RESIST
JI Microb. Drug Resist.
PD DEC 1
PY 2013
VL 19
IS 6
BP 421
EP 427
DI 10.1089/mdr.2013.0056
PG 7
WC Infectious Diseases; Microbiology; Pharmacology & Pharmacy
SC Infectious Diseases; Microbiology; Pharmacology & Pharmacy
GA 255PX
UT WOS:000327253400001
PM 23789809
ER
PT J
AU Karnes, JH
Gong, Y
Pacanowski, MA
McDonough, CW
Arwood, MJ
Langaee, TY
Pepine, CJ
Johnson, JA
Cooper-DeHoff, RM
AF Karnes, Jason H.
Gong, Yan
Pacanowski, Michael A.
McDonough, Caitrin W.
Arwood, Meghan J.
Langaee, Taimour Y.
Pepine, Carl J.
Johnson, Julie A.
Cooper-DeHoff, Rhonda M.
TI Impact of TCF7L2 single nucleotide polymorphisms on
hydrochlorothiazide-induced diabetes
SO PHARMACOGENETICS AND GENOMICS
LA English
DT Article
DE diabetes mellitus; hydrochlorothiazide; pharmacogenetics; TCF7L2
ID GENOME-WIDE ASSOCIATION; CORONARY-ARTERY-DISEASE; VERAPAMIL
SR-TRANDOLAPRIL; JOINT NATIONAL COMMITTEE; BLOOD-PRESSURE CONTROL;
CARDIOVASCULAR OUTCOMES; HYPERTENSIVE PATIENTS; SUSCEPTIBILITY LOCI;
FASTING GLUCOSE; GENE-EXPRESSION
AB ObjectiveThiazide diuretics have been associated with increased risk for new onset diabetes (NOD), but pharmacogenetic markers of thiazide-induced NOD are not well studied. Single nucleotide polymorphisms (SNPs) in the transcription factor 7-like 2 gene (TCF7L2) represent the strongest and most reproducible genetic associations with diabetes. We investigated the association of tag SNPs in TCF7L2 with thiazide-induced NOD.MethodsWe identified cases that developed NOD and age, sex, and race/ethnicity-matched controls from the INternational VErapamil SR-Trandolapril STudy (INVEST). INVEST compared cardiovascular outcomes between two antihypertensive treatment strategies in ethnically diverse patients with hypertension and coronary artery disease. We genotyped 101 TCF7L2 tag SNPs and used logistic regression to test for pharmacogenetic (SNPxhydrochlorothiazide treatment) interactions. Permuted interaction P values were corrected with the P-ACT test and adjusted for diabetes-related variables.ResultsIn INVEST whites, we observed three TCF7L2 SNPs with significant SNPxtreatment interactions for NOD. The strongest pharmacogenetic interaction was observed for rs7917983 [synergy index 3.37 (95% CI 1.72-6.59), P=5.0x10(-4), P-ACT=0.03], which was associated with increased NOD risk in hydrochlorothiazide-treated patients [odds ratio 1.53 (1.04-2.25), P=0.03] and decreased NOD risk in non hydrochlorothiazide-treated patients [odds ratio 0.48 (0.27-0.86), P=0.02]. The TCF7L2 SNP rs4506565, previously associated with diabetes, showed a similar, significant pharmacogenetic association.ConclusionOur results suggest that hydrochlorothiazide treatment is an environmental risk factor that increases diabetes risk beyond that attributed to TCF7L2 variation in white, hypertensive patients. Further study and replication of our results is needed to confirm pharmacogenetic influences of TCF7L2 SNPs on thiazide-induced NOD.
C1 [Karnes, Jason H.] Vanderbilt Univ, Dept Med, Div Clin Pharmacol, Nashville, TN USA.
[Karnes, Jason H.; Gong, Yan; McDonough, Caitrin W.; Arwood, Meghan J.; Langaee, Taimour Y.; Johnson, Julie A.; Cooper-DeHoff, Rhonda M.] Univ Florida, Dept Pharmacotherapy & Translat Res, Gainesville, FL 32610 USA.
[Gong, Yan; Langaee, Taimour Y.; Johnson, Julie A.; Cooper-DeHoff, Rhonda M.] Univ Florida, Dept Pharmacotherapy & Translat Res, Ctr Pharmacogen, Gainesville, FL 32610 USA.
[Pepine, Carl J.; Johnson, Julie A.; Cooper-DeHoff, Rhonda M.] Univ Florida, Div Cardiovasc Med, Dept Med, Gainesville, FL 32610 USA.
[Pacanowski, Michael A.] US FDA, Off Clin Pharmacol, Silver Spring, MD USA.
RP Cooper-DeHoff, RM (reprint author), Univ Florida, Dept Pharmacotherapy & Translat Res, POB 100486, Gainesville, FL 32610 USA.
EM dehoff@cop.ufl.edu
FU National Institutes of Health (Bethesda, Maryland, USA) [U01 GM074492];
Pharmacogenetics Research Network; National Institutes of Health [R01
HL74730, HL086558]; Abbott Laboratories; University of Florida
Opportunity Fund; National Center for Research Resources [TL1RR029888];
National Institute of Child Health & Human Development [T32GM007569];
National Institute of General Medical Sciences
FX This work is supported by a grant from the National Institutes of Health
(Bethesda, Maryland, USA), grant U01 GM074492, funded as part of the
Pharmacogenetics Research Network. Additional support for this work
includes: National Institutes of Health grants R01 HL74730 and HL086558
(R.M.C.-D.); and grants from Abbott Laboratories and the University of
Florida Opportunity Fund. The project described was supported by Award
Number TL1RR029888 from the National Center for Research Resources
(J.H.K.) and Award Number T32GM007569 from the National Institute of
Child Health & Human Development and the National Institute of General
Medical Sciences (J.H.K.). The authors thank Ben Burkley, Lynda
Stauffer, and Cheryl Galloway for processing and genotyping samples and
the patients who participated in INVEST-GENES.
NR 50
TC 5
Z9 6
U1 0
U2 2
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1744-6872
EI 1744-6880
J9 PHARMACOGENET GENOM
JI Pharmacogenet. Genomics
PD DEC
PY 2013
VL 23
IS 12
BP 697
EP 705
DI 10.1097/FPC.0000000000000012
PG 9
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Pharmacology
& Pharmacy
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Pharmacology
& Pharmacy
GA 251YR
UT WOS:000326971400006
PM 24128935
ER
PT J
AU Wysowski, DK
Greene, P
AF Wysowski, Diane K.
Greene, Patty
TI Trends in osteoporosis treatment with oral and intravenous
bisphosphonates in the United States, 2002-2012
SO BONE
LA English
DT Article
DE Bisphosphonates; Alendronate; Risedronate; Ibandronate; Osteoporosis
ID FRACTURE INTERVENTION TRIAL; POSTMENOPAUSAL OSTEOPOROSIS; VERTEBRAL
FRACTURES; RANDOMIZED-TRIAL; ZOLEDRONIC ACID; ALENDRONATE; BONE; WOMEN;
RISK; OSTEONECROSIS
AB Bisphosphonates have been widely prescribed to postmenopausal women for treatment and prevention of osteoporosis. Given a background of reports of recent safety problems, questions about optimal duration of use, and the patent expiration of Fosamax in February 2008, we accessed data from pharmaceutical marketing research databases to describe trends in dispensed prescriptions and sales of oral bisphosphonates, characteristics of patients and prescribers, and sales of intravenous bisphosphonates for osteoporosis treatment.
An estimated 21.3 million prescriptions for oral bisphosphonates were dispensed in U.S. retail pharmacies in 2002 that increased 46% to a peak of 31.0 million in 2007 and 2008, and declined by 53% in a four year-period to 14.7 million in 2012. Sales data (number of packages sold in all settings of care) showed parallel trends (66% increase from 2002 through 2007 and 51% decrease from 2007 through 2012). Similarly, intravenous bisphosphonate sales for osteoporosis treatment grew 3.8-fold from 149.5 thousand packages in 2007 to 561.6 thousand in 2010, followed by a 22% decrease in 2012.
Data from an ongoing monthly office-based survey indicated physicians mentioned oral bisphosphonates primarily in visits of older aged Caucasian women with lower body mass for osteoporosis. Frequencies of oral bisphosphonate mentions increased between 2002 and 2012 in visits of Asians and for osteopenia diagnoses. These data indicate a substantial decline in prescriptions and sales of oral (since 2007-2008) and intravenous (since 2010) bisphosphonates for osteoporosis treatment in the United States. Reasons for, and implications of, the decline should be considered for future research. Published by Elsevier Inc.
C1 [Wysowski, Diane K.; Greene, Patty] US FDA, Off Surveillance & Epidemiol, Silver Spring, MD 20993 USA.
RP Wysowski, DK (reprint author), US FDA, Div Epidemiol 1, Off Surveillance & Epidemiol, 10903 New Hampshire Ave,Bldg 22,Room 2406, Silver Spring, MD 20993 USA.
EM diane.wysowski@fda.hhs.gov; patty.greene@fda.hhs.gov
NR 28
TC 34
Z9 34
U1 0
U2 18
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 8756-3282
EI 1873-2763
J9 BONE
JI Bone
PD DEC
PY 2013
VL 57
IS 2
BP 423
EP 428
DI 10.1016/j.bone.2013.09.008
PG 6
WC Endocrinology & Metabolism
SC Endocrinology & Metabolism
GA 250JB
UT WOS:000326848000014
PM 24063946
ER
PT J
AU Sheldon, LK
Wise, B
Carlson, JR
Dowds, C
Sarchet, V
Sanchez, JA
AF Sheldon, Lisa Kennedy
Wise, Barbara
Carlson, Julie R.
Dowds, Cynthia
Sarchet, Vanessa
Sanchez, Jose Angel
TI Developing a Longitudinal Cancer Nursing Education Program in Honduras
SO JOURNAL OF CANCER EDUCATION
LA English
DT Article
DE Nursing; Clinical oncology; Education; Developing countries
ID HEALTH-CARE; PRIORITIES; COUNTRIES; MODEL
AB The present paper is a longitudinal study which aims to develop and deliver cancer nursing education conferences in Honduras using volunteer nurse educators. This program intends to (1) perform site assessments of work environments and resources for cancer care in Honduras, (2) develop cancer nursing education programs, (3) survey conference participants continuing education needs, (4) deliver cancer nursing education conferences, and (5) share data with local and global partners for future cancer programs. The study draws on a longitudinal program development with site assessments, data collection, and educational conferences at two time points. Assessments and surveys were used for conference development and delivery by volunteer nurse educators. Site assessments and conferences were delivered twice. Data were collected regarding assessments and surveys to inform program development. Survey data revealed that < 4 % had formal training in cancer care and > 65 % had internet access. Participants desired more information about handling of chemotherapy, symptom management, and palliative care. Volunteer nurse educators perform site assessments and develop educational programming for cancer nurses. Local and global partners should explore internet-based programs between site visits to create sustainable education programs.
C1 [Sheldon, Lisa Kennedy] Univ Massachusetts Boston, Boston, MA 02125 USA.
[Wise, Barbara] US FDA, Silver Spring, MD USA.
[Carlson, Julie R.] OSF St Anthony Med Ctr, Rockford, IL USA.
[Dowds, Cynthia] Ashland Univ, Ashland, OH USA.
[Sarchet, Vanessa] Amer Soc Clin Oncol, Washington, DC USA.
[Sanchez, Jose Angel] Hosp Escuela Tegucigalpa, Tegucigalpa, Honduras.
RP Sheldon, LK (reprint author), Univ Massachusetts Boston, 100 Morrissey Blvd, Boston, MA 02125 USA.
EM lisa.kennedysheldon@umb.edu; bwisea@yahoo.com;
Julie.R.Carlson@osfhealthcare.org; cdowds@ashland.edu;
Vanessa.Sarchet@asco.org; jose.skiro@gmail.com
OI Sheldon, Lisa Kennedy/0000-0002-5958-8529
NR 23
TC 3
Z9 3
U1 1
U2 16
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 0885-8195
EI 1543-0154
J9 J CANCER EDUC
JI J. Cancer Educ.
PD DEC
PY 2013
VL 28
IS 4
BP 669
EP 675
DI 10.1007/s13187-013-0497-6
PG 7
WC Oncology; Education, Scientific Disciplines; Public, Environmental &
Occupational Health
SC Oncology; Education & Educational Research; Public, Environmental &
Occupational Health
GA 242ZQ
UT WOS:000326286200012
PM 23912757
ER
PT J
AU Gill, RB
Bowman, JJ
Krogmann, T
Wollenberg, K
Asher, DM
Cohen, JI
AF Gill, Rachel B.
Bowman, J. Jason
Krogmann, Tammy
Wollenberg, Kurt
Asher, David M.
Cohen, Jeffrey I.
TI Coding potential of UL/b ' from the initial source of rhesus
cytomegalovirus Strain 68-1
SO VIROLOGY
LA English
DT Article
DE Human cytomegalovirus; Rhesus cytomegalovirus; Cercopithecine
herpesvirus: macacine herpesvirus 3; Cynomolgus macaque cytomegalovirus;
UL/b '
ID ENDOTHELIAL-CELLS; ANTIBODY-RESPONSE; IN-VITRO; MACAQUES; COMPLEX;
INFECTION; ENCODES; GENES; REPLICATION; CHEMOKINE
AB Rhesus cytomegalovirus (RhCMV) 68-1 is the prototypic strain of RhCMV that has been used for pathogenesis and vaccine development. We determined the complete sequence of the RhCMV 68-1 UL/b' region directly from the original urine from which RhCMV 68-1 was isolated in 1968, and compared it to other RhCMVs. The laboratory passaged RhCMV 68-1 has inversions, deletions, and stop codons in UL/b' that are absent in the original isolate and other low passage RhCMV isolates. Fourteen of the 17 open reading frames (ORFs) in 68-1 UL/b' in the original isolate share >95% amino acid identity with low passage RhCMV. The original isolate retains 6 ORFs that encode alpha-chemokine-like proteins, including RhUL146 and RhUL146b that share only 92% and 81% amino acid identity, respectively, with a contemporary low passage RhCMV isolate. Identification of the original RhCMV 68-1 UL/b' sequence is important for using RhCMV 68-1 in pathogenesis and vaccine studies. (C) 2013 Elsevier Inc. All rights reserved.
C1 [Gill, Rachel B.; Bowman, J. Jason; Krogmann, Tammy; Cohen, Jeffrey I.] NIH, Med Virol Sect, Infect Dis Lab, Bethesda, MD 20892 USA.
[Wollenberg, Kurt] NIH, Bioinformat & Computat Biosci Branch, Bethesda, MD 20892 USA.
[Asher, David M.] US FDA, Lab Bacterial & Transmissible Spongiform Encephal, Div Emerging & Transfus Transmitted Dis, Rockville, MD 20852 USA.
RP Cohen, JI (reprint author), NIH, Infect Dis Lab, Bldg 50,Rm 6134,50 South Dr,MSC1807, Bethesda, MD 20892 USA.
EM jcohen@niaid.nih.gov
FU National Institute of Allergy and Infectious Diseases
FX This study was supported by the intramural research program of the
National Institute of Allergy and Infectious Diseases. We thank Anita
Mora and Heather Murphy of Rocky Mountain Laboratories (NIAID) for their
assistance with artwork, Yanmei Wang for assistance with viral DNA
quantification, and Peter Barry for advice with sequencing.
NR 44
TC 1
Z9 1
U1 0
U2 0
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0042-6822
J9 VIROLOGY
JI Virology
PD DEC
PY 2013
VL 447
IS 1-2
BP 208
EP 212
DI 10.1016/j.virol.2013.08.026
PG 5
WC Virology
SC Virology
GA 246QF
UT WOS:000326553500023
PM 24210116
ER
PT J
AU Rudneva, IA
Timofeeva, TA
Ignatieva, AV
Shilov, AA
Krylov, PS
Ilyushina, NA
Kaverin, NV
AF Rudneva, Irina A.
Timofeeva, Tatiana A.
Ignatieva, Anna V.
Shilov, Aleksandr A.
Krylov, Petr S.
Ilyushina, Natalia A.
Kaverin, Nikolai V.
TI Pleiotropic effects of hemagglutinin amino acid substitutions of H5
influenza escape mutants
SO VIROLOGY
LA English
DT Article
DE Influenza escape mutants; H5 hemagglutinin; Pleiotropic
antibody-neutralizing mutations
ID A VIRUS; ANTIGENIC SPECIFICITY; ADAPTATION; MOLECULE; EPITOPES; SITES
AB In the present study we assessed pleiotropic characteristics of the antibody-selected mutations. We examined pH optimum of fusion, temperatures of HA heat inactivation, and in vitro and in vivo replication kinetics of the previously obtained influenza H5 escape mutants. Our results showed that HA1 N142K mutation significantly lowered the pH of fusion optimum. Mutations of the escape mutants located in the HA lateral loop significantly affected H5 HA thermostability (P < 0.05). HA changes at positions 131, 144, 145, and 156 and substitutions at positions 131, 142, 145, and 156 affected the replicative ability of H5 escape mutants in vitro and in vivo, respectively. Overall, a co-variation between antigenic specificity and different HA phenotypic properties has been demonstrated. We believe that the monitoring of pleiotropic effects of the HA mutations found in H5 escape mutants is essential for accurate prediction of mutants with pandemic potential. (C) 2013 Elsevier Inc. All rights reserved.
C1 [Rudneva, Irina A.; Timofeeva, Tatiana A.; Ignatieva, Anna V.; Shilov, Aleksandr A.; Krylov, Petr S.; Kaverin, Nikolai V.] DI Ivanovskii Inst Virol, Moscow 123098, Russia.
[Ilyushina, Natalia A.] FDA CDER, Bethesda, MD 20892 USA.
RP Ilyushina, NA (reprint author), FDA CDER, 29 Lincoln Dr, Bethesda, MD 20892 USA.
EM Natalia.Ilyushina@fda.hhs.gov; nik.kaverin@gmail.com
FU Russian Foundation for Basic Research (RFBR) [13-04-00257]
FX We are especially grateful to Dr. Alexei G. Prilipov for helpful
discussions and help with the experiments on HA thermostability. The
work was supported by Grant #13-04-00257 of Russian Foundation for Basic
Research (RFBR).
NR 28
TC 3
Z9 3
U1 0
U2 5
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0042-6822
J9 VIROLOGY
JI Virology
PD DEC
PY 2013
VL 447
IS 1-2
BP 233
EP 239
DI 10.1016/j.virol.2013.09.013
PG 7
WC Virology
SC Virology
GA 246QF
UT WOS:000326553500026
PM 24210119
ER
PT J
AU Sanchez, MA
Rabin, BA
Gaglio, B
Henton, M
Elzarrad, MK
Purcell, P
Glasgow, RE
AF Sanchez, Michael A.
Rabin, Borsika A.
Gaglio, Bridget
Henton, Michelle
Elzarrad, M. Khair
Purcell, Peyton
Glasgow, Russell E.
TI A systematic review of eHealth cancer prevention and control
interventions: new technology, same methods and designs?
SO TRANSLATIONAL BEHAVIORAL MEDICINE
LA English
DT Review
DE eHealth; Pragmatic trials; Systematic review; Design; PRECIS; External
validity; RE-AIM framework
AB There has been a recent surge of eHealth programs in cancer and other content areas, but few reviews have focused on the methodologies and designs employed in these studies. We conducted a systematic review of studies on eHealth interventions on cancer prevention and control published between 2001 and 2010 applying the Pragmatic Explanatory Continuum Indicator Summary (PRECIS) criteria and external validity components from the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. We identified 113 studies that focused on cancer prevention and control of eHealth interventions. Most studies fell midway along the explanatory/pragmatic trial continuum, but few reported on various practical feasibility criteria for translation. Despite vast interest in cancer eHealth and the applied nature of this field, few studies considered key external validity issues. There is a need for use of alternative pragmatic study designs and transparent reporting of external validity components to produce more rapid and generalizable results.
C1 [Sanchez, Michael A.; Elzarrad, M. Khair] NCI, Bethesda, MD 20892 USA.
[Rabin, Borsika A.; Henton, Michelle] Kaiser Permanente Colorado, CRN Canc Commun Res Ctr, Denver, CO USA.
[Gaglio, Bridget] Kaiser Permanente Midatlantic States, Midatlantic Permanente Res Inst, Rockville, MD USA.
[Elzarrad, M. Khair] NCI, US FDA, Interagency Oncol Task Force IOTF Fellowship Canc, Bethesda, MD 20892 USA.
[Purcell, Peyton] SAIC Frederick Inc, CMRP, Clin Res Directorate, Natl Lab Canc Res, Frederick, MD USA.
RP Sanchez, MA (reprint author), NCI, Bethesda, MD 20892 USA.
EM sanchezgarciama@mail.nih.gov
FU National Cancer Institute Centers of Excellence in Cancer Communication
Research [P20CA137219]; National Cancer Institute; National Institutes
of Health [HHSN261200800001E]
FX The preparation of this manuscript was partially funded through the
National Cancer Institute Centers of Excellence in Cancer Communication
Research (award number P20CA137219). This project has been funded, in
whole or in part, with federal funds from the National Cancer Institute,
the National Institutes of Health, under contract no. HHSN261200800001E.
The content of this publication does not necessarily reflect the views
or policies of the Department of Health and Human Services, nor does it
mention of trade names, commercial products, or organizations implying
endorsement by the US government. The opinions expressed are those of
the authors and do not necessarily reflect those of the National Cancer
Institute.
NR 31
TC 8
Z9 8
U1 3
U2 6
PU SPRINGER INTERNATIONAL PUBLISHING AG
PI CHAM
PA GEWERBESTRASSE 11, CHAM, CH-6330, SWITZERLAND
SN 1869-6716
EI 1613-9860
J9 TRANSL BEHAV MED
JI Transl. Behav. Med.
PD DEC
PY 2013
VL 3
IS 4
BP 392
EP 401
DI 10.1007/s13142-013-0224-1
PG 10
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA V39LR
UT WOS:000209413000008
PM 24294327
ER
PT J
AU Erickson, MC
Liao, J
Payton, AS
Webb, CC
Ma, L
Zhang, GD
Flitcroft, I
Doyle, MP
Beuchat, LR
AF Erickson, Marilyn C.
Liao, Jean
Payton, Alison S.
Webb, Cathy C.
Ma, Li
Zhang, Guodong
Flitcroft, Ian
Doyle, Michael P.
Beuchat, Larry R.
TI Fate of Escherichia coli O157:H7 and Salmonella in soil and lettuce
roots as affected by potential home gardening practices
SO JOURNAL OF THE SCIENCE OF FOOD AND AGRICULTURE
LA English
DT Article
DE Salmonella; Escherichia coli O157:H7; internalization; lettuce; soil;
water stress; compost amendment
ID ENTERICA SEROVAR NEWPORT; MICROBIAL COMMUNITY; IRRIGATION WATER;
ENDOPHYTIC COLONIZATION; ARABIDOPSIS-THALIANA; STRAIN SPECIFICITY;
O157-H7; INTERNALIZATION; RHIZOSPHERE; SURVIVAL
AB BACKGROUNDThe survival and distribution of enteric pathogens in soil and lettuce systems were investigated in response to several practices (soil amendment supplementation and reduced watering) that could be applied by home gardeners.
RESULTSLeaf lettuce was grown in manure compost/top soil (0:5, 1:5 or 2:5 w/w) mixtures. Escherichia coliO157:H7 or Salmonella was applied at a low or high dose (10(3) or 10(6) colony-forming units (CFU) mL(-1)) to the soil of seedlings and mid-age plants. Supplementation of top soil with compost did not affect pathogen survival in the soil or on root surfaces, suggesting that nutrients were not a limiting factor. Salmonella populations on root surfaces were 0.7-0.8 log CFU g(-1) lower for mid-age plants compared with seedlings. E. coliO157:H7 populations on root surfaces were 0.8 log CFU g(-1) lower for mid-age plants receiving 40 mL of water compared with plants receiving 75 mL of water on alternate days. Preharvest internalization of E. coliO157:H7 and Salmonella into lettuce roots was not observed at any time.
CONCLUSIONBased on the environmental conditions and high pathogen populations in soil used in this study, internalization of Salmonella or E. coliO157:H7 into lettuce roots did not occur under practices that could be encountered by inexperienced home gardeners. (c) 2013 Society of Chemical Industry
C1 [Erickson, Marilyn C.; Liao, Jean; Payton, Alison S.; Webb, Cathy C.; Doyle, Michael P.; Beuchat, Larry R.] Univ Georgia, Ctr Food Safety, Griffin, GA 30223 USA.
[Erickson, Marilyn C.; Liao, Jean; Payton, Alison S.; Webb, Cathy C.; Doyle, Michael P.; Beuchat, Larry R.] Univ Georgia, Dept Food Sci & Technol, Griffin, GA 30223 USA.
[Ma, Li] Oklahoma State Univ, Natl Inst Microbial Forens & Food & Agr Biosecur, Stillwater, OK 74078 USA.
[Zhang, Guodong] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Flitcroft, Ian] Univ Georgia, Dept Crop & Soil Sci, Griffin, GA 30223 USA.
RP Erickson, MC (reprint author), Univ Georgia, Ctr Food Safety, 1109 Expt St, Griffin, GA 30223 USA.
EM mericks@uga.edu
FU Fresh Express, Inc.; USDA NIFSI [2007-51110-03812]
FX Financial support for this study was provided in part by Fresh Express,
Inc., by USDA NIFSI grant #2007-51110-03812 and by contributions to the
University of Georgia's Center for Food Safety. Thanks are extended to
Chris Smith, Lindsey Davey and Derrick Huckaby for their technical
assistance.
NR 58
TC 4
Z9 4
U1 2
U2 37
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0022-5142
EI 1097-0010
J9 J SCI FOOD AGR
JI J. Sci. Food Agric.
PD DEC
PY 2013
VL 93
IS 15
BP 3841
EP 3849
DI 10.1002/jsfa.6321
PG 9
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 244PA
UT WOS:000326400300025
PM 23893354
ER
PT J
AU Stine, CB
Nochetto, C
Gieseker, CM
Evans, ER
Hasbrouck, NR
Mayer, TD
Girard, L
Reimschuessel, R
AF Stine, C. B.
Nochetto, C.
Gieseker, C. M.
Evans, E. R.
Hasbrouck, N. R.
Mayer, T. D.
Girard, L.
Reimschuessel, R.
TI Depletion of melamine and cyanuric acid in kidney of catfish Ictalurus
punctatus and trout Oncorhynchus mykiss
SO JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS
LA English
DT Article
ID CRYSTAL-FORMATION; F344 RATS; EXPOSURE
AB A risk assessment conducted in 2007 identified significant knowledge gaps about tissue residues of melamine and related triazine analogs such as cyanuric acid in animals that had eaten contaminated food. The USFDA subsequently designed studies to determine residue levels in muscle, serum, and kidneys of catfish and trout given a single gavage dose of 20mg/kg body weight (BW) of melamine, cyanuric acid, or 20mg/kg BW of both compounds simultaneously. Renal triazines were determined by LC-MS/MS at postdose days 1, 3, 7, 14, 28 (and day 42 for trout). When dosed individually, melamine and cyanuric acid kidney residues depleted much faster than those in fish given both compounds together. Combined dose residue depletion was punctuated by extreme outliers due to the formation of persistent renal melamine cyanurate crystals.
C1 [Stine, C. B.; Nochetto, C.; Gieseker, C. M.; Evans, E. R.; Hasbrouck, N. R.; Mayer, T. D.; Girard, L.; Reimschuessel, R.] US FDA, Ctr Vet Med, Laurel, MD 20708 USA.
RP Stine, CB (reprint author), US FDA, Ctr Vet Med, 8401 Muirkirk Rd, Laurel, MD 20708 USA.
EM Cynthia.Stine@fda.hhs.gov
NR 16
TC 1
Z9 1
U1 1
U2 8
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0140-7783
EI 1365-2885
J9 J VET PHARMACOL THER
JI J. Vet. Pharmacol. Ther.
PD DEC
PY 2013
VL 36
IS 6
BP 617
EP 620
DI 10.1111/jvp.12058
PG 4
WC Pharmacology & Pharmacy; Veterinary Sciences
SC Pharmacology & Pharmacy; Veterinary Sciences
GA 246KE
UT WOS:000326536000013
PM 23682764
ER
PT J
AU McCarthy, PC
Saksena, R
Peterson, DC
Lee, CH
An, YM
Cipollo, JF
Vann, WF
AF McCarthy, Pumtiwitt C.
Saksena, Rina
Peterson, Dwight C.
Lee, Che-Hung
An, Yanming
Cipollo, John F.
Vann, Willie F.
TI Chemoenzymatic synthesis of immunogenic meningococcal group C polysialic
acid-tetanus Hc fragment glycoconjugates
SO GLYCOCONJUGATE JOURNAL
LA English
DT Article
DE Glycoconjugate vaccines; Neisseria meningitidis; Tetanus toxin C
fragment; Chemoenzymatic synthesis; Click chemistry
ID DIALKYL SQUARATE CHEMISTRY; HIGH-LEVEL EXPRESSION; ESCHERICHIA-COLI;
NEISSERIA-MENINGITIDIS; CAMPYLOBACTER-JEJUNI; CAPSULAR POLYSACCHARIDE;
CONJUGATE VACCINE; IMMUNE-RESPONSE; SIALIC ACIDS; O-ANTIGEN
AB Vaccination with meningococcal glycoconjugate vaccines has decreased the incidence of invasive meningitis worldwide. These vaccines contain purified capsular polysaccharides attached to a carrier protein. Because of derivatization chemistries used in the process, conjugation of polysaccharide to protein often results in heterogeneous mixtures. Well-defined vaccines are needed to determine the relationship between vaccine structure and generated immune response. Here, we describe efforts to produce well-defined vaccine candidates by chemoenzymatic synthesis. Chemically synthesized lactosides were substrates for recombinant sialyltransferase enzymes from Camplyobacter jejuni and Neisseria meningitidis serogroup C. These resulting oligosialic acids have the same alpha(2-9) sialic acid repeat structure as Neisseria polysaccharide capsule with the addition of a conjugatable azide aglycon. The degree of polymerization (DP) of carbohydrate products was controlled by inclusion of the inhibitor CMP-9-deoxy-NeuNAc. Polymers with estimated DP < 47 (median DP 25) and DP < 100 (median DP 51) were produced. The receptor binding domain of the tetanus toxin protein (TetHc) was coupled as a carrier to the enzymatically synthesized oligosialic acids. Recombinant TetHc was derivatized with an alkyne squarate. Protein modification sites were determined by trypsin proteolysis followed by LC/MS-MSE analysis of peptides. Oligosialic acid azides were conjugated to modified TetHc via click chemistry. These chemoenzymatically prepared glycoconjugates were reactive in immunoassays with specific antibodies against either group C polysaccharide or TetHc. Sera of mice immunized with oligosialic acid-TetHc glycoconjugates contained much greater levels of polysaccharide-reactive IgG than the sera of control mice receiving unconjugated oligosialic acids. There was no apparent difference between glycoconjugates containing oligosaccharides of DP < 47 and DP < 100. These results suggest that chemoenzymatic synthesis may provide a viable method for making defined meningococcal vaccine candidates.
C1 [McCarthy, Pumtiwitt C.; Saksena, Rina; Peterson, Dwight C.; Lee, Che-Hung; An, Yanming; Cipollo, John F.; Vann, Willie F.] US FDA, Lab Bacterial Polysaccharides, CBER, Bethesda, MD 20892 USA.
RP Vann, WF (reprint author), US FDA, Lab Bacterial Polysaccharides, CBER, 8800 Rockville Pike, Bethesda, MD 20892 USA.
EM willie.vann@fda.hhs.gov
FU Oak Ridge Institute for Science and Education; National Institutes of
Health Pharmacology Research Associate Training (PRAT) Program
FX P. C. M was supported by postdoctoral fellowships from the Oak Ridge
Institute for Science and Education and the National Institutes of
Health Pharmacology Research Associate Training (PRAT) Program. The
authors acknowledge Justine Vionnet and Dr. Karen Muindi for technical
assistance. The authors also acknowledge Drs. Daron Freedberg and Marcos
Battistel for HSQC NMR spectra.
NR 40
TC 8
Z9 8
U1 1
U2 23
PU SPRINGER
PI DORDRECHT
PA VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS
SN 0282-0080
EI 1573-4986
J9 GLYCOCONJUGATE J
JI Glycoconjugate J.
PD DEC
PY 2013
VL 30
IS 9
BP 857
EP 870
DI 10.1007/s10719-013-9490-x
PG 14
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 241TB
UT WOS:000326189600005
PM 23949787
ER
PT J
AU Zidan, AS
Spinks, CB
Habib, MJ
Khan, MA
AF Zidan, Ahmed S.
Spinks, Crystal B.
Habib, Muhammad J.
Khan, Mansoor A.
TI Formulation and transport properties of tenofovir loaded liposomes
through Caco-2 cell model
SO JOURNAL OF LIPOSOME RESEARCH
LA English
DT Article
DE Caco-2; cytotoxicity; permeability; proliposomes; tenofovir
ID DRUG-DELIVERY; CATIONIC LIPOSOMES; HIV-INFECTION; ABSORPTION;
PERMEABILITY; DIFFUSION; PHARMACOKINETICS; DISOPROXIL; MONOLAYERS;
CAVEOLAE
AB The aim was to investigate the potential of proliposomes to improve the permeability of tenofovir, anti-HIV, for oral delivery. Tenofovir was incorporated into phosphatidylcholine proliposomes and their absorption was determined in Caco-2 cell cultures grown on Transwell inserts using aqueous drug solutions as reference. Five batches of proliposomes were prepared with different stearylamine levels and characterized in terms of vesicular morphology, drug encapsulation efficiency (EEF), drug leakage, vesicular sizing and surface charges. Cytotoxicity of the reconstituted liposomes was evaluated by the MTT assay. The obtained results showed that increasing the incorporated percentage of stearylamine led to an increase in drug encapsulation, a slower drug leakage and larger liposomes formed. Compared to the drug solutions at corresponding concentrations, the proposed formulations showed a positive relationship (R-2 = 0.9756) for the influence of increasing the stearylamine percentage on reduction of mitochondrial activity. Regarding the drug permeability, enhancements of apparent permeability by 16.5- and 5.2-folds were observed for proliposomes formulations with 5% and 15% stearylamine, respectively. A good correlation was observed between the Caco-2 and dialysis models that might indicate passive diffusion as well as paracellular transport as suggested mechanisms for drug absorption. Cationic proliposomes offered a potential formulation to improve the permeation of tenofovir.
C1 [Zidan, Ahmed S.] King Abdulaziz Univ, Fac Pharm, Dept Pharmaceut & Ind Pharm, Jeddah 21413, Saudi Arabia.
[Zidan, Ahmed S.] Zagazig Univ, Fac Pharm, Zagazig, Egypt.
[Spinks, Crystal B.; Khan, Mansoor A.] US FDA, Div Prod Qual Res, Off Pharmaceut Sci, Rockville, MD 20857 USA.
[Spinks, Crystal B.; Habib, Muhammad J.] Howard Univ, Dept Pharmaceut Sci, Sch Pharm, Washington, DC 20059 USA.
RP Khan, MA (reprint author), US FDA, Div Prod Qual Res, Off Pharmaceut Sci, Rockville, MD 20857 USA.
EM Manssor.khan@fda.hhs.gov
RI Zidan, Ahmed/I-1147-2012
NR 49
TC 6
Z9 6
U1 0
U2 20
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 0898-2104
EI 1532-2394
J9 J LIPOSOME RES
JI J. Liposome Res.
PD DEC
PY 2013
VL 23
IS 4
BP 318
EP 326
DI 10.3109/08982104.2013.810645
PG 9
WC Biochemistry & Molecular Biology; Pharmacology & Pharmacy
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy
GA 232VM
UT WOS:000325522500007
PM 23915251
ER
PT J
AU Van Doren, JM
Blodgett, RJ
Pouillot, R
Westerman, A
Kleinmeier, D
Ziobro, GC
Ma, YQ
Hammack, TS
Gill, V
Muckenfuss, MF
Fabbri, L
AF Van Doren, Jane M.
Blodgett, Robert J.
Pouillot, Regis
Westerman, Ann
Kleinmeier, Daria
Ziobro, George C.
Ma, Yinqing
Hammack, Thomas S.
Gill, Vikas
Muckenfuss, Martin F.
Fabbri, Linda
TI Prevalence, level and distribution of Salmonella in shipments of
imported capsicum and sesame seed spice offered for entry to the United
States: Observations and modeling results
SO FOOD MICROBIOLOGY
LA English
DT Article
DE Salmonella contamination; Spice; Enumeration; Maximum likelihood
estimation; Microbial contamination assessment
ID MICROBIAL DISTRIBUTIONS; MICROBIOLOGICAL SAFETY; RISK-ASSESSMENT;
ALFALFA SEEDS; NUT KERNELS; OUTBREAK; CONFIDENCE; PRODUCTS; GERMANY;
IMPACT
AB In response to increased concerns about spice safety, the United States Food and Drug Administration (FDA) initiated research to characterize the prevalence and levels of Salmonella in imported spices. 299 imported dried capsicum shipments and 233 imported sesame seed shipments offered for entry to the United States were sampled. Observed Salmonella shipment prevalence was 3.3% (1500 g examined; 95% CI 1.6-6.1%) for capsicum and 9.9% (1500 g; 95% Confidence Interval (CI) 6.3-14%) for sesame seed. Within shipment contamination was not inconsistent with a Poisson distribution. Shipment mean Salmonella level estimates among contaminated shipments ranged from 6 x 10(-4) to 0.09 (capsicum) or 6 x 10(-4) to 0.04 (sesame seed) MPN/g. A gamma-Poisson model provided the best fit to observed data for both imported shipments of capsicum and imported shipments of sesame seed sampled in this study among the six parametric models considered. Shipment mean levels of Salmonella vary widely between shipments; many contaminated shipments contain low levels of contamination. Examination of sampling plan efficacy for identifying contaminated spice shipments from these distributions indicates that sample size of spice examined is critical. Sampling protocols examining 25 g samples are predicted to be able to identify a small fraction of contaminated shipments of imported capsicum or sesame seeds. Published by Elsevier Ltd.
C1 [Van Doren, Jane M.; Blodgett, Robert J.; Pouillot, Regis; Kleinmeier, Daria; Ziobro, George C.; Ma, Yinqing; Hammack, Thomas S.; Gill, Vikas] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Westerman, Ann; Fabbri, Linda] US FDA, Off Regulatory Affairs, Silver Spring, MD 20993 USA.
[Muckenfuss, Martin F.] US FDA, Off Regulatory Affairs, Rockville, MD 20857 USA.
RP Van Doren, JM (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM jane.vandoren@fda.hhs.gov
RI Pouillot, Regis/E-8103-2010
OI Pouillot, Regis/0000-0002-6107-5212
FU FDA; Center for Food Safety and Applied Nutrition
FX The authors recognize and thank the hundreds of Office of Regulatory
Affairs (ORA) field staff within FDA's district offices who participated
in the sampling assignment associated with this study, including
Consumer Safety Officers and Inspectors who collected spice shipment
information, and laboratory scientists who analyzed the spice samples
for presence of Salmonella, sero-typing and antibiotic resistance. We
also thank and acknowledge FDA/CFSAN staff members who helped develop
and implement the field assignment associated with this study. The
results of this study will be incorporated into the risk profile on
pathogens and filth being development by FDA and we thank the following
risk profile team members who reviewed this manuscript: Drs. Mickey
Parish and Obianugu Nsofor from FDA/CFSAN and Drs. Karen Neil and Laura
Gieraltowski from CDC/OID. Additional scientists from CDC and FDA also
provided helpful comments. This work was funded by the FDA. This work
was supported in part by an appointment to the Research Participation
Program at the Center for Food Safety and Applied Nutrition administered
by the Oak Ridge Institute for Science and Education through an
interagency agreement between the U.S. Department of Energy and the FDA.
NR 44
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U2 29
PU ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
EI 1095-9998
J9 FOOD MICROBIOL
JI Food Microbiol.
PD DEC
PY 2013
VL 36
IS 2
BP 149
EP 160
DI 10.1016/j.fm.2013.05.003
PG 12
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 226MF
UT WOS:000325039700005
PM 24010593
ER
PT J
AU Hellberg, RS
Martin, KG
Keys, AL
Haney, CJ
Shen, YL
Smiley, RD
AF Hellberg, Rosalee S.
Martin, Keely G.
Keys, Ashley L.
Haney, Christopher J.
Shen, Yuelian
Smiley, R. Derike
TI 16S rRNA partial gene sequencing for the differentiation and molecular
subtyping of Listeria species
SO FOOD MICROBIOLOGY
LA English
DT Article
DE Listeria; 16S rRNA gene; DNA sequencing; MicroSeq ID; Molecular
subtyping
ID INTRAGENOMIC HETEROGENEITY; CLINICAL MICROBIOLOGY; GENOME SEQUENCE;
MULTIPLEX PCR; SP NOV.; IDENTIFICATION; MONOCYTOGENES; DIVERSITY;
BACTERIA; STRAINS
AB Use of 16S rRNA partial gene sequencing within the regulatory workflow could greatly reduce the time and labor needed for confirmation and subtyping of Listeria monocytogenes. The goal of this study was to build a 16S rRNA partial gene reference library for Listeria spp. and investigate the potential for 16S rRNA molecular subtyping. A total of 86 isolates of Listeria representing L innocua, L. seeligeri, L welshimeri, and L. monocytogenes were obtained for use in building the custom library. Seven non-Listeria species and three additional strains of Listeria were obtained for use in exclusivity and food spiking tests. Isolates were sequenced for the partial 16S rRNA gene using the MicroSeq ID 500 Bacterial Identification Kit (Applied Biosystems). High-quality sequences were obtained for 84 of the custom library isolates and 23 unique 16S sequence types were discovered for use in molecular subtyping. All of the exclusivity strains were negative for Listeria and the three Listeria strains used in food spiking were consistently recovered and correctly identified at the species level. The spiking results also allowed for differentiation beyond the species level, as 87% of replicates for one strain and 100% of replicates for the other two strains consistently matched the same 16S type. (C) 2013 Elsevier Ltd. All rights reserved.
C1 [Hellberg, Rosalee S.] Chapman Univ, Sch Earth & Environm Sci Food Sci & Nutr, Orange, CA 92866 USA.
[Martin, Keely G.; Keys, Ashley L.; Haney, Christopher J.; Smiley, R. Derike] US FDA, Off Regulatory Affairs, Arkansas Reg Lab, Jefferson, AR 72079 USA.
[Shen, Yuelian] US FDA, Off Regulatory Affairs, Off Reg Operat, Div Field Sci, Rockville, MD 20857 USA.
RP Hellberg, RS (reprint author), Chapman Univ, Sch Earth & Environm Sci Food Sci & Nutr, 1 Univ Dr, Orange, CA 92866 USA.
EM hellberg@chapman.edu
NR 37
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U1 1
U2 31
PU ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
J9 FOOD MICROBIOL
JI Food Microbiol.
PD DEC
PY 2013
VL 36
IS 2
BP 231
EP 240
DI 10.1016/j.fm.2013.06.001
PG 10
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 226MF
UT WOS:000325039700014
PM 24010602
ER
PT J
AU Buzatu, DA
Cooper, WM
Summage-West, C
Sutherland, JB
Williams, AJ
Bass, DA
Smith, LL
Woodruff, RS
Christman, JM
Reid, S
Tucker, RK
Haney, CJ
Ahmed, A
Rafii, F
Wilkes, JG
AF Buzatu, Dan A.
Cooper, Willie M.
Summage-West, Christine
Sutherland, John B.
Williams, Anna J.
Bass, Deborah A.
Smith, Lisa L.
Woodruff, Robert S.
Christman, Jessica M.
Reid, Steven
Tucker, Randal K.
Haney, Christopher J.
Ahmed, Ashfaqe
Rafii, Fatemeh
Wilkes, Jon G.
TI Photobleaching with phloxine B sensitizer to reduce food matrix
interference for detection of Escherichia coli serotype O157:H7 in fresh
spinach by flow cytometry
SO FOOD MICROBIOLOGY
LA English
DT Article
DE Flow cytometry; RAPID-B; Food matrix interference; Photobleaching; Same
day analysis; Escherichia coli O157:H7
ID SAMPLE PREPARATION; APPLE JUICE; O157-H7; OUTBREAK; O157/H7
AB A flow cytometric method (RAPlD-B (TM)) with detection sensitivity of one viable cell of Escherichia coli serotype O157:H7 in fresh spinach (Spinacia oleracea) was developed and evaluated. The major impediment to achieving this performance was mistaking autofluorescing spinach particles for tagged target cells. Following a 5 h non-selective enrichment, artificially inoculated samples were photobleached, using phloxine B as a photosensitizer. Samples were centrifuged at high speed to concentrate target cells, then gradient centrifuged to separate them from matrix debris. In external laboratory experiments, RAPID-B and the reference method both correctly detected E. coli 0157:H7 at inoculations of ca. 15 cells. In a follow-up study, after 4 cell inoculations of positives and 6 h enrichment, RAPID-B correctly identified 92% of 25 samples. The RAPID-B method limit of detection (LOD) was one cell in 25 g. It proved superior to the reference method (which incorporated real time-PCR, selective enrichment, and culture plating elements) in accuracy and speed. Published by Elsevier Ltd.
C1 [Buzatu, Dan A.; Cooper, Willie M.; Summage-West, Christine; Sutherland, John B.; Williams, Anna J.; Tucker, Randal K.; Rafii, Fatemeh; Wilkes, Jon G.] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Bass, Deborah A.; Smith, Lisa L.; Woodruff, Robert S.; Christman, Jessica M.; Reid, Steven; Ahmed, Ashfaqe] US FDA, Arkansas Reg Lab, Jefferson, AR 72079 USA.
[Haney, Christopher J.] US FDA, Ctr Tobacco Prod, Rockville, MD 20850 USA.
RP Wilkes, JG (reprint author), US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM dan.buzatu@fda.hhs.gov; willie.cooper@fda.hhs.gov;
christine.summage-west@fda.hhs.gov; john.sutherland@fda.hhs.gov;
anna.williams@fda.hhs.gov; deborah.bass@fda.hhs.gov;
lisal.smith@fda.hhs.gov; robert.woodruff@fda.hhs.gov;
jessica.christman@fda.hhs.gov; steven.reid@fda.hhs.gov;
viceroy@arkansas.net; christopher.haney@fda.hhs.gov;
fatemeh.rafii@fda.hhs.gov; jon.wilkes@fda.hhs.gov
NR 29
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U1 4
U2 39
PU ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
EI 1095-9998
J9 FOOD MICROBIOL
JI Food Microbiol.
PD DEC
PY 2013
VL 36
IS 2
BP 416
EP 425
DI 10.1016/j.fm.2013.07.007
PG 10
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 226MF
UT WOS:000325039700036
PM 24010624
ER
PT J
AU Van Doren, JM
Neil, KP
Parish, M
Gieraltowski, L
Gould, LH
Gombas, KL
AF Van Doren, Jane M.
Neil, Karen P.
Parish, Mickey
Gieraltowski, Laura
Gould, L. Hannah
Gombas, Kathy L.
TI Foodborne illness outbreaks from microbial contaminants in spices,
1973-2010
SO FOOD MICROBIOLOGY
LA English
DT Review
DE Foodborne illness; Spice; Salmonella; Food safety; Microbial
contaminants
ID UNITED-STATES; MICROBIOLOGICAL QUALITY; HUMAN SALMONELLOSIS; BLACK
PEPPER; FOOD; INFECTIONS; PATHOGENS; PREVALENCE; RESISTANCE; PRODUCTS
AB This review identified fourteen reported illness outbreaks attributed to consumption of pathogen-contaminated spice during the period 1973-2010. Countries reporting outbreaks included Canada, Denmark, England and Wales, France, Germany, New Zealand, Norway, Serbia, and the United States. Together, these outbreaks resulted in 1946 reported human illnesses, 128 hospitalizations and two deaths. Infants/children were the primary population segments impacted by 36% (5/14) of spice-attributed outbreaks. Four outbreaks were associated with multiple organisms. Salmonella enterica subspecies enterica was identified as the causative agent in 71% (10/14) of outbreaks, accounting for 87% of reported illnesses. Bacillus spp. was identified as the causative agent in 29% (4/10) of outbreaks, accounting for 13% of illnesses. 71% (10/14) of outbreaks were associated with spices classified as fruits or seeds of the source plant. Consumption of ready-to-eat foods prepared with spices applied after the final food manufacturing pathogen reduction step accounted for 70% of illnesses. Pathogen growth in spiced food is suspected to have played a role in some outbreaks, but it was not likely a contributing factor in three of the larger Salmonella outbreaks, which involved low-moisture foods. Root causes of spice contamination included contributions from both early and late stages of the farm-to-table continuum. Published by Elsevier Ltd.
C1 [Van Doren, Jane M.; Parish, Mickey; Gombas, Kathy L.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Neil, Karen P.; Gieraltowski, Laura; Gould, L. Hannah] Ctr Dis Control & Prevent, Natl Ctr Emerging & Zoonot Infect Dis, Div Foodborne Waterborne & Environm Dis, Atlanta, GA 30333 USA.
RP Van Doren, JM (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM jane.vandoren@fda.hhs.gov
FU United States FDA; CDC
FX The authors thank the many federal, state and international scientists
who discussed the outbreak investigations with the authors and in some
cases, provided additional information about the outbreak investigations
that were incorporated into this manuscript, especially C. L Little
(Health Protection Agency, United Kingdom.), G. Delmas (Institut de
Veille Sanitaire, France), J. Higa (California Department of Public
Health), R. Ireland and D. Quilliam (Rhode Island Department of Public
Health), and M. Allard, T. DuVernoy, E. Pomeroy, S. Gordon, and E.
Strain (FDA). We also thank S. Mettee for her assistance in reviewing
CDC's Foodborne Disease Outbreak and Surveillance System, and I.
Williams (CDC), for his feedback on this manuscript throughout its
development. The results of this study will be incorporated into the
risk profile on pathogens and filth in spices being developed by FDA and
we thank the following risk profile team members who reviewed and
commented on this manuscript: V. Gill, D. Kleinmeier, M. Muckenfuss, O.
Nsofor, A. Westerman, and G. C. Ziobro (FDA). Additional scientists from
CDC and FDA also provided helpful comments. This work was funded by the
United States FDA and CDC.
NR 71
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U1 1
U2 88
PU ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
J9 FOOD MICROBIOL
JI Food Microbiol.
PD DEC
PY 2013
VL 36
IS 2
BP 456
EP 464
DI 10.1016/j.fm.2013.04.014
PG 9
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 226MF
UT WOS:000325039700041
PM 24010629
ER
PT J
AU Micallef, SA
Goldstein, RER
George, A
Ewing, L
Tall, B
Boyer, MS
Joseph, SW
Sapkota, AR
AF Micallef, Shirley A.
Goldstein, Rachel E. Rosenberg
George, Ashish
Ewing, Laura
Tall, Ben D.
Boyer, Marc S.
Joseph, Sam W.
Sapkota, Amy R.
TI Diversity, distribution and antibiotic resistance of Enterococcus spp.
recovered from tomatoes, leaves, water and soil on US Mid-Atlantic farms
SO FOOD MICROBIOLOGY
LA English
DT Article
DE Pre-harvest tomatoes; Enterococcus spp.; Enterococcus faecalis;
Antibiotic resistance; Food safety; Soil; Water; Amplified fragment
length polymorphism
ID ANTIMICROBIAL RESISTANCE; MULTIPLEX PCR; FRESH PRODUCE; CASSELIFLAVUS;
VIRULENCE; FOODS; IDENTIFICATION; POPULATIONS; MENINGITIS; DISPERSAL
AB Antibiotic-resistant enterococci are important opportunistic pathogens and have been recovered from retail tomatoes. However, it is unclear where and how tomatoes are contaminated along the farm-to-fork continuum. Specifically, the degree of pre-harvest contamination with enterococci is unknown. We evaluated the prevalence, diversity and antimicrobial susceptibilities of enterococci collected from tomato farms in the Mid-Atlantic United States. Tomatoes, leaves, groundwater, pond water, irrigation ditch water, and soil were sampled and tested for enterococci using standard methods. Antimicrobial susceptibility testing was performed using the Sensititre microbroth dilution system. Enterococcus faecalis isolates were characterized using amplified fragment length polymorphism to assess dispersal potential. Enterococci (n = 307) occurred in all habitats and colonization of tomatoes was common. Seven species were identified: Enterococcus casseliflavus, E. faecalis, Enterococcus gallinarum, Enterococcus faecium, Enterococcus avis, Enterococcus hirae and Enterococcus raffinosus. E. casseliflavus predominated in soil and on tomatoes and leaves, and E. faecalis predominated in pond water. On plants, distance from the ground influenced presence of enterococci. E. faecalis from samples within a farm were more closely related than those from samples between farms. Resistance to rifampicin, quinupristin/dalfopristin, ciprofloxacin and levofloxacin was prevalent. Consumption of raw tomatoes as a potential exposure risk for antibiotic-resistant Enterococcus spp. deserves further attention. (C) 2013 Elsevier Ltd. All rights reserved.
C1 [Micallef, Shirley A.; Goldstein, Rachel E. Rosenberg; George, Ashish; Joseph, Sam W.; Sapkota, Amy R.] Univ Maryland, Sch Publ Hlth, Maryland Inst Appl Environm Hlth, College Pk, MD 20742 USA.
[Ewing, Laura; Tall, Ben D.] US Food & Drug Adm FDA, Virulence Mech Branch, Div Virulence Assessment, OARSA,CFSAN, Laurel, MD 20708 USA.
[Boyer, Marc S.] US Food & Drug Adm FDA, Off Food Def Commun & Emergency Response, CFSAN, College Pk, MD 20740 USA.
RP Sapkota, AR (reprint author), Univ Maryland, Sch Publ Hlth, Maryland Inst Appl Environm Hlth, Room 2234P,SPH Bldg, College Pk, MD 20742 USA.
EM ars@umd.edu
RI Sapkota, Amy/A-6046-2011;
OI Tall, Ben/0000-0003-0399-3629
FU University of Maryland; Joint Institute for Food Safety and Applied
Nutrition (JIFSAN); Centers for Disease Control and Prevention (CDC)
[5U01CI000310]
FX The authors would like to thank Steve Rideout, Andrew J. Estrin and
Cristina R. McClaughlin for their help in the planning stages of this
project and the Virginia Institute for Marine Sciences for laboratory
space during sampling. This research was supported by the University of
Maryland, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
and Grant/Cooperative Agreement Number 5U01CI000310 from the Centers for
Disease Control and Prevention (CDC). Its contents are solely the
responsibility of the authors and do not necessarily represent the
official views of CDC.
NR 35
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U1 4
U2 76
PU ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
J9 FOOD MICROBIOL
JI Food Microbiol.
PD DEC
PY 2013
VL 36
IS 2
BP 465
EP 474
DI 10.1016/j.fm.2013.04.016
PG 10
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 226MF
UT WOS:000325039700042
PM 24010630
ER
PT J
AU Kang, L
Carter, R
Darcy, K
Kauderer, J
Liao, SY
AF Kang, Le
Carter, Randy
Darcy, Kathleen
Kauderer, James
Liao, Shu-Yuan
TI A fast Monte Carlo expectation-maximization algorithm for estimation in
latent class model analysis with an application to assess diagnostic
accuracy for cervical neoplasia in women with atypical glandular cells
SO JOURNAL OF APPLIED STATISTICS
LA English
DT Article
DE adjusted information matrix; bootstrap standard errors; diagnostic
accuracy; imperfect gold standard; latent class model; MCEM estimation
ID EM ALGORITHM; MAXIMUM-LIKELIHOOD; CONDITIONAL DEPENDENCE; CYTOLOGIC
DIAGNOSIS; INFORMATION MATRIX; GOLD STANDARD; UNITED-STATES; BINARY
DATA; TESTS; PREVALENCE
AB In this article, we use a latent class model (LCM) with prevalence modeled as a function of covariates to assess diagnostic test accuracy in situations where the true disease status is not observed, but observations on three or more conditionally independent diagnostic tests are available. A fast Monte Carlo expectation-maximization (MCEM) algorithm with binary (disease) diagnostic data is implemented to estimate parameters of interest; namely, sensitivity, specificity, and prevalence of the disease as a function of covariates. To obtain standard errors for confidence interval construction of estimated parameters, the missing information principle is applied to adjust information matrix estimates. We compare the adjusted information matrix-based standard error estimates with the bootstrap standard error estimates both obtained using the fast MCEM algorithm through an extensive Monte Carlo study. Simulation demonstrates that the adjusted information matrix approach estimates the standard error similarly with the bootstrap methods under certain scenarios. The bootstrap percentile intervals have satisfactory coverage probabilities. We then apply the LCM analysis to a real data set of 122 subjects from a Gynecologic Oncology Group study of significant cervical lesion diagnosis in women with atypical glandular cells of undetermined significance to compare the diagnostic accuracy of a histology-based evaluation, a carbonic anhydrase-IX biomarker-based test and a human papillomavirus DNA test.
C1 [Kang, Le] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Carter, Randy] SUNY Buffalo, Dept Biostat, Buffalo, NY 14214 USA.
[Carter, Randy] SUNY Buffalo, Inst Healthcare Informat, Buffalo, NY 14203 USA.
[Carter, Randy; Darcy, Kathleen; Kauderer, James] GOG Stat & Data Ctr, Buffalo, NY 14263 USA.
[Liao, Shu-Yuan] Univ Calif Irvine, Sch Med, Irvine, CA 92697 USA.
RP Carter, R (reprint author), SUNY Buffalo, Dept Biostat, 3435 Main St, Buffalo, NY 14214 USA.
EM rcarter@buffalo.edu
FU National Cancer Institute; GOG Tissue Bank [CA 27469]; GOG Statistical
and Data Center [CA 37517]; Research Participation Program at the Center
for Devices and Radiological Health
FX This study was supported by National Cancer Institute grants to the
Gynecologic Oncology Group (GOG) Administrative Office and the GOG
Tissue Bank (CA 27469), and the GOG Statistical and Data Center (CA
37517). Le Kang was supported in part by an appointment to the Research
Participation Program at the Center for Devices and Radiological Health
administered by the Oak Ridge Institute for Science and Education
through an interagency agreement between the US Department of Energy and
the US Food and Drug Administration. The authors would like to thank the
anonymous referees for helpful discussions and comments that greatly
improved the article. A supplementary R code to implement the fast MCEM
algorithm described in this article and the real data example with
patient ID information removed are available upon request.
NR 51
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U1 0
U2 4
PU TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXON, ENGLAND
SN 0266-4763
J9 J APPL STAT
JI J. Appl. Stat.
PD DEC 1
PY 2013
VL 40
IS 12
BP 2699
EP 2719
DI 10.1080/02664763.2013.825704
PG 21
WC Statistics & Probability
SC Mathematics
GA 228PF
UT WOS:000325198000010
PM 24163493
ER
PT J
AU Rosenberg, AS
Roivainen, M
Hovi, T
Liu, Q
Murphy, PM
AF Rosenberg, A. S.
Roivainen, M.
Hovi, T.
Liu, Q.
Murphy, P. M.
TI CCR5 Deficiency and Severe Polio Infection in the 1984 Outbreak in
Finland
SO JOURNAL OF MEDICAL VIROLOGY
LA English
DT Article
DE poliovirus; CCR5delta32; neuropathology
ID NILE-VIRUS-INFECTION; CHEMOKINE RECEPTORS; POLIOMYELITIS
AB CCR5, a leukocyte chemoattractant receptor for chemokines CCL3, CCL4, and CCL5, promotes innate and adaptive immune responses by mediating leukocyte trafficking within lymph nodes and to peripheral tissues and is also known as a co-receptor for HIV cell entry. Homozygous inheritance of a complete loss-of-function mutation in CCR5 (CCR532/CCR532) is associated with symptomatic neuroinflammatory disease in humans with West Nile and Tickborne Encephalitis flavivirus infections. This study sought to establish whether CCR5 deficiency could also be a determinant of clinical outcome after infection by poliovirus which results in central nervous system damage in only a small proportion of cases. We analyzed serum samples from seven patients and 79 controls, collected during the 1984-1985 polio outbreak in Finland, where CCR532 is relatively common in the general population. The results excluded CCR5 deficiency as the sole determinant of severe neurologic disease after poliovirus infection in this population. J. Med. Virol. 85:2139-2140, 2013. (c) 2013 Wiley Periodicals, Inc.
C1 [Rosenberg, A. S.] US FDA, Div Therapeut Prot, Off Biotechnol Prod, CDER, Silver Spring, MD USA.
[Roivainen, M.; Hovi, T.] Natl Inst Hlth & Welf THL, Dept Infect Dis Surveillance & Control, Virol Unit, Helsinki, Finland.
[Liu, Q.; Murphy, P. M.] NIAID, Lab Mol Immunol, NIH, Bethesda, MD 20892 USA.
RP Rosenberg, AS (reprint author), US FDA, Div Therapeut Prot, Off Biotechnol Prod, CDER, Silver Spring, MD USA.
EM amy.rosenberg@fda.hhs.gov
NR 10
TC 0
Z9 0
U1 0
U2 16
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0146-6615
J9 J MED VIROL
JI J. Med. Virol.
PD DEC
PY 2013
VL 85
IS 12
BP 2139
EP 2140
DI 10.1002/jmv.23739
PG 2
WC Virology
SC Virology
GA 227ZE
UT WOS:000325153400012
PM 24037958
ER
PT J
AU Kang, L
Xiong, CJ
Tian, LL
AF Kang, Le
Xiong, Chengjie
Tian, Lili
TI Estimating confidence intervals for the difference in diagnostic
accuracy with three ordinal diagnostic categories without a gold
standard
SO COMPUTATIONAL STATISTICS & DATA ANALYSIS
LA English
DT Article
DE EM algorithm; Generalized pivot; Gold standard; Parametric bootstrap;
Volume under the ROC surface
ID ROC ANALYSIS; CHOICE
AB With three ordinal diagnostic categories, the most commonly used measures for the overall diagnostic accuracy are the volume under the ROC surface (VUS) and partial volume under the ROC surface (PVUS), which are the extensions of the area under the ROC curve (AUC) and partial area under the ROC curve (PAUC), respectively. A gold standard (GS) test on the true disease status is required to estimate the VUS and PVUS. However, oftentimes it may be difficult, inappropriate, or impossible to have a GS because of misclassification error, risk to the subjects or ethical concerns. Therefore, in many medical research studies, the true disease status may remain unobservable. Under the normality assumption, a maximum likelihood (ML) based approach using the expectation-maximization (EM) algorithm for parameter estimation is proposed. Three methods using the concepts of generalized pivot and parametric/nonparametric bootstrap for confidence interval estimation of the difference in paired VUSs and PVUSs without a GS are compared. The coverage probabilities of the investigated approaches are numerically studied. The proposed approaches are then applied to a real data set of 118 subjects from a cohort study in early stage Alzheimer's disease (AD) from the Washington University Knight Alzheimer's Disease Research Center to compare the overall diagnostic accuracy of early stage AD between two different pairs of neuropsychological tests. (C) 2013 Elsevier B.V. All rights reserved.
C1 [Kang, Le] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Xiong, Chengjie] Washington Univ, Div Biostat, St Louis, MO 63110 USA.
[Tian, Lili] SUNY Buffalo, Dept Biostat, Buffalo, NY 14214 USA.
RP Tian, LL (reprint author), SUNY Buffalo, Dept Biostat, 706 Kimball Tower,3435 Main St, Buffalo, NY 14214 USA.
EM ltian@buffalo.edu
FU National Institute on Aging [P50 AG05681, P01 AG03991, R01 AG034119]
FX This study was partly supported by National Institute on Aging grant P50
AG05681, P01 AG03991, and R01 AG034119 for Dr. Chengjie Xiong. The
opinions expressed are those of the authors and not necessarily those of
the Editors. The authors thank the referees for helpful discussions and
comments.
NR 19
TC 1
Z9 1
U1 0
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0167-9473
EI 1872-7352
J9 COMPUT STAT DATA AN
JI Comput. Stat. Data Anal.
PD DEC
PY 2013
VL 68
BP 326
EP 338
DI 10.1016/j.csda.2013.07.007
PG 13
WC Computer Science, Interdisciplinary Applications; Statistics &
Probability
SC Computer Science; Mathematics
GA 225NA
UT WOS:000324968400022
ER
PT J
AU Rong, ZM
Alayash, AI
Wilson, MT
Cooper, CE
AF Rong, Zimei
Alayash, Abdu I.
Wilson, Michael T.
Cooper, Chris E.
TI Modulating hemoglobin nitrite reductase activity through allostery: A
mathematical model
SO NITRIC OXIDE-BIOLOGY AND CHEMISTRY
LA English
DT Article
DE Nitrite; Nitric oxide; Hemoglobin; Nitrite reductase activity; Kinetics;
Fetal
ID HUMAN CIRCULATION; OXIDE; OXYGEN; NO; PHYSIOLOGY; VASODILATION;
CONTRIBUTES; SYNTHASES; BIOLOGY; FETAL
AB The production of nitric oxide by hemoglobin (Hb) has been proposed to play a major role in the control of blood flow. Because of the allosteric nature of hemoglobin, the nitrite reductase activity is a complex function of oxygen partial pressure P-O2. We have previous developed a model to obtain the micro rate constants for nitrite reduction by R state (k(R)) and T state (k(T)) hemoglobin in terms of the experimental maximal macro rate constant k(Nmax) and the corresponding oxygen concentration P-O2max. However, because of the intrinsic difficulty in obtaining accurate macro rate constant k(N), from available experiments, we have developed an alternative method to determine the micro reaction rate constants (k(R) and k(T)) by fitting the simulated macro reaction rate curve (k(N) versus P-O2) to the experimental data. We then use our model to analyze the effect of pH (Bohr Effect) and blood ageing on the nitrite reductase activity, showing that the fall of bisphosphoglycerate (BPG) during red cell storage leads to increase NO production. Our model can have useful predictive and explanatory power. For example, the previously described enhanced nitrite reductase activity of ovine fetal Hb, in comparison to the adult protein, may be understood in terms of a weaker interaction with BPG and an increase in the value of k(T) from 0.0087 M(-1)s(-1) to 0.083 M(-1)s(-1). (C) 2013 Elsevier Inc. All rights reserved.
C1 [Rong, Zimei; Wilson, Michael T.; Cooper, Chris E.] Univ Essex, Sch Biol Sci, Colchester CO4 3SQ, Essex, England.
[Alayash, Abdu I.] US FDA, Ctr Biol Evaluat & Res, Lab Biochem & Vasc Biol, Bethesda, MD 20892 USA.
[Rong, Zimei] Univ Nottingham Ningbo China, Ctr English Language Educ, Ningbo 315100, Zhejiang, Peoples R China.
RP Rong, ZM (reprint author), Univ Essex, Sch Biol Sci, Wivenhoe Pk, Colchester CO4 3SQ, Essex, England.
EM zrong@essex.ac.uk; Abdu.Alayash@fda.nhs.gov; wilsmt@essex.ac.uk;
ccooper@essex.ac.uk
OI Rong, Zimei/0000-0002-7642-3160; Cooper, Chris/0000-0003-0381-3990
FU Leverhulme Trust [F/00 213/T]; National Institutes of Health (NIH)
[HL110900]; U.S. Food and Drug Administration [MODSCI 2012]
FX This work is financially supported by the Leverhulme Trust (F/00
213/T).; The authors acknowledge the expert assistance of Francine Wood
in performing oxygen equilibrium curves and Drs. M. P. Gelderman
(CBER/FDA) and M. H. Yazer (University of Pittsburgh) for providing and
processing blood samples used in this study. This work was supported in
part by The National Institutes of Health (NIH) under grants HL110900
and the U.S. Food and Drug Administration (MODSCI 2012) (AIA).
NR 26
TC 1
Z9 1
U1 1
U2 11
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 1089-8603
EI 1089-8611
J9 NITRIC OXIDE-BIOL CH
JI Nitric Oxide-Biol. Chem.
PD NOV 30
PY 2013
VL 35
BP 193
EP 198
DI 10.1016/j.niox.2013.10.007
PG 6
WC Biochemistry & Molecular Biology; Cell Biology
SC Biochemistry & Molecular Biology; Cell Biology
GA 270IP
UT WOS:000328312400024
PM 24177061
ER
PT J
AU Gupta, A
Khan, MA
AF Gupta, Abhay
Khan, Mansoor A.
TI Challenges of pediatric formulations: A FDA science perspective
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Editorial Material
C1 [Gupta, Abhay; Khan, Mansoor A.] US FDA, Ctr Drug Evaluat & Res, Div Prod Qual Res, Silver Spring, MD 20993 USA.
RP Khan, MA (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Prod Qual Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM mansoor.khan@fda.hhs.gov
NR 6
TC 0
Z9 0
U1 1
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
EI 1873-3476
J9 INT J PHARMACEUT
JI Int. J. Pharm.
PD NOV 30
PY 2013
VL 457
IS 1
BP 346
EP 348
DI 10.1016/j.ijpharm.2013.08.064
PG 4
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 248FU
UT WOS:000326681800041
PM 24216242
ER
PT J
AU Ou, W
Li, PJ
Reiser, J
AF Ou, Wu
Li, Pingjuan
Reiser, Jakob
TI Targeting of Herpes Simplex Virus 1 Thymidine Kinase Gene Sequences into
the OCT4 Locus of Human Induced Pluripotent Stem Cells
SO PLOS ONE
LA English
DT Article
ID SUICIDE GENE; GANCICLOVIR RESISTANCE; REGULATORY CIRCUITRY; SELECTIVE
ABLATION; TUMOR-FORMATION; IN-VITRO; EXPRESSION; TRANSPLANTATION;
DIFFERENTIATION; SURVIVAL
AB The in vitro differentiation of human induced pluripotent stem cells (hiPSC) to generate specific types of cells is inefficient, and the remaining undifferentiated cells may form teratomas. This raises safety concerns for clinical applications of hiPSC-derived cellular products. To improve the safety of hiPSC, we attempted to site-specifically insert a herpes simplex virus 1 thymidine kinase (HSV1-TK) suicide gene at the endogenous OCT4 (POU5F1) locus of hiPSC. Since the endogenous OCT4 promoter is active in undifferentiated cells only, we speculated that the HSV1-TK suicide gene will be transcribed in undifferentiated cells only and that the remaining undifferentiated cells can be depleted by treating them with the prodrug ganciclovir (GCV) prior to transplantation. To insert the HSV1-TK gene at the OCT4 locus, we cotransfected hiPSC with a pair of plasmids encoding an OCT4-specific zinc finger nuclease (ZFN) and a donor plasmid harboring a promoter-less transgene cassette consisting of HSV1-TK and puromycin resistance gene sequences, flanked by OCT4 gene sequences. Puromycin resistant clones were established and characterized regarding their sensitivity to GCV and the site of integration of the HSV1-TK/puromycin resistance gene cassette. Of the nine puromycin-resistant iPSC clones analyzed, three contained the HSV1-TK transgene at the OCT4 locus, but they were not sensitive to GCV. The other six clones were GCV-sensitive, but the TK gene was located at off-target sites. These TK-expressing hiPSC clones remained GCV sensitive for up to 90 days, indicating that TK transgene expression was stable. Possible reasons for our failed attempt to selectively target the OCT4 locus are discussed.
C1 [Ou, Wu; Li, Pingjuan; Reiser, Jakob] US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA.
RP Reiser, J (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA.
EM Jakob.Reiser@fda.hhs.gov
FU FDA Medical Countermeasures Initiative (MCMi) grant; U.S. Department of
Energy; U.S. Food and Drug Administration
FX This study was supported by an FDA Medical Countermeasures Initiative
(MCMi) grant. This project was supported in part by an appointment of PL
to the Research Participation Program at the Center for Biologics
Evaluation and Research administered by the Oak Ridge Institute for
Science and Education through an interagency agreement between the U.S.
Department of Energy and the U.S. Food and Drug Administration. The
funders had no role in study design, data collection and analysis,
decision to publish, or preparation of the manuscript.
NR 47
TC 3
Z9 4
U1 0
U2 1
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD NOV 29
PY 2013
VL 8
IS 11
AR e81131
DI 10.1371/journal.pone.0081131
PG 9
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 261MX
UT WOS:000327670300024
PM 24312266
ER
PT J
AU Najafi, A
Ghafourian, K
Paixao, A
Aljaabari, M
Canos, D
Asch, F
Panza, J
Cooper, HA
AF Najafi, Amir
Ghafourian, Kambiz
Paixao, Andre
Aljaabari, Mohamed
Canos, Daniel
Asch, Federico
Panza, Julio
Cooper, Howard A.
TI Diagnosis of Cardiogenic Shock Without the Use of a Pulmonary Artery
Catheter
SO CIRCULATION
LA English
DT Meeting Abstract
CT Scientific Sessions and Resuscitation Science Symposium of the
American-Heart-Association
CY NOV 16-17, 2013
CL Dallas, TX
SP Amer Heart Assoc
DE Shock, cardiogenic; Noninvasive cardiac imaging; Echocardiography
C1 [Najafi, Amir; Ghafourian, Kambiz; Asch, Federico; Panza, Julio; Cooper, Howard A.] MedStar Heart Inst, Washington, DC USA.
[Paixao, Andre; Aljaabari, Mohamed] MedStar Washington Hosp Cntr, Washington, DC USA.
[Canos, Daniel] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 1
U2 1
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0009-7322
EI 1524-4539
J9 CIRCULATION
JI Circulation
PD NOV 26
PY 2013
VL 128
IS 22
SU S
MA 16279
PG 2
WC Cardiac & Cardiovascular Systems; Peripheral Vascular Disease
SC Cardiovascular System & Cardiology
GA AC0CR
UT WOS:000332162905455
ER
PT J
AU Tereshchenko, LG
Rizzi, P
Mewton, N
Jardim, GV
Murthy, S
Strauss, D
Liu, CY
Marchlinski, F
Spooner, P
Berger, R
Kellman, P
Lima, J
AF Tereshchenko, Larisa G.
Rizzi, Patricia
Mewton, Nathan
Jardim, Gustavo Volpe
Murthy, Sindhoora
Strauss, David
Liu, Chia-Yiang
Marchlinski, Francis
Spooner, Peter
Berger, Ronald
Kellman, Peter
Lima, Joao
TI Infiltrated Atrial Fat Characterizes Underlying Atrial Fibrillation
Substrate in Patients at Risk
SO CIRCULATION
LA English
DT Meeting Abstract
CT Scientific Sessions and Resuscitation Science Symposium of the
American-Heart-Association
CY NOV 16-17, 2013
CL Dallas, TX
SP Amer Heart Assoc
DE Cardiac MRI; Atrial fibrillation
C1 [Tereshchenko, Larisa G.; Rizzi, Patricia; Mewton, Nathan; Jardim, Gustavo Volpe; Liu, Chia-Yiang; Spooner, Peter; Berger, Ronald; Lima, Joao] Johns Hopkins Univ Som, Baltimore, MD USA.
[Murthy, Sindhoora] Johns Hopkins Univ, Baltimore, MD USA.
[Strauss, David] US FDA, Silver Spring, MD USA.
[Marchlinski, Francis] Hosp Univ Penn, Philadelphia, PA 19104 USA.
[Kellman, Peter] NHLBI, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0009-7322
EI 1524-4539
J9 CIRCULATION
JI Circulation
PD NOV 26
PY 2013
VL 128
IS 22
SU S
MA 12402
PG 1
WC Cardiac & Cardiovascular Systems; Peripheral Vascular Disease
SC Cardiovascular System & Cardiology
GA AC0CR
UT WOS:000332162902224
ER
PT J
AU Zusterzeel, R
Canos, D
Sanders, W
Silverman, H
MaCurdy, T
Worrall, C
Kelman, J
Strauss, D
AF Zusterzeel, Robbert
Canos, Daniel
Sanders, William
Silverman, Henry
MaCurdy, Thomas
Worrall, Christopher
Kelman, Jeffrey
Strauss, David
TI Cardiac Resynchronization Therapy is Associated With Increased Mortality
in Right Bundle Branch Block Patients
SO CIRCULATION
LA English
DT Meeting Abstract
CT Scientific Sessions and Resuscitation Science Symposium of the
American-Heart-Association
CY NOV 16-17, 2013
CL Dallas, TX
SP Amer Heart Assoc
DE Resynchronization therapy; Bi-ventricular pacing; Heart failure
C1 [Zusterzeel, Robbert; Canos, Daniel; Sanders, William; Strauss, David] US FDA, Cntr Devices & Radiol Hlth, Silver Spring, MD USA.
[Silverman, Henry] Acumen LLC, Burlingame, CA USA.
[MaCurdy, Thomas] Acumen LLC, Rsch, Burlingame, CA USA.
[Worrall, Christopher; Kelman, Jeffrey] Cntrs Medicare & Medicaid Serv, Baltimore, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0009-7322
EI 1524-4539
J9 CIRCULATION
JI Circulation
PD NOV 26
PY 2013
VL 128
IS 22
SU S
MA 15233
PG 2
WC Cardiac & Cardiovascular Systems; Peripheral Vascular Disease
SC Cardiovascular System & Cardiology
GA AC0CR
UT WOS:000332162904462
ER
PT J
AU Sullivan, HW
O'Donoghue, AC
Aikin, KJ
AF Sullivan, Helen W.
O'Donoghue, Amie C.
Aikin, Kathryn J.
TI Presenting Quantitative Information About Placebo Rates to Patients
SO JAMA INTERNAL MEDICINE
LA English
DT Letter
ID TRIALS
C1 [Sullivan, Helen W.; O'Donoghue, Amie C.; Aikin, Kathryn J.] Food & Drug Adm, Ctr Drug Evaluat & Res, Off Prescript Drug Promot, Silver Spring, MD 20993 USA.
RP Sullivan, HW (reprint author), Food & Drug Adm, Ctr Drug Evaluat & Res, Off Prescript Drug Promot, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM helensullivan@fda.hhs.gov
NR 6
TC 0
Z9 0
U1 0
U2 1
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60654-0946 USA
SN 2168-6106
EI 2168-6114
J9 JAMA INTERN MED
JI JAMA Intern. Med.
PD NOV 25
PY 2013
VL 173
IS 21
DI 10.1001/jamainternmed.2013.10399
PG 2
WC Medicine, General & Internal
SC General & Internal Medicine
GA AA2WG
UT WOS:000330954300013
PM 24126622
ER
PT J
AU Slavov, SH
Pearce, BA
Buzatu, DA
Wilkes, JG
Beger, RD
AF Slavov, Svetoslav H.
Pearce, Bruce A.
Buzatu, Dan A.
Wilkes, Jon G.
Beger, Richard D.
TI Complementary PLS and KNN algorithms for improved 3D-QSDAR consensus
modeling of AhR binding
SO JOURNAL OF CHEMINFORMATICS
LA English
DT Article
DE QSAR; Molecular descriptors; Quantitative spectral data-activity
relationship (3D-QSDAR); Estrogen receptor binding; Molecular modeling
ID DIBENZO-P-DIOXINS; POLYCHLORINATED DIBENZOFURANS; BIPHENYLS BINDING;
TOXICITY; QSAR; DESCRIPTORS; PREDICTION; DFT
AB Multiple validation techniques (Y-scrambling, complete training/test set randomization, determination of the dependence of R-test(2) on the number of randomization cycles, etc.) aimed to improve the reliability of the modeling process were utilized and their effect on the statistical parameters of the models was evaluated. A consensus partial least squares (PLS)-similarity based k-nearest neighbors (KNN) model utilizing 3D-SDAR (three dimensional spectral data-activity relationship) fingerprint descriptors for prediction of the log(1/EC50) values of a dataset of 94 aryl hydrocarbon receptor binders was developed. This consensus model was constructed from a PLS model utilizing 10 ppm x 10 ppm x 0.5 angstrom bins and 7 latent variables (R-test(2) of 0.617), and a KNN model using 2 ppm x 2 ppm x 0.5 angstrom bins and 6 neighbors (R-test(2) of 0.622). Compared to individual models, improvement in predictive performance of approximately 10.5% (R-test(2) of 0.685) was observed. Further experiments indicated that this improvement is likely an outcome of the complementarity of the information contained in 3D-SDAR matrices of different granularity. For similarly sized data sets of Aryl hydrocarbon (AhR) binders the consensus KNN and PLS models compare favorably to earlier reports. The ability of 3D-QSDAR (three dimensional quantitative spectral data-activity relationship) to provide structural interpretation was illustrated by a projection of the most frequently occurring bins on the standard coordinate space, thus allowing identification of structural features related to toxicity.
C1 [Slavov, Svetoslav H.; Pearce, Bruce A.; Buzatu, Dan A.; Wilkes, Jon G.; Beger, Richard D.] US FDA, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Beger, RD (reprint author), US FDA, Div Syst Biol, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM Richard.Beger@fda.hhs.gov
FU F.D.A.
FX The authors thank F.D.A. for the financial support.
NR 31
TC 10
Z9 10
U1 0
U2 21
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1758-2946
J9 J CHEMINFORMATICS
JI J. Cheminformatics
PD NOV 21
PY 2013
VL 5
AR 47
DI 10.1186/1758-2946-5-47
PG 16
WC Chemistry, Multidisciplinary; Computer Science, Information Systems;
Computer Science, Interdisciplinary Applications
SC Chemistry; Computer Science
GA 283DR
UT WOS:000329226000001
PM 24257141
ER
PT J
AU Young, WM
South, P
Begley, TH
Noonan, GO
AF Young, Wendy M.
South, Paul
Begley, Timothy H.
Noonan, Gregory O.
TI Determination of Perfluorochemicals in Fish and Shellfish Using Liquid
Chromatography-Tandem Mass Spectrometry
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE perfluorochemicals; method validation; fish; shellfish
ID PERFLUORINATED COMPOUNDS; HUMAN EXPOSURE; PERFLUOROALKYL ACIDS; FOOD
SIMULANTS; POPULATION; PERFLUOROOCTANESULFONATE; PERFLUOROCARBOXYLATES;
MIGRATION; CHEMICALS; WATER
AB This paper reports the validation and application of a method for determination of 10 perfluorochemicals (PFCs) in retail fish and shellfish. The analytes of interest were 7 perfluorinated carboxylates and 3 perfluorinated sulfonates. Fish and shellfish samples were digested with a basic solution of 10 mM sodium hydroxide in methanol before sonication and solid phase extraction through weak anion exchange. Analysis was performed using liquid chromatography tandem mass spectrometry. Recoveries from spiking five different types of fish and shellfish indicate that the method performs similarly with different fish types, and recoveries were over 90% for all analytes. Forty-six retail samples, collected between 2010 and 2012, including 13 different types of fish and shellfish were analyzed for PFCs. The 13 different types included the top 10 most-consumed fish and shellfish in the United States according to data collected by the National Fisheries Institute. Two Standard Reference Materials were also analyzed. Most fish and shellfish had no detected PFCs; only 11 samples of the 46 tested had detectable concentrations of PFCs.
C1 [Young, Wendy M.; South, Paul; Begley, Timothy H.; Noonan, Gregory O.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Young, WM (reprint author), 5100 Paint Branch Pkwy,HFS 706, College Pk, MD 20740 USA.
EM wendy.young@fda.hhs.gov
NR 29
TC 3
Z9 3
U1 3
U2 29
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
EI 1520-5118
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD NOV 20
PY 2013
VL 61
IS 46
BP 11166
EP 11172
DI 10.1021/jf403935g
PG 7
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 253QC
UT WOS:000327103400040
PM 24144282
ER
PT J
AU Lei, HY
Li, TW
Hung, GC
Li, BJ
Tsai, S
Lo, SC
AF Lei, Haiyan
Li, Tianwei
Hung, Guo-Chiuan
Li, Bingjie
Tsai, Shien
Lo, Shyh-Ching
TI Identification and characterization of EBV genomes in spontaneously
immortalized human peripheral blood B lymphocytes by NGS technology
SO BMC GENOMICS
LA English
DT Article
DE Epstein Barr Virus; Mycoplasma; Next-generation sequencing; Human
immortalized B lymphocytes
ID EPSTEIN-BARR-VIRUS; NASOPHARYNGEAL CARCINOMA; GASTRIC-CARCINOMA; VIRAL
GENOMES; DNA-SEQUENCE; CELLS; LYMPHOMA; BIOPSIES
AB Background: We conducted genomic sequencing to identify Epstein Barr Virus (EBV) genomes in 2 human peripheral blood B lymphocytes that underwent spontaneous immortalization promoted by mycoplasma infections in culture, using the high-throughput sequencing (HTS) Illumina MiSeq platform. The purpose of this study was to examine if rapid detection and characterization of a viral agent could be effectively achieved by HTS using a platform that has become readily available in general biology laboratories.
Results: Raw read sequences, averaging 175 bps in length, were mapped with DNA databases of human, bacteria, fungi and virus genomes using the CLC Genomics Workbench bioinformatics tool. Overall 37,757 out of 49,520,834 total reads in one lymphocyte line (# K4413-Mi) and 28,178 out of 45,335,960 reads in the other lymphocyte line (# K4123-Mi) were identified as EBV sequences. The two EBV genomes with estimated 35.22-fold and 31.06-fold sequence coverage respectively, designated K4413-Mi EBV and K4123-Mi EBV (GenBank accession number KC440852 and KC440851 respectively), are characteristic of type-1 EBV.
Conclusions: Sequence comparison and phylogenetic analysis among K4413-Mi EBV, K4123-Mi EBV and the EBV genomes previously reported to GenBank as well as the NA12878 EBV genome assembled from database of the 1000 Genome Project showed that these 2 EBVs are most closely related to B95-8, an EBV previously isolated from a patient with infectious mononucleosis and WT-EBV. They are less similar to EBVs associated with nasopharyngeal carcinoma (NPC) from Hong Kong and China as well as the Akata strain of a case of Burkitt's lymphoma from Japan. They are most different from type 2 EBV found in Western African Burkitt's lymphoma.
C1 [Lei, Haiyan; Li, Tianwei; Hung, Guo-Chiuan; Li, Bingjie; Tsai, Shien; Lo, Shyh-Ching] Food & Drug Adm, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Tissue Microbiol Lab,Off Cellular Tissue & Gene T, Bethesda, MD 20892 USA.
RP Lo, SC (reprint author), Food & Drug Adm, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Tissue Microbiol Lab,Off Cellular Tissue & Gene T, NIH Bldg 29B,Rm 1NN06,29 Lincoln Dr, Bethesda, MD 20892 USA.
EM ShyhChing.Lo@fda.hhs.gov
FU FDA Modernizing Science research grant; U.S. Department of Energy; U.S.
Food and Drug Administration
FX The study was supported in part by FDA Modernizing Science research
grant and supported in part by an appointment to the Research
Participation Program at the CBER of FDA administered by the Oak Ridge
Institute for Science and Education through an interagency agreement
between the U.S. Department of Energy and the U.S. Food and Drug
Administration.
NR 22
TC 17
Z9 18
U1 1
U2 11
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1471-2164
J9 BMC GENOMICS
JI BMC Genomics
PD NOV 19
PY 2013
VL 14
AR 804
DI 10.1186/1471-2164-14-804
PG 9
WC Biotechnology & Applied Microbiology; Genetics & Heredity
SC Biotechnology & Applied Microbiology; Genetics & Heredity
GA 274YM
UT WOS:000328642100005
PM 24252203
ER
PT J
AU Yamazaki, A
Wu, CL
Cheng, WC
Badano, A
AF Yamazaki, Asumi
Wu, Chih-Lei
Cheng, Wei-Chung
Badano, Aldo
TI Spatial resolution and noise in organic light-emitting diode displays
for medical imaging applications
SO OPTICS EXPRESS
LA English
DT Article
ID LIQUID-CRYSTAL DISPLAYS; VIEWING ANGLE; CONTRAST; DEVICES;
5-MILLION-PIXEL; PERFORMANCE; RADIOLOGY; IMAGES; POWER; IPAD
AB We report on the resolution and noise characteristics of handheld and workstation organic light-emitting diode (OLED) displays in comparison with liquid crystal displays (LCDs). The results demonstrate advantages, in terms of sharpness, of handheld OLED displays with modulation transfer function (MTF) values exceeding 0.60 at the Nyquist frequencies. The OLED workstation included in this study exhibits significant signal contamination among adjacent pixels resulting in degraded resolution performance indicated by horizontal and vertical MTF values of 0.13 and 0.24 at the Nyquist frequency. On the other hand, its noise characteristics are superior to the LCD workstation tested. While the noise power spectral (NPS) values of the OLED workstation are 8.0x10(-6) mm(2) at 1 mm(-1), the LCD workstation has NPS values of 2.6x10(-5) mm(2). Although phone-size OLED displays have superior resolution and noise per pixel, the perceived resolution characteristics at appropriate viewing distances are inferior to tablet-size and workstation LCDs. In addition, our results show some degree of dependency of the resolution and noise on luminance level and viewing orientation. We also found a slightly degraded resolution and increased low-frequency noise at off-normal orientations in the handheld displays. (C) 2013 Optical Society of America
C1 [Yamazaki, Asumi; Wu, Chih-Lei; Cheng, Wei-Chung; Badano, Aldo] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Yamazaki, Asumi] Nagoya Univ, Grad Sch Med Sci, Nagoya, Aichi 4618673, Japan.
RP Badano, A (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM Aldo.Badano@fda.hhs.gov
RI Cheng, Wei-Chung/E-6240-2014;
OI badano, aldo/0000-0003-3712-6670
FU U.S. DOE; U.S. FDA
FX AY and CW acknowledge funding by appointments to the Research
Participation Program at the CDRH administered by the Oak Ridge
Institute for Science and Education through an interagency agreement
between the U.S. DOE and the U.S. FDA. The mention of commercial
products herein is not to be construed as either an actual or implied
endorsement of such products by the Department of Health and Human
Services. This is a contribution of the FDA and is not subject to
copyright.
NR 28
TC 2
Z9 2
U1 2
U2 18
PU OPTICAL SOC AMER
PI WASHINGTON
PA 2010 MASSACHUSETTS AVE NW, WASHINGTON, DC 20036 USA
SN 1094-4087
J9 OPT EXPRESS
JI Opt. Express
PD NOV 18
PY 2013
VL 21
IS 23
BP 28111
EP 28133
DI 10.1364/OE.21.028111
PG 23
WC Optics
SC Optics
GA 258YG
UT WOS:000327494000055
PM 24514325
ER
PT J
AU Xu, XM
Siddiqui, A
Khan, MA
AF Xu, Xiaoming
Siddiqui, Akhtar
Khan, Mansoor A.
TI Focused beam reflectance measurement to monitor nimodipine precipitation
process
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Article
DE Nimodipine; Crystallization; Focused beam reflectance measurement;
Moisture content; Liquid-filled capsule
AB Crystallization of nimodipine in liquid-filled soft gelatin capsule during storage was reported for some commercial products, resulting in product recalls due to product quality and more importantly safety concerns. In this study, a real time particle monitoring tool, focused beam reflectance measurement, was used to evaluate the precipitation conditions of nimodipine in co-solvents. Upon water addition, two particle populations were discovered, appearing at different percentage of water content. Two transitions (i.e. sudden increase in particle counts) were observed, possibility related to nucleation and crystal growth of nimodipine. Furthermore, lowering storage temperature increased the tendency of nimodipine precipitation. Most critically, it was determined that with certain excipient, the drug precipitation occurred at approximately 7% (w/w) water content. Considering that all the orally administered liquid filled soft gelatin capsule shells contain residue water content as plasticizer, moisture transfer from the shell to the formulation may occur during long term storage, resulting in drug precipitation, particularly under cold temperature conditions. Published by Elsevier B.V.
C1 [Xu, Xiaoming; Siddiqui, Akhtar; Khan, Mansoor A.] US FDA, Div Prod Qual Res, OTR OPS, Silver Spring, MD 20993 USA.
RP Khan, MA (reprint author), US FDA, Div Prod Qual Res, OTR OPS, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Xiaoming.Xu@fda.hhs.gov; Akhtar.Siddiqui@fda.hhs.gov;
Mansoor.Khan@fda.hhs.gov
OI Xu, Xiaoming/0000-0003-1672-0830
NR 9
TC 4
Z9 4
U1 0
U2 8
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
EI 1873-3476
J9 INT J PHARMACEUT
JI Int. J. Pharm.
PD NOV 18
PY 2013
VL 456
IS 2
BP 353
EP 356
DI 10.1016/j.ijpharm.2013.08.083
PG 4
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 234LC
UT WOS:000325644600011
PM 24016702
ER
PT J
AU Rahman, Z
Khan, MA
AF Rahman, Ziyaur
Khan, Mansoor A.
TI Hunter screening design to understand the product variability of solid
dispersion formulation of a peptide antibiotic
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Article
DE Vancomycin; Polyethylene glycol; Dissolution; Potency; Design of
experiment
ID COLON-SPECIFIC DELIVERY; LOADED PLGA NANOPARTICLES; CAPSULE
FORMULATIONS; VANCOMYCIN; STABILITY; BIOAVAILABILITY; DISSOLUTION;
RELEASE; SYSTEM; DRUGS
AB The focus of present research was to understand and control the variability of solid dispersion (SD) formulation of non-ribosomal peptide antibiotic, vancomycin (VCM). Hunter screening design was constructed using seven independent variables namely melting temperature (X-1), congealing temperature (X-2), mixing time (X-3), type of capsule shell (X-4), filling method (X-5), molecular weight of polyethylene glycol (PEG, X-6) and surfactant type (X-7), and responses measured were cumulative percentage of VCM released in 45 min (Y-1) and potency (Y-2). The SD formulations were prepared by melt-fusion method, and tested for dissolution, potency, and characterized by Fourier transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD) and near infrared chemical imaging (NIR-CI). Statistically significant (p < 0.05) effect of congealing temperature (X-2), type of capsule shell (X-4), filling method (X-5), molecular weight of PEG (X-6) was revealed on Y-1, and R-2 of 0.992 was obtained between experimental and predicted value. None of the factors have statistically significant (p > 0.05) influence on Y-2. SEM, DSC and PXRD indicated crystalline nature of SD formulations. Homogeneity of SD formulations was shown by NIR-CI images. In summary, the quality of VCM SD formulations could be assured by controlling the critical factors during manufacturing. Published by Elsevier B.V.
C1 [Rahman, Ziyaur; Khan, Mansoor A.] US FDA, Ctr Drug Evaluat & Res, Div Prod Qual & Res, Rockville, MD 20857 USA.
RP Khan, MA (reprint author), FDA CDER DPQR, LS Bldg 64,Room 1070,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Mansoor.Khan@fda.hhs.gov
OI Rahman, Ziyaur/0000-0002-0402-825X
NR 36
TC 5
Z9 5
U1 1
U2 15
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
EI 1873-3476
J9 INT J PHARMACEUT
JI Int. J. Pharm.
PD NOV 18
PY 2013
VL 456
IS 2
BP 572
EP 582
DI 10.1016/j.ijpharm.2013.07.062
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 234LC
UT WOS:000325644600038
PM 23994761
ER
PT J
AU Ning, YMM
Pierce, W
Maher, VE
Karuri, S
Tang, SH
Chiu, HJ
Palmby, T
Zirkelbach, JF
Marathe, D
Mehrotra, N
Liu, Q
Ghosh, D
Cottrell, CL
Leighton, J
Sridhara, R
Ibrahim, A
Justice, R
Pazdur, R
AF Ning, Yangmin M.
Pierce, William
Maher, V. Ellen
Karuri, Stella
Tang, Sheng-Hui
Chiu, Haw-Jyh
Palmby, Todd
Zirkelbach, Jeanne Fourie
Marathe, Dhananjay
Mehrotra, Nitin
Liu, Qi
Ghosh, Debasis
Cottrell, Christy L.
Leighton, John
Sridhara, Rajeshwari
Ibrahim, Amna
Justice, Robert
Pazdur, Richard
TI Enzalutamide for Treatment of Patients with Metastatic
Castration-Resistant Prostate Cancer Who Have Previously Received
Docetaxel: U.S. Food and Drug Administration Drug Approval Summary
SO CLINICAL CANCER RESEARCH
LA English
DT Article
ID INCREASED SURVIVAL; PREDNISONE; MITOXANTRONE; ABIRATERONE; TRIAL
AB This article summarizes the regulatory evaluation that led to the full approval of enzalutamide (XTANDI, Medivation Inc.) by the U. S. Food and Drug Administration (FDA) on August 31, 2012, for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. This approval was based on the results of a randomized, placebo-controlled trial which randomly allocated 1,199 patients with mCRPC who had received prior docetaxel to receive either enzalutamide, 160 mg orally once daily (n = 800), or placebo (n = 399). All patients were required to continue androgen deprivation therapy. The primary endpoint was overall survival. At the prespecified interim analysis, a statistically significant improvement in overall survival was demonstrated for the enzalutamide arm compared with the placebo arm [HR = 0.63; 95% confidence interval: 0.53-0.75; P < 0.0001]. The median overall survival durations were 18.4 months and 13.6 months in the enzalutamide and placebo arms, respectively. The most common adverse reactions (>= 10%) included asthenia or fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, and upper respiratory infection. Seizures occurred in 0.9% of patients on enzalutamide compared with no patients on the placebo arm. Overall, the FDA's review and analyses of the submitted data confirmed that enzalutamide had a favorable benefit-risk profile in the study patient population, thus supporting its use for the approved indication. The recommended dose is 160 mg of enzalutamide administered orally once daily. Enzalutamide represents the third product that the FDA has approved in the same disease setting within a period of 2 years. (C) 2013 AACR.
C1 [Ning, Yangmin M.; Pierce, William; Maher, V. Ellen; Chiu, Haw-Jyh; Palmby, Todd; Cottrell, Christy L.; Leighton, John; Ibrahim, Amna; Justice, Robert; Pazdur, Richard] US FDA, Off Hematol & Oncol Prod, Off New Drugs, Silver Spring, MD 20993 USA.
[Karuri, Stella; Tang, Sheng-Hui; Sridhara, Rajeshwari] US FDA, Off Biostat, Silver Spring, MD 20993 USA.
[Zirkelbach, Jeanne Fourie; Marathe, Dhananjay; Mehrotra, Nitin; Liu, Qi] US FDA, Off Clin Pharmacol, Silver Spring, MD 20993 USA.
[Ghosh, Debasis] US FDA, Off New Drug Qual Assessment, Silver Spring, MD 20993 USA.
[Ghosh, Debasis] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Ning, YMM (reprint author), US FDA, Off Hematol & Oncol Prod, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 22,Room 2139, Silver Spring, MD 20993 USA.
EM ningy@cder.fda.gov
NR 14
TC 15
Z9 16
U1 0
U2 7
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
EI 1557-3265
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD NOV 15
PY 2013
VL 19
IS 22
BP 6067
EP 6073
DI 10.1158/1078-0432.CCR-13-1763
PG 7
WC Oncology
SC Oncology
GA 256NU
UT WOS:000327320900003
PM 24141628
ER
PT J
AU Mujat, M
Ferguson, RD
Iftimia, N
Hammer, DX
Nedyalkov, I
Wosnik, M
Legner, H
AF Mujat, Mircea
Ferguson, R. Daniel
Iftimia, Nicusor
Hammer, Daniel X.
Nedyalkov, Ivaylo
Wosnik, Martin
Legner, Hartmut
TI Optical coherence tomography-based micro-particle image velocimetry
SO OPTICS LETTERS
LA English
DT Article
ID DOPPLER TOMOGRAPHY
AB We present a new application of optical coherence tomography (OCT), widely used in biomedical imaging, to flow analysis in near-wall hydrodynamics for marine research. This unique capability, called OCT micro-particle image velocimetry, provides a high-resolution view of microscopic flow phenomena and measurement of flow statistics within the first millimeter of a boundary layer. The technique is demonstrated in a small flow cuvette and in a water tunnel. (C) 2013 Optical Society of America
C1 [Mujat, Mircea; Ferguson, R. Daniel; Iftimia, Nicusor; Hammer, Daniel X.; Legner, Hartmut] Phys Sci Inc, Andover, MA 01810 USA.
[Hammer, Daniel X.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20902 USA.
[Nedyalkov, Ivaylo; Wosnik, Martin] Univ New Hampshire, Dept Mech Engn, Durham, NH 03824 USA.
RP Mujat, M (reprint author), Phys Sci Inc, 20 New England Business Ctr, Andover, MA 01810 USA.
EM mujat@psicorp.com
RI Wosnik, Martin/L-5632-2013
OI Wosnik, Martin/0000-0001-9290-3327
FU ONR SBIR [N00014-10-M-0180]; NSF-MRI [0821608]
FX Support through ONR SBIR Phase 1 Contract No. N00014-10-M-0180 to H.
Legner/PSI and NSF-MRI Award No. 0821608 to M. Wosnik/UNH is gratefully
acknowledged.
NR 11
TC 6
Z9 7
U1 1
U2 7
PU OPTICAL SOC AMER
PI WASHINGTON
PA 2010 MASSACHUSETTS AVE NW, WASHINGTON, DC 20036 USA
SN 0146-9592
EI 1539-4794
J9 OPT LETT
JI Opt. Lett.
PD NOV 15
PY 2013
VL 38
IS 22
BP 4558
EP 4561
DI 10.1364/OL.38.004558
PG 4
WC Optics
SC Optics
GA 254DB
UT WOS:000327142600010
PM 24322073
ER
PT J
AU Goyal, KG
Dong, ML
Nguemaha, VM
Worth, BW
Judge, PT
Calhoun, WR
Bali, LM
Bali, S
AF Goyal, K. G.
Dong, M. L.
Nguemaha, V. M.
Worth, B. W.
Judge, P. T.
Calhoun, W. R.
Bali, L. M.
Bali, S.
TI Empirical model of total internal reflection from highly turbid media
SO OPTICS LETTERS
LA English
DT Article
ID COMPLEX REFRACTIVE-INDEX; LIGHT-SCATTERING; EVANESCENT-WAVE;
CRITICAL-ANGLE; LIQUIDS
AB We demonstrate, to the best of our knowledge, a first accurate empirical model for reflectance measurements from highly turbid media over the full range of incident angles, i.e., for reflectivity values going from unity in the total internal reflection regime to nearly zero when almost all the light is transmitted. Evidence that our model is accurate is provided by extraction of the particle size, followed by independent verification with dynamic light scattering. Our methodology is in direct contrast with the prevalent approach in turbid media of focusing on only the critical angle region, which is just a small subset of the entire reflectance data. (C) 2013 Optical Society of America
C1 [Goyal, K. G.; Dong, M. L.; Nguemaha, V. M.; Worth, B. W.; Judge, P. T.; Bali, L. M.; Bali, S.] Miami Univ, Dept Phys, Oxford, OH 45056 USA.
[Calhoun, W. R.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Bali, S (reprint author), Miami Univ, Dept Phys, Oxford, OH 45056 USA.
EM balis@miamioh.edu
FU Petroleum Research Fund; Dillon-Kane, LLC
FX Funding from Petroleum Research Fund and Dillon-Kane, LLC, is gratefully
acknowledged. We thank Miami University's Instrumentation Lab for help
with Labview. We are grateful to three anonymous referees whose
insightful suggestions contributed immensely to this Letter.
NR 19
TC 8
Z9 8
U1 1
U2 7
PU OPTICAL SOC AMER
PI WASHINGTON
PA 2010 MASSACHUSETTS AVE NW, WASHINGTON, DC 20036 USA
SN 0146-9592
EI 1539-4794
J9 OPT LETT
JI Opt. Lett.
PD NOV 15
PY 2013
VL 38
IS 22
BP 4888
EP 4891
DI 10.1364/OL.38.004888
PG 4
WC Optics
SC Optics
GA 254DB
UT WOS:000327142600095
PM 24322158
ER
PT J
AU Li, Q
Guo, D
Dong, ZQ
Zhang, W
Zhang, L
Huang, SM
Polli, JE
Shu, Y
AF Li, Qing
Guo, Dong
Dong, Zhongqi
Zhang, Wei
Zhang, Lei
Huang, Shiew-Mei
Polli, James E.
Shu, Yan
TI Ondansetron can enhance cisplatin-induced nephrotoxicity via inhibition
of multiple toxin and extrusion proteins (MATEs)
SO TOXICOLOGY AND APPLIED PHARMACOLOGY
LA English
DT Article
DE Cisplatin; Drug interaction; Multidrug and toxin extrusion protein;
Nephrotoxicity; Ondansetron; Organic cation transporter
ID ORGANIC CATION TRANSPORTERS; AGENT-INDUCED NEPHROTOXICITY;
GENETIC-VARIATION; INDUCED EMESIS; HUMAN KIDNEY; MULTIDRUG; METFORMIN;
CIMETIDINE; OCT2; MICE
AB The nephrotoxicity limits the clinical application of cisplatin. Human organic cation transporter 2 (OCT2) and multidrug and toxin extrusion proteins (MATEs) work in concert in the elimination of cationic drugs such as cisplatin from the kidney. We hypothesized that co-administration of ondansetron would have an effect on cisplatin nephrotoxicity by altering the function of cisplatin transporters. The inhibitory potencies of ondansetron on metformin accumulation mediated by OCT2 and MATEs were determined in the stable HEK-293 cells expressing these transporters. The effects of ondansetron on drug disposition in vivo were examined by conducting the pharmacokinetics of metformin, a classical substrate for OCTs and MATEs, in wild-type and Mate1-/- mice. The nephrotoxicity was assessed in the wild-type and Mate1-/- mice received cisplatin with and without ondansetron. Both MATEs, including human MATE1, human MATE2-K, and mouse Mate1, and OCT2 (human and mouse) were subject to ondansetron inhibition, with much greater potencies by ondansetron on MATEs. Ondansetron significantly increased tissue accumulation and pharmacokinetic exposure of metformin in wild-type but not in Mate1-/- mice. Moreover, ondansetron treatment significantly enhanced renal accumulation of cisplatin and cisplatin-induced nephrotoxicity which were indicated by increased levels of biochemical and molecular biomarkers and more severe pathohistological changes in mice. Similar increases in nephrotoxicity were caused by genetic deficiency of MATE function in mice. Therefore, the potent inhibition of MATEs by ondansetron enhances the nephrotoxicity associated with cisplatin treatment in mice. Potential nephrotoxic effects of combining the chemotherapeutic cisplatin and the antiemetic 5-hydroxytryptamine-3 (5-HT3) receptor antagonists, such as ondansetron, should be investigated in patients. (C) 2013 Elsevier Inc. All rights reserved.
C1 [Li, Qing; Dong, Zhongqi; Zhang, Wei; Polli, James E.; Shu, Yan] Univ Maryland, Dept Pharmaceut Sci, Sch Pharm, Baltimore, MD 21201 USA.
[Li, Qing; Guo, Dong; Zhang, Wei] Cent S Univ, Inst Clin Pharmacol, Changsha 410078, Hunan, Peoples R China.
[Zhang, Lei; Huang, Shiew-Mei] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Shu, Y (reprint author), Univ Maryland, Dept Pharmaceut Sci, Sch Pharm, 20 Penn St,HSFII Room 555, Baltimore, MD 21201 USA.
EM yshu@rx.umaryland.edu
FU National Institute of General Medical Sciences of the National
Institutes of Health (NIH) [R01GM099742]; US Food and Drug
Administration (FDA) [U01FD004320]; National Natural Science Foundation
(NNSF) of China [81001445, 81273595]
FX The present study was supported by the National Institute of General
Medical Sciences of the National Institutes of Health (NIH) under Award
R01GM099742 (Y.S.) and by the US Food and Drug Administration (FDA)
under Award U01FD004320 (J.E.P., Y.S.). Qing Li and Wei Zhang received
research support from the National Natural Science Foundation (NNSF) of
China (81001445, Q.L; 81273595, W.Z.). The content is solely the
responsibility of the authors and does not necessarily represent the
official views of the NIH, FDA and NNSF.
NR 51
TC 20
Z9 22
U1 1
U2 10
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0041-008X
EI 1096-0333
J9 TOXICOL APPL PHARM
JI Toxicol. Appl. Pharmacol.
PD NOV 15
PY 2013
VL 273
IS 1
BP 100
EP 109
DI 10.1016/j.taap.2013.08.024
PG 10
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 256DN
UT WOS:000327290000012
PM 24001450
ER
PT J
AU Lin, ZM
Fisher, JW
Wang, R
Ross, MK
Filipov, NM
AF Lin, Zhoumeng
Fisher, Jeffrey W.
Wang, Ran
Ross, Matthew K.
Filipov, Nikolay M.
TI Estimation of placental and lactational transfer and tissue distribution
of atrazine and its main metabolites in rodent dams, fetuses, and
neonates with physiologically based pharmacokinetic modeling
SO TOXICOLOGY AND APPLIED PHARMACOLOGY
LA English
DT Article
DE Atrazine; PBPK modeling; Pesticides; Developmental toxicity; Pregnancy;
Lactation
ID SPRAGUE-DAWLEY RATS; BLOOD PARTITION-COEFFICIENTS; MULTIROUTE EXPOSURE
MODEL; IN-VITRO METABOLISM; N-OCTANOL-WATER; PREGNANT RAT; GUINEA-PIG;
CYTOCHROME-P450 ENZYMES; POSTNATAL-DEVELOPMENT; TRICHLOROACETIC-ACID
AB Atrazine (ATR) is a widely used chlorotriazine herbicide, a ubiquitous environmental contaminant, and a potential developmental toxicant. To quantitatively evaluate placental/lactational transfer and fetal/neonatal tissue dosimetry of ATR and its major metabolites, physiologically based pharmacokinetic models were developed for rat dams, fetuses and neonates. These models were calibrated using pharmacokinetic data from rat dams repeatedly exposed (oral gavage; 5 mg/kg) to ATR followed by model evaluation against other available rat data. Model simulations corresponded well to the majority of available experimental data and suggest that: (1) the fetus is exposed to both ATR and its major metabolite didealkylatrazine (DACT) at levels similar to maternal plasma levels, (2) the neonate is exposed mostly to DACT at levels two-thirds lower than maternal plasma or fetal levels, while lactational exposure to ATR is minimal, and (3) gestational carryover of DACT greatly affects its neonatal dosimetry up until mid-lactation. To test the model's cross-species extrapolation capability, a pharmacoldnetic study was conducted with pregnant C57BL/6 mice exposed (oral gavage; 5 mg/kg) to ATR from gestational day 12 to 18. By using mouse-specific parameters, the model predictions fitted well with the measured data, including placental ATR/DACT levels. However, fetal concentrations of DACT were overestimated by the model (10-fold). This overestimation suggests that only around 10% of the DACT that reaches the fetus is tissue-bound. These rodent models could be used in fetal/neonatal tissue dosimetry predictions to help design/interpret early life toxicity/ pharmacokinetic studies with ATR and as a foundation for scaling to humans. (C) 2013 Elsevier Inc. All rights reserved.
C1 [Lin, Zhoumeng; Filipov, Nikolay M.] Univ Georgia, Dept Physiol & Pharmacol, Coll Vet Med, Athens, GA 30602 USA.
[Lin, Zhoumeng; Filipov, Nikolay M.] Univ Georgia, Interdisciplinary Toxicol Program, Athens, GA 30602 USA.
[Fisher, Jeffrey W.] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Wang, Ran; Ross, Matthew K.] Mississippi State Univ, Coll Vet Med, Ctr Environm Hlth Sci, Dept Basic Sci, Mississippi State, MS 39762 USA.
[Wang, Ran] Jiangsu Acad Agr Sci, Inst Food Safety, Nanjing 210014, Peoples R China.
RP Filipov, NM (reprint author), Univ Georgia, Dept Physiol & Pharmacol, 501 DW Brooks Dr, Athens, GA 30602 USA.
EM filipov@uga.edu
OI Lin, Zhoumeng/0000-0002-8731-8366
NR 128
TC 13
Z9 13
U1 0
U2 25
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0041-008X
EI 1096-0333
J9 TOXICOL APPL PHARM
JI Toxicol. Appl. Pharmacol.
PD NOV 15
PY 2013
VL 273
IS 1
BP 140
EP 158
DI 10.1016/jtaap.2013.08.010
PG 19
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 256DN
UT WOS:000327290000016
PM 23958493
ER
PT J
AU Ferreira, TPT
de Arantes, ACS
do Nascimento, CVMF
Olsen, PC
Trentin, PG
Rocco, PRM
Hogaboam, CM
Puri, RK
Martins, MA
Silva, PMRE
AF Ferreira, Tatiana Paula T.
de Arantes, Ana Carolina S.
do Nascimento, Caio Victor M. F.
Olsen, Priscilla C.
Trentin, Patricia G.
Rocco, Patricia R. M.
Hogaboam, Cory M.
Puri, Raj K.
Martins, Marco Aurelio
Rodrigues e Silva, Patricia Machado
TI IL-13 Immunotoxin Accelerates Resolution of Lung Pathological Changes
Triggered by Silica Particles in Mice
SO JOURNAL OF IMMUNOLOGY
LA English
DT Article
ID INDUCED PULMONARY-FIBROSIS; PSEUDOMONAS EXOTOXIN; INTERLEUKIN-13
RECEPTOR; IL-13-RESPONSIVE CELLS; AIRWAY INFLAMMATION;
SIGNAL-TRANSDUCTION; THERAPEUTIC TARGET; CARCINOMA-CELLS; LYMPH-NODES;
T-CELLS
AB Instillation of silica into the lungs of rodents results in pathological changes that strongly mimic human silicosis, an occupational lung disease marked by restrictive airway obstruction, inflammation, and fibrosis. Because IL-13 is a pivotal proinflammatory and fibro-genic cytokine, we examined whether a recombinant immunotoxin comprised of human IL-13 and a mutated form of Pseudomonas exotoxin (IL-13-PE) might affect pathological features of experimental silicosis. Mice received a single intranasal instillation of silica particles and were treated with intranasal IL-13-PE every other day from days 21 to 27 postsilica. The sensitivity of putative cell targets to IL-13-PE was also assessed in in vitro settings. Upregulation of IL-13, its receptor subunits IL-13R alpha 1 and IL-13R alpha 2, and shared receptor IL-4R alpha were associated with development of granulomatous lung inflammation triggered by silica. IL-13-PE inhibited silica-induced granuloma and fibrotic responses noted at 24 h and 15 d after the last treatment. Upregulation of TNF-alpha, TGF-beta, and chemokines, as well as increased collagen deposition and airway hyperreactivity to methacholine were all clearly sensitive to IL-13-PE. In addition, IL-13-PE inhibited both IL-13-induced proliferation of cultured lung fibroblasts from silicotic mice and silica-induced IL-8 generation from A549 cells. In conclusion, our findings show that therapeutic treatment with IL-13-PE can reverse important pathological features caused by inhalation of silica particles, suggesting that this recombinant immunotoxin is a promising molecular template in drug discovery for the treatment of silicosis.
C1 [Ferreira, Tatiana Paula T.; de Arantes, Ana Carolina S.; do Nascimento, Caio Victor M. F.; Olsen, Priscilla C.; Trentin, Patricia G.; Martins, Marco Aurelio; Rodrigues e Silva, Patricia Machado] Fundacao Oswaldo Cruz, Inst Oswaldo Cruz, Lab Inflammat, BR-21045900 Rio De Janeiro, Brazil.
[Rocco, Patricia R. M.] Univ Fed Rio de Janeiro, Lab Pulm Invest, BR-21941901 Rio De Janeiro, Brazil.
[Hogaboam, Cory M.] Univ Michigan, Dept Pathol, Sch Med, Ann Arbor, MI 48109 USA.
[Puri, Raj K.] US FDA, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA.
RP Silva, PMRE (reprint author), Fundacao Oswaldo Cruz, Inst Oswaldo Cruz, Lab Inflammat, Ave Brasil 4365, BR-21045900 Rio De Janeiro, Brazil.
EM patmar@ioc.fiocruz.br
RI Olsen, Priscilla/I-8994-2012; hogaboam, cory /M-3578-2014
FU Conselho Nacional de Desenvolvimento Cientifico and Tecnologico
[CNPq-476470/2009-9]; Fundacao Carlos Chagas de Apoio a Pesquisa do
Estado do Rio de Janeiro [FAPERJ-E-26/102.362/2009]; Programa de Auxilio
a Pesquisa Estrategica em Saude [PAPES 5-305674/2009-9]; European
Community's Seventh Framework Programme [HEALTH-F4-2011-281608]
FX This work was supported by the Conselho Nacional de Desenvolvimento
Cientifico and Tecnologico (Grant CNPq-476470/2009-9), Fundacao Carlos
Chagas de Apoio a Pesquisa do Estado do Rio de Janeiro (Grant
FAPERJ-E-26/102.362/2009), Programa de Auxilio a Pesquisa Estrategica em
Saude (Grant PAPES 5-305674/2009-9), and the European Community's
Seventh Framework Programme (FP7-2007-2013) under Grant
HEALTH-F4-2011-281608.
NR 56
TC 9
Z9 9
U1 0
U2 7
PU AMER ASSOC IMMUNOLOGISTS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-1767
EI 1550-6606
J9 J IMMUNOL
JI J. Immunol.
PD NOV 15
PY 2013
VL 191
IS 10
BP 5220
EP 5229
DI 10.4049/jimmunol.1203551
PG 10
WC Immunology
SC Immunology
GA 247AK
UT WOS:000326584600035
PM 24133168
ER
PT J
AU Sherman, RE
Li, J
Shapley, S
Robb, M
Woodcock, J
AF Sherman, Rachel E.
Li, Jun
Shapley, Stephanie
Robb, Melissa
Woodcock, Janet
TI Expediting Drug Development - The FDA's New "Breakthrough Therapy"
Designation
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Editorial Material
C1 [Sherman, Rachel E.; Li, Jun; Shapley, Stephanie; Robb, Melissa; Woodcock, Janet] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Sherman, RE (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
NR 1
TC 43
Z9 47
U1 0
U2 2
PU MASSACHUSETTS MEDICAL SOC
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
EI 1533-4406
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD NOV 14
PY 2013
VL 369
IS 20
BP 1877
EP 1880
DI 10.1056/NEJMp1311439
PG 4
WC Medicine, General & Internal
SC General & Internal Medicine
GA 300MP
UT WOS:000330468300005
PM 24224621
ER
PT J
AU Pinto, VB
Burden, R
Wagner, A
Moran, EE
Lee, CH
AF Pinto, Valerian B.
Burden, Robert
Wagner, Allyn
Moran, Elizabeth E.
Lee, Che-Hung
TI The Development of an Experimental Multiple Serogroups Vaccine for
Neisseria meningitidis
SO PLOS ONE
LA English
DT Article
ID PNEUMOCOCCAL CONJUGATE VACCINE; SERUM BACTERICIDAL ACTIVITY; MEMBRANE
VESICLE VACCINE; MENINGOCOCCAL MENINGITIS; GROUP-B; STRAINS; PROTEIN;
POLYSACCHARIDES; EPIDEMIOLOGY; DETERMINANT
AB A native outer membrane vesicles (NOMV) vaccine was developed from three antigenically diverse strains of Neisseria meningitidis that express the L1,8, L2, and L3,7 lipooligosaccharide (LOS) immunotypes, and whose synX, and lpxL1 genes were deleted.. Immunogenicity studies in mice showed that the vaccine induced bactericidal antibody against serogroups B, C, W, Y and X N. meningitidis strains. However, this experimental NOMV vaccine was not effective against serogroup A N. meningitidis strains. N. meningitidis capsular polysaccharide (PS) from serogroups A, C, W and Y were effective at inducing bactericidal antibody when conjugated to either tetanus toxoid or the fHbp1-fHbp2 fusion protein fHbp(1+2). The combination of the NOMV vaccine and the N. meningitidis serogroup A capsular polysaccharide (MAPS) protein conjugate was capable of inducing bactericidal antibodies against a limited number of N. meningitidis strains from serogroups A, B, C, W, Y and X tested in this study.
C1 [Pinto, Valerian B.; Burden, Robert; Wagner, Allyn; Moran, Elizabeth E.] WRAIR, Div Bacterial & Rickettsial Dis, Silver Spring, MD USA.
[Lee, Che-Hung] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Pinto, VB (reprint author), WRAIR, Div Bacterial & Rickettsial Dis, Silver Spring, MD USA.
EM vpinto21@msn.com
FU Military Infectious Disease Research Program
FX This work was supported by the Military Infectious Disease Research
Program. The funders had no role in study design, data collection and
analysis, decision to publish, or preparation of the manuscript.
NR 36
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U1 1
U2 7
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD NOV 14
PY 2013
VL 8
IS 11
DI 10.1371/journal.pone.0079304
PG 10
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 254DJ
UT WOS:000327143800058
ER
PT J
AU Blomquist, TM
Crawford, EL
Lovett, JL
Yeo, J
Stanoszek, LM
Levin, A
Li, J
Lu, M
Shi, LM
Muldrew, K
Willey, JC
AF Blomquist, Thomas M.
Crawford, Erin L.
Lovett, Jennie L.
Yeo, Jiyoun
Stanoszek, Lauren M.
Levin, Albert
Li, Jia
Lu, Mei
Shi, Leming
Muldrew, Kenneth
Willey, James C.
TI Targeted RNA-Sequencing with Competitive Multiplex-PCR Amplicon
Libraries
SO PLOS ONE
LA English
DT Article
ID POLYMERASE-CHAIN-REACTION; MESSENGER-RNA; EXPRESSION; SEQ; QUANTITATION;
DNA; TRANSCRIPTS; TOOL
AB Whole transcriptome RNA-sequencing is a powerful tool, but is costly and yields complex data sets that limit its utility in molecular diagnostic testing. A targeted quantitative RNA-sequencing method that is reproducible and reduces the number of sequencing reads required to measure transcripts over the full range of expression would be better suited to diagnostic testing. Toward this goal, we developed a competitive multiplex PCR-based amplicon sequencing library preparation method that a) targets only the sequences of interest and b) controls for inter-target variation in PCR amplification during library preparation by measuring each transcript native template relative to a known number of synthetic competitive template internal standard copies. To determine the utility of this method, we intentionally selected PCR conditions that would cause transcript amplification products (amplicons) to converge toward equimolar concentrations (normalization) during library preparation. We then tested whether this approach would enable accurate and reproducible quantification of each transcript across multiple library preparations, and at the same time reduce (through normalization) total sequencing reads required for quantification of transcript targets across a large range of expression. We demonstrate excellent reproducibility (R-2 = 0.997) with 97% accuracy to detect 2-fold change using External RNA Controls Consortium (ERCC) reference materials; high inter-day, inter-site and inter-library concordance (R-2 = 0.97-0.99) using FDA Sequencing Quality Control (SEQC) reference materials; and cross-platform concordance with both TaqMan qPCR (R-2 = 0.96) and whole transcriptome RNA-sequencing following "traditional'' library preparation using Illumina NGS kits (R-2 = 0.94). Using this method, sequencing reads required to accurately quantify more than 100 targeted transcripts expressed over a 10(7)-fold range was reduced more than 10,000-fold, from 2.3x10(9) to 1.4x10(5) sequencing reads. These studies demonstrate that the competitive multiplex-PCR amplicon library preparation method presented here provides the quality control, reproducibility, and reduced sequencing reads necessary for development and implementation of targeted quantitative RNA-sequencing biomarkers in molecular diagnostic testing.
C1 [Blomquist, Thomas M.; Crawford, Erin L.; Yeo, Jiyoun; Stanoszek, Lauren M.; Willey, James C.] Univ Toledo, Dept Med, Toledo, OH 43606 USA.
[Lovett, Jennie L.; Muldrew, Kenneth] Univ Toledo, Dept Pathol, Toledo, OH USA.
[Levin, Albert; Li, Jia; Lu, Mei] Henry Ford Hlth Syst, Dept Publ Hlth Sci, Detroit, MI USA.
[Shi, Leming] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Blomquist, TM (reprint author), Univ Toledo, Dept Med, Hlth Sci Campus, Toledo, OH 43606 USA.
EM thomas.blomquist@utoledo.edu
RI Lovett, Jennie/S-2996-2016
FU National Institutes of Health, National Cancer Institute [RC2-CA147652,
IMAT R21-CA138397]; National Heart Lung and Blood Institute
[RO1-HL108016]; University of Toledo Medical Center George Isaac
Research Fund
FX Significant portions of this study were paid for with funding provided
by National Institutes of Health, National Cancer Institute
(RC2-CA147652 and IMAT R21-CA138397) and National Heart Lung and Blood
Institute (RO1-HL108016); and the University of Toledo Medical Center
George Isaac Research Fund. The funders had no role in study design,
data collection and analysis, decision to publish, or preparation of the
manuscript.
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PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD NOV 13
PY 2013
VL 8
IS 11
AR e79120
DI 10.1371/journal.pone.0079120
PG 14
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 255QK
UT WOS:000327254700093
PM 24236095
ER
PT J
AU Yamazaki, A
Liu, P
Cheng, WC
Badano, A
AF Yamazaki, Asumi
Liu, Peter
Cheng, Wei-Chung
Badano, Aldo
TI Image Quality Characteristics of Handheld Display Devices for Medical
Imaging
SO PLOS ONE
LA English
DT Article
ID RADIOLOGY; RESOLUTION; SYSTEMS; NOISE; IPAD; CT
AB Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2x10(-5) mm(2) at 1 mm(-1), while handheld displays have values lower than 3.7x10(-6) mm(2). Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices.
C1 [Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Yamazaki, Asumi] Nagoya Univ, Grad Sch Med Sci, Nagoya, Aichi 4648601, Japan.
RP Badano, A (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
EM aldo.badano@fda.hhs.gov
RI Cheng, Wei-Chung/E-6240-2014;
OI badano, aldo/0000-0003-3712-6670
FU appointments to the Research Participation Program at the CDRH; Oak
Ridge Institute for Science and Education
FX AY and PL acknowledge funding by appointments to the Research
Participation Program at the CDRH administered by the Oak Ridge
Institute for Science and Education through an interagency agreement
between the U.S. DOE and the U.S. FDA. The funders had no role in study
design, data collection and analysis, decision to publish, or
preparation of the manuscript.
NR 21
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U1 0
U2 16
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD NOV 13
PY 2013
VL 8
IS 11
AR e79243
DI 10.1371/journal.pone.0079243
PG 11
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 255QK
UT WOS:000327254700112
PM 24236113
ER
PT J
AU Lipiski, M
Deuel, JW
Baek, JH
Engelsberger, WR
Buehler, PW
Schaer, DJ
AF Lipiski, Miriam
Deuel, Jeremy W.
Baek, Jin Hyen
Engelsberger, Wolfgang R.
Buehler, Paul W.
Schaer, Dominik J.
TI Human Hp1-1 and Hp2-2 Phenotype-Specific Haptoglobin Therapeutics Are
Both Effective In Vitro and in Guinea Pigs to Attenuate Hemoglobin
Toxicity
SO ANTIOXIDANTS & REDOX SIGNALING
LA English
DT Article
ID LOW-DENSITY-LIPOPROTEIN; SCAVENGER RECEPTOR; ATHEROSCLEROTIC PLAQUE; RAT
CIRCULATION; HEME UPTAKE; GENOTYPE; IRON; OXIDATION; DISEASE; CD163
AB Aims: Infusion of purified haptoglobin (Hp) functions as an effective hemoglobin (Hb) scavenging therapeutic in animal models of hemolysis to prevent cardiovascular and renal injury. Epidemiologic studies demonstrate the phenotype heterogeneity of human Hp proteins and suggest differing vascular protective potential imparted by the dimeric Hp1-1 and the polymeric Hp2-2. Results:In vitro experiments and in vivo studies in guinea pigs were performed to evaluate phenotype-specific differences in Hp therapeutics. We found no differences between the two phenotypes in Hb binding and intravascular compartmentalization of Hb in vivo. Both Hp1-1 and Hp2-2 attenuate Hb-induced blood pressure response and renal iron deposition. These findings were consistent with equal prevention of Hb endothelial translocation. The modulation of oxidative Hb reactions by the two Hp phenotypes was not found to be different. Both phenotypes stabilize the ferryl (Fe4+) Hb transition state, provide heme retention within the complex, and prevent Hb-driven low-density lipoprotein (LDL) peroxidation. Hb-mediated peroxidation of LDL resulted in endothelial toxicity, which was equally blocked by the addition of Hp1-1 and Hp2-2. Innovation and Conclusion: The present data do not provide support for the concept that phenotype-specific Hp therapeutics offer differential efficacy in mitigating acute Hb toxicity. Antioxid. Redox Signal. 19, 1619-1633.
C1 [Lipiski, Miriam; Deuel, Jeremy W.; Engelsberger, Wolfgang R.; Schaer, Dominik J.] Univ Zurich Hosp, Div Internal Med, CH-8091 Zurich, Switzerland.
[Baek, Jin Hyen; Buehler, Paul W.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Schaer, DJ (reprint author), Univ Zurich Hosp, Div Internal Med, CH-8091 Zurich, Switzerland.
EM paul.buehler@fda.hhs.gov; dominik.schaer@usz.ch
FU Swiss National Science Foundation [310030/120658, 31003A/138500];
University of Zurich; Swiss Federal Commission for Technology and
Innovation (CTI); FDA
FX This work was supported by the Swiss National Science Foundation (grants
310030/120658 and 31003A/138500), the University of Zurich Research
Priority Program "Integrative Human Physiology," the Swiss Federal
Commission for Technology and Innovation (CTI), and FDA Internal
Funding. The findings and conclusions in this article have not been
formally disseminated by the FDA and should not be construed to
represent any agency determination or policy.
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U1 0
U2 8
PU MARY ANN LIEBERT, INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1523-0864
EI 1557-7716
J9 ANTIOXID REDOX SIGN
JI Antioxid. Redox Signal.
PD NOV 10
PY 2013
VL 19
IS 14
BP 1619
EP 1633
DI 10.1089/ars.2012.5089
PG 15
WC Biochemistry & Molecular Biology; Endocrinology & Metabolism
SC Biochemistry & Molecular Biology; Endocrinology & Metabolism
GA 239PF
UT WOS:000326037100002
PM 23418677
ER
PT J
AU ElZarrad, MK
Mukhopadhyay, P
Mohan, N
Hao, EK
Dokmanovic, M
Hirsch, DS
Shen, Y
Pacher, P
Wu, WJ
AF ElZarrad, M. Khair
Mukhopadhyay, Partha
Mohan, Nishant
Hao, Enkui
Dokmanovic, Milos
Hirsch, Dianne S.
Shen, Yi
Pacher, Pal
Wu, Wen Jin
TI Trastuzumab Alters the Expression of Genes Essential for Cardiac
Function and Induces Ultrastructural Changes of Cardiomyocytes in Mice
SO PLOS ONE
LA English
DT Article
ID CONGESTIVE-HEART-FAILURE; DILATED CARDIOMYOPATHY; BREAST-CANCER; INDUCED
CARDIOTOXICITY; INDUCED APOPTOSIS; BLOOD-PRESSURE; VENTRICULAR MYOCYTES;
CIRCADIAN VARIATION; TROPONIN-I; STRESS
AB Treatment with trastuzumab, a humanized monoclonal antibody directed against the extracellular domain of Human Epidermal Growth Factor Receptor 2 (HER2), very successfully improves outcomes for women with HER2-positive breast cancer. However, trastuzumab treatment was recently linked to potentially irreversible serious cardiotoxicity, the mechanisms of which are largely elusive. This study reports that trastuzumab significantly alters the expression of myocardial genes essential for DNA repair, cardiac and mitochondrial functions, which is associated with impaired left ventricular performance in mice coupled with significant ultrastructural alterations in cardiomyocytes revealed by electron microscopy. Furthermore, trastuzumab treatment also promotes oxidative stress and apoptosis in myocardium of mice, and elevates serum levels of cardiac troponin-I (cTnI) and cardiac myosin light chain-1 (cMLC1). The elevated serum levels of cMLC1 in mice treated with trastuzumab highlights the potential that cMLC1 could be a useful biomarker for trastuzumab-induced cardiotoxicity.
C1 [ElZarrad, M. Khair; Mohan, Nishant; Dokmanovic, Milos; Hirsch, Dianne S.; Shen, Yi; Wu, Wen Jin] US FDA, Div Monoclonal Antibodies, Off Biotechnol Prod, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
[ElZarrad, M. Khair] NCI, Interagcy Oncol Task Force IOTF Fellowship Progra, NIH, Bethesda, MD 20892 USA.
[Mukhopadhyay, Partha; Hao, Enkui; Pacher, Pal] NIAAA, Lab Physiol Studies, NIH, Bethesda, MD USA.
RP Wu, WJ (reprint author), US FDA, Div Monoclonal Antibodies, Off Biotechnol Prod, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
EM wen.wu@fda.hhs.gov
RI MUKHOPADHYAY, PARTHA/G-3890-2010; Pacher, Pal/B-6378-2008
OI MUKHOPADHYAY, PARTHA/0000-0002-1178-1274; Pacher,
Pal/0000-0001-7036-8108
FU Federal Drug Administration-Office of Women's Health Research Science
Program Award [750912CDR]; Interagency Oncology Task Force Joint
Fellowship Program; United States Food and Drug Administration; National
Cancer Institute
FX This study is supported by Federal Drug Administration-Office of Women's
Health Research Science Program Award to WJW (Project ID: 750912CDR) and
the Interagency Oncology Task Force Joint Fellowship Program sponsored
by the United States Food and Drug Administration and National Cancer
Institute. The funders had no role in study design, data collection and
analysis, decision to publish, or preparation of the manuscript.
NR 56
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U1 0
U2 6
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD NOV 8
PY 2013
VL 8
IS 11
AR e79543
DI 10.1371/journal.pone.0079543
PG 14
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 255CG
UT WOS:000327216200073
PM 24255707
ER
PT J
AU Bird, ST
Delaney, JAC
Brophy, JM
Etminan, M
Skeldon, SC
Hartzema, AG
AF Bird, Steven T.
Delaney, Joseph A. C.
Brophy, James M.
Etminan, Mahyar
Skeldon, Sean C.
Hartzema, Abraham G.
TI Tamsulosin treatment for benign prostatic hyperplasia and risk of severe
hypotension in men aged 40-85 years in the United States: risk window
analyses using between and within patient methodology
SO BMJ-BRITISH MEDICAL JOURNAL
LA English
DT Article
ID CONTROLLED CASE SERIES; URINARY-TRACT SYMPTOMS; BLOCKERS; SAFETY
AB Objective To characterize risk of hypotension requiring admission to hospital in middle aged and older men treated with tamsulosin for benign prostatic hyperplasia.
Design Population based retrospective cohort study (between patient methodology) and self controlled case series (within patient methodology).
Setting Healthcare claims data from the IMS Lifelink database in the United States.
Participants Men aged 40-85 years with private US healthcare insurance entering the cohort at their first dispensing for tamsulosin or for a 5a reductase inhibitor (5ARI) between January 2001 and June 2011 after a minimum of six months' enrolment.
Main outcomes measures Hypotension requiring admission to hospital. Cox proportional hazards models estimated rate ratios at time varying intervals during follow-up: weeks 1-4, 5-8, and 9-12 after tamsulosin initiation; weeks 1-4, 5-8, and 9-12 after restarting tamsulosin (after a four week gap); and maintenance tamsulosin treatment (remaining exposed person time). Covariates included age, calendar year, demographics, antihypertensive use, healthcare use, and a Charlson comorbidity score. A self controlled case series, having implicit control for time invariant covariates, was additionally conducted.
Results Among 383 567 new users of study drugs (tamsulosin 297 596; 5ARI 85 971), 2562 admissions to hospital for severe hypotension were identified. The incidence for hypotension was higher for tamsulosin (42.4 events per 10 000 person years) than for 5ARIs (31.3 events per 10 000 person years) or all accrued person time (29.1 events per 10 000 person years). After tamsulosin initiation, the cohort analysis identified an increased rate of hypotension during weeks 1-4 (rate ratio 2.12 (95% confidence interval 1.29 to 3.04)) and 5-8 (1.51 (1.04 to 2.18)), and no significant increase at weeks 9-12. The rate ratio for hypotension also increased at weeks 1-4 (1.84 (1.46 to 2.33)) and 5-8 (1.85 (1.45 to 2.36)) after restarting tamsulosin, as did maintenance tamsulosin treatment (1.19 (1.07 to 1.32)). The self controlled case series gave similar results as the cohort analysis.
Conclusions We observed a temporal association between tamsulosin use for benign prostatic hyperplasia and severe hypotension during the first eight weeks after initiating treatment and the first eight weeks after restarting treatment. This association suggests that physicians should focus on improving counseling strategies to warn patients regarding the "first dose phenomenon" with tamsulosin.
C1 [Bird, Steven T.] US FDA, Ctr Drug Evaluat & Res, Off Surveillance & Epidemiol, Dept Epidemiol, Silver Spring, MD USA.
[Bird, Steven T.; Hartzema, Abraham G.] Univ Florida, Coll Pharm & Epidemiol Pharmaceut Outcomes & Poli, Gainesville, FL USA.
[Delaney, Joseph A. C.] Univ Washington, Sch Publ Hlth, Dept Epidemiol, Seattle, WA 98195 USA.
[Brophy, James M.] McGill Univ, Royal Victoria Hosp, Ctr Hlth, Montreal, PQ H3A 1A1, Canada.
[Etminan, Mahyar] Univ British Columbia, Fac Med, Therapeut Evaluat Unit, Prov Hlth Serv Author, Vancouver, BC V5Z 1M9, Canada.
[Skeldon, Sean C.] Univ Toronto, Dept Surg, Div Urol, Toronto, ON, Canada.
[Skeldon, Sean C.] Univ British Columbia, Dept Urol Sci, Vancouver, BC V5Z 1M9, Canada.
RP Etminan, M (reprint author), Univ British Columbia, Fac Med, Therapeut Evaluat Unit, Prov Hlth Serv Author, Vancouver, BC V5Z 1M9, Canada.
EM metminan@popi.ubc.ca
FU McGill University Health Center; Fonds de la Recherche en Sante du
Quebec; Ministere de la Sante et des Services Sociaux
FX This work was funded in part by the McGill University Health Center,
Fonds de la Recherche en Sante du Quebec, and the Ministere de la Sante
et des Services Sociaux. The authors had full autonomy in the study
design; the collection, analysis, and interpretation of data; the
writing of the article; and the decision to submit it for publication.
The authors have no other conflicts or competing interests to declare.
Competing interests: All authors have completed the ICMJE uniform
disclosure form at www.icmje.org/coi_disclosure. pdf and declare:
support from the McGill University Health Center, Fonds de la Recherche
en Sante du Quebec, and the Ministere de la Sante et des Services
Sociaux for the submitted work; JMB has received peer review financial
support from le Fonds de la Recherche en Sante du Quebec, JACD has a
research grant from the Agency for Healthcare Research and Quality, AGH
is a principal investigator for the Observational Medical Outcomes
Partnership, a private-public partnership designed to help improve drug
safety monitoring, and STB is employed by the US Food and Drug
Administration; no other relationships or activities that could appear
to have influenced the submitted work.
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PU BMJ PUBLISHING GROUP
PI LONDON
PA BRITISH MED ASSOC HOUSE, TAVISTOCK SQUARE, LONDON WC1H 9JR, ENGLAND
SN 1756-1833
J9 BMJ-BRIT MED J
JI BMJ-British Medical Journal
PD NOV 5
PY 2013
VL 347
AR f6320
DI 10.1136/bmj.f6320
PG 8
WC Medicine, General & Internal
SC General & Internal Medicine
GA 250XL
UT WOS:000326890000002
PM 24192967
ER
PT J
AU Rashid, MM
McKean, JW
Kloke, JD
AF Rashid, M. Mushfiqur
McKean, Joseph W.
Kloke, John D.
TI REVIEW OF RANK-BASED PROCEDURES FOR MULTICENTER CLINICAL TRIALS
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Review
DE Covariates; Mixed models; Nonparametric; Rank regression scores;
Repeated measures; Robust; Variance components; Wilcoxon procedures
ID LINEAR-MODELS; ROBUST ANALYSIS; MIXED MODELS; INFERENCES; REGRESSION
AB This article reviews nonparametric alternatives to the mixed model normal theory analysis for the analyses of multicenter clinical trials. Under a mixed model, the traditional analysis is based on maximum likelihood theory under normal errors. This analysis, though, is not robust to outliers. Robust, rank-based, Wilcoxon-type procedures are reviewed for a multicenter clinical trial for the mixed model but without the assumption of normality. These procedures retain the high efficiency of Wilcoxon methods for simple location problems and are based on a fitting criterion which is robust to outliers in response space. A simple weighting scheme can be employed so that the procedures are robust to outliers in factor (design) space as well as response space. These rank-based analyses offer a complete analysis, including estimation of fixed effects and their standard errors, and tests of linear hypotheses. Both rank-based estimates of contrasts and individual treatment effects are reviewed. We illustrate the analyses using real data from a clinical trial.
C1 [Rashid, M. Mushfiqur] US FDA, Silver Spring, MD USA.
[McKean, Joseph W.] Western Michigan Univ, Kalamazoo, MI 49008 USA.
[Kloke, John D.] Univ Wisconsin, Madison, WI USA.
RP McKean, JW (reprint author), Western Michigan Univ, Dept Stat, Kalamazoo, MI 49008 USA.
EM joseph.mckean@wmich.edu
NR 21
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U1 0
U2 7
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PD NOV 2
PY 2013
VL 23
IS 6
BP 1207
EP 1227
DI 10.1080/10543406.2013.834919
PG 21
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 236HR
UT WOS:000325786600001
PM 24138428
ER
PT J
AU Ross, HJ
Hilton, T
Puri, S
Joshi, B
Han, J
Bhattacharya, B
Moudgil, T
Dubay, C
Sanborn, RE
Hu, HM
Van De Ven, R
Urba, W
Aung, S
Puri, R
Fox, BA
AF Ross, Helen J.
Hilton, Traci
Puri, Sachin
Joshi, Bharat
Han, Jing
Bhattacharya, Bhaskar
Moudgil, Tarsem
Dubay, Christopher
Sanborn, Rachel E.
Hu, Hong-Ming
Van De Ven, Reineke
Urba, Walter
Aung, Sandra
Puri, Raj
Fox, Bernard A.
TI A NOVEL AUTOPHAGOSOME NON-SMALL CELL LUNG CANCER VACCINE (DRIBBLES)
CONTAINS SHORT-LIVED PROTEINS, DEFECTIVE RIBOSOMAL PRODUCTS, AT LEAST
NINE NCI-PRIORITIZED ANTIGENS, AND AGONISTS FOR TLR 2, 3, 4, 7, AND 9
SO JOURNAL OF THORACIC ONCOLOGY
LA English
DT Meeting Abstract
DE Lung cancer vaccines; T-cell immune response; autophagosome; clinical
trial
C1 [Ross, Helen J.] Mayo Clin, Rochester, MN USA.
[Hilton, Traci; Aung, Sandra] Ubivac, Portland, OR USA.
[Puri, Sachin; Moudgil, Tarsem; Dubay, Christopher; Sanborn, Rachel E.; Hu, Hong-Ming; Van De Ven, Reineke; Urba, Walter; Fox, Bernard A.] Robert W Franz Canc Ctr, Earle A Chiles Res Inst, Portland, OR USA.
[Joshi, Bharat; Han, Jing; Bhattacharya, Bhaskar; Puri, Raj] US FDA, Tumor Vaccine & Biotechnol Branch, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
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U1 1
U2 2
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1556-0864
EI 1556-1380
J9 J THORAC ONCOL
JI J. Thorac. Oncol.
PD NOV
PY 2013
VL 8
SU 2
MA O08.01
BP S160
EP S160
PG 1
WC Oncology; Respiratory System
SC Oncology; Respiratory System
GA AM1RE
UT WOS:000339624900194
ER
PT J
AU Farel, CE
Parker, SD
Muessig, KE
Grodensky, CA
Jones, C
Golin, CE
Fogel, CI
Wohl, DA
AF Farel, Claire E.
Parker, Sharon D.
Muessig, Kathryn E.
Grodensky, Catherine A.
Jones, Chaunetta
Golin, Carol E.
Fogel, Catherine I.
Wohl, David A.
TI Sexuality, Sexual Practices, and HIV Risk Among Incarcerated
African-American Women in North Carolina
SO WOMENS HEALTH ISSUES
LA English
DT Article
ID TRANSMITTED INFECTIONS; BEHAVIORS; IDENTITY; MEN; DISPARITIES;
DETAINEES; JAIL
AB Background: Women who have been in prison carry a greater lifetime risk of HIV for reasons that are not well understood. This effect is amplified in the Southeastern United States, where HIV incidence and prevalence is especially high among African-American (AA) women. The role of consensual sexual partnerships in the context of HIV risk, especially same-sex partnerships, merits further exploration.
Methods: We conducted digitally recorded qualitative interviews with 29 AA women (15 HIV positive, 14 HIV negative) within 3 months after entry into the state prison system. We explored potential pre-incarceration HIV risk factors, including personal sexual practices. Two researchers thematically coded interview transcripts and a consensus committee reviewed coding.
Results: Women reported complex sexual risk profiles during the 6 months before incarceration, including sex with women as well as prior sexual partnerships with both men and women. Condom use with primary male partners was low and a history of transactional sex work was prevalent. These behaviors were linked with substance use, particularly among HIV-positive women.
Conclusions: Although women may not formally identify as bisexual or lesbian, sex with women was an important component of this cohort's sexuality. Addressing condom use, heterogeneity of sexual practices, and partner concurrency among at-risk women should be considered for reducing HIV acquisition and preventing forward transmission in women with a history of incarceration. Copyright (C) 2013 by the Jacobs Institute of Women's Health. Published by Elsevier Inc.
C1 [Farel, Claire E.] Univ N Carolina, Sch Med, Inst Global Hlth & Infect Dis, Chapel Hill, NC 27599 USA.
[Parker, Sharon D.] Brown Univ, Sch Med, Div Infect Dis, Providence, RI 02912 USA.
[Parker, Sharon D.] Miriam Hosp, Providence, RI 02906 USA.
[Muessig, Kathryn E.] Univ N Carolina, Dept Hlth Behav, Inst Global Hlth & Infect Dis, Gillings Sch Global Publ Hlth, Chapel Hill, NC 27599 USA.
[Grodensky, Catherine A.] Univ N Carolina, Social & Behav Sci Res Core, Ctr AIDS Res, Chapel Hill, NC 27599 USA.
[Jones, Chaunetta] US FDA, Off Hlth Commun & Educ, Ctr Tobacco Prod, Rockville, MD 20857 USA.
[Golin, Carol E.] Univ N Carolina, Gillings Sch Global Publ Hlth, Dept Med, Dept Hlth Behav, Chapel Hill, NC 27599 USA.
[Golin, Carol E.] Univ N Carolina, Sch Med, Chapel Hill, NC USA.
[Fogel, Catherine I.] Univ N Carolina, Sch Nursing, Chapel Hill, NC 27599 USA.
[Wohl, David A.] Univ N Carolina, Inst Global Hlth & Infect Dis, HIV Serv North Carolina Dept Correct, Chapel Hill, NC 27599 USA.
RP Farel, CE (reprint author), Univ N Carolina, Sch Med, Ctr Infect Dis, 130 Mason Farm Rd,CB 7030 2nd Floor Bioinformat, Chapel Hill, NC 27599 USA.
EM cfarel@med.unc.edu
FU NCATS NIH HHS [UL1TR000083, UL1 TR000083]; NIAID NIH HHS [P30 AI50410,
P30 AI050410]; NICHD NIH HHS [K24 HD069204]; NIDA NIH HHS [F32 DA030268,
F32 DA030268-01, T32 DA013911]; NIMH NIH HHS [R25 MH083620]
NR 26
TC 1
Z9 1
U1 3
U2 6
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1049-3867
EI 1878-4321
J9 WOMEN HEALTH ISS
JI Womens Health Iss.
PD NOV-DEC
PY 2013
VL 23
IS 6
BP E357
EP E364
DI 10.1016/j.whi.2013.08.006
PG 8
WC Public, Environmental & Occupational Health; Women's Studies
SC Public, Environmental & Occupational Health; Women's Studies
GA AO1XY
UT WOS:000341110100006
PM 24183410
ER
PT J
AU Miller, DL
AF Miller, Donald L.
TI EFFORTS TO OPTIMIZE RADIATION PROTECTION IN INTERVENTIONAL FLUOROSCOPY
SO HEALTH PHYSICS
LA English
DT Article
DE National Council on Radiation Protection and Measurements; fluoroscopy;
medical radiation; radiation protection
ID TRANSLUMINAL CORONARY ANGIOPLASTY; QUALITY IMPROVEMENT GUIDELINES;
INDUCED SKIN INJURY; OF-THE-LITERATURE; CARDIAC-CATHETERIZATION;
RADIOLOGY PROCEDURES; GUIDED PROCEDURES; PEDIATRIC-PATIENTS;
ARTERY-STENOSIS; SAFETY PROGRAM
AB While it has been known for more than a century that radiation presents risks to both the physician and the patient, skin injuries from fluoroscopy became increasingly rare after the 1930s, and radiation risk from fluoroscopy appeared to be adequately controlled. However, beginning in approximately 1975, new technologies and materials for interventional devices were developed. These enabled new procedures, and as these were instituted, skin injuries again occurred in patients. Four central issues were identified: equipment, quality management, operator training, and occupational radiation protection. Recognition that these were areas for improvement provoked changes in technology and practice that continue today.
C1 US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Miller, DL (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM donald.miller@fda.hhs.gov
NR 110
TC 5
Z9 6
U1 0
U2 3
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0017-9078
EI 1538-5159
J9 HEALTH PHYS
JI Health Phys.
PD NOV
PY 2013
VL 105
IS 5
BP 435
EP 444
DI 10.1097/HP.0b013e31829c355a
PG 10
WC Environmental Sciences; Public, Environmental & Occupational Health;
Nuclear Science & Technology; Radiology, Nuclear Medicine & Medical
Imaging
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Nuclear Science & Technology; Radiology, Nuclear Medicine &
Medical Imaging
GA 299BB
UT WOS:000330368400007
PM 24077043
ER
PT J
AU Eichelberger, SL
Sultana, I
Gao, J
Getie-Kebtie, M
Alterman, M
Eichelberger, MC
AF Eichelberger, Schafer L.
Sultana, Ishrat
Gao, Jin
Getie-Kebtie, Melkamu
Alterman, Michail
Eichelberger, Maryna C.
TI Potency under pressure: the impact of hydrostatic pressure on antigenic
properties of influenza virus hemagglutinin
SO INFLUENZA AND OTHER RESPIRATORY VIRUSES
LA English
DT Article
DE Hemagglutinin; hydrostatic pressure; immunogenicity; influenza; potency
ID SINGLE-RADIAL-IMMUNODIFFUSION; IMMUNODEFICIENCY-VIRUS; SUBUNIT VACCINE;
MEMBRANE-FUSION; INACTIVATION; ASSAY; NEURAMINIDASE; PROTECTION;
INFECTION; ANTIBODY
AB Background Influenza vaccines are effective in protecting against illness and death caused by this seasonal pathogen. The potency of influenza vaccines is measured by single radial immunodiffusion (SRID) assay that quantifies antigenic forms of hemagglutinin (HA). Hydrostatic pressure results in loss of binding of influenza virus to red blood cells, but it is not known whether this infers loss of potency.
Objectives Our goal was to determine the impact of pressure on HA antigenic structure.
Methods Viruses included in the 2010-2011 trivalent influenza vaccine were subjected to increasing number of cycles at 35 000 psi in a barocycler, and the impact of this treatment measured by determining hemagglutination units (HAU) and potency. Potency was assessed by SRID and immunogenicity in mice.
Results After 25 cycles of pressure, the potency measured by SRID assay was below the limit of quantification for the H1N1 and B viruses used in our study, while the H3N2 component retained some potency that was lost after 50 pressure cycles. Pressure treatment also resulted in loss of HAU, but this did not strictly correlate with the potency value. Curiously, loss of potency was abrogated when influenza A, but not B, antigens were exposed to pressure in chicken egg allantoic fluid. Protection against pressure appeared to be mediated by specific interactions because addition of bovine serum albumin did not have the same effect.
Conclusions Our results show that pressure-induced loss of potency is strain dependent and suggests that pressure treatment may be useful for identifying vaccine formulations that improve HA stability.
C1 [Eichelberger, Schafer L.; Getie-Kebtie, Melkamu; Alterman, Michail] Off Cell Tissue & Gene Therapy, Div Cellular & Gene Therapies, Bethesda, MD USA.
[Sultana, Ishrat; Gao, Jin; Eichelberger, Maryna C.] US FDA, Div Viral Prod, Off Vaccine Res & Review, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Eichelberger, MC (reprint author), US FDA, Div Viral Prod, Off Vaccine Res & Review, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM maryna.eichelberger@fda.hhs.gov
FU Pandemic Influenza funds
FX We thank CBER's animal care managers and staff for excellent animal
husbandry, Vladimir Lugovtsev and Ewan Plant for helpful suggestions
during the preparation of this manuscript. This study was supported by
Pandemic Influenza funds. SLE and IS were supported by training funds
administered by the Oak Ridge Institute for Science and Education.
NR 33
TC 1
Z9 1
U1 0
U2 9
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 1750-2640
EI 1750-2659
J9 INFLUENZA OTHER RESP
JI Influenza Other Respir. Viruses
PD NOV
PY 2013
VL 7
IS 6
BP 961
EP 968
DI 10.1111/irv.12102
PG 8
WC Infectious Diseases; Virology
SC Infectious Diseases; Virology
GA AA3OG
UT WOS:000331001400013
PM 23496824
ER
PT J
AU Nielsen, LH
Gordon, S
Holm, R
Selen, A
Rades, T
Mullertz, A
AF Nielsen, Line Hagner
Gordon, Sarah
Holm, Rene
Selen, Arzu
Rades, Thomas
Mullertz, Anette
TI Preparation of an amorphous sodium furosemide salt improves solubility
and dissolution rate and leads to a faster T-max after oral dosing to
rats
SO EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
LA English
DT Article
DE Poorly soluble drugs; Amorphous salt; Furosemide; Biorelevant
dissolution; Solubility; Oral bioavailability
ID WATER-SOLUBLE DRUGS; HUMAN INTESTINAL FLUIDS; PHYSICOCHEMICAL
CHARACTERIZATION; GASTROINTESTINAL-TRACT; PHARMACEUTICAL SYSTEMS; SOLID
DISPERSION; MELT EXTRUSION; STABILITY; BIOAVAILABILITY; INDOMETHACIN
AB Amorphous forms of furosemide sodium salt and furosemide free acid were prepared by spray drying. For the preparation of the amorphous free acid, methanol. was utilised as the solvent, whereas the amorphous sodium salt was formed from a sodium hydroxide-containing aqueous solvent in equimolar amounts of NaOH and furosemide. Information about the structural differences between the two amorphous forms was obtained by Fourier Transform Infrared Spectroscopy (FTIR), and glass transition temperature (T-g) was determined using Differential Scanning Calorimetry (DSC). The stability and devitrification tendency of the two amorphous forms were investigated by X-ray Powder Diffraction (XRPD). The apparent solubility of the two amorphous forms and the crystalline free acid form of furosemide in various gastric and intestinal stimulated media was determined. Moreover, the dissolution characteristics of the two amorphous forms and of crystalline free acid were investigated.
FTIR confirmed molecular differences between the amorphous free acid and salt. The amorphous salt showed a T-g of 101.2 degrees C, whereas the T-g for the amorphous free acid was found to be 61.8 degrees C. The amorphous free acid was physically stable for 4 days at 22 degrees C and 33% relative humidity (RH), while the amorphous salt exhibited physical stability for 291 days at the same storage conditions. When storing the amorphous forms at 40 degrees C and 75% RH both forms converted to crystalline forms after 2 days.
The apparent solubility of the amorphous salt form was higher than that of both amorphous and crystalline free acid in all media studied. All three forms of furosemide exhibited a greater solubility in the presence of biorelevant media as compared to buffer, however, an overall trend for a further increase in solubility in relation to an increase in media surfactant concentration was not seen. The amorphous salt demonstrated an 8- and 20-fold higher intrinsic dissolution rate (IDR) when compared to amorphous and crystalline free acid, respectively.
The promising properties of the amorphous salt in vitro were further evaluated in an in vivo study, where solid dosage forms of the amorphous salt, amorphous and crystalline free acid and a solution of furosemide were administered orally to rats. The amorphous salt exhibited a significantly faster T-max compared to the solution and amorphous and crystalline free acid. C-max for the solution was significantly higher compared to the three furosemide forms. No significant difference was found in AUC and absolute bioavailability for the solution, crystalline free acid and the two amorphous forms of furosemide. It can be concluded that the higher IDR and higher apparent solubility of the amorphous salt resulted in a faster T-max compared to the amorphous and crystalline free acid. Published by Elsevier B.V.
C1 [Nielsen, Line Hagner; Gordon, Sarah; Holm, Rene; Rades, Thomas; Mullertz, Anette] Univ Copenhagen, Dept Pharm, Fac Hlth & Med Sci, DK-2100 Copenhagen, Denmark.
[Holm, Rene] H Lundbeck & Co AS, Biol & Pharmaceut Sci, Valby, Denmark.
[Selen, Arzu] US FDA, Silver Spring, MD USA.
[Mullertz, Anette] Univ Copenhagen, Dept Pharm, Fac Hlth & Med Sci, Bioneer FARMA, DK-2100 Copenhagen, Denmark.
RP Mullertz, A (reprint author), Univ Copenhagen, Dept Pharm, Fac Hlth & Med Sci, Bioneer FARMA, Univ Pk 2, DK-2100 Copenhagen, Denmark.
EM anette.mullertz@sund.ku.dk
RI Hagner Nielsen, Line/C-7312-2014;
OI Hagner Nielsen, Line/0000-0002-3789-4816; Rades,
Thomas/0000-0002-7521-6020; Mullertz, Anette/0000-0003-3020-8892
FU Villum Kann Rasmussen Foundation
FX The authors would like to acknowledge the Villum Kann Rasmussen
Foundation for financial support in form of NAnoMEChanical sensors and
actuators, fundamentals and new directions (NAMEC) - a VKR Centre of
Excellence. Martin Lau Christiansen (Department of Pharmacy, University
of Copenhagen) is acknowledged for assistance with the pharmacokinetic
analysis and Richard T. Lostritto (US Food and Drug Administration) for
assistance with the manuscript. Furthermore, the personnel in the animal
facilities at H. Lundbeck A/S are acknowledged for their skilful
handling of the rats. Part of the work presented in this paper is the
result of a collaborative project, carried out in partnership between
the University of Copenhagen, the Institute of Pharmaceutical
Technology, Goethe University, Frankfurt and the US Food and Drug
Administration.
NR 45
TC 18
Z9 18
U1 3
U2 60
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0939-6411
EI 1873-3441
J9 EUR J PHARM BIOPHARM
JI Eur. J. Pharm. Biopharm.
PD NOV
PY 2013
VL 85
IS 3
BP 942
EP 951
DI 10.1016/j.ejpb.2013.09.002
PN B
PG 10
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 296QP
UT WOS:000330200800014
PM 24075980
ER
PT J
AU Rahman, Z
Siddiqui, A
Khan, MA
AF Rahman, Ziyaur
Siddiqui, Akhtar
Khan, Mansoor A.
TI Orally disintegrating tablet of novel salt of antiepileptic drug:
Formulation strategy and evaluation
SO EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
LA English
DT Article
DE Lamotrigine-cyclamate salt; Orally disintegrating tablet; Disintegration
time; Electronic tongue; Near infrared chemical imaging; Dissolution
ID ELECTRONIC TONGUE; TANNATE COMPLEXES; COATED TABLETS; ADHERENCE;
MEDICATION
AB The aim of present research was to design and evaluate orally disintegrating tablet (ODT) of novel lamotrigine-cyclamate salt. Box-Behnken response surface methodology was selected to design the optimized formulation. The independent factors selected were tablet hardness (X-1), disintegrant (X-2) and lubricant (X-3) levels, and responses chosen were disintegration time (DT, Y-1), friability (Y-2), T-50 (Y-3), and T-90 (Y-4). The tablets were also characterized for drug uniformity by near infrared chemical imaging (NIR-CI) and taste masking evaluation by electronic tongue. All the selected independent variables were statistically (p < 0.05) effect the Y-1 while Y-2, Y-3, and Y-4 affected only by X-2. The optimized ODT was found to meet the regulatory requirement of DT and friability specification. The NIR-CI images indicated uniform distribution of active and inactive ingredients within the tablets. The electronic tongue results were analyzed by principle component analysis (PCA). It indicated that novel salt of lamotrigine and its ODT formulation have a taste similar to cyclamic acid which is indicated by close proximity on PCA score plot, lower Euclidean distance, and high discrimination index values. Furthermore, these parameters were very close to ODT placebo formulation. On the other hand, lamotrigine, its ODT, and placebo formulation were far from each other. In summary, lamotrigine salt provides another avenue for pediatric friendly formulation for children and will enhance patience compliance. Published by Elsevier B.V.
C1 [Rahman, Ziyaur; Siddiqui, Akhtar; Khan, Mansoor A.] US FDA, Div Prod Qual & Res, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Khan, MA (reprint author), FDA CDER DPQR, LS Bldg 64,Room 1070,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Mansoor.Khan@fda.hhs.gov
OI Rahman, Ziyaur/0000-0002-0402-825X
FU FDA-NIH interagency agreement; MCMi infrastructure support grant; Oak
Ridge Institute for Science and Education (ORISE)
FX This research was supported in part by FDA-NIH interagency agreement and
also by the MCMi infrastructure support grant. The authors would also
like to thank the Oak Ridge Institute for Science and Education (ORISE)
for supporting the post-doctoral research.
NR 41
TC 8
Z9 11
U1 2
U2 12
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0939-6411
EI 1873-3441
J9 EUR J PHARM BIOPHARM
JI Eur. J. Pharm. Biopharm.
PD NOV
PY 2013
VL 85
IS 3
BP 1300
EP 1309
DI 10.1016/j.ejpb.2013.06.006
PN B
PG 10
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 296QP
UT WOS:000330200800055
PM 23800704
ER
PT J
AU Munoz, MA
Liu, W
Delaney, JAC
Brown, E
Mugavero, MJ
Mathews, WC
Napravnik, S
Willig, JH
Eron, JJ
Hunt, PW
Kahn, JO
Saag, MS
Kitahata, MM
Crane, HM
AF Munoz, Monica A.
Liu, Wei
Delaney, Joseph A. C.
Brown, Elizabeth
Mugavero, Michael J.
Mathews, W. Chris
Napravnik, Sonia
Willig, James H.
Eron, Joseph J.
Hunt, Peter W.
Kahn, James O.
Saag, Michael S.
Kitahata, Mari M.
Crane, Heidi M.
TI Comparative Effectiveness of Fish Oil Versus Fenofibrate, Gemfibrozil,
and Atorvastatin on Lowering Triglyceride Levels Among HIV-Infected
Patients in Routine Clinical Care
SO JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
LA English
DT Article; Proceedings Paper
CT 27th International Conference on Pharmacoepidemiology and Therapeutic
Risk Management
CY AUG 16, 2011
CL Chicago, IL
DE fish oil; triglycerides; dyslipidemia; fibrates; HIV
ID CORONARY-HEART-DISEASE; N-3 FATTY-ACIDS; ANTIRETROVIRAL THERAPY;
CARDIOVASCULAR EVENTS; MYOCARDIAL-INFARCTION; ETHYL-ESTERS;
RISK-FACTORS; DIETARY; HYPERTRIGLYCERIDEMIA; TRIAL
AB Objective: The goal of this study was to compare the effectiveness of fish oil, fenofibrate, gemfibrozil, and atorvastatin on reducing triglyceride (TG) levels among a large cohort of HIV-infected patients in clinical care.
Design: Retrospective observational cohort study.
Methods: The primary endpoint was absolute change in TG levels measured using the last TG value pretreatment and the first TG value posttreatment. A pre-post quasi-experimental design was used to estimate the change in TG because of initiating fish oil. Linear regression models examined the comparative effectiveness of treatment with fish oil versus gemfibrozil, fenofibrate, or atorvastatin for TG reduction. Models were adjusted for baseline differences in age, sex, race, CD4(+) cell count, diabetes, body mass index, protease inhibitor use, and time between TG measures.
Results: A total of 493 patients (mean age, 46 years; 95% male) were included (46 patients receiving gemfibrozil; 80, fenofibrate; 291, atorvastatin; and 76, fish oil) with a mean baseline TG of 347 mg/dL. New use of fish oil decreased TG [Delta TG, -45 mg/dL; 95% confidence interval (CI): -80 to -11] in the pre-post study. Compared with fish oil (reference), fibrates were more effective (Delta TG, -66; 95% CI: -120 to -12) in reducing TG levels, whereas atorvastatin was not (Delta TG, -39; 95% CI: -86 to 9).
Conclusions: In HIV-infected patients in routine clinical care, fish oil is less effective than fibrates (but not atorvastatin) at lowering TG values. Fish oil may still represent an attractive alternative for patients with moderately elevated TGs, particularly among patients who may not want or tolerate fibrates.
C1 [Munoz, Monica A.; Liu, Wei; Delaney, Joseph A. C.] Univ Florida, Dept Pharmaceut Outcome & Policy, Gainesville, FL USA.
[Munoz, Monica A.] US FDA, Silver Spring, MD USA.
[Kitahata, Mari M.; Crane, Heidi M.] Univ Washington, Dept Med, Seattle, WA 98106 USA.
[Brown, Elizabeth] Univ Washington, Dept Biostat, Seattle, WA 98106 USA.
[Mugavero, Michael J.; Willig, James H.; Saag, Michael S.] Univ Alabama Birmingham, Dept Med, Birmingham, AL 35294 USA.
[Mathews, W. Chris] Univ Calif San Diego, Dept Med, San Diego, CA 92103 USA.
[Napravnik, Sonia; Eron, Joseph J.] Univ N Carolina, Dept Med, Chapel Hill, NC USA.
[Hunt, Peter W.; Kahn, James O.] Univ Calif San Francisco, Dept Med, San Francisco, CA USA.
RP Crane, HM (reprint author), Univ Washington, Harborview Med Ctr, 325 9th Ave,Box 359931, Seattle, WA 98106 USA.
EM hcrane@uw.edu
RI Mathews, William/E-4451-2010
OI Mathews, William/0000-0002-2352-0725
FU AHRQ HHS [R21 HS019516, R21HS019516]; NIAID NIH HHS [P30AI027757, R24
AI067039, R24AI067039, P30 AI027757, P30 AI050410]
NR 36
TC 8
Z9 8
U1 0
U2 1
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1525-4135
EI 1077-9450
J9 JAIDS-J ACQ IMM DEF
JI JAIDS
PD NOV 1
PY 2013
VL 64
IS 3
BP 254
EP 260
PG 7
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 300GY
UT WOS:000330453600005
PM 23892238
ER
PT J
AU Zhang, G
Brown, EW
Hammack, TS
AF Zhang, G.
Brown, E. W.
Hammack, T. S.
TI Comparison of different preenrichment broths, egg:preenrichment broth
ratios, and surface disinfection for the detection of Salmonella
enterica ssp enterica serovar Enteritidis in shell eggs
SO POULTRY SCIENCE
LA English
DT Article
DE Salmonella; detection; enrichment; broth; egg
ID RAPID DETECTION; UNITED-STATES; LAYING HENS; ENRICHMENT; POULTRY;
GROWTH; POOLS; SPP.; MEAT
AB Salmonella enterica ssp. enterica serovar Enteritidis is the leading reported cause of Salmonella infections. Most Salmonella Enteritidis infections are associated with whole shell eggs and egg products. This project attempted to lay the foundation for improving the Food and Drug Administration's current Bacteriological Analytical Manual method for the detection of Salmonella Enteritidis in shell eggs. Two Salmonella Enteritidis isolates were used for comparisons among different preenrichment and enrichment media and for the evaluation of egg: preenrichment broth ratios for the detection of Salmonella Enteritidis in shell eggs. The effect of surface disinfection on the detection of Salmonella Enteritidis in shell eggs was also investigated. The results indicated that tryptic soy broth (TSB) was similar to TSB plus ferrous sulfate, but significantly (alpha = 0.05) better than nutrient broth, Universal Preenrichment broth, and buffered peptone water when used for preenrichment of Salmonella in shell eggs. Salmonella Enteritidis populations after enrichment with Rappaport-Vassiliadis broth were 0.40 to 1.11 log cfu/mL of culture lower than those in preenrichment cultures. The reduction was statistically significant (alpha = 0.05). Egg: broth ratios at 1:9 and 1:2 produced significantly (alpha = 0.05) higher Salmonella Enteritidis populations after preenrichment with TSB with inoculum levels at 4 cfu/100 g of eggs and 40 cfu/1,000 g of eggs than the ratio at 1:1. Salmonella Enteritidis populations in TSB preenrichment cultures of shell eggs surface-disinfected with 70% alcohol: iodine/potassium iodide solution and untreated control were 9.11 +/- 0.11 and 9.18 +/- 0.05 log cfu/mL, respectively, for SE 13-2, and 9.20 +/- 0.04 and 9.16 +/- 0.05 log cfu/mL, respectively, for SE CDC_2010K_1543. Surface disinfection of eggs did not reduce the sensitivity of detection of Salmonella Enteritidis in liquid eggs. These results could improve the Food and Drug Administration's current Bacteriological Analytical Manual method for the detection of Salmonella in shell eggs by simplifying the preenrichment medium and changing the sample handling before enrichment.
C1 [Zhang, G.; Brown, E. W.; Hammack, T. S.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Zhang, G (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM Guodong.Zhang@fda.hhs.gov
NR 24
TC 0
Z9 0
U1 4
U2 12
PU POULTRY SCIENCE ASSOC INC
PI SAVOY
PA 1111 N DUNLAP AVE, SAVOY, IL 61874-9604 USA
SN 0032-5791
EI 1525-3171
J9 POULTRY SCI
JI Poult. Sci.
PD NOV
PY 2013
VL 92
IS 11
BP 3010
EP 3016
DI 10.3382/ps.2013-03022
PG 7
WC Agriculture, Dairy & Animal Science
SC Agriculture
GA 301IE
UT WOS:000330525200024
PM 24135606
ER
PT J
AU Betts, KR
Hinsz, VB
AF Betts, Kevin R.
Hinsz, Verlin B.
TI Strong shared representations promote schema-consistent memory errors in
groups
SO GROUP PROCESSES & INTERGROUP RELATIONS
LA English
DT Article
DE cognitive representations; error correction; groups; memory errors;
shared representations
ID RECOGNITION MEMORY; FALSE MEMORIES; COLLABORATION; INFORMATION; RECALL;
INDIVIDUALS; PERFORMANCE; INHIBITION; PREDICTION; JUDGMENTS
AB We created the conditions necessary for cognitive representations to develop by presenting individuals and groups with word lists consisting of items high and low in associative strength. Strong cognitive representations were found to promote more schema-consistent memory errors than weaker representations. Moreover, strong cognitive representations resulted in more of these errors for groups than individuals. Weak cognitive representations, in contrast, resulted in fewer of these errors for groups than individuals. We find that variation in the frequency of memory errors between individuals and groups is influenced by the strength of shared representations that interfere with the ability of groups to correct schema-consistent memory errors among their members. Further analyses suggest that strong shared representations also aid correct recall relative to weak shared representations. We conclude that despite general advantages of collaboration, select circumstances that allow for strong shared representations may promote schema-consistent memory errors in groups.
C1 [Betts, Kevin R.] US FDA, Silver Spring, MD 20993 USA.
[Hinsz, Verlin B.] N Dakota State Univ, Fargo, ND USA.
RP Betts, KR (reprint author), US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Kevin.Betts@fda.hhs.gov
NR 43
TC 3
Z9 3
U1 4
U2 10
PU SAGE PUBLICATIONS LTD
PI LONDON
PA 1 OLIVERS YARD, 55 CITY ROAD, LONDON EC1Y 1SP, ENGLAND
SN 1368-4302
EI 1461-7188
J9 GROUP PROCESS INTERG
JI Group Process Intergroup Relat.
PD NOV
PY 2013
VL 16
IS 6
BP 734
EP 751
DI 10.1177/1368430213486206
PG 18
WC Psychology, Social
SC Psychology
GA 298IJ
UT WOS:000330317100006
ER
EF