FN Thomson Reuters Web of Science™
VR 1.0
PT J
AU Trucksess, MW
Fu, WS
Oles, CJ
White, KD
AF Trucksess, Mary W.
Fu, Wu-Sheng
Oles, Carolyn J.
White, Kevin D.
TI Determination of Zearalenone in Botanical Dietary Supplements, Soybeans,
Grains, and Grain Products by Immunoaffinity Column Cleanup and Liquid
Chromatography: Single-Laboratory Validation
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID MYCOTOXIN ZEARALENONE; PRECOCIOUS PUBERTY
AB The accuracy, repeatability, and reproducibility characteristics of a method for measuring levels of zearalenone (ZON) in botanical root products, soybeans, grains, and grain products were determined by an AOAC single-laboratory validation procedure. Replicates of 10 test portions of each powdered root product (black cohosh, ginger, ginseng), brown rice flour, brown rice grain, oat flour, rice bran, soybeans, and wheat flour at each spiking level (ZON at 0, 50, 100, and 200 mu g/kg) were analyzed on 3 separate days. Test samples were extracted with methanol water (75 + 25, v/v). The extracts were centrifuged or filtered, diluted with phosphate-buffered saline (PBS) containing 0.5% Tween 20, and filtered; the filtrates were applied to an immunoaffinity column containing antibodies specific for ZON. After the column was washed with methanol PBS (15 + 85, v/v) containing 0.5% Tween 20 and then with water, the toxin was eluted from the column with methanol, and the eluate was diluted with water. The eluate containing the toxin was then subjected to RPLC with fluorescence detection. All commodities that were found to contain ZON at < 10 mu g/kg were used for the recovery study. The average within-day and between-days recoveries of ZON added at levels of 50-200 mu g/kg ranged from 82 to 88% and from 81 to 84%, respectively, for all test commodities. The total average of within- and between-day SD and RSDr values for all test commodities ranged from 2.5 to 7.3 mu g/kg and from 4.6 to 6.2%, respectively. HorRat values were < 1.3 for all matrixes examined. The tested method was found to be acceptable for the matrixes examined.
C1 [Trucksess, Mary W.; Fu, Wu-Sheng; Oles, Carolyn J.] US FDA, Off Regulatory Sci, Div Bioanalyt Chem, College Pk, MD 20740 USA.
[White, Kevin D.] US FDA, Off Regulatory Sci, Div Analyt Chem, College Pk, MD 20740 USA.
RP Trucksess, MW (reprint author), US FDA, Off Regulatory Sci, Div Bioanalyt Chem, College Pk, MD 20740 USA.
EM mary.trucksess@fda.hhs.gov
FU Office of Dietary Supplements, National Institutes of Health, Bethesda,
MD; U.S. Department of Energy; U.S. Food and Drug Administration
FX This work was supported in part by the Office of Dietary Supplements,
National Institutes of Health, Bethesda, MD, and 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 U.S. Food and Drug Administration. We would
like to thank Jeanne I. Rader for her support and guidance.
NR 16
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U1 1
U2 7
PU AOAC INT
PI GAITHERSBURG
PA 481 N FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
EI 1944-7922
J9 J AOAC INT
JI J. AOAC Int.
PD MAR-APR
PY 2011
VL 94
IS 2
BP 589
EP 595
PG 7
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 750KH
UT WOS:000289544500027
PM 21563694
ER
PT J
AU Kim, HY
Eyheramonho, MB
Pichavant, M
Cambaceres, CG
Matangkasombut, P
Cervio, G
Kuperman, S
Moreiro, R
Konduru, K
Manangeeswaran, M
Freeman, GJ
Kaplan, GG
DeKruyff, RH
Umetsu, DT
Rosenzweig, SD
AF Kim, Hye Young
Belen Eyheramonho, Maria
Pichavant, Muriel
Gonzalez Cambaceres, Carlos
Matangkasombut, Ponpan
Cervio, Guillermo
Kuperman, Silvina
Moreiro, Rita
Konduru, Krishnamurthy
Manangeeswaran, Mohanraj
Freeman, Gordon J.
Kaplan, Gerardo G.
DeKruyff, Rosemarie H.
Umetsu, Dale T.
Rosenzweig, Sergio D.
TI A polymorphism in TIM1 is associated with susceptibility to severe
hepatitis A virus infection in humans
SO JOURNAL OF CLINICAL INVESTIGATION
LA English
DT Article
ID KILLER T-CELLS; ACUTE LIVER-FAILURE; AIRWAY HYPERREACTIVITY; MUCIN
DOMAIN; NKT CELLS; PHOSPHATIDYLSERINE RECEPTOR; FULMINANT-HEPATITIS;
APOPTOTIC CELLS; HIV-1 INFECTION; ATOPIC DISEASE
AB During infection with the hepatitis A virus (HAV), most patients develop mild or asymptomatic disease. However,, a small number of patients develop serious, life-threatening hepatitis. We investigated this variability in disease severity by examining 30 Argentinean patients with HAV-induced acute liver failure in a case-control, cross-sectional, observational study. We found that HAV-induced severe liver disease was associated with a 6-amino-acid insertion in TIM1/HAVCR1 (157insMTTTVP), the gene encoding the HAV receptor. This polymorphism was previously shown to be associated with protection against asthma and allergic diseases and with HIV progression. In binding assays, the TIM-1 protein containing the 157insMTTTVP insertion polymorphism bound HAV more efficiently. When expressed by human natural killer T (NKT) cells, this long form resulted in greater NKT cell cytolytic activity against HAV-infected liver cells, compared with the shorter TIM-1 protein without the polymorphism. To our knowledge, the 157insMTTTVP polymorphism in TIM1 is the first genetic susceptibility factor shown to predispose to HAV-induced acute liver failure. Furthermore, these results suggest that HAV infection has driven the natural selection of shorter forms of the TIM-1 protein, which binds HAV less efficiently, thereby protecting against severe HAV-induced disease, but which may predispose toward inflammation associated with asthma and allergy.
C1 [Kim, Hye Young; Pichavant, Muriel; Matangkasombut, Ponpan; DeKruyff, Rosemarie H.; Umetsu, Dale T.] Harvard Univ, Sch Med, Childrens Hosp Boston, Dept Pediat,Div Immunol, Boston, MA 02115 USA.
[Belen Eyheramonho, Maria; Gonzalez Cambaceres, Carlos; Cervio, Guillermo; Kuperman, Silvina; Moreiro, Rita; Rosenzweig, Sergio D.] Hosp Nacl Pediat JP Garrahan, Div Immunol, Buenos Aires, DF, Argentina.
[Belen Eyheramonho, Maria; Gonzalez Cambaceres, Carlos; Cervio, Guillermo; Kuperman, Silvina; Moreiro, Rita; Rosenzweig, Sergio D.] Hosp Nacl Pediat JP Garrahan, Div Liver Transplantat, Buenos Aires, DF, Argentina.
[Belen Eyheramonho, Maria; Gonzalez Cambaceres, Carlos; Cervio, Guillermo; Kuperman, Silvina; Moreiro, Rita; Rosenzweig, Sergio D.] Hosp Nacl Pediat JP Garrahan, Div Transfus Med, Buenos Aires, DF, Argentina.
[Belen Eyheramonho, Maria; Gonzalez Cambaceres, Carlos; Cervio, Guillermo; Kuperman, Silvina; Moreiro, Rita; Rosenzweig, Sergio D.] Hosp Nacl Pediat JP Garrahan, Div Lab Med, Buenos Aires, DF, Argentina.
[Konduru, Krishnamurthy; Manangeeswaran, Mohanraj; Kaplan, Gerardo G.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Freeman, Gordon J.] Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA.
[Rosenzweig, Sergio D.] NIAID, Infect Dis Susceptibil Unit, Host Def Lab, NIH, Bethesda, MD 20892 USA.
RP Umetsu, DT (reprint author), Harvard Univ, Sch Med, Childrens Hosp, Div Immunol,Karp Labs, Rm 10127,1 Blackfan Circle, Boston, MA 02115 USA.
EM dale.umetsu@childrens.harvard.edu; srosenzweig@niaid.nih.gov
FU Fortabat Endowment of the David Rockefeller Center for Latin American
Studies at Harvard University; NIH [P01 AI054456]; FDA
FX We thank Leslie Kalish for help with the statistical analysis; and Mirta
Ciocca, Miriam Cuarterolo, Oscar Imventarza, Javier Goni, Ana Del Pozo,
Jorge Sasbon, Stefania Pittaluga, and Maria T. de Davila for valuable
comments and support. These studies were supported by the de Fortabat
Endowment of the David Rockefeller Center for Latin American Studies at
Harvard University, by a grant from the NIH (P01 AI054456), and with FDA
intramural funds. 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.
NR 47
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U1 1
U2 3
PU AMER SOC CLINICAL INVESTIGATION INC
PI ANN ARBOR
PA 35 RESEARCH DR, STE 300, ANN ARBOR, MI 48103 USA
SN 0021-9738
J9 J CLIN INVEST
JI J. Clin. Invest.
PD MAR
PY 2011
VL 121
IS 3
BP 1111
EP 1118
DI 10.1172/JCI44182
PG 8
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA 729YQ
UT WOS:000287991000029
PM 21339644
ER
PT J
AU Huang, X
Ning, YM
Gulley, JL
Kluetz, PG
Adelberg, D
Mulquin, M
Madan, RA
Bassim, C
Figg, WD
Dahut, WL
AF Huang, X.
Ning, Y. M.
Gulley, J. L.
Kluetz, P. G.
Adelberg, D.
Mulquin, M.
Madan, R. A.
Bassim, C.
Figg, W. D.
Dahut, W. L.
TI Phase II trial of bevacizumab (A), lenalidomide (R), docetaxel (D), and
prednisone (P) in patients (pts)with metastatic castration-resistant
prostate cancer (mCRPC)
SO JOURNAL OF CLINICAL ONCOLOGY
LA English
DT Meeting Abstract
C1 NCI, US FDA, Silver Spring, MD USA.
NCI, Med Oncol Branch, NIH, Bethesda, MD 20892 USA.
Natl Inst Dent & Craniolfacial Res, NIH, Bethesda, MD USA.
NCI, Mol Pharmacol Sect, NIH, Bethesda, MD 20892 USA.
RI Gulley, James/K-4139-2016; Figg Sr, William/M-2411-2016
OI Gulley, James/0000-0002-6569-2912;
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC CLINICAL ONCOLOGY
PI ALEXANDRIA
PA 2318 MILL ROAD, STE 800, ALEXANDRIA, VA 22314 USA
SN 0732-183X
EI 1527-7755
J9 J CLIN ONCOL
JI J. Clin. Oncol.
PD MAR 1
PY 2011
VL 29
IS 7
SU S
MA 138
PG 1
WC Oncology
SC Oncology
GA V31JU
UT WOS:000208880700139
PM 27968512
ER
PT J
AU Burall, LS
Simpson, AC
Datta, AR
AF Burall, Laurel S.
Simpson, Alexandra C.
Datta, Atin R.
TI Evaluation of a Serotyping Scheme Using a Combination of an
Antibody-Based Serogrouping Method and a Multiplex PCR Assay for
Identifying the Major Serotypes of Listeria monocytogenes
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID GENOME DNA MICROARRAY; UNITED-STATES; STRAINS; IDENTIFICATION;
VIRULENCE; FOOD; DISCRIMINATION; VALIDATION; STANDARD; SEROVARS
AB To evaluate a simplified serotyping scheme, we used a combination of an antibody-based serogrouping assay that identified only type 1 and type 4 strains and a multiplex PCR-based serogrouping assay to analyze 362 L. monocytogenes isolates collected over more than 20 years. The multiplex PCR assay also incorporated a set of primers specific for L. monocyto genes hlyA gene to verify the species identification of these isolates. A subset (n = 120) of these isolates were also serotyped with the Denka Seiken serotyping scheme, which is often considered the "gold standard" for serotyping of L. monocytogenes. The results indicate that the multiplex PCR-based assay, in combination with an antibody-based serogrouping assay, correctly identified serotypes of 96% of the previously serotyped isolates. Compared with the Denka Seiken method, the combination method also performed better in identifying serotypes of 120 previously unserotyped L. monocytogenes isolates. Thus, the combination scheme appears to be a simple and rapid way to identify serotypes 1/2a, 1/2b, 1/2c, 3a, 3b, 3c, and 4b isolates, which are the predominant L. monocytogenes serotypes found in food, environmental, and clinical samples.
C1 [Burall, Laurel S.; Simpson, Alexandra C.; Datta, Atin R.] US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Datta, AR (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
EM atin.datta@fda.hhs.gov
FU University of Maryland, Joint Institute of Food Safety and Nutrition
FX We thank Lewis Graves and Martin Wiedman for several strains used in
this study. We also thank the anonymous reviewers for their valuable
comments. A. C. Simpson was supported by the University of Maryland,
Joint Institute of Food Safety and Nutrition student internship program.
NR 35
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U1 0
U2 3
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD MAR
PY 2011
VL 74
IS 3
BP 403
EP 409
DI 10.4315/0362-028X.JFP-10-355
PG 7
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 734DK
UT WOS:000288313200008
PM 21375876
ER
PT J
AU Zheng, N
Zhang, XY
Rosania, GR
AF Zheng, Nan
Zhang, Xinyuan
Rosania, Gus R.
TI Effect of Phospholipidosis on the Cellular Pharmacokinetics of
Chloroquine
SO JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
LA English
DT Article
ID CELLS; TRANSPORTER; KIDNEY; BIOGENESIS; LYSOSOMES; DRUG; AMODIAQUINE;
METABOLISM; EXPRESSION; PREDICTION
AB In vivo, the weakly basic, lipophilic drug chloroquine (CQ) accumulates in the kidney to concentrations more than a thousand-fold greater than those in plasma. To study the cellular pharmacokinetics of chloroquine in cells derived from the distal tubule, Madin-Darby canine kidney cells were incubated with CQ under various conditions. CQ progressively accumulated without exhibiting steady-state behavior. Experiments failed to yield evidence that known active transport mechanisms mediated CQ uptake at the plasma membrane. CQ induced a phospholipidosis-like phenotype, characterized by the appearance of numerous multivesicular and multilamellar bodies (MLBs/MVBs) within the lumen of expanded cytoplasmic vesicles. Other induced phenotypic changes including changes in the volume and pH of acidic organelles were measured, and the integrated effects of all these changes were computationally modeled to establish their impact on intracellular CQ mass accumulation. Based on the passive transport behavior of CQ, the measured phenotypic changes fully accounted for the continuous, nonsteady-state CQ accumulation kinetics. Consistent with the simulation results, Raman confocal microscopy of live cells confirmed that CQ became highly concentrated within induced, expanded cytoplasmic vesicles that contained multiple MLBs/MVBs. Progressive CQ accumulation was increased by sucrose, a compound that stimulated the phospholipidosis-like phenotype, and was decreased by bafilomycin A1, a compound that inhibited this phenotype. Thus, phospholipidosis-associated changes in organelle structure and intracellular membrane content can exert a major influence on the local bioaccumulation and biodistribution of drugs.
C1 [Zheng, Nan; Rosania, Gus R.] Univ Michigan, Dept Pharmaceut Sci, Coll Pharm, Ann Arbor, MI 48109 USA.
[Zhang, Xinyuan] US FDA, Off Gener Drugs, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Rosania, GR (reprint author), Univ Michigan, Dept Pharmaceut Sci, Coll Pharm, 428 Church St, Ann Arbor, MI 48109 USA.
EM grosania@umich.edu
FU National Institutes of Health National Institute of General Medical
Sciences [R01-GM078200]
FX This work was supported by the National Institutes of Health National
Institute of General Medical Sciences [Grant R01-GM078200] (to G.R.R).
NR 40
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U1 0
U2 5
PU AMER SOC PHARMACOLOGY EXPERIMENTAL THERAPEUTICS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3995 USA
SN 0022-3565
J9 J PHARMACOL EXP THER
JI J. Pharmacol. Exp. Ther.
PD MAR
PY 2011
VL 336
IS 3
BP 661
EP 671
DI 10.1124/jpet.110.175679
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 723AI
UT WOS:000287477200009
PM 21156819
ER
PT J
AU Ohashi, M
Bertke, AS
Patel, A
Krause, PR
AF Ohashi, Masahiro
Bertke, Andrea S.
Patel, Amita
Krause, Philip R.
TI Spread of Herpes Simplex Virus to the Spinal Cord Is Independent of
Spread to Dorsal Root Ganglia
SO JOURNAL OF VIROLOGY
LA English
DT Article
ID EXPERIMENTAL GENITAL-INFECTION; REACTIVATION; TYPE-2; HSV-1; MODEL;
EXPRESSION; PHENOTYPES; SITE; MICE
AB Levels of herpes simplex virus 1 (HSV-1) and HSV-2 DNA in dorsal root ganglia (DRG) and spinal cord (SC) were quantified after inoculation of guinea pig genitals and footpads. In genital infection, viral DNA reached SC and DRG simultaneously (at 2 to 3 days after inoculation) but was more abundant in SC than in DRG. After inoculation of footpads, which lack parasympathetic innervation, the viruses spread more efficiently to DRG than to SC. These results show important differences between genital and footpad infections, including independence of spread to DRG and SC, and imply that autonomic neurons may play an important role in the pathogenesis of viral latency after genital inoculation.
C1 [Ohashi, Masahiro; Bertke, Andrea S.; Patel, Amita; Krause, Philip R.] FDA CBER, Bethesda, MD 20892 USA.
RP Krause, PR (reprint author), FDA CBER, HFM 457,29 Lincoln Dr, Bethesda, MD 20892 USA.
EM philip.krause@fda.hhs.gov
OI Krause, Philip/0000-0002-1045-7536
FU Japan Herpesvirus Infectious Forum Scholarship Awards in Herpesvirus
Infections Research
FX M.O. acknowledges financial support from the Japan Herpesvirus
Infectious Forum Scholarship Awards in Herpesvirus Infections Research.
NR 19
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Z9 8
U1 0
U2 2
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
EI 1098-5514
J9 J VIROL
JI J. Virol.
PD MAR
PY 2011
VL 85
IS 6
BP 3030
EP 3032
DI 10.1128/JVI.02426-10
PG 3
WC Virology
SC Virology
GA 735AT
UT WOS:000288386500055
PM 21159869
ER
PT J
AU Cadieux, N
Parra, M
Cohen, H
Maric, D
Morris, SL
Brennan, MJ
AF Cadieux, Nathalie
Parra, Marcela
Cohen, Hannah
Maric, Dragan
Morris, Sheldon L.
Brennan, Michael J.
TI Induction of cell death after localization to the host cell mitochondria
by the Mycobacterium tuberculosis PE_PGRS33 protein
SO MICROBIOLOGY-SGM
LA English
DT Article
ID PE-PGRS PROTEINS; GENOME SEQUENCE; VII SECRETION; MACROPHAGES;
EXPRESSION; NECROSIS; APOPTOSIS; VIRULENCE; SYSTEM; FAMILY
AB PE_PGRS33 is the most studied member of the unique PE family of mycobacterial proteins. These proteins are composed of a PE domain (Pro-Glu motif), a linker region and a PGRS domain (polymorphic GC-rich-repetitive sequence). Previous studies have shown that PE_PGRS33 is surface-exposed, constitutively expressed during growth and infection, involved in creating antigenic diversity, and able to induce death in transfected or infected eukaryotic cells. In this study, we showed that PE_PGRS33 co-localizes to the mitochondria of transfected cells, a phenomenon dependent on the linker region and the PGRS domain, but not the PE domain. Using different genetic fusions and chimeras, we also demonstrated a direct correlation between localization to the host mitochondria and the induction of cell death. Finally, although all constructs localizing to the mitochondria did induce apoptosis, only the wild-type PE_PGRS33 with its own PE domain also induced primary necrosis, indicating a potentially important role for the PE domain. Considering the importance of primary necrosis in Mycobacterium tuberculosis dissemination during natural infection, the PE_PGRS33 protein may play a crucial role in the pathogenesis of tuberculosis.
C1 [Cadieux, Nathalie; Brennan, Michael J.] AERAS Global TB Vaccine Fdn, Rockville, MD USA.
[Cadieux, Nathalie; Parra, Marcela; Cohen, Hannah; Morris, Sheldon L.; Brennan, Michael J.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Maric, Dragan] Natl Inst Neurol Disorders & Stroke, NIH, Flow Cytometry Core Facil, Bethesda, MD USA.
RP Cadieux, N (reprint author), AERAS Global TB Vaccine Fdn, Rockville, MD USA.
EM ncadieux@aeras.org
FU National Vaccine Program Office of the Department of Health and Human
Services
FX We would like to thank Veerabadran Dheenadhayalan, Karen Meysick and
Jackie Muller for invaluable discussions during this study. This work
was supported in part by a grant from the National Vaccine Program
Office of the Department of Health and Human Services to M. j. B.
NR 45
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U1 0
U2 5
PU SOC GENERAL MICROBIOLOGY
PI READING
PA MARLBOROUGH HOUSE, BASINGSTOKE RD, SPENCERS WOODS, READING RG7 1AG,
BERKS, ENGLAND
SN 1350-0872
J9 MICROBIOL-SGM
JI Microbiology-(UK)
PD MAR
PY 2011
VL 157
BP 793
EP 804
DI 10.1099/mic.0.041996-0
PN 3
PG 12
WC Microbiology
SC Microbiology
GA 740ZN
UT WOS:000288833000018
PM 21081760
ER
PT J
AU Strader, MB
Costantino, N
Elkins, CA
Chen, CY
Patel, I
Makusky, AJ
Choy, JS
Court, DL
Markey, SP
Kowalak, JA
AF Strader, Michael Brad
Costantino, Nina
Elkins, Christopher A.
Chen, Cai Yun
Patel, Isha
Makusky, Anthony J.
Choy, John S.
Court, Donald L.
Markey, Sanford P.
Kowalak, Jeffrey A.
TI A Proteomic and Transcriptomic Approach Reveals New Insight into
beta-methylthiolation of Escherichia coli Ribosomal Protein S12
SO MOLECULAR & CELLULAR PROTEOMICS
LA English
DT Article
ID TRANSFER-RNA; MASS-SPECTROMETRY; POSTTRANSLATIONAL MODIFICATION;
STRUCTURAL INSIGHTS; GENE-EXPRESSION; MESSENGER-RNA; 70S RIBOSOME; MIAB
PROTEIN; FNR; METHYLATION
AB beta-methylthiolation is a novel post-translational modification mapping to a universally conserved Asp 88 of the bacterial ribosomal protein S12. This S12 specific modification has been identified on orthologs from multiple bacterial species. The origin and functional significance was investigated with both a proteomic strategy to identify candidate S12 interactors and expression microarrays to search for phenotypes that result from targeted gene knockouts of select candidates. Utilizing an endogenous recombinant E. coli S12 protein with an affinity tag as bait, mass spectrometric analysis identified candidate S12 binding partners including RimO (previously shown to be required for this post-translational modification) and YcaO, a conserved protein of unknown function. Transcriptomic analysis of bacterial strains with deleted genes for RimO and YcaO identified an overlapping transcriptional phenotype suggesting that YcaO and RimO likely share a common function. As a follow up, quantitative mass spectrometry additionally indicated that both proteins dramatically impacted the modification status of S12. Collectively, these results indicate that the YcaO protein is involved in beta-methylthiolation of S12 and its absence impairs the ability of RimO to modify S12. Additionally, the proteomic data from this study provides direct evidence that the E. coli specific beta-methylthiolation likely occurs when S12 is assembled as part of a ribosomal subunit. Molecular & Cellular Proteomics 10: 10.1074/mcp.M110.005199, 1-10, 2011.
C1 [Strader, Michael Brad; Chen, Cai Yun; Makusky, Anthony J.; Markey, Sanford P.; Kowalak, Jeffrey A.] NIMH, Lab Neurotoxicol, Bethesda, MD 20892 USA.
[Costantino, Nina; Court, Donald L.] NCI, Frederick Canc Res & Dev Ctr, Frederick, MD 21702 USA.
[Elkins, Christopher A.; Patel, Isha] US FDA, Laurel, MD 20708 USA.
[Choy, John S.] NCI, Bethesda, MD 20892 USA.
RP Strader, MB (reprint author), NIMH, Lab Neurotoxicol, Bldg 10 Ctr Dr,Room 3D42,10 Ctr Dr,MSC 1262, Bethesda, MD 20892 USA.
EM straderm@mail.nih.gov
FU National Institute of Mental Health [1ZIAMH000274]
FX This work was supported by the Intramural Research Program of the
National Institute of Mental Health(1ZIAMH000274).
NR 45
TC 6
Z9 8
U1 0
U2 0
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 1535-9476
EI 1535-9484
J9 MOL CELL PROTEOMICS
JI Mol. Cell. Proteomics
PD MAR
PY 2011
VL 10
IS 3
AR M110.005199
DI 10.1074/mcp.M110.005199
PG 10
WC Biochemical Research Methods
SC Biochemistry & Molecular Biology
GA 728AY
UT WOS:000287847200022
PM 21169565
ER
PT J
AU Dickson, PI
Pariser, AR
Groft, SC
Ishihara, RW
McNeil, DE
Tagle, D
Griebel, DJ
Kaler, SG
Mink, JW
Shapiro, EG
Bjoraker, KJ
Krivitzky, L
Provenzale, JM
Gropman, A
Orchard, P
Raymond, G
Cohen, BH
Steiner, RD
Goldkind, SF
Nelson, RM
Kakkis, E
Patterson, MC
AF Dickson, P. I.
Pariser, A. R.
Groft, S. C.
Ishihara, R. W.
McNeil, D. E.
Tagle, D.
Griebel, D. J.
Kaler, S. G.
Mink, J. W.
Shapiro, E. G.
Bjoraker, K. J.
Krivitzky, L.
Provenzale, J. M.
Gropman, A.
Orchard, P.
Raymond, G.
Cohen, B. H.
Steiner, R. D.
Goldkind, S. F.
Nelson, R. M.
Kakkis, E.
Patterson, M. C.
TI Research challenges in central nervous system manifestations of inborn
errors of metabolism
SO MOLECULAR GENETICS AND METABOLISM
LA English
DT Review
DE Inborn errors of metabolism; Central nervous system; Rare disease;
Orphan drug designation; Translational research
ID BONE-MARROW-TRANSPLANTATION; STEM-CELL TRANSPLANTATION; UREA CYCLE
DISORDERS; X-LINKED ADRENOLEUKODYSTROPHY; ENZYME REPLACEMENT THERAPY;
INFANTILE KRABBES-DISEASE; HURLER-SYNDROME; MUCOPOLYSACCHARIDOSIS-I;
MENKES-DISEASE; INITIAL-EXPERIENCE
AB The Research Challenges in CNS Manifestations of Inborn Errors of Metabolism workshop was designed to address challenges in translating potential therapies for these rare disorders, and to highlight novel therapeutic strategies and innovative approaches to CNS delivery, assessment of effects and directions for the future in the treatment of these diseases. Therapies for the brain in inborn errors represent some of the greatest challenges to translational research due to the special properties of the brain, and of inborn errors themselves. This review covers the proceedings of this workshop as submitted by participants. Scientific, ethical and regulatory issues are discussed, along with ways to measure outcomes and the conduct of clinical trials. Participants included regulatory and funding agencies, clinicians, scientists, industry and advocacy groups. Published by Elsevier Inc.
C1 [Ishihara, R. W.; Griebel, D. J.] US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Div Gastroenterol Prod, Silver Spring, MD 20993 USA.
[Dickson, P. I.] Harbor UCLA, Dept Pediat, LA Biomed Res Inst, Torrance, CA 90502 USA.
[Groft, S. C.] NIH, Off Rare Dis Res, Bethesda, MD 20892 USA.
[McNeil, D. E.] US FDA, Off Orphan Prod Dev, Off Commissioner, Silver Spring, MD 20993 USA.
[Tagle, D.] NINDS, NIH, Ctr Neurosci, Bethesda, MD 20892 USA.
[Kaler, S. G.] NICHHD, Unit Human Copper Metab, Program Mol Med, NIH, Bethesda, MD 20892 USA.
[Mink, J. W.] Univ Rochester, Sch Med & Dent, Dept Neurol, Rochester, NY 14642 USA.
[Mink, J. W.] Univ Rochester, Sch Med & Dent, Dept Pediat, Rochester, NY 14642 USA.
[Shapiro, E. G.] Univ Minnesota, Dept Neurol, Minneapolis, MN 55455 USA.
[Shapiro, E. G.] Univ Minnesota, Dept Pediat, Minneapolis, MN 55455 USA.
[Bjoraker, K. J.] Univ Colorado, Childrens Hosp Denver, Aurora, CO 80045 USA.
[Krivitzky, L.] Natl Rehabil Hosp, Childrens Res Inst, Ctr Res Neurosci, Childrens Natl Med Ctr, Washington, DC 20010 USA.
[Provenzale, J. M.] Duke Univ, Med Ctr, Dept Radiol, Durham, NC 27710 USA.
[Provenzale, J. M.] Emory Univ, Sch Med, Dept Radiol, Atlanta, GA 30322 USA.
[Provenzale, J. M.] Emory Univ, Sch Med, Dept Oncol, Atlanta, GA 30322 USA.
[Provenzale, J. M.] Emory Univ, Sch Med, Dept Biomed Engn, Atlanta, GA 30322 USA.
[Gropman, A.] Childrens Natl Med Ctr, Neurogenet Program, Washington, DC 20010 USA.
[Orchard, P.] Univ Minnesota, Dept Pediat, Minneapolis, MN 55455 USA.
[Orchard, P.] Univ Minnesota, Inst Human Genet, Minneapolis, MN 55455 USA.
[Raymond, G.] Johns Hopkins Univ, Kennedy Krieger Inst, Baltimore, MD 21205 USA.
[Raymond, G.] Johns Hopkins Univ, Dept Neurol, Baltimore, MD 21205 USA.
[Cohen, B. H.] Cleveland Clin, Neurol Inst, Brain Tumor & Neurooncol Ctr, Cleveland, OH 44195 USA.
[Steiner, R. D.] Oregon Hlth & Sci Univ, Dept Pediat, Portland, OR 97239 USA.
[Steiner, R. D.] Oregon Hlth & Sci Univ, Dept Mol & Med Genet, Doembecher Childrens Hosp, Portland, OR 97239 USA.
[Goldkind, S. F.] US FDA, Off Good Clin Practice, Off Commissioner, Silver Spring, MD 20993 USA.
[Nelson, R. M.] US FDA, Off Pediat Therapeut, Off Commissioner, Silver Spring, MD 20993 USA.
[Kakkis, E.] Kakkis EveryLife Fdn, Novato, CA 94949 USA.
[Patterson, M. C.] Mayo Clin, Div Child & Adolescent Neurol, Rochester, MN 55905 USA.
RP Pariser, AR (reprint author), US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Div Gastroenterol Prod, 10903 New Hampshire Ave,WO22-6474, Silver Spring, MD 20993 USA.
EM Pdickson@ucla.edu; Anne.pariser@fda.hhs.gov; Stephen.groft@nih.gov;
Richard.ishihara@fda.hhs.gov; Dawn.mcneil@fda.hhs.gov;
Tagled@ninds.nih.gov; Donna.griebel@fda.hhs.gov; Kalers@mail.nih.gov;
Jonathan_Mink@rochester.edu; Shapi004@umn.edu;
Bjoraker.kendra@tchden.org; LKrivitz@cnmc.org; Prove001@mc.duke.edu;
Agropman@cnmc.org; Orcha001@umn.edu; Raymond@kennedykrieger.org;
Bhcohenmd@aol.com; Steinerr@ohsu.edu; Sara.goldkind@fda.hhs.gov;
Robert.nelson@fda.hhs.gov; Ekakkis@kakkis.org; Patterson.marc@mayo.edu
OI Steiner, Robert/0000-0003-4177-4590; Patterson, Marc/0000-0002-1116-126X
FU NIH Office Rare Diseases Research, National Institute of Neurological
Disorders and Stroke; FDA Center for Drug Evaluation and Research,
Division of Gastroenterology; National Institute of Child Health and
Development Intramural Research Program; Batten Disease Support and
Research Association [R01NS060022]; Lysosomal Disease Network;
NS065768-01; Urea Cycle Disorders Consortium NIH [RR019453]; National
Institute of Neurological Disorders and Stroke [NS054242]; Eunice
Kennedy Shriver National Institute of Child Health and Human Development
[HD057136]; Food and Drug Administration [FD003450]; Genzyme
Corporation; Stem Cells Inc.
FX The Research Challenges in CNS Manifestations of Inborn Errors of
Metabolism workshop was funded by the NIH Office Rare Diseases Research,
National Institute of Neurological Disorders and Stroke, and the FDA
Center for Drug Evaluation and Research, Division of Gastroenterology
Products. Research presented was funded by: National Institute of Child
Health and Development Intramural Research Program (SGK), Batten Disease
Support and Research Association (JWM, R01NS060022), the Lysosomal
Disease Network U54 (EGS, NS065768-01), the Urea Cycle Disorders
Consortium NIH U54 (RR019453), the National Institute of Neurological
Disorders and Stroke (PID, NS054242), the Eunice Kennedy Shriver
National Institute of Child Health and Human Development (GR, HD057136),
the Food and Drug Administration (PID, FD003450), Genzyme Corporation,
and Stem Cells Inc.
NR 44
TC 8
Z9 9
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 1096-7192
J9 MOL GENET METAB
JI Mol. Genet. Metab.
PD MAR
PY 2011
VL 102
IS 3
BP 326
EP 338
DI 10.1016/j.ymgme.2010.11.164
PG 13
WC Endocrinology & Metabolism; Genetics & Heredity; Medicine, Research &
Experimental
SC Endocrinology & Metabolism; Genetics & Heredity; Research & Experimental
Medicine
GA 727CA
UT WOS:000287773800156
PM 21176882
ER
PT J
AU Paule, MG
Li, M
Allen, RR
Liu, F
Zou, X
Hotchkiss, C
Hanig, JP
Patterson, TA
Slikker, W
Wang, C
AF Paule, M. G.
Li, M.
Allen, R. R.
Liu, F.
Zou, X.
Hotchkiss, C.
Hanig, J. P.
Patterson, T. A.
Slikker, W., Jr.
Wang, C.
TI Ketamine anesthesia during the first week of life can cause long-lasting
cognitive deficits in rhesus monkeys
SO NEUROTOXICOLOGY AND TERATOLOGY
LA English
DT Article
DE Developmental neurotoxicity; Brain function; Ketamine anesthesia;
Cognition; Nonhuman primate
ID DEVELOPING RAT-BRAIN; INDUCED DEVELOPMENTAL NEUROAPOPTOSIS;
CENTRAL-NERVOUS-SYSTEM; NMDA RECEPTOR ANTAGONISTS; BEHAVIORAL-TEST
BATTERY; EXCITATORY AMINO-ACIDS; OPERANT TEST BATTERY; NEURONAL
CELL-DEATH; APOPTOTIC NEURODEGENERATION; NONHUMAN-PRIMATES
AB Previously our laboratory has shown that ketamine exposure (24 h of clinically relevant anesthesia) causes significant increases in neuronal cell death in perinatal rhesus monkeys. Sensitivity to this ketamine-induced neurotoxicity was observed on gestational days 120-123 (in utero exposure via maternal anesthesia) and on postnatal days (PNDs) 5-6, but not on PNDs 35-37. In the present study, six monkeys were exposed on PND 5 or 6 to intravenous ketamine anesthesia to maintain a light surgical plane for 24 h and six control animals were unexposed. At 7 months of age all animals were weaned and began training to perform a series of cognitive function tasks as part of the National Center for Toxicological Research (NCTR) Operant Test Battery (OTB). The OTB tasks used here included those for assessing aspects of learning, motivation, color discrimination, and short-term memory. Subjects responded for banana-flavored food pellets by pressing response levers and press-plates during daily (M-F) test sessions (50 min) and were assigned training scores based upon their individual performance. As reported earlier (Paule et al., 2009) beginning around 10 months of age, control animals significantly outperformed (had higher training scores than) ketamine-exposed animals for approximately the next 10 months. For animals now over 3 and one-half years of age, the cognitive impairments continue to manifest in the ketamine-exposed group as poorer performance in the OTB learning and color and position discrimination tasks, as deficits in accuracy of task performance, but also in response speed. There are also apparent differences in the motivation of these animals which may be impacting OTB performance. These observations demonstrate that a single 24-h episode of ketamine anesthesia, occurring during a sensitive period of brain development, results in very long-lasting deficits in brain function in primates and provide proof-of-concept that general anesthesia during critical periods of brain development can result in subsequent functional deficits. Supported by NICHD, CDER/FDA and NCTR/FDA. Published by Elsevier Inc.
C1 [Paule, M. G.; Li, M.; Liu, F.; Zou, X.; Patterson, T. A.; Slikker, W., Jr.; Wang, C.] US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
[Allen, R. R.] Peak Stat Serv, Evergreen, CO USA.
[Hotchkiss, C.] Bionetics Corp, Jefferson, AR USA.
[Hanig, J. P.] US FDA, Ctr Drug Evaluat & Res, Jefferson, AR 72079 USA.
RP Paule, MG (reprint author), US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM merle.paule@fda.hhs.gov
FU National Center for Toxicological Research (NCTR)/U.S. Food and Drug
Administration (FDA); Center for Drug Evaluation and Research
(CDER)/FDA; National Institute of Child Health and Human Development
(NICHD)
FX This work was supported by the National Center for Toxicological
Research (NCTR)/U.S. Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER)/FDA and the National Institute of Child
Health and Human Development (NICHD).
NR 86
TC 172
Z9 182
U1 2
U2 20
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0892-0362
J9 NEUROTOXICOL TERATOL
JI Neurotoxicol. Teratol.
PD MAR-APR
PY 2011
VL 33
IS 2
BP 220
EP 230
DI 10.1016/j.ntt.2011.01.001
PG 11
WC Neurosciences; Toxicology
SC Neurosciences & Neurology; Toxicology
GA 766YC
UT WOS:000290821500005
PM 21241795
ER
PT J
AU Cuevas, E
Lantz, SM
Tobon-Velasco, JC
Newport, GD
Wu, QG
Virmani, A
Ali, SF
Santamaria, A
AF Cuevas, Elvis
Lantz, Susan M.
Cesar Tobon-Velasco, J.
Newport, Glenn D.
Wu, Qiangen
Virmani, Ashraf
Ali, Syed F.
Santamaria, Abel
TI On the in vivo early toxic properties of A beta(25-35) peptide in the
rat hippocampus: Involvement of the Receptor-for-Advanced
Glycation-End-Products and changes in gene expression
SO NEUROTOXICOLOGY AND TERATOLOGY
LA English
DT Article
DE Receptor-for-Advanced Glycation-End-Products; Amyloid-beta(25-35);
Oxidative stress; Gene expression; Neurotoxicity; Neurodegeneration
ID AMYLOID-BETA-PEPTIDE; E-DEFICIENT MICE; NF-KAPPA-B; ALZHEIMERS-DISEASE;
OXIDATIVE STRESS; AGE-RAGE; ACTIVATION; INFLAMMATION; IDENTIFICATION;
NEUROTOXICITY
AB Amyloid-beta peptide (A beta) deposition is assumed to play a pathogenic role in the brain of Alzheimer's disease patients. To date, the precise mechanisms underlying A beta toxicity are not fully understood. A recent hypothesis suggesting that the Receptor-for-Advanced-Glycation-End-Products (RAGE)-a trans-membrane protein signaling for oxidative stress-is involved in A beta toxicity is gaining attention. Early A beta toxicity could indeed help to explain the deleterious events further produced by this molecule in the brain. In this work, we evaluated the pattern of early expression of RAGE in the toxic model induced by A beta(25-35) in rat CA1 region. Intrahippocampal injections of A beta(25-35) in rats increased the RAGE expression at 24 h post-injection; this event was accompanied by increased components of RAGE downstream signaling in hippocampal cells, such as enhanced expression of the pro-apoptotic factor NF-kappa B, increased nitric oxide production. LDH leakage, mitochondrial dysfunction, increased TNF-alpha expression, antioxidant genes down-regulation, and augmented neurodegeneration. Our findings support an active role of RAGE during the early stages of A beta(25-35) toxicity in the hippocampus. (C) 2010 Elsevier Inc. All rights reserved.
C1 [Cuevas, Elvis; Cesar Tobon-Velasco, J.; Santamaria, Abel] SSA, Lab Aminoacidos Excitadores, Inst Nacl Neurol & Neurociurgia Manuel Velasco Su, Mexico City 14269, DF, Mexico.
[Cuevas, Elvis; Lantz, Susan M.; Newport, Glenn D.; Ali, Syed F.; Santamaria, Abel] Natl Ctr Toxicol Res, Neurochem Lab, Div Neurotoxicol, Jefferson, AR 72079 USA.
[Wu, Qiangen] Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
[Virmani, Ashraf] Sigma Tau Hlth Sci, I-00040 Pomezia, Italy.
RP Santamaria, A (reprint author), SSA, Lab Aminoacidos Excitadores, Inst Nacl Neurol & Neurociurgia Manuel Velasco Su, Mexico City 14269, DF, Mexico.
EM absada@yahoo.com
RI Wu, Qiangen/F-7581-2014
OI Wu, Qiangen/0000-0002-7595-2837
NR 45
TC 10
Z9 10
U1 1
U2 3
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0892-0362
J9 NEUROTOXICOL TERATOL
JI Neurotoxicol. Teratol.
PD MAR-APR
PY 2011
VL 33
IS 2
BP 288
EP 296
DI 10.1016/j.ntt.2010.12.002
PG 9
WC Neurosciences; Toxicology
SC Neurosciences & Neurology; Toxicology
GA 766YC
UT WOS:000290821500013
PM 21216281
ER
PT J
AU Abu-Asab, MS
Chaouchi, M
Alesci, S
Galli, S
Laassri, M
Cheema, AK
Atouf, F
VanMeter, J
Amri, H
AF Abu-Asab, Mones S.
Chaouchi, Mohamed
Alesci, Salvatore
Galli, Susana
Laassri, Majid
Cheema, Amrita K.
Atouf, Fouad
VanMeter, John
Amri, Hakima
TI Biomarkers in the Age of Omics: Time for a Systems Biology Approach
SO OMICS-A JOURNAL OF INTEGRATIVE BIOLOGY
LA English
DT Review
ID BREAST-CANCER PATIENTS; PROSTATE-CANCER; MUTATOR PHENOTYPE; EVOLUTION;
DISCOVERY; HETEROGENEITY; DISEASE; MICROARRAYS; CARCINOMAS; LIKELIHOOD
AB Limitations to biomarker discovery are not only technical or bioinformatic but conceptual as well. In our attempt to offer a solution, we are highlighting three issues that we think are limiting progress in biomarkers discovery. First, the confusion stemming from the imposition of a pathology-type immunohistochemical marker (IHCM) concept on omics data without fully understanding the characteristics and limitations of IHCMs as applied in clinical pathology. Second, the lack of serious consideration for the scope of disease heterogeneity. Third, the refusal of the biomedical community to borrow from other biological disciplines their well established methods for dealing with heterogeneity. Therefore, real progress in biomarker discovery will be attained when we recognize that an omics biomarker cannot be assigned and validated without a priori data modeling and subtyping of the disease itself to reveal the extent of its heterogeneity, and its omics' clonal aberrations (drivers) underlying its subtypes and pathways' diversity. To further support our viewpoints, we are contributing a novel a systems biology method such as parsimony phylogenetic approach for disease modeling prior to biomarker circumscription. As an analytical approach that has been successfully used for a half of a century in other biological disciplines, parsimony phylogenetics simultaneously achieves several objectives: it provides disease modeling in a hierarchical phylogenetic classification, identifies biomarkers as the shared derived expressions or mutations-synapomorphies, constructs the omics profiles of specimens based on the most parsimonious arrangement of their heterogeneous data, and permits network profiling of affected signaling pathways as the biosignature of disease classes.
C1 [Chaouchi, Mohamed; Amri, Hakima] Georgetown Univ, Sch Med, Dept Physiol & Biophys, Washington, DC 20007 USA.
[Abu-Asab, Mones S.; Galli, Susana] NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
[Alesci, Salvatore] Pfizer, Discovery Translat Med, Collegeville, PA USA.
[Laassri, Majid] US FDA, Lab Methods Dev, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Cheema, Amrita K.] Georgetown Univ, Lombardi Comprehens Canc Ctr, Dept Oncol, Washington, DC 20007 USA.
[Atouf, Fouad] US Pharmacopeia, Biol & Biotechnol, Rockville, MD USA.
[VanMeter, John] Georgetown Univ, Sch Med, Dept Neurol, Washington, DC 20007 USA.
RP Amri, H (reprint author), Georgetown Univ, Sch Med, Dept Physiol & Biophys, Washington, DC 20007 USA.
EM amrih@georgetown.edu
OI Abu-Asab, Mones/0000-0002-4047-1232
FU Intramural NIH HHS [Z99 CA999999]
NR 57
TC 33
Z9 33
U1 1
U2 3
PU MARY ANN LIEBERT INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1536-2310
J9 OMICS
JI OMICS
PD MAR
PY 2011
VL 15
IS 3
BP 105
EP 112
DI 10.1089/omi.2010.0023
PG 8
WC Biotechnology & Applied Microbiology; Genetics & Heredity
SC Biotechnology & Applied Microbiology; Genetics & Heredity
GA 730XY
UT WOS:000288072100003
PM 21319991
ER
PT J
AU Yang, L
Wang, KJ
Chen, JA
Jegga, AG
Luo, H
Shi, LM
Wan, CL
Guo, XZ
Qin, SY
He, GA
Feng, GY
He, L
AF Yang, Lun
Wang, Kejian
Chen, Jian
Jegga, Anil G.
Luo, Heng
Shi, Leming
Wan, Chunling
Guo, Xizhi
Qin, Shengying
He, Guang
Feng, Guoyin
He, Lin
TI Exploring Off-Targets and Off-Systems for Adverse Drug Reactions via
Chemical-Protein Interactome - Clozapine-Induced Agranulocytosis as a
Case Study
SO PLOS COMPUTATIONAL BIOLOGY
LA English
DT Article
ID DIFFERENT ETHNIC-GROUPS; INDUCED TOXICITY; LIVER-INJURY; RISK-FACTORS;
GENOME-WIDE; DATABASE; GENE; PREDICTION; HYPERSENSITIVITY; DETERMINANTS
AB In the era of personalized medical practice, understanding the genetic basis of patient-specific adverse drug reaction (ADR) is a major challenge. Clozapine provides effective treatments for schizophrenia but its usage is limited because of life-threatening agranulocytosis. A recent high impact study showed the necessity of moving clozapine to a first line drug, thus identifying the biomarkers for drug-induced agranulocytosis has become important. Here we report a methodology termed as antithesis chemical-protein interactome (CPI), which utilizes the docking method to mimic the differences in the drug-protein interactions across a panel of human proteins. Using this method, we identified HSPA1A, a known susceptibility gene for CIA, to be the off-target of clozapine. Furthermore, the mRNA expression of HSPA1A-related genes (off-target associated systems) was also found to be differentially expressed in clozapine treated leukemia cell line. Apart from identifying the CIA causal genes we identified several novel candidate genes which could be responsible for agranulocytosis. Proteins related to reactive oxygen clearance system, such as oxidoreductases and glutathione metabolite enzymes, were significantly enriched in the antithesis CPI. This methodology conducted a multi-dimensional analysis of drugs' perturbation to the biological system, investigating both the off-targets and the associated off-systems to explore the molecular basis of an adverse event or the new uses for old drugs.
C1 [Yang, Lun; Wang, Kejian; Chen, Jian; Luo, Heng; Wan, Chunling; Guo, Xizhi; Qin, Shengying; He, Guang; Feng, Guoyin; He, Lin] Shanghai Jiao Tong Univ, Bio X Ctr, Key Lab Genet Dev & Neuropsychiat Disorders, Minist Educ, Shanghai 200030, Peoples R China.
[Yang, Lun; He, Lin] Fudan Univ, Inst Biomed Sci, Shanghai 200433, Peoples R China.
[Yang, Lun; Shi, Leming] Fudan Univ, Sch Pharm, Shanghai 200433, Peoples R China.
[Jegga, Anil G.] Cincinnati Childrens Hosp Med Ctr, Div Biomed Informat, Cincinnati, OH USA.
[Jegga, Anil G.] Univ Cincinnati, Dept Pediat, Cincinnati, OH 45221 USA.
[Jegga, Anil G.] Univ Cincinnati, Dept Comp Sci, Cincinnati, OH 45221 USA.
[He, Lin] Chinese Acad Sci, Inst Nutr Sci, Shanghai Inst Biol Sci, Shanghai, Peoples R China.
RP Yang, L (reprint author), US FDA, Ctr Bioinformat, Natl Ctr Toxicol Res, Jefferson, AZ USA.
EM lun.yang@gmail.com; helinhelin3@gmail.com
RI Yang, Lun/B-4859-2012; Jegga, Anil/H-6140-2011; Luo, Heng/D-3616-2016
OI Jegga, Anil/0000-0002-4881-7752; Luo, Heng/0000-0001-5192-8878
FU National Natural Science Foundation of China (NSFC) [30900841]; 973
Program [2010CB529600, 2007CB947300]; 863 Program [2006AA02A407,
2009AA022701]; Shanghai Municipal Commission of Science and Technology
[09DJ1400601]; National Key Project for the Investigation of New Drugs
[2008ZX09312-003]; Shanghai Leading Academic Discipline Project [B205]
FX This work was mainly supported by National Natural Science Foundation of
China (NSFC grant No. 30900841). This work was also supported in part by
the 973 Program (2010CB529600, 2007CB947300), the 863 Program
(2006AA02A407, 2009AA022701), the Shanghai Municipal Commission of
Science and Technology Program (09DJ1400601), the National Key Project
for the Investigation of New Drugs 2008ZX09312-003 and the Shanghai
Leading Academic Discipline Project (B205). The funders had no role in
study design, data collection and analysis, decision to publish, or
preparation of the manuscript.
NR 74
TC 58
Z9 61
U1 0
U2 9
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 1160 BATTERY STREET, STE 100, SAN FRANCISCO, CA 94111 USA
SN 1553-7358
J9 PLOS COMPUT BIOL
JI PLoS Comput. Biol.
PD MAR
PY 2011
VL 7
IS 3
AR e1002016
DI 10.1371/journal.pcbi.1002016
PG 13
WC Biochemical Research Methods; Mathematical & Computational Biology
SC Biochemistry & Molecular Biology; Mathematical & Computational Biology
GA 743CU
UT WOS:000288995500035
PM 21483481
ER
PT J
AU Deyton, LR
AF Deyton, Lawrence R.
TI FDA Tobacco Product Regulations: A Powerful Tool for Tobacco Control
SO PUBLIC HEALTH REPORTS
LA English
DT Editorial Material
ID UNITED-STATES; SMOKING
C1 US FDA, Ctr Tobacco Prod, Rockville, MD 20850 USA.
RP Deyton, LR (reprint author), US FDA, Ctr Tobacco Prod, 9200 Corp Blvd, Rockville, MD 20850 USA.
EM ctpexecsec@fda.hhs.gov
NR 7
TC 4
Z9 4
U1 1
U2 2
PU ASSOC SCHOOLS PUBLIC HEALTH
PI WASHINGTON
PA 1101 15TH ST NW, STE 910, WASHINGTON, DC 20005 USA
SN 0033-3549
J9 PUBLIC HEALTH REP
JI Public Health Rep.
PD MAR-APR
PY 2011
VL 126
IS 2
BP 167
EP 169
PG 3
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA 723ZX
UT WOS:000287547000006
PM 21387945
ER
PT J
AU Anderson, AL
Verrill, LA
Sahyoun, NR
AF Anderson, Amy L.
Verrill, Linda A.
Sahyoun, Nadine R.
TI Food Safety Perceptions and Practices of Older Adults
SO PUBLIC HEALTH REPORTS
LA English
DT Article
ID FOODBORNE ILLNESS; BEHAVIORS; CONSUMER; RISK; CONSUMPTION; KNOWLEDGE;
HEALTH; PATHOGENS; STATES
AB Objectives. Older adults are considered more vulnerable to foodborne illness due to lowered immune function. We compared the food safety perceptions and practices of older and younger adults and determined associations with demographic characteristics.
Methods. We focused on 1,317 participants years of age from the U.S. Food and Drug Administration's 2006 Food Safety Survey, a telephone survey of a nationally representative sample of American consumers. We used data on participants <60 years of age to compare younger and older adults, and used Pearson's Chi-square tests to determine whether perceptions and practices differed by age, gender, level of education, living arrangement, and race/ethnicity. We conducted multiple logistic regression analysis to assess relationships of demographic characteristics and food safety perceptions with food safety practices of older adults.
Results. We found that adults years of age were more likely to follow recommended food safety practices than those <60 years of age. Sixty-six percent of adults years of age reported eating potentially hazardous foods in the past year compared with 81% of adults <60 years of age. Among people >= 60 years of age, women, those with less education, and nonwhite individuals generally had better food safety practices and a greater awareness of food safety risk.
Conclusions. These findings suggest that certain subsets of the older adult population are less likely to follow recommended food safety practices and, thus, are at greater risk of foodborne illness. Food safety education for older adults should target men and those with more education and higher incomes.
C1 [Anderson, Amy L.; Sahyoun, Nadine R.] Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
[Verrill, Linda A.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Anderson, AL (reprint author), Univ Maryland, Dept Nutr & Food Sci, 0112 Skinner Bldg, College Pk, MD 20742 USA.
EM aanders3@umd.edu
RI Sahyoun, Nadine/G-2608-2011
FU U.S. Department of Agriculture; National Institute of Food and
Agriculture; U.S. Food and Drug Administration; Center for Food Safety
and Applied Nutrition
FX This study was supported by the U.S. Department of Agriculture, National
Institute of Food and Agriculture, and the U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition.
NR 26
TC 9
Z9 10
U1 1
U2 7
PU ASSOC SCHOOLS PUBLIC HEALTH
PI WASHINGTON
PA 1101 15TH ST NW, STE 910, WASHINGTON, DC 20005 USA
SN 0033-3549
J9 PUBLIC HEALTH REP
JI Public Health Rep.
PD MAR-APR
PY 2011
VL 126
IS 2
BP 220
EP 227
PG 8
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA 723ZX
UT WOS:000287547000013
PM 21387952
ER
PT J
AU Hricak, H
Brenner, DJ
Adelstein, SJ
Frush, DP
Hall, EJ
Howell, RW
McCollough, CH
Mettler, FA
Pearce, MS
Suleiman, OH
Thrall, JH
Wagner, LK
AF Hricak, Hedvig
Brenner, David J.
Adelstein, S. James
Frush, Donald P.
Hall, Eric J.
Howell, Roger W.
McCollough, Cynthia H.
Mettler, Fred A.
Pearce, Mark S.
Suleiman, Orhan H.
Thrall, James H.
Wagner, Louis K.
TI Managing Radiation Use in Medical Imaging : A Multifaceted Challenge
SO RADIOLOGY
LA English
DT Article
ID ATOMIC-BOMB SURVIVORS; CARDIAC COMPUTED-TOMOGRAPHY; FLUOROSCOPICALLY
GUIDED PROCEDURES; CORONARY-ARTERY-DISEASE; MULTISLICE HELICAL CT;
MULTIDETECTOR-ROW CT; LOW-DOSE RADIATION; BREAST-CANCER;
IONIZING-RADIATION; DECISION-SUPPORT
AB This special report aims to inform the medical community about the many challenges involved in managing radiation exposure in a way that maximizes the benefit-risk ratio. The report discusses the state of current knowledge and key questions in regard to sources of medical imaging radiation exposure, radiation risk estimation, dose reduction strategies, and regulatory options.
C1 [Hricak, Hedvig] Mem Sloan Kettering Canc Ctr, Dept Radiol, New York, NY 10021 USA.
[Brenner, David J.; Hall, Eric J.] Columbia Univ, Ctr Radiol Res, Med Ctr, New York, NY 10032 USA.
[Adelstein, S. James] Harvard Univ, Sch Med, Dept Radiol, Boston, MA 02115 USA.
[Frush, Donald P.] Duke Med Ctr, Div Pediat Radiol, Durham, NC USA.
[Howell, Roger W.] UMDNJ New Jersey Med Sch Canc Ctr, Dept Radiol, Newark, NJ USA.
[McCollough, Cynthia H.] Mayo Clin, Dept Radiol, Rochester, MN USA.
[Mettler, Fred A.] Univ New Mexico, Dept Radiol, Albuquerque, NM 87131 USA.
[Pearce, Mark S.] Newcastle Univ, Inst Hlth & Soc, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England.
[Suleiman, Orhan H.] US FDA, Off New Drugs, Silver Spring, MD USA.
[Thrall, James H.] Massachusetts Gen Hosp, Dept Radiol, Boston, MA 02114 USA.
[Wagner, Louis K.] Univ Texas Med Sch Houston, Dept Diagnost & Intervent Imaging, Houston, TX USA.
RP Hricak, H (reprint author), Mem Sloan Kettering Canc Ctr, Dept Radiol, 1275 York Ave,Suite C-278, New York, NY 10021 USA.
EM mullnea@mskcc.org
RI Frush, Donald/M-6457-2015
OI Frush, Donald/0000-0002-6928-4465
FU NASA [NNJO5H138G]; DOE [SC0001634]; Siemens Medical Solutions; American
College of Radiology
FX E.J.H. Financial activities related to the present article:
institutional grants from NASA NNJO5H138G and DOE-SC0001634. Financial
activities not related to the present article: is paid for consultancy
(teaching) elsewhere, is paid for employment as professor emeritus at
Columbia University, is paid for expert testimony for several court
cases, and receives payment for lectures including service on speakers
bureaus teaching residents, receives royalties for textbook, receives
institutional grants for payment for development of educational
presentations, receives money for stock or stock options as part of
retirement portfolio, receives money for travel, accommodations, meeting
expenses for resident lectures. Other relationships: none to disclose.;
C.H.M. Financial activities related to the present article: received
institutional payment for travel expenses to the National Academies of
Science sponsored Beebe Symposium in December 2009. Financial activities
not related to the present article: received research grant related to
CT imaging from Siemens Medical Solutions. Other relationships: none to
disclose.; Financial activities not related to the present article:
receives a stipend for service as board chair from American College of
Radiology
NR 122
TC 117
Z9 125
U1 3
U2 16
PU RADIOLOGICAL SOC NORTH AMERICA
PI OAK BROOK
PA 820 JORIE BLVD, OAK BROOK, IL 60523 USA
SN 0033-8419
J9 RADIOLOGY
JI Radiology
PD MAR
PY 2011
VL 258
IS 3
BP 889
EP 905
DI 10.1148/radiol.10101157
PG 17
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 724JX
UT WOS:000287573100026
PM 21163918
ER
PT J
AU Laughren, T
Levin, R
AF Laughren, Thomas
Levin, Robert
TI Food and Drug Administration Commentary on Methodological Issues in
Negative Symptom Trials
SO SCHIZOPHRENIA BULLETIN
LA English
DT Editorial Material
C1 [Laughren, Thomas; Levin, Robert] US FDA, Div Psychiat Prod, Silver Spring, MD USA.
RP Laughren, T (reprint author), 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Thomas.Laughren@fda.hhs.gov
NR 3
TC 19
Z9 19
U1 0
U2 0
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0586-7614
J9 SCHIZOPHRENIA BULL
JI Schizophr. Bull.
PD MAR
PY 2011
VL 37
IS 2
BP 255
EP 256
DI 10.1093/schbul/sbq162
PG 2
WC Psychiatry
SC Psychiatry
GA 726SB
UT WOS:000287745300007
PM 21245124
ER
PT J
AU Bradford, BU
Lock, EF
Kosyk, O
Kim, S
Uehara, T
Harbourt, D
DeSimone, M
Threadgill, DW
Tryndyak, V
Pogribny, IP
Bleyle, L
Koop, DR
Rusyn, I
AF Bradford, Blair U.
Lock, Eric F.
Kosyk, Oksana
Kim, Sungkyoon
Uehara, Takeki
Harbourt, David
DeSimone, Michelle
Threadgill, David W.
Tryndyak, Volodymyr
Pogribny, Igor P.
Bleyle, Lisa
Koop, Dennis R.
Rusyn, Ivan
TI Interstrain Differences in the Liver Effects of Trichloroethylene in a
Multistrain Panel of Inbred Mice
SO TOXICOLOGICAL SCIENCES
LA English
DT Article
DE trichloroethylene; metabolism; genetics; peroxisome
proliferator-activated receptor alpha; acute exposure; gene expression
ID ACTIVATED-RECEPTOR-ALPHA; TANDEM MASS-SPECTROMETRY; GENE-EXPRESSION;
TRICHLOROACETIC-ACID; DICHLOROACETIC ACID; MOUSE-LIVER; PPAR-ALPHA;
TUMOR-INDUCTION; LIQUID-CHROMATOGRAPHY; HUMAN VOLUNTEERS
AB Trichloroethylene (TCE) is a widely used industrial chemical and a common environmental contaminant. It is a well-known carcinogen in rodents and a probable carcinogen in humans. Studies utilizing panels of mouse inbred strains afford a unique opportunity to understand both metabolic and genetic basis for differences in responses to TCE. We tested the hypothesis that strain- and liver-specific toxic effects of TCE are genetically controlled and that the mechanisms of toxicity and susceptibility can be uncovered by exploring responses to TCE using a diverse panel of inbred mouse strains. TCE (2100 mg/kg) or corn oil vehicle was administered by gavage to 6- to 8-week-old male mice of 15 mouse strains. Serum and liver were collected at 2, 8, and 24 h postdosing and were analyzed for TCE metabolites, hepatocellular injury, and gene expression of liver. TCE metabolism, as evident from the levels of individual oxidative and conjugative metabolites, varied considerably between strains. TCE treatment-specific effect on the liver transcriptome was strongly dependent on genetic background. Peroxisome proliferator-activated receptor-mediated molecular networks, consisting of the metabolism genes known to be induced by TCE, represent some of the most pronounced molecular effects of TCE treatment in mouse liver that are dependent on genetic background. Conversely, cell death, liver necrosis, and immune-mediated response pathways, which are altered by TCE treatment in liver, are largely genetic background independent. These studies provide better understanding of the mechanisms of TCE-induced toxicity anchored on metabolism and genotype-phenotype correlations that may define susceptibility or resistance.
C1 [Bradford, Blair U.; Kosyk, Oksana; Kim, Sungkyoon; Uehara, Takeki; Rusyn, Ivan] Univ N Carolina, Dept Environm Sci & Engn, Chapel Hill, NC 27599 USA.
[Lock, Eric F.] Univ N Carolina, Dept Stat & Operat Res, Chapel Hill, NC 27599 USA.
[Harbourt, David; DeSimone, Michelle; Threadgill, David W.; Rusyn, Ivan] Univ N Carolina, Dept Curriculum Toxicol, Chapel Hill, NC 27599 USA.
[Threadgill, David W.] N Carolina State Univ, Dept Genet, Raleigh, NC 27695 USA.
[Tryndyak, Volodymyr; Pogribny, Igor P.] Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Bleyle, Lisa; Koop, Dennis R.] Oregon Hlth & Sci Univ, Dept Physiol & Pharmacol, Portland, OR 97239 USA.
RP Rusyn, I (reprint author), Univ N Carolina, Dept Environm Sci & Engn, 0031 Michael Hooker Res Ctr, Chapel Hill, NC 27599 USA.
EM iir@unc.edu
RI Rusyn, Ivan/S-2426-2016; Threadgill, David/N-4425-2013
OI Threadgill, David/0000-0003-3538-1635
FU National Institutes of Health [P42 ES005948]
FX National Institutes of Health grant (P42 ES005948).
NR 58
TC 20
Z9 20
U1 2
U2 5
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1096-6080
J9 TOXICOL SCI
JI Toxicol. Sci.
PD MAR
PY 2011
VL 120
IS 1
BP 206
EP 217
DI 10.1093/toxsci/kfq362
PG 12
WC Toxicology
SC Toxicology
GA 726SZ
UT WOS:000287747800019
PM 21135412
ER
PT J
AU Tubaro, A
Durando, P
Del Favero, G
Ansaldi, F
Icardi, G
Deeds, JR
Sosa, S
AF Tubaro, A.
Durando, P.
Del Favero, G.
Ansaldi, F.
Icardi, G.
Deeds, J. R.
Sosa, S.
TI Case definitions for human poisonings postulated to palytoxins exposure
SO TOXICON
LA English
DT Article
DE Palytoxin; Seafood poisoning; Marine aerosol; Aquarium zoanthids;
Ostreopsis; Palythoa; Case definition; Case report
ID DINOFLAGELLATE OSTREOPSIS-SIAMENSIS; MEDITERRANEAN SEA; PUTATIVE
PALYTOXIN; MASS-SPECTROMETRY; COASTAL WATERS; TYRRHENIAN SEA; MOUSE
BIOASSAY; HUMAN FATALITY; CORAL-REEF; TOXIN
AB A series of case reports and anecdotal references describe the adverse effects on human health ascribed to the marine toxin palytoxin (PLTX) after different exposure routes. They include poisonings after oral intake of contaminated seafood, but also inhalation and cutaneous/systemic exposures after direct contact with aerosolized seawater during Ostreopsis blooms and/or through maintaining aquaria containing cnidarian zoanthids. The symptoms commonly recorded during PLTX intoxication are general malaise and weakness, associated with myalgia, respiratory effects, impairment of the neuromuscular apparatus and abnormalities in cardiac function. Systemic symptoms are often recorded together with local damages whose intensity varies according to the route and length of exposure. Gastrointestinal malaise or respiratory distress is common for oral and inhalational exposure, respectively. In addition, irritant properties of PLTX probably account for the inflammatory reactions typical of cutaneous and inhalational contact. Unfortunately, the toxin identification and/or quantification are often incomplete or missing and cases of poisoning are indirectly ascribed to PLTXs, according only to symptoms, anamnesis and environmental/epidemiological investigations (i.e. zoanthid handling or ingestion of particular seafood). Based on the available literature, we suggest a "case definition of PLTX poisonings" according to the main exposure routes, and, we propose the main symptoms to be checked, as well as, hemato-clinical analysis to be carried out. We also suggest the performance of specific analyses both on biological specimens of patients, as well as, on the contaminated materials responsible for the poisoning. A standardized protocol for data collection could provide a more rapid and reliable diagnosis of palytoxin-poisoning, but also the collection of necessary data for the risk assessment for this family of toxins. (C) 2011 Elsevier Ltd. All rights reserved.
C1 [Tubaro, A.; Del Favero, G.; Sosa, S.] Univ Trieste, Dept Mat & Nat Resources, I-34127 Trieste, Italy.
[Durando, P.; Ansaldi, F.; Icardi, G.] Univ Genoa, Dept Hlth Sci, Sect Hyg & Prevent Med, I-16132 Genoa, Italy.
[Durando, P.; Ansaldi, F.; Icardi, G.] San Martino Univ Hosp Genoa, I-16132 Genoa, Italy.
[Deeds, J. R.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Tubaro, A (reprint author), Univ Trieste, Dept Mat & Nat Resources, Via A Valerio 6, I-34127 Trieste, Italy.
EM tubaro@units.it
FU Italian Ministry of Education, University and Research (MIUR)
FX This work was supported by a grant of the Italian Ministry of Education,
University and Research (MIUR). Authors thank Cristiano Alicino, MD,
post-graduate student at the School of Specialization in Hygiene and
Preventive Medicine of the University of Genoa (Italy) who contributed
to the drawing up of the section 5 entitled "Poisonings after postulated
exposure to seawater and/or aerosol during Ostreopsis blooms" of the
manuscript.
NR 88
TC 89
Z9 91
U1 3
U2 17
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0041-0101
J9 TOXICON
JI Toxicon
PD MAR 1
PY 2011
VL 57
IS 3
SI SI
BP 478
EP 495
DI 10.1016/j.toxicon.2011.01.005
PG 18
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 747LP
UT WOS:000289321600014
PM 21255599
ER
PT J
AU Tang, SX
Zhao, JQ
Viswanath, R
Nyambi, PN
Redd, AD
Dastyar, A
Spacek, LA
Quinn, TC
Wang, X
Wood, O
Gaddam, D
Devadas, K
Hewlett, IK
AF Tang, Shixing
Zhao, Jiangqin
Viswanath, Ragupathy
Nyambi, Phillipe N.
Redd, Andrew D.
Dastyar, Armeta
Spacek, Lisa A.
Quinn, Thomas C.
Wang, Xue
Wood, Owen
Gaddam, Durga
Devadas, Krishnakumar
Hewlett, Indira K.
TI Absence of detectable xenotropic murine leukemia virus-related virus in
plasma or peripheral blood mononuclear cells of human immunodeficiency
virus Type 1-infected blood donors or individuals in Africa
SO TRANSFUSION
LA English
DT Article
ID CHRONIC-FATIGUE-SYNDROME; HUMAN RETROVIRUS XMRV; PROSTATE-CANCER
AB BACKGROUND: Since the identification of xenotropic murine leukemia virus-related virus (XMRV) in prostate cancer patients in 2006 and in chronic fatigue syndrome patients in 2009, conflicting findings have been reported regarding its etiologic role in human diseases and prevalence in general populations. In this study, we screened both plasma and peripheral blood mononuclear cells (PBMNCs) collected in Africa from blood donors and human immunodeficiency virus Type 1 (HIV-1)-infected individuals to gain evidence of XMRV infection in this geographic region.
STUDY DESIGN AND METHODS: A total of 199 plasma samples, 19 PBMNC samples, and 50 culture supernatants from PBMNCs of blood donors from Cameroon found to be infected with HIV-1 and HIV-1 patients from Uganda were screened for XMRV infection using a sensitive nested polymerase chain reaction (PCR) or reverse transcription (RT)-PCR assay.
RESULTS: Using highly sensitive nested PCR or RT-PCR and real-time PCR assays capable of detecting at least 10 copies of XMRV plasmid DNA per reaction, none of the 268 samples tested were found to be XMRV DNA or RNA positive.
CONCLUSIONS: Our results failed to demonstrate the presence of XMRV infection in African blood donors or individuals infected with HIV-1. More studies are needed to understand the prevalence, epidemiology, and geographic distribution of XMRV infection worldwide.
C1 US FDA, Mol Virol Lab, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
NYU, Sch Med, Dept Pathol, New York, NY USA.
Johns Hopkins Univ, Sch Med, Div Intramural Res, NIAID,NIH, Baltimore, MD USA.
RP Tang, SX (reprint author), US FDA, Mol Virol Lab, Ctr Biol Evaluat & Res, 1401 Rockville Pike, Rockville, MD 20892 USA.
EM shixing.tang@fda.hhs.gov; indira.hewlett@fda.hhs.gov
FU Division of Intramural Research, NIAID, NIH
FX This work was supported in part by Division of Intramural Research,
NIAID, NIH.
NR 22
TC 21
Z9 21
U1 0
U2 2
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 MAR
PY 2011
VL 51
IS 3
BP 463
EP 468
DI 10.1111/j.1537-2995.2010.02932.x
PG 6
WC Hematology
SC Hematology
GA 732DZ
UT WOS:000288166200005
PM 21077909
ER
PT J
AU Simmons, G
Glynn, SA
Holmberg, JA
Coffin, JM
Hewlett, IK
Lo, SC
Mikovits, JA
Switzer, WM
Linnen, JM
Busch, MP
AF Simmons, Graham
Glynn, Simone A.
Holmberg, Jerry A.
Coffin, John M.
Hewlett, Indira K.
Lo, Shyh-Ching
Mikovits, Judy A.
Switzer, William M.
Linnen, Jeffrey M.
Busch, Michael P.
CA Blood XMRV Sci Res Working Grp
TI The Blood Xenotropic Murine Leukemia Virus-Related Virus Scientific
Research Working Group: mission, progress, and plans
SO TRANSFUSION
LA English
DT Editorial Material
ID CHRONIC-FATIGUE-SYNDROME; PROSTATE-CANCER; INFECTIOUS RETROVIRUS; MOUSE
DNA; XMRV; DISEASE; CONTAMINATION; CELLS; RISK; SEQUENCES
C1 [Simmons, Graham] Blood Syst Res Inst, San Francisco, CA 94118 USA.
[Simmons, Graham] Univ Calif San Francisco, San Francisco, CA 94118 USA.
[Glynn, Simone A.] NHLBI, Transfus Med & Cellular Therapeut Branch, Div Blood Dis & Resources, NIH, Bethesda, MD 20892 USA.
Dept Hlth & Human Serv, Washington, DC USA.
NCI, Bethesda, MD 20892 USA.
Tufts Univ, Sch Med, Boston, MA 02111 USA.
US FDA, Off Blood Res & Review, Silver Spring, MD USA.
US FDA, Div Cellular & Gene Therapies Review, Silver Spring, MD USA.
Univ Nevada, Reno, NV 89557 USA.
Whittemore Peterson Inst, Reno, NV USA.
Ctr Dis Control & Prevent, Div HIV AIDS Prevent, Atlanta, GA USA.
Gen Probe Inc, San Diego, CA USA.
RP Simmons, G (reprint author), Blood Syst Res Inst, 270 Mason Ave, San Francisco, CA 94118 USA.
EM gsimmons@bloodsystems.org; glynnsa@nhlbi.nih.gov
RI Simmons, Graham/G-3523-2012
OI Simmons, Graham/0000-0002-9615-7023
FU NHLBI NIH HHS [N01HB-57181, N01HB57181, HHSN268200517181C]; PHS HHS
[HHSN268200517181C]
NR 40
TC 21
Z9 21
U1 0
U2 3
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 MAR
PY 2011
VL 51
IS 3
BP 643
EP 653
DI 10.1111/j.1537-2995.2011.03063.x
PG 11
WC Hematology
SC Hematology
GA 732DZ
UT WOS:000288166200028
PM 21366602
ER
PT J
AU Bruner, DW
Hanisch, LJ
Reeve, BB
Trotti, AM
Schrag, D
Sit, L
Mendoza, TR
Minasian, L
O'Mara, A
Denicoff, AM
Rowland, JH
Montello, M
Geoghegan, C
Abernethy, AP
Clauser, SB
Castro, K
Mitchell, SA
Burke, L
Trentacosti, AM
Basch, EM
AF Bruner, Deborah Watkins
Hanisch, Laura J.
Reeve, Bryce B.
Trotti, Andy M.
Schrag, Deborah
Sit, Laura
Mendoza, Tito R.
Minasian, Lori
O'Mara, Ann
Denicoff, Andrea M.
Rowland, Julia H.
Montello, Michael
Geoghegan, Cindy
Abernethy, Amy P.
Clauser, Steven B.
Castro, Kathleen
Mitchell, Sandra A.
Burke, Laurie
Trentacosti, Ann Marie
Basch, Ethan M.
TI Stakeholder perspectives on implementing the National Cancer Institute's
patient-reported outcomes version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE)
SO TRANSLATIONAL BEHAVIORAL MEDICINE
LA English
DT Article
DE Patient-reported outcomes; Symptoms; adverse events; Oncology; Cancer;
Clinical trials; Toxicity; safety; Tolerability; Comparative
effectiveness research; Cooperative groups; National Cancer Institute
AB The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.
C1 [Bruner, Deborah Watkins] Univ Penn, Abramson Canc Ctr, Sch Nursing, Philadelphia, PA 19104 USA.
[Hanisch, Laura J.] Univ Penn, Abramson Canc Ctr, Canc Control & Outcomes Program, Philadelphia, PA 19104 USA.
[Reeve, Bryce B.] Univ N Carolina, Gillings Sch Global Publ Hlth, Lineberger Comprehens Canc Ctr, Dept Hlth Policy & Management, Chapel Hill, NC 27599 USA.
[Trotti, Andy M.] Univ S Florida, Coll Med, H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL 33612 USA.
[Schrag, Deborah] Dana Farber Canc Inst, Gastrointestinal Canc Ctr, Boston, MA 02115 USA.
[Sit, Laura; Basch, Ethan M.] Mem Sloan Kettering Canc Ctr, Dept Epidemiol & Biostat, Hlth Outcomes Grp, New York, NY 10065 USA.
[Mendoza, Tito R.] Univ Texas MD Anderson Canc Ctr, Dept Symptom Res, Houston, TX 77030 USA.
[Minasian, Lori] NCI, Community Oncol & Prevent Trials Res Grp, Canc Prevent Div, NIH, Bethesda, MD 20892 USA.
[O'Mara, Ann] NCI, Palliat Care Res Community Oncol & Prevent Trial, Canc Prevent Div, Bethesda, MD 20892 USA.
[Denicoff, Andrea M.] NCI, Clin Invest Branch, CTEP, Div Canc Treatment & Diag, Bethesda, MD 20892 USA.
[Rowland, Julia H.] NCI, Off Canc Survivorship, Div Canc Control & Populat Sci, NIH,DHHS, Bethesda, MD 20892 USA.
[Montello, Michael] NCI, Clin Trials Technol, Bethesda, MD 20892 USA.
[Geoghegan, Cindy] Breast Canc Network Strength, Chicago, IL 60603 USA.
[Abernethy, Amy P.] Duke Univ, Med Ctr, Sch Med, Dept Med, Durham, NC 27710 USA.
[Clauser, Steven B.; Castro, Kathleen; Mitchell, Sandra A.] NCI, Outcomes Res Branch, Appl Res Program, Div Canc Control & Populat Sci, Bethesda, MD 20892 USA.
[Burke, Laurie; Trentacosti, Ann Marie] US FDA, Study Endpoints & Label Dev, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Basch, EM (reprint author), Mem Sloan Kettering Canc Ctr, Dept Epidemiol & Biostat, Hlth Outcomes Grp, 307 E 63rd St,2nd Floor, New York, NY 10065 USA.
EM basche@mskcc.org
OI Abernethy, Amy/0000-0001-6930-8722
FU National Cancer Institute [HHSN261200800043C]
FX This work was supported by the National Cancer Institute under contract
HHSN261200800043C awarded to Dr. Ethan Basch, PI.
NR 26
TC 16
Z9 17
U1 0
U2 2
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 MAR
PY 2011
VL 1
IS 1
BP 110
EP 122
DI 10.1007/s13142-011-0025-3
PG 13
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA V39LG
UT WOS:000209411900019
PM 24073038
ER
PT J
AU Lu, HX
Khurana, S
Verma, N
Manischewitz, J
King, L
Beigel, JH
Golding, H
AF Lu, Hanxin
Khurana, Surender
Verma, Nitin
Manischewitz, Jody
King, Lisa
Beigel, John H.
Golding, Hana
TI A Rapid Flp-In System for Expression of Secreted H5N1 Influenza
Hemagglutinin Vaccine Immunogen in Mammalian Cells
SO PLOS ONE
LA English
DT Article
ID EFFICACY; SAFETY; PURIFICATION; ANTIBODIES; ADULTS; VIRUS; DUCKS
AB Background: Continuing transmissions of highly pathogenic H5N1 viruses in poultry and humans underscores the need for a rapid response to potential pandemic in the form of vaccine. Recombinant technologies for production of immunogenic hemagglutinin (HA) could provide an advantage over the traditional inactivated vaccine manufacturing process. Generation of stably transfected mammalian cells secreting properly folded HA proteins is important for scalable controlled manufacturing.
Methodology/Principal Findings: We have developed a Flp-In based 293 stable cell lines through targeted site-specific recombination for expression of secreted hemagglutinin (HA) proteins and evaluated their immunogenicity. H5N1 globular domain HA1(1-330) and HA0(1-500) proteins were purified from the supernatants of 293 Flp-In stable cell lines. Both proteins were properly folded as confirmed by binding to H5N1-neutralizing conformation-dependent human monoclonal antibodies. The HA0 (with unmodified cleavage site) was monomeric, while the HA1 contained oligomeric forms. Upon rabbit immunization, both HA proteins elicited neutralizing antibodies against the homologous virus (A/Vietnam/1203/2004, clade 1) as well as cross-neutralizing antibodies against heterologous H5N1 clade 2 strains, including A/Indonesia/5/2005. These results exceeded the human antibody responses against the inactivated sub-virion H5N1 vaccine.
Conclusions/Significance: Our data suggest that the 293 Flp-In system could serve as a platform for rapid expression of HA immunogens in mammalian cells from emerging influenza strains.
C1 [Lu, Hanxin; Khurana, Surender; Verma, Nitin; Manischewitz, Jody; King, Lisa; Golding, Hana] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[Beigel, John H.] NIAID, Immunoregulat Lab, Div Intramural Res, SAIC Frederick,NCI Frederick, Frederick, MD USA.
RP Lu, HX (reprint author), US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
EM hana.golding@fda.hhs.gov
OI Tripp, Ralph/0000-0002-2924-9956
FU National Cancer Institute, National Institutes of Health
[HHSN261200800001E]; National Institute of Allergy and Infectious
Diseases, National Institutes of Health
FX This project was funded in part with federal funds from the National
Cancer Institute, National Institutes of Health, under contract no.
HHSN261200800001E and in part by the National Institute of Allergy and
Infectious Diseases, 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 23
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U1 0
U2 4
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD FEB 28
PY 2011
VL 6
IS 2
AR e17297
DI 10.1371/journal.pone.0017297
PG 8
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 729EM
UT WOS:000287931400050
PM 21386997
ER
PT J
AU Wu, HQ
White, M
Khan, MA
AF Wu, Huiquan
White, Maury
Khan, Mansoor A.
TI Quality-by-Design (QbD): An integrated process analytical technology
(PAT) approach for a dynamic pharmaceutical co-precipitation process
characterization and process design space development
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Article
DE Quality-by-Design (QbD); Process analytical technology (PAT);
Co-precipitation; Real-time process monitoring; Critical process
variable; Design space
ID PARTICLE-SIZE DISTRIBUTION; MULTIVARIATE CALIBRATION; FORMULATION
VARIABLES; LASER BACKSCATTERING; AGITATED SUSPENSIONS; FBRM;
CRYSTALLIZATION; QUANTIFICATION; OPTIMIZATION; PRODUCT
AB The aim of this work was to develop an integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and design space development. A dynamic co-precipitation process by gradually introducing water to the ternary system of naproxen-Eudragit L100-alcohol was monitored at real-time in situ via Lasentec FBRM and PVM. 3D map of count-time-chord length revealed three distinguishable process stages: incubation, transition, and steady-state. The effects of high risk process variables (slurry temperature, stirring rate, and water addition rate) on both derived co-precipitation process rates and final chord-length-distribution were evaluated systematically using a 3(3) full factorial design. Critical process variables were identified via ANOVA for both transition and steady state. General linear models (GLM) were then used for parameter estimation for each critical variable. Clear trends about effects of each critical variable during transition and steady state were found by GLM and were interpreted using fundamental process principles and Nyvlt's transfer model. Neural network models were able to link process variables with response variables at transition and steady state with R(2) of 0.88-0.98. PVM images evidenced nucleation and crystal growth. Contour plots illustrated design space via critical process variables' ranges. It demonstrated the utility of integrated PAT approach for QbD development. Published by Elsevier B.V.
C1 [Wu, Huiquan; White, Maury; Khan, Mansoor A.] OTR OPS CDER FDA, HFD 940, DPQR, Silver Spring, MD 20993 USA.
RP Wu, HQ (reprint author), OTR OPS CDER FDA, HFD 940, DPQR, FDA White Oak Campus,Life Sci Bldg 64,Room 1080, Silver Spring, MD 20993 USA.
EM Huiquan.Wu@fda.hhs.gov
NR 48
TC 43
Z9 46
U1 2
U2 31
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
J9 INT J PHARMACEUT
JI Int. J. Pharm.
PD FEB 28
PY 2011
VL 405
IS 1-2
BP 63
EP 78
DI 10.1016/j.ijpharm.2010.11.045
PG 16
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 720KK
UT WOS:000287279400008
PM 21138762
ER
PT J
AU Jeannot, E
Pogribny, IP
Beland, FA
Rusyn, I
AF Jeannot, Emmanuelle
Pogribny, Igor P.
Beland, Frederick A.
Rusyn, Ivan
TI Chronic administration of ethanol leads to an increased incidence of
hepatocellular adenoma by promoting H-ras-mutated cells
SO CANCER LETTERS
LA English
DT Article
DE Alcohol; Liver tumors; H-ras; beta-Catenin; HNF1 alpha
ID MOUSE-LIVER TUMORS; OXIDATIVE DNA-DAMAGE; MUTATIONAL ANALYSIS;
MITOCHONDRIAL-DNA; LUNG-TUMORS; ALCOHOL; MICE; CARCINOGENESIS;
EXPRESSION; ONCOGENE
AB This study used tissue samples from male B6C3F1 mice treated with ethanol in drinking water (0%, 2.5%, or 5%) for 4 or 104 weeks. We tested whether chronic alcohol drinking promotes oxidative stress in the liver and characterized the mutation profile of spontaneous and ethanol-induced tumors. We show that ethanol does not cause detectable oxidative stress in the liver at any time point and acts by promoting H-ras mutated cells. (c) 2010 Elsevier Ireland Ltd. All rights reserved.
C1 [Jeannot, Emmanuelle; Rusyn, Ivan] Univ N Carolina, Dept Environm Sci & Engn, Chapel Hill, NC 27599 USA.
[Pogribny, Igor P.; Beland, Frederick A.] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Rusyn, I (reprint author), Univ N Carolina, Dept Environm Sci & Engn, Chapel Hill, NC 27599 USA.
EM iir@unc.edu
RI Rusyn, Ivan/S-2426-2016
FU NIH [ES005948, ES012689, ES015241]
FX This work was supported, in part, by grants from NIH (ES005948,
ES012689, and ES015241). The views expressed in this paper do not
necessarily represent those of the US Food and Drug Administration. None
of the authors has any actual or potential competing financial
interests.
NR 52
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Z9 5
U1 0
U2 1
PU ELSEVIER IRELAND LTD
PI CLARE
PA ELSEVIER HOUSE, BROOKVALE PLAZA, EAST PARK SHANNON, CO, CLARE, 00000,
IRELAND
SN 0304-3835
J9 CANCER LETT
JI Cancer Lett.
PD FEB 28
PY 2011
VL 301
IS 2
BP 161
EP 167
DI 10.1016/j.canlet.2010.11.010
PG 7
WC Oncology
SC Oncology
GA 724CY
UT WOS:000287554900005
PM 21168264
ER
PT J
AU Hamburg, MA
AF Hamburg, Margaret A.
TI Advancing Regulatory Science
SO SCIENCE
LA English
DT Editorial Material
C1 US FDA, Rockville, MD 20857 USA.
RP Hamburg, MA (reprint author), US FDA, Rockville, MD 20857 USA.
NR 0
TC 42
Z9 42
U1 0
U2 14
PU AMER ASSOC ADVANCEMENT SCIENCE
PI WASHINGTON
PA 1200 NEW YORK AVE, NW, WASHINGTON, DC 20005 USA
SN 0036-8075
J9 SCIENCE
JI Science
PD FEB 25
PY 2011
VL 331
IS 6020
BP 987
EP 987
DI 10.1126/science.1204432
PG 1
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 726DM
UT WOS:000287699000001
PM 21350129
ER
PT J
AU Pearson, RJ
Gatti, PJ
Sahibzada, N
Massari, VJ
Gillis, RA
AF Pearson, Rebecca J.
Gatti, Philip J.
Sahibzada, Niaz
Massari, V. John
Gillis, Richard A.
TI Ultrastructural evidence for selective GABAergic innervation of CNS
vagal projections to the antrum of the rat
SO AUTONOMIC NEUROSCIENCE-BASIC & CLINICAL
LA English
DT Article
DE GABA; GAD67; Ultrastructure; Immunohistochemistry; Brainstem;
Gastrointestinal; Antrum; Vagus; Motoneuron
ID DORSAL MOTOR NUCLEUS; FUNCTIONAL DYSPEPSIA; ELECTRON-MICROSCOPY;
TRACTUS-SOLITARIUS; SYNAPTIC CURRENTS; BRAIN-STEM; NEURONS; VAGUS;
RECEPTORS; CISAPRIDE
AB We reported pharmacological data suggesting that stimulation of a vago-vagal reflex activates GABAergic neurons in the hindbrain that inhibit dorsal motor nucleus of the vagus (DMV) neurons projecting to the antrum, but not to the fundus (Ferreira et al., 2002). The purpose of this study was to use an ultrastructural approach to test the hypothesis that GABAergic terminals form synapses with DMV antrum-projecting neurons, but not with DMV fundus-projecting neurons. A retrograde tracer, CTB-HRP, was injected into the gastric smooth muscle of either the fundus or the antrum of anesthetized rats. Animals were re-anesthetized 48 h later and perfusion-fixed with acrolein and paraformaldehyde. Brainstems were processed histochemically for CTB-HRP, and immunocytochemically for glutamic acid decarboxylase isoenzyme 67 immunoreactivity (GAD67-IR) by dual-labeling electron microscopic methods. Most cell bodies and dendrites of neurons that were retrogradely labeled from the stomach occurred at the level of the area postrema. Examination of 214 synapses on 195 neurons that projected to the antrum revealed that 23.0 +/- 3.6% (n = 4) of synaptic contacts were with GAD67-IR terminals. The examination of 220 synapses on 203 fundus-projecting neurons revealed that only 7.9 +/- 3.1% (n = 4) of synaptic contacts were with GAD67-IR terminals. The difference between GAD67-IR synaptic contacts with antrum- and fundus-projecting neurons was statistically significant (p < 0.05). These data suggest that brainstem circuitry controlling the antrum involves GABAergic transmission. (C) 2010 Elsevier B.V. All rights reserved.
C1 [Pearson, Rebecca J.; Sahibzada, Niaz; Gillis, Richard A.] Georgetown Univ, Dept Pharmacol, Med Ctr, Washington, DC 20057 USA.
[Gatti, Philip J.; Massari, V. John] Howard Univ, Coll Med, Dept Pharmacol, Washington, DC 20059 USA.
[Gatti, Philip J.] FDA CDER, Dept Pharmacol, Div Cardiorenal Prod, Silver Spring, MD USA.
RP Gillis, RA (reprint author), Georgetown Univ, Dept Pharmacol, Med Ctr, 3900 Reservoir Rd NW, Washington, DC 20057 USA.
EM gillisr@georgetown.edu
OI Sahibzada, Niaz/0000-0002-4169-370X
FU NIH [R01 DK57105, R01 DK56925, R24MH067627, U54NS039407, F31NS049786];
Division of Research Infrastructure, National Center for Research
Resources, NIH [2 G12 RR003048]
FX NIH grant #'s: R01 DK57105 (RAG). R01 DK56925 (RAG), R24MH067627 (VJM),
U54NS039407 (VJM), and F31NS049786 (RJP). Supported in part by grant 2
G12 RR003048 from the RCMI Program, Division of Research Infrastructure,
National Center for Research Resources, NIH.
NR 31
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U1 1
U2 3
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1566-0702
J9 AUTON NEUROSCI-BASIC
JI Auton. Neurosci-Basic Clin.
PD FEB 24
PY 2011
VL 160
IS 1-2
BP 21
EP 26
DI 10.1016/j.autneu.2010.10.010
PG 6
WC Neurosciences
SC Neurosciences & Neurology
GA 729XZ
UT WOS:000287989000004
PM 21112817
ER
PT J
AU Mody, RK
Greene, SA
Gaul, L
Sever, A
Pichette, S
Zambrana, I
Dang, T
Gass, A
Wood, R
Herman, K
Cantwell, LB
Falkenhorst, G
Wannemuehler, K
Hoekstra, RM
McCullum, I
Cone, A
Franklin, L
Austin, J
Delea, K
Behravesh, CB
Sodha, SV
Yee, JC
Emanuel, B
Al-Khaldi, SF
Jefferson, V
Williams, IT
Griffin, PM
Swerdlow, DL
AF Mody, Rajal K.
Greene, Sharon A.
Gaul, Linda
Sever, Adrianne
Pichette, Sarah
Zambrana, Ingrid
Dang, Thi
Gass, Angie
Wood, Rene
Herman, Karen
Cantwell, Laura B.
Falkenhorst, Gerhard
Wannemuehler, Kathleen
Hoekstra, Robert M.
McCullum, Isaac
Cone, Amy
Franklin, Lou
Austin, Jana
Delea, Kristin
Behravesh, Casey Barton
Sodha, Samir V.
Yee, J. Christopher
Emanuel, Brian
Al-Khaldi, Sufian F.
Jefferson, Val
Williams, Ian T.
Griffin, Patricia M.
Swerdlow, David L.
TI National Outbreak of Salmonella Serotype Saintpaul Infections:
Importance of Texas Restaurant Investigations in Implicating Jalapeno
Peppers
SO PLOS ONE
LA English
DT Article
ID INTERNATIONAL OUTBREAK; FRESH PRODUCE; UNITED-STATES; MULTISTATE
OUTBREAK; CONSUMPTION; TOMATOES; GROWTH
AB Background: In May 2008, PulseNet detected a multistate outbreak of Salmonella enterica serotype Saintpaul infections. Initial investigations identified an epidemiologic association between illness and consumption of raw tomatoes, yet cases continued. In mid-June, we investigated two clusters of outbreak strain infections in Texas among patrons of Restaurant A and two establishments of Restaurant Chain B to determine the outbreak's source.
Methodology/Principal Findings: We conducted independent case-control studies of Restaurant A and B patrons. Patients were matched to well controls by meal date. We conducted restaurant environmental investigations and traced the origin of implicated products. Forty-seven case-patients and 40 controls were enrolled in the Restaurant A study. Thirty case-patients and 31 controls were enrolled in the Restaurant Chain B study. In both studies, illness was independently associated with only one menu item, fresh salsa (Restaurant A: matched odds ratio [mOR], 37; 95% confidence interval [CI], 7.2-386; Restaurant B: mOR, 13; 95% CI 1.3-infinity). The only ingredient in common between the two salsas was raw jalapeno peppers. Cultures of jalapeno peppers collected from an importer that supplied Restaurant Chain B and serrano peppers and irrigation water from a Mexican farm that supplied that importer with jalapeno and serrano peppers grew the outbreak strain.
Conclusions/Significance: Jalapeno peppers, contaminated before arrival at the restaurants and served in uncooked fresh salsas, were the source of these infections. Our investigations, critical in understanding the broader multistate outbreak, exemplify an effective approach to investigating large foodborne outbreaks. Additional measures are needed to reduce produce contamination.
C1 [Mody, Rajal K.; Sever, Adrianne] Ctr Dis Control & Prevent, Sci Educ & Profess Dev Program Off, Epidem Intelligence Serv, Atlanta, GA 30333 USA.
[Mody, Rajal K.; Greene, Sharon A.; Herman, Karen; Cantwell, Laura B.; Falkenhorst, Gerhard; Wannemuehler, Kathleen; Hoekstra, Robert M.; McCullum, Isaac; Austin, Jana; Behravesh, Casey Barton; Sodha, Samir V.; Williams, Ian T.; Griffin, Patricia M.; Swerdlow, David L.] Ctr Dis Control & Prevent, Div Foodborne Waterborne & Environm Dis, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA USA.
[Gaul, Linda; Dang, Thi] Texas Dept State Hlth Serv, Austin, TX USA.
[Pichette, Sarah; Zambrana, Ingrid; Yee, J. Christopher; Emanuel, Brian; Al-Khaldi, Sufian F.; Jefferson, Val] US FDA, Silver Spring, MD USA.
[Gass, Angie; Wood, Rene; Cone, Amy; Franklin, Lou] Wichita Falls Wichita Cty Publ Hlth Dist, Wichita Falls, TX USA.
[Delea, Kristin] Ctr Dis Control & Prevent, Natl Ctr Environm Hlth, Atlanta, GA USA.
RP Mody, RK (reprint author), Ctr Dis Control & Prevent, Sci Educ & Profess Dev Program Off, Epidem Intelligence Serv, Atlanta, GA 30333 USA.
EM rmody@cdc.gov
FU core government
FX This work was supported by core government funding. The funders had no
role in study design, data collection and analysis, decision to publish,
or preparation of the manuscript.
NR 24
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U1 1
U2 9
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD FEB 23
PY 2011
VL 6
IS 2
AR e16579
DI 10.1371/journal.pone.0016579
PG 7
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 725PJ
UT WOS:000287657500012
PM 21373185
ER
PT J
AU Kim, DH
Song, CG
Ilev, IK
Kang, JU
AF Kim, Do-Hyun
Song, Chul-Gyu
Ilev, Ilko K.
Kang, Jin U.
TI Axial-scanning low-coherence interferometer method for noncontact
thickness measurement of biological samples
SO APPLIED OPTICS
LA English
DT Article
ID REFRACTIVE-INDEX; TISSUE; LIGHT
AB We investigated a high-precision optical method for measuring the thickness of biological samples regardless of their transparency. The method is based on the precise measurement of optical path length difference of the end surfaces of objects, using a dual-arm axial-scanning low-coherence interferometer. This removes any consideration of the shape, thickness, or transparency of testing objects when performing the measurement. Scanning the reference simplifies the measurement setup, resulting in unambiguous measurement. Using a 1310 nm wavelength superluminescent diode, with a 65 nm bandwidth, the measurement accuracy was as high as 11.6 mu m. We tested the method by measuring the thickness of both transparent samples and nontransparent soft biological tissues.
C1 [Kim, Do-Hyun; Ilev, Ilko K.] US FDA, Silver Spring, MD 20993 USA.
[Song, Chul-Gyu] Chonbuk Natl Univ, Ctr Adv Image & Informat Technol, Jeonju 561756, Jeonbuk, South Korea.
[Kang, Jin U.] Johns Hopkins Univ, Baltimore, MD 21218 USA.
RP Kim, DH (reprint author), US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM do-hyun.kim@fda.hhs.gov
RI Kang, Jin/A-3228-2010
NR 11
TC 6
Z9 6
U1 0
U2 2
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 FEB 20
PY 2011
VL 50
IS 6
BP 970
EP 974
DI 10.1364/AO.50.000970
PG 5
WC Optics
SC Optics
GA 724KI
UT WOS:000287574600023
PM 21343978
ER
PT J
AU Collier, JW
Shah, RB
Bryant, AR
Habib, MJ
Khan, MA
Faustino, PJ
AF Collier, J. W.
Shah, R. B.
Bryant, A. R.
Habib, M. J.
Khan, M. A.
Faustino, P. J.
TI Development and application of a validated HPLC method for the analysis
of dissolution samples of levothyroxine sodium drug products
SO JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
LA English
DT Article
DE Levothyroxine; Dissolution; Drug product; HPLC; Validation
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; MASS-SPECTROMETRY METHOD; CONTENT
UNIFORMITY; TABLET FORMULATIONS; THYROXINE; PHASE; QUANTIFICATION;
STABILITY; ASSAY; TRIIODOTHYRONINE
AB A rapid, selective, and sensitive gradient HPLC method was developed for the analysis of dissolution samples of levothyroxine sodium tablets. Current USP methodology for levothyroxine (L-T(4)) was not adequate to resolve co-elutants from a variety of levothyroxine drug product formulations. The USP method for analyzing dissolution samples of the drug product has shown significant intra- and inter-day variability. The sources of method variability include chromatographic interferences introduced by the dissolution media and the formulation excipients. In the present work, chromatographic separation of levothyroxine was achieved on an Agilent 1100 Series HPLC with a Waters Nova-pak column (250 mm x 3.9 mm) using a 0.01 M phosphate buffer (pH 3.0)-methanol (55:45, v/v) in a gradient elution mobile phase at a flow rate of 1.0 mL/min and detection UV wavelength of 225 nm. The injection volume was 800 mu L and the column temperature was maintained at 28 degrees C. The method was validated according to USP Category I requirements. The validation characteristics included accuracy, precision, specificity, linearity, and analytical range. The standard curve was found to have a linear relationship (r(2) > 0.99) over the analytical range of 0.08-0.8 mu g/mL. Accuracy ranged from 90 to 110% for low quality control (QC) standards and 95 to 105% for medium and high QC standards. Precision was <2% at all QC levels. The method was found to be accurate, precise, selective, and linear for L-T(4) over the analytical range. The HPLC method was successfully applied to the analysis of dissolution samples of marketed levothyroxine sodium tablets. Published by Elsevier B.V.
C1 [Collier, J. W.; Shah, R. B.; Bryant, A. R.; Khan, M. A.; Faustino, P. J.] US FDA, Div Prod Qual Res, Off Testing & Res, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Collier, J. W.; Habib, M. J.] Howard Univ, Dept Pharmaceut Sci, Sch Pharm, Washington, DC 20059 USA.
RP Faustino, PJ (reprint author), US FDA, Div Prod Qual Res, Off Testing & Res, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM patrick.faustino@fda.hhs.gov
FU NCRR NIH HHS [G12 RR003048, G12 RR003048-22]
NR 21
TC 9
Z9 10
U1 2
U2 23
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0731-7085
J9 J PHARMACEUT BIOMED
JI J. Pharm. Biomed. Anal.
PD FEB 20
PY 2011
VL 54
IS 3
BP 433
EP 438
DI 10.1016/j.jpba.2010.08.025
PG 6
WC Chemistry, Analytical; Pharmacology & Pharmacy
SC Chemistry; Pharmacology & Pharmacy
GA 687YL
UT WOS:000284814300001
PM 20947276
ER
PT J
AU Dunn, JD
Gryniewicz-Ruzicka, CM
Kauffman, JF
Westenberger, BJ
Buhse, LF
AF Dunn, Jamie D.
Gryniewicz-Ruzicka, Connie M.
Kauffman, John F.
Westenberger, Benjamin J.
Buhse, Lucinda F.
TI Using a portable ion mobility spectrometer to screen dietary supplements
for sibutramine
SO JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
LA English
DT Article
DE Ion mobility spectrometry; Portable; Hand-held; Weight loss drugs;
Herbal dietary supplements
ID CHEMICAL WARFARE AGENTS; SYNTHETIC ADULTERANTS; MASS-SPECTROMETRY;
WEIGHT-LOSS; ESI-MS; DRUGS; SWABS
AB In response to recent incidents of undeclared sibutramine, an appetite suppressant found in dietary supplements, we developed a method to detect sibutramine using hand-held ion mobility spectrometers with an analysis time of 15s. Ion mobility spectrometry is a high-throughput and sensitive technique that has been used for illicit drug, explosive, volatile organic compound and chemical warfare detection. We evaluated a hand-held ion mobility spectrometer as a tool for the analysis of supplement extracts containing sibutramine. The overall instrumental limit of detection of five portable ion mobility spectrometers was 2 ng of sibutramine HCl. When sample extractions containing 30 ng/mu l or greater of sibutramine were analyzed, saturation of the ionization chamber of the spectrometer occurred and the instrument required more than three cleaning cycles to remove the drug. Hence, supplement samples suspected of containing sibutramine should be prepared at concentrations of 2-20 ng/mu l. To obtain this target concentration range for products containing unknown amounts of sibutramine, we provided a simple sample preparation procedure, allowing the U.S. Food and Drug Administration or other agencies to screen products using the portable ion mobility spectrometer. Published by Elsevier B.V.
C1 [Dunn, Jamie D.; Gryniewicz-Ruzicka, Connie M.; Kauffman, John F.; Westenberger, Benjamin J.; Buhse, Lucinda F.] US FDA, Div Pharmaceut Anal, St Louis, MO 63101 USA.
RP Dunn, JD (reprint author), US FDA, Div Pharmaceut Anal, 1114 Market St, St Louis, MO 63101 USA.
EM Jamie.Dunn@fda.hhs.gov
FU U.S. FDA Center for Drug Evaluation and Research
FX We would like to thank the U.S. FDA ORA scientists, Gary Dzidowski, Mark
Henry, Sarah McMullen, Temar Williams and Valentino Fiorella and the DPA
scientists Terry Moore and Wei Ye for participating in the study.
Funding was provided by the U.S. FDA Center for Drug Evaluation and
Research Critical Path program.
NR 32
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U1 2
U2 22
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0731-7085
J9 J PHARMACEUT BIOMED
JI J. Pharm. Biomed. Anal.
PD FEB 20
PY 2011
VL 54
IS 3
BP 469
EP 474
DI 10.1016/j.jpba.2010.09.017
PG 6
WC Chemistry, Analytical; Pharmacology & Pharmacy
SC Chemistry; Pharmacology & Pharmacy
GA 687YL
UT WOS:000284814300007
PM 20940091
ER
PT J
AU Robertson, JS
Nicolson, C
Harvey, R
Johnson, R
Major, D
Guilfoyle, K
Roseby, S
Newman, R
Collin, R
Wallis, C
Engelhardt, OG
Wood, JM
Le, JH
Manojkumar, R
Pokorny, BA
Silverman, J
Devis, R
Bucher, D
Verity, E
Agius, C
Camuglia, S
Ong, C
Rockman, S
Curtis, A
Schoofs, P
Zoueva, O
Xie, H
Li, X
Lin, ZS
Ye, ZP
Chen, LM
O'Neill, E
Balishe, A
Lipatov, AS
Guo, Z
Isakova, I
Davis, CT
Rivailler, P
Gustin, KM
Belser, JA
Maines, TR
Tumpey, TM
Xu, XY
Katz, JM
Klimov, A
Cox, NJ
Donis, RO
AF Robertson, James S.
Nicolson, Carolyn
Harvey, Ruth
Johnson, Rachel
Major, Diane
Guilfoyle, Kate
Roseby, Sarah
Newman, Robert
Collin, Rebecca
Wallis, Chantal
Engelhardt, Othmar G.
Wood, John M.
Le, Jianhua
Manojkumar, Ramanunninair
Pokorny, Barbara A.
Silverman, Jeanmarie
Devis, Rene
Bucher, Doris
Verity, Erin
Agius, Catherine
Camuglia, Sarina
Ong, Chi
Rockman, Steven
Curtis, Anne
Schoofs, Peter
Zoueva, Olga
Xie, Hang
Li, Xing
Lin, Zhengshi
Ye, Zhiping
Chen, Li-Mei
O'Neill, Eduardo
Balishe, Amanda
Lipatov, Aleksandr S.
Guo, Zhu
Isakova, Irina
Davis, Charles T.
Rivailler, Pierre
Gustin, Kortney M.
Belser, Jessica A.
Maines, Taronna R.
Tumpey, Terrence M.
Xu, Xiyan
Katz, Jacqueline M.
Klimov, Alexander
Cox, Nancy J.
Donis, Ruben O.
TI The development of vaccine viruses against pandemic A(H1N1) influenza
SO VACCINE
LA English
DT Article
DE Influenza vaccines; Candidate vaccine viruses; Reverse genetics; High
growth reassortants; HA antigen yield
ID A VIRUS; REVERSE GENETICS; GENERATION; RECOMBINANTS; SYSTEM; EGG; DNA
AB Wild type human influenza viruses do not usually grow well in embryonated hens' eggs, the substrate of choice for the production of inactivated influenza vaccine, and vaccine viruses need to be developed specifically for this purpose. In the event of a pandemic of influenza, vaccine viruses need to be created with utmost speed. At the onset of the current A(H1N1) pandemic in April 2009, a network of laboratories began a race against time to develop suitable candidate vaccine viruses. Two approaches were followed, the classical reassortment approach and the more recent reverse genetics approach. This report describes the development and the characteristics of current pandemic H1N1 candidate vaccine viruses. (C) 2010 Elsevier Ltd. All rights reserved.
C1 [Robertson, James S.; Nicolson, Carolyn; Harvey, Ruth; Johnson, Rachel; Major, Diane; Guilfoyle, Kate; Roseby, Sarah; Newman, Robert; Collin, Rebecca; Wallis, Chantal; Engelhardt, Othmar G.; Wood, John M.] Natl Inst Biol Stand & Controls, Div Virol, Potters Bar EN6 3QG, Herts, England.
[Le, Jianhua; Manojkumar, Ramanunninair; Pokorny, Barbara A.; Silverman, Jeanmarie; Devis, Rene; Bucher, Doris] New York Med Coll, Dept Microbiol & Immunol, Valhalla, NY 10595 USA.
[Zoueva, Olga; Xie, Hang; Li, Xing; Lin, Zhengshi; Ye, Zhiping] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Chen, Li-Mei; O'Neill, Eduardo; Balishe, Amanda; Lipatov, Aleksandr S.; Guo, Zhu; Isakova, Irina; Davis, Charles T.; Rivailler, Pierre; Gustin, Kortney M.; Belser, Jessica A.; Maines, Taronna R.; Tumpey, Terrence M.; Xu, Xiyan; Katz, Jacqueline M.; Klimov, Alexander; Cox, Nancy J.; Donis, Ruben O.] Ctr Dis Control & Prevent, Influenza Div, Atlanta, GA 30333 USA.
RP Robertson, JS (reprint author), Natl Inst Biol Stand & Controls, Div Virol, Blanche Lane, Potters Bar EN6 3QG, Herts, England.
EM jim.robertson@nibsc.hpa.org.uk
RI Isakova-Sivak, Irina/C-1034-2014
OI Isakova-Sivak, Irina/0000-0002-2801-1508
NR 28
TC 49
Z9 53
U1 2
U2 8
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD FEB 17
PY 2011
VL 29
IS 9
BP 1836
EP 1843
DI 10.1016/j.vaccine.2010.12.044
PG 8
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 730TV
UT WOS:000288058500015
PM 21199698
ER
PT J
AU Getie-Kebtie, M
Lazarev, A
Eichelberger, M
Alterman, M
AF Getie-Kebtie, Melkamu
Lazarev, Alexander
Eichelberger, Maryna
Alterman, Michail
TI Label-free mass spectrometry-based relative quantification of proteins
separated by one-dimensional gel electrophoresis
SO ANALYTICAL BIOCHEMISTRY
LA English
DT Article
DE Label-free; Protein quantification; In-gel digestion; Pressure cycling
technology; MALDI-TOF/TOF
ID LASER-DESORPTION/IONIZATION TIME; QUANTITATIVE PROTEOMICS; ABSOLUTE
QUANTIFICATION; LIQUID-CHROMATOGRAPHY; CYTOCHROME-P450 ISOZYMES; MALDI;
IDENTIFICATION; PERFORMANCE; MIXTURES; EXPRESSION
AB Here we present a matrix-assisted laser desorption/ionization tandem time-of-flight (MALDI-TOF/TOF)-based label-free relative protein quantification strategy that involves sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) separation of proteins followed by in-gel trypsin digestion. The main problem encountered in gel-based protein quantification is the difficulty in achieving complete and consistent proteolytic digestion. To solve this problem, we developed a high-pressure-assisted in-gel trypsin digestion method that is based on pressure cycling technology (PCT). The PCT approach performed at least as well as the conventional overnight in-gel trypsin digestion approach in parameters such as number of peaks detected, number of peptides identified, and sequence coverage, and the digestion time was reduced to 45 min. The gel/mass spectrometry (MS)-based label-free protein quantification method presented in this work proved the applicability of the signal response factor concept for relative protein quantification previously demonstrated by other groups using the liquid chromatography (LC)/MS platform. By normalizing the average signal intensities of the three most intense peptides of each protein with the average intensities of spiked synthetic catalase tryptic peptides, which we used as an internal standard, we observed spot-to-spot and lane-to-lane coefficients of variation of less than 10 and 20%, respectively. We also demonstrated that the method can be used for determining the relative quantities of proteins comigrating during electrophoretic separation. Published by Elsevier Inc.
C1 [Getie-Kebtie, Melkamu; Alterman, Michail] US FDA, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Lazarev, Alexander] Pressure BioSci, S Easton, MA 02375 USA.
[Eichelberger, Maryna] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Alterman, M (reprint author), US FDA, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM michail.alterman@fda.hhs.gov
FU CBER Pandemic Influenza Unmet Needs; Biomedical Advanced Research and
Development Authority
FX The authors gratefully acknowledge critical reading of the manuscript by
Dr. V. Gross. This project was supported by funding provided by CBER
Pandemic Influenza Unmet Needs and by the Biomedical Advanced Research
and Development Authority.
NR 36
TC 10
Z9 10
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 0003-2697
J9 ANAL BIOCHEM
JI Anal. Biochem.
PD FEB 15
PY 2011
VL 409
IS 2
BP 202
EP 212
DI 10.1016/j.ab.2010.10.023
PG 11
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 719CH
UT WOS:000287176600006
PM 20971051
ER
PT J
AU Stein, WD
Gulley, JL
Schlom, J
Madan, RA
Dahut, W
Figg, WD
Ning, YM
Arlen, PM
Price, D
Bates, SE
Fojo, T
AF Stein, Wilfred D.
Gulley, James L.
Schlom, Jeff
Madan, Ravi A.
Dahut, William
Figg, William D.
Ning, Yang-min
Arlen, Phil M.
Price, Doug
Bates, Susan E.
Fojo, Tito
TI Tumor Regression and Growth Rates Determined in Five Intramural NCI
Prostate Cancer Trials: The Growth Rate Constant as an Indicator of
Therapeutic Efficacy
SO CLINICAL CANCER RESEARCH
LA English
DT Article
ID PHASE-II TRIAL; RADICAL PROSTATECTOMY; PLUS THALIDOMIDE;
CLINICAL-TRIALS; DOUBLING TIME; WORKING GROUP; SURVIVAL; DOCETAXEL;
VACCINE; RECOMMENDATIONS
AB Purpose: In solid tumors such as prostate cancer, novel paradigms are needed to assess therapeutic efficacy. We utilized a method estimating tumor growth and regression rate constants from serial PSA measurements, and assessed its potential in patients with metastatic castration resistant prostate carcinoma (mCRPC).
Experimental Design: Patients were enrolled in five phase II studies, including an experimental vaccine trial, representing the evolution of therapy in mCRPC. PSA measurements obtained before, and during, therapy were used. Data analysis using a two-phase mathematical equation yielded concomitant PSA growth and regression rate constants.
Results: Growth rate constants (g) can be estimated while patients receive therapy and in such patients g is superior to PSA-DT in predicting OS. Incremental reductions in growth rate constants were recorded in successive trials with a 10-fold slower g in the most recent combination therapy trial (log g = 10(-3.17)) relative to single-agent thalidomide (log g = 10(-2.08)) more than a decade earlier. Growth rate constants correlated with survival, except in patients receiving vaccine-based therapy where the evidence demonstrates prolonged survival presumably due to immunity developing subsequent to vaccine administration.
Conclusion: Incremental reductions in tumor growth rate constants suggest increased efficacy in successive chemotherapy trials. The derived growth rate constant correlates with survival, and may be used to assess efficacy. The PSA-TRICOM vaccine appears to have provided marked benefit not apparent during vaccination, but consistent with subsequent development of a beneficial immune response. If validated as a surrogate for survival, growth rate constants would offer an important new efficacy endpoint for clinical trials. Clin Cancer Res; 17(4); 907-17. (C) 2010 AACR.
C1 [Stein, Wilfred D.; Madan, Ravi A.; Dahut, William; Figg, William D.; Price, Doug; Bates, Susan E.; Fojo, Tito] NCI, Med Oncol Branch, NIH, Bethesda, MD 20892 USA.
[Gulley, James L.; Schlom, Jeff; Madan, Ravi A.; Arlen, Phil M.] NCI, Tumor Immunol & Biol Lab, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Stein, Wilfred D.] Hebrew Univ Jerusalem, Alexander Silberman Inst Life Sci, Dept Biol Chem, IL-91904 Jerusalem, Israel.
[Ning, Yang-min] US FDA, DDOP OODP CDER, Silver Spring, MD USA.
RP Fojo, T (reprint author), NCI, Med Oncol Branch, NIH, NIH Bldg 10,RM 12N226,9000 Rockville Pike, Bethesda, MD 20892 USA.
EM tfojo@helix.nih.gov
RI Gulley, James/K-4139-2016; Figg Sr, William/M-2411-2016
OI Gulley, James/0000-0002-6569-2912;
NR 37
TC 115
Z9 115
U1 0
U2 3
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD FEB 15
PY 2011
VL 17
IS 4
BP 907
EP 917
DI 10.1158/1078-0432.CCR-10-1762
PG 11
WC Oncology
SC Oncology
GA 728ZM
UT WOS:000287913200030
PM 21106727
ER
PT J
AU Jelinek, I
Leonard, JN
Price, GE
Brown, KN
Meyer-Manlapat, A
Goldsmith, PK
Wang, Y
Venzon, D
Epstein, SL
Segal, DM
AF Jelinek, Ivett
Leonard, Joshua N.
Price, Graeme E.
Brown, Kevin N.
Meyer-Manlapat, Anna
Goldsmith, Paul K.
Wang, Yan
Venzon, David
Epstein, Suzanne L.
Segal, David M.
TI TLR3-Specific Double-Stranded RNA Oligonucleotide Adjuvants Induce
Dendritic Cell Cross-Presentation, CTL Responses, and Antiviral
Protection
SO JOURNAL OF IMMUNOLOGY
LA English
DT Article
ID TOLL-LIKE RECEPTOR-3; BONE-MARROW CULTURES; ANTIGEN PRESENTATION; INNATE
IMMUNITY; IN-VIVO; ADAPTIVE IMMUNITY; CUTTING EDGE; RECOGNITION;
ACTIVATION; CD8(+)
AB Maturation of dendritic cells (DC) to competent APC is essential for the generation of acquired immunity and is a major function of adjuvants. dsRNA, a molecular signature of viral infection, drives DC maturation by activating TLR3, but the size of dsRNA required to activate DC and the expression patterns of TLR3 protein in DC subsets have not been established. In this article, we show that cross-priming CD8 alpha(+) and CD103(+) DC subsets express much greater levels of TLR3 than other DC. In resting DC, TLR3 is located in early endosomes and other intracellular compartments but migrates to LAMP1(+) endosomes on stimulation with a TLR3 ligand. Using homogeneous dsRNA oligonucleotides (ONs) ranging in length from 25 to 540 bp, we observed that a minimum length of similar to 90 bp was sufficient to induce CD86, IL-12p40, IFN-beta, TNF-alpha, and IL-6 expression, and to mature DC into APC that cross-presented exogenous Ags to CD8(+) T cells. TLR3 was essential for activation of DC by dsRNA ONs, and the potency of activation increased with dsRNA length and varied between DC subsets. In vivo, dsRNA ONs, in a size-dependent manner, served as adjuvants for the generation of Ag-specific CTL and for inducing protection against lethal challenge with influenza virus when given with influenza nucleoprotein as an immunogen. These results provide the basis for the development of TLR3-specific adjuvants capable of inducing immune responses tailored for viral pathogens. The Journal of Immunology, 2011, 186: 2422-2429.
C1 [Jelinek, Ivett; Leonard, Joshua N.; Brown, Kevin N.; Meyer-Manlapat, Anna; Wang, Yan; Segal, David M.] NCI, Expt Immunol Branch, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Price, Graeme E.; Epstein, Suzanne L.] US FDA, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Goldsmith, Paul K.] NCI, Antibody & Prot Purificat Unit, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Venzon, David] NCI, Biostat & Data Management Sect, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
RP Segal, DM (reprint author), NCI, Expt Immunol Branch, Ctr Canc Res, NIH, Bldg 10,Room 4B36,10 Ctr Dr, Bethesda, MD 20892 USA.
EM dave_segal@nih.gov
RI Leonard, Joshua/B-7649-2009
FU National Cancer Institute; National Institute of Allergy and Infectious
Diseases
FX This work was supported by the Intramural Research Program of the
National Cancer Institute and by a National Institutes of Health/Food
and Drug Administration Intramural Biodefense Award from the National
Institute of Allergy and Infectious Diseases.
NR 64
TC 81
Z9 83
U1 0
U2 4
PU AMER ASSOC IMMUNOLOGISTS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-1767
J9 J IMMUNOL
JI J. Immunol.
PD FEB 15
PY 2011
VL 186
IS 4
BP 2422
EP 2429
DI 10.4049/jimmunol.1002845
PG 8
WC Immunology
SC Immunology
GA 715KF
UT WOS:000286882700062
PM 21242525
ER
PT J
AU Kanswal, S
Katsenelson, N
Allman, W
Uslu, K
Blake, MS
Akkoyunlu, M
AF Kanswal, Sunita
Katsenelson, Nora
Allman, Windy
Uslu, Kadriye
Blake, Milan S.
Akkoyunlu, Mustafa
TI Suppressive Effect of Bacterial Polysaccharides on BAFF System Is
Responsible for Their Poor Immunogenicity
SO JOURNAL OF IMMUNOLOGY
LA English
DT Article
ID INDEPENDENT TYPE-2 ANTIGENS; PLASMA-CELL DIFFERENTIATION;
NECROSIS-FACTOR FAMILY; B-CELLS; IMMUNE-RESPONSE;
STREPTOCOCCUS-PNEUMONIAE; CAPSULAR POLYSACCHARIDE; ANTIBODY-RESPONSE;
CONJUGATE VACCINE; CPG OLIGODEOXYNUCLEOTIDES
AB Capsular polysaccharides of encapsulated bacteria are weakly immunogenic T cell-independent type 2 (TI-2) Ags. Recent findings suggest that BAFF system molecules have a critical role in the development of Ab responses against TI-2 Ags. In this study, we investigated the effect of bacterial polysaccharides on B cell responses to BAFF and a proliferation-inducing ligand (APRIL). We determined that B cells exposed to meningococcal type C polysaccharide (MCPS) or group B Streptococcus serotype V (GBS-V) were unresponsive to BAFF- and APRIL-induced Ig secretion. Moreover, MCPS and GBS-V strongly downregulated transmembrane activator and calcium-modulator and cyclophilin ligand interactor, the BAFF and APRIL receptor that is responsible for Ab development against TI-2 Ags. Interestingly, (4-hydroxy-3-nitrophenyl) acetyl-Ficoll (NP-Ficoll), a prototype TI-2 Ag, did not manifest a suppressive effect on B cells. Paradoxically, whereas GBS-V and MCPS inhibited IFN-gamma-induced BAFF production from dendritic cells, NP-Ficoll strongly increased BAFF secretion. TLR 9 agonist CpG deoxyoligonucleotide (ODN) was able to reverse the MCPS-mediated transmembrane activator and calcium-modulator and cyclophilin ligand interactor suppression but could not rescue the Ig secretion in BAFF- or APRIL-stimulated B cells. In support of these in vitro observations, it was observed that CpG ODN could help augment the Ab response against NP in mice immunized with a CpG ODN-containing NP-Ficoll vaccine but exhibited only marginal adjuvant activity for MCPS vaccine. Collectively, these results suggest a mechanism for the weak immunogenicity of bacterial polysaccharides and explain the previously observed differences between bacterial polysaccharide and NP-Ficoll immunogenicity. The Journal of Immunology, 2011, 186: 2430-2443.
C1 [Kanswal, Sunita; Katsenelson, Nora; Allman, Windy; Uslu, Kadriye; Blake, Milan S.; Akkoyunlu, Mustafa] US FDA, Lab Bacterial Polysaccharides, Div Bacterial Parasit & Allergen Prod, CBER, Rockville, MD 20852 USA.
RP Akkoyunlu, M (reprint author), US FDA, Lab Bacterial Polysaccharides, Div Bacterial Parasit & Allergen Prod, CBER, 29 Lincoln Dr,HFM 428,Bldg 29,Room 516-B, Rockville, MD 20852 USA.
EM Mustafa.Akkoyunlu@fda.hhs.gov
RI Akkoyunlu, Mustafa/I-5712-2012
NR 56
TC 19
Z9 19
U1 1
U2 3
PU AMER ASSOC IMMUNOLOGISTS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-1767
J9 J IMMUNOL
JI J. Immunol.
PD FEB 15
PY 2011
VL 186
IS 4
BP 2430
EP 2443
DI 10.4049/jimmunol.1002976
PG 14
WC Immunology
SC Immunology
GA 715KF
UT WOS:000286882700063
PM 21248261
ER
PT J
AU Slager, SL
Rabe, KG
Achenbach, SJ
Vachon, CM
Goldin, LR
Strom, SS
Lanasa, MC
Spector, LG
Rassenti, LZ
Leis, JF
Camp, NJ
Glenn, M
Kay, NE
Cunningham, JM
Hanson, CA
Marti, GE
Weinberg, JB
Morrison, VA
Link, BK
Call, TG
Caporaso, NE
Cerhan, JR
AF Slager, Susan L.
Rabe, Kari G.
Achenbach, Sara J.
Vachon, Celine M.
Goldin, Lynn R.
Strom, Sara S.
Lanasa, Mark C.
Spector, Logan G.
Rassenti, Laura Z.
Leis, Jose F.
Camp, Nicola J.
Glenn, Martha
Kay, Neil E.
Cunningham, Julie M.
Hanson, Curtis A.
Marti, Gerald E.
Weinberg, J. Brice
Morrison, Vicki A.
Link, Brian K.
Call, Timothy G.
Caporaso, Neil E.
Cerhan, James R.
TI Genome-wide association study identifies a novel susceptibility locus at
6p21.3 among familial CLL
SO BLOOD
LA English
DT Article
ID CHRONIC LYMPHOCYTIC-LEUKEMIA; NON-HODGKIN-LYMPHOMA; FOLLICULAR LYMPHOMA;
RISK; VARIANTS; GENES
AB Prior genome-wide association (GWA) studies have identified 10 susceptibility loci for risk of chronic lymphocytic leukemia (CLL). To identify additional loci, we performed a GWA study in 407 CLL cases (of which 102 had a family history of CLL) and 296 controls. Moreover, given the strong familial risk of CLL, we further subset our GWA analysis to the CLL cases with a family history of CLL to identify loci specific to these familial CLL cases. Our top hits from these analyses were evaluated in an additional sample of 252 familial CLL cases and 965 controls. Using all available data, we identified and confirmed an independent association of 4 single-nucleotide polymorphisms (SNPs) that met genome-wide statistical significance within the IRF8 (interferon regulatory factor 8) gene (combined P values <= 3.37 x 10(-8)), located in the previously identified 16q24.1 locus. Subsetting to familial CLL cases, we identified and confirmed a new locus on chromosome 6p21.3 (combined P value = 6.92 x 10(-9)). This novel region harbors the HLA-DQA1 and HLA-DRB5 genes. Finally, we evaluated the 10 previously reported SNPs in the overall sample and replicated 8 of them. Our findings support the hypothesis that familial CLL cases have additional genetic variants not seen in sporadic CLL. Additional loci among familial CLL cases may be identified through larger studies. (Blood. 2011;117(6):1911-1916)
C1 [Slager, Susan L.; Rabe, Kari G.; Achenbach, Sara J.; Vachon, Celine M.; Leis, Jose F.; Kay, Neil E.; Cunningham, Julie M.; Hanson, Curtis A.; Call, Timothy G.; Cerhan, James R.] Mayo Clin, Coll Med, Rochester, MN 55905 USA.
[Goldin, Lynn R.; Caporaso, Neil E.] NCI, Div Canc Epidemiol & Genet, Bethesda, MD 20892 USA.
[Strom, Sara S.] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA.
[Lanasa, Mark C.; Weinberg, J. Brice] Duke Univ, Med Ctr, Durham, NC USA.
[Spector, Logan G.; Morrison, Vicki A.] Univ Minnesota, Minneapolis, MN USA.
[Rassenti, Laura Z.] Univ Calif San Diego, Med Ctr, Moores Canc Ctr, La Jolla, CA 92093 USA.
[Camp, Nicola J.; Glenn, Martha] Univ Utah, Sch Med, Salt Lake City, UT USA.
[Marti, Gerald E.] US FDA, Bethesda, MD 20014 USA.
[Weinberg, J. Brice] Durham Vet Adm Med Ctr, Durham, NC USA.
[Morrison, Vicki A.] Minneapolis Vet Adm Med Ctr, Minneapolis, MN USA.
[Link, Brian K.] Univ Iowa, Iowa City, IA USA.
RP Slager, SL (reprint author), Mayo Clin, Coll Med, 200 1st St SW, Rochester, MN 55905 USA.
EM slager@mayo.edu
OI Cerhan, James/0000-0002-7482-178X; Spector, Logan/0000-0003-2516-0222
FU National Institutes of Health (NIH) [CA118444, CA92153]; NIH, NCI;
Veterans Affairs Research Service; Chronic Lymphocytic Leukemia Research
Consortium; National Center for Research Resources; NIH Roadmap for
Medical Research [1 UL1 RR024150]; NCI [CA15083, N01-PC-35 141];
University of Utah Huntsman Cancer Institute; Utah State Department of
Health; University of Utah; Leukemia & Lymphoma Society; Bernstein
Family Fund for Leukemia and Lymphoma Research
FX This work was supported by National Institutes of Health (NIH) grants
CA118444 and CA92153; the Intramural Research Program of the NIH, NCI;
the Veterans Affairs Research Service, and the Chronic Lymphocytic
Leukemia Research Consortium. Additional support was provided by the
National Center for Research Resources, a component of NIH and the NIH
Roadmap for Medical Research (1 UL1 RR024150) and by the NCI (CA15083).
Data collection in Utah was made possible by the Utah Population
Database and the Utah Registry. Partial support for all data in the Utah
Population Database was provided by the University of Utah Huntsman
Cancer Institute. The Utah Cancer Registry is funded by contract
N01-PC-35 141 from the NCI Surveillance Epidemiology and End Results
program with additional support from the Utah State Department of Health
and the University of Utah. Sample collection at Duke University was
supported by a Leukemia & Lymphoma Society Career Development Award (to
M.C.L.) and by the Bernstein Family Fund for Leukemia and Lymphoma
Research.
NR 17
TC 61
Z9 64
U1 0
U2 6
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD FEB 10
PY 2011
VL 117
IS 6
BP 1911
EP 1916
DI 10.1182/blood-2010-09-308205
PG 6
WC Hematology
SC Hematology
GA 719HA
UT WOS:000287192300026
PM 21131588
ER
PT J
AU Behrman, RE
Benner, JS
Brown, JS
McClellan, M
Woodcock, J
Platt, R
AF Behrman, Rachel E.
Benner, Joshua S.
Brown, Jeffrey S.
McClellan, Mark
Woodcock, Janet
Platt, Richard
TI Developing the Sentinel System - A National Resource for Evidence
Development
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Editorial Material
ID SAFETY
C1 [Behrman, Rachel E.; Woodcock, Janet] US FDA, Silver Spring, MD USA.
[Benner, Joshua S.; McClellan, Mark] Brookings Inst, Engelberg Ctr Hlth Care Reform, Washington, DC 20036 USA.
[Brown, Jeffrey S.; Platt, Richard] Harvard Pilgrim Hlth Care Inst, Dept Populat Med, Boston, MA USA.
[Brown, Jeffrey S.; Platt, Richard] Harvard Univ, Sch Med, Boston, MA USA.
RP Behrman, RE (reprint author), US FDA, Silver Spring, MD USA.
NR 5
TC 138
Z9 140
U1 1
U2 3
PU MASSACHUSETTS MEDICAL SOC
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD FEB 10
PY 2011
VL 364
IS 6
BP 498
EP 499
DI 10.1056/NEJMp1014427
PG 2
WC Medicine, General & Internal
SC General & Internal Medicine
GA 718QH
UT WOS:000287139900003
PM 21226658
ER
PT J
AU Yakes, BJ
Deeds, J
White, K
DeGrasse, SL
AF Yakes, Betsy Jean
Deeds, Jonathan
White, Kevin
DeGrasse, Stacey L.
TI Evaluation of Surface Plasmon Resonance Biosensors for Detection of
Tetrodotoxin in Food Matrices and Comparison to Analytical Methods
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE Tetrodotoxin; surface plasmon resonance; Immunoassay; food matrices
ID SELF-ASSEMBLED MONOLAYERS; RECEPTOR-BINDING ASSAY; PARALYTIC SHELLFISH;
TAKIFUGU-OBLONGUS; SPR SENSOR; TOXINS; MILK; IMMUNOSENSOR; SAXITOXIN;
MARINE
AB Tetrodotoxin (TTX) is a low molecular weight neurotoxin found in a number of animal species, including pufferfish. One emerging method for TTX detection employs surface plasmon resonance (SPR) immunosensors. SPR, an optical technique that allows for label-free, real-time, multiplexed analysis, can have detection limits that rival many of the conventional transduction methods. Preliminary SPR approaches for TTX were successful, yet suffered from low throughput and used noncommercial instrumentation. To advance this method for broader use, the immunoassay was transferred to a commercial instrument and optimized for improved detection. This manuscript outlines the assay development and results for complex matrices relevant to seafood safety (pufferfish) and food adulteration (milk, apple juice). In addition, results are compared to those obtained using receptor binding assay, ELISA, HPLC-FD, and LC/MS/MS detection techniques. Results highlight the advantages of SPR assays, including rapid screening capability with low reagent consumption and low- to subppb detection limits.
C1 [Yakes, Betsy Jean; Deeds, Jonathan; White, Kevin; DeGrasse, Stacey L.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Yakes, BJ (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM betsy.yakes@fda.hhs.gov
RI Yakes, Betsy/K-2646-2012;
OI DeGrasse, Stacey/0000-0001-7808-4193
FU CFSAN; U.S. Department of Energy; U.S. Food and Drug Administration
FX B.J.Y. was supported during the initial part of this project in part by
an appointment with the Research Participation Program at CFSAN
administered by the Oak Ridge Institute for Science and Education
operated under an interagency agreement between the U.S. Department of
Energy and the U.S. Food and Drug Administration.
NR 42
TC 16
Z9 16
U1 3
U2 47
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD FEB 9
PY 2011
VL 59
IS 3
BP 839
EP 846
DI 10.1021/jf103779k
PG 8
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 712ZR
UT WOS:000286705300009
PM 21192708
ER
PT J
AU Hellberg, RSR
Naaum, AM
Handy, SM
Hanner, RH
Deeds, JR
Yancy, HF
Morrissey, MT
AF Hellberg, Rosalee S. Rasmussen
Naaum, Amanda M.
Handy, Sara M.
Hanner, Robert H.
Deeds, Jonathan R.
Yancy, Haile F.
Morrissey, Michael T.
TI Interlaboratory Evaluation of a Real-Time Multiplex Polymerase Chain
Reaction Method for Identification of Salmon and Trout Species in
Commercial Products
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE Real-time PCR; interlaboratory study; salmon; trout; species
identification; multiplex PCR
ID HADDOCK MELANOGRAMMUS-AEGLEFINUS; DNA BARCODES; FISH; PCR; PROBES;
QUANTIFICATION; SEAFOOD
AB This interlaboratory study evaluated a real-time multiplex polymerase chain reaction (PCR) method for identification of salmon and trout species in a range of commercial products in North America. Eighty salmon and trout products were tested with this method by three independent laboratories. Samples were collected in the United States and Canada, and only the collecting institution was aware of the species declaration. Following analysis with real-time PCR, all three laboratories were able to identify species in 79 of the 80 products, with 100% agreement on species assignment. A low level of fraud was detected, with only four products (5%) found to be substituted or mixtures of two species. The results for two of the fraudulent products were confirmed with alternate methods, but the other two products were heavily processed and could not be verified with methods other than real-time PCR. Overall, the results of this study show the usefulness and versatility of this real-time PCR method for the identification of commercial salmon and trout species.
C1 [Hellberg, Rosalee S. Rasmussen; Morrissey, Michael T.] Oregon State Univ, Food Innovat Ctr, Portland, OR 97211 USA.
[Naaum, Amanda M.; Hanner, Robert H.] Univ Guelph, Dept Integrat Biol, Guelph, ON N1G 2W1, Canada.
[Handy, Sara M.; Deeds, Jonathan R.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Yancy, Haile F.] US FDA, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
RP Hellberg, RSR (reprint author), Oregon State Univ, Food Innovat Ctr, 1207 NW Naito Pkwy, Portland, OR 97211 USA.
EM rosalee.hellberg@gmail.com
RI Handy, Sara/C-6195-2008
FU Oregon Innovation Council; Advanced Foods and Materials Network (AFMNet)
FX This project was funded by the Oregon Innovation Council. We also
acknowledge support for A.M.N. and R.H.H. from the Advanced Foods and
Materials Network (AFMNet).
NR 35
TC 7
Z9 7
U1 3
U2 14
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD FEB 9
PY 2011
VL 59
IS 3
BP 876
EP 884
DI 10.1021/jf103241y
PG 9
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 712ZR
UT WOS:000286705300014
ER
PT J
AU Gregori, L
AF Gregori, Luisa
TI A prototype assay to detect vCJD-infected blood
SO LANCET
LA English
DT Editorial Material
ID CREUTZFELDT-JAKOB-DISEASE; INFECTIVITY
C1 US FDA, Rockville, MD 20852 USA.
RP Gregori, L (reprint author), US FDA, Rockville, MD 20852 USA.
EM luisa.gregori@fda.hhs.gov
NR 11
TC 8
Z9 8
U1 0
U2 1
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0140-6736
J9 LANCET
JI Lancet
PD FEB 5
PY 2011
VL 377
IS 9764
BP 444
EP 446
DI 10.1016/S0140-6736(11)60057-3
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 721TX
UT WOS:000287381800006
PM 21295340
ER
PT J
AU Chakrabarty, S
Snyder, JT
Shen, JJ
Azmi, H
Hu, PQ
Chen, QA
Ragheb, JA
AF Chakrabarty, Sagarika
Snyder, James T.
Shen, Jijia
Azmi, Hooman
Hu, Paul Q.
Chen, Qian
Ragheb, Jack A.
TI Human CD14(hi) monocytes and myeloid dendritic cells provide a cell
contact-dependent costimulatory signal for early CD40 ligand expression
SO BLOOD
LA English
DT Article
ID ACTIVATED T-CELLS; GERMINAL CENTER FORMATION; IL-2 MESSENGER-RNA;
RESTING B-CELLS; CD40-CD40 LIGAND; ANTIGEN PRESENTATION; HUMORAL
IMMUNITY; CD154 EXPRESSION; GAMMA PRODUCTION; IGM SYNDROME
AB CD40L on CD4(+) T cells plays a vital role in the activation of antigen-presenting cells, thus catalyzing a positive feedback loop for T-cell activation. Despite the pivotal juxtaposition of CD40L between antigen-presenting cells and T-cell activation, only a T-cell receptor stimulus is thought to be required for early CD40L surface expression. We show, for the first time, that CD40L expression on peripheral blood CD4(+) T cells is highly dependent on a cell-cell interaction with CD14(hi)CD16(-) monocytes. Interactions with ICAM-1, LFA-3, and to a lesser extent CD80/CD86 contribute to this enhancement of CD40L expression but are not themselves sufficient. The contact-mediated increase in CD40L expression is dependent on new mRNA and protein synthesis. Circulating myeloid dendritic cells also possess this costimulatory activity. By contrast, CD14(lo)CD16(+) monocytes, plasmacytoid dendritic cells, B-cell lymphoma lines, and resting, activated, and Epstein-Barr virus-immortalized primary B cells all lack the capacity to up-regulate early CD40L. The latter indicates that a human B cell cannot activate its cognate T cell to deliver CD40L-mediated help. This finding has functional implications for the role of biphasic CD40L expression, suggesting that the early phase is associated with antigen-presenting cell activation, whereas the late phase is related to B-cell activation. (Blood. 2011; 117(5): 1585-1594)
C1 [Chakrabarty, Sagarika; Snyder, James T.; Shen, Jijia; Azmi, Hooman; Hu, Paul Q.; Chen, Qian; Ragheb, Jack A.] NEI, Immunol Lab, NIH, Bethesda, MD 20892 USA.
[Ragheb, Jack A.] US FDA, Immunol Lab, Div Therapeut Prot, Off Biol Prod,Ctr Drug Evaluat & Res,Dept Hlth &, Bethesda, MD 20014 USA.
RP Ragheb, JA (reprint author), 29 Lincoln Dr,Bldg 29B,Rm 4G13,HFD 122, Bethesda, MD 20892 USA.
EM jr50b@nih.gov
FU Department of Health and Human Services
FX This work was supported by the Department of Health and Human Services
(intramural funding).
NR 68
TC 3
Z9 3
U1 0
U2 1
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD FEB 3
PY 2011
VL 117
IS 5
BP 1585
EP 1594
DI 10.1182/blood-2008-01-130252
PG 10
WC Hematology
SC Hematology
GA 715WV
UT WOS:000286925500025
PM 20634374
ER
PT J
AU Gamalo, MA
Tiwari, RC
AF Gamalo, Mark A.
Tiwari, Ram C.
TI Testing Noninferiority Through Generalized p-values
SO STATISTICS IN BIOPHARMACEUTICAL RESEARCH
LA English
DT Article
DE Generalized test function; Noninferiority; Sample size; Type I error
ID NON-INFERIORITY TRIALS; BEHRENS-FISHER PROBLEM; ACTIVE-CONTROL TRIALS;
VARIANCE-COMPONENTS; CONFIDENCE-INTERVALS; STATISTICAL-METHODS; PLACEBO;
ISSUES; CHOICE; DESIGN
AB Testing for noninferiority of a new experimental drug compared to a standard reference drug has generally been carried out through statistical tests assuming equal variances. In this article, we present a generalized p-value approach for assessing noninferiority that gives exact tail probabilities when variances are not equal between treatments. Two generalized test functions are constructed corresponding to the fixed-margin and synthesis approaches of retaining a fraction of the reference treatment's effect relative to placebo in historical trials. Monte Carlo simulations are used to compute the p-value. Performance of these test functions are evaluated and results indicate that the generalized test function for the fixed-margin retention performs well in terms of maintaining the Type I error probabilities. Its power also increases and approaches 1 as both the sample size and the parameter denoting the fraction of the effect of the reference drug with respect to placebo increase. Furthermore, confidence intervals (CI's) can be easily constructed using duality between CI's and accepting or rejecting noninferiority.
C1 [Gamalo, Mark A.; Tiwari, Ram C.] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Gamalo, MA (reprint author), US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM mark.gamalo@fda.hhs.gov
NR 31
TC 1
Z9 1
U1 1
U2 4
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 2011
VL 3
IS 1
BP 87
EP 96
DI 10.1198/sbr.2010.09028
PG 10
WC Mathematical & Computational Biology; Statistics & Probability
SC Mathematical & Computational Biology; Mathematics
GA 791HS
UT WOS:000292656400008
ER
PT J
AU Naum, M
Brown, EW
Mason-Gamer, RJ
AF Naum, Marianna
Brown, Eric W.
Mason-Gamer, Roberta J.
TI Is a robust phylogeny of the enterobacterial plant pathogens attainable?
SO CLADISTICS
LA English
DT Letter
ID HORIZONTAL GENE-TRANSFER; 16S RIBOSOMAL-RNA; MOLECULAR PHYLOGENY;
ESCHERICHIA-COLI; ENTERIC BACTERIA; COMB-NOV; ERWINIA; EVOLUTION;
SEQUENCES; SALMONELLA
AB Sequences from gapA, gyrA and ompA were used to evaluate the relationships of the enterobacterial plant pathogens, and assess whether a robust phylogeny can be ascertained using this group of housekeeping genes. Up to 48 taxa were included in a combined phylogenetic analysis to explore the evolutionary distribution of plant pathogenic species across the family Enterobacteriaceae. Phylogenies were reconstructed from gapA, gyrA and ompA gene sequences using maximum parsimony and maximum likelihood algorithms, and phylogenetic congruence was evaluated by the incongruence length difference test and the partition addition bootstrap alteration approach. The resulting gene trees were found to be incongruent, with gapA supporting a monophyletic origin for the plant pathogenic species. In contrast, gyrA and ompA supported multiple polyphyletic origins of Erwinia, Brenneria, Pectobacterium and Pantoea in conjunction with a previously published 16S rDNA phylogeny. However, none of the trees (not even the published 16S rDNA gene tree) supports the current taxonomic classification of these genera into four clades, with Pantoea forming the only monophyletic group in the gapA, gyrA and 16S rDNA trees. Finally, the gapA, gyrA and previously published 16S rDNA phylogenies differ in the taxonomic placement of several bacterial strains which are separated in the three trees. The observed incongruence among the four gene histories is likely to be the result of horizontal transfer events, confounding the search for a robust set of housekeeping genes with a shared evolutionary history that could be used to confidently characterize the relationships of the plant pathogenic enterobacteria. (C) The Willi Hennig Society 2010.
C1 [Naum, Marianna; Mason-Gamer, Roberta J.] Univ Illinois, Dept Biol Sci, Chicago, IL 60611 USA.
[Naum, Marianna; Brown, Eric W.] US FDA, Div Microbiol, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Naum, M (reprint author), Univ Illinois, Dept Biol Sci, Chicago, IL 60611 USA.
EM marianna.naum@fda.hhs.gov
NR 55
TC 6
Z9 6
U1 0
U2 11
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0748-3007
J9 CLADISTICS
JI Cladistics
PD FEB
PY 2011
VL 27
IS 1
BP 80
EP 93
DI 10.1111/j.1096-0031.2010.00313.x
PG 14
WC Evolutionary Biology
SC Evolutionary Biology
GA 702DQ
UT WOS:000285875200010
ER
PT J
AU Philip, R
Carrington, L
Chan, M
AF Philip, Reena
Carrington, Lea
Chan, Maria
TI US FDA perspective on challenges in co-developing in vitro companion
diagnostics and targeted cancer therapeutics
SO BIOANALYSIS
LA English
DT Article
AB Recent advances in cancer therapy are based on agents that specifically target the products of the genes mutated in cancer cells. Development of companion diagnostic tests for these agents can simplify the drug-discovery process, make clinical trials more efficient and informative, and be used to individualize the therapy of cancer patients. Companion diagnostic development has Many challenges. Examples include the reluctance of drug companies to restrict the uses of their drugs through biomarker tests, difficulties of developing companion diagnostics from discovery to clinical validation and the regulatory challenges in developing effective mechanisms to synchronize reviews of therapeutics with diagnostic devices used to personalize treatment. This article addresses the various challenges in developing companion diagnostics along with the US FDA's approach to regulation of companion diagnostic devices.
C1 [Philip, Reena; Carrington, Lea; Chan, Maria] US FDA, Div Immunol & Hematol Devices, Off In Vitro Diagnost Device Evaluat, Silver Spring, MD 20993 USA.
[Philip, Reena; Carrington, Lea; Chan, Maria] US FDA, Safety Ctr Device & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Philip, R (reprint author), US FDA, Div Immunol & Hematol Devices, Off In Vitro Diagnost Device Evaluat, 10903 New Hampshire Ave,WO66,Room 5528, Silver Spring, MD 20993 USA.
EM reena.philip@fda.hhs.gov
NR 16
TC 19
Z9 19
U1 1
U2 6
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
J9 BIOANALYSIS
JI Bioanalysis
PD FEB
PY 2011
VL 3
IS 4
BP 383
EP 389
DI 10.4155/BIO.11.1
PG 7
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 745RF
UT WOS:000289182600009
PM 21338257
ER
PT J
AU Weaver, EV
McDowell, E
Fisher, B
Latimer, KS
Suttie, AW
AF Weaver, E., V
McDowell, E.
Fisher, B.
Latimer, K. S.
Suttie, A. W.
TI Comparison of Toxicology Parameters in Pregnant and Nonpregnant Rats
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE reproductive toxicology; clinical and anatomic pathology in pregnant
rats; changes in rodent pregnancy
C1 [Weaver, E., V; McDowell, E.; Latimer, K. S.; Suttie, A. W.] Covance Labs, Vienna, VA USA.
[Fisher, B.] US FDA, Div Biol, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, White Oak, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 100
EP 100
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200032
ER
PT J
AU Cotton, LM
Burgess, S
Crenshaw, S
Stitcher, B
Fisher, BR
AF Cotton, L. M.
Burgess, S.
Crenshaw, S.
Stitcher, B.
Fisher, B. R.
TI THE Effects of Ifosfamide and Cypermethrin on the Male Reproductive
Systems of New Zealand White (NZW) and Dutch Belted (DB) Rabbits
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE male reproductive system; sperm analysis; New Zealand White and Dutch
belted rabbits
C1 [Cotton, L. M.; Burgess, S.; Stitcher, B.] Covance Labs, Vienna, VA USA.
[Crenshaw, S.] Tauri Grp, Alexandria, VA USA.
[Fisher, B. R.] US FDA, Div Biol, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, White Oak, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 101
EP 101
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200035
ER
PT J
AU McKeon, M
Fisher, B
Latimer, K
Suttie, A
Makle, B
Williams, C
AF McKeon, M.
Fisher, B.
Latimer, K.
Suttie, A.
Makle, B.
Williams, C.
TI The Effects of Continuous Infusion Rates on Pre- and Postnatal
Development, Including Maternal Function in Rats
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE developmental and reproductive toxicology; continuous infusion;
time-mated rats
C1 [McKeon, M.; Fisher, B.; Latimer, K.; Suttie, A.; Makle, B.; Williams, C.] Covance Labs, Vienna, VA USA.
[McKeon, M.; Fisher, B.; Latimer, K.; Suttie, A.; Makle, B.; Williams, C.] US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Biol, White Oak, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 111
EP 111
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200060
ER
PT J
AU Ghantous, H
AF Ghantous, Hanan
TI Symp Ic Introduction to Division of Anti-Viral Products
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE FDA; regulatory; pharmacology/toxicology
C1 [Ghantous, Hanan] US FDA, CDER, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 115
EP 115
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200073
ER
PT J
AU O'Shaughnessy, J
AF O'Shaughnessy, Jacqueline
TI Symp Ia Division of Scientific Investigations (DSI): Inspections of
Nonclinical Testing Facilities
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [O'Shaughnessy, Jacqueline] US FDA, CDER, Off Compliance, Div Sci Investigat, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 115
EP 115
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200071
ER
PT J
AU Wasserman, A
AF Wasserman, Adam
TI Symp Ib Introduction to Division of Anesthetic and Analgesia Products
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Wasserman, Adam] US FDA, CDER, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 115
EP 115
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200072
ER
PT J
AU Jensen, DN
AF Jensen, Donald Nick
TI Symp Id Introduction to Division of Cardiovascular and Renal Products
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE FDA; regulatory; pharmacology/toxicology
C1 [Jensen, Donald Nick] US FDA, CDER, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 116
EP 116
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200074
ER
PT J
AU Wasserman, A
AF Wasserman, Adam
TI Symp Ie Overview of Pharmacology/Toxicology at the Office of New Drugs
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Wasserman, Adam] US FDA, CDER, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 116
EP 116
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200075
ER
PT J
AU Powell, AM
AF Powell, Andrea M.
TI Symp IIIa An Introduction to the "Animal Rule"-Approval of New Drug and
Biological Products When Human Efficacy Studies are Not Ethical or
Feasible
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE animal rule; medical countermeasure; animal efficacy studies
C1 [Powell, Andrea M.] US FDA, Off Counter Terrorism & Emergency Coordinat, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 117
EP 117
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200079
ER
PT J
AU Beren, JJ
AF Beren, Joel J.
TI Symp IVd A Clinical Veterinary Perspective on How to Prepare for Your
NHP Study and Get a Good Nights Sleep as a Study Director
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Beren, Joel J.] FDA CBER DVS, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 1
U2 1
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 120
EP 120
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200087
ER
PT J
AU DeFelice, A
AF DeFelice, Albert
TI Symp VId Use of Ultrasound in Preclinical Hemodynamic and Safety
Assessment of Investigational Drugs
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [DeFelice, Albert] US FDA, Off Drug Evaluat 1, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 122
EP 122
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200097
ER
PT J
AU Harrouk, WA
AF Harrouk, Wafa A.
TI Symp Xd The Use of Minipigs in FDA-Regulated Products: Experiences From
the OND Division of Dermatology and Dental Products
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Harrouk, Wafa A.] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 127
EP 127
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200114
ER
PT J
AU Carrington, CD
Bolger, PM
AF Carrington, C. D.
Bolger, P. M.
TI Symp XIVb Elemental Contaminants and Dietary Exposure
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Carrington, C. D.; Bolger, P. M.] US FDA, Chem Hazards Assessment Staff, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 132
EP 132
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200130
ER
PT J
AU Mamata, D
AF Mamata, De
TI Symp XIVe Toxicity of Heavy and Trace Metals: Regulatory Perspectives
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Mamata, De] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 133
EP 133
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200133
ER
PT J
AU Bourcier, T
AF Bourcier, Todd
TI Symp XVIb Regulatory Preclinical Development of Dipeptidyl Peptidase 4
Inhibitors
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE type 2 diabetes; preclinical toxicology; dipeptidyl peptidase-4
inhibitors
C1 [Bourcier, Todd] US FDA, CDER, Div Metab & Endocrine Prod, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 134
EP 134
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200137
ER
PT J
AU El-Hage, J
Bourcier, T
Carlson, D
Hummer, B
Timerstein, M
AF El-Hage, Jeri
Bourcier, Todd
Carlson, David
Hummer, Brian
Timerstein, Mark
TI Symp XVIa Therapies for Type 2 Diabetes: Nonclinical Safety Assessments
and Risk Evaluation
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [El-Hage, Jeri] Aclairo Pharmaceut Dev Grp, Vienna, VA USA.
[Bourcier, Todd; Carlson, David; Hummer, Brian] US FDA, DMEP, Rockville, MD 20857 USA.
[Timerstein, Mark] Bristol Myers Squibb Co, New Brunswick, NJ USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 134
EP 134
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200136
ER
PT J
AU Hummer, BT
AF Hummer, B. Timothy
TI Symp XVIc GLP-1 Receptor Agonists: Extrapolating Nonclinical Data to
Human Risk
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE type 2 diabetes; glucagon like peptide-1 (GLP-1); thyroid c-cells
C1 [Hummer, B. Timothy] US FDA, CDER, Div Metab & Endocrine Prod, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 134
EP 135
PG 2
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200138
ER
PT J
AU Carlson, DB
AF Carlson, David B.
TI Symp XVId Preclinical Toxicology Of Glucokinase Activators - A Promising
New Therapeutic Class for Diabetes?
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
DE glucokinase activators; type 2 diabetes; animal models
C1 [Carlson, David B.] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 135
EP 135
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200139
ER
PT J
AU Ghantous, H
AF Ghantous, Hanan
TI Symp XVIIg A Behind the Scenes Look at FDA Guidances
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Ghantous, Hanan] US FDA, CDER, Div Antiviral Prod, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 136
EP 136
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200145
ER
PT J
AU Reid, L
AF Reid, Lynnda
TI Symp XVIIf FDA Update-Pregnancy and Lactation Labeling Rule
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Reid, Lynnda] US FDA, CDER, Div Reprod & Urol Prod, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 2
U2 2
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 136
EP 136
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200144
ER
PT J
AU Topper, M
AF Topper, Molly (Shea)
TI Symp XVIIc Perspective of an FDA Pharmacology/Toxicology Reviewer on
Change
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Meeting Abstract
CT 31st Annual Meeting of the American-College-of-Toxicology
CY NOV 07-10, 2010
CL Baltimore, MD
SP Amer Coll Toxicol
C1 [Topper, Molly (Shea)] US FDA, CDER, Div Pulm Allergy & Rheumatol Prod, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 1
U2 1
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 136
EP 136
PG 1
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200142
ER
PT J
AU Chen, KJ
Felten, R
Chen, L
Ogden, N
AF Chen, Kejing
Felten, Richard
Chen, Long
Ogden, Neil
TI REGULATORY PERSPECTIVE OF OPTICAL IMAGING DEVICES: TECHNOLOGY,
INDICATIONS, AND FUTURE CHALLENGES
SO LASERS IN SURGERY AND MEDICINE
LA English
DT Meeting Abstract
C1 [Chen, Kejing; Felten, Richard; Chen, Long; Ogden, Neil] US FDA, Off Device Evaluat, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0196-8092
J9 LASER SURG MED
JI Lasers Surg. Med.
PD FEB
PY 2011
VL 43
SU 23
MA 20
BP 913
EP 913
PG 1
WC Dermatology; Surgery
SC Dermatology; Surgery
GA 735EK
UT WOS:000288396000019
ER
PT J
AU Jiang, WL
Lionberger, R
Yu, LX
AF Jiang, Wenlei
Lionberger, Robert
Yu, Lawrence X.
TI In vitro and in vivo characterizations of PEGylated liposomal
doxorubicin
SO BIOANALYSIS
LA English
DT Review
ID ACCELERATED BLOOD CLEARANCE; DRUG-RELEASE; THERAPEUTIC ACTIVITY;
ANTITUMOR-ACTIVITY; INTERSTITIAL PH; CHAIN-LENGTH; SOLID TUMORS;
PHARMACOKINETICS; PLASMA; FORMULATIONS
AB One challenge in developing a nanoparticle drug-delivery system is understanding the critical physicochemical properties that may impact its in vivo performance and establishing analytical techniques that can adequately characterize in vitro and in vivo properties. Doxil (R) /Caelyx (R), a PEGylated liposornal doxorubincin (PLD), is one of the leading approved nanoparticle product used in cancer therapy. In this review, we use PLD as an example to illustrate identification of key in vitro and in vivo characteristics. The following characteristics, including liposome composition, state of encapsulated drug, internal environment of liposome, liposome size distribution, lamellarity, grafted polyethylene glycol at the liposome surface, electrical surface potential or charge, and in vitro leakage, are considered critical to demonstrate the supramolecular structure of PLD and ensure consistent drug delivery to cancer tissues. Corresponding analytical techniques are discussed to determine these liposome characteristics. Furthermore, in vivo stability of the PLD can be determined by plasma pharmacokinetics of both free and liposome-encapsulated drug. A better understanding of the critical in vitro and in vivo liposome characteristics together with improvements in analytical technology will enable generic liposome product development and ensure liposome product quality.
C1 [Jiang, Wenlei; Lionberger, Robert; Yu, Lawrence X.] US FDA, Off Gener Drugs, Rockville, MD 20855 USA.
RP Lionberger, R (reprint author), US FDA, Off Gener Drugs, 7519 Standish Pl, Rockville, MD 20855 USA.
EM robert.lionberger@fda.hhs.gov
NR 69
TC 38
Z9 40
U1 3
U2 64
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
J9 BIOANALYSIS
JI Bioanalysis
PD FEB
PY 2011
VL 3
IS 3
BP 333
EP 344
DI 10.4155/BIO.10.204
PG 12
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 730QT
UT WOS:000288049900016
PM 21320053
ER
PT J
AU Agarwal, S
Zhang, L
Huang, S
AF Agarwal, S.
Zhang, L.
Huang, S.
TI RELEVANCE AND VALUE OF IN VITRO P-GP INHIBITION DATA FOR NEW MOLECULAR
ENTITIES
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Agarwal, S.; Zhang, L.; Huang, S.] US FDA, Off Clin Pharmacol, Off Translat Sci, CDER, Silver Spring, MD USA.
NR 0
TC 1
Z9 1
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S40
EP S40
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100127
ER
PT J
AU Bai, JP
Lesko, LJ
Abernethy, DR
AF Bai, J. P.
Lesko, L. J.
Abernethy, D. R.
TI USE OF PHARMACOLOGY, BIOLOGY, AND DISEASE/GENE NETWORKS TO ADVANCE
MECHANISM FOR CLINICALLY OBSERVED ADVERSE EVENTS
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Bai, J. P.; Lesko, L. J.; Abernethy, D. R.] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S43
EP S43
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100136
ER
PT J
AU Chung, S
Hand, A
Vaidyanathan, J
Choe, S
Sahajwalla, C
AF Chung, S.
Hand, A.
Vaidyanathan, J.
Choe, S.
Sahajwalla, C.
TI RENAL FUNCTION CHANGE WITH AGING: CROSS-SECTIONAL VERSUS LONGITUDINAL
ANALYSIS.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Chung, S.; Hand, A.; Vaidyanathan, J.; Choe, S.; Sahajwalla, C.] FDA CDER OTS OCP, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 2
U2 3
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S34
EP S34
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100108
ER
PT J
AU Fan, Y
Agarwal, S
Zhang, L
Lesko, LJ
Huang, S
AF Fan, Y.
Agarwal, S.
Zhang, L.
Lesko, L. J.
Huang, S.
TI REVIEW OF TRANSPORTER-RELATED POST-MARKETING REQUIREMENT
(PMR)/POST-MARKETING COMMITMENT (PMC) STUDY REPORTS.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Fan, Y.; Agarwal, S.; Zhang, L.; Lesko, L. J.; Huang, S.] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S37
EP S37
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100117
ER
PT J
AU Gnjidic, D
Hilmer, SN
Le Couteur, DG
Abernethy, DR
AF Gnjidic, D.
Hilmer, S. N.
Le Couteur, D. G.
Abernethy, D. R.
TI DRUG BURDEN INDEX AND BEERS CRITERIA: IMPACT ON FUNCTION IN OLDER ADULTS
LIVING IN LOW-LEVEL CARE FACILITIES
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Gnjidic, D.; Hilmer, S. N.; Le Couteur, D. G.] Univ Sydney, Sydney, NSW 2006, Australia.
[Gnjidic, D.; Hilmer, S. N.] Royal N Shore Hosp, Sydney, NSW, Australia.
[Le Couteur, D. G.] Concord Hosp, Sydney, NSW, Australia.
[Abernethy, D. R.] US FDA, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 3
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S14
EP S14
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100043
ER
PT J
AU Kawai, VK
Grijalva, C
Arbogast, P
Curtis, JR
Solomon, DH
Delzell, E
Ouellet-Hellstrom, R
Herrinton, L
Mitchell, E
Chen, L
Liu, L
Stein, CM
Griffin, MR
AF Kawai, V. K.
Grijalva, C.
Arbogast, P.
Curtis, J. R.
Solomon, D. H.
Delzell, E.
Ouellet-Hellstrom, R.
Herrinton, L.
Mitchell, E.
Chen, L.
Liu, L.
Stein, C. M.
Griffin, M. R.
TI NARCOTIC USE DOES NOT DECREASE AFTER INITIATION OF DMARD THERAPY IN
PATIENTS WITH RHEUMATOID ARTHRITIS
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Kawai, V. K.; Grijalva, C.; Arbogast, P.; Mitchell, E.; Stein, C. M.; Griffin, M. R.] Vanderbilt Univ, Sch Med, Nashville, TN 37212 USA.
[Curtis, J. R.; Delzell, E.; Chen, L.] Univ Alabama, Div Clin Immunol & Rheumatol, Birmingham, AL 35294 USA.
[Solomon, D. H.] Brigham & Womens Hosp, Boston, MA 02115 USA.
[Ouellet-Hellstrom, R.] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Herrinton, L.; Liu, L.] Kaiser Permanente No Calif, Div Res, Oakland, CA USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S13
EP S13
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100040
ER
PT J
AU Morrissey, KM
Wen, C
Huang, S
Zhang, L
Giacomini, KM
AF Morrissey, K. M.
Wen, C.
Huang, S.
Zhang, L.
Giacomini, K. M.
TI DEVELOPMENT OF A PUBLIC DRUG TRANSPORTER DATABASE
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Morrissey, K. M.; Wen, C.; Giacomini, K. M.] Univ Calif San Francisco, Dept Bioengn & Therapeut Sci, San Francisco, CA 94143 USA.
[Huang, S.; Zhang, L.] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S40
EP S40
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100126
ER
PT J
AU Naraharisetti, SB
Nallani, SC
Pacanowski, MA
Doddapaneni, S
AF Naraharisetti, S. B.
Nallani, S. C.
Pacanowski, M. A.
Doddapaneni, S.
TI ARE SINGLE NUCLEOTIDE POLYMORPHISMS OF CYP2C9 A RISK FACTOR FOR
NSAID-ASSOCIATED ADVERSE EVENTS?
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Naraharisetti, S. B.; Nallani, S. C.; Doddapaneni, S.] US FDA, Div Clin Pharmacol 2, Off Clin Pharmacol, Silver Spring, MD USA.
[Pacanowski, M. A.] US FDA, Genom Grp, Off Clin Pharmacol, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S74
EP S74
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100237
ER
PT J
AU Park, EJ
Ko, CW
Crentsil, V
Zhang, J
Zhang, L
Huang, SM
Xiao, S
Mehrotra, N
Alabi, E
Stockbridge, N
Xu, NN
AF Park, E. J.
Ko, C. W.
Crentsil, V.
Zhang, J.
Zhang, L.
Huang, S. M.
Xiao, S.
Mehrotra, N.
Alabi, E.
Stockbridge, N.
Xu, N. N.
TI A COMPARISION OF CG AND MDRD EQUATIONS FOR DOSAGE ADJUSTMENT IN RENAL
IMPAIRMENT
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Park, E. J.; Ko, C. W.; Crentsil, V.; Zhang, J.; Zhang, L.; Huang, S. M.; Xiao, S.; Mehrotra, N.; Alabi, E.; Stockbridge, N.; Xu, N. N.] US FDA, CDER, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S40
EP S40
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100128
ER
PT J
AU Park, EJ
Pai, MP
Zhang, J
Dong, T
Ko, CW
Crentsil, V
Stockbridge, NL
Xu, NN
AF Park, E. J.
Pai, M. P.
Zhang, J.
Dong, T.
Ko, C. W.
Crentsil, V.
Stockbridge, N. L.
Xu, N. N.
TI ESTIMATION OF CREATININE CLEARANCE (ECLCR) ACROSS ALL WEIGHT STRATA.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Park, E. J.; Zhang, J.; Dong, T.; Ko, C. W.; Crentsil, V.; Stockbridge, N. L.; Xu, N. N.] FDA CDER, Silver Spring, MD USA.
[Pai, M. P.] Albany Coll Pharm, Albany, NY USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S32
EP S33
PG 2
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100103
ER
PT J
AU Tompkins, LM
Zhao, P
Zhang, L
Huang, S
AF Tompkins, L. M.
Zhao, P.
Zhang, L.
Huang, S.
TI DIFFERENTIAL EFFECTS OF HEPATIC INSUFFICIENCY ON SENSITIVE CYP
SUBSTRATES
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Tompkins, L. M.; Zhao, P.; Zhang, L.; Huang, S.] US FDA, Off Clin Pharmacol, CDER, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S40
EP S41
PG 2
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100129
ER
PT J
AU Zhang, L
Hu, NL
Agarwal, S
Huang, S
AF Zhang, L.
Hu, N. L.
Agarwal, S.
Huang, S.
TI INVESTIGATION OF POSSIBLE FORMULATION EFFECT ON DIGOXIN ABSORPTION.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT 112th Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 02-05, 2011
CL Dallas, TX
SP Amer Soc Clin Pharmacol & Therapeut
C1 [Zhang, L.; Agarwal, S.; Huang, S.] US FDA, Off Clin Pharmacol, Off Translat Sci, CDER, Silver Spring, MD USA.
[Hu, N. L.] Purdue Univ, Coll Pharm, W Lafayette, IN 47907 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
SU 1
BP S39
EP S39
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712DE
UT WOS:000286644100125
ER
PT J
AU Zhang, X
Paule, MG
Newport, GD
Sadovova, N
Berridge, MS
Apana, SM
Kabalka, G
Miao, W
Slikker, W
Wang, C
AF Zhang, X.
Paule, M. G.
Newport, G. D.
Sadovova, N.
Berridge, M. S.
Apana, S. M.
Kabalka, G.
Miao, W.
Slikker, W., Jr.
Wang, Cheng
TI MicroPET imaging of ketamine-induced neuronal apoptosis with
radiolabeled DFNSH
SO JOURNAL OF NEURAL TRANSMISSION
LA English
DT Article
DE Ketamine; Apoptosis; MicroPET; DFNSH
ID DEVELOPING RAT-BRAIN; EXPERIMENTAL CEREBRAL STROKE; DEATH IN-VIVO;
CELL-DEATH; EARLY EXPOSURE; ANNEXIN-V; PET; NEURODEGENERATION;
NEUROTOXICITY; ANESTHETICS
AB Recent reports indicate that 6-12 h of ketamine anesthesia can trigger neuronal apoptosis in postnatal day (PND) 7 rats. In vitro, ex vivo, and confocal fluorescent imaging studies suggest that dansyl compounds can accumulate within the cytoplasm of the apoptotic cell. High-resolution positron emission tomography (microPET) imaging has been proposed as a minimally invasive method for detecting apoptosis in the rat brain. Compared with [(18)F]-labeled annexin V, which binds to externalized phosphatidylserine (PS) on the outer membrane of apoptotic cells, intracellular uptake of the dansylhydrazone of p-fluorobenzaldehyde (DFNSH) may lead to improved target-to-background contrast ratios. In this study, the effect of ketamine on the uptake and retention of [(18)F]-DFNSH in the rat brain was investigated using microPET imaging. On PND 7, rat pups in the experimental group were exposed, at 2-h intervals, to six subcutaneous injections of ketamine (20 mg/kg) and control rat pups received six injections of saline. On PND 35, [(18)F]-DFNSH (37 MBq) was injected into the tail vein of rats and microPET images were obtained over 2 h following the injection. Radiolabeled tracer accumulation in the region of interest (ROI) in the frontal cortex was converted into standard uptake values (SUVs). The radiotracer was quickly distributed into the brains of both ketamine- and saline-treated rats. Compared with the control group, the uptake of [(18)F]-DFNSH was significantly increased in the ROI, frontal cortex area of ketamine-treated rats. In addition, the wash-out duration of the tracer was prolonged in the ketamine-treated animals. This study demonstrates that microPET imaging is capable of distinguishing differences in retention of [(18)F]-DFNSH in ROI and suggests that this compound may serve as a minimally invasive biomarker of neuronal apoptosis in rodents.
C1 [Zhang, X.; Paule, M. G.; Newport, G. D.; Slikker, W., Jr.; Wang, Cheng] US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
[Sadovova, N.] Toxicol Pathol Associates, Jefferson, AR 72079 USA.
[Berridge, M. S.; Apana, S. M.] 3D Imaging LLC, Little Rock, AR 72113 USA.
[Kabalka, G.; Miao, W.] Univ Tennessee, Knoxville, TN 37920 USA.
RP Wang, C (reprint author), US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM cheng.wang@fda.hhs.gov
FU National Center for Toxicological Research (NCTR)/US Food and Drug
Administration (FDA)
FX This document has been reviewed in accordance with United States Food
and Drug Administration (FDA) policy and approved for publication.
Approval does not signify that the contents necessarily reflect the
position or opinions of the FDA nor does mention of trade names or
commercial products constitute endorsement or recommendation for use.
The views expressed in this report are those of the authors and do not
necessarily reflect the views of the FDA. This work was supported by the
National Center for Toxicological Research (NCTR)/US Food and Drug
Administration (FDA). The kind provision of a chromatographic standard
of DFNSH by Dr. Kabalka is gratefully acknowledged.
NR 45
TC 8
Z9 8
U1 1
U2 9
PU SPRINGER WIEN
PI WIEN
PA SACHSENPLATZ 4-6, PO BOX 89, A-1201 WIEN, AUSTRIA
SN 0300-9564
J9 J NEURAL TRANSM
JI J. Neural Transm.
PD FEB
PY 2011
VL 118
IS 2
BP 203
EP 211
DI 10.1007/s00702-010-0499-z
PG 9
WC Clinical Neurology; Neurosciences
SC Neurosciences & Neurology
GA 732JE
UT WOS:000288180000007
PM 20963452
ER
PT J
AU Moro, PL
Broder, K
Zheteyeva, Y
Walton, K
Rohan, P
Sutherland, A
Guh, A
Haber, P
DeStefano, F
Vellozzi, C
AF Moro, Pedro L.
Broder, Karen
Zheteyeva, Yenlik
Walton, Kimp
Rohan, Patricia
Sutherland, Andrea
Guh, Alice
Haber, Penina
DeStefano, Frank
Vellozzi, Claudia
TI Adverse events in pregnant women following administration of trivalent
inactivated influenza vaccine and live attenuated influenza vaccine in
the Vaccine Adverse Event Reporting System, 1990-2009
SO AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
LA English
DT Article
DE pregnancy; seasonal influenza vaccine; surveillance; vaccine safety
ID BELLS-PALSY; PANDEMIC INFLUENZA; SAFETY; IMMUNIZATION; GUIDELINES;
HEALTH; IMPACT; RATES
AB OBJECTIVE: The objective of the study was to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received seasonal influenza vaccines to assess for potential vaccine safety concerns.
STUDY DESIGN: We searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine (TIV) from July 1, 1990 through June 30, 2009, or live attenuated influenza vaccine (LAIV) from July 1, 2003, through June 30, 2009.
RESULTS: A total of 148 reports after TIV and 27 reports after LAIV were identified. Twenty TIV (13.5%) and 1 LAIV (4%) reports were classified as serious. No specific AEs were reported in 30 TIV (20.3%) and 16 LAIV (59%) reports. The most common pregnancy-specific AE was spontaneous abortion: 17 after TIV (11.5%) and 3 after LAIV (11%). The reporting rate of spontaneous abortion was 1.9 per million pregnant women vaccinated.
CONCLUSION: No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of TIV or LAIV.
C1 [Moro, Pedro L.; Broder, Karen; Zheteyeva, Yenlik; Walton, Kimp; Guh, Alice; Haber, Penina; DeStefano, Frank; Vellozzi, Claudia] Ctr Dis Control & Prevent, Immunizat Safety Off, Div Healthcare Qual Promot, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA.
[Rohan, Patricia; Sutherland, Andrea] 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, Natl Ctr Emerging & Zoonot Infect Dis, 1600 Clifton Rd,MS D26, Atlanta, GA 30333 USA.
NR 30
TC 29
Z9 30
U1 0
U2 5
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0002-9378
J9 AM J OBSTET GYNECOL
JI Am. J. Obstet. Gynecol.
PD FEB
PY 2011
VL 204
IS 2
AR 146.e1
DI 10.1016/j.ajog.2010.08.050
PG 7
WC Obstetrics & Gynecology
SC Obstetrics & Gynecology
GA 715HV
UT WOS:000286874900022
PM 20965490
ER
PT J
AU Castelan-Vega, J
Corvette, L
Sirota, L
Arciniega, J
AF Castelan-Vega, Juan
Corvette, Laura
Sirota, Lev
Arciniega, Juan
TI Reduction of Immunogenicity of Anthrax Vaccines Subjected to Thermal
Stress, as Measured by a Toxin Neutralization Assay
SO CLINICAL AND VACCINE IMMUNOLOGY
LA English
DT Article
ID PROTECTIVE ANTIGEN; LETHAL TOXIN; BACILLUS-ANTHRACIS; INACTIVATION;
VALIDATION
AB We report that a toxin neutralization assay (TNA) can detect a decrease in the immunogenicity of anthrax vaccines as a consequence of brief exposure to elevated temperature. This attribute of TNA may help in adopting immunogenicity as a replacement of the current potency test, which involves protection from lethal challenge.
C1 [Castelan-Vega, Juan; Corvette, Laura; Sirota, Lev; Arciniega, Juan] Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
RP Arciniega, J (reprint author), Ctr Biol Evaluat & Res, Mail Code HFM-443,1401 Rockville Pike, Rockville, MD 20852 USA.
EM Juan.Arciniega@fda.hhs.gov
FU Biomedical Advanced Research and Development Authority; U. S. Department
of Energy; U. S. Food and Drug Administration
FX This project was supported by the Biomedical Advanced Research and
Development Authority and by J.C.-V.'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 an interagency agreement between the U. S. Department
of Energy and the U. S. Food and Drug Administration. J.C.-V. is also
grateful for the support from COTEPABE and the Instituto Politecnico
Nacional (Mexico). L. S. was supported in part by a CBER director's
Critical Path grant.
NR 10
TC 9
Z9 9
U1 0
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 1556-6811
J9 CLIN VACCINE IMMUNOL
JI Clin. Vaccine Immunol.
PD FEB
PY 2011
VL 18
IS 2
BP 349
EP 351
DI 10.1128/CVI.00267-10
PG 3
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 712GJ
UT WOS:000286653900023
PM 21147935
ER
PT J
AU Wang, SJ
Hung, HMJ
O'Neill, R
AF Wang, Sue-Jane
Hung, H. M. James
O'Neill, Robert
TI Adaptive design clinical trials and trial logistics models in CNS drug
development
SO EUROPEAN NEUROPSYCHOPHARMACOLOGY
LA English
DT Review
DE Learn-and-Confirm; Learn-versus-Confirm; Sample size re-estimation;
Trial logistics model; Two-stage adaptive selection
ID MODERN PROTOCOL DESIGN; RECEPTOR ANTAGONIST; SYMPTOM REDUCTION; SUICIDE
RISK; SAMPLE-SIZE; MIGRAINE; PLACEBO; ATTRITION; INTERIM
AB In central nervous system therapeutic areas, there are general concerns with establishing efficacy thought to be sources of high attrition rate in drug development. For instance, efficacy endpoints are often subjective and highly variable. There is a lack of robust or operational biomarkers to substitute for soft endpoints. In addition, animal models are generally poor, unreliable or unpredictive. To increase the probability of success in central nervous system drug development program, adaptive design has been considered as an alternative designs that provides flexibility to the conventional fixed designs and has been viewed to have the potential to improve the efficiency in drug development processes. In addition, successful implementation of an adaptive design trial relies on establishment of a trustworthy logistics model that ensures integrity of the trial conduct. In accordance with the spirit of the U.S. Food and Drug Administration adaptive design draft guidance document recently released, this paper enlists the critical considerations from both methodological aspects and regulatory aspects in reviewing an adaptive design proposal and discusses two general types of adaptations, sample size planning and re-estimation, and two-stage adaptive design. Literature examples of adaptive designs in central nervous system are used to highlight the principles laid out in the U.S. FDA draft guidance. Four logistics models seen in regulatory adaptive design applications are introduced. In general, complex adaptive designs require simulation studies to access the design performance. For an adequate and well-controlled clinical trial, if a Learn-and-Confirm adaptive selection approach is considered, the study-wise type I error rate should be adhered to. However, it is controversial to use the simulated type I error rate to address a strong control of the study-wise type I error rate. Published by Elsevier B.V.
C1 [Wang, Sue-Jane; O'Neill, Robert] US FDA, Off Biostat, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Hung, H. M. James] US FDA, Div Biometr 1, Off Biostat, OTS CDER, Silver Spring, MD 20993 USA.
RP Wang, SJ (reprint author), US FDA, Off Biostat, Off Translat Sci, Ctr Drug Evaluat & Res, HFD-700,WO 21,MailStop Room 3562,10903 New Hampsh, Silver Spring, MD 20993 USA.
EM suejane.wang@fda.hhs.gov
NR 28
TC 12
Z9 12
U1 0
U2 7
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0924-977X
J9 EUR NEUROPSYCHOPHARM
JI Eur. Neuropsychopharmacol.
PD FEB
PY 2011
VL 21
IS 2
BP 159
EP 166
DI 10.1016/j.euroneuro.2010.09.003
PG 8
WC Clinical Neurology; Neurosciences; Pharmacology & Pharmacy; Psychiatry
SC Neurosciences & Neurology; Pharmacology & Pharmacy; Psychiatry
GA 725BJ
UT WOS:000287619900003
PM 20933373
ER
PT J
AU Wolf, R
Voscopolous, C
Winston, J
Cattaisson, C
Darwiche, N
Glick, A
Weinberg, WC
Vogel, JC
Goldsmith, P
Hennings, H
Yuspa, SH
AF Wolf, R.
Voscopolous, C.
Winston, J.
Cattaisson, C.
Darwiche, N.
Glick, A.
Weinberg, W. C.
Vogel, J. C.
Goldsmith, P.
Hennings, H.
Yuspa, S. H.
TI S100A7 (psoriasin) and S100A15 (koebnerisin) marks tumor progression
during skin carcinogenesis
SO EXPERIMENTAL DERMATOLOGY
LA English
DT Meeting Abstract
CT 38th Annual Meeting of the
Arbeitsgemeinschaft-Dermatologishche-Forschung
CY FEB 17-19, 2011
CL Tuebingen, GERMANY
SP Arbeitsgemeinsch Dermatol Forsch
C1 [Wolf, R.; Voscopolous, C.; Winston, J.; Cattaisson, C.; Darwiche, N.; Glick, A.; Hennings, H.; Yuspa, S. H.] NCI, Lab Canc Biol & Genet, NIH, Bethesda, MD 20892 USA.
[Wolf, R.] Univ Munich, Dept Dermatol & Allergol, Munich, Germany.
[Weinberg, W. C.] US FDA, Bethesda, MD 20014 USA.
[Vogel, J. C.] NCI, Dermatol Branch, NIH, Bethesda, MD 20892 USA.
[Goldsmith, P.] NCI, Antibody & Prot Purificat Unit, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0906-6705
J9 EXP DERMATOL
JI Exp. Dermatol.
PD FEB
PY 2011
VL 20
IS 2
MA P222
BP 197
EP 197
PG 1
WC Dermatology
SC Dermatology
GA 709UZ
UT WOS:000286468200240
ER
PT J
AU Parsons, BL
AF Parsons, Barbara L.
TI Monoclonal tumor origin is an underlying misconception of the RESIC
approach
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Letter
C1 US FDA, Natl Ctr Toxicol Res, Div Genet & Mol Toxicol, Jefferson, AR 72079 USA.
RP Parsons, BL (reprint author), US FDA, Natl Ctr Toxicol Res, Div Genet & Mol Toxicol, Jefferson, AR 72079 USA.
EM barbara.parsons@fda.hhs.gov
NR 5
TC 5
Z9 5
U1 0
U2 3
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 1
PY 2011
VL 108
IS 5
BP E15
EP E15
DI 10.1073/pnas.1017998108
PG 1
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 714JA
UT WOS:000286804700001
PM 21239682
ER
PT J
AU Wang, YJ
Dou, JH
Cross, KP
Valerio, LG
AF Wang, Yun-Jan
Dou, Jinhui
Cross, Kevin P.
Valerio, Luis G., Jr.
TI Computational analysis for hepatic safety signals of constituents
present in botanical extracts widely used by women in the United States
for treatment of menopausal symptoms
SO REGULATORY TOXICOLOGY AND PHARMACOLOGY
LA English
DT Article
DE Botanicals; Safety; Dietary supplements; Computational science; QSAR;
Modeling; Liver toxicity; Women's health; Menopausal symptoms;
Menopause; Hormone replacement therapy; Black cohosh; Chasteberry; Hops;
Red clover
ID URINARY-TRACT TOXICITIES; HOPS HUMULUS-LUPULUS; CIMICIFUGA-RACEMOSA;
N-ACETYLCYSTEINE; BLACK COHOSH; DIETARY PHYTOESTROGENS; MOUSE-LIVER;
RED-CLOVER; HEPATOTOXICITY; XANTHOHUMOL
AB Black cohosh, red clover, hops, and chasteberry are botanicals commonly used to alleviate menopausal symptoms in the US, and are examined in this study as part of a FDA Office of Women's Health research collaboration to expand knowledge on the safety of these botanical products. Computational approaches using classic (quantitative) structure-activity relationships ((Q)SAR), probabilistic reasoning, machine learning methods, and human expert rule-based systems were employed to deliver human hepatobiliary adverse effect predictions. The objective is to profile and analyze constituents that are alerting for the human hepatobiliary adverse effects. Computational analysis of positively predicted constituents showed that common structural features contributing to the hepatobiliary adverse effect predictions contain phenolic, flavone, isoflavone, glucoside conjugated flavone and isoflavone, and 4-hydroxyacetophenone structures. Specifically, protocatechuic acid from black cohosh, benzofuran and 4-vinylphenol from chasteberry, and xanthohumol I from hops were botanical constituents predicted positive for liver toxicity endpoints and were also confirmed with literature findings. However, comparison between the estimated human exposure to these botanical constituents and the LOAEL and NOAEL in published animal liver toxicology studies for these constituents demonstrated varying margins of safety. This study will serve as regulatory decision support information for regulators at the FDA to help with the process of prioritizing chemicals for testing. Published by Elsevier Inc.
C1 [Wang, Yun-Jan; Valerio, Luis G., Jr.] US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Wang, Yun-Jan] GlobalNet Serv, Rockville, MD 20852 USA.
[Dou, Jinhui] US FDA, Bot Review Team, Off Drug Evaluat 6, Off New Drugs,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Cross, Kevin P.] Leadscope Inc, Columbus, OH 43215 USA.
RP Valerio, LG (reprint author), US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,White Oak 51,Room 4218, Silver Spring, MD 20993 USA.
EM Luis.Valerio@fda.hhs.gov
FU US FDA, Office of Women's Health
FX The authors thank the US FDA, Office of Women's Health for funding this
research project. We thank Barbara Minnier for assistance with chemical
structures.
NR 61
TC 5
Z9 6
U1 1
U2 9
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0273-2300
EI 1096-0295
J9 REGUL TOXICOL PHARM
JI Regul. Toxicol. Pharmacol.
PD FEB
PY 2011
VL 59
IS 1
BP 111
EP 124
DI 10.1016/j.yrtph.2010.09.012
PG 14
WC Medicine, Legal; Pharmacology & Pharmacy; Toxicology
SC Legal Medicine; Pharmacology & Pharmacy; Toxicology
GA 727BM
UT WOS:000287772300012
PM 20920542
ER
PT J
AU Lanzarotta, A
Gratz, S
Brueggemeyer, T
Witkowski, M
AF Lanzarotta, Adam
Gratz, Samuel
Brueggemeyer, Thomas
Witkowski, Mark
TI A Targeted Approach to Detect Controlled Substances in Suspect Tablets
Using Attenuated Total Internal Reflection Fourier-Transform Infrared
Spectroscopic Imaging
SO SPECTROSCOPY
LA English
DT Article
ID IDENTIFICATION
AB Suspect "ecstasy" tablets have been analyzed using attenuated total internal reflection Fourier-transform infrared (ATR-FT-IR) spectroscopic imaging to confirm the presence of several controlled substances that were first identified using liquid chromatography electrospray ionization mass spectrometry (LC-ESI-MS). The ATR-FT-IR method was a targeted approach that involved searching standard FT-IR spectra (of the components already detected by LC-ESI-MS) against each spectrum contained in an ATR-FT-IR image. The method potentially can be used in the future both as an initial screen and as a confirmatory method for other analytical techniques.
C1 [Lanzarotta, Adam; Witkowski, Mark] US FDA, Trace Examinat Sect, Forens Chem Ctr, Cincinnati, OH USA.
[Gratz, Samuel] US FDA, Separat Sect 2, Forens Chem Ctr, Cincinnati, OH USA.
[Brueggemeyer, Thomas] US FDA, Separat Spect & Mol Biol Sect, Forens Chem Ctr, Cincinnati, OH USA.
RP Lanzarotta, A (reprint author), US FDA, Trace Examinat Sect, Forens Chem Ctr, Cincinnati, OH USA.
EM Adam.Lanzarotta@fda.hhs.gov
NR 13
TC 6
Z9 6
U1 0
U2 0
PU ADVANSTAR COMMUNICATIONS INC
PI WOODLAND HILLS
PA 6200 CANOGA AVE, 2ND FLR, WOODLAND HILLS, CA 91367 USA
SN 0887-6703
J9 SPECTROSCOPY-US
JI Spectroscopy
PD FEB
PY 2011
VL 26
IS 2
BP 34
EP +
PG 7
WC Spectroscopy
SC Spectroscopy
GA 724FG
UT WOS:000287560900003
ER
PT J
AU Samuelson, F
Gallas, BD
Myers, KJ
Petrick, N
Pinsky, P
Sahiner, B
Campbell, G
Pennello, GA
AF Samuelson, Frank
Gallas, Brandon D.
Myers, Kyle J.
Petrick, Nicholas
Pinsky, Paul
Sahiner, Berkman
Campbell, Gregory
Pennello, Gene A.
TI The Importance of ROC Data
SO ACADEMIC RADIOLOGY
LA English
DT Letter
ID PERFORMANCE
C1 [Samuelson, Frank; Gallas, Brandon D.; Myers, Kyle J.; Petrick, Nicholas; Pinsky, Paul; Sahiner, Berkman; Campbell, Gregory; Pennello, Gene A.] US FDA, Ctr Devices & Radiol Hlth, Washington, DC 20204 USA.
RP Samuelson, F (reprint author), US FDA, Ctr Devices & Radiol Hlth, Washington, DC 20204 USA.
OI Gallas, Brandon/0000-0001-7332-1620
NR 5
TC 8
Z9 8
U1 0
U2 2
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1076-6332
J9 ACAD RADIOL
JI Acad. Radiol.
PD FEB
PY 2011
VL 18
IS 2
BP 257
EP 258
DI 10.1016/j.acra.2010.10.016
PG 2
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 712XI
UT WOS:000286699200019
PM 21232688
ER
PT J
AU Zang, QD
Keire, DA
Wood, RD
Buhse, LF
Moore, CMV
Nasr, M
Al-Hakim, A
Trehy, ML
Welsh, WJ
AF Zang, Qingda
Keire, David A.
Wood, Richard D.
Buhse, Lucinda F.
Moore, Christine M. V.
Nasr, Moheb
Al-Hakim, Ali
Trehy, Michael L.
Welsh, William J.
TI Class Modeling Analysis of Heparin H-1 NMR Spectral Data Using the Soft
Independent Modeling of Class Analogy and Unequal Class Modeling
Techniques
SO ANALYTICAL CHEMISTRY
LA English
DT Article
ID NUCLEAR-MAGNETIC-RESONANCE; OVERSULFATED CHONDROITIN SULFATE; ADVERSE
CLINICAL EVENTS; MULTIVARIATE CALIBRATION METHODS; ARTIFICIAL
NEURAL-NETWORKS; LOW-MOLECULAR-WEIGHT; ANTICOAGULANT ACTIVITY;
CHEMOMETRIC TECHNIQUES; DERMATAN SULFATE; SPECTROSCOPY
AB To differentiate heparin samples with varying amounts of dermatan sulfate (DS) impurities and oversulfated chondroitin sulfate (OSCS) contaminants, proton NMR spectral data for heparin sodium active pharmaceutical ingredient samples from different manufacturers were analyzed using multivariate chemometric techniques. A total of 168 samples were divided into three groups: (a) Heparin, [DS] <= 1.0% and [OSCS] = 0%; (b) DS, [DS] > 1.0% and [OSCS] = 0%; (c) OSCS, [OSCS] > 0% with any content of DS. The chemometric models were constructed and validated using two well-established methods: soft independent modeling of class analogy (SIMCA) and unequal class modeling (UNEQ). While SIMCA modeling was conducted using the entire set of variables extracted from the NMR spectral data, UNEQ modeling was combined with variable reduction using stepwise linear discriminant analysis to comply with the requirement that the number of samples per class exceed the number of variables in the model by at least 3-fold. Comparison of the results from these two modeling approaches revealed that UNEQ had greater sensitivity (fewer false positives) while SIMCA had greater specificity (fewer false negatives). For Heparin, DS, and OSCS, respectively, the sensitivity was 78% (56/72),74% (37/50), and 85% (39/46) from SIMCA modeling and 88% (63/72), 90% (45/50), and 91% (42/46) from UNEQ modeling. Importantly, the specificity of both the SIMCA and UNEQ models was 100% (46/46) for Heparin with respect to OSCS; no OSCS-containing sample was misclassified as Heparin. The specificity of the SIMCA model (45/50, or 90%) was superior to that of the UNEQ model (27/50, or 54%) for Heparin with respect to DS samples. However, the overall prediction ability of the UNEQ model (85%) was notably better than that of the SIMCA model (76%) for the Heparin vs DS vs OSCS classes. The models were challenged with blends of heparin spiked with nonsulfated, partially sulfated, or fully oversulfated chondroitin sulfate A, dermatan sulfate, or heparan sulfate at the 1.0, 5.0, and 10.0 wt % levels. The results from the present study indicate that the combination of H-1 NMR spectral data and class modeling techniques (viz., SIMCA and UNEQ) represents a promising strategy for assessing the quality of commercial heparin samples with respect to impurities and contaminants. The methodologies show utility for applications beyond heparin to other complex products.
C1 [Zang, Qingda; Keire, David A.; Welsh, William J.] Univ Med & Dent New Jersey, Dept Pharmacol, Robert Wood Johnson Med Sch, Piscataway, NJ 08854 USA.
[Zang, Qingda; Wood, Richard D.] Snowdon Inc, Monmouth Jct, NJ 08852 USA.
[Zang, Qingda] Univ Med & Dent New Jersey, Dept Hlth Informat, Sch Hlth Related Profess, Newark, NJ 07107 USA.
[Keire, David A.; Buhse, Lucinda F.; Trehy, Michael L.] Food & Drug Adm, Ctr Drug Evaluat & Res, Div Pharmaceut Anal, St Louis, MO 63101 USA.
[Moore, Christine M. V.; Nasr, Moheb; Al-Hakim, Ali] Food & Drug Adm, Ctr Drug Evaluat & Res, Office New Drug Qual Assessment, Silver Spring, MD 20993 USA.
RP Welsh, WJ (reprint author), Univ Med & Dent New Jersey, Dept Pharmacol, Robert Wood Johnson Med Sch, Piscataway, NJ 08854 USA.
EM welshwj@umdnj.edu
NR 52
TC 12
Z9 12
U1 2
U2 9
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0003-2700
J9 ANAL CHEM
JI Anal. Chem.
PD FEB 1
PY 2011
VL 83
IS 3
BP 1030
EP 1039
DI 10.1021/ac102832t
PG 10
WC Chemistry, Analytical
SC Chemistry
GA 712TR
UT WOS:000286689600057
PM 21192734
ER
PT J
AU Lu, QJ
Malinauskas, RA
AF Lu, Qijin
Malinauskas, Richard A.
TI Comparison of Two Platelet Activation Markers Using Flow Cytometry After
In Vitro Shear Stress Exposure of Whole Human Blood
SO ARTIFICIAL ORGANS
LA English
DT Article
DE Platelet activation; Flow cytometry; Shear stress; Rheometer;
P-selectin; PAC1; Human blood
ID VENTRICULAR ASSIST DEVICE; CARDIOPULMONARY BYPASS; HEPARIN;
ANTICOAGULANT; THROMBOSIS; PUMP; AGGREGATION; ANTIBODIES
AB Platelet activation is the initiating step to thromboembolic complications in blood-contacting medical devices. Currently, there are no widely accepted testing protocols or relevant metrics to assess platelet activation during the in vitro evaluation of new medical devices. In this article, two commonly used platelet activation marker antibodies, CD62P (platelet surface P-selectin) and PAC1 (activated GP IIb/IIIa), were evaluated using flow cytometry. Anticoagulant citrate dextrose solution A (ACDA) and heparin anticoagulated human blood from healthy donors were separately exposed to shear stresses of 0, 10, 15, and 20 Pa for 120 s using a cone-plate rheometer model, and immediately mixed with the platelet marker antibodies for analysis. To monitor for changes in platelet reactivity between donors and over time, blood samples were also evaluated after exposure to 0, 2, and 20 mu M of adenosine diphosphate (ADP). Following ADP stimulation, the percentage of both CD62P and PAC1 positive platelets increased in a dose dependent fashion, even 8 h after the blood was collected. After shear stress stimulation, both CD62P and PAC1 positive platelets increased significantly at shear stress levels of 15 and 20 Pa when ACDA was used as the anticoagulant. However, for heparinized blood, the PAC1 positive platelets decreased with increasing shear stress, while the CD62P positive platelets increased. Besides the anticoagulant effect, the platelet staining buffer also impacted PAC1 response, but had little effect on CD62P positive platelets. These data suggest that CD62P is a more reliable marker compared with PAC1 for measuring shear-dependent platelet activation and it has the potential for use during in vitro medical device testing.
C1 [Lu, Qijin; Malinauskas, Richard A.] US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
RP Lu, QJ (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
EM qijin.lu@fda.hhs.gov
NR 44
TC 11
Z9 11
U1 1
U2 14
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0160-564X
J9 ARTIF ORGANS
JI Artif. Organs
PD FEB
PY 2011
VL 35
IS 2
BP 137
EP 144
DI 10.1111/j.1525-1594.2010.01051.x
PG 8
WC Engineering, Biomedical; Transplantation
SC Engineering; Transplantation
GA 721ZQ
UT WOS:000287398100011
PM 20946295
ER
PT J
AU Emily, JW
Wise, RP
Menschik, D
Shadomy, SV
Iskander, J
Beeler, J
Varricchio, F
Ball, R
AF Woo, Emily Jane
Wise, Robert P.
Menschik, David
Shadomy, Sean V.
Iskander, John
Beeler, Judy
Varricchio, Frederick
Ball, Robert
TI Thrombocytopenia after vaccination: Case reports to the US Vaccine
Adverse Event Reporting System, 1990-2008
SO VACCINE
LA English
DT Article
DE Vaccine; Thrombocytopenia; Postmarketing safety; Adverse event
ID POSTLICENSURE SAFETY SURVEILLANCE; VARICELLA VACCINE; UNITED-STATES; MMR
VACCINE; PURPURA; IMMUNIZATION; RUBELLA; VAERS; DRUG; ANTIBODIES
AB We reviewed thrombocytopenia (TP) reports to the US Vaccine Adverse Event Reporting System (VAERS). We examined TP patterns for differences in single versus multiple immunization reports, presence of a live viral vaccine, seriousness, age, and interval to symptom onset. We found 1510 reports of possible TP and after exclusions evaluated 1440 for possible causes. Most (1078; 75%) met the regulatory definition of a serious adverse event. TP was reported after inactivated and live viral vaccines. Platelet counts <10 x 10(9)/L were reported. Identified vaccines could be prioritized for hypothesis-testing studies. Published by Elsevier Ltd.
C1 [Woo, Emily Jane; Wise, Robert P.; Menschik, David; Beeler, Judy; Varricchio, Frederick; Ball, Robert] US FDA, CBER, OBE, Rockville, MD 20852 USA.
[Shadomy, Sean V.; Iskander, John] Ctr Dis Control & Prevent, Atlanta, GA USA.
RP Emily, JW (reprint author), US FDA, CBER, OBE, Food & Drug Adm HFM-222,1401 Rockville Pike, Rockville, MD 20852 USA.
EM jane.woo@fda.hhs.gov
NR 35
TC 0
Z9 0
U1 0
U2 2
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 FEB 1
PY 2011
VL 29
IS 6
BP 1319
EP 1323
DI 10.1016/j.vaccine.2010.11.051
PG 5
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 721FU
UT WOS:000287339800030
ER
PT J
AU Boyce, JA
Assa'a, A
Burks, AW
Jones, SM
Sampson, HA
Wood, RA
Plaut, M
Cooper, SE
Fenton, MJ
Arshad, SH
Bahna, SL
Beck, LA
Byrd-Bredbenner, C
Camargo, CA
Eichenfield, L
Furuta, GT
Hanifin, JM
Jones, C
Kraft, M
Levy, BD
Lieberman, P
Luccioli, S
McCall, KM
Schneider, LC
Simon, RA
Simons, FER
Teach, SJ
Yawn, BP
Schwaninger, JM
AF Boyce, Joshua A.
Assa'a, Amal
Burks, A. Wesley
Jones, Stacie M.
Sampson, Hugh A.
Wood, Robert A.
Plaut, Marshall
Cooper, Susan E.
Fenton, Matthew J.
Arshad, S. Hasan
Bahna, Sami L.
Beck, Lisa A.
Byrd-Bredbenner, Carol
Camargo, Carlos A., Jr.
Eichenfield, Lawrence
Furuta, Glenn T.
Hanifin, Jon M.
Jones, Carol
Kraft, Monica
Levy, Bruce D.
Lieberman, Phil
Luccioli, Stefano
McCall, Kathleen M.
Schneider, Lynda C.
Simon, Ronald A.
Simons, F. Estelle R.
Teach, Stephen J.
Yawn, Barbara P.
Schwaninger, Julie M.
TI Guidelines for the diagnosis and management of food allergy in the
United States: Summary of the NIAID-Sponsored Expert Panel Report
SO NUTRITION
LA English
DT Article
C1 [Plaut, Marshall; Cooper, Susan E.; Fenton, Matthew J.; Schwaninger, Julie M.] NIAID, Div Allergy Immunol & Transplantat, NIH, Bethesda, MD 20892 USA.
[Boyce, Joshua A.] Harvard Univ, Brigham & Womens Hosp, Div Rheumatol Immunol & Allergy, Dept Med,Massachusetts Gen Hosp, Boston, MA 02115 USA.
[Camargo, Carlos A., Jr.] Harvard Univ, Brigham & Womens Hosp, Dept Emergency Med,Div Rheumatol Allergy & Immuno, Massachusetts Gen Hosp,Dept Med, Boston, MA 02115 USA.
[Levy, Bruce D.] Brigham & Womens Hosp, Partners Asthma Ctr, Pulm & Crit Med Div, Boston, MA 02115 USA.
[Assa'a, Amal] Univ Cincinnati, Div Allergy & Immunol, Cincinnati Childrens Hosp, Med Ctr, Cincinnati, OH 45221 USA.
[Burks, A. Wesley] Duke Univ, Med Ctr, Dept Pediat, Div Allergy & Immunol, Durham, NC 27706 USA.
[Kraft, Monica] Duke Univ, Med Ctr, Dept Med, Div Pulm Allergy & Crit Care Med, Durham, NC 27706 USA.
[Jones, Stacie M.] Univ Arkansas Med Sci, Arkansas Childrens Hosp, Div Allergy & Immunol, Dept Pediat, Little Rock, AR 72205 USA.
[Sampson, Hugh A.] Mt Sinai Sch Med, Elliot & Roslyn Jaffe Food Allergy Inst, Div Allergy & Immunol, Dept Pediat, New York, NY USA.
[Wood, Robert A.] Johns Hopkins Univ, Sch Med, Dept Pediat, Div Allergy & Immunol, Baltimore, MD 21205 USA.
[Arshad, S. Hasan] Univ Southampton, Southampton SO9 5NH, Hants, England.
[Arshad, S. Hasan] St Marys Hosp, David Hide Asthma & Allergy Res Ctr, Newport PO30 5TG, Isle Of Wight, England.
[Arshad, S. Hasan] Southampton Univ Hosp NHS Trust, Southampton SO16 6YD, Hants, England.
[Bahna, Sami L.] Louisiana State Univ, Hlth Sci Ctr, Allergy & Immunol Sect, Dept Pediat, Baton Rouge, LA 70803 USA.
[Beck, Lisa A.] Univ Rochester, Med Ctr, Dept Dermatol, Rochester, NY 14642 USA.
[Byrd-Bredbenner, Carol] Rutgers State Univ, Dept Nutr Sci, New Brunswick, NJ 08903 USA.
[Eichenfield, Lawrence] Rady Childrens Hosp, Div Pediat & Adolescent Dermatol, San Diego, CA USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Pediat, San Diego, CA 92103 USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Med, San Diego, CA 92103 USA.
[Furuta, Glenn T.] Childrens Hosp Denver, Sect Pediat Gastroenterol Hepatol & Nutr, Digest Hlth Inst, Aurora, CO USA.
[Furuta, Glenn T.] Natl Jewish Hlth, Dept Pediat, Denver, CO USA.
Univ Colorado, Denver Sch Med, Dept Pediat, Aurora, CO USA.
Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA.
Allergy & Asthma Network Mothers Asthmat, Mclean, VA USA.
Univ Tennessee, Coll Med, Dept Med, Div Allergy & Immunol, Knoxville, TN 37996 USA.
US FDA, Off Food Addit Safety, College Pk, MD USA.
Childrens Hosp Orange Cty, Orange, CA USA.
Childrens Hosp Boston, Div Immunol, Boston, MA USA.
Scripps Clin, Div Allergy Asthma & Immunol, San Diego, CA USA.
Univ Manitoba, Fac Med, Dept Pediat, Winnipeg, MB R3T 2N2, Canada.
Univ Manitoba, Fac Med, Dept Child Hlth & Immunol, Winnipeg, MB R3T 2N2, Canada.
Childrens Natl Med Ctr, Div Emergency Med, Washington, DC 20010 USA.
Olmsted Med Ctr, Dept Res, Rochester, MN USA.
Univ Minnesota, Sch Med, Dept Family & Community Hlth, Minneapolis, MN 55455 USA.
RP Fenton, MJ (reprint author), NIAID, Div Allergy Immunol & Transplantat, NIH, 6610 Rockledge Dr,Room 6503, Bethesda, MD 20892 USA.
EM fentonm@niaid.nih.gov
RI Byrd-Bredbenner, Carol/F-8064-2015
OI Byrd-Bredbenner, Carol/0000-0002-8010-3987
FU NIAID; GlaxoSmithKline; Food Allergy and Anaphylaxis Network; Gerber;
Mead Johnson; National Institutes of Health; Food Allergy Initiative;
National Institutes of Health (Division of Receipt and Referral,
National Institute of Allergy and Infectious Diseases, National Center
for Complementary and Alternative Medicine); Phadia AB; Genentech;
National Institutes of Health (National Institute of Allergy and
Infectious Diseases); National Institute of Health Research, UK;
American Academy of Allergy, Asthma, and Immunology; National Eczema
Association; US Department of Agriculture; Canned Food Alliance; New
Jersey Department of Health and Senior Services; Dey; Novartis;
Astellas; Astellas, Ferndale; Johnson Johnson; Sinclair; Stiefel;
Therapeutics Inc.; American Gastrointestinal Association; ALZA; Astellas
Pharma US, Inc; Asubio Pharmaceuticals, Inc.; Centocor, Inc; Corgentech;
Nucryst Pharmaceuticals; Seattle Genetics; Shionogi USA; AllerGen;
Canadian Allergy, Asthma and Immunology Foundation/Anaphylaxis Canada;
Canadian Institutes of Health, Research; AstraZeneca Foundation;
Aventis; Child Health Center Board; CNMC Research Advisory Council;
National Association of Chain Drug Stores Foundation; National
Institutes of Health (National Institute of Allergy and Infectious,
Diseases: National Heart, Lung, and Blood Institute);
Novartis/Genentech; Robert Woods Johnson Foundation; US Centers for
Disease Control and Prevention; US Public Health Service; Washington,
DC, Department of Health
FX NIAID-sponsored Expert Panel; A. Assa'ad holds, or is listed as an
inventor on, US patent application #10/566903, entitled "Genetic markers
of food allergy." She has served as a consultant for GlaxoSmithKline and
as a speaker for the American College of Allergy, Asthma, and,
Immunology, the North East Allergy Society, the Virginia Allergy
Society, the New, England Allergy Society, and the American Academy of
Pediatrics. Dr Assa'ad has, received funding/grant support from
GlaxoSmithKline.; A. W. Burks holds, or is listed as an inventor on,
multiple US patents related to food allergy. He owns stock in Allertein
and MastCell, Inc, and is a minority stockholder in Dannon Co
Probiotics. He has served as a consultant for ActoGeniX NV, McNeil
Nutritionals, Mead Johnson, and Novartis. He has served on the speaker's
bureau for EpiPen/Dey, LP, and has served on the data monitoring
committee for Genentech. He has served on an expert panel for Nutricia.
Dr Burks has received funding/grant support from the Food Allergy and
Anaphylaxis Network, Gerber, Mead Johnson, and the National Institutes
of Health.; H. A. Sampson holds, or is listed as an inventor on,
multiple US patents related to food allergy. He owns stock in Allertein
Therapeutics. He is the immediate past president of the American Academy
of Allergy, Asthma, and Immunology. He has served as a consultant for
Allertein Therapeutics, the American Academy of Allergy, Asthma, and
Immunology, the Food Allergy Initiative, and Schering Plough. He has
received, funding/grant support for research projects from the Food
Allergy Initiative, the National Institutes of Health (Division of
Receipt and Referral, National Institute of Allergy and Infectious
Diseases, National Center for Complementary and Alternative Medicine),
and Phadia AB. He is a co-owner of Herbal Spring, LLC.; R. A. Wood has
served as a speaker/advisory board member for GlaxoSmithKline, Merck,
and Dey. He has received funding/grant support from Genentech and the,
National Institutes of Health (National Institute of Allergy and
Infectious Diseases).; S. H. Arshad has received funding/grant support
from the National Institutes of Health and the National Institute of
Health Research, UK.; L. A. Beck has received funding/grant support from
the American Academy of Allergy, Asthma, and Immunology, the National
Eczema Association, and the National Institutes of Health.; C.
Byrd-Bredbenner owns stock in Johnson & Johnson. She has received
funding/grant support from the US Department of Agriculture, the Canned
Food Alliance, and the New Jersey Department of Health and Senior
Services.; C. A. Camargo Jr has consulted for Dey and Novartis. He has
received funding/grant support from a variety of government agencies and
not-for-profit research foundations, as well as Dey and Novartis.; L.
Eichenfield has received funding/grant support from a variety of
not-for-profit foundations, as well as Astellas, Ferndale, Johnson &
Johnson, Novartis, Sinclair, Stiefel, and Therapeutics Inc.; G. T.
Furuta has served as a consultant and/or speaker to Caption Therapeutics
and TAP. He has received funding/grant support from the American
Gastrointestinal Association and the National Institutes of Health.; J.
M. Hanifin has served as served as a consultant for ALZA, Anesiva, Inc,
Barrier Therapeutics, Inc, Milliken & Company, Nordic Biotech, Novartis
Pharmaceuticals Corporation, Shionogi USA, Taisho Pharmaceutical R&D,
Inc, Teikoku Pharma USA, Inc, UCB, York Pharma, ZARS, Inc, and
ZymoGenetics. He has served as an investigator or received research
funding from ALZA, Astellas Pharma US, Inc, Asubio Pharmaceuticals, Inc.
Centocor, Inc, Corgentech, Novartis, Nucryst Pharmaceuticals, Seattle
Genetics, and Shionogi USA.; F. E. R. Simons holds a patent on
"Fast-disintegrating epinephrine tablets for sublingual administration."
She is a past-president of the American Academy of Allergy, Asthma and
Immunology and of the Canadian Society of Allergy and Clinical
Immunology. She is a member of the advisory boards of Dey, Intelliject,
and ALK-Abello. She has received funding/grant support from AllerGen,
the Canadian Allergy, Asthma and Immunology Foundation/Anaphylaxis
Canada, and the Canadian Institutes of Health, Research.; S.J. Teach has
served as a speaker for AstraZeneca. He has received funding/grant
support from the AstraZeneca Foundation, Aventis, the Child Health
Center Board, the CNMC Research Advisory Council, the National
Association of Chain Drug Stores Foundation, the National Institutes of
Health (National Institute of Allergy and Infectious, Diseases: National
Heart, Lung, and Blood Institute), Novartis/Genentech, the Robert Woods
Johnson Foundation, the US Centers for Disease Control and Prevention,
the US Public Health Service, and the Washington, DC, Department of
Health.
NR 0
TC 18
Z9 18
U1 1
U2 23
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0899-9007
EI 1873-1244
J9 NUTRITION
JI Nutrition
PD FEB
PY 2011
VL 27
IS 2
BP 253
EP 267
DI 10.1016/j.nut.2010.12.001
PG 15
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 710UL
UT WOS:000286542400022
PM 21215925
ER
PT J
AU Shpyleva, SI
Tryndyak, VP
Kovalchuk, O
Starlard-Davenport, A
Chekhun, VF
Beland, FA
Pogribny, IP
AF Shpyleva, Svitlana I.
Tryndyak, Volodymyr P.
Kovalchuk, Olga
Starlard-Davenport, Athena
Chekhun, Vasyl' F.
Beland, Frederick A.
Pogribny, Igor P.
TI Role of ferritin alterations in human breast cancer cells
SO BREAST CANCER RESEARCH AND TREATMENT
LA English
DT Article
DE Breast cancer; Ferritin; Iron; MicroRNA miR-200
ID H-CHAIN; DIFFERENTIAL EXPRESSION; MESENCHYMAL TRANSITION; MELANOMA
PROGRESSION; OXIDATIVE STRESS; DRUG-RESISTANCE; MIR-200 FAMILY; IRON;
GENES; OVEREXPRESSION
AB Breast cancer is the most common malignancy in women. Successful treatment of breast cancer relies on a better understanding of the molecular mechanisms involved in breast cancer initiation and progression. Recent studies have suggested a crucial role of perturbations in ferritin levels and tightly associated with this, the deregulation of intracellular iron homeostasis; however, the underlying molecular mechanisms for the cancer-linked ferritin alterations remain largely unknown and often with conflicting conclusions. Therefore, this study was undertaken to define the role of ferritin in breast cancer. We determined that human breast cancer cells with an epithelial phenotype, such as MCF-7, MDA-MB-361, T-47D, HCC70 and cells, expressed low levels of ferritin light chain, ferritin heavy chain, transferrin, transferring receptor, and iron-regulatory proteins 1 and 2. In contrast, expression of these proteins was substantially elevated in breast cancer cells with an aggressive mesenchymal phenotype, such as Hs-578T, BT-549, and especially MDA-MB-231 cells. The up-regulation of ferritin light chain and ferritin heavy chain in MDA-MB-231 cells was accompanied by alterations in the subcellular distribution of these proteins as characterized by an increased level of nuclear ferritin and a lower level of the cellular labile iron pool as compared to MCF-7 cells. We established that ferritin heavy chain is a target of miRNA miR-200b, suggesting that its up-regulation in MDA-MB-231 cells may be triggered by the low expression of miR-200b. Ectopic up-regulation of miR-200b by transfection of MDA-MB-231 cells with miR-200b substantially decreased the level of ferritin heavy chain. More importantly, miR-200b-induced down-regulation of ferritin was associated with an increased sensitivity of the MDA-MB-231 cells to the chemotherapeutic agent doxorubicin. These results suggest that perturbations in ferritin levels are associated with the progression of breast cancer toward a more advanced malignant phenotype.
C1 [Shpyleva, Svitlana I.; Tryndyak, Volodymyr P.; Starlard-Davenport, Athena; Beland, Frederick A.; Pogribny, Igor P.] Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
[Shpyleva, Svitlana I.; Chekhun, Vasyl' F.] RE Kavetsky Inst Expt Pathol Oncol & Radiobiol, Dept Mech Anticanc Therapy, UA-03022 Kiev, Ukraine.
[Kovalchuk, Olga] Univ Lethbridge, Dept Biol Sci, Lethbridge, AB T1K 3M4, Canada.
RP Pogribny, IP (reprint author), Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
EM igor.pogribny@fda.hhs.gov
NR 42
TC 53
Z9 57
U1 0
U2 17
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 0167-6806
J9 BREAST CANCER RES TR
JI Breast Cancer Res. Treat.
PD FEB
PY 2011
VL 126
IS 1
BP 63
EP 71
DI 10.1007/s10549-010-0849-4
PG 9
WC Oncology
SC Oncology
GA 709VT
UT WOS:000286470200007
PM 20390345
ER
PT J
AU Khurana, S
Verma, S
Verma, N
Crevar, CJ
Carter, DM
Manischewitz, J
King, LR
Ross, TM
Golding, H
AF Khurana, Surender
Verma, Swati
Verma, Nitin
Crevar, Corey J.
Carter, Donald M.
Manischewitz, Jody
King, Lisa R.
Ross, Ted M.
Golding, Hana
TI Bacterial HA1 Vaccine against Pandemic H5N1 Influenza Virus: Evidence of
Oligomerization, Hemagglutination, and Cross-Protective Immunity in
Ferrets
SO JOURNAL OF VIROLOGY
LA English
DT Article
ID RECOMBINANT HEMAGGLUTININ; STRUCTURAL BASIS; BINDING; TRANSPORT;
ANTIBODY; RECEPTOR; IMMUNOGENICITY; GLYCOPROTEIN; RESPONSES; PROTEINS
AB The impending influenza virus pandemic requires global vaccination to prevent large-scale mortality and morbidity, but traditional influenza virus vaccine production is too slow for rapid responses. We have developed bacterial systems for expression and purification of properly folded functional hemagglutinin as a rapid response to emerging pandemic strains. A recombinant H5N1 (A/Vietnam/1203/2004) hemagglutinin globular domain (HA1) was produced in Escherichia coli under controlled redox refolding conditions. Importantly, the properly folded HA1(1-320), i.e., HA1 lacking amino acids 321 to 330, contained >= 75% functional oligomers without addition of foreign oligomerization sequence. Site-directed mutagenesis mapped the oligomerization signal to the HA1 N-terminal Ile-Cys-Ile residues at positions 3 to 5. The purified HA1 oligomers (but not monomers) bound fetuin and agglutinated red blood cells. Upon immunization of rabbits, the oligomeric HA1(1-320) elicited potent neutralizing antibodies against homologous and heterologous H5N1 viruses more rapidly than HA1(28-320) containing only monomers. Ferrets vaccinated with oligomeric HA1 (but not monomeric HA1 with the N terminus deleted) at 15 and 3 mu g/dose were fully protected from lethality and weight loss after challenge with homologous H5N1 (A/Vietnam/1203/2004, clade 1) virus, as well as heterologous clade 2.2 H5N1 (A/WooperSwan/Mongolia/244/2005) virus. Protection was associated with a significant reduction in viral loads in the nasal washes of homologous and heterologous virus challenged ferrets. This is the first study that describes the presence of an N-terminal oligomerization sequence in the globular domain of influenza virus hemagglutinin. Our findings suggest that functional oligomeric rHA1-based vaccines can be produced efficiently in bacterial systems and can be easily upscaled in response to a pandemic influenza virus threat.
C1 [Khurana, Surender; Verma, Swati; Verma, Nitin; Manischewitz, Jody; King, Lisa R.; Golding, Hana] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Crevar, Corey J.; Carter, Donald M.; Ross, Ted M.] Univ Pittsburgh, Ctr Vaccine Res, Pittsburgh, PA 15261 USA.
RP Golding, H (reprint author), US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, 8800 Rockville Pike, Bethesda, MD 20892 USA.
EM hana.golding@fda.hhs.gov
FU NIH/NIAID [UO1-AI077771]; DMID, NIH [IAA 224-10-1006]
FX This study was funded in part by an American Recovery and Reinvestment
Act supplement to NIH/NIAID grant UO1-AI077771 to T. M. R. This study
was also partly supported by IAA 224-10-1006 from DMID, NIH.
NR 35
TC 37
Z9 42
U1 1
U2 9
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
J9 J VIROL
JI J. Virol.
PD FEB
PY 2011
VL 85
IS 3
BP 1246
EP 1256
DI 10.1128/JVI.02107-10
PG 11
WC Virology
SC Virology
GA 705PC
UT WOS:000286147400009
PM 21084473
ER
PT J
AU Lyn-Cook, LE
Tareke, E
Word, B
Starlard-Davenport, A
Lyn-Cook, BD
Hammons, GJ
AF Lyn-Cook, Lascelles E., Jr.
Tareke, Eden
Word, Beverly
Starlard-Davenport, Athena
Lyn-Cook, Beverly D.
Hammons, George J.
TI Food contaminant acrylamide increases expression of Cox-2 and nitric
oxide synthase in breast epithelial cells
SO TOXICOLOGY AND INDUSTRIAL HEALTH
LA English
DT Article
DE Acrylamide; PhIP; nitric oxide synthase; Cox-2; breast
ID CANCER; GLYCIDAMIDE; CYCLOOXYGENASE; INFLAMMATION; CARCINOGEN;
METABOLITE; EXPOSURE; HUMANS; WOMEN; PHIP
AB Acrylamide has been discovered in foods cooked at high temperature. A potentially harmful effect of this dietary component has been suggested by data indicating its association with increased breast cancer. This study investigated the potential effects of acrylamide in nontumorigenic breast cells by assessing expression levels of inducible nitric oxide synthase (iNOS) and cycloogenase-2 (Cox-2) and NOS activity, which are known to be early molecular changes in disease formation. Treatment of cells with acrylamide increased levels of iNOS (both expression and activity) and Cox-2. Its potent metabolite, glycidamide, also induced both iNOS and Cox-2, with induction of iNOS occurring at a lower concentration. 2-Amino-1-methyl-6-phenylimidazo[4,5-b] pyridine (PhIP), another food-borne carcinogen, was found to induce Cox-2 expression. Combining acrylamide with PhIP did not result in a further increase. These studies suggest that further research is needed to determine the role of carcinogens formed from cooking foods in inducing early molecular changes associated with breast cancer.
C1 [Tareke, Eden; Word, Beverly; Starlard-Davenport, Athena; Lyn-Cook, Beverly D.; Hammons, George J.] Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Lyn-Cook, Lascelles E., Jr.] Univ Arkansas, Little Rock, AR 72204 USA.
RP Hammons, GJ (reprint author), Natl Ctr Toxicol Res, HFT 100, Jefferson, AR 72079 USA.
EM ghammons@nctr.fda.gov
NR 47
TC 8
Z9 8
U1 0
U2 10
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0748-2337
J9 TOXICOL IND HEALTH
JI Toxicol. Ind. Health
PD FEB
PY 2011
VL 27
IS 1
BP 11
EP 18
DI 10.1177/0748233710380217
PG 8
WC Public, Environmental & Occupational Health; Toxicology
SC Public, Environmental & Occupational Health; Toxicology
GA 706FX
UT WOS:000286204500002
PM 20713430
ER
PT J
AU Saylor, DM
Guyer, JE
Wheeler, D
Warren, JA
AF Saylor, David M.
Guyer, Jonathan E.
Wheeler, Daniel
Warren, James A.
TI Predicting microstructure development during casting of drug-eluting
coatings
SO ACTA BIOMATERIALIA
LA English
DT Article
DE Microstructure; Coating; Modeling; Simulation; Diffusion
ID CONFOCAL RAMAN MICROSCOPY; POLYMER-SOLVENT SYSTEMS;
DIFFUSION-COEFFICIENTS; RELEASE; STENT; SOLUBILITY
AB We have devised a novel diffuse interface formulation to model the development of chemical and physical inhomogeneities, i.e. microstructure, during the process of casting drug-eluting coatings. These inhomogeneities, which depend on the coating constituents and manufacturing conditions, can have a profound affect on the rate and extent of drug release, and therefore the ability of coated medical devices to function successfully. By deriving the model equations in a time-dependent reference frame, we find that it is computationally viable to probe a wide, physically relevant range of material and process quantities. To illustrate the application of the model, we have evaluated the impact of manufacturing solvent, coating thickness and evaporation rate on microstructure development. Our results suggest that modifying these process conditions can have a strong and nearly discontinuous effect on coating microstructure, and therefore on drug release. Further, we demonstrate that the model can be applied to processes that involve the incremental application of the coating in layers or passes. This new model formulation, which can also be used to predict the kinetics of drug release, provides a tool to elucidate and quantify the relationships between process variables, microstructure and performance. Establishing these relationships can reduce empiricism in materials selection and process design, providing a facile and efficient means to tailor the underlying microstructure and achieve a desired drug-release behavior. Published by Elsevier Ltd. on behalf of Acta materialia Inc.
C1 [Saylor, David M.] US FDA, Div Chem & Mat Sci, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Guyer, Jonathan E.; Wheeler, Daniel; Warren, James A.] NIST, Div Met, Mat Sci & Engn Lab, Gaithersburg, MD 20899 USA.
RP Saylor, DM (reprint author), US FDA, Div Chem & Mat Sci, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM david.saylor@fda.hhs.gov
RI Wheeler, Daniel/C-8994-2009; Warren, James/B-1698-2008; Guyer,
Jonathan/M-5165-2016
OI Wheeler, Daniel/0000-0002-2653-7418; Warren, James/0000-0001-6887-1206;
Guyer, Jonathan/0000-0002-1407-6589
NR 27
TC 3
Z9 3
U1 0
U2 10
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 1742-7061
EI 1878-7568
J9 ACTA BIOMATER
JI Acta Biomater.
PD FEB
PY 2011
VL 7
IS 2
BP 604
EP 613
DI 10.1016/j.actbio.2010.09.019
PG 10
WC Engineering, Biomedical; Materials Science, Biomaterials
SC Engineering; Materials Science
GA 713AP
UT WOS:000286707700016
PM 20858554
ER
PT J
AU Arzhantsev, S
Li, XA
Kauffman, JF
AF Arzhantsev, Sergey
Li, Xiang
Kauffman, John F.
TI Rapid Limit Tests for Metal Impurities in Pharmaceutical Materials by
X-ray Fluorescence Spectroscopy Using Wavelet Transform Filtering
SO ANALYTICAL CHEMISTRY
LA English
DT Article
ID ATOMIC-ABSORPTION-SPECTROMETRY; DIETARY CALCIUM SUPPLEMENTS;
MASS-SPECTROMETRY; PEAK DETECTION; LEAD CONTENT; PRODUCTS; MEDICINE;
CHEMOMETRICS; ELEMENTS; SPECTRA
AB We introduce a new method for analysis of X-ray fluorescence (XRF). spectra based on continuous wavelet transform filters, and the method is applied to the determination of toxic metals in, pharmaceutical materials using hand-held XRF spectrometers. The method uses the continuous wavelet transform to filter the signal and noise components of the spectrum. We present a limit test that compares the wavelet domain signal-to-noise ratios at the energies of the elements of interest to an empirically determined signal-to-noise decision threshold. The limit test is advantageous because it does not require the user to measure calibration samples prior to measurement, though system suitability tests are still recommended. The limit test was evaluated in a collaborative study that involved five different hand-held XRF spectrometers used by multiple analysts in six separate laboratories across the United States. In total, more than 1200 measurements were performed. The detection limits estimated for arsenic, lead, mercury, and chromium were 8, 14, 20, and 150 mu g/g, respectively.
C1 [Arzhantsev, Sergey; Li, Xiang; Kauffman, John F.] Ctr Drug Evaluat & Res, US FDA, Div Pharmaceut Anal, St Louis, MO 63101 USA.
RP Arzhantsev, S (reprint author), Ctr Drug Evaluat & Res, US FDA, Div Pharmaceut Anal, St Louis, MO 63101 USA.
EM sergey.arzhantsev@fda.hhs.gov
FU Oak Ridge Institute for Science and Education (ORISE); FDA Center for
Drug Evaluation and Research
FX The authors acknowledge FDA Office of Regulatory Affairs field
scientists Luella Rossi, Gary Dzidowski, Mark Henry, Dongping Dai, and
Diana C. Mould for participating in the collaborative study. S.A. and
X.L. were supported by the Oak Ridge Institute for Science and Education
(ORISE). This work was funded by the FDA Center for Drug Evaluation and
Research Critical Path Program. The information presented here reflects
the current thinking and experience of the authors. However, this is not
an official policy document and should not be used in lieu of
regulations, published FDA guidances, or direct discussions with the
agency.
NR 41
TC 27
Z9 28
U1 3
U2 23
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0003-2700
J9 ANAL CHEM
JI Anal. Chem.
PD FEB 1
PY 2011
VL 83
IS 3
BP 1061
EP 1068
DI 10.1021/ac1028598
PG 8
WC Chemistry, Analytical
SC Chemistry
GA 712TR
UT WOS:000286689600061
PM 21222440
ER
PT J
AU Chen, YH
Ross, WH
Whiting, RC
Van Stelten, A
Nightingale, KK
Wiedmann, M
Scott, VN
AF Chen, Yuhuan
Ross, William H.
Whiting, Richard C.
Van Stelten, Anna
Nightingale, Kendra K.
Wiedmann, Martin
Scott, Virginia N.
TI Variation in Listeria monocytogenes Dose Responses in Relation to
Subtypes Encoding a Full-Length or Truncated Internalin A
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID TO-EAT FOODS; QUANTITATIVE RISK-ASSESSMENT; PREGNANT GUINEA-PIGS;
INDUCED STILLBIRTHS; INLA; VIRULENCE; MODEL; POLYMORPHISM; DISTINCT;
STRAINS
AB Internalin A (InlA; encoded by inlA) facilitates the crossing of the intestinal barrier by Listeria monocytogenes. Mutations leading to a premature stop codon (PMSC) in inlA and thus attenuated mammalian virulence have been reported. We recently characterized 502 L. monocytogenes food isolates from a retail survey and 507 human clinical isolates from multiple U. S. states with respect to the presence/absence of inlA mutations. The objective of this study was to investigate the hypothesis that dose responses for human listeriosis vary between L. monocytogenes strains with and those without a PMSC in inlA. Subtype-specific prevalence and concentration distributions in food, along with epidemiologic and consumption data, were input into established dose-response models to generate an r value (probability of a cell causing illness). Under the conservative assumption that L. monocytogenes levels at retail represent levels consumed, mean log(10) r values were -8.1 and -10.7 for L. monocytogenes subtypes with genes encoding a full-length and a truncated InlA, respectively. L. monocytogenes carrying a 5' frameshift mutation in a homopolymeric tract showed a mean log10 r value of -12.1. Confidence intervals for the r values and their differences varied depending on subtypes. When the increase in concentration of L. monocytogenes subtypes between retail and consumption was considered, mean log10 r values were reduced to -10.4, -13.8, and -12.8 for the subtypes with genes encoding a full-length InlA, for the subtypes carrying a PMSC in inlA, and for all L. monocytogenes isolates regardless of subtype, respectively. Our study provides further quantitative evidence that L. monocytogenes subtypes vary in abilities and relative likelihoods of causing human disease, which were mechanistically related to defined genetic markers.
C1 [Chen, Yuhuan; Scott, Virginia N.] Grocery Manufacturers Assoc, Washington, DC USA.
[Ross, William H.] Hlth Canada, Food Directorate, Ottawa, ON K1A 0L2, Canada.
[Whiting, Richard C.] Exponent, Bowie, MD USA.
[Van Stelten, Anna; Nightingale, Kendra K.] Colorado State Univ, Dept Anim Sci, Ft Collins, CO 80523 USA.
[Wiedmann, Martin] Cornell Univ, Dept Food Sci, Ithaca, NY 14853 USA.
RP Chen, YH (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Room 2A-009,Mail Code HFS-005,5100 Paint Branch P, College Pk, MD 20740 USA.
EM Yuhuan.Chen@fda.hhs.gov
RI Wiedmann, Martin/A-9683-2008
OI Wiedmann, Martin/0000-0002-4168-5662
FU National Research Initiative of the USDA Cooperative State Research,
Education and Extension Service [2005-35201-16266]; North America Branch
of the International Life Sciences Institute Technical Committee on Food
Microbiology
FX This project was supported by the National Research Initiative of the
USDA Cooperative State Research, Education and Extension Service, grant
2005-35201-16266. We thank the North America Branch of the International
Life Sciences Institute Technical Committee on Food Microbiology for a
grant from which the framework of the growth model in this study was
initially developed.
NR 48
TC 18
Z9 19
U1 0
U2 8
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD FEB
PY 2011
VL 77
IS 4
BP 1171
EP 1180
DI 10.1128/AEM.01564-10
PG 10
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 717WM
UT WOS:000287078100003
PM 21169442
ER
PT J
AU Gavrielides, MA
Gallas, BD
Lenz, P
Badano, A
Hewitt, SM
AF Gavrielides, Marios A.
Gallas, Brandon D.
Lenz, Petra
Badano, Aldo
Hewitt, Stephen M.
TI Observer Variability in the Interpretation of HER2/neu
Immunohistochemical Expression With Unaided and Computer-Aided Digital
Microscopy
SO ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE
LA English
DT Article
ID CELLULAR IMAGING-SYSTEM; IN-SITU HYBRIDIZATION; BREAST-CANCER; TISSUE
MICROARRAYS; VIRTUAL MICROSCOPY; INTEROBSERVER REPRODUCIBILITY;
QUANTITATIVE-ANALYSIS; PROTEIN EXPRESSION; HER-2/NEU STATUS; RECEPTOR
STATUS
AB Context.-Observer variability in digital microscopy and the effect of computer-aided digital microscopy are underexamined areas in need of further research, considering the increasing use and future role of digital imaging in pathology. A reduction in observer variability using computer aids could enhance the statistical power of studies designed to determine the utility of new biomarkers and accelerate their incorporation in clinical practice.
Objectives.-To quantify interobserver and intraobserver variability in immunohistochemical analysis of HER2/neu with digital microscopy and computer-aided digital microscopy, and to test the hypothesis that observer agreement in the quantitative assessment of HER2/neu immunohistochemical expression is increased with the use of computer-aided microscopy.
Design.-A set of 335 digital microscopy images extracted from 64 breast cancer tissue slides stained with a HER2 antibody, were read by 14 observers in 2 reading modes: the unaided mode and the computer-aided mode. In the unaided mode, HER2 images were displayed on a calibrated color monitor with no other information, whereas in the computer-aided mode, observers were shown a HER2 image along with a corresponding feature plot showing computer-extracted values of membrane staining intensity and membrane completeness for the particular image under examination and, at the same time, mean feature values of the different HER2 categories. In both modes, observers were asked to provide a continuous score of HER2 expression.
Results.-Agreement analysis performed on the output of the study showed significant improvement in both interobserver and intraobserver agreement when the computer-aided reading mode was used to evaluate preselected image fields.
Conclusion.-The role of computer-aided digital microscopy in reducing observer variability in immunohistochemistry is promising. (Arch Pathol Lab Med. 2011;135:233-242)
C1 [Gavrielides, Marios A.; Gallas, Brandon D.; Badano, Aldo] US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Lenz, Petra; Hewitt, Stephen M.] NCI, Pathol Lab, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
RP Gavrielides, MA (reprint author), US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave,Bldg 62,Room 4114, Silver Spring, MD 20993 USA.
EM marios.gavrielides@fda.hhs.gov
OI Gallas, Brandon/0000-0001-7332-1620; Hewitt,
Stephen/0000-0001-8283-1788; badano, aldo/0000-0003-3712-6670
NR 43
TC 30
Z9 31
U1 1
U2 7
PU COLLEGE AMER PATHOLOGISTS
PI NORTHFIELD
PA C/O KIMBERLY GACKI, 325 WAUKEGAN RD, NORTHFIELD, IL 60093-2750 USA
SN 0003-9985
J9 ARCH PATHOL LAB MED
JI Arch. Pathol. Lab. Med.
PD FEB
PY 2011
VL 135
IS 2
BP 233
EP 242
PG 10
WC Medical Laboratory Technology; Medicine, Research & Experimental;
Pathology
SC Medical Laboratory Technology; Research & Experimental Medicine;
Pathology
GA 722KG
UT WOS:000287430500017
PM 21284444
ER
PT J
AU Doughty, E
Kertesz-Farkas, A
Bodenreider, O
Thompson, G
Adadey, A
Peterson, T
Kann, MG
AF Doughty, Emily
Kertesz-Farkas, Attila
Bodenreider, Olivier
Thompson, Gary
Adadey, Asa
Peterson, Thomas
Kann, Maricel G.
TI Toward an automatic method for extracting cancer- and other
disease-related point mutations from the biomedical literature
SO BIOINFORMATICS
LA English
DT Article
ID PROSTATE-CANCER; GROWTH-FACTOR; GENE; SYSTEM; VALIDATION; DATABASE; TEXT
AB Motivation: A major goal of biomedical research in personalized medicine is to find relationships between mutations and their corresponding disease phenotypes. However, most of the disease-related mutational data are currently buried in the biomedical literature in textual form and lack the necessary structure to allow easy retrieval and visualization. We introduce a high-throughput computational method for the identification of relevant disease mutations in PubMed abstracts applied to prostate (PCa) and breast cancer (BCa) mutations.
Results: We developed the extractor of mutations (EMU) tool to identify mutations and their associated genes. We benchmarked EMU against MutationFinder-a tool to extract point mutations from text. Our results show that both methods achieve comparable performance on two manually curated datasets. We also benchmarked EMU's performance for extracting the complete mutational information and phenotype. Remarkably, we show that one of the steps in our approach, a filter based on sequence analysis, increases the precision for that task from 0.34 to 0.59 (PCa) and from 0.39 to 0.61 (BCa). We also show that this high-throughput approach can be extended to other diseases.
Discussion: Our method improves the current status of disease-mutation databases by significantly increasing the number of annotated mutations. We found 51 and 128 mutations manually verified to be related to PCa and Bca, respectively, that are not currently annotated for these cancer types in the OMIM or Swiss-Prot databases. EMU's retrieval performance represents a 2-fold improvement in the number of annotated mutations for PCa and BCa. We further show that our method can benefit from full-text analysis once there is an increase in Open Access availability of full-text articles.
C1 [Doughty, Emily; Kertesz-Farkas, Attila; Thompson, Gary; Adadey, Asa; Peterson, Thomas; Kann, Maricel G.] Univ Maryland Baltimore Cty, Baltimore, MD 21250 USA.
[Kertesz-Farkas, Attila] US FDA, Div Imaging & Appl Math, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Bodenreider, Olivier] Natl Lib Med, Bethesda, MD 20894 USA.
RP Kann, MG (reprint author), Univ Maryland Baltimore Cty, Baltimore, MD 21250 USA.
EM mkann@umbc.edu
RI Kann, Maricel/E-5701-2012
FU National Institutes of Health (NIH) [1K22CA143148, R01LM009722]; Centre
for Devices and Radiological Health; US Food and Drug Administration;
NIH, National Library of Medicine
FX This work was supported by the National Institutes of Health (NIH)
[1K22CA143148, MGK (PI) and R01LM009722, MGK (collaborator)]. A. K. F.
acknowledges funding from the Research Fellowship Program of the Centre
for Devices and Radiological Health, administrated by the Oak Ridge
Associated Universities through a contact with the US Food and Drug
Administration. Additional funding (OB) was provided by the Intramural
Research Program of the NIH, National Library of Medicine.
NR 32
TC 26
Z9 26
U1 0
U2 3
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1367-4803
J9 BIOINFORMATICS
JI Bioinformatics
PD FEB 1
PY 2011
VL 27
IS 3
BP 408
EP 415
DI 10.1093/bioinformatics/btq667
PG 8
WC Biochemical Research Methods; Biotechnology & Applied Microbiology;
Computer Science, Interdisciplinary Applications; Mathematical &
Computational Biology; Statistics & Probability
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Computer Science; Mathematical & Computational Biology; Mathematics
GA 716RN
UT WOS:000286991300016
PM 21138947
ER
PT J
AU He, WW
Liu, Y
Yuan, JS
Yin, JJ
Wu, XC
Hu, XN
Zhang, K
Liu, JB
Chen, CY
Ji, YL
Guo, YT
AF He, Weiwei
Liu, Ying
Yuan, Jinshan
Yin, Jun-Jie
Wu, Xiaochun
Hu, Xiaona
Zhang, Ke
Liu, Jianbo
Chen, Chunying
Ji, Yinglu
Guo, Yuting
TI Au@Pt nanostructures as oxidase and peroxidase mimetics for use in
immunoassays
SO BIOMATERIALS
LA English
DT Article
DE Platinum; Nanostructures; Oxidase; Peroxidase; Catalase; Immunoassays
ID OXYGEN REDUCTION REACTION; GOLD NANORODS; HYDROGEN-PEROXIDE; GLUCOSE
DETECTION; PLATINUM NANOPARTICLES; CATALYTIC-ACTIVITY; SUPEROXIDE ANION;
CONTRAST AGENTS; MECHANISM; GROWTH
AB In this paper, we demonstrated that Au nanorods coated with a shell composed of Pt nanodots (Au@Pt nanostructures) exhibited intrinsic oxidase-like, peroxidase-like and catalase-like activity, catalyzing oxygen and hydrogen peroxide reduction and the dismutation decomposition of hydrogen peroxide to produce oxygen. Based on these findings, we established an Au@Pt nanostructures based enzyme linked immunosorbent assay (ELISA) for the detection of mouse interleukin 2 (IL-2). In comparison with natural enzymes, Au@Pt nanostructures have advantages of low cost, easy preparation, better stability, and tunable catalytic activity (compared with HRP), which make them a promising enzyme mimetic candidate and may find potential applications in biocatalysis, bioassays, and nano-biomedicine such as reactive oxygen species (ROS)-related fields (anti-aging and therapeutics for neurodegenerative diseases and cancers). (c) 2010 Elsevier Ltd. All rights reserved.
C1 [Yin, Jun-Jie] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[He, Weiwei; Wu, Xiaochun; Hu, Xiaona; Zhang, Ke; Liu, Jianbo; Ji, Yinglu; Guo, Yuting] Natl Ctr Nanosci & Technol, CAS Key Lab Standardizat & Measurement Nanotechno, Beijing 100190, Peoples R China.
[Liu, Ying; Yuan, Jinshan; Chen, Chunying] Natl Ctr Nanosci & Technol, CAS Key Lab Biol Effects Nanomat & Nanosafety, Beijing 100190, Peoples R China.
[He, Weiwei] Xuchang Univ, Inst Surface Micro & Nano Mat, Xuchang 461000, Peoples R China.
RP Yin, JJ (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM JunJie.Yin@fda.hhs.gov; wuxc@nanoctr.cn; chenchy@nanoctr.cn
RI Yin, Jun Jie /E-5619-2014
FU National Natural Science Foundation of China [20773032]; National Basic
Research Program of China [2006CB932602, 2006CB705600]
FX The work was supported by National Natural Science Foundation of China
(Grant No. 20773032) and the National Basic Research Program of China
(2006CB932602 and 2006CB705600).
NR 40
TC 201
Z9 207
U1 30
U2 222
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0142-9612
J9 BIOMATERIALS
JI Biomaterials
PD FEB
PY 2011
VL 32
IS 4
BP 1139
EP 1147
DI 10.1016/j.biomaterials.2010.09.040
PG 9
WC Engineering, Biomedical; Materials Science, Biomaterials
SC Engineering; Materials Science
GA 699PL
UT WOS:000285675200021
PM 21071085
ER
PT J
AU Fan, J
Yin, JJ
Ning, B
Wu, XC
Hu, Y
Ferrari, M
Anderson, GJ
Wei, JY
Zhao, YL
Nie, GJ
AF Fan, Jia
Yin, Jun-Jie
Ning, Bo
Wu, Xiaochun
Hu, Ye
Ferrari, Mauro
Anderson, Gregory J.
Wei, Jingyan
Zhao, Yuliang
Nie, Guangjun
TI Direct evidence for catalase and peroxidase activities of
ferritin-platinum nanoparticles
SO BIOMATERIALS
LA English
DT Article
DE Biomimetic enzymes; Catalase activities; ESR; Ferritin; Nanoparticles
ID OXIDE NANOPARTICLES; METHANOL OXIDATION; APOFERRITIN; PROTEIN;
SUPEROXIDE; TOXICOLOGY; STRESS; CARBON; CERIUM; CAGE
AB Using apoferritin (apoFt) as a nucleation substrate, we have successfully synthesized 1-2 nm platinum nanoparticles (Pt-Ft) which are highly stable. By directly measuring the products of Pt-Ft-catalyzed reactions, we showed, with no doubt, Pt-Ft possesses both catalase and peroxidase activities. With hydrogen peroxide as substrate, we observed oxygen gas bubbles were generated from hydrogen peroxide decomposed by Pt-Ft: the generation of oxygen gas strongly supports Pt-Ft reacts as catalase, other than peroxidase. While with organic dyes and hydrogen peroxide as substrates, distinctive color products were formed catalyzed by Pt-Ft, which indicates a peroxidase-like activity. Interestingly, these biomimetic properties showed differential response to pH and temperature for different reaction substrates. Pt-Ft showed a significant increase in catalase activity with increasing pH and temperature. The HRP-like activity of Pt-Ft was optimal at physiological temperature and slightly acidic conditions. Our current study demonstrates that Pt-Ft possesses both catalase and peroxidase activities for different substrates under different conditions. (C) 2010 Elsevier Ltd. All rights reserved.
C1 [Fan, Jia; Wei, Jingyan] Jilin Univ, Coll Pharmaceut Sci, Changchun 130021, Peoples R China.
[Fan, Jia; Ning, Bo; Wu, Xiaochun; Nie, Guangjun] Natl Ctr Nanosci & Technol, CAS Key Lab Biol Effects Nanomat & Nanosafety, Beijing 100190, Peoples R China.
[Yin, Jun-Jie] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Hu, Ye; Ferrari, Mauro] Univ Texas Hlth Sci Ctr Houston, Dept Nanomed & Biomed Engn, Houston, TX 77031 USA.
[Anderson, Gregory J.] Royal Brisbane Hosp, Queensland Inst Med Res, Brisbane, Qld 4029, Australia.
[Zhao, Yuliang] Chinese Acad Sci, Inst High Energy Phys, CAS Key Lab Biol Effects Nanomat & Nanosafety, Beijing 100864, Peoples R China.
RP Wei, JY (reprint author), Jilin Univ, Coll Pharmaceut Sci, Changchun 130021, Peoples R China.
EM jingyanwei@yahoo.com.cn; zhaoyuliang@ihep.ac.cn; niegj@nanoctr.cn
RI Yin, Jun Jie /E-5619-2014; Anderson, Gregory/G-4148-2013;
OI Anderson, Gregory/0000-0002-8814-5866; nie, guangjun/0000-0001-5040-9793
FU MOST [2009AA03Z335, 2010CB933600, 2011CB933403]; NSFC [10979011,
30900278]; CAS
FX This work was supported by grants from MOST 863 (2009AA03Z335), MOST 973
program (2010CB933600, 2011CB933403) and NSFC (10979011; 30900278). GN
acknowledges the support of CAS Hundred Talents Program. We thank Herman
Lutterodt for help with ESR study and Professor Sarah Perrett for her
suggestions.
NR 38
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U1 13
U2 122
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0142-9612
J9 BIOMATERIALS
JI Biomaterials
PD FEB
PY 2011
VL 32
IS 6
BP 1611
EP 1618
DI 10.1016/j.biomaterials.2010.11.004
PG 8
WC Engineering, Biomedical; Materials Science, Biomaterials
SC Engineering; Materials Science
GA 712WX
UT WOS:000286698100017
PM 21112084
ER
PT J
AU Beyer, BK
Chernoff, N
Danielsson, BR
Davis-Bruno, K
Harrouk, W
Hood, RD
Janer, G
Liminga, UW
Kim, JH
Rocca, M
Rogers, J
Scialli, AR
AF Beyer, Bruce K.
Chernoff, Neil
Danielsson, Bengt R.
Davis-Bruno, Karen
Harrouk, Wafa
Hood, Ronald D.
Janer, Gemma
Liminga, Ulla Wandel
Kim, James H.
Rocca, Meredith
Rogers, John
Scialli, Anthony R.
TI ILSI/HESI Maternal Toxicity Workshop Summary: Maternal Toxicity and Its
Impact on Study Design and Data Interpretation
SO BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY
LA English
DT Article
DE maternal-fetal interactions; mechanisms of teratogenesis;
pharmaceuticals; safety assessment; developmental toxicity; maternal
toxicity; prenatal; teratology
ID ANTIARRHYTHMIC AGENT ALMOKALANT; EMBRYONIC CARDIAC-ARRHYTHMIA;
UTEROPLACENTAL BLOOD-FLOW; DEVELOPMENTAL TOXICITY; FETAL DEVELOPMENT;
RHYTHM ABNORMALITIES; INTRAUTERINE GROWTH; BLOCKING ACTIVITY; FOOD
RESTRICTION; DIGITAL DEFECTS
AB Workshops on maternal toxicity were held at the annual Society of Toxicology, Teratology Society, and European Teratology Society meetings in 2009. Speakers presented background information prior to a general discussion on this topic.
The following recommendations/options are based on the outcome of the discussions at the workshops:
1. A comprehensive evaluation of all available data from general toxicity studies, range-finding Developmental and Reproductive Toxicology (DART) studies, class effects, structure-activity relationships, exposure studies, etc. is essential for appropriate dose selection for definitive DART studies. The intent is to avoid marked maternal toxicity leading to mortality or decreased body weight gains of greater than 20% for prolonged periods.
(a) Evaluate alternative endpoints for dose selection and data interpretation (e.g., target tissue effects and pharmacology) for biotherapeutics.
(b) Evaluate additional maternal parameters based on effects and/or target organs observed in short-term (e.g., 2- or 4-week) general toxicity studies. 2. Evaluate all available data to determine a cause-effect relationship for developmental toxicity.
(a) Conduct a pair-feeding/pair-watering study as a follow-up.
(b) Evaluate individual data demonstrating maternal toxicity in the mother with adverse embryo-fetal outcomes in the litter associated with the affected mother.
(c) Conduct single-dose studies at increasing doses as a complement to conventional embryo-fetal toxicity studies for certain classes of compounds that affect the hERG channel. 3. Support statements that embryo-fetal effects are caused by maternal toxicity and/or exaggerated pharmacology, especially for malformations.
(a) Provide mechanistic or other supporting data.
(b) Establish the relevance of the DART findings in animals for human exposures. Birth Defects Res (Part B) 92:36-51, 2011. (C) 2010 Wiley-Liss, Inc.
C1 [Beyer, Bruce K.] Sanofi Aventis US Inc, Disposit Safety & Anim Res Preclin Safety, Dept Disposit Safety & Anim Res Preclin Safety, Bridgewater, NJ 08807 USA.
[Chernoff, Neil; Rogers, John] US EPA, Tox Assessment Div, Natl Hlth & Environm Effects Res Lab, Off Res & Dev, Res Triangle Pk, NC 27711 USA.
[Danielsson, Bengt R.] Pharmanet Dev Grp, Consultancy Div, Stockholm, Sweden.
[Danielsson, Bengt R.] Uppsala Univ, Dept Pharmaceut Biosci, Uppsala, Sweden.
[Davis-Bruno, Karen; Harrouk, Wafa] US FDA, CDER OND, Silver Spring, MD USA.
[Hood, Ronald D.] Univ Alabama, Dept Biol Sci, Tuscaloosa, AL USA.
[Hood, Ronald D.] Ronald D Hood & Associates, Toxicol Consultants, Tuscaloosa, AL USA.
[Janer, Gemma] Palau Pharma SA, Dept Pharmacol & Toxicol, Palau de Plegamans, Spain.
[Liminga, Ulla Wandel] Med Prod Agcy, Sci & Regulatory Strategy, Uppsala, Sweden.
[Kim, James H.] ILSI Hlth & Environm Sci Inst, Washington, DC USA.
[Rocca, Meredith] Elan Pharmaceut, Dept Nonclin Safety Evaluat, San Francisco, CA USA.
[Scialli, Anthony R.] Tetra Tech Sci, Washington, DC USA.
RP Beyer, BK (reprint author), Sanofi Aventis US Inc, Disposit Safety & Anim Res Preclin Safety, Dept Disposit Safety & Anim Res Preclin Safety, Mail Stop JR2-103B,1041 Route 202-206,POB 6800, Bridgewater, NJ 08807 USA.
EM bruce.beyer@sanofi-aventis.com
FU Health and Environmental Sciences Institute (HESI)
FX Grant sponsor: Health and Environmental Sciences Institute (HESI).
NR 72
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U1 2
U2 5
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1542-9733
J9 BIRTH DEFECTS RES B
JI Birth Defects Res. Part B-Dev. Reprod. Toxicol.
PD FEB
PY 2011
VL 92
IS 1
BP 36
EP 51
DI 10.1002/bdrb.20281
PG 16
WC Oncology; Genetics & Heredity; Toxicology
SC Oncology; Genetics & Heredity; Toxicology
GA 729XF
UT WOS:000287986900004
PM 21312321
ER
PT J
AU Hamilton, AS
Albertsen, PC
Johnson, TK
Hoffman, R
Morrell, D
Deapen, D
Penson, DF
AF Hamilton, Ann S.
Albertsen, Peter C.
Johnson, Terri Kang
Hoffman, Richard
Morrell, Donna
Deapen, Dennis
Penson, David F.
TI Trends in the treatment of localized prostate cancer using supplemented
cancer registry data
SO BJU INTERNATIONAL
LA English
DT Article
ID QUALITY-OF-LIFE; ANDROGEN-DEPRIVATION THERAPY; RADICAL PROSTATECTOMY;
UNITED-STATES; HIGH-RISK; BRACHYTHERAPY; OUTCOMES; MANAGEMENT;
RADIATION; DISEASE
AB What's known on the subject? and What does the study add?
Variation in treatment of localized prostate cancer has been shown to exist according to demographic and clinical factors, patient and provider preference, and region of residence since there is no consensus concerning appropriate treatment.
Between 1998 and 2002 the proportion of men choosing watchful waiting declined from 12.6% to 9.0% while those receiving brachytherapy (with or without external beam radiation therapy) increased from 14.9% to 17.7%. Based on Gleason score, PSA, and age at diagnosis, younger African-American men may be receiving less aggressive therapy than indicated, while older men with low risk tumours may be receiving more aggressive therapy than necessary.
OBJECTIVE
To conduct an analysis of localized prostate cancer treatment in the USA between 1998 and 2002.
PATIENTS AND METHODS
Results from the National Cancer Institute's Patterns of Care study from 10 regional cancer registries in 1998 and 14 registries in 2002 were compared using univariate and multivariate statistical methods.
RESULTS
Patients with localized prostate cancer in 2002 were younger, had lower prostate-specific antigen values, and higher Gleason scores compared with those diagnosed in 1998. Little change occurred in age-adjusted percentages of men who were treated with a radical prostatectomy (45-46%) or by external beam radiation (EBRT) alone (19-20%). The proportion receiving brachytherapy (BT), alone or with EBRT, increased from 14.9 to 17.7%, while the proportion receiving watchful waiting declined from 12.6 to 9.0%. Younger African-American men with intermediate/high-risk disease were less likely to receive any type of aggressive therapy in comparison with Non-Hispanic White men. Over 70% of men who were >= 75 years of age, with low-risk disease, were treated with EBRT or BT.
CONCLUSIONS
Older men with low-risk disease might be overtreated with aggressive therapy, while younger intermediate/high-risk African-American men appear less likely to receive indicated aggressive therapy.
C1 [Hamilton, Ann S.] Univ So Calif, Keck Sch Med, USC Norris Comprehens Canc Ctr, Los Angeles, CA 90089 USA.
[Albertsen, Peter C.] Univ Connecticut, Ctr Hlth, Div Urol, Farmington, CT USA.
[Johnson, Terri Kang] US FDA, Div Biostat, Off Biometr & Surveillance, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Hoffman, Richard] New Mexico VA Hlth Care Syst, Med Serv, Albuquerque, NM USA.
[Hoffman, Richard] Univ New Mexico, Sch Med, Dept Med, Albuquerque, NM 87131 USA.
[Penson, David F.] Vanderbilt Univ, Med Ctr, Ctr Surg Qual & Outcomes Res, Nashville, TN USA.
RP Hamilton, AS (reprint author), Univ So Calif, Keck Sch Med, USC Norris Comprehens Canc Ctr, 1441 Eastlake Ave,Rm 3427A,MC1975, Los Angeles, CA 90089 USA.
EM ahamilt@usc.edu
FU NCI [N01-PC-35133, N01-PC-35135, N01-PC-35136, N01-PC-35137,
N01-PC-35138, N01PC-35139, N01-PC-35141, N01-PC-35142, N01-PC-35143,
N01-PC-35145, N02-PC-15104, N02-PC-15105, N02-PC-15106, N02-PC-15107];
Centers for Disease Control and Preventions National Program of Cancer
Registries [U55/CCR921930-02]
FX The authors would like to acknowledge the contributions of the
participating SEER registries and staffs. Without their dedicated
efforts this research could not have been conducted. Each registry was
funded by the NCI under the following contract numbers: N01-PC-35133,
N01-PC-35135, N01-PC-35136, N01-PC-35137, N01-PC-35138, N01PC-35139,
N01-PC-35141, N01-PC-35142, N01-PC-35143, N01-PC-35145, N02-PC-15104,
N02-PC-15105, N02-PC-15106 and N02-PC-15107 (see list below for further
details). The collection of California cancer incidence data was
supported by: the California Department of Health Services, as part of
the statewide cancer reporting programme mandated by California Health
and Safety Code Section 103885; the NCI SEER programme under contract
N01-PC-35139 awarded to the Cancer Prevention Institute of California,
contract N01-PC-35139 awarded to the University of Southern California,
and contract N02-PC-15105 awarded to the Public Health Institute; and
the Centers for Disease Control and Preventions National Program of
Cancer Registries, under agreement # U55/CCR921930-02 awarded to the
Public Health Institute. The ideas and opinions expressed herein are
those of the author(s) and endorsement by the State of California,
Department of Health Services, the NCI, and the Centers for Disease
Control and Prevention or their contractors and subcontractors is not
intended nor should be inferred.
NR 36
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U1 0
U2 7
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1464-4096
J9 BJU INT
JI BJU Int.
PD FEB
PY 2011
VL 107
IS 4
BP 576
EP 584
DI 10.1111/j.1464-410X.2010.09514.x
PG 9
WC Urology & Nephrology
SC Urology & Nephrology
GA 713WE
UT WOS:000286767300010
PM 20735387
ER
PT J
AU Cho, S
Bashaw, ED
AF Cho, S.
Bashaw, E. D.
TI Clinical Pharmacology for Development of Topical Dermatological
Products: Present and Future Opportunities for Safety and Efficacy
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Editorial Material
AB The development of topical products for dermatological diseases represents an untapped opportunity for the clinical pharmacologist. Assessment of bioavailability of topical drugs and its utility in weighing benefit vs. risk has been unique and challenging, compared with assessments for conventional systemic drugs. However, with continued advances in analytical methods and growing interests in discovering biomarkers, the future opportunities for clinical pharmacology to advance topical drug development processes are enormous and will be limited only by our drive and determination to push science forward.
C1 [Cho, S.; Bashaw, E. D.] US FDA, Off Clin Pharmacol, Silver Spring, MD USA.
RP Cho, S (reprint author), US FDA, Off Clin Pharmacol, Silver Spring, MD USA.
EM seongeun.cho@fda.hhs.gov
NR 5
TC 2
Z9 2
U1 1
U2 3
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
IS 2
BP 167
EP 169
DI 10.1038/clpt.2010.283
PG 3
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 711JA
UT WOS:000286585500008
PM 21252932
ER
PT J
AU Zhao, P
Zhang, L
Grillo, JA
Liu, Q
Bullock, JM
Moon, YJ
Song, P
Brar, SS
Madabushi, R
Wu, TC
Booth, BP
Rahman, NA
Reynolds, KS
Berglund, EG
Lesko, LJ
Huang, SM
AF Zhao, P.
Zhang, L.
Grillo, J. A.
Liu, Q.
Bullock, J. M.
Moon, Y. J.
Song, P.
Brar, S. S.
Madabushi, R.
Wu, T. C.
Booth, B. P.
Rahman, N. A.
Reynolds, K. S.
Berglund, E. Gil
Lesko, L. J.
Huang, S-M
TI Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling
and Simulation During Regulatory Review
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Article
ID DRUG-DRUG INTERACTIONS; IN-VITRO DATA; TISSUE DISTRIBUTION; MIDAZOLAM
CLEARANCE; SILDENAFIL CITRATE; HUMAN-POPULATIONS; RENAL IMPAIRMENT;
LIVER-CIRRHOSIS; STEADY-STATE; PREDICTION
AB Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic (e. g., organ dysfunction, age, genetics) and extrinsic (e. g., drug-drug interactions) factors, alone or in combinations, on drug exposure. The use of this tool is increasing at all stages of the drug development process. This report reviews recent instances of the use of PBPK in decision-making during regulatory review. The examples are based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs (INDs) and new drug applications (NDAs) received between July 2008 and June 2010. The use of PBPK modeling and simulation facilitated the following types of decisions: the need to conduct specific clinical pharmacology studies, specific study designs, and appropriate labeling language. The report also discusses the challenges encountered when PBPK modeling and simulation were used in these cases and recommends approaches to facilitating full utilization of this tool.
C1 [Zhao, P.; Zhang, L.; Grillo, J. A.; Liu, Q.; Bullock, J. M.; Moon, Y. J.; Song, P.; Brar, S. S.; Madabushi, R.; Wu, T. C.; Booth, B. P.; Rahman, N. A.; Reynolds, K. S.; Lesko, L. J.; Huang, S-M] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Berglund, E. Gil] Med Prod Agcy, Efficacy & Safety 2, Uppsala, Sweden.
RP Huang, SM (reprint author), US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
EM ShiewMei.Huang@fda.hhs.gov
NR 45
TC 169
Z9 178
U1 3
U2 37
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2011
VL 89
IS 2
BP 259
EP 267
DI 10.1038/clpt.2010.298
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 711JA
UT WOS:000286585500024
PM 21191381
ER
PT J
AU Lee, HW
Muniyappa, R
Yan, X
Yue, LQ
Linden, EH
Chen, H
Hansen, BC
Quon, MJ
AF Lee, Ho-Won
Muniyappa, Ranganath
Yan, Xu
Yue, Lilly Q.
Linden, Ellen H.
Chen, Hui
Hansen, Barbara C.
Quon, Michael J.
TI Comparison between Surrogate Indexes of Insulin Sensitivity/Resistance
and Hyperinsulinemic Euglycemic Glucose Clamps in Rhesus Monkeys
SO ENDOCRINOLOGY
LA English
DT Article
ID HOMEOSTASIS MODEL ASSESSMENT; DEPENDENT DIABETES-MELLITUS; FASTING
PLASMA-GLUCOSE; REDUCES BLOOD-PRESSURE; GREEN TEA POLYPHENOL; METABOLIC
SYNDROME; NONHUMAN-PRIMATES; ISLET AMYLOIDOSIS; MACACA-MULATTA; CHECK
INDEX
AB The euglycemic glucose clamp is the reference method for assessing insulin sensitivity in humans and animals. However, clamps are ill-suited for large studies because of extensive requirements for cost, time, labor, and technical expertise. Simple surrogate indexes of insulin sensitivity/resistance including quantitative insulin-sensitivity check index (QUICKI) and homeostasis model assessment (HOMA) have been developed and validated in humans. However, validation studies of QUICKI and HOMA in both rats and mice suggest that differences in metabolic physiology between rodents and humans limit their value in rodents. Rhesus monkeys are a species more similar to humans than rodents. Therefore, in the present study, we evaluated data from 199 glucose clamp studies obtained from a large cohort of 86 monkeys with a broad range of insulin sensitivity. Data were used to evaluate simple surrogate indexes of insulin sensitivity/resistance (QUICKI, HOMA, Log HOMA, 1/HOMA, and 1/Fasting insulin) with respect to linear regression, predictive accuracy using a calibration model, and diagnostic performance using receiver operating characteristic. Most surrogates had modest linear correlations with SI(Clamp) (r approximate to 0.4-0.64) with comparable correlation coefficients. Predictive accuracy determined by calibration model analysis demonstrated better predictive accuracy of QUICKI than HOMA and Log HOMA. Receiver operating characteristic analysis showed equivalent sensitivity and specificity of most surrogate indexes to detect insulin resistance. Thus, unlike in rodents but similar to humans, surrogate indexes of insulin sensitivity/resistance including QUICKI and log HOMA may be reasonable to use in large studies of rhesus monkeys where it may be impractical to conduct glucose clamp studies. (Endocrinology 152: 414-423, 2011)
C1 [Lee, Ho-Won; Muniyappa, Ranganath; Chen, Hui; Quon, Michael J.] NIH, Diabet Unit, Natl Ctr Complementary & Alternat Med, Bethesda, MD 20892 USA.
[Yan, Xu; Yue, Lilly Q.] US FDA, Div Biostat, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Linden, Ellen H.; Hansen, Barbara C.] Univ S Florida, Obes Diabet & Aging Res Ctr, Dept Pediat, Coll Med, St Petersburg, FL 33701 USA.
[Linden, Ellen H.; Hansen, Barbara C.] Univ S Florida, Dept Internal Med, Coll Med, St Petersburg, FL 33701 USA.
RP Lee, HW (reprint author), NIH, Diabet Unit, Natl Ctr Complementary & Alternat Med, Bldg 10, Bethesda, MD 20892 USA.
RI Hansen, Barbara/J-8723-2012;
OI Hansen, Barbara/0000-0001-9646-3525; Quon, Michael/0000-0002-9601-9915;
Quon , Michael /0000-0002-5289-3707
FU National Center for Complementary and Alternative Medicine, National
Institutes of Health; American Diabetes Association
FX This work was supported in part by the Intramural Research Program,
National Center for Complementary and Alternative Medicine, National
Institutes of Health, and in part by a Clinical Research Award from the
American Diabetes Association (to M.J.Q.). The primate colony support
was via National Institutes of Health National Institute on Aging N01AG3
1012 and continues under National Institutes of Health
HHSN263200800022C, institutional, and private funds (to B.C.H.).
NR 42
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U1 0
U2 4
PU ENDOCRINE SOC
PI CHEVY CHASE
PA 8401 CONNECTICUT AVE, SUITE 900, CHEVY CHASE, MD 20815-5817 USA
SN 0013-7227
J9 ENDOCRINOLOGY
JI Endocrinology
PD FEB
PY 2011
VL 152
IS 2
BP 414
EP 423
DI 10.1210/en.2010-1164
PG 10
WC Endocrinology & Metabolism
SC Endocrinology & Metabolism
GA 709FA
UT WOS:000286422100012
PM 21209021
ER
PT J
AU Wu, KM
Yao, JQ
Boring, D
AF Wu, Kuei-Meng
Yao, Jiaqin
Boring, Daniel
TI Green Tea Extract-Induced Lethal Toxicity in Fasted but Not in Nonfasted
Dogs
SO INTERNATIONAL JOURNAL OF TOXICOLOGY
LA English
DT Article
DE green tea extract; fasted dogs; polyphenols
ID SAFETY
AB Recent chronic toxicity studies performed on green tea extracts in fasted dogs have revealed some unique dose-limiting lethal liver, gastrointestinal, and renal toxicities. Key findings included necrosis of hepatic cells, gastrointestinal epithelia and renal tubules, atrophy of reproductive organs, atrophy and necrosis of hematopoietic tissues, and associated hematological changes. The polyphenol cachetins (a mixture of primarily epigallocatechin gallate [>= 55%]; plus up to 10% each of epigallocatechin, epicatechin, and epigallocatechin gallate) appeared to be the causative agents for the observed toxicities because they are the active ingredients of green tea extract studied. Conduct of the study in nonfasted dogs under the same testing conditions and dose levels showed unremarkable results. Assuming both studies were valid, at the identified no observed adverse effect levels (NOAEL) of each study, systemic exposures (based on area under the curve [AUC]) were actually lower in fasted than nonfasted dogs, suggesting that fasting may have rendered the target organ systems potentially more vulnerable to the effects of green tea extract. The toxicity mechanisms that produced lethality are not known, but the results are scientifically intriguing. Because tea drinking has become more popular in the United States and abroad, the mode of action and site of action of green tea extract-induced lethal toxicities during fasting and the role of other phytochemical components of Folia Camellia sinensis (including nonpolyphenol fractions, which are often consumed when whole-leaf products are presented) warrant further investigation.
C1 [Wu, Kuei-Meng] US FDA, Div Antiviral Prod, CDER, Silver Spring, MD 20993 USA.
[Yao, Jiaqin] US FDA, Div Dermatol & Dent Prod, CDER, Silver Spring, MD 20993 USA.
[Boring, Daniel] NCI, Chemoprevent Agent Dev Res Grp, Canc Prevent Div, Bethesda, MD 20892 USA.
RP Wu, KM (reprint author), US FDA, Div Antiviral Prod, CDER, Silver Spring, MD 20993 USA.
EM kueimeng.wu@fda.hhs.gov
NR 9
TC 8
Z9 8
U1 2
U2 2
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 1091-5818
J9 INT J TOXICOL
JI Int. J. Toxicol.
PD FEB
PY 2011
VL 30
IS 1
BP 19
EP 20
DI 10.1177/1091581810387445
PG 2
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 733RJ
UT WOS:000288280200002
PM 21098339
ER
PT J
AU Collison, M
Khurana, T
Slater, JE
AF Collison, M.
Khurana, T.
Slater, J. E.
TI Production of Single Chain Variable Fragment Antibodies (scFv) for the
Characterization of German Cockroach (GCr) Extracts
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Meeting Abstract
CT American-Academy-of-Allergy-Asthma-and-Immunology Annual Meeting
CY MAR 18-22, 2011
CL San Francisco, CA
SP Amer Acad Allergy Asthma & Immunol
C1 [Collison, M.; Khurana, T.; Slater, J. E.] Lab Immunobiochem DBPAP CBER FDA, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0091-6749
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2011
VL 127
IS 2
SU S
BP AB119
EP AB119
DI 10.1016/j.jaci.2010.12.476
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 832YI
UT WOS:000295846400458
ER
PT J
AU El Fiky, A
Perreault, R
Kirschman, K
Rabin, RL
AF El Fiky, A.
Perreault, R.
Kirschman, K.
Rabin, R. L.
TI Interferon beta Expression is Attenuated In Human Model of Alternatively
Activated Macrophages
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Meeting Abstract
CT American-Academy-of-Allergy-Asthma-and-Immunology Annual Meeting
CY MAR 18-22, 2011
CL San Francisco, CA
SP Amer Acad Allergy Asthma & Immunol
C1 [El Fiky, A.; Perreault, R.; Kirschman, K.; Rabin, R. L.] US FDA, CBER, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0091-6749
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2011
VL 127
IS 2
SU S
BP AB127
EP AB127
DI 10.1016/j.jaci.2010.12.506
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 832YI
UT WOS:000295846400488
ER
PT J
AU Hillyer, P
Chen, A
Navarro, M
Schramm, LM
Mane, VP
Gold, DM
Raviv, N
Rabin, RL
AF Hillyer, P.
Chen, A.
Navarro, M.
Schramm, L. M.
Mane, V. P.
Gold, D. M.
Raviv, N.
Rabin, R. L.
TI Strain Dependent Differences in Magnitude and Timing of Innate Immune
Responses to Respiratory Syncytial Virus (RSV) in Human Monocyte Derived
Dendritic Cells (MDDC)
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Meeting Abstract
CT American-Academy-of-Allergy-Asthma-and-Immunology Annual Meeting
CY MAR 18-22, 2011
CL San Francisco, CA
SP Amer Acad Allergy Asthma & Immunol
C1 [Hillyer, P.; Chen, A.; Navarro, M.; Schramm, L. M.; Mane, V. P.; Gold, D. M.; Raviv, N.; Rabin, R. L.] CBER FDA, Bethesda, 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
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2011
VL 127
IS 2
SU S
BP AB166
EP AB166
DI 10.1016/j.jaci.2010.12.660
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 832YI
UT WOS:000295846400642
ER
PT J
AU Khurana, T
Collison, M
Chew, F
Slater, JE
AF Khurana, T.
Collison, M.
Chew, F.
Slater, J. E.
TI Identification of Novel Allergens of Blatella germanica using Single
Chain Variable Fragment Antibodies
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 MAR 18-22, 2011
CL San Francisco, CA
SP Amer Acad Allergy Asthma & Immunol (AAAAI)
C1 [Khurana, T.; Collison, M.; Slater, J. E.] Lab Immunobiochem CBER FDA, Bethesda 117548, MD USA.
[Chew, F.] Natl Univ Singapore, Dept Biol Sci, Allergy & Mol Immunol Lab, Singapore, Singapore.
NR 0
TC 0
Z9 0
U1 3
U2 6
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0091-6749
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD FEB
PY 2011
VL 127
IS 2
SU S
BP AB119
EP AB119
DI 10.1016/j.jaci.2010.12.477
PG 1
WC Allergy; Immunology
SC Allergy; Immunology
GA 832YI
UT WOS:000295846400459
ER
PT J
AU Darney, S
Fowler, B
Grandjean, P
Heindel, J
Mattison, D
Slikker, W
AF Darney, Sally
Fowler, Bruce
Grandjean, Philippe
Heindel, Jerrold
Mattison, Donald
Slikker, William, Jr.
TI Prenatal Programming and Toxicity II (PPTOX II): Role of Environmental
Stressors in the Developmental Origins of Disease
SO JOURNAL OF DEVELOPMENTAL ORIGINS OF HEALTH AND DISEASE
LA English
DT Editorial Material
C1 [Fowler, Bruce] Ctr Dis Control, Div Toxicol & Environm Med, ATSDR, Atlanta, GA 30333 USA.
[Grandjean, Philippe] Univ So Denmark, Odense, Denmark.
[Heindel, Jerrold] NIEHS, Organs & Syst Pathobiol Branch, Res Triangle Pk, NC USA.
[Mattison, Donald] NICHD, Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, NIH, HHS, Bethesda, MD USA.
[Slikker, William, Jr.] US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
OI Mattison, Donald/0000-0001-5623-0874
NR 2
TC 0
Z9 0
U1 0
U2 1
PU CAMBRIDGE UNIV PRESS
PI CAMBRIDGE
PA EDINBURGH BLDG, SHAFTESBURY RD, CB2 8RU CAMBRIDGE, ENGLAND
SN 2040-1744
J9 J DEV ORIG HLTH DIS
JI J. Dev. Orig. Health Dis.
PD FEB
PY 2011
VL 2
IS 1
BP 2
EP 2
DI 10.1017/S2040174411000109
PG 1
WC Public, Environmental & Occupational Health
SC Public, Environmental & Occupational Health
GA 755LW
UT WOS:000289933800001
ER
PT J
AU Zou, W
Al-Khaldi, SF
Branham, WS
Han, T
Fuscoe, JC
Han, J
Foley, SL
Xu, J
Fang, H
Cerniglia, CE
Nayak, R
AF Zou, Wen
Al-Khaldi, Sufian F.
Branham, William S.
Han, Tao
Fuscoe, James C.
Han, Jing
Foley, Steven L.
Xu, Joshua
Fang, Hong
Cerniglia, Carl E.
Nayak, Rajesh
TI Microarray analysis of virulence gene profiles in Salmonella serovars
from food/food animal environment
SO JOURNAL OF INFECTION IN DEVELOPING COUNTRIES
LA English
DT Article
DE Salmonella; virulence associated genes; microarray; pathogenicity
ID DNA MICROARRAY; PATHOGENICITY ISLANDS; ENTERICA SEROVARS;
IDENTIFICATION; STRAINS; DISEASE; HOST
AB Introduction: Rapid, accurate and inexpensive analysis of the disease-causing potential of foodborne pathogens is an important consideration in food safety and biodefense, particularly in developing countries. The objective of this study is to demonstrate the use of a robust and inexpensive microarray platform to assay the virulence gene profiles in Salmonella from food and/or the food animal environment, and then use ArrayTrack (TM) for data analysis.
Methodology: The spotted array consisted of 69 selected Salmonella-specific virulence gene probes (65bp each). These probes were printed on poly-L-lysine-coated slides. Genomic DNA was digested with Sau3AI, labeled with Cy3 dye, hybridized to the gene probes, and the images were captured and analyzed by GenePix 4000B and ArrayTrack (TM), a free software developed by Food and Drug Administration (FDA) researchers.
Results: Nearly 58% of the virulence-associated genes tested were present in all Salmonella strains tested. In general, genes belonging to inv, pip, prg, sic, sip, spa or ttr families were detected in more than 90% of the isolates, while the iacP, avrA, invH, rhuM, sirA, sopB, sopE or sugR genes were detected in 40 to 80% of the isolates. The gene variability was independent of the Salmonella serotype.
Conclusions: This hybridization array presents an accurate and cost-effective method for evaluating the disease-causing potential of Salmonella in outbreak investigations by targeting a selective set of Salmonella-associated virulence genes.
C1 [Han, Jing; Foley, Steven L.; Cerniglia, Carl E.; Nayak, Rajesh] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Zou, Wen] US FDA, Div Personalized Nutr & Med, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Al-Khaldi, Sufian F.] US FDA, Div Microbiol Studies, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Branham, William S.; Han, Tao; Fuscoe, James C.] US FDA, Div Syst Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Xu, Joshua; Fang, Hong] US FDA, Z Tech Corp, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Nayak, R (reprint author), US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM Rajesh.Nayak@fda.hhs.gov
FU Oak Ridge Institute for Science and Education; US Department of Energy;
US Food and Drug Administration
FX We thank Drs. Mark Walderhaug from the USFDA Center for Food Safety and
Applied Nutrition (CFSAN), Brett Kenney from West Virginia University,
Doris Farmer from the USFDA Office of Regulatory Affairs (ORA), and
Virginia L. Miller from Washington University for providing the
Salmonella test and control strains. We thank Dr. Ronald Lorentzen from
CFSAN for the travel fund from the USFDA Scientific Collaboration
Program between CFSAN and the National Center for Toxicological Research
(NCTR). We are grateful to Drs. James J. Chen, John Sutherland, Chris A.
Elkins, Huizhong Chen, and Nathan Twaddle for critical reading of this
manuscript. Wen Zou and Jing Han acknowledge support of their
fellowships from the Oak Ridge Institute for Science and Education,
administered through an interagency agreement between the US Department
of Energy and the US Food and Drug Administration.
NR 31
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Z9 26
U1 0
U2 5
PU J INFECTION DEVELOPING COUNTRIES
PI TRAMANIGLIO
PA JIDC CENT OFF PORTO CONTE RICERCHE RES CTR, S P 55, PORTO CONTE CAPO
CACCIA KM 8.400 LOC, TRAMANIGLIO, 07041, ITALY
SN 1972-2680
J9 J INFECT DEV COUNTR
JI J. Infect. Dev. Ctries.
PD FEB
PY 2011
VL 5
IS 2
BP 94
EP 105
PG 12
WC Infectious Diseases
SC Infectious Diseases
GA 905BR
UT WOS:000301246800003
PM 21389588
ER
PT J
AU Macintyre, HL
Stutes, AL
Smith, WL
Dorsey, CP
Abraham, A
Dickey, RW
AF Macintyre, Hugh L.
Stutes, Adrienne L.
Smith, William L.
Dorsey, Carol P.
Abraham, Ann
Dickey, Robert W.
TI Environmental correlates of community composition and toxicity during a
bloom of Pseudo-nitzschia spp. in the northern Gulf of Mexico
SO JOURNAL OF PLANKTON RESEARCH
LA English
DT Article
DE Pseudo-nitzschia; bloom; pigment; domoic acid; temperature; groundwater
discharge
ID DOMOIC ACID PRODUCTION; INORGANIC CARBON ACQUISITION; HARMFUL ALGAL
BLOOMS; MARINE-PHYTOPLANKTON; RUBISCO ACTIVASE; ELECTRON-TRANSPORT;
PHOTOSYNTHETIC PARAMETERS; TEMPERATURE ADAPTATION; SILICATE LIMITATION;
SPECTRAL ABSORPTION
AB The potentially toxic diatom genus Pseudo-nitzschia is a common component of the microalgal assemblage in the northern Gulf of Mexico. We characterized community structure in Mobile Bay and the adjacent littoral Gulf in a bloom year (2005) and non-bloom year (2006). In both cases, a shift from domination by eukaryotes to cyanobacteria was correlated with seasonal changes in temperature, whereas the overall biomass was correlated with total nutrient concentrations down the estuarine salinity gradient. The bloom of Pseudo-nitzschia spp. followed a period of high discharge from local aquifers that are highly contaminated with nitrate. The diatom assemblage in both bloom and non-bloom years was dominated by a suite of 12 common genera that formed three distinct clusters. The first cluster contained a single centric genus and dominated only a small fraction of samples. The second comprised four benthic and tychopelagic genera and was most common inside the shallow waters of Mobile Bay. The third comprised seven planktonic genera, including Pseudo-nitzschia spp., which was most closely associated with two well-described bloom-forming genera, Chaeloceros and Skeletonema. We argue that these occupy a ruderal niche, blooming after peaks in discharge of submarine groundwater along the littoral Gulf of Mexico. The 2005 bloom of Pseudo-nitzschia spp. was toxic, with domoic acid concentrations reaching 8.0 mu g L(-1) and mean cell toxin quotas reaching 4.9 pg cell(-1). The mean cell toxin quotas were highly correlated (R = 0.97) with a multivariate statistic based on environmental data and were maximal at low silicate concentration, high salinity and dissolved inorganic carbon, and high irradiance. The correlations are consistent with photoacclimative status, with toxicity being highest under conditions likely to lead to excess "photon pressure", an imbalance between generation of photosynthetic reductant and its consumption downstream.
C1 [Macintyre, Hugh L.; Stutes, Adrienne L.] Dauphin Isl Sea Lab, Dauphin Isl, AL 36528 USA.
[Macintyre, Hugh L.] Dalhousie Univ, Dept Oceanog, Halifax, NS B3H 4J1, Canada.
[Stutes, Adrienne L.] Hart Crowser Inc, Seattle, WA 98109 USA.
[Smith, William L.; Dorsey, Carol P.; Abraham, Ann] Alabama Dept Publ Hlth, Mobile Div Lab, Mobile, AL 36608 USA.
US FDA, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
RP Macintyre, HL (reprint author), Dauphin Isl Sea Lab, 101 Bienville Blvd, Dauphin Isl, AL 36528 USA.
EM hugh.macintyre@dal.ca
RI MacIntyre, Hugh/B-4555-2011
OI MacIntyre, Hugh/0000-0002-8852-6984
FU EPA Alabama Center for Estuarine Research; Alabama Oyster Reef
Restoration Program; Mobile Bay National Estuary Program
FX Aspects of this work were supported by grants from EPA Alabama Center
for Estuarine Research, Alabama Oyster Reef Restoration Program and the
Mobile Bay National Estuary Program to HM.
NR 123
TC 22
Z9 22
U1 3
U2 43
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0142-7873
J9 J PLANKTON RES
JI J. Plankton Res.
PD FEB
PY 2011
VL 33
IS 2
BP 273
EP 295
DI 10.1093/plankt/fbq146
PG 23
WC Marine & Freshwater Biology; Oceanography
SC Marine & Freshwater Biology; Oceanography
GA 716FC
UT WOS:000286953500007
ER
PT J
AU Plinston, C
Hart, P
Chong, A
Hunter, N
Foster, J
Piccardo, P
Manson, JC
Barron, RM
AF Plinston, Chris
Hart, Patricia
Chong, Angela
Hunter, Nora
Foster, James
Piccardo, Pedro
Manson, Jean C.
Barron, Rona M.
TI Increased Susceptibility of Human-PrP Transgenic Mice to Bovine
Spongiform Encephalopathy Infection following Passage in Sheep
SO JOURNAL OF VIROLOGY
LA English
DT Article
ID CREUTZFELDT-JAKOB-DISEASE; HUMAN PRION PROTEIN; HUMAN TRANSMISSION; BSE
INFECTIVITY; SCRAPIE AGENT; VARIANT CJD; STRAIN; BRAIN; VCJD; GOAT
AB The risk of the transmission of ruminant transmissible spongiform encephalopathy (TSE) to humans was thought to be low due to the lack of association between sheep scrapie and the incidence of human TSE. However, a single TSE agent strain has been shown to cause both bovine spongiform encephalopathy (BSE) and human vCJD, indicating that some ruminant TSEs are transmissible to humans. While the transmission of cattle BSE to humans in transgenic mouse models has been inefficient, indicating the presence of a significant transmission barrier between cattle and humans, BSE has been transmitted to a number of other species. Here, we aimed to further investigate the human transmission barrier following the passage of BSE in a sheep. Following inoculation with cattle BSE, gene-targeted transgenic mice expressing human PrP showed no clinical or pathological signs of TSE disease. However, following inoculation with an isolate of BSE that had been passaged through a sheep, TSE-associated vacuolation and proteinase K-resistant PrP deposition were observed in mice homozygous for the codon 129-methionine PRNP gene. This observation may be due to higher titers of the BSE agent in sheep or an increased susceptibility of humans to BSE prions following passage through a sheep. However, these data confirm that, contrary to previous predictions, it is possible that a sheep prion is transmissible to humans and that BSE from other species is a public health risk.
C1 [Plinston, Chris; Hart, Patricia; Chong, Angela; Hunter, Nora; Foster, James; Piccardo, Pedro; Manson, Jean C.; Barron, Rona M.] Univ Edinburgh, Roslin Inst, Neuropathogenesis Div, Roslin EH25 9PS, Midlothian, Scotland.
[Plinston, Chris; Hart, Patricia; Chong, Angela; Hunter, Nora; Foster, James; Piccardo, Pedro; Manson, Jean C.; Barron, Rona M.] Univ Edinburgh, RDSVS, Roslin EH25 9PS, Midlothian, Scotland.
[Piccardo, Pedro] US FDA, Lab Bacterial & TSE Agents, Rockville, MD 20857 USA.
RP Barron, RM (reprint author), Univ Edinburgh, Roslin Inst, Neuropathogenesis Div, Roslin EH25 9PS, Midlothian, Scotland.
EM rona.barron@roslin.ed.ac.uk
RI Barron, Rona/C-7703-2013;
OI Barron, Rona/0000-0003-4512-9177; Hart, Patricia/0000-0002-9634-3483
FU United Kingdom Department for Environment, Food and Rural Affairs
(Defra) [SE1439, SE1441]; NIH-NIAID [Y1-A1-4893-02, 224-05-1307]
FX This work was funded by contracts SE1439 and SE1441 from the United
Kingdom Department for Environment, Food and Rural Affairs (Defra), and
NIH-NIAID agreement Y1-A1-4893-02 and FDA agreement 224-05-1307.
NR 31
TC 26
Z9 26
U1 0
U2 7
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
J9 J VIROL
JI J. Virol.
PD FEB
PY 2011
VL 85
IS 3
BP 1174
EP 1181
DI 10.1128/JVI.01578-10
PG 8
WC Virology
SC Virology
GA 705PC
UT WOS:000286147400002
PM 21084466
ER
PT J
AU Freed, M
de Zwart, JA
Loud, JT
El Khouli, RH
Myers, KJ
Greene, MH
Duyn, JH
Badano, A
AF Freed, Melanie
de Zwart, Jacco A.
Loud, Jennifer T.
El Khouli, Riham H.
Myers, Kyle J.
Greene, Mark H.
Duyn, Jeff H.
Badano, Aldo
TI An anthropomorphic phantom for quantitative evaluation of breast MRI
SO MEDICAL PHYSICS
LA English
DT Article
DE breast imaging; phantom; standardization; MRI
ID CONTRAST-ENHANCED MRI; PREOPERATIVE ASSESSMENT; PARAMETER-ESTIMATION;
SURGICAL-MANAGEMENT; DIAGNOSTIC-ACCURACY; RELAXATION-TIMES; CANCER;
TISSUE; IMPACT; OPTIMIZATION
AB Purpose: In this study, the authors aim to develop a physical, tissue-mimicking phantom for quantitative evaluation of breast MRI protocols. The objective of this phantom is to address the need for improved standardization in breast MRI and provide a platform for evaluating the influence of image protocol parameters on lesion detection and discrimination. Quantitative comparisons between patient and phantom image properties are presented.
Methods: The phantom is constructed using a mixture of lard and egg whites, resulting in a random structure with separate adipose- and glandular-mimicking components. T(1) and T(2) relaxation times of the lard and egg components of the phantom were estimated at 1.5 T from inversion recovery and spin-echo scans, respectively, using maximum-likelihood methods. The image structure was examined quantitatively by calculating and comparing spatial covariance matrices of phantom and patient images. A static, enhancing lesion was introduced by creating a hollow mold with stereolithography and filling it with a gadolinium-doped water solution.
Results: Measured phantom relaxation values fall within 2 standard errors of human values from the literature and are reasonably stable over 9 months of testing. Comparison of the covariance matrices of phantom and patient data demonstrates that the phantom and patient data have similar image structure. Their covariance matrices are the same to within error bars in the anterior-posterior direction and to within about two error bars in the right-left direction. The signal from the phantom's adipose-mimicking material can be suppressed using active fat-suppression protocols. A static, enhancing lesion can also be included with the ability to change morphology and contrast agent concentration.
Conclusions: The authors have constructed a phantom and demonstrated its ability to mimic human breast images in terms of key physical properties that are relevant to breast MRI. This phantom provides a platform for the optimization and standardization of breast MRI imaging protocols for lesion detection and characterization. [DOI: 10.1118/1.3533899]
C1 [Freed, Melanie; Myers, Kyle J.; Badano, Aldo] US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Freed, Melanie] Univ Maryland, Dept Bioengn, College Pk, MD 20742 USA.
[de Zwart, Jacco A.; Duyn, Jeff H.] Natl Inst Neurol Disorders & Stroke, Adv MRI Sect, Lab Funct & Mol Imaging, NIH, Bethesda, MD USA.
[Loud, Jennifer T.; Greene, Mark H.] NCI, Clin Genet Branch, Div Canc Epidemiol & Genet, NIH, Bethesda, MD 20892 USA.
[El Khouli, Riham H.] NIH, Dept Radiol & Imaging Sci, Bethesda, MD 20892 USA.
[El Khouli, Riham H.] Johns Hopkins Univ, Sch Med, Dept Radiol, Baltimore, MD 21205 USA.
[El Khouli, Riham H.] Suez Canal Univ, Sch Med, Dept Diagnost Radiol, Ismailia, Egypt.
RP Freed, M (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 melanie.freed@fda.hhs.gov
OI badano, aldo/0000-0003-3712-6670
FU Office of Women's Health at the Food and Drug Administration; Center for
Devices and Radiological Health; U.S. Department of Energy; U.S. Food
and Drug Administration; NINDS/NIH; NCI
FX The authors thank Rachel Brem (GWU Hospital), Brian Garra (FDA/CDRH),
and Eileen Thompson (GWU Hospital) for acquisition of GE clinical images
of the phantom; Eugene O'Bryan, Randy Bidinger, and Bruce Fleharty
(FDA/CDRH) for advice on design and construction of custom phantom jars;
Brandon D. Gallas (FDA/CDRH) for discussions on covariance matrices and
maximum-likelihood estimation; Christian Graff for discussions on
bounded maximization; and Han Wen (NHLBI/NIH) for providing MRI scan
time. The authors also acknowledge the use of facilities in Radiology
and Imaging Sciences at the NIH Clinical Center. This study was
supported, in part, by a research grant from the Office of Women's
Health at the Food and Drug Administration. This project was supported,
in part, by an appointment to the Research Participation Program at the
Center for Devices and Radiological Health administered by 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. This research was sponsored, in part, by the Intramural
Research Program of NINDS/NIH. J. T. Loud and M. H. Greene were
supported by funding from the NCI Intramural Research Program.
NR 60
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U1 0
U2 10
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 2011
VL 38
IS 2
BP 743
EP 753
DI 10.1118/1.3533899
PG 11
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 716DI
UT WOS:000286945000022
PM 21452712
ER
PT J
AU Armato, SG
McLennan, G
Bidaut, L
McNitt-Gray, MF
Meyer, CR
Reeves, AP
Zhao, BS
Aberle, DR
Henschke, CI
Hoffman, EA
Kazerooni, EA
MacMahon, H
van Beek, EJR
Yankelevitz, D
Biancardi, AM
Bland, PH
Brown, MS
Engelmann, RM
Laderach, GE
Max, D
Pais, RC
Qing, DPY
Roberts, RY
Smith, AR
Starkey, A
Batra, P
Caligiuri, P
Farooqi, A
Gladish, GW
Jude, CM
Munden, RF
Petkovska, I
Quint, LE
Schwartz, LH
Sundaram, B
Dodd, LE
Fenimore, C
Gur, D
Petrick, N
Freymann, J
Kirby, J
Hughes, B
Casteele, AV
Gupte, S
Sallam, M
Heath, MD
Kuhn, MH
Dharaiya, E
Burns, R
Fryd, DS
Salganicoff, M
Anand, V
Shreter, U
Vastagh, S
Croft, BY
Clarke, LP
AF Armato, Samuel G., III
McLennan, Geoffrey
Bidaut, Luc
McNitt-Gray, Michael F.
Meyer, Charles R.
Reeves, Anthony P.
Zhao, Binsheng
Aberle, Denise R.
Henschke, Claudia I.
Hoffman, Eric A.
Kazerooni, Ella A.
MacMahon, Heber
van Beek, Edwin J. R.
Yankelevitz, David
Biancardi, Alberto M.
Bland, Peyton H.
Brown, Matthew S.
Engelmann, Roger M.
Laderach, Gary E.
Max, Daniel
Pais, Richard C.
Qing, David P-Y
Roberts, Rachael Y.
Smith, Amanda R.
Starkey, Adam
Batra, Poonam
Caligiuri, Philip
Farooqi, Ali
Gladish, Gregory W.
Jude, C. Matilda
Munden, Reginald F.
Petkovska, Iva
Quint, Leslie E.
Schwartz, Lawrence H.
Sundaram, Baskaran
Dodd, Lori E.
Fenimore, Charles
Gur, David
Petrick, Nicholas
Freymann, John
Kirby, Justin
Hughes, Brian
Casteele, Alessi Vande
Gupte, Sangeeta
Sallam, Maha
Heath, Michael D.
Kuhn, Michael H.
Dharaiya, Ekta
Burns, Richard
Fryd, David S.
Salganicoff, Marcos
Anand, Vikram
Shreter, Uri
Vastagh, Stephen
Croft, Barbara Y.
Clarke, Laurence P.
TI The Lung Image Database Consortium, (LIDC) and Image Database Resource
Initiative (IDRI): A Completed Reference Database of Lung Nodules on CT
Scans
SO MEDICAL PHYSICS
LA English
DT Article
DE lung nodule; computed tomography (CT); thoracic imaging; interobserver
variability; computer-aided diagnosis (CAD)
ID COMPUTED-TOMOGRAPHY SCANS; PULMONARY NODULES; SCREENING TRIAL; AIDED
DETECTION; CANCER; TRUTH; PERFORMANCE; SELECTION; NELSON; CAD
AB Purpose: The development of computer-aided diagnostic (CAD) methods for lung nodule detection, classification, and quantitative assessment can be facilitated through a well-characterized repository of computed tomography (CT) scans. The Lung Image Database Consortium (LIDC) and Image Database Resource Initiative (IDRI) completed such a database, establishing a publicly available reference for the medical imaging research community. Initiated by the National Cancer Institute (NCI), further advanced by the Foundation for the National Institutes of Health (FNIH), and accompanied by the Food and Drug Administration (FDA) through active participation, this public-private partnership demonstrates the success of a consortium founded on a consensus-based process.
Methods: Seven academic centers and eight medical imaging companies collaborated to identify, address, and resolve challenging organizational, technical, and clinical issues to provide a solid foundation for a robust database. The LIDC/IDRI Database contains 1018 cases, each of which includes images from a clinical thoracic CT scan and an associated XML file that records the results of a two-phase image annotation process performed by four experienced thoracic radiologists. In the initial blinded-read phase, each radiologist independently reviewed each CT scan and marked lesions belonging to one of three categories ("nodule >= 3 mm," "nodule < 3 mm," and "non-nodule >= 3 mm"). In the subsequent unblinded-read phase, each radiologist independently reviewed their own marks along with the anonymized marks of the three other radiologists to render a final opinion. The goal of this process was to identify as completely as possible all lung nodules in each CT scan without requiring forced consensus.
Results: The Database contains 7371 lesions marked "nodule" by at least one radiologist. 2669 of these lesions were marked "nodule >= 3 mm" by at least one radiologist, of which 928 (34.7%) received such marks from all four radiologists. These 2669 lesions include nodule outlines and subjective nodule characteristic ratings.
Conclusions: The LIDC/IDRI Database is expected to provide an essential medical imaging research resource to spur CAD development, validation, and dissemination in clinical practice. [DOI: 10.1118/1.3528204]
C1 [Armato, Samuel G., III; MacMahon, Heber; Engelmann, Roger M.; Roberts, Rachael Y.; Caligiuri, Philip] Univ Chicago, Dept Radiol, Chicago, IL 60637 USA.
[McLennan, Geoffrey] Univ Iowa, Carver Coll Med, Dept Internal Med, Div Pulm, Iowa City, IA 52242 USA.
[McNitt-Gray, Michael F.; Aberle, Denise R.; Brown, Matthew S.; Pais, Richard C.; Qing, David P-Y; Batra, Poonam; Jude, C. Matilda; Petkovska, Iva] Univ Calif Los Angeles, David Geffen Sch Med, Dept Radiol Sci, Los Angeles, CA 90024 USA.
[Meyer, Charles R.] Univ Michigan, Dept Radiol, Sch Med, Ann Arbor, MI 48109 USA.
[Reeves, Anthony P.; Biancardi, Alberto M.] Cornell Univ, Sch Elect & Comp Engn, Ithaca, NY 14853 USA.
[Zhao, Binsheng] Mem Sloan Kettering Canc Ctr, Dept Med Phys, New York, NY 10065 USA.
[Henschke, Claudia I.; Yankelevitz, David; Max, Daniel; Farooqi, Ali] Mt Sinai Sch Med, Dept Radiol, New York, NY 10029 USA.
[Hoffman, Eric A.; van Beek, Edwin J. R.; Smith, Amanda R.] Univ Iowa, Carver Coll Med, Dept Radiol, Iowa City, IA 52242 USA.
[Kazerooni, Ella A.] Univ Michigan Hlth Syst, Dept Radiol, Cardiovasc Ctr 5482, Ann Arbor, MI 48109 USA.
[Bland, Peyton H.; Laderach, Gary E.] Univ Michigan, Dept Radiol, BSRB A502, Ann Arbor, MI 48109 USA.
[Gladish, Gregory W.] Univ Texas MD Anderson Canc Ctr, Dept Diagnost Radiol, Unit 1478, Houston, TX 77030 USA.
[Munden, Reginald F.] Univ Texas MD Anderson Canc Ctr, Dept Diagnost Imaging, Unit 1478, Houston, TX 77030 USA.
[Schwartz, Lawrence H.] Mem Sloan Kettering Canc Ctr, Dept Radiol, New York, NY 10065 USA.
[Sundaram, Baskaran] Univ Michigan Hlth Syst, Dept Radiol, CVC 5481, Ann Arbor, MI 48109 USA.
[Fenimore, Charles] NIST, Informat Access Div, Gaithersburg, MD 20899 USA.
[Gur, David] Univ Pittsburgh, Dept Radiol, Pittsburgh, PA 15213 USA.
[Petrick, Nicholas] US FDA, Silver Spring, MD 20993 USA.
[Freymann, John; Kirby, Justin] SAIC Frederick Inc, Bethesda, MD 20892 USA.
[Hughes, Brian] TerpSys, Rockville, MD 20852 USA.
[Casteele, Alessi Vande] Agfa HealthCare NV, B-2640 Mortsel, Belgium.
[Gupte, Sangeeta] FUJIFILM Med Syst USA Inc, Stamford, CT 06902 USA.
[Sallam, Maha] iCAD Inc, Nashua, NH 03062 USA.
[Heath, Michael D.] Carestream Hlth Inc, Rochester, NY 14615 USA.
[Kuhn, Michael H.] Philips Med Syst DMC GmbH, D-22315 Hamburg, Germany.
[Dharaiya, Ekta] Philips Healthcare, Highland Hts, OH 44143 USA.
[Burns, Richard; Fryd, David S.] Riverain Med, Miamisburg, OH 45342 USA.
[Salganicoff, Marcos; Anand, Vikram] Siemens Med Solut USA Inc, Malvern, PA 19355 USA.
[Shreter, Uri] GE Healthcare, Waukesha, WI 53188 USA.
[Vastagh, Stephen] Med Imaging & Technol Alliance, Arlington, VA 22209 USA.
[Croft, Barbara Y.; Clarke, Laurence P.] NCI, Canc Imaging Program, Bethesda, MD 20892 USA.
[Henschke, Claudia I.] Weill Cornell Med Coll, Dept Radiol, New York, NY USA.
RP Armato, SG (reprint author), Univ Chicago, Dept Radiol, 5841 S Maryland Ave,MC 2026, Chicago, IL 60637 USA.
EM s-armato@uchicago.edu
RI Croft, Barbara/D-1248-2013;
OI Croft, Barbara/0000-0003-2544-150X; Bidaut, Luc/0000-0001-8253-2606;
Munden, Reginald/0000-0003-3836-5067; Aberle, Denise/0000-0002-8858-3401
FU USPHS [U01CA091085, U01CA091090, U01CA091099, U01CA091100, U01CA091103];
NCI [HHSN261200800001E]; Foundation for the National Institutes of
Health; University of Chicago; American Legacy Foundation; Flight
Attendants' Medical Research Institute; AstraZeneca, Inc.;
GlaxoSmithKline and Carestream Health Inc.
FX This paper is dedicated to the memory of Geoffrey McLennan, M. D.,
Ph.D., who served as the Chair of the LIDC/IDRI Steering Committee since
the inception of the project. Dr. McLennan provided the constant source
of motivation, perspective, and determination that moved this database
from an idea to reality. His extraordinary scientific and clinical
vision, combined with his unfettered perseverance and uncompromising
optimism, will be greatly missed by all his co-authors, colleagues, and
friends. The authors would like express their sincere appreciation to
the late Robert F. Wagner, Ph.D., whose enlightened perspective on
medical image analysis performance studies provided the foundation for
the statistical considerations on which the LIDC/IDRI Database was
founded. Supported in part by USPHS Grant Nos. U01CA091085, U01CA091090,
U01CA091099, U01CA091100, and U01CA091103 and by NCI Contract No.
HHSN261200800001E. Funding was obtained through the Foundation for the
National Institutes of Health from contributions provided by the medical
imaging companies that participated in the IDRI. Disclosure statement:
S. G. A. and H. M. receive royalties and licensing fees through the
University of Chicago related to computer-aided diagnosis. H. M. is a
consultant to Riverain, a company that produces software for lung nodule
detection. A. P. R. is a paid consultant of and holds stock in
VisionGate, Inc. A. P. R. is a coinventor on a patent and other pending
patents owned by Cornell Research Foundation which are non-exclusively
licensed to General Electric and are related to technology involving
computer-aided diagnostic methods, including measurement of nodules. A.
P. R. receives research support in the form of grants and contracts
from: NCI, American Legacy Foundation, Flight Attendants' Medical
Research Institute, AstraZeneca, Inc., GlaxoSmithKline and Carestream
Health Inc. D.Y. is a named inventor on a number of patents and patent
applications relating to the evaluation of diseases of the chest
including measurement of nodules. Some of these, which are owned by
Cornell Research Foundation (CRF) are nonexclusively licensed to General
Electric. As an inventor of these patents, D.Y. is entitled to a share
of any compensation which CRF may receive from its commercialization of
these patents.
NR 45
TC 139
Z9 144
U1 3
U2 38
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 2011
VL 38
IS 2
BP 915
EP 931
DI 10.1118/1.3528204
PG 17
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 716DI
UT WOS:000286945000038
PM 21452728
ER
PT J
AU Kurhanewicz, J
Vigneron, DB
Brindle, K
Chekmenev, EY
Comment, A
Cunningham, CH
DeBerardinis, RJ
Green, GG
Leach, MO
Rajan, SS
Rizi, RR
Ross, BD
Warren, WS
Malloy, CR
AF Kurhanewicz, John
Vigneron, Daniel B.
Brindle, Kevin
Chekmenev, Eduard Y.
Comment, Arnaud
Cunningham, Charles H.
DeBerardinis, Ralph J.
Green, Gary G.
Leach, Martin O.
Rajan, Sunder S.
Rizi, Rahim R.
Ross, Brian D.
Warren, Warren S.
Malloy, Craig R.
TI Analysis of Cancer Metabolism by Imaging Hyperpolarized Nuclei:
Prospects for Translation to Clinical Research
SO NEOPLASIA
LA English
DT Article
ID MAGNETIC-RESONANCE-SPECTROSCOPY; C-13 MR SPECTROSCOPY; TUMOR-CELL
GROWTH; IN-VIVO; CARBOXYPEPTIDASE G2; NMR-SPECTROSCOPY; CONTRAST AGENT;
BREAST-CANCER; PARA-HYDROGEN; BRAIN-TUMORS
AB A major challenge in cancer biology is to monitor and understand cancer metabolism in vivo with the goal of improved diagnosis and perhaps therapy. Because of the complexity of biochemical pathways, tracer methods are required for detecting specific enzyme-catalyzed reactions. Stable isotopes such as C-13 or N-15 with detection by nuclear magnetic resonance provide the necessary information about tissue biochemistry, but the crucial metabolites are present in low concentration and therefore are beyond the detection threshold of traditional magnetic resonance methods. A solution is to improve sensitivity by a factor of 10,000 or more by temporarily redistributing the populations of nuclear spins in a magnetic field, a process termed hyperpolarization. Although this effect is short-lived, hyperpolarized molecules can be generated in an aqueous solution and infused in vivo where metabolism generates products that can be imaged. This discovery lifts the primary constraint on magnetic resonance imaging for monitoring metabolism-poor sensitivity-while preserving the advantage of biochemical information. The purpose of this report was to briefly summarize the known abnormalities in cancer metabolism, the value and limitations of current imaging methods for metabolism, and the principles of hyperpolarization. Recent preclinical applications are described. Hyperpolarization technology is still in its infancy, and current polarizer equipment and methods are suboptimal. Nevertheless, there are no fundamental barriers to rapid translation of this exciting technology to clinical research and perhaps clinical care.
C1 [Kurhanewicz, John; Vigneron, Daniel B.] Univ Calif San Francisco, Dept Radiol & Biomed Imaging, San Francisco, CA 94158 USA.
[Brindle, Kevin] Univ Cambridge, Dept Biochem, Cambridge CB2 1QW, England.
[Chekmenev, Eduard Y.] Vanderbilt Univ, Dept Radiol, Nashville, TN USA.
[Cunningham, Charles H.] Univ Toronto, Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada.
[Comment, Arnaud] Ecole Polytech Fed Lausanne, Lab Funct & Metab Imaging, Lausanne, Switzerland.
[DeBerardinis, Ralph J.] UT SW Med Ctr, Dept Pediat, Dallas, TX USA.
[Green, Gary G.] Univ York, York Neuroimaging Ctr, York YO10 5DD, N Yorkshire, England.
[Leach, Martin O.] Royal Marsden Hosp, Inst Canc Res, London SW3 6JJ, England.
[Rajan, Sunder S.] US FDA, Ctr Devices & Radiol Hlth, White Oak, MD USA.
[Rizi, Rahim R.] Univ Penn, Dept Radiol, Philadelphia, PA 19104 USA.
[Ross, Brian D.] Huntington Med Res Inst, Dept Magnet Resonance Spect, Pasadena, CA USA.
[Warren, Warren S.] Duke Univ, Dept Chem, Durham, NC 27706 USA.
[Malloy, Craig R.] UT SW Med Ctr, Adv Imaging Res Ctr, Dallas, TX USA.
[Malloy, Craig R.] VA N Texas Healthcare Syst, Dallas, TX USA.
RP Kurhanewicz, J (reprint author), Univ Calif San Francisco, Dept Radiol & Biomed Imaging, Mission Bay Campus,Byers Hall,Room 203E,1700 4th, San Francisco, CA 94158 USA.
EM John.Kurhanewicz@radiology.ucsf.edu
RI leach, martin/C-2248-2008; Comment, Arnaud/G-5693-2011; Green,
Gary/D-3543-2009; Chekmenev, Eduard/J-5908-2013
OI Chekmenev, Eduard/0000-0002-8745-8801; leach,
martin/0000-0002-0756-5368; Comment, Arnaud/0000-0002-8484-3448; Green,
Gary/0000-0003-1977-7509;
FU NCRR NIH HHS [P41 RR002584]; NIBIB NIH HHS [R01 EB002122]
NR 151
TC 309
Z9 312
U1 10
U2 81
PU NEOPLASIA PRESS
PI ANN ARBOR
PA 1150 W MEDICAL CENTER DR, MSRB III, RM 9303, ANN ARBOR, MI 48109-0648
USA
SN 1522-8002
J9 NEOPLASIA
JI Neoplasia
PD FEB
PY 2011
VL 13
IS 2
BP 81
EP 97
DI 10.1593/neo.101102
PG 17
WC Oncology
SC Oncology
GA 716DC
UT WOS:000286944300001
PM 21403835
ER
PT J
AU Liu, YX
Lo, YC
Qian, L
Crews, FT
Wilson, B
Chen, HL
Wu, HM
Chen, SH
Wei, K
Lu, RB
Ali, S
Hong, JS
AF Liu, Yuxin
Lo, Yi-Ching
Qian, Li
Crews, Fulton Tim
Wilson, Belinda
Chen, Hui-Ling
Wu, Hung-Ming
Chen, Shih-Heng
Wei, Ke
Lu, Ru-Band
Ali, Syed
Hong, Jau-Shyong
TI Verapamil protects dopaminergic neuron damage through a novel
anti-inflammatory mechanism by inhibition of microglial activation
SO NEUROPHARMACOLOGY
LA English
DT Article
DE Calcium channel blocker; Oxidative stress and neuroinflammation
ID CALCIUM-CHANNEL BLOCKERS; LIPOPOLYSACCHARIDE-INDUCED NEUROTOXICITY;
NITRIC-OXIDE SYNTHASE; SUPEROXIDE GENERATION; RACEMIC VERAPAMIL;
CEREBRAL-ISCHEMIA; HUMAN-NEUTROPHILS; NEUROPROTECTION; EXPRESSION;
ANTAGONISTS
AB Verapamil has been shown to be neuroprotective in several acute neurotoxicity models due to blockade of calcium entry into neurons. However, the potential use of veraparnil to treat chronic neurodegenerative diseases has not been reported. Using rat primary mesencephalic neuron/glia cultures, we report that verapamil significantly inhibited LPS-induced dopaminergic neurotoxicity in both pre- and post-treatment experiments. Reconstituted culture studies revealed that the presence of microglia was essential in verapamil-elicited neuroprotection. Mechanistic studies showed that decreased production of inflammatory mediators from LPS-stimulated microglia underlay neuroprotective property of verapamil. Further studies demonstrated that microglial NADPH oxidase (PHOX), the key superoxide-producing enzyme, but not calcium channel in neurons, is the site of action for the neuroprotective effect of verapamil. This conclusion was supported by the following two observations: 1) Verapamil failed to show protective effect on LPS-induced dopaminergic neurotoxicity in PHOX-deficient (deficient in the catalytic subunit of gp91(phox)) neuron/glia cultures: 2) Ligand binding studies showed that the binding of [H-3]Verapamil onto gp91(phox) transfected COS7 cell membranes was higher than the non-transfected control. The calcium channel-independent neuroprotective property of verapamil was further supported by the finding that R(+)-verapamil, a less active form in blocking calcium channel, showed the same potency in neuroprotection, inhibition of pro-inflammatory factors production and binding capacity to gp91(phox) membranes as R(-)-verapamil, the active isomer of calcium channel blocker. In conclusion, our results demonstrate a new indication of verapamil-mediated neuroprotection through a calcium channel-independent pathway and provide a valuable avenue for the development of therapy for inflammation-related neurodegenerative diseases. Published by Elsevier Ltd.
C1 [Liu, Yuxin; Lo, Yi-Ching; Qian, Li; Wilson, Belinda; Chen, Hui-Ling; Wu, Hung-Ming; Chen, Shih-Heng; Wei, Ke; Hong, Jau-Shyong] Natl Inst Environm Hlth Sci, Neuropharmacol Sect, Res Triangle Pk, NC 27709 USA.
[Lo, Yi-Ching] Kaohsiung Med Univ, Dept Pharmacol, Kaohsiung 807, Taiwan.
[Crews, Fulton Tim] Univ N Carolina, Sch Med, Bowles Ctr Alcohol Studies, Chapel Hill, NC 27599 USA.
[Liu, Yuxin] Hebei Univ, Sch Pharmaceut Sci, Lab Cell Pharmacol, Baoding, Peoples R China.
[Chen, Hui-Ling; Wu, Hung-Ming; Chen, Shih-Heng; Lu, Ru-Band] Natl Cheng Kung Univ & Hosp, Dept Psychiat, Tainan, Taiwan.
[Ali, Syed] Neurochem Lab NCTR, Jefferson, AR USA.
RP Hong, JS (reprint author), Natl Inst Environm Hlth Sci, Neuropharmacol Sect, Res Triangle Pk, NC 27709 USA.
EM hong3@niehs.nih.gov
FU National Institutes of Health, National Institute of Environmental
Health Sciences, U.S.A.; NIAAA; UNC Bowles Center for Alcohol Studies,
U.S.A.; National Science Council, Taiwan [NSC-96-2320-B-037-039-MY3]
FX This research was supported by the Intramural Research Program of the
National Institutes of Health, National Institute of Environmental
Health Sciences, U.S.A.; the Extramural grants from NIAAA (FTC) as well
as The UNC Bowles Center for Alcohol Studies (YL and FTC), U.S.A.; and
the National Science Council (grant NSC-96-2320-B-037-039-MY3), Taiwan.
NR 34
TC 12
Z9 12
U1 0
U2 3
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0028-3908
J9 NEUROPHARMACOLOGY
JI Neuropharmacology
PD FEB-MAR
PY 2011
VL 60
IS 2-3
BP 373
EP 380
DI 10.1016/j.neuropharm.2010.10.002
PG 8
WC Neurosciences; Pharmacology & Pharmacy
SC Neurosciences & Neurology; Pharmacology & Pharmacy
GA 717NL
UT WOS:000287054600021
PM 20950631
ER
PT J
AU Mendrick, DL
AF Mendrick, Donna L.
TI Transcriptional profiling to identify biomarkers of disease and drug
response
SO PHARMACOGENOMICS
LA English
DT Review
DE biomarkers; blood gene expression; genomics; microarray; miRNA;
personalized; medicine pharmacogenomics; PMN translational
ID GENE-EXPRESSION PROFILES; BLOOD MONONUCLEAR-CELLS; JUVENILE IDIOPATHIC
ARTHRITIS; CORONARY-ARTERY-DISEASE; INDUCED LIVER-INJURY;
PERIPHERAL-BLOOD; HUNTINGTONS-DISEASE; ISCHEMIC-STROKE; MOLECULAR
CLASSIFICATION; CIRCULATING MICRORNAS
AB The discovery, biological qualification and analytical validation of genomic biomarkers requires extensive collaborations between individuals with expertise in biology, statistics, bioinformatics, chemistry, clinical medicine, regulatory science and so on. For clinical utility, blood-borne biomarkers (e.g., mRNA and miRNA) of organ damage, drug toxicity and/or response would be preferred to those that are tissue based. Currently used biomarkers such as serum creatinine (indicating renal dysfunction) denote organ damage whether caused by disease, physical injury or drugs. Therefore, it is anticipated that studies of disease will discover biomarkers that can also be used to identify drug-induced injury and vice versa. This article describes transcriptomic blood-borne biomarkers that have been reported to be connected with disease and drug toxicity. Much more qualification and validation needs to be carried out before many of these biomarkers can prove useful. Discussed here are some of the lessons learned and roadblocks to success.
C1 US FDA, Div Syst Biol, HFT 230, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Mendrick, DL (reprint author), US FDA, Div Syst Biol, HFT 230, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM donna.mendrick@fda.hhs.gov
NR 89
TC 21
Z9 21
U1 0
U2 11
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1462-2416
J9 PHARMACOGENOMICS
JI Pharmacogenomics
PD FEB
PY 2011
VL 12
IS 2
BP 235
EP 249
DI 10.2217/PGS.10.184
PG 15
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 741RE
UT WOS:000288881000015
PM 21332316
ER
PT J
AU Jacob, CC
Reimschuessel, R
Von Tungeln, LS
Olson, GR
Warbritton, AR
Hattan, DG
Beland, FA
da Costa, GG
AF Jacob, Cristina C.
Reimschuessel, Renate
Von Tungeln, Linda S.
Olson, Greg R.
Warbritton, Alan R.
Hattan, David G.
Beland, Frederick A.
da Costa, Goncalo Gamboa
TI Dose-Response Assessment of Nephrotoxicity from a 7-Day Combined
Exposure to Melamine and Cyanuric Acid in F344 Rats
SO TOXICOLOGICAL SCIENCES
LA English
DT Article
DE melamine; cyanuric acid; melamine cyanurate; nephrotoxicity
ID TOXICITY; CATS
AB The intentional adulteration of pet food with melamine and derivatives, including cyanuric acid, has been implicated in the kidney failure and death of a large number of cats and dogs in the United States. Although individually these compounds present low toxicity, coexposure can lead to the formation of melamine cyanurate crystals in the nephrons and eventual kidney failure. To determine the dose-response for nephrotoxicity upon coadministration of melamine and cyanuric acid, groups of male and female F344 rats (six animals per sex per group) were fed 0 (control), 7, 23, 69, 229, or 694 ppm of both melamine and cyanuric acid; 1388 ppm melamine; or 1388 ppm cyanuric acid in the diet for 7 days. No toxicity was observed in the rats exposed to the individual compounds, whereas anorexia and a statistically significant increase in blood urea nitrogen and serum creatinine levels was observed in the animals treated with 229 and 694 ppm melamine and cyanuric acid. The kidneys of these animals were grossly enlarged and pale yellow. Large numbers of crystalline structures deposited in the tubules were seen on sections in kidneys from all rats in these treatment groups. No significant changes were detected in the remaining treatment groups exposed to both melamine and cyanuric acid. In the melamine-only treatment group, 5 of 12 rats had scattered crystals present in renal tubules when examined by wet mount. These were not observed by histopathology. The observed adverse effect level (8.6 mg/kg bw [body weight]/day) and benchmark dose modeling data (8.4-10.9 mg/kg bw/day) determined in this study suggest that the tolerable daily intake values derived from studies conducted with melamine alone may underestimate the risk from coexposures to melamine and cyanuric acid.
C1 [Jacob, Cristina C.; Von Tungeln, Linda S.; Beland, Frederick A.; da Costa, Goncalo Gamboa] Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
[Reimschuessel, Renate] Ctr Vet Med, Laurel, MD 20708 USA.
[Olson, Greg R.; Warbritton, Alan R.] Toxicol Pathol Associates, Jefferson, AR 72079 USA.
[Hattan, David G.] Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP da Costa, GG (reprint author), Natl Ctr Toxicol Res, Div Biochem Toxicol, HET 233,3900 NCTR Rd, Jefferson, AR 72079 USA.
EM goncalo.gamboa@fda.hhs.gov
RI Jacob, Cristina/A-3885-2015
OI Jacob, Cristina/0000-0003-2652-3865
FU National Center for Toxicological Research/Food and Drug Administration
[224-07-0007]; National Institute for Environmental Health
Sciences/National Toxicology Program
FX National Center for Toxicological Research/Food and Drug Administration
(Interagency Agreement No. 224-07-0007) with the National Institute for
Environmental Health Sciences/National Toxicology Program.
NR 22
TC 32
Z9 33
U1 0
U2 6
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1096-6080
J9 TOXICOL SCI
JI Toxicol. Sci.
PD FEB
PY 2011
VL 119
IS 2
BP 391
EP 397
DI 10.1093/toxsci/kfq333
PG 7
WC Toxicology
SC Toxicology
GA 710XH
UT WOS:000286549800013
PM 21030430
ER
PT J
AU Fux, E
Smith, JL
Tong, MM
Guzman, L
Anderson, DM
AF Fux, Elie
Smith, Juliette L.
Tong, Mengmeng
Guzman, Leonardo
Anderson, Donald M.
TI Toxin profiles of five geographical isolates of Dinophysis spp. from
North and South America
SO TOXICON
LA English
DT Article
DE Dinophysis; Diarrhetic shellfish poisoning; Okadaic acid;
Dinophysistoxin
ID CHROMATOGRAPHY-MASS-SPECTROMETRY; SHELLFISH POISONING TOXINS;
PECTENOTOXIN-2 SECO ACID; MUSSELS MYTILUS-EDULIS; DIARRHETIC SHELLFISH;
OKADAIC ACID; LIQUID-CHROMATOGRAPHY; PROROCENTRUM-LIMA; NEW-ZEALAND;
CAUSATIVE TOXIN
AB Marine dinoflagellates of the genus Dinophysis can produce toxins of the okadaic acid (OA) and pectenotoxin (PTX) groups. These lipophilic toxins accumulate in filter-feeding shellfish and cause an illness in consumers called diarrhetic shellfish poisoning (DSP). In 2008, a bloom of Dinophysis led to the closure of shellfish harvesting areas along the Texas coast, one of the first DSP-related closures in the U.S. This event resulted in a broad study of toxin production in isolates of Dinophysis spp. from U.S. waters. In the present study, we compared toxin profiles in geographical isolates of Dinophysis collected in the U.S. (Eel Pond, Woods Hole MA; Martha's Vineyard, MA; and Port Aransas Bay, Texas), and in those from Canada (Blacks Harbour, Bay of Fundy) and Chile (Reloncavi Estuary), when cultured in the laboratory under the same conditions. For each isolate, the mitochondrial cox1 gene was sequenced to assist in species identification. Strains from the northeastern U.S. and Canada were all assigned to Dinophysis acuminata, while those from Chile and Texas were most likely within the D. acuminata complex whereas precise species designation could not be made with this marker. Toxins were detected in all Dinophysis isolates and each isolate had a different profile. Toxin profiles of isolates from Eel Pond, Martha's Vineyard, and Bay of Fundy were most similar, in that they all contained OA. DTX1, and PTX2. The Eel Pond isolate also contained OA-D8 and DTX1-D7, and low levels (unconfirmed structurally) of DTX1-D8 and DTX1-D9. D. acuminata from Martha's Vineyard produced DTX1-D7, along with OA, DTX1, and PTX2, as identified in both the cells and the culture medium. D. acuminata from the Bay of Fundy produced DTX1 and PTX2, as found in both cells and culture medium, while only trace amounts of OA were detected in the medium. The Dinophysis strain from Texas only produced OA, and the one from Chile only PTX2, as confirmed in both cells and culture medium. Published by Elsevier Ltd.
C1 [Fux, Elie] US FDA, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
[Smith, Juliette L.; Tong, Mengmeng; Anderson, Donald M.] Woods Hole Oceanog Inst, Dept Biol, Woods Hole, MA 02543 USA.
[Tong, Mengmeng] Nankai Univ, Coll Environm Sci & Engn, Tianjin 300071, Peoples R China.
[Guzman, Leonardo] Inst Fomento Pesquero, Balmaceda 252, Puerto Montt, Chile.
RP Fux, E (reprint author), US FDA, Gulf Coast Seafood Lab, 1 Iberville Dr, Dauphin Isl, AL 36528 USA.
EM eliefux@hotmail.com
RI tong, mengmeng/B-2669-2012; Toxinas, Inct/I-1933-2013
FU NSF [OCE-0850421]; Ocean Life Institute; Coastal Ocean Institute at the
Woods Hole Oceanographic Institution; Woods Hole Center for Oceans and
Human Health through NSF [OCE-0430724]; NIEHS [1 P50 ES012742]; Ministry
of Education, People's Republic of China [707011]; China Scholarship
Council; Food and Drug Administration
FX Funding was provided by NSF Grant OCE-0850421, the Ocean Life Institute
and the Coastal Ocean Institute at the Woods Hole Oceanographic
Institution, and the Woods Hole Center for Oceans and Human Health
through NSF grant OCE-0430724 and NIEHS grant 1 P50 ES012742. MMT would
like to thank the Ministry of Education, People's Republic of China for
financial support as a Grand Fostering Project (No. 707011) and the
China Scholarship Council. This project was supported in part by an
appointment to the Research Participation Program administered by the
Oak Ridge Institute for Science and Education through an agreement with
the for the Food and Drug Administration. We also thank Dr. Jeremiah D.
Hackett (Department of Ecology and Evolutionary Biology, University of
Arizona, USA) who helped in the isolation of Dinophysis and Dr.
Christopher Miles (Norway's National Veterinary Institute) and Dr.
Michael Quilliam (NRC - Canada) for their generous gifts of PTX11 and
OA-D8, respectively. We also would like to thank Deana L Erdner from the
University of Texas Marine Science Institute, Port Aransas, for
supplying the isolate from this location as well as Dave Kulis (Woods
Hole Oceanographic Institution) for collecting the samples from the Bay
of Fundy. Thanks to Dr. Steve Plakas from the FDA, Gulf Coast Seafood
laboratory, Dauphin Island, USA, for his very valuable comments on this
manuscript.
NR 70
TC 42
Z9 42
U1 0
U2 24
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0041-0101
J9 TOXICON
JI Toxicon
PD FEB
PY 2011
VL 57
IS 2
BP 275
EP 287
DI 10.1016/j.toxicon.2010.12.002
PG 13
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 725FA
UT WOS:000287629400011
PM 21147146
ER
PT J
AU Dasgupta, S
Banerjee, RK
Hariharan, P
Myers, MR
AF Dasgupta, Subhashish
Banerjee, Rupak K.
Hariharan, Prasanna
Myers, Matthew R.
TI Beam localization in HIFU temperature measurements using thermocouples,
with application to cooling by large blood vessels
SO ULTRASONICS
LA English
DT Article
DE HIFU; Beam positioning error; Thermocouple artifacts; Blood flow
cooling; Thermal dose
ID INTENSITY FOCUSED ULTRASOUND; FUNCTION MINIMIZATION; TISSUE; EQUATION;
RADIOFREQUENCY; HYPERTHERMIA; SIMULATIONS; CALIBRATION; ABLATION; FIELD
AB Experimental studies of thermal effects in high-intensity focused ultrasound (HIFU) procedures are often performed with the aid of fine wire thermocouples positioned within tissue phantoms. Thermocouple measurements are subject to several types of error which must be accounted for before reliable inferences can be made on the basis of the measurements. Thermocouple artifact due to viscous heating is one source of error. A second is the uncertainty regarding the position of the beam relative to the target location or the thermocouple junction, due to the error in positioning the beam at the junction. This paper presents a method for determining the location of the beam relative to a fixed pair of thermocouples. The localization technique reduces the uncertainty introduced by positioning errors associated with very narrow HIFU beams. The technique is presented in the context of an investigation into the effect of blood flow through large vessels on the efficacy of HIFU procedures targeted near the vessel. Application of the beam localization method allowed conclusions regarding the effects of blood flow to be drawn from previously inconclusive (because of localization uncertainties) data. Comparison of the position-adjusted transient temperature profiles for flow rates of 0 and 400 ml/min showed that blood flow can reduce temperature elevations by more than 10%, when the HIFU focus is within a 2 mm distance from the vessel wall. At acoustic power levels of 17.3 and 24.8 W there is a 20- to 70-fold decrease in thermal dose due to the convective cooling effect of blood flow, implying a shrinkage in lesion size. The beam-localization technique also revealed the level of thermocouple artifact as a function of sonication time, providing investigators with an indication of the quality of thermocouple data for a given exposure time. The maximum artifact was found to be double the measured temperature rise, during initial few seconds of sonication. (C) 2010 Elsevier B.V. All rights reserved.
C1 [Dasgupta, Subhashish; Banerjee, Rupak K.] Univ Cincinnati, Dept Mech Engn, Cincinnati, OH 45220 USA.
[Banerjee, Rupak K.] Univ Cincinnati, Dept Biomed Engn, Cincinnati, OH 45220 USA.
[Hariharan, Prasanna; Myers, Matthew R.] US FDA, Div Solid & Fluid Mech, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Banerjee, RK (reprint author), Univ Cincinnati, Dept Mech Ind & Nucl Engn, 593 Rhodes Hall,ML 0072, Cincinnati, OH 45221 USA.
EM rupak.banerjee@uc.edu
FU National Science Foundation [0552036]
FX Financial support from the National Science Foundation (Grant No.
0552036) is greatly acknowledged.
NR 32
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U1 0
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0041-624X
J9 ULTRASONICS
JI Ultrasonics
PD FEB
PY 2011
VL 51
IS 2
BP 171
EP 180
DI 10.1016/j.ultras.2010.07.007
PG 10
WC Acoustics; Radiology, Nuclear Medicine & Medical Imaging
SC Acoustics; Radiology, Nuclear Medicine & Medical Imaging
GA 682KC
UT WOS:000284400900009
PM 20817250
ER
PT J
AU Xie, H
Jing, XH
Li, X
Lin, ZS
Plant, E
Zoueva, O
Yang, H
Ye, ZP
AF Xie, Hang
Jing, Xianghong
Li, Xing
Lin, Zhengshi
Plant, Ewan
Zoueva, Olga
Yang, Hong
Ye, Zhiping
TI Immunogenicity and Cross-Reactivity of 2009-2010 Inactivated Seasonal
Influenza Vaccine in US Adults and Elderly
SO PLOS ONE
LA English
DT Article
ID LABORATORY-CONFIRMED INFLUENZA; ANTIBODY-RESPONSES; UNITED-STATES;
VIRUS; CHILDREN; AGE; INFECTION; STRAINS; SERUM; MATCH
AB The campaign of 2009-2010 Northern Hemisphere seasonal vaccination was concurrent with the 2009 H1N1 pandemic. Using a hemagglutination inhibition (HAI) assay, we evaluated the immunogenicity and cross-reactivity of 2009-2010 inactivated trivalent influenza vaccine (TIV) in US adult and elderly populations. Vaccination of TIV resulted in a robust boost on the antibody response of all subjects to seasonal A/Brisbane/59/2007 (H1N1) and A/Uruguay/716/2007 (H3N2) with over 70% of recipients reaching a seroprotective titer of 40. B/Brisbane/60/2008 was the least immunogenic among the three seasonal vaccine strains with <30% of TIV recipients reaching a seroprotective titer of 40. TIV vaccination also induced a moderate boost on the pandemic specific antibody responses. Twenty-four percent of adults and 36% of elderly reached a seroprotective HAI titer of 40 or more against pandemic A/South Carolina/18/2009 (H1N1) after receiving TIV compared to 4% and 7% at the beginning of vaccination, respectively. In addition, 22% of adults and 34% of elderly showed an increase of 4-fold or more in A/South Carolina/18/2009 specific HAI titers after TIV vaccination. The pandemic specific cross-reactive antibodies strongly correlated with the post-vaccination HAI titers against the seasonal H3N2 vaccine strain in all subjects.
C1 [Xie, Hang; Jing, Xianghong; Li, Xing; Lin, Zhengshi; Plant, Ewan; Zoueva, Olga; Ye, Zhiping] US FDA, Lab Resp Viral Dis, Div Viral Prod, Off Vaccine Res & Review, Bethesda, MD 20014 USA.
[Yang, Hong] US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Bethesda, MD USA.
RP Xie, H (reprint author), US FDA, Lab Resp Viral Dis, Div Viral Prod, Off Vaccine Res & Review, Bethesda, MD 20014 USA.
EM Hang.Xie@fda.hhs.gov; Zhiping.Ye@fda.hhs.gov
OI Plant, Ewan/0000-0003-0166-5939
FU Center for Biologics Evaluation; Research/Food and Drug Administration
FX This study was supported by Center for Biologics Evaluation and
Research/Food and Drug Administration institutional research funds. The
funders had no role in study design, data collection and analysis,
decision to publish, or preparation of the manuscript.
NR 27
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U1 0
U2 2
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 31
PY 2011
VL 6
IS 1
AR e16650
DI 10.1371/journal.pone.0016650
PG 7
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 714UK
UT WOS:000286834300109
PM 21304946
ER
PT J
AU Ghosh, P
Ghosh, K
Tiwari, RC
AF Ghosh, Pulak
Ghosh, Kaushik
Tiwari, Ram C.
TI Bayesian approach to cancer-trend analysis using age-stratified Poisson
regression models
SO STATISTICS IN MEDICINE
LA English
DT Article
DE cancer mortality; cancer incidence; cancer surveillance; joinpoint
regression; SEER program; Dirichlet process prior
ID INFORMATION; SELECTION; MIXTURES; RATES
AB Annual Percentage Change (APC) summarizes trends in age-adjusted cancer rates over short time-intervals. This measure implicitly assumes linearity of the log-rates over the intervals in question, which may not be valid, especially for relatively longer time-intervals. An alternative is the Average Annual Percentage Change (AAPC), which computes a weighted average of APC values over intervals where log-rates are piece-wise linear.
In this article, we propose a Bayesian approach to calculating APC and AAPC values from age-adjusted cancer rate data. The procedure involves modeling the corresponding counts using age-specific Poisson regression models with a log-link function that contains unknown joinpoints. The slope-changes at the joinpoints are assumed to have a mixture distribution with point mass at zero and the joinpoints are assumed to be uniformly distributed subject to order-restrictions. Additionally, the age-specific intercept parameters are modeled nonparametrically using a Dirichlet process prior. The proposed method can be used to construct Bayesian credible intervals for AAPC using age-adjusted mortality rates. This provides a significant improvement over the currently available frequentist method, where variance calculations are done conditional on the joinpoint locations.
Simulation studies are used to demonstrate the success of the method in capturing trend-changes. Finally, the proposed method is illustrated using data on prostate cancer incidence. Copyright (C) 2010 John Wiley & Sons, Ltd.
C1 [Ghosh, Kaushik] Univ Nevada, Dept Math Sci, Las Vegas, NV 89154 USA.
[Ghosh, Pulak] Indian Inst Management, Dept Quantitat Methods & Informat Syst, Bangalore 560076, Karnataka, India.
[Tiwari, Ram C.] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Ghosh, K (reprint author), Univ Nevada, Dept Math Sci, 4505 Maryland Pkwy,Box 454020, Las Vegas, NV 89154 USA.
EM kaushik.ghosh@unlv.edu
NR 29
TC 2
Z9 2
U1 1
U2 7
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 0277-6715
J9 STAT MED
JI Stat. Med.
PD JAN 30
PY 2011
VL 30
IS 2
BP 127
EP 139
DI 10.1002/sim.4077
PG 13
WC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Medicine, Research &
Experimental; Statistics & Probability
SC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Research & Experimental
Medicine; Mathematics
GA 701TU
UT WOS:000285847100002
PM 20839366
ER
PT J
AU Koenig, HC
Sutherland, A
Izurieta, HS
McGonagle, D
AF Koenig, Helen C.
Sutherland, Andrea
Izurieta, Hector S.
McGonagle, Dennis
TI Application of the immunological disease continuum to study autoimmune
and other inflammatory events after vaccination
SO VACCINE
LA English
DT Article
DE Autoimmune diseases; Immunological disease continuum; Vaccine safety
surveillance; Vaccine adverse events
ID GUILLAIN-BARRE-SYNDROME; TOLL-LIKE RECEPTORS; ARTHRITIS FOLLOWING
TETANUS; HEPATITIS-B VACCINATION; REPORTING SYSTEM VAERS;
CENTRAL-NERVOUS-SYSTEM; REACTIVE ARTHRITIS; ADVERSE EVENTS; MOLECULAR
MIMICRY; IMMUNE-COMPLEXES
AB In vaccine safety monitoring, the evaluation of possible autoimmune events is challenging. Developing grouping systems based on pathophysiology, instead of organ systems, may enhance our ability to identify or verify associations between vaccines and adverse immunologically mediated events in clinical trials and post-licensure surveillance. Emerging data suggest that self-directed tissue inflammation occurs along a continuum from innate immune-driven diseases to adaptive immune-driven diseases. Herein, we develop this proposed classification for the vaccination setting in which inflammatory diseases are placed along a continuum according to the two major arms of the immune system, the innate immune arm (mediated by cells including neutrophils, macrophages and complement) and the adaptive immune arm (cell-mediated and humoral response). We incorporate hypersensitivity reactions and molecular mimicry vaccine-related reactions into this mechanistic scheme. We show how this could have important implications to assess mechanisms of potential immune-mediated adverse events following vaccination. (C) 2010 Published by Elsevier Ltd.
C1 [McGonagle, Dennis] Chapel Allerton Hosp, Leeds Inst Mol Med, Sect Musculoskeletal Dis, Leeds LS7 4SA, W Yorkshire, England.
[Koenig, Helen C.; Sutherland, Andrea; Izurieta, Hector S.] Ctr Biol Evaluat & Res, Food & Drug Adm, Rockville, MD USA.
[McGonagle, Dennis] Univ Leeds, Leeds NIHR Biomed Res Unit, Leeds Inst Mol Med, Leeds, W Yorkshire, England.
RP McGonagle, D (reprint author), Chapel Allerton Hosp, Leeds Inst Mol Med, Sect Musculoskeletal Dis, Chapeltown Rd, Leeds LS7 4SA, W Yorkshire, England.
EM d.g.mcgonagle@leeds.ac.uk
FU UK National Institute of Health Research; WELMEC; Wellcome Trust; EPSRC
[WT 088908/Z/09/Z]; UK National Institute of Health Research and
Arthritis Research UK
FX We would like to thank Drs. Douglas Pratt, Alexandra S. Worobec and Jay
Slater, from the Center for Biologics Evaluation and Research, Food and
Drug Administration, and Dr. Noel Rose, from Johns Hopkins Bloomberg
School of Public Health, for their critical review of this manuscript.
Dr. McGonagle's work is funded in part by the UK National Institute of
Health Research and in part through WELMEC, a Centre of Excellence in
Medical Engineering funded by the Wellcome Trust and EPSRC, under grant
number WT 088908/Z/09/Z.; Dr. McGonagle is funded by the UK National
Institute of Health Research and Arthritis Research UK. There were no
other funding sources for the preparation of this manuscript.
NR 101
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U1 0
U2 2
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 JAN 29
PY 2011
VL 29
IS 5
BP 913
EP 919
DI 10.1016/j.vaccine.2010.10.044
PG 7
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 720QS
UT WOS:000287295800009
PM 21036134
ER
PT J
AU Delmonte, P
Kia, ARF
Kramer, JKG
Mossoba, MM
Sidisky, L
Rader, JI
AF Delmonte, Pierluigi
Kia, Ali-Reza Fardin
Kramer, John K. G.
Mossoba, Magdi M.
Sidisky, Len
Rader, Jeanne I.
TI Separation characteristics of fatty acid methyl esters using SLB-IL111,
a new ionic liquid coated capillary gas chromatographic column
SO JOURNAL OF CHROMATOGRAPHY A
LA English
DT Article
DE Ionic liquids; Gas chromatography (GC); GLC; trans fat; Fatty acids;
Conjugated linoleic acid (CLA); cis- and trans-MUFA; Separation of
synthetic CLA isomers; Separation of synthetic MUFA isomers; GC
separations on ionic liquid columns; SP-2560; CP-Sil-88; SLB-IL111
ID CONJUGATED LINOLEIC ACIDS; THIN-LAYER-CHROMATOGRAPHY; TRANS-OCTADECENOIC
ACID; HUMAN-MILK LIPIDS; CP-SIL 88; STATIONARY PHASES; OCTADECADIENOIC
ACID; POSITIONAL ISOMERS; FISH-OIL; CIS
AB The ionic liquid SLB-IL111 column, available from Supelco Inc., is a novel fused capillary gas chromatography (GC) column capable of providing enhanced separations of fatty acid methyl esters (FAMEs) compared to the highly polar cyanopropyl siloxane columns currently recommended for the separation of cis- and trans isomers of fatty acids (FAs), and marketed as SP-2560 and CP-Sil 88. The SLB-IL111 column was operated isothermal at 168 degrees C, with hydrogen as carrier gas at 1.0 mL/min, and the elution profile was characterized using authentic GC standards and synthetic mono-unsaturated fatty acids (MUFAs) and conjugated linoleic acid (CLA) isomers as test mixtures. The SLB-IL111 column provided an improved separation of cis- and trans-18:1 and cis/trans CLA isomers. This is the first direct GC separation of c9,t11-from t7,c9-CLA, and t15-18:1 from c9-18:1, both of which previously required complimentary techniques for their analysis using cyanopropyl siloxane columns. The SLB-IL111 column also provided partial resolution of t13/t14-18:1, c8- from c6/c7-18:1, and for several t,t-CLA isomer pairs. This column also provided elution profiles of the geometric and positional isomers of the 16:1, 20:1 and 18:3 FAMEs that were complementary to those obtained using the cyanopropyl siloxane columns. However, on the SLB-IL111 column the saturated FAs eluted between the cis- and trans MUFAs unlike cyanopropyl siloxane columns that gave a clear separation of most saturated FAs. These differences in elution pattern can be exploited to obtain a more complete analysis of complex lipid mixtures present in ruminant fats. Published by Elsevier B.V.
C1 [Delmonte, Pierluigi; Kia, Ali-Reza Fardin; Mossoba, Magdi M.; 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.
[Sidisky, Len] Supelco Sigma Aldrich, Bellefonte, PA USA.
RP Delmonte, P (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, HFS-717,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM Pierluigi.delmonte@fda.hhs.gov; jkgkramer@rogers.com
NR 40
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U1 2
U2 64
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0021-9673
J9 J CHROMATOGR A
JI J. Chromatogr. A
PD JAN 21
PY 2011
VL 1218
IS 3
BP 545
EP 554
DI 10.1016/j.chroma.2010.11.072
PG 10
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 712QI
UT WOS:000286680900022
PM 21176911
ER
PT J
AU Jin, QH
Yu, LR
Wang, LF
Zhang, ZJ
Kasper, LH
Lee, JE
Wang, CC
Brindle, PK
Dent, SYR
Ge, K
AF Jin, Qihuang
Yu, Li-Rong
Wang, Lifeng
Zhang, Zhijing
Kasper, Lawryn H.
Lee, Ji-Eun
Wang, Chaochen
Brindle, Paul K.
Dent, Sharon Y. R.
Ge, Kai
TI Distinct roles of GCN5/PCAF-mediated H3K9ac and CBP/p300-mediated
H3K18/27ac in nuclear receptor transactivation
SO EMBO JOURNAL
LA English
DT Article
DE CBP and p300; GCN5 and PCAF; histone acetylation; nuclear receptor
ID HISTONE H3; GENE-EXPRESSION; TRANSCRIPTIONAL REGULATION; HUMAN GENOME;
CHROMATIN; ACETYLATION; COMPLEX; P300; ACETYLTRANSFERASE; ACTIVATION
AB Histone acetyltransferases (HATs) GCN5 and PCAF (GCN5/PCAF) and CBP and p300 (CBP/p300) are transcription co-activators. However, how these two distinct families of HATs regulate gene activation remains unclear. Here, we show deletion of GCN5/PCAF in cells specifically and dramatically reduces acetylation on histone H3K9 (H3K9ac) while deletion of CBP/p300 specifically and dramatically reduces acetylations on H3K18 and H3K27 (H3K18/27ac). A ligand for nuclear receptor (NR) PPAR delta induces sequential enrichment of H3K18/27ac, RNA polymerase II (Pol H) and H3K9ac on PPAR delta target gene Angptl4 promoter, which correlates with a robust Angptl4 expression. Inhibiting transcription elongation blocks ligand-induced H3K9ac, but not H3K18/27ac, on the Angptl4 promoter. Finally, we show GCN5/PCAF and GCN5/PCAF-mediated H3K9ac correlate with, but are surprisingly dispensable for, NR target gene activation. In contrast, CBP/p300 and their HAT activities are essential for ligand-induced Pol II recruitment on, and activation of, NR target genes. These results highlight the substrate and site specificities of HATs in cells, demonstrate the distinct roles of GCN5/PCAF- and CBP/p300-mediated histone acetylations in gene activation, and suggest an important role of CBP/p300-mediated H3K18/27ac in NR-dependent transcription. The EMBO Journal (2011) 30, 249-262. doi:10.1038/emboj.2010.318; Published online 3 December 2010
C1 [Jin, Qihuang; Wang, Lifeng; Lee, Ji-Eun; Wang, Chaochen; Ge, Kai] NIDDK, Nucl Receptor Biol Sect, CEB, NIH, Bethesda, MD 20892 USA.
[Yu, Li-Rong] US FDA, Ctr Excellence Prote, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR USA.
[Zhang, Zhijing; Dent, Sharon Y. R.] Univ Texas MD Anderson Canc Ctr, Dept Biochem & Mol Biol, Houston, TX 77030 USA.
[Kasper, Lawryn H.] St Jude Childrens Hosp, Dept Biochem, Memphis, TN 38105 USA.
RP Ge, K (reprint author), NIDDK, Nucl Receptor Biol Sect, CEB, NIH, Bldg 10,Room 8N307C,9000 Rockville Pike, Bethesda, MD 20892 USA.
EM kaig@niddk.nih.gov
RI Lee, Ji-Eun/F-7891-2011; Wang, Lifeng/I-4888-2012;
OI Lee, Ji-Eun/0000-0002-3768-7016; Wang, Lifeng/0000-0003-4752-6547; Ge,
Kai/0000-0002-7442-5138
FU NIDDK, NIH; NIH [R01GM067718, DE018183]
FX We thank Y Barak and R Evans for providing PPAR
deltaflox/flox mice, Z Wang and K Zhao for validated histone
modification antibodies, R Roeder for Ada2b, SPT3 and Ada2a antibodies,
and D Mendrick for critical reading of the paper. This work was
supported by the Intramural Research Program of the NIDDK, NIH to KG,
NIH R01GM067718 to SYRD and NIH DE018183 to PKB.
NR 55
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U1 5
U2 19
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0261-4189
J9 EMBO J
JI Embo J.
PD JAN 19
PY 2011
VL 30
IS 2
BP 249
EP 262
DI 10.1038/emboj.2010.318
PG 14
WC Biochemistry & Molecular Biology; Cell Biology
SC Biochemistry & Molecular Biology; Cell Biology
GA 719DE
UT WOS:000287179100004
PM 21131905
ER
PT J
AU Hillebrenner, MG
Swain, JA
Zuckerman, B
AF Hillebrenner, Matthew G.
Swain, Julie A.
Zuckerman, Bram
TI VARC Consensus Report: The FDA Perspective
SO JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
LA English
DT Editorial Material
C1 [Hillebrenner, Matthew G.; Swain, Julie A.; Zuckerman, Bram] US FDA, Ctr Devices & Radiol Hlth, Off Device Evaluat, Silver Spring, MD 20993 USA.
RP Hillebrenner, MG (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Device Evaluat, 10903 New Hampshire Ave,WO66-1232, Silver Spring, MD 20993 USA.
EM matthew.hillebrenner@fda.hhs.gov
NR 2
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 0735-1097
J9 J AM COLL CARDIOL
JI J. Am. Coll. Cardiol.
PD JAN 18
PY 2011
VL 57
IS 3
BP 270
EP 271
DI 10.1016/j.jacc.2010.12.004
PG 2
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 705LS
UT WOS:000286133900004
PM 21216554
ER
PT J
AU Chen, QY
Snapper, CM
Sen, G
AF Chen, Quanyi
Snapper, Clifford M.
Sen, Goutam
TI Endogenous IL-1R1 Signaling Is Critical for Cognate CD4(+) T Cell Help
for Induction of In Vivo Type 1 and Type 2 Antipolysaccharide and
Antiprotein Ig Isotype Responses to Intact Streptococcus pneumoniae, but
Not to a Soluble Pneumococcal Conjugate Vaccine (Retraction of vol 177,
pg 6044, 2006)
SO JOURNAL OF IMMUNOLOGY
LA English
DT Correction
C1 [Chen, Quanyi; Snapper, Clifford M.] Uniformed Serv Univ Hlth Sci, Dept Pathol, Bethesda, MD 20814 USA.
[Sen, Goutam] Ctr Biol Evaluat & Res, Food & Drug Adm, Rockville, MD USA.
RP Chen, QY (reprint author), Uniformed Serv Univ Hlth Sci, Dept Pathol, 4301 Jones Bridge Rd, Bethesda, MD 20814 USA.
NR 1
TC 0
Z9 0
U1 0
U2 3
PU AMER ASSOC IMMUNOLOGISTS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-1767
J9 J IMMUNOL
JI J. Immunol.
PD JAN 15
PY 2011
VL 186
IS 2
BP 1289
EP 1289
DI 10.4049/jimmunol.1090127
PG 1
WC Immunology
SC Immunology
GA 702TB
UT WOS:000285917700068
PM 21209288
ER
PT J
AU Edison, SE
Lin, LA
Gamble, BM
Wong, J
Zhang, K
AF Edison, Sara. E.
Lin, Lora A.
Gamble, Bryan M.
Wong, Jon
Zhang, Kai
TI Surface swabbing technique for the rapid screening for pesticides using
ambient pressure desorption ionization with high-resolution mass
spectrometry
SO RAPID COMMUNICATIONS IN MASS SPECTROMETRY
LA English
DT Article
ID ION-SOURCE; IDENTIFICATION; RESIDUES; MS
AB A rapid screening method for pesticides has been developed to promote more efficient processing of produce entering the United States. Foam swabs were used to recover a multiclass mixture of 132 pesticides from the surfaces of grapes, apples, and oranges. The swabs were analyzed using direct analysis in real time (DART) ionization coupled with a high-resolution Exactive Orbitrap (TM) mass spectrometer. By using a DART helium temperature gradient from 100-350 degrees C over 3 min, a minimal separation of analytes based on volatility differences was achieved. This, combined with the Exactive's mass resolution of 100 000, allowed the chromatographic step, along with the typical compositing and extraction steps associated with gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/mass spectrometry (LC/MS) approaches, to be eliminated. Detection of 86% of the analytes present was consistently achieved at levels of 2 ng/g (per each apple or orange) and 10 ng/g (per grape). A resolution study was conducted with four pairs of isobaric compounds analyzed at a mass resolution of 100 000. Baseline separation was achieved with analyte ions differing in mass by 25ppm and analyte ions with a mass difference of 10ppm were partially resolved. In addition, field samples that had undergone traditional sample preparation using QuEChERS (quick, easy, cheap, rugged, and safe) were analyzed using both LC/MS and DART-MS and the results from the two techniques were found to be comparable in terms of identification of the pesticides present. The use of swabs greatly increased sample throughput by reducing sample preparation and analysis time. Published in 2010 by John Wiley & Sons, Ltd.
C1 [Edison, Sara. E.; Lin, Lora A.; Gamble, Bryan M.] US FDA, Forens Chem Ctr, Cincinnati, OH USA.
[Wong, Jon; Zhang, Kai] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Edison, SE (reprint author), US FDA, Forens Chem Ctr, Cincinnati, OH USA.
EM sara.edison@fda.hhs.gov
NR 18
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U1 9
U2 49
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 0951-4198
J9 RAPID COMMUN MASS SP
JI Rapid Commun. Mass Spectrom.
PD JAN 15
PY 2011
VL 25
IS 1
BP 127
EP 139
DI 10.1002/rcm.4831
PG 13
WC Biochemical Research Methods; Chemistry, Analytical; Spectroscopy
SC Biochemistry & Molecular Biology; Chemistry; Spectroscopy
GA 694QY
UT WOS:000285313900017
PM 21157860
ER
PT J
AU Gannavaram, S
Sharma, P
Duncan, RC
Salotra, P
Nakhasi, HL
AF Gannavaram, Sreenivas
Sharma, Paresh
Duncan, Robert C.
Salotra, Poonam
Nakhasi, Hira L.
TI Mitochondrial Associated Ubiquitin Fold Modifier-1 Mediated Protein
Conjugation in Leishmania donovani
SO PLOS ONE
LA English
DT Article
ID PLASMODIUM-FALCIPARUM; TRYPANOSOMA-CRUZI; PARASITIC PROTOZOA; LIGASE;
IDENTIFICATION; SYSTEM; PROTEASOME; EXPRESSION; GENES; TARENTOLAE
AB In this report, we demonstrate the existence of the ubiquitin fold modifier-1 (Ufm1) and its conjugation pathway in trypanosomatid parasite Leishmania donovani. LdUfm1 is activated by E1-like enzyme LdUba5. LdUfc1 (E2) specifically interacted with LdUfm1 and LdUba5 to conjugate LdUfm1 to proteinaceous targets. Mass spectrometry analysis revealed that LdUfm1 is conjugated to Leishmania protein targets that are associated with mitochondria. Immunofluorescence experiments showed that Leishmania Ufm1, Uba5 and Ufc1 are associated with the mitochondria. The demonstration that all the components of this system as well as the substrates are associated with mitochondrion suggests it may have physiological roles not yet described in any other organism. Overexpression of a non-conjugatable form of LdUfm1 and an active site mutant of LdUba5 resulted in reduced survival of Leishmania in the macrophage. Since mitochondrial activities are developmentally regulated in the life cycle of trypanosomatids, Ufm1 mediated modifications of mitochondrial proteins may be important in such regulation. Thus, Ufm1 conjugation pathway in Leishmania could be explored as a potential drug target in the control of Leishmaniasis.
C1 [Gannavaram, Sreenivas; Duncan, Robert C.; Nakhasi, Hira L.] US FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[Sharma, Paresh; Salotra, Poonam] Inst Pathol ICMR, New Delhi, India.
RP Gannavaram, S (reprint author), US FDA, Lab Emerging Pathogens, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
EM salotra@vsnl.com; hira.nakhasi@fda.hhs.gov
RI Duncan, Robert/I-8168-2015
OI Duncan, Robert/0000-0001-8409-2501
NR 44
TC 8
Z9 9
U1 0
U2 2
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 14
PY 2011
VL 6
IS 1
AR e16156
DI 10.1371/journal.pone.0016156
PG 13
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 710MS
UT WOS:000286516500032
PM 21264253
ER
PT J
AU Herishanu, Y
Perez-Galan, P
Liu, DL
Biancotto, A
Pittaluga, S
Vire, B
Gibellini, F
Njuguna, N
Lee, E
Stennett, L
Raghavachari, N
Liu, PC
McCoy, JP
Raffeld, M
Stetler-Stevenson, M
Yuan, C
Sherry, R
Arthur, DC
Maric, I
White, T
Marti, GE
Munson, P
Wilson, WH
Wiestner, A
AF Herishanu, Yair
Perez-Galan, Patricia
Liu, Delong
Biancotto, Angelique
Pittaluga, Stefania
Vire, Berengere
Gibellini, Federica
Njuguna, Ndegwa
Lee, Elinor
Stennett, Lawrence
Raghavachari, Nalini
Liu, Poching
McCoy, J. Philip
Raffeld, Mark
Stetler-Stevenson, Maryalice
Yuan, Constance
Sherry, Richard
Arthur, Diane C.
Maric, Irina
White, Therese
Marti, Gerald E.
Munson, Peter
Wilson, Wyndham H.
Wiestner, Adrian
TI The lymph node microenvironment promotes B-cell receptor signaling,
NF-kappa B activation, and tumor proliferation in chronic lymphocytic
leukemia
SO BLOOD
LA English
DT Article
ID TOLL-LIKE RECEPTORS; GENE-EXPRESSION; ZAP-70 EXPRESSION; GENOMIC
ABERRATIONS; DISEASE PROGRESSION; ANTIGEN RECEPTOR; MUTATION STATUS;
CROSS-LINKING; SURVIVAL; IGM
AB Chronic lymphocytic leukemia (CLL), an incurable malignancy of mature B lymphocytes, involves blood, bone marrow, and secondary lymphoid organs such as the lymph nodes (LN). A role of the tissue microenvironment in the pathogenesis of CLL is hypothesized based on in vitro observations, but its contribution in vivo remains ill-defined. To elucidate the effects of tumor-host interactions in vivo, we purified tumor cells from 24 treatment-naive patients. Samples were obtained concurrently from blood, bone marrow, and/or LN and analyzed by gene expression profiling. We identified the LN as a key site in CLL pathogenesis. CLL cells in the LN showed up-regulation of gene signatures, indicating B-cell receptor (BCR) and nuclear factor-kappa B activation. Consistent with antigen-dependent BCR signaling and canonical nuclear factor-kappa B activation, we detected phosphorylation of SYK and I kappa B alpha, respectively. Expression of BCR target genes was stronger in clinically more aggressive CLL, indicating more effective BCR signaling in this subtype in vivo. Tumor proliferation, quantified by the expression of the E2F and c-MYC target genes and verified with Ki67 staining by flow cytometry, was highest in the LN and was correlated with clinical disease progression. These data identify the disruption of tumor microenvironment interactions and the inhibition of BCR signaling as promising therapeutic strategies in CLL. This study is registered at http://clinicaltrials.gov as NCT00019370. (Blood. 2011;117(2):563-574)
C1 [Herishanu, Yair; Perez-Galan, Patricia; Vire, Berengere; Gibellini, Federica; Njuguna, Ndegwa; Lee, Elinor; Stennett, Lawrence; Wiestner, Adrian] NHLBI, Hematol Branch, NIH, Bethesda, MD 20892 USA.
[Liu, Delong; Munson, Peter] NIH, Math & Stat Comp Lab, Div Computat Biosci, Ctr Informat Technol, Bethesda, MD 20892 USA.
[Biancotto, Angelique; McCoy, J. Philip] NIH, Ctr Human Immunol, Bethesda, MD 20892 USA.
[Pittaluga, Stefania; Raffeld, Mark; Stetler-Stevenson, Maryalice; Yuan, Constance; Arthur, Diane C.] NCI, Pathol Lab, Bethesda, MD 20892 USA.
[Sherry, Richard] NCI, Surg Branch, Bethesda, MD 20892 USA.
[Maric, Irina] NIH, Dept Lab Med, Ctr Clin, Bethesda, MD 20892 USA.
[White, Therese] NCI, Ctr Canc Res, Bethesda, MD 20892 USA.
[Marti, Gerald E.; Wilson, Wyndham H.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Wiestner, A (reprint author), NHLBI, Hematol Branch, NIH, Bldg 10,CRC 3-5140,10 Ctr Dr, Bethesda, MD 20892 USA.
EM wiestnera@mail.nih.gov
FU American Physician Fellowship (APF); NIH, the National Heart, Lung, and
Blood Institute; National Cancer Institute
FX Foremost we thank our patients for their willingness to undergo
additional or more extensive procedures to make this research possible.
We thank Dr Lou Staudt for lymphochip microarrays, the NCI surgery team
for performing excisional lymph node biopsies, and Theresa Davies-Hill
for assistance in processing biopsy specimens. We thank Drs Lou Staudt,
Neal Young, Cindy Dunbar, and Clifton Mo for helpful discussions and
critical reading of the manuscript. We gratefully acknowledge the
American Physician Fellowship (APF) for support of Y.H.; This research
was also supported by the Intramural Research Program of the NIH, the
National Heart, Lung, and Blood Institute, and the National Cancer
Institute.
NR 50
TC 327
Z9 336
U1 5
U2 23
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD JAN 13
PY 2011
VL 117
IS 2
BP 563
EP 574
DI 10.1182/blood-2010-05-284984
PG 12
WC Hematology
SC Hematology
GA 705ZD
UT WOS:000286178700026
PM 20940416
ER
PT J
AU Savan, R
McFarland, AP
Reynolds, DA
Feigenbaum, L
Ramakrishnan, K
Karwan, M
Shirota, H
Klinman, DM
Dunleavy, K
Pittaluga, S
Anderson, SK
Donnelly, RP
Wilson, WH
Young, HA
AF Savan, Ram
McFarland, Adelle P.
Reynolds, Della A.
Feigenbaum, Lionel
Ramakrishnan, Karthika
Karwan, Megan
Shirota, Hidekazu
Klinman, Dennis M.
Dunleavy, Kieron
Pittaluga, Stefania
Anderson, Stephen K.
Donnelly, Raymond P.
Wilson, Wyndham H.
Young, Howard A.
TI A novel role for IL-22R1 as a driver of inflammation
SO BLOOD
LA English
DT Article
ID LARGE-CELL LYMPHOMA; EFFECTIVE THERAPY; NPM-ALK; CHAIN; ACTIVATION;
EXPRESSION; KINASE; TRANSLOCATION; CONTRIBUTES; ANTIBODY
AB The interleukin (IL)-22R1 chain of the heterodimeric IL-22 receptor is not expressed on normal leukocytes, but this receptor is expressed on T cells from anaplastic lymphoma kinase-positive (ALK(+)) anaplastic large cell lymphoma (ALCL) patients. To investigate the consequences of aberrant expression of this receptor on lymphocytes, we generated transgenic mice that express IL-22R1 on lymphocytes. The health of these animals progressively deteriorated at 8 to 12 weeks of age, as they displayed respiratory distress, rough coat and sluggish movement, and subsequent lethality due to multiorgan inflammation. The IL-22R1 transgenic animals developed neutrophilia that correlated with increased levels of circulating IL-17 and granulocyte colony-stimulating factor. In addition, these mice had increased serum IL-22 levels, suggesting that T cells expressing IL-22R1 generate IL-22 in a positive autoregulatory loop. As a result of the mouse model findings, we analyzed circulating cytokine levels in ALK(+)ALCL patients and detected elevated levels of IL-22, IL-17, and IL-8 in untreated patient samples. Importantly, IL-22 and IL-17 were undetectable in all patients who were in complete remission after chemotherapy. This study documents a previously unknown role of IL-22R1 in inflammation and identifies the involvement of IL-22R1/IL-22 in ALK(+)ALCL. (Blood. 2011;117(2):575-584)
C1 [Savan, Ram; McFarland, Adelle P.; Reynolds, Della A.; Ramakrishnan, Karthika; Shirota, Hidekazu; Klinman, Dennis M.; Anderson, Stephen K.; Young, Howard A.] Ctr Canc Res, Canc & Inflammat Program, Frederick, MD 21702 USA.
[Feigenbaum, Lionel; Karwan, Megan] NCI, Lab Anim Sci Program, SAIC Frederick Inc, Frederick, MD 21701 USA.
[Dunleavy, Kieron; Wilson, Wyndham H.] NCI, Metab Branch, Lymphoma Therapeut Sect, Ctr Canc Res, Bethesda, MD 20892 USA.
[Pittaluga, Stefania] NCI, Pathol Lab, Hematopathol Sect, Ctr Canc Res, Bethesda, MD 20892 USA.
[Donnelly, Raymond P.] US FDA, Div Therapeut Prot, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
RP Young, HA (reprint author), Ctr Canc Res, Canc & Inflammat Program, POB B,Bldg 560, Frederick, MD 21702 USA.
EM savanr@mail.nih.gov; YoungHow@mail.nih.gov
RI Anderson, Stephen/B-1727-2012
OI Anderson, Stephen/0000-0002-7856-4266
FU NIH, National Cancer Institute, Center for Cancer Research; National
Cancer Institute, NIH [HHSN261200800001E]
FX This work was supported by the Intramural Research Program of the NIH,
National Cancer Institute, Center for Cancer Research. This project has
been funded with federal funds from the National Cancer Institute, NIH,
under contract HHSN261200800001E.
NR 28
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Z9 28
U1 0
U2 1
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD JAN 13
PY 2011
VL 117
IS 2
BP 575
EP 584
DI 10.1182/blood-2010-05-285908
PG 10
WC Hematology
SC Hematology
GA 705ZD
UT WOS:000286178700027
PM 20971950
ER
PT J
AU Fan, XH
Shao, L
Fang, H
Tong, WD
Cheng, YY
AF Fan, Xiaohui
Shao, Li
Fang, Hong
Tong, Weida
Cheng, Yiyu
TI Cross-Platform Comparison of Microarray-Based Multiple-Class Prediction
SO PLOS ONE
LA English
DT Article
ID GENE-EXPRESSION MEASUREMENTS; DNA MICROARRAYS; QUALITY-CONTROL;
OLIGONUCLEOTIDE; CANCER; TECHNOLOGIES; CLASSIFIERS; CONSISTENCY;
CALIBRATION; PROGNOSIS
AB High-throughput microarray technology has been widely applied in biological and medical decision-making research during the past decade. However, the diversity of platforms has made it a challenge to re-use and/or integrate datasets generated in different experiments or labs for constructing array-based diagnostic models. Using large toxicogenomics datasets generated using both Affymetrix and Agilent microarray platforms, we carried out a benchmark evaluation of cross-platform consistency in multiple-class prediction using three widely-used machine learning algorithms. After an initial assessment of model performance on different platforms, we evaluated whether predictive signature features selected in one platform could be directly used to train a model in the other platform and whether predictive models trained using data from one platform could predict datasets profiled using the other platform with comparable performance. Our results established that it is possible to successfully apply multiple-class prediction models across different commercial microarray platforms, offering a number of important benefits such as accelerating the possible translation of biomarkers identified with microarrays to clinically-validated assays. However, this investigation focuses on a technical platform comparison and is actually only the beginning of exploring cross-platform consistency. Further studies are needed to confirm the feasibility of microarray-based cross-platform prediction, especially using independent datasets.
C1 [Fan, Xiaohui; Shao, Li; Cheng, Yiyu] Zhejiang Univ, Coll Pharmaceut Sci, Pharmaceut Informat Inst, Hangzhou 310003, Zhejiang, Peoples R China.
[Fang, Hong] Z Tech Corp, Jefferson, AZ USA.
[Tong, Weida] US FDA, Natl Ctr Toxicol Res, Jefferson, AZ USA.
RP Fan, XH (reprint author), Zhejiang Univ, Coll Pharmaceut Sci, Pharmaceut Informat Inst, Hangzhou 310003, Zhejiang, Peoples R China.
EM weida.tong@fda.hhs.gov; chengyy@zju.edu.cn
FU National Science Foundation of China [30801556]; Higher Education of
China [20090101110126]; Science Foundation of Chinese University
[2009QNA7031]
FX This work was supported by the National Science Foundation of China (No.
30801556), the Research Fund for the Doctoral Program of Higher
Education of China (No. 20090101110126), and Science Foundation of
Chinese University (No. 2009QNA7031). The funders or the sponsor (Z-Tech
Corporation) had no role in study design, data collection and analysis,
decision to publish, or preparation of the manuscript.
NR 30
TC 10
Z9 11
U1 0
U2 9
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 11
PY 2011
VL 6
IS 1
AR e16067
DI 10.1371/journal.pone.0016067
PG 7
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 710LU
UT WOS:000286514000019
PM 21264309
ER
PT J
AU Posnack, NG
Lee, NH
Brown, R
Sarvazyan, N
AF Posnack, Nikki Gillum
Lee, Norman H.
Brown, Ronald
Sarvazyan, Narine
TI Gene expression profiling of DEHP-treated cardiomyocytes reveals
potential causes of phthalate arrhythmogenicity
SO TOXICOLOGY
LA English
DT Article
DE Cardiac myocyte; Microarray; Gene expression; Phthalate; Connexin-43;
Calcium handling; Arrhythmia
ID CARDIAC MYOCYTES; DI(2-ETHYLHEXYL) PHTHALATE; GAP-JUNCTIONS;
MONO-(2-ETHYLHEXYL) PHTHALATE; RYANODINE RECEPTOR; HUMAN-REPRODUCTION;
CALCIUM-RELEASE; HEART; PROTEINS; INFANTS
AB Background: Di-(2-ethylhexyl)-phthalate (DEHP) is a widely used plasticizer that imparts flexibility to polyvinyl chloride. We have recently reported that clinically relevant concentrations of DEHP can affect electrical coupling between cardiac myocytes causing significant rhythm disturbances. The underlying causes for this effect are currently unknown.
Objectives: To use data on global mRNA expression as a tool to reveal possible pathways leading to arrhythmogenic effects of DEHP.
Methods: Rat neonatal cardiomyocytes were treated with 50 DEHP for 72 h. Extracted RNA samples were hybridized onto Affymetrix Rat Gene 1.0 ST arrays. The mRNA expression of a subset of genes was validated by qRT-PCR. In a second set of experiments, cells were treated in a concentration dependent manner to identify genes affected by low DEHP concentrations.
Results: DEHP exposure is associated with global changes in mRNA expression, with differentially expressed genes overrepresented in 47 Gene Ontology categories. Modified expression was detected for genes associated with cell electrical activity, calcium handling, adhesion and microtubular transport. For a number of key proteins, including kinesin, TGF beta 2, alpha-tubulin, and alpha 1 & beta 1 integrins, changes in mRNA levels were confirmed on the level of the protein expression. A number of genes associated with cell adhesion and electrical activity were identified as early DEHP targets as they were affected by concentrations as low as 1 mu g/mL
Conclusions: Exposure of neonatal rat cardiomyocytes to clinically relevant DEHP concentrations leads to global changes in mRNA expression. These changes help to explain the arrhythmogenic effects of phthalates on these cells. (C) 2010 Elsevier Ireland Ltd. All rights reserved.
C1 [Posnack, Nikki Gillum; Lee, Norman H.; Sarvazyan, Narine] George Washington Univ, Dept Physiol & Pharmacol, Washington, DC 20037 USA.
[Brown, Ronald] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Sarvazyan, N (reprint author), George Washington Univ, Dept Physiol & Pharmacol, 2300 Eye St, Washington, DC 20037 USA.
EM phynas@gmail.com
RI Posnack, Nikki/F-1170-2013
OI Posnack, Nikki/0000-0002-3880-7200
FU National Institutes of Health [HL076722, 1F32ES019057, CA120316]; GWU
Catherine Birch McCormick Center
FX The authors thank Luther Swift for isolation of cardiomyocytes and Yi
Lian and Dr. Sydney Fu for their assistance with microarray processing.
This work was supported by the National Institutes of Health (HL076722
to NS, 1F32ES019057 to NGP and CA120316 to NHL) and the GWU Catherine
Birch McCormick Center.
NR 43
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Z9 17
U1 1
U2 5
PU ELSEVIER IRELAND LTD
PI CLARE
PA ELSEVIER HOUSE, BROOKVALE PLAZA, EAST PARK SHANNON, CO, CLARE, 00000,
IRELAND
SN 0300-483X
J9 TOXICOLOGY
JI Toxicology
PD JAN 11
PY 2011
VL 279
IS 1-3
BP 54
EP 64
DI 10.1016/j.tox.2010.09.007
PG 11
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 718GU
UT WOS:000287109900007
PM 20920545
ER
PT J
AU Van Dole, KB
West, SL
Mease, M
Olsen, A
AF Van Dole, Kristen B.
West, Suzanne L.
Mease, Mary
Olsen, Axel
TI Perception of Drug Safety and Knowledge Influences Drug Selection
SO ARCHIVES OF INTERNAL MEDICINE
LA English
DT Letter
ID BENEFITS; RISKS
C1 [Van Dole, Kristen B.; West, Suzanne L.] Univ N Carolina, Dept Epidemiol, Gillings Sch Publ Hlth, Chapel Hill, NC USA.
[Mease, Mary] US FDA, Ctr Drug & Evaluat Res, Silver Spring, MD USA.
[Olsen, Axel] Pharmaceut Safety Inst, Newtown, PA USA.
RP Van Dole, KB (reprint author), GlaxoSmithKline Inc, Worldwide Epidemiol Dept, POB 13398,5 Moore Dr, Res Triangle Pk, NC 27709 USA.
EM kristen.b.van-dole@gsk.com
NR 3
TC 0
Z9 0
U1 1
U2 2
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60610-0946 USA
SN 0003-9926
J9 ARCH INTERN MED
JI Arch. Intern. Med.
PD JAN 10
PY 2011
VL 171
IS 1
BP 90
EP 91
DI 10.1001/archinternmed.2010.470
PG 2
WC Medicine, General & Internal
SC General & Internal Medicine
GA 703YO
UT WOS:000286018100018
PM 21220667
ER
PT J
AU Dreyer, ZE
Dinndorf, PA
Camitta, B
Sather, H
La, MK
Devidas, M
Hilden, JM
Heerema, NA
Sanders, JE
McGlennen, R
Willman, CL
Carroll, AJ
Behm, F
Smith, FO
Woods, WG
Godder, K
Reaman, GH
AF Dreyer, Zoann E.
Dinndorf, Patricia A.
Camitta, Bruce
Sather, Harland
La, Mei K.
Devidas, Meenakshi
Hilden, Joanne M.
Heerema, Nyla A.
Sanders, Jean E.
McGlennen, Ron
Willman, Cheryl L.
Carroll, Andrew J.
Behm, Fred
Smith, Franklin O.
Woods, William G.
Godder, Kamar
Reaman, Gregory H.
TI Analysis of the Role of Hematopoietic Stem-Cell Transplantation in
Infants With Acute Lymphoblastic Leukemia in First Remission and MLL
Gene Rearrangements: A Report From the Children's Oncology Group
SO JOURNAL OF CLINICAL ONCOLOGY
LA English
DT Article
ID BONE-MARROW-TRANSPLANTATION; PROGNOSTIC-FACTORS; CLINICAL-TRIALS;
POOR-PROGNOSIS; CANCER GROUP; CHILDHOOD; IRRADIATION
AB Purpose
Although the majority of children with acute lymphoblastic leukemia (ALL) are cured with current therapy, the event-free survival (EFS) of infants with ALL, particularly those with mixed lineage leukemia (MLL) gene rearrangements, is only 30% to 40%. Relapse has been the major source of treatment failure for these patients. The parallel Children's Cancer Group (CCG) 1953 and Pediatric Oncology Group (POG) 9407 studies were designed to test the hypothesis that more intensive therapy, including dose intensification of chemotherapy, and hematopoietic stem-cell transplantation (HSCT) would improve the outcome for this group of patients.
Patients and Methods
One hundred eighty-nine infants (CCG 1953, n = 115; POG 9407, n = 74) were enrolled between October 1996 and August 2000. For infants with the MLL gene rearrangement and an appropriate donor, HSCT was the preferred treatment on CCG 1953 and investigator option on POG 9407 after completion of the second phase of therapy. Fifty-three infants underwent HSCT.
Results
The 5-year EFS rate was 48.8% (95% CI, 33.9% to 63.7%) in patients who received HSCT and 48.7% (95% CI, 33.8% to 63.6%) in patients treated with chemotherapy alone (P = .60). Transplantation outcomes were not affected by the preparatory regimen or donor source.
Conclusion
Our data suggest that routine use of HSCT for infants with MLL-rearranged ALL is not indicated. However, limited by small numbers, this study should not be considered the definitive answer to this question. J Clin Oncol 29:214-222. (C) 2010 by American Society of Clinical Oncology
C1 Texas Childrens Hosp, Houston, TX 77030 USA.
US FDA, Silver Spring, MD USA.
Midwest Childrens Canc Ctr, Milwaukee, WI USA.
Childrens Oncol Grp, Arcadia, CA USA.
Peyton Manning Childrens Hosp St Vincent, Indianapolis, IN USA.
Nationwide Childrens Hosp, Columbus, OH USA.
Seattle Childrens Hosp, Seattle, WA USA.
Univ Minnesota Med Sch, Minneapolis, MN USA.
Univ New Mexico Sch Med, Albuquerque, NM USA.
Univ Alabama, Birmingham, AL USA.
Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH USA.
Univ Illinois, Chicago, IL USA.
Emory Univ Childrens Healthcare Atlanta, Aflac Canc Ctr, Atlanta, GA USA.
Virginia Commonwealth Univ Hlth Care Syst, Med Coll Virginia, Richmond, VA USA.
RP Dreyer, ZE (reprint author), 6621 Fannin, Houston, TX 77030 USA.
EM zedreyer@txccc.org
FU National Cancer Institute, National Institutes of Health, Bethesda, MD
[U10 CA98543, U10 CA98413]
FX Supported by Chair Grant No. U10 CA98543 and Statistics and Data Center
Grant No. U10 CA98413 to the Children's Oncology Group from the National
Cancer Institute, National Institutes of Health, Bethesda, MD.
NR 28
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U2 3
PU AMER SOC CLINICAL ONCOLOGY
PI ALEXANDRIA
PA 2318 MILL ROAD, STE 800, ALEXANDRIA, VA 22314 USA
SN 0732-183X
J9 J CLIN ONCOL
JI J. Clin. Oncol.
PD JAN 10
PY 2011
VL 29
IS 2
BP 214
EP 222
DI 10.1200/JCO.2009.26.8938
PG 9
WC Oncology
SC Oncology
GA 703GC
UT WOS:000285965400026
PM 21135279
ER
PT J
AU Ali, MM
Amialchuk, A
Dwyer, DS
AF Ali, Mir M.
Amialchuk, Aliaksandr
Dwyer, Debra S.
TI The Social Contagion Effect of Marijuana Use among Adolescents
SO PLOS ONE
LA English
DT Article
ID DRUG-USE; SUBSTANCE USE; ALCOHOL-CONSUMPTION; HEALTH
AB Background: Research on adolescent substance use has consistently identified a strong relationship between adolescent behavior and the behavior of their peers. However, peer effects are difficult to estimate and causal interpretations must be undertaken with caution since individuals in most cases choose with whom to associate. In this paper we seek to empirically quantify the causal role of peer social networks in explaining marijuana usage among adolescents.
Methods and Findings: Using data from a nationally representative sample of adolescents we utilize a multivariate structural model with school-level fixed effects to account for the problems of contextual effects, correlated effects and peer selections to purge the potential biases from the estimates of peer influence. Our peer group measures are drawn not only from the nomination of close friends (N = 6,377), but also from classmates (N = 19,335). Marijuana usage among the peer groups were constructed using the peers' own report of their marijuana consumption. Controlling for parent level characteristics, and other demographic parameters, we find that a 10% increase in the proportion of close friends and classmates who use marijuana increases the probability that an individual chooses to use marijuana by 5%.
Conclusion: Our findings indicate that peer effects are important determinants of marijuana use even after controlling for potential biases We also found evidence to show that the influence of close friends and the more exogenous classmates are quite similar in magnitude under our preferred specification, supporting theory predicting the importance of peer influence. Effective policy aimed at reducing marijuana usage among adolescents would consider these significant peer effects.
C1 [Ali, Mir M.; Amialchuk, Aliaksandr] Univ Toledo, Dept Econ, Toledo, OH 43606 USA.
[Dwyer, Debra S.] SUNY Stony Brook, Sch Hlth Technol & Management, Stony Brook, NY 11794 USA.
[Dwyer, Debra S.] SUNY Stony Brook, Dept Econ, Stony Brook, NY 11794 USA.
[Ali, Mir M.] US FDA, Off Regulat Policy & Social Sci, College Pk, MD USA.
RP Ali, MM (reprint author), Univ Toledo, Dept Econ, 2801 W Bancroft St, Toledo, OH 43606 USA.
EM mir.ali@fda.hhs.gov
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 Food and 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 23
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U1 1
U2 10
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 10
PY 2011
VL 6
IS 1
AR e16183
DI 10.1371/journal.pone.0016183
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 710LL
UT WOS:000286513100030
PM 21264337
ER
PT J
AU Hinchey, J
Jeon, BY
Alley, H
Chen, B
Goldberg, M
Derrick, S
Morris, S
Jacobs, WR
Porcelli, SA
Lee, S
AF Hinchey, Joseph
Jeon, Bo Y.
Alley, Holly
Chen, Bing
Goldberg, Michael
Derrick, Steven
Morris, Sheldon
Jacobs, William R., Jr.
Porcelli, Steven A.
Lee, Sunhee
TI Lysine Auxotrophy Combined with Deletion of the SecA2 Gene Results in a
Safe and Highly Immunogenic Candidate Live Attenuated Vaccine for
Tuberculosis
SO PLOS ONE
LA English
DT Article
ID CD8(+) T-CELLS; MYCOBACTERIUM-TUBERCULOSIS; FUNCTIONAL IMPAIRMENT;
IMMUNE-RESPONSE; VIRAL-INFECTION; BCG; SMEGMATIS; DIAMINOPIMELATE;
GENERATION; EFFECTOR
AB Tuberculosis (TB) caused by Mycobacterium tuberculosis remains a major global health problem, despite the widespread use of the M. bovis Bacille Calmette-Guerin (BCG) vaccine and the availability of drug therapies. In recent years, the high incidence of coinfection of M. tuberculosis and HIV, as well as escalating problems associated with drug resistance, has raised ominous concerns with regard to TB control. Vaccination with BCG has not proven highly effective in controlling TB, and also has been associated with increasing concerns about the potential for the vaccine to cause disseminated mycobacterial infection in HIV infected hosts. Thus, the development of an efficacious and safe TB vaccine is generally viewed as a critical to achieving control of the ongoing global TB pandemic. In the current study, we have analyzed the vaccine efficacy of an attenuated M. tuberculosis strain that combines a mutation that enhances T cell priming (Delta secA2) with a strongly attenuating lysine auxotrophy mutation (Delta lysA). The Delta secA2 mutant was previously shown to be defective in the inhibition of apoptosis and markedly increased priming of antigen-specific CD8(+) T cells in vivo. Similarly, the Delta secA2 Delta lysA strain retained enhanced apoptosis and augmented CD8+ T cell stimulatory effects, but with a noticeably improved safety profile in immunosuppressed mice. Thus, the M. tuberculosis Delta secA2 Delta lysA mutant represents a live attenuated TB vaccine strain with the potential to deliver increased protection and safety compared to standard BCG vaccination.
C1 [Hinchey, Joseph; Chen, Bing; Goldberg, Michael; Jacobs, William R., Jr.; Porcelli, Steven A.] Albert Einstein Coll Med, Dept Microbiol & Immunol, Bronx, NY 10467 USA.
[Jeon, Bo Y.] Yonsei Univ, Coll Med, Dept Microbiol, Seoul, South Korea.
[Alley, Holly; Lee, Sunhee] Duke Human Vaccine Inst, Durham, NC USA.
[Derrick, Steven; Morris, Sheldon] US FDA, Ctr Biol Evaluat, Bethesda, MD 20014 USA.
[Jacobs, William R., Jr.] Albert Einstein Coll Med, Howard Hughes Med Inst, Bronx, NY 10467 USA.
[Porcelli, Steven A.] Montefiore Med Ctr, Albert Einstein Coll Med, Dept Med, Bronx, NY 10467 USA.
RP Hinchey, J (reprint author), Albert Einstein Coll Med, Dept Microbiol & Immunol, Bronx, NY 10467 USA.
EM sunhee.lee@duke.edu
FU NIH [U54 AI057157, AI063537]; Einstein Cancer Center (NIH/NCI) [NIH/NCI
CA013330]; Einstein Center for AIDS Research (NIH) [NIH AI-51519]
FX SL was supported by NIH grant U54 AI057157. SAP and WRJ were supported
by NIH Program Project Grant AI063537. Flow cytometry studies were
carried out using core facilities supported by the Einstein Cancer
Center (NIH/NCI CA013330) and the Einstein Center for AIDS Research (NIH
AI-51519). The funders had no role in study design, data collection and
analysis, decision to publish, or preparation of the manuscript.
NR 32
TC 21
Z9 22
U1 1
U2 7
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD JAN 10
PY 2011
VL 6
IS 1
AR e15857
DI 10.1371/journal.pone.0015857
PG 7
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 710LL
UT WOS:000286513100014
PM 21264335
ER
PT J
AU Sejvar, JJ
Kohl, KS
Gidudu, J
Amato, A
Bakshi, N
Baxter, R
Burwen, DR
Cornblath, DR
Cleerbout, J
Edwards, KM
Heininger, U
Hughes, R
Khuri-Bulos, N
Korinthenberg, R
Law, BJ
Munro, U
Maltezou, HC
Nell, P
Oleske, J
Sparks, R
Velentgas, P
Vermeer, P
Wiznitzer, M
AF Sejvar, James J.
Kohl, Katrin S.
Gidudu, Jane
Amato, Anthony
Bakshi, Nandini
Baxter, Roger
Burwen, Dale R.
Cornblath, David R.
Cleerbout, Jan
Edwards, Kathryn M.
Heininger, Ulrich
Hughes, Richard
Khuri-Bulos, Najwa
Korinthenberg, Rudolf
Law, Barbara J.
Munro, Ursula
Maltezou, Helena C.
Nell, Patricia
Oleske, James
Sparks, Robert
Velentgas, Priscilla
Vermeer, Patricia
Wiznitzer, Max
CA Brighton Collaboration GBS Working
TI Guillain-Barre syndrome and Fisher syndrome: Case definitions and
guidelines for collection, analysis, and presentation of immunization
safety data
SO VACCINE
LA English
DT Article
DE Guillain-Barre syndrome; Neuropathy; Fisher syndrome; Acute inflammatory
demyelinating polyradiculoneuropathy; Adverse event; Immunization;
Guidelines; Case definition
ID MEDIATED NEUROLOGIC DISEASE; MOTOR AXONAL NEUROPATHY; MOLECULAR MIMICRY;
INFLUENZA VACCINATION; UNITED-STATES; ELECTRODIAGNOSTIC CRITERIA;
CAMPYLOBACTER-JEJUNI; DIAGNOSTIC-CRITERIA; RABIES VACCINATION;
EPIDEMIOLOGY
C1 [Sejvar, James J.; Kohl, Katrin S.; Gidudu, Jane] Ctr Dis Control & Prevent, Atlanta, GA 30333 USA.
[Amato, Anthony] Brigham & Womens Hosp, Dept Neurol, Div Neuromuscular Dis, Boston, MA 02115 USA.
[Velentgas, Priscilla] Harvard Univ, Sch Med, Dept Ambulatory Care & Prevent, Boston, MA USA.
[Bakshi, Nandini; Baxter, Roger] NCK Kaiser Permanente, Oakland, CA USA.
[Burwen, Dale R.] US FDA, Rockville, MD 20857 USA.
[Cornblath, David R.] Johns Hopkins Univ, Sch Med, Baltimore, MD USA.
[Cleerbout, Jan] GlaxoSmithKline Biol, Rixensart, Belgium.
[Edwards, Kathryn M.] Vanderbilt Univ, Sch Med, Nashville, TN 37212 USA.
[Heininger, Ulrich] Univ Childrens Hosp, Basel, Switzerland.
[Hughes, Richard] Kings Coll London, Sch Med, London WC2R 2LS, England.
[Khuri-Bulos, Najwa] Jordan Univ Hosp, Amman, Jordan.
[Korinthenberg, Rudolf] Univ Hosp Freiburg, Freiburg, Germany.
[Law, Barbara J.] Publ Hlth Agcy Canada, Ottawa, ON, Canada.
[Munro, Ursula] Sanofi Pasteur MSD GmbH, Walldorf, Germany.
[Maltezou, Helena C.] Hellen Ctr Dis Control & Prevent, Athens, Greece.
[Nell, Patricia] USAF, Airforce Reserve Command, Sturgeon Bay, WI USA.
[Oleske, James] Univ Hosp, New Jersey Med Sch, Morris Plains, NJ USA.
[Sparks, Robert] Vanderbilt Univ, Med Ctr, Nashville, TN USA.
[Velentgas, Priscilla] Harvard Pilgrim Hlth Care, Boston, MA USA.
[Vermeer, Patricia] Natl Inst Publ Hlth & Environm, NL-3720 BA Bilthoven, Netherlands.
[Wiznitzer, Max] Univ Hosp Cleveland, Dept Neurol, Cleveland, OH 44106 USA.
RP Sejvar, JJ (reprint author), Ctr Dis Control & Prevent, Atlanta, GA 30333 USA.
EM secretariat@brightoncollaboration.org
OI Korinthenberg, Rudolf/0000-0002-4638-3460
FU WHO
FX The authors are grateful for the support and helpful comments from
members of Brighton Collaboration Steering Committee during the time of
the development of this document, who are not already included as
authors (Mike Blum, Paul Heath, Hector Izurieta, Brigitte Keller
Stanislawski, Katrin Kohl Odile Leroy), and the participants in the
Reference Group (Adam Rudiger, Adderson Elisabeth, Aguilar Maria,
Aldrovandi Grace, Allen Mary, Bachtiar Novilia Sjafri, Barami A. A.
Salim, Baxter Roger, Bettinger Julie, Bilynsky Roman, Blum Michael,
Bonhoeffer Jan, Brady Michael, Buettcher Michael, Buttery Jim, Cane
Alejandro, Chang Soju, Chatterjee Arani, Chawla Krishan, Cherian Thomas,
Cleerbout Jan, Close Philippe, Condit Richard, Cornblath David, Couch
Robert B., da Costa Christopher, Davis Larry, de Menezes Martins
Reinaldo, de Vries Corinne, Deotti Sandra Maria, Dimitrijevic Dragana,
Dong Duo, Evengard Birgitta, Falup-Pecurariu Cristian, Fernandopulle
Rohini, Ferreira Germano, Fisher Margaret C, Galama Jochem, Gallegos
Karl, Gershman Mark, Gibbs Neville, Gidudu Jane, Gurwith Marc, Halsey
Neal, Hanlon Erin, Hitchcock William, Hossain Shah, Huang Wan-Ting,
Hunter Deborah, Isaacs David, Jacobson Robert, Johann-Liang Rosemary,
Jones Barbara, Jovancevic Milivoj, Kaisar Mahfuzul Islam, Kang
Gagandeep, Klug Bettina, Korinthenberg Rudolf, Kulcsar Andrea, Lee
Grace, Lievano Fabio, MacDonald Noni, Mahmood Asif, Maltezou Helena,
Martin Martin Susana, McIntosh G David, Mentzer Dirk, Meredith Stefanie,
Meszner Zsofia, Milstien Julie, Minor Mary, Modlin John, Montgomery Jay,
Morse Ann, Munro Ursula, Nalin David, Nell Patricia, Nimmannitya
Suchitra, Nisslein Thomas, Nokleby Hanne, Nwosu Kenneth, Oleske James
M., Patnaik Badri, Pinheiro Luis, Pourmalek Farshad, Ramasamy Ranjan,
Rump Eva-Beate, Samson Heather, Santos Eliane, Schuller Elisabeth,
Schultze Viola, Sidhu Maninder K., Sillan Francoise, Sliman Joseph, Soh
Bee Leng Sally, Sparks Robert, Sprenger Ralf, Steele Russell, Stoller
Rudolf, Storsaeter Jann, Suznjevic Vladimir, Tebaa Amina, Tridente
Giuseppe, Trimis Georgios, Uhnoo Ingrid, Van Dinther Kristy, Varricchio
Frederick, Ventura Rafael, Vilella Anna, Warden Beverly, Weston William,
Wimalaratne Omala, Wong Virginia, Chun-Nei, Zajdowicz Thad, Zaman
Khalequz, Zanoni Giovanna, Zielinski Andrzej, and Zuber Patrick and
harmonization work by Michael Buettcher, Sabine Faisst, and Jan
Bonhoeffer. We are also grateful for the support of WHO and ECDC for
creating this document. Finally, we would like to thank the members of
the WHO/CIOMS Working Group on Vaccine Pharmacovigilance
(http://www.cioms.ch/frame current programme. htm) for the review of,
constructive comments on, and endorsement of this document.
NR 84
TC 120
Z9 123
U1 3
U2 13
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 JAN 10
PY 2011
VL 29
IS 3
BP 599
EP 612
DI 10.1016/j.vaccine.2010.06.003
PG 14
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 715AQ
UT WOS:000286853200031
PM 20600491
ER
PT J
AU Imam, SZ
Zhou, Q
Yamamoto, A
Valente, AJ
Ali, SF
Bains, M
Roberts, JL
Kahle, PJ
Clark, RA
Li, SL
AF Imam, Syed Z.
Zhou, Qing
Yamamoto, Ayako
Valente, Anthony J.
Ali, Syed F.
Bains, Mona
Roberts, James L.
Kahle, Philipp J.
Clark, Robert A.
Li, Senlin
TI Novel Regulation of Parkin Function through c-Abl-Mediated Tyrosine
Phosphorylation: Implications for Parkinson's Disease
SO JOURNAL OF NEUROSCIENCE
LA English
DT Article
ID UBIQUITIN LIGASE ACTIVITY; PROTECTIVE FUNCTION; S-NITROSYLATION; PROTEIN
LIGASE; CELL-DEATH; MUTATIONS; SUBSTRATE; STRESS; NEURODEGENERATION;
PATHOGENESIS
AB Mutations in parkin, an E3 ubiquitin ligase, are the most common cause of autosomal-recessive Parkinson's disease (PD). Here, we show that the stress-signaling non-receptor tyrosine kinase c-Abl links parkin to sporadic forms of PD via tyrosine phosphorylation. Under oxidative and dopaminergic stress, c-Abl was activated in cultured neuronal cells and in striatum of adult C57BL/6 mice. Activated c-Abl was found in the striatum of PD patients. Concomitantly, parkin was tyrosine-phosphorylated, causing loss of its ubiquitin ligase and cytoprotective activities, and the accumulation of parkin substrates, AIMP2(aminoacyl tRNA synthetase complex-interacting multifunctional protein 2) (p38/JTV-1) and FBP-1.STI-571, a selective c-Abl inhibitor, prevented tyrosine phosphorylation of parkin and restored its E3 ligase activity and cytoprotective function both in vitro and in vivo. Our results suggest that tyrosine phosphorylation of parkin by c-Abl is a major post-translational modification that leads to loss of parkin function and disease progression in sporadic PD. Moreover, inhibition of c-Abl offers new therapeutic opportunities for blocking PD progression.
C1 [Imam, Syed Z.; Zhou, Qing; Valente, Anthony J.; Clark, Robert A.; Li, Senlin] Univ Texas Hlth Sci Ctr San Antonio, Dept Med, San Antonio, TX 78229 USA.
[Imam, Syed Z.; Bains, Mona; Roberts, James L.; Li, Senlin] Univ Texas Hlth Sci Ctr San Antonio, Dept Pharmacol, San Antonio, TX 78229 USA.
[Imam, Syed Z.; Roberts, James L.; Clark, Robert A.; Li, Senlin] Univ Texas Hlth Sci Ctr San Antonio, Barshop Inst Longev & Aging Studies, San Antonio, TX 78229 USA.
[Imam, Syed Z.; Clark, Robert A.; Li, Senlin] S Texas Vet Hlth Care Syst, San Antonio, TX 78229 USA.
[Yamamoto, Ayako; Kahle, Philipp J.] Univ Clin Tubingen, Lab Funct Neurogenet, Dept Neurodegenerat, Hertie Inst Clin Brain Res, D-72076 Tubingen, Germany.
[Ali, Syed F.] US FDA, Neurochem Lab, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Imam, SZ (reprint author), Univ Texas Hlth Sci Ctr San Antonio, Dept Med, 7703 Floyd Curl Dr, San Antonio, TX 78229 USA.
EM imam@uthscsa.edu; lis1@uthscsa.edu
FU US National Institutes of Health; Department of Veterans Affairs;
Michael J. Fox Foundation; Parkinson's Disease Foundation; San Antonio
Area Foundation; American Parkinson Disease Association; Executive
Research Council of University of Texas Health Science Center; San
Antonio (UTHSCSA); German National Genome Research Network [NGFN-2];
European Union
FX This work was supported by grants from the US National Institutes of
Health, Department of Veterans Affairs, Michael J. Fox Foundation,
Parkinson's Disease Foundation, San Antonio Area Foundation, American
Parkinson Disease Association, Executive Research Council of University
of Texas Health Science Center, San Antonio (UTHSCSA), the German
National Genome Research Network (NGFN-2), and the European Union
(N)EUROPARK consortium. The technical assistance of Xuyean Liao, Doran
Pearson, Lora Judge, Heather Dudley, and Wuqiong Ma is acknowledged. We
thank F. Fiesel (Hertie Institute, Tubingen, Germany) for helpful
suggestions, and S.T. Weintraub and K. Hakala for MS analyses (UTHSCSA
Institutional Mass Spectrometry Laboratory). Parkin plasmids and
constructs, antibodies to AIMP2, and postmortem human samples were kind
gifts from Ted M. Dawson (Johns Hopkins University, Baltimore, MD). We
also thank Dr. Dawson's lab for processing of some human samples. c-Abl
and Arg constructs were kind gifts from B. Li (Institute of Molecular
and Cell Biology, Singapore), D. Kufe (Dana-Farber Cancer Institute,
Harvard Medical School, Cambridge, MA), and Z. M. Yuan (Harvard School
of Public Health). Recombinant tyrosine kinase fragment of c-Abl was a
kind gift from M. Seeliger and J. Kuriyan (Howard Hughes Medical
Institute, University of California, Berkeley, CA). FBP-1 cDNA was
kindly provided by D. Levens (National Cancer Institute, National
Institutes of Health, Bethesda, MD). Lenti-shRNA to parkin was kindly
provided by P. Aebischer and R. Zuffrey (Ecole Polytechnique Federale
Lausanne, Lausanne, Switzerland). STI-571 was provided by Novartis
Pharma.
NR 30
TC 58
Z9 58
U1 0
U2 6
PU SOC NEUROSCIENCE
PI WASHINGTON
PA 11 DUPONT CIRCLE, NW, STE 500, WASHINGTON, DC 20036 USA
SN 0270-6474
J9 J NEUROSCI
JI J. Neurosci.
PD JAN 5
PY 2011
VL 31
IS 1
BP 157
EP 163
DI 10.1523/JNEUROSCI.1833-10.2011
PG 7
WC Neurosciences
SC Neurosciences & Neurology
GA 702SH
UT WOS:000285915100018
PM 21209200
ER
PT J
AU Whittlesey, KJ
Lee, MH
Dang, JYM
Colehour, M
Arcidiacono, J
Lazarus, E
Kaplan, DS
Fink, D
Durfor, CN
Batra, A
Hilbert, SL
Grayeski, DL
McFarland, R
Witten, C
AF Whittlesey, Kevin J.
Lee, Mark H.
Dang, Jiyoung M.
Colehour, Maegen
Arcidiacono, Judith
Lazarus, Ellen
Kaplan, David S.
Fink, Donald
Durfor, Charles N.
Batra, Ashok
Hilbert, Stephen L.
Grayeski, Deborah Lavoie
McFarland, Richard
Witten, Celia
BE Atala, A
Lanza, R
Thomson, JA
Nerem, R
TI Overview of the FDA Regulatory Process
SO PRINCIPLES OF REGENERATIVE MEDICINE, 2ND EDITION
LA English
DT Article; Book Chapter
ID ADENOVIRUS VECTORS; IN-VITRO; CELLS; KERATINOCYTES; REQUIREMENTS;
STANDARDS; PRODUCTS; FRZB-1; WNT-8
C1 [Whittlesey, Kevin J.] US FDA, Off Commissioner, Silver Spring, MD USA.
[Lee, Mark H.; Arcidiacono, Judith; Lazarus, Ellen; Fink, Donald; McFarland, Richard; Witten, Celia] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Dang, Jiyoung M.; Colehour, Maegen; Kaplan, David S.; Durfor, Charles N.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Batra, Ashok] SUNY Syracuse, Syracuse, NY USA.
[Batra, Ashok] US Biotechnol & Pharma Consulting Grp, Potomac, MD USA.
[Hilbert, Stephen L.] Childrens Mercy Hosp, Kansas City, MO 64108 USA.
[Grayeski, Deborah Lavoie] M Squared Associates Inc, Alexandria, VA USA.
RP Whittlesey, KJ (reprint author), US FDA, Off Commissioner, Silver Spring, MD USA.
NR 70
TC 4
Z9 4
U1 0
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
BN 978-0-12-381423-4
PY 2011
BP 1145
EP 1168
DI 10.1016/B978-0-12-381422-7.10063-X
PG 24
WC Cell & Tissue Engineering; Developmental Biology
SC Cell Biology; Developmental Biology
GA BCS97
UT WOS:000311305200063
ER
PT S
AU Platisa, L
Marchessoux, C
Kimpe, T
Vansteenkiste, E
Badano, A
Philips, W
AF Platisa, Ljiljana
Marchessoux, Cedric
Kimpe, Tom
Vansteenkiste, Ewout
Badano, Aido
Philips, Wilfried
GP IEEE
TI Channelized Hotelling Observers for Signal Detection in Stack-Mode
Reading of Volumetric Images on Medical Displays with Slow Response Time
SO 2011 IEEE NUCLEAR SCIENCE SYMPOSIUM AND MEDICAL IMAGING CONFERENCE
(NSS/MIC)
SE IEEE Nuclear Science Symposium Conference Record
LA English
DT Proceedings Paper
CT IEEE Nuclear Science Symposium/Medical Imaging Conference (NSS/MIC)/18th
International Workshop on Room-Temperature Semiconductor X-Ray and
Gamma-Ray Detectors
CY OCT 23-29, 2011
CL Valencia, SPAIN
SP IEEE, Inst Elect & Elect Engineers Nucl & Plasma Sci Soc (IEEE NPSS)
ID BOOTSTRAP; NOISE
AB Volumetric medical images are commonly read in stack-browsing mode. However, previous studies suggest that slow temporal response of medical liquid crystal displays may degrade the diagnostic accuracy (lesion detectability) at browsing rates as low as 10 frames per second (fps). Recently, a multi-slice channelized Hotelling observer (msCHO) model was proposed to estimate the detection performance in 3D images. This implementation of the msCHO restricted the analysis to the luminance of a display pixel at the end of the frame time (end-of-frame luminance) while ignoring the luminance transition within the frame time (intra-frame luminance). Such an approach fails to differentiate between, for example, the commonly found case of two displays with different temporal profiles of luminance as long as their end-of-frame luminance levels are the same. In order to overcome this limitation of the msCHO, we propose a new upsampled msCHO (umsCHO) which acts on images obtained using both the intra-frame and the end-of-frame luminance information. The two models are compared on a set of synthesized 3D images for a range of browsing rates (16.67, 25 and 50 fps). Our results demonstrate that, depending on the details of the luminance transition profiles, neglecting the intra-frame luminance information may lead to over-or underestimation of lesion detectability. Therefore, we argue that using the umsCHO rather than msCHO model is more appropriate for estimating the detection performance in the stack-browsing mode.
C1 [Platisa, Ljiljana; Vansteenkiste, Ewout] Univ Ghent, Dept Telecommun & Informat Proc TELIN IPI IBBT, Grp Image Proc & Interpretat, St Pietersnieuwstr 41, B-9000 Ghent, Belgium.
[Marchessoux, Cedric; Kimpe, Tom] Technol & Innovat Grp, Hlth Div, B-8500 Kortrijk, Belgium.
[Badano, Aido] CDRH, Off Sci & Engn Labs, Div Imaging & Appl Math, FDA, Silver Spring, MD 20993 USA.
RP Platisa, L (reprint author), Univ Ghent, Dept Telecommun & Informat Proc TELIN IPI IBBT, Grp Image Proc & Interpretat, St Pietersnieuwstr 41, B-9000 Ghent, Belgium.
EM Ljiljana.Platisa@telin.ugent.be
NR 15
TC 0
Z9 0
U1 0
U2 3
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 1082-3654
BN 978-1-4673-0120-6
J9 IEEE NUCL SCI CONF R
PY 2011
BP 2697
EP 2702
PG 6
WC Engineering, Electrical & Electronic; Physics, Applied; Imaging Science
& Photographic Technology; Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Physics; Imaging Science & Photographic Technology;
Radiology, Nuclear Medicine & Medical Imaging
GA BAM64
UT WOS:000304755602194
ER
PT S
AU Calderon, SN
AF Calderon, Silvia N.
BE Nagase, H
TI Nonpeptidic Delta (delta) Opioid Agonists and Antagonists of the
Diarylmethylpiperazine Class: What Have We Learned?
SO CHEMISTRY OF OPIOIDS
SE Topics in Current Chemistry
LA English
DT Review; Book Chapter
DE delta Agonists; delta Antagonists; Diphenylmethylpiperazines;
Nonpeptidic delta ligands; SNC 80
ID RECEPTOR-MEDIATED PHENOMENA; N-SUBSTITUTED BENZOTRIAZOLES; DISPLAYS
SELECTIVE BINDING; MESSAGE-ADDRESS CONCEPT; PHARMACOLOGICAL
CHARACTERIZATION; HIGHLY POTENT; HIGH-AFFINITY; LIGANDS; SNC-80; ANALOGS
AB The discovery of the selective delta (delta) opioid agonists SNC 80 and BW373U86, which possess a diarylmethylpiperazine structure unique among opioids, represented a major advance in the field of delta-opioid ligands. Extensive research has recently been performed to uncover the structure-activity relationships (SAR) of this class of ligands, thereby providing valuable tools for the pharmacological characterization of the delta opioid receptor. This review focuses on the SAR of this unique series of ligands, and provides an overview of the various chemical routes that have been developed and optimized through the years to allow the syntheses of these ligands on a multigram scale. The search for selective delta opioid agonists and antagonists, as well as for those with mixed opioid agonist properties with potential therapeutic value, continues. Several questions regarding the interaction at the molecular level of diphenylmethylpiperazine derivatives and related analogs with opioid receptors and in particular with the delta opioid system still remain unanswered. Indeed, the development and pharmacological characterization of novel nonpeptidic delta opioid ligands remains an active area of research, as it may provide a better understanding of the role of this receptor in multiple disease states and disorders.
C1 US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Calderon, SN (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM silvia.calderon@fda.hhs.gov
NR 61
TC 2
Z9 2
U1 1
U2 5
PU SPRINGER-VERLAG BERLIN
PI BERLIN
PA HEIDELBERGER PLATZ 3, D-14197 BERLIN, GERMANY
SN 0340-1022
BN 978-3-642-18107-8
J9 TOP CURR CHEM
JI Top. Curr. Chem.
PY 2011
VL 299
BP 121
EP 140
DI 10.1007/128_2010_83
D2 10.1007/978-3-642-18107-8
PG 20
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA BAZ17
UT WOS:000306137700006
PM 21630509
ER
PT S
AU Woodruff, RS
Yan, J
Jones, MY
Watanabe, F
Biris, A
Chen, T
AF Woodruff, Robert S.
Yan, Jian
Jones, Margie Y.
Watanabe, Fumiya
Biris, Alexandru
Chen, Tao
BE Tarasenko, O
TI "Evaluation of Genotoxicity of Titanium Dioxide Nanoparticles using the
Ames Test and In Vitro Comet Assay"
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Meeting Abstract
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
C1 [Woodruff, Robert S.] US FDA, Div Microbiol, Arkansas Reg Lab, Jefferson, AR USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 35
EP 36
PG 2
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100015
ER
PT S
AU Pogribna, M
Nichols, J
Cozart, C
Siitonen, P
Walker, NJ
Boudreau, M
AF Pogribna, Marta
Nichols, J.
Cozart, C.
Siitonen, P.
Walker, N. J.
Boudreau, Mary
BE Tarasenko, O
TI "Tissue Distribution of Different Sizes of Silver Nanoparticles in
Sprague-Dawley Rats"
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Meeting Abstract
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
C1 [Pogribna, Marta; Nichols, J.; Cozart, C.; Siitonen, P.; Boudreau, Mary] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 59
EP 60
PG 2
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100063
ER
PT S
AU Alusta, P
Buzatu, D
Tarasenko, O
Wilkes, J
Darsey, J
AF Alusta, Pierre
Buzatu, Dan
Tarasenko, Olga
Wilkes, Jon
Darsey, Jerry
BE Tarasenko, O
TI DIRECT IMPACT CORONA IONIZATION OF BACTERIA FOR RAPID, REPRODUCIBLE
IDENTIFICATION VIA SPECTRAL PATTERN RECOGNITION
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Proceedings Paper
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
DE direct impact corona ionization; mass spectrometry; rapid bacterial
identification
ID PYROLYSIS-MASS-SPECTROMETRY
AB A novel atmospheric pressure ionization process, Direct Impact Corona Ionization (DICI), is described here. In this process, a corona impinges onto the flat surface of a stainless steel pin carrying a thin film of dried bacterial suspension, the analyte. Two electrodes - a corona electrode and the sample pin - are immersed in hot inert He gas flux, flowing past them towards a 0.4 mm orifice leading to a mass spectrometer analyzer. An electric potential of 1.5 - 3.0 kV is placed between the two. At distances less than 1 cm, an intermittent arc is formed. At approximately 4 mm, the arc becomes a continuous corona discharge (plasma). The plasma is hot enough to: A) locally melt the impact zone on the steel pin, and B) ablate the dry thin bacterial film deposited on the metal pin. Biomolecular ions as heavy as 790 m/z are generated. Mass spectral fingerprints of bacteria are obtained with a high degree of reproducibility by selecting the highest intensity of an "indicator ion", 560.5 m/z or another relatively heavy ion whose appearance signals efficient vaporization of low volatility components.
C1 [Alusta, Pierre; Buzatu, Dan; Wilkes, Jon] US FDA, Ctr Innovat Technol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Alusta, P (reprint author), US FDA, Ctr Innovat Technol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
FU ORISE (Oak Ridge, TN); ORISE; NCTR; IBC [09093.]
FX This study was supported by ORISE (Oak Ridge, TN). Sincere appreciation
is extended to Bruce Pearce, Richard Beger, Tom Schmitt, Randal Tucker,
Tom Heinze, Richard Rassmussen, Reggie Hall, Don Paine, John Sutherland,
Mohammed Nawaz, Rajesh Nayak, Steven Foley, Ricky Holland, Fumiya
Watanabe, Nysia George and the Array Track TM development team at the
NCTR for their scientific and computational insights. This study
conforms to the IBC protocol # 09093.
NR 13
TC 0
Z9 0
U1 0
U2 0
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 128
EP 134
DI 10.1063/1.3587468
PG 7
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100075
ER
PT S
AU Eassa, S
Bose, C
Alusta, P
Tarasenko, O
AF Eassa, Souzan
Bose, Chhanda
Alusta, Pierre
Tarasenko, Olga
BE Tarasenko, O
TI DETECTION METHOD OF TOXOPLASMA GONDII TACHYZOITES
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Proceedings Paper
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
ID RISK-FACTORS; INFECTION; OLIGOSACCHARIDES; GLYCOSYLATION; RECOGNITION;
PREGNANCY; ROLES
AB Tachyzoites are considered to be the most important stage of Toxoplasma gondii which causes toxoplasmosis. T. gondii is, an obligate intracellular parasite which infects a wide range of cells. The present study was designed to develop a method for an early detection of T. gondii tachyzoites. The method comprised of a binding assay which was analyzed using principal component and cluster analysis. Our data showed that glycoconjugates GC1, GC2, GC3 and GC10 exhibit a significantly higher binding affinity for T. gondii tachyzoites as compared to controls (T. gondii only, PAA only, GC 1, 2, 3, and 10 only).
C1 [Eassa, Souzan; Tarasenko, Olga] Univ Arkansas, Little Rock, AR 72204 USA.
[Bose, Chhanda; Alusta, Pierre] Cent Arkansas Vet Healthcare Syst, Little Rock, AR 72204 USA.
[Alusta, Pierre] Natl Ctr Toxicol Res, FDA Labs, Jefferson, AR USA.
RP Eassa, S (reprint author), Univ Arkansas, Little Rock, AR 72204 USA.
NR 24
TC 0
Z9 0
U1 0
U2 0
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 157
EP 164
DI 10.1063/1.3587472
PG 8
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100079
ER
PT B
AU Robertson, SM
Piscitelli, SC
Struble, KA
AF Robertson, Sarah M.
Piscitelli, Stephen C.
Struble, Kimberly A.
BE Piscitelli, SC
Rodvold, KA
Pai, MP
TI Drug Interactions with Antiretrovirals for HIV Infection
SO DRUG INTERACTIONS IN INFECTIOUS DISEASES, THIRD EDITION
SE Infectious Disease
LA English
DT Article; Book Chapter
ID TENOFOVIR DISOPROXIL FUMARATE; IMMUNODEFICIENCY-VIRUS PROTEASE;
PHARMACOKINETIC INTERACTION; HEALTHY-VOLUNTEERS; NEGATIVE VOLUNTEERS;
CYP3A4 INHIBITORS; PLASMA-LEVELS; RALTEGRAVIR; RITONAVIR; MARAVIROC
AB Despite great strides in human immunodeficiency virus (HIV) drug development, the management of drug interactions remains a key component of patient care. A number of new drugs have been approved in the past 5 years, including two new classes of antiretrovirals: CCR5 antagonists and integrase inhibitors. HIV treatment is complex, generally requiring at least three antiretrovirals in addition to medications for supportive care and concomitant infections. Many antiretrovirals have clinically significant drug interactions that require dosage adjustment. This chapter reviews important drug interactions for the newest antiretrovirals and provides detailed tables to guide clinicians on patient management.
C1 [Robertson, Sarah M.] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Struble, Kimberly A.] US FDA, Div Antiviral Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Piscitelli, Stephen C.] GlaxoSmithKline Inc, Clin Pharmacol, Infect Dis, Res Triangle Pk, NC USA.
RP Robertson, SM (reprint author), US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,White Oak Bldg 22, Silver Spring, MD 20993 USA.
EM Sarah.Robertson@fda.hhs.gov
NR 95
TC 5
Z9 5
U1 0
U2 0
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
BN 978-1-61779-212-0
J9 INFECT DIS
PY 2011
BP 425
EP 470
DI 10.1007/978-1-61779-213-7_13
D2 10.1007/978-1-61779-213-7
PG 46
WC Infectious Diseases; Medicine, General & Internal; Pharmacology &
Pharmacy
SC Infectious Diseases; General & Internal Medicine; Pharmacology &
Pharmacy
GA BYU08
UT WOS:000300328700013
ER
PT S
AU Wang, SJ
Anugu, V
Nguyen, T
Rose, N
Burns, J
McKenna, M
Petrick, N
Summers, RM
AF Wang, Shijun
Anugu, Vishal
Tan Nguyen
Rose, Natalie
Burns, Joseph
McKenna, Matthew
Petrick, Nicholas
Summers, Ronald M.
GP IEEE
TI FUSION OF MACHINE INTELLIGENCE AND HUMAN INTELLIGENCE FOR COLONIC POLYP
DETECTION IN CT COLONOGRAPHY
SO 2011 8TH IEEE INTERNATIONAL SYMPOSIUM ON BIOMEDICAL IMAGING: FROM NANO
TO MACRO
SE IEEE International Symposium on Biomedical Imaging
LA English
DT Proceedings Paper
CT 8th IEEE International Symposium on Biomedical Imaging (ISBI) - From
Nano to Macro
CY MAR 30-APR 02, 2011
CL Chicago, IL
SP Inst Elect & Electron Engn, Engn Med & Biol Soc (EMBS), IEEE Signal Proc Soc (SPS)
DE Computed tomographic colonography; computer aided detection; Amazon
MTurk; alpha -integration; classifier fusion
ID TOMOGRAPHIC VIRTUAL COLONOSCOPY; COMPUTER-AIDED DETECTION; FALSE
POSITIVES; REDUCTION
AB In this paper, we proposed a novel method to improve colonic polyp detection in computed tomographic colonography. Utilizing the human knowledge workers via the Amazon Mechanical Turk (MTurk) webservice, we distributed polyp detections from a computer-aided detection system (CAD) to anonymous online knowledge workers and asked them to distinguish true and false polyp candidates. We combined decisions from the CAD system (machine intelligence) and the MTurk workers (human intelligence) using alpha-integration. Preliminary experimental results indicated that the combined decisions were superior to either alone, with area under the receiver operating characteristic curve improving by 5.8% and 7.0% compared with CAD and MTurk workers alone, respectively.
C1 [Wang, Shijun; Anugu, Vishal; Tan Nguyen; Rose, Natalie; Burns, Joseph; McKenna, Matthew; Summers, Ronald M.] NIH, Imaging Biomarkers & Comp Aided Diag Lab, Ctr Clin, Bldg 10,Room 1C224,MSC 1182, Bethesda, MD 20892 USA.
[Petrick, Nicholas] U S Food & Drug Adm, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Burns, Joseph] Univ Calif, Irvine Med Ctr, Dept Radiol Sci, Orange, CA 92868 USA.
RP Summers, RM (reprint author), NIH, Imaging Biomarkers & Comp Aided Diag Lab, Ctr Clin, Bldg 10,Room 1C224,MSC 1182, Bethesda, MD 20892 USA.
EM rms@mail.nih.gov
FU Intramural Research Programs of the NIH Clinical Center; U.S. Food and
Drug Administration
FX This research was supported by the Intramural Research Programs of the
NIH Clinical Center and the U.S. Food and Drug Administration (NP).
NR 12
TC 7
Z9 7
U1 0
U2 3
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 1945-7928
BN 978-1-4244-4128-0
J9 I S BIOMED IMAGING
PY 2011
BP 160
EP 164
PG 5
WC Engineering, Biomedical; Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Radiology, Nuclear Medicine & Medical Imaging
GA BYH79
UT WOS:000298849400038
ER
PT S
AU Vidal, C
Beggs, D
Younes, L
Jain, SK
Jedynak, B
AF Vidal, Camille
Beggs, Dale
Younes, Laurent
Jain, Sanjay K.
Jedynak, Bruno
GP IEEE
TI INCORPORATING USER INPUT IN TEMPLATE-BASED SEGMENTATION
SO 2011 8TH IEEE INTERNATIONAL SYMPOSIUM ON BIOMEDICAL IMAGING: FROM NANO
TO MACRO
SE IEEE International Symposium on Biomedical Imaging
LA English
DT Proceedings Paper
CT 8th IEEE International Symposium on Biomedical Imaging (ISBI) - From
Nano to Macro
CY MAR 30-APR 02, 2011
CL Chicago, IL
SP Inst Elect & Electron Engn, Engn Med & Biol Soc (EMBS), IEEE Signal Proc Soc (SPS)
DE Registration; Template-based Segmentation; User Input; Diseased Organs
AB We present a simple and elegant method to incorporate user input in a template-based segmentation method for diseased organs. The user provides a partial segmentation of the organ of interest, which is used to guide the template towards its target. The user also highlights some elements of the background that should be excluded from the final segmentation. We derive by likelihood maximization a registration algorithm from a simple statistical image model in which the user labels are modeled as Bernoulli random variables. The resulting registration algorithm minimizes the sum of square differences between the binary template and the user labels, while preventing the template from shrinking, and penalizing for the inclusion of background elements into the final segmentation. We assess the performance of the proposed algorithm on synthetic images in which the amount of user annotation is controlled. We demonstrate our algorithm on the segmentation of the lungs of Mycobacterium tuberculosis infected mice from mu CT images.
C1 [Vidal, Camille] US FDA, Div Imaging & Appl Math, CDRH, Rockville, MD 20857 USA.
[Younes, Laurent; Jedynak, Bruno] US FDA, Ctr Imaging Sci, Rockville, MD 20857 USA.
[Beggs, Dale; Younes, Laurent; Jedynak, Bruno] Johns Hopkins Univ, Dept Appl Math & Stat, Baltimore, MD 21218 USA.
[Jain, Sanjay K.] Johns Hopkins Univ, Ctr Tuberculosis Res, Baltimore, MD 21218 USA.
RP Vidal, C (reprint author), US FDA, Div Imaging & Appl Math, CDRH, Rockville, MD 20857 USA.
NR 5
TC 2
Z9 2
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 1945-7928
BN 978-1-4244-4128-0
J9 I S BIOMED IMAGING
PY 2011
BP 1434
EP 1437
PG 4
WC Engineering, Biomedical; Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Radiology, Nuclear Medicine & Medical Imaging
GA BYH79
UT WOS:000298849400326
ER
PT S
AU Sanders, ME
Levy, DD
AF Sanders, Mary Ellen
Levy, Dan D.
BA Sanders, ME
Levy, DD
BF Sanders, ME
Levy, DD
TI The science and regulations of probiotic food and supplement product
labeling
SO PROBIOTIC FOODS AND SUPPLEMENTS
SE Annals of the New York Academy of Sciences
LA English
DT Article; Proceedings Paper
CT Symposium on Probiotic Foods and Supplements - The Science and
Regulations of Labeling
CY JUN 12, 2010
CL New York Acad Sci, New York, NY
HO New York Acad Sci
DE probiotics; dietary supplements; FDA; structure/function claims
ID IRRITABLE-BOWEL-SYNDROME; LACTOBACILLUS
AB Presented by the New York Academy of Sciences, the U.S. Food and Drug Administration (FDA), and the U.S. Office of Dietary Supplements of the National Institutes of Health, the symposium "Probiotic Foods and Supplements: The Science and Regulations of Labeling," was held on June 12, 2010 at the New York Academy of Sciences, New York, NY, the goals of which were to facilitate the exchange of ideas regarding labeling and substantiation of claims for probiotics among academic, industry, and regulatory professionals, and to discuss ways to translate and communicate research results in a truthful way to the consumer and to such health professionals as physicians, pharmacists, and dieticians. The target audience for this symposium included academicians interested in conducting research on the health benefits of probiotics; scientists; communications personnel, and regulatory specialists from companies involved in, or interested in, the marketing of probiotics; U. S. government regulatory experts tasked with oversight of probiotic foods and dietary supplement products; and other experts in the field interested in the development of probiotics for the U. S. market.
C1 [Sanders, Mary Ellen] Dairy & Food Culture Technol, Centennial, CO 80122 USA.
[Levy, Dan D.] US FDA, New Dietary Ingredient Review Team, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Sanders, ME (reprint author), Dairy & Food Culture Technol, 7119 S Glencoe Ct, Centennial, CO 80122 USA.
EM mes@mesanders.com; Dan.Levy@fda.hhs.gov; mes@mesanders.com;
Dan.Levy@fda.hhs.gov
FU National Center for Complementary and Alternative Medicine, a component
of the National Institutes of Health
FX This conference report was made possible, in part, by support from the
National Center for Complementary and Alternative Medicine, a component
of the National Institutes of Health. The views expressed in written
conference materials or publications and by speakers and moderators do
not necessarily reflect the official policies of the National Institutes
of Health; nor do mention of trade names, commercial practices, or
organizations imply endorsement by the U.S. government.
NR 24
TC 13
Z9 15
U1 3
U2 15
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 2011
VL 1219
IS S1
BP E1
EP E23
DI 10.1111/j.1749-6632.2010.05956.x
PG 23
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA BZD70
UT WOS:000301188100001
PM 21332758
ER
PT J
AU Huang, Y
Zhang, K
Kang, JU
Calogero, D
James, RH
Ilev, IK
AF Huang, Yong
Zhang, Kang
Kang, Jin U.
Calogero, Don
James, Robert H.
Ilev, Ilko K.
GP IEEE
TI A Novel Non-Contact Common-Path Fourier Domain Optical Coherence
Tomography Method for Intraocular Lens Power Measurement In-Vitro
SO 2011 IEEE PHOTONICS CONFERENCE (PHO)
LA English
DT Proceedings Paper
CT IEEE Photonics Conference (PHO)
CY OCT 09-13, 2011
CL Arlington, VA
SP IEEE
DE cataract; intraocular lens dioptric power; common-path Fourier domain
optical coherence tomography
AB We developed a novel non-contact common path FD-OCT method to measure the dioptric power of intraocular lenses in-vitro. This method can be applied to a wide range of IOLs.
C1 [Huang, Yong; Calogero, Don; James, Robert H.; Ilev, Ilko K.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Huang, Y (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM yhuang60@jhu.edu
RI Kang, Jin/A-3228-2010
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
BN 978-1-4244-8939-8
PY 2011
BP 727
EP 728
PG 2
WC Engineering, Electrical & Electronic
SC Engineering
GA BYQ41
UT WOS:000299750700364
ER
PT J
AU Bumbaugh, AC
Lacher, DW
AF Bumbaugh, Alyssa C.
Lacher, David W.
BE Walk, ST
Feng, PCH
TI Gene Acquisition and Loss in the Phylogenetic Lineages of the Invasive
Escherichia coli
SO POPULATION GENETICS OF BACTERIA: A TRIBUTE TO THOMAS S. WHITTAM
LA English
DT Article; Book Chapter
ID SHIGELLA-FLEXNERI 2A; SHE PATHOGENICITY ISLAND; COMPLETE GENOME
SEQUENCE; BACTERIAL PATHOGENS; IRON TRANSPORT; EVOLUTIONARY
RELATIONSHIPS; MOLECULAR CHARACTERIZATION; GENOTYPIC CHARACTERIZATION;
SALMONELLA-TYPHIMURIUM; ANTIVIRULENCE LOCI
C1 [Bumbaugh, Alyssa C.] Shippensburg Univ, Dept Biol, Shippensburg, PA 17257 USA.
[Lacher, David W.] US FDA, Div Mol Biol, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Bumbaugh, AC (reprint author), Shippensburg Univ, Dept Biol, Shippensburg, PA 17257 USA.
NR 89
TC 0
Z9 0
U1 1
U2 1
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-711-4
PY 2011
BP 135
EP 156
PG 22
WC Evolutionary Biology; Microbiology
SC Evolutionary Biology; Microbiology
GA BYN76
UT WOS:000299463700011
ER
PT J
AU Abu-Ali, GS
Springman, AC
Ouellette, LM
Wick, L
Qi, WH
Vanaja, SK
Bergholz, TM
Lacher, DW
Walk, ST
Tietjen, JA
Steinsland, H
Riordan, JT
Manning, SD
AF Abu-Ali, Galeb S.
Springman, A. Cody
Ouellette, Lindsey M.
Wick, Lukas
Qi, Weihong
Vanaja, Sivapriya Kalisan
Bergholz, Teresa M.
Lacher, David W.
Walk, Seth T.
Tietjen, Jillian A.
Steinsland, Hans
Riordan, James T.
Manning, Shannon D.
BE Walk, ST
Feng, PCH
TI Molecular Evolution of Enterohemorrhagic Escherichia coli and
Application to Epidemiology
SO POPULATION GENETICS OF BACTERIA: A TRIBUTE TO THOMAS S. WHITTAM
LA English
DT Article; Book Chapter
ID HEMOLYTIC-UREMIC SYNDROME; HEMORRHAGIC COLITIS; GENOMIC DIVERSITY;
GENETIC DIVERSITY; O157-H7 INFECTION; MASSIVE OUTBREAK; HUMAN-DISEASE;
SAKAI CITY; EMERGENCE; SEQUENCE
C1 [Abu-Ali, Galeb S.; Lacher, David W.] US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
[Springman, A. Cody; Ouellette, Lindsey M.; Manning, Shannon D.] Michigan State Univ, E Lansing, MI 48824 USA.
[Wick, Lukas] Biosynth AG, CH-9422 Staad, Switzerland.
[Qi, Weihong] Swiss Fed Inst Technol, Funct Genom Ctr Zurich Uni, CH-8057 Zurich, Switzerland.
[Vanaja, Sivapriya Kalisan] Univ Massachusetts, Sch Med, Worcester, MA 01655 USA.
[Bergholz, Teresa M.] Cornell Univ, Dept Food Sci, Ithaca, NY 14853 USA.
[Walk, Seth T.] Univ Michigan Hlth Syst, Dept Internal Med, Div Infect Dis, Ann Arbor, MI 48109 USA.
[Tietjen, Jillian A.] Univ Michigan, Genet Counseling Dept, Ann Arbor, MI 48109 USA.
[Steinsland, Hans] Univ Bergen, Dept Biomed, N-5009 Bergen, Norway.
[Riordan, James T.] Univ S Florida, Dept Cell Biol Microbiol & Mol Biol, Tampa, FL 33063 USA.
RP Abu-Ali, GS (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RI Bergholz, Teresa/A-2815-2010
OI Bergholz, Teresa/0000-0002-3976-5858
NR 42
TC 0
Z9 0
U1 0
U2 2
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-711-4
PY 2011
BP 287
EP 302
PG 16
WC Evolutionary Biology; Microbiology
SC Evolutionary Biology; Microbiology
GA BYN76
UT WOS:000299463700019
ER
PT S
AU Chen, WJ
Petrick, N
Sahiner, B
AF Chen, Weijie
Petrick, Nicholas
Sahiner, Berkman
BE Manning, DJ
Abbey, CK
TI Assessment of updated CAD without a new reader study: effect of
calibration of computer output on the computer-aided reader performance
in CADx
SO MEDICAL IMAGING 2011: 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, 2011
CL Lake Buena Vista, FL
SP SPIE, Dynasil Corp/RMD Res, AAPM - Amer Assoc Physicists Med, DQE Instruments, Inc, Ocean Thin Films, Inc, Univ Cent Florida, CREOL - Coll Opt & Photon, VIDA Diagnost, Inc
DE calibration; CADx; assessment; ROC analysis
AB It is very resource-demanding to assess each new version of a CAD system through a new reader study. We conjecture that the aided reader performance on a new version can be predicted by using certain characteristics of the computer output and the reader study conducted when the CAD system was initially introduced. This would likely reduce the need for additional reader studies. However, investigations are needed to develop a sound scientific foundation to test this conjecture. In this work, we consider a CADx system that outputs a disease score to aid the physician in making a diagnostic decision on a located lesion. Our major contribution is to show that calibration, reflected as a change in scale, is a characteristic of the computer output that needs to be considered in order to predict the aided reader performance in a new CADx version without a reader study. We used a bivariate-bi-beta distribution to model the joint distribution of the decision variable underlying the reader without aid and the decision variable underlying the version 1 computer output in the initial version. We then applied a monotonic transformation to the computer output to simulate the computer output in a new version, i.e., the scores in the two versions differ only in calibration (specifically a change in scale). By further modeling certain mechanisms that the human reader may use for combining the computer output and the reader-alone scores, we computed the aided reader performance in terms of AUC for the new version of the CADx system. Our results show that the aided reader performance could depend on the degree of calibration difference between the two CAD system outputs. We conclude that for the purpose of predicting the aided reader performance of a new version of the CADx system, ROC performance (or any other rank-based metric) of the stand-alone CADx system may not be sufficient by itself.
C1 [Chen, Weijie; Petrick, Nicholas; Sahiner, Berkman] US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs CDRH, Silver Spring, MD 20993 USA.
RP Chen, WJ (reprint author), US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs CDRH, Silver Spring, MD 20993 USA.
EM weijie.chen@fda.hhs.gov
NR 8
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 978-0-81948-508-3
J9 PROC SPIE
PY 2011
VL 7966
AR 79661P
DI 10.1117/12.878278
PG 8
WC Optics; Imaging Science & Photographic Technology; Radiology, Nuclear
Medicine & Medical Imaging
SC Optics; Imaging Science & Photographic Technology; Radiology, Nuclear
Medicine & Medical Imaging
GA BXL76
UT WOS:000296320800055
ER
PT S
AU Sahiner, B
Petrick, N
Paquerault, S
Chen, WJ
Nguyen, T
AF Sahiner, Berkman
Petrick, Nicholas
Paquerault, Sophie
Chen, Weijie
Tien Nguyen
BE Manning, DJ
Abbey, CK
TI Agreement Between Two Versions of a CADx System: A Simulation Study
SO MEDICAL IMAGING 2011: 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, 2011
CL Lake Buena Vista, FL
SP SPIE, Dynasil Corp/RMD Res, AAPM - Amer Assoc Physicists Med, DQE Instruments, Inc, Ocean Thin Films, Inc, Univ Cent Florida, CREOL - Coll Opt & Photon, VIDA Diagnost, Inc
DE Agreement; concordance; standalone performance; CAD system update
ID SUPPORT VECTOR MACHINES; CLASSIFICATION
AB A simulation study was conducted to investigate the agreement between original and updated versions of a computer-aided diagnosis (CADx) system. Performances of two versions of a CADx system are traditionally compared using metrics derived from the receiver operating characteristic (ROC) curve. These aggregate standalone performance measures may reveal the overall improvement of the CADx system due to the update, but do not provide information about the specific change in CADx output for individual cases. To address this issue, we used the concordance measure, which compares the ordering of scores for pairs of cases between system versions (i.e., before and after the update of the system). In this preliminary study, the system update that we investigated was an enlargement of the training data set, which is often encountered in the development of a subsequent CADx system version for improving performance. We separately studied the effect of the size of the original training set, the number of features, and the distribution and separation of the two classes in the feature space on the concordance and AUC measures. When the effect of an update was compared among datasets with differences in intrinsic class separation, concordance was in general larger when the intrinsic class separation was larger. The amount of change in AUC between the original and updated CADx system did not always predict the degree of agreement between the two system versions. A large improvement in AUC could be accompanied with either a larger or smaller agreement between the original and updated systems. Quantification of the degree of agreement in standalone performance between different versions of a CADx system may serve to define a major algorithm update, and better depict the impact of that update.
C1 [Sahiner, Berkman; Petrick, Nicholas; Paquerault, Sophie; Chen, Weijie; Tien Nguyen] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Sahiner, B (reprint author), 10903 New Hampshire Ave WO62-4106, Silver Spring, MD 20993 USA.
EM berkman.sahiner@fda.hhs.gov
NR 10
TC 0
Z9 0
U1 1
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 978-0-81948-508-3
J9 PROC SPIE
PY 2011
VL 7966
AR 79660J
DI 10.1117/12.877727
PG 8
WC Optics; Imaging Science & Photographic Technology; Radiology, Nuclear
Medicine & Medical Imaging
SC Optics; Imaging Science & Photographic Technology; Radiology, Nuclear
Medicine & Medical Imaging
GA BXL76
UT WOS:000296320800018
ER
PT J
AU Van Dort, ME
Kande, G
Rauch, JN
John, CS
Comeau, A
Bowen, WD
Rehemtulla, A
Ross, BD
AF Van Dort, M. E.
Kande, G.
Rauch, J. N.
John, C. S.
Comeau, A.
Bowen, W. D.
Rehemtulla, A.
Ross, B. D.
TI Development of [F-18]-labeled Benzamides as Sigma Receptor Radioligands
for Tumor Imaging
SO JOURNAL OF LABELLED COMPOUNDS & RADIOPHARMACEUTICALS
LA English
DT Meeting Abstract
C1 [Van Dort, M. E.; Kande, G.; Rauch, J. N.; Ross, B. D.] Univ Michigan, Sch Med, Dept Radiol, Ann Arbor, MI USA.
[Rehemtulla, A.] Univ Michigan, Sch Med, Dept Radiat Oncol, Ann Arbor, MI USA.
[John, C. S.] CDER, Off Clin Pharmacol, Silver Spring, MD USA.
[Comeau, A.; Bowen, W. D.] Brown Univ, Dept Mol Pharmacol, Providence, RI 02912 USA.
NR 3
TC 0
Z9 0
U1 0
U2 1
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0362-4803
J9 J LABELLED COMPD RAD
JI J. Label. Compd. Radiopharm.
PY 2011
VL 54
SU 1
BP S216
EP S216
PG 1
WC Biochemical Research Methods; Chemistry, Medicinal; Chemistry,
Analytical
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy; Chemistry
GA 833RC
UT WOS:000295901600216
ER
PT J
AU Trehy, ML
Ye, W
Hadwiger, ME
Moore, TW
Allgire, JF
Woodruff, JT
Ahadi, SS
Black, JC
Westenberger, BJ
AF Trehy, Michael L.
Ye, Wei
Hadwiger, Michael E.
Moore, Terry W.
Allgire, James F.
Woodruff, Jeffrey T.
Ahadi, Shafiq S.
Black, John C.
Westenberger, Benjamin J.
TI ANALYSIS OF ELECTRONIC CIGARETTE CARTRIDGES, REFILL SOLUTIONS, AND SMOKE
FOR NICOTINE AND NICOTINE RELATED IMPURITIES
SO JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
LA English
DT Article
DE anatabine; cigarette; cotinine; e-cigarette; nicotine; smokeless
ID FREE-BASE NICOTINE; PARTICULATE MATTER; CHROMATOGRAPHY; DELIVERY
AB The objective of this study was to determine nicotine and the nicotine related impurities, that is, cotinine, myosmine, anatabine, anabasine, and beta-nicotyrine, in electronic cigarette cartridges, the liquid used to fill the cartridges, and from smoke generated using the electronic cigarette devices. An HPLC method was validated for the determination. Samples of nicotine containing products were purchased via the internet from NJOY, Smoking Everywhere, CIXI, and Johnson Creek. Electronic cigarette devices were purchased from NJOY, Smoking Everywhere, and CIXI. The results from the testing found that (1) the nicotine content labeling was not accurate with some manufacturers, (2) nicotine is present in the "smoke" from electronic cigarettes, and (3) nicotine related impurities contents in cartridges and refills were found to vary by electronic cigarette manufacturer.
C1 [Trehy, Michael L.; Ye, Wei; Hadwiger, Michael E.; Moore, Terry W.; Allgire, James F.; Woodruff, Jeffrey T.; Ahadi, Shafiq S.; Black, John C.; Westenberger, Benjamin J.] US FDA, Div Pharmaceut Anal, St Louis, MO 63101 USA.
RP Trehy, ML (reprint author), US FDA, Div Pharmaceut Anal, 1114 Market St, St Louis, MO 63101 USA.
EM Michael.Trehy@fda.hhs.gov
NR 17
TC 108
Z9 112
U1 11
U2 105
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1082-6076
J9 J LIQ CHROMATOGR R T
JI J. Liq. Chromatogr. Relat. Technol.
PY 2011
VL 34
IS 14
BP 1442
EP 1458
DI 10.1080/10826076.2011.572213
PG 17
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 837UU
UT WOS:000296230900012
ER
PT J
AU Abliz, E
Collins, JE
Bell, H
Tata, DB
AF Abliz, Erkinay
Collins, Joshua E.
Bell, Howard
Tata, Darrell B.
TI Novel applications of diagnostic X-rays in activating a clinical
photodynamic drug: Photofrin II through X-ray induced visible
luminescence from "rare-earth" formulated particles
SO JOURNAL OF X-RAY SCIENCE AND TECHNOLOGY
LA English
DT Article
DE X-ray induced luminescence; photodynamic therapy; reactive oxygen
species detection; singlet oxygen; Photofrin II; Gadolinium Oxysulfide
particles
ID ABSOLUTE EFFICIENCY; SINGLET OXYGEN; NANOPARTICLES; RADIATION; THERAPY;
SCREENS; CANCER; CELLS; PORPHYRINS
AB Introduction: In this communication we report on a novel non-invasive methodology in utilizing "soft" energy diagnostic X-rays to indirectly activate a photo-agent utilized in photodynamic therapy (PDT): Photofrin II (Photo II) through X-ray induced luminescence from Gadolinium Oxysulfide (20 micron dimension) particles doped with Terbium: Gd(2)O(2)S:Tb. Photodynamic agents such as Photo II utilized in PDT possess a remarkable property to become preferentially retained within the tumor's micro-environment. Upon the photo-agent's activation through (visible light) photon absorption, the agents exert their cellular cytotoxicity through type I and type II pathways through extensive generation of reactive oxygen species (ROS); namely, singlet oxygen (1)O(2), superoxide anion O(2)(-), and hydrogen peroxide H(2)O(2), within the intra-tumoral environment. Unfortunately, due to shallow visible light penetration depth (similar to 2 mm to 5 mm) in tissues, the current PDT strategy has largely been restricted to the treatment of surface tumors, such as the melanomas. Additional invasive strategies through optical fibers are currently utilized in getting the visible light into the intended deep seated targets within the body for PDT.
Methods: X-ray induced visible luminescence from Gd(2)O(2)S:Tb particles were spectroscopically characterized, and the potential in-vitro cellular cytotoxicity of Gd(2)O(2)S:Tb particles on human glioblastoma cells (due to 48 Hrs Gd(2)O(2)S:Tb particle exposure) was screened through the MTS cellular metabolic assay. In-vitro human glioblastoma cellular exposures in presence of Photo II with Gd(2)O(2)S:Tb particles were performed in the dark in sterile 96 well tissue culture plates, and the corresponding changes in the metabolic activities of the glioblastoma due to 15 minutes of (diagnostic energy) X-ray exposure was determined 48 Hrs after treatment through the MTS assay.
Results: Severe suppression (> 90% relative to controls) in the cellular metabolic activity of human glioblastoma was measured due to the treatment of clinically relevant concentrations of 20 mu g/ml Photo II, with Gd(2)O(2)S:Tb particles, and (120 kVp) diagnostic X-rays. Taken together, the in-vitro findings herein provide the basis for future studies in determining the safety and efficacy of this non-invasive X-ray induced luminescence strategy in activating photo-agent in deep seated tumors.
C1 [Tata, Darrell B.] US FDA, Silver Spring, MD USA.
[Abliz, Erkinay] George Washington Univ, Dept Elect & Comp Engn, Washington, DC USA.
[Collins, Joshua E.; Bell, Howard] Intelligent Mat Inc, Princeton, NJ USA.
RP Tata, DB (reprint author), US FDA, White Oak Campus, Silver Spring, MD USA.
EM Darayash.Tata@fda.hhs.gov
NR 26
TC 6
Z9 6
U1 1
U2 35
PU IOS PRESS
PI AMSTERDAM
PA NIEUWE HEMWEG 6B, 1013 BG AMSTERDAM, NETHERLANDS
SN 0895-3996
J9 J X-RAY SCI TECHNOL
JI J. X-Ray Sci. Technol.
PY 2011
VL 19
IS 4
BP 521
EP 530
DI 10.3233/XST-2011-0311
PG 10
WC Instruments & Instrumentation; Optics; Physics, Applied
SC Instruments & Instrumentation; Optics; Physics
GA 836VZ
UT WOS:000296146500008
PM 25214384
ER
PT J
AU Rubin, DB
AF Rubin, Daniel B.
TI An Alternative to Pooling Kaplan-Meier Curves in Time-to-Event
Meta-Analysis
SO INTERNATIONAL JOURNAL OF BIOSTATISTICS
LA English
DT Article
DE meta-analysis; survival analysis; Simpson's paradox
ID TYPE-2 DIABETES-MELLITUS; MYOCARDIAL-INFARCTION; ROSIGLITAZONE; RISK;
REGRESSION; ESTIMATOR; DEATH
AB A meta-analysis that uses individual-level data instead of study-level data is widely considered to be a gold standard approach, in part because it allows a time-to-event analysis. Unfortunately, with the common practice of presenting Kaplan-Meier survival curves after pooling subjects across randomized trials, using individual-level data can actually be a step backwards; a Simpson's paradox can occur in which pooling incorrectly reverses the direction of an association. We introduce a nonparametric procedure for synthesizing survival curves across studies that is designed to avoid this difficulty and preserve the integrity of randomization. The technique is based on a counterfactual formulation in which we ask what pooled survival curves would look like if all subjects in all studies had been assigned treatment, or if all subjects had been assigned to control arms. The method is related to a Kaplan-Meier adjustment proposed in 2005 by Xie and Liu to correct for confounding in nonrandomized studies, but is formulated for the meta-analysis setting. The procedure is discussed in the context of examining rosiglitazone and cardiovascular adverse events.
C1 Food & Drug Adm, Rockville, MD 20857 USA.
RP Rubin, DB (reprint author), Food & Drug Adm, Rockville, MD 20857 USA.
NR 26
TC 1
Z9 1
U1 1
U2 6
PU BERKELEY ELECTRONIC PRESS
PI BERKELEY
PA 2809 TELEGRAPH AVENUE, STE 202, BERKELEY, CA 94705 USA
SN 1557-4679
J9 INT J BIOSTAT
JI Int. J. Biostat.
PY 2011
VL 7
IS 1
AR 18
DI 10.2202/1557-4679.1289
PG 27
WC Mathematical & Computational Biology; Statistics & Probability
SC Mathematical & Computational Biology; Mathematics
GA 832FX
UT WOS:000295789600018
ER
PT B
AU Wen, ZN
Su, ZQ
Liu, J
Ning, BT
Guo, L
Tong, WD
Shi, LM
AF Wen, Zhining
Su, Zhenqiang
Liu, Jie
Ning, Baitang
Guo, Lei
Tong, Weida
Shi, Leming
BE Lu, HHS
Scholkopf, B
Zhao, HY
TI The MicroArray Quality Control (MAQC) Project and Cross-Platform
Analysis of Microarray Data
SO HANDBOOK OF STATISTICAL BIOINFORMATICS
SE Springer Handbooks of Computational Statistics
LA English
DT Article; Book Chapter
ID GENE-EXPRESSION MEASUREMENTS; BIG BLUE RATS; DNA MICROARRAY; ARRAYS;
REPRODUCIBILITY; CONSISTENCY; LIVER; MUTAGENICITY; RIDDELLIINE;
SPECIFICITY
AB As a powerful tool for genome-wide gene expression analysis, DNA microarray technology is widely used in biomedical research. One important application of microarrays is to identify differentially expressed genes (DEGs) between two distinct biological conditions, e.g. disease versus normal or treatment versus control, so that the underlying molecular mechanism differentiating the two conditions maybe revealed. Mechanistic interpretation of microarray results requires the identification of reproducible and reliable lists of DEGs, because irreproducible lists of DEGs may lead to different biological conclusions. Many vendors are providing microarray platforms of different characteristics for gene expression analysis, and the widely publicized apparent lack of intra- and cross-platform concordance in DEGs from microarray analysis of the same sets of study samples has been of great concerns to the scientific community and regulatory agencies like the US Food and Drug Administration (FDA). In this chapter, we describe the study design of and the main findings from the FDA-led MicroArray Quality Control (MAQC) project that aims to objectively assess the performance of different microarray platforms and the advantages and limitations of various competing statistical methods in identifying DEGs from microarray data. Using large data sets generated on two human reference RNA samples established by the MAQC project, we show that the levels of concordance in inter-laboratory and cross-platform comparisons are generally high. Furthermore, the levels of concordance largely depend on the statistical criteria used for ranking and selecting DEGs, irrespective of the chosen platforms or test sites. Importantly, a straightforward method combining fold-change ranking with a non-stringent P-value cutoff produces more reproducible lists of DEGs than those by t-test P-value ranking. Similar conclusions are reached when microarray data sets from a rat toxicogenomics study are analyzed. The availability of the MAQC reference RNA samples and the large reference data sets provides a unique resource for the gene expression community to reach consensus on the "best practices" for the generation, analysis, and applications of microarray data in drug development and personalized medicine.
C1 [Shi, Leming] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Shi, LM (reprint author), US FDA, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM leming.shi@fda.hhs.gov
NR 42
TC 3
Z9 3
U1 0
U2 3
PU SPRINGER-VERLAG BERLIN
PI BERLIN
PA HEIDELBERGER PLATZ 3, D-14197 BERLIN, GERMANY
BN 978-3-642-16344-9
J9 SPR HBK COMPU STAT
PY 2011
BP 171
EP 192
DI 10.1007/978-3-642-16345-6_9
D2 10.1007/978-3-642-16345-6
PG 22
WC Computer Science, Theory & Methods; Mathematical & Computational
Biology; Medical Informatics; Statistics & Probability
SC Computer Science; Mathematical & Computational Biology; Medical
Informatics; Mathematics
GA BVV63
UT WOS:000292903100009
ER
PT J
AU Kim, BS
Kim, JN
Cerniglia, CE
AF Kim, Bong-Soo
Kim, Jong Nam
Cerniglia, Carl E.
TI In Vitro Culture Conditions for Maintaining a Complex Population of
Human Gastrointestinal Tract Microbiota
SO JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY
LA English
DT Article
ID 16S RIBOSOMAL-RNA; GRADIENT GEL-ELECTROPHORESIS; HUMAN GUT; INTESTINAL
MICROFLORA; BACTERIAL-POPULATIONS; GENTIAN-VIOLET; PCR PRIMERS;
COMMUNITIES; DIVERSITY; COLON
AB A stable intestinal microbiota is important in maintaining human physiology and health. Although there have been a number of studies using in vitro and in vivo approaches to determine the impact of diet and xenobiotics on intestinal microbiota, there is no consensus for the best in vitro culture conditions for growth of the human gastrointestinal microbiota. To investigate the dynamics and activities of intestinal microbiota, it is important for the culture conditions to support the growth of a wide range of intestinal bacteria and maintain a complex microbial community representative of the human gastrointestinal tract. Here, we compared the bacterial community in three culture media: brain heart infusion broth and high-and low-carbohydrate medium with different growth supplements. The bacterial community was analyzed using denaturing gradient gel electrophoresis (DGGE), pyrosequencing and real-time PCR. Based on the molecular analysis, this study indicated that the 3% fecal inoculum in low-concentration carbohydrate medium with 1% autoclaved fecal supernatant provided enhanced growth conditions to conduct in vitro studies representative of the human intestinal microbiota.
C1 [Kim, Bong-Soo; Kim, Jong Nam; Cerniglia, Carl E.] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Cerniglia, CE (reprint author), US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM carl.cerniglia@fda.hhs.gov
RI Kim, Bong-Soo/L-4779-2013
OI Kim, Bong-Soo/0000-0003-1243-8280
FU National Center for Toxicological Research
FX This research was supported in part by an appointment to the Research
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 Food and Drug Administration. The views presented in this paper
are not necessarily those of the Food and Drug Administration. Bong-Soo
Kim and Jong Nam Kim contributed equally to this work.
NR 38
TC 12
Z9 12
U1 1
U2 22
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 1110-7243
J9 J BIOMED BIOTECHNOL
JI J. Biomed. Biotechnol.
PY 2011
AR 838040
DI 10.1155/2011/838040
PG 10
WC Biotechnology & Applied Microbiology; Medicine, Research & Experimental
SC Biotechnology & Applied Microbiology; Research & Experimental Medicine
GA 816YI
UT WOS:000294637600001
ER
PT S
AU Zeng, RP
Myers, KJ
AF Zeng, Rongping
Myers, Kyle J.
BE Pelc, NJ
Samei, E
Nishikawa, RM
TI Task-based comparative study of iterative image reconstruction methods
for limited-angle x-ray tomography
SO MEDICAL IMAGING 2011: PHYSICS OF MEDICAL IMAGING
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging 2011 - Physics of Medical Imaging
CY FEB 13-17, 2011
CL Lake Buena Vista, FL
SP Dynasil Corp/RMD Res, Amer Assoc Physicists Med, DQE Instruments, Inc, Ocean Thin Films, Inc, Univ Cent Florida, CREOL - Coll Opt & Photon, VIDA Diagnost, Inc, SPIE
AB For tomography that has available only projection views from a limited angular span, such as is the case in an x-ray tomosynthesis system, the image reconstruction problem is ill-posed. Reconstruction methods play an important role in optimizing the image quality for human interpretation. In this work we compare three popular iterative image reconstruction methods that have been applied to digital tomosynthesis systems: the simultaneous algebraic reconstruction technique (SART), the maximum-likelihood (ML) and the total-variation regularized least-square reconstruction method (TVLS). Quality of the images reconstructed from these three methods is assessed through task-based performance. Two tasks are considered in this work: lesion detection and shape discrimination. Area under the ROC curve (AUC) is used as the figure-of-merit. Our simulation results indicate that TVLS and SART perform very similarly and better than the ML in terms of lesion detectability, while the ML performs better than the other two in terms of shape discrimination ability.
C1 [Zeng, Rongping] US FDA, Off Sci, Rockville, MD 20857 USA.
RP Zeng, RP (reprint author), US FDA, Off Sci, Rockville, MD 20857 USA.
NR 17
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 978-0-8194-8503-8
J9 PROC SPIE
PY 2011
VL 7961
AR 796137
DI 10.1117/12.878098
PG 9
WC Engineering, Electrical & Electronic; Optics; Physics, Applied;
Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Optics; Physics; Radiology, Nuclear Medicine & Medical
Imaging
GA BWL08
UT WOS:000294178500106
ER
PT B
AU Todd, ECD
Bartleson, CA
Guzewich, JJ
Tan, A
Lee, M
Nazarowec-White, M
AF Todd, Ewen C. D.
Bartleson, Charles A.
Guzewich, John J.
Tan, Agnes
Lee, Marilyn
Nazarowec-White, Maria
CA Int Assoc Food Protection
GP CFIIAFP
TI Procedures to Investigate Foodborne Illness Sixth Edition 2011
SO PROCEDURES TO INVESTIGATE FOODBORNE ILLNESS, SIXTH EDITION 2011
LA English
DT Article; Book Chapter
ID RISK-BASED APPROACH; UNITED-STATES; FOOD WORKERS; DISEASE OUTBREAKS;
SURVEILLANCE; INFECTIONS; SPREAD; GASTROENTERITIS; LIMITATIONS;
PATHOGENS
C1 [Todd, Ewen C. D.] Ewen Todd Consulting, Okemos, MI USA.
[Bartleson, Charles A.] Washington State Dept Hlth, Olympia, WA USA.
[Guzewich, John J.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
[Tan, Agnes] Univ Melbourne, Dept Microbiol & Immunol, Publ Hlth Lab, Microbiol Diagnost Unit, Melbourne, Vic, Australia.
[Lee, Marilyn] Ryerson Univ, Sch Occupat & Publ Hlth, Toronto, ON, Canada.
[Nazarowec-White, Maria] Hlth Canada, Hlth Prod & Food Branch, Ottawa, ON K1A 0L2, Canada.
[Nazarowec-White, Maria] Bur Microbiol Hazards, Ottawa, ON, Canada.
RP Todd, ECD (reprint author), Ewen Todd Consulting, Okemos, MI USA.
OI Todd, Ewen/0000-0001-7266-279X
NR 45
TC 5
Z9 5
U1 0
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-8395-4
PY 2011
BP 1
EP +
PG 161
WC Food Science & Technology
SC Food Science & Technology
GA BVZ32
UT WOS:000293199800001
ER
PT S
AU Petrick, N
Kim, HJG
Clunie, D
Borradaile, K
Ford, R
Zeng, RP
Gavrielides, MA
McNitt-Gray, MF
Fenimore, C
Lu, ZQJ
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.
Fenimore, Charles
Lu, Z. Q. John
Zhao, Binsheng
Buckler, Andrew J.
BE Summers, RM
VanGinneken, B
TI Evaluation of 1D, 2D and 3D nodule size estimation by radiologists for
spherical and non-spherical nodules through CT thoracic phantom imaging
SO MEDICAL IMAGING 2011: COMPUTER-AIDED DIAGNOSIS
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging 2011 - Computer-Aided Diagnosis
CY FEB 15-17, 2011
CL Lake Buena Vista, FL
SP SPIE, Dynasil Corp/RMD Res, Amer Assoc Physicists Med, DQE Instruments, Inc, Ocean Thin Films, Inc, Univ Cent Florida, CREOL - Coll Opt & Photon, VIDA Diagnost, Inc
DE Size Estimation; Lung Nodules; CT Imaging; Phantom Study; Reader Study;
Reader Variability
ID LUNG-CANCER; VOLUMETRIC CT; SOLID TUMORS; BIOMARKER; QUALIFICATION
AB The purpose of this work was to estimate bias in measuring the size of spherical and non-spherical lesions by radiologists using three sizing techniques under a variety of simulated lesion and reconstruction slice thickness conditions. We designed a reader study in which six radiologists estimated the size of 10 synthetic nodules of various sizes, shapes and densities embedded within a realistic anthropomorphic thorax phantom from CT scan data. In this manuscript we report preliminary results for the first four readers (Readers 1-4). Two repeat CT scans of the phantom containing each nodule were acquired using a Philips 16-slice scanner at a 0.8 and 5 mm slice thickness. The readers measured the sizes of all nodules for each of the 40 resulting scans (10 nodules x 2 slice thickness x 2 repeat scans) using three sizing techniques (1D longest in-slice dimension; 2D area from longest in-slice dimension and corresponding longest perpendicular dimension; 3D semi-automated volume) in each of 2 reading sessions. The normalized size was estimated for each sizing method and an inter-comparison of bias among methods was performed. The overall relative biases (standard deviation) of the 1D, 2D and 3D methods for the four readers subset (Readers 1-4) were -13.4 (20.3), -15.3 (28.4) and 4.8 (21.2) percentage points, respectively. The relative biases for the 3D volume sizing method was statistically lower than either the 1D or 2D method (p<0.001 for 1D vs. 3D and 2D vs. 3D).
C1 [Petrick, Nicholas; Zeng, Rongping; Gavrielides, Marios A.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
RP Petrick, N (reprint author), WO62-4118,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM nicholas.petrick@fda.hhs.gov
OI Ford, Robert/0000-0002-0958-1505; Buckler, Andrew/0000-0002-0786-4835
NR 12
TC 2
Z9 2
U1 2
U2 5
PU SPIE-INT SOC OPTICAL ENGINEERING
PI BELLINGHAM
PA 1000 20TH ST, PO BOX 10, BELLINGHAM, WA 98227-0010 USA
SN 0277-786X
BN 978-0-81948-505-2
J9 PROC SPIE
PY 2011
VL 7963
AR 79630D
DI 10.1117/12.878265
PG 7
WC Engineering, Electrical & Electronic; Optics; Radiology, Nuclear
Medicine & Medical Imaging
SC Engineering; Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BWL95
UT WOS:000294211100011
ER
PT J
AU Karmakar, A
Xu, Y
Mahmood, MW
Zhang, YB
Saeed, LM
Mustafa, T
Ali, S
Biris, AR
Biris, AS
AF Karmakar, Alokita
Xu, Yang
Mahmood, Meena W.
Zhang, Yongbin
Saeed, Lamya Mohammed
Mustafa, Thikra
Ali, Syed
Biris, Alexandru R.
Biris, Alexandru S.
TI Radio-frequency induced in vitro thermal ablation of cancer cells by EGF
functionalized carbon-coated magnetic nanoparticles
SO JOURNAL OF MATERIALS CHEMISTRY
LA English
DT Article
ID IRON-OXIDE NANOPARTICLES; DRUG-DELIVERY; ROCK-I; NANOTUBES; APOPTOSIS;
VIVO; CASPASE-3; ASSAYS; LINES; FRAGMENTATION
AB Carbon-shelled, iron-based magnetic nanoparticles (C/Fe MNPs) were found to act as strong heat generating agents when exposed to radio-frequency (RF) energy with the ability to thermally destroy cancer cells. In order to efficiently deliver MNPs to cancer cells and to enhance the effectiveness of the RF treatment, human epidermal growth factor (EGF) was bioconjugated with the C/Fe MNPs for their specific delivery to two cancer cell lines, MCF-7 breast cancer cells and Panc-1 pancreatic cancer cells, respectively. These cell lines overexpress the epidermal growth factor receptors (EGFRs) and were used in this study as models. EGF-MNPs have shown higher surface binding efficiency towards the MCF-7 cells based on the comparative zeta-potential measurements. Confocal optical microscopy further confirmed that EGF-bioconjugated MNPs highly accumulated around and inside of these cancer cells. RF treatment was found to destroy 92.8% of MCF-7 breast cancer cells during 10 minutes of treatment when EGF was bound to the nanoparticles, while 37.3% of cells died when MNPs alone were used in identical conditions. Panc-1 cancer cells exhibit a higher resistance than MCF-7 cells when they were exposed to MNPs or RF treatment. Cytotoxicity studies demonstrated that the EGF-C/Fe MNP bioconjugates present lower toxicity compared to the C/Fe MNP. Caspase assay studies demonstrated that the MCF-7 cancer cells underwent an apoptotic process by the caspase 3 deficiency pathway showing no evidence of morphological changes such as membrane blebbing.
C1 [Karmakar, Alokita; Xu, Yang; Mahmood, Meena W.; Saeed, Lamya Mohammed; Mustafa, Thikra; Biris, Alexandru S.] Univ Arkansas, Nanotechnol Ctr, Little Rock, AR 72204 USA.
[Zhang, Yongbin] US FDA, Natl Ctr Toxicol Res, Off Sci Coordinat, Jefferson, AR 72079 USA.
[Ali, Syed] US FDA, Natl Ctr Toxicol Res, Neurochem Lab, Div Neurotoxicol, Jefferson, AR 72079 USA.
[Biris, Alexandru R.] Natl Inst Res & Dev Isotop & Mol Technol, RO-3400 Cluj Napoca, Romania.
RP Xu, Y (reprint author), Univ Arkansas, Nanotechnol Ctr, 2801 S Univ Ave, Little Rock, AR 72204 USA.
EM yxxu@ualr.edu; asbiris@ualr.edu
FU Arkansas Science and Technology Authority (ASTA) [08-CAT-03]; US Army
TATRC program
FX Support for this research received from the Arkansas Science and
Technology Authority (ASTA) grant # 08-CAT-03 is greatly appreciated.
The financial support provided by the US Army TATRC program is highly
appreciated.
NR 40
TC 12
Z9 12
U1 3
U2 18
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 0959-9428
J9 J MATER CHEM
JI J. Mater. Chem.
PY 2011
VL 21
IS 34
BP 12761
EP 12769
DI 10.1039/c1jm10569h
PG 9
WC Chemistry, Physical; Materials Science, Multidisciplinary
SC Chemistry; Materials Science
GA 807LC
UT WOS:000293898300027
ER
PT J
AU Manirarora, JN
Parnell, SA
Hu, YH
Kosiewicz, MM
Alard, P
AF Manirarora, Jean N.
Parnell, Sarah A.
Hu, Yoon-Hyeon
Kosiewicz, Michele M.
Alard, Pascale
TI NOD Dendritic Cells Stimulated with Lactobacilli Preferentially Produce
IL-10 versus IL-12 and Decrease Diabetes Incidence
SO CLINICAL & DEVELOPMENTAL IMMUNOLOGY
LA English
DT Article
ID REGULATORY T-CELLS; ORGAN-SPECIFIC AUTOIMMUNITY; ANTIGEN-PRESENTING
CELLS; PRONE MOUSE STRAINS; KAPPA-B ACTIVITY; IN-VITRO; INTERLEUKIN-10
PRODUCTION; IMMUNE-SYSTEM; APC FUNCTION; MICE
AB Dendritic cells (DCs) from NOD mice produced high levels of IL-12 that induce IFN gamma-producing T cells involved in diabetes development. We propose to utilize the microorganism ability to induce tolerogenic DCs to abrogate the proinflammatory process and prevent diabetes development. NOD DCs were stimulated with Lactobacilli (nonpathogenic bacteria targeting TLR2) or lipoteichoic acid (LTA) from Staphylococcus aureus (TLR2 agonist). LTA-treated DCs produced much more IL-12 than IL-10 and accelerated diabetes development when transferred into NOD mice. In contrast, stimulation of NOD DCs with L. casei favored the production of IL-10 over IL-12, and their transfer decreased disease incidence which anti-IL-10R antibodies restored. These data indicated that L. casei can induce NOD DCs to develop a more tolerogenic phenotype via production of the anti-inflammatory cytokine, IL-10. Evaluation of the relative production of IL-10 and IL-12 by DCs may be a very useful means of identifying agents that have therapeutic potential.
C1 [Manirarora, Jean N.; Parnell, Sarah A.; Hu, Yoon-Hyeon; Kosiewicz, Michele M.; Alard, Pascale] Univ Louisville HSC, Dept Microbiol & Immunol, Louisville, KY 40202 USA.
[Manirarora, Jean N.] US FDA, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
RP Alard, P (reprint author), Univ Louisville HSC, Dept Microbiol & Immunol, 319 Abraham Flexner Way, Louisville, KY 40202 USA.
EM p0alar01@gwise.louisville.edu
FU University of Louisville School of Medicine; NIH [R56DK075892]; Ruth L.
Kirschstein NRSA
FX This research was supported by funds from the University of Louisville
School of Medicine, and NIH R56DK075892 (PA). J.N. Manirarora was
supported by a Ruth L. Kirschstein NRSA. The authors thank Mike Myers
and Jason L. Hudkins for technical assistance; Chris Worth for cell
sorting; the staff of the animal facility for animal care. J.N.
Manirarora and S. A. Parnell contributed equally to this work.
NR 63
TC 5
Z9 5
U1 0
U2 1
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 1740-2522
J9 CLIN DEV IMMUNOL
JI Clin. Dev. Immunol.
PY 2011
AR 630187
DI 10.1155/2011/630187
PG 12
WC Immunology
SC Immunology
GA 803LW
UT WOS:000293583800001
ER
PT J
AU Xu, AQ
Zhang, YT
Amato, PR
AF Xu, Anqi
Zhang, Yuanting
Amato, Paul R.
TI A Comparison of Divorce Risk Models, in China and the United States
SO JOURNAL OF COMPARATIVE FAMILY STUDIES
LA English
DT Article
AB Divorce has become more common in China. However, studies of Chinese marriage and family life have lagged because relevant data are sparse. Using a divorce risk model, this study compares China and the United States. Chinese data came from a 2007-2008 Shanghai study containing 1,070 married or cohabiting respondents. The U.S. data came from the 2000 Survey of Marriage and Family Life containing 2,100 married individuals. In both countries, marital quality (happiness) was higher when couples frequently shared activities, reported few arguments, had not experienced marital violence, thought it would be difficult to replace their current spouses, and grew up with happily married parents. Moreover, in both countries, divorce risk (thinking about divorce) was negatively associated with marital quality, marital duration, believing that marriage is for life, reporting few quarrels, and the absence of marital violence. Differences between samples also emerged, which may reflect unique cultural aspects of Chinese and American society.
C1 [Xu, Anqi] Shanghai Acad Social Sci, Inst Sociol, Shanghai 200020, Peoples R China.
[Zhang, Yuanting] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Amato, Paul R.] Penn State Univ, Dept Sociol, University Pk, PA 16802 USA.
RP Xu, AQ (reprint author), Shanghai Acad Social Sci, Inst Sociol, 599-7-622 Huaihai Rd M, Shanghai 200020, Peoples R China.
NR 8
TC 1
Z9 1
U1 1
U2 10
PU J COMPARATIVE FAMILY STUDIES
PI CALGARY
PA UNIV CALGARY-DEPT SOCIOLOGY 2500 UNIVERSITY DRIVE NW, CALGARY, AB T2N
1N4, CANADA
SN 0047-2328
J9 J COMP FAM STUD
JI J. Comp. Fam. Stud.
PY 2011
VL 42
IS 2
BP 289
EP +
PG 8
WC Family Studies
SC Family Studies
GA 797FK
UT WOS:000293109700009
ER
PT J
AU Wang, WW
Scharfstein, D
Wang, CG
Daniels, M
Needham, D
Brower, R
AF Wang, Weiwei
Scharfstein, Daniel
Wang, Chenguang
Daniels, Michael
Needham, Dale
Brower, Roy
TI Estimating the causal effect of low tidal volume ventilation on survival
in patients with acute lung injury
SO JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES C-APPLIED STATISTICS
LA English
DT Article
DE Bayesian inference; Causal inference; Dynamic treatment regime;
G-computation formula
ID RESPIRATORY-DISTRESS-SYNDROME; DYNAMIC TREATMENT REGIMES; MARGINAL
STRUCTURAL MODELS; MECHANICAL VENTILATION; INFERENCE; TRIALS;
PARAMETERS; MORTALITY; OUTCOMES; ARDS
AB Acute lung injury is a condition that is characterized by acute onset of severe hypoxaemia and bilateral pulmonary infiltrates. Patients typically require mechanical ventilation in an intensive care unit. Low tidal volume ventilation (LTVV), which is a time varying dynamic treatment regime, has been recommended as an effective ventilation strategy. This recommendation was based on the results of a randomized clinical trial designed to compare low versus high tidal volume strategies by the Acute Respiratory Distress Syndrome Network. After publication of the trial, some critics focused on the high non-adherence rates in the LTVV arm suggesting that non-adherence occurred because treating physicians felt that deviating from the prescribed regime would improve patients' outcomes. We seek to address this controversy by estimating the survival distribution in the counterfactual setting where all patients assigned to LTVV followed the regime. Inference is based on a fully Bayesian implementation of Robins's G-computation formula. In addition to reanalysing data from the original trial, we also apply our methodology to data from a subsequent trial, which implemented the LTVV regime in both of its study arms and also suffered from non-adherence.
C1 [Scharfstein, Daniel] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Biostat, Baltimore, MD 21205 USA.
[Wang, Weiwei] Univ Texas Hlth Sci Ctr, Houston, TX USA.
[Wang, Chenguang] Food & Drug Adm, Silver Spring, MD USA.
[Daniels, Michael] Univ Florida, Gainesville, FL USA.
[Needham, Dale; Brower, Roy] Johns Hopkins Sch Med, Baltimore, MD USA.
RP Scharfstein, D (reprint author), Johns Hopkins Bloomberg Sch Publ Hlth, Dept Biostat, 615 N Wolfe St, Baltimore, MD 21205 USA.
EM dscharf@jhsph.edu
FU National Institutes of Health [NO1-HR-46046-64, NO1-HR-16146-54,
R01-CA-85295, R01-AI-078835, P30-MH-086043]
FX This research was sponsored by National Institutes of Health contracts
NO1-HR-46046-64, NO1-HR-16146-54, R01-CA-85295, R01-AI-078835 and
P30-MH-086043.
NR 43
TC 2
Z9 3
U1 0
U2 2
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0035-9254
J9 J R STAT SOC C-APPL
JI J. R. Stat. Soc. Ser. C-Appl. Stat.
PY 2011
VL 60
BP 475
EP 496
DI 10.1111/j.1467-9876.2010.00757.x
PN 4
PG 22
WC Statistics & Probability
SC Mathematics
GA 798TT
UT WOS:000293235800001
PM 22025809
ER
PT B
AU Padilla, F
Wear, K
AF Padilla, Frederic
Wear, Keith
BE Laugier, P
Haiat, G
TI Scattering by Trabecular Bone
SO BONE QUANTITATIVE ULTRASOUND
LA English
DT Article; Book Chapter
DE Anisotropy; Apparent backscatter coefficient; Attenuation; Role of
scattering; Autocorrelation; Backcatter; Backscatter coefficient
measurement; Binary mixture model; Born approximation; Broadband
Ultrasound Backscatter; Faran cylinder model; Multiple scattering; Shear
waves; Thin cylinder model; Trabecular thickness; Velocity dispersion;
Weak scattering model
ID BOVINE CANCELLOUS BONE; ULTRASONIC BACKSCATTER COEFFICIENT;
FREQUENCY-DEPENDENCE; IN-VITRO; HUMAN CALCANEUS; ACOUSTIC PROPERTIES;
MIMICKING PHANTOMS; QUANTITATIVE ULTRASOUND; MECHANICAL-PROPERTIES;
SPECTRUM ANALYSIS
AB This chapter reviews models for scattering of ultrasound by cancellous bone, methods for measuring scattering, and empirical results. Theory and measurements are presented for the dependence of backscatter on frequency and mean trabecular thickness. Additional topics discussed include the inverse problem (that is, estimating cancellous bone properties based on scattering measurements), the extent of multiple scattering in cancellous bone, and the role of scattering in determining attenuation. The potential advantages and intrinsic difficulties of backscatter as a clinical measurement are discussed. Results of clinical trials are presented.
C1 [Padilla, Frederic] Univ Paris 06, CNRS, Lab Imagerie Parametr, UMR 7623, F-75006 Paris, France.
[Padilla, Frederic] Univ Michigan, Med Ctr, Dept Radiol, Ann Arbor, MI 48109 USA.
[Wear, Keith] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
RP Padilla, F (reprint author), Univ Paris 06, CNRS, Lab Imagerie Parametr, UMR 7623, F-75006 Paris, France.
EM fpadilla@umich.edu; keith.wear@fda.hhs.gov
NR 95
TC 9
Z9 9
U1 0
U2 1
PU SPRINGER-VERLAG BERLIN
PI BERLIN
PA HEIDELBERGER PLATZ 3, D-14197 BERLIN, GERMANY
BN 978-94-007-0016-1
PY 2011
BP 123
EP 145
DI 10.1007/978-94-007-0017-8_6
D2 10.1007/978-94-007-0017-8
PG 23
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA BSU37
UT WOS:000285825800007
ER
PT J
AU Li, F
Nie, L
Wu, G
Qiao, JJ
Zhang, WW
AF Li, Feng
Nie, Lei
Wu, Gang
Qiao, Jianjun
Zhang, Weiwen
TI Prediction and Characterization of Missing Proteomic Data in
Desulfovibrio vulgaris
SO COMPARATIVE AND FUNCTIONAL GENOMICS
LA English
DT Article
ID TANDEM MASS-SPECTROMETRY; MESSENGER-RNA EXPRESSION; INTEGRATIVE
ANALYSIS; UNDETECTED PROTEINS; SEQUENCE FEATURES; GENE-EXPRESSION;
NEURAL-NETWORKS; ABUNDANCE; GENOMICS; HILDENBOROUGH
AB Proteomic datasets are often incomplete due to identification range and sensitivity issues. It becomes important to develop methodologies to estimate missing proteomic data, allowing better interpretation of proteomic datasets and metabolic mechanisms underlying complex biological systems. In this study, we applied an artificial neural network to approximate the relationships between cognate transcriptomic and proteomic datasets of Desulfovibrio vulgaris, and to predict protein abundance for the proteins not experimentally detected, based on several relevant predictors, such as mRNA abundance, cellular role and triple codon counts. The results showed that the coefficients of determination for the trained neural network models ranged from 0.47 to 0.68, providing better modeling than several previous regression models. The validity of the trained neural network model was evaluated using biological information (i.e. operons). To seek understanding of mechanisms causing missing proteomic data, we used a multivariate logistic regression analysis and the result suggested that some key factors, such as protein instability index, aliphatic index, mRNA abundance, effective number of codons (N-c) and codon adaptation index (CAI) values may be ascribed to whether a given expressed protein can be detected. In addition, we demonstrated that biological interpretation can be improved by use of imputed proteomic datasets.
C1 [Qiao, Jianjun; Zhang, Weiwen] Tianjin Univ, Sch Chem Engn & Technol, Tianjin 300072, Peoples R China.
[Li, Feng] Off Biometr OTS CDER FDA, Div Biometr 2, Silver Spring, MD 20993 USA.
[Nie, Lei] Off Biometr OTS CDER FDA, Div Biometr 4, Silver Spring, MD 20993 USA.
[Wu, Gang] Univ Maryland Baltimore Cty, Dept Biol Sci, Baltimore, MD 21250 USA.
RP Zhang, WW (reprint author), Tianjin Univ, Sch Chem Engn & Technol, Tianjin 300072, Peoples R China.
EM Weiwen.Zhang@asu.edu
FU National Basic Research Program of China [2011CBA00803]
FX The research work of J. QIAO and W. ZHANG was supported by National
Basic Research Program of China (2011CBA00803). This paper reflects the
views of F. Li and L. Nie should not be construed to represent FDA's
view or policies.
NR 40
TC 4
Z9 4
U1 0
U2 3
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 1531-6912
J9 COMP FUNCT GENOM
JI Compar. Funct. Genom.
PY 2011
AR 780973
DI 10.1155/2011/780973
PG 16
WC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Genetics & Heredity
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Genetics & Heredity
GA 787ON
UT WOS:000292386700001
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Utility of Microbiological Testing for Safety and Quality
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 12
TC 0
Z9 0
U1 0
U2 3
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 3
EP 11
DI 10.1007/978-1-4419-9374-8_1
PG 9
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500001
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Validation of Control Measures
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID TEMPERATURE
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 25
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 13
EP 32
DI 10.1007/978-1-4419-9374-8_2
PG 20
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500002
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Verification of Process Control
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 14
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 33
EP 40
DI 10.1007/978-1-4419-9374-8_3
PG 8
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500003
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Verification of Environmental Control
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 4
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 41
EP 45
DI 10.1007/978-1-4419-9374-8_4
PG 5
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500004
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Corrective Actions to Reestablish Control
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 3
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 47
EP 54
DI 10.1007/978-1-4419-9374-8_5
PG 8
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500005
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Microbiological Testing in Customer-Supplier Relations
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 2
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 55
EP 60
DI 10.1007/978-1-4419-9374-8_6
PG 6
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500006
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Applications and Use of Criteria and Other Tests
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID MICROBIOLOGICAL CRITERIA
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 9
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 63
EP 73
DI 10.1007/978-1-4419-9374-8_7
PG 11
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500007
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Meat Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 19
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 75
EP 93
DI 10.1007/978-1-4419-9374-8_8
PG 19
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500008
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Poultry Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID BROILER CARCASSES; RISK-ASSESSMENT; CAMPYLOBACTER
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 27
TC 0
Z9 0
U1 0
U2 3
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 95
EP 106
DI 10.1007/978-1-4419-9374-8_9
PG 12
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500009
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Fish and Seafood Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID BIOGENIC-AMINES
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 22
TC 0
Z9 0
U1 0
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 107
EP 133
DI 10.1007/978-1-4419-9374-8_10
PG 27
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500010
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Feeds and Pet Food
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID ESCHERICHIA-COLI O157; CONTAMINATED DRY DOG; ANIMAL FEED;
SALMONELLA-ENTERICA; PELLETING PROCESS; UNITED-STATES; HUMAN HEALTH;
BY-PRODUCTS; BSE AGENT; CAT FOOD
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 52
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 135
EP 145
DI 10.1007/978-1-4419-9374-8_11
PG 11
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500011
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Vegetables and Vegetable Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID MICROBIAL RISK-ASSESSMENT; LISTERIA-MONOCYTOGENES; IRRIGATION WATER;
MICROBIOLOGICAL QUALITY; CONSUMPTION; PATHOGENS; MUSHROOMS; SPROUTS;
GROWTH; FRUIT
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 41
TC 0
Z9 0
U1 0
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 147
EP 176
DI 10.1007/978-1-4419-9374-8_12
PG 30
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500012
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Fruits and Fruit Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID ESCHERICHIA-COLI O157-H7; LISTERIA-MONOCYTOGENES; CHLORINE DIOXIDE;
SALMONELLA-MONTEVIDEO; REDUCING SALMONELLA; FROZEN RASPBERRIES; FRESH
CANTALOUPES; UNITED-STATES; RAW TOMATOES; GROWTH
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 71
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 177
EP 195
DI 10.1007/978-1-4419-9374-8_13
PG 19
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500013
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Spice, Dry Soups and Asian Flavorings
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID BIOGENIC-AMINES
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 27
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 197
EP 208
DI 10.1007/978-1-4419-9374-8_14
PG 12
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500014
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Cereals and Cereal Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID BACILLUS-CEREUS; QUALITY; RICE
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 22
TC 1
Z9 1
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 209
EP 225
DI 10.1007/978-1-4419-9374-8_15
PG 17
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500015
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Nuts, Oilseeds, Dried Legumes and Coffee
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID SALMONELLA-ENTERITIDIS; ASPERGILLUS-FLAVUS; OCHRATOXIN-A; PEANUT BUTTER;
AFLATOXIN; ALMONDS; OUTBREAK; SURVIVAL; KERNELS; QUALITY
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 48
TC 0
Z9 0
U1 0
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 227
EP 239
DI 10.1007/978-1-4419-9374-8_16
PG 13
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500016
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Cocoa, Chocolate and Confectionery
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID OCHRATOXIN-A; INTERNATIONAL OUTBREAK; SALMONELLA; FUNGI; QUALITY; BEANS
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 22
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 241
EP 246
DI 10.1007/978-1-4419-9374-8_17
PG 6
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500017
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Oil- and Fat-Based Foods
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID MEAN PARTICLE DIAMETERS
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 3
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 247
EP 261
DI 10.1007/978-1-4419-9374-8_18
PG 15
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500018
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Sugar, Syrups and Honey
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID INFANT BOTULISM; CLOSTRIDIUM-BOTULINUM
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 16
TC 0
Z9 0
U1 0
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 263
EP 268
DI 10.1007/978-1-4419-9374-8_19
PG 6
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500019
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Water
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID DRINKING-WATER; PSEUDOMONAS-AERUGINOSA; RISK-ASSESSMENT; OUTBREAKS;
TASTE; ODOR
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 26
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 281
EP 289
DI 10.1007/978-1-4419-9374-8_21
PG 9
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500021
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Eggs and Egg Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 19
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 291
EP 303
DI 10.1007/978-1-4419-9374-8_22
PG 13
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500022
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Milk and Dairy Products
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID RAW-MILK; PARATUBERCULOSIS; SAMPLES
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 37
TC 0
Z9 0
U1 0
U2 3
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 305
EP 327
DI 10.1007/978-1-4419-9374-8_23
PG 23
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500023
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Shelf-Stable Heat Treated Foods
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID SPICES; BACTERIAL; SPORES; JUICE
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 29
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 329
EP 337
DI 10.1007/978-1-4419-9374-8_24
PG 9
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500024
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Dry Foods for Infants and Young Children
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID WEANING FOOD; MICROBIOLOGICAL EVALUATION; NUTRITION; AFRICA
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 26
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 339
EP 348
DI 10.1007/978-1-4419-9374-8_25
PG 10
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500025
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Combination Foods
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 4
TC 0
Z9 0
U1 0
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 349
EP 354
DI 10.1007/978-1-4419-9374-8_26
PG 6
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500026
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Sampling Considerations and Statistical Aspects of Sampling Plans
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID MICROBIOLOGICAL ANALYSIS; FOOD; PERFORMANCE; VALIDATION
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 17
TC 0
Z9 0
U1 1
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 355
EP 364
DI 10.1007/978-1-4419-9374-8
PG 10
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500027
ER
PT B
AU Chen, Y
Brown, E
Knabel, SJ
AF Chen, Yi
Brown, Eric
Knabel, Stephen J.
BE Wiedmann, M
Zhang, W
TI Molecular Epidemiology of Foodborne Pathogens
SO GENOMICS OF FOODBORNE BACTERIAL PATHOGENS
SE Food Microbiology and Food Safety
LA English
DT Article; Book Chapter
ID FIELD GEL-ELECTROPHORESIS; FRAGMENT-LENGTH-POLYMORPHISM;
SINGLE-NUCLEOTIDE POLYMORPHISMS; MULTILOCUS ENZYME ELECTROPHORESIS;
LISTERIA-MONOCYTOGENES STRAINS; ESCHERICHIA-COLI O157-H7; COMMERCIAL
SOFTWARE PACKAGES; VIRULENCE-ASSOCIATED GENES; TANDEM REPEAT ANALYSIS;
SEQUENCE TYPING MLST
C1 [Chen, Yi; Brown, Eric] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Knabel, Stephen J.] Penn State Univ, Dept Food Sci, University Pk, PA 16802 USA.
RP Chen, Y (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM yi.chen@fda.hhs.gov; eric.brown@fda.hhs.gov; sjk9@psu.edu
NR 145
TC 2
Z9 2
U1 1
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-7685-7
J9 FOOD MICROBIOL FOOD
PY 2011
BP 403
EP 453
DI 10.1007/978-1-4419-7686-4_12
D2 10.1007/978-1-4419-7686-4
PG 51
WC Food Science & Technology
SC Food Science & Technology
GA BTP58
UT WOS:000287716900012
ER
PT B
AU Taylor, DR
AF Taylor, Deborah R.
BE Tan, SL
He, YP
TI Hepatitis C Virus: Public Resources
SO HEPATITIS C: ANTIVIRAL DRUG DISCOVERY AND DEVELOPMENT
LA English
DT Article; Book Chapter
ID HCV INTERNATIONAL STANDARD
AB The tremendous progress in the field of HCV research has led to an explosion of resources, ranging from research tools and scientific reagents to information sources, including internet tools, meetings and conferences, and regulation policies. Access to such valuable HCV resources is important to facilitate HCV pathogenesis research as well as drug discovery and development. This chapter summarizes the current major resources that are publicly available for scientists, physicians, health professionals, educators, and patients.
C1 US FDA, CBER,Off Blood Res & Review, Div Emerging & Transfus Transmitted Dis, Lab Chron Hepatitis & Innate Immun, Bethesda, MD 20014 USA.
RP Taylor, DR (reprint author), US FDA, CBER,Off Blood Res & Review, Div Emerging & Transfus Transmitted Dis, Lab Chron Hepatitis & Innate Immun, Bethesda, MD 20014 USA.
EM Deborah.Taylor@FDA.HHS.gov
NR 3
TC 0
Z9 0
U1 1
U2 2
PU CAISTER ACADEMIC PRESS
PI WYMONDHAM
PA 32 HEWITTS LANE, WYMONDHAM NR 18 0JA, ENGLAND
BN 978-1-904455-78-3
PY 2011
BP 67
EP 73
PG 7
WC Immunology; Infectious Diseases; Pharmacology & Pharmacy
SC Immunology; Infectious Diseases; Pharmacology & Pharmacy
GA BUH82
UT WOS:000289380100004
ER
PT B
AU Farrell, AT
Dagher, RN
Pazdur, R
AF Farrell, Ann T.
Dagher, Ramzi N.
Pazdur, Richard
BE Hidalgo, M
Eckhardt, SG
GarrettMayer, E
Clendeninn, NJ
TI Role of the US Food and Drug Administration in Cancer Drug Development
SO PRINCIPLES OF ANTICANCER DRUG DEVELOPMENT
SE Cancer Drug Discovery and Development
LA English
DT Article; Book Chapter
C1 [Farrell, Ann T.] US FDA, Div Hematol Prod, OODP, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Dagher, Ramzi N.] Pfizer Inc, Global Regulatory, Worldwide Regulatory Strategy, New London, CT 06320 USA.
[Dagher, Ramzi N.] Pfizer Inc, Oncol Business Unit, New London, CT 06320 USA.
RP Farrell, AT (reprint author), US FDA, Div Hematol Prod, OODP, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM ann.farrell@fda.hhs.gov; ramzi.dagher@pfizer.com;
richard.pazdur@fda.hhs.gov
NR 28
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 978-1-4419-7357-3
J9 CANCER DRUG DISCOV D
JI Canc. Drug. Disc. Dev.
PY 2011
BP 305
EP 332
DI 10.1007/978-1-4419-7358-0_12
PG 28
WC Oncology; Pharmacology & Pharmacy
SC Oncology; Pharmacology & Pharmacy
GA BTC93
UT WOS:000286531700012
ER
PT S
AU Wang, QZ
Le, D
Ramella-Roman, J
Pfefer, J
AF Wang, Quanzeng
Le, Du
Ramella-Roman, Jessica
Pfefer, Joshua
BE Raghavachari, R
Liang, R
TI Broadband UV-Vis optical property measurement in layered turbid media
SO DESIGN AND QUALITY FOR BIOMEDICAL TECHNOLOGIES IV
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Design and Quality for Biomedical Technologies IV
CY JAN 23-25, 2011
CL San Francisco, CA
SP SPIE
DE optical property; mucosal tissue; Monte Carlo; neural network;
reflectance; broadband; fiberoptic
ID DIFFUSE-REFLECTANCE SPECTRA; EPITHELIAL TISSUE; MODEL; REFLECTOMETRY;
SPECTROSCOPY; DIAGNOSIS; PROBE
AB Quantitative data on the fundamental optical properties (OPs) of biological tissue, including absorption and reduced scattering coefficients are important for elucidating light propagation during optical spectroscopy and facilitating diagnostic device design and optimization, and may enable rapid detection of early neoplasia. However, systems for in situ broadband measurement of mucosal tissue OPs in the ultraviolet-visible range have not been realized. In this study, we evaluated a fiberoptic-based reflectance system, coupled with neural network inverse models (trained with Monte Carlo simulation data), for measuring OPs in highly attenuating, two-layer turbid media. The experimental system incorporated a broadband light source, a fiberoptic probe and a CCD camera. The calibration method involved a set of standard nigrosin-microsphere phantoms as well as a more permanent spectralon phantom for quality assurance testing and recalibration. The system was experimentally evaluated using two-layer hydrogel phantoms with hemoglobin and polystyrene microspheres. The effects of tissue top-layer thickness and fitting approaches based on known absorption and scattering distributions were discussed. With our method, measurements with error less than 28% were obtained in the wavelength range of 350-630 nm.
C1 [Wang, Quanzeng; Pfefer, Joshua] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Wang, QZ (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
NR 14
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 978-0-81948-428-4
J9 PROC SPIE
PY 2011
VL 7891
AR 78910F
DI 10.1117/12.879647
PG 10
WC Biophysics; Engineering, Biomedical; Optics
SC Biophysics; Engineering; Optics
GA BVL26
UT WOS:000291793300007
ER
PT J
AU Gilks, WR
Wang, CY
AF Gilks, Walter R.
Wang, Chinying
TI A Non-Parametric Method for Detecting Specificity Determining Sites in
Protein Sequence Alignments
SO STATISTICAL APPLICATIONS IN GENETICS AND MOLECULAR BIOLOGY
LA English
DT Article
DE multiple sequence alignment; parsimony; phylogenetics; protein sequence;
randomisation; specificity determining sites; subfamily
ID FUNCTIONAL SPECIFICITY; DETERMINING RESIDUES; PREDICTION; EVOLUTION;
FAMILIES; DIVERGENCE; POSITIONS
AB Specificity determining sites (SDSs) in alignments of protein sequences are sites at which subfamilies of the aligned sequences have been under differential selective pressure. Identifying SDSs is important because they are key in understanding the functional specificity of each subfamily. Differential selection at an SDS will result in differences between subfamilies in the distribution of amino-acids at that site. However, statistical analysis of such differences is complicated by phylogenetic relationships within each subfamily, which profoundly influence these differences. We develop a non-parametric approach to evaluating purely statistical SDS evidence in a sequence alignment, taking account of phylogeny through a novel tree-respecting randomisation based on the principle of parsimony. Our approach does not exploit bioinformatic measures based on amino-acid properties or rates of evolution, as do other methods. Our intention is thereby to supplement and strengthen other methods of SDS prediction, not to compete with them. Our methodology is implemented in the R package called SDSparsimony, freely downloadable from http://www.maths.leeds.ac.uk/%7Ewally.gilks/SDSparsimonyPackage/Welcome.html.
C1 [Gilks, Walter R.] Univ Leeds, Harpenden, Herts, England.
[Gilks, Walter R.] Rothamsted Res, Harpenden, Herts, England.
Food & Drug Adm, Ctr Biol Evaluat & Res, Rockville, MD USA.
RP Gilks, WR (reprint author), Univ Leeds, Harpenden, Herts, England.
EM wally.gilks@maths.leeds.ac.uk; Chinying.Wang@fda.hhs.gov
NR 27
TC 0
Z9 0
U1 1
U2 3
PU WALTER DE GRUYTER GMBH
PI BERLIN
PA GENTHINER STRASSE 13, D-10785 BERLIN, GERMANY
SN 2194-6302
EI 1544-6115
J9 STAT APPL GENET MOL
JI Stat. Appl. Genet. Mol. Biol.
PY 2011
VL 10
IS 1
AR 20
DI 10.2202/1544-6115.1584
PG 32
WC Biochemistry & Molecular Biology; Mathematical & Computational Biology;
Statistics & Probability
SC Biochemistry & Molecular Biology; Mathematical & Computational Biology;
Mathematics
GA 759DO
UT WOS:000290221100004
ER
PT J
AU Gnjidic, D
Hilmer, SN
Le Couteur, DG
Abernethy, DR
AF Gnjidic, Danijela
Hilmer, Sarah N.
Le Couteur, David G.
Abernethy, Darrell R.
TI Drug burden index (DBI) and Beers criteria: impact on function in older
people
SO JOURNAL OF PHARMACOLOGICAL SCIENCES
LA English
DT Meeting Abstract
CT 84th Annual Meeting of the Japanese-Pharmacological-Society/11th
Southeast Asian Western Pacific Regional Meeting of Pharmacologists
CY MAR 22-24, 2011
CL Yokohama, JAPAN
SP Japanese Pharmacolog Soc
C1 [Gnjidic, Danijela; Hilmer, Sarah N.] Royal N Shore Hosp, Dept Clin Pharmacol & Aged Care, St Leonards, NSW 2065, Australia.
[Gnjidic, Danijela; Hilmer, Sarah N.; Le Couteur, David G.] Univ Sydney, Sydney Med Sch, Sydney, NSW 2006, Australia.
[Le Couteur, David G.] Concord Hosp, Ctr Educ & Res Ageing, Sydney, NSW, Australia.
[Abernethy, Darrell R.] US FDA, Off Clin Pharmacol, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU JAPANESE PHARMACOLOGICAL SOC
PI KYOTO
PA EDITORIAL OFF, KANTOHYA BLDG GOKOMACHI-EBISUGAWA NAKAGYO-KU, KYOTO, 604,
JAPAN
SN 1347-8613
J9 J PHARMACOL SCI
JI J. Pharmacol. Sci.
PY 2011
VL 115
SU 1
BP 288P
EP 288P
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 743QU
UT WOS:000289034601535
ER
PT J
AU Li, MJ
Hanson, T
AF Li, Meijuan
Hanson, Timothy
TI Bayesian non-parametric multivariate statistical models for testing
association between quantitative traits and candidate genes in
structured populations
SO JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES C-APPLIED STATISTICS
LA English
DT Article
DE Association mapping; Kinship; Linkage disequilibrium; Multivariate
mixture of Polya trees; Population structure
ID FLOWERING-LOCUS-C; LINKAGE DISEQUILIBRIUM; ARABIDOPSIS; INFERENCE;
MIXTURES; VERNALIZATION; RELATEDNESS; REPRESSOR; VARIANTS; FRIGIDA
AB Population-based linkage disequilibrium mapping permits finer scale mapping than linkage analysis. However, the population-based association mapping is subject to false positive results due to the population structure and the kinship between the samples. Although there is interest in simultaneously testing the association between a candidate gene and the multiple phenotypes of interest, the currently available association mapping methods are limited to univariate traits only. Here we present a new method for population-based multitrait candidate gene association mapping as a Bayesian semiparametric approach, where the error distribution is flexibly modelled via a multivariate mixture of Polya trees centred on the family of multivariate normal distributions. The method that we develop accounts for the population structure and the complex relatedness between the samples. We compare the new proposal in type I error rate and power with the existing multivariate version of the parametric model of Yu and co-workers and Li's univariate semiparametric model by using the previously published two type Arabidopsis thaliana flowering data sets of association mapping, as well as simulated data.
C1 [Li, Meijuan] US FDA, Div Biostat, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
RP Li, MJ (reprint author), US FDA, Div Biostat, Ctr Devices & Radiol Hlth, Bldg 66,Room 2225,10903 New Hampshire Ave, Silver Spring, MD USA.
EM meijuan.li@fda.hhs.gov
RI Hanson, Timothy/A-9127-2016
NR 29
TC 0
Z9 0
U1 0
U2 2
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0035-9254
J9 J R STAT SOC C-APPL
JI J. R. Stat. Soc. Ser. C-Appl. Stat.
PY 2011
VL 60
BP 207
EP 219
DI 10.1111/j.1467-9876.2010.00741.x
PN 2
PG 13
WC Statistics & Probability
SC Mathematics
GA 730EX
UT WOS:000288017300004
ER
PT J
AU Mossoba, MM
Seiler, A
Steinhart, H
Kramer, JKG
Rodrigues-Saona, L
Griffith, AP
Pierceall, R
van de Voort, FR
Sedman, J
Ismail, AA
Barr, D
Da Costa, PA
Li, H
Zhang, Y
Liu, X
Bradley, M
AF Mossoba, M. M.
Seiler, A.
Steinhart, H.
Kramer, J. K. G.
Rodrigues-Saona, L.
Griffith, A. P.
Pierceall, R.
van de Voort, F. R.
Sedman, J.
Ismail, A. A.
Barr, D.
Da Costa Filho, P. A.
Li, H.
Zhang, Y.
Liu, X.
Bradley, M.
TI Regulatory Infrared Spectroscopic Method for the Rapid Determination of
Total Isolated Trans Fat: A Collaborative Study
SO JOURNAL OF THE AMERICAN OIL CHEMISTS SOCIETY
LA English
DT Article
DE Fats and oils; Infrared; Spectroscopy; Lipid chemistry; Lipid analysis
ID ISOMERS
AB Using attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy, collaborating scientists in ten different laboratories measured (in duplicate) the total trans fat content of ten fat or oil test samples, two of which were blind duplicates. The procedure used entailed measuring the height of the negative second derivative of the IR absorption band at 966 cm(-1). This absorption is attributed to the C-H deformation vibration that is characteristic of isolated (non-conjugated) double bonds with the trans configuration. The precision of ATR-FTIR results in this international collaborative study was satisfactory and led to the approval of this validated procedure as official method AOCS Cd 14e-09 in late 2009. This official method is also suitable for analysis of total isolated trans fat and oil products containing, or supplemented with, trans conjugated linoleic acid (CLA) isomers. Although this method does not require derivatization of the oil or fat test materials, as required for GC, fats and oils in foods must be extracted with organic solvents before analysis. This method is also rapid (5 min) and does not require any weighing or quantitative dilution of unknown neat fat or oil test samples in any solvent. The AOCS Cd 14e-09 method is suitable for determination of test samples with zero trans fat, which is defined according to the US labeling regulations as 0.5 g trans fat per serving or 1.8% trans fat, as a percentage of total fat.
C1 [Mossoba, M. M.; Seiler, A.] Food & Drug Adm, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Seiler, A.; Steinhart, H.] Univ Hamburg, Hamburg, Germany.
[Kramer, J. K. G.] Agr & Agri Food Canada, Guelph, ON, Canada.
[Rodrigues-Saona, L.] Ohio State Univ, Columbus, OH 43210 USA.
[Griffith, A. P.; Pierceall, R.] Archer Daniels Midland Co, Decatur, IL USA.
[van de Voort, F. R.; Sedman, J.; Ismail, A. A.] McGill Univ, Ste Anne De Bellevue, PQ, Canada.
[Barr, D.] Deakin Univ, Burwood, Vic, Australia.
[Da Costa Filho, P. A.] Nestle Res Ctr, CH-1000 Lausanne, Switzerland.
[Li, H.] Bruker Opt, Billerica, MA USA.
[Zhang, Y.; Liu, X.] Bruker Opt China, Beijing, Peoples R China.
[Bradley, M.] Thermo Elect, Madison, WI USA.
RP Mossoba, MM (reprint author), Food & Drug Adm, Ctr Food Safety & Appl Nutr, Mail Stop HFS 717,Room BE 012,5100 Paint Branch P, College Pk, MD 20740 USA.
EM magdi.mossoba@fda.hhs.gov
NR 15
TC 8
Z9 8
U1 0
U2 8
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 0003-021X
J9 J AM OIL CHEM SOC
JI J. Am. Oil Chem. Soc.
PD JAN
PY 2011
VL 88
IS 1
BP 39
EP 46
DI 10.1007/s11746-010-1648-0
PG 8
WC Chemistry, Applied; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 721RJ
UT WOS:000287372200005
ER
PT J
AU Vu, NT
Rickard, JD
Sullivan, MP
Richfield-Fratz, N
Weisz, A
AF Vu, Nga T.
Rickard, James D.
Sullivan, Michael P.
Richfield-Fratz, Naomi
Weisz, Adrian
TI DETERMINATION OF INTERMEDIATES AND SUBSIDIARY COLORS IN THE COLOR
ADDITIVE FDC RED NO. 4 (PONCEAU SX) USING HIGH-PERFORMANCE LIQUID
CHROMATOGRAPHY
SO JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
LA English
DT Article
DE 3-[(2; 4-dimethyl-6-sulfophenyl)azo]-4-hydroxy-1-naphthalenesulfonic
acid; 4-hydroxy-1-naphthalenesulfonic acid; 5-amino-2;
4-dimethyl-1-benzenesulfonic acid; C; I; 14700; FDC Red No; 4;
High-speed countercurrent chromatography (HSCCC); HPLC; Ponceau SX
ID COUNTER-CURRENT CHROMATOGRAPHY
AB Specifications in the U.S. Code of Federal Regulations for the color additive FDC Red No. 4 (Color Index 14700) limit the levels of the intermediates, 5-amino-2,4-dimethyl-1-benzenesulfonic acid (AMBSA) and 4-hydroxy-1-naphthalenesulfonic acid (HNSA), and of subsidiary colors. The present study reports the development of a high-performance liquid chromatography (HPLC) method for the quantitative determination of these intermediates and subsidiary colors in one analysis. The most commonly-found subsidiary color, 3-[(2,4-dimethyl-6-sulfophenyl)azo]-4-hydroxy-1-naphthalenesulfonic acid (6SSC), is determined and is used as a secondary reference material to determine the quantities of other subsidiary colors present. High-speed countercurrent chromatography was used to obtain purified HNSA and 6SSC for use as reference materials. AMBSA, HNSA, and 6SSC were quantified by using five-point calibration curves with data points that ranged from 0.028-0.234%, 0.031-0.252%, and 0.113-2.036% by weight, respectively. The HPLC method is rapid (50min for the total analysis cycle) and simple to implement. It was applied to the analysis of test portions from 23 lots of FDC Red No. 4 submitted to the U.S. Food and Drug Administration (FDA) for certification and was later implemented by the FDA for routine batch certification of FDC Red No. 4.
C1 [Vu, Nga T.; Rickard, James D.; Sullivan, Michael P.; Richfield-Fratz, Naomi; Weisz, Adrian] 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, HFS 106,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM adrian.weisz@fda.hhs.gov
NR 8
TC 5
Z9 5
U1 1
U2 5
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 CHESTNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1082-6076
EI 1520-572X
J9 J LIQ CHROMATOGR R T
JI J. Liq. Chromatogr. Relat. Technol.
PY 2011
VL 34
IS 2
BP 106
EP 115
AR PII 931975951
DI 10.1080/10826076.2010.526874
PG 10
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 714NV
UT WOS:000286817200003
ER
PT J
AU Tata, DB
Waynant, RW
AF Tata, Darrell B.
Waynant, Ronald W.
TI Laser therapy: A review of its mechanism of action and potential medical
applications
SO LASER & PHOTONICS REVIEWS
LA English
DT Review
DE Laser therapy; stimulation; inhibition; hydrogen peroxide; reactive
oxygen species (ROS); metabolic activity; adenosine triphosphate (ATP);
nuclear factor k beta photobiomodulation; LLLT (Low-Level Light Therapy)
ID LOW-LEVEL LASER; HELIUM-NEON LASER; CARPAL-TUNNEL-SYNDROME; NEAR-IR
RADIATION; HYDROGEN-PEROXIDE; REACTIVE OXYGEN; IN-VITRO; PHOTODYNAMIC
THERAPY; NEUROLOGICAL DEFICITS; 670-NM PHOTOTHERAPY
AB Civilizations in antiquity have endeavored to champion the use of light to treat illnesses in the human body. Although laser light has unique applications in medicine, its mechanism of action for low intensity exposures on cells, tissues, and the body continues to be controversial after nearly 50 years of investigations. This paper presents evidence for visible red and near infrared light to induce (indirect) generation of hydrogen peroxide as an important chemical messenger behind the stimulatory and inhibitory responses observed to low intensity light exposures. It is hypothesized that other ionizing or non-ionizing modalities can either directly or indirectly induce / or generate H2O2 in an aqueous environment and could also bring about similar stimulatory or inhibitory bio-effects. One salient parameter which governs the bio-response is the level of generated H2O2. The authors discuss the mechanism which enables a small amount of hydrogen peroxide generated by light to produce beneficial effects.
C1 [Tata, Darrell B.; Waynant, Ronald W.] US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Phys, Silver Spring, MD 20993 USA.
RP Waynant, RW (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Phys, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM ronald.waynant@fda.hhs.gov
NR 137
TC 9
Z9 11
U1 2
U2 28
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 1863-8880
J9 LASER PHOTONICS REV
JI Laser Photon. Rev.
PD JAN
PY 2011
VL 5
IS 1
BP 1
EP 12
DI 10.1002/lpor.200900032
PG 12
WC Optics; Physics, Applied; Physics, Condensed Matter
SC Optics; Physics
GA 712QV
UT WOS:000286682200003
ER
PT J
AU Schlessinger, S
Kokko, K
Fratkin, J
Butt, F
Hawxby, A
Todaro, M
Henderson, H
Seawright, A
Parker, C
Byers, P
Gonzalez-Peralta, R
Kayler, L
Fauerbach, L
Lawrence, R
Haafi, A
Stanek, D
Hammond, R
Thoroughman, D
Pippen, T
Johnson, S
Mahle, W
Lyon, G
Laporte, K
Kanter, K
Ivey, M
Arnold, K
Lance, S
Navarro-Almario, E
Farnon, E
Kuehnert, M
Shieh, W
Paddock, C
Zaki, S
Drew, C
Schmitz, A
Sejvar, J
Sriram, R
Visvesvara, G
Beach, M
Yoder, J
Roy, S
Qvarnstrom, Y
Bandea, R
daSilva, A
Bosserman, E
Budge, P
Lutterloh, E
AF Schlessinger, S.
Kokko, K.
Fratkin, J.
Butt, F.
Hawxby, A.
Todaro, M.
Henderson, H.
Seawright, A.
Parker, C.
Byers, P.
Gonzalez-Peralta, R.
Kayler, L.
Fauerbach, L.
Lawrence, R.
Haafi, A.
Stanek, D.
Hammond, R.
Thoroughman, D.
Pippen, T.
Johnson, S.
Mahle, W.
Lyon, G., III
Laporte, K.
Kanter, K.
Ivey, M.
Arnold, K.
Lance, S.
Navarro-Almario, E.
Farnon, E.
Kuehnert, M.
Shieh, W.
Paddock, C.
Zaki, S.
Drew, C.
Schmitz, A.
Sejvar, J.
Sriram, R.
Visvesvara, G.
Beach, M.
Yoder, J.
Roy, S.
Qvarnstrom, Y.
Bandea, R.
daSilva, A.
Bosserman, E.
Budge, P.
Lutterloh, E.
TI Balamuthia mandrillaris Transmitted Through Organ Transplantation -
Mississippi, 2009
SO AMERICAN JOURNAL OF TRANSPLANTATION
LA English
DT Editorial Material
ID MENINGOENCEPHALITIS; PATIENT
C1 [Schlessinger, S.] Mississippi Organ Recovery Agcy, Flowood, MS USA.
[Kokko, K.; Fratkin, J.; Butt, F.; Hawxby, A.; Todaro, M.; Henderson, H.; Seawright, A.; Parker, C.] Univ Mississippi, Med Ctr, University, MS 38677 USA.
[Gonzalez-Peralta, R.; Kayler, L.; Fauerbach, L.; Lawrence, R.; Haafi, A.] Univ Florida, Shands Hosp, Gainesville, FL 32611 USA.
[Mahle, W.; Lyon, G., III; Laporte, K.; Kanter, K.] Emory Univ, Atlanta, GA 30322 USA.
[Navarro-Almario, E.] US FDA, Rockville, MD 20857 USA.
[Budge, P.; Lutterloh, E.] CDC, Atlanta, GA 30333 USA.
RP Schlessinger, S (reprint author), Mississippi Organ Recovery Agcy, Flowood, MS USA.
NR 10
TC 0
Z9 0
U1 0
U2 1
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1600-6135
J9 AM J TRANSPLANT
JI Am. J. Transplant.
PD JAN
PY 2011
VL 11
IS 1
BP 173
EP 176
DI 10.1111/j.1600-6143.2010.03395_1.x
PG 4
WC Surgery; Transplantation
SC Surgery; Transplantation
GA 700ZG
UT WOS:000285783500026
ER
PT J
AU Ganesan, D
Lindvall, M
Cleaveland, R
Jetley, R
Jones, P
Zhang, Y
AF Ganesan, Dharmalingam
Lindvall, Mikael
Cleaveland, Rance
Jetley, Raoul
Jones, Paul
Zhang, Yi
GP IEEE
TI Architecture Reconstruction and Analysis of Medical Device Software
SO 2011 9TH WORKING IEEE/IFIP CONFERENCE ON SOFTWARE ARCHITECTURE (WICSA)
LA English
DT Proceedings Paper
CT 9th Working IEEE/IFIP Conference on Software Architecture (WICSA) on
Architecture Across Boundaries/CompArch Conference
CY JUN 20-24, 2011
CL Boulder, CO
SP IEEE, IFIP, IEEE Comp Soc, IBM, Siemens Corp Res, Carnegie Mellon Univ, Software Engn Inst
DE Medical device safety; Testability; Verifiability; Static Analysis;
Reverse Architecting
ID MODEL
AB New research is underway at the FDA to investigate the benefits of integrating architecture analysis into safety evaluations of medical-device software. Due to the complexity in setting up testing environments for such software, the FDA is unable to conduct large-scale safety testing; instead, it must rely on other techniques to build an argument for whether the software is safe or not. The architecture analysis approach, formalized using relational algebra, is based on reconstructing abstract, yet precise, architectural views from source code to help build such arguments about safety. This paper discusses the use of the formal approach to analyze the Computer-Assisted Resuscitation Algorithm (CARA) software, which controls an infusion pump designed to provide automated assistance for transfusing blood. The results suggest that a) architecture analysis offers many insights related to software quality in general and testability (i.e., the ease of testing) and its impact on safety in particular, and b) architectural analysis results can be used to help configure static analysis tools to improve their performance for verifying safety properties.
C1 [Ganesan, Dharmalingam; Lindvall, Mikael; Cleaveland, Rance] Fraunhofer CESE, College Pk, MD USA.
[Jetley, Raoul; Jones, Paul; Zhang, Yi] FDA, Silver Spring, MD USA.
RP Ganesan, D (reprint author), Fraunhofer CESE, College Pk, MD USA.
EM dganesan@fc-md.umd.edu; mlindvall@fc-md.umd.edu;
rcleaveland@fc-md.umd.edu; raoul.jetley@fda.hhs.gov;
paul.jones@fda.hhs.gov; yi.zhang2@fda.hhs.gov
NR 28
TC 3
Z9 3
U1 0
U2 2
PU IEEE COMPUTER SOC
PI LOS ALAMITOS
PA 10662 LOS VAQUEROS CIRCLE, PO BOX 3014, LOS ALAMITOS, CA 90720-1264 USA
BN 978-0-7695-4351-2
PY 2011
BP 194
EP 203
DI 10.1109/WICSA.2011.33
PG 10
WC Computer Science, Software Engineering; Engineering, Electrical &
Electronic
SC Computer Science; Engineering
GA BYL75
UT WOS:000299279500024
ER
PT S
AU Johannesen, L
AF Johannesen, Lars
BE Murray, A
TI Assessment of ECG Quality on an Android Platform
SO 2011 COMPUTING IN CARDIOLOGY
SE Computing in Cardiology Series
LA English
DT Proceedings Paper
CT Conference on Computing in Cardiology
CY SEP 18-21, 2011
CL Hangzhou, PEOPLES R CHINA
SP European Soc Cardiol, Zhejiang Univ, EMB, IEEE, Drager, Mortara, Philips, Univ Rochester, Telemetr & Holter ECG Warehouse, Physiol Measurement, Mindray, GE Healthcare, Zoll, Edan, GSMA
AB An algorithm to determine quality of ECGs can enable inexperienced nurses and paramedics to record ECGs of sufficient diagnostic quality.
We propose an algorithm that can assess the quality of an ECG designed for an Android-based platform. The algorithm is based on previously established ECG quality metrics for quantifying ECG quality but designed in a way to make it efficient to run on a mobile platform.
Using the training data set the proposed algorithm obtained a sensitivity of 91% and a specificity of 85%. Testing against the test data sets, resulted in a score of 0.88 (events 1 and 2) and 0.79 (events 3).
The proposed algorithm discriminates between ECGs of good and bad quality, which could help diagnose patients earlier and reduce associated treatment costs.
C1 [Johannesen, Lars] US FDA, Div Pharmacometr, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Johannesen, L (reprint author), 10903 New Hampshire Ave,Bldg 51, Silver Spring, MD 20993 USA.
EM lars.johannesen@fda.hhs.gov
NR 7
TC 4
Z9 4
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 0276-6574
BN 978-1-4577-0611-0
J9 COMPUT CARDIOL
PY 2011
VL 38
BP 433
EP 436
PG 4
WC Cardiac & Cardiovascular Systems; Computer Science, Interdisciplinary
Applications
SC Cardiovascular System & Cardiology; Computer Science
GA BAP78
UT WOS:000305132500110
ER
PT S
AU Connors, M
Agrawal, A
Liang, CP
Chen, Y
Drezek, R
Pfefer, J
AF Connors, Megan
Agrawal, Anant
Liang, Chia-Pin
Chen, Yu
Drezek, Rebekah
Pfefer, Joshua
GP IEEE
TI Characterizing the Point Spread Function of Retinal OCT Devices with a
Model Eye-Based Phantom
SO 2011 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 MAY 01-06, 2011
CL Baltimore, MD
ID OPTICAL COHERENCE TOMOGRAPHY
AB We have designed, fabricated, and tested a nanoparticle-embedded phantom incorporated into a model eye for characterizing the point spread function of retinal OCT devices in three dimensions under realistic imaging conditions.
C1 [Connors, Megan; Agrawal, Anant; Liang, Chia-Pin; Pfefer, Joshua] Food & Drug Adm, Ctr Devices & Radiol Hlth, Silver Spring, MD 20902 USA.
[Connors, Megan] Univ Maryland, Dept Elect & Comp Engn, Coll Park, MD 21228 USA.
[Liang, Chia-Pin; Chen, Yu] Univ Maryland, Dept Bioengn, Coll Park, MD 21228 USA.
[Drezek, Rebekah] Rice Univ, Dept Elect & Comp Engn, Houston, TX 77251 USA.
RP Connors, M (reprint author), Food & Drug Adm, Ctr Devices & Radiol Hlth, Silver Spring, MD 20902 USA.
EM Anant.Agrawal@fda.hhs.gov
NR 2
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
BN 978-1-55752-910-7
J9 CONF LASER ELECTR
PY 2011
PG 2
WC Engineering, Electrical & Electronic; Optics; Physics, Applied
SC Engineering; Optics; Physics
GA BXB77
UT WOS:000295612400037
ER
PT S
AU Ilev, I
AF Ilev, Ilko
GP IEEE
TI Beyond Diffraction Limited Imaging and Sensing in Nanobiophotonics
SO 2011 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 MAY 01-06, 2011
CL Baltimore, MD
ID MICROSCOPY
AB Based on simple fiber-optic approaches, we present some advanced nanobiophotonics methods for ultrahigh-resolution bioimaging and biosensing beyond the diffraction barrier in the subwavelength nanometric range at cellular, intracellular and bulk tissue level. (C) 2011 Optical Society of America
C1 US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
RP Ilev, I (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Silver Spring, MD 20993 USA.
EM ilko.ilev@eob.cdrh.fda.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
BN 978-1-55752-910-7
J9 CONF LASER ELECTR
PY 2011
PG 2
WC Engineering, Electrical & Electronic; Optics; Physics, Applied
SC Engineering; Optics; Physics
GA BXB77
UT WOS:000295612402236
ER
PT S
AU Le, D
Wang, Q
Ramella-Roman, J
Pfefer, J
AF Le, D.
Wang, Q.
Ramella-Roman, J.
Pfefer, J.
GP IEEE
TI Theoretical Analysis of a Technique for Broadband Optical Property
Estimation in Two-layer Tissue
SO 2011 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 MAY 01-06, 2011
CL Baltimore, MD
AB Our data processing algorithms for determination of optical properties in two-layer tissue from broadband reflectance are evaluated. By combining Monte Carlo, neural network and spectral fitting approaches, accurate estimates can be produced.
C1 [Le, D.; Wang, Q.; Pfefer, J.] Food & Drug Adm, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Le, D.; Ramella-Roman, J.] Catholic Univ Amer, Dept Biomed Engn, Washington, DC 20064 USA.
RP Le, D (reprint author), Food & Drug Adm, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM quanzeng.wang@fda.hhs.gov
NR 3
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
BN 978-1-55752-910-7
J9 CONF LASER ELECTR
PY 2011
PG 2
WC Engineering, Electrical & Electronic; Optics; Physics, Applied
SC Engineering; Optics; Physics
GA BXB77
UT WOS:000295612400032
ER
PT S
AU Gala, HD
Peng, R
Zeng, RP
Freed, M
O'Bryan, E
Jennings, RJ
AF Gala, Hugo de las Heras
Peng, Rui
Zeng, Rongping
Freed, Melanie
O'Bryan, Eugene
Jennings, Robert J.
GP IEEE
TI A versatile laboratory platform for studying x-ray 3D breast imaging
SO 2011 IEEE NUCLEAR SCIENCE SYMPOSIUM AND MEDICAL IMAGING CONFERENCE
(NSS/MIC)
SE IEEE Nuclear Science Symposium Conference Record
LA English
DT Proceedings Paper
CT IEEE Nuclear Science Symposium/Medical Imaging Conference (NSS/MIC)/18th
International Workshop on Room-Temperature Semiconductor X-Ray and
Gamma-Ray Detectors
CY OCT 23-29, 2011
CL Valencia, SPAIN
SP IEEE, Inst Elect & Elect Engineers Nucl & Plasma Sci Soc (IEEE NPSS)
AB Purpose: This paper presents the features of a new laboratory x-ray platform for 3D breast imaging at FDA and initial projection images and tomosynthesis reconstructions.
Materials and methods: The laboratory consists of an x-ray generator, x-ray tube and detector, as well as seven stepper motors controlling four linear and three rotary stages. All components are currently being integrated using Lab View to allow for an automated operation of the lab. We used 3 different phantoms to obtain initial images. From all the possible geometry arrangements and techniques possible with the system, we selected a breast tomosynthesis acquisition protocol that is similar to those used by systems being investigated or developed by industry. The simultaneous algebraic reconstruction technique (SART) was used to obtain the reconstructions.
Results and conclusion: The laboratory provides a flexible platform for performing studies in 3D breast x-ray imaging that can be used to study the effect of different system components on image quality and lead to a better understanding of the system performance.
C1 [Gala, Hugo de las Heras] Quart GmbH, D-85604 Zorneding, Germany.
[Gala, Hugo de las Heras; Peng, Rui; Zeng, Rongping; Freed, Melanie; O'Bryan, Eugene; Jennings, Robert J.] US FDA, Ctr Dev & Radiol Hlth, Silver Spring, MD 20993 USA.
[Freed, Melanie] Pontificia Univ Catolica Chile, Santiago, Chile.
RP Gala, HD (reprint author), Quart GmbH, D-85604 Zorneding, Germany.
EM hugo.delasheras@daad-alumni.de; rui.peng@fda.hhs.gov;
rongping.zeng@fda.hhs.gov; freed@fis.puc.cl; Eugene.OBryan@fda.hhs.gov;
RobertJ.Jennings@fda.hhs.gov
FU ORISE; Office of Women's Health. He now works part-time for Quart GmbH
FX He was funded by an ORISE fellowship and supported in part by the Office
of Women's Health. He now works part-time for Quart GmbH
NR 13
TC 0
Z9 0
U1 0
U2 1
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 1082-3654
BN 978-1-4673-0120-6
J9 IEEE NUCL SCI CONF R
PY 2011
BP 2851
EP 2854
PG 4
WC Engineering, Electrical & Electronic; Physics, Applied; Imaging Science
& Photographic Technology; Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Physics; Imaging Science & Photographic Technology;
Radiology, Nuclear Medicine & Medical Imaging
GA BAM64
UT WOS:000304755603015
ER
PT J
AU Samuelson, F
Brown, DG
AF Samuelson, Frank
Brown, David G.
GP IEEE
TI Application of Cover's Theorem to the Evaluation of the Performance of
CI Observers
SO 2011 INTERNATIONAL JOINT CONFERENCE ON NEURAL NETWORKS (IJCNN)
LA English
DT Proceedings Paper
CT International Joint Conference on Neural Networks (IJCNN)
CY JUL 31-AUG 05, 2011
CL San Jose, CA
SP Int Neural Network Soc (INNS), IEEE Computat Intelligence Soc (CIS), Natl Sci Fdn (NSF), Cognimem Technol, Inc, Univ Cincinnati Coll Engn & Appl Sci, Toyota Res Inst N Amer, Univ Cincinnati, Sch Elect & Compu Syst
AB For any N points arbitrarily located in a d-dimensional space, Thomas Cover popularized and augmented a theorem that gives an expression for the number of the 2(N) possible two-class dichotomies of those points that are separable by a hyperplane. Since separation of two-class dichotomies in d dimensions is a common problem addressed by computational intelligence (CI) decision functions or "observers," Cover's theorem provides a benchmark against which CI observer performance can be measured. We demonstrate that the performance of a simple perceptron approaches the ideal performance and how a single layer MLP and an SVM fare in comparison. We show how Cover's theorem can be used to develop a procedure for CI parameter optimization and to serve as a descriptor of CI complexity. Both simulated and micro-array genomic data are used.
C1 [Samuelson, Frank; Brown, David G.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Samuelson, F (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave,Bldg 62,Rm 3105, Silver Spring, MD 20993 USA.
EM frank.samuelson@fda.hhs.gov; david.brown@fda.hhs.gov
NR 10
TC 1
Z9 1
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
BN 978-1-4244-9636-5
PY 2011
BP 1020
EP 1026
PG 7
WC Computer Science, Artificial Intelligence; Computer Science, Information
Systems; Computer Science, Theory & Methods; Engineering, Electrical &
Electronic
SC Computer Science; Engineering
GA BXX80
UT WOS:000297541201021
ER
PT J
AU Chen, WJ
Brown, DG
AF Chen, Weijie
Brown, David G.
GP IEEE
TI Optimistic bias in the assessment of high dimensional classifiers with a
limited dataset
SO 2011 INTERNATIONAL JOINT CONFERENCE ON NEURAL NETWORKS (IJCNN)
LA English
DT Proceedings Paper
CT International Joint Conference on Neural Networks (IJCNN)
CY JUL 31-AUG 05, 2011
CL San Jose, CA
SP Int Neural Network Soc (INNS), IEEE Computat Intelligence Soc (CIS), Natl Sci Fdn (NSF), Cognimem Technol, Inc, Univ Cincinnati Coll Engn & Appl Sci, Toyota Res Inst N Amer, Univ Cincinnati, Sch Elect & Compu Syst
ID GENE-EXPRESSION DATA; MICROARRAY DATA; OVER-OPTIMISM; SELECTION;
CLASSIFICATION; BIOINFORMATICS; VALIDATION; PITFALLS
AB It is commonly recognized that using the same dataset for training and testing the classifier introduces optimistic bias in estimating classifier performance. However, bias of the same kind may still exist even when independent datasets are used for training and testing a classifier. This problem is especially important in the setting of high dimensional feature space and limited data. Bioinformatics data is typically characterized by a tremendous amount of data per patient but from a limited number of patients. Often the entire data set is utilized in a "pre-training" stage during which the feature set is winnowed to a manageable number, and the parameters of the training algorithm are established. Subsequently the data is bifurcated into training and test sets; however, bias has already been introduced into the classifier development process. We investigate the significance of this bias by performing simulated gene expression experiments. We find that, for data with moderate intrinsic separability and modest sample size, any observed separation is due to selection bias introduced in the aforementioned pre-training process. For greater intrinsic separability, correct data hygiene, i.e., complete separation of development and validation data yields a positive result, but one far less impressive than that mistakenly obtained using incomplete data separation.
C1 [Chen, Weijie; Brown, David G.] US FDA, Silver Spring, MD 20993 USA.
RP Chen, WJ (reprint author), US FDA, Silver Spring, MD 20993 USA.
EM Weijie.chen@fda.hhs.gov; david.brown@fda.hhs.gov
NR 15
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
BN 978-1-4244-9636-5
PY 2011
BP 2698
EP 2703
PG 6
WC Computer Science, Artificial Intelligence; Computer Science, Information
Systems; Computer Science, Theory & Methods; Engineering, Electrical &
Electronic
SC Computer Science; Engineering
GA BXX80
UT WOS:000297541202121
ER
PT J
AU Boehmer, JL
Olumee-Shabon, Z
AF Boehmer, Jamie L.
Olumee-Shabon, Zohra
BE Veas, F
TI Veterinary Biomarker Discovery: Proteomic Analysis of Acute Phase
Proteins
SO ACUTE PHASE PROTEINS AS EARLY NON-SPECIFIC BIOMARKERS OF HUMAN AND
VETERINARY DISEASES
LA English
DT Article; Book Chapter
ID C-REACTIVE PROTEIN; SERUM-AMYLOID-A; DISSOCIATION MASS-SPECTROMETRY;
HEAVY-CHAIN 4; ALPHA(1)-ACID GLYCOPROTEIN; ALPHA-1-ACID GLYCOPROTEIN;
DAIRY-COWS; EXPERIMENTAL-INFECTION; ESCHERICHIA-COLI;
ACTINOBACILLUS-PLEUROPNEUMONIAE
C1 [Boehmer, Jamie L.; Olumee-Shabon, Zohra] US FDA, Ctr Vet Med, Res Off, Rockville, MD 20857 USA.
RP Boehmer, JL (reprint author), US FDA, Ctr Vet Med, Res Off, Rockville, MD 20857 USA.
NR 95
TC 0
Z9 0
U1 0
U2 0
PU INTECH EUROPE
PI RIJEKA
PA JANEZA TRDINE9, RIJEKA, 51000, CROATIA
BN 978-953-307-873-1
PY 2011
BP 189
EP 210
D2 10.5772/1045
PG 22
WC Immunology; Pathology
SC Immunology; Pathology
GA BE6CS
UT WOS:000373891800010
ER
PT J
AU Wilcox, N
Goldberg, A
AF Wilcox, Neil
Goldberg, Alan
TI Food for Thought ... on Validation. A Puzzle or a Mystery: an Approach
Founded on New Science
SO ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
LA English
DT Article
DE in vitro; 21(st) century toxicity testing; test method validation
ID TOXICITY TEST PROCEDURES; RECOMMENDATIONS
AB The notion of test method validation, when applied to in vitro models, has been subjected to standards, practices, and regulatory mandates that may represent significant barriers to the development of new methods based on target toxicological pathways, mode of action, and mechanistic endpoints. Currently, there is an expectation that toxicity test methods used for regulatory purposes must be formally validated by a legislated body. In this manuscript, we review the genesis of current formal validation programs, their purpose, their justification for future need, and an examination of the scientific process as the driving force. With the collision of three major international events in the scientific and regulatory communities (viz. EU Cosmetic Directive, EU REACH legislation, and the NRC publication, Toxicity Testing in the 21(st) Century: A Vision and a Strategy), there may be a need for a shift in the current validation paradigm. Further, test method validity may be recognized by the appropriate authorities when specific criteria and the fundamental precepts of reliability and reproducibility have been adequately met.
C1 [Wilcox, Neil] US FDA, Off Cosmet & Colors, College Pk, MD 20740 USA.
[Goldberg, Alan] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Ctr Alternat Anim Testing, Baltimore, MD USA.
RP Wilcox, N (reprint author), US FDA, Off Cosmet & Colors, 5100 Paint Branch Pkwy,CPK2,HFS 125, College Pk, MD 20740 USA.
EM Neil.wilcox@fda.hhs.gov
NR 17
TC 5
Z9 5
U1 0
U2 0
PU SPEKTRUM AKAD VERLAG
PI HEIDELBERG
PA SLEVOGTSTRASSE 3-5, D-69126 HEIDELBERG, GERMANY
SN 1868-596X
J9 ALTEX-ALTERN ANIM EX
JI ALTEX-Altern. Anim. Exp.
PY 2011
VL 28
IS 1
BP 3
EP 8
PG 6
WC Instruments & Instrumentation; Medicine, Research & Experimental
SC Instruments & Instrumentation; Research & Experimental Medicine
GA 734SQ
UT WOS:000288358600002
PM 21311846
ER
PT J
AU Silbergeld, EK
Contreras, EQ
Hartung, T
Hirsch, C
Hogberg, H
Jachak, AC
Jordan, W
Landsiedel, R
Morris, J
Patri, A
Pounds, JG
Ruiz, AD
Shvedova, A
Tanguay, R
Tatarazako, N
van Vliet, E
Walker, NJ
Wiesner, M
Wilcox, N
Zurlo, J
AF Silbergeld, Ellen K.
Contreras, Elizabeth Q.
Hartung, Thomas
Hirsch, Cordula
Hogberg, Helena
Jachak, Ashish C.
Jordan, William
Landsiedel, Robert
Morris, Jeffery
Patri, Anil
Pounds, Joel G.
de Vizcaya Ruiz, Andrea
Shvedova, Anna
Tanguay, Robert
Tatarazako, Norihasa
van Vliet, Erwin
Walker, Nigel J.
Wiesner, Mark
Wilcox, Neil
Zurlo, Joanne
TI Nanotoxicology: "The End of the Beginning" - Signs on the Roadmap to a
Strategy for Assuring the Safe Application and Use of Nanomaterials
SO ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
LA English
DT Article
DE nanomaterials; nanotoxicology; alternative methods; 3Rs; Tox-21c
AB In October 2010, a group of experts met as part of the transatlantic think tank for toxicology (t(4)) to exchange ideas about the current status and future of safety testing of nanomaterials. At present, there is no widely accepted path forward to assure appropriate and effective hazard identification for engineered nanomaterials. The group discussed needs for characterization of nanomaterials and identified testing protocols that incorporate the use of innovative alternative whole models such as zebrafish or C. elegans, as well as in vitro or alternative methods to examine specific functional pathways and modes of action. The group proposed elements of a potential testing scheme for nanomaterials that works towards an integrated testing strategy, incorporating the goals of the NRC report Toxicity Testing in the 21(st) Century: A Vision and a Strategy by focusing on pathways of toxic response, and utilizing an evidence-based strategy for developing the knowledge base for safety assessment. Finally, the group recommended that a reliable, open, curated database be developed that interfaces with existing databases to enable sharing of information.
C1 [Silbergeld, Ellen K.; Jachak, Ashish C.] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Environm Hlth Sci, Baltimore, MD USA.
[Contreras, Elizabeth Q.] Rice Univ, Dept Chem, Houston, TX USA.
[Hartung, Thomas; Hogberg, Helena; van Vliet, Erwin; Zurlo, Joanne] Johns Hopkins Bloomberg Sch Publ Hlth, Ctr Alternat Anim Testing, Baltimore, MD USA.
[Hirsch, Cordula] Empa Swiss Fed Labs Mat Sci & Technol, St Gallen, Switzerland.
[Jordan, William; Morris, Jeffery] US EPA, Washington, DC 20460 USA.
[Landsiedel, Robert] BASF, Ludwigshafen, Germany.
[Patri, Anil] NCI, Nanotechnol Characterizat Lab, NIH, Frederick, MD 21701 USA.
[Pounds, Joel G.] Pacific NW Natl Lab, Richland, WA 99352 USA.
[de Vizcaya Ruiz, Andrea] CINVESTAV, Mexico City 14000, DF, Mexico.
[Shvedova, Anna] CDC, Natl Inst Occupat Safety & Hlth, Morgantown, WV USA.
[Tanguay, Robert] Oregon State Univ, Dept Environm & Mol Toxicol, Corvallis, OR 97331 USA.
[Tatarazako, Norihasa] Natl Inst Environm Sci, Tsukuba, Ibaraki, Japan.
[Walker, Nigel J.] Natl Inst Environm Hlth Sci, Res Triangle Pk, NC USA.
[Walker, Nigel J.] NIEHS, Natl Toxicol Program, Res Triangle Pk, NC 27709 USA.
[Wiesner, Mark] Duke Univ, Dept Civil & Environm Engn, Durham, NC 27706 USA.
[Wilcox, Neil] US FDA, Off Cosmet & Colors, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Zurlo, J (reprint author), Johns Hopkins Ctr Alternat Anim Testing, 615 N Wolfe St,W7032, Baltimore, MD 21205 USA.
EM jzurlo@jhsph.edu
RI Landsiedel, Robert/D-1960-2012; Walker, Nigel/D-6583-2012;
Nanotechnology Characterization Lab, NCL/K-8454-2012
OI Landsiedel, Robert/0000-0003-3756-1904; Walker,
Nigel/0000-0002-9111-6855;
FU Doerenkamp-Zbinden Foundation
FX We thank the Doerenkamp-Zbinden Foundation for sponsoring this workshop
as part of the t4 activities.
NR 5
TC 10
Z9 10
U1 1
U2 11
PU SPEKTRUM AKAD VERLAG
PI HEIDELBERG
PA SLEVOGTSTRASSE 3-5, D-69126 HEIDELBERG, GERMANY
SN 1868-596X
J9 ALTEX-ALTERN ANIM EX
JI ALTEX-Altern. Anim. Exp.
PY 2011
VL 28
IS 3
BP 236
EP 241
PG 6
WC Instruments & Instrumentation; Medicine, Research & Experimental
SC Instruments & Instrumentation; Research & Experimental Medicine
GA 829IZ
UT WOS:000295573100006
PM 21993959
ER
PT J
AU Nelson, RM
Beauchamp, T
Miller, VA
Reynolds, W
Ittenbach, RF
Luce, MF
AF Nelson, Robert M.
Beauchamp, Tom
Miller, Victoria A.
Reynolds, William
Ittenbach, Richard F.
Luce, Mary Frances
TI The Concept of Voluntary Consent
SO AMERICAN JOURNAL OF BIOETHICS
LA English
DT Article
DE authenticity; control; decision making; informed consent;
intentionality; voluntariness
ID CLINICAL-TRIALS; INFORMED-CONSENT; UNDUE INDUCEMENT; FOLLOW-UP;
PARTICIPATION; RANDOMIZATION; COMMUNICATION; ATTRITION; AUTONOMY; ENTER
AB Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals' perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research.
C1 [Nelson, Robert M.] US FDA, Off Pediat Therapeut, Silver Spring, MD 20993 USA.
[Beauchamp, Tom] Georgetown Univ, Washington, DC 20057 USA.
[Miller, Victoria A.] Univ Penn, Sch Med, Philadelphia, PA 19104 USA.
[Reynolds, William] Richard Stockton Coll New Jersey, Pomona, NJ USA.
[Ittenbach, Richard F.] Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH USA.
[Luce, Mary Frances] Duke Univ, Durham, NC 27706 USA.
RP Nelson, RM (reprint author), US FDA, Off Pediat Therapeut, 10903 New Hampshire Ave,WO32,Room 5126, Silver Spring, MD 20993 USA.
EM robert.nelson@fda.hhs.gov
RI Ittenbach, Richard/Q-1806-2015
FU National Science Foundation [SES-0527618]; National Institutes of
Health, National Cancer Institute [R21CA118377-01A1]; Institutional
Development Grant
FX This research was supported in part by grants from the National Science
Foundation (SES-0527618; Drs. Nelson, Luce, and Beauchamp); the National
Institutes of Health, National Cancer Institute (R21CA118377-01A1; Dr.
Nelson); and an Institutional Development Grant to The Center for
Research Integrity, Department of Anesthesiology and Critical Care
Medicine, The Children's Hospital of Philadelphia. Address
correspondence to Dr. Robert M. Nelson, U. S. Food and Drug
Administration, Office of Pediatric Therapeutics, 10903 New Hampshire
Ave., WO32, Room 5126, Silver Spring, MD 20993, USA. E-mail:
robert.nelson@fda.hhs.gov
NR 60
TC 33
Z9 34
U1 6
U2 23
PU ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXFORDSHIRE, ENGLAND
SN 1526-5161
J9 AM J BIOETHICS
JI Am. J. Bioeth.
PY 2011
VL 11
IS 8
BP 6
EP 16
DI 10.1080/15265161.2011.583318
PG 11
WC Ethics; Medical Ethics; Social Issues; Social Sciences, Biomedical
SC Social Sciences - Other Topics; Medical Ethics; Social Issues;
Biomedical Social Sciences
GA 806VO
UT WOS:000293843800005
PM 21806428
ER
PT J
AU Nelson, RM
AF Nelson, Robert M.
TI A Relative Standard for Minimal Risk is Unnecessary and Potentially
Harmful to Children: Lessons from the Phambili Trial
SO AMERICAN JOURNAL OF BIOETHICS
LA English
DT Editorial Material
C1 US FDA, Off Pediat Therapeut, Silver Spring, MD 20993 USA.
RP Nelson, RM (reprint author), US FDA, Off Pediat Therapeut, 10903 New Hampshire Ave,WO32,Room 5126, Silver Spring, MD 20993 USA.
EM robert.nelson@fda.hhs.gov
NR 3
TC 0
Z9 0
U1 0
U2 2
PU ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXFORDSHIRE, ENGLAND
SN 1526-5161
J9 AM J BIOETHICS
JI Am. J. Bioeth.
PY 2011
VL 11
IS 6
BP 14
EP 16
AR PII 938601501
DI 10.1080/15265161.2011.568588
PG 3
WC Ethics; Medical Ethics; Social Issues; Social Sciences, Biomedical
SC Social Sciences - Other Topics; Medical Ethics; Social Issues;
Biomedical Social Sciences
GA 779UV
UT WOS:000291808600004
PM 21678206
ER
PT J
AU Nelson, RM
Beauchamp, TL
AF Nelson, Robert M.
Beauchamp, Tom L.
TI Response to Open Peer Commentaries on "The Concept of Voluntary Consent"
SO AMERICAN JOURNAL OF BIOETHICS
LA English
DT Letter
C1 [Nelson, Robert M.] US FDA, Off Pediat Therapeut, Off Commissioner, Silver Spring, MD 20993 USA.
[Beauchamp, Tom L.] Georgetown Univ, Washington, DC 20057 USA.
RP Nelson, RM (reprint author), US FDA, Off Pediat Therapeut, Off Commissioner, 10903 New Hampshire Ave,WO32-5126, Silver Spring, MD 20993 USA.
EM Robert.nelson@fda.hhs.gov
FU NCI NIH HHS [R21CA118377-01A1]
NR 14
TC 0
Z9 0
U1 0
U2 5
PU ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXFORDSHIRE, ENGLAND
SN 1526-5161
J9 AM J BIOETHICS
JI Am. J. Bioeth.
PY 2011
VL 11
IS 8
BP W1
EP W3
DI 10.1080/15265161.2011.600621
PG 3
WC Ethics; Medical Ethics; Social Issues; Social Sciences, Biomedical
SC Social Sciences - Other Topics; Medical Ethics; Social Issues;
Biomedical Social Sciences
GA 806VO
UT WOS:000293843800001
PM 21806424
ER
PT J
AU Chan, PC
Peckham, JC
Malarkey, DE
Kissling, GE
Travlos, GS
Fu, PP
AF Chan, Po-Chuen
Peckham, John C.
Malarkey, David E.
Kissling, Grace E.
Travlos, Gregory S.
Fu, Peter P.
TI Two-Year Toxicity and Carcinogenicity Studies of Panax ginseng in
Fischer 344 Rats and B6C3F1 Mice
SO AMERICAN JOURNAL OF CHINESE MEDICINE
LA English
DT Article
DE Panax ginseng; Toxicity; Carcinogenicity; Herbal Dietary Supplements
ID ZERO-DOSE CONTROL; GENE-EXPRESSION CHANGES; EXTRACT; TESTS; KAVA;
SUPPLEMENTS; METABOLISM; REGRESSION; MORTALITY; ANIMALS
AB Ginseng is one of the most popular herbal supplements on the US market. Numerous reports of adverse effects from products containing ginseng have been filed with the US Food and Drug Administration (FDA) and the literature documents a "ginseng abuse syndrome" among regular users. However, the chronic toxic effects of ginseng are not well characterized. Because of its significant human exposure and the fact that little information on its toxicity is available, Panax ginseng was nominated by the US National Institutes of Health (NIH) to the US National Toxicology Program (NTP) to assess its carcinogenic potential. In this paper, we reported the results of NTP chronic toxicity and tumorigenicity bioassay. It shows that, under these experimental conditions, Panax ginseng is not toxic or tumorigenic.
C1 [Chan, Po-Chuen; Peckham, John C.; Malarkey, David E.; Kissling, Grace E.; Travlos, Gregory S.] NIEHS, Res Triangle Pk, NC 27709 USA.
[Fu, Peter P.] Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Chan, PC (reprint author), NIEHS, Res Triangle Pk, NC 27709 USA.
EM chanp@niehs.nih.gov
FU NIH, National Institute of Environmental Health Sciences
FX We thank Drs. Frederick A. Beland, Rick Irwin, In Ok Surh and Charles
Alden for critical review of this manuscript. This research was partly
supported by the Intramural Research Program of the NIH, National
Institute of Environmental Health Sciences.
NR 54
TC 15
Z9 18
U1 0
U2 9
PU WORLD SCIENTIFIC PUBL CO PTE LTD
PI SINGAPORE
PA 5 TOH TUCK LINK, SINGAPORE 596224, SINGAPORE
SN 0192-415X
EI 1793-6853
J9 AM J CHINESE MED
JI Am. J. Chin. Med.
PY 2011
VL 39
IS 4
BP 779
EP 788
DI 10.1142/S0192415X11009184
PG 10
WC Integrative & Complementary Medicine; Medicine, General & Internal
SC Integrative & Complementary Medicine; General & Internal Medicine
GA 785CP
UT WOS:000292205300012
PM 21721156
ER
PT J
AU Rodriguez, JD
Westenberger, BJ
Buhse, LF
Kauffman, JF
AF Rodriguez, Jason D.
Westenberger, Benjamin J.
Buhse, Lucinda F.
Kauffman, John F.
TI Standardization of Raman spectra for transfer of spectral libraries
across different instruments
SO ANALYST
LA English
DT Article
ID RELATIVE INTENSITY CORRECTION; RESPONSE FUNCTION; SPECTROSCOPY;
CALIBRATION; SPECTROMETERS; IDENTIFICATION; SENSITIVITY; DATABASE
AB In this paper we evaluate methods for standardization of Raman spectra that are required to improve spectral correlation computations between spectra measured on different instruments. Five commercially-available 785 nm Raman spectrometers from different vendors were included in the study. These spectrometers have diverse specifications and performance levels and range in size from laboratory-based instruments to field-deployable portable and handheld platforms. Since each Raman spectrometer has different characteristics, spectra obtained on one instrument cannot readily be compared to a library acquired on a different instrument without performing various types of spectral corrections (standardization). We outline a procedure that combines previously established Raman shift and intensity correction protocols with a resolution matching step to facilitate the comparison of a centralized master library with spectra acquired on different geographically distributed Raman spectrometers. The standardization procedure is effective in reducing the inherent instrument-to-instrument variability so that spectra from different spectrometers can be compared and reliable results obtained using library-based spectral correlation methods. The findings have important implications for the ability to transfer Raman spectral libraries between instruments.
C1 [Rodriguez, Jason D.; Westenberger, Benjamin J.; Buhse, Lucinda F.; Kauffman, John F.] US FDA, Div Pharmaceut Anal, Ctr Drug Evaluat & Res, St Louis, MO 63101 USA.
RP Kauffman, JF (reprint author), US FDA, Div Pharmaceut Anal, Ctr Drug Evaluat & Res, 1114 Market St,Room 1002, St Louis, MO 63101 USA.
EM john.kauffman@fda.hhs.gov
FU FDA Center for Drug Evaluation and Research; U.S. Department of Energy;
U.S. Food and Drug Administration
FX This project was supported in part by the FDA Center for Drug Evaluation
and Research Critical Path Program and by an appointment (J.D.R.) 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 U.S. Department
of Energy and the U.S. Food and Drug Administration.
NR 25
TC 23
Z9 23
U1 0
U2 32
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 0003-2654
J9 ANALYST
JI Analyst
PY 2011
VL 136
IS 20
BP 4232
EP 4240
DI 10.1039/c1an15636e
PG 9
WC Chemistry, Analytical
SC Chemistry
GA 826EJ
UT WOS:000295334000022
PM 21874199
ER
PT J
AU Keire, DA
Ye, HP
Trehy, ML
Ye, W
Kolinski, RE
Westenberger, BJ
Buhse, LF
Nasr, M
Al-Hakim, A
AF Keire, David A.
Ye, Hongping
Trehy, Michael L.
Ye, Wei
Kolinski, Richard E.
Westenberger, Benjamin J.
Buhse, Lucinda F.
Nasr, Moheb
Al-Hakim, Ali
TI Characterization of currently marketed heparin products: key tests for
quality assurance
SO ANALYTICAL AND BIOANALYTICAL CHEMISTRY
LA English
DT Article
DE Heparin; OSCS; SAX-HPLC; NMR; CE; Factor IIa/Xa
ID MAGNETIC-RESONANCE-SPECTROSCOPY; OVERSULFATED CHONDROITIN SULFATE;
ADVERSE CLINICAL EVENTS; ANTICOAGULANT ACTIVITY; DERMATAN SULFATE;
GLYCOSAMINOGLYCANS; CONFORMATION; CONTAMINANTS; NMR
AB During the 2007-2008 heparin crisis, it was found that the United States Pharmacopeia (USP) testing monograph for unfractionated heparin sodium (UFH) did not detect the presence of the contaminant, oversulfated chondroitin sulfate (OSCS) in heparin. In response to this concern, new tests and specifications were developed by the Food and Drug Administration (FDA) and USP and put in place to not only detect the contaminant OSCS but also to improve assurance of quality and purity of the drug product. Additional tests were also developed to monitor the heparin supply chain for other possible economically motivated additives or impurities. In 2009, a new USP monograph was put in place that includes 500 MHz (1)H NMR, SAX-HPLC, %galactosamine in total hexosamine, and anticoagulation time assays with purified factor IIa or factor Xa. These tests represent orthogonal approaches for UFH identification, measurement of bioactivity, and for detection of process impurities or contaminants in UFH. The FDA has applied these analytical approaches to the study of UFH active pharmaceutical ingredients in the marketplace. Here, we describe results from a comprehensive survey of UFH collected from seven different sources after the 2009 monograph revision and compare these data with results obtained on other heparin samples collected during the 2007-2008 crisis.
C1 [Keire, David A.; Ye, Hongping; Trehy, Michael L.; Ye, Wei; Kolinski, Richard E.; Westenberger, Benjamin J.; Buhse, Lucinda F.] US FDA, Div Pharmaceut Anal, CDER, St Louis, MO 63101 USA.
[Nasr, Moheb; Al-Hakim, Ali] US FDA, Off New Drug Qual Assessment, CDER, Silver Spring, MD 20993 USA.
RP Keire, DA (reprint author), US FDA, Div Pharmaceut Anal, CDER, 1114 Market St, St Louis, MO 63101 USA.
EM David.Keire@fda.hhs.gov
NR 34
TC 19
Z9 19
U1 0
U2 13
PU SPRINGER HEIDELBERG
PI HEIDELBERG
PA TIERGARTENSTRASSE 17, D-69121 HEIDELBERG, GERMANY
SN 1618-2642
J9 ANAL BIOANAL CHEM
JI Anal. Bioanal. Chem.
PD JAN
PY 2011
VL 399
IS 2
BP 581
EP 591
DI 10.1007/s00216-010-4023-y
PG 11
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 700YQ
UT WOS:000285781900006
PM 20680615
ER
PT J
AU Zang, QD
Keire, DA
Wood, RD
Buhse, LF
Moore, CMV
Nasr, M
Al-Hakim, A
Trehy, ML
Welsh, WJ
AF Zang, Qingda
Keire, David A.
Wood, Richard D.
Buhse, Lucinda F.
Moore, Christine M. V.
Nasr, Moheb
Al-Hakim, Ali
Trehy, Michael L.
Welsh, William J.
TI Determination of galactosamine impurities in heparin samples by
multivariate regression analysis of their H-1 NMR spectra
SO ANALYTICAL AND BIOANALYTICAL CHEMISTRY
LA English
DT Article
DE Heparin; Galactosamine impurities; Proton nuclear magnetic resonance
(H-1 NMR); Multivariate regression (MVR); Variable selection
ID NUCLEAR-MAGNETIC-RESONANCE; OVERSULFATED CHONDROITIN SULFATE;
CAPILLARY-ZONE-ELECTROPHORESIS; SUPPORT VECTOR REGRESSION; GENETIC
ALGORITHMS; DERMATAN SULFATE; CALIBRATION METHODS; ANTICOAGULANT
ACTIVITY; VARIABLE SELECTION; SPECTROSCOPY
AB Heparin, a widely used anticoagulant primarily extracted from animal sources, contains varying amounts of galactosamine impurities. Currently, the United States Pharmacopeia (USP) monograph for heparin purity specifies that the weight percent of galactosamine (%Gal) may not exceed 1%. In the present study, multivariate regression (MVR) analysis of H-1 NMR spectral data obtained from heparin samples was employed to build quantitative models for the prediction of %Gal. MVR analysis was conducted using four separate methods: multiple linear regression, ridge regression, partial least squares regression, and support vector regression (SVR). Genetic algorithms and stepwise selection methods were applied for variable selection. In each case, two separate prediction models were constructed: a global model based on dataset A which contained the full range (0-10%) of galactosamine in the samples and a local model based on the subset dataset B for which the galactosamine level (0-2%) spanned the 1% USP limit. All four regression methods performed equally well for dataset A with low prediction errors under optimal conditions, whereas SVR was clearly superior among the four methods for dataset B. The results from this study show that H-1 NMR spectroscopy, already a USP requirement for the screening of contaminants in heparin, may offer utility as a rapid method for quantitative determination of %Gal in heparin samples when used in conjunction with MVR approaches.
C1 [Zang, Qingda; Welsh, William J.] Univ Med & Dent New Jersey, Robert Wood Johnson Med Sch, Dept Pharmacol, Piscataway, NJ 08854 USA.
[Zang, Qingda; Wood, Richard D.] Snowdon Inc, Monmouth Jct, NJ 08852 USA.
[Zang, Qingda] Univ Med & Dent New Jersey, Dept Hlth Informat, Sch Hlth Related Profess, Newark, NJ 07107 USA.
[Keire, David A.; Buhse, Lucinda F.; Trehy, Michael L.] US FDA, Div Pharmaceut Anal, CDER, St Louis, MO 63101 USA.
[Moore, Christine M. V.; Nasr, Moheb; Al-Hakim, Ali] US FDA, Off New Drug Qual Assessment, CDER, Silver Spring, MD 20993 USA.
RP Welsh, WJ (reprint author), Univ Med & Dent New Jersey, Robert Wood Johnson Med Sch, Dept Pharmacol, Piscataway, NJ 08854 USA.
EM welshwj@umdnj.edu
NR 52
TC 16
Z9 16
U1 0
U2 12
PU SPRINGER HEIDELBERG
PI HEIDELBERG
PA TIERGARTENSTRASSE 17, D-69121 HEIDELBERG, GERMANY
SN 1618-2642
J9 ANAL BIOANAL CHEM
JI Anal. Bioanal. Chem.
PD JAN
PY 2011
VL 399
IS 2
BP 635
EP 649
DI 10.1007/s00216-010-4268-5
PG 15
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 700YQ
UT WOS:000285781900011
PM 20953772
ER
PT J
AU Korch, GW
Niemi, SM
Bergman, NH
Carucci, DJ
Ehrlich, SA
Gronvall, GK
Hartung, T
Heitman, E
Kotb, M
Kuhn, JH
Lyons, CR
Morse, SS
Murphy, FA
Patel, VS
Swearengen, JR
Bloom, F
Bayne, KA
Davis, MA
Garnett, NL
Clark, JAM
Marsman, DS
Neil, G
Nevalainen, TO
Niemi, SM
Novak, MA
Pangalos, M
Rollin, BE
Roth, JA
Sharples, F
Anestidou, L
Fletcher, CH
Worthy, J
AF Korch, George W., Jr.
Niemi, Steven M.
Bergman, Nicholas H.
Carucci, Daniel J.
Ehrlich, Susan A.
Gronvall, Gigi Kwik
Hartung, Thomas
Heitman, Elizabeth
Kotb, Malak
Kuhn, Jens H.
Lyons, C. Rick
Morse, Stephen S.
Murphy, Frederick A.
Patel, Vikram S.
Swearengen, James R.
Bloom, Floyd
Bayne, Kathryn A.
Davis, Myrtle A.
Garnett, Nelson L.
Clark, Judy A. Macarthur
Marsman, Daniel S.
Neil, Garry
Nevalainen, Timo Olavi
Niemi, Steven M.
Novak, Melinda A.
Pangalos, Menelas
Rollin, Bernard E.
Roth, James A.
Sharples, Frances
Anestidou, Lida
Fletcher, Cameron H.
Worthy, Jason
CA Comm Anim Models Assessing Counter
Inst Lab Anim Res
GP Natl Res Council
TI ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
Summary
SO ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
LA English
DT Editorial Material; Book Chapter
C1 [Korch, George W., Jr.] Johns Hopkins Univ, Baltimore, MD 21205 USA.
[Niemi, Steven M.; Niemi, Steven M.] Massachusetts Gen Hosp, Ctr Comparat Med, Charlestown, MA USA.
[Bergman, Nicholas H.; Swearengen, James R.] Battelle Natl Biodef Inst, Frederick, MD USA.
[Carucci, Daniel J.] Global Hlth Consulting, Washington, DC USA.
[Ehrlich, Susan A.] Arizona Court Appeals, Phoenix, AZ USA.
[Gronvall, Gigi Kwik] Univ Pittsburgh, Med Ctr, Ctr Biosecur, Baltimore, MD USA.
[Hartung, Thomas] Johns Hopkins Univ, Sch Publ Hlth, Baltimore, MD USA.
[Heitman, Elizabeth] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Clin & Res Eth, Nashville, TN USA.
[Kotb, Malak] Univ Cincinnati, Coll Med, Dept Mol Genet Biochem & Microbiol, Cincinnati, OH 45267 USA.
[Kuhn, Jens H.] NIAID, NIH, New Maximum Containment Facil, Integrated Res Facil Ft Detrick IRF Frederick, Frederick, MD USA.
[Lyons, C. Rick] Colorado State Univ, Infect Dis Res Ctr, Ft Collins, CO 80523 USA.
[Morse, Stephen S.] Columbia Univ, Sch Publ Hlth, New York, NY USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Dept Pathol, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Inst Human Infect & Immun, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Biodef & Emerging Infect Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Galveston Natl Lab, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Trop Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, McLaughlin Endowment Infect & Immun, Galveston, TX 77555 USA.
[Patel, Vikram S.] US FDA, Div Drug Safety Res, CDER, Silver Spring, MD USA.
[Bloom, Floyd] Scripps Res Inst, Mol & Integrat Neurosci Dept, La Jolla, CA 92037 USA.
[Bayne, Kathryn A.] Assoc Assessment & Accreditat Lab Anim Care Int, Frederick, MD USA.
[Davis, Myrtle A.] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA.
[Garnett, Nelson L.] Lab Anim Care & Use Programs, Dickerson, MD USA.
[Clark, Judy A. Macarthur] Anim Sci Procedures Inspectorate, Home Off, London, England.
[Marsman, Daniel S.] Procter & Gamble Co, Mason, OH USA.
[Neil, Garry] Johnson & Johnson, Corp Off Sci & Technol, New Brunswick, NJ USA.
[Nevalainen, Timo Olavi] Univ Eastern Finland, Kuopio, Finland.
[Novak, Melinda A.] Univ Massachusetts, Dept Psychol, Amherst, MA 01003 USA.
[Pangalos, Menelas] AstraZeneca, Innovat Med, Alderley Pk, England.
[Rollin, Bernard E.] Colorado State Univ, Dept Philosophy, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Behav Sci, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Anim Sci, Ft Collins, CO 80523 USA.
[Roth, James A.] Iowa State Univ, Coll Vet Med, Ctr Food Secur & Publ Hlth, Ames, IA USA.
RP Korch, GW (reprint author), Johns Hopkins Univ, Baltimore, MD 21205 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU NATL ACADEMIES PRESS
PI WASHINGTON
PA 2101 CONSTITUTION AVE, WASHINGTON, DC 20418 USA
BN 978-0-309-21909-9
PY 2011
BP 1
EP 5
PG 5
WC Medical Ethics; Medicine, Research & Experimental
SC Medical Ethics; Research & Experimental Medicine
GA BC4IN
UT WOS:000352547700001
ER
PT J
AU Korch, GW
Niemi, SM
Bergman, NH
Carucci, DJ
Ehrlich, SA
Gronvall, GK
Hartung, T
Heitman, E
Kotb, M
Kuhn, JH
Lyons, CR
Morse, SS
Murphy, FA
Patel, VS
Swearengen, JR
Bloom, F
Bayne, KA
Davis, MA
Garnett, NL
Clark, JAM
Marsman, DS
Neil, G
Nevalainen, TO
Niemi, SM
Novak, MA
Pangalos, M
Rollin, BE
Roth, JA
Sharples, F
Anestidou, L
Fletcher, CH
Worthy, J
AF Korch, George W., Jr.
Niemi, Steven M.
Bergman, Nicholas H.
Carucci, Daniel J.
Ehrlich, Susan A.
Gronvall, Gigi Kwik
Hartung, Thomas
Heitman, Elizabeth
Kotb, Malak
Kuhn, Jens H.
Lyons, C. Rick
Morse, Stephen S.
Murphy, Frederick A.
Patel, Vikram S.
Swearengen, James R.
Bloom, Floyd
Bayne, Kathryn A.
Davis, Myrtle A.
Garnett, Nelson L.
Clark, Judy A. Macarthur
Marsman, Daniel S.
Neil, Garry
Nevalainen, Timo Olavi
Niemi, Steven M.
Novak, Melinda A.
Pangalos, Menelas
Rollin, Bernard E.
Roth, James A.
Sharples, Frances
Anestidou, Lida
Fletcher, Cameron H.
Worthy, Jason
CA Comm Anim Models Assessing Counter
Inst Lab Anim Res
GP Natl Res Council
TI ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
Introduction
SO ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
LA English
DT Editorial Material; Book Chapter
ID YERSINIA-PESTIS; EVOLUTION; PLAGUE; TSG101
C1 [Korch, George W., Jr.] Johns Hopkins Univ, Baltimore, MD 21205 USA.
[Niemi, Steven M.; Niemi, Steven M.] Massachusetts Gen Hosp, Ctr Comparat Med, Charlestown, MA USA.
[Bergman, Nicholas H.; Swearengen, James R.] Battelle Natl Biodef Inst, Frederick, MD USA.
[Carucci, Daniel J.] Global Hlth Consulting, Washington, DC USA.
[Ehrlich, Susan A.] Arizona Court Appeals, Phoenix, AZ USA.
[Gronvall, Gigi Kwik] Univ Pittsburgh, Med Ctr, Ctr Biosecur, Baltimore, MD USA.
[Hartung, Thomas] Johns Hopkins Univ, Sch Publ Hlth, Baltimore, MD USA.
[Heitman, Elizabeth] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Clin & Res Eth, Nashville, TN USA.
[Kotb, Malak] Univ Cincinnati, Coll Med, Dept Mol Genet Biochem & Microbiol, Cincinnati, OH 45267 USA.
[Kuhn, Jens H.] NIAID, NIH, New Maximum Containment Facil, Integrated Res Facil Ft Detrick IRF Frederick, Frederick, MD USA.
[Lyons, C. Rick] Colorado State Univ, Infect Dis Res Ctr, Ft Collins, CO 80523 USA.
[Morse, Stephen S.] Columbia Univ, Sch Publ Hlth, New York, NY USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Dept Pathol, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Inst Human Infect & Immun, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Biodef & Emerging Infect Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Galveston Natl Lab, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Trop Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, McLaughlin Endowment Infect & Immun, Galveston, TX 77555 USA.
[Patel, Vikram S.] US FDA, Div Drug Safety Res, CDER, Silver Spring, MD USA.
[Bloom, Floyd] Scripps Res Inst, Mol & Integrat Neurosci Dept, La Jolla, CA 92037 USA.
[Bayne, Kathryn A.] Assoc Assessment & Accreditat Lab Anim Care Int, Frederick, MD USA.
[Davis, Myrtle A.] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA.
[Garnett, Nelson L.] Lab Anim Care & Use Programs, Dickerson, MD USA.
[Clark, Judy A. Macarthur] Anim Sci Procedures Inspectorate, Home Off, London, England.
[Marsman, Daniel S.] Procter & Gamble Co, Mason, OH USA.
[Neil, Garry] Johnson & Johnson, Corp Off Sci & Technol, New Brunswick, NJ USA.
[Nevalainen, Timo Olavi] Univ Eastern Finland, Kuopio, Finland.
[Novak, Melinda A.] Univ Massachusetts, Dept Psychol, Amherst, MA 01003 USA.
[Pangalos, Menelas] AstraZeneca, Innovat Med, Alderley Pk, England.
[Rollin, Bernard E.] Colorado State Univ, Dept Philosophy, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Behav Sci, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Anim Sci, Ft Collins, CO 80523 USA.
[Roth, James A.] Iowa State Univ, Coll Vet Med, Ctr Food Secur & Publ Hlth, Ames, IA USA.
RP Korch, GW (reprint author), Johns Hopkins Univ, Baltimore, MD 21205 USA.
NR 14
TC 0
Z9 0
U1 0
U2 0
PU NATL ACADEMIES PRESS
PI WASHINGTON
PA 2101 CONSTITUTION AVE, WASHINGTON, DC 20418 USA
BN 978-0-309-21909-9
PY 2011
BP 7
EP 13
PG 7
WC Medical Ethics; Medicine, Research & Experimental
SC Medical Ethics; Research & Experimental Medicine
GA BC4IN
UT WOS:000352547700002
ER
PT J
AU Korch, GW
Niemi, SM
Bergman, NH
Carucci, DJ
Ehrlich, SA
Gronvall, GK
Hartung, T
Heitman, E
Kotb, M
Kuhn, JH
Lyons, CR
Morse, SS
Murphy, FA
Patel, VS
Swearengen, JR
Bloom, F
Bayne, KA
Davis, MA
Garnett, NL
Clark, JAM
Marsman, DS
Neil, G
Nevalainen, TO
Niemi, SM
Novak, MA
Pangalos, M
Rollin, BE
Roth, JA
Sharples, F
Anestidou, L
Fletcher, CH
Worthy, J
AF Korch, George W., Jr.
Niemi, Steven M.
Bergman, Nicholas H.
Carucci, Daniel J.
Ehrlich, Susan A.
Gronvall, Gigi Kwik
Hartung, Thomas
Heitman, Elizabeth
Kotb, Malak
Kuhn, Jens H.
Lyons, C. Rick
Morse, Stephen S.
Murphy, Frederick A.
Patel, Vikram S.
Swearengen, James R.
Bloom, Floyd
Bayne, Kathryn A.
Davis, Myrtle A.
Garnett, Nelson L.
Clark, Judy A. Macarthur
Marsman, Daniel S.
Neil, Garry
Nevalainen, Timo Olavi
Niemi, Steven M.
Novak, Melinda A.
Pangalos, Menelas
Rollin, Bernard E.
Roth, James A.
Sharples, Frances
Anestidou, Lida
Fletcher, Cameron H.
Worthy, Jason
CA Comm Anim Models Assessing Counter
Inst Lab Anim Res
GP Natl Res Council
TI Evaluation of Current and Future TMT-Used Animal Models
SO ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
LA English
DT Article; Book Chapter
ID EBOLA-VIRUS-INFECTION; MARBURG HEMORRHAGIC-FEVER; VERVET MONKEY DISEASE;
HUMAN ANTHRAX VACCINE; GUINEA-PIGS; BACILLUS-ANTHRACIS;
FRANCISELLA-TULARENSIS; DRUG DEVELOPMENT; CYNOMOLGUS MACAQUES; PRIMATE
MODELS
C1 [Korch, George W., Jr.] Johns Hopkins Univ, Baltimore, MD 21205 USA.
[Niemi, Steven M.; Niemi, Steven M.] Massachusetts Gen Hosp, Ctr Comparat Med, Charlestown, MA USA.
[Bergman, Nicholas H.; Swearengen, James R.] Battelle Natl Biodef Inst, Frederick, MD USA.
[Carucci, Daniel J.] Global Hlth Consulting, Washington, DC USA.
[Ehrlich, Susan A.] Arizona Court Appeals, Phoenix, AZ USA.
[Gronvall, Gigi Kwik] Univ Pittsburgh, Med Ctr, Ctr Biosecur, Baltimore, MD USA.
[Hartung, Thomas] Johns Hopkins Univ, Sch Publ Hlth, Baltimore, MD USA.
[Heitman, Elizabeth] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Clin & Res Eth, Nashville, TN USA.
[Kotb, Malak] Univ Cincinnati, Coll Med, Dept Mol Genet Biochem & Microbiol, Cincinnati, OH 45267 USA.
[Kuhn, Jens H.] NIAID, NIH, New Maximum Containment Facil, Integrated Res Facil Ft Detrick IRF Frederick, Frederick, MD USA.
[Lyons, C. Rick] Colorado State Univ, Infect Dis Res Ctr, Ft Collins, CO 80523 USA.
[Morse, Stephen S.] Columbia Univ, Sch Publ Hlth, New York, NY USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Dept Pathol, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Inst Human Infect & Immun, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Biodef & Emerging Infect Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Galveston Natl Lab, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Trop Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, McLaughlin Endowment Infect & Immun, Galveston, TX 77555 USA.
[Patel, Vikram S.] US FDA, Div Drug Safety Res, CDER, Silver Spring, MD USA.
[Bloom, Floyd] Scripps Res Inst, Mol & Integrat Neurosci Dept, La Jolla, CA 92037 USA.
[Bayne, Kathryn A.] Assoc Assessment & Accreditat Lab Anim Care Int, Frederick, MD USA.
[Davis, Myrtle A.] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA.
[Garnett, Nelson L.] Lab Anim Care & Use Programs, Dickerson, MD USA.
[Clark, Judy A. Macarthur] Anim Sci Procedures Inspectorate, Home Off, London, England.
[Marsman, Daniel S.] Procter & Gamble Co, Mason, OH USA.
[Neil, Garry] Johnson & Johnson, Corp Off Sci & Technol, New Brunswick, NJ USA.
[Nevalainen, Timo Olavi] Univ Eastern Finland, Kuopio, Finland.
[Novak, Melinda A.] Univ Massachusetts, Dept Psychol, Amherst, MA 01003 USA.
[Pangalos, Menelas] AstraZeneca, Innovat Med, Alderley Pk, England.
[Rollin, Bernard E.] Colorado State Univ, Dept Philosophy, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Behav Sci, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Anim Sci, Ft Collins, CO 80523 USA.
[Roth, James A.] Iowa State Univ, Coll Vet Med, Ctr Food Secur & Publ Hlth, Ames, IA USA.
RP Korch, GW (reprint author), Johns Hopkins Univ, Baltimore, MD 21205 USA.
NR 115
TC 0
Z9 0
U1 0
U2 0
PU NATL ACADEMIES PRESS
PI WASHINGTON
PA 2101 CONSTITUTION AVE, WASHINGTON, DC 20418 USA
BN 978-0-309-21909-9
PY 2011
BP 15
EP 37
PG 23
WC Medical Ethics; Medicine, Research & Experimental
SC Medical Ethics; Research & Experimental Medicine
GA BC4IN
UT WOS:000352547700003
ER
PT J
AU Korch, GW
Niemi, SM
Bergman, NH
Carucci, DJ
Ehrlich, SA
Gronvall, GK
Hartung, T
Heitman, E
Kotb, M
Kuhn, JH
Lyons, CR
Morse, SS
Murphy, FA
Patel, VS
Swearengen, JR
Bloom, F
Bayne, KA
Davis, MA
Garnett, NL
Clark, JAM
Marsman, DS
Neil, G
Nevalainen, TO
Niemi, SM
Novak, MA
Pangalos, M
Rollin, BE
Roth, JA
Sharples, F
Anestidou, L
Fletcher, CH
Worthy, J
AF Korch, George W., Jr.
Niemi, Steven M.
Bergman, Nicholas H.
Carucci, Daniel J.
Ehrlich, Susan A.
Gronvall, Gigi Kwik
Hartung, Thomas
Heitman, Elizabeth
Kotb, Malak
Kuhn, Jens H.
Lyons, C. Rick
Morse, Stephen S.
Murphy, Frederick A.
Patel, Vikram S.
Swearengen, James R.
Bloom, Floyd
Bayne, Kathryn A.
Davis, Myrtle A.
Garnett, Nelson L.
Clark, Judy A. Macarthur
Marsman, Daniel S.
Neil, Garry
Nevalainen, Timo Olavi
Niemi, Steven M.
Novak, Melinda A.
Pangalos, Menelas
Rollin, Bernard E.
Roth, James A.
Sharples, Frances
Anestidou, Lida
Fletcher, Cameron H.
Worthy, Jason
CA Comm Anim Models Assessing Counter
Inst Lab Anim Res
GP Natl Res Council
TI Ethical and Regulatory Challenges in the Development of Countermeasures
SO ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
LA English
DT Article; Book Chapter
ID VACCINE; CONSENT; ANTHRAX
C1 [Korch, George W., Jr.] Johns Hopkins Univ, Baltimore, MD 21205 USA.
[Niemi, Steven M.; Niemi, Steven M.] Massachusetts Gen Hosp, Ctr Comparat Med, Charlestown, MA USA.
[Bergman, Nicholas H.; Swearengen, James R.] Battelle Natl Biodef Inst, Frederick, MD USA.
[Carucci, Daniel J.] Global Hlth Consulting, Washington, DC USA.
[Ehrlich, Susan A.] Arizona Court Appeals, Phoenix, AZ USA.
[Gronvall, Gigi Kwik] Univ Pittsburgh, Med Ctr, Ctr Biosecur, Baltimore, MD USA.
[Hartung, Thomas] Johns Hopkins Univ, Sch Publ Hlth, Baltimore, MD USA.
[Heitman, Elizabeth] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Clin & Res Eth, Nashville, TN USA.
[Kotb, Malak] Univ Cincinnati, Coll Med, Dept Mol Genet Biochem & Microbiol, Cincinnati, OH 45267 USA.
[Kuhn, Jens H.] NIAID, NIH, New Maximum Containment Facil, Integrated Res Facil Ft Detrick IRF Frederick, Frederick, MD USA.
[Lyons, C. Rick] Colorado State Univ, Infect Dis Res Ctr, Ft Collins, CO 80523 USA.
[Morse, Stephen S.] Columbia Univ, Sch Publ Hlth, New York, NY USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Dept Pathol, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Inst Human Infect & Immun, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Biodef & Emerging Infect Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Galveston Natl Lab, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Trop Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, McLaughlin Endowment Infect & Immun, Galveston, TX 77555 USA.
[Patel, Vikram S.] US FDA, Div Drug Safety Res, CDER, Silver Spring, MD USA.
[Bloom, Floyd] Scripps Res Inst, Mol & Integrat Neurosci Dept, La Jolla, CA 92037 USA.
[Bayne, Kathryn A.] Assoc Assessment & Accreditat Lab Anim Care Int, Frederick, MD USA.
[Davis, Myrtle A.] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA.
[Garnett, Nelson L.] Lab Anim Care & Use Programs, Dickerson, MD USA.
[Clark, Judy A. Macarthur] Anim Sci Procedures Inspectorate, Home Off, London, England.
[Marsman, Daniel S.] Procter & Gamble Co, Mason, OH USA.
[Neil, Garry] Johnson & Johnson, Corp Off Sci & Technol, New Brunswick, NJ USA.
[Nevalainen, Timo Olavi] Univ Eastern Finland, Kuopio, Finland.
[Novak, Melinda A.] Univ Massachusetts, Dept Psychol, Amherst, MA 01003 USA.
[Pangalos, Menelas] AstraZeneca, Innovat Med, Alderley Pk, England.
[Rollin, Bernard E.] Colorado State Univ, Dept Philosophy, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Behav Sci, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Anim Sci, Ft Collins, CO 80523 USA.
[Roth, James A.] Iowa State Univ, Coll Vet Med, Ctr Food Secur & Publ Hlth, Ames, IA USA.
RP Korch, GW (reprint author), Johns Hopkins Univ, Baltimore, MD 21205 USA.
NR 37
TC 0
Z9 0
U1 0
U2 0
PU NATL ACADEMIES PRESS
PI WASHINGTON
PA 2101 CONSTITUTION AVE, WASHINGTON, DC 20418 USA
BN 978-0-309-21909-9
PY 2011
BP 39
EP 49
PG 11
WC Medical Ethics; Medicine, Research & Experimental
SC Medical Ethics; Research & Experimental Medicine
GA BC4IN
UT WOS:000352547700004
ER
PT J
AU Korch, GW
Niemi, SM
Bergman, NH
Carucci, DJ
Ehrlich, SA
Gronvall, GK
Hartung, T
Heitman, E
Kotb, M
Kuhn, JH
Lyons, CR
Morse, SS
Murphy, FA
Patel, VS
Swearengen, JR
Bloom, F
Bayne, KA
Davis, MA
Garnett, NL
Clark, JAM
Marsman, DS
Neil, G
Nevalainen, TO
Niemi, SM
Novak, MA
Pangalos, M
Rollin, BE
Roth, JA
Sharples, F
Anestidou, L
Fletcher, CH
Worthy, J
AF Korch, George W., Jr.
Niemi, Steven M.
Bergman, Nicholas H.
Carucci, Daniel J.
Ehrlich, Susan A.
Gronvall, Gigi Kwik
Hartung, Thomas
Heitman, Elizabeth
Kotb, Malak
Kuhn, Jens H.
Lyons, C. Rick
Morse, Stephen S.
Murphy, Frederick A.
Patel, Vikram S.
Swearengen, James R.
Bloom, Floyd
Bayne, Kathryn A.
Davis, Myrtle A.
Garnett, Nelson L.
Clark, Judy A. Macarthur
Marsman, Daniel S.
Neil, Garry
Nevalainen, Timo Olavi
Niemi, Steven M.
Novak, Melinda A.
Pangalos, Menelas
Rollin, Bernard E.
Roth, James A.
Sharples, Frances
Anestidou, Lida
Fletcher, Cameron H.
Worthy, Jason
CA Comm Anim Models Assessing Counter
Inst Lab Anim Res
GP Natl Res Council
TI Developing New Animal Models for Biodefense Research
SO ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
LA English
DT Article; Book Chapter
ID ANTHRAX
C1 [Korch, George W., Jr.] Johns Hopkins Univ, Baltimore, MD 21205 USA.
[Niemi, Steven M.; Niemi, Steven M.] Massachusetts Gen Hosp, Ctr Comparat Med, Charlestown, MA USA.
[Bergman, Nicholas H.; Swearengen, James R.] Battelle Natl Biodef Inst, Frederick, MD USA.
[Carucci, Daniel J.] Global Hlth Consulting, Washington, DC USA.
[Ehrlich, Susan A.] Arizona Court Appeals, Phoenix, AZ USA.
[Gronvall, Gigi Kwik] Univ Pittsburgh, Med Ctr, Ctr Biosecur, Baltimore, MD USA.
[Hartung, Thomas] Johns Hopkins Univ, Sch Publ Hlth, Baltimore, MD USA.
[Heitman, Elizabeth] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Clin & Res Eth, Nashville, TN USA.
[Kotb, Malak] Univ Cincinnati, Coll Med, Dept Mol Genet Biochem & Microbiol, Cincinnati, OH 45267 USA.
[Kuhn, Jens H.] NIAID, NIH, New Maximum Containment Facil, Integrated Res Facil Ft Detrick IRF Frederick, Frederick, MD USA.
[Lyons, C. Rick] Colorado State Univ, Infect Dis Res Ctr, Ft Collins, CO 80523 USA.
[Morse, Stephen S.] Columbia Univ, Sch Publ Hlth, New York, NY USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Dept Pathol, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Inst Human Infect & Immun, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Biodef & Emerging Infect Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Galveston Natl Lab, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Trop Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, McLaughlin Endowment Infect & Immun, Galveston, TX 77555 USA.
[Patel, Vikram S.] US FDA, Div Drug Safety Res, CDER, Silver Spring, MD USA.
[Bloom, Floyd] Scripps Res Inst, Mol & Integrat Neurosci Dept, La Jolla, CA 92037 USA.
[Bayne, Kathryn A.] Assoc Assessment & Accreditat Lab Anim Care Int, Frederick, MD USA.
[Davis, Myrtle A.] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA.
[Garnett, Nelson L.] Lab Anim Care & Use Programs, Dickerson, MD USA.
[Clark, Judy A. Macarthur] Anim Sci Procedures Inspectorate, Home Off, London, England.
[Marsman, Daniel S.] Procter & Gamble Co, Mason, OH USA.
[Neil, Garry] Johnson & Johnson, Corp Off Sci & Technol, New Brunswick, NJ USA.
[Nevalainen, Timo Olavi] Univ Eastern Finland, Kuopio, Finland.
[Novak, Melinda A.] Univ Massachusetts, Dept Psychol, Amherst, MA 01003 USA.
[Pangalos, Menelas] AstraZeneca, Innovat Med, Alderley Pk, England.
[Rollin, Bernard E.] Colorado State Univ, Dept Philosophy, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Behav Sci, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Anim Sci, Ft Collins, CO 80523 USA.
[Roth, James A.] Iowa State Univ, Coll Vet Med, Ctr Food Secur & Publ Hlth, Ames, IA USA.
RP Korch, GW (reprint author), Johns Hopkins Univ, Baltimore, MD 21205 USA.
NR 19
TC 0
Z9 0
U1 0
U2 0
PU NATL ACADEMIES PRESS
PI WASHINGTON
PA 2101 CONSTITUTION AVE, WASHINGTON, DC 20418 USA
BN 978-0-309-21909-9
PY 2011
BP 51
EP 59
PG 9
WC Medical Ethics; Medicine, Research & Experimental
SC Medical Ethics; Research & Experimental Medicine
GA BC4IN
UT WOS:000352547700005
ER
PT J
AU Korch, GW
Niemi, SM
Bergman, NH
Carucci, DJ
Ehrlich, SA
Gronvall, GK
Hartung, T
Heitman, E
Kotb, M
Kuhn, JH
Lyons, CR
Morse, SS
Murphy, FA
Patel, VS
Swearengen, JR
Bloom, F
Bayne, KA
Davis, MA
Garnett, NL
Clark, JAM
Marsman, DS
Neil, G
Nevalainen, TO
Niemi, SM
Novak, MA
Pangalos, M
Rollin, BE
Roth, JA
Sharples, F
Anestidou, L
Fletcher, CH
Worthy, J
AF Korch, George W., Jr.
Niemi, Steven M.
Bergman, Nicholas H.
Carucci, Daniel J.
Ehrlich, Susan A.
Gronvall, Gigi Kwik
Hartung, Thomas
Heitman, Elizabeth
Kotb, Malak
Kuhn, Jens H.
Lyons, C. Rick
Morse, Stephen S.
Murphy, Frederick A.
Patel, Vikram S.
Swearengen, James R.
Bloom, Floyd
Bayne, Kathryn A.
Davis, Myrtle A.
Garnett, Nelson L.
Clark, Judy A. Macarthur
Marsman, Daniel S.
Neil, Garry
Nevalainen, Timo Olavi
Niemi, Steven M.
Novak, Melinda A.
Pangalos, Menelas
Rollin, Bernard E.
Roth, James A.
Sharples, Frances
Anestidou, Lida
Fletcher, Cameron H.
Worthy, Jason
CA Comm Anim Models Assessing Counter
Inst Lab Anim Res
GP Natl Res Council
TI Alternative Approaches to Animal Testing for Biodefense Countermeasures
SO ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS
LA English
DT Article; Book Chapter
ID MONKEYPOX VIRUS; NONHUMAN-PRIMATES; GENE-EXPRESSION; COMPLEX; RESPONSES;
SMALLPOX; DESIGN; TRAITS; CELLS; HEMAGGLUTININ
C1 [Korch, George W., Jr.] Johns Hopkins Univ, Baltimore, MD 21205 USA.
[Niemi, Steven M.; Niemi, Steven M.] Massachusetts Gen Hosp, Ctr Comparat Med, Charlestown, MA USA.
[Bergman, Nicholas H.; Swearengen, James R.] Battelle Natl Biodef Inst, Frederick, MD USA.
[Carucci, Daniel J.] Global Hlth Consulting, Washington, DC USA.
[Ehrlich, Susan A.] Arizona Court Appeals, Phoenix, AZ USA.
[Gronvall, Gigi Kwik] Univ Pittsburgh, Med Ctr, Ctr Biosecur, Baltimore, MD USA.
[Hartung, Thomas] Johns Hopkins Univ, Sch Publ Hlth, Baltimore, MD USA.
[Heitman, Elizabeth] Vanderbilt Univ, Med Ctr, Ctr Biomed Eth & Soc, Clin & Res Eth, Nashville, TN USA.
[Kotb, Malak] Univ Cincinnati, Coll Med, Dept Mol Genet Biochem & Microbiol, Cincinnati, OH 45267 USA.
[Kuhn, Jens H.] NIAID, NIH, New Maximum Containment Facil, Integrated Res Facil Ft Detrick IRF Frederick, Frederick, MD USA.
[Lyons, C. Rick] Colorado State Univ, Infect Dis Res Ctr, Ft Collins, CO 80523 USA.
[Morse, Stephen S.] Columbia Univ, Sch Publ Hlth, New York, NY USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Dept Pathol, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Inst Human Infect & Immun, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Biodef & Emerging Infect Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Galveston Natl Lab, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, Ctr Trop Dis, Galveston, TX 77555 USA.
[Murphy, Frederick A.] Univ Texas Med Branch, McLaughlin Endowment Infect & Immun, Galveston, TX 77555 USA.
[Patel, Vikram S.] US FDA, Div Drug Safety Res, CDER, Silver Spring, MD USA.
[Bloom, Floyd] Scripps Res Inst, Mol & Integrat Neurosci Dept, La Jolla, CA 92037 USA.
[Bayne, Kathryn A.] Assoc Assessment & Accreditat Lab Anim Care Int, Frederick, MD USA.
[Davis, Myrtle A.] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA.
[Garnett, Nelson L.] Lab Anim Care & Use Programs, Dickerson, MD USA.
[Clark, Judy A. Macarthur] Anim Sci Procedures Inspectorate, Home Off, London, England.
[Marsman, Daniel S.] Procter & Gamble Co, Mason, OH USA.
[Neil, Garry] Johnson & Johnson, Corp Off Sci & Technol, New Brunswick, NJ USA.
[Nevalainen, Timo Olavi] Univ Eastern Finland, Kuopio, Finland.
[Novak, Melinda A.] Univ Massachusetts, Dept Psychol, Amherst, MA 01003 USA.
[Pangalos, Menelas] AstraZeneca, Innovat Med, Alderley Pk, England.
[Rollin, Bernard E.] Colorado State Univ, Dept Philosophy, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Behav Sci, Ft Collins, CO 80523 USA.
[Rollin, Bernard E.] Colorado State Univ, Dept Anim Sci, Ft Collins, CO 80523 USA.
[Roth, James A.] Iowa State Univ, Coll Vet Med, Ctr Food Secur & Publ Hlth, Ames, IA USA.
RP Korch, GW (reprint author), Johns Hopkins Univ, Baltimore, MD 21205 USA.
NR 66
TC 0
Z9 0
U1 0
U2 0
PU NATL ACADEMIES PRESS
PI WASHINGTON
PA 2101 CONSTITUTION AVE, WASHINGTON, DC 20418 USA
BN 978-0-309-21909-9
PY 2011
BP 61
EP 76
PG 16
WC Medical Ethics; Medicine, Research & Experimental
SC Medical Ethics; Research & Experimental Medicine
GA BC4IN
UT WOS:000352547700006
ER
PT J
AU Couderc, JP
Garnett, C
Li, M
Handzel, R
McNitt, S
Xia, XJ
Polonsky, S
Zareba, W
AF Couderc, Jean-Philippe
Garnett, Christine
Li, Mike
Handzel, Robert
McNitt, Scott
Xia, Xiajuan
Polonsky, Slava
Zareba, Wojciech
TI Highly Automated QT Measurement Techniques in 7 Thorough QT Studies
Implemented under ICH E14 Guidelines
SO ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
LA English
DT Article
DE thorough QT study; drug cardiotoxicity; moxifloxacin; QT interval;
electrocardiogram; drug safety
ID HEART-RATE CORRECTION; TORSADES-DE-POINTES; CARDIAC REPOLARIZATION;
INTERVAL MEASUREMENT; HEALTHY-SUBJECTS; VENTRICULAR REPOLARIZATION;
QT/QTC INTERVAL; PROLONGATION; MOXIFLOXACIN; ELECTROCARDIOGRAM
AB Thorough QT (TQT) studies are designed to evaluate potential effect of a novel drug on the ventricular repolarization process of the heart using QTc prolongation as a surrogate marker for torsades de pointes. The current process to measure the QT intervals from the thousands of electrocardiograms is lengthy and expensive. In this study, we propose a validation of a highly automatic-QT interval measurement (HA-QT) method. We applied a HA-QT method to the data from 7 TQT studies. We investigated both the placebo and baseline-adjusted QTc interval prolongation induced by moxifloxacin (positive control drug) at the time of expected peak concentration. The comparative analysis evaluated the time course of moxifloxacin-induced QTc prolongation in one study as well. The absolute HA-QT data were longer than the FDA-approved QTc data. This trend was not different between ECGs from the moxifloxacin and placebo arms: 9.6 +/- 24 ms on drug and 9.8 +/- 25 ms on placebo. The difference between methods vanished when comparing the placebo-baseline-adjusted QTc prolongation (1.4 +/- 2.8 ms, P = 0.4). The differences in precision between the HA-QT and the FDA-approved measurements were not statistically different from zero: 0.1 +/- 0.1 ms (P = 0.7). Also, the time course of the moxifloxacin-induced QTc prolongation adjusted for placebo was not statistically different between measurements methods. Ann Noninvasive Electrocardiol 2011;16(1):13-24
C1 [Couderc, Jean-Philippe; McNitt, Scott; Xia, Xiajuan; Polonsky, Slava; Zareba, Wojciech] Univ Rochester, Med Ctr, Heart Res Follow Up Program, Dept Cardiol, Rochester, NY 14642 USA.
[Garnett, Christine; Li, Mike] US FDA, Div Cardiovasc & Renal Prod, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Handzel, Robert] Univ Rochester, Sch Biomed Engn, Rochester, NY 14642 USA.
RP Couderc, JP (reprint author), Univ Rochester, Med Ctr, Heart Res Follow Up Program, Dept Cardiol, Box 653, Rochester, NY 14642 USA.
EM jean-philippe.couderc@heart.rochester.edu
FU National Institute for Health [R01HL084402]
FX This work was funded by the National Institute for Health through the
R01HL084402 award.
NR 45
TC 18
Z9 18
U1 0
U2 0
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1082-720X
J9 ANN NONINVAS ELECTRO
JI Ann. Noninvasive Electrocardiol.
PD JAN
PY 2011
VL 16
IS 1
BP 13
EP 24
DI 10.1111/j.1542-474X.2010.00402.x
PG 12
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 709HF
UT WOS:000286428400003
PM 21251129
ER
PT S
AU Woodcock, J
Behrman, RE
Dal Pan, GJ
AF Woodcock, Janet
Behrman, Rachel E.
Dal Pan, Gerald J.
BE Caskey, CT
TI Role of Postmarketing Surveillance in Contemporary Medicine
SO ANNUAL REVIEW OF MEDICINE, VOL 62, 2011
SE Annual Review of Medicine
LA English
DT Review; Book Chapter
DE drug safety; safe use; Sentinel Initiative; Sentinel System; adverse
event
ID ADVERSE DRUG EVENTS; APLASTIC-ANEMIA; FELBAMATE
AB Contemporary medicine is a large and complex system involving many participants, all of whom play a critical role in managing the risks intrinsic to medical product use. Despite the robust premarket review and approval process of the U.S. Food and Drug Administration (FDA), new information will inevitably be learned in the postmarketing period about the safety of medicines and how they are and should be used. For much of this information, FDA relies on public reports about possible adverse events. In turn, the public depends on FDA to communicate the most up-to-date safety information on medical products to better inform treatment decisions. Expanding the scope and strengthening the capabilities of the drug safety surveillance system are among key FDA projects designed to reduce avoidable injury and death from medication use. Although improving drug safety is our goal and obligation to the public, FDA cannot protect the public adequately without the active involvement of all participants in healthcare.
C1 [Woodcock, Janet; Behrman, Rachel E.; Dal Pan, Gerald J.] US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Woodcock, J (reprint author), US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
EM Janet.Woodcock@fda.hhs.gov; Rachel.Behrman@fda.hhs.gov;
Gerald.DalPan@fda.hhs.gov
NR 17
TC 18
Z9 18
U1 0
U2 1
PU ANNUAL REVIEWS
PI PALO ALTO
PA 4139 EL CAMINO WAY, PO BOX 10139, PALO ALTO, CA 94303-0897 USA
SN 0066-4219
BN 978-0-8243-0562-8
J9 ANNU REV MED
JI Annu. Rev. Med.
PY 2011
VL 62
BP 1
EP 10
DI 10.1146/annurev-med-060309-164311
PG 10
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA BTS32
UT WOS:000287956900001
PM 20809798
ER
PT J
AU Boyd, SD
Maldarelli, F
Sereti, I
Ouedraogo, GL
Rehm, CA
Boltz, V
Shoemaker, D
Pau, AK
AF Boyd, Sarita D.
Maldarelli, Frank
Sereti, Irini
Ouedraogo, G. Laissa
Rehm, Catherine A.
Boltz, Valerie
Shoemaker, Diana
Pau, Alice K.
TI Transmitted raltegravir resistance in an HIV-1 CRF_AG-infected patient
SO ANTIVIRAL THERAPY
LA English
DT Article
ID ANTIRETROVIRAL DRUG-RESISTANCE; REVERSE-TRANSCRIPTASE; INTEGRASE
INHIBITORS; MUTATIONS; NAIVE; THERAPY; SUSCEPTIBILITY; INDIVIDUALS;
PREVALENCE; CITIES
AB Here, we describe an HIV-infected patient with pretreatment resistance to raltegravir, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors, and the ultimate ability to achieve viral suppression. Pretreatment integrase resistance testing is not routinely performed because transmitted integrase mutations conferring resistance to raltegravir are currently thought to be negligible. We suggest obtaining a pretreatment integrase genotype in patients with transmitted multiclass drug resistance in order to create an optimal first regimen and increase the chance for virological suppression.
C1 [Boyd, Sarita D.; Sereti, Irini; Ouedraogo, G. Laissa; Rehm, Catherine A.; Shoemaker, Diana; Pau, Alice K.] NIAID, NIH, Bethesda, MD 20892 USA.
[Boyd, Sarita D.; Ouedraogo, G. Laissa] SAIC Frederick Inc, Frederick, MD USA.
[Maldarelli, Frank; Boltz, Valerie] NCI, HIV Drug Resistance Program, NIH, Bethesda, MD 20892 USA.
RP Boyd, SD (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
EM sarita.boyd@fda.hhs.gov
FU National Institute of Allergy and Infectious Diseases, National
Institutes of Health; National Cancer Institute, National Institutes of
Health [HHSN261200800001E]
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. It is also funded, in part, with federal funds
from the National Cancer Institute, National Institutes of Health, under
contract number HHSN261200800001E. The content of this publication does
not necessarily reflect the views or policies of 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 22
TC 29
Z9 31
U1 0
U2 1
PU INT MEDICAL PRESS LTD
PI LONDON
PA 2-4 IDOL LANE, LONDON EC3R 5DD, ENGLAND
SN 1359-6535
J9 ANTIVIR THER
JI Antivir. Ther.
PY 2011
VL 16
IS 2
BP 257
EP 261
DI 10.3851/IMP1749
PG 5
WC Infectious Diseases; Pharmacology & Pharmacy; Virology
SC Infectious Diseases; Pharmacology & Pharmacy; Virology
GA 813NZ
UT WOS:000294375500017
PM 21447876
ER
PT J
AU Kouiavskaia, DV
Dragunsky, EM
Liu, HM
Oberste, MS
Collett, MS
Chumakov, KM
AF Kouiavskaia, Diana V.
Dragunsky, Eugenia M.
Liu, Hong-Mei
Oberste, M. Steven
Collett, Marc S.
Chumakov, Konstantin M.
TI Immunological and pathogenic properties of poliovirus variants selected
for resistance to antiviral drug V-073
SO ANTIVIRAL THERAPY
LA English
DT Article
AB Background: The National Research Council has recommended development of polio antiviral drugs to assist in management of outbreaks and to mitigate adverse consequences of vaccination. V-073 is a small molecule poliovirus capsid inhibitor that is being developed for these purposes. Antiviral use raises the potential of treatment-emergent resistance. Understanding virological consequences of resistance is important.
Methods: Six independent laboratory-derived V-073-resistant poliovirus variants were characterized for their ability to be neutralized by conventional vaccine-induced immune sera, to elicit serum neutralizing antibodies upon CD-1 mouse immunization, and to replicate in and to cause paralysis of TgPVR21 mice.
Results: V-073-resistant variants were effectively neutralized by oral perliovirus vaccine and inactivated poliovirus vaccine human immune sera. All variants elicited virus neutralizing antibody titres in CD-1 mice that were comparable to drug-susceptible parental and Sabin vaccine strain viruses. Infection efficiency of TgPVR21 mice by variants was comparable to (1 of 6 variants) or considerably lower than (5 of 6 variants) parental viruses. Drug-resistant variants replicated to levels comparable to (1 of 6 variants) or substantially less than (5 of 6 variants) their drug-susceptible parental viruses and were on average 1.4 log(10) (range 0.3 to >2.8 log(10)) less neurovirulent.
Conclusions: Laboratory-derived V-073-resistant variants exhibit clear attenuation of pathogenic properties while maintaining immunological features of drug-susceptible viruses.
C1 [Collett, Marc S.] ViroDefense Inc, Rockville, MD USA.
[Kouiavskaia, Diana V.; Dragunsky, Eugenia M.; Chumakov, Konstantin M.] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Liu, Hong-Mei; Oberste, M. Steven] Ctr Dis Control & Prevent, Atlanta, GA USA.
RP Collett, MS (reprint author), ViroDefense Inc, Rockville, MD USA.
EM mscollett@aol.com
FU CBER/FDA [224-06-1322 / Y1-AI-6153-01]; NIAID/NIH [224-06-1322 /
Y1-AI-6153-01]; Task Force for Global Health, Inc. through WHO; Task
Force for Global Health, Inc. through Rotary International; ViroDefense
Inc.
FX The work was supported by the Interagency Agreement number 224-06-1322 /
Y1-AI-6153-01 between CBER/FDA and NIAID/NIH. ViroDefense Inc. received
financial support from The Task Force for Global Health, Inc. through
grants from the WHO and Rotary International. We thank Dr Walter Dowdle
for his continued support.; MSC is a principal of ViroDefense Inc., the
corporate sponsor of drug candidate V-073. All other authors declare no
competing interests. The findings and conclusions in this report are
those of the authors and do not necessarily represent the views of
Centers for Diseases Control and Prevention or Food and Drug
Administration.
NR 11
TC 14
Z9 14
U1 0
U2 2
PU INT MEDICAL PRESS LTD
PI LONDON
PA 2-4 IDOL LANE, LONDON EC3R 5DD, ENGLAND
SN 1359-6535
J9 ANTIVIR THER
JI Antivir. Ther.
PY 2011
VL 16
IS 7
BP 999
EP 1004
DI 10.3851/IMP1838
PG 6
WC Infectious Diseases; Pharmacology & Pharmacy; Virology
SC Infectious Diseases; Pharmacology & Pharmacy; Virology
GA 846ZO
UT WOS:000296941900008
PM 22024515
ER
PT J
AU Feng, PCH
Councell, T
Keys, C
Monday, SR
AF Feng, Peter C. H.
Councell, Terry
Keys, Christine
Monday, Steven R.
TI Virulence Characterization of Shiga-Toxigenic Escherichia coli Isolates
from Wholesale Produce
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID HEMOLYTIC-UREMIC SYNDROME; ENTEROCYTE EFFACEMENT; MULTIPLEX PCR;
STRAINS; CATTLE; LOCUS; SEROTYPES; SAA; O113-H21; BRAZIL
AB The 13 Shiga-toxigenic Escherichia coli (STEC) strains isolated from wholesale spinach and lettuce consisted mostly of serotypes that have not been implicated in illness. Among these strains, however, were two O113:H21 that carried virulence genes common to this pathogenic serotype (stx(2), ehxA, saa, and subAB), suggesting that their presence in ready-to-eat produce may be of health concern.
C1 [Feng, Peter C. H.; Keys, Christine; Monday, Steven R.] US FDA, Div Microbiol, College Pk, MD 20740 USA.
[Councell, Terry] Agr Mkt Serv, USDA, Manassas, VA USA.
RP Feng, PCH (reprint author), US FDA, Div Microbiol, HFS-711,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM peter.feng@fda.hhs.gov
NR 21
TC 11
Z9 11
U1 0
U2 4
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD JAN
PY 2011
VL 77
IS 1
BP 343
EP 345
DI 10.1128/AEM.01872-10
PG 3
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 697WK
UT WOS:000285550300040
PM 21057025
ER
PT B
AU Ali, AA
Salminen, W
Leakey, JE
AF Ali, Akhtar Afshan
Salminen, William
Leakey, Julian E.
BE Bagchi, D
Moriyama, H
Raychaudhuri, SP
TI Hexosamine Flux and the Efficacy and Safety of Glucosamine in the
Treatment of Osteoarthritis
SO ARTHRITIS: PATHOPHYSIOLOGY, PREVENTION, AND THERAPEUTICS
LA English
DT Article; Book Chapter
ID GROWTH-FACTOR-BETA; PERFORMANCE LIQUID-CHROMATOGRAPHY; HUMAN ARTICULAR
CHONDROCYTES; ORAL CHONDROITIN SULFATE; INSULIN-RESISTANCE; KNEE
OSTEOARTHRITIS; TGF-BETA; MESANGIAL CELLS; GENE-EXPRESSION; DOUBLE-BLIND
C1 [Ali, Akhtar Afshan; Salminen, William] Natl Ctr Toxicol Res, Dept Syst Biol, Div Hepatotox, Jefferson, AR 72079 USA.
[Leakey, Julian E.] Natl Ctr Toxicol Res, Off Sci Coordinat, Jefferson, AR 72079 USA.
RP Ali, AA (reprint author), Natl Ctr Toxicol Res, Dept Syst Biol, Div Hepatotox, Jefferson, AR 72079 USA.
NR 133
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 978-1-4398-1687-5; 978-1-4398-1686-8
PY 2011
BP 261
EP 282
PG 22
WC Rheumatology
SC Rheumatology
GA BC4XP
UT WOS:000352993600021
ER
PT B
AU O'May, GA
Brady, RA
Prabhakara, R
Leid, JG
Calhoun, JH
Shirtliff, ME
AF O'May, Graeme A.
Brady, Rebecca A.
Prabhakara, Ranjani
Leid, Jeff G.
Calhoun, Jason H.
Shirtliff, Mark E.
BE Bjarnsholt, T
Moser, C
Jensen, PO
Hoiby, N
TI Osteomyelitis
SO BIOFILM INFECTIONS
LA English
DT Article; Book Chapter
ID RESISTANT STAPHYLOCOCCUS-AUREUS; ACUTE HEMATOGENOUS OSTEOMYELITIS;
BACTERIAL BIOFILM FORMATION; FIBRINOGEN-BINDING PROTEIN; DIABETIC FOOT
INFECTIONS; QUORUM-SENSING CONTROL; PSEUDOMONAS-AERUGINOSA; SEPTIC
ARTHRITIS; CYSTIC-FIBROSIS; DNA RELEASE
C1 [O'May, Graeme A.; Prabhakara, Ranjani; Shirtliff, Mark E.] Univ Maryland, Sch Dent, Dept Microbial Pathogenesis, Baltimore, MD 21201 USA.
[Brady, Rebecca A.] CBER FDA, Bethesda, MD 20892 USA.
[Leid, Jeff G.] No Arizona Univ, Ctr Microbial Genet & Genom, Flagstaff, AZ 86011 USA.
[Calhoun, Jason H.] Ohio State Univ, Med Ctr, Dept Orthoped, Columbus, OH 43210 USA.
RP Shirtliff, ME (reprint author), Univ Maryland, Sch Dent, Dept Microbial Pathogenesis, 650 W Baltimore St, Baltimore, MD 21201 USA.
EM jeff.leid@nau.edu; mshirtliff@umaryland.edu
OI Shirtliff, Mark/0000-0002-8913-3445
NR 126
TC 5
Z9 6
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-6083-2
PY 2011
BP 111
EP 137
DI 10.1007/978-1-4419-6084-9_7
D2 10.1007/978-1-4419-6084-9
PG 27
WC Microbiology
SC Microbiology
GA BSC47
UT WOS:000284120900007
ER
PT S
AU Volokhov, DV
Kong, H
Herold, K
Chizhikov, VE
Rasooly, A
AF Volokhov, Dmitriy V.
Kong, Hyesuk
Herold, Keith
Chizhikov, Vladimir E.
Rasooly, Avraham
BE Khademhosseini, A
Suh, KY
Zourob, M
TI Oligonucleotide Microarrays for Identification of Microbial Pathogens
and Detection of Their Virulence-Associated or Drug-Resistance
Determinants
SO BIOLOGICAL MICROARRAYS: METHODS AND PROTOCOLS
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Microarray; Microbial pathogens; Virulence factors; Food safety
ID ESCHERICHIA-COLI O157-H7; BACTERIAL PHYLOGENY; SIGNATURE SEQUENCES;
QUANTITATIVE ASSAY; DNA PROBES; HYBRIDIZATION; GENE; MULTIANALYTE;
IMMUNOASSAY; STABILITY
AB Microarrays are spatially ordered arrays with ligands chemically immobilized in discrete spots on a solid matrix, usually a microscope slide. Microarrays are a high-throughput large-scale screening system enabling simultaneous identification fa large number of labeled target molecules (up to several hundred thousand) that bind specifically to the immobilized ligands of the array. DNA microarrays represent a promising tool for clinical, environmental, and industrial microbiology since the technology allows relatively rapid identification of large number of genetic determinants simultaneously, providing detailed genomic level information regarding the pathogen species, including identification of their virulence-associated factors and the presence of antibiotic resistance genes. In this chapter, we describe key aspects and methodologies important for the development and use of DNA microarrays for microbial diagnostics.
C1 [Volokhov, Dmitriy V.; Kong, Hyesuk; Chizhikov, Vladimir E.] US FDA, Ctr Biol Evaluat & Res, Kensington, MD USA.
[Herold, Keith] Univ Maryland, Dept Bioengn, College Pk, MD 20742 USA.
[Rasooly, Avraham] NCI, NIH, US FDA, Bethesda, MD 20892 USA.
RP Volokhov, DV (reprint author), US FDA, Ctr Biol Evaluat & Res, Kensington, MD USA.
NR 60
TC 3
Z9 3
U1 1
U2 3
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-934115-95-4
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2011
VL 671
BP 55
EP 94
DI 10.1007/978-1-59745-551-0_3
D2 10.1007/978-1-59745-551-0
PG 40
WC Biochemical Research Methods; Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA BSA51
UT WOS:000284031200003
PM 20967623
ER
PT S
AU Chen, T
Li, ZG
AF Chen, Tao
Li, Zhiguang
BE Tarasenko, O
TI "Transcriptome Analysis Gene Expression Profiles in Kidneys of Rats
Treated with Aristolochic" Acid"
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Meeting Abstract
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
C1 [Chen, Tao; Li, Zhiguang] US FDA, Div Genet & Mol Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 34
EP 35
PG 2
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100013
ER
PT S
AU Li, ZG
Chen, T
AF Li, Zhiguang
Chen, Tao
BE Tarasenko, O
TI "Human Carcinogen Atristolochic Acid Induces Dysregulated microRNA
Expression in Rat Kidneys"
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Meeting Abstract
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
C1 [Li, Zhiguang; Chen, Tao] US FDA, Div Genet & Mol Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 37
EP 38
PG 2
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100019
ER
PT S
AU Paule, MG
AF Paule, Merle G.
BE Tarasenko, O
TI "The Biology of Neurotoxicity: using Technology to Advance Discovery"
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Meeting Abstract
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
C1 [Paule, Merle G.] Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 39
EP 39
PG 1
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100023
ER
PT S
AU Chidambaram, M
Trbojevich, R
Woodling, K
Heinze, T
Siitonen, P
AF Chidambaram, Mani
Trbojevich, Raul
Woodling, Kellie
Heinze, Thomas
Siitonen, Paul
BE Tarasenko, O
TI "Optmization of the Analytical Method for Measuring Low Levels of
Bisphenol A (BPA) and Ethinylestradiol (Ee2) by Liquid
Chromatography/Electron Spray Ionization Mass Spectrometry (LC/ESI/MS)"
SO BIOLOGY, NANOTECHNOLOGY, TOXICOLOGY, AND APPLICATIONS: PROCEEDINGS OF
THE 5TH BIONANOTOX AND APPLICATIONS INTERNATIONAL RESEARCH CONFERENCE
SE AIP Conference Proceedings
LA English
DT Meeting Abstract
CT 5th BioNanoTox and Applications International Research Conference
CY NOV 04-05, 2010
CL Little Rock, AR
SP U S Food & Drug Adm, Arkansas Sci & Technol Author, Winthrop Rockefeller Fdn, Coll Sci & Math, Univ Arkansas, Grad Sch (UALR), Univ Arkansas, Med Sci (UAMS), Arkansas Biosci Inst, BioNanoTox Intl (BNT), UALRs Grad Sch, Dept Biol, Biol Club
C1 [Chidambaram, Mani; Trbojevich, Raul; Woodling, Kellie; Heinze, Thomas; Siitonen, Paul] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA.
NR 0
TC 0
Z9 0
U1 1
U2 3
PU AMER INST PHYSICS
PI MELVILLE
PA 2 HUNTINGTON QUADRANGLE, STE 1NO1, MELVILLE, NY 11747-4501 USA
SN 0094-243X
BN 978-0-7354-0910-1
J9 AIP CONF PROC
PY 2011
VL 1326
BP 52
EP 52
PG 1
WC Biology; Nanoscience & Nanotechnology; Toxicology
SC Life Sciences & Biomedicine - Other Topics; Science & Technology - Other
Topics; Toxicology
GA BZT53
UT WOS:000302909100047
ER
PT B
AU Rubin, S
Vandermeulen, C
AF Rubin, Steven
Vandermeulen, Corinne
BE Samal, SK
TI Mumps Virus
SO BIOLOGY OF PARAMYXOVIRUSES
LA English
DT Article; Book Chapter
ID VESICULAR STOMATITIS-VIRUS; NEWCASTLE-DISEASE VIRUS;
HEMAGGLUTININ-NEURAMINIDASE PROTEIN; NUCLEOTIDE-SEQUENCE ANALYSIS;
RESPIRATORY SYNCYTIAL VIRUS; LINKED IMMUNOSORBENT-ASSAY; RECOMBINANT
VACCINIA VIRUS; NEUROVIRULENCE SAFETY TEST; CENTRAL NERVOUS-SYSTEM;
REPLICATION IN-VITRO
AB Mumps virus, a member of the Rubulavirus genus in the Paramyxoviridae family, causes a communicable illness characterized by a wide array of acute inflammatory reactions. Mumps outbreaks were common in the pre-vaccine era, with nearly everyone having been exposed by adolescence based on the presence of virus-specific antibody. The hallmark of infection is the painful enlargement of the parotid gland, and, although perceived as a benign childhood disease, mumps was the leading cause of aseptic meningitis and sensorineural deafness prior to the adoption of widespread vaccine use. The changing epidemiology of mumps in the post-vaccine era has renewed interest in the virus, specifically in regards to the biology of the virus, development of new diagnostic tools, investigation of immune responses following vaccination and the epidemiological effects of mumps vaccination in large populations. This chapter reviews the current knowledge of mumps virus as an infectious agent, the immune response to infection and its epidemiology, prevention and control measures.
C1 [Vandermeulen, Corinne] Ctr Youth Hlth Care KU Leuven, Louvain, Belgium.
[Rubin, Steven] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Vandermeulen, C (reprint author), Ctr Youth Hlth Care KU Leuven, Louvain, Belgium.
EM Steven.Rubin@fda.hhs.gov; corinne.vandermeulen@uzleuven.be
NR 358
TC 2
Z9 2
U1 0
U2 1
PU CAISTER ACADEMIC PRESS
PI WYMONDHAM
PA 32 HEWITTS LANE, WYMONDHAM NR 18 0JA, ENGLAND
BN 978-1-904455-85-1
PY 2011
BP 5
EP 36
PG 32
WC Infectious Diseases; Virology
SC Infectious Diseases; Virology
GA BVP39
UT WOS:000292216900002
ER
PT J
AU Soon, GG
Nie, L
Hammerstrom, T
Zeng, W
Chu, HT
AF Soon, Guoxing G.
Nie, Lei
Hammerstrom, Thomas
Zeng, Wen
Chu, Haitao
TI Meeting the demand for more sophisticated study designs. A proposal for
a new type of clinical trial: the hybrid design
SO BMJ OPEN
LA English
DT Article
AB Background: Treatment effect is traditionally assessed through either superiority or non-inferiority clinical trials. Investigators may find that because of safety concerns and/or wide variability across strata of the superiority margin of active controls over placebo, neither a superiority nor a non-inferiority trial design is ethical or practical in some disease populations. Prior knowledge may allow and drive study designers to consider more sophisticated designs for a clinical trial.
Design: In this paper, the authors propose hybrid designs which may combine a superiority design in one subgroup with a non-inferiority design in another subgroup or combine designs with different control regimens in different subgroups in one trial when a uniform design is unethical or impractical. The authors show how the hybrid design can be planned and how inferences can be made. Through two examples, the authors illustrate the scenarios where hybrid designs are useful while the conventional designs are not preferable.
Conclusion: The hybrid design is a useful alternative to current superiority and non-inferiority designs.
C1 [Soon, Guoxing G.; Nie, Lei; Hammerstrom, Thomas; Zeng, Wen] US FDA, Div Biometr 4, Off Biostat, OTS,CDER, Silver Spring, MD USA.
[Chu, Haitao] Univ Minnesota Twin Cities, Div Biostat, Minneapolis, MN USA.
RP Nie, L (reprint author), US FDA, Div Biometr 4, Off Biostat, OTS,CDER, Silver Spring, MD USA.
EM lei.nie@fda.hhs.gov
OI Chu, Haitao/0000-0003-0932-598X
NR 22
TC 2
Z9 2
U1 0
U2 2
PU BMJ PUBLISHING GROUP
PI LONDON
PA BRITISH MED ASSOC HOUSE, TAVISTOCK SQUARE, LONDON WC1H 9JR, ENGLAND
SN 2044-6055
J9 BMJ OPEN
JI BMJ Open
PY 2011
VL 1
IS 2
AR e000156
DI 10.1136/bmjopen-2011-000156
PG 7
WC Medicine, General & Internal
SC General & Internal Medicine
GA V27UQ
UT WOS:000208638500014
PM 22021876
ER
PT J
AU Mahmood, I
AF Mahmood, Iftekhar
TI Evaluation of a morphine maturation model for the prediction of morphine
clearance in children: how accurate is the predictive performance of the
model?
SO BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
LA English
DT Article
DE allometric scaling; clearance; maturation model; paediatric population
ID INTRAVENOUS MORPHINE; NEWBORN-INFANTS; DRUG CLEARANCE; PHARMACOKINETICS;
KINETICS; PREMATURE; ONTOGENY; PATHWAYS; INFUSION; ADULTS
AB The pharmacokinetics of morphine are well known in pre-term and term neonates, infants, younger and older children, as well as in adults. There are circumstances when a pharmacokinetic study may not be possible in children (especially neonates and infants), and as a result one would like to predict drug clearance in children. Several methods, such as allometric scaling and prediction based on incorporation of physiological parameters, have been suggested. Recently a morphine maturation model has been proposed to predict morphine clearance in the paediatric population.
WHAT THIS STUDY ADDS
The current study evaluates the predictive performance of the morphine maturation model for the prediction of morphine clearance in pre-term, term, infants and children up to 5 years of age. The results of the study highlight the shortcomings of the model to predict morphine clearance in children in aforementioned age groups.
AIMS
Recently, a maturation model that incorporates a sigmoidal E(max) type model has been proposed for the estimation of morphine clearance in paediatric patients. The primary objective of this report is to evaluate the predictive performance of the morphine maturation model for the prediction of morphine clearance in children of different ages. The secondary objective of this report is to evaluate the predictive performance of exponent 0.75 on bodyweight in the absence of the sigmoidal part of the morphine maturation model.
METHODS
In order to evaluate the predictive performance of the morphine maturation model, the clearance values of morphine for individual children (preterm neonates to 5-year-old children; n = 147) were obtained from the literature. The predicted clearance of morphine in an individual child, obtained from the maturation model as well as from the fixed exponent 0.75 was compared with the observed clearance in that individual child.
RESULTS
The morphine maturation model's predictive power in neonates, infants and younger children is poor and the inclusion of the sigmoidal part in the model only helps in reducing the substantial error introduced in the prediction due to the application of exponent 0.75 on bodyweight. Furthermore, the real benefit of the sigmoidal E(max) part of the model disappears by 1 year of age.
CONCLUSIONS
The morphine maturation model has a poor predictive power of morphine clearance in preterm and term neonates, infants and very young children and may not be of any practical value for the prediction of morphine clearance in this age group.
C1 US FDA, OBRR, Ctr Biol Evaluat & Research, Rockville, MD 20852 USA.
RP Mahmood, I (reprint author), US FDA, OBRR, Ctr Biol Evaluat & Research, 1451 Rockville Pike, Rockville, MD 20852 USA.
EM Iftekhar.mahmood@fda.hhs.gov
NR 22
TC 15
Z9 16
U1 0
U2 1
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0306-5251
J9 BRIT J CLIN PHARMACO
JI Br. J. Clin. Pharmacol.
PD JAN
PY 2011
VL 71
IS 1
BP 88
EP 94
DI 10.1111/j.1365-2125.2010.03802.x
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 692KR
UT WOS:000285152200011
PM 21143504
ER
PT J
AU Rosado, LAR
Rodriguez-Canales, J
Zhang, BL
AF Rosado, Leslie A. Rivera
Rodriguez-Canales, Jaime
Zhang, Baolin
TI Association of D4-GDI expression with breast cancer progression
SO CANCER BIOMARKERS
LA English
DT Article
DE D4-GDI; breast cancer; progression; immunohistochemistry
ID GDP-DISSOCIATION INHIBITOR; DRUG-INDUCED APOPTOSIS; CELL-LINES;
RHO-GTPASES; GENE-EXPRESSION; METASTASIS; TUMOR; INVASIVENESS; PROTEINS;
RHOGDI2
AB D4-GDI is a key regulator of Rho GTPases that have been implicated in several aspects of breast tumorigenesis. We have previously found that D4-GDI was selectively expressed in breast cancer cell lines over normal mammary epithelial cells [45]. In this study, we investigated the expression level of D4-GDI in breast tumor specimens (n = 165) by immunohistochemistry using a validated antibody that specifically recognizes the full-length D4-GDI protein. D4-GDI was predominantly expressed in the luminal cells of the duct in contrast to the myoepithelial cells of the outer layer. The percentage of D4-GDI positive samples were found to be higher in the early stages of breast cancers followed by a significant decrease in malignant tumors and metastatic lesions when compared to normal breast tissues (p < 0.01). Analysis of matched samples confirmed the lower expression of D4-GDI in malignant tumors than normal adjacent tissues, while there was no further decrease in metastatic lesions. These results suggest that D4-GDI may function as a biphasic regulator of breast cancer progression and metastasis.
C1 [Rosado, Leslie A. Rivera; Zhang, Baolin] US FDA, Div Therapeut Prot, Off Biotechnol Prod, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
[Rodriguez-Canales, Jaime] NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
RP Zhang, BL (reprint author), 29 Lincoln Dr,Bldg 29A,Rm 2A01,HFD 122, Bethesda, MD 20892 USA.
EM Baolin.Zhang@fda.hhs.gov
OI Rodriguez-Canales, Jaime/0000-0002-0885-2377
FU FDA
FX We thank Dr. John Gillespie from Pathology Consultant Services for
tissue microarray analysis and scoring and helpful discussions on the
pathology of breast tissues. This research was supported by the FDA
Critical Path funding.
NR 46
TC 3
Z9 3
U1 0
U2 2
PU IOS PRESS
PI AMSTERDAM
PA NIEUWE HEMWEG 6B, 1013 BG AMSTERDAM, NETHERLANDS
SN 1574-0153
J9 CANCER BIOMARK
JI Cancer Biomark.
PY 2011
VL 10
IS 3-4
BP 163
EP 173
DI 10.3233/CBM-2012-0240
PG 11
WC Oncology
SC Oncology
GA 957JK
UT WOS:000305157500006
ER
PT J
AU Glasser, SP
Willard, J
Defelice, A
Lawrence, J
Hung, J
Obot, E
Girton, J
Targum, S
Throckmorton, D
Mangano, D
Lipicky, RJ
AF Glasser, Stephen P.
Willard, James
Defelice, Albert
Lawrence, John
Hung, James
Obot, Evelyn
Girton, John
Targum, Shari
Throckmorton, Douglas
Mangano, Dennis
Lipicky, Raymond J.
TI Is Randomization to Placebo Safe? Risk in Placebo-Controlled Angina
Trials: Angina Risk Meta-Analysis
SO CARDIOLOGY
LA English
DT Article
DE Angina; Arrhythmia; Congestive heart failure; Placebo; Stroke; Transient
ischemic attack; Ventricular tachycardia
ID CLINICAL-TRIALS; HYPERTENSION
AB Objective: It was the aim of this study to document the risks of symptomatic patients with angina in placebo-controlled, anti-anginal drug development trials in which symptom-limited exercise testing was used as the primary endpoint. Patients and Methods: The original case report forms submitted to the United States Food and Drug Administration in support of approval of new or supplemental new drug applications between 1973 and 2001 were identified and subjected to a by-patient meta-analysis, utilizing both a maximum likelihood analysis and classical Mantel-Haenszel methods. Results: There were 63 placebo-controlled, clinical trials that randomized 10,865 patients, with 1,047 patient-years of observation time. The trials involved 21 different chemical entities from 4 different drug classes. The relative risk (RR) for withdrawal (placebo compared to drug-treated patients) was not increased [RR = 0.92, 95% confidence interval (CI) 0.78-1.08; p = 0.28]. Of interest, a RR of 0.54 (95% CI 0.26-1.04; p < 0.068) for irreversible harm (a combination of cerebrovascular accidents, myocardial infarction and death) and a RR of 0.89 (95% CI 0.61-1.30; p = 0.56) for serious cardiovascular events (myocardial infarction, congestive heart failure, cerebrovascular accidents) both non-statistically significantly favored being randomized to placebo. Conclusions:For the development of current or future drugs for the treatment of angina, there is no obvious contraindication to the use of placebo controls and exercise tolerance testing. Copyright (C) 2012 S. Karger AG, Basel
C1 [Glasser, Stephen P.] Univ Alabama, Birmingham, AL 35202 USA.
[Willard, James; Defelice, Albert; Lawrence, John; Hung, James; Targum, Shari; Throckmorton, Douglas] US FDA, Rockville, MD 20857 USA.
[Obot, Evelyn] NIH, Bethesda, MD 20892 USA.
[Mangano, Dennis] Ischemia Res & Educ Fdn, San Francisco, CA USA.
[Lipicky, Raymond J.] Lipicky LLC, N Potomac, MD USA.
RP Glasser, SP (reprint author), Univ Alabama, 1717 11th Ave S, Birmingham, AL 35202 USA.
EM sglasser@uab.edu
OI Glasser, Stephen/0000-0001-9620-6406
NR 17
TC 0
Z9 0
U1 0
U2 3
PU KARGER
PI BASEL
PA ALLSCHWILERSTRASSE 10, CH-4009 BASEL, SWITZERLAND
SN 0008-6312
J9 CARDIOLOGY
JI Cardiology
PY 2011
VL 120
IS 3
BP 174
EP 181
DI 10.1159/000335522
PG 8
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 888AM
UT WOS:000299976200012
PM 22261892
ER
PT S
AU Tyner, K
Sadrieh, N
AF Tyner, Katherine
Sadrieh, Nakissa
BE McNeil, SE
TI Considerations When Submitting Nanotherapeutics to FDA/CDER for
Regulatory Review
SO CHARACTERIZATION OF NANOPARTICLES INTENDED FOR DRUG DELIVERY
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Nano-therapeutic; nano-pharmaceutics; characterization; regulatory;
safety assessment
ID DYNAMIC LIGHT-SCATTERING; DRUG-DELIVERY; NANOPARTICLES
AB The Food and Drug Administration (FDA) does not, as yet, have specific guidances for products containing nanoscale materials. As announced in the report issued by the FDA Nanotechnology Task Force (July 2007), however, there are recommendations to various centers within the FDA to develop guidances for industry. Regardless of the lack of explicit FDA guidances, there are therapeutics currently on the market containing nanoscale materials, and additional novel nanomaterial-containing therapeutics arc being developed with the hopes of being submitted for regulatory review and approval. While, for the most part, these novel nanomaterial-containing products are being evaluated using the same regulatory requirements as products that do not contain nanomaterials, it is increasingly evident that at least in the area of characterization of nanomaterials used in drug products, there may be areas where special focus is needed. Specific areas include the validity of applying small molecule principles and methodologies to nanomaterial-containing products, the effects the nanomaterial will impart to the rest of the formulation (or vice versa), and how the physicochemical properties may be impacted by biological settings. Similarly, for safety evaluation, biodistribution studies will be at the core of any evaluation of products containing nanomaterials. These biodistribution studies will, in effect, be indicative of where the nanoparticles are traveling and possibly accumulating, therefore subjecting those sites to increased likelihood of toxicological effects. This chapter focuses on questions and considerations that may arise for sponsors during product characterization, as well as considerations for the appropriate design and conduct of in vivo toxicology studies. This chapter will also review how current FDA guidances apply to nanotherapeutics.
This chapter reflects the current thinking and experience of the authors. However, this is not a policy document and should not be used in lieu of regulations, published FDA guidances, or direct discussions with the agency.
C1 [Tyner, Katherine; Sadrieh, Nakissa] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Tyner, K (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
NR 20
TC 28
Z9 28
U1 1
U2 14
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-60327-197-4
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2011
VL 697
BP 17
EP 31
DI 10.1007/978-1-60327-198-1_3
D2 10.1007/978-1-60327-198-1
PG 15
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Pharmacology & Pharmacy
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy
GA BSU98
UT WOS:000285851400003
PM 21116951
ER
PT B
AU Buehler, PW
D'Agnillo, F
AF Buehler, Paul W.
D'Agnillo, Felice
BE Mozzarelli, A
Bettati, S
TI Animal Models and Oxidative Biomarkers to Evaluate Preclinical Safety of
Extracellular Hemoglobins
SO CHEMISTRY AND BIOCHEMISTRY OF OXYGEN THERAPEUTICS: FROM TRANSFUSION TO
ARTIFICIAL BLOOD
LA English
DT Article; Book Chapter
ID CROSS-LINKED HEMOGLOBIN; CELL-FREE HEMOGLOBIN; SEVERE UNCONTROLLED
HEMORRHAGE; SMALL-VOLUME RESUSCITATION; OXYGEN CARRIER HBOC-201; FOCAL
CEREBRAL-ISCHEMIA; TRANSGENIC SICKLE MICE; INDUCED RENAL-FAILURE;
ENDOTHELIAL-CELLS; NITRIC-OXIDE
C1 [Buehler, Paul W.; D'Agnillo, Felice] US FDA, Ctr Biol Evaluat & Res CBER, Div Hematol, Lab Biochem & Vasc Biol, Rockville, MD 20857 USA.
RP Buehler, PW (reprint author), US FDA, Ctr Biol Evaluat & Res CBER, Div Hematol, Lab Biochem & Vasc Biol, Rockville, MD 20857 USA.
NR 106
TC 0
Z9 0
U1 0
U2 0
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
BN 978-1-119-97543-4; 978-0-470-68668-3
PY 2011
BP 391
EP 411
D2 10.1002/9781119975427
PG 21
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA BA5XQ
UT WOS:000337054800029
ER
PT J
AU Fisher, RW
Reed, JL
Snoy, PJ
Mikolajczyk, MG
Bray, M
Scott, DE
Kennedy, MC
AF Fisher, R. W.
Reed, J. L.
Snoy, P. J.
Mikolajczyk, M. G.
Bray, M.
Scott, D. E.
Kennedy, M. C.
TI Postexposure Prevention of Progressive Vaccinia in SCID Mice Treated
with Vaccinia Immune Globulin
SO CLINICAL AND VACCINE IMMUNOLOGY
LA English
DT Article
ID VIRUS-INFECTION; ECZEMA VACCINATUM; SMALLPOX VACCINEE; MAST-CELLS;
CIDOFOVIR; PROTECTION; EFFICACY; RECEPTOR; MODEL; IGG
AB A recently reported case of progressive vaccinia (PV) in an immunocompromised patient has refocused attention on this condition. Uniformly fatal prior to the licensure of vaccinia immune globulin (VIG) in 1978, PV was still fatal in about half of VIG-treated patients overall, with a greater mortality rate in infants and children. Additional therapies would be needed in the setting of a smallpox bioterror event, since mass vaccination following any variola virus release would inevitably result in exposure of immunocompromised people through vaccination or contact with vaccinees. Well-characterized animal models of disease can support the licensure of new products when human studies are not ethical or feasible, as in the case of PV. We chose vaccinia virus-scarified SCID mice to model PV. As in immunocompromised humans, vaccinia virus-scarified SCID animals develop enlarging primary lesions with minimal or no inflammation, eventual distal virus spread, and lethal outcomes if left untreated. Postexposure treatment with VIG slowed disease progression, caused local lesion regression, and resulted in the healthy survival of most of the mice for more than 120 days. Combination treatment with VIG and topical cidofovir also resulted in long-term disease-free survival of most of the animals, even when initiated 7 days postinfection. These results support the possibility that combination treatments may be effective in humans and support using this SCID model of PV to test new antibody therapies and combination therapies and to provide further insights into the pathogenesis and treatment of PV.
C1 [Fisher, R. W.; Reed, J. L.; Mikolajczyk, M. G.; Scott, D. E.; Kennedy, M. C.] US FDA, Lab Plasma Derivat, Div Hematol, Off Blood Res & Review,Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Snoy, P. J.] US FDA, Div Vet Serv, Off Management, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Bray, M.] NIAID, Integrated Res Facil, NIH, Ft Detrick, MD USA.
RP Fisher, RW (reprint author), US FDA, Lab Plasma Derivat, Div Hematol, Off Blood Res & Review,Ctr Biol Evaluat & Res, HFM-345,1401 Rockville Pike, Rockville, MD 20852 USA.
EM Robert.Fisher@fda.hhs.gov
FU NIAID for biodefense research
FX This work was supported in part by an interagency agreement with NIAID
for biodefense research.
NR 42
TC 9
Z9 9
U1 0
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 1556-6811
J9 CLIN VACCINE IMMUNOL
JI Clin. Vaccine Immunol.
PD JAN
PY 2011
VL 18
IS 1
BP 67
EP 74
DI 10.1128/CVI.00280-10
PG 8
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 702BK
UT WOS:000285869400006
PM 21106779
ER
PT J
AU Rose, CE
Romero-Steiner, S
Burton, RL
Carlone, GM
Goldblatt, D
Nahm, MH
Ashton, L
Haston, M
Ekstrom, N
Haikala, R
Kayhty, H
Henckaerts, I
Durant, N
Poolman, JT
Fernsten, P
Yu, XH
Hu, BT
Jansen, KU
Blake, M
Simonetti, ER
Hermans, PWM
Plikaytis, BD
AF Rose, Charles E.
Romero-Steiner, Sandra
Burton, Robert L.
Carlone, George M.
Goldblatt, David
Nahm, Moon H.
Ashton, Lindsey
Haston, Mitch
Ekstrom, Nina
Haikala, Raili
Kayhty, Helena
Henckaerts, Isabelle
Durant, Nathalie
Poolman, Jan T.
Fernsten, Phil
Yu, Xinhong
Hu, Branda T.
Jansen, Kathrin U.
Blake, Milan
Simonetti, Elles R.
Hermans, Peter W. M.
Plikaytis, Brian D.
TI Multilaboratory Comparison of Streptococcus pneumoniae Opsonophagocytic
Killing Assays and Their Level of Agreement for the Determination of
Functional Antibody Activity in Human Reference Sera
SO CLINICAL AND VACCINE IMMUNOLOGY
LA English
DT Article
ID PNEUMOCOCCAL ANTIBODIES
AB Antibody-mediated killing of Streptococcus pneumoniae (pneumococcus) by phagocytes is an important mechanism of protection of the human host against pneumococcal infections. Measurement of opsonophagocytic antibodies by use of a standardized opsonophagocytic assay (OPA) is important for the evaluation of candidate vaccines and required for the licensure of new pneumococcal conjugate vaccine formulations. We assessed agreement among six laboratories that used their own optimized OPAs on a panel of 16 human reference sera for 13 pneumococcal serotypes. Consensus titers, estimated using an analysis-of-variance (ANOVA) mixed-effects model, provided a common reference for assessing agreement among these laboratories. Agreement was evaluated in terms of assay accuracy, reproducibility, repeatability, precision, and bias. We also reviewed four acceptance criterion intervals for assessing the comparability of protocols when assaying the same reference sera. The precision, accuracy, and concordance results among laboratories and the consensus titers revealed acceptable agreement. The results of this study indicate that the bioassays evaluated in this study are robust, and the resultant OPA values are reproducible for the determination of functional antibody titers specific to 13 pneumococcal serotypes when performed by laboratories using highly standardized but not identical assays. The statistical methodologies employed in this study may serve as a template for evaluating future multilaboratory studies.
C1 [Rose, Charles E.; Plikaytis, Brian D.] Ctr Dis Control & Prevent, Biostat Off, Div Bacterial Dis, Natl Ctr Immunizat & Resp Dis, Atlanta, GA 30333 USA.
[Romero-Steiner, Sandra; Carlone, George M.] Ctr Dis Control & Prevent, Meningitis & Vaccine Preventable Dis Branch, Div Bacterial Dis, Natl Ctr Immunizat & Resp Dis, Atlanta, GA 30333 USA.
[Burton, Robert L.; Nahm, Moon H.] Univ Alabama, Dept Pathol, Birmingham, AL 35294 USA.
[Goldblatt, David; Ashton, Lindsey; Haston, Mitch] UCL, Immunobiol Unit, Inst Child Hlth, London, England.
[Ekstrom, Nina; Haikala, Raili; Kayhty, Helena] Natl Inst Hlth & Welf, Dept Vaccinat & Immune Protect, Helsinki, Finland.
[Henckaerts, Isabelle; Durant, Nathalie; Poolman, Jan T.] GlaxoSmithKline Biol, Bacterial Vaccines Program, R&D, B-1330 Rixensart, Belgium.
[Fernsten, Phil; Yu, Xinhong; Hu, Branda T.; Jansen, Kathrin U.] Pfizer Vaccine Res, Pearl River, NY 10965 USA.
[Blake, Milan] US FDA, Div Bacterial Parasit & Allergenic Prod, Ctr Biol Evaluat & Res, Rockville, MD 20851 USA.
[Simonetti, Elles R.; Hermans, Peter W. M.] Radboud Univ Nijmegen, Med Ctr, Dept Pediat, NL-6525 ED Nijmegen, Netherlands.
RP Rose, CE (reprint author), Ctr Dis Control & Prevent, Biostat Off, Div Bacterial Dis, Natl Ctr Immunizat & Resp Dis, Bldg 1,Room 5044,MS C-09,1600 Clifton Rd, Atlanta, GA 30333 USA.
EM CRose@cdc.gov
RI Goldblatt, David/C-5972-2008; Hermans, Peter/H-8042-2014; Simonetti,
Elles/N-2966-2016;
OI Goldblatt, David/0000-0002-0769-5242; Romero-Steiner,
Sandra/0000-0003-4128-7768; Nahm, Moon/0000-0002-6922-1042
FU NIH [AI-30021 (NIH/NIAID/DMID)]
FX This project was funded in part by NIH contract AI-30021
(NIH/NIAID/DMID) to the University of Alabama at Birmingham (M.H.N.).
NR 25
TC 24
Z9 27
U1 0
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 1556-6811
J9 CLIN VACCINE IMMUNOL
JI Clin. Vaccine Immunol.
PD JAN
PY 2011
VL 18
IS 1
BP 135
EP 142
DI 10.1128/CVI.00370-10
PG 8
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 702BK
UT WOS:000285869400015
PM 21084458
ER
PT J
AU Kutanzi, KR
Yurchenko, OV
Beland, FA
Checkhun, VF
Pogribny, IP
AF Kutanzi, Kristy R.
Yurchenko, Olga V.
Beland, Frederick A.
Checkhun, Vasyl' F.
Pogribny, Igor P.
TI MicroRNA-mediated drug resistance in breast cancer
SO CLINICAL EPIGENETICS
LA English
DT Review
DE microRNA; Drug resistance; Breast cancer
AB Chemoresistance is one of the major hurdles to overcome for the successful treatment of breast cancer. At present, there are several mechanisms proposed to explain drug resistance to chemotherapeutic agents, including decreased intracellular drug concentrations, mediated by drug transporters and metabolic enzymes; impaired cellular responses that affect cell cycle arrest, apoptosis, and DNA repair; the induction of signaling pathways that promote the progression of cancer cell populations; perturbations in DNA methylation and histone modifications; and alterations in the availability of drug targets. Both genetic and epigenetic theories have been put forward to explain the mechanisms of drug resistance. Recently, a small non-coding class of RNAs, known as microRNAs, has been identified as master regulators of key genes implicated in mechanisms of chemoresistance. This article reviews the role of microRNAs in regulating chemoresistance and highlights potential therapeutic targets for reversing miRNA-mediated drug resistance. In the future, microRNA-based treatments, in combination with traditional chemotherapy, may be a new strategy for the clinical management of drug-resistant breast cancers.
C1 [Kutanzi, Kristy R.; Beland, Frederick A.; Pogribny, Igor P.] Natl Ctr Toxicol Res, Div Biochem Toxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
[Yurchenko, Olga V.; Checkhun, Vasyl' F.] RE Kavetsky Inst Expt Pathol Oncol & Radiobiol, Dept Mech Anticanc Therapy, Kiev, Ukraine.
RP Kutanzi, KR (reprint author), Natl Ctr Toxicol Res, Div Biochem Toxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM kristy.kutanzi@fda.hhs.gov; igor.pogribny@fda.hhs.gov
NR 140
TC 63
Z9 67
U1 1
U2 3
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1868-7083
J9 CLIN EPIGENETICS
JI Clin. Epigenetics
PY 2011
VL 2
BP 171
EP 185
DI 10.1007/s13148-011-0040-8
PG 15
WC Oncology
SC Oncology
GA V42ST
UT WOS:000209634200028
ER
PT J
AU Lee, JY
Garnett, CE
Gobburu, JVS
Bhattaram, VA
Brar, S
Earp, JC
Jadhav, PR
Krudys, K
Lesko, LJ
Li, F
Liu, J
Madabushi, R
Marathe, A
Mehrotra, N
Tornoe, C
Wang, Y
Zhu, H
AF Lee, Joo Yeon
Garnett, Christine E.
Gobburu, Jogarao V. S.
Bhattaram, Venkatesh A.
Brar, Satjit
Earp, Justin C.
Jadhav, Pravin R.
Krudys, Kevin
Lesko, Lawrence J.
Li, Fang
Liu, Jiang
Madabushi, Rajnikanth
Marathe, Anshu
Mehrotra, Nitin
Tornoe, Christoffer
Wang, Yaning
Zhu, Hao
TI Impact of Pharmacometric Analyses on New Drug Approval and Labelling
Decisions A Review of 198 Submissions Between 2000 and 2008
SO CLINICAL PHARMACOKINETICS
LA English
DT Article
ID PEDIATRICS
AB Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application (BLA) submissions to the US FDA to support drug approval, labelling and trial design decisions. Pharmacometrics is defined as a science that quantifies drug, disease and trial information to aid drug development, therapeutic decisions and/or regulatory decisions. In this report, we present the results of a survey evaluating the impact of pharmacometric analyses on regulatory decisions for 198 submissions during the period from 2000 to 2008. Pharmacometric review of NDAs included independent, quantitative analyses by FDA pharmacometricians, even when such analysis was not conducted by the sponsor, as well as evaluation of the sponsor's report. During 2000-2008, the number of reviews with pharmacometric analyses increased dramatically and the number of reviews with an impact on approval and labelling also increased in a similar fashion. We also present the impact of pharmacometric analyses on selection of paediatric dosing regimens, approval of regimens that had not been directly studied in clinical trials and provision of evidence of effectiveness to support a single pivotal trial. Case studies are presented to better illustrate the role of pharmacometric analyses in regulatory decision making.
C1 [Lee, Joo Yeon; Garnett, Christine E.; Gobburu, Jogarao V. S.; Bhattaram, Venkatesh A.; Brar, Satjit; Earp, Justin C.; Jadhav, Pravin R.; Krudys, Kevin; Lesko, Lawrence J.; Li, Fang; Liu, Jiang; Madabushi, Rajnikanth; Marathe, Anshu; Mehrotra, Nitin; Tornoe, Christoffer; Wang, Yaning; Zhu, Hao] US FDA, Div Pharmacometr, Off Clin Pharmacol, Silver Spring, MD USA.
RP Lee, JY (reprint author), 10903 New Hampshire Ave,Room 3198,Bldg 51, Silver Spring, MD 20993 USA.
EM jooyeon2.lee@fda.hhs.gov
NR 11
TC 44
Z9 46
U1 1
U2 10
PU ADIS INT LTD
PI AUCKLAND
PA 41 CENTORIAN DR, PRIVATE BAG 65901, MAIRANGI BAY, AUCKLAND 1311, NEW
ZEALAND
SN 0312-5963
J9 CLIN PHARMACOKINET
JI Clin. Pharmacokinet.
PY 2011
VL 50
IS 10
BP 627
EP 635
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 832ND
UT WOS:000295810800002
PM 21895036
ER
PT S
AU Garnett, CE
Lee, JY
Gobburu, JVS
AF Garnett, Christine E.
Lee, Joo Yeon
Gobburu, Jogarao V. S.
BE Kimko, HHC
Peck, CC
TI Contribution of Modeling and Simulation in the Regulatory Review and
Decision-Making: US FDA Perspective
SO CLINICAL TRIAL SIMULATIONS: APPLICATIONS AND TRENDS
SE AAPS Advances in the Pharmaceutical Sciences Series
LA English
DT Article; Book Chapter
ID CLINICAL DRUG DEVELOPMENT; LABELING DECISIONS; IMPACT; PHARMACOKINETICS;
PHARMACODYNAMICS; PHARMACOMETRICS; INTEGRATION; EXPERIENCE; APPROVAL
AB The Division of Pharmacometrics at the U.S. FDA engages in regulatory reviews, research and policy development. During 2000-2008, over 50% of pharmacometric reviews of 198 NDA and BLA applications influenced approval and safety decisions. During this time, pharmacometric analyses were used in pediatric dose selection, and approval of doses not directly studied in effectiveness trials. Additionally, pharmacometrics has been used in FDA advice on protocol design to optimize dosing regimens based on benefit-risk for clinical testing, and to provide confirmatory evidence of effectiveness. Current research projects aim to solve drug development challenges and develop policies grounded in pharmacometric principles and methodologies.
C1 [Garnett, Christine E.; Lee, Joo Yeon; Gobburu, Jogarao V. S.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Garnett, CE (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM Christine.Garnett@fda.gov
NR 49
TC 5
Z9 5
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
SN 2210-7371
BN 978-1-4419-7414-3
J9 AAPS ADV PHARM SCI
PY 2011
VL 1
BP 37
EP 57
DI 10.1007/978-1-4419-7415-0_3
D2 10.1007/978-1-4419-7415-0
PG 21
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA BSY60
UT WOS:000286132800003
ER
PT J
AU Rellahan, BL
Graham, L
Hirsch, D
Kennett, S
Rawat, R
Brorson, K
Swisher, J
AF Rellahan, B. L.
Graham, L.
Hirsch, D.
Kennett, S.
Rawat, R.
Brorson, K.
Swisher, J.
BE MooYoung, M
TI Recent and Emerging Trends and Concerns Related to the Manufacturing and
Testing of Monoclonal Antibodies Intended for Clinical Use
SO COMPREHENSIVE BIOTECHNOLOGY, VOL 3: INDUSTRIAL BIOTECHNOLOGY AND
COMMODITY PRODUCTS, 2ND EDITION
LA English
DT Article; Book Chapter
ID CELL-CULTURE; IN-VIVO; DESIGN; CLEARANCE; THERAPEUTICS; QUALITY; ENGAGE;
FUTURE
C1 [Rellahan, B. L.; Graham, L.; Hirsch, D.; Kennett, S.; Rawat, R.] US FDA, Bethesda, MD 20014 USA.
[Brorson, K.; Swisher, J.] US FDA, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
RP Rellahan, BL (reprint author), US FDA, Bethesda, MD 20014 USA.
NR 40
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
BN 978-0-08-088504-9
PY 2011
BP 363
EP 375
PG 13
WC Biotechnology & Applied Microbiology
SC Biotechnology & Applied Microbiology
GA BA3VS
UT WOS:000334940100032
ER
PT J
AU Kaiser, AD
AF Kaiser, A. D.
BE MooYoung, M
TI Combination Products Are Not Solely Biological Products, Drugs, or
Devices: A Regulatory Perspective
SO COMPREHENSIVE BIOTECHNOLOGY, VOL 3: INDUSTRIAL BIOTECHNOLOGY AND
COMMODITY PRODUCTS, 2ND EDITION
LA English
DT Article; Book Chapter
C1 US FDA, Silver Spring, MD 20993 USA.
RP Kaiser, AD (reprint author), US FDA, Silver Spring, MD 20993 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
BN 978-0-08-088504-9
PY 2011
BP 399
EP 409
PG 11
WC Biotechnology & Applied Microbiology
SC Biotechnology & Applied Microbiology
GA BA3VS
UT WOS:000334940100035
ER
PT J
AU Lee, K
AF Lee, K.
BE MooYoung, M
TI Regulatory Aspects of Chemistry Manufacturing and Controls for
Investigational New Drug Applications and Biologic License Applications
to the United States Food and Drug Administration
SO COMPREHENSIVE BIOTECHNOLOGY, VOL 3: INDUSTRIAL BIOTECHNOLOGY AND
COMMODITY PRODUCTS, 2ND EDITION
LA English
DT Article; Book Chapter
ID QUALITY; DESIGN; BIOPHARMACEUTICALS; RECOMMENDATIONS; OPTIMIZATION;
THERAPEUTICS; PERSPECTIVE; ANTIBODIES; PRODUCTS
C1 US FDA, Bethesda, MD 20014 USA.
RP Lee, K (reprint author), US FDA, Bethesda, MD 20014 USA.
NR 43
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
BN 978-0-08-088504-9
PY 2011
BP 439
EP 452
PG 14
WC Biotechnology & Applied Microbiology
SC Biotechnology & Applied Microbiology
GA BA3VS
UT WOS:000334940100038
ER
PT J
AU Cordoba-Rodriguez, R
AF Cordoba-Rodriguez, R.
BE MooYoung, M
TI Raw Materials in the Manufacture of Biotechnology Products
SO COMPREHENSIVE BIOTECHNOLOGY, VOL 3: INDUSTRIAL BIOTECHNOLOGY AND
COMMODITY PRODUCTS, 2ND EDITION
LA English
DT Article; Book Chapter
ID CONTAMINATION; CELLS
C1 US FDA, Bethesda, MD 20014 USA.
RP Cordoba-Rodriguez, R (reprint author), US FDA, Bethesda, MD 20014 USA.
NR 18
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
BN 978-0-08-088504-9
PY 2011
BP 453
EP 458
PG 6
WC Biotechnology & Applied Microbiology
SC Biotechnology & Applied Microbiology
GA BA3VS
UT WOS:000334940100039
ER
PT J
AU Vallejos, JR
Moreira, A
Rao, G
Brorson, K
AF Vallejos, J. R.
Moreira, A.
Rao, G.
Brorson, K.
BE MooYoung, M
TI Integrating Process Scouting Devices (PSDs) With Bench-Scale Devices:
Challenges and Opportunities for Mammalian Cell Culture
SO COMPREHENSIVE BIOTECHNOLOGY, VOL 3: INDUSTRIAL BIOTECHNOLOGY AND
COMMODITY PRODUCTS, 2ND EDITION
LA English
DT Article; Book Chapter
ID GLUTAMINE-BINDING-PROTEIN; MINIATURE BIOREACTOR; SHAKEN BIOREACTORS;
OXYGEN-TRANSFER; MASS-TRANSFER; MICROBIOREACTOR; FERMENTATION;
BIOSENSORS; GROWTH; SYSTEM
C1 [Vallejos, J. R.; Moreira, A.; Rao, G.] Univ Maryland Baltimore Cty, Baltimore, MD 21228 USA.
[Brorson, K.] US FDA, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
RP Vallejos, JR (reprint author), Univ Maryland Baltimore Cty, Baltimore, MD 21228 USA.
NR 36
TC 2
Z9 2
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
BN 978-0-08-088504-9
PY 2011
BP 659
EP 667
PG 9
WC Biotechnology & Applied Microbiology
SC Biotechnology & Applied Microbiology
GA BA3VS
UT WOS:000334940100056
ER
PT J
AU Kim, SJ
Kweon, O
Cerniglia, CE
AF Kim, S-J
Kweon, O.
Cerniglia, C. E.
BE MooYoung, M
Agathos, S
TI Proteomic Applications to Elucidate Bacterial Aromatic Hydrocarbon
Metabolic Pathways
SO COMPREHENSIVE BIOTECHNOLOGY, VOL 6: ENVIRONMENTAL BIOTECHNOLOGY AND
SAFETY, 2ND EDITION
LA English
DT Article; Book Chapter
ID MYCOBACTERIUM-VANBAALENII PYR-1; BURKHOLDERIA-XENOVORANS LB400;
RING-HYDROXYLATING DIOXYGENASES; ACINETOBACTER-LWOFFII K24;
BETA-KETOADIPATE PATHWAY; SP STRAIN PYR-1; PSEUDOMONAS-PUTIDA;
GEL-ELECTROPHORESIS; CATABOLIC PATHWAYS; MASS-SPECTROMETRY
C1 [Kim, S-J; Kweon, O.; Cerniglia, C. E.] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Kim, SJ (reprint author), US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 56
TC 1
Z9 1
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
BN 978-0-08-088504-9
PY 2011
BP 105
EP 114
PG 10
WC Biotechnology & Applied Microbiology; Engineering, Environmental
SC Biotechnology & Applied Microbiology; Engineering
GA BA3WV
UT WOS:000335042600011
ER
PT J
AU Wang, L
Abbasi, F
Jasper, GA
Kreitman, RJ
Liewehr, DJ
Marti, GE
Stetler-Stevenson, M
AF Wang, Lili
Abbasi, Fatima
Jasper, Gregory A.
Kreitman, Robert J.
Liewehr, David J.
Marti, Gerald E.
Stetler-Stevenson, Maryalice
TI Variables in the Quantification of CD4 in Normals and Hairy Cell
Leukemia Patients
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Article
DE quantitative flow cytometry; CD4 quantification; anti-CD4 PE unimolar
conjugate; sample preparation method
ID FLOW CYTOMETRIC ANALYSIS; T-LYMPHOCYTES; EXPRESSION; QUANTITATION;
SPECIMENS; BEADS
AB Background: Quantitative flow cytometry (QFCM) is being applied in the clinical flow cytometry laboratory. Quantitative normal T-cell CD4 expression represents a biologic standard and quality control agent. However, low levels of CD4 expression were detected in normal T-cells in Hairy Cell Leukemia (HCL) samples.
Methods: The QuantiBrite System (R) was used to determine the level of CD4 expression (mean antibody bound per cell, ABC) in fresh and shipped HCL blood and fresh normal donor blood (NDB). The effects of shipping, lysing reagent, cell preparation method, and antibody lot were evaluated.
Results: Shipped HCL specimens (n = 69) had a significantly lower mean CD4 ABC of 38,788 (CV = 9.1%) compared to fresh specimens (n = 105) CD4 value of 40,330 (CV = 8.4%) (P < 0.05). In NDB, significant differences were seen for fresh versus shipped specimens using the stain/lyse method but not for lyse/stain method. Consistent differences in CD4 ABC based upon antibody lot were observed in fresh HCL and NDB samples. Stain/lyse and lyse/stain methods using NH(4)Cl lyse were compared in NDB using identical samples and antibodies. The NDB CD4 ABC values obtained with the lyse (NH(4)Cl)/stain method (45,562, 3.7% CV) were lower than those obtained with the stain/lyse (NH(4)Cl) method (49,955, 3.3% CV) with P < 0.001.
Conclusions: CD4 expression in HCL patient samples is not inherently different from that observed in NDB and therefore may serve as a biological control in clinical QFCM. Technical variables impact significantly on QFCM of CD4. Published 2010 Wiley-Liss, Inc.(dagger)
C1 [Jasper, Gregory A.; Stetler-Stevenson, Maryalice] NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
[Wang, Lili] NIST, Chem Sci & Technol Lab, Gaithersburg, MD 20899 USA.
[Abbasi, Fatima] CBER FDA, Div Cell & Gene Therapies, Lab Stem Cell Biol, Cellular & Tissue Therapy Branch,Off Cellular Tis, Bethesda, MD 20892 USA.
[Kreitman, Robert J.] NCI, Clin Immunotherapy Sect, NIH, Bethesda, MD 20892 USA.
[Liewehr, David J.] NCI, Biostat & Data Management Sect, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
RP Stetler-Stevenson, M (reprint author), NCI, Pathol Lab, NIH, Bldg 10,Room 2A-33,Mail Stop 1500, Bethesda, MD 20892 USA.
EM stetler@mail.nih.gov
FU NIH; NCI; CBER; FDA
FX Grant sponsors: NIH, NCI, CBER, FDA.
NR 20
TC 7
Z9 7
U1 1
U2 2
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1552-4949
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD JAN
PY 2011
VL 80B
IS 1
BP 51
EP 56
DI 10.1002/cyto.b.20541
PG 6
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 703MC
UT WOS:000285981000008
PM 20687201
ER
PT B
AU Braddy, AC
Conner, DP
AF Braddy, April C.
Conner, Dale P.
BE Murthy, SN
TI Regulatory Perspective of Dermatokinetic Studies
SO Dermatokinetics of Therapeutic Agents
LA English
DT Article; Book Chapter
ID DOSE-RESPONSE; BIOEQUIVALENCE
C1 [Conner, Dale P.] Uniformed Serv Univ Hlth Sci, Bethesda, MD 20814 USA.
[Conner, Dale P.] Scios Nova Inc, Pharmacokinet, Sunnyvale, CA USA.
RP Braddy, AC (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Div Bioequivalence, Rockville, MD 20857 USA.
NR 13
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
BN 978-1-4398-0478-0; 978-1-4398-0477-3
PY 2011
BP 193
EP 201
D2 10.1201/b10845
PG 9
WC Dermatology; Pharmacology & Pharmacy
SC Dermatology; Pharmacology & Pharmacy
GA BC5NJ
UT WOS:000353399200008
ER
PT J
AU Heemstra, HE
Leufkens, HGM
Rodgers, RPC
Xu, K
Voordouw, BCG
Braun, MM
AF Heemstra, Harald E.
Leufkens, Hubert G. M.
Rodgers, R. P. Channing
Xu, Kui
Voordouw, Bettie C. G.
Braun, M. Miles
TI Characteristics of orphan drug applications that fail to achieve
marketing approval in the USA
SO DRUG DISCOVERY TODAY
LA English
DT Review
ID PULMONARY ARTERIAL-HYPERTENSION; 6-MINUTE WALK DISTANCE; RARE DISEASES;
END-POINTS; INVESTIGATIONAL DRUGS; CYSTIC-FIBROSIS; CLINICAL-TRIALS;
SUCCESS RATES; MEDICINES; ACCESS
AB The US Orphan Drug Act has fostered the development of drugs for patients with rare diseases by granting 'orphan designations', although several orphan drugs for which a marketing application has been submitted to the FDA have failed to obtain approval. This study identified the clinical trial design, the level of experience of the sponsor and the level of interaction with the FDA to be associated with non-approval. Sponsors, therefore, should engage in dialogue with the FDA and thoughtfully design pivotal clinical trials in accordance with FDA guidance documents.
C1 [Heemstra, Harald E.; Leufkens, Hubert G. M.; Voordouw, Bettie C. G.] Med Evaluat Board, NL-2500 BE The Hague, Netherlands.
[Rodgers, R. P. Channing; Xu, Kui; Braun, M. Miles] US FDA, FDA Off Orphan Prod Dev, Silver Spring, MD 20993 USA.
[Heemstra, Harald E.; Voordouw, Bettie C. G.] Steering Comm Orphan Drugs, NL-2509 AE The Hague, Netherlands.
RP Leufkens, HGM (reprint author), Med Evaluat Board, POB 16229, NL-2500 BE The Hague, Netherlands.
EM hg.leufkens@cbg-meb.nl
NR 36
TC 23
Z9 23
U1 1
U2 15
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 1359-6446
J9 DRUG DISCOV TODAY
JI Drug Discov. Today
PD JAN
PY 2011
VL 16
IS 1-2
BP 73
EP 80
DI 10.1016/j.drudis.2010.11.006
PG 8
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 712TO
UT WOS:000286689300010
PM 21094692
ER
PT B
AU Reynolds, KS
AF Reynolds, Kellie Schoolar
BE Piscitelli, SC
Rodvold, KA
Pai, MP
TI Drug Interaction Considerations Throughout Drug Development
SO DRUG INTERACTIONS IN INFECTIOUS DISEASES, THIRD EDITION
SE Infectious Disease
LA English
DT Article; Book Chapter
ID METABOLIZING-ENZYMES; NUCLEAR RECEPTORS; IN-VITRO; COCKTAIL;
TRANSPORTERS; INDUCTION; CYP3A4; EFFICACY; 2C9; 3A4
AB The objectives of a drug interaction program are to determine whether there are interactions with an NME (new molecular entity) that necessitate a dose adjustment of the NME or other drugs that it might be used with, or whether an interaction requires a contraindication or special precautions. The program should begin early in drug development so the clinical implications of interactions can be assessed adequately in clinical studies. It is important that all studies are conducted using rigorous scientific procedures. The clinical significance of interactions should be assessed based on exposure-response knowledge of the affected drug.. Drug labels need to include complete information about the potential for drug interactions, including instructions for dose adjustments and special monitoring or precautions.
C1 US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Reynolds, KS (reprint author), US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
EM Kellie.Reynolds@fda.hhs.gov
NR 41
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
BN 978-1-61779-212-0
J9 INFECT DIS
PY 2011
BP 613
EP 630
DI 10.1007/978-1-61779-213-7_18
D2 10.1007/978-1-61779-213-7
PG 18
WC Infectious Diseases; Medicine, General & Internal; Pharmacology &
Pharmacy
SC Infectious Diseases; General & Internal Medicine; Pharmacology &
Pharmacy
GA BYU08
UT WOS:000300328700018
ER
PT J
AU Jones, SC
Sorbello, A
Boucher, RM
AF Jones, S. Christopher
Sorbello, Alfred
Boucher, Robert M.
TI Fluoroquinolone-Associated Myasthenia Gravis Exacerbation Evaluation of
Postmarketing Reports from the US FDA Adverse Event Reporting System and
a Literature Review
SO DRUG SAFETY
LA English
DT Article
ID NEUROMUSCULAR-TRANSMISSION; CIPROFLOXACIN; ANTIBIOTICS; CHLOROQUINE;
OFLOXACIN
AB Background: Exacerbations of myasthenia gravis have been reported in antibacterial-treated patients. In animal and in vitro models of experimentally-induced myasthenia gravis, fluoroquinolones exhibit neuromuscular blockade.
Objective: The aim of this retrospective study was to evaluate postmarketing adverse event reports submitted to the US FDA and case reports published in the scientific literature for a potential association between fluoroquinolone exposure and acute exacerbations of myasthenia gravis.
Methods: On 1 March 2011, we searched the FDA Adverse Event Reporting System (AERS) database to retrieve all reports of myasthenia gravis exacerbation as a serious adverse event in patients treated with fluoroquinolones. We also conducted an Internet-based search using EMBASE for additional English-language cases in the scientific literature.
Results: We identified a total of 37 unique cases describing myasthenia gravis exacerbation following fluoroquinolone systemic exposure. We retrieved AERS reports for 27 non-ventilated patients administered the following fluoroquinolones: levofloxacin (n=9), moxifloxacin (n=6), ciprofloxacin (n=6), ofloxacin (n=2), gatifloxacin (n=2), norfloxacin (n=1) and trovafloxacin (n=1). Additionally, we retrieved ten case reports published in the literature involving non-ventilated patients administered ciprofloxacin (n=4), levofloxacin (n=2) and ofloxacin, norfloxacin, pefloxacin and prulifloxacin (1 patient each). Myasthenia gravis exacerbations developed a median of 1 day following fluoroquinolone exposure. The 37 cases describe dyspnoea (n=19; 51%), myasthenic crisis requiring ventilatory support (n=11; 30%) and death (n=2; 5%). Additional exacerbation-related adverse events were generalized muscle weakness (n=20; 54%), dysphagia (n=9; 24%), diplopia (n=6; 16%) and ptosis (n=6; 16%). Six patients (16%) experienced a positive rechallenge, with recurrent myasthenia gravis exacerbation after fluoroquinolone reintroduction.
Conclusions: Fluoroquinolone exposure may result in potentially life-threatening myasthenia gravis exacerbations in patients with underlying disease. Healthcare professionals should be aware of this serious drug-disease association and carefully weigh the benefit-risks of fluoroquinolones when treating infections in non-ventilated myasthenic patients.
C1 [Jones, S. Christopher; Sorbello, Alfred; Boucher, Robert M.] US FDA, Ctr Drug Evaluat & Res, Off Surveillance & Epidemiol, Div Pharmacovigilance 2, Silver Spring, MD 20993 USA.
RP Jones, SC (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Surveillance & Epidemiol, Div Pharmacovigilance 2, 10903 New Hampshire Ave,Bldg 22,Rm 3464, Silver Spring, MD 20993 USA.
NR 25
TC 8
Z9 13
U1 0
U2 2
PU ADIS INT LTD
PI AUCKLAND
PA 41 CENTORIAN DR, PRIVATE BAG 65901, MAIRANGI BAY, AUCKLAND 1311, NEW
ZEALAND
SN 0114-5916
J9 DRUG SAFETY
JI Drug Saf.
PY 2011
VL 34
IS 10
BP 839
EP 847
PG 9
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
GA 827QR
UT WOS:000295443500004
PM 21879778
ER
PT J
AU Hillebrenner, MG
Swain, JA
Zuckerman, B
AF Hillebrenner, Matthew G.
Swain, Julie A.
Zuckerman, Bram
TI VARC consensus report: the FDA perspective
SO EUROPEAN HEART JOURNAL
LA English
DT Editorial Material
C1 [Hillebrenner, Matthew G.; Swain, Julie A.; Zuckerman, Bram] US FDA, Off Device Evaluat, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Hillebrenner, MG (reprint author), US FDA, Off Device Evaluat, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave,WO66-1232, Silver Spring, MD 20993 USA.
EM matthew.hillebrenner@fda.hhs.gov
NR 2
TC 2
Z9 2
U1 0
U2 1
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0195-668X
J9 EUR HEART J
JI Eur. Heart J.
PD JAN
PY 2011
VL 32
IS 2
BP 138
EP 139
DI 10.1093/eurheartj/ehq414
PG 2
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 706JU
UT WOS:000286215500006
PM 21216740
ER
PT J
AU Ostera, G
Tokumasu, F
Teixeira, C
Collin, N
Sa, J
Hume, J
Kumar, S
Ribeiro, J
Lukat-Rodgers, GS
Rodgers, KR
AF Ostera, Graciela
Tokumasu, Fuyuki
Teixeira, Clarissa
Collin, Nicolas
Sa, Juliana
Hume, Jennifer
Kumar, Sanjai
Ribeiro, Jose
Lukat-Rodgers, Gudrun S.
Rodgers, Kenton R.
TI Plasmodium falciparum: Nitric oxide modulates heme speciation in
isolated food vacuoles
SO EXPERIMENTAL PARASITOLOGY
LA English
DT Article
DE Protozoa; Plasmodium falciparum; Malaria; Nitric oxide; Heme; Hemozoin;
Antimalarials; Food vacuole
ID REDUCTIVE NITROSYLATION; SCHISTOSOMA-MANSONI; MALARIA PARASITE;
BETA-HEMATIN; HEMOZOIN; COMPLEXES; CRYSTALLIZATION; ADDUCTS; INSECT; NO
AB Nitric oxide (NO) and NO-derived reactive nitrogen species (RNS) are present in the food vacuole (FV) of Plasmodium falciparum trophozoites. The product of PFL1555w, a putative cytochrome 65, localizes in the FV membrane, similar to what was previously observed for the product of PF13_0353, a putative cytochrome 65 reductase. These two gene products may contribute to NO generation by denitrification chemistry from nitrate and/or nitrite present in the erythrocyte cytosol. The possible coordination of NO to heme species present in the food vacuole was probed by resonance Raman spectroscopy. The spectroscopic data revealed that in situ generated NO interacts with heme inside the intact FVs to form ferrous heme nitrosyl complexes that influence intra-vacuolar heme solubility. The formation of heme nitrosyl complexes within the FV is a previously unrecognized factor that could affect the equilibrium between soluble and crystallized heme within the FV in vivo. (C) 2010 Elsevier Inc. All rights reserved.
C1 [Ostera, Graciela; Tokumasu, Fuyuki; Teixeira, Clarissa; Sa, Juliana; Hume, Jennifer; Ribeiro, Jose] NIAID, Lab Malaria & Vector Res, NIH, Rockville, MD 20852 USA.
[Collin, Nicolas] Univ Lausanne, Dept Biochem, CH-1066 Epalinges, Switzerland.
[Kumar, Sanjai] US FDA, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Lukat-Rodgers, Gudrun S.; Rodgers, Kenton R.] N Dakota State U, Dept Chem & Biochem, Fargo, ND 58108 USA.
RP Ostera, G (reprint author), Georgetown Univ, Dept Biochem, Washington, DC 20057 USA.
EM osterag@georgetown.edu; kent.rodgers@ndsu.edu
OI Tokumasu, Fuyuki/0000-0003-2790-1071; Ribeiro, Jose/0000-0002-9107-0818
FU NIH-NIAID [AI072719]
FX The authors would like to thank Drs. Thomas Wellems, Jesus Valenzuela,
Alan Schechter and F. Ann Walker for their helpful discussions and
contributions to this project. This research was supported by the
Intramural Research Program of the NIAID, NIH and by NIH-NIAID (AI072719
to K.R.R.).
NR 31
TC 8
Z9 8
U1 0
U2 6
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0014-4894
J9 EXP PARASITOL
JI Exp. Parasitol.
PD JAN
PY 2011
VL 127
IS 1
BP 1
EP 8
DI 10.1016/j.exppara.2010.05.006
PG 8
WC Parasitology
SC Parasitology
GA 710BV
UT WOS:000286486800001
PM 20493843
ER
PT J
AU Brekhman, V
Lugassie, J
Zaffryar-Eilot, S
Sabo, E
Kessler, O
Smith, V
Golding, H
Neufeld, G
AF Brekhman, Vera
Lugassie, Jennie
Zaffryar-Eilot, Shelly
Sabo, Edmond
Kessler, Ofra
Smith, Victoria
Golding, Hana
Neufeld, Gera
TI Receptor activity modifying protein-3 mediates the protumorigenic
activity of lysyl oxidase-like protein-2
SO FASEB JOURNAL
LA English
DT Article
DE LOXL2; RAMP3; invasion; tumor progression
ID TUMOR PROGRESSION; CANCER-CELLS; CALCITONIN RECEPTOR; MOLECULAR ROLE;
IN-VIVO; ADRENOMEDULLIN; AMYLIN; GROWTH; INVASION; ANGIOGENESIS
AB Lysyl oxidase-like protein-2 (LOXL2) induces epithelial to mesenchymal transition and promotes invasiveness. To understand the mechanisms involved, we examined the effect of LOXL2 overexpression in MCF-7 cells on gene expression. We found that LOXL2 up-regulated the expression of receptor activity modifying protein-3 (RAMP3). Expression of RAMP3 in MDA-MB-231 cells in which LOXL2 expression was inhibited restored vimentin expression, invasiveness, and tumor development. Inhibition of RAMP3 expression in MDA-MB-231 cells mimicked the effects produced by inhibition of LOXL2 expression and was accompanied by inhibition of p38 phosphorylation. LOXL2 overexpression in these cells did not restore invasiveness, suggesting that RAMP3 functions downstream to LOXL2. LOXL2 and RAMP3 are strongly coexpressed in human colon, breast, and gastric carcinomas but not in normal colon or gastric epithelial cells. RAMP3 associates with several G-protein-coupled receptors forming receptors for peptides, such as adrenomedullin and amylin. We hypothesized that RAMP3 could function as a transducer of autocrine signals induced by such peptides. However, the proinvasive effects of RAMP3 could not be abrogated following inhibition of the expression or activity of these peptides. Our experiments suggest that the protumorigenic effects of LOXL2 are partially mediated by RAMP3 and that RAMP3 inhibitors may function as antitumorigenic agents.-Brekhman, V., Lugassie, J., Zaffryar-Eilot, S., Sabo, E., Kessler, O., Smith, V., Golding, H., Neufeld, G. Receptor activity modifying protein-3 mediates the protumorigenic activity of lysyl oxidase-like protein-2. FASEB J. 25, 55-65 (2011). www.fasebj.org
C1 [Brekhman, Vera; Lugassie, Jennie; Zaffryar-Eilot, Shelly; Sabo, Edmond; Kessler, Ofra; Neufeld, Gera] Technion Israel Inst Technol, Canc Res & Vasc Biol Ctr, Bruce Rappaport Fac Med, IL-31096 Haifa, Israel.
[Sabo, Edmond] Rambam Med Ctr, Haifa, Israel.
[Smith, Victoria] Arresto Biosci Inc, Palo Alto, CA USA.
[Golding, Hana] Food & Drug Adm, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Neufeld, G (reprint author), Technion Israel Inst Technol, Canc Res & Vasc Biol Ctr, Bruce Rappaport Fac Med, POB 9679,1 Efron St, IL-31096 Haifa, Israel.
EM gera@tx.technion.ac.il
FU Arresto Biosciences Inc. (Palo Alto, CA, USA); U.S. Army
[W81XWH-04-1-0430]
FX This work was funded, in part, by a grant from Arresto Biosciences Inc.
(Palo Alto, CA, USA; G.N.) and in part by a grant from the U.S. Army
(W81XWH-04-1-0430; G.N. and H. G.). The authors thank Dr. Scott Ogg for
critically reading the manuscript. The authors thank Dr. Robert Kerbel
(Women's College Health Sciences Centre, Toronto, ON, Canada) and Dr.
Israel Vlodavsky (Faculty of Medicine, Technion, Haifa, Israel) for
gifts of cells.
NR 43
TC 18
Z9 18
U1 0
U2 4
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD JAN
PY 2011
VL 25
IS 1
BP 55
EP 65
DI 10.1096/fj.10-162677
PG 11
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 702BL
UT WOS:000285869500006
PM 20802105
ER
PT J
AU Chen, ST
AF Chen, Shaw T.
TI Regulation of research: Is it a drug trial or a supplement trial?
SO FITOTERAPIA
LA English
DT Article
DE Regulatory requirements; Clinical studies; Dietary supplements
AB Investigators and sponsors of dietary supplement research need to know the relevant regulatory requirements and how to comply with them. This brief review describes how research on dietary supplements is regulated by FDA. In general, whether an FDA sanctioned Investigational New Drug (IND) application is required for a human research project on dietary supplement depends on the intended use and clinical setting of the clinical study, and not on the supplement's physical or chemical properties. Even if the study product is already available on the market as a dietary supplement, an IND will be required for products that will be used as a drug to treat, mitigate or prevent a disease or its related conditions in the proposed clinical study. On the other hand, for studies on structure and function endpoints, and not on drug use, no IND will be required. The paper also discusses the principles FDA uses to determine whether an IND is needed for clinical studies of surrogate endpoints that do not lead to approvable drug claims. Useful FDA contact information is also provided. (C) 2010 Published by Elsevier B.V.
C1 US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Chen, ST (reprint author), US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Rm 22-5306, Silver Spring, MD 20993 USA.
EM shaw.chen@fda.hhs.gov
NR 0
TC 1
Z9 1
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0367-326X
J9 FITOTERAPIA
JI Fitoterapia
PD JAN
PY 2011
VL 82
IS 1
SI SI
BP 14
EP 16
DI 10.1016/j.fitote.2010.11.011
PG 3
WC Chemistry, Medicinal; Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 724HS
UT WOS:000287567300004
PM 21073930
ER
PT J
AU Edison, SE
Lin, LA
Parrales, L
AF Edison, S. E.
Lin, L. A.
Parrales, L.
TI Practical considerations for the rapid screening for pesticides using
ambient pressure desorption ionisation with high-resolution mass
spectrometry
SO FOOD ADDITIVES AND CONTAMINANTS PART A-CHEMISTRY ANALYSIS CONTROL
EXPOSURE & RISK ASSESSMENT
LA English
DT Article
DE LC/MS; pesticide residues
ID REAL-TIME; VEGETABLES; FRUIT; AIR
AB A rapid screening method for pesticides has been developed to streamline the processing of produce entering the United States. Foam swabs were used to recover multi-class mixtures of 240, 140, 132 and 60 pesticides from the surfaces of apples, kiwis, peaches and tomatoes. The mixtures were selected to span a large range of chemical classes, polarities, solubilities and sizes to provide a broad look at how this technique will perform for a variety of analytes. The swabs were analysed using direct analysis in real-time (DART) ionisation coupled with a high-resolution Exactive Orbitrap (TM) mass spectrometer. This study expands the types of commodities analysed using this method and explores the feasibility of compositing multiple units of produce per batch to analyse a representative sample. It was established that whilst smooth-skinned produce, such as apples, maintained a high detection rate for the pesticide mixtures even when ten apples are swabbed with one foam disk, commodities with rougher surfaces, such as peaches, suffered a decrease in detection rate when ten peaches are swabbed with one foam disk. In order to maintain some consistency across the sample preparation process, a composite size of three units was selected. The varying topography of the commodities necessitated minor modifications to the method; for example, analysis of kiwi required that the hair on the surface be shaved prior to swabbing to achieve good recovery. Additionally, the effect of storage conditions on detection rate was analysed by spiking the surface of tomatoes at levels of 5 and 10 ng g(-1) for each pesticide, storing them under refrigeration and ambient conditions for 3 and 8 days, and then analysing the surface using this method. After 8 days of storage under both conditions more than 80% of the pesticides in the mixture were detected. Also, analysis of the multi-class mixtures was performed in both positive-and negative-ion mode and many classes were detected in both modes. Some classes, such thiocarbamates, phenylamides and organochlorine pesticides, were only observed in the positive-ion mode, whilst benzoylphenylurea pesticides were only detected in the negative-ion mode.
C1 [Edison, S. E.; Lin, L. A.] US FDA, Forens Chem Ctr, Cincinnati, OH 45237 USA.
[Parrales, L.] US FDA, San Francisco Dist Lab, Alameda, CA 94502 USA.
RP Edison, SE (reprint author), US FDA, Forens Chem Ctr, 6751 Steger Dr, Cincinnati, OH 45237 USA.
EM Sara.edison@fda.hhs.gov
NR 14
TC 27
Z9 27
U1 3
U2 38
PU TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXON, ENGLAND
SN 1944-0049
J9 FOOD ADDIT CONTAM A
JI Food Addit. Contam. Part A-Chem.
PY 2011
VL 28
IS 10
SI SI
BP 1393
EP 1404
DI 10.1080/19440049.2011.596165
PG 12
WC Chemistry, Applied; Food Science & Technology; Toxicology
SC Chemistry; Food Science & Technology; Toxicology
GA 848CW
UT WOS:000297027500010
PM 21838598
ER
PT J
AU Cowley, SC
Elkins, KL
AF Cowley, Siobhan C.
Elkins, Karen L.
TI Immunity to Francisella
SO FRONTIERS IN MICROBIOLOGY
LA English
DT Review
DE Francisella; immunity; innate; adaptive; lymphocyte; cytokine
AB In recent years, studies on the intracellular pathogen Francisella tularensis have greatly intensified, generating a wealth of new information on the interaction of this organism with the immune system. Here we review the basic elements of the innate and adaptive immune responses that contribute to protective immunity against Francisella species, with special emphasis on new data that has emerged in the last 5 years. Most studies have utilized the mouse model of infection, although there has been an expansion of work on human cells and other new animal models. In mice, basic immune parameters that operate in defense against other intracellular pathogen infections, such as interferon gamma, TNF-alpha, and reactive nitrogen intermediates, are central for control of Francisella infection. However, new important immune mediators have been revealed, including IL-17A, Toll-like receptor 2, and the inflammasome. Further, a variety of cell types in addition to macrophages are now recognized to support Francisella growth, including epithelial cells and dendritic cells. CD4+ and CD8+T cells are clearly important for control of primary infection and vaccine-induced protection, but new T cell subpopulations and the mechanisms employed by T cells are only beginning to be defined. A significant role for B cells and specific antibodies has been established, although their contribution varies greatly between bacterial strains of lower and higher virulence. Overall, recent data profile a pathogen that is adept at subverting host immune responses, but susceptible to many elements of the immune system's antimicrobial arsenal.
C1 [Cowley, Siobhan C.; Elkins, Karen L.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Cowley, SC (reprint author), US FDA, Ctr Biol Evaluat & Res, Lab Mycobacterial Dis & Cellular Immunol, Div Bacterial Parasit & Allergen Prod,Off Vaccine, HFM 431,29 Lincoln Dr,Room 516, Bethesda, MD 20892 USA.
EM siobhan.cowley@fda.hhs.gov
NR 197
TC 49
Z9 50
U1 1
U2 4
PU FRONTIERS RESEARCH FOUNDATION
PI LAUSANNE
PA PO BOX 110, LAUSANNE, 1015, SWITZERLAND
SN 1664-302X
J9 FRONT MICROBIOL
JI Front. Microbiol.
PY 2011
VL 2
AR 26
DI 10.3389/fmicb.2011.00026
PG 21
WC Microbiology
SC Microbiology
GA V31DE
UT WOS:000208863500036
PM 21687418
ER
PT B
AU Patterson, TA
Paule, MG
AF Patterson, Tucker A.
Paule, Merle G.
BE Bolon, B
Butt, MT
TI COGNITIVE ASSESSMENTS IN NONHUMAN PRIMATES
SO FUNDAMENTAL NEUROPATHOLOGY FOR PATHOLOGISTS AND TOXICOLOGISTS:
PRINCIPLES AND TECHNIQUES
LA English
DT Article; Book Chapter
ID OPERANT TEST BATTERY; BEHAVIORAL-TEST BATTERY; RHESUS-MONKEY
PERFORMANCE; COMPLEX BRAIN-FUNCTION; WORKING-MEMORY;
METHYLENEDIOXYMETHAMPHETAMINE MDMA; PROGRESSIVE RATIO; PREFRONTAL
CORTEX; MARIJUANA SMOKE; ACQUISITION
C1 [Patterson, Tucker A.; Paule, Merle G.] US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Patterson, TA (reprint author), US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 47
TC 0
Z9 0
U1 0
U2 0
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
BN 978-0-470-93994-9; 978-0-470-22733-6
PY 2011
BP 115
EP 123
D2 10.1002/9780470939956
PG 9
WC Clinical Neurology; Toxicology
SC Neurosciences & Neurology; Toxicology
GA BA6JJ
UT WOS:000337159300010
ER
PT B
AU Sarkar, S
Schmued, L
AF Sarkar, Sumit
Schmued, Larry
BE Bolon, B
Butt, MT
TI FLUORO-JADE DYES: FLUOROCHROMES FOR THE HISTOCHEMICAL LOCALIZATION OF
DEGENERATING NEURONS
SO FUNDAMENTAL NEUROPATHOLOGY FOR PATHOLOGISTS AND TOXICOLOGISTS:
PRINCIPLES AND TECHNIQUES
LA English
DT Article; Book Chapter
ID RAT FOREBRAIN; EXPOSURE; PROGRESSION; CORTEX; MARKER; MYELIN; NERVE;
BRAIN
C1 [Sarkar, Sumit; Schmued, Larry] US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Sarkar, S (reprint author), US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 22
TC 4
Z9 4
U1 0
U2 0
PU BLACKWELL SCIENCE PUBL
PI OXFORD
PA OSNEY MEAD, OXFORD OX2 0EL, ENGLAND
BN 978-0-470-93994-9; 978-0-470-22733-6
PY 2011
BP 171
EP 179
D2 10.1002/9780470939956
PG 9
WC Clinical Neurology; Toxicology
SC Neurosciences & Neurology; Toxicology
GA BA6JJ
UT WOS:000337159300014
ER
PT J
AU Shields, JM
AF Shields, Joan M.
BE Fratamico, P
Liu, Y
Kathariou, S
TI Cyclospora cayetanensis: a Review of the Genome
SO GENOMES OF FOODBORNE AND WATERBORNE PATHOGENS
LA English
DT Review; Book Chapter
ID COCCIDIAN PARASITES APICOMPLEXA; MOLECULAR PHYLOGENETIC ANALYSIS;
TRANSCRIBED SPACER REGION; RIBOSOMAL-RNA GENE; REAL-TIME PCR;
CRYPTOSPORIDIUM-PARVUM; CONTROLLED-TRIAL; EIMERIA-TENELLA; INFECTION;
OUTBREAK
C1 US FDA, Div Virulence Assessment, Virulence Mech Branch, Laurel, MD 20708 USA.
RP Shields, JM (reprint author), US FDA, Div Virulence Assessment, Virulence Mech Branch, Laurel, MD 20708 USA.
NR 78
TC 0
Z9 0
U1 0
U2 2
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-457-1
PY 2011
BP 299
EP 308
PG 10
WC Food Science & Technology; Genetics & Heredity; Microbiology
SC Food Science & Technology; Genetics & Heredity; Microbiology
GA BTZ28
UT WOS:000288488300022
ER
PT J
AU Strauss, DG
Poole, JE
Wagner, GS
Selvester, RH
Miller, JM
Rn, JA
Johnson, G
McNulty, SE
Mark, DB
Lee, KL
Bardy, GH
Wu, KC
AF Strauss, David G.
Poole, Jeanne E.
Wagner, Galen S.
Selvester, Ronald H.
Miller, Julie M.
Rn, Jill Anderson
Johnson, George
McNulty, Steven E.
Mark, Daniel B.
Lee, Kerry L.
Bardy, Gust H.
Wu, Katherine C.
TI An ECG index of myocardial scar enhances prediction of defibrillator
shocks: An analysis of the Sudden Cardiac Death in Heart Failure Trial
SO HEART RHYTHM
LA English
DT Article
DE Sudden death; Defibrillation; Electrocardiography; Electrophysiology;
Tachyarrhythmias
ID QRS SCORING SYSTEM; IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR;
CARDIOVASCULAR MAGNETIC-RESONANCE; INFARCT TISSUE HETEROGENEITY;
LEFT-VENTRICULAR DYSFUNCTION; ISCHEMIC CARDIOMYOPATHY; EJECTION
FRACTION; SIZE; PERFORMANCE; VALIDATION
AB BACKGROUND Only a minority of patients receiving implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden death receive appropriate shocks, yet almost as many are subjected to inappropriate shocks and device complications. Identifying and quantifying myocardial scar, which forms the substrate for ventricular tachyarrhythmias, may improve risk stratification.
OBJECTIVE This study sought to determine whether the absence of myocardial scar detected by novel 12-lead electrocardiographic (ECG) Selvester QRS scoring criteria identifies patients with low risk for appropriate ICD shocks.
METHODS We applied QRS scoring to 797 patients from the ICD arm of the Sudden Cardiac Death in Heart Failure Trial. Patients were followed up for a median of 45.5 months for ventricular tachycardia/fibrillation treated by the ICD or sudden tachyarrhythmic death (combined group referred to as VT/VF).
RESULTS Increasing QRS score scar size predicted higher rates of VT/VF. Patients with no scar (QRS score = 0) represented a particularly low-risk cohort with 48% fewer VT/VF events than the rest of the population (absolute difference 11%; hazard ratio 0.52, 95% confidence interval 0.31 to 0.88). QRS score scar absence versus presence remained a significant prognostic factor after controlling for 10 clinically relevant variables. Combining QRS score (scar absence versus presence) with ejection fraction (>= 25% versus <25%) distinguished low-, middle-, and high-risk subgroups with 73% fewer VT/VF events in the low-risk versus high-risk group (absolute difference 22%; hazard ratio = 0.27, 95% confidence interval 0.12 to 0.62).
CONCLUSION Patients with no scar by QRS scoring have significantly fewer VT/VF events. This inexpensive 12-lead ECG tool provides unique, incremental prognostic information and should be considered in risk-stratifying algorithms for selecting patients for ICDs.
C1 [Strauss, David G.; Miller, Julie M.; Wu, Katherine C.] Johns Hopkins Med Inst, Dept Med, Div Cardiol, Baltimore, MD 21205 USA.
[Strauss, David G.] US FDA, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Poole, Jeanne E.; Rn, Jill Anderson; Bardy, Gust H.] Seattle Inst Cardiac Res, Seattle, WA USA.
[Wagner, Galen S.; Johnson, George; McNulty, Steven E.; Mark, Daniel B.; Lee, Kerry L.] Duke Clin Res Inst, Durham, NC USA.
[Selvester, Ronald H.] Mem Hosp, Res Ctr, Long Beach, CA USA.
RP Wu, KC (reprint author), Johns Hopkins Univ Hosp, Div Cardiol, 600 N Wolfe St,Carnegie 568, Baltimore, MD 21287 USA.
EM kwu@jhmi.edu
RI Strauss, David/A-9211-2012;
OI Mark, Daniel/0000-0001-6340-8087
FU Sarnoff Cardiovascular Research Foundation (Great Falls, VA); Donald W.
Reynolds Cardiovascular Research Center at Johns Hopkins University
(Baltimore, MD); Doris Duke Charitable Foundation (New York, NY); NHLBI,
National Institutes of Health [UO1 HL55766, UO1 HL55297, UO1 HL55496];
Medtronic; Wyeth-Ayerst Laboratories; Knoll Pharmaceuticals; Biotronik;
Physio-Control; Welch-Allyn; Abbott Laboratories; Abbott Vascular
Business; Abiomed; Acorn Cardiovascular; St. Jude Medical
FX Dr. Strauss was supported by the Sarnoff Cardiovascular Research
Foundation (Great Falls, VA) for work at Johns Hopkins, and has
subsequently moved to the U.S. Food and Drug Administration. Views
expressed do not represent those of the FDA. Dr. Wu and Dr. Miller were
supported by the Donald W. Reynolds Cardiovascular Research Center at
Johns Hopkins University (Baltimore, MD), and Dr. Miller was supported
by the Doris Duke Charitable Foundation (New York, NY). The main
SCD-HeFT study was supported by grants (UO1 HL55766, UO1 HL55297, and
UO1 HL55496) from the NHLBI, National Institutes of Health, and by
Medtronic, Wyeth-Ayerst Laboratories, and Knoll Pharmaceuticals. Dr.
Poole has received speaking fees from Medtronic, Boston Scientific and
St. Jude Medical, and a research grant from Biotronik. Dr. Wagner has
received research support from Physio-Control and Welch-Allyn. Dr. Mark
has received research support from Abbott Laboratories, Abbott Vascular
Business, Abiomed, and Acorn Cardiovascular. Dr. Bardy has received
research grants from St. Jude Medical, is a consultant for Phillips
Medical and Cardiac Sciences, and is a board member and has equity and
intellectual property in Cameron Health Inc. This study is registered at
http://www.clinicaltrials.gov - identifier NCT00000609. Address reprint
requests and correspondence: Dr. Katherine C. Wu, Division of
Cardiology, Johns Hopkins Hospital, 600 North Wolfe Street, Carnegie
568, Baltimore, MD 21287. E-mail address: kwu@jhmi.edu. (Received August
19, 2010; accepted September 22, 2010.)
NR 35
TC 28
Z9 30
U1 0
U2 6
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1547-5271
J9 HEART RHYTHM
JI Heart Rhythm
PD JAN
PY 2011
VL 8
IS 1
BP 38
EP 45
DI 10.1016/j.hrthm.2010.09.071
PG 8
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 698VW
UT WOS:000285622700010
PM 20884379
ER
PT J
AU Afdhal, NH
McHutchison, JG
Zeuzem, S
Mangia, A
Pawlotsky, JM
Murray, JS
Shianna, KV
Tanaka, Y
Thomas, DL
Booth, DR
Goldstein, DB
AF Afdhal, Nezam H.
McHutchison, John G.
Zeuzem, Stefan
Mangia, Alessandra
Pawlotsky, Jean-Michel
Murray, Jeffrey S.
Shianna, Kevin V.
Tanaka, Yasuhito
Thomas, David L.
Booth, David R.
Goldstein, David B.
CA Pharmacogenetics Hepatitis C
TI Hepatitis C Pharmacogenetics: State of the Art in 2010
SO HEPATOLOGY
LA English
DT Review
ID PEGYLATED INTERFERON-ALPHA; GENETIC-VARIATION; IL28B POLYMORPHISM;
ANTIVIRAL ACTIVITY; RIBAVIRIN THERAPY; VIRUS-REPLICATION; IFN-LAMBDA;
GENOTYPE 1; INFECTION; KINETICS
AB In 2009, a correlated set of polymorphisms in the region of the interleukin-28B (IL28B) gene were associated with clearance of genotype 1 hepatitis C virus (HCV) in patients treated with pegylated interferon-alfa and ribavirin. The same polymorphisms were subsequently associated with spontaneous clearance of HCV in untreated patients. The link between IL28B genotype and HCV clearance may impact decisions regarding initiation of current therapy, the design and interpretation of clinical studies, the economics of treatment, and the process of regulatory approval for new anti-HCV therapeutic agents. (HEPATOLOGY 2011;53:336-345)
C1 [Afdhal, Nezam H.] Beth Israel Deaconess Med Ctr, Div Gastroenterol & Hepatol, Boston, MA 02215 USA.
[Afdhal, Nezam H.] Harvard Univ, Sch Med, Boston, MA 02215 USA.
[McHutchison, John G.] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA.
[Shianna, Kevin V.; Goldstein, David B.] Duke Univ, Med Ctr, Ctr Human Genome Variat, Durham, NC USA.
[Zeuzem, Stefan] JW Goethe Univ Hosp, Dept Internal Med, Frankfurt, Germany.
[Mangia, Alessandra] IRCCS Casa Sollievo Sofferenza, Div Gastroenterol, San Giovanni Rotondo, Italy.
[Pawlotsky, Jean-Michel] Univ Paris EST, Hop Henri Mondor, Dept Virol, Creteil, France.
[Murray, Jeffrey S.] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Tanaka, Yasuhito] Nagoya City Univ, Dept Virol, Nagoya, Aichi, Japan.
[Tanaka, Yasuhito] Nagoya City Univ, Liver Unit, Nagoya, Aichi, Japan.
[Thomas, David L.] Johns Hopkins Univ, Sch Med, Div Infect Dis, Baltimore, MD 21205 USA.
[Booth, David R.] Univ Sydney, Westmead Millennium Inst, Sydney, NSW, Australia.
RP Afdhal, NH (reprint author), Beth Israel Deaconess Med Ctr, Div Gastroenterol & Hepatol, 110 Francis St, Boston, MA 02215 USA.
EM nafdhal@caregroup.harvard.edu
RI Fellay, Jacques/A-6681-2009
OI Fellay, Jacques/0000-0002-8240-939X
FU Abbott Laboratories, Abbott Park, IL; Anadys Pharmaceuticals, Inc., San
Diego, CA; Bristol-Myers Squibb, Princeton, NJ; Genentech, Inc.,
Hoboken, NJ; Gilead Sciences, Inc., Foster City, CA; Globe-Immune, Inc.,
Louisville, CO; Human Genome Sciences, Inc., Rockville, MD; Idera
Pharmaceuticals, Inc., Cambridge, MA; LabCorp, Burlington, NC; Liver
Institute for Education and Research, NJ; Medtronic, Inc., Minneapolis,
MN; Merck & Co., Inc., Kenilworth, NJ; Monogram Business Sciences, Inc.,
South San Francisco, CA; Pharmasset, Inc., Princeton, NJ; Roche
Laboratories, South San Francisco, CA; Roche Molecular Diagnostics,
Pleasanton, CA; Roche Pharmaceuticals, Palo Alto, CA; Scynexis, Inc.,
Durham, NC; Tibotec BVBA, Beerse, Belgium; Tibotec, Inc., Titusville,
NJ; Vertex Pharmaceuticals, Inc., Cambridge, MA; Virco BVBA, Beerse,
Belgium; Abbott Laboratories; Anadys Pharmaceuticals; Bristol-Myers
Squibb; Gilead Sciences, Inc.; Human Genome Sciences, Inc.; Idera
Pharmaceuticals, Inc.; Liver Institute for Education and Research; Merck
Co., Inc.; Pharmasset, Inc.; Scynexis, Inc.; Tibotec BVBA; Tibotec,
Inc.; Vertex Pharmaceuticals, Inc.; Globe Immune, Inc.; Lab Corp;
Medtronic, Inc.; Monogram Business Sciences, Inc.; Roche Laboratories;
Roche Pharmaceuticals
FX The costs of this meeting were sponsored by Abbott Laboratories, Abbott
Park, IL; Anadys Pharmaceuticals, Inc., San Diego, CA; Bristol-Myers
Squibb, Princeton, NJ; Genentech, Inc., Hoboken, NJ; Gilead Sciences,
Inc., Foster City, CA; Globe-Immune, Inc., Louisville, CO; Human Genome
Sciences, Inc., Rockville, MD; Idera Pharmaceuticals, Inc., Cambridge,
MA; LabCorp, Burlington, NC; Liver Institute for Education and Research,
NJ; Medtronic, Inc., Minneapolis, MN; Merck & Co., Inc., Kenilworth, NJ;
Monogram Business Sciences, Inc., South San Francisco, CA; Pharmasset,
Inc., Princeton, NJ; Roche Laboratories, South San Francisco, CA; Roche
Molecular Diagnostics, Pleasanton, CA; Roche Pharmaceuticals, Palo Alto,
CA; Scynexis, Inc., Durham, NC; Tibotec BVBA, Beerse, Belgium; Tibotec,
Inc., Titusville, NJ; Vertex Pharmaceuticals, Inc., Cambridge, MA; and
Virco BVBA, Beerse, Belgium.; John G. McHutchison, Kevin V. Shianna, and
David B. Goldstein are coinventors of patents commercially protecting
the use of IL28B and ITPA genetic variation to predict treatment
response and anemia for patients undergoing treatment for chronic
hepatitis C infection. Nezam H. Afdhal reports the following financial
relationships: Abbott Laboratories (consulting, advisory arrangements),
Anadys Pharmaceuticals (consulting, advisory arrangements),
Bristol-Myers Squibb (consulting, speakers' bureau, research grants),
Gilead Sciences, Inc. (consulting, speakers' bureau, research grants),
Human Genome Sciences, Inc. (consulting, advisory arrangements, research
grants), Idera Pharmaceuticals, Inc. (consulting), Liver Institute for
Education and Research (director), Merck & Co., Inc. (consulting,
advisory arrangements, speakers' bureau, research grants), Pharmasset,
Inc. (consulting), Scynexis, Inc. (consulting), Tibotec BVBA (advisory
arrangements), Tibotec, Inc. (consulting, advisory arrangements,
research grants), Vertex Pharmaceuticals, Inc. (consulting, advisory
arrangements, research grants). John G. McHutchison reports the
following financial relationships: Abbott Laboratories (research
grants), Anadys Pharmaceuticals (advisory arrangements, research
grants), Bristol-Myers Squibb (advisory arrangements, research grants),
Gilead Sciences, Inc. (stock ownership or equity, employment), Globe
Immune, Inc. (advisory arrangements, research grants), Human Genome
Sciences, Inc. (advisory arrangements, research grants), Idera
Pharmaceuticals, Inc. (advisory arrangements, research grants), Lab Corp
(consulting), Liver Institute for Education and Research (unrestricted
grants), Medtronic, Inc. (research grants), Merck & Co., Inc. (advisory
arrangements, research grants, intellectual property), Monogram Business
Sciences, Inc. (advisory arrangements), Pharmasset, Inc. (consulting,
research grants), Roche Laboratories (research grants), Roche
Pharmaceuticals (research grants), Scynexis, Inc. (consulting, research
grants), Tibotec BVBA (research grants), Tibotec, Inc. (research
grants), Vertex Pharmaceuticals, Inc. (consulting, advisory
arrangements, research grants). Stefan Zeuzem reports the following
financial relationships: Abbott Laboratories (consulting), Anadys
Pharmaceuticals (consulting), Bristol-Myers Squibb (consulting,
speakers' bureau), Genentech (consulting, speakers' bureau), Gilead
Sciences, Inc. (consulting, speakers' bureau), Human Genome Sciences,
Inc. (consulting), Idera Pharmaceuticals, Inc. (consulting), Merck &
Co., Inc. (consulting, speakers' bureau), Pharmasset, Inc. (consulting),
Roche Molecular Diagnostics (speakers' bureau), Roche Pharmaceuticals
(consulting, speakers' bureau), Tibotec BVBA (consulting), Vertex
Pharmaceuticals, Inc. (consulting). Alessandra Mangia reports the
following financial relationships: Merck & Co., Inc. (research grants),
Roche Pharmaceuticals (advisory arrangements), Tibotec, Inc. (advisory
arrangements). Jean-Michel Pawlotsky reports the following
NR 26
TC 95
Z9 101
U1 1
U2 11
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0270-9139
J9 HEPATOLOGY
JI Hepatology
PD JAN
PY 2011
VL 53
IS 1
BP 336
EP 345
DI 10.1002/hep.24052
PG 10
WC Gastroenterology & Hepatology
SC Gastroenterology & Hepatology
GA 709AB
UT WOS:000286406300035
PM 21254181
ER
PT S
AU Singh, P
Nayak, R
Kwon, YM
AF Singh, Pallavi
Nayak, Rajesh
Kwon, Young Min
BE Kwon, YM
Ricke, SC
TI Target-Enrichment Through Amplification of Hairpin-Ligated Universal
Targets for Next-Generation Sequencing Analysis
SO HIGH-THROUGHPUT NEXT GENERATION SEQUENCING: METHODS AND APPLICATION
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Target-enrichment; Multiple targets; Next-generation sequencing; Hairpin
selector; PCR amplification
ID MUTATION DISCOVERY; GENES
AB With rapid development of next-generation sequencing (NGS) technologies, it is becoming increasingly feasible to sequence entire genomes of various organisms from virus to human. However, in many occasions, it is still more practical to sequence and analyze only small regions of the entire genome that arc informative for the purpose of the experiment. Although many target-enrichment or target capture methods exist, each method has its own strength and weakness in terms of the number of enriched targets, specificity, drop-off rate, and uniformity in capturing target DNA sequences. Many applications require a consistently low drop-off rate and high uniformity of enriched targets for routine collection of meaningful data. Here, we describe a simple and robust PCR-based protocol that can allow simultaneous amplification of numerous target regions. This method employs target-specific hairpin selectors to create DNA templates that contain target regions flanked by common universal priming sequences. We demonstrated the utility of this method by applying it for simultaneous amplification of 21 targets in the range of 191-604 bp from 41 different Salmonella strains using bar-coded universal primers. Analysis of 454 FLX pyrosequencing data demonstrated the promising performance of this method in terms of specificity and uniformity. This method, with great potential for robust amplification of hundreds of targets, should find broad applications for efficient analysis of multiple genomic targets for various experimental goals.
C1 [Singh, Pallavi; Kwon, Young Min] Univ Arkansas, Cell & Mol Biol Program, Fayetteville, AR 72701 USA.
[Nayak, Rajesh] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Kwon, Young Min] Univ Arkansas, Dept Poultry Sci, Fayetteville, AR 72701 USA.
RP Singh, P (reprint author), Univ Arkansas, Cell & Mol Biol Program, Fayetteville, AR 72701 USA.
OI Singh, Pallavi/0000-0002-0283-7459
NR 7
TC 5
Z9 5
U1 0
U2 3
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-61779-088-1
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2011
VL 733
BP 267
EP 278
DI 10.1007/978-1-61779-089-8_19
D2 10.1007/978-1-61779-089-8
PG 12
WC Biochemical Research Methods; Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA BUI26
UT WOS:000289444000019
PM 21431777
ER
PT J
AU Dormitzer, PR
Galli, G
Castellino, F
Golding, H
Khurana, S
Del Giudice, G
Rappuoli, R
AF Dormitzer, Philip R.
Galli, Grazia
Castellino, Flora
Golding, Hana
Khurana, Surender
Del Giudice, Giuseppe
Rappuoli, Rino
TI Influenza vaccine immunology
SO IMMUNOLOGICAL REVIEWS
LA English
DT Review
DE influenza; vaccine; immunology; pandemic; immunization; memory
ID LIVE ATTENUATED INFLUENZA; A/DUCK/SINGAPORE/97 H5N3 VACCINE; HONG-KONG
INFLUENZA; A VIRUS-VACCINES; MF59-ADJUVANTED INFLUENZA;
ANTIBODY-RESPONSES; WHOLE-VIRUS; T-CELLS; B-CELLS; NEURAMINIDASE
ANTIBODY
AB Studying the spread of influenza in human populations and protection by influenza vaccines provides important insights into immunity against influenza. The 2009 H1N1 pandemic has taught the most recent lessons. Neutralizing and receptor-blocking antibodies against hemagglutinin are the primary means of protection from the spread of pandemic and seasonal strains. Anti-neuraminidase antibodies seem to play a secondary role. More broadly cross-reactive forms of immunity may lessen disease severity but are insufficient to prevent epidemic spread. Priming by prior exposure to related influenza strains through infection or immunization permits rapid, potent antibody responses to immunization. Priming is of greater importance to the design of immunization strategies than the immunologically fascinating phenomenon of dominant recall responses to previously encountered strains (original antigenic sin). Comparisons between non-adjuvanted inactivated vaccines and live attenuated vaccines demonstrate that both can protect, with some advantage of live attenuated vaccines in children and some advantage of inactivated vaccines in those with multiple prior exposures to influenza antigens. The addition of oil-in-water emulsion adjuvants to inactivated vaccines provides enhanced functional antibody titers, greater breadth of antibody cross-reactivity, and antigen dose sparing. The MF59 adjuvant broadens the distribution of B-cell epitopes recognized on HA and NA following immunization.
C1 [Dormitzer, Philip R.; Galli, Grazia; Castellino, Flora; Del Giudice, Giuseppe; Rappuoli, Rino] Novartis Vaccines & Diagnost, Cambridge, MA 02139 USA.
[Dormitzer, Philip R.; Galli, Grazia; Castellino, Flora; Del Giudice, Giuseppe; Rappuoli, Rino] Novartis Vaccines & Diagnost, Siena, Italy.
[Golding, Hana; Khurana, Surender] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Dormitzer, PR (reprint author), Novartis Vaccines & Diagnost, 350 Massachusetts Ave, Cambridge, MA 02139 USA.
EM philip.dormitzer@novartis.com
RI Chiang, Vincent, Ming-Hsien/D-4312-2016
OI Chiang, Vincent, Ming-Hsien/0000-0002-2029-7863
NR 93
TC 86
Z9 88
U1 2
U2 26
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0105-2896
J9 IMMUNOL REV
JI Immunol. Rev.
PD JAN
PY 2011
VL 239
BP 167
EP 177
DI 10.1111/j.1600-065X.2010.00974.x
PG 11
WC Immunology
SC Immunology
GA 700TE
UT WOS:000285766400011
PM 21198671
ER
PT J
AU Jenkins, A
Cote, C
Twenhafel, N
Merkel, T
Bozue, J
Welkos, S
AF Jenkins, Amy
Cote, Christopher
Twenhafel, Nancy
Merkel, Tod
Bozue, Joel
Welkos, Susan
TI Role of Purine Biosynthesis in Bacillus anthracis Pathogenesis and
Virulence
SO INFECTION AND IMMUNITY
LA English
DT Article
ID GUINEA-PIGS; PROTECTIVE ANTIGEN; ESCHERICHIA-COLI; MURINE MODEL;
SALMONELLA-TYPHIMURIUM; NUCLEOSIDE TRANSPORT; SPORE GERMINATION; FULLY
VIRULENT; MOUSE MODEL; SUBTILIS
AB Bacillus anthracis, the etiological agent of anthrax, is a spore-forming, Gram-positive bacterium and a category A biothreat agent. Screening of a library of transposon-mutagenized B. anthracis spores identified a mutant displaying an altered phenotype that harbored a mutated gene encoding the purine biosynthetic enzyme PurH. PurH is a bifunctional protein that catalyzes the final steps in the biosynthesis of the purine IMP. We constructed and characterized defined purH mutants of the virulent B. anthracis Ames strain. The virulence of the purH mutants was assessed in guinea pigs, mice, and rabbits. The spores of the purH mutants were as virulent as wild-type spores in mouse intranasal and rabbit subcutaneous infection models but were partially attenuated in a mouse intraperitoneal model. In contrast, the purH mutant spores were highly attenuated in guinea pigs regardless of the administration route. The reduced virulence in guinea pigs was not due solely to a germination defect, since both bacilli and toxins were detected in vivo, suggesting that the significant attenuation was associated with a growth defect in vivo. We hypothesize that an intact purine biosynthetic pathway is required for the virulence of B. anthracis in guinea pigs.
C1 [Jenkins, Amy; Cote, Christopher; Bozue, Joel; Welkos, Susan] USAMRIID, Bacteriol Div, Frederick, MD 21702 USA.
[Twenhafel, Nancy] USAMRIID, Div Pathol, Frederick, MD 21702 USA.
[Merkel, Tod] US FDA, Lab Resp & Special Pathogens, Div Bacterial Parasit & Allergen Prod, CBER, Bethesda, MD 20014 USA.
RP Welkos, S (reprint author), USAMRIID, Bacteriol Div, 1425 Porter St, Frederick, MD 21702 USA.
EM Susan.welkos@us.army.mil
FU Defense Threat Reduction Agency JSTO-CBD [02-4-5C-023]
FX The research described here was sponsored by the Defense Threat
Reduction Agency JSTO-CBD as 02-4-5C-023 (to S. W.)/Medical
Research/Material Command Research Plan.
NR 72
TC 23
Z9 23
U1 2
U2 6
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0019-9567
J9 INFECT IMMUN
JI Infect. Immun.
PD JAN
PY 2011
VL 79
IS 1
BP 153
EP 166
DI 10.1128/IAI.00925-10
PG 14
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 697WJ
UT WOS:000285550200014
PM 21041498
ER
PT J
AU Bell, RL
Gonzalez-Escalona, N
Stones, R
Brown, EW
AF Bell, Rebecca L.
Gonzalez-Escalona, Narjol
Stones, Robert
Brown, Eric W.
TI Phylogenetic evaluation of the 'Typhimurium' complex of Salmonella
strains using a seven-gene multi-locus sequence analysis
SO INFECTION GENETICS AND EVOLUTION
LA English
DT Article
DE Salmonella enterica; Phylogenetics; Multi-locus sequence analysis;
Reference collection; Genetic diversity
ID FIELD GEL-ELECTROPHORESIS; ENTERICA SEROVAR TYPHIMURIUM;
ESCHERICHIA-COLI; POPULATION-STRUCTURE; TYPING DATA; EVOLUTIONARY;
RECOMBINATION; PATHOGENS; INCONGRUENCE; CLONES
AB Salmonella enterica comprises over 2500 serovars, many of which are significant foodborne pathogens in humans. The ability to subtype these microbes is difficult due to the highly clonal nature of many Salmonella strains and a lack of congruence among traditional typing approaches. This work examines the phylogenetic utility of a multi-locus sequence typing (MIST) approach to discriminate between members of a closely related collection of salmonellae, the Salmonella reference collection A (SARA). This 72 strain collection, referred to as the 'Typhimurium' complex, consists of S. Typhimurium and its four closest serological relatives. In this analysis, nucleotide sequences from seven housekeeping genes (aroC, dnaN, hemD, hisD, purE, sucA, and thrA) were PCR amplified, sequenced, and combined into a single concatenated character matrix providing 3360 bp for cladistic analysis. The resultant most parsimonious tree yielded seven clades of Salmonella strains that partitioned largely along serovar divisions within the collection except for five 'Paratyphi B' strains, two 'Saintpaul' strains, and two 'Typhimurium' strains. Convergence in the SARA tree was approximately 20% indicating that the vast majority of sequence changes were phylogenetically informative. Despite a high consistency among nucleotide substitutions, analysis of congruence identified several SARA strains with recombinant alleles in the concatenated matrix. These findings point to important differences among phylogenetic contributions made by the individual genes comprising this MLST dataset. Published by Elsevier B.V.
C1 [Bell, Rebecca L.; Gonzalez-Escalona, Narjol; Brown, Eric W.] US FDA, Div Microbiol, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Stones, Robert] Food & Environm Res Agcy, York YO41 1LZ, N Yorkshire, England.
RP Bell, RL (reprint author), US FDA, Div Microbiol, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy,Mailstop HFS-712, College Pk, MD 20740 USA.
EM rebecca.bell@fda.hhs.gov
RI Gonzalez-Escalona, Narjol/A-7598-2009;
OI Gonzalez-Escalona, Narjol/0000-0003-4568-0022
FU Center for Food Safety and Applied Nutrition
FX We are very grateful to E. Strain, M. Naum, J. Zheng, and M. Allard, for
insightful comments and to E.F. Boyd for kindly contributing strains. R.
Bell was supported in part by an appointment with the Research
Participation Program at the Center for Food Safety and Applied
Nutrition administered by Oak Ridge Institute for Science and Education
through and interagency agreement between the U.S. Department of Energy
and the U.S. Food and Drug Administration
NR 40
TC 11
Z9 11
U1 0
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1567-1348
J9 INFECT GENET EVOL
JI Infect. Genet. Evol.
PD JAN
PY 2011
VL 11
IS 1
BP 83
EP 91
DI 10.1016/j.meegid.2010.10.005
PG 9
WC Infectious Diseases
SC Infectious Diseases
GA 711AT
UT WOS:000286558800012
PM 20970525
ER
PT J
AU Trujillo, S
Keys, CE
Brown, EW
AF Trujillo, Socrates
Keys, Christine E.
Brown, Eric W.
TI Evaluation of the taxonomic utility of six-enzyme pulsed-field gel
electrophoresis in reconstructing Salmonella subspecies phylogeny
SO INFECTION GENETICS AND EVOLUTION
LA English
DT Article
DE Salmonella enterica; PFGE; Taxonomy; Phylogenetic analysis; Serovar;
Subspecies; Cladistics; Congruence
ID ESCHERICHIA-COLI O157-H7; HORIZONTAL GENE-TRANSFER; LENGTH DIFFERENCE
TEST; REFERENCE COLLECTION; MOLECULAR PHYLOGENY; UNITED-STATES; STRAINS;
RECOMBINATION; INCONGRUENCE; RELATEDNESS
AB Pulsed-field gel electrophoresis (PFGE) remains an important tool in the molecular epidemiological evaluation of strains emerging from disease outbreak clusters. Recent studies of Escherichia coli O157:H7 and Salmonella Enteritidis have noted marked improvements in the discriminatory power of PFGE when combining band profiles from up to six restriction enzyme datasets into a single concatenated analysis. This approach has provided more accurate assignments of genetic relationships among closely related strains and allowed effective phylogenetic inference of host and geographical reservoirs. Although this approach enhances epidemiological congruence among closely related strains, it remains unclear to what extent six-enzyme PFGE pattern similarity reiterates evolutionary relatedness among more distantly related Salmonella strains (i.e., serovar or subspecies levels). Here, taxonomic accuracy of six-enzyme PFGE is tested phylogenetically across two distinct Salmonella enterica populations-Salmonella reference collection B (SARB), representing the breadth of taxonomic diversity of S. enterica subspecies I only, and Salmonella reference collection C (SARC), comprising the seven disparate subspecies of S. enterica plus S. bongori. Cladistic analysis of SAR strains revealed substantial polyphyly between the two strain collections such that numerous SARB strains clustered more closely with diverged SARC subspecies rather than with other members of subspecies I. Also, in several cases, SARC sibling strains from the same subspecies were evolutionary obscured-broken into distant locales on the most parsimonious six-enzyme trees. Genetic diversity among SARB and SARC strains was comparable at 45% and 47%, respectively, while congruence testing revealed discordance among individual enzyme datasets. While six-enzyme PFGE is effective in ascertaining accurate genetic relationships for more closely related strains (e.g, strains within the same serovar), reconstitution of evolutionarily meaningful strain groupings may be elusive for Salmonella at the serovar level and above. Thus, caution is warranted when applying PFGE with a limited number of enzymes as the primary phylogenetic marker in these instances. Published by Elsevier B.V.
C1 [Trujillo, Socrates; Keys, Christine E.; Brown, Eric W.] US FDA, Div Microbiol, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Trujillo, S (reprint author), US FDA, Div Microbiol, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy,Mailstop HFS-712, College Pk, MD 20740 USA.
EM socrates.trujillo@gmail.com
NR 44
TC 6
Z9 6
U1 0
U2 4
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1567-1348
EI 1567-7257
J9 INFECT GENET EVOL
JI Infect. Genet. Evol.
PD JAN
PY 2011
VL 11
IS 1
BP 92
EP 102
DI 10.1016/j.meegid.2010.10.004
PG 11
WC Infectious Diseases
SC Infectious Diseases
GA 711AT
UT WOS:000286558800013
PM 20959148
ER
PT S
AU Graff, CG
Myers, KJ
AF Graff, Christian G.
Myers, Kyle J.
BE Szekely, G
Hahn, HK
TI The Ideal Observer Objective Assessment Metric for Magnetic Resonance
Imaging Application to Signal Detection Tasks
SO INFORMATION PROCESSING IN MEDICAL IMAGING
SE Lecture Notes in Computer Science
LA English
DT Proceedings Paper
CT 22nd International Conference on Information Processing in Medical
Imaging (IPMI)
CY JUL 03-08, 2011
CL GERMANY
SP Swiss Natl Ctr Competence Res Comp-Aided & Image-Guided Med Intervent (NCCR Co-Me), Bayer HealthCare, Diagnost Imaging, MeVis Med Solut AG, Siemens AG, HealthCare Sect, Zurich Ctr Imaging Sci & Technol (CIMST)
ID NOISE MEASUREMENTS; SNR; PERFORMANCE
AB The ideal Bayesian observer is a mathematical construct which makes optimal use of all statistical information about the object and imaging system to perform a task. Its performance serves as an upper bound on any observer's task performance. In this paper a methodology based on the ideal observer for assessing magnetic resonance (MR) acquisition sequences and reconstruction algorithms is developed. The ideal observer in the context of MR imaging is defined and expressions for ideal observer performance metrics are derived. Comparisons are made between the raw-data ideal observer and image-based ideal observer to elucidate the effect of image reconstruction on task performance. Lesion detection tasks are studied in detail via analytical expressions and simulations. The effect of imaging sequence parameters on lesion detectability is shown and the advantages of this methodology over image quality metrics currently in use in MR imaging is demonstrated.
C1 [Graff, Christian G.; Myers, Kyle J.] US FDA, Ctr Devices & Radiol Hlth, Div Imaging & Appl Math, Silver Spring, MD USA.
RP Graff, CG (reprint author), US FDA, Ctr Devices & Radiol Hlth, Div Imaging & Appl Math, Silver Spring, MD USA.
EM christian.graff@fda.hhs.gov
NR 10
TC 2
Z9 2
U1 0
U2 5
PU SPRINGER-VERLAG BERLIN
PI BERLIN
PA HEIDELBERGER PLATZ 3, D-14197 BERLIN, GERMANY
SN 0302-9743
BN 978-3-642-22091-3
J9 LECT NOTES COMPUT SC
PY 2011
VL 6801
BP 760
EP 771
PG 12
WC Computer Science, Interdisciplinary Applications; Computer Science,
Theory & Methods; Radiology, Nuclear Medicine & Medical Imaging
SC Computer Science; Radiology, Nuclear Medicine & Medical Imaging
GA BAW91
UT WOS:000305885000062
ER
PT J
AU Fischhoff, B
AF Fischhoff, Baruch
BE Fischhoff, B
Chauvin, C
TI Communicating About Analysis
SO INTELLIGENCE ANALYSIS: BEHAVIORAL AND SOCIAL SCIENTIFIC FOUNDATIONS
LA English
DT Article; Book Chapter
ID DECISION-MAKING; PROBABILITY; FORECASTS; MODELS; RISK
C1 [Fischhoff, Baruch] Carnegie Mellon Univ, Dept Social & Decis Sci, Pittsburgh, PA 15213 USA.
[Fischhoff, Baruch] Carnegie Mellon Univ, Dept Engn & Publ Policy, Pittsburgh, PA 15213 USA.
[Fischhoff, Baruch] Soc Risk Anal, New York, NY USA.
[Fischhoff, Baruch] Soc Judgment & Decis Making, Washington, DC USA.
[Fischhoff, Baruch] Amer Psychol Soc, Washington, DC USA.
[Fischhoff, Baruch] Amer Psychol Assoc, Washington, DC USA.
[Fischhoff, Baruch] US FDA, Risk Commun Advisory Comm, Rockville, MD 20857 USA.
[Fischhoff, Baruch] US EPA, Sci Advisory Board, Homeland Secur Advisory Comm, Washington, DC USA.
RP Fischhoff, B (reprint author), Carnegie Mellon Univ, Dept Social & Decis Sci, Pittsburgh, PA 15213 USA.
NR 54
TC 1
Z9 1
U1 0
U2 0
PU NATL ACADEMIES PRESS
PI WASHINGTON
PA 2101 CONSTITUTION AVE, WASHINGTON, DC 20418 USA
BN 978-0-309-17698-9
PY 2011
BP 227
EP 248
PG 22
WC Multidisciplinary Sciences; Social Sciences, Interdisciplinary
SC Science & Technology - Other Topics; Social Sciences - Other Topics
GA BC4IE
UT WOS:000352541500015
ER
PT S
AU Stokes, WS
Kulpa-Eddy, J
McFarland, R
AF Stokes, William S.
Kulpa-Eddy, Jodie
McFarland, Richard
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI The International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing:
introduction and summary
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE veterinary vaccines; human vaccines; ICCVAM; potency testing; safety
testing; alternatives
ID INACTIVATED RABIES VACCINES; QUALITY-CONTROL; RECOMMENDATIONS; CHALLENGE
AB Vaccines contribute to improved animal and human health and welfare by preventing diseases and deaths from infectious diseases. However, testing necessary to ensure vaccine effectiveness and safety can involve large numbers of animals and significant pain and distress. NICEATM and ICCVAM recently convened an international workshop to review the state of the science of available alternative methods and approaches that can further reduce, refine, and replace the use of animals for human and veterinary vaccine potency and safety testing, and to identify research, development, and validation efforts necessary to further advance new and improved alternative methods. Workshop participants identified human and veterinary vaccines that should have the highest priority for future efforts. Prioritization criteria included testing that involves significant pain and distress, large numbers of animals, and pathogens that are dangerous to people and animals. Participants noted that in vitro antigen quantification assays have replaced animals for potency testing for some killed vaccines, and recommended that this approach be expanded to other vaccines. Recommendations to support more humane animal use included development and use of humane endpoints for all challenge tests, development of serologic assays to replace challenge tests, and development of in vitro toxin neutralization tests (TNT) to replace in vivo TNTs. Workshop participants recommended several approaches that might further reduce the number of animals required for specific potency tests. Participants also recommended priority vaccines for which alternative safety testing methods should be pursed and that would have the greatest impact on avoiding pain and distress and reducing animal numbers. Finally, workshop participants recommended enhanced international harmonization and cooperation efforts and closer collaborations between human and veterinary researchers to expedite progress. Implementation of the workshop recommendations is expected to advance new methods for vaccine testing that will reduce animal use, benefit animal welfare, and ensure continued and improved protection of human and animal health. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of the National Toxicology Program Interagency for the Evaluation of Alternative Toxicological Methods (NICEATM).
C1 [Stokes, William S.] NIEHS, Natl Toxicol Program, Interagcy Ctr Evaluat Alternat Toxicol Methods, Div Natl Toxicol Program, POB 12233, Res Triangle Pk, NC 27709 USA.
[Kulpa-Eddy, Jodie] US Dept, Agr Anim & Plant Hlth Inspect Serv Vet Serv, Riverdale, MD USA.
[McFarland, Richard] US FDA, Ctr Biol Evaluat & Res, Rockville, MD USA.
RP Stokes, WS (reprint author), NIEHS, Natl Toxicol Program, Interagcy Ctr Evaluat Alternat Toxicol Methods, Div Natl Toxicol Program, POB 12233, Res Triangle Pk, NC 27709 USA.
EM stokes@niehs.nih.gov
NR 58
TC 13
Z9 13
U1 0
U2 3
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 1
EP 15
DI 10.1016/j.provac.2011.10.001
PG 15
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900001
ER
PT S
AU McFarland, R
Verthelyi, D
Casey, W
Arciniega, J
Isbrucker, R
Schmitt, M
Finn, T
Descamps, J
Horiuchi, Y
Sesardic, D
Stickings, P
Johnson, NW
Lipscomb, E
Allen, D
AF McFarland, Richard
Verthelyi, Daniela
Casey, Warren
Arciniega, Juan
Isbrucker, Richard
Schmitt, Michael
Finn, Theresa
Descamps, Johan
Horiuchi, Yoshinobu
Sesardic, Dorothea
Stickings, Paul
Johnson, Nelson W.
Lipscomb, Elizabeth
Allen, David
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI Non-animal replacement methods for human vaccine potency testing: state
of the science and future directions
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE human vaccines; vaccine potency testing; vaccine safety testing;
replacement alternatives; ICCVAM
ID RABIES VACCINES; ANIMAL-MODELS; UNITED-STATES; COMBINATION; ELISA
AB NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods, and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. This report addresses methods and strategies identified by workshop participants for replacement of animals used for potency testing of human vaccines. Vaccines considered to have the highest priority for future efforts were (1) vaccines for which antigen quantification methods are already developed but not validated, (2) vaccines/components that require the largest number of animals, (3) vaccines that require an in vivo challenge test, and (4) vaccines with in vivo tests that are highly variable and cause a significant number of invalid tests. Vaccine potency tests identified as the highest priorities for replacement were those for diphtheria and tetanus, pertussis (whole cell and acellular), rabies, anthrax, polio vaccine (inactivated) and complex combination vaccines based on DT or DTwP/aP. Research into understanding the precise mechanism of protection afforded by vaccines and the identification of clinically relevant immunological markers are needed to facilitate the successful implementation of in vitro testing alternatives. This report also identifies several priority human vaccines and associated research objectives that are necessary to successfully implement in vitro vaccine potency testing alternatives. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of the National Toxicology Program Interagency for the Evaluation of Alternative Toxicological Methods (NICEATM).
C1 [McFarland, Richard; Casey, Warren] NIEHS, Natl Toxicol Program, Interagcy Ctr Evaluat Alternat Toxicol Methods, POB 12233, Res Triangle Pk, NC 27709 USA.
[McFarland, Richard; Arciniega, Juan; Schmitt, Michael; Finn, Theresa] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[Casey, Warren] Natl Inst Environm Hlth Sci, Div Natl Toxicol Program, Ctr Evaluat Alternat Toxicol Methods, Natl Toxicol Program Interagency, Morrisville, NC USA.
[Isbrucker, Richard] Hlth Canada, Ctr Vaccine Evaluat, Ottawa, ON, Canada.
[Descamps, Johan] GlaxoSmithKline Biol, Rixensart, Belgium.
[Horiuchi, Yoshinobu] Pharmaceut & Med Devices Agcy Japan, Tokyo, Japan.
[Sesardic, Dorothea; Stickings, Paul] Natl Inst Biol Standards & Control, Hlth Protect Agcy, Ridge, England.
[Johnson, Nelson W.; Lipscomb, Elizabeth; Allen, David] Integrated Lab Syst Inc, Morrisville, NC USA.
RP Casey, W (reprint author), NIEHS, Natl Toxicol Program, Interagcy Ctr Evaluat Alternat Toxicol Methods, POB 12233, Res Triangle Pk, NC 27709 USA.
EM warren.casey@nih.gov
NR 70
TC 9
Z9 9
U1 1
U2 9
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 16
EP 32
DI 10.1016/j.provac.2011.10.002
PG 17
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900002
ER
PT S
AU Casey, W
Schmitt, M
McFarland, R
Isbrucker, R
Levis, R
Arciniega, J
Descamps, J
Finn, T
Hendriksen, C
Horiuchi, Y
Keller, J
Kojima, H
Sesardic, D
Stickings, P
Johnson, NW
Lipscomb, E
Allen, D
AF Casey, Warren
Schmitt, Michael
McFarland, Richard
Isbrucker, Richard
Levis, Robin
Arciniega, Juan
Descamps, Johan
Finn, Theresa
Hendriksen, Coenraad
Horiuchi, Yoshinobu
Keller, James
Kojima, Hajime
Sesardic, Dorothea
Stickings, Paul
Johnson, Nelson W.
Lipscomb, Elizabeth
Allen, David
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI Improving animal welfare and reducing animal use for human vaccine
potency testing: state of the science and future directions
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE human vaccines; vaccine potency testing; vaccine safety testing;
refinement alternatives; reduction alternatives; ICCVAM
ID QUALITY-CONTROL; VALIDATION
AB NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. Topics were addressed in detail by speakers and workshop participants and are reported in a series of six reports. This workshop report, the third in the series, addresses methods and strategies for human vaccine potency testing that can refine animal use to lessen pain and distress, improve animal welfare, and reduce animal use. Workshop participants agreed that the following potency tests for human vaccines should have the highest priority for development of reduction and/or refinement methods: (1) potency tests for vaccines that are most commonly used, (2) potency tests that require the largest number of animals, (3) potency tests that cause severe animal pain and distress, (4) potency tests where the knowledge base of each antigen is advanced, and (5) potency tests for which alternative methods already exist or are in development. Based on these criteria, the highest-priority human vaccines were identified as diphtheria and tetanus vaccines, pertussis vaccines (whole cell and acellular), rabies vaccine, anthrax vaccine, and complex combination vaccines (containing diphtheria, tetanus, and pertussis together with other antigens such as IPV, Hib, and HepB). For successful implementation of reduction and refinement alternatives, further research is required into the development and broader use of humane endpoints, serological potency methods, and approaches that would reduce the number of animals used in currently approved potency assays. Because the workshop focused on both human and veterinary vaccines, workshop participants also recommended that human vaccine potency testing methods for rabies and tetanus be reviewed for their potential application to the corresponding veterinary vaccines. Participants agreed that achieving broader acceptance and use of alternative methods, requires that the general principles and procedures for the validation of alternative methods for vaccines be standardized/harmonized internationally. The research, development, validation, and harmonization activities recommended at this workshop are expected to lead to new reduction and/or refinement of animal use in human vaccine potency testing methods and more widespread adoption of existing methods that can reduce animal use and improve animal welfare while ensuring the continued safety and efficacy of human vaccines. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of the National Toxicology Program Interagency for the Evaluation of Alternative Toxicological Methods (NICEATM).
C1 [Casey, Warren] Natl Inst Environm Hlth Sci, Natl Toxicol Program, Interagcy Ctr Evaluat Alternat Toxicol Methods, POB 12233, Res Triangle Pk, NC 27709 USA.
[Schmitt, Michael; McFarland, Richard; Levis, Robin; Arciniega, Juan; Finn, Theresa; Keller, James] United States Food & Drug Adm, Ctr Biol Evaluat & Res, Rockville, MD USA.
[Isbrucker, Richard] Hlth Canada, Ctr Vaccine Evalut, Ottawa, ON, Canada.
[Descamps, Johan] GlaxoSmithKline Biol, Rixensart, Belgium.
[Hendriksen, Coenraad] Netherlands Vaccine Inst, Bilthoven, Netherlands.
[Horiuchi, Yoshinobu] Pharmaceut & Med Devices Agcy, Tokyo, Japan.
[Kojima, Hajime] Japanese Ctr Validat Alternat Methods, Tokyo, Japan.
[Sesardic, Dorothea; Stickings, Paul] Natl Inst Biol Stand & Controls, Hlth Protect Agcy, Hertford, England.
[Johnson, Nelson W.; Lipscomb, Elizabeth; Allen, David] Integrated Syst Lab Inc, Res Triangle Pk, NC USA.
RP Casey, W (reprint author), Natl Inst Environm Hlth Sci, Natl Toxicol Program, Interagcy Ctr Evaluat Alternat Toxicol Methods, POB 12233, Res Triangle Pk, NC 27709 USA.
EM warren.casey@nih.gov
NR 66
TC 11
Z9 11
U1 0
U2 7
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 33
EP 46
DI 10.1016/j.provac.2011.10.003
PG 14
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900003
ER
PT S
AU Isbrucker, R
Levis, R
Casey, W
McFarland, R
Schmitt, M
Arciniega, J
Descamps, J
Finn, T
Hendriksen, C
Horiuchi, Y
Keller, J
Kojima, H
Sesardic, D
Stickings, P
Johnson, NW
Allen, D
AF Isbrucker, Richard
Levis, Robin
Casey, Warren
McFarland, Richard
Schmitt, Michael
Arciniega, Juan
Descamps, Johan
Finn, Theresa
Hendriksen, Coenraad
Horiuchi, Yoshinobu
Keller, James
Kojima, Hajime
Sesardic, Dorothea
Stickings, Paul
Johnson, Nelson W.
Allen, David
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI Alternative methods and strategies to reduce, refine, and replace animal
use for human vaccine post-licensing safety testing: state of the
science and future directions
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE human vaccines; vaccine safety testing; vaccine potency testing; 3Rs
alternatives; ICCVAM
ID QUALITY-CONTROL; PERTUSSIS TOXIN; POLIOVIRUS; ENDOTOXIN; ASSAY
AB NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods, and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use (the 3Rs). Six topics were addressed in detail by speakers and workshop participants and are reported in a series of reports. This workshop report, the fifth in the series, addresses methods and strategies for human vaccine post-licensing safety testing that can reduce, refine, and replace animal use. It also provides recommendations for priority research and other activities necessary to advance the development and/or implementation of 3Rs methods for human vaccine post-licensing safety testing. Workshop participants agreed that future 3Rs activities should give highest priority to vaccine safety tests that (1) use the most animals per test and for which many vaccine lots are tested annually, (2) produce high variability and/or require frequent repeat tests, (3) are associated with severe animal pain and distress, and/or (4) involve nonhuman primates. Based on these criteria, safety tests for diphtheria, pertussis, oral polio, and tetanus vaccines were identified as the highest priorities. Recommended priority research, development, and validation activities included (1) expanding use of the transgenic mouse model for oral polio vaccine, and (2) developing alternatives to the monkey neurovirulence test for preclinical safety and lot release neurovirulence testing of mumps vaccines. Implementation of the workshop recommendations is expected to advance alternative in vitro methods for human vaccine post-licensing safety testing that will benefit animal welfare while ensuring continued production of safe human vaccines and protection of human and animal health. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of the National Toxicology Program Interagency for the Evaluation of Alternative Toxicological Methods (NICEATM).
C1 [Casey, Warren] NIEHS, Natl Toxicol Program Interagency Ctr, Evaluat Alternat Toxicol Methods, Div Natl Toxicol Program, Res Triangle Pk, NC USA.
[Isbrucker, Richard] Hlth Canada, Ctr Vaccine Evaluat, Ottawa, ON, Canada.
[Levis, Robin; McFarland, Richard; Schmitt, Michael; Arciniega, Juan; Finn, Theresa; Keller, James] US FDA, Ctr Biol Evaluat & Res, Rockville, MD USA.
[Descamps, Johan] GlaxoSmithKline Biol, Rixensart, Belgium.
[Hendriksen, Coenraad] Netherlands Vaccine Inst, Bilthoven, Netherlands.
[Horiuchi, Yoshinobu] Pharmaceut & Med Devices Agcy Japan, Tokyo, Japan.
[Kojima, Hajime] Japanese Ctr Validat Alternat Methods, Tokyo, Japan.
[Sesardic, Dorothea; Stickings, Paul] Natl Inst Biol Stand & Controls, Hlth Protect Agcy, Hertford, England.
[Johnson, Nelson W.; Allen, David] Integrated Lab Syst Inc, Res Triangle Pk, NC USA.
RP Casey, W (reprint author), NIEHS, Natl Toxicol Program Interagency Ctr, Evaluat Alternat Toxicol Methods, Div Natl Toxicol Program, Res Triangle Pk, NC USA.
EM warren.casey@nih.gov
NR 66
TC 9
Z9 9
U1 1
U2 11
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 106
EP 119
DI 10.1016/j.provac.2011.10.004
PG 14
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900007
ER
PT S
AU Finn, TM
AF Finn, Theresa M.
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI US FDA requirements for human vaccine product safety and potency testing
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE human vaccines; vaccine potency testing; vaccine safety testing; FDA
requirements; alternative methods
AB The Office of Vaccines Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) regulates preventative and therapeutic vaccines for infectious disease indications for use in humans. The framework for regulation of biological products includes Statutes (e.g. The U. S. Food, Drug and Cosmetic Act and the Public Health Service Act), regulations as defined in the Code of Federal Regulations (CFR) and guidance documents. Approval of a biologics license for a product, including vaccines, is based on a demonstration of safety, purity, and potency and assurance that the facility for manufacture, processing, and packaging meets standards to ensure that product released for distribution is safe, pure and potent. The regulatory definitions of safety, purity and potency are detailed in Title 21 of the Code of Federal regulations (CFR) Part 600. All manufacturing information including tests for safety, purity, and potency for a particular product must be documented in the Biologics License Application (BLA). Potency testing may be performed on the final bulk sample or final container sample and may consist of either in vivo or in vitro tests or both. To change a potency or safety test post-licensure requires a Supplement to the License and data to support a modified or alternative test. CBER encourages the development and use of appropriate alternative methods for vaccine safety and potency testing. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of Integrated Laboratory Systems, Inc.
C1 US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
RP Finn, TM (reprint author), US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
EM theresa.finn@fda.hhs.gov
NR 0
TC 7
Z9 7
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 137
EP 140
DI 10.1016/j.provac.2011.10.010
PG 4
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900010
ER
PT S
AU Keller, JE
AF Keller, James E.
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI Overview of currently approved serological methods with a focus on
diphtheria and tetanus toxoid potency testing
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE tetanus; diphtheria; toxoid; potency
ID INHIBITION TOBI TEST; CELL-CULTURE METHOD; TOXIN NEUTRALIZATION;
ANTITOXIN TITRATION; CLOSTRIDIAL TOXINS; GUINEA-PIGS; VERO CELLS;
HUMAN-SERA; VACCINES; ALUM
AB Vaccines are biological products made from living organisms. The natural complexity of biological molecules along with the inherent uncertainties of product manufacturing introduces the likelihood that random alterations can impact the quality of the vaccine each time it is made. The factors that can affect the final product are often unknown. Testing for potency of vaccine bulk or product dispensed into final containers was designed with the hope of ensuring that a vaccine is effective when used during its approved dating period and that its protective activity was not inadvertently altered during any phase of production. Ideally, potency testing measures a biological or biochemical property of the vaccine that is related to its ability to elicit protective immunity in the target population and provide some assurance that consistent clinical benefit is derived from each lot of product. Potency methods vary depending on the nature and composition of the vaccine. In vivo potency testing might entail immunizing groups of laboratory animals and then challenging them directly to measure survival, or involve serological potency assays in which sera from immunized laboratory animals are tested for the ability to neutralize pathogens or toxins. In the U.S., diphtheria toxoid and tetanus toxoid potency tests have customarily involved a serological method. This approach uses fewer animals than would have been required using a direct challenge method, while providing satisfactory evidence that each toxoid lot could induce protective immunity. This paper will discuss the details of the original U. S. test method for diphtheria and tetanus toxoid potency and present issues that must be considered when developing and validating non-animal-based approaches to refine or replace these tests. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of Integrated Laboratory Systems, Inc.
C1 US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Keller, JE (reprint author), US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM james.keller@fda.hhs.gov
NR 49
TC 8
Z9 8
U1 0
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 192
EP 199
DI 10.1016/j.provac.2011.10.019
PG 8
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900019
ER
PT S
AU Arciniega, JL
Dominguez-Castillo, RI
AF Arciniega, Juan L.
Dominguez-Castillo, Rocio I.
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI Development and validation of serological methods for human vaccine
potency testing: case study of an anthrax vaccine
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE potency testing; anthrax; TNA
ID PROTECTIVE ANTIGEN; TOXIN NEUTRALIZATION; BACILLUS-ANTHRACIS; LETHAL
TOXIN; BINDING; ELISA; MICE
AB Only one anthrax vaccine (Anthrax Vaccine Adsorbed, AVA) is licensed in the US to date, although new vaccines are under development. Logistic difficulties with the potency testing of AVA, plus humane considerations, have prompted the development of an alternative test method that can be used as a potency test not only for AVA, but also for newer vaccines. A potency test is not limited to measuring the concentration and quality of the antigen in the final formulation at the time of vaccine release, but should also detect changes in these characteristics during the dating period of the product, to ensure that the vaccine has retained its potency. We have developed a mouse immunogenicity test with potential for use as a potency test for anthrax vaccines. This model is based on the measurement of antibodies induced by a fixed dose of antigen. The test consists of two stages: a) the induction of antibodies in mice with one pre-selected test dose of vaccine; and b) the measurement of the response. We have established the test dose for AVA and experimental vaccines based on the use of anthrax Protective Antigen (PA). Two types of assays, an ELISA and a toxin neutralization assay (TNA) have been employed to measure antibodies to PA. TNA may be more useful in predicting vaccine efficacy, since it measures the neutralizing activity of sera against the cytotoxic effect of the toxin formed by PA when associated with Lethal Factor. However, anti-PA ELISA is less demanding from a technical point of view. Therefore, if ELISA were capable of detecting accurately changes in antigen quantity and quality, then it could be selected as the antibody-measuring test. Studies in our laboratory suggest that even though ELISA and TNA results are correlated, they may not be strictly interchangeable for quantification of anti-PA antibodies after a single immunization of mice with a test dose of anthrax vaccine. We have also found that TNA is better suited than ELISA to detect changes in immunogenicity caused by vaccine exposure to high temperature for very short periods (two minutes). These results open the possibility that an immunogenicity test in which TNA is used to quantify the anti-PA antibody responses can be used to measure vaccine potency of anthrax vaccines at the end of the manufacturing process and periodically after the finished product has been placed in storage, instead of an active protection test that requires lethal challenge. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of Integrated Laboratory Systems, Inc.
C1 [Arciniega, Juan L.; Dominguez-Castillo, Rocio I.] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
RP Arciniega, JL (reprint author), US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike, Rockville, MD 20852 USA.
EM juan.arciniega@fda.hhs.gov
NR 18
TC 8
Z9 8
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 213
EP 220
DI 10.1016/j.provac.2011.10.021
PG 8
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900021
ER
PT S
AU Arciniega, JL
Corvette, L
Hsu, H
Lynn, F
Romani, T
Dobbelaer, R
AF Arciniega, Juan L.
Corvette, Laura
Hsu, Henry
Lynn, Freyja
Romani, Theresa
Dobbelaer, Roland
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI Target alternative vaccine safety testing strategies for pertussis toxin
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE pertussis; vaccine; testing
ID HISTAMINE-SENSITIZATION TEST; ADP-RIBOSYLATION ACTIVITY;
BORDETELLA-PERTUSSIS; RESIDUAL ACTIVITY; QUALITY-CONTROL; ASSAY; CELL;
LOCUS; BPHS; RESPONSIVENESS
AB All acellular pertussis (aP) vaccines in use contain chemically inactivated pertussis toxin (PT). The finding that mice, naturally resistant to the effects of histamine, become sensitive upon injection of minute amounts of PT, led to the development of the test for residual PT known as the histamine sensitization assay (HSA). The HSA used by U. S.-licensed manufacturers is a limit test that shows that the residual bioactivity of PT in a single human dose of vaccine is below a threshold. Limit tests do not allow quantitative measurement. When the method is newly established at the point of use, three or more dilutions of pure PT are used to verify that mice injected with the vaccine came from a shipment that have sensitivity consistent with historical values. Sensitizability is expressed as an HSD50 (the dose that sensitizes 50% of a group of mice). However, once linearity of the dose response has been demonstrated, the assay may be simplified so as to include in each test only a single control group injected with PT. This assay simplification constitutes an example of the so-called "consistency approach." A Japanese variant of the HSA uses a drop in body temperature as a nonlethal alternative index of PT-mediated sensitization and can provide a quantitative estimate of the residual PT activity of a vaccine. However, the advantage of a quantitative method is not obvious, because the amount of PT that is unsafe for humans is unknown. In addition, although the use of a nonlethal endpoint constitutes an important refinement, the need for a reference group in the test to obtain a quantitative estimate increases the number of animals required, relative to the number used in a simplified limit test. Moreover, the nonlethal endpoint might be adapted to the limit test format, and important steps have been taken in this regard. Finally, one option under early evaluation is the possibility of using the results from two in vitro assays, an enzymatic activity assay and a binding assay, to replace the HSA. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of Integrated Laboratory Systems, Inc.
C1 [Arciniega, Juan L.; Corvette, Laura; Hsu, Henry; Lynn, Freyja; Romani, Theresa] US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike, Rockville, MD 20852 USA.
[Dobbelaer, Roland] Inst Scientigique Sante Publique, Brussels, Belgium.
RP Arciniega, JL (reprint author), US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike, Rockville, MD 20852 USA.
EM juan.arciniega@fda.hhs.gov
NR 42
TC 8
Z9 8
U1 0
U2 4
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 248
EP 260
DI 10.1016/j.provac.2011.10.026
PG 13
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900026
ER
PT S
AU Rubin, SA
AF Rubin, Steven A.
BE KulpaEddy, J
McFarland, R
Stokes, WS
TI Toward replacement of the monkey neurovirulence test in vaccine safety
testing
SO INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND
REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE
OF THE SCIENCE AND FUTURE DIRECTIONS
SE Procedia in Vaccinology
LA English
DT Proceedings Paper
CT International Workshop on Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine Potency and Safety Testing - State
of the Science and Future Directions
CY SEP 14-16, 2010
CL Bethesda, MD
DE vaccine; neurovirulence safety testing; monkey; MAPREC; MPS
ID ORAL POLIOVIRUS VACCINE; MUMPS-VIRUS NEUROVIRULENCE; RHESUS-MONKEYS;
RAT-BRAIN; MICE; LIVE
AB For live, attenuated vaccines derived from neurotropic wild-type viruses, regulatory authorities require neurovirulence safety testing, typically using monkeys, to assure the absence of residual neurotoxicity. Ethical concerns surrounding the use of nonhuman primates in product testing, coupled with questions over its predictive value, has resulted in a concerted effort to replace monkey-based neurovirulence safety testing with more informative, validated alternative methods that include the use of lower animal species (e.g., mice and rats) and/or in vitro assays such as mutation analysis by PCR and restriction enzyme cleavage (MAPREC). MAPREC is a WHO-approved screening tool to assess reversion to neurovirulence of oral poliovirus vaccine (OPV). Monitoring the genetic consistency of OPV lots by identification and quantification of the mutational profile using the recently developed technology of massively parallel sequencing (MPS) also holds promise not only as a replacement for nonhuman primate testing of OPV lots but for other vaccines for which animal-based tests are currently performed as a measure of manufacturing consistency and freedom of adventitious virus contamination. In many cases, the greatest hurdle to availability of such alternative methods has been the process rather than the science. This report summarizes the current status of alternative methods of neurovirulence safety testing, both those validated and those currently in development. (C) 2011 Published by Elsevier Ltd. Selection and/or peer-review under responsibility of Integrated Laboratory Systems, Inc.
C1 US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
RP Rubin, SA (reprint author), US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike, Rockville, MD 20852 USA.
EM Steven.rubin@fda.hhs.gov
NR 24
TC 7
Z9 8
U1 0
U2 4
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA SARA BURGERHARTSTRAAT 25, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1877-282X
J9 PROCEDIA VACCINOL
JI Procedia Vaccinol.
PY 2011
VL 5
BP 261
EP 265
DI 10.1016/j.provac.2011.10.027
PG 5
WC Public, Environmental & Occupational Health; Immunology; Medicine,
Research & Experimental
SC Public, Environmental & Occupational Health; Immunology; Research &
Experimental Medicine
GA BYU28
UT WOS:000300380900027
ER
PT J
AU Handy, SM
Deeds, JR
Ivanova, NV
Hebert, PDN
Hanner, RH
Ormos, A
Weigt, LA
Moore, MM
Yancy, HF
AF Handy, Sara M.
Deeds, Jonathan R.
Ivanova, Natalia V.
Hebert, Paul D. N.
Hanner, Robert H.
Ormos, Andrea
Weigt, Lee A.
Moore, Michelle M.
Yancy, Haile F.
TI A Single-Laboratory Validated Method for the Generation of DNA Barcodes
for the Identification of Fish for Regulatory Compliance
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID PHYLOGENETIC TREES; SEAFOOD; LIFE
AB The U.S. Food and Drug Administration is responsible for ensuring that the nation's food supply is safe and accurately labeled. This task is particularly challenging in the case of seafood where a large variety of species are marketed, most of this commodity is imported, and processed product is difficult to identify using traditional morphological methods. Reliable species identification is critical for both foodborne illness investigations and for prevention of deceptive practices, such as those where species are intentionally mislabeled to circumvent import restrictions or for resale as species of higher value. New methods that allow accurate and rapid species identifications are needed, but any new methods to be used for regulatory compliance must be both standardized and adequately validated. "DNA barcoding" is a process by which species discriminations are achieved through the use of short, standardized gene fragments. For animals, a fragment (655 base pairs starting near the 5' end) of the cytochrome c oxidase subunit 1 mitochondrial gene has been shown to provide reliable species level discrimination in most cases. We provide here a protocol with single-laboratory validation for the generation of DNA barcodes suitable for the identification of seafood products, specifically fish, in a manner that is suitable for FDA regulatory use.
C1 [Handy, Sara M.; Deeds, Jonathan R.] US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Ivanova, Natalia V.; Hebert, Paul D. N.] Univ Guelph, Biodivers Inst Ontario, Canadian Ctr DNA Barcoding, Guelph, ON N1G 2W1, Canada.
[Hanner, Robert H.] Univ Guelph, Dept Integrat Biol, Guelph, ON N1G 2W1, Canada.
[Ormos, Andrea; Weigt, Lee A.] Smithsonian Inst, Natl Museum Nat Hist, Labs Analyt Biol, Washington, DC 20013 USA.
[Moore, Michelle M.] US FDA, Off Regulatory Affairs, Pacific Reg Lab NW, Appl Technol Ctr, Bothell, WA 98021 USA.
[Yancy, Haile F.] US FDA, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
RP Handy, SM (reprint author), US FDA, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM Sara.Handy@fda.hhs.gov
RI Handy, Sara/C-6195-2008; Hebert, Paul/C-4161-2013
OI Hebert, Paul/0000-0002-3081-6700
FU Genome Canada through the Ontario Genomics Institute; Natural Sciences
and Engineering Research Council of Canada; Advanced Foods and Materials
Network
FX We would like to thank Karen Blickenstaff (FDA Center for Veterinary
Medicine) for instruction and support on the ABI 3730 sequencer; Jeff
Williams and Jerry Finan (Fish Division of NMNH) for fish
authentication; Errol Strain (FDA Center for Food Safety and Applied
Nutrition) for his help with data analysis; and Yolanda Jones (FDA
Center for Veterinary Medicine) for sample preparation. The pilot
studies carried out at CCDB were supported by grants to P.D.N.H. from
Genome Canada through the Ontario Genomics Institute, and Natural
Sciences and Engineering Research Council of Canada. We also acknowledge
the laboratory assistance of Heather Braid during pilot studies
conducted in the Department of Integrative Biology at the University of
Guelph, with grant support to R.H.H. from Advanced Foods and Materials
Network.
NR 32
TC 55
Z9 59
U1 3
U2 33
PU AOAC INT
PI GAITHERSBURG
PA 481 N FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD JAN-FEB
PY 2011
VL 94
IS 1
BP 201
EP 210
PG 10
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 719QA
UT WOS:000287222000024
PM 21391497
ER
PT J
AU McClure, FD
Lee, JK
AF McClure, Foster D.
Lee, Jung K.
TI Determination of Operating Characteristic, Retesting, and Testing Amount
Probabilities Associated with Testing for the Presence of Salmonella in
Foods
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
AB The relatively small perceived probability associated with retesting a food for the presence of Salmonella at low levels is often considered as one of the reasons that a confirmatory or check-analysis tends to disagree in practice with the results of an original test. Given a retesting process where a retest is only performed to confirm an original positive Salmonella test, the probability that both the original and retest will test positive for Salmonella has been traditionally determined by some as the product of the probabilities of a positive Salmonella test for the original and retest samples. When examining the probabilities associated with the retesting process, we found that our results disagreed with those based on intuitions apparently held by others concerning how these probabilities should be calculated. For Salmonella testing, operating characteristic values were computed to demonstrate the protections afforded by the Salmonella sampling plans presented in the U.S. Food and Drug Administration's Bacteriological Analytical Manual and to obtain the probability of a positive Salmonella test. The geometric distribution was examined for possible utility in determining the probabilities associated with testing amounts, i.e., the number of Salmonella tests needed to obtain a positive test.
C1 [McClure, Foster D.; Lee, Jung K.] US FDA, Ctr Food Safety & Appl Nutr, Off Food Def Commun & Emergency Response, Div Publ Hlth & Biostat, College Pk, MD 20740 USA.
RP McClure, FD (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Food Def Commun & Emergency Response, Div Publ Hlth & Biostat, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM fdmc5100@yahoo.com
NR 8
TC 1
Z9 1
U1 1
U2 2
PU AOAC INT
PI GAITHERSBURG
PA 481 N FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD JAN-FEB
PY 2011
VL 94
IS 1
BP 327
EP 334
PG 8
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 719QA
UT WOS:000287222000038
PM 21391511
ER
PT J
AU Peredeltchouk, M
David, SAW
Bhattacharya, B
Volokhov, DV
Chizhikov, V
AF Peredeltchouk, M.
David, S. A. Wilson
Bhattacharya, B.
Volokhov, D. V.
Chizhikov, V.
TI Detection of mycoplasma contamination in cell substrates using reverse
transcription-PCR assays
SO JOURNAL OF APPLIED MICROBIOLOGY
LA English
DT Article
DE 16S rRNA; detection; mycoplasma; PCR; reverse transcription
ID RIBOSOMAL-RNA; NUCLEIC-ACIDS; BACTERIA; AMPLIFICATION; TECHNOLOGY;
DIAGNOSIS; BLOOD
AB Aims:
To assess the limit of detection (LOD) and the feasibility of 16S rRNA-based reverse transcription-PCR (RT-PCR) assays for advanced detection of mycoplasma contamination in cell substrates.
Materials and Methods:
The RT-PCR approach is based on detecting the 16S rRNA molecules that, in contrast to genomic bacterial DNA, are represented by multiple copies in mycoplasma cell. The number of 16S rRNA molecules in mycoplasma cells of five species i.e. Mycoplasma arginini, Myc. fermentans, Myc. hyorhinis, Myc. orale and Acholeplasma laidlawii, all known to be frequent cell line contaminants in industrial and research laboratories, was measured using molecular methods. The results of two independently prepared mycoplasma cultures harvested at the stationary phase of their growth showed that the 16S rRNA copy number per cell varied in the range from about 400 to 2000 copies, depending on species, but stayed close between different preparations of one species. The assessment of the LOD of the in-house 16S rRNA-based RT-PCR was performed using samples of MDCK cell culture spiked with different amounts of five aforementioned mycoplasma species. To minimize the bias in methods comparison, the LOD of the RT-PCR assay was expressed in terms of genome equivalents (GEs) and compared with that determined for highly optimized 16S rDNA-based mycoplasma testing methods previously described in scientific literature.
Conclusions:
The results of the study showed that the in-house 16S rRNA-based RT-PCR assay was able to reliably detect the presence of less than one mycoplasma GE that is at least 10-fold higher of the LOD previously determined for well-optimized 16S rDNA-based assays developed and described by other researchers.
Significance and Impact of the Study:
The results of the study showed that rapid RT-PCR methods based on the detection of bacterial 16S rRNA are able to expedite mycoplasma testing of cell cultures (1-2 days vs 28 days) and to ensure the limits of detection comparable to that of currently used culture-based mycoplasma testing methods.
C1 [Chizhikov, V.] US FDA, Ctr Biol Evaluat & Res, Off Vaccine Res & Review, Div Viral Prod,Lab Methods Dev, Rockville, MD 20852 USA.
RP Chizhikov, V (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Vaccine Res & Review, Div Viral Prod,Lab Methods Dev, HFM-470,1401 Rockville Pike, Rockville, MD 20852 USA.
EM vladimir.chizhikov@fda.hhs.gov
NR 17
TC 5
Z9 6
U1 0
U2 11
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1364-5072
J9 J APPL MICROBIOL
JI J. Appl. Microbiol.
PD JAN
PY 2011
VL 110
IS 1
BP 54
EP 60
DI 10.1111/j.1365-2672.2010.04853.x
PG 7
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 693EO
UT WOS:000285207600006
PM 20854458
ER
PT J
AU Li, Q
Zheng, G
Tiwari, R
AF Li, Q.
Zheng, G.
Tiwari, R.
TI Analysis of ordered categorical data with score averaging: with
applications to case-control genetic associations
SO JOURNAL OF APPLIED STATISTICS
LA English
DT Article
DE case-control genetic associations; MAX; ordered categorical data;
robustness; score averaging tests; trend tests
ID GENOME-WIDE ASSOCIATION; NUISANCE PARAMETER; STATISTICAL-METHODS;
CONTINGENCY-TABLES; TREND TESTS; RISK; DRAWBACKS; MAXIMUM; CANCER;
CHOICE
AB The trend test is often used for the analysis of 2 x K ordered categorical data, in which K pre-specified increasing scores are used. There have been discussions on how to assign these scores and the impact of the outcomes on different scores. The scores are often assigned based on the data-generating model. When this model is unknown, using the trend test is not robust. We discuss the weighted average of a trend test over all scientifically plausible choices of scores or models. This approach is more computationally efficient than a commonly used robust test MAX when K is large. Our discussion is for any ordered 2 x K table, but simulation and applications to real data are focused on case-control genetic association studies. Although there is no single test optimal for all choices of scores, our numerical results show that some score averaging tests can achieve the performance of MAX.
C1 [Li, Q.] Chinese Acad Sci, Acad Math & Syst Sci, Beijing 100190, Peoples R China.
[Zheng, G.] US Natl Heart Lung & Blood Inst, Off Biostat Res, Bethesda, MD 20892 USA.
[Tiwari, R.] US FDA, Ctr Drug Evaluat & Res, Off Biostat, Silver Spring, MD 20993 USA.
RP Li, Q (reprint author), Chinese Acad Sci, Acad Math & Syst Sci, Beijing 100190, Peoples R China.
EM liqz@amss.ac.cn
FU National Young Science Foundation of China [10901155]
FX The work of Q. Li was supported in part by the National Young Science
Foundation of China (grant 10901155).
NR 24
TC 1
Z9 1
U1 0
U2 3
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.
PY 2011
VL 38
IS 9
BP 1833
EP 1843
DI 10.1080/02664763.2010.529881
PG 11
WC Statistics & Probability
SC Mathematics
GA 873YF
UT WOS:000298921300006
ER
PT J
AU Goodman, MS
Li, Y
Tiwari, RC
AF Goodman, Melody S.
Li, Yi
Tiwari, Ram C.
TI Detecting multiple change points in piecewise constant hazard functions
SO JOURNAL OF APPLIED STATISTICS
LA English
DT Article
DE survival analysis; change points; piecewise constant; hazard function;
cancer
ID 2-PHASE REGRESSION; RATE MODEL; INFERENCE; LIKELIHOOD; CANCER
AB The National Cancer Institute (NCI) suggests a sudden reduction in prostate cancer mortality rates, likely due to highly successful treatments and screening methods for early diagnosis. We are interested in understanding the impact of medical breakthroughs, treatments, or interventions, on the survival experience for a population. For this purpose, estimating the underlying hazard function, with possible time change points, would be of substantial interest, as it will provide a general picture of the survival trend and when this trend is disrupted. Increasing attention has been given to testing the assumption of a constant failure rate against a failure rate that changes at a single point in time. We expand the set of alternatives to allow for the consideration of multiple change-points, and propose a model selection algorithm using sequential testing for the piecewise constant hazard model. These methods are data driven and allow us to estimate not only the number of change points in the hazard function but where those changes occur. Such an analysis allows for better understanding of how changing medical practice affects the survival experience for a patient population. We test for change points in prostate cancer mortality rates using the NCI Surveillance, Epidemiology, and End Results dataset.
C1 [Goodman, Melody S.] SUNY Stony Brook, Grad Program Publ Hlth, Dept Prevent Med, Sch Med, Stony Brook, NY 11794 USA.
[Li, Yi] Harvard Univ, Dept Biostat, Boston, MA 02115 USA.
[Li, Yi] Dana Farber Canc Inst, Dept Biostat & Computat Biol, Boston, MA 02115 USA.
[Tiwari, Ram C.] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Goodman, MS (reprint author), Washington Univ, Sch Med, Dept Surg, Div Publ Hlth Sci, St Louis, MO 63110 USA.
EM goodmanm@wudosis.wustl.edu
RI Goodman, Melody/F-6768-2011
OI Goodman, Melody/0000-0001-8932-624X
FU National Institute of Child Health and Human Development [5 F31
HD043695]; National Institute of Health [R01CA95747]
FX The research of M. S. G. was supported by National Institute of Child
Health and Human Development grant 5 F31 HD043695. The research of Y.L.
was supported by National Institute of Health grant R01CA95747. Views
expressed by R. C. T. here are his own and do not necessarily represent
those of Food and Drug Administration.
NR 17
TC 13
Z9 13
U1 2
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.
PY 2011
VL 38
IS 11
BP 2523
EP 2532
DI 10.1080/02664763.2011.559209
PG 10
WC Statistics & Probability
SC Mathematics
GA 873YY
UT WOS:000298923300010
PM 22707842
ER
PT J
AU Soon, GX
AF Soon, Guoxing (Greg)
TI Missing Data-Moving Forward
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Clinical trial; External data; Missing data; Prevention; Treatment
C1 US FDA, Div Biometr 4, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Soon, GX (reprint author), US FDA, Div Biometr 4, Off Biostat, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,WO21-3606, Silver Spring, MD 20993 USA.
EM Guoxing.Soon@fda.hhs.gov
NR 3
TC 0
Z9 0
U1 0
U2 0
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 2
SI SI
BP 177
EP 179
AR PII 934433288
DI 10.1080/10543406.2011.550093
PG 3
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 733RZ
UT WOS:000288281800001
PM 21390994
ER
PT J
AU Campbell, G
Pennello, G
Yue, L
AF Campbell, Gregory
Pennello, Gene
Yue, Lilly
TI Missing Data in the Regulation of Medical Devices
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Bayesian statistics; Diagnostic medical tests; Nonrandomized studies;
Propensity scores; Sensitivity analysis; Verification bias
ID DIAGNOSTIC-TESTS; CLINICAL-TRIALS; GOLD STANDARD; VERIFICATION;
IMPUTATION; CANCER; ISSUES; BIAS
AB Handling missing data is an important consideration in the analysis of data from all kinds of medical device studies. Missing data in medical device studies can arise for all the reasons one might expect in pharmaceutical clinical trials. In addition, they occur by design, in nonrandomized device studies, and in evaluations of diagnostic tests. For dichotomous endpoints, a tipping point analysis can be used to examine nonparametrically the sensitivity of conclusions to missing data. In general, sensitivity analysis is an important tool to study deviations from simple assumptions about missing data, such as the data being missing at random. Approaches to missing data in Bayesian trials are discussed, including sensitivity analysis. Many types of missing data that can occur with diagnostic test evaluations are surveyed. Careful planning and conduct are recommended to minimize missing data. Although difficult, the prespecification of all missing data analysis strategies is encouraged before any data are collected.
C1 [Campbell, Gregory; Pennello, Gene; Yue, Lilly] US FDA, Div Biostat, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Campbell, G (reprint author), US FDA, Div Biostat, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM greg.campbell@fda.hhs.gov
NR 26
TC 12
Z9 13
U1 0
U2 6
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 2
SI SI
BP 180
EP 195
AR PII 934436658
DI 10.1080/10543406.2011.550094
PG 16
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 733RZ
UT WOS:000288281800002
PM 21390995
ER
PT J
AU Scott, JA
Hsu, H
AF Scott, John A.
Hsu, Henry
TI Missing Data Issues at the FDA Center for Biologics Evaluation and
Research
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Biologics; Blood; FDA guidance; Missing data; Vaccines
AB Missing data in clinical trials pose a tremendous problem in the regulatory setting. The U.S. Food and Drug Administration relies on statistically rigorous evidence of safety and efficacy as a precondition for granting marketing approval for drugs, biologics, and many devices. The presence of missing data can compromise the integrity of any statistical analysis, further complicating a regulatory decision-making process with significant public health, legal, and financial implications. We review the unique missing data challenges faced by the Center for Biologics Evaluation and Research and discuss limitations in our current approach to these issues and potential directions for improvement.
C1 [Scott, John A.; Hsu, Henry] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
RP Scott, JA (reprint author), US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike,HFM-219, Rockville, MD 20852 USA.
EM John.Scott@fda.hhs.gov
OI Scott, John/0000-0002-9116-948X
NR 3
TC 0
Z9 0
U1 0
U2 3
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 2
SI SI
BP 196
EP 201
AR PII 934435323
DI 10.1080/10543406.2011.550095
PG 6
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 733RZ
UT WOS:000288281800003
PM 21390996
ER
PT J
AU Berger, VW
Vali, B
AF Berger, Vance W.
Vali, Behrang
TI Intent-to-Randomize Corrections for Missing Data Resulting from Run-In
Selection Bias in Clinical Trials for Chronic Conditions
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Enrichment; Intent-to-Randomize; Missing Completely at Random; Run-in
ID PHYSICIANS-HEALTH; ENRICHMENT; PERIOD; EFFICIENCY; VALIDITY; DESIGNS
AB In many clinical trials for chronic conditions a run-in period is used prior to randomization. Often, only those participants who meet certain criteria during the run-in phase go on to get randomized. The others, along with the information that they might have provided, are excluded from the study. This exclusion of the relevant response data from any subsequent study analysis can be considered as resulting in missing data; although quite common in practice, this approach has expectedly been shown to create a bias in favor of the active treatment when this active treatment is used during the run-in. Hence, many randomized clinical trials report overly optimistic results, with the extent of the bias depending in large part on how many otherwise eligible subjects were excluded due to the use of the run-in. If these biased trials are to contribute valid information to medical decision making, then the biases need to be corrected, and this involves accounting for all participants who were intended to be randomized. We propose specific imputation methods for doing so.
C1 [Berger, Vance W.] NCI, EPN, Bethesda, MD 20892 USA.
[Vali, Behrang] US FDA, Div Biometr 3, OB OTS CDER, Silver Spring, MD USA.
RP Berger, VW (reprint author), NCI, EPN, Suite 3131,6130 Execut Blvd, Bethesda, MD 20892 USA.
EM vb78c@nih.gov
NR 25
TC 5
Z9 5
U1 0
U2 3
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 WALNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 2
SI SI
BP 263
EP 270
AR PII 934436828
DI 10.1080/10543406.2011.550107
PG 8
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 733RZ
UT WOS:000288281800007
PM 21391000
ER
PT J
AU Li, XB
Caffo, BS
AF Li, Xianbin
Caffo, Brian S.
TI Comparison of Proportions for Composite Endpoints with Missing
Components
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Comparison of proportions; Maximum likelihood estimator; Missing data;
Three-component composite endpoint
ID CROSS-CLASSIFIED DATA; CONTINGENCY-TABLES
AB Composite endpoints are commonly used in clinical trials. When there are missing values in their individual components, inappropriate handling of the missingness may create inefficient or even biased estimates of the proportions of successes in composite endpoints. Assuming missingness is completely at random or dependent on baseline covariates, we derived a maximum likelihood estimator of the proportion of successes in a three-component composite endpoint and closed-form variance for the proportion, and compared two groups in the difference in proportions and in the logarithm of a relative risk. Sample size and statistical power were studied. Simulation studies were used to evaluate the performance of the developed methods. With a moderate sample size the developed methods works satisfactorily.
C1 [Li, Xianbin] US FDA, Silver Spring, MD USA.
[Caffo, Brian S.] Johns Hopkins Univ, Baltimore, MD USA.
RP Li, XB (reprint author), CDER OTS OB OBIV, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM xianbin.li@fda.hhs.gov
FU FDA/CDER [08-42]
FX The research is supported by the FDA/CDER Regulatory Science and Review
Enhancement program (RSR #08-42). The authors would like to thank the
anonymous referees for their thoughtful suggestions, which greatly
improved the paper.
NR 6
TC 0
Z9 0
U1 0
U2 2
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 2
SI SI
BP 271
EP 281
AR PII 934436775
DI 10.1080/10543406.2011.550109
PG 11
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 733RZ
UT WOS:000288281800008
PM 21391001
ER
PT J
AU Kim, Y
AF Kim, Yongman
TI Missing Data Handling in Chronic Pain Trials
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE BOCF; Chronic pain trial; Continuous responder analysis; LOCF; Missing
data; Two-part model analysis
ID LONGITUDINAL CLINICAL-TRIALS
AB In chronic pain trials, proper handling of missing data due to dropout is an important issue because the dropout rate is high and the study conclusion may depend on the method chosen. The intent-to-treat (ITT) principle usually requires imputations for missing data to include the dropouts as well as completers in the statistical analysis. However, a statistical analysis with imputation might lead to a misinterpretation of clinical data. In chronic pain trials, treatment-related dropouts are clinical outcomes themselves. For example, an early dropout due to toxicity usually indicates a treatment failure, as does a dropout due to lack of efficacy. Problems with traditional methods such as last observation carried forward (LOCF) or baseline observation carried forward (BOCF) are identified especially in the chronic pain setting. Alternative methods, such as continuous responder analysis and two-part model analysis, treating dropouts as clinical events, are introduced with an example of osteoarthritis clinical trial data.
C1 US FDA, Silver Spring, MD 20993 USA.
RP Kim, Y (reprint author), US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM yongman.kim@fda.hhs.gov
NR 9
TC 15
Z9 15
U1 1
U2 3
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 2
SI SI
BP 311
EP 325
AR PII 934434071
DI 10.1080/10543406.2011.550112
PG 15
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 733RZ
UT WOS:000288281800011
PM 21391004
ER
PT J
AU Dinh, P
Yang, PL
AF Dinh, Phillip
Yang, Peiling
TI Handling Baselines in Repeated Measures Analyses with Missing Data at
Random
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Baseline; Longitudinal data; Missing at random; MMRM
ID CLINICAL-TRIALS; COVARIANCE; LIKELIHOOD; INFERENCE; MODELS
AB In longitudinal clinical studies, after randomization at baseline, subjects are followed for a period of time for development of symptoms. A mixed model for repeated measures (MMRM) can be used to analyze data from such studies. Fitzmaurice et al. (2004) outlined five approaches for handling baseline responses in an MMRM analysis. They are: (1) Retain the baselines as part of the outcome vector and make no assumptions about group differences in the mean response at baseline. (2) Retain the baselines as part of the outcome vector and assume the group means are equal at baseline. (3) Subtract the baselines from all of the remaining post-baseline responses, and analyze the differences from baseline. (4) Use the baselines as a covariate in the analysis of the post-baseline responses, assuming homogeneous regression slopes. (5) Use the baselines as a covariate in the analysis of the post-baseline responses, allowing different regression slopes. In this paper, we evaluate these five approaches in the presence of data missing at random. We evaluate the approaches based on the bias of the estimate and the coverage accuracy of the confidence interval. The results suggest that strategies 2 and 5 are recommended.
C1 [Dinh, Phillip; Yang, Peiling] US FDA, Div Biometr 1, Off Biostat Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Dinh, P (reprint author), US FDA, Div Biometr 1, Off Biostat Off Translat Sci, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 21,Room 4633, Silver Spring, MD 20993 USA.
EM Phillip.Dinh@fda.hhs.gov
NR 24
TC 1
Z9 1
U1 1
U2 8
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 2
SI SI
BP 326
EP 341
AR PII 934432268
DI 10.1080/10543406.2011.550113
PG 16
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 733RZ
UT WOS:000288281800012
PM 21391005
ER
PT J
AU Siddiqui, O
AF Siddiqui, Ohidul
TI MMRM versus MI in Dealing with Missing DataA Comparison Based on 25 NDA
Data Sets
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE LOCF; MAR; Missing data; MMRM analysis; Multiple imputation
ID CLINICAL-TRIALS; MULTIPLE IMPUTATION; LONGITUDINAL DATA; DROP-OUT;
SPECIFICATION; MODELS; ERROR; LOCF
AB Both multiple imputation (MI) and mixed-effects model repeated measures (MMRM) approaches appear to be better choices than the traditional last-observation-carried-forward (LOCF) approach in analyzing incomplete clinical trial data sets in drug development research. However, relative performances of these two approaches are unknown in controlling type I error rate and statistical power in the hypothesis testing of determining the efficacy of an investigational drug. Little research has been done in comparing robustness of the two approaches in analyzing ignorable missing data of clinical trials. In this research, a comparison between the MI and MMRM approaches is made in analyzing the simulated incomplete data sets and 25 New Drug Application (NDA) data sets of neuropsychiatric drug products. The MMRM approach appears to be a better choice in maintaining statistical properties of a test as compared to the MI approach in dealing with ignorable missing data of clinical trials.
C1 US FDA, Off Biostat, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Siddiqui, O (reprint author), US FDA, Off Biostat, Off Translat Sci, Ctr Drug Evaluat & Res, 10903 New Hampshire Av,Rm 4606, Silver Spring, MD 20993 USA.
EM ohidul.siddiqui@fda.hhs.gov
NR 32
TC 10
Z9 11
U1 0
U2 4
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.
PY 2011
VL 21
IS 3
BP 423
EP 436
AR PII 935354193
DI 10.1080/10543401003777995
PG 14
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 742QA
UT WOS:000288958200004
PM 21442517
ER
PT J
AU Huque, MF
Alosh, M
Bhore, R
AF Huque, Mohammad F.
Alosh, Mohamed
Bhore, Rafia
TI Addressing Multiplicity Issues of a Composite Endpoint and Its
Components in Clinical Trials
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Composite endpoint; Component endpoints; Multiple testing
ID STRATEGY
AB Randomized controlled clinical trials often use a composite endpoint as a primary endpoint especially when treatment effects or frequency of individual components of the composite are likely to be small and combining them makes clinical sense for the disease under study. An advantage of the composite endpoint is that, as it combines multiple endpoints to a single endpoint, it reduces or eliminates the multiplicity problem of testing multiple endpoints. In addition, accumulating evidence from individual endpoints into the composite endpoint can lead to better study power and reduce the study size and the duration of the trial. However, composite endpoints can also lead to ambiguous findings and consequently cause difficulty in interpreting study results, for example, when individual component endpoints of a composite show treatment effects in different directions. Also, multiplicity issues will arise if a study sponsor seeks efficacy claims for specific components of the composite or for a targeted subgroup of patients. This paper visits some of these issues and presents some solutions through applications of multiple testing strategies.
C1 [Huque, Mohammad F.] US FDA, Div Biometr 4, Off Biostat, OTS,CDER, Silver Spring, MD 20993 USA.
[Alosh, Mohamed] US FDA, Div Biometr 3, Off Biostat, OTS,CDER, Silver Spring, MD 20993 USA.
[Bhore, Rafia] Univ Texas SW Med Ctr Dallas, Div Biostat, Dept Clin Sci, Dallas, TX 75390 USA.
RP Huque, MF (reprint author), US FDA, Div Biometr 4, Off Biostat, OTS,CDER, Bldg 21,Room 3510,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM mohammad.huque@fda.hhs.gov
NR 22
TC 24
Z9 24
U1 0
U2 10
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 4
SI SI
BP 610
EP 634
AR PII 936782823
DI 10.1080/10543406.2011.551327
PG 25
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 754GA
UT WOS:000289841700004
PM 21516560
ER
PT J
AU Dmitrienko, A
Kordzakhia, G
Tamhane, AC
AF Dmitrienko, Alex
Kordzakhia, George
Tamhane, Ajit C.
TI Multistage and Mixture Parallel Gatekeeping Procedures in Clinical
Trials
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Closure principle; Familywise error rate; Multiple comparisons; Mixture
procedure; Parallel gatekeeping
ID MULTIPLE TESTS
AB Gatekeeping procedures have been developed to solve multiplicity problems arising in clinical trials with hierarchical objectives where the null hypotheses that address these objectives are grouped into ordered families. A general method for constructing multistage parallel gatekeeping procedures was proposed by Dmitrienko et al. (2008). The objective of this paper is to study two related classes of parallel gatekeeping procedures. Restricting to two-family hypothesis testing problems, we first use the mixture method developed in Dmitrienko and Tamhane (2011) to define a class of parallel gatekeeping procedures derived using the closure principle that can be more powerful than multistage gatekeeping procedures. Second, we show that power of multistage gatekeeping procedures can also be improved by using -exhaustive tests for the component procedures. Extensions of these results for multiple families are stated. Illustrative examples from clinical trials are given.
C1 [Dmitrienko, Alex] Eli Lilly & Co, Lilly Corp Ctr, Indianapolis, IN 46285 USA.
[Kordzakhia, George] US FDA, Silver Spring, MD USA.
[Tamhane, Ajit C.] Northwestern Univ, Evanston, IL USA.
RP Dmitrienko, A (reprint author), Eli Lilly & Co, Lilly Corp Ctr, Indianapolis, IN 46285 USA.
EM dmitrienko_alex@lilly.com
RI Tamhane, Ajit/B-7495-2009
NR 20
TC 9
Z9 9
U1 0
U2 1
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 4
SI SI
BP 726
EP 747
AR PII 936782666
DI 10.1080/10543406.2011.551333
PG 22
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 754GA
UT WOS:000289841700010
PM 21516566
ER
PT J
AU Wang, SJ
Hung, HMJ
O'Neill, R
AF Wang, Sue-Jane
Hung, H. M. James
O'Neill, Robert
TI Regulatory Perspectives on Multiplicity in Adaptive Design Clinical
Trials throughout a Drug Development Program
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Confirmatory; Exploratory; Learn and confirm; Probability of correct
decision; Probability of correct selection; Probability of success
ID GROUP-SEQUENTIAL TRIALS; STATISTICAL CONSIDERATIONS; HYPOTHESES
SELECTION; 2-STAGE DESIGN; SAMPLE-SIZE; END-POINTS; INTERIM; BOUNDARIES;
PATIENT; WIZARD
AB A clinical research program for drug development often consists of a sequence of clinical trials that may begin with uncontrolled and nonrandomized trials, followed by randomized trials or randomized controlled trials. Adaptive designs are not infrequently proposed for use. In the regulatory setting, the success of a drug development program can be defined to be that the experimental treatment at a specific dose level including regimen and frequency is approved based on replicated evidence from at least two confirmatory trials. In the early stage of clinical research, multiplicity issues are very broad. What is the maximum tolerable dose in an adaptive dose escalation trial? What should the dose range be to consider in an adaptive dose-ranging trial? What is the minimum effective dose in an adaptive dose-response study given the tolerability and the toxicity observable in short term or premarketing trials? Is establishing the dose-response relationship important or the ability to select a superior treatment with high probability more important? In the later stage of clinical research, multiplicity problems can be formulated with better focus, depending on whether the study is for exploration to estimate or select design elements or for labeling consideration. What is the study objective for an early-phase versus a later phase adaptive clinical trial? How many doses are to be studied in the early exploratory adaptive trial versus in the confirmatory adaptive trial? Is the intended patient population well defined or is the applicable patient population yet to be adaptively selected in the trial due to the potential patient and/or disease heterogeneity? Is the primary efficacy endpoint well defined or still under discussion providing room for adaptation? What are the potential treatment indications that may adaptively lead to an intended-to-treat patient population and the primary efficacy endpoint? In this work we stipulate the multiplicity issues with adaptive designs encountered in regulatory applications. For confirmatory adaptive design clinical trials, controlling studywise type I error and type II error is of paramount importance. For exploratory adaptive trials, we define the probability of correct selection of design features, e.g., dose, effect size, and the probability of correct decision for drug development. We assert that maximizing these probabilities would be critical to determine whether the drug development program continues or how to plan the confirmatory trials if the development continues.
C1 [Wang, Sue-Jane; O'Neill, Robert] 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,Mail Stop, Silver Spring, MD 20993 USA.
EM suejane.wang@fda.hhs.gov
FU 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, number 05-02, 05-14, provided by Center for Drug Evaluation and
Research of the U.S. Food and Drug Administration. The authors thank Dr.
Martin Posch, the guest editor for this special issue, for the kind
invitation for publication. The research views expressed in this paper
are the authors' professional views and not necessarily those of the
U.S. Food and Drug Administration.
NR 43
TC 2
Z9 2
U1 0
U2 4
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 4
SI SI
BP 846
EP 859
AR PII 936782866
DI 10.1080/10543406.2011.552878
PG 14
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 754GA
UT WOS:000289841700017
PM 21516573
ER
PT J
AU Li, XF
Xu, YL
AF Li, Xuefeng
Xu, Yunling
TI BAYESIAN APPROACHES FOR MEDICAL PRODUCT EVALUATION-TODAY AND TOMORROW
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Editorial Material
C1 [Li, Xuefeng; Xu, Yunling] US FDA, Div Biostat, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Li, XF (reprint author), US FDA, Div Biostat, OSB CDRH, 10903 New Hamsphire Ave, Silver Spring, MD 20993 USA.
EM xuefeng.li@fda.hhs.gov; yun-ling.xu@fda.hhs.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 5
SI SI
BP 869
EP 870
DI 10.1080/10543406.2012.589291
PG 2
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 882PJ
UT WOS:000299575900001
PM 21830919
ER
PT J
AU Campbell, G
AF Campbell, Gregory
TI BAYESIAN STATISTICS IN MEDICAL DEVICES: INNOVATION SPARKED BY THE FDA
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Adaptive designs; Bayesian hierarchical models; Implants;
Noninferiority; Software
ID CLINICAL-TRIALS; ATRIAL-FIBRILLATION; DIAGNOSTIC-TESTS; GOLD STANDARD;
PREVALENCE; EXPERIENCE; OUTCOMES; THERAPY; ABSENCE; DESIGN
AB Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.
C1 US FDA, Div Biostat, Silver Spring, MD 20993 USA.
RP Campbell, G (reprint author), US FDA, Div Biostat, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Greg.campbell@fda.hhs.gov
NR 35
TC 11
Z9 12
U1 0
U2 6
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 530 WALNUT STREET, STE 850, PHILADELPHIA, PA 19106 USA
SN 1054-3406
EI 1520-5711
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 5
SI SI
BP 871
EP 887
DI 10.1080/10543406.2011.589638
PG 17
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 882PJ
UT WOS:000299575900002
PM 21830920
ER
PT J
AU Gamalo, MA
Wu, R
Tiwari, RC
AF Gamalo, Mark A.
Wu, Rui
Tiwari, Ram C.
TI BAYESIAN APPROACH TO NONINFERIORITY TRIALS FOR PROPORTIONS
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Bayesian criterion; Bayesian paradigm; Beta-binomial; Noninferiority
margin; Normal approximation
ID NON-INFERIORITY TRIALS; ACTIVE-CONTROL TRIALS; STATISTICAL-METHODS;
PLACEBO; ISSUES
AB Noninferiority trials are unique because they are dependent upon historical information in order to make meaningful interpretation of their results. Hence, a direct application of the Bayesian paradigm in sequential learning becomes apparently useful in the analysis. This paper describes a Bayesian procedure for testing noninferiority in two-arm studies with a binary primary endpoint that allows the incorporation of historical data on an active control via the use of informative priors. In particular, the posteriors of the response in historical trials are assumed as priors for its corresponding parameters in the current trial, where that treatment serves as the active control. The Bayesian procedure includes a fully Bayesian method and two normal approximation methods on the prior and/or on the posterior distributions. Then a common Bayesian decision criterion is used but with two prespecified cutoff levels, one for the approximation methods and the other for the fully Bayesian method, to determine whether the experimental treatment is noninferior to the active control. This criterion is evaluated and compared with the frequentist method using simulation studies in keeping with regulatory framework that new methods must protect type I error and arrive at a similar conclusion with existing standard strategies. Results show that both methods arrive at comparable conclusions of noninferiority when applied to a modified real data set. The advantage of the proposed Bayesian approach lies in its ability to provide posterior probabilities for effect sizes of the experimental treatment over the active control.
C1 [Gamalo, Mark A.; Tiwari, Ram C.] US FDA, Off Biostat, Silver Spring, MD 20993 USA.
[Wu, Rui] Univ Connecticut, Dept Stat, Storrs, CT 06269 USA.
RP Gamalo, MA (reprint author), US FDA, Off Biostat, Silver Spring, MD 20993 USA.
EM Mark.Gamalo@fda.hhs.gov
NR 15
TC 8
Z9 8
U1 0
U2 5
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 5
SI SI
BP 902
EP 919
DI 10.1080/10543406.2011.589646
PG 18
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 882PJ
UT WOS:000299575900004
PM 21830922
ER
PT J
AU Bonangelino, P
Irony, T
Liang, SD
Li, XF
Mukhi, V
Ruan, SL
Xu, YL
Yang, XT
Wang, CG
AF Bonangelino, Pablo
Irony, Telba
Liang, Shengde
Li, Xuefeng
Mukhi, Vandana
Ruan, Shiling
Xu, Yunling
Yang, Xiting
Wang, Chenguang
TI BAYESIAN APPROACHES IN MEDICAL DEVICE CLINICAL TRIALS: A DISCUSSION WITH
EXAMPLES IN THE REGULATORY SETTING
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Bayesian adaptive designs; Bayesian hierarchical models; Clinical
significance; Multiregional clinical trial; Prior distribution;
Regulatory agency; Subgroup analysis
ID MULTIREGIONAL TRIAL; SAMPLE-SIZE; REGIONS
AB Challenging statistical issues often arise in the design and analysis of clinical trials to assess safety and effectiveness of medical devices in the regulatory setting. The use of Bayesian methods in the design and analysis of medical device clinical trials has been increasing significantly in the past decade, not only due to the availability of prior information, but mainly due to the appealing nature of Bayesian clinical trial designs. The Center for Devices and Radiological Health at the Food and Drug Administration (FDA) has gained extensive experience with the use of Bayesian statistical methods and has identified some important issues that need further exploration. In this article, we discuss several topics relating to the use of Bayesian statistical methods in medical device trials, based on our experience and real applications. We illustrate the benefits and challenges of Bayesian approaches when incorporating prior information to evaluate the effectiveness and safety of a medical device. We further present an example of a Bayesian adaptive clinical trial and compare it to a traditional frequentist design. Finally, we discuss the use of Bayesian hierarchical models for multiregional trials and highlight the advantages of the Bayesian approach when specifying clinically relevant study hypotheses.
C1 [Bonangelino, Pablo; Irony, Telba; Liang, Shengde; Li, Xuefeng; Mukhi, Vandana; Ruan, Shiling; Xu, Yunling; Yang, Xiting; Wang, Chenguang] US FDA, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Irony, T (reprint author), US FDA, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM Telba.irony@fda.hhs.gov
NR 18
TC 4
Z9 4
U1 0
U2 3
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 5
SI SI
BP 938
EP 953
DI 10.1080/10543406.2011.589650
PG 16
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 882PJ
UT WOS:000299575900006
PM 21830924
ER
PT J
AU Pennello, GA
AF Pennello, Gene A.
TI BAYESIAN ANALYSIS OF DIAGNOSTIC TEST ACCURACY WHEN DISEASE STATE IS
UNVERIFIED FOR SOME SUBJECTS
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Data augmentation; Gibbs sampling; Missing at random; Nonignorable
missing data mechanism; Selection model; Sensitivity analysis
ID GOLD STANDARD; SENSITIVITY-ANALYSIS; VERIFICATION; PREVALENCE; ABSENCE;
MODELS; BIAS
AB Studies of the accuracy of medical tests to diagnose the presence or absence of disease can suffer from an inability to verify the true disease state in everyone. When verification is missing at random (MAR), the missing data mechanism can be ignored in likelihood-based inference. However, this assumption may not hold even approximately. When verification is nonignorably missing, the most general model of the distribution of disease state, test result, and verification indicator is overparameterized. Parameters are only partially identified, creating regions of ignorance for maximum likelihood estimators. For studies of a single test, we use Bayesian analysis to implement the most general nonignorable model, a reduced nonignorable model with identifiable parameters, and the MAR model. Simple Gibbs sampling algorithms are derived that enable computation of the posterior distribution of test accuracy parameters. In particular, the posterior distribution is easily obtained for the most general nonignorable model, which makes relatively weak assumptions about the missing data mechanism. For this model, the posterior distribution combines two sources of uncertainty: ignorance in the estimation of partially identified parameters, and imprecision due to finite sampling variability. We compare the three models on data from a study of the accuracy of scintigraphy to diagnose liver disease.
C1 US FDA, Div Biostat, Silver Spring, MD 20993 USA.
RP Pennello, GA (reprint author), US FDA, Div Biostat, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM gene.pennello@fda.hhs.gov
NR 19
TC 6
Z9 7
U1 0
U2 5
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 5
SI SI
BP 954
EP 970
DI 10.1080/10543406.2011.590921
PG 17
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 882PJ
UT WOS:000299575900007
PM 21830925
ER
PT J
AU Scott, JA
Hand, AL
Sian, LS
AF Scott, John A.
Hand, Austin L.
Sian, Layla S.
TI BayesWeb: A USER-FRIENDLY PLATFORM FOR EXPLORATORY BAYESIAN ANALYSIS OF
SAFETY SIGNALS FROM SMALL CLINICAL TRIALS
SO JOURNAL OF BIOPHARMACEUTICAL STATISTICS
LA English
DT Article
DE Bayesian analysis; Exploratory; Phase I; Phase II; Safety; Statistical
software
ID DESIGN
AB Safety signals observed in early-phase clinical trials can have profound implications for the development of new medical products. It is difficult to interpret the occurrence of safety signals in small clinical trials, where formal inferential procedures may be impractical. We advocate wider use of simple Bayesian methods to explore and understand safety signals from small clinical trials. We describe a new web-based application, BayesWeb.com, that makes such exploratory Bayesian methods accessible to subject-matter experts. We illustrate the use of this software with an example from a hypothetical phase I trial for a Factor VIII product for patients with hemophilia A.
C1 [Scott, John A.; Hand, Austin L.] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
[Hand, Austin L.] Baylor Univ, Dept Stat, Waco, TX 76798 USA.
[Sian, Layla S.] Univ Pittsburgh, Ctr Res Hlth Care Data Ctr, Pittsburgh, PA USA.
RP Scott, JA (reprint author), US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
EM John.Scott@fda.hhs.gov
OI Scott, John/0000-0002-9116-948X
NR 19
TC 1
Z9 1
U1 0
U2 1
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1054-3406
J9 J BIOPHARM STAT
JI J. Biopharm. Stat.
PY 2011
VL 21
IS 5
SI SI
BP 1030
EP 1041
DI 10.1080/10543406.2011.590924
PG 12
WC Pharmacology & Pharmacy; Statistics & Probability
SC Pharmacology & Pharmacy; Mathematics
GA 882PJ
UT WOS:000299575900011
PM 21830929
ER
PT J
AU Zheng, J
Keys, CE
Zhao, SH
Ahmed, R
Meng, JH
Brown, EW
AF Zheng, Jie
Keys, Christine E.
Zhao, Shaohua
Ahmed, Rafiq
Meng, Jianghong
Brown, Eric W.
TI Simultaneous Analysis of Multiple Enzymes Increases Accuracy of
Pulsed-Field Gel Electrophoresis in Assigning Genetic Relationships
among Homogeneous Salmonella Strains
SO JOURNAL OF CLINICAL MICROBIOLOGY
LA English
DT Article
ID ENTERICA SEROTYPE ENTERITIDIS; ESCHERICHIA-COLI O157-H7; TANDEM REPEAT
ANALYSIS; TYPHIMURIUM DT104; HOST ADAPTATION; UNITED-STATES; PHAGE
TYPES; SEQUENCE; RECOMBINATION; EVOLUTION
AB Due to a highly homogeneous genetic composition, the subtyping of Salmonella enterica serovar Enteritidis strains to an epidemiologically relevant level remains intangible for pulsed-field gel electrophoresis (PFGE). We reported previously on a highly discriminatory PFGE-based subtyping scheme for S. enterica serovar Enteritidis that relies on a single combined cluster analysis of multiple restriction enzymes. However, the ability of a subtyping method to correctly infer genetic relatedness among outbreak strains is also essential for effective molecular epidemiological traceback. In this study, genetic and phylogenetic analyses were performed to assess whether concatenated enzyme methods can cluster closely related salmonellae into epidemiologically relevant hierarchies. PFGE profiles were generated by use of six restriction enzymes (XbaI, BlnI, SpeI, SfiI, PacI, and NotI) for 74 strains each of S. enterica serovar Enteritidis and S. enterica serovar Typhimurium. Correlation analysis of Dice similarity coefficients for all pairwise strain comparisons underscored the importance of combining multiple enzymes for the accurate assignment of genetic relatedness among Salmonella strains. The mean correlation increased from 81% and 41% for single-enzyme PFGE up to 99% and 96% for five-enzyme combined PFGE for S. enterica serovar Enteritidis and S. enterica serovar Typhimurium strains, respectively. Data regressions approached 100% correlation among Dice similarities for S. enterica serovar Enteritidis and S. enterica serovar Typhimurium strains when a minimum of six enzymes were concatenated. Phylogenetic congruence measures singled out XbaI, BlnI, SfiI, and PacI as most concordant for S. enterica serovar Enteritidis, while XbaI, BlnI, and SpeI were most concordant among S. enterica serovar Typhimurium strains. Together, these data indicate that PFGE coupled with sufficient enzyme numbers and combinations is capable of discerning accurate genetic relationships among Salmonella serovars comprising highly homogeneous strain complexes.
C1 [Zheng, Jie; Keys, Christine E.; Brown, Eric W.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Zhao, Shaohua] US FDA, Ctr Vet Med, Laurel, MD 20708 USA.
[Ahmed, Rafiq] Canadian Sci Ctr Human & Anim Hlth, Natl Microbiol Lab, Winnipeg, MB, Canada.
[Zheng, Jie; Meng, Jianghong] Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
RP Brown, EW (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM eric.brown@fda.hhs.gov
NR 41
TC 14
Z9 14
U1 0
U2 1
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0095-1137
EI 1098-660X
J9 J CLIN MICROBIOL
JI J. Clin. Microbiol.
PD JAN
PY 2011
VL 49
IS 1
BP 85
EP 94
DI 10.1128/JCM.00120-10
PG 10
WC Microbiology
SC Microbiology
GA 701AQ
UT WOS:000285787100011
PM 20980570
ER
PT J
AU Madabushi, R
Cox, DS
Hossain, M
Boyle, DA
Patel, BR
Young, G
Choi, YM
Gobburu, JVS
AF Madabushi, Rajanikanth
Cox, Donna S.
Hossain, Mohammad
Boyle, Duane A.
Patel, Bela R.
Young, Guy
Choi, Young-Moon
Gobburu, Jogarao V. S.
TI Pharmacokinetic and Pharmacodynamic Basis for Effective Argatroban
Dosing in Pediatrics
SO JOURNAL OF CLINICAL PHARMACOLOGY
LA English
DT Article
DE Heparin-induced thrombocytopenia; argatroban; pediatrics;
pharmacokinetics; pharmacodynamics; activated plasma thromboplastin time
(aPTT); simulation
ID HEPARIN-INDUCED THROMBOCYTOPENIA; LABELING DECISIONS; DRUG APPLICATIONS;
CHILDREN; THERAPY; IMPACT; PHARMACOMETRICS; APPROVAL
AB The objective was to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of argatroban in pediatric patients and derive dosing recommendations. An open-label multicenter trial was conducted in pediatric patients (n = 18 from birth to 16 years). A population modeling approach was used to characterize pharmacokinetics and pharmacodynamics of argatroban in pediatric patients. Simulations were performed to derive a dosing regimen for pediatric patients. The estimated clearance of argatroban in pediatric patients was 2-fold lower than that in healthy adults. Body weight was significant predictor of argatroban clearance. The clearance in a typical 20-kg pediatric patient was 3.1 L/h. In 4 patients with elevated serum bilirubin levels, the estimated clearance was 0.6 L/h. Effect on activated plasma thromboplastin time (aPTT) was found to be concentration dependent. Simulations suggested that a starting dose of 0.75 mu g/kg/min in pediatric patients was comparable in performance to 2.0 mu g/kg/min approved in adults for attaining target aPTT and risk for bleeding. A dose increment step size of 0.25 mu g/kg/min was suitable for titration. The PK/PD of argatroban was reasonably characterized in pediatrics. Plasma concentration-aPTT relationship was used to derive a safe starting dose and titration scheme for the first time in pediatric patients and was incorporated into the US prescribing information for argatroban.
C1 [Madabushi, Rajanikanth; Choi, Young-Moon; Gobburu, Jogarao V. S.] FDA, Off Clin Pharmacol, Off Translat Sci, CDER, Silver Spring, MD 20993 USA.
[Cox, Donna S.; Hossain, Mohammad; Boyle, Duane A.; Patel, Bela R.] GlaxoSmithKline Inc, Clin Pharmacol Modeling & Simulat, King Of Prussia, PA USA.
[Young, Guy] Childrens Hosp Los Angeles, Ctr Thrombosis & Hemostasis, Los Angeles, CA 90027 USA.
RP Madabushi, R (reprint author), FDA, Off Clin Pharmacol, Off Translat Sci, CDER, 10903 New Hampshire Ave,Bldg 21,Rm 2172, Silver Spring, MD 20993 USA.
EM Rajnikanth.Madabushi@fda.hhs.gov
FU GlaxoSmithKline; Encysive Pharmaceuticals, Inc
FX GlaxoSmithKline and Encysive Pharmaceuticals, Inc, provided study
support. Donna S. Cox, Mohammad Hossain, Duane A. Boyle, and Bela R.
Patel are employees of GlaxoSmithKline. The study sponsors
(specifically, the authors employed by GlaxoSmithKline) were involved in
study design; data collection, analysis, or data interpretation.
NR 27
TC 26
Z9 26
U1 0
U2 2
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0091-2700
J9 J CLIN PHARMACOL
JI J. Clin. Pharmacol.
PD JAN
PY 2011
VL 51
IS 1
BP 19
EP 28
DI 10.1177/0091270010365550
PG 10
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 694ZS
UT WOS:000285341000003
PM 20421511
ER
PT J
AU Sanetti, LMH
Fallon, LM
AF Sanetti, Lisa M. Hagermoser
Fallon, Lindsay M.
TI Treatment Integrity Assessment: How Estimates of Adherence, Quality, and
Exposure Influence Interpretation of Implementation
SO JOURNAL OF EDUCATIONAL AND PSYCHOLOGICAL CONSULTATION
LA English
DT Article
ID GOOD BEHAVIOR GAME; PREVENTIVE INTERVENTIONS; SCHOOL; CLASSROOM;
OUTCOMES; PROGRAM; IMPACT; CONSULTATION; 1ST-GRADE; ISSUES
AB The assessment of treatment integrity is important for determining the effectiveness of an intervention. Treatment integrity, a multidimensional construct, can be evaluated in two ways: by session or component. In this study, adherence, quality, and exposure data are estimated using permanent product data from implementation of the PAX Good Behavior Game to demonstrate how varied assessment of treatment integrity can influence interpretation of implementation. Implications for implementers and school-based decisions are discussed.
C1 [Sanetti, Lisa M. Hagermoser] Univ Connecticut, Neag Sch Educ, Storrs, CT 06269 USA.
[Sanetti, Lisa M. Hagermoser] Univ Connecticut, CBER, Storrs, CT 06269 USA.
[Fallon, Lindsay M.] Univ Connecticut, Sch Psychol, Storrs, CT 06269 USA.
RP Sanetti, LMH (reprint author), Univ Connecticut, Neag Sch Educ, 249 Glenbrook Rd,Unit 2064, Storrs, CT 06269 USA.
EM lisa.sanetti@uconn.edu
NR 34
TC 9
Z9 9
U1 2
U2 3
PU ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD
PI ABINGDON
PA 4 PARK SQUARE, MILTON PARK, ABINGDON OX14 4RN, OXFORDSHIRE, ENGLAND
SN 1047-4412
J9 J EDUC PSYCHOL CONS
JI J. Educ. Psychol. Consult.
PY 2011
VL 21
IS 3
BP 209
EP 232
DI 10.1080/10474412.2011.595163
PG 24
WC Psychology, Educational
SC Psychology
GA 885AW
UT WOS:000299751100003
ER
PT J
AU Mollenhauer, MAM
Bradshaw, SG
Fair, PA
Mcguinn, WD
Peden-Adams, MM
AF Mollenhauer, Meagan A. M.
Bradshaw, Sarah G.
Fair, Patricia A.
Mcguinn, W. David
Peden-Adams, Margie M.
TI Effects of perfluorooctane sulfonate (PFOS) exposure on markers of
inflammation in female B6C3F1 mice
SO JOURNAL OF ENVIRONMENTAL SCIENCE AND HEALTH PART A-TOXIC/HAZARDOUS
SUBSTANCES & ENVIRONMENTAL ENGINEERING
LA English
DT Article
DE PFOS; inflammation; IL-6; TNF; cytokines; immune; macrophages
ID ACTIVATED-RECEPTOR-ALPHA; TUMOR-NECROSIS-FACTOR;
PEROXISOME-PROLIFERATOR; PERFLUORINATED COMPOUNDS; PERFLUOROALKYL ACIDS;
GENE-EXPRESSION; TURSIOPS-TRUNCATUS; NUCLEAR RECEPTORS; HUMORAL
IMMUNITY; FATTY-ACIDS
AB Perfluorooctane sulfonate (PFOS; 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonic acid) has been reported to alter humoral immune functions, but inflammatory processes following PFOS exposure have not been fully characterized. Therefore, the current study, assessed TNF- and IL-6 concentrations in serum and peritoneal lavage fluid, numbers of splenoctyes expressing intracellular TNF-, IL-6, IL-10 or IL-1, and ex vivo TNF- and IL-6 production by peritoneal macrophages following either in vivo or in vitro LPS exposure. Adult female B6C3F1 mice were exposed orally for 28 days to 0, 1, 3, or 300 mg PFOS/kg total administered dose [TAD] (e.g., 0, 0.0331, 0.0993 or 9.93 mg/kg/day). Body and spleen masses were significantly reduced in the highest PFOS treatment group compared to the control group, whereas liver mass was significantly increased. Serum TNF- levels were significantly decreased following exposure to 1 mg PFOS/kg TAD as compared to controls, while serum IL-6 levels were increased. IL-6 concentrations in peritoneal lavage fluid decreased with increasing dose. PFOS treatment did not alter numbers of splenocytes expressing intracellular levels of TNF-, IL-10 or IL-1. Numbers of splenocytes expressing intracellular levels of IL-6 were significantly decreased in the 3 mg/kg treatment as compared to controls. Overall, these data suggest that PFOS exposure can alter some inflammatory processes, which could potentially lead to misdirected inflammatory responses.
C1 [Peden-Adams, Margie M.] Univ Nevada, Harry Reid Ctr Environm Studies, Las Vegas, NV 89154 USA.
[Bradshaw, Sarah G.] Med Univ S Carolina, Dept Microbiol & Immunol, Charleston, SC 29425 USA.
[Peden-Adams, Margie M.] Univ Nevada, Harry Reid Ctr Environm Studies, NOAA NOS CCEHBR, Charleston, SC 29412 USA.
[Mcguinn, W. David] US FDA, Silver Spring, MD USA.
RP Peden-Adams, MM (reprint author), Univ Nevada, Harry Reid Ctr Environm Studies, NOAA NOS CCEHBR, Rm 248,219 Ft Johnson Rd, Charleston, SC 29412 USA.
EM pedenadams@gmail.com
FU National Oceanic and Atmospheric Administration/National Ocean
Service/Center for Coastal Environmental Health and Biomolecular
Research
FX This publication does not constitute an endorsement of any commercial
product or intend to be an opinion beyond scientific or other results
obtained by the National Oceanic and Atmospheric Administration (NOAA).
No reference shall be made to NOAA, or this publication furnished by
NOAA, to any advertising or sales promotion which would indicate or
imply that NOAA recommends or endorses any proprietary product mentioned
herein, or which has as its purpose an interest to cause the advertised
product to be used or purchased because of this publication. The project
was funded in part by the National Oceanic and Atmospheric
Administration/National Ocean Service/Center for Coastal Environmental
Health and Biomolecular Research and internal university funding. The
authors have no conflict of interest to declare.
NR 68
TC 15
Z9 15
U1 1
U2 5
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1093-4529
J9 J ENVIRON SCI HEAL A
JI J. Environ. Sci. Health Part A-Toxic/Hazard. Subst. Environ. Eng.
PY 2011
VL 46
IS 2
BP 97
EP 108
AR PII 931349041
DI 10.1080/10934529.2011.532418
PG 12
WC Engineering, Environmental; Environmental Sciences
SC Engineering; Environmental Sciences & Ecology
GA 696AQ
UT WOS:000285414700001
PM 21170772
ER
PT J
AU Ray, PC
Yu, HT
Fu, PP
AF Ray, Paresh Chandra
Yu, Hongtao
Fu, Peter P.
TI Nanogold-Based Sensing of Environmental Toxins: Excitement and
Challenges
SO JOURNAL OF ENVIRONMENTAL SCIENCE AND HEALTH PART C-ENVIRONMENTAL
CARCINOGENESIS & ECOTOXICOLOGY REVIEWS
LA English
DT Review
DE Gold nanoparticle; sensing; bacteria; metals; nitroaromatics
ID ENHANCED RAMAN-SCATTERING; HYPER-RAYLEIGH SCATTERING; NONLINEAR-OPTICAL
PROPERTIES; ESCHERICHIA-COLI O157-H7; GOLD NANOPARTICLE PROBES; TARGETED
PHOTOTHERMAL LYSIS; DYNAMIC LIGHT-SCATTERING; HUMAN SKIN KERATINOCYTES;
SINGLE-MOLECULE; ENERGY-TRANSFER
AB There have been tremendous advances in the past ten years on the development of various nanomaterials-based sensors for detection of environmental toxins. Nanogold is of special interest because of its unique shape- and size-dependent optical properties, hyper-quenching ability, super surface-enhanced Raman and dynamic light scattering, and surface-modifiability by small organic molecules and biomolecules. These unique optical properties of nanogold have been explored for ultra-sensitive detection, while its surface-modifiability has been explored for selectivity. In general, the nanogold-based sensors are highly selective and sensitive along with simple sample preparation and sensor design. In this review article, we intend to capture some of the recent advances in nanogold-based sensor development and mechanistic studies, especially for bacteria, heavy metals, and nitroaromatic compounds. Undoubtedly, these developments will generate a lot of excitement for environmental scientists and toxicologists as well as the general public.
C1 [Ray, Paresh Chandra; Yu, Hongtao] Jackson State Univ, Dept Chem & Biochem, Jackson, MS 39217 USA.
[Fu, Peter P.] Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Ray, PC (reprint author), Jackson State Univ, Dept Chem & Biochem, Jackson, MS 39217 USA.
EM paresh.c.ray@jsums.edu
FU NSF-PREM [DMR-0611539]; ARO through ERDC [W911NF-06-1-0512]; NIH/NCRR
RCMI [G12RR013459]
FX The authors wish to thank various sources for financial support for some
part of this research: NSF-PREM grant #DMR-0611539, ARO grant
#W911NF-06-1-0512 through ERDC, and NIH/NCRR RCMI Grant #G12RR013459.
NR 207
TC 16
Z9 16
U1 1
U2 50
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1059-0501
J9 J ENVIRON SCI HEAL C
JI J. Environ. Sci. Health Pt. C-Environ. Carcinog. Ecotoxicol. Rev.
PY 2011
VL 29
IS 1
BP 52
EP 89
AR PII 935125366
DI 10.1080/10590501.2011.551315
PG 38
WC Oncology; Environmental Sciences; Toxicology
SC Oncology; Environmental Sciences & Ecology; Toxicology
GA 738XY
UT WOS:000288677100003
PM 21424976
ER
PT J
AU Zhang, YT
Lee, GR
AF Zhang, Yuanting
Lee, Gary R.
TI Intercountry Versus Transracial Adoption: Analysis of Adoptive Parents'
Motivations and Preferences in Adoption
SO JOURNAL OF FAMILY ISSUES
LA English
DT Article
DE adoption; intercountry; transracial; motivations
ID INTERNATIONAL ADOPTION; UNITED-STATES; CHILDREN; PERSPECTIVE;
IMMIGRATION; FAMILIES; AMERICA
AB The United States is one of the major baby-receiving countries in the world. Relatively little research has focused on why there is such a high demand for intercountry adoption. Using in-depth qualitative interviews with adoptive parents, the authors explored the reasons why Americans prefer to adopt foreign-born children instead of adopting minority children domestically. Other than infertility reasons, concerns about domestic adoption, and the uneven domestic supply and demand of "desirable" children, the authors' findings suggested that there was a perception that American children available for adoption presented difficult problems whereas foreign children presented interesting challenges. The "problems" inherent in children from American foster care were confounded with race differences. Studying adoption motivations will not only help us better understand the domestic adoption situation, especially why so many Black children are left behind in foster care, it may also reveal important insights into current race relations and distances between groups in the United States.
C1 [Lee, Gary R.] Bowling Green State Univ, Dept Sociol, Bowling Green, OH 43403 USA.
[Zhang, Yuanting] US FDA, College Pk, MD USA.
RP Lee, GR (reprint author), Bowling Green State Univ, Dept Sociol, 219 Williams Hall, Bowling Green, OH 43403 USA.
EM grlee@bgnet.bgsu.edu
NR 50
TC 19
Z9 19
U1 1
U2 19
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0192-513X
J9 J FAM ISSUES
JI J. Fam. Issues
PD JAN
PY 2011
VL 32
IS 1
BP 75
EP 98
DI 10.1177/0192513X10375410
PG 24
WC Family Studies
SC Family Studies
GA 694IV
UT WOS:000285290800004
ER
PT J
AU Savoye, F
Feng, P
Rozand, C
Bouvier, M
Gleizal, A
Thevenot, D
AF Savoye, F.
Feng, P.
Rozand, C.
Bouvier, M.
Gleizal, A.
Thevenot, D.
TI Comparative Evaluation of a Phage Protein Ligand Assay with Real-Time
PCR and a Reference Method for the Detection of Escherichia coli O157:H7
in Raw Ground Beef and Trimmings
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID IMMUNOMAGNETIC SEPARATION; MULTIPLEX PCR; O157-H7; GROWTH; CATTLE;
MEDIA; PREVALENCE; OUTBREAK; STRAINS; O157H7
AB Enterohemorrhagic Escherichia coli O157:H7 is an important pathogen associated with infections caused by consumption of undercooked raw meat. Sensitive and rapid detection methods for E. coli O157:H7 are essential for the meat industry to ensure a safe meat supply. This study was conducted to compare the sensitivity of the VIDAS ultraperformance E. coli test (ECPT UP) with a noncommercial real-time (RT) PCR method and the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS) reference method for detecting E. coli O157:H7 in raw ground beef. Optimal enrichment times and the efficacy of testing different types of raw meat, either as individual samples (25 g) or as composites (375 g), were examined. For 25-g samples of each type of raw ground beef tested, 6 h of enrichment was sufficient for both the VIDAS ECPT UP and RT-PCR methods, but for 375-g samples, 24 h of enrichment was required. Both the VIDAS ECPT UP and RT-PCR methods produced results similar to those obtained with the USDA-FSIS reference method after 18 to 24 h of enrichment. The primer specificity of the RT-PCR assay and the highly specific phage ligand used in the VIDAS ECPT UP for target recognition enabled the detection of low levels of E. coli O157:H7 in 25 g of various types of raw ground beef. The tests also allowed the detection of E. coli O157:H7 in composite raw ground beef and trimmings in samples of up to 375 g.
C1 [Savoye, F.; Rozand, C.; Bouvier, M.; Gleizal, A.; Thevenot, D.] Vetagro Sup Lyon, Unite Microbiol Alimentaire & Previs, F-69280 Marcy Letoile, France.
[Feng, P.] US FDA, Div Microbiol, College Pk, MD 20740 USA.
RP Savoye, F (reprint author), Vetagro Sup Lyon, Unite Microbiol Alimentaire & Previs, 1 Av Bourgelat, F-69280 Marcy Letoile, France.
EM f.savoye@vetagro-sup.fr
NR 41
TC 13
Z9 14
U1 0
U2 8
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2011
VL 74
IS 1
BP 6
EP 12
DI 10.4315/0362-028X.JFP-10-271
PG 7
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 704EC
UT WOS:000286032900001
PM 21219756
ER
PT J
AU Xia, XD
Meng, JH
Zhao, SH
Bodeis-Jones, S
Gaines, SA
Ayers, SL
McDermott, PF
AF Xia, Xiaodong
Meng, Jianghong
Zhao, Shaohua
Bodeis-Jones, Sonya
Gaines, Stuart A.
Ayers, Sherry L.
McDermott, Patrick F.
TI Identification and Antimicrobial Resistance of Extraintestinal
Pathogenic Escherichia coli from Retail Meats
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID MULTIDRUG-RESISTANT; PHYLOGENETIC GROUP; COLI STRAINS; VIRULENCE;
PRODUCTS; FOODS; ACQUISITION; INFECTIONS; MINNESOTA; ORIGIN
AB Extraintestinal pathogenic Escherichia coli (ExPEC) causes a variety of infections outside the gastrointestinal tract. Retail meats are frequently contaminated with E. coli strains, and they might serve as a vehicle for transmitting ExPEC. A total of 1,275 E. coli isolates recovered from ground beef, ground turkey, chicken breasts, and pork chops obtained in Georgia, Maryland, Oregon, and Tennessee in 2006 were investigated for the presence of ExPEC by using multiplex PCR. Identified ExPEC isolates were assigned to serogroups and phylogenetic groups and then analyzed for antimicrobial susceptibility. Approximately 16% (200 of 1,275) of the E. coli isolates were identified as ExPEC, based on defined genetic criteria. The occurrence of ExPEC was highest in E. coli isolated from ground turkey (23.5%) and chicken breasts (20.2%), and less frequent in isolates from pork chops (8.3%) and ground beef (3.4%). Phylogenetic grouping revealed that most (66.5%) ExPEC isolates fell into the same phylogenetic groups (B2 and D) as did virulent human ExPEC strains. Among the 15 antimicrobial agents tested, resistance to tetracycline (67.0%), sulfisoxazole (59.5%), and streptomycin (46.0%) was most frequent. Most ExPEC isolates (n = 163 [81.5%]) were resistant to at least one antimicrobial agent, and more than half (n = 114 [57%]) exhibited resistance to at least three drugs. This study found that ExPEC strains, including antimicrobial-resistant strains, were frequent among E. coli recovered from retail meats, especially those from chicken and turkey products. These findings indicate a need to better understand the role of certain meat types as potential sources of human ExPEC infection.
C1 [Zhao, Shaohua; Bodeis-Jones, Sonya; Gaines, Stuart A.; Ayers, Sherry L.; McDermott, Patrick F.] USDA, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
[Xia, Xiaodong; Meng, Jianghong] Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
[Meng, Jianghong] Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
RP McDermott, PF (reprint author), USDA, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
EM Patrick.McDermott@fda.hhs.gov
FU Joint Institute for Food Safety and Applied Nutrition of the University
of Maryland; U.S. Food and Drug Administration
FX This study was supported in part by the Joint Institute for Food Safety
and Applied Nutrition of the University of Maryland and the U.S. Food
and Drug Administration. We are grateful to Dr. James R. Johnson of the
University of Minnesota for providing clinical E. coli strains.
NR 35
TC 15
Z9 16
U1 0
U2 12
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 2011
VL 74
IS 1
BP 38
EP 44
DI 10.4315/0362-028X.JFP-10-251
PG 7
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 704EC
UT WOS:000286032900006
PM 21219761
ER
PT J
AU Rummel, N
Chung, I
Shaikh, B
AF Rummel, Nathan
Chung, Ivy
Shaikh, Badar
TI DETERMINATION OF ALBENDAZOLE, FENBENDAZOLE, AND THEIR METABOLITES IN
MOUSE PLASMA BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY USING
FLUORESCENCE AND ULTRAVIOLET DETECTION
SO JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
LA English
DT Article
DE albendazole; albendazole metabolites; fenbendazole; fenbendazole
metabolites; high performance liquid chromatography; mouse plasma
ID SHEEP PLASMA; IN-VITRO; SULFOXIDE; SULFONE; MICE; RICOBENDAZOLE;
OXFENDAZOLE; DISPOSITION; GROWTH; CATTLE
AB A rapid and reliable high performance liquid chromatographic (HPLC) method has been developed and validated for the determination of albendazole (ABZ), albendazole sulfoxide (ABZSO), albendazole sulfone (ABZSO(2)); fenbendazole (FBZ), fenbendazole sulfoxide (FBZSO), and fenbendazole sulfone (FBZSO(2)) in mouse plasma. The mouse plasma was made alkaline with potassium carbonate and extracted with ethylacetate. The extracts were evaporated, reconstituted in mobile phase, and analyzed by HPLC. The chromatography was carried out on a reversed-phase column using acetonitrile-methanol-buffer as the mobile phase. The fenbendazole and its metabolites were detected by using UV detector set at the wavelength of 290 nm. The albendazole and its metabolites were detected by a fluorescence detector with excitation and emission wavelengths of 290 and 330 nm, respectively. The average recoveries of ABZ, ABZSO, and ABZSO(2) from fortified control plasma samples were 95, 82, and 92%, respectively. Similarly, the average recoveries of FBZ, FBZSO, and FBZSO(2) were 64, 90, and 94%, respectively. The average CVs were <= 15% for all of the compounds. The method was applied to incurred mouse plasma samples to determine ABZ, FBZ, and their metabolites.
C1 [Rummel, Nathan; Shaikh, Badar] US FDA, Ctr Vet Med Off Res, Laurel, MD 20708 USA.
[Chung, Ivy] Harvard Univ, Sch Med, Vasc Biol Program, Boston, MA USA.
[Chung, Ivy] Childrens Hosp, Karp Family Res Labs, Boston, MA 02115 USA.
RP Shaikh, B (reprint author), US FDA, Ctr Vet Med Off Res, 8401 Muirkirk Rd, Laurel, MD 20708 USA.
EM shaikh@fda.hhs.gov
RI Chung, Ivy/C-3804-2012
NR 20
TC 2
Z9 3
U1 0
U2 16
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1082-6076
J9 J LIQ CHROMATOGR R T
JI J. Liq. Chromatogr. Relat. Technol.
PY 2011
VL 34
IS 18
BP 2211
EP 2223
DI 10.1080/10826076.2011.587219
PG 13
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 880AF
UT WOS:000299375600014
ER
PT J
AU Gnjidic, D
Hilmer, SN
Roughead, EE
Gilbert, AL
Le Couteur, DG
Abernethy, DR
AF Gnjidic, Danijela
Hilmer, Sarah N.
Roughead, Elizabeth E.
Gilbert, Andrew L.
Le Couteur, David G.
Abernethy, Darrell R.
TI Drug burden index (DBI) and mortality in Australian veteran population
SO JOURNAL OF PHARMACOLOGICAL SCIENCES
LA English
DT Meeting Abstract
CT 84th Annual Meeting of the Japanese-Pharmacological-Society/11th
Southeast Asian Western Pacific Regional Meeting of Pharmacologists
CY MAR 22-24, 2011
CL Yokohama, JAPAN
SP Japanese Pharmacolog Soc
C1 [Gnjidic, Danijela; Hilmer, Sarah N.] Royal N Shore Hosp, Dept Clin Pharmacol & Aged Care, St Leonards, NSW 2065, Australia.
[Gnjidic, Danijela; Hilmer, Sarah N.; Le Couteur, David G.] Univ Sydney, Sydney Med Sch, Sydney, NSW 2006, Australia.
[Le Couteur, David G.] Concord Hosp, Ctr Educ & Res Ageing, Sydney, NSW, Australia.
[Roughead, Elizabeth E.; Gilbert, Andrew L.] Univ S Australia, Qual Use Meds & Pharm Res Ctr, Adelaide, SA 5001, Australia.
[Abernethy, Darrell R.] US FDA, Off Clin Pharmacol, Silver Spring, MD USA.
RI Gilbert, Andrew/C-6892-2009; Roughead, Elizabeth/G-4431-2010
OI Roughead, Elizabeth/0000-0002-6811-8991
NR 0
TC 0
Z9 0
U1 0
U2 2
PU JAPANESE PHARMACOLOGICAL SOC
PI KYOTO
PA EDITORIAL OFF, KANTOHYA BLDG GOKOMACHI-EBISUGAWA NAKAGYO-KU, KYOTO, 604,
JAPAN
SN 1347-8613
J9 J PHARMACOL SCI
JI J. Pharmacol. Sci.
PY 2011
VL 115
SU 1
BP 288P
EP 288P
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 743QU
UT WOS:000289034601536
ER
PT J
AU Taylor, AD
Vaisocherova, H
Deeds, J
DeGrasse, S
Jiang, SY
AF Taylor, Allen D.
Vaisocherova, Hana
Deeds, Jonathan
DeGrasse, Stacey
Jiang, Shaoyi
TI Tetrodotoxin Detection by a Surface Plasmon Resonance Sensor in
Pufferfish Matrices and Urine
SO JOURNAL OF SENSORS
LA English
DT Article
AB Tetrodotoxin (TTX) poisoning is most commonly associated with consumption of pufferfish. TTX is a low molecular weight (similar to 319 Da) neurotoxin that selectively blocks voltage-sensitive Na+-gated ion channels. The standard method accepted worldwide for monitoring TTX toxicity in food matrices is the mouse bioassay. Ethical concerns from live animal testing, low sample throughput, and analytical inaccuracies have led to the need for an alternative method. We have previously established that surface plasmon resonance (SPR) sensors can quantify TTX in aqueous buffer samples by an antibody-based inhibition assay. In this paper, we report the extension of the assay for the detection of TTX in both clinical- and food-relevant matrices. The assay was optimized for application to three relevant complex matrices: pufferfish liver extract, pufferfish muscle extract, and human urine. Matrix effects are discussed and calibration curves are presented. Naturally contaminated pufferfish liver and muscle extracts were analyzed by the SPR method, and the data is compared to liquid-chromatography electrospray-ionization multiple reactions monitoring mass spectrometry (LC/ESI/MRM/MS) data. Ten samples, including three from a poisoning incident, two control monkfish samples, and five toxic pufferfish samples, were analyzed using this method, and the data is compared to LC/ESI/MRM/MS analysis of the samples.
C1 [Taylor, Allen D.; Vaisocherova, Hana; Jiang, Shaoyi] Univ Washington, Dept Chem Engn, Seattle, WA 98195 USA.
[Deeds, Jonathan; DeGrasse, Stacey] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP DeGrasse, S (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM stacy.degrasse@fda.hhs.gov; sjiang@uw.edu
RI Evans, David/H-6325-2013; Lisalova, Hana/H-4706-2014;
OI Lisalova, Hana/0000-0002-8755-2398; DeGrasse, Stacey/0000-0001-7808-4193
FU National Research Initiative of the USDA Cooperative State Research,
Education and Extension Service [2005-35201-16321]; United States Food
and Drug Administration [HHSF223200610011]; Intel Foundation Ph.D.
Fellowship Award; Kaiser Aluminum Fellowship Award at the University of
Washington
FX The authors are grateful to Betsy Yakes for her comments and revision of
this paper prior to submission. This project was supported by the
National Research Initiative of the USDA Cooperative State Research,
Education and Extension Service, Grant no. 2005-35201-16321 and the
United States Food and Drug Administration, Grant no. HHSF223200610011.
Allen D. Taylor was partially supported by the Intel Foundation Ph.D.
Fellowship Award and the Kaiser Aluminum Fellowship Award at the
University of Washington.
NR 32
TC 7
Z9 7
U1 2
U2 23
PU HINDAWI PUBLISHING CORPORATION
PI NEW YORK
PA 410 PARK AVENUE, 15TH FLOOR, #287 PMB, NEW YORK, NY 10022 USA
SN 1687-725X
EI 1687-7268
J9 J SENSORS
JI J. Sens.
PY 2011
AR 601704
DI 10.1155/2011/601704
PG 10
WC Engineering, Electrical & Electronic; Instruments & Instrumentation
SC Engineering; Instruments & Instrumentation
GA V31DS
UT WOS:000208864900016
ER
PT J
AU Gardner, JY
Brillhart, DE
Benjamin, MM
Dixon, LG
Mitchell, LM
Dimandja, JMD
AF Gardner, J. Yvette
Brillhart, Darcy E.
Benjamin, Melissa M.
Dixon, Lurlene G.
Mitchell, LaTonya M.
Dimandja, Jean-Marie D.
TI The use of GC x GC/TOF MS with multivariate analysis for the
characterization of foodborne pathogen bacteria profiles
SO JOURNAL OF SEPARATION SCIENCE
LA English
DT Article
DE Bacterial fatty acid methyl esters; Chemical index template; GC x GC/TOF
MS; Multidimensional scaling; Principal component analysis
ID 2-DIMENSIONAL GAS-CHROMATOGRAPHY; MASS-SPECTROMETRY; FATTY-ACIDS;
RETENTION INDEXES; MICROORGANISMS; IDENTIFICATION; DIFFERENTIATION;
CLASSIFICATION; HYDROCARBONS; COMMUNITIES
AB The cellular fatty acid profiles of eight strains of Bacillus, Staphylococcus, and Enterobacteriacae (Escherichia coli and Salmonella) were analyzed by comprehensive two-dimensional gas chromatography/time-of-flight mass spectrometry. A novel template method was developed to standardize the raw two-dimensional gas chromatography retention data through the use of a chemical indexing mixture. Analyte retention coordinates were normalized in the primary dimension with respect to a series of n-alkanes (Kovats index) and in the secondary dimension with respect to a series of aromatic hydrocarbons (Lee index). Fatty acid profiles extracted from the templates were compared by multidimensional scaling and principal component analysis. Differences in the profiles of Gram-positive and Gram-negative bacteria were observed, and a series of heterogeneous mixtures comprising different fractions (containing one Gram-positive and one Gram-negative bacteria strain) were also distinguished from their homogeneous constituents.
C1 [Dimandja, Jean-Marie D.] Spelman Coll, Dept Chem, Atlanta, GA 30314 USA.
[Dimandja, Jean-Marie D.] Georgia Inst Technol, Inst Bioengn & Biosci, Atlanta, GA 30332 USA.
[Gardner, J. Yvette] Clayton State Univ, Dept Nat Sci, Morrow, GA USA.
[Brillhart, Darcy E.; Benjamin, Melissa M.; Dixon, Lurlene G.; Mitchell, LaTonya M.] US FDA, SE Reg Lab, Atlanta, GA USA.
RP Dimandja, JMD (reprint author), Spelman Coll, Dept Chem, 350 Spelman Lane SW,Box 279, Atlanta, GA 30314 USA.
EM jdimandja@spelman.edu
FU NSF [0923295]; NASA under NSF Center for Chemical Evolution
[CHE-1004570]
FX This work was jointly supported by NSF and the NASA Astrobiology
Program, under the NSF Center for Chemical Evolution, CHE-1004570.
Financial support from NSF grant 0923295 (NSF/MRI) is also gratefully
acknowledged.
NR 48
TC 17
Z9 17
U1 1
U2 21
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 1615-9306
J9 J SEP SCI
JI J. Sep. Sci.
PD JAN
PY 2011
VL 34
IS 2
BP 176
EP 185
DI 10.1002/jssc.201000612
PG 10
WC Chemistry, Analytical
SC Chemistry
GA 724VD
UT WOS:000287603400008
PM 21246723
ER
PT J
AU Gwise, TE
Zhou, JH
Hu, FF
AF Gwise, Thomas E.
Zhou, Jianhui
Hu, Feifang
TI An optimal response adaptive biased coin design with k heteroscedastic
treatments
SO JOURNAL OF STATISTICAL PLANNING AND INFERENCE
LA English
DT Article
DE Heteroscedasticity; k treatments; Response adaptive design
ID SEQUENTIAL CLINICAL-TRIALS; PLAY-WINNER RULE; RANDOMIZATION PROCEDURES;
ASYMPTOTIC PROPERTIES; PROGNOSTIC FACTORS
AB For comparing treatments in clinical trials, Atkinson (1982) introduced optimal biased coins for balancing patients across treatment assignments by using D-optimality under the assumption of homoscedastic responses of different treatments. However, this assumption can be violated in many real applications. In this paper, we relax the homoscedasticity assumption in the k treatments setting with k>2. A general family of optimal response adaptive biased coin designs are proposed following Atkinson's procedure. Asymptotic properties of the proposed designs are obtained. Some advantages of the proposed design are discussed. (C) 2010 Elsevier B.V. All rights reserved.
C1 [Zhou, Jianhui; Hu, Feifang] Univ Virginia, Dept Stat, Charlottesville, VA 22904 USA.
[Gwise, Thomas E.] US FDA, Rockville, MD 20857 USA.
RP Zhou, JH (reprint author), Univ Virginia, Dept Stat, POB 400135,Kerchof Hall, Charlottesville, VA 22904 USA.
EM jz9p@virginia.edu
NR 17
TC 4
Z9 4
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-3758
EI 1873-1171
J9 J STAT PLAN INFER
JI J. Stat. Plan. Infer.
PD JAN
PY 2011
VL 141
IS 1
BP 235
EP 242
DI 10.1016/j.jspi.2010.06.013
PG 8
WC Statistics & Probability
SC Mathematics
GA 660UA
UT WOS:000282670100018
ER
PT J
AU Nie, L
Chen, Y
Chu, HT
AF Nie, Lei
Chen, Yong
Chu, Haitao
TI Asymptotic variances of maximum likelihood estimator for the correlation
coefficient from a BVN distribution with one variable subject to
censoring
SO JOURNAL OF STATISTICAL PLANNING AND INFERENCE
LA English
DT Article
DE Censoring; Limit of detection; Maximum likelihood estimator
ID DETECTION LIMITS; VIRAL LOAD; POPULATIONS; SAMPLES
AB This paper deals with the problem of estimating the Pearson correlation coefficient when one variable is subject to left or right censoring. In parallel to the classical results on the Pearson correlation coefficient, we derive a workable formula, through tedious computation and intensive simplification, of the asymptotic variances of the maximum likelihood estimators in two cases: (1) known means and variances and (2) unknown means and variances. We illustrate the usefulness of the asymptotic results in experimental designs. Published by Elsevier B.V.
C1 [Chu, Haitao] Univ Minnesota Twin Cities, Div Biostat, Minneapolis, MN 55455 USA.
[Nie, Lei] US FDA, Div 4, Off Biometr, OTS,CDER, Silver Spring, MD 20993 USA.
[Chen, Yong] Univ Texas Hlth Sci Ctr, Div Biostat, Houston, TX 77030 USA.
RP Chu, HT (reprint author), Univ Minnesota Twin Cities, Div Biostat, Minneapolis, MN 55455 USA.
EM chux0051@umn.edu
RI Chu, Haitao /J-7576-2012;
OI Chu, Haitao/0000-0003-0932-598X
NR 15
TC 2
Z9 2
U1 1
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-3758
J9 J STAT PLAN INFER
JI J. Stat. Plan. Infer.
PD JAN
PY 2011
VL 141
IS 1
BP 392
EP 401
DI 10.1016/j.jspi.2010.06.021
PG 10
WC Statistics & Probability
SC Mathematics
GA 660UA
UT WOS:000282670100032
ER
PT J
AU Boyce, JA
Assa'ad, A
Burks, AW
Jones, SM
Sampson, HA
Wood, RA
Plaut, M
Cooper, SF
Fenton, MJ
Arshad, SH
Bahna, SL
Beck, LA
Byrd-Bredbenner, C
Camargo, CA
Eichenfield, L
Furuta, GT
Hanifin, JM
Jones, C
Kraft, M
Levy, BD
Lieberman, P
Luccioli, S
McCall, KM
Schneider, LC
Simon, RA
Simons, FER
Teach, SJ
Yawn, BP
Schwaninger, JM
AF Boyce, Joshua A.
Assa'ad, Amal
Burks, A. Wesley
Jones, Stacie M.
Sampson, Hugh A.
Wood, Robert A.
Plaut, Marshall
Cooper, Susan F.
Fenton, Matthew J.
Arshad, S. Hasan
Bahna, Sami L.
Beck, Lisa A.
Byrd-Bredbenner, Carol
Camargo, Carlos A., Jr.
Eichenfield, Lawrence
Furuta, Glenn T.
Hanifin, Jon M.
Jones, Carol
Kraft, Monica
Levy, Bruce D.
Lieberman, Phil
Luccioli, Stefano
McCall, Kathleen M.
Schneider, Lynda C.
Simon, Ronald A.
Simons, F. Estelle R.
Teach, Stephen J.
Yawn, Barbara P.
Schwaninger, Julie M.
TI Guidelines for the Diagnosis and Management of Food Allergy in the
United States: Summary of the NIAID-Sponsored Expert Panel Report
SO JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
LA English
DT Article
AB This document is a summary report of the Guidelines for the Diagnosis and Management of Food Allergy in the United States. The full guidelines can be found online at http://www.jacionline.org
C1 [Plaut, Marshall; Cooper, Susan F.; Fenton, Matthew J.; Schwaninger, Julie M.] NIAID, Div Allergy Immunol & Transplantat, NIH, Bethesda, MD 20892 USA.
[Boyce, Joshua A.] Harvard Univ, Sch Med, Brigham & Womens Hosp, Dept Med,Div Rheumatol Immunol & Allergy, Cambridge, MA 02138 USA.
[Camargo, Carlos A., Jr.] Harvard Univ, Sch Med, Massachusetts Gen Hosp,Dept Emergency Med, Dept Med,Div Rheumatol Allergy & Immunol, Cambridge, MA 02138 USA.
[Levy, Bruce D.] Brigham & Womens Hosp, Partners Asthma Ctr, Pulm & Crit Med Div, Boston, MA 02115 USA.
[Levy, Bruce D.] Harvard Univ, Sch Med, Boston, MA USA.
[Assa'ad, Amal] Univ Cincinnati, Cincinnati Childrens Hosp Med Ctr, Div Allergy & Immunol, Cincinnati, OH 45221 USA.
[Burks, A. Wesley] Duke Univ, Med Ctr, Dept Pediat, Div Allergy & Immunol, Durham, NC 27710 USA.
[Kraft, Monica] Duke Univ, Med Ctr, Dept Med, Div Pulm Allergy & Crit Care Med, Durham, NC 27710 USA.
[Jones, Stacie M.] Univ Arkansas Med Sci, Arkansas Childrens Hosp, Dept Pediat, Div Allergy & Immunol, Little Rock, AR 72205 USA.
[Sampson, Hugh A.] Mt Sinai Sch Med, Elliot & Roslyn Jaffe Food Allergy Inst, Dept Pediat, Div Allergy & Immunol, New York, NY USA.
[Wood, Robert A.] Johns Hopkins Univ, Sch Med, Dept Pediat, Div Allergy & Immunol, Baltimore, MD 21205 USA.
[Arshad, S. Hasan] Univ Southampton, Sch Med, Southampton SO9 5NH, Hants, England.
[Arshad, S. Hasan] Southampton Univ Hosp NHS Trust, Southampton, Hants, England.
[Bahna, Sami L.] Louisiana State Univ, Hlth Sci Ctr, Dept Pediat, Allergy & Immunol Sect, Baton Rouge, LA 70803 USA.
[Beck, Lisa A.] Univ Rochester, Dept Dermatol, Med Ctr, Rochester, NY 14627 USA.
[Byrd-Bredbenner, Carol] Rutgers State Univ, Dept Nutr Sci, New Brunswick, NJ 08903 USA.
[Eichenfield, Lawrence] Rady Childrens Hosp, Div Pediat & Adolescent Dermatol, San Diego, CA USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Pediat, San Diego, CA 92103 USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Med, San Diego, CA 92103 USA.
[Furuta, Glenn T.] Childrens Hosp Denver, Digest Hlth Inst, Sect Pediat Gastroenterol Hepatol & Nutr, Aurora, CO USA.
[Furuta, Glenn T.] Natl Jewish Hlth, Dept Pediat, Denver, CO USA.
[Furuta, Glenn T.] Univ Colorado, Dept Pediat, Denver Sch Med, Aurora, CO USA.
[Hanifin, Jon M.] Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA.
[Jones, Carol] Allergy & Asthma Network Mothers Asthmat, Mclean, VA USA.
[Lieberman, Phil] Univ Tennessee, Coll Med, Div Allergy & Immunol, Dept Med, Knoxville, TN 37996 USA.
[Luccioli, Stefano] US FDA, Off Food Addit Safety, College Pk, MD USA.
[McCall, Kathleen M.] Childrens Hosp Orange Cty, Orange, CA USA.
[Schneider, Lynda C.] Childrens Hosp Boston, Div Immunol, Boston, MA USA.
[Simon, Ronald A.] Scripps Clin, Div Allergy Asthma & Immunol, San Diego, CA USA.
[Simons, F. Estelle R.] Univ Manitoba, Fac Med, Dept Pediat, Winnipeg, MB R3T 2N2, Canada.
[Simons, F. Estelle R.] Univ Manitoba, Fac Med, Dept Child Hlth & Immunol, Winnipeg, MB R3T 2N2, Canada.
[Teach, Stephen J.] Childrens Natl Med Ctr, Div Emergency Med, Washington, DC 20010 USA.
[Yawn, Barbara P.] Olmsted Med Ctr, Dept Res, Rochester, MN USA.
[Yawn, Barbara P.] Univ Minnesota, Sch Med, Dept Family & Community Hlth, Minneapolis, MN 55455 USA.
RP Fenton, MJ (reprint author), NIAID, Div Allergy Immunol & Transplantat, NIH, 6610 Rockledge Dr,Room 3105, Bethesda, MD 20892 USA.
EM fentonm@niaid.nih.gov
RI Byrd-Bredbenner, Carol/F-8064-2015
OI Byrd-Bredbenner, Carol/0000-0002-8010-3987
FU National Institutes of Health; GlaxoSmithKline; Food Allergy and
Anaphylaxis Network; Gerber; Mead Johnson; Dyax Corp; National Peanut
Board; Food Allergy Initiative; National Institutes of Health (Division
of Receipt and Referral, National Institute of Allergy and Infectious
Diseases, National Center for Complementary and Alternative Medicine);
Phadia AB; Genentech; National Institutes of Health (National Institute
of Allergy and Infectious Diseases); National Institutes of Health and
the National Institute of Health Research, UK; American Academy of
Allergy, Asthma, and Immunology; National Eczema Association; US
Department of Agriculture; Canned Food Alliance; New Jersey Department
of Health and Senior Services; variety of government agencies;
not-for-profit research foundations; Dey; Novartis; variety of
not-for-profit foundations; Astellas; Ferndale; Johnson Johnson;
Sinclair; Stiefel; Therapeutics Inc.; American Gastrointestinal
Association; ALZA; Astellas Pharma US, Inc; Asubio Pharmaceuticals, Inc;
Centocor, Inc; Corgentech; Nucryst Pharmaceuticals; Seattle Genetics;
Shionogi USA; variety of not-for-profit research foundations; AllerGen;
Canadian Allergy, Asthma and Immunology Foundation/Anaphylaxis Canada;
Canadian Institutes of Health Research; AstraZeneca Foundation; Aventis;
Child Health Center Board; CNMC Research Advisory Council; National
Association of Chain Drug Stores Foundation; National Institutes of
Health (National Institute of Allergy and Infectious Diseases; National
Heart, Lung, and Blood Institute); Novartis/Genentech; Robert Woods
Johnson Foundation; US Centers for Disease Control and Prevention; US
Public Health Service; Washington, DC, Department of Health
FX J.A. Boyce has served on the Advisory Board of GlaxoSmithKline. He has
served as a consultant and/or speaker for Altana, GlaxoSmithKline, and
Merck. He has received funding/grant support from the National
Institutes of Health.; Dr Assa'ad has received funding/grant support
from GlaxoSmithKline.; Dr Burks has received funding/grant support from
the Food Allergy and Anaphylaxis Network, Gerber, Mead Johnson, and the
National Institutes of Health.; S.M. Jones has served as a speaker and
grant reviewer and has served on the medical advisory committee for the
Food Allergy and Anaphylaxis Network.She has received funding/grant
support from Dyax Corp, the Food Allergy and Anaphylaxis Network, Mead
Johnson, the National Peanut Board, and the National Institutes of
Health.; H.A. Sampson holds, or is listed as an inventor on, multiple US
patents related to food allergy. He owns stock in Allertein
Therapeutics. He is the immediate past president of the American Academy
of Allergy, Asthma, and Immunology. He has served as a consultant for
Allertein Therapeutics, the American Academy of Allergy, Asthma, and
Immunology, the Food Allergy Initiative, and Schering Plough. He has
received funding/grant support for research projects from the Food
Allergy Initiative, the National Institutes of Health (Division of
Receipt and Referral, National Institute of Allergy and Infectious
Diseases, National Center for Complementary and Alternative Medicine),
and Phadia AB. He is a co-owner of Herbal Spring, LLC.; R.A. Wood has
served as a speaker/advisory board member for GlaxoSmithKline, Merck,
and Dey. He has received funding/grant support from Genentech and the
National Institutes of Health (National Institute of Allergy and
Infectious Diseases).; S.H. Arshad has received funding/grant support
from the National Institutes of Health and the National Institute of
Health Research, UK.; S.L. Bahna has received funding/grant support from
Genentech.; L.A. Beck has received funding/grant support from the
American Academy of Allergy, Asthma, and Immunology, the National Eczema
Association, and the National Institutes of Health.; C. Byrd-Bredbenner
owns stock in Johnson & Johnson. She has received funding/grant support
from the US Department of Agriculture, the Canned Food Alliance, and the
New Jersey Department of Health and Senior Services.; C.A. Camargo Jr
has consulted for Dey and Novartis. He has received funding/grant
support from a variety of government agencies and not-for-profit
research foundations, as well as Dey and Novartis.; L. Eichenfield has
received funding/grant support from a variety of not-for-profit
foundations, as well as Astellas, Ferndale, Johnson & Johnson, Novartis,
Sinclair, Stiefel, and Therapeutics Inc.; G.T. Furuta has served as a
consultant and/or speaker to Ception Therapeutics and TAP. He has
received funding/grant support from the American Gastrointestinal
Association and the National Institutes of Health.; J.M. Hanifin has
served as served as a consultant for ALZA, Anesiva, Inc, Barrier
Therapeutics, Inc, Milliken & Company, Nordic Biotech, Novartis
Pharmaceuticals Corporation, Shionogi USA, Taisho Pharmaceutical R&D,
Inc, Teikoku Pharma USA, Inc, UCB, York Pharma, ZARS, Inc, and
ZymoGenetics. He has served as an investigator or received research
funding from ALZA, Astellas Pharma US, Inc, Asubio Pharmaceuticals, Inc,
Centocor, Inc, Corgentech, Novartis, Nucryst Pharmaceuticals, Seattle
Genetics, and Shionogi USA.; M. Kraft has served as a consultant and/or
speaker for Astra-Zeneca, Genentech, GlaxoSmithKline, Merck, Novartis,
and Sepracor. She has received funding/grant support from Genentech,
GlaxoSmithKline, the National Institutes of Health and Novartis.; L.C.
Schneider has served as a consultant/clinical advisor for the Food
Allergy Initiative. She has received funding/grant support from a
variety of not-for-profit research foundations, as well as Novartis and
the National Institutes of Health.; F.E.R. Simons holds a patent on
"Fast-disintegrating epinephrine tablets for sublingual administration."
She is a past-president of the American Academy of Allergy, Asthma, and
Immunology and of the Canadian Society of Allergy and Clinical
Immunology. She is a member of the advisory boards of Dey, Intelliject,
and ALK-Abello. She has received funding/grant support from AllerGen,
the Canadian Allergy, Asthma and Immunology Foundation/Anaphylaxis
Canada, and the Canadian Institutes of Health Research.; S.J. Teach has
served as a speaker for AstraZeneca. He has received funding/grant
support from the AstraZeneca Foundation, Aventis, the Child Health
Center Board, the CNMC Research Advisory Council, the National
Association of Chain Drug Stores Foundation, the National Institutes of
Health (National Institute of Allergy and Infectious Diseases; National
Heart, Lung, and Blood Institute), Novartis/Genentech, the Robert Woods
Johnson Foundation, the US Centers for Disease Control and Prevention,
the US Public Health Service, and the Washington, DC, Department of
Health.
NR 0
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Z9 13
U1 0
U2 4
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0190-9622
J9 J AM ACAD DERMATOL
JI J. Am. Acad. Dermatol.
PD JAN
PY 2011
VL 64
IS 1
BP 175
EP 192
DI 10.1016/j.jaad.2010.11.020
PG 18
WC Dermatology
SC Dermatology
GA 701XF
UT WOS:000285857800021
PM 21167411
ER
PT J
AU Lee, S
Poet, TS
Smith, JN
Hjerpe, AL
Gunawan, R
Timchalk, C
AF Lee, S.
Poet, T. S.
Smith, J. N.
Hjerpe, A. L.
Gunawan, R.
Timchalk, C.
TI IMPACT OF REPEATED NICOTINE AND ALCOHOL COEXPOSURE ON IN VITRO AND IN
VIVO CHLORPYRIFOS DOSIMETRY AND CHOLINESTERASE INHIBITION
SO JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH-PART A-CURRENT ISSUES
LA English
DT Article
ID PHARMACODYNAMIC PBPK/PD MODEL; ETHANOL-METABOLIZING CYP2E1; HUMAN
LIVER-MICROSOMES; ORGANOPHOSPHORUS PESTICIDES; CHEMICAL-MIXTURES;
RAT-LIVER; INSECTICIDE CHLORPYRIFOS; CYTOCHROMES P450; INDUCTION;
EXPOSURE
AB Chlorpyrifos (CPF) is an organophosphorus insecticide, and neurotoxicity results from inhibition of acetylcholinesterase (AChE) by its metabolite, chlorpyrifos-oxon. Routine consumption of alcohol and tobacco modifies metabolic and physiological processes impacting the metabolism and pharmacokinetics of other xenobiotics, including pesticides. This study evaluated the influence of repeated ethanol and nicotine coexposure on in vivo CPF dosimetry and cholinesterase (ChE) response (ChE- includes AChE and/or butyrylcholinesterase (BuChE)). Hepatic microsomes were prepared from groups of naive, ethanol-only (1 g/kg/d, 7 d, po), and ethanol + nicotine (1 mg/kg/d 7 d, sc)-treated rats, and the in vitro metabolism of CPF was evaluated. For in vivo studies, rats were treated with saline or ethanol (1 g/kg/d, po)+ nicotine (1 mg/kg/d, sc) in addition to CPF (1 or 5 mg/kg/d, po) for 7 d. The major CPF metabolite, 3,5,6-trichloro-2-pyridinol (TCPy), in blood and urine and the plasma ChE and brain acetylcholinesterase (AChE) activities were measured in rats. There were differences in pharmacokinetics, with higher TCPy peak concentrations and increased blood TCPy AUC in ethanol + nicotine groups compared to CPF only (approximately 1.8- and 3.8-fold at 1 and 5 mg CPF doses, respectively). Brain AChE activities after ethanol + nicotine treatments showed significantly less inhibition following repeated 5 mg CPF/kg dosing compared to CPF only (96 +/- 13 and 66 +/- 7% of naive at 4 h post last CPF dosing, respectively). Although brain AChE activity was minimal inhibited for the 1-mg CPF/kg/d groups, the ethanol + nicotine pretreatment resulted in a similar trend (i.e., slightly less inhibition). No marked differences were observed in plasma ChE activities due to the alcohol + nicotine treatments. In vitro, CPF metabolism was not markedly affected by repeated ethanol or both ethanol + nicotine exposures. Compared with a previous study of nicotine and CPF exposure, there were no apparent additional exacerbating effects due to ethanol coexposure.
C1 [Poet, T. S.; Smith, J. N.; Hjerpe, A. L.; Gunawan, R.; Timchalk, C.] Pacific NW Natl Lab, Ctr Biol Monitoring & Modeling, Richland, WA 99352 USA.
[Lee, S.] US FDA, Atlanta, GA USA.
RP Timchalk, C (reprint author), Pacific NW Natl Lab, Ctr Biol Monitoring & Modeling, 902 Battelle Blvd,POB 999,MSIN P7-59, Richland, WA 99352 USA.
EM Charles.timchalk@pnl.gov
FU Dow Chemical Company; Centers for Disease Control and Prevention
(CDC)/National Institute for Occupational Safety and Health (NIOSH)
[CDC/NIOSH] [R01-OH003629]
FX Although Drs. Timchalk and Poet have received funding from the Dow
Chemical Company, the manufacturer of chlorpyrifos, to conduct research,
the Dow Chemical Company did not have any involvement in the study
design, analysis, and interpretation of data, in the writing of the
report, or in the decision to submit this paper for publication. We
gratefully acknowledge Dr. J. Campbell for valuable discussions.
Although the research described in this article has been funded by the
Centers for Disease Control and Prevention (CDC)/National Institute for
Occupational Safety and Health (NIOSH) [CDC/NIOSH grant (R01-OH003629)
to Dr. Timchalk], it has not been subject to any CDC/NIOSH review and
therefore does not necessarily reflect the official views of the
agencies; its contents are solely the responsibility of the authors and
no public endorsement should be inferred.
NR 70
TC 1
Z9 1
U1 0
U2 2
PU TAYLOR & FRANCIS INC
PI PHILADELPHIA
PA 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
SN 1528-7394
J9 J TOXICOL ENV HEAL A
JI J. Toxicol. Env. Health Part A
PY 2011
VL 74
IS 20
BP 1334
EP 1350
DI 10.1080/15287394.2011.567958
PG 17
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 865PD
UT WOS:000298321900003
PM 21899407
ER
PT J
AU Balsam, J
Ossandon, M
Kostov, Y
Bruck, HA
Rasooly, A
AF Balsam, Joshua
Ossandon, Miguel
Kostov, Yordan
Bruck, Hugh Alan
Rasooly, Avraham
TI Lensless CCD-based fluorometer using a micromachined optical Soller
collimator
SO LAB ON A CHIP
LA English
DT Article
ID STAPHYLOCOCCAL-ENTEROTOXIN-B; ON-CHIP MICROSCOPY; BOTULINUM NEUROTOXIN;
NEUROTRANSMITTER RELEASE; OPTOFLUIDIC MICROSCOPY;
CAENORHABDITIS-ELEGANS; PROTEOLYTIC CLEAVAGE; CARBON NANOTUBES; ARRAY
BIOSENSOR; PROTEIN
AB In this paper, we describe a simple charge-coupled device (CCD) based lensless fluorometer with sensitivity in the range of current ELISA plate readers. In our lensfree fluorometer, a multi-wavelength LED light source was used for fluorophore excitation. To collimate the light, we developed a simple optical Soller collimator based on a "stack of pinholes'' (a stack of black PMMA with array of pinholes machined with laser) enabling the light to be collimated from the LED through the filters and the assay's microfluidics directly onto the CCD without a lens. The elimination of the lens that is used in almost all other current CCD based detection systems has four major advantages: (1) It simplifies the device design and fabrication while reducing cost. (2) It reduces the distance between the sample and the measuring device (without a lens the distance needed to focus the image on the CCD is reduced and the fluorometer can be more compact). (3) It couples the CCD and the detected surface by using an optical Soller Collimator which allows the use of filters for fluorescence detection. (4) It also uncouples the CCD and the microfluidics to enable the use of interchangeable fluidics while protecting the delicate CCD. The lensless CCD-based fluorometer is capable of detecting 16 samples simultaneously, and was used for in vitro detection of botulinum neurotoxin serotype A (BoNT-A) activity with a FRET assay that measures cleavage of a fluorophore-tagged peptide substrate specific for BoNT-A (SNAP-25) by the toxin light chain (LcA). The limit of detection (LOD) of our lensless fluorometer is 1.25 nM, which is similar to the LOD of a modern ELISA plate reader. Combined with microfluidics, this simple low cost point-of-care (POC) medical diagnostic system may be useful for the performance of many other complex medical diagnostic assays without a laboratory and thus potentially enhancing the accessibility and the quality of health care delivery in underserved populations.
C1 [Balsam, Joshua; Rasooly, Avraham] US FDA, Div Biol, Off Sci & Engn, Silver Spring, MD 20993 USA.
[Balsam, Joshua; Bruck, Hugh Alan] UMCP, College Pk, MD 20742 USA.
[Ossandon, Miguel; Rasooly, Avraham] NCI, Bethesda, MD 20892 USA.
[Kostov, Yordan] Univ Maryland Baltimore Cty, Ctr Adv Sensor Technol, Baltimore, MD 21250 USA.
[Rasooly, Avraham] NCI, NIH, Rockville, MD 20852 USA.
RP Rasooly, A (reprint author), US FDA, Div Biol, Off Sci & Engn, Silver Spring, MD 20993 USA.
EM rasoolya@mail.nih.gov
NR 52
TC 22
Z9 22
U1 3
U2 16
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1473-0197
J9 LAB CHIP
JI Lab Chip
PY 2011
VL 11
IS 5
BP 941
EP 949
DI 10.1039/c0lc00431f
PG 9
WC Biochemical Research Methods; Chemistry, Multidisciplinary; Nanoscience
& Nanotechnology
SC Biochemistry & Molecular Biology; Chemistry; Science & Technology -
Other Topics
GA 722CW
UT WOS:000287409600023
PM 21243150
ER
PT S
AU Yin, JJ
Xia, Q
Lutterodt, H
Wamer, W
Fu, PP
AF Yin, J. J.
Xia, Q.
Lutterodt, H.
Wamer, W.
Fu, P. P.
BE Renou, JP
Belton, PS
Webb, GA
TI APPLICATION OF ELECTRON SPIN RESONANCE SPECTROSCOPY TO STUDY DIETARY
INGREDIENTS AND SUPPLEMENTS - DUAL ANTIOXIDANT AND PROOXIDANT FUNCTIONS
OF RETINYL PALMITATE
SO MAGNETIC RESONANCE IN FOOD SCIENCE: AN EXCITING FUTURE
SE Royal Society of Chemistry Special Publications
LA English
DT Proceedings Paper
CT 10th International Conference on the Applications of Magnetic Resonance
in Food Science
CY SEP 13-15, 2010
CL Clermont Ferrand, FRANCE
SP Clermont Ferrand Theix Inst Natl Rech Agronomique
ID CONJUGATED LINOLEIC-ACID; LIPID-PEROXIDATION; UVA PHOTOIRRADIATION;
OXYGEN DIFFUSION; SINGLET OXYGEN; FUMONISIN B-1; MEMBRANES;
PHOTODECOMPOSITION; CARDIOMYOCYTES; SUPEROXIDE
C1 [Yin, J. J.; Wamer, W.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Xia, Q.; Fu, P. P.] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Lutterodt, H.] Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
RP Yin, JJ (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM junjie.yin@fda.hhs.gov
NR 22
TC 2
Z9 2
U1 0
U2 0
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, CAMBRIDGE CB4 4WF, CAMBS, ENGLAND
SN 0260-6291
BN 978-1-84973-299-4
J9 ROY SOC CH
PY 2011
IS 332
BP 126
EP 135
DI 10.1039/9781849732994-00126
PG 10
WC Food Science & Technology
SC Food Science & Technology
GA BA5CZ
UT WOS:000336552200018
ER
PT S
AU Wong, JW
Zhang, K
Hayward, DG
Kai-Meng, C
AF Wong, Jon W.
Zhang, Kai
Hayward, Douglas G.
Kai-Meng, Chin
BE Zweigenbaum, J
TI Multiresidue Pesticide Analysis by Capillary Gas Chromatography-Mass
Spectrometry
SO MASS SPECTROMETRY IN FOOD SAFETY: METHODS AND PROTOCOLS
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE Gas chromatography-mass spectrometry; QuEChERS; Targeted analysis;
Non-targeted data acquisition; Multiresidue methods
ID FLAME PHOTOMETRIC DETECTION; SOLID-PHASE EXTRACTION; ORGANOPHOSPHORUS
PESTICIDES; LIQUID-CHROMATOGRAPHY; QUECHERS METHOD; GINSENG ROOT;
RESIDUES; PRODUCE; VEGETABLES; CONTAMINANTS
AB A multiresidue pesticide method using a modified QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) procedure and capillary gas chromatography-mass spectrometry (GC-MS) is described for the determination of 166 organochlorine, organophosphorus, and pyrethroid pesticides, metabolites, and isomers in spinach. The pesticides from spinach were extracted using acetonitrile saturated with magnesium sulfate and sodium chloride, followed by solid-phase dispersive cleanup using primary-secondary amine and graphitized carbon black sorbents and toluene. Analysis is performed using different GC-MS techniques emphasizing the benefits of non-targeted acquisition and targeted screening procedures. Non-targeted data acquisition of pesticides in the spinach was demonstrated using GC coupled to a single quadrupole mass spectrometery (GC-MS) in full scan mode or multidimensional GC-time-of-flight mass spectrometery (GC x GC-TOF/MS), along with deconvolution software and libraries. Targeted screening was achieved using GC-single quadrupole mass spectrometry in selective ion monitoring (GC-MS/SIM) mode or -tandem mass spectrometry (GC-MS/MS) in multiple reaction monitoring mode. The development of these techniques demonstrates the powerful use of GC-MS for the screening, identification, and quantitation of pesticide residues in foods.
C1 [Wong, Jon W.; Zhang, Kai; Hayward, Douglas G.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
[Kai-Meng, Chin] Agilent Technol, Wilmington, DE USA.
RP Wong, JW (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
NR 22
TC 5
Z9 5
U1 2
U2 9
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DR, STE 208, TOTOWA, NJ 07512-1165 USA
SN 1064-3745
BN 978-1-61779-135-2
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2011
VL 747
BP 131
EP 172
DI 10.1007/978-1-61779-136-9_6
D2 10.1007/978-1-61779-136-9
PG 42
WC Biochemical Research Methods; Biochemistry & Molecular Biology; Food
Science & Technology
SC Biochemistry & Molecular Biology; Food Science & Technology
GA BVP44
UT WOS:000292219300006
PM 21643907
ER
PT S
AU Paquerault, S
Sahiner, B
Kettermann, A
Yarusso, LM
Hadjiiski, LM
Chan, HP
AF Paquerault, Sophie
Sahiner, Berkman
Kettermann, Anna
Yarusso, Laura M.
Hadjiiski, Lubomir M.
Chan, Heang-Ping
BE Manning, DJ
Abbey, CK
TI Analysis of the number of distinct findings obtained by multiple readers
in an MRMC study: When do findings obtained from the addition of new
readers become redundant, or otherwise negligible?
SO MEDICAL IMAGING 2011: 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, 2011
CL Lake Buena Vista, FL
SP SPIE, Dynasil Corp/RMD Res, AAPM - Amer Assoc Physicists Med, DQE Instruments, Inc, Ocean Thin Films, Inc, Univ Cent Florida, CREOL - Coll Opt & Photon, VIDA Diagnost, Inc
DE MRMC observer study; computer-aided diagnosis (CAD) system; prediction
model; reader performance
ID COMPUTER-AIDED DIAGNOSIS; RADIOLOGISTS DETECTION; PERFORMANCE; SYSTEMS;
SIZE
AB The ultimate goal of this project is to investigate whether the effect of a computer-aided detection (CAD) system on readers' performance (especially, in situation of an upgrade of the CAD system, or between two different CAD systems with similar design) can be accurately predicted without having to perform a multi-reader multi-case (MRMC) observer study and, if such prediction is possible, to establish the underlying methodology. Our current study is intended to provide evidence that would substantiate efforts toward such investigation. The objectives of this study were 1) to investigate the relationship between the number of radiologists reading a dataset of thoracic computed tomography (CT) images to identify lung nodules and the number of distinct findings and 2) to determine the number of readers needed to identify almost all clinically distinct findings in a dataset. We used data from a multi-reader multi-case (MRMC) observer study that consisted of six radiologists interpreting 85 thoracic CT examinations. To further illustrate our approach, we also utilized simulated data consisting of twelve readers interpreting 198 samples equally distributed between three levels of detection difficulty. For each possible reader grouping, the number of distinct findings identified by the readers in the group was calculated. Five types of regression models used to describe the relationship between the average number of distinct findings per case and the number of readers needed were compared. The result showed that the logistic model best fitted both the thoracic CT data and the simulated data. Our assumption is that adding more readers after a certain reader set size would mostly add redundant findings and, therefore, the benefit would be negligible. Using this model, the predicted number of readers was found to depend on the type of findings considered. Our study showed that the number of clinically distinct findings that can be identified by radiologists on CT lung examinations without the use of a CAD system may be limited and that identifying almost all of these findings may only require a limited number of readers.
C1 [Paquerault, Sophie; Sahiner, Berkman; Kettermann, Anna] US FDA, CDRH, Silver Spring, MD 20993 USA.
RP Paquerault, S (reprint author), US FDA, CDRH, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM sophie.paquerault@telecom-paristech.org
NR 8
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 978-0-81948-508-3
J9 PROC SPIE
PY 2011
VL 7966
AR 79661M
DI 10.1117/12.878103
PG 10
WC Optics; Imaging Science & Photographic Technology; Radiology, Nuclear
Medicine & Medical Imaging
SC Optics; Imaging Science & Photographic Technology; Radiology, Nuclear
Medicine & Medical Imaging
GA BXL76
UT WOS:000296320800053
ER
PT S
AU Abboud, S
Lee, K
Vinehout, K
Paquerault, S
Kyprianou, IS
AF Abboud, Samir
Lee, Kristina
Vinehout, Kaleb
Paquerault, Sophie
Kyprianou, Iacovos S.
BE Pelc, NJ
Samei, E
Nishikawa, RM
TI A comparison of methods for estimating the line spread function of a CT
imaging system
SO MEDICAL IMAGING 2011: PHYSICS OF MEDICAL IMAGING
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Medical Imaging 2011 - Physics of Medical Imaging
CY FEB 13-17, 2011
CL Lake Buena Vista, FL
SP Dynasil Corp/RMD Res, Amer Assoc Physicists Med, DQE Instruments, Inc, Ocean Thin Films, Inc, Univ Cent Florida, CREOL - Coll Opt & Photon, VIDA Diagnost, Inc, SPIE
ID MODULATION TRANSFER-FUNCTION; DIGITAL RADIOGRAPHY; WIRE
AB A quantitative description of the deterministic properties of a CT system is necessary when evaluating image quality. The most common such metric is the modulation transfer function (MTF), usually calculated from a line spread function (LSF) or point spread function (PSF). Currently, there exist many test objects used to measure the LSF or PSF. In this paper we report on a comparison of these measures using: a thin foil slit test object, a teflon cube edge test object and a novel "negative" cube test object. Images were acquired using a custom-built bench-top flat-panel-based cone-beam CT scanner and a cylindrical water-filled PMMA phantom with the test objects embedded in the middle. From the 3-dimensional reconstructed volumes, we estimated the LSF either directly or as estimated from the edge spread function. From these, a modulation transfer function can be estimated, and the frequency dependent image transfer of each object can be reported.
C1 [Abboud, Samir; Paquerault, Sophie; Kyprianou, Iacovos S.] US FDA, Ctr Devices & Radiol Hlth, Div Imaging & Appl Math, Silver Spring, MD 20993 USA.
RP Abboud, S (reprint author), US FDA, Ctr Devices & Radiol Hlth, Div Imaging & Appl Math, 10903 New Hampshire Ave,W062-3109, Silver Spring, MD 20993 USA.
EM samir.abboud@fda.hhs.gov
NR 12
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 978-0-8194-8503-8
J9 PROC SPIE
PY 2011
VL 7961
AR 79615V
DI 10.1117/12.877665
PG 10
WC Engineering, Electrical & Electronic; Optics; Physics, Applied;
Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Optics; Physics; Radiology, Nuclear Medicine & Medical
Imaging
GA BWL08
UT WOS:000294178500198
ER
PT J
AU Nada, A
Krishnaiah, YSR
Zaghloul, AA
Khattab, I
AF Nada, Aly
Krishnaiah, Yellela S. R.
Zaghloul, Abdel-Azim
Khattab, Ibrahim
TI In vitro and in vivo Permeation of Vitamin E and Vitamin E Acetate from
Cosmetic Formulations
SO MEDICAL PRINCIPLES AND PRACTICE
LA English
DT Article
DE Vitamin E; Vitamin E acetate; Cosmetics; Permeation; Neonatal rats
ID STRATUM-CORNEUM; PERCUTANEOUS-ABSORPTION; ALPHA-TOCOPHEROL; HAIRLESS
MOUSE; SKIN; ANTIOXIDANTS; INHIBITION; SUNSCREENS; METABOLISM; EPIDERMIS
AB Objective: To investigate the ability of alpha-tocopherol acetate (TA) and alpha-tocopherol (T), widely used ingredients in cosmetics, to cross the epidermal barrier using the neonatal rat as a model. Materials and Methods: The content of T and TA in four marketed products (A-D) and two experimental formulations (F1, F2) was investigated by HPLC. An in vitro permeation study was performed in neonatal rat epidermis using diffusion cells. In vivo permeation was studied in neonatal rats after repeated application of the products and analysis of T and TA in the stratum corneum/deeper skin layers. Results: Variable contents of TA were found in the marketed products (0.12-0.53%). No vitamin permeation was detected through the stratum corneum as in vitro biological barrier after 4 h. No detectable T and TA were seen in the in vivo permeation study in the epidermis. Variable degrees of drug penetration (4.3-12.6%) of the applied dose into the deeper skin layers were observed, depending on the formulation. In vivo application of TA-containing preparations did not result in any transformation of TA into T under the described experimental conditions. Conclusion: TA and T exhibited variable skin penetration and TA did not transform into T under the experimental conditions. The data underscored the need for further studies to optimize such formulations to improve vitamin E transdermal permeation and eventually achieve the expected cosmetic/therapeutic outcome. Copyright (C) 2011 S. Karger AG, Basel
C1 [Nada, Aly; Krishnaiah, Yellela S. R.; Zaghloul, Abdel-Azim; Khattab, Ibrahim] Kuwait Univ, Dept Pharmaceut, Fac Pharm, Jabriya, Kuwait.
[Krishnaiah, Yellela S. R.] US FDA, Silver Spring, MD USA.
RP Nada, A (reprint author), Kuwait Univ, Dept Pharmaceut, Fac Pharm, POB 24923, Safat 13110, Kuwait.
EM alynada@hsc.edu.kw
FU Kuwait University [PP01/05]
FX This work was supported by Kuwait University Research Grant No. PP01/05.
The authors appreciate the technical help of Dr. F. Bandarkar, Mrs. E.
Abraham, Mr. S. Abraham, Mrs. D. Nabil as well as Mrs. L. Varghese and
Mrs. A. Thomas.
NR 20
TC 1
Z9 2
U1 2
U2 8
PU KARGER
PI BASEL
PA ALLSCHWILERSTRASSE 10, CH-4009 BASEL, SWITZERLAND
SN 1011-7571
J9 MED PRIN PRACT
JI Med. Princ. Pract.
PY 2011
VL 20
IS 6
BP 509
EP 513
DI 10.1159/000329883
PG 5
WC Medicine, General & Internal
SC General & Internal Medicine
GA 832ZO
UT WOS:000295850400004
PM 21986007
ER
PT B
AU Cole, M
Kasuga, F
Farber, JM
Anderson, W
Anelich, L
Buchanan, RL
Cordier, JL
Dahms, S
Dewanti-Hariyadi, R
Flowers, RS
Franco, BDGM
Gorris, LGM
Gram, L
Lammerding, AM
Liu, XM
Potter, M
Ross, T
Swanson, KMJ
Taniwaki, M
Teufel, P
Zwietering, M
AF Cole, Martin
Kasuga, Fumiko
Farber, Jeffrey M.
Anderson, Wayne
Anelich, Lucia
Buchanan, Robert L.
Cordier, Jean-Louis
Dahms, Susanne
Dewanti-Hariyadi, Ratih
Flowers, Russ S.
Franco, Bernadette D. G. M.
Gorris, Leon G. M.
Gram, Lone
Lammerding, Anna M.
Liu, Xiumei
Potter, Morris
Ross, Tom
Swanson, Katherine M. J.
Taniwaki, Marta
Teufel, Paul
Zwietering, Marcel
CA ICMSF
GP ICMSF
TI Nonalcoholic Beverages
SO MICROORGANISMS IN FOODS 8: USE OF DATA FOR ASSESSING PROCESS CONTROL AND
PRODUCT ACCEPTANCE
LA English
DT Article; Book Chapter
ID ALICYCLOBACILLUS-ACIDOTERRESTRIS; HEAT-RESISTANCE; BYSSOCHLAMYS;
PERFORMANCE; TEA
C1 [Cole, Martin] CSIRO, N Ryde, NSW 2113, Australia.
[Kasuga, Fumiko] Natl Inst Hlth Sci, Tokyo, Japan.
[Buchanan, Robert L.] Univ Maryland, College Pk, MD 20742 USA.
[Dahms, Susanne] Freie Univ, Berlin, Germany.
[Dewanti-Hariyadi, Ratih] Bogor Agr Univ, Bogor, Indonesia.
[Flowers, Russ S.] Silliker Grp Corp, Homewood, IL USA.
[Franco, Bernadette D. G. M.] Univ Sao Paulo, Sao Paulo, SP, Brazil.
[Gram, Lone] Tech Univ Denmark, DK-2800 Lyngby, Denmark.
[Lammerding, Anna M.] Publ Hlth Agcy Canada, Guelph, ON, Canada.
[Liu, Xiumei] Minist Hlth, China CDC, Beijing, Peoples R China.
[Potter, Morris] US FDA, Ctr Food Safety & Appl Nutr, Atlanta, GA USA.
[Ross, Tom] Univ Tasmania, Hobart, Tas, Australia.
[Swanson, Katherine M. J.] Ecolab, Eagan, MN USA.
[Taniwaki, Marta] Inst Tecnol Alimentos, Campinas, SP, Brazil.
[Teufel, Paul] Fed Dairy Res Ctr, Kiel, Germany.
[Zwietering, Marcel] Wageningen Univ, Wageningen, Netherlands.
RP Cole, M (reprint author), CSIRO, N Ryde, NSW 2113, Australia.
NR 27
TC 0
Z9 0
U1 0
U2 1
PU SPRINGER
PI NEW YORK
PA 233 SPRING STREET, NEW YORK, NY 10013, UNITED STATES
BN 978-1-4419-9373-1
PY 2011
BP 269
EP 280
DI 10.1007/978-1-4419-9374-8_20
PG 12
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BVN85
UT WOS:000292008500020
ER
PT J
AU Hunt, RC
Geetha, S
Allen, CE
Hershko, K
Fathke, R
Kong, PL
Plum, E
Struble, EB
Soejima, K
Friedman, S
Garfield, S
Balaji, S
Kimchi-Sarfaty, C
AF Hunt, Ryan C.
Geetha, S.
Allen, Courtni E.
Hershko, Klilah
Fathke, Robert
Kong, Philip L.
Plum, Elizabeth
Struble, Evi Budo
Soejima, Kenji
Friedman, Scott
Garfield, Susan
Balaji, S.
Kimchi-Sarfaty, Chava
TI Detection of a secreted metalloprotease within the nuclei of liver cells
SO MOLECULAR BIOSYSTEMS
LA English
DT Article
ID VON-WILLEBRAND-FACTOR; THROMBOTIC THROMBOCYTOPENIC PURPURA; LOCALIZATION
SIGNALS; PROSTATE-CANCER; STELLATE CELLS; CUB DOMAINS; ADAMTS13;
PROTEIN; TRANSLOCATION; IDENTIFICATION
AB ADAMTS13 is a secreted zinc metalloprotease expressed by various cell types. Here, we investigate its cellular pathway in endogenously expressing liver cell lines and after transient transfection with ADAMTS13. Besides compartmentalizations of the cellular secretory system, we detected an appreciable level of endogenous ADAMTS13 within the nucleus. A positively charged amino acid cluster (R-Q-R-Q-R-Q-R-R) present in the ADAMTS13 propeptide may act as a nuclear localization signal (NLS). Fusing this NLS-containing region to eGFP greatly potentiated its nuclear localization. Bioinformatics analysis suggests that the ADAMTS13 CUB-2 domain has a double-stranded beta helix (DSBH) structural architecture characteristic of various protein-protein interaction modules like nucleoplasmins, class I collagenase, tumor necrosis factor ligand superfamily, supernatant protein factor (SPF) and the B1 domain of neuropilin-2. Based on this contextual evidence and that largely conserved polar residues could be mapped on to a template CUB domain homolog, we hypothesize that a region in the ADAMTS13 CUB-2 domain with conserved polar residues might be involved in protein-protein interaction within the nucleus.
C1 [Garfield, Susan] NCI, Expt Carcinogenesis Lab, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
[Hunt, Ryan C.; Geetha, S.; Allen, Courtni E.; Hershko, Klilah; Fathke, Robert; Kong, Philip L.; Plum, Elizabeth; Kimchi-Sarfaty, Chava] US FDA, Lab Hemostasis, Div Hematol, Ctr Biol, Bethesda, MD 20892 USA.
[Struble, Evi Budo] US FDA, Lab Plasma Derivat, Div Hematol, Ctr Biol, Bethesda, MD 20892 USA.
[Soejima, Kenji] Chemoserotherapeut Res Inst, Res Dept 1, Kumamoto, Japan.
[Friedman, Scott] Mt Sinai Sch Med, Div Liver Dis, New York, NY 10029 USA.
[Balaji, S.] NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20892 USA.
RP Garfield, S (reprint author), NCI, Expt Carcinogenesis Lab, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
EM Susan.Garfield@nih.hhs.gov; Balaji_Santhanam@DFCI.HARVARD.EDU;
Chava.kimchi-sarfaty@fda.hhs.gov
FU Intramural NIH HHS [Z01 BC010858-01]
NR 34
TC 4
Z9 4
U1 0
U2 2
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1742-206X
J9 MOL BIOSYST
JI Mol. Biosyst.
PY 2011
VL 7
IS 6
BP 2012
EP 2018
DI 10.1039/c0mb00303d
PG 7
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 763PR
UT WOS:000290572700023
PM 21479334
ER
PT B
AU Schneider, KR
Strawn, LK
Lampel, KA
Warren, BR
AF Schneider, K. R.
Strawn, L. K.
Lampel, K. A.
Warren, B. R.
BE Liu, D
TI Shigella
SO MOLECULAR DETECTION OF HUMAN BACTERIAL PATHOGENS
LA English
DT Article; Book Chapter
ID ACTIN-BASED MOTILITY; ENTEROINVASIVE ESCHERICHIA-COLI;
POLYMERASE-CHAIN-REACTION; SHIGA TOXIN; FLEXNERI 2A; UNIPOLAR
LOCALIZATION; SONNEI INFECTION; DYSENTERIAE TYPE-1; AEROBACTIN GENES;
ICEBERG LETTUCE
C1 [Schneider, K. R.] Univ Florida, Dept Food Sci & Human Nutr, Gainesville, FL 32611 USA.
[Strawn, L. K.] Cornell Univ, Dept Food Sci, Ithaca, NY 14853 USA.
[Lampel, K. A.] US FDA, Div Microbiol, College Pk, MD USA.
[Warren, B. R.] ConAgra Foods Inc, Res Qual & Innovat, Omaha, NE USA.
RP Schneider, KR (reprint author), Univ Florida, Dept Food Sci & Human Nutr, Gainesville, FL 32611 USA.
NR 129
TC 0
Z9 0
U1 1
U2 2
PU CRC PRESS-TAYLOR & FRANCIS GROUP
PI BOCA RATON
PA 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA
BN 978-1-4398-1239-6; 978-1-4398-1238-9
PY 2011
BP 1049
EP 1062
D2 10.1201/b10848
PG 14
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA BC7QK
UT WOS:000355145400090
ER
PT J
AU Li, YH
Sosnik, J
Brassard, L
Reese, M
Spiridonov, NA
Bates, TC
Johnson, GR
Anguita, J
Visconti, PE
Salicioni, AM
AF Li, Yahui
Sosnik, Julian
Brassard, Laura
Reese, Michael
Spiridonov, Nikolay A.
Bates, Tonya C.
Johnson, Gibbes R.
Anguita, Juan
Visconti, Pablo E.
Salicioni, Ana M.
TI Expression and localization of five members of the testis-specific
serine kinase (Tssk) family in mouse and human sperm and testis
SO MOLECULAR HUMAN REPRODUCTION
LA English
DT Article
DE Tssk kinases; testis-specific; signal transduction; contraception; sperm
function
ID SERINE/THREONINE KINASE; SPERMATOGENIC CELLS; CAPACITATION; PROTEINS;
PHOSPHORYLATION; IDENTIFICATION; CLEAVAGE; FUSION; IZUMO
AB Members of the testis-specific serine/threonine kinases (Tssk) family may have a role in sperm differentiation in the testis and/or fertilization. To gain insight into the functional relevance of these kinases, their expression was examined both at the mRNA and protein levels. Quantitative PCR analysis confirmed that all five Tssk mRNAs are almost exclusively expressed postmeiotically in the testis. Recombinant mouse and human Tssks were cloned and used for validation of an array of commercial and custom-made antibodies against Tssks. Immunolocalization in mouse testis, and in mouse and human sperm, showed that Tssk1, Tssk2, Tssk4 and Tssk6, but not Tssk3, were present in mouse sperm and in germ cells from mouse testis. TSSK1, TSSK2 and TSSK6 were also detected in human sperm, while TSSK3 was absent. In both mouse and human sperm, Tssk1 was partially soluble, while Tssk2, Tssk4 and Tssk6 were insoluble in non-ionic detergents. In vitro recombinant TSSK2 activity assays showed maximum enzymatic activity at 5 mM Mg(2+) and a Km for ATP of similar to 10 mu M. These, observations together with findings that the Tssk1/Tssk2 double knock-out as well as the Tssk6 null mice are sterile without presenting other detectable defects, suggest that these kinases could be used as targets for male contraception.
C1 [Li, Yahui; Sosnik, Julian; Brassard, Laura; Reese, Michael; Bates, Tonya C.; Anguita, Juan; Visconti, Pablo E.; Salicioni, Ana M.] Univ Massachusetts, Dept Vet & Anim Sci, Amherst, MA 01003 USA.
[Spiridonov, Nikolay A.; Johnson, Gibbes R.] US FDA, Div Therapeut Prot, Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
RP Salicioni, AM (reprint author), Univ Massachusetts, Dept Vet & Anim Sci, Amherst, MA 01003 USA.
EM asalicioni@vasci.umass.edu
RI Sosnik, Julian/A-8310-2010; Anguita, Juan/D-5432-2011; Spiridonov,
Nikolay/B-6287-2014
OI Sosnik, Julian/0000-0002-0528-9929; Anguita, Juan/0000-0003-2061-7182;
FU NIH [HD038082, HD044044, HD050341, F31HD049324]; University of
Massachusetts; Baystate Medical Center; Gustavus and Louise Pfeiffer
Research Foundation
FX This study was supported by grants NIH HD038082, NIH HD044044 and NIH
HD050341 (to P.E.V.), by the Collaborative Biomedical Research (CBR)
Program between the University of Massachusetts and Baystate Medical
Center (to A.M.S.), and by NIH F31HD049324 (to J.S.). Characterization
of Tssks in human subjects was supported in part by the Gustavus and
Louise Pfeiffer Research Foundation.
NR 32
TC 26
Z9 31
U1 1
U2 7
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1360-9947
J9 MOL HUM REPROD
JI Mol. Hum. Reprod.
PD JAN
PY 2011
VL 17
IS 1
BP 42
EP 56
DI 10.1093/molehr/gaq071
PG 15
WC Developmental Biology; Obstetrics & Gynecology; Reproductive Biology
SC Developmental Biology; Obstetrics & Gynecology; Reproductive Biology
GA 696CL
UT WOS:000285419400005
PM 20729278
ER
PT B
AU Whelton, AJ
Duncan, TV
Koontz, JL
Nguyen, T
AF Whelton, A. J.
Duncan, T. V.
Koontz, J. L.
Nguyen, T.
BE Laudon, M
Romanowicz, B
TI Nanoparticle Release from Polymer Nanocomposites Used for Potable Water
Infrastructure and Food Packaging: Current Progress & Beyond
SO NANOTECHNOLOGY 2011: BIO SENSORS, INSTRUMENTS, MEDICAL, ENVIRONMENT AND
ENERGY, NSTI-NANOTECH 2011, VOL 3
LA English
DT Proceedings Paper
CT NSTI Nanotechnology Conference and Expo
CY JUN 13-16, 2011
CL Boston, MA
SP Clean Technol & Sustainable Ind Org, European Patent Off, Greenberg Traurig, Innovat & Mat Sci Inst, Jackson Walker LLP, Linde Nanomaterials, Lockheed Martin, Nano Sci & Technol Inst, Nano Tech Japan, NanoEurope Fair & Conf, Nanpolis Suzhou, Suzhou Nanotech Co Ltd, Natl Inst Standards & Technol, Ctr Nanoscale Sci & Technol, Fraunhofer, Res Germany, TechConnect, Technol Innovat Program, Canadian Trade Commiss Serv, Italian Trade Commiss
DE nanoparticle; water; food; release; infrastructure
AB Nanoparticle (NP) enhanced polymers have the potential to revolutionize food packaging and water pipe performance, though release of NPs from these materials has gone relatively unstudied. A literature review was conducted to identify potential NP release pathways from nanomposite materials into food and water. Results show little is known, and this lack of knowledge prevents responsible commercialization of safe and innovative nano enhanced products, development of predictive health risk models, and generation of science based environmental, health, and safety focused regulation. Common limitations of past studies are that quantitative results were not described, NP detection methods were lacking, and metal ions were not differentiated from NPs. Science has not quantitatively determined if and under what conditions nanocomposites release NPs into food and water matrices. Future research needs are also identified.
C1 [Whelton, A. J.] Univ S Alabama, Mobile, AL 36688 USA.
[Duncan, T. V.; Koontz, J. L.] FDA, Bedford Pk, IL USA.
[Nguyen, T.] NIST, Gaithersburg, MD 20899 USA.
RP Whelton, AJ (reprint author), Univ S Alabama, Mobile, AL 36688 USA.
EM ajwhelton@usouthal.edu; Timothy.Duncan@fda.hhs.gov;
John.Koontz@fda.hhs.gov; Tinh.Nguyen@nist.gov
NR 39
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 978-1-4398-7138-6
PY 2011
BP 505
EP 508
PG 4
WC Energy & Fuels; Engineering, Environmental; Nanoscience &
Nanotechnology; Medicine, Research & Experimental; Materials Science,
Biomaterials
SC Energy & Fuels; Engineering; Science & Technology - Other Topics;
Research & Experimental Medicine; Materials Science
GA BG9XC
UT WOS:000394061000133
ER
PT J
AU Lee, CA
Hillgren, KM
Zhang, L
Polli, JW
AF Lee, Caroline A.
Hillgren, Kathleen M.
Zhang, Lei
Polli, Joseph W.
CA Int Transporter Consortium
TI Response from the International Transporter Consortium
SO NATURE REVIEWS DRUG DISCOVERY
LA English
DT Letter
ID INTESTINAL P-GLYCOPROTEIN; DRUG INTERACTIONS; GRAPEFRUIT JUICE; CACO-2
CELLS; DIGOXIN; TALINOLOL; INCREASES; HUMANS; BIOAVAILABILITY;
KETOCONAZOLE
C1 [Polli, Joseph W.] GlaxoSmithKline Inc, Res Triangle Pk, NC 27709 USA.
[Lee, Caroline A.] Pfizer Global Res & Dev, La Jolla Labs, San Diego, CA 92121 USA.
[Hillgren, Kathleen M.] Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA.
[Zhang, Lei] Food & Drug Adm, Ctr Drug Evaluat & Res, Off Translat Sci, Off Clin Pharmacol, Silver Spring, MD 20993 USA.
RP Polli, JW (reprint author), GlaxoSmithKline Inc, POB 13398, Res Triangle Pk, NC 27709 USA.
EM caroline.lee01@pfizer.com; leik.zhang@fda.hhs.gov;
joseph.w.polli@gsk.com
NR 21
TC 3
Z9 3
U1 0
U2 2
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 1474-1776
J9 NAT REV DRUG DISCOV
JI Nat. Rev. Drug Discov.
PD JAN
PY 2011
VL 10
IS 1
DI 10.1038/nrd3028-c2
PG 2
WC Biotechnology & Applied Microbiology; Pharmacology & Pharmacy
SC Biotechnology & Applied Microbiology; Pharmacology & Pharmacy
GA 700YV
UT WOS:000285782400019
ER
PT J
AU Mays, J
Butts, CL
AF Mays, Jacqueline
Butts, Cherie L.
TI Intercommunication between the Neuroendocrine and Immune Systems: Focus
on Myasthenia Gravis
SO NEUROIMMUNOMODULATION
LA English
DT Article
DE Autoimmunity; Thymoma; Acetylcholine receptor; Steroid hormones; Immune
system
ID RECEPTOR ALPHA-SUBUNIT; ACETYLCHOLINE-RECEPTOR; NEUROMUSCULAR-JUNCTION;
CLASS-II; T-CELLS; ANTIBODIES; ESTROGEN; EXPRESSION; PREGNANCY; THYMOMA
AB Crosstalk exists between the nervous, endocrine, and immune systems, and perturbations in these interactions have been associated with disease. This includes production of neuroendocrine factors that alter immune system activity and increase susceptibility to or severity of immune-related conditions, such as myasthenia gravis (MG) - a T-cell-dependent, B-cell-mediated autoimmune disorder. MG results from impairment of transmission to the neuromuscular junction and involves the thymus - especially in early-onset disease, but the exact mechanism by which the thymus impacts disease is unclear. MG afflicts millions of individuals worldwide each year, and both men and women can develop symptoms. However, prevalence and age of onset differs between men and women. Women exhibit higher incidence and earlier age of onset compared to men, and disease fluctuates during pregnancy. This suggests that sex hormones play a role in influencing disease outcome. In this review, we will consider what is known about the manifestation of MG, theories on how different forms of MG are influenced or alleviated by steroid hormones, current treatment options, and what measures could be important to consider in the future. Copyright (C) 2011 S. Karger AG, Basel
C1 [Butts, Cherie L.] US FDA, Immunol Lab, Div Therapeut Prot, Off Biotechnol Prod,Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
[Mays, Jacqueline] NIAID, Viral Dis Lab, NIH, Bethesda, MD 20892 USA.
RP Butts, CL (reprint author), US FDA, Immunol Lab, Div Therapeut Prot, Off Biotechnol Prod,Ctr Drug Evaluat & Res, 8800 Rockville Pike,HFD 122,Bldg 29A,Room 3B19, Bethesda, MD 20892 USA.
EM cherie.butts@fda.hhs.gov
NR 57
TC 3
Z9 3
U1 0
U2 1
PU KARGER
PI BASEL
PA ALLSCHWILERSTRASSE 10, CH-4009 BASEL, SWITZERLAND
SN 1021-7401
J9 NEUROIMMUNOMODULAT
JI Neuroimmunomodulation
PY 2011
VL 18
IS 5
BP 320
EP 327
DI 10.1159/000329491
PG 8
WC Endocrinology & Metabolism; Immunology; Neurosciences
SC Endocrinology & Metabolism; Immunology; Neurosciences & Neurology
GA 823XT
UT WOS:000295162000008
PM 21952684
ER
PT J
AU Pereira, FC
Gough, B
Macedo, TR
Ribeiro, CF
Ali, SF
Binienda, ZK
AF Pereira, Frederico C.
Gough, Bobby
Macedo, Tice R.
Ribeiro, Carlos F.
Ali, Syed F.
Binienda, Zbigniew K.
TI Buprenorphine Modulates Methamphetamine-Induced Dopamine Dynamics in the
Rat Caudate Nucleus
SO NEUROTOXICITY RESEARCH
LA English
DT Article
DE In vivo microdialysis; Dopamine; Opioids/methamphetamine combination;
Caudate nucleus
ID NOCICEPTIN/ORPHANIN FQ; RHESUS-MONKEYS; COCAINE ABUSE; MORPHINE;
DEPENDENCE; RECEPTOR; MECHANISMS; ACCUMBENS; TURNOVER; RELEASE
AB Methamphetamine (METH) abuse and addiction present a major problem in the United States and globally. Oxidative stress associated with exposure to METH mediates to the large extent METH-evoked neurotoxicity. While there are currently no medications approved for treating METH addiction, its pharmacology provides opportunities for potential pharmacotherapeutic adjuncts to behavioral therapy in the treatment of METH addiction. Opioid receptor agonists can modulate the activity of dopamine neurons and could, therefore, modify the pharmacodynamic effects of METH in the dopaminergic system. Efficacy of the adjunctive medication with buprenorphine has been demonstrated in the treatment of cocaine addiction extending beyond opiate addiction. We investigated the interactions of morphine (10 mg/kg) and buprenorphine (0.01 and 10 mg/kg) with METH (2 mg/kg) affecting striatal dopaminergic transmission. The extracellular concentration of dopamine (DA) and its metabolite 3,4-dihydroxyphenylacetic acid (DOPAC) were determined using brain microdialysis coupled with high performance liquid chromatography with electrochemical detection (HPLC-ED) in the caudate nucleus of adult, awake, male Sprague-Dawley rats. Compared to METH alone, extracellular DA release was prolonged for 140 min without changes in DA peak-effect by combined treatment with morphine/METH. Morphine did not change DOPAC efflux evoked by METH. On the other hand, both buprenorphine doses attenuated the METH-induced DA peak-effect. However, whereas high buprenorphine dose extended DA outflow for 190 min, the low-dose abbreviated DA release. High buprenorphine dose also shortened METH-induced decrease in DOPAC efflux. Data confirm that opiates modulate dopaminergic neurotransmission evoked by METH. Alteration of dopaminergic response to METH challenge under buprenorphine may suggest effectiveness of buprenorphine treatment in METH addiction.
C1 [Pereira, Frederico C.; Macedo, Tice R.; Ribeiro, Carlos F.] Univ Coimbra, Inst Pharmacol & Therapeut, Biomed Inst Res Light & Image, Fac Med, P-3000354 Coimbra, Portugal.
[Gough, Bobby; Ali, Syed F.; Binienda, Zbigniew K.] FDA NCTR, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Pereira, FC (reprint author), Univ Coimbra, Inst Pharmacol & Therapeut, Biomed Inst Res Light & Image, Fac Med, Subunit 1 Polo 3, P-3000354 Coimbra, Portugal.
EM fredcp@ci.uc.pt; zbigniew.binienda@fda.hhs.gov
OI Pereira, Frederico/0000-0002-9381-3320
NR 38
TC 6
Z9 6
U1 1
U2 3
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1029-8428
J9 NEUROTOX RES
JI Neurotox. Res.
PD JAN
PY 2011
VL 19
IS 1
BP 94
EP 101
DI 10.1007/s12640-009-9143-9
PG 8
WC Neurosciences
SC Neurosciences & Neurology
GA 721QB
UT WOS:000287368600010
PM 20033362
ER
PT J
AU Croft, D
O'Kelly, G
Wu, GM
Haw, R
Gillespie, M
Matthews, L
Caudy, M
Garapati, P
Gopinath, G
Jassal, B
Jupe, S
Kalatskaya, I
Mahajan, S
May, B
Ndegwa, N
Schmidt, E
Shamovsky, V
Yung, C
Birney, E
Hermjakob, H
D'Eustachio, P
Stein, L
AF Croft, David
O'Kelly, Gavin
Wu, Guanming
Haw, Robin
Gillespie, Marc
Matthews, Lisa
Caudy, Michael
Garapati, Phani
Gopinath, Gopal
Jassal, Bijay
Jupe, Steven
Kalatskaya, Irina
Mahajan, Shahana
May, Bruce
Ndegwa, Nelson
Schmidt, Esther
Shamovsky, Veronica
Yung, Christina
Birney, Ewan
Hermjakob, Henning
D'Eustachio, Peter
Stein, Lincoln
TI Reactome: a database of reactions, pathways and biological processes
SO NUCLEIC ACIDS RESEARCH
LA English
DT Article
ID COMMUNITY STANDARD; PHYLOGENETIC TREES; REPRESENTATION; COLLECTION;
UPDATE
AB Reactome (http://www.reactome.org) is a collaboration among groups at the Ontario Institute for Cancer Research, Cold Spring Harbor Laboratory, New York University School of Medicine and The European Bioinformatics Institute, to develop an open source curated bioinformatics database of human pathways and reactions. Recently, we developed a new web site with improved tools for pathway browsing and data analysis. The Pathway Browser is an Systems Biology Graphical Notation (SBGN)-based visualization system that supports zooming, scrolling and event highlighting. It exploits PSIQUIC web services to overlay our curated pathways with molecular interaction data from the Reactome Functional Interaction Network and external interaction databases such as IntAct, BioGRID, ChEMBL, iRefIndex, MINT and STRING. Our Pathway and Expression Analysis tools enable ID mapping, pathway assignment and overrepresentation analysis of user-supplied data sets. To support pathway annotation and analysis in other species, we continue to make orthology-based inferences of pathways in non-human species, applying Ensembl Compara to identify orthologs of curated human proteins in each of 20 other species. The resulting inferred pathway sets can be browsed and analyzed with our Species Comparison tool. Collaborations are also underway to create manually curated data sets on the Reactome framework for chicken, Drosophila and rice.
C1 [Wu, Guanming; Haw, Robin; Caudy, Michael; Kalatskaya, Irina; May, Bruce; Yung, Christina; Stein, Lincoln] Ontario Inst Canc Res Informat & Biocomp, Toronto, ON M5G 0A3, Canada.
[Croft, David; O'Kelly, Gavin; Garapati, Phani; Jassal, Bijay; Jupe, Steven; Ndegwa, Nelson; Schmidt, Esther; Birney, Ewan; Hermjakob, Henning] Wellcome Trust Genome Campus, European Bioinformat Inst, Cambridge CB10 1SD, England.
[Gillespie, Marc] St Johns Univ, Coll Pharm & Allied Hlth Profess, Queens, NY 11439 USA.
[Matthews, Lisa; Mahajan, Shahana; Shamovsky, Veronica; D'Eustachio, Peter] NYU, Sch Med, Dept Biochem, New York, NY 10016 USA.
[Gopinath, Gopal] US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
[Mahajan, Shahana] CUNY Hunter Coll, Sch Hlth Sci, New York, NY 10010 USA.
[Stein, Lincoln] Cold Spring Harbor Lab, Cold Spring Harbor, NY 11724 USA.
[Stein, Lincoln] Univ Toronto, Dept Mol Genet, Toronto, ON M5S 1A1, Canada.
RP Stein, L (reprint author), Ontario Inst Canc Res Informat & Biocomp, Toronto, ON M5G 0A3, Canada.
EM Peter.D'Eustachio@nyumc.org; lincoln.stein@gmail.com
RI Gichora, Nelson /E-1749-2015; Haw, Robin/D-1393-2009;
OI Kalatskaya, Irina/0000-0002-1663-859X; Hermjakob,
Henning/0000-0001-8479-0262; Gichora, Nelson /0000-0002-5853-879X; Jupe,
Steven/0000-0001-5807-0069; Croft, David/0000-0001-6363-8595; Garapati,
Phani Vijay/0000-0003-0941-2207; Gillespie, Marc/0000-0002-5766-1702;
Matthews, Lisa/0000-0001-5707-3065; Haw, Robin/0000-0002-2013-7835;
D'Eustachio, Peter/0000-0002-5494-626X; Yung,
Christina/0000-0003-2958-150X; Birney, Ewan/0000-0001-8314-8497
FU National Human Genome Research Institute at the National Institutes of
Health [P41 HG003751]; European Union [LSHG-CT-2005-518254]; Ontario
Institute for Cancer Research
FX National Human Genome Research Institute at the National Institutes of
Health (grant number P41 HG003751); European Union 6th Framework
Programme 'ENFIN' (grant number LSHG-CT-2005-518254). Funding for open
access charge: Ontario Institute for Cancer Research.
NR 38
TC 499
Z9 508
U1 3
U2 30
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0305-1048
J9 NUCLEIC ACIDS RES
JI Nucleic Acids Res.
PD JAN
PY 2011
VL 39
SU 1
BP D691
EP D697
DI 10.1093/nar/gkq1018
PG 7
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 701PA
UT WOS:000285831700110
PM 21067998
ER
PT J
AU Boyce, JA
Assa'ad, A
Burks, AW
Jones, SM
Sampson, HA
Wood, RA
Plaut, M
Cooper, SF
Fenton, MJ
Arshad, SH
Bahna, SL
Beck, LA
Byrd-Bredbenner, C
Camargo, CA
Eichenfield, L
Furuta, GT
Hanifin, JM
Jones, C
Kraft, M
Levy, BD
Lieberman, P
Luccioli, S
McCall, KM
Schneider, LC
Simon, RA
Simons, FER
Teach, SJ
Yawn, BP
Schwaninger, JM
AF Boyce, Joshua A.
Assa'ad, Amal
Burks, A. Wesley
Jones, Stacie M.
Sampson, Hugh A.
Wood, Robert A.
Plaut, Marshall
Cooper, Susan F.
Fenton, Matthew J.
Arshad, S. Hasan
Bahna, Sami L.
Beck, Lisa A.
Byrd-Bredbenner, Carol
Camargo, Carlos A., Jr.
Eichenfield, Lawrence
Furuta, Glenn T.
Hanifin, Jon M.
Jones, Carol
Kraft, Monica
Levy, Bruce D.
Lieberman, Phil
Luccioli, Stefano
McCall, Kathleen M.
Schneider, Lynda C.
Simon, Ronald A.
Simons, F. Estelle R.
Teach, Stephen J.
Yawn, Barbara P.
Schwaninger, Julie M.
TI Guidelines for the Diagnosis and Management of Food Allergy in the
United States: Summary of the NIAID-Sponsored Expert Panel Report
SO NUTRITION RESEARCH
LA English
DT Article
C1 [Plaut, Marshall; Cooper, Susan F.; Fenton, Matthew J.; Schwaninger, Julie M.] NIAID, Div Allergy Immunol & Transplantat, NIH, Bethesda, MD 20892 USA.
[Boyce, Joshua A.] Harvard Univ, Brigham & Womens Hosp, Massachusetts Gen Hosp, Dept Med,Sch Med,Div Rheumatol Immunol & Allergy, Boston, MA 02115 USA.
[Camargo, Carlos A., Jr.] Harvard Univ, Dept Emergency Med, Massachusetts Gen Hosp, Dept Med,Div Rheumatol Allergy & Immunol,Sch Med, Boston, MA 02115 USA.
[Levy, Bruce D.] Brigham & Womens Hosp, Pulm & Crit Med Div, Partners Asthma Ctr, Boston, MA 02115 USA.
[Assa'ad, Amal] Univ Cincinnati, Cincinnati Childrens Hosp Med Ctr, Div Allergy & Immunol, Cincinnati, OH USA.
[Burks, A. Wesley] Duke Univ, Med Ctr, Dept Pediat, Div Allergy & Immunol, Durham, NC 27710 USA.
[Kraft, Monica] Duke Univ, Med Ctr, Dept Med, Div Pulm Allergy & Crit Care Med, Durham, NC 27710 USA.
[Jones, Stacie M.] Univ Arkansas Med Sci, Arkansas Childrens Hosp, Dept Pediat, Div Allergy & Immunol, Little Rock, AR 72205 USA.
[Sampson, Hugh A.] Mt Sinai Sch Med, Dept Pediat, Div Allergy & Immunol, Elliot & Roslyn Jaffe Food Allergy Inst, New York, NY USA.
[Wood, Robert A.] Johns Hopkins Univ, Sch Med, Dept Pediat, Div Allergy & Immunol, Baltimore, MD 21205 USA.
[Arshad, S. Hasan] Univ Southampton, Sch Med, Southampton, Hants, England.
[Arshad, S. Hasan] St Marys Hosp, David Hide Asthma & Allergy Res Ctr, Newport, Wight, England.
[Arshad, S. Hasan] Southampton Univ Hosp NHS Trust, Southampton, Hants, England.
[Bahna, Sami L.] Louisiana State Univ, Hlth Sci Ctr, Dept Pediat, Allergy & Immunol Sect, Shreveport, LA 71105 USA.
[Beck, Lisa A.] Univ Rochester, Dept Dermatol, Med Ctr, Rochester, NY 14627 USA.
[Byrd-Bredbenner, Carol] Rutgers State Univ, Dept Nutr Sci, New Brunswick, NJ 08903 USA.
[Eichenfield, Lawrence] Rady Childrens Hosp, Div Pediat & Adolescent Dermatol, San Diego, CA USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Pediat, San Diego, CA 92103 USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Med, San Diego, CA 92103 USA.
[Furuta, Glenn T.] Childrens Hosp Denver, Digest Hlth Inst, Sect Pediat Gastroenterol Hepatol & Nutr, Aurora, CO USA.
[Furuta, Glenn T.] Natl Jewish Hlth, Dept Pediat, Denver, CO USA.
[Furuta, Glenn T.] Univ Colorado Denver, Sch Med, Dept Pediat, Aurora, CO USA.
[Hanifin, Jon M.] Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA.
[Jones, Carol] Allergy & Asthma Network Mothers Asthmat, Mclean, VA USA.
[Lieberman, Phil] Univ Tennessee, Dept Med, Coll Med, Div Allergy & Immunol, Memphis, TN 38104 USA.
[Luccioli, Stefano] US FDA, Off Food Addit Safety, College Pk, MD USA.
[McCall, Kathleen M.] Childrens Hosp Orange Cty, Orange, CA 92668 USA.
[Schneider, Lynda C.] Childrens Hosp Boston, Div Immunol, Boston, MA USA.
[Simon, Ronald A.] Scripps Clin, Div Allergy Asthma & Immunol, San Diego, CA USA.
[Simons, F. Estelle R.] Univ Manitoba, Fac Med, Dept Pediat, Winnipeg, MB, Canada.
[Simons, F. Estelle R.] Univ Manitoba, Fac Med, Dept Child Hlth & Immunol, Winnipeg, MB, Canada.
[Teach, Stephen J.] Childrens Natl Med Ctr, Div Emergency Med, Washington, DC 20010 USA.
[Yawn, Barbara P.] Olmsted Med Ctr, Dept Res, Rochester, MN USA.
[Yawn, Barbara P.] Univ Minnesota, Sch Med, Dept Family & Community Hlth, Minneapolis, MN 55455 USA.
RP Fenton, MJ (reprint author), NIAID, Div Allergy Immunol & Transplantat, NIH, 6610 Rockledge Dr,Room 3105, Bethesda, MD 20892 USA.
EM fentonm@niaid.nih.gov
RI Byrd-Bredbenner, Carol/F-8064-2015
OI Byrd-Bredbenner, Carol/0000-0002-8010-3987
FU National Institutes of Health; GlaxoSmithKline; Food Allergy and
Anaphylaxis Network; Gerber; Mead Johnson; Dyax Corp; National Peanut
Board; Food Allergy Initiative; National Institutes of Health (Division
of Receipt and Referral, National Institute of Allergy and Infectious
Diseases, National Center for Complementary and Alternative Medicine);
Phadia AB; Genentech; National Institutes of Health (National Institute
of Allergy and Infectious Diseases); National Institute of Health
Research, UK; American Academy of Allergy, Asthma, and Immunology;
National Eczema Association; US Department of Agriculture; Canned Food
Alliance; New Jersey Department of Health and Senior Services; variety
of government agencies; Dey; Novartis; Astellas; Ferndale; Johnson
Johnson; Sinclair; Stiefel; Therapeutics Inc
FX J. A. Boyce has served on the Advisory Board of GlaxoStmithKline. He has
served as a consultant and/or speaker for Altana, GlaxoSmithKline, and
Merck. He has received funding/grant support from the National
Institutes of Health.; A. Assa'ad holds, or is listed as an inventor on,
US patent application #10/566903, entitled "Genetic markers of food
allergy." She has served as a consultant for GlaxoStmithKline and as a
speaker for the American College of Allergy, Asthma, and Immunology, the
North East Allergy Society, the Virginia Allergy Society, the New
England Allergy Society, and the American Academy of Pediatrics. Dr
Assa'ad has received funding/grant support from GlaxoSmithKline.; A. W.
Burks holds, or is listed as an inventor on, multiple US patents related
to food allergy. He owns stock in Allertein and MastCell, Inc, and is a
minority stockholder in Daimon Co Probiotics. He has served as a
consultant for ActoGeniX NV, McNeil Nutritionals, Mead Johnson, and
Novartis. He has served on the speaker's bureau for EpiPen/Dey, LP, and
has served on the data monitoring committee for Genentech. He has served
on an expert panel for Nutricia. Dr Burks has received funding/grant
support from the Food Allergy and Anaphylaxis Network, Gerber, Mead
Johnson, and the National Institutes of Health.; S. M. Jones has served
as a speaker and grant reviewer and has served on the medical advisory
committee for the Food Allergy and Anaphylaxis Network. She has received
funding/grant support from Dyax Corp, the Food Allergy and Anaphylaxis
Network, Mead Johnson, the National Peanut Board, and the National
Institutes of Health.; H. A. Sampson holds, or is listed as an inventor
on, multiple US patents related to food allergy. He owns stock in
Allertein Therapeutics. He is the immediate past president of the
American Academy of Allergy, Asthma, and Immunology. He has served as a
consultant for Allertein Therapeutics, the American Academy of Allergy,
Asthma, and Immunology, the Food Allergy Initiative, and Schering
Plough. He has received funding/grant support for research projects from
the Food Allergy Initiative, the National Institutes of Health (Division
of Receipt and Referral, National Institute of Allergy and Infectious
Diseases, National Center for Complementary and Alternative Medicine),
and Phadia AB. He is a co-owner of Herbal Spring, LLC.; R. A. Wood has
served as a speaker/advisory board member for GlaxoSmithKline, Merck,
and Dey. He has received funding/grant support from Genentech and the
National Institutes of Health (National Institute of Allergy and
Infectious Diseases).; S. H. Arshad has received funding/grant support
from the National Institutes of Health and the National Institute of
Health Research, UK.; S. L. Bahna has received funding/grant support
from Genentech.; L. A. Beck has received funding/grant support from the
American Academy of Allergy, Asthma, and Immunology, the National Eczema
Association, and the National Institutes of Health.; C. Byrd-Bredbenner
owns stock in Johnson & Johnson. She has received funding/grant support
from the US Department of Agriculture, the Canned Food Alliance, and the
New Jersey Department of Health and Senior Services.; C. A. Camargo Jr
has consulted for Dey and Novartis. He has received funding/grant
support from a variety of government agencies and not-for-profit
research foundations, as well as Dey and Novartis.; L. Eichenfield has
received funding/grant support from a variety of not-for-profit
foundations, as well as Astellas, Ferndale, Johnson & Johnson, Novartis,
Sinclair, Stiefel, and Therapeutics Inc.
NR 1
TC 33
Z9 39
U1 0
U2 8
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0271-5317
J9 NUTR RES
JI Nutr. Res.
PD JAN
PY 2011
VL 31
IS 1
BP 61
EP 75
DI 10.1016/j.nutres.2011.01.001
PG 15
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 724ZB
UT WOS:000287613900010
PM 21310308
ER
PT J
AU Casak, SJ
Lemery, SJ
Shen, YL
Rothmann, MD
Khandelwal, A
Zhao, H
Davis, G
Jarral, V
Keegan, P
Pazdur, R
AF Casak, Sandra J.
Lemery, Steven J.
Shen, Yuan Li
Rothmann, Mark D.
Khandelwal, Aakanksha
Zhao, Hong
Davis, Gina
Jarral, Vaishali
Keegan, Patricia
Pazdur, Richard
TI US Food and Drug Administration Approval: Rituximab in Combination with
Fludarabine and Cyclophosphamide for the Treatment of Patients with
Chronic Lymphocytic Leukemia
SO ONCOLOGIST
LA English
DT Article
DE FDA; Rituximab; Chronic lymphocytic leukemia; Fludarabine;
Cyclophosphamide
ID PROGRESSION-FREE SURVIVAL
AB Purpose. To describe the clinical studies that led to the FDA approval of rituximab in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with chronic lymphocytic leukemia (CLL).
Materials and Methods. The results of two multinational, randomized trials in CLL patients comparing rituximab combined with fludarabine and cyclophosphamide versus FC were reviewed. The primary endpoint of both studies was progression-free survival (PFS).
Results. The addition of rituximab to FC decreased the risk of a PFS event by 44% in 817 previously untreated patients and by 24% in 552 previously treated patients. Median survival times could not be estimated. Exploratory analysis in patients older than 70 suggested that there was no benefit to patients when rituximab was added to FC. The safety profile observed in both trials was consistent with the known toxicity profile of rituximab, FC, or CLL.
Conclusions. On the basis of the demonstration of clinically meaningful prolongation of PFS, the FDA granted regular approval to rituximab in combination with FC for the treatment of patients with CLL. The magnitude of the treatment effect in patients 70 years and older is uncertain. The Oncologist 2011; 16: 97-104
C1 [Casak, Sandra J.] US FDA, Div Biol Oncol Prod, Ctr Drug Evaluat & Res, Off New Drugs,Off Oncol Drug Prod, Silver Spring, MD 20993 USA.
[Shen, Yuan Li; Rothmann, Mark D.] US FDA, Ctr Drug Evaluat & Res, Off Biostat, Silver Spring, MD 20993 USA.
[Khandelwal, Aakanksha; Zhao, Hong] US FDA, Ctr Drug Evaluat & Res, Off Clin Pharmacol, Silver Spring, MD 20993 USA.
RP Casak, SJ (reprint author), US FDA, Div Biol Oncol Prod, Ctr Drug Evaluat & Res, Off New Drugs,Off Oncol Drug Prod, 10903 New Hampshire Ave,Bldg 22,Room 5223, Silver Spring, MD 20993 USA.
EM Sandra.Casak@fda.hhs.gov
NR 8
TC 13
Z9 16
U1 0
U2 1
PU ALPHAMED PRESS
PI DURHAM
PA 318 BLACKWELL ST, STE 260, DURHAM, NC 27701-2884 USA
SN 1083-7159
J9 ONCOLOGIST
JI Oncologist
PD JAN
PY 2011
VL 16
IS 1
BP 97
EP 104
DI 10.1634/theoncologist.2010-0306
PG 8
WC Oncology
SC Oncology
GA 710JB
UT WOS:000286506600011
PM 21212432
ER
PT S
AU Agrawal, A
Chang, R
Connors, M
Stafford, C
Hwang, J
Pfefer, TJ
AF Agrawal, Anant
Chang, Robert
Connors, Megan
Stafford, Christopher
Hwang, Jeeseong
Pfefer, T. Joshua
BE Nordstrom, RJ
Cote, GL
TI System-independent assessment of OCT axial resolution with a "bar chart"
phantom
SO OPTICAL DIAGNOSTICS AND SENSING XI: TOWARD POINT-OF-CARE DIAGNOSTICS AND
DESIGN AND PERFORMANCE VALIDATION OF PHANTOMS USED IN CONJUNCTION WITH
OPTICAL MEASUREMENT OF TISSUE III
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Optical Diagnostics and Sensing XI - Toward Point-of-Care
Diagnostics and Design and Performance Validation of Phantoms Used in
Conjunction with Optical Measurement of Tissue III
CY JAN 22-26, 2011
CL San Francisco, CA
SP SPIE
DE phantoms; optical coherence tomography; resolution
ID OPTICAL COHERENCE TOMOGRAPHY; SCATTERING
AB We present a optical phantom approach for the characterization of OCT axial resolution and contrast via multilayered "bar charts." We explored two methods to fabricate these phantoms: the first is based on monolayers of light-scattering microspheres with an intervening layer of transparent silicone, and the second involves alternating layers of scattering-enhanced silicone and transparent silicone. Varying the diameter of the microspheres and the thickness of the silicone layers permits different spatial frequencies to be realized in the axial dimension of the phantoms. Because the phantom's dimensions are accurately known independent of the OCT system, no information about the system's spatial calibration is required. We quantified the degree to which the bars in each phantom could be resolved with OCT, which provides insights into the axial contrast transfer function. Initial testing of these phantoms on time-resolved and Fourier-domain OCT platforms indicated that our approach can provide accurate, system-independent estimates of resolution.
C1 [Agrawal, Anant; Connors, Megan; Pfefer, T. Joshua] US FDA, Opt Diagnost Devices Lab, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Agrawal, A (reprint author), US FDA, Opt Diagnost Devices Lab, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
EM anant.agrawal@fda.hhs.gov
NR 11
TC 4
Z9 4
U1 1
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 978-0-8194-8443-7
J9 PROC SPIE
PY 2011
VL 7906
AR 79060R
DI 10.1117/12.880958
PG 7
WC Optics; Radiology, Nuclear Medicine & Medical Imaging
SC Optics; Radiology, Nuclear Medicine & Medical Imaging
GA BZS23
UT WOS:000302694400019
ER
PT S
AU Kim, DH
Ilev, IK
Han, YG
AF Kim, Do-Hyun
Ilev, Ilko K.
Han, Young-Geun
BE Gannot, I
TI A Thickness Measurement Method for Biological Samples using Lensed-Fiber
Sensors
SO OPTICAL FIBERS, SENSORS, AND DEVICES FOR BIOMEDICAL DIAGNOSTICS AND
TREATMENT XI
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Optical Fibers, Sensors, and Devices for Biomedical
Diagnostics and Treatment XI
CY JAN 22-23, 2011
CL San Francisco, CA
SP SPIE
DE confocal microscopy; fiber sensor; thickness measurement
ID DIFFERENTIAL CONFOCAL MICROSCOPY; OPTICAL COHERENCE TOMOGRAPHY;
REFRACTIVE-INDEX; INTERFEROMETRY; TISSUE
AB We present a simple fiber-optic confocal method for high-precision thickness measurement of optically transparent and non-transparent objects that require noncontact measurement. The method is based on measurement of confocal back-reflection responses from the opposite surfaces of objects, which imposes inessential limitations on the shape, thickness, and transparency of testing objects. A novel reference comparison method to eliminate additional errors existing commonly in confocal microscope designs is adapted. The measurement error highly depends on the axial response of confocal microscope, and was measured to be 5.0 mu m using a single-mode optical fiber construction, 60x objective lenses, and a 658-nm-wavelength laser source. We demonstrate the method using lensed-fiber sensors, which reduces the size of the experimental setup so that the method can be utilized for smaller samples at in-vivo situation. We demonstrate the proof-of-concept measurement using biological samples.
C1 [Kim, Do-Hyun; Ilev, Ilko K.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Kim, DH (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM do-hyun.kim@fda.hhs.gov
NR 12
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 978-0-8194-8431-4
J9 PROC SPIE
PY 2011
VL 7894
AR 789416
DI 10.1117/12.881640
PG 8
WC Engineering, Biomedical; Optics
SC Engineering; Optics
GA BXY47
UT WOS:000297622000029
ER
PT S
AU Kim, DH
AF Kim, Do-Hyun
BE Gannot, I
TI Evaluation of Phototoxicity from Scanning Biophotonic Devices
SO OPTICAL FIBERS, SENSORS, AND DEVICES FOR BIOMEDICAL DIAGNOSTICS AND
TREATMENT XI
SE Proceedings of SPIE
LA English
DT Proceedings Paper
CT Conference on Optical Fibers, Sensors, and Devices for Biomedical
Diagnostics and Treatment XI
CY JAN 22-23, 2011
CL San Francisco, CA
SP SPIE
DE phototoxicity; scanning devices; optical radiation hazard
ID LASER; EXPOSURE; BEAM
AB Scanning light sources in biophotonic devices are considered as either extended or pulsed sources when their potential optical hazard is evaluated. While the existing evaluation criteria are directly applicable to scanning light sources in most cases, different dwell-time and overlap between the beams need to be taken into account to obtain maximum irradiation. The effect of dwell-time and overlap of scanning light source on the irradiation of lights to skin was theoretically and experimentally analyzed in this report.
C1 US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Kim, DH (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM do-hyun.kim@fda.hhs.gov
NR 4
TC 2
Z9 2
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 978-0-8194-8431-4
J9 PROC SPIE
PY 2011
VL 7894
AR 78940H
DI 10.1117/12.882004
PG 10
WC Engineering, Biomedical; Optics
SC Engineering; Optics
GA BXY47
UT WOS:000297622000013
ER
PT J
AU Antunes, AMM
Novais, DA
da Silva, JLF
Santos, PP
Oliveira, MC
Beland, FA
Marques, MM
AF Antunes, Alexandra M. M.
Novais, David A.
Ferreira da Silva, J. L.
Santos, Pedro P.
Conceicao Oliveira, M.
Beland, Frederick A.
Matilde Marques, M.
TI Synthesis and oxidation of 2-hydroxynevirapine, a metabolite of the HIV
reverse transcriptase inhibitor nevirapine
SO ORGANIC & BIOMOLECULAR CHEMISTRY
LA English
DT Article
ID TO-CHILD TRANSMISSION; INDUCED SKIN RASH; DOSE NEVIRAPINE; QUINONE
IMINE; ANTIRETROVIRAL THERAPY; PERIODATE OXIDATION; ACETYL HYPOFLUORITE;
PREVOST REACTION; LACTOPEROXIDASE; SINGLE
AB Nevirapine (11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2'3'e][1,4]diazepin-6-one, NVP) is a non-nucleoside HIV-1 reverse transcriptase inhibitor used to prevent mother-to-child transmission of the virus. However, severe hepatotoxicity and serious adverse cutaneous effects have raised concerns about the safety of NVP administration. NVP metabolism yields several phenol-type derivatives conceivably capable of undergoing further metabolic oxidation to electrophilic quinoid species that could react with bionucleophiles. The covalent adducts thus formed might be at the genesis of toxic responses. As an initial step to test this hypothesis, we synthesized the phenolic metabolite, 2-hydroxy-NVP, and investigated its oxidation in vitro. Using potassium nitrosodisulfonate and sodium periodate as model oxidants, we obtained evidence for fast generation of an electrophilic quinone-imine, which readily underwent hydrolytic conversion to fully characterized spiro derivatives, 1'-cyclopropyl-4-methyl-1H,1'H-spiro[pyridine-2,2'-pyrido[2,3-d]pyrimidine]-3,4',6(3'H)-trione in aqueous media and 1'-cyclopropyl-4-methyl-1'H,2H-spiro[pyridine-3,2'-pyrido[2,3-d]pyrimidine]2,4',6(1H,3'H)-trione in non-aqueous media. The spiro compound generated in aqueous solution underwent subsequent hydrolytic degradation of the NVP ring system, whereas the one formed in non-aqueous media was stable to hydrolysis. The product profile observed with the chemical oxidants in aqueous solution was replicated using lactoperoxidase-mediated oxidation of 2-hydroxy-NVP. These observations suggest that metabolic activation of NVP, via Phase I oxidation to 2-hydroxy-NVP and subsequent generation of a quinone-imine, could occur in vivo and play a role in NVP-induced toxicity.
C1 [Antunes, Alexandra M. M.; Novais, David A.; Ferreira da Silva, J. L.; Santos, Pedro P.; Conceicao Oliveira, M.; Matilde Marques, M.] Univ Tecn Lisboa, Inst Super Tecn, Ctr Quim Estrut, P-1049001 Lisbon, Portugal.
[Beland, Frederick A.] Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Antunes, AMM (reprint author), Univ Tecn Lisboa, Inst Super Tecn, Ctr Quim Estrut, P-1049001 Lisbon, Portugal.
EM alexandra.antunes@ist.utl.pt; matilde.marques@ist.utl.pt
RI Silva, Joao/H-7770-2012; Oliveira, Maria Conceicao/H-8263-2012; Marques,
M. Matilde/E-2535-2012; PTMS, RNEM/C-1589-2014; Antunes,
Alexandra/B-7871-2009; Santos, Pedro Paulo/P-1769-2016;
OI Silva, Joao/0000-0002-9751-9268; Oliveira, Maria
Conceicao/0000-0002-3068-4920; Marques, M. Matilde/0000-0002-7526-4962;
Antunes, Alexandra/0000-0003-1827-7369; Santos, Pedro
Paulo/0000-0003-3045-4591; Ferreira da Silva, Joao/0000-0003-2797-5206
FU Fundacao para a Ciencia e a Tecnologia (FCT), Portugal
[PEst-OE/QUI/UI0100/2011, PPCDT/QUI/56582/2004,
PTDC/QUI-QUI/113910/2009]; National Center for Toxicological
Research/Food and Drug Administration [Y1ES1027]; National Institute of
Environmental Health Sciences [Y1ES1027]
FX We thank the Portuguese NMR Network (IST-UTL Center) and the Portuguese
MS Network (IST-UTL Center) for providing access to the facilities. This
work was supported in part by Fundacao para a Ciencia e a Tecnologia
(FCT), Portugal, through pluriannual funds to Centro de Quimica
Estrutural (PEst-OE/QUI/UI0100/2011) and research grants
PPCDT/QUI/56582/2004 and PTDC/QUI-QUI/113910/2009, and by Interagency
Agreement Y1ES1027 between the National Center for Toxicological
Research/Food and Drug Administration and the National Institute of
Environmental Health Sciences/National Toxicology Program. The opinions
expressed in this paper do not necessarily represent those of the U. S.
Food and Drug Administration.
NR 81
TC 15
Z9 15
U1 0
U2 16
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 1477-0520
EI 1477-0539
J9 ORG BIOMOL CHEM
JI Org. Biomol. Chem.
PY 2011
VL 9
IS 22
BP 7822
EP 7835
DI 10.1039/c1ob06052j
PG 14
WC Chemistry, Organic
SC Chemistry
GA 837LE
UT WOS:000296203700033
PM 21969039
ER
PT J
AU Kerlikowske, G
Jones, CM
LaBelle, RM
Condon, TP
AF Kerlikowske, Gil
Jones, Christopher M.
LaBelle, Regina M.
Condon, Timothy P.
TI Prescription Drug Monitoring Programs-Lack of Effectiveness or a Call to
Action?
SO PAIN MEDICINE
LA English
DT Editorial Material
ID NONMEDICAL USE
C1 [Jones, Christopher M.] US Dept HHS, US FDA, Washington, DC 20201 USA.
[Condon, Timothy P.] US Dept HHS, NIDA, Washington, DC 20201 USA.
NR 13
TC 4
Z9 4
U1 0
U2 1
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1526-2375
J9 PAIN MED
JI Pain Med.
PY 2011
VL 12
IS 5
BP 687
EP 689
DI 10.1111/j.1526-4637.2011.01108.x
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 762OM
UT WOS:000290489300001
PM 21481174
ER
PT J
AU Reid, MC
Bennett, DA
Chen, WG
Eldadah, BA
Farrar, JT
Ferrell, B
Gallagher, RM
Hanlon, JT
Herr, K
Horn, SD
Inturrisi, CE
Lemtouni, S
Lin, YW
Michaud, K
Morrison, RS
Neogi, T
Porter, LL
Solomon, DH
Von Korff, M
Weiss, K
Witter, J
Zacharoff, KL
AF Reid, M. Cary
Bennett, David A.
Chen, Wen G.
Eldadah, Basil A.
Farrar, John T.
Ferrell, Bruce
Gallagher, Rollin M.
Hanlon, Joseph T.
Herr, Keela
Horn, Susan D.
Inturrisi, Charles E.
Lemtouni, Salma
Lin, Yu Woody
Michaud, Kaleb
Morrison, R. Sean
Neogi, Tuhina
Porter, Linda L.
Solomon, Daniel H.
Von Korff, Michael
Weiss, Karen
Witter, James
Zacharoff, Kevin L.
TI Improving the Pharmacologic Management of Pain in Older Adults:
Identifying the Research Gaps and Methods to Address Them
SO PAIN MEDICINE
LA English
DT Review
DE Analgesic Use; Chronic Noncancer Pain; Older Adults
ID CHRONIC NONCANCER PAIN; NONSTEROIDAL ANTIINFLAMMATORY DRUGS; OBSTRUCTIVE
PULMONARY-DISEASE; PERSISTENT NONMALIGNANT PAIN; NURSING-HOME RESIDENTS;
NATIONAL-DATA-BANK; MUSCULOSKELETAL PAIN; UNITED-STATES; COGNITIVE
IMPAIRMENT; RHEUMATIC-DISEASES
AB Objective. There has been a growing recognition of the need for better pharmacologic management of chronic pain among older adults. To address this need, the National Institutes of Health Pain Consortium sponsored an "Expert Panel Discussion on the Pharmacological Management of Chronic Pain in Older Adults" conference in September 2010 to identify research gaps and strategies to address them. Specific emphasis was placed on ascertaining gaps regarding use of opioid and nonsteroidal anti-inflammatory medications because of continued uncertainties regarding their risks and benefits.
Design. Eighteen panel members provided oral presentations; each was followed by a multidisciplinary panel discussion. Meeting transcripts and panelists' slide presentations were reviewed to identify the gaps and the types of studies and research methods panelists suggested could best address them.
Results. Fifteen gaps were identified in the areas of treatment (e.g., uncertainty regarding the long-term safety and efficacy of commonly prescribed analgesics), epidemiology (e.g., lack of knowledge regarding the course of common pain syndromes), and implementation (e.g., limited understanding of optimal strategies to translate evidence-based pain treatments into practice). Analyses of data from electronic health care databases, observational cohort studies, and ongoing cohort studies (augmented with pain and other relevant outcomes measures) were felt to be practical methods for building an age-appropriate evidence base to improve the pharmacologic management of pain in later life.
Conclusion. Addressing the gaps presented in the current report was judged by the panel to have substantial potential to improve the health and wellbeing of older adults with chronic pain.
C1 [Reid, M. Cary] Weill Cornell Med Ctr, Div Geriatr & Gerontol, New York, NY 10065 USA.
[Bennett, David A.] Rush Univ, Med Ctr, Dept Neurol Sci, Rush Alzheimers Dis Ctr, Chicago, IL 60612 USA.
[Chen, Wen G.] NIA, Behav & Syst Neurosci Branch, Div Neurosci, Bethesda, MD 20892 USA.
[Eldadah, Basil A.] NIA, Div Geriatr & Clin Gerontol, Bethesda, MD 20892 USA.
[Farrar, John T.] Univ Penn, Dept Epidemiol, Philadelphia, PA 19104 USA.
[Farrar, John T.] Univ Penn, Dept Neurol, Philadelphia, PA 19104 USA.
[Ferrell, Bruce] UCLA Sch Med, Div Geriatr, Los Angeles, CA USA.
Univ Penn, Sch Med, Philadelphia VA Med Ctr, Penn Pain Med Ctr, Philadelphia, PA 19104 USA.
Univ Penn, Sch Med, Dept Psychiat, Philadelphia, PA 19104 USA.
Univ Penn, Sch Med, Dept Anesthesiol & Crit Care, Philadelphia, PA 19104 USA.
[Gallagher, Rollin M.] Univ Pittsburgh, Dept Geriatr Med, Pittsburgh, PA USA.
[Hanlon, Joseph T.] VA Pittsburgh Hlth Syst, Geriatr Res Educ & Clin Ctr, Pittsburgh, PA USA.
[Herr, Keela] Univ Iowa, Coll Nursing, John A Hartford Ctr Geriatr Nursing Excellence, Iowa City, IA 52242 USA.
[Horn, Susan D.] Inst Clin Outcomes Res, Salt Lake City, UT USA.
[Inturrisi, Charles E.] Weill Cornell Med Coll, Dept Pharmacol, New York, NY USA.
[Lemtouni, Salma; Weiss, Karen] US FDA, Ctr Drug Evaluat & Res, Washington, DC 20204 USA.
[Lin, Yu Woody] Natl Inst Drug Abuse, Div Clin Neurosci & Behav Res, Bethesda, MD USA.
[Michaud, Kaleb] Univ Nebraska Med Ctr, Omaha, NE USA.
[Michaud, Kaleb] Natl Data Bank Rheumat Dis, Wichita, KS USA.
[Morrison, R. Sean] Mt Sinai Sch Med, Brookdale Dept Geriatr & Palliat Med, New York, NY USA.
[Neogi, Tuhina] Boston Univ, Sch Med, Sect Clin Epidemiol Res & Training Unit, Boston, MA 02118 USA.
[Neogi, Tuhina] Boston Univ, Sch Med, Rheumatol Sect, Boston, MA 02118 USA.
[Porter, Linda L.] Natl Inst Neurol Disorders & Stroke, Bethesda, MD USA.
[Solomon, Daniel H.] Harvard Univ, Brigham & Womens Hosp, Div Pharmacoepidemiol & Pharmacoecon, Sch Med, Boston, MA 02115 USA.
[Solomon, Daniel H.] Brigham & Womens Hosp, Div Rheumatol, Boston, MA 02115 USA.
[Von Korff, Michael] Ctr Hlth Studies Grp Hlth Cooperat, Seattle, WA USA.
[Witter, James] NIAMSD, Div Skin & Rheumat Dis, Bethesda, MD 20892 USA.
[Zacharoff, Kevin L.] Inflexxion Inc, Newton, MA USA.
RP Reid, MC (reprint author), Weill Cornell Med Ctr, Div Geriatr & Gerontol, 525 E 68th St,Box 39, New York, NY 10065 USA.
EM mcr2004@med.cornell.edu
RI Inturrisi, Charles/E-7365-2013;
OI Reid, Cary/0000-0001-8117-662X; Neogi, Tuhina/0000-0002-9515-1711
FU Edward R. Roybal Center for Translational Research on Aging, NIA [P30
AG22845]; NIA [P30AG10161, R01AG15819, R01AG17917, P30AG028741,
K24AG022345, R01AG030141, R01AG034181]; National Center for Research
Resources [UL1RR024134]; National Institute of Aging [P30AG024827,
T32AG021885, K07AG033174, R01AG034056, R56AG027017, U01AG012553];
National Institute of Mental Health [R34MH082682]; National Institute of
Nursing [R01NR010135]; AHRQ [R01HS017695, R01HS018721, K12HS019461]; VA
Health Services [IIR-06-062]; National Cancer Institute [R01CA115363];
National Institute of Nursing Research [T32NR011147]; NIDA [RC2DA028928,
R01DA022557]; National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS) [RC1AR058601, K23AR055127, K24AR055989]
FX The authors would like to acknowledge the participation of all the
conference attendees, who are listed in Appendix A. Dr. Reid was
supported by an Edward R. Roybal Center for Translational Research on
Aging Award (P30 AG22845) provided by the NIA. Dr. Bennett was supported
by NIA grants P30AG10161, R01AG15819, and R01AG17917. Dr. Farrar was
supported by a grant from the National Center for Research Resources
(UL1RR024134). Dr. Hanlon was supported by National Institute of Aging
grants (P30AG024827, T32AG021885, K07AG033174, R01AG034056, R56AG027017,
U01AG012553), a National Institute of Mental Health grant (R34MH082682),
a National Institute of Nursing Research grant (R01NR010135), AHRQ
grants (R01HS017695, R01HS018721, K12HS019461), and a VA Health Services
Research grant (IIR-06-062). Dr. Herr was supported by grants from the
National Cancer Institute (R01CA115363) and National Institute of
Nursing Research (T32NR011147). Drs. Horn and Inturrisi were supported
by American Recovery and Reinvestment Act (ARRA) grant RC2DA028928 from
NIDA. Dr. Michaud was supported by an ARRA grant from the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(RC1AR058601). Dr. Neogi was supported by a grant from the NIAMS
(K23AR055127). Dr. Morrison was supported by grants from the NIA
(P30AG028741, K24AG022345, and R01AG030141). Dr. Solomon was supported
by a grant from the NIAMS (K24AR055989). Dr. Von Korff was supported by
grants from the NIDA (R01DA022557) and the NIA (R01AG034181).
NR 106
TC 37
Z9 38
U1 7
U2 19
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1526-2375
J9 PAIN MED
JI Pain Med.
PY 2011
VL 12
IS 9
BP 1336
EP 1357
DI 10.1111/j.1526-4637.2011.01211.x
PG 22
WC Medicine, General & Internal
SC General & Internal Medicine
GA 822MJ
UT WOS:000295051500009
PM 21834914
ER
PT J
AU Muhammad, RD
Haber, P
Broder, KR
Leroy, Z
Ball, R
Braun, MM
Davis, RL
McMahon, AW
AF Muhammad, Riyadh D.
Haber, Penina
Broder, Karen R.
Leroy, Zanie
Ball, Robert
Braun, M. Miles
Davis, Robert L.
McMahon, Ann W.
TI Adverse Events Following Trivalent Inactivated Influenza Vaccination in
Children Analysis of the Vaccine Adverse Event Reporting System
SO PEDIATRIC INFECTIOUS DISEASE JOURNAL
LA English
DT Article
DE influenza vaccine; vaccine safety; adverse event
ID GUILLAIN-BARRE-SYNDROME; IMMUNIZATION PRACTICES ACIP; SAFETY DATALINK
PROJECT; UNITED-STATES; ROTAVIRUS VACCINATION; ADVISORY-COMMITTEE;
VIRUS-VACCINE; VAERS; ADULTS; INTUSSUSCEPTION
AB Background: The Advisory Committee on Immunization Practices' recommendations for influenza vaccination of children have expanded from the long-standing recommendation to vaccinate high-risk children aged >= 6 months, to vaccinating all 6- to 23-month-olds (2004), 2- to 4-year-olds (2006), and 5- to 18-year-olds (2008).
Objective: To identify new or unexpected adverse events (AEs) after trivalent inactivated vaccine (TIV) in children.
Methods: We analyzed reports after TIV to the Vaccine Adverse Event Reporting System from 1990-2006 in children aged 2 to 17 years, and from the 2008-2009 influenza season in children aged 5 to 17 years. Empiric Bayesian data mining techniques were used to identify new or unexpected AEs during 1990-2006.
Results: During 1990-2006, the Vaccine Adverse Event Reporting System received 2054 reports of children aged 2 to 17 years with a peak in the 2003-2004 influenza season. In 2008-2009, 506 reports describing 5 to 17 year olds were received. The serious reports of tests performed after TIV were approximately 10% of all reports from 2001-2006, and 6% of the reports in the 2008-2009 season. Data mining showed an increased proportion of medication errors and Guillain Barre Syndrome (GBS). The findings of GBS could not be interpreted as causally related to vaccination. Among 201 reports of medication error, 94% had no AE reported other than the medication error itself.
Conclusion: In this analysis, we found no unexpected AEs. Our review of medication error and GBS reports suggests that ongoing monitoring in these areas is appropriate.
C1 [Muhammad, Riyadh D.; Ball, Robert; Braun, M. Miles; McMahon, Ann W.] US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Rockville, MD 20857 USA.
[Haber, Penina; Broder, Karen R.; Leroy, Zanie; Davis, Robert L.] Ctr Dis Control & Prevent, Div Healthcare Qual Promot, Immunizat Safety Off, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA USA.
RP McMahon, AW (reprint author), 10903 New Hampshire Ave,WO 22,Room 3474, Silver Spring, MD 20993 USA.
EM ann.mcmahon@fda.hhs.gov
NR 56
TC 4
Z9 4
U1 0
U2 2
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0891-3668
J9 PEDIATR INFECT DIS J
JI Pediatr. Infect. Dis. J.
PD JAN
PY 2011
VL 30
IS 1
BP E1
EP E8
DI 10.1097/INF.0b013e3181ff9795
PG 8
WC Immunology; Infectious Diseases; Pediatrics
SC Immunology; Infectious Diseases; Pediatrics
GA 697FU
UT WOS:000285498800001
PM 21042229
ER
PT J
AU Dunne, J
Murphy, D
Wharton, G
AF Dunne, Julia
Murphy, Dianne
Wharton, Gerold
TI The Globalization of Pediatric Trials: Should We be Worried?
SO PEDIATRICS
LA English
DT Letter
C1 [Dunne, Julia; Murphy, Dianne; Wharton, Gerold] US FDA, Off Pediat Therapeut, Off Commissioner, Silver Spring, MD 20993 USA.
RP Dunne, J (reprint author), US FDA, Off Pediat Therapeut, Off Commissioner, Silver Spring, MD 20993 USA.
NR 1
TC 1
Z9 1
U1 0
U2 0
PU AMER ACAD PEDIATRICS
PI ELK GROVE VILLAGE
PA 141 NORTH-WEST POINT BLVD,, ELK GROVE VILLAGE, IL 60007-1098 USA
SN 0031-4005
J9 PEDIATRICS
JI Pediatrics
PD JAN
PY 2011
VL 127
IS 1
BP E252
EP E253
DI 10.1542/peds.2010-3381A
PG 5
WC Pediatrics
SC Pediatrics
GA 700YT
UT WOS:000285782200035
PM 21196576
ER
PT J
AU Lacher, DW
AF Lacher, David W.
BE Walk, ST
Feng, PCH
TI The Evolutionary Model of Escherichia coli O157:H7
SO POPULATION GENETICS OF BACTERIA: A TRIBUTE TO THOMAS S. WHITTAM
LA English
DT Article; Book Chapter
ID HEMOLYTIC-UREMIC SYNDROME; O157-H7; VIRULENCE; O157H7; GENE; DIVERSITY;
EMERGENCE; SEROTYPES; OUTBREAK; STRAINS
C1 US FDA, Div Mol Biol, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Lacher, DW (reprint author), US FDA, Div Mol Biol, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
NR 21
TC 1
Z9 1
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-711-4
PY 2011
BP 227
EP 239
PG 13
WC Evolutionary Biology; Microbiology
SC Evolutionary Biology; Microbiology
GA BYN76
UT WOS:000299463700015
ER
PT J
AU Feng, PCH
Monday, SR
AF Feng, Peter C. H.
Monday, Steven R.
BE Walk, ST
Feng, PCH
TI Evolutionary Emergence and Impact of Atypical Escherichia coli O157:H7
Strains
SO POPULATION GENETICS OF BACTERIA: A TRIBUTE TO THOMAS S. WHITTAM
LA English
DT Article; Book Chapter
ID HEMOLYTIC UREMIC SYNDROME; HEMORRHAGIC COLITIS; SEROTYPE O157-H7;
GENETIC-ANALYSIS; TOXIN-2 GENES; IDENTIFICATION; ANTIGEN; EXPRESSION;
INFECTION; VARIANTS
C1 [Feng, Peter C. H.; Monday, Steven R.] US FDA, Div Microbiol, College Pk, MD 20740 USA.
RP Feng, PCH (reprint author), US FDA, Div Microbiol, College Pk, MD 20740 USA.
NR 36
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-711-4
PY 2011
BP 241
EP 255
PG 15
WC Evolutionary Biology; Microbiology
SC Evolutionary Biology; Microbiology
GA BYN76
UT WOS:000299463700016
ER
PT S
AU Croley, TR
AF Croley, Timothy R.
BE Walls, D
Loughran, ST
TI Ultra-Performance Liquid Chromatography-Mass Spectrometry of Proteins
SO PROTEIN CHROMATOGRAPHY: METHODS AND PROTOCOLS
SE Methods in Molecular Biology
LA English
DT Article; Book Chapter
DE UPLC; Intact proteins; Mass spectrometry; Protein identification;
Chromatography
ID STATIONARY-PHASE; TOP-DOWN; STABILITY; SILICA
AB The commercialization of ultra-performance liquid chromatography (UPLC) has allowed more researchers to take advantage of the benefits of this work. Many researchers are exploring this technique to reduce analytical throughput and to increase resolution. The majority of this work has focused on small molecule analysis; however, this technique can provide the same advantages for the analysis of proteins. Traditionally, protein chromatography has suffered from a number of issues such as carryover, peak splitting, peak broadening, and poor peak shape. Because UPLC utilizes a smaller particle at a higher pressure and flow rate, many of these issues are remedied. When used in combination with mass spectrometry, UPLC becomes a powerful tool for protein identification, characterization, and quantitation. In this work we show how UPLC/MS can be used to separate and identify intact proteins.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Croley, TR (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD USA.
FU PHS HHS [U90/CCU317014]
NR 14
TC 1
Z9 1
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 978-1-60761-912-3
J9 METHODS MOL BIOL
JI Methods Mol. Biol.
PY 2011
VL 681
BP 419
EP 429
DI 10.1007/978-1-60761-913-0_23
D2 10.1007/978-1-60761-913-0
PG 11
WC Biochemical Research Methods; Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA BSD42
UT WOS:000284201200023
PM 20978979
ER
PT B
AU Hoorfar, J
Cahill, S
Clarke, R
Barker, GC
Fazil, A
Wong, DLF
Feng, PCH
AF Hoorfar, J.
Cahill, S.
Clarke, R.
Barker, G. C.
Fazil, A.
Wong, D. L. F.
Feng, P. C. H.
BE Hoorfar, J
TI THE PUBLIC HEALTH, INDUSTRIAL, AND GLOBAL SIGNIFICANCE OF RAPID
MICROBIOLOGICAL FOOD TESTING
SO RAPID DETECTION, CHARACTERIZATION, AND ENUMERATION OF FOODBORNE
PATHOGENS
LA English
DT Article; Book Chapter
ID QUANTITATIVE RISK-ASSESSMENT; PCR; PATHOGENS; TOOL
C1 [Hoorfar, J.] Tech Univ Denmark DTU, Natl Food Inst, DK-2860 Soborg, Denmark.
[Cahill, S.; Clarke, R.] Food & Agr Org United Nations, Nutr & Consumer Protect Div, I-00183 Rome, Italy.
[Barker, G. C.] Inst Food Res, Norwich NR4 7UA, Norfolk, England.
[Fazil, A.] Publ Hlth Agcy Canada, Guelph, ON N1G 5B2, Canada.
[Wong, D. L. F.] World Hlth Org, Sustainable Dev & Healthy Environm, Food Safety Zoonoses & Foodborne Dis, CH-1211 Geneva 27, Switzerland.
[Feng, P. C. H.] US FDA, College Pk, MD 20740 USA.
RP Hoorfar, J (reprint author), Tech Univ Denmark DTU, Natl Food Inst, Morkhoj Bygade 28, DK-2860 Soborg, Denmark.
RI Barker, Gary /B-5429-2013
OI Barker, Gary /0000-0003-1844-6257
NR 32
TC 1
Z9 1
U1 0
U2 1
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-712-1; 978-1-55581-542-4
PY 2011
BP 1
EP 12
D2 10.1128/9781555817121
PG 12
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BC6EK
UT WOS:000353832700002
ER
PT B
AU Reynisson, E
Rudi, K
Marteinsson, VP
Nakayama, J
Sakamoto, N
Rasooly, A
Hoorfar, J
AF Reynisson, E.
Rudi, K.
Marteinsson, V. P.
Nakayama, J.
Sakamoto, N.
Rasooly, A.
Hoorfar, J.
BE Hoorfar, J
TI AUTOMATED AND LARGE-SCALE CHARACTERIZATION OF MICROBIAL COMMUNITIES IN
FOOD PRODUCTION
SO RAPID DETECTION, CHARACTERIZATION, AND ENUMERATION OF FOODBORNE
PATHOGENS
LA English
DT Article; Book Chapter
ID 16S RIBOSOMAL-RNA; COD GADUS-MORHUA; GRADIENT GEL-ELECTROPHORESIS;
NUCLEOTIDE PRIMER EXTENSION; PURE CULTURE TECHNIQUE;
MODIFIED-ATMOSPHERE; FLOW-CYTOMETRY; OLIGONUCLEOTIDE MICROARRAY; DNA
MICROARRAY; GENE ANALYSIS
C1 [Reynisson, E.; Marteinsson, V. P.] Matis Iceland Food Res & Biothech R&D, IS-113 Reykjavik, Iceland.
[Rudi, K.] Nofima Food, N-1430 As, Norway.
[Rudi, K.] Hedmark Univ Coll, N-2318 Hamar, Norway.
[Nakayama, J.; Sakamoto, N.] Kyushu Univ, Fac Agr, Grad Sch, Dept Biosci & Biotechnol,Higashi Ku, Fukuoka 812, Japan.
[Rasooly, A.] US FDA, Div Biol, Off Sci & Engn, Silver Spring, MD 20993 USA.
[Rasooly, A.] NCI, Canc Diag Program, Rockville, MD 20852 USA.
[Hoorfar, J.] Tech Univ Denmark, Natl Food Inst, DK-2860 Soborg, Denmark.
RP Reynisson, E (reprint author), Matis Iceland Food Res & Biothech R&D, Vinlandsleio 12, IS-113 Reykjavik, Iceland.
NR 104
TC 2
Z9 2
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-712-1; 978-1-55581-542-4
PY 2011
BP 63
EP 79
D2 10.1128/9781555817121
PG 17
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BC6EK
UT WOS:000353832700005
ER
PT B
AU Hitchins, AD
Jordan, KN
Sanaa, M
Wagner, M
AF Hitchins, A. D.
Jordan, K. N.
Sanaa, M.
Wagner, M.
BE Hoorfar, J
TI LISTERIA MONOCYTOGENES IN MILK, CHEESE, AND THE DAIRY ENVIRONMENT
SO RAPID DETECTION, CHARACTERIZATION, AND ENUMERATION OF FOODBORNE
PATHOGENS
LA English
DT Article; Book Chapter
ID REAL-TIME PCR; POLYMERASE-CHAIN-REACTION; TANDEM-REPEAT ANALYSIS; LOCUS
VARIABLE-NUMBER; MULTIPLEX PCR; IMMUNOMAGNETIC CAPTURE; MOLECULAR
EPIDEMIOLOGY; QUANTITATIVE DETECTION; COUNT METHOD; WHOLE MILK
C1 [Hitchins, A. D.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Jordan, K. N.] TEAGASC, Moorepk Food Res Ctr, Fermoy, Cork, Ireland.
[Sanaa, M.] Directorate Risk Assessment, Agence Francaise Securite Sanit Aliments, F-94701 Maisons Alfort, France.
[Wagner, M.] Univ Vet Med, Inst Milk Hyg Milk Technol & Food Sci, A-1210 Vienna, Austria.
RP Hitchins, AD (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
NR 64
TC 1
Z9 1
U1 2
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N STREET NW, WASHINGTON, DC 20036-2904 USA
BN 978-1-55581-712-1; 978-1-55581-542-4
PY 2011
BP 257
EP 274
D2 10.1128/9781555817121
PG 18
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA BC6EK
UT WOS:000353832700019
ER
PT B
AU Bright, S
AF Bright, Susan
BE Gupta, RC
TI Postmarket surveillance and regulatory considerations in reproductive
and developmental toxicology: an FDA perspective
SO REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY
LA English
DT Article; Book Chapter
ID VACCINE; PREGNANCY
C1 US FDA, Ctr Vet Med, Off Surveillance & Compliance, Rockville, MD 20857 USA.
RP Bright, S (reprint author), US FDA, Ctr Vet Med, Off Surveillance & Compliance, Rockville, MD 20857 USA.
NR 30
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 978-0-12-382033-4
PY 2011
BP 75
EP 88
DI 10.1016/B978-0-12-382032-7.10007-4
PG 14
WC Reproductive Biology; Toxicology
SC Reproductive Biology; Toxicology
GA BEX82
UT WOS:000318575300008
ER
PT J
AU Hansen, DK
Inselman, AL
AF Hansen, Deborah K.
Inselman, Amy L.
BE Gupta, RC
TI Applications of stem cells in developmental toxicology
SO REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY
LA English
DT Article; Book Chapter
ID HUMAN EMBRYONIC STEM; VITRO EMBRYOTOXICITY TEST;
FIBROBLAST-GROWTH-FACTOR; TOXICITY TEST PROCEDURES; HUMAN SOMATIC-CELLS;
IN-VITRO; SELF-RENEWAL; MAINTAINS PLURIPOTENCY; DEFINED FACTORS; MOUSE
EMBRYOS
C1 [Hansen, Deborah K.; Inselman, Amy L.] FDA Natl Ctr Toxicol Res, Div Personalized Nutr & Med, Jefferson, AR USA.
RP Hansen, DK (reprint author), FDA Natl Ctr Toxicol Res, Div Personalized Nutr & Med, Jefferson, AR USA.
NR 99
TC 0
Z9 0
U1 0
U2 2
PU ELSEVIER ACADEMIC PRESS INC
PI SAN DIEGO
PA 525 B STREET, SUITE 1900, SAN DIEGO, CA 92101-4495 USA
BN 978-0-12-382033-4
PY 2011
BP 783
EP 792
DI 10.1016/B978-0-12-382032-7.10058-X
PG 10
WC Reproductive Biology; Toxicology
SC Reproductive Biology; Toxicology
GA BEX82
UT WOS:000318575300059
ER
PT J
AU Choudhuri, S
AF Choudhuri, Supratim
BE Gupta, RC
TI Epigenetic regulation of gene and genome expression
SO REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY
LA English
DT Article; Book Chapter
ID DIETARY-PROTEIN RESTRICTION; CAENORHABDITIS-ELEGANS; DNA METHYLATION;
SMALL RNAS; PREGNANT RATS; CHROMATIN; MECP2; CANCER; ROLES; NUCLEOSOMES
C1 US FDA, Ctr Food Safety & Appl Nutr, Off Food Addit Safety, Div Biotechnol & GRAS Notice Review, College Pk, MD USA.
RP Choudhuri, S (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Food Addit Safety, Div Biotechnol & GRAS Notice Review, College Pk, MD USA.
NR 60
TC 0
Z9 0
U1 0
U2 1
PU ELSEVIER ACADEMIC PRESS INC
PI SAN DIEGO
PA 525 B STREET, SUITE 1900, SAN DIEGO, CA 92101-4495 USA
BN 978-0-12-382033-4
PY 2011
BP 801
EP 813
DI 10.1016/B978-0-12-382032-7.10060-8
PG 13
WC Reproductive Biology; Toxicology
SC Reproductive Biology; Toxicology
GA BEX82
UT WOS:000318575300061
ER
PT B
AU Getie-Kebtie, M
Alterman, MA
AF Getie-Kebtie, Melkamu
Alterman, Michail A.
BE Ivanov, AR
Lazarev, AV
TI Exploring the Capabilities of the Protein Identification by
Unconventional Sample Preparation Approaches: LC/MALDI/On-Target
Digestion Approach and High Pressure-Assisted In-Gel Tryptic Digestion
SO SAMPLE PREPARATION IN BIOLOGICAL MASS SPECTROMETRY
LA English
DT Article; Book Chapter
DE LC; MALDI; PCT; Tryptic Digestion; On-target
ID PROTEOMICS
AB The rapid and comprehensive separation, identification, and characterization of proteins from complex biological samples are formidable challenges that the growing field of proteomics faces. A robust and efficient digest of separated proteins is central to the development of any quantitative and/or qualitative proteomic approach. We describe here two unconventional approaches to a trypsin digestion of biological samples. One of those approaches integrates separation of proteins using RP-HPLC with on-target proteolytic digestion of the proteins for subsequent MALD1-MS analysis. This approach allows the combined information from peptide mass fingerprinting (PMF), MS/MS peptide fragment fingerprinting (PPF) and whole protein MS to increase confidence in protein identification and structural analysis of proteins. The other approach is based on the application of high-pressure cycling technology (PCT) for in-gel trypsin digest of 1D electrophoretically separated proteins. That approach was used in our laboratory to develop a label-free mass spectrometry based method for a relative quantification of proteins after SDS PAGE separation, including co-migrating proteins.
C1 [Getie-Kebtie, Melkamu; Alterman, Michail A.] US FDA, Tumor Vaccines & Biotechnol Branch, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Alterman, MA (reprint author), US FDA, Tumor Vaccines & Biotechnol Branch, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM Melkamu.Getiekebtie@fda.hhs.gov; michail.alterman@fda.hhs.gov
NR 4
TC 0
Z9 1
U1 1
U2 1
PU SPRINGER
PI DORDRECHT
PA PO BOX 17, 3300 AA DORDRECHT, NETHERLANDS
BN 978-94-007-0758-0
PY 2011
BP 141
EP 155
DI 10.1007/978-94-007-0828-0_9
D2 10.1007/978-94-007-0828-0
PG 15
WC Biochemical Research Methods
SC Biochemistry & Molecular Biology
GA BVY63
UT WOS:000293148700010
ER
PT J
AU Ortiz, PG
Hansen, SH
Shah, VP
Sonne, J
Benfeldt, E
AF Ortiz, P. Garcia
Hansen, S. H.
Shah, V. P.
Sonne, J.
Benfeldt, E.
TI Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by
in vivo Microdialysis Sampling and Tape Stripping Methodology
SO SKIN PHARMACOLOGY AND PHYSIOLOGY
LA English
DT Article
DE Bioequivalence; Cutaneous penetration; Percutaneous permeation; Dermal
drug levels; Dermatopharmacokinetic method; Microdialysis; Tape
stripping; Drug delivery, topical; Metronidazole
ID DERMATOLOGICAL DRUG PRODUCTS; CUTANEOUS MICRODIALYSIS; SKIN;
FORMULATIONS; PENETRATION; STANDARDIZATION; BIOAVAILABILITY;
PERSPECTIVES; ABSORPTION; DERMATITIS
AB Aim: To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence. Methods: Nine microdialysis probes were inserted in the volar aspect of the left forearm of 14 healthy volunteers and, following application of the 3 metronidazole creams, microdialysis samples were collected for 5 h. On the right forearm, tape strip sampling was performed 30 and 120 min after product application. At the end of the experiment, ultrasound scanning measurements confirmed that all probes were placed inside the dermis. Results:There was no statistical difference in penetration of the 3 topicals as determined by microdialysis. However, their bioequivalence could not be determined due to intersubject variability exceeding the criteria for bioequivalence evaluation. Tape strip sampling established a bio-equivalence between 2 of the creams, but rejected any bio-equivalence between these 2 formulations and the third. The third formulation was a generic formulation approved despite containing a lower concentration of metronidazole (0.75%) than the innovator formulation (1.0%). The result of the bioequivalence evaluation depends on the methodology employed. Conclusion: Whenever the dermis is the target tissue, microdialysis provides the most relevant information on drug bioavailability. Copyright (C) 2010 S. Karger AG, Basel
C1 [Ortiz, P. Garcia; Benfeldt, E.] Univ Copenhagen, Gentofte Hosp, Dept Dermatoallergol, Hellerup, Denmark.
[Sonne, J.] Univ Copenhagen, Gentofte Hosp, Clin Pharmacol Unit, Hellerup, Denmark.
[Hansen, S. H.] Univ Copenhagen, Dept Pharmaceut & Analyt Chem, Pharmaceut Fac, Copenhagen, Denmark.
[Shah, V. P.] US FDA, Off Pharmaceut Sci, Rockville, MD 20857 USA.
RP Ortiz, PG (reprint author), Gentofte Univ Hosp, Dept Dermatol, Niels Andersens Vej 65, DK-2900 Hellerup, Denmark.
EM patriciagarcia@dadlnet.dk
FU Aage Bang's Foundation; Hans and Nora Buchards Foundation; Danish
Hospital Foundation for Medical Research Region of Copenhagen; Faeroe
Islands and Greenland; Leo Foundation; Mrs. Liv Bryhn's Foundation;
Danish Psoriasis Foundation; Foundation for Scientific Research without
Animal Experiments
FX This study was supported by grants from Aage Bang's Foundation, Hans and
Nora Buchards Foundation, the Danish Hospital Foundation for Medical
Research Region of Copenhagen, the Faeroe Islands and Greenland, the Leo
Foundation, Mrs. Liv Bryhn's Foundation, the Danish Psoriasis Foundation
and the Foundation for Scientific Research without Animal Experiments.
NR 34
TC 10
Z9 10
U1 1
U2 7
PU KARGER
PI BASEL
PA ALLSCHWILERSTRASSE 10, CH-4009 BASEL, SWITZERLAND
SN 1660-5527
J9 SKIN PHARMACOL PHYS
JI Skin Pharmacol. Physiol.
PY 2011
VL 24
IS 1
BP 44
EP 53
DI 10.1159/000320151
PG 10
WC Dermatology; Pharmacology & Pharmacy
SC Dermatology; Pharmacology & Pharmacy
GA 694AC
UT WOS:000285265500007
ER
PT J
AU Rubin, DB
AF Rubin, Daniel B.
TI A Calibrated Multiclass Extension of AdaBoost
SO STATISTICAL APPLICATIONS IN GENETICS AND MOLECULAR BIOLOGY
LA English
DT Article
DE AdaBoost; boosting; multiclass classification
ID CLASSIFICATION METHODS; BOOSTING ALGORITHMS; STATISTICAL VIEW;
PREDICTION
AB AdaBoost is a popular and successful data mining technique for binary classification. However, there is no universally agreed upon extension of the method for problems with more than two classes. Most multiclass generalizations simply reduce the problem to a series of binary classification problems. The statistical interpretation of AdaBoost is that it operates through loss-based estimation: by using an exponential loss function as a surrogate for misclassification loss, it sequentially minimizes empirical risk through fitting a base classifier to iteratively reweighted training data. While there are several extensions using loss-based estimation with multiclass base classifiers, these use multiclass versions of the exponential loss that are not classification calibrated: unless restrictions are placed on conditional class probabilities, it becomes possible to have optimal surrogate risk but poor misclassification risk. In this work, we introduce a new AdaBoost extension called AdaBoost. SL that does not reduce the problem into binary subproblems and that uses a classification-calibrated multiclass exponential loss function. Numerical experiments show the algorithm performs well on benchmark datasets.
C1 US FDA, Rockville, MD 20857 USA.
RP Rubin, DB (reprint author), US FDA, Rockville, MD 20857 USA.
NR 31
TC 0
Z9 0
U1 0
U2 3
PU WALTER DE GRUYTER GMBH
PI BERLIN
PA GENTHINER STRASSE 13, D-10785 BERLIN, GERMANY
SN 2194-6302
EI 1544-6115
J9 STAT APPL GENET MOL
JI Stat. Appl. Genet. Mol. Biol.
PY 2011
VL 10
IS 1
AR 54
DI 10.2202/1544-6115.1731
PG 25
WC Biochemistry & Molecular Biology; Mathematical & Computational Biology;
Statistics & Probability
SC Biochemistry & Molecular Biology; Mathematical & Computational Biology;
Mathematics
GA 855TT
UT WOS:000297588600004
ER
PT J
AU Yan, LK
Liu, AY
Li, ZH
Zheng, G
AF Yan, Lihan K.
Liu, Aiyi
Li, Zhaohai
Zheng, Gang
TI Optimal two-stage sequential robust design for gene-intervention studies
SO STATISTICS AND ITS INTERFACE
LA English
DT Article
DE Optimal two-stage design; MAX; Group sequential; Gene-intervention
ID GENOME-WIDE ASSOCIATION; CLINICAL-TRIALS; SAMPLE-SIZE; TREND TESTS;
PROPORTIONS; STATISTICS; MAXIMUM; MARKERS; POWER
AB Gene-intervention studies investigate the responsiveness to therapies according to individuals' genetic profiles. We propose a two-stage sequential design for these studies and investigate the cost of the sample size versus the statistical power. In a typical sequential design, a single normally distributed test statistic is used. For a genetic study, the robust test is used because of the uncertainty of the underlying genetic model (e. g. the recessive, additive or dominant models). The robust test statistic that we consider in the two-stage sequential design is the maximum of three correlated normally distributed statistics, each which is optimal under the corresponding genetic model. We study various factors that affect minimizing the average sample number (ASN) or maximizing the power of a gene-intervention study under the two-stage sequential design and make recommendations for the optimal solutions under different scenarios.
C1 [Yan, Lihan K.] US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Liu, Aiyi] Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, Biostat & Bioinformat Branch, Rockville, MD USA.
[Li, Zhaohai] George Washington Univ, Dept Stat, Washington, DC 20052 USA.
[Zheng, Gang] NHLBI, Off Biostat Res, Bethesda, MD 20892 USA.
RP Yan, LK (reprint author), US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
EM lihan.yan@fda.hhs.gov; liua@mail.nih.gov; zli@gwu.edu;
zhengg@nhlbi.nih.gov
OI Liu, Aiyi/0000-0002-6618-5082
FU Eunice Kennedy Shriver National Institute of Child Health and Human
Development, National Institutes of Health
FX We would like to thank the reviewers for their helpful comments which
strengthened the presentation of this paper. We would also like to thank
Ms. Heather Liu for her editorial help. Research of A. Liu is supported
by the Intramural Research Program of the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, National
Institutes of Health. The opinions expressed in the article are those of
the authors, not necessarily of the National Institutes of Health, nor
the Food and Drug Administration.
NR 36
TC 0
Z9 0
U1 0
U2 0
PU INT PRESS BOSTON, INC
PI SOMERVILLE
PA PO BOX 43502, SOMERVILLE, MA 02143 USA
SN 1938-7989
EI 1938-7997
J9 STAT INTERFACE
JI Stat. Interface
PY 2011
VL 4
IS 4
BP 431
EP 441
PG 11
WC Mathematical & Computational Biology; Mathematics, Interdisciplinary
Applications
SC Mathematical & Computational Biology; Mathematics
GA 861DY
UT WOS:000298000500002
ER
PT J
AU Bolon, B
Garman, RH
Gundersen, HJG
Johnson, GA
Kaufmann, W
Krinke, G
Little, PB
Makris, SL
Mellon, RD
Sulik, KK
Jensen, K
AF Bolon, Brad
Garman, Robert H.
Gundersen, Hans Jorgen G.
Johnson, G. Allan
Kaufmann, Wolfgang
Krinke, Georg
Little, Peter B.
Makris, Susan L.
Mellon, R. Daniel
Sulik, Kathleen K.
Jensen, Karl
TI Continuing Education Course #3: Current Practices and Future Trends in
Neuropathology Assessment for Developmental Neurotoxicity Testing
SO TOXICOLOGIC PATHOLOGY
LA English
DT Article
DE developmental neurotoxicity; neuropathology; risk assessment
ID MAGNETIC-RESONANCE MICROSCOPY; INDUCED BRAIN ABNORMALITIES; RAT-BRAIN;
ACUTE INSULT; EXPOSURE; SIZE
AB The continuing education course on Developmental Neurotoxicity Testing (DNT) was designed to communicate current practices for DNT neuropathology, describe promising innovations in quantitative analysis and noninvasive imaging, and facilitate a discussion among experienced neuropathologists and regulatory scientists regarding suitable DNT practices. Conventional DNT neuropathology endpoints are qualitative histopathology and morphometric endpoints of particularly vulnerable sites (e. g., cerebral, cerebellar, or hippocampal thickness). Novel imaging and stereology measurements hold promise for automated analysis of factors that cannot be effectively examined in routinely processed specimens (e. g., cell numbers, fiber tract integrity). The panel recommended that dedicated DNT neuropathology data sets be acquired on a minimum of 8 sections (for qualitative assessment) or 3 sections (for quantitative linear and stereological analyses) using a small battery of stains to examine neurons and myelin. Where guidelines permit discretion, immersion fixation is acceptable for younger animals (postnatal day 22 or earlier), and peripheral nerves may be embedded in paraffin. Frequent concerns regarding DNT data sets include false-negative outcomes due to processing difficulties (e. g., lack of concordance among sections from different animals) and insensitive analytical endpoints (e. g., qualitative evaluation) as well as false-positive results arising from overinterpretation or misreading by inexperienced pathologists.
C1 [Jensen, Karl] US EPA, NHEERL, ORD, Res Triangle Pk, NC 27711 USA.
[Bolon, Brad] GEMpath Inc, Longmont, CO USA.
[Garman, Robert H.] Consultants Vet Pathol, Murrysville, PA USA.
[Gundersen, Hans Jorgen G.] Univ Aarhus, DK-8000 Aarhus, Denmark.
[Johnson, G. Allan] Duke Univ, Durham, NC USA.
[Kaufmann, Wolfgang] BASF, Ludwigshafen, Germany.
[Little, Peter B.] Charles River Labs Inc, Durham, NC USA.
[Makris, Susan L.] US EPA, Washington, DC 20460 USA.
[Mellon, R. Daniel] US FDA, Silver Spring, MD USA.
[Sulik, Kathleen K.] Univ N Carolina, Chapel Hill, NC USA.
RP Jensen, K (reprint author), US EPA, NHEERL, ORD, Mail Drop B105-06, Res Triangle Pk, NC 27711 USA.
EM jensen.karl@epa.gov
OI Johnson, G.Allan/0000-0002-7606-5447
FU NCI NIH HHS [U24 CA092656]; NCRR NIH HHS [P41 RR005959]
NR 32
TC 8
Z9 8
U1 1
U2 3
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0192-6233
J9 TOXICOL PATHOL
JI Toxicol. Pathol.
PD JAN
PY 2011
VL 39
IS 1
BP 289
EP 293
DI 10.1177/0192623310386247
PG 5
WC Pathology; Toxicology
SC Pathology; Toxicology
GA 800QU
UT WOS:000293379600032
PM 21075916
ER
PT J
AU DeGrasse, SL
DeGrasse, JA
Reuter, K
AF DeGrasse, Stacey L.
DeGrasse, Jeffrey A.
Reuter, Kevin
TI Solid core column technology applied to HPLC-FD of paralytic shellfish
toxins
SO TOXICON
LA English
DT Article
DE Column; HPLC; Oxidation; Paralytic shellfish toxins; Saxitoxin; Solid
core; Fused core
ID FUSED-CORE
AB Pre-column oxidation liquid chromatography with fluorescence detection is a chemical method for analyzing paralytic shellfish toxins. In order to improve the sample throughput and efficiency of AOAC Method 2005.06, solid core particle column technology was evaluated. We demonstrate that supplanting the original fully porous particle column with a solid core particle column reduces sample analysis time from 15 to 5 min per sample and improves resolution. Published by Elsevier Ltd.
C1 [DeGrasse, Stacey L.; DeGrasse, Jeffrey A.] US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, Div Analyt Chem,Spect & Mass Spectrometry Branch, College Pk, MD 20740 USA.
[Reuter, Kevin] Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
RP DeGrasse, SL (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Regulatory Sci, Div Analyt Chem,Spect & Mass Spectrometry Branch, 5100 Paint Branch Pkwy,HFS 707, College Pk, MD 20740 USA.
EM Stacey.DeGrasse@fda.hhs.gov
RI DeGrasse, Jeffrey/J-1151-2014;
OI DeGrasse, Jeffrey/0000-0003-3178-6301; DeGrasse,
Stacey/0000-0001-7808-4193
NR 15
TC 7
Z9 7
U1 0
U2 6
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0041-0101
J9 TOXICON
JI Toxicon
PD JAN
PY 2011
VL 57
IS 1
BP 179
EP 182
DI 10.1016/j.toxicon.2010.11.004
PG 4
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 716TV
UT WOS:000286997300024
PM 21078334
ER
PT J
AU Alam, SK
Feleppa, EJ
Rondeau, M
Kalisz, A
Garra, BS
AF Alam, S. Kaisar
Feleppa, Ernest J.
Rondeau, Mark
Kalisz, Andrew
Garra, Brian S.
TI Ultrasonic Multi-Feature Analysis Procedure for Computer-Aided Diagnosis
of Solid Breast Lesions
SO ULTRASONIC IMAGING
LA English
DT Article
DE Breast cancer; computer-aided diagnosis (CAD); fractal analysis;
tnorphometric analysis; multi-feature analysis; ROC; sonography;
spectrum analysis; texture analysis; tissue characterization; tumor
classification; ultrasonic imaging; ultrasound
ID SELF-ORGANIZING MAP; TEXTURE ANALYSIS; TISSUE CHARACTERIZATION;
DISCRIMINANT-ANALYSIS; SONOGRAPHIC FEATURES; SPECTRAL PARAMETERS;
LOGISTIC-REGRESSION; CANCER; CLASSIFICATION; NODULES
AB We have developed quantitative descriptors to provide an objective means of noninvasive identification of cancerous breast lesions. These descriptors include quantitative acoustic features assessed using spectrum analysis of ultrasonic radiofrequency (rt) echo signals and morphometric properties related to lesion shape. Acoustic features include measures of echogenicity, heterogeneity and shadowing, computed by generating spectral-parameter images of the lesion and surrounding tissue. Spectral-parameter values are derived from rf echo signals at each pixel using a sliding-window Fourier analysis. We derive quantitative acoustic features from spectral-parameter maps of the lesion and adjacent areas. We quantify morphometric features by geometric and fractal analysis of traced lesion boundaries. Initial results on biopsy-proven cases show that although a single parameter cannot reliably discriminate cancerous from noncancerous breast lesions, multi-feature analysis provides excellent discrimination for this data set. We have processed data for 130 biopsy-proven patients, acquired during routine ultrasonic examinations at three clinical sites and produced an area under the receiver-operating-characteristics (ROC) curve of 0.947 +/- 0.045. Among the quantitative descriptors, lesion-margin definition, spiculation and border irregularity are the most useful; some additional morphometric features (such as border irregularity) also are particularly effective in lesion classification. Our findings are consistent with many of the BI-RADS (Breast Imaging Reporting and Data System) breast-lesion-classification criteria in use today.
C1 [Alam, S. Kaisar; Feleppa, Ernest J.; Rondeau, Mark; Kalisz, Andrew] Riverside Res, New York, NY 10038 USA.
[Garra, Brian S.] US FDA, Silver Spring, MD 20903 USA.
RP Alam, SK (reprint author), Riverside Res, 156 William St, New York, NY 10038 USA.
EM kalam@riversideresearch.org
FU US Army Medical Research and Materiel Command [DAMD17-98-1-8331]; Susan
G. Komen for the Cure [KG081601]; Advanced Technology Laboratories
FX This work was supported in part by US Army Medical Research and Materiel
Command grant DAMD17-98-1-8331 and Susan G. Komen for the Cure grant
KG081601. We are indebted to our late colleague Dr. Frederic Lizzi for
his inspirational support and advice with the analysis. Data used in
this study were acquired at the University of Cincinnati, Thomas
Jefferson University, and Yale University. The original data provided by
these three collaborating medical centers were acquired with funding
provided by Advanced Technology Laboratories, which currently is a
division of Philips Corporation. Ms. Rumana Huq and Ms. Stella Urban
traced lesions using custom software.
NR 55
TC 12
Z9 12
U1 2
U2 6
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0161-7346
EI 1096-0910
J9 ULTRASONIC IMAGING
JI Ultrason. Imaging
PD JAN
PY 2011
VL 33
IS 1
BP 17
EP 38
PG 22
WC Acoustics; Engineering, Biomedical; Radiology, Nuclear Medicine &
Medical Imaging
SC Acoustics; Engineering; Radiology, Nuclear Medicine & Medical Imaging
GA 765HW
UT WOS:000290697100002
PM 21608446
ER
PT S
AU Botsis, T
Ball, R
AF Botsis, Taxiarchis
Ball, Robert
BE Moen, A
Andersen, SK
Aarts, J
Hurlen, P
TI Network Analysis of Possible Anaphylaxis Cases Reported to the US
Vaccine Adverse Event Reporting System after H1N1 Influenza Vaccine
SO USER CENTRED NETWORKED HEALTH CARE
SE Studies in Health Technology and Informatics
LA English
DT Proceedings Paper
CT 23 rd Conference of the European Federation of Medical Informatics (MIE)
CY AUG 28-31, 2011
CL Forum Databehandling Helsesektoren, Oslo, NORWAY
SP European Federat Med Informat
HO Forum Databehandling Helsesektoren
DE Spontaneous Reporting System; Network Analysis; VAERS; H1N1
AB The identification of signals from spontaneous reporting systems plays an important role in monitoring the safety of medical products. Network analysis (NA) allows the representation of complex interactions among the key elements of such systems. We developed a network for a subset of the US Vaccine Adverse Event Reporting System (VAERS) by representing the vaccines/adverse events (AEs) and their interconnections as the nodes and the edges, respectively; this subset we focused upon included possible anaphylaxis reports that were submitted for the H1N1 influenza vaccine. Subsequently, we calculated the main metrics that characterize the connectivity of the nodes and applied the island algorithm to identify the densest region in the network and, thus, identify potential safety signals. AEs associated with anaphylaxis formed a dense region in the `anaphylaxis' network demonstrating the strength of NA techniques for pattern recognition. Additional validation and development of this approach is needed to improve future pharmacovigilance efforts.
C1 [Botsis, Taxiarchis; Ball, Robert] US FDA, OBE, CBER, Rockville, MD 20852 USA.
RP Botsis, T (reprint author), US FDA, OBE, CBER, Woodmont Off Complex 1,Room 306N, Rockville, MD 20852 USA.
EM Taxiarchis.Botsis@fda.hhs.gov
NR 11
TC 4
Z9 4
U1 1
U2 2
PU IOS PRESS
PI AMSTERDAM
PA NIEUWE HEMWEG 6B, 1013 BG AMSTERDAM, NETHERLANDS
SN 0926-9630
BN 978-1-60750-806-9
J9 STUD HEALTH TECHNOL
PY 2011
VL 169
BP 564
EP 568
DI 10.3233/978-1-60750-806-9-564
PG 5
WC Health Care Sciences & Services; Medical Informatics
SC Health Care Sciences & Services; Medical Informatics
GA BA4DP
UT WOS:000335401700110
PM 21893812
ER
PT S
AU Aidoo, A
Manjanatha, MG
AF Aidoo, Anane
Manjanatha, Mugimane G.
BE Mutanen, M
Pajari, AM
TI Influence of dietary Soy Isoflavones Genistein and Daidzein on
Genotoxicity and Mammary Carcinogenicity in Rats Exposed to the Model
Carcinogen 7,12-Dimethylbenz[a]anthracene (DMBA)
SO VEGETABLES, WHOLE GRAINS, AND THEIR DERIVATIVES IN CANCER PREVENTION
SE Diet and Cancer
LA English
DT Article; Book Chapter
DE Estrogen replacement therapy; Phytoestrogens; Soy isoflavones -
genistein and daidzein; Genotoxicity; Carcinogenicity;
7,12-dimethylbenz[a]anthracene
ID SPRAGUE-DAWLEY RATS; CORONARY-HEART-DISEASE; BREAST-CANCER;
POSTMENOPAUSAL WOMEN; TRANSGENIC MICE; FEMALE RATS; IN-VITRO; ESTROGEN;
PHYTOESTROGENS; RISK
AB Epidemiological studies provide evidence for the possibility of preventing cancer and/or forestalling the complications of menopause through the consumption of foods containing phytoestrogens such as soy isoflavones. Lifestyle changes in technologically advanced societies, however, limit the consumption of adequate foods to meet health needs; thus supplements of phytoestrogen including soy isoflavones daidzein (DZ) and genistein (GE), considered to be compounds in soy that impart beneficial effects, are ingested in large quantities on a regular basis. This raises health concern since isoflavones are structurally similar to steroidal hormones, and it is possible that they may alter endogenous hormone metabolism and influence the pathogenesis of steroid-dependent diseases such as breast and prostate cancer. Equally important, humans are consistently exposed to mutagenic carcinogens whose toxicities could be enhanced by interaction with ingested isoflavones. Recent report indicates that DZ and GE are not only mutagenic, but also they enhance chemical carcinogenesis in animal models. Here, we report the results of feeding rats with DZ and GE to determine whether the genotoxicity and mammary carcinogenesis induced by the potent rodent mammary carcinogen dimethylbenz[a]anthracene (DMBA) could be altered. The data obtained suggest that DZ and GE diets given separately did not significantly alter DMBA-induced mutagenicity in lymphocytes, liver, mammary and heart, and carcinogenicity in the mammary. The mixture of DZ and GE was effective in reducing DMBA effects, suggesting that consuming diets containing more than one soy isoflavones as opposed to taking supplements in isolation, could impart some benefits; these results are discussed together with other animal studies reported on soy isoflavones.
C1 [Aidoo, Anane; Manjanatha, Mugimane G.] FDA Jefferson Labs, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
RP Aidoo, A (reprint author), FDA Jefferson Labs, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
EM anane.aidoo@fda.hhs.gov; mugimane.manjanatha@fda.hhs.gov
NR 78
TC 0
Z9 0
U1 0
U2 2
PU SPRINGER
PI DORDRECHT
PA PO BOX 17, 3300 AA DORDRECHT, NETHERLANDS
SN 1361-8075
BN 978-90-481-9799-6
J9 DIET CANCER
JI Diet Cancer
PY 2011
VL 2
BP 143
EP 171
DI 10.1007/978-90-481-9800-9_7
D2 10.1007/978-90-481-9800-9
PG 29
WC Oncology; Nutrition & Dietetics
SC Oncology; Nutrition & Dietetics
GA BRR13
UT WOS:000283462100007
ER
PT J
AU Peters, SM
Yancy, H
Bremer, E
Monroe, J
Paul, D
Stubbs, JT
Myers, MJ
AF Peters, Sharla M.
Yancy, Haile
Bremer, Eric
Monroe, Jason
Paul, David
Stubbs, John T., III
Myers, Michael J.
TI In vitro identification and verification of inflammatory biomarkers in
swine
SO VETERINARY IMMUNOLOGY AND IMMUNOPATHOLOGY
LA English
DT Article
DE Inflammation; qRT-PCR; Microarray
ID PAS DOMAIN PROTEIN-1; MYCOBACTERIUM-TUBERCULOSIS; DENDRITIC CELL;
MONOCYTE DIFFERENTIATION; GENE-EXPRESSION; ACTIVATION; S100A12; CD1;
PATHWAYS; RECEPTOR
AB Currently there are no non-steroidal anti-inflammatory drugs (NSAIDs) approved for the control of inflammation in swine due to a lack of validated animal models and suitable biomarkers to assess drug efficacy. This study investigates the differential expression of genes altered in response to Escherichia coli lipopolysaccharide (LPS) induced inflammation which may serve as indicators of NSAID efficacy. Unstimulated whole blood from swine was mixed with tissue culture media, stimulated with LPS, and RNA extracted at the following time points Oh, 1 h, 3 h, 24 h and 48 h. Total RNA was extracted and analyzed using a commercial swine DNA microarray. The DNA microarray was utilized as a screen to determine potential biomarkers, focusing on the genes that exhibited the greatest degree of differential expression. A master list of 57 genes was formed based on the differential expression as a result of the stimulation. Following analysis, 12 genes whose expressions were significantly altered (8 up- and 4 down-regulated) were chosen for verification via quantitative RT-PCR (qRT-PCR). The qRT-PCR analysis confirmed the differential expression of 11 of the 12 genes chosen via the microarray analyses. Specifically, traditional genes such as SAA, G-CSF, and IL-10 were up-regulated, while CD4 was down-regulated; all of the genes were altered by 24 h or 48 h post-stimulation. We demonstrate here that expression of these 11 genes is altered as a direct result of LPS stimulation and consequently inflammation. Published by Elsevier B.V.
C1 [Peters, Sharla M.; Yancy, Haile; Myers, Michael J.] US FDA CVM, Laurel, MD 20708 USA.
[Peters, Sharla M.; Stubbs, John T., III] Howard Univ, Dept Microbiol, Washington, DC 20059 USA.
[Bremer, Eric; Monroe, Jason; Paul, David] Precis Biomarker Resources, Evanston, IL 60201 USA.
RP Myers, MJ (reprint author), US FDA CVM, 8401 Muirkirk Rd, Laurel, MD 20708 USA.
EM michael.myers@fda.hhs.gov
NR 28
TC 4
Z9 4
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0165-2427
J9 VET IMMUNOL IMMUNOP
JI Vet. Immunol. Immunopathol.
PD JAN
PY 2011
VL 139
IS 1
BP 67
EP 72
DI 10.1016/j.vetimm.2010.08.001
PG 6
WC Immunology; Veterinary Sciences
SC Immunology; Veterinary Sciences
GA 715DK
UT WOS:000286860400009
PM 20828834
ER
PT J
AU Johnson, TJ
Thorsness, JL
Anderson, CP
Lynne, AM
Foley, SL
Han, J
Fricke, WF
McDermott, PF
White, DG
Khatri, M
Stell, AL
Flores, C
Singer, RS
AF Johnson, Timothy J.
Thorsness, Jessica L.
Anderson, Cole P.
Lynne, Aaron M.
Foley, Steven L.
Han, Jing
Fricke, W. Florian
McDermott, Patrick F.
White, David G.
Khatri, Mahesh
Stell, Adam L.
Flores, Cristian
Singer, Randall S.
TI Horizontal Gene Transfer of a ColV Plasmid Has Resulted in a Dominant
Avian Clonal Type of Salmonella enterica Serovar Kentucky
SO PLOS ONE
LA English
DT Article
ID PATHOGENIC ESCHERICHIA-COLI; ANTIMICROBIAL RESISTANCE; VIRULENCE
PLASMIDS; DNA-SEQUENCE; PREVALENCE; STRAINS; CHICKENS; POULTRY;
IMMUNOGENICITY; COLONIZATION
AB Salmonella enterica continues to be a significant cause of foodborne gastrointestinal illness in humans. A wide variety of Salmonella serovars have been isolated from production birds and from retail poultry meat. Recently, though, S. enterica subsp. enterica serovar Kentucky has emerged as one of the prominent Salmonella serovars isolated from broiler chickens. Recent work suggests that its emergence apparently coincides with its acquisition of a ColV virulence plasmid. In the present study, we examined 902 Salmonella isolates belonging to 59 different serovars for the presence of this plasmid. Of the serovars examined, the ColV plasmid was found only among isolates belonging to the serovars Kentucky (72.9%), Typhimurium (15.0%) and Heidelberg (1.7%). We demonstrated that a single PFGE clonal type of S. Kentucky harbors this plasmid, and acquisition of this plasmid by S. Kentucky significantly increased its ability to colonize the chicken cecum and cause extraintestinal disease. Comparison of the completed sequences of three ColV plasmids from S. Kentucky isolated from different geographical locales, timepoints and sources revealed a nearly identical genetic structure with few single nucleotide changes or insertions/deletions. Overall, it appears that the ColV plasmid was recently acquired by a single clonal type S. Kentucky and confers to its host enhanced colonization and fitness capabilities. Thus, the potential for horizontal gene transfer of virulence and fitness factors to Salmonella from other enteric bacteria exists in poultry, representing a potential human health hazard.
C1 [Johnson, Timothy J.; Thorsness, Jessica L.; Khatri, Mahesh; Stell, Adam L.; Flores, Cristian; Singer, Randall S.] Univ Minnesota, Dept Vet & Biomed Sci, St Paul, MN 55108 USA.
[Anderson, Cole P.; Lynne, Aaron M.] Sam Houston State Univ, Dept Biol Sci, Huntsville, TX 77340 USA.
[Foley, Steven L.; Han, Jing] US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
[Fricke, W. Florian] Univ Maryland, Sch Med, Inst Genome Sci, Baltimore, MD 21201 USA.
[McDermott, Patrick F.; White, David G.] US FDA, Ctr Vet Med, Res Off, Div Anim & Food Microbiol, Laurel, MD USA.
RP Johnson, TJ (reprint author), Univ Minnesota, Dept Vet & Biomed Sci, St Paul, MN 55108 USA.
EM joh04207@umn.edu
FU Minnesota Agricultural Experiment Station [MINV-063-054]; Food Safety
Research and Response Network [2005-35212-15287]
FX This project was funded by the Minnesota Agricultural Experiment
Station, grant MINV-063-054 and by the Food Safety Research and Response
Network, which is supported by the National Research Initiative of the
United States Department of Agriculture Cooperative State Research,
Education and Extension Service, grant number # 2005-35212-15287. The
funders had no role in study design, data collection and analysis,
decision to publish, or preparation of the manuscript.
NR 46
TC 33
Z9 34
U1 0
U2 13
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD DEC 22
PY 2010
VL 5
IS 12
AR e15524
DI 10.1371/journal.pone.0015524
PG 10
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 698FG
UT WOS:000285578000033
PM 21203520
ER
PT J
AU Teferedegne, B
Murata, H
Quinones, M
Peden, K
Lewis, AM
AF Teferedegne, Belete
Murata, Haruhiko
Quinones, Mariam
Peden, Keith
Lewis, Andrew M., Jr.
TI Patterns of microRNA Expression in Non-Human Primate Cells Correlate
with Neoplastic Development In Vitro
SO PLOS ONE
LA English
DT Article
ID HUMAN BREAST-CANCER; HUMAN TUMOR-CELLS; DOWN-REGULATION; VERO CELLS;
MESENCHYMAL TRANSITION; EPITHELIAL-CELLS; NKG2D; METASTASIS;
TRANSFORMATION; PROGRESSION
AB MicroRNAs (miRNAs) are small noncoding RNAs that negatively regulate gene expression post-transcriptionally. They play a critical role in developmental and physiological processes and have been implicated in the pathogenesis of several diseases including cancer. To identify miRNA signatures associated with different stages of neoplastic development, we examined the expression profile of 776 primate miRNAs in VERO cells (a neoplastically transformed cell line being used for the manufacture of viral vaccines), progenitor primary African green monkey kidney (pAGMK) cells, and VERO cell derivatives: spontaneously immortalized, non-tumorigenic, low-passage VERO cells (10-87 LP); tumorigenic, high-passage VERO cells (10-87 HP); and a cell line (10-87 T) derived from a 10-87 HP cell tumor xenograft in athymic nude mice. When compared with pAGMK cells, the majority of miRNAs were expressed at lower levels in 10-87 LP, 10-87 HP, and 10-87 T cells. We identified 10 up-regulated miRNAs whose level of expression correlated with VERO cell evolution from a non-tumorigenic phenotype to a tumorigenic phenotype. The overexpression of miR-376a and the polycistronic cluster of miR-376a, miR-376b and miR-376c conferred phenotypic changes to the non-tumorigenic 10-87 LP cells that mimic the tumorigenic 10-87 HP cells. Thirty percent of miRNAs that were components of the identified miRNAs in our spontaneously transformed AGMK cell model are also dysregulated in a variety of human tumors. These results may prove to be relevant to the biology of neoplastic development. In addition, one or more of these miRNAs could be biomarkers for the expression of a tumorigenic phenotype.
C1 [Teferedegne, Belete; Murata, Haruhiko; Lewis, Andrew M., Jr.] US FDA, Lab DNA Viruses, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[Peden, Keith] US FDA, Lab Retrovirus Res, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[Quinones, Mariam] NIH, Bioinformat & Computat Biosci Branch, Bethesda, MD 20892 USA.
RP Teferedegne, B (reprint author), US FDA, Lab DNA Viruses, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
EM andrew.lewis@fda.hhs.gov
FU Division of Microbiology and Infectious Diseases (DMID); National
Institute of Allergy and Infectious Diseases (NIAID) through Biologics
Evaluation and Research (CBER); Food and Drug Administration (FDA)
FX This work is partially supported by a contract from the Division of
Microbiology and Infectious Diseases (DMID), National Institute of
Allergy and Infectious Diseases (NIAID) through an interagency agreement
with Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration (FDA). The funders had no role in study design, data
collection and analysis, decision to publish, or preparation of the
manuscript.
NR 78
TC 13
Z9 13
U1 0
U2 2
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 22
PY 2010
VL 5
IS 12
AR e14416
DI 10.1371/journal.pone.0014416
PG 12
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 698FG
UT WOS:000285578000017
PM 21203544
ER
PT J
AU Verthelyi, D
Wang, VV
AF Verthelyi, Daniela
Wang, Vivian
TI Trace Levels of Innate Immune Response Modulating Impurities (IIRMIs)
Synergize to Break Tolerance to Therapeutic Proteins
SO PLOS ONE
LA English
DT Article
ID TOLL-LIKE RECEPTORS; B-CELL ACTIVATION; CPG OLIGODEOXYNUCLEOTIDES;
DENDRITIC CELLS; BACTERIAL-DNA; IN-VIVO; MYD88-INDEPENDENT PATHWAYS;
VACCINE ADJUVANTS; GENE-EXPRESSION; LIPOPOLYSACCHARIDE
AB Therapeutic proteins such as monoclonal antibodies, replacement enzymes and toxins have significantly improved the therapeutic options for multiple diseases, including cancer and inflammatory diseases as well as enzyme deficiencies and inborn errors of metabolism. However, immune responses to these products are frequent and can seriously impact their safety and efficacy. Of the many factors that can impact protein immunogenicity, this study focuses on the role of innate immune response modulating impurities (IIRMIs) that could be present despite product purification and whether these impurities can synergize to facilitate an immunogenic response to therapeutic proteins. Using lipopolysaccharide (LPS) and CpG ODN as IIRMIs we showed that trace levels of these impurities synergized to induce IgM, IFN gamma, TNF alpha and IL-6 expression. In vivo, trace levels of these impurities synergized to increase antigen-specific IgG antibodies to ovalbumin. Further, whereas mice treated with human erythropoietin showed a transient increase in hematocrit, those that received human erythropoietin containing low levels of IIRMIs had reduced response to erythropoietin after the 1(st) dose and developed long-lasting anemia following subsequent doses. This suggests that the presence of IIRMIs facilitated a breach in tolerance to the endogenous mouse erythropoietin. Overall, these studies indicate that the risk of enhancing immunogenicity should be considered when establishing acceptance limits of IIRMIs for therapeutic proteins.
C1 [Verthelyi, Daniela; Wang, Vivian] US FDA, Div Therapeut Prot, Off Biotechnol Prod, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
RP Verthelyi, D (reprint author), US FDA, Div Therapeut Prot, Off Biotechnol Prod, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
EM daniela.verthelyi@fda.hhs.gov
NR 55
TC 13
Z9 13
U1 0
U2 5
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD DEC 22
PY 2010
VL 5
IS 12
AR e15252
DI 10.1371/journal.pone.0015252
PG 9
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 698FG
UT WOS:000285578000026
PM 21203556
ER
PT J
AU Jackson, RD
Gabriel, S
Pariser, A
Feig, P
AF Jackson, Rebecca D.
Gabriel, Sherine
Pariser, Anne
Feig, Peter
TI Training the Translational Scientist
SO SCIENCE TRANSLATIONAL MEDICINE
LA English
DT Editorial Material
AB A Clinical and Translational Science Awards Industry Forum titled "Promoting Efficient and Effective Collaborations Among Academia, Government, and Industry" was held in February 2010. A session at this forum was organized to address the training and skills needed to develop a biomedical scientific workforce that interfaces academia, government agencies, and industry to support the process of translating science into applicable means to improve health. By examining the requisite competencies and training resources for scientists in each of these sectors, opportunities for collaboration and adoption of new educational strategies were identified that could help to address barriers to translational research education and career development.
C1 [Jackson, Rebecca D.] Ohio State Univ, Ctr Clin & Translat Sci, Columbus, OH 43210 USA.
[Pariser, Anne] Food & Drug Adm, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Gabriel, Sherine] Mayo Clin, Off Strateg Alliance, Rochester, MN 55905 USA.
[Feig, Peter] Merck Res Labs, Rahway, NJ 07065 USA.
RP Jackson, RD (reprint author), Ohio State Univ, Ctr Clin & Translat Sci, Columbus, OH 43210 USA.
EM jackson.20@osu.edu
FU NCRR NIH HHS [UL1 RR025755]
NR 0
TC 4
Z9 4
U1 1
U2 5
PU AMER ASSOC ADVANCEMENT SCIENCE
PI WASHINGTON
PA 1200 NEW YORK AVE, NW, WASHINGTON, DC 20005 USA
SN 1946-6234
J9 SCI TRANSL MED
JI Sci. Transl. Med.
PD DEC 22
PY 2010
VL 2
IS 63
AR 63mr2
DI 10.1126/scitranslmed.3001632
PG 3
WC Cell Biology; Medicine, Research & Experimental
SC Cell Biology; Research & Experimental Medicine
GA 735UK
UT WOS:000288444900005
PM 21178132
ER
PT J
AU Kamikawa, TL
Mikolajczyk, MG
Kennedy, M
Zhang, P
Wang, W
Scott, DE
Alocilja, EC
AF Kamikawa, Tracy L.
Mikolajczyk, Malgorzata G.
Kennedy, Michael
Zhang, Pei
Wang, Wei
Scott, Dorothy E.
Alocilja, Evangelyn C.
TI Nanoparticle-based biosensor for the detection of emerging pandemic
influenza strains
SO BIOSENSORS & BIOELECTRONICS
LA English
DT Article; Proceedings Paper
CT World Congress on Biosensors
CY MAY 26-28, 2010
CL Scotland, ENGLAND
DE Influenza; Biosensor; Direct-charge transfer; Electrically active;
Immunomagnetic; Polyaniline
ID CHARGE TRANSFER BIOSENSOR; BACILLUS-ANTHRACIS SPORES;
MAGNETIC-PROPERTIES; POLYANILINE; VIRUS; ELECTRODES; SENSITIVITY;
BIOLOGY; HUMANS; ASSAY
AB Electrically active magnetic (EAM) nanoparticles, consisting of aniline monomer polymerized around gamma iron(III) oxide (gamma-Fe(2)O(3)) cores, serve as the basis of a direct-charge transfer biosensor developed for detection of surface glycoprotein hemagglutinin (HA) from the Influenza A virus (FLUAV) H5N1 (A/Vietnam/1203/04). H5N1 preferentially binds alpha 2,3-linked host glycan receptors. EAM nanoparticles were immunofunctionalized with antibodies against target HA. Glycans preincubated with HA in 10% mouse serum were incubated with anti-HA-EAM complexes. The anti-HA-EAM complexes effectively acted as immunomagnetic separator of HA from mouse serum matrix. EAM nanoparticles served as the biosensor transducer for cyclic voltammetry measurements. The polyaniline was made electrically active by hydrochloric acid doping. Experimental results indicate that the biosensor is able to detect recombinant H5 HA at 1.4 mu M in 10% mouse serum, with high specificity for H5 as compared to H1 (H1N1 A/South Carolina/1/18). This novel design applies EAM nanoparticles in a sensitive, specific, affordable, and easy-to-use biosensor with applications in disease monitoring and biosecurity. (C) 2010 Elsevier B.V. All rights reserved.
C1 [Kamikawa, Tracy L.; Alocilja, Evangelyn C.] Michigan State Univ, Dept Biosyst & Agr Engn, E Lansing, MI 48824 USA.
[Kamikawa, Tracy L.; Mikolajczyk, Malgorzata G.; Kennedy, Michael; Zhang, Pei; Scott, Dorothy E.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Wang, Wei] Michigan State Univ, Dept Crop & Soil Sci, E Lansing, MI 48824 USA.
RP Alocilja, EC (reprint author), Michigan State Univ, Dept Biosyst & Agr Engn, 115 Farrall Hall, E Lansing, MI 48824 USA.
EM alocilja@msu.edu
RI Wang, Wei/F-6555-2011
NR 44
TC 21
Z9 22
U1 3
U2 33
PU ELSEVIER ADVANCED TECHNOLOGY
PI OXFORD
PA OXFORD FULFILLMENT CENTRE THE BOULEVARD, LANGFORD LANE, KIDLINGTON,
OXFORD OX5 1GB, OXON, ENGLAND
SN 0956-5663
J9 BIOSENS BIOELECTRON
JI Biosens. Bioelectron.
PD DEC 15
PY 2010
VL 26
IS 4
SI SI
BP 1346
EP 1352
DI 10.1016/j.bios.2010.07.047
PG 7
WC Biophysics; Biotechnology & Applied Microbiology; Chemistry, Analytical;
Electrochemistry; Nanoscience & Nanotechnology
SC Biophysics; Biotechnology & Applied Microbiology; Chemistry;
Electrochemistry; Science & Technology - Other Topics
GA 708ZQ
UT WOS:000286403400030
PM 20729069
ER
PT J
AU Tong, WD
Fan, XH
AF Tong, Weida
Fan, Xiaohui
TI Statistical Evaluation of Clinical Usefulness of Microarrays for Cancer
Prognosis Needs to be Placed in the Context of Clinical Reality-Response
SO CLINICAL CANCER RESEARCH
LA English
DT Letter
ID VALIDATION
C1 [Tong, Weida] US FDA, Natl Ctr Toxicol Res, Ctr Bioinformat, Jefferson, AR 72079 USA.
[Fan, Xiaohui] Coll Pharmaceut Sci, Pharmaceut Informat Inst, Hangzhou, Zhejiang, Peoples R China.
RP Tong, WD (reprint author), US FDA, Natl Ctr Toxicol Res, Ctr Bioinformat, Jefferson, AR 72079 USA.
NR 7
TC 0
Z9 0
U1 0
U2 0
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD DEC 15
PY 2010
VL 16
IS 24
BP 6181
EP 6181
DI 10.1158/1078-0432.CCR-10-1921
PG 1
WC Oncology
SC Oncology
GA 695YJ
UT WOS:000285408600037
ER
PT J
AU Doerge, DR
Vanlandingham, M
Twaddle, NC
Delclos, KB
AF Doerge, Daniel R.
Vanlandingham, Michelle
Twaddle, Nathan C.
Delclos, K. Barry
TI Lactational transfer of bisphenol A in Sprague-Dawley rats
SO TOXICOLOGY LETTERS
LA English
DT Review
DE Bisphenol A; Lactation; Neonatal; Mass spectrometry
ID MEASURING ENVIRONMENTAL PHENOLS; TANDEM MASS-SPECTROMETRY;
LIQUID-CHROMATOGRAPHY; PERINATAL EXPOSURE; BREAST-MILK; FEMALE RATS;
PHARMACOKINETICS; DISPOSITION; METABOLISM; EXCRETION
AB Bisphenol A (BPA), an important industrial chemical to which humans are exposed on a daily basis, has long been associated with endocrine disruption in experimental animal models. Such exposures are of concern, particularly during fetal and early neonatal periods, because of greater vulnerability of developing organs to aberrant endocrine signaling. Although rarely reported, information about internal exposures to the receptor-active aglycone form of BPA during the perinatal period is essential to accurate assessment of potential risks. Lactating Sprague-Dawley dams were treated by daily gavage with 100 mu g/kg bw d6-BPA starting at birth. Conjugated and aglycone forms of BPA were then measured by using LC/MS/MS in milk from lactating dams on PND 7 and in serum from dams and their pups on PND 10. All samples were collected 1 h after dosing, a time selected to produce nearly maximal levels. While aglycone BPA was detected in all dam serum and milk samples, none was detected in pup serum (<0.2 nM). Doses delivered to pups lactationally, estimated from milk concentrations and body weights, were 300-fold lower than the dose administered to the dams. Similarly, serum concentrations of total BPA in pups were 300-fold lower than those in their dams. Furthermore, plasma concentrations of total BPA in PND 10 rat pups were 500-fold lower than peak levels achieved following direct oral delivery of the same dose to the same age pups. These findings of significant dose attenuation for the active aglycone form of BPA, relative to that of the dam, suggest high potency for toxicological effects derived exclusively from lactational transfer. Alternatively, studies that include lactational exposure and report minimal effects from BPA should consider the possibility that inadequate internal exposures were achieved during the critical postnatal period. Published by Elsevier Ireland Ltd.
C1 [Doerge, Daniel R.; Vanlandingham, Michelle; Twaddle, Nathan C.; Delclos, K. Barry] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Doerge, DR (reprint author), US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, 3900 NCRT Rd, Jefferson, AR 72079 USA.
EM daniel.doerge@fda.hhs.gov
FU NCTR/FDA [224-07-0007]; National Institute for Environmental Health
Sciences/National Toxicology Program [224-07-0007]
FX This research was supported in part by Interagency Agreement
#224-07-0007 between NCTR/FDA and the National Institute for
Environmental Health Sciences/National Toxicology Program. This document
has been reviewed in accordance with U.S. Food and Drug Administration
(FDA) policy and approved for publication. Approval does not signify
that the contents necessarily reflect the position or opinions of the
FDA nor does mention of trade names or commercial products constitute
endorsement or recommendation for use. The findings and conclusions in
this report are those of the authors and do not necessarily represent
the views of the FDA. The authors gratefully acknowledge helpful
discussions with Dr. M.L. Camacho, NCTR.
NR 36
TC 38
Z9 38
U1 1
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 DEC 15
PY 2010
VL 199
IS 3
BP 372
EP 376
DI 10.1016/j.toxlet.2010.09.022
PG 5
WC Toxicology
SC Toxicology
GA 694UT
UT WOS:000285325200022
PM 20933065
ER
PT J
AU Boehmer, JL
DeGrasse, JA
McFarland, MA
Tall, EA
Shefcheck, KJ
Ward, JL
Bannerman, DD
AF Boehmer, Jamie L.
DeGrasse, Jeffrey A.
McFarland, Melinda A.
Tall, Elizabeth A.
Shefcheck, Kevin J.
Ward, Jeffrey L.
Bannerman, Douglas D.
TI The proteomic advantage: Label-free quantification of proteins expressed
in bovine milk during experimentally induced coliform mastitis
SO VETERINARY IMMUNOLOGY AND IMMUNOPATHOLOGY
LA English
DT Article; Proceedings Paper
CT Annual Scientific Meeting on Cutting Edge Technologies - Animalomics/
Conference on Research Workers in Animal Diseases (CRWAD)
CY DEC 07-09, 2009
CL Chicago, IL
SP Amer Assoc Vet Immunologists
DE Bovine milk proteome; Liquid chromatography/tandem mass spectrometry
(LC-MS/MS); Coliform mastitis; Label-free quantification
ID COMPLEMENT FRAGMENT C5A; INNATE IMMUNE-RESPONSES; SERUM AMYLOID-A;
HEAVY-CHAIN 4; MASS-SPECTROMETRY; ESCHERICHIA-COLI; INTRAMAMMARY
INFECTION; SHOTGUN PROTEOMICS; DAIRY-COWS; INFLAMMATORY CYTOKINES
AB Coliform mastitis remains a primary focus of dairy cattle disease research due in part to the lack of efficacious treatment options for the deleterious side effects of exposure to LPS, including profound intra-mammary inflammation. To facilitate new veterinary drug approvals, reliable biomarkers are needed to evaluate the efficacy of adjunctive therapies for the treatment of inflammation associated with coliform mastitis. Most attempts to characterize the host response to LPS, however, have been accomplished using ELISAs. Because a relatively limited number of bovine-specific antibodies are commercially available, reliance on antibodies can be very limiting for biomarker discovery. Conversely, proteomic approaches boast the capability to analyze an unlimited number of protein targets in a single experiment, independent of antibody availability. Liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS), a widely used proteomic strategy for the identification of proteins in complex mixtures, has gained popularity as a means to characterize proteins in various bovine milk fractions, both under normal physiological conditions as well as during clinical mastitis. The biological complexity of bovine milk has, however, precluded the complete annotation of the bovine milk proteome. Conventional approaches to reducing sample complexity, including fractionation and the removal of high abundance proteins, has improved proteome coverage, but the dynamic range of proteins present, and abundance of a relatively small number of proteins, continues to hinder comparative proteomic analyses of bovine milk. Nonetheless, advances in both liquid chromatography and mass spectrometry instrumentation, including nano-flow liquid chromatography (nano-LC), nano-spray ionization, and faster scanning speeds and ionization efficiency of mass spectrometers, have improved analyses of complex samples. In the current paper, we review the proteomic approaches used to conduct comparative analyses of milk from healthy cows and cows with clinical mastitis, as well as proteins related to the host response that have been identified in mastitic milk. Additionally, we present data that suggests the potential utility of LC-MS/MS label-free quantification as an alternative to costly labeling strategies for the relative quantification of individual proteins in complex mixtures. Temporal expression patterns generated using spectral counts, an LC-MS/MS label-free quantification strategy, corresponded well with ELISA data for acute phase proteins with commercially available antibodies. Combined, the capability to identify low abundance proteins, and the potential to generate temporal expression profiles, indicate the advantages of using proteomics as a screening tool in biomarker discovery analyses to assess biologically relevant proteins modulated during disease, including previously uncharacterized targets. Published by Elsevier B.V.
C1 [Boehmer, Jamie L.; Tall, Elizabeth A.; Ward, Jeffrey L.] US FDA, Ctr Vet Med, Laurel, MD 20708 USA.
[DeGrasse, Jeffrey A.; McFarland, Melinda A.; Shefcheck, Kevin J.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Bannerman, Douglas D.] USDA ARS, Bovine Funct Genom Lab, Beltsville, MD 20705 USA.
RP Boehmer, JL (reprint author), US FDA, Ctr Vet Med, 8401 Muirkirk Rd, Laurel, MD 20708 USA.
EM jamie.boehmer@fda.hhs.gov
RI McFarland, Melinda/A-1866-2013; DeGrasse, Jeffrey/J-1151-2014
OI DeGrasse, Jeffrey/0000-0003-3178-6301
NR 63
TC 30
Z9 31
U1 2
U2 17
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0165-2427
J9 VET IMMUNOL IMMUNOP
JI Vet. Immunol. Immunopathol.
PD DEC 15
PY 2010
VL 138
IS 4
SI SI
BP 252
EP 266
DI 10.1016/j.vetimm.2010.10.004
PG 15
WC Immunology; Veterinary Sciences
SC Immunology; Veterinary Sciences
GA 697QX
UT WOS:000285531500003
PM 21067814
ER
PT J
AU Kutanzi, KR
Koturbash, I
Bronson, RT
Pogribny, IP
Kovalchuk, O
AF Kutanzi, Kristy R.
Koturbash, Igor
Bronson, Roderick T.
Pogribny, Igor P.
Kovalchuk, Olga
TI Imbalance between apoptosis and cell proliferation during early stages
of mammary gland carcinogenesis in ACI rats
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE Cell proliferation; Breast carcinogenesis; Estrogen; Ionizing radiation;
Apoptosis; p53
ID BREAST-CANCER; EPITHELIAL-CELLS; P53 PATHWAY; C-MYC; MDM2; DEATH;
GENOME; OVEREXPRESSION; TRANSFORMATION; INSTABILITY
AB Estrogen and ionizing radiation are well-documented human breast carcinogens yet the exact mechanisms of their deleterious effects on mammary gland remain to be discerned Here we analyze the balance between cellular proliferation and apoptosis in the mammary glands of rats exposed to estrogen and X-ray radiation and the combined action of these carcinogenic agents
For the first time we show that combined exposure to estrogen and radiation has a synergistic effect on cell proliferation in the mammary glands of ACI rats as evidenced by a substantially greater magnitude of cell proliferation especially after 12 and 18 weeks of treatment when compared to mammary glands of rats exposed to estrogen or radiation alone We also demonstrate that an Imbalance between cell proliferation and apoptosis rather than enhanced cell proliferation or apoptosis suppression alone may be a driving force for carcinogenesis Our studies further suggest that compromised functional activity of p53 may be one of the mechanisms responsible for the proliferation/apoptosis imbalance
In sum the results of our study indicate that evaluation of the extent of cell proliferation and apoptosis before the onset of preneoplastic lesions may be a potential biomarker of breast cancer risk after exposure to breast carcinogens (C) 2010 Elsevier B V All rights reserved
C1 [Pogribny, Igor P.] Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
[Kutanzi, Kristy R.; Koturbash, Igor; Kovalchuk, Olga] Univ Lethbridge, Dept Biol Sci, Lethbridge, AB T1K 3M4, Canada.
[Bronson, Roderick T.] Harvard Univ, Sch Med, Dept Pathol, Boston, MA 02115 USA.
RP Pogribny, IP (reprint author), Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
FU Alberta Cancer Research Institute; Canadian Breast Cancer Foundation;
Vanier Canada Graduate Scholarship; National Science and Engineering
Research Council; Queen Elizabeth II Graduate Scholarship; Alberta
Heritage for Medical Research Scholarship
FX Work was supported by the Alberta Cancer Research Institute and Canadian
Breast Cancer Foundation Operating grants to Olga Kovalchuk Kristy
Kutanzi is a recipient of the Vanier Canada Graduate Scholarship
National Science and Engineering Research Council Graduate Scholarship,
Queen Elizabeth II Graduate Scholarship and the Alberta Heritage for
Medical Research Scholarship We are thankful to Rocio Rodriguez-Juarez
for technical assistance and to Dr Valentina Titova for careful
proofreading of this manuscript
NR 36
TC 2
Z9 3
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD DEC 10
PY 2010
VL 694
IS 1-2
BP 1
EP 6
DI 10.1016/j.mrfmmm.2010.07.006
PG 6
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 699MQ
UT WOS:000285667900001
PM 20659487
ER
PT J
AU Smoker, M
Tran, K
Smith, RE
AF Smoker, Michael
Tran, Kevin
Smith, Robert E.
TI Determination of Polycyclic Aromatic Hydrocarbons (PAHs) in Shrimp
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE PAHs; PhotoSpray; LC-MS/MS; shrimp
ID ATMOSPHERIC-PRESSURE PHOTOIONIZATION; MASS-SPECTROMETRY;
LIQUID-CHROMATOGRAPHY; IONIZATION; FLOW
AB A simple and rapid method for determining polycyclic aromatic hydrocarbons (PAHs) in shrimp is described. For sample preparation, the quick and simple QuEChERS procedure was used. Reverse-phase chromatography using an octadecyl silica (C(18)) column and water/acetonitrile gradient elution was used to separate analyte mixtures. After separation, PAHs were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS) equipped with the atmospheric pressure photoionization (PhotoSpray APPI) source operating in the positive-ion mode. In this methodology, all 16 common PAHs were used and toluene served as a charged dopant to efficiently ionize analyte molecules through secondary reactions. Spikes were performed at 0.2 and 1 mu g/g with and without primary and secondary amine (PSA) sorbent cleanup. Recoveries of PAHs were good, with ion ratios that agreed well between the spikes and standards. Without cleanup at 0.2 mu g/mL, seven compounds had relatively low recovery (49-69%) and one compound, naphthalene, had a somewhat high recovery of 129%. At 1 mu g/mL without cleanup, only three compounds had slightly lower recovery (66--67%). When PSA cleanup was performed, all PAH recoveries were within 75-125% at both spike levels.
C1 [Smoker, Michael; Tran, Kevin; Smith, Robert E.] US FDA, Total Diet & Pesticide Res Ctr, Lenexa, KS 66214 USA.
RP Smith, RE (reprint author), US FDA, Total Diet & Pesticide Res Ctr, 11630 W 80th St, Lenexa, KS 66214 USA.
EM robert.smith@fda.hhs.gov
NR 14
TC 28
Z9 28
U1 1
U2 47
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD DEC 8
PY 2010
VL 58
IS 23
BP 12101
EP 12104
DI 10.1021/jf1029652
PG 4
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 686BW
UT WOS:000284672800006
PM 21062062
ER
PT J
AU Kainz, W
Guag, J
Benkler, S
Szczerba, D
Neufeld, E
Krauthamer, V
Myklebust, J
Bassen, H
Chang, I
Chavannes, N
Kim, JH
Sarntinoranont, M
Kuster, N
AF Kainz, W.
Guag, J.
Benkler, S.
Szczerba, D.
Neufeld, E.
Krauthamer, V.
Myklebust, J.
Bassen, H.
Chang, I.
Chavannes, N.
Kim, J. H.
Sarntinoranont, M.
Kuster, N.
TI Development and validation of a magneto-hydrodynamic solver for blood
flow analysis
SO PHYSICS IN MEDICINE AND BIOLOGY
LA English
DT Article
ID FIELDS
AB The objective of this study was to develop a numerical solver to calculate the magneto-hydrodynamic (MHD) signal produced by a moving conductive liquid, i.e. blood flow in the great vessels of the heart, in a static magnetic field. We believe that this MHD signal is able to non-invasively characterize cardiac blood flow in order to supplement the present non-invasive techniques for the assessment of heart failure conditions. The MHD signal can be recorded on the electrocardiogram (ECG) while the subject is exposed to a strong static magnetic field. The MHD signal can only be measured indirectly as a combination of the heart's electrical signal and the MHD signal. The MHD signal itself is caused by induced electrical currents in the blood due to the moving of the blood in the magnetic field. To characterize and eventually optimize MHD measurements, we developed a MHD solver based on a finite element code. This code was validated against literature, experimental and analytical data. The validation of the MHD solver shows good agreement with all three reference values. Future studies will include the calculation of the MHD signals for anatomical models. We will vary the orientation of the static magnetic field to determine an optimized location for the measurement of the MHD blood flow signal.
C1 [Kainz, W.; Guag, J.; Krauthamer, V.; Myklebust, J.; Bassen, H.; Chang, I.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Benkler, S.; Chavannes, N.] Schmid & Partner Engn AG, Zurich, Switzerland.
[Szczerba, D.; Neufeld, E.; Kuster, N.] Fdn Res Informat Technol Soc ITIS, Zurich, Switzerland.
[Kim, J. H.; Sarntinoranont, M.] Univ Florida, Soft Tissue Mech & Drug Delivery Lab, Gainesville, FL 32611 USA.
RP Kainz, W (reprint author), US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
EM wolfgang.kainz@fda.hhs.gov
OI Myklebust, Joel/0000-0002-8709-9706
NR 10
TC 7
Z9 7
U1 1
U2 6
PU IOP PUBLISHING LTD
PI BRISTOL
PA TEMPLE CIRCUS, TEMPLE WAY, BRISTOL BS1 6BE, ENGLAND
SN 0031-9155
J9 PHYS MED BIOL
JI Phys. Med. Biol.
PD DEC 7
PY 2010
VL 55
IS 23
BP 7253
EP 7261
DI 10.1088/0031-9155/55/23/005
PG 9
WC Engineering, Biomedical; Radiology, Nuclear Medicine & Medical Imaging
SC Engineering; Radiology, Nuclear Medicine & Medical Imaging
GA 680UN
UT WOS:000284261000019
PM 21081822
ER
PT J
AU Hamburg, MA
AF Hamburg, Margaret A.
TI SHATTUCK LECTURE Innovation, Regulation, and the FDA
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Article
ID WOMEN
C1 US FDA, Off Commissioner, Silver Spring, MD 20993 USA.
RP Hamburg, MA (reprint author), US FDA, Off Commissioner, 10903 New Hampshire Ave,Bldg 1,Rm 2217, Silver Spring, MD 20993 USA.
EM margaret.hamburg@fda.hhs.gov
NR 12
TC 25
Z9 25
U1 0
U2 8
PU MASSACHUSETTS MEDICAL SOC
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD DEC 2
PY 2010
VL 363
IS 23
BP 2228
EP 2232
DI 10.1056/NEJMsa1007467
PG 5
WC Medicine, General & Internal
SC General & Internal Medicine
GA 688EP
UT WOS:000284832900010
PM 21121835
ER
PT J
AU Volpe, DA
AF Volpe, Donna A.
TI Application of Method Suitability for Drug Permeability Classification
SO AAPS JOURNAL
LA English
DT Review
DE artificial membranes; drug permeability; ex vivo perfusion; in situ
perfusion; in vitro cell monolayers; method suitability
ID IN-VITRO PERMEABILITY; INTESTINAL PERMEABILITY; CACO-2 MONOLAYERS;
ABSORPTION MODELS; CELL-CULTURES; RAT; TRANSPORT; PREDICTION;
VALIDATION; SYSTEM
AB Experimental models of permeability in animals, excised tissues, cell monolayers, and artificial membranes are important during drug discovery and development as permeability is one of several factors affecting the intestinal absorption of oral drug products. The utility of these models is demonstrated by their ability to predict a drug's in vivo intestinal absorption. Within the various permeability models, there are differences in the performance of the assays, along with variability in animal species, tissue sources, and cell types, resulting in a variety of experimental permeability values for the same drug among laboratories. This has led to a need for assay standardization within laboratories to ensure applicability in the drug development process. Method suitability provides a generalized approach to standardize and validate a permeability model within a laboratory. First, assay methodology is optimized and validated for its various experimental parameters along with acceptance criteria for the assay. Second, the suitability of the model is demonstrated by a rank order relationship between experimental permeability values and human extent of absorption of known model compounds. Lastly, standard compounds are employed to classify a test drug's intestinal permeability and ensure assay reproducibility and quality. This review will provide examples of the different aspects method suitability for in situ (intestinal perfusions), ex vivo (everted intestinal sacs, diffusion chambers), and in vitro (cell monolayers, artificial membranes) experimental permeability models. Through assay standardization, reference standards, and acceptance criteria, method suitability assures the dependability of experimental data to predict a drug's intestinal permeability during discovery, development, and regulatory application.
C1 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 61
TC 27
Z9 28
U1 1
U2 18
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1550-7416
J9 AAPS J
JI AAPS J.
PD DEC
PY 2010
VL 12
IS 4
BP 670
EP 678
DI 10.1208/s12248-010-9227-8
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 735OF
UT WOS:000288426100020
PM 20811966
ER
PT J
AU Nagavelli, LR
Lionberger, RA
Sayeed, VA
Yu, L
Allgire, J
Smith, A
Wokovich, A
Westenberger, BJ
Buhse, L
AF Nagavelli, Laxma R.
Lionberger, Robert A.
Sayeed, Vilayat A.
Yu, Lawrence
Allgire, James
Smith, Anjanette
Wokovich, Anna
Westenberger, Benjamin J.
Buhse, Lucinda
TI Analysis of Bead Sizes for MR Capsules Labeled for Sprinkle
SO AAPS PHARMSCITECH
LA English
DT Article
DE bead size; generic drugs; modified-release capsules; quality target
product profile; sprinkle
ID NATURAL FOODS; MASTICATION
AB The bead sizes used in approved modified release capsules labeled for sprinkling on food was investigated to generate bead size guidelines for generic products labeled for sprinkling. The conclusions from a survey of FDA databases were corroborated with experimental data obtained by measuring the bead sizes of several reference-listed drugs on the market labeled for administration by sprinkling on food. The experimental data show that majority of the marketed products were found to have bead sizes of less than 1,500 mu m (1.5 mm). Based on this information, a bead size of less than 1,500 mu m should generally be considered acceptable for use in generic products labeled for sprinkling.
C1 [Nagavelli, Laxma R.; Lionberger, Robert A.; Sayeed, Vilayat A.; Yu, Lawrence] US FDA, Off Gener Drugs, Off Pharmaceut Sci, Rockville, MD 20855 USA.
[Allgire, James; Smith, Anjanette; Wokovich, Anna; Westenberger, Benjamin J.; Buhse, Lucinda] US FDA, Div Pharmaceut Anal, Off Pharmaceut Sci, St Louis, MO 63101 USA.
RP Sayeed, VA (reprint author), US FDA, Off Gener Drugs, Off Pharmaceut Sci, 7500 Standish Pl, Rockville, MD 20855 USA.
EM Vilayat.sayeed@fda.hhs.gov
NR 9
TC 2
Z9 2
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1530-9932
J9 AAPS PHARMSCITECH
JI AAPS PharmSciTech
PD DEC
PY 2010
VL 11
IS 4
BP 1508
EP 1510
DI 10.1208/s12249-010-9529-2
PG 3
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 735PE
UT WOS:000288428600003
PM 20936439
ER
PT J
AU Kligfield, P
Green, CL
Mortara, J
Sager, P
Stockbridge, N
Li, M
Zhang, J
George, S
Rodriguez, I
Bloomfield, D
Krucoff, MW
AF Kligfield, Paul
Green, Cynthia L.
Mortara, Justin
Sager, Philip
Stockbridge, Norman
Li, Michael
Zhang, Joanne
George, Samuel
Rodriguez, Ignacio
Bloomfield, Daniel
Krucoff, Mitchell W.
TI The Cardiac Safety Research Consortium electrocardiogram warehouse:
Thorough QT database specifications and principles of use for algorithm
development and testing
SO AMERICAN HEART JOURNAL
LA English
DT Article
ID IDENTIFICATION; PROLONGATION; QT/QTC
AB This document examines the formation, structure, and principles guiding the use of electrocardiogram (ECG) data sets obtained during thorough QT studies that have been derived from the ECG Warehouse of the Cardiac Safety Research Consortium (CSRC). These principles are designed to preserve the fairness and public interest of access to these data, commensurate with the mission of the CSRC. The data sets comprise anonymized XML formatted digitized ECGs and descriptive variables from placebo and positive control arms of individual studies previously submitted on a proprietary basis to the US Food and Drug Administration by pharmaceutical sponsors. Sponsors permit the release of these studies into the public domain through the CSRC on behalf of the Food and Drug Administration's Critical Path Initiative and public health interest. For algorithm research protocols submitted to and approved by CSRC, unblinded "training" ECG data sets are provided for algorithm development and for initial evaluation, whereas separate blinded "testing" data sets are used for formal algorithm evaluation in cooperation with the CSRC according to methods detailed in this document. (Am Heart J 2010;160:1023-8.)
C1 [Kligfield, Paul] Weill Cornell Med Coll, Div Cardiol, Dept Med, New York, NY USA.
[Green, Cynthia L.; Krucoff, Mitchell W.] Duke Univ, Med Ctr, Durham, NC USA.
[Green, Cynthia L.; Krucoff, Mitchell W.] Duke Clin Res Inst, Durham, NC USA.
[Mortara, Justin] Mortara Instrument, Milwaukee, WI USA.
[Sager, Philip] Sager Consulting Partners, San Francisco, CA USA.
[Stockbridge, Norman; Li, Michael; Zhang, Joanne] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
[George, Samuel] NewCardio Inc, Santa Clara, CA USA.
[Rodriguez, Ignacio] Merck & Co Inc, Merck Res Labs, Rahway, NJ 07065 USA.
[Bloomfield, Daniel] Hoffmann La Roche Inc, Nutley, NJ 07110 USA.
RP Kligfield, P (reprint author), Weill Cornell Med Ctr, 525 E 68th St, New York, NY 10065 USA.
EM pkligfi@med.cornell.edu
FU Clinical and Translational Sciences Award [UL1 RR024128]
FX CLG was supported in part by a Clinical and Translational Sciences Award
Grant to Duke University (UL1 RR024128).
NR 9
TC 15
Z9 15
U1 0
U2 0
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0002-8703
J9 AM HEART J
JI Am. Heart J.
PD DEC
PY 2010
VL 160
IS 6
BP 1023
EP 1028
DI 10.1016/j.ahj.2010.09.002
PG 6
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 692WW
UT WOS:000285187600010
PM 21146653
ER
PT J
AU Brustkern, AM
Buhse, LF
Nasr, M
Al-Hakim, A
Keire, DA
AF Brustkern, Adam M.
Buhse, Lucinda F.
Nasr, Moheb
Al-Hakim, Ali
Keire, David A.
TI Characterization of Currently Marketed Heparin Products: Reversed-Phase
Ion-Pairing Liquid Chromatography Mass Spectrometry of Heparin Digests
SO ANALYTICAL CHEMISTRY
LA English
DT Article
ID OVERSULFATED CHONDROITIN SULFATE; ADVERSE CLINICAL EVENTS;
CAPILLARY-ELECTROPHORESIS; DISACCHARIDE COMPOSITION; OLIGOSACCHARIDES;
QUANTIFICATION; IDENTIFICATION; ISOMERS
AB Here we report results from the analyses by enzymatic digestion and reversed-phase ion pairing liquid chromatography mass spectrometry (RPIP-LC-MS) of active pharmaceutical ingredient (API) unfractionated heparins (UFHs) from six different manufacturers and one USP standard sample We employed a reverse phase ionpairing chromatography method using a C(18) column and hexylamine as the ion pairing reagent with acetonitrile gradient elution to separate disaccharides generated from the digestion of the heparins by lyase I and III (E C 4 2 2 7 and 4 2 2 8) before introduction into an ion-trap mass spectrometer by an electrospray ionization (ESI) interface Extracted ion chromatograms (EICs) were used to determine the relative abundance of the disaccharides by mass spectrometry Eight disaccharides were observed and a similar composition profile was observed from digests of 20 UFH samples The compositional profile determined from these experiments provides a measure of the norm and range of variation in "good" heparin to which future preparations can be compared Furthermore, the profile obtained in the RPIP-LC-MS assay is sensitive to the presence of the contaminant, oversulfated chondroitin sulfate A (OSCS), in heparin
C1 [Brustkern, Adam M.; Buhse, Lucinda F.; Keire, David A.] US FDA, Div Pharmaceut Anal, CDER, St Louis, MO 63101 USA.
[Nasr, Moheb; Al-Hakim, Ali] US FDA, Off New Drug Qual Assessment, CDER, Silver Spring, MD 20993 USA.
RP Keire, DA (reprint author), US FDA, Div Pharmaceut Anal, CDER, St Louis, MO 63101 USA.
NR 31
TC 32
Z9 35
U1 0
U2 17
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0003-2700
J9 ANAL CHEM
JI Anal. Chem.
PD DEC 1
PY 2010
VL 82
IS 23
BP 9865
EP 9870
DI 10.1021/ac102301j
PG 6
WC Chemistry, Analytical
SC Chemistry
GA 686AG
UT WOS:000284668600040
PM 21069966
ER
PT J
AU Lyn-Cook, BD
Mohammed, SI
Davis, C
Word, B
Haefele, A
Wang, HG
Hammons, G
AF Lyn-Cook, Beverly D.
Mohammed, Sulma I.
Davis, Cornelius
Word, Beverly
Haefele, Aaron
Wang, Honggang
Hammons, George
TI Gender Differences in Gemcitabine (Gemzar) Efficacy in Cancer Cells:
Effect of Indole-3-Carbinol
SO ANTICANCER RESEARCH
LA English
DT Article
DE Sex differences; pancreatic cancer; gemcitabine; indole-3-carbinol
ID FACTOR-KAPPA-B; PANCREATIC-CANCER; DNA METHYLATION; DIETARY
INDOLE-3-CARBINOL; DEOXYCYTIDINE KINASE; TRANSCRIPTION FACTOR;
RANDOMIZED-TRIAL; EXPRESSION; INHIBITION; CARCINOGENESIS
AB Pancreatic cancer has a poor prognosis, mainly due to lack of effective therapies. This study demonstrated the ability of dietary agent, indole-3-carbinol (I3C), to lower the LD50 of gemcitabine (Gemzar) in decreasing growth of both male (MiaPaca2) and female (SU86.86) pancreatic cancer cells. Female pancreatic cancer cells were more resistant to gemcitabine alone. Additionally, RT-PCR analysis of MiaPaca2 cells treated with I, 10 or 100 mu M of I3C showed that I3C reactivated the tumor suppressor gene p16INK4a in pancreatic cancer cells. Methylated-specific PCR analysis indicated that I3C demethylated the promoter region of p16INK4a, which was methylated in the untreated cancer cells. p16INK4a inactivation through promoter hypermethylation is considered an early event in pancreatic carcinogenesis. A positive control using 5-azacytidine also reactivated p16INK4a. This study demonstrated the potential of I3C, a possible nontoxic hypomethylating agent, combined with the anticancer agent, gemcitabine, to be a powerful strategy for treating pancreatic cancer.
C1 [Lyn-Cook, Beverly D.; Davis, Cornelius; Word, Beverly; Haefele, Aaron; Wang, Honggang; Hammons, George] US FDA, Off Regulatory Act, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Mohammed, Sulma I.] Purdue Univ, Canc Res Ctr, W Lafayette, IN 47907 USA.
RP Lyn-Cook, BD (reprint author), US FDA, Off Regulatory Act, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM Beverly.lyn-cook@fda.hhs.gov
NR 42
TC 5
Z9 5
U1 2
U2 5
PU INT INST ANTICANCER RESEARCH
PI ATHENS
PA EDITORIAL OFFICE 1ST KM KAPANDRITIOU-KALAMOU RD KAPANDRITI, PO BOX 22,
ATHENS 19014, GREECE
SN 0250-7005
J9 ANTICANCER RES
JI Anticancer Res.
PD DEC
PY 2010
VL 30
IS 12
BP 4907
EP 4913
PG 7
WC Oncology
SC Oncology
GA 717BV
UT WOS:000287018100016
PM 21187469
ER
PT J
AU Zhao, S
Young, SR
Tong, E
Abbott, JW
Womack, N
Friedman, SL
McDermott, PF
AF Zhao, S.
Young, S. R.
Tong, E.
Abbott, J. W.
Womack, N.
Friedman, S. L.
McDermott, P. F.
TI Antimicrobial Resistance of Campylobacter Isolates from Retail Meat in
the United States between 2002 and 2007
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID FIELD GEL-ELECTROPHORESIS; MACROLIDE RESISTANCE; JEJUNI INFECTIONS;
COLI; SALMONELLA; QUINOLONE; POULTRY; FLUOROQUINOLONE; SURVEILLANCE;
PREVALENCE
AB The emergence of antimicrobial resistance in Campylobacter spp. has been a growing public health concern globally. The objectives of this study were to determine the prevalence, antimicrobial susceptibility, and genetic relatedness of Campylobacter spp. recovered by the National Antimicrobial Resistance Monitoring System (NARMS) retail meat program. Retail meat samples (n = 24,566) from 10 U.S. states collected between 2002 and 2007, consisting of 6,138 chicken breast, 6,109 ground turkey, 6,171 ground beef, and 6,148 pork chop samples, were analyzed. A total of 2,258 Campylobacter jejuni, 925 Campylobacter coli, and 7 Campylobacter lari isolates were identified. Chicken breast samples showed the highest contamination rate (49.9%), followed by ground turkey (1.6%), whereas both pork chops and ground beef had <0.5% contamination. The most common resistance was to doxycycline/tetracycline (46.6%), followed by nalidixic acid (18.5%), ciprofloxacin (17.4%), azithromycin and erythromycin (2.8%), telithromycin (2.4%), clindamycin (2.2%), and gentamicin (<0.1%). In a subset of isolates tested, no resistance to meropenem and florfenicol was seen. C. coli isolates showed higher resistance rates to antimicrobials, with the exception of doxycycline/tetracycline, than those seen for C. jejuni. Pulsed-field gel electrophoresis (PFGE) fingerprinting resulted in 1,226 PFGE profiles among the 2,318 isolates, with many clones being widely dispersed throughout the 6-year sampling period.
C1 [Zhao, S.; Young, S. R.; Tong, E.; Abbott, J. W.; Womack, N.; Friedman, S. L.; McDermott, P. F.] US FDA, Res Off, CVM, Div Anim & Food Microbiol, Laurel, MD 20708 USA.
RP Zhao, S (reprint author), US FDA, Res Off, CVM, Div Anim & Food Microbiol, 8401 Muirkirk Rd, Laurel, MD 20708 USA.
EM shaohua.zhao@fda.hhs.gov
NR 38
TC 45
Z9 47
U1 0
U2 10
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD DEC
PY 2010
VL 76
IS 24
BP 7949
EP 7956
DI 10.1128/AEM.01297-10
PG 8
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 688VO
UT WOS:000284882800007
PM 20971875
ER
PT J
AU Savoie, N
Garofolo, F
van Amsterdam, P
Bansal, S
Beaver, C
Bedford, P
Booth, BP
Evans, C
Jemal, M
Lefebvre, M
de Silva, ALL
Lowes, S
Marini, JC
Masse, R
Mawer, L
Ormsby, E
Rocci, ML
Viswanathan, CT
Wakelin-Smith, J
Welink, J
White, JT
Woolf, E
AF Savoie, Natasha
Garofolo, Fabio
van Amsterdam, Peter
Bansal, Surendra
Beaver, Chris
Bedford, Patrick
Booth, Brian P.
Evans, Christopher
Jemal, Mohammed
Lefebvre, Marc
Lopes de Silva, Arthur Leonardo
Lowes, Steve
Marini, Joseph C.
Masse, Robert
Mawer, Louise
Ormsby, Eric
Rocci, Mario L., Jr.
Viswanathan, C. T.
Wakelin-Smith, Jason
Welink, Jan
White, Joleen T.
Woolf, Eric
TI 2010 White Paper on Recent Issues in Regulated Bioanalysis & Global
Harmonization of Bioanalytical Guidance
SO BIOANALYSIS
LA English
DT Article
ID VALIDATION GROUP WORKSHOP; LIGAND-BINDING ASSAYS; CALIBRATION;
RECOMMENDATIONS; FORUM
AB The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.
C1 [Savoie, Natasha; Garofolo, Fabio; Lefebvre, Marc] Algorithme Pharma Inc, Montreal, PQ H7V 4B3, Canada.
[van Amsterdam, Peter] Abbott Healthcare Prod BV, Weesp, Netherlands.
[Bansal, Surendra] Hoffmann La Roche Inc, Nutley, NJ 07110 USA.
[Bedford, Patrick; Ormsby, Eric] Hlth Canada TPD, Ottawa, ON, Canada.
[Booth, Brian P.; Viswanathan, C. T.] US FDA, CDER, Silver Spring, MD USA.
[Evans, Christopher] GlaxoSmithKline Inc, King Of Prussia, PA USA.
[Jemal, Mohammed; White, Joleen T.] Bristol Myers Squibb Co, Princeton, NJ USA.
[Lopes de Silva, Arthur Leonardo] ANVISA, Brasilia, DF, Brazil.
[Lowes, Steve] Advion BioServ Inc, Ithaca, NY USA.
[Marini, Joseph C.] Inc Johnson & Johnson, Centocor R&D, Radnor, PA USA.
[Masse, Robert] Anapharm PharmaNet, Quebec City, PQ, Canada.
[Mawer, Louise; Wakelin-Smith, Jason] Med & Healthcare Prod Regulatory Agcy, London, England.
[Rocci, Mario L., Jr.] ICON Dev Solut, Whitesboro, NY USA.
[Welink, Jan] Med Evaluat Board, The Hague, Netherlands.
[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
FU Anapharm; Cetero Research; Pharma Medica; Pharma Medica, PPD; Algorithme
Pharma; Alta Analytical Laboratory; PerkinElmer; AB Sciex; ICON; Waters;
Advion; Biovail; KCAS; ABC Labs; Maxxam; GYROS; ZefSci; Varian; Cedra;
Tandem Labs
FX Workshop sustaining sponsors: Anapharm, Cetero Research, Pharma Medica,
PPD, Algorithme Pharma, Alta Analytical Laboratory, PerkinElmer, AB
Sciex, ICON, Waters, Advion, Biovail Contract Research, KCAS, ABC Labs,
Maxxam, GYROS, ZefSci, Varian, Cedra, Tandem Labs.
NR 32
TC 68
Z9 70
U1 0
U2 3
PU FUTURE SCI LTD
PI LONDON
PA UNITED HOUSE, 2 ALBERT PL, LONDON, N3 1QB, ENGLAND
SN 1757-6180
J9 BIOANALYSIS
JI Bioanalysis
PD DEC
PY 2010
VL 2
IS 12
BP 1945
EP 1960
DI 10.4155/BIO.10.164
PG 16
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 695WQ
UT WOS:000285403700009
PM 21110739
ER
PT J
AU Hung, HMJ
Wang, SJ
AF Hung, H. M. James
Wang, Sue-Jane
TI Challenges to multiple testing in clinical trials
SO BIOMETRICAL JOURNAL
LA English
DT Article; Proceedings Paper
CT 6th International Conference on Multiple Comparison Procedures (MCP
2009)
CY MAR 24-27, 2009
CL Tokyo Univ Sci, Tokyo, JAPAN
HO Tokyo Univ Sci
DE Composite endpoint; Familywise; Non-inferiority; Sequentially rejective;
Studywise
ID SECONDARY END-POINTS; CLEAR STATISTICAL SIGNIFICANCE; REGULATORY
APPLICATIONS; IF
AB Multiple testing problems are complex in evaluating statistical evidence in pivotal clinical trials for regulatory applications. However, a common practice is to employ a general and rather simple multiple comparison procedure to handle the problems. Applying multiple comparison adjustments is to ensure proper control of type I error rates. However, in many practices, the emphasis of the type I error rate control often leads to a choice of a statistically valid multiple test procedure but the common sense is overlooked. The challenges begin with confusions in defining a relevant family of hypotheses for which the type I error rates need to be properly controlled. Multiple testing problems are in a wide variety, ranging from testing multiple doses and endpoints jointly, composite endpoint, non-inferiority and superiority, to studying time of onset of a treatment effect, and searching for minimum effective dose or a patient subgroup in which the treatment effect lies. To select a valid and sensible multiple test procedure, the first step should be to tailor the selection to the study questions and to the ultimate clinical decision tree. Then evaluation of statistical power performance should come in to play in the next step to fine tune the selected procedure.
C1 [Hung, H. M. James] US FDA, Div Biometr 1, OB OTS CDER, Silver Spring, MD 20993 USA.
[Wang, Sue-Jane] US FDA, Off Biostat, OTS CDER, Silver Spring, MD 20993 USA.
RP Hung, HMJ (reprint author), US FDA, Div Biometr 1, OB OTS CDER, 10903 New Hampshire Ave,HFD 710, Silver Spring, MD 20993 USA.
EM hsienming.hung@fda.hhs.gov
NR 20
TC 17
Z9 17
U1 3
U2 10
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 0323-3847
J9 BIOMETRICAL J
JI Biom. J.
PD DEC
PY 2010
VL 52
IS 6
SI SI
BP 747
EP 756
DI 10.1002/bimj.200900206
PG 10
WC Mathematical & Computational Biology; Statistics & Probability
SC Mathematical & Computational Biology; Mathematics
GA 693XO
UT WOS:000285258900005
ER
PT J
AU Wang, SJ
Hung, HMJ
O'Neill, RT
AF Wang, Sue-Jane
Hung, H. M. James
O'Neill, Robert T.
TI Impacts on type I error rate with inappropriate use of learn and confirm
in confirmatory adaptive design trials
SO BIOMETRICAL JOURNAL
LA English
DT Article; Proceedings Paper
CT 6th International Conference on Multiple Comparison Procedures (MCP
2009)
CY MAR 24-27, 2009
CL Tokyo Univ Sci, Tokyo, JAPAN
HO Tokyo Univ Sci
DE Adaptive design; Learn and confirm; Learning free type I error rate;
Studywise type I error rate
ID II/III CLINICAL-TRIALS; HYPOTHESES SELECTION; PREDICTIVE POWER; INTERIM
AB A two-stage adaptive design trial is a single trial that combines the learning data from stage 1 (or phase II) and the confirming data in stage 2 (or phase III) for formal statistical testing. We call it a "Learn and Confirm" trial. The studywise type I error rate remains to be at issue in a "Learn and Confirm" trial. For studying multiple doses or multiple enpdoints, a "Learn and Confirm" adaptive design can be more attractive than a fixed design approach. This is because intuitively the learning data in stage 1 should not be subjected to type I error scrutiny if there is no formal interim analysis performed and only an adaptive selection of design parameters is made at stage 1. In this work, we conclude from extensive simulation studies that the intuition is most often misleading. That is, regardless of whether or not there is a formal interim analysis for making an adaptive selection, the type I error rates are always at risk of inflation. Inappropriate use of any "Learn and Confirm" strategy should not be overlooked.
C1 [Wang, Sue-Jane; O'Neill, Robert T.] 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,HFD 700, Silver Spring, MD 20993 USA.
EM suejane.wang@fda.hhs.gov
NR 25
TC 10
Z9 11
U1 0
U2 4
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 0323-3847
J9 BIOMETRICAL J
JI Biom. J.
PD DEC
PY 2010
VL 52
IS 6
SI SI
BP 798
EP 810
DI 10.1002/bimj.200900207
PG 13
WC Mathematical & Computational Biology; Statistics & Probability
SC Mathematical & Computational Biology; Mathematics
GA 693XO
UT WOS:000285258900009
PM 21154897
ER
PT J
AU Westfall, PH
Troendle, JF
Pennello, G
AF Westfall, Peter H.
Troendle, James F.
Pennello, Gene
TI Multiple McNemar Tests
SO BIOMETRICS
LA English
DT Article
DE Bonferroni-Holm; Bootstrap; Discreteness; Exact tests; Multiple
comparisons; Postmarket surveillance; Predictive model
ID BOOTSTRAP
AB P>Methods for performing multiple tests of paired proportions are described. A broadly applicable method using McNemar's exact test and the exact distributions of all test statistics is developed; the method controls the familywise error rate in the strong sense under minimal assumptions. A closed form (not simulation-based) algorithm for carrying out the method is provided. A bootstrap alternative is developed to account for correlation structures. Operating characteristics of these and other methods are evaluated via a simulation study. Applications to multiple comparisons of predictive models for disease classification and to postmarket surveillance of adverse events are given.
C1 [Westfall, Peter H.] Texas Tech Univ, Area ISQS, Lubbock, TX 79409 USA.
[Troendle, James F.] Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, Biostat & Bioinformat Branch, Bethesda, MD 20892 USA.
[Pennello, Gene] US FDA, Epidemiol Branch, Ctr Devices & Radiol Hlth, HFZ 541, Rockville, MD 20850 USA.
RP Westfall, PH (reprint author), Texas Tech Univ, Area ISQS, Lubbock, TX 79409 USA.
EM peter.westfall@ttu.edu
FU NIH, NICHD
FX This research was supported in part by the Intramural Research Program
of the NIH, NICHD.
NR 20
TC 7
Z9 7
U1 2
U2 6
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0006-341X
J9 BIOMETRICS
JI Biometrics
PD DEC
PY 2010
VL 66
IS 4
BP 1185
EP 1191
DI 10.1111/j.1541-0420.2010.01408.x
PG 7
WC Biology; Mathematical & Computational Biology; Statistics & Probability
SC Life Sciences & Biomedicine - Other Topics; Mathematical & Computational
Biology; Mathematics
GA 693DN
UT WOS:000285204900020
PM 20345498
ER
PT J
AU Reutter, D
Schutzer, SE
Craft, CM
Fletcher, J
Fricke, FL
Holowachuk, SA
Johnson, RC
Keim, PS
Pearson, JL
Sibert, RW
Velsko, S
AF Reutter, Dennis
Schutzer, Steven E.
Craft, Charles M.
Fletcher, Jacqueline
Fricke, Frederick L.
Holowachuk, Scott A.
Johnson, Rudolph C.
Keim, Paul S.
Pearson, James L.
Sibert, Robert W.
Velsko, Steve
TI PLANNING FOR EXERCISES OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND
NUCLEAR (CBRN) FORENSIC CAPABILITIES
SO BIOSECURITY AND BIOTERRORISM-BIODEFENSE STRATEGY PRACTICE AND SCIENCE
LA English
DT Article
ID BIOTERRORISM; PREPAREDNESS; TOPOFF
AB A forensic capability to help identify perpetrators and exclude innocent people should be an integral part of a strategy against terrorist attacks. Exercises have been conducted to increase our preparedness and response capabilities to chemical, biological, radiological, and nuclear (CBRN) terrorist attacks. However, incorporating forensic components into these exercises has been deficient. CBRN investigations rely on forensic results, so the need to integrate a forensic component and forensics experts into comprehensive exercises is paramount. This article provides guidance for planning and executing exercises at local, state, federal, and international levels that test the effectiveness of forensic capabilities for CBRN threats. The guidelines presented here apply both to situations where forensics is only a component of a more general exercise and where forensics is the primary focus of the exercise.
C1 [Reutter, Dennis] Lawrence Livermore Natl Lab, Forens Sci Ctr, Livermore, CA 94551 USA.
[Schutzer, Steven E.] Univ Med & Dent New Jersey, New Jersey Med Sch, Dept Med, Newark, NJ 07103 USA.
[Craft, Charles M.] Sandia Natl Labs, Albuquerque, NM 87185 USA.
[Fletcher, Jacqueline] Oklahoma State Univ, Natl Inst Microbial Forens & Food & Agr Biosecur, Dept Entomol & Plant Pathol, Stillwater, OK 74078 USA.
[Fricke, Frederick L.] US FDA, Cincinnati, OH USA.
[Holowachuk, Scott A.] Def Res & Dev Canada, Dept Natl Def, Forens Grp, Operat Support Sect, Suffield, AB, Canada.
[Johnson, Rudolph C.] Ctr Dis Control & Prevent, Chem Terrorism Method Dev Grp, Div Sci Lab, Natl Ctr Environm Hlth, Atlanta, GA USA.
[Keim, Paul S.] No Arizona Univ, Flagstaff, AZ 86011 USA.
[Pearson, James L.] Virginia Dept Gen Serv, DCLS, Div Consolidated Lab Serv, Richmond, VA USA.
[Sibert, Robert W.] Dept Homeland Secur, Sci & Technol Directorate, Chem Forens Program, Washington, DC USA.
[Velsko, Steve] Lawrence Livermore Natl Lab, Global Secur Directorate, Livermore, CA USA.
RP Reutter, D (reprint author), Lawrence Livermore Natl Lab, Forens Sci Ctr, POB 808,L-091, Livermore, CA 94551 USA.
EM reutter1@llnl.gov
RI Keim, Paul/A-2269-2010
NR 10
TC 2
Z9 2
U1 3
U2 14
PU MARY ANN LIEBERT INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1538-7135
J9 BIOSECUR BIOTERROR
JI Biosecur. Bioterror.
PD DEC
PY 2010
VL 8
IS 4
BP 343
EP 355
DI 10.1089/bsp.2010.0023
PG 13
WC Public, Environmental & Occupational Health; International Relations
SC Public, Environmental & Occupational Health; International Relations
GA 692WO
UT WOS:000285186800006
PM 21142761
ER
PT J
AU Shao, Y
Liu, Y
Shao, C
Hu, J
Li, X
Li, F
Zhang, L
Zhao, D
Sun, L
Zhao, X
Kopecko, DJ
Kalvakolanu, DV
Li, Y
Xu, DQ
AF Shao, Y.
Liu, Y.
Shao, C.
Hu, J.
Li, X.
Li, F.
Zhang, L.
Zhao, D.
Sun, L.
Zhao, X.
Kopecko, D. J.
Kalvakolanu, D. V.
Li, Y.
Xu, D. Q.
TI Enhanced tumor suppression in vitro and in vivo by co-expression of
survivin-specific siRNA and wild-type p53 protein
SO CANCER GENE THERAPY
LA English
DT Article
DE prostate cancer; p53; survivin; siRNA
ID ACID-ACTIVATED REGULATOR; PROSTATE-CANCER; BREAST-CANCER;
DOWN-REGULATION; TRANSCRIPTIONAL REPRESSION; TARGETING SURVIVIN;
CELL-DEATH; IFN-BETA; AURORA-B; C-MYC
AB The development of malignant prostate cancer involves multiple genetic alterations. For example, alterations in both survivin and p53 are reported to have crucial roles in prostate cancer progression. However, little is known regarding the interrelationships between p53 and survivin in prostate cancer. Our data demonstrate that the expression of survivin is inversely correlated with that of wtp53 protein (r(s)-0.548) in prostate cancer and in normal prostate tissues. We have developed a therapeutic strategy, in which two antitumor factors, small interfering RNA-survivin and p53 protein, are co-expressed from the same plasmid, and have examined their effects on the growth of PC3, an androgen-independent prostate cancer cell line. When p53 was expressed along with a survivin-specific short hairpin RNA (shRNA), tumor cell proliferation was significantly suppressed and apoptosis occurred. In addition, this combination also abrogated the expression of downstream target molecules such as cyclin-dependent kinase 4 and c-Myc, while enhancing the expression of GRIM19. These changes in gene expression occurred distinctly in the presence of survivin-shRNA/wtp53 compared with control or single treatment groups. Intratumoral injection of the co-expressed construct inhibited the growth and survival of tumor xenografts in a nude mouse model. These studies revealed evidence of an interaction between p53 and survivin proteins plus a complex signaling network operating downstream of the wtp53-survivin pathway that actively controls tumor cell proliferation, survival and apoptosis. Cancer Gene Therapy (2010) 17, 844-854; doi: 10.1038/cgt.2010.41; published online 13 August 2010
C1 [Shao, Y.; Liu, Y.; Shao, C.; Li, X.; Li, F.; Zhang, L.; Zhao, D.; Sun, L.; Zhao, X.; Li, Y.] Jilin Univ, Dis Prevent & Treatment Res Ctr, Dept Pathophysiol, Norman Bethune Coll Med & Prostate, Changchun 130021, Peoples R China.
[Hu, J.] Univ Maryland, Sch Dent, Dept Oncol & Diagnost Sci, Baltimore, MD 21201 USA.
[Kopecko, D. J.; Xu, D. Q.] US FDA, Lab Enter & Sexually Transmitted Dis, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
[Kalvakolanu, D. V.] Univ Maryland, Sch Med, Dept Microbiol & Immunol, Greene Baum Canc Ctr,Mol Biol Program, Baltimore, MD 21201 USA.
RP Li, Y (reprint author), Jilin Univ, Dis Prevent & Treatment Res Ctr, Dept Pathophysiol, Norman Bethune Coll Med & Prostate, Changchun 130021, Peoples R China.
EM lyang@jlu.edu.cnor; deqi.xu@fda.hhs.gov
FU The Research Fund for the Doctoral Program of Higher Education China
[20070183012]; NIH [CA105005, CA78282]
FX This work was supported by 'The Research Fund for the Doctoral Program
of Higher Education China' in 2007. Grant 20070183012. We thank Dr
Ruijuan Gao, Tyler Bassett and Suqin Pan for providing valuable help and
technical support. DVK is supported by the NIH grants CA105005 and
CA78282.
NR 46
TC 9
Z9 11
U1 0
U2 8
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 0929-1903
J9 CANCER GENE THER
JI Cancer Gene Ther.
PD DEC
PY 2010
VL 17
IS 12
BP 844
EP 854
DI 10.1038/cgt.2010.41
PG 11
WC Biotechnology & Applied Microbiology; Oncology; Genetics & Heredity;
Medicine, Research & Experimental
SC Biotechnology & Applied Microbiology; Oncology; Genetics & Heredity;
Research & Experimental Medicine
GA 680EC
UT WOS:000284214200003
PM 20706288
ER
PT J
AU Kim, PW
Nambiar, S
AF Kim, Peter W.
Nambiar, Sumathi
TI Meta-Analysis of a Possible Signal of Increased Mortality Associated
with Cefepime Use Reply
SO CLINICAL INFECTIOUS DISEASES
LA English
DT Letter
C1 [Kim, Peter W.; Nambiar, Sumathi] US FDA, Ctr Drug Evaluat & Res, Off Antimicrobial Prod, Silver Spring, MD 20993 USA.
RP Kim, PW (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Antimicrobial Prod, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM peter.kim@fda.hhs.gov
NR 5
TC 1
Z9 1
U1 0
U2 0
PU UNIV CHICAGO PRESS
PI CHICAGO
PA 1427 E 60TH ST, CHICAGO, IL 60637-2954 USA
SN 1058-4838
J9 CLIN INFECT DIS
JI Clin. Infect. Dis.
PD DEC 1
PY 2010
VL 51
IS 11
BP 1351
EP 1352
PG 2
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 675RZ
UT WOS:000283850200025
ER
PT J
AU Lesko, LJ
Zineh, I
Huang, SM
AF Lesko, L. J.
Zineh, I.
Huang, S-M
TI What Is Clinical Utility and Why Should We Care?
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Editorial Material
ID PERSONALIZED MEDICINE; IMMINENT REALITY; DRUG DEVELOPMENT; ELUSIVE DREAM
C1 [Lesko, L. J.; Zineh, I.; Huang, S-M] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Lesko, LJ (reprint author), US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
EM lawrence.lesko@fda.hhs.gov; lssam.Zineh@fda.hhs.gov;
ShiewMei.Huang@fda.hhs.gov
NR 27
TC 37
Z9 39
U1 1
U2 4
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD DEC
PY 2010
VL 88
IS 6
BP 729
EP 733
DI 10.1038/clpt.2010.229
PG 5
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 684BR
UT WOS:000284522500001
PM 21081937
ER
PT J
AU Woodcock, J
AF Woodcock, J.
TI Assessing the Clinical Utility of Diagnostics Used in Drug Therapy
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Article
ID SURROGATE END-POINTS; COLORECTAL-CANCER; BIOMARKERS; QUANTITY; SURVIVAL;
QUALITY; LIFE
AB There is an ongoing debate over the evidentiary standards that should be applied for introduction of new diagnostics into routine clinical practice. Many call for evidence of "clinical utility," i.e., a positive impact on patient outcomes. A diagnostic, when used with a medicine, has clinical utility if it improves the outcomes of drug therapy. Improved outcomes may be defined broadly, including benefits, harm reduction, and patient-reported outcomes. Much of the controversy centers around the methods of demonstrating clinical utility. For instance, are randomized prospective trials the only acceptable source of data? Practically speaking, many sources of evidence-mechanistic, pharmacologic, and observational-can contribute to a finding of clinical utility, depending on the circumstances. Clinical utility is highly indication specific, and achieving it is dependent on good analytical and diagnostic test performance.
C1 US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Woodcock, J (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
EM janet.woodcock@fda.hhs.gov
NR 22
TC 36
Z9 38
U1 0
U2 3
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0009-9236
EI 1532-6535
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD DEC
PY 2010
VL 88
IS 6
BP 765
EP 773
DI 10.1038/clpt.2010.230
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 684BR
UT WOS:000284522500017
PM 20981005
ER
PT J
AU Temple, R
AF Temple, R.
TI Enrichment of Clinical Study Populations
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Article
ID CORONARY-HEART-DISEASE; BREAST-CANCER; FAILURE; SUPPRESSION; PREVENTION;
ENCAINIDE; MORTALITY; SURVIVAL; PLACEBO; EVENTS
AB Those who conduct clinical trials "enrich" study populations in a variety of ways in order to identify a population of patients in whom a drug effect, if present, is more likely to be demonstrable. The principal ways to do this are as follows: (i) practical enrichment, i.e., generally seeking to reduce noise (variability of measurement) and heterogeneity (by avoiding the enrollment of patients with other diseases and individuals in whom the disease disappears spontaneously), (ii) prognostic enrichment, i.e., finding patients who are likely to have the event of interest when enrolling for risk-reduction studies, and (iii) predictive enrichment, i.e., finding the individuals who are more likely to respond. Enrichment fits well into the growing interest in "individualization" of therapy but creates some tension with another trend, namely, the desire for "real-world studies" with less restrictive entry criteria and other requirements.
C1 US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
RP Temple, R (reprint author), US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
EM Robert.Temple@fda.hhs.gov
NR 15
TC 39
Z9 39
U1 0
U2 6
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD DEC
PY 2010
VL 88
IS 6
BP 774
EP 778
DI 10.1038/clpt.2010.233
PG 5
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 684BR
UT WOS:000284522500018
PM 20944560
ER
PT J
AU Brunelle, JK
Zhang, BL
AF Brunelle, Joslyn K.
Zhang, Baolin
TI Apoptosis assays for quantifying the bioactivity of anticancer drug
products
SO DRUG RESISTANCE UPDATES
LA English
DT Review
DE Anticancer drugs; Bioactivity assays; Caspases; FRET
ID INDEPENDENT CELL-DEATH; TUMOR-NECROSIS-FACTOR; BREAST-CANCER CELLS;
BCL-2 FAMILY; ALAMAR-BLUE; P53 PATHWAY; PROTEIN-S; THERAPY;
PHAGOCYTOSIS; RECEPTORS
AB The goal of cancer therapy is to kill cancer cells Many anticancer drugs are designed to kill cells by inducing apoptosis However the potency assays used for measuring the bioactivity of these products are generally cell viability assays which do not distinguish between cell death and growth inhibition There are a number of commercial assays available to measure apoptosis however many of these assays are not appropriate for use in high throughput screening formats preferred by Industry to measure drug activity also known as potency due to their inherent low robustness and/or high variability This review outlines the strengths and weaknesses of current apoptosis assays and highlights new promising assay developments for evaluation of anticancer therapeutics such as the design of fluorescent and luminescent constructs to be applied as caspase substrates Published by Elsevier Ltd
C1 [Brunelle, Joslyn K.; Zhang, Baolin] US FDA, Div Therapeut Prot, Off Biotechnol Prod, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Zhang, BL (reprint author), 29 Lincoln Dr,Bldg 29A,Rm 2A01,HFD 122, Bethesda, MD 20892 USA.
NR 68
TC 23
Z9 24
U1 0
U2 9
PU CHURCHILL LIVINGSTONE
PI EDINBURGH
PA JOURNAL PRODUCTION DEPT, ROBERT STEVENSON HOUSE, 1-3 BAXTERS PLACE,
LEITH WALK, EDINBURGH EH1 3AF, MIDLOTHIAN, SCOTLAND
SN 1368-7646
J9 DRUG RESIST UPDATE
JI Drug Resist. Update
PD DEC
PY 2010
VL 13
IS 6
BP 172
EP 179
DI 10.1016/j.drup.2010.09.001
PG 8
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 699LU
UT WOS:000285665700002
PM 20947411
ER
PT J
AU Diaz-Amigo, C
AF Diaz-Amigo, Carmen
TI Towards a Comprehensive Validation of ELISA Kits for Food Allergens:
Case 1-Egg
SO FOOD ANALYTICAL METHODS
LA English
DT Article; Proceedings Paper
CT 5th Workshop on Food Allergen Methodologies
CY MAY 11-14, 2008
CL Halifax, CANADA
DE Egg; Allergy; ELISA; Validation; Reference Material
ID EGG; PROTEINS
AB There are several enzyme-linked immunosorbent assay (ELISA) kits in the market that have been proven to be useful for the determination of egg in foods. However, inconsistent results that are obtained when different kits are used make the selection of one kit over another very difficult. Two different approaches were used to help understand why results vary among kits. Different kits were used to analyze spiked egg material [NIST reference material (RM) 8445] in wheat flour (raw ingredients) and cookies containing egg as an ingredient baked for different periods of time (processed food). These results were compared with immunoblotting using conjugated antibodies from the commercial kits to determine the antibody specificity and sample extraction efficiency. ELISA results can be difficult to compare because reporting units differ among kits. Results from both ELISA and immunoblotting are in agreement regarding the decreased detection of proteins in baked cookie extracts. Moreover, immunoblotting showed that this reduction is due to reduced protein content in these extracts. However, a properly selected extraction solution may help improve the solubility of certain egg proteins in processed foods. Harmonization of the reporting unit system along with the use of a common reference material is recommended as the path forward in the standardization of detection methods for food allergens. This would assist the end user in making an informed decision regarding the selection of the most appropriate kit for his or her purpose.
C1 US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Diaz-Amigo, C (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 8301 Muirkirk Rd, Laurel, MD 20708 USA.
EM carmen.westphal@fda.hhs.gov
NR 11
TC 13
Z9 14
U1 0
U2 7
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1936-9751
J9 FOOD ANAL METHOD
JI Food Anal. Meth.
PD DEC
PY 2010
VL 3
IS 4
SI SI
BP 344
EP 350
DI 10.1007/s12161-009-9094-z
PG 7
WC Food Science & Technology
SC Food Science & Technology
GA 680ST
UT WOS:000284255400009
ER
PT J
AU Diaz-Amigo, C
AF Diaz-Amigo, Carmen
TI Towards a Comprehensive Validation of ELISA Kits for Food Allergens.
Case 2-Milk
SO FOOD ANALYTICAL METHODS
LA English
DT Article; Proceedings Paper
CT 5th Workshop on Food Allergen Methodologies
CY MAY 11-14, 2008
CL Halifax, CANADA
DE Milk; Food Allergy; ELISA; Validation; Reference Material
ID COWS MILK ALLERGY; ANAPHYLAXIS; TOLERANCE; CHILDREN
AB Milk and milk derivatives are common ingredients in food products. Undeclared milk is one of the leading causes of recalls in many countries, including the USA, and cases of allergic reactions have been reported due to unexpected exposures. There are commercial enzyme-linked immunosorbent assay (ELISA) kits available to the food industry to comply with the law by ensuring label accuracy and to identify potential sources of cross-contact. These kits are also used by regulatory agencies as part of their compliance programs. However, none of the commercial ELISAs for milk have been validated. Performance of ELISA kits for food allergens is affected by matrix, food processing, and stability and solubility of target proteins, among others factors. The performance of different commercial kits for milk allergens was evaluated by comparing a standard [National Institute of Standards and Technology (NIST) SRM #1549] spiked in wheat flour. We also compared the effect of food processing on detectability of milk proteins from incurred peanut butter cookies baked at various times. Kits differed in their ability to detect heat-treated milk proteins in baked cookies. Immunoblots clearly showed differences in antibody specificities and in their ability to detect proteins in processed foods. Factors such as undefined antibody specificity and differences in sample extraction solutions, materials used for calibrators, and reporting units contribute to variability of results among test kits and, hence, to increased uncertainty regarding the most appropriate use of the kits. Moreover, the use of incurred vs. spiked samples may affect protein recovery and, therefore, jeopardize the quantitative nature of the kit.
C1 US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Diaz-Amigo, C (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 8301 Muirkirk Rd, Laurel, MD 20708 USA.
EM carmen.westphal@fda.hhs.gov
NR 9
TC 13
Z9 13
U1 0
U2 18
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1936-9751
J9 FOOD ANAL METHOD
JI Food Anal. Meth.
PD DEC
PY 2010
VL 3
IS 4
SI SI
BP 351
EP 356
DI 10.1007/s12161-009-9095-y
PG 6
WC Food Science & Technology
SC Food Science & Technology
GA 680ST
UT WOS:000284255400010
ER
PT J
AU Ravel, A
Davidson, VJ
Ruzante, JM
Fazil, A
AF Ravel, Andre
Davidson, Valerie J.
Ruzante, Juliana M.
Fazil, Aamir
TI Foodborne Proportion of Gastrointestinal Illness: Estimates from a
Canadian Expert Elicitation Survey
SO FOODBORNE PATHOGENS AND DISEASE
LA English
DT Article
ID UNITED-STATES; FOOD; INFECTIONS; DISEASE
AB The study used a structured expert elicitation survey to derive estimates of the foodborne attributable proportion for nine illnesses caused by enteric pathogens in Canada. It was based on a similar study conducted in the United States and focused on Campylobacter, Escherichia coli O157:H7, Listeria monocytogenes, nontyphoidal Salmonella enterica, Shigella spp., Vibrio spp., Yersinia enterocolitica, Cryptosporidium parvum, and Norwalk-like virus. For each pathogen, experts were asked to provide their best estimate and low and high limits for the proportion of foodborne illness relative to total cases. In addition, they provided background information with regard to food safety experience, including self-evaluated expertise for each pathogen on a 5-point scale. A snowball approach was used to identify 152 experts within Canada. The experts' background details were summarized using descriptive statistics. Factor analysis was used to determine whether the variability in best estimates was related to self-assessed level of expertise or other background information. Cluster analysis followed by beta function fitting was undertaken on best estimates from experts who self-evaluated their expertise 3 or higher. In parallel, Monte Carlo resampling was run using triangular distributions based on each expert's best estimate and its limits. Sixty-six experts encompassing various academic backgrounds, fields of expertise, and experiences relevant to food safety provided usable data. Considerable variation between experts in their estimated foodborne attributable proportions was observed over all diseases, without any relationship to the expert's background. Uncertainty about their estimate (measured by the low and high limits) varied between experts and between pathogens as well. Both cluster analysis and Monte Carlo resampling clearly indicated disagreement between experts for Campylobacter, E. coli O157, L. monocytogenes, Salmonella, Vibrio, and Y. enterocolitica. In the absence of more reliable estimates, the observed discrepancy between experts must be explored and understood before one can judge which opinion is the best.
C1 [Ravel, Andre] Publ Hlth Agcy Canada, Lab Foodborne Zoonoses, Fac Med Vet, St Hyacinthe, PQ J2S 2M1, Canada.
[Davidson, Valerie J.] Univ Guelph, Sch Engn, Guelph, ON N1G 2W1, Canada.
[Ruzante, Juliana M.] Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
[Fazil, Aamir] Publ Hlth Agcy Canada, Lab Foodborne Zoonoses, Guelph, ON, Canada.
RP Ravel, A (reprint author), Publ Hlth Agcy Canada, Lab Foodborne Zoonoses, Fac Med Vet, Pavillon Sante Publ Vet 3190,Rue Sicotte, St Hyacinthe, PQ J2S 2M1, Canada.
EM andre_ravel@phac-aspc.gc.ca
FU Natural Sciences and Engineering Research Council (NSERC) of Canada
FX The authors thank Sandra Hoffmann from Resources for the Future,
Washington DC, and Paul Fishbeck from Carnegie Mellon University,
Pittsburgh PA, for their advice and permission to use their survey tool.
The authors thank all experts helping build the expert list and those
answering the survey. The authors also thank Natalya Obushenko at the
Laboratory for Foodborne Zoonoses, Guelph ON, who participated in the
data analysis. Financial support from the Strategic Grants program of
the Natural Sciences and Engineering Research Council (NSERC) of Canada
to undertake this work is gratefully acknowledged.
NR 20
TC 17
Z9 17
U1 0
U2 6
PU MARY ANN LIEBERT INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1535-3141
J9 FOODBORNE PATHOG DIS
JI Foodborne Pathog. Dis.
PD DEC
PY 2010
VL 7
IS 12
BP 1463
EP 1472
DI 10.1089/fpd.2010.0582
PG 10
WC Food Science & Technology
SC Food Science & Technology
GA 688GH
UT WOS:000284837300004
PM 20704505
ER
PT J
AU Kaput, J
Evelo, CT
Perozzi, G
van Ommen, B
Cotton, R
AF Kaput, Jim
Evelo, Chris T.
Perozzi, Giuditta
van Ommen, Ben
Cotton, Richard
TI Connecting the Human Variome Project to nutrigenomics
SO GENES AND NUTRITION
LA English
DT Editorial Material
DE Nutrigenomics; Human Variome Project; Harmonization
ID COPY NUMBER VARIATION; DEVELOPING-COUNTRIES; GLOBAL HEALTH; HUMAN
GENOME; PARTICIPATORY RESEARCH; NUTRITIONAL GENOMICS; HUMAN-POPULATIONS;
GENETIC-VARIATION; GRAND CHALLENGES; DISEASE
AB Nutrigenomics is the science of analyzing and understanding gene-nutrient interactions, which because of the genetic heterogeneity, varying degrees of interaction among gene products, and the environmental diversity is a complex science. Although much knowledge of human diversity has been accumulated, estimates suggest that similar to 90% of genetic variation has not yet been characterized. Identification of the DNA sequence variants that contribute to nutrition-related disease risk is essential for developing a better understanding of the complex causes of disease in humans, including nutrition-related disease. The Human Variome Project (HVP; http://www.humanvariomeproject.org) is an international effort to systematically identify genes, their mutations, and their variants associated with phenotypic variability and indications of human disease or phenotype. Since nutrigenomic research uses genetic information in the design and analysis of experiments, the HVP is an essential collaborator for ongoing studies of gene-nutrient interactions. With the advent of next generation sequencing methodologies and the understanding of the undiscovered variation in human genomes, the nutrigenomic community will be generating novel sequence data and results. The guidelines and practices of the HVP can guide and harmonize these efforts.
C1 [Kaput, Jim] US FDA, Div Personalised Nutr & Med, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Evelo, Chris T.] Maastricht Univ, Dept Bioinformat BiGCaT, Maastricht, Netherlands.
[Perozzi, Giuditta] INRAN Natl Res Inst Food & Nutr, I-00178 Rome, Italy.
[van Ommen, Ben] TNO Qual Life, NL-3700 AJ Zeist, Netherlands.
[Cotton, Richard] Genom Disorders Res Ctr, Melbourne, Vic 3053, Australia.
RP Kaput, J (reprint author), US FDA, Div Personalised Nutr & Med, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM James.kaput@fda.hhs.gov
RI Evelo, Chris/D-2914-2009; Perozzi, Giuditta/A-7460-2016
OI Evelo, Chris/0000-0002-5301-3142; Perozzi, Giuditta/0000-0003-1755-6104
NR 72
TC 1
Z9 2
U1 0
U2 3
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1555-8932
J9 GENES NUTR
JI Genes Nutr.
PD DEC
PY 2010
VL 5
IS 4
BP 275
EP 283
DI 10.1007/s12263-010-0186-6
PG 9
WC Genetics & Heredity; Nutrition & Dietetics
SC Genetics & Heredity; Nutrition & Dietetics
GA 682SO
UT WOS:000284423500001
PM 28300226
ER
PT J
AU van Ommen, B
El-Sohemy, A
Hesketh, J
Kaput, J
Fenech, M
Evelo, CT
McArdle, HJ
Bouwman, J
Lietz, G
Mathers, JC
Fairweather-Tait, S
van Kranen, H
Elliott, R
Wopereis, S
Ferguson, LR
Meplan, C
Perozzi, G
Allen, L
Rivero, D
AF van Ommen, Ben
El-Sohemy, Ahmed
Hesketh, John
Kaput, Jim
Fenech, Michael
Evelo, Chris T.
McArdle, Harry J.
Bouwman, Jildau
Lietz, Georg
Mathers, John C.
Fairweather-Tait, Sue
van Kranen, Henk
Elliott, Ruan
Wopereis, Suzan
Ferguson, Lynnette R.
Meplan, Catherine
Perozzi, Giuditta
Allen, Lindsay
Rivero, Damariz
CA Micronutrient Genomics Project Wor
TI The Micronutrient Genomics Project: a community-driven knowledge base
for micronutrient research
SO GENES AND NUTRITION
LA English
DT Review
DE Micronutrient; Bioinformatics; Database; Genomics
ID BETA-CAROTENE; VITAMIN-A; STABLE-ISOTOPES; METABOLISM; RIBOFLAVIN;
FOLATE; DEFICIENCY; DATABASE; DISEASE; BIOLOGY
AB Micronutrients influence multiple metabolic pathways including oxidative and inflammatory processes. Optimum micronutrient supply is important for the maintenance of homeostasis in metabolism and, ultimately, for maintaining good health. With advances in systems biology and genomics technologies, it is becoming feasible to assess the activity of single and multiple micronutrients in their complete biological context. Existing research collects fragments of information, which are not stored systematically and are thus not optimally disseminated. The Micronutrient Genomics Project (MGP) was established as a community-driven project to facilitate the development of systematic capture, storage, management, analyses, and dissemination of data and knowledge generated by biological studies focused on micronutrient-genome interactions. Specifically, the MGP creates a public portal and open-source bioinformatics toolbox for all "omics" information and evaluation of micronutrient and health studies. The core of the project focuses on access to, and visualization of, genetic/genomic, transcriptomic, proteomic and metabolomic information related to micronutrients. For each micronutrient, an expert group is or will be established combining the various relevant areas (including genetics, nutrition, biochemistry, and epidemiology). Each expert group will (1) collect all available knowledge, (2) collaborate with bioinformatics teams towards constructing the pathways and biological networks, and (3) publish their findings on a regular basis. The project is coordinated in a transparent manner, regular meetings are organized and dissemination is arranged through tools, a toolbox web portal, a communications website and dedicated publications.
C1 [van Ommen, Ben; Bouwman, Jildau; Wopereis, Suzan] TNO Qual Life, NL-3700 AJ Zeist, Netherlands.
[El-Sohemy, Ahmed] Univ Toronto, Dept Nutr Sci, Toronto, ON M5S 3E2, Canada.
[Hesketh, John; Meplan, Catherine] Newcastle Univ, Sch Med, Inst Cell & Mol Biosci, Newcastle Upon Tyne NE2 4HH, Tyne & Wear, England.
[Kaput, Jim] US FDA, Div Personalized Nutr & Med, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Fenech, Michael] CSIRO Food & Nutr Sci, Adelaide Bc, SA 5000, Australia.
[Evelo, Chris T.] Maastricht Univ, Dept Bioinformat BiGCaT, Maastricht, Netherlands.
[McArdle, Harry J.] Univ Aberdeen, Rowett Inst Nutr & Hlth, Aberdeen AB21 9SB, Scotland.
[Lietz, Georg] Newcastle Univ, Human Nutr Res Ctr, Sch Agr Food & Rural Dev, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England.
[Mathers, John C.] Newcastle Univ, Inst Ageing & Hlth, Human Nutr Res Ctr, Newcastle Upon Tyne NE2 4HH, Tyne & Wear, England.
RP van Ommen, B (reprint author), TNO Qual Life, POB 360, NL-3700 AJ Zeist, Netherlands.
EM ben.vanommen@tno.nl; a.el.sohemy@utoronto.ca; j.e.hesketh@ncl.ac.uk;
james.kaput@fda.hhs.gov; chris.evelo@bigcat.unimaas.nl;
h.mcardle@abdn.ac.uk; jildau.bouwman@tno.nl; Georg.lietz@ncl.ac.uk;
john.mathers@newcastle.ac.uk; Catherine.meplan@ncl.ac.uk
RI Lietz, Georg/A-4084-2012; Fairweather-Tait, Susan/K-4251-2012; Evelo,
Chris/D-2914-2009; Perozzi, Giuditta/A-7460-2016;
OI Evelo, Chris/0000-0002-5301-3142; Perozzi, Giuditta/0000-0003-1755-6104;
Mathers, John/0000-0003-3406-3002; El-Sohemy, Ahmed/0000-0002-8877-6414
FU Canadian Institutes of Health Research (CIHR); Office of Biotechnology,
Genomics and Population Health of the Public Health Agency of Canada
(BGPH/PHAC); United States Food and Drug Administration (FDA); European
Nutrigenomics Organisation; Eurreca; Advanced Foods and Materials
Network (AFMNet)
FX Funding for the Vancouver planning workshop was provided by a Meetings,
Planning and Dissemination Grant from the Canadian Institutes of Health
Research (CIHR), as well as contributions from the Office of
Biotechnology, Genomics and Population Health of the Public Health
Agency of Canada (BGPH/PHAC), the United States Food and Drug
Administration (FDA), the European Nutrigenomics Organisation
(http://www.nugo.org), Eurreca (http://www.eurreca.org) and the Advanced
Foods and Materials Network (AFMNet). This work has been approved for
publication by the FDA but it does not necessarily reflect official
agency policy.
NR 48
TC 21
Z9 22
U1 0
U2 9
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1555-8932
J9 GENES NUTR
JI Genes Nutr.
PD DEC
PY 2010
VL 5
IS 4
BP 285
EP 296
DI 10.1007/s12263-010-0192-8
PG 12
WC Genetics & Heredity; Nutrition & Dietetics
SC Genetics & Heredity; Nutrition & Dietetics
GA 682SO
UT WOS:000284423500002
PM 21189865
ER
PT J
AU Miller, HI
AF Miller, Henry I.
TI Benighted EC Politicians Reject Food from Cloned Animals
SO GENETIC ENGINEERING & BIOTECHNOLOGY NEWS
LA English
DT Editorial Material
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.
EM henry.miller@stanford.edu
NR 0
TC 0
Z9 0
U1 0
U2 0
PU MARY ANN LIEBERT INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1935-472X
J9 GENET ENG BIOTECHN N
JI Genet. Eng. Biotechnol. News
PD DEC
PY 2010
VL 30
IS 21
BP 6
EP 8
PG 3
WC Biotechnology & Applied Microbiology; Genetics & Heredity
SC Biotechnology & Applied Microbiology; Genetics & Heredity
GA 693OU
UT WOS:000285234200001
ER
PT J
AU Kohonen-Corish, MRJ
Al-Aama, JY
Auerbach, AD
Axton, M
Barash, CI
Bernstein, I
Beroud, C
Burn, J
Cunningham, F
Cutting, GR
den Dunnen, JT
Greenblatt, MS
Kaput, J
Katz, M
Lindblom, A
Macrae, F
Maglott, D
Moslein, G
Povey, S
Ramesar, R
Richards, S
Seminara, D
Sobrido, MJ
Tavtigian, S
Taylor, G
Vihinen, M
Winship, I
Cotton, RGH
AF Kohonen-Corish, Maija R. J.
Al-Aama, Jumana Y.
Auerbach, Arleen D.
Axton, Myles
Barash, Carol Isaacson
Bernstein, Inge
Beroud, Christophe
Burn, John
Cunningham, Fiona
Cutting, Garry R.
den Dunnen, Johan T.
Greenblatt, Marc S.
Kaput, Jim
Katz, Michael
Lindblom, Annika
Macrae, Finlay
Maglott, Donna
Moeslein, Gabriela
Povey, Sue
Ramesar, Raj
Richards, Sue
Seminara, Daniela
Sobrido, Maria-Jesus
Tavtigian, Sean
Taylor, Graham
Vihinen, Mauno
Winship, Ingrid
Cotton, Richard G. H.
CA Contributors Human Variome Project
TI How to Catch All Those Mutations-The Report of the Third Human Variome
Project Meeting, UNESCO Paris, May 2010
SO HUMAN MUTATION
LA English
DT Editorial Material
DE mutation; variation; genomics; genetic disease
ID RECOMMENDATIONS
AB The third Human Variome Project (HVP) Meeting "Integration and Implementation" was held under UNESCO Patronage in Paris, France, at the UNESCO Headquarters May 10-14, 2010. The major aims of the HVP are the collection, curation, and distribution of all human genetic variation affecting health. The HVP has drawn together disparate groups, by country, gene of interest, and expertise, who are working for the common good with the shared goal of pushing the boundaries of the human variome and collaborating to avoid unnecessary duplication. The meeting addressed the 12 key areas that form the current framework of HVP activities: Ethics; Nomenclature and Standards; Publication, Credit and Incentives; Data Collection from Clinics; Overall Data Integration and Access-Peripheral Systems/Software; Data Collection from Laboratories; Assessment of Pathogenicity; Country Specific Collection; Translation to Healthcare and Personalized Medicine; Data Transfer, Databasing, and Curation; Overall Data Integration and Access-Central Systems; and Funding Mechanisms and Sustainability. In addition, three societies that support the goals and the mission of HVP also held their own Workshops with the view to advance disease-specific variation data collection and utilization: the International Society for Gastrointestinal Hereditary Tumours, the Micronutrient Genomics Project, and the Neurogenetics Consortium. Hum Mutat 31:1374-1381, 2010. (c) 2010 Wiley-Liss, Inc.
C1 [Kohonen-Corish, Maija R. J.] Univ NSW, St Vincents Clin Sch, Garvan Inst Med Res, Canc Res Program, Sydney, NSW 2010, Australia.
[Al-Aama, Jumana Y.] King Abdulaziz Univ, Dept Med Genet, Fac Med, Jeddah 21413, Saudi Arabia.
[Al-Aama, Jumana Y.] King Abdulaziz Univ, Princess Al Jawhara Ctr Excellence Res Hereditary, Jeddah 21413, Saudi Arabia.
[Auerbach, Arleen D.] Rockefeller Univ, Program Human Genet & Hematol, New York, NY 10021 USA.
[Axton, Myles] Nat Publishing Grp, New York, NY USA.
[Barash, Carol Isaacson] Boston Univ, Dept Philosophy Genet Eth & Policy Consulting, Boston, MA 02215 USA.
[Bernstein, Inge] Hvidovre Univ Hosp, Dept Surg Gastroenterol, Copenhagen, Denmark.
[Beroud, Christophe] Univ Montpellier 1, Hop Arnaud Villeneuve, Genet Mol Lab, INSERM,U827, Montpellier, France.
[Burn, John] Newcastle Univ, Inst Human Genet, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England.
[Cunningham, Fiona] EBI, Cambridge CB10 1SD, England.
[Cutting, Garry R.] Johns Hopkins Univ, Sch Med, Inst Med Genet, Baltimore, MD USA.
[den Dunnen, Johan T.] Leiden Univ, Med Ctr, Leiden, Netherlands.
[Greenblatt, Marc S.] Univ Vermont, Coll Med, Burlington, VT USA.
[Kaput, Jim] US FDA, Div Personalized Nutr & Med, Natl Ctr Toxicol Res, Jefferson, AR USA.
[Katz, Michael] March Dimes Fdn, White Plains, NY USA.
[Lindblom, Annika] Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden.
[Macrae, Finlay] Dept Colorectal Med & Genet, Parkville, Vic, Australia.
[Macrae, Finlay] Univ Melbourne, Royal Melbourne Hosp, Dept Med, Parkville, Vic, Australia.
[Maglott, Donna] NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20892 USA.
[Moeslein, Gabriela] HELIOS St Josefs Hosp, Bochum, Germany.
[Povey, Sue] UCL, Div Life Sci, London, England.
[Ramesar, Raj] Univ Cape Town, Inst Infect Dis & Mol Med, Div Human Genet, MRC Human Genet Res Unit, ZA-7700 Rondebosch, South Africa.
[Richards, Sue] Oregon Hlth & Sci Univ, Portland, OR 97201 USA.
[Seminara, Daniela] NCI, Bethesda, MD 20892 USA.
[Sobrido, Maria-Jesus] Inst Hlth Carlos III, Ctr Biomed Network Res Rare Disorders CIBERER, Fdn Publ Galega Med Xenom, Madrid, Spain.
[Tavtigian, Sean] Univ Utah, Sch Med, Huntsman Canc Inst, Dept Oncol Sci, Salt Lake City, UT USA.
[Taylor, Graham] St James Univ Hosp, Leeds, W Yorkshire, England.
[Vihinen, Mauno] Univ Tampere, Inst Med Technol, FIN-33101 Tampere, Finland.
[Vihinen, Mauno] Tampere Univ Hosp, Res Ctr, Tampere, Finland.
[Winship, Ingrid] Univ Melbourne, Royal Melbourne Hosp, Melbourne, Vic 3050, Australia.
[Cotton, Richard G. H.] Genom Disorders Res Ctr, Melbourne, Vic, Australia.
RP Kohonen-Corish, MRJ (reprint author), Univ NSW, St Vincents Clin Sch, Garvan Inst Med Res, Canc Res Program, 384 Victoria St, Sydney, NSW 2010, Australia.
EM m.corish@garvan.org.au
RI Ramesar, Raj/I-6941-2015; BEROUD, Christophe/A-8381-2008; Vihinen,
Mauno/A-8452-2012; LABO, U827/A-8632-2008
OI Ramesar, Raj/0000-0001-5688-1634; BEROUD,
Christophe/0000-0003-2986-8738; Axton, J. Myles/0000-0002-8042-4131;
Cunningham, Fiona/0000-0002-7445-2419; Auerbach,
Arleen/0000-0002-6911-8379; Winship, Ingrid/0000-0001-8535-6003;
Vihinen, Mauno/0000-0002-9614-7976;
FU NIDDK NIH HHS [R37 DK044003, R37 DK044003-21]
NR 7
TC 23
Z9 27
U1 0
U2 9
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1059-7794
J9 HUM MUTAT
JI Hum. Mutat.
PD DEC
PY 2010
VL 31
IS 12
BP 1374
EP 1381
DI 10.1002/humu.21379
PG 8
WC Genetics & Heredity
SC Genetics & Heredity
GA 693VG
UT WOS:000285252900015
PM 20960468
ER
PT J
AU Hillyer, P
Chen, A
Navarro, M
Schramm, LM
Mane, VP
Rabin, RL
AF Hillyer, P.
Chen, A.
Navarro, M.
Schramm, L. M.
Mane, V. P.
Rabin, R. L.
TI Respiratory syncytial virus (RSV) strain dependent differences in
induction of type I and III interferon subtypes and innate immune
responses
SO IMMUNOLOGY
LA English
DT Meeting Abstract
CT Annual Congress of the British-Society-for-Immunology
CY DEC 06-10, 2010
CL Liverpool, ENGLAND
SP British Soc Immunol
C1 [Hillyer, P.; Chen, A.; Navarro, M.; Schramm, L. M.; Mane, V. P.; Rabin, R. L.] USFDA, Ctr Biol Evaluat & Res, Lab Immunobiochem, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0019-2805
J9 IMMUNOLOGY
JI Immunology
PD DEC
PY 2010
VL 131
SU 1
BP 138
EP 138
PG 1
WC Immunology
SC Immunology
GA 689XL
UT WOS:000284964100453
ER
PT J
AU Belay, ED
Schonberger, LB
Brown, P
Priola, SA
Chesebro, B
Will, RG
Asher, DM
AF Belay, Ermias D.
Schonberger, Lawrence B.
Brown, Paul
Priola, Suzette A.
Chesebro, Bruce
Will, Robert G.
Asher, David M.
TI Disinfection and Sterilization of Prion-Contaminated Medical Instruments
SO INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
LA English
DT Letter
ID CREUTZFELDT-JAKOB-DISEASE; DECONTAMINATION; ENCEPHALOPATHIES;
TRANSMISSION; INFECTIVITY; STEEL
C1 [Belay, Ermias D.; Schonberger, Lawrence B.] Ctr Dis Control & Prevent, Atlanta, GA USA.
[Priola, Suzette A.; Chesebro, Bruce] NIH, Hamilton, MT USA.
[Asher, David M.] US FDA, Silver Spring, MD USA.
[Will, Robert G.] United Kingdom Natl Creutzfeldt Jakob Dis Surveil, Edinburgh, Midlothian, Scotland.
RP Belay, ED (reprint author), 1600 Clifton Rd, Atlanta, GA 30333 USA.
EM EBelay@cdc.gov
RI Belay, Ermias/A-8829-2013
NR 15
TC 5
Z9 5
U1 0
U2 7
PU UNIV CHICAGO PRESS
PI CHICAGO
PA 1427 E 60TH ST, CHICAGO, IL 60637-2954 USA
SN 0899-823X
J9 INFECT CONT HOSP EP
JI Infect. Control Hosp. Epidemiol.
PD DEC
PY 2010
VL 31
IS 12
BP 1304
EP 1306
DI 10.1086/657579
PG 3
WC Public, Environmental & Occupational Health; Infectious Diseases
SC Public, Environmental & Occupational Health; Infectious Diseases
GA 675PJ
UT WOS:000283842300018
PM 21047181
ER
PT J
AU Hoffmann, M
Fischer, M
Ottesen, A
McCarthy, PJ
Lopez, JV
Brown, EW
Monday, SR
AF Hoffmann, Maria
Fischer, Markus
Ottesen, Andrea
McCarthy, Peter J.
Lopez, Jose V.
Brown, Eric W.
Monday, Steven R.
TI Population dynamics of Vibrio spp. associated with marine sponge
microcosms
SO ISME JOURNAL
LA English
DT Article
DE 16S rRNA gene sequencing; 16S-23S rRNA intergenic spacer region; Phylum
Porifera; speciation; Vibrio
ID SEQUENCE DATA; ENVIRONMENT; ARB
AB Vibrio is a diverse genus of marine-associated bacteria with at least 74 species and more expected as additional marine ecospheres are interrogated. This report describes a phylogenetic reconstruction of Vibrio isolates derived from one such unique ecosystem, marine sponges (Phylum Porifera) collected from depths of 150 to 1242 feet. 16S rRNA gene sequencing along with molecular typing of 16S-23S rRNA intergenic spacer regions clustered many sponge-associated Vibrio (spp) with current known species. That is, several benthic Vibrio species commensal with Porifera sponges seemed genetically linked to vibrios associated with coastal or shallow-water communities, signalling a panmictic population structure among seemingly ecologically disparate strains. Conversely, phylogenetic analysis provided evidence for at least two novel Vibrio speciation events within this specific sponge microcosm. Collectively, these findings earmark this still relatively unknown environment as a bastion of taxonomic and phylogenetic variability for the genus and probably other bacterial taxa. The ISME Journal (2010) 4, 1608-1612; doi:10.1038/ismej.2010.85; published online 1 July 2010
C1 [Hoffmann, Maria; Ottesen, Andrea; Brown, Eric W.; Monday, Steven R.] US FDA, Div Microbiol, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Hoffmann, Maria; Fischer, Markus] Univ Hamburg, Dept Chem, Inst Food Chem, Hamburg, Germany.
[McCarthy, Peter J.] Florida Atlantic Univ, Ctr Marine Biomed & Biotechnol Res, Harbor Branch, Oceanog Inst, Ft Pierce, FL USA.
[Lopez, Jose V.] Nova SE Univ, Oceanog Ctr, Dania, FL USA.
RP Hoffmann, M (reprint author), US FDA, Div Microbiol, Ctr Food Safety & Appl Nutr, Mailstop HFS-711,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM maria.hoffman@fda.hhs.gov
RI Fischer, Markus/G-9477-2012;
OI McCarthy, Peter/0000-0002-2396-7463; Lopez, Jose/0000-0002-1637-4125
FU Center for Food Safety and Applied Nutrition
FX We would like to thank Marianna Naum for her assistance with the maximum
likelihood analyses. This project was supported by an appointment of MH
to the Research Fellowship Program for the Center for Food Safety and
Applied Nutrition administered by the Oak Ridge Associated Universities.
This work denotes HBOI contribution number 1805.
NR 20
TC 11
Z9 11
U1 1
U2 6
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 75 VARICK ST, 9TH FLR, NEW YORK, NY 10013-1917 USA
SN 1751-7362
J9 ISME J
JI ISME J.
PD DEC
PY 2010
VL 4
IS 12
BP 1608
EP 1612
DI 10.1038/ismej.2010.85
PG 5
WC Ecology; Microbiology
SC Environmental Sciences & Ecology; Microbiology
GA 701SW
UT WOS:000285844700012
PM 20596073
ER
PT J
AU Boyce, JA
Assa'ad, A
Burks, AW
Jones, SM
Sampson, HA
Wood, RA
Plaut, M
Cooper, SF
Fenton, MJ
Arshad, SH
Bahna, SL
Beck, LA
Byrd-Bredbenner, C
Camargo, CA
Eichenfield, L
Furuta, GT
Hanifin, JM
Jones, C
Kraft, M
Levy, BD
Lieberman, P
Luccioli, S
McCall, KM
Schneider, LC
Simon, RA
Simons, FER
Teach, SJ
Yawn, BP
Schwaninger, JM
AF Boyce, Joshua A.
Assa'ad, Amal
Burks, A. Wesley
Jones, Stacie M.
Sampson, Hugh A.
Wood, Robert A.
Plaut, Marshall
Cooper, Susan F.
Fenton, Matthew J.
Arshad, S. Hasan
Bahna, Sami L.
Beck, Lisa A.
Byrd-Bredbenner, Carol
Camargo, Carlos A., Jr.
Eichenfield, Lawrence
Furuta, Glenn T.
Hanifin, Jon M.
Jones, Carol
Kraft, Monica
Levy, Bruce D.
Lieberman, Phil
Luccioli, Stefano
McCall, Kathleen M.
Schneider, Lynda C.
Simon, Ronald A.
Simons, F. Estelle R.
Teach, Stephen J.
Yawn, Barbara P.
Schwaninger, Julie M.
TI Guidelines for the Diagnosis and Management of Food Allergy in the
United States: Summary of the NIAID-Sponsored Expert Panel Report
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Article
C1 [Plaut, Marshall; Cooper, Susan F.; Fenton, Matthew J.; Schwaninger, Julie M.] NIAID, Div Allergy Immunol & Transplantat, NIH, Bethesda, MD 20892 USA.
[Boyce, Joshua A.] Harvard Univ, Brigham & Womens Hosp, Sch Med, Div Rheumatol Immunol & Allergy,Dept Med, Boston, MA 02115 USA.
[Assa'ad, Amal] Univ Cincinnati, Div Allergy & Immunol, Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH USA.
[Burks, A. Wesley] Duke Univ, Med Ctr, Dept Pediat, Div Allergy & Immunol, Durham, NC 27710 USA.
[Jones, Stacie M.] Univ Arkansas Med Sci, Div Allergy & Immunol, Dept Pediat, Arkansas Childrens Hosp, Little Rock, AR 72205 USA.
[Sampson, Hugh A.] Mt Sinai Sch Med, Elliot & Roslyn Jaffe Food Allergy Inst, Div Allergy & Immunol, Dept Pediat, New York, NY USA.
[Wood, Robert A.] Johns Hopkins Univ, Sch Med, Dept Pediat, Div Allergy & Immunol, Baltimore, MD USA.
[Arshad, S. Hasan] Univ Southampton, Sch Med, Southampton, Hants, England.
[Arshad, S. Hasan] St Marys Hosp, David Hide Asthma & Allergy Res Ctr, Newport, Wight, England.
[Arshad, S. Hasan] Southampton Univ Hosp NHS Trust, Southampton, Hants, England.
[Bahna, Sami L.] Louisiana State Univ, Hlth Sci Ctr, Dept Pediat, Allergy & Immunol Sect, Shreveport, LA 71105 USA.
[Beck, Lisa A.] Univ Rochester, Dept Dermatol, Med Ctr, Rochester, NY 14627 USA.
[Byrd-Bredbenner, Carol] Rutgers State Univ, Dept Nutr Sci, New Brunswick, NJ 08903 USA.
[Camargo, Carlos A., Jr.] Harvard Univ, Massachusetts Gen Hosp, Sch Med, Dept Emergency Med, Boston, MA USA.
[Camargo, Carlos A., Jr.] Harvard Univ, Sch Med, Dept Med, Div Rheumatol Allergy & Immunol,Massachusetts Gen, Boston, MA USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Pediat, San Diego, CA 92103 USA.
[Eichenfield, Lawrence] Univ Calif San Diego, Dept Med, San Diego, CA 92103 USA.
[Eichenfield, Lawrence] Rady Childrens Hosp, Div Pediat & Adolescent Dermatol, San Diego, CA USA.
[Furuta, Glenn T.] Childrens Hosp Denver, Sect Pediat Gastroenterol Hepatol & Nutr, Digest Hlth Inst, Aurora, CO USA.
[Furuta, Glenn T.] Univ Colorado, Dept Pediat, Denver Sch Med, Aurora, CO USA.
[Furuta, Glenn T.] Natl Jewish Hlth, Dept Pediat, Denver, CO USA.
[Hanifin, Jon M.] Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA.
[Jones, Carol] Allergy & Asthma Network Mothers Asthmat, Mclean, VA USA.
[Kraft, Monica] Duke Univ, Med Ctr, Dept Med, Div Pulm Allergy & Crit Care Med, Durham, NC 27710 USA.
[Levy, Bruce D.] Brigham & Womens Hosp, Partners Asthma Ctr, Div Pulm & Crit Care Med, Boston, MA 02115 USA.
[Levy, Bruce D.] Harvard Univ, Sch Med, Boston, MA USA.
[Lieberman, Phil] Univ Tennessee, Dept Med, Div Allergy & Immunol, Coll Med, Memphis, TN 38104 USA.
[Luccioli, Stefano] US FDA, Off Food Addit Safety, College Pk, MD USA.
[McCall, Kathleen M.] Childrens Hosp Orange Cty, Orange, CA USA.
[Schneider, Lynda C.] Childrens Hosp Boston, Div Immunol, Boston, MA USA.
[Simon, Ronald A.] Scripps Clin, Div Allergy Asthma & Immunol, San Diego, CA USA.
[Simons, F. Estelle R.] Univ Manitoba, Fac Med, Dept Pediat, Winnipeg, MB, Canada.
[Simons, F. Estelle R.] Univ Manitoba, Fac Med, Dept Child Hlth & Immunol, Winnipeg, MB, Canada.
[Teach, Stephen J.] Childrens Natl Med Ctr, Div Emergency Med, Washington, DC 20010 USA.
[Yawn, Barbara P.] Olmsted Med Ctr, Dept Res, Rochester, MN USA.
[Yawn, Barbara P.] Univ Minnesota, Sch Med, Dept Family & Community Hlth, Minneapolis, MN 55455 USA.
RP Fenton, MJ (reprint author), NIAID, Div Allergy Immunol & Transplantat, NIH, 6610 Rockledge Dr,Room 3105, Bethesda, MD 20892 USA.
EM fentonm@niaid.nih.gov
RI Byrd-Bredbenner, Carol/F-8064-2015
OI Byrd-Bredbenner, Carol/0000-0002-8010-3987
FU National Institutes of Health; GlaxoSmithKline; Food Allergy and
Anaphylaxis Network, Gerber, Mead Johnson; Dyax Corp; Food Allergy and
Anaphylaxis Network, Mead Johnson; National Peanut Board; Food Allergy
Initiative; National Institutes of Health (Division of Receipt and
Referral, National Institute of Allergy and Infectious Diseases,
National Center for Complementary and Alternative Medicine); Phadia AB;
Genentech; National Institutes of Health (National Institute of Allergy
and Infectious Diseases); National Institute of Health Research, UK;
American Academy of Allergy, Asthma, and Immunology; National Eczema
Association; US Department of Agriculture; Canned Food Alliance; New
Jersey Department of Health and Senior Services; Dey; Novartis;
Astellas; Ferndale; Johnson Johnson; Sinclair; Stiefel; Therapeutics
Inc.; American Gastrointestinal Association; ALZA; Astellas Pharma US,
Inc; Asubio Pharmaceuticals, Inc; Centocor, Inc; Corgentech; Nucryst
Pharmaceuticals; Seattle Genetics; Shionogi USA; Merck; Sepracor; Dey
Laboratories; Schering-Plough; AstraZenica; TEVA; Pfizer; MEDA; Alcon;
Intelliject; US Food and Drug Administration; AllerGen; Canadian
Allergy; Asthma and Immunology Foundation/Anaphylaxis Canada; Canadian
Institutes of Health Research; AstraZeneca Foundation; Aventis; Child
Health Center Board; CNMC Research Advisory Council; National
Association of Chain Drug Stores Foundation; National Institutes of
Health (National Institute of Allergy and Infectious Diseases; National
Heart, Lung, and Blood Institute); Novartis/Genentech; Robert Woods
Johnson Foundation; US Centers for Disease Control and Prevention; US
Public Health Service; Washington, DC, Department of Health
FX J. A. Boyce has served on the Advisory Board of GlaxoSmithKline. He has
served as a consultant and/or speaker for Altana, GlaxoSmithKline, and
Merck. He has received funding/grant support from the National
Institutes of Health.; A. Assa'ad holds, or is listed as an inventor on,
US patent application #10/566903, entitled "Genetic markers of food
allergy." She has served as a consultant for GlaxoSmithKline and as a
speaker for the American College of Allergy, Asthma, and Immunology, the
North East Allergy Society, the Virginia Allergy Society, the New
England Allergy Society, and the American Academy of Pediatrics. Dr
Assa'ad has received funding/grant support from GlaxoSmithKline.; A. W.
Burks holds, or is listed as an inventor on, multiple US patents related
to food allergy. He owns stock in Allertein and MastCell, Inc, and is a
minority stockholder in Dannon Co Probiotics. He has served as a
consultant for ActoGeniX NV, McNeil Nutritionals, Mead Johnson, and
Novartis. He has served on the speaker's bureau for EpiPen/Dey, LP, and
has served on the data monitoring committee for Genentech. He has served
on an expert panel for Nutricia. Dr Burks has received funding/grant
support from the Food Allergy and Anaphylaxis Network, Gerber, Mead
Johnson, and the National Institutes of Health.; S. M. Jones has served
as a speaker and grant reviewer and has served on the medical advisory
committee for the Food Allergy and Anaphylaxis Network. She has received
funding/grant support from Dyax Corp, the Food Allergy and Anaphylaxis
Network, Mead Johnson, the National Peanut Board, and the National
Institutes of Health.; H. A. Sampson holds, or is listed as an inventor
on, multiple US patents related to food allergy. He owns stock in
Allertein Therapeutics. He is the immediate past president of the
American Academy of Allergy, Asthma, and Immunology. He has served as a
consultant for Allertein Therapeutics, the American Academy of Allergy,
Asthma, and Immunology, the Food Allergy Initiative, and Schering
Plough. He has received funding/grant support for research projects from
the Food Allergy Initiative, the National Institutes of Health (Division
of Receipt and Referral, National Institute of Allergy and Infectious
Diseases, National Center for Complementary and Alternative Medicine),
and Phadia AB. He is a co-owner of Herbal Spring, LLC.; R. A. Wood has
served as a speaker/advisory board member for GlaxoSmithKline, Merck,
and Dey. He has received funding/grant support from Genentech and the
National Institutes of Health (National Institute of Allergy and
Infectious Diseases).; S. H. Arshad has received funding/grant support
from the National Institutes of Health and the National Institute of
Health Research, UK.; S. L. Bahna has received funding/grant support
from Genentech.; L. A. Beck has received funding/grant support from the
American Academy of Allergy, Asthma, and Immunology, the National Eczema
Association, and the National Institutes of Health.; C. Byrd-Bredbenner
owns stock in Johnson & Johnson. She has received funding/grant support
from the US Department of Agriculture, the Canned Food Alliance, and the
New Jersey Department of Health and Senior Services.; C. A. Camargo Jr
has consulted for Dey and Novartis. He has received funding/grant
support from a variety of government agencies and not-for-profit
research foundations, as well as Dey and Novartis.; L. Eichenfield has
received funding/grant support from a variety of not-for-profit
foundations, as well as Astellas, Ferndale, Johnson & Johnson, Novartis,
Sinclair, Stiefel, and Therapeutics Inc.; G. T. Furuta has served as a
consultant and/or speaker to Ception Therapeutics and TAP. He has
received funding/grant support from the American Gastrointestinal
Association and the National Institutes of Health.; J. M. Hanifin has
served as served as a consultant for ALZA, Anesiva, Inc, Barrier
Therapeutics, Inc, Milliken & Company, Nordic Biotech, Novartis
Pharmaceuticals Corporation, Shionogi USA, Taisho Pharmaceutical R&D,
Inc, Teikoku Pharma USA, Inc, UCB, York Pharma, ZARS, Inc, and
ZymoGenetics. He has served as an investigator or received research
funding from ALZA, Astellas Pharma US, Inc, Asubio Pharmaceuticals, Inc,
Centocor, Inc, Corgentech, Novartis, Nucryst Pharmaceuticals, Seattle
Genetics, and Shionogi USA.; M. Kraft has served as a consultant and/or
speaker for Astra-Zeneca, Genentech, GlaxoSmithKline, Merck, Novartis,
and Sepracor. She has received funding/grant support from Genentech,
GlaxoSmithKline, the National Institutes of Health and Novartis.; B. D.
Levy holds, or is listed as an inventor on, US patent applications
#20080064746 entitled "Lipoxins and aspirin-triggered lipoxins and their
stable analogs in the treatment of asthma and inflammatory airway
diseases" and #20080096961 entitled "Use of docosatrienes, resolvins and
their stable analogs in the treatment of airway diseases and asthma." He
owns stock in Resolvyx Pharmaceuticals. He has served as a consultant
for Bayer Healthcare and Resolvyx Pharmaceuticals. Dr Levy has received
funding/grant support from the National Institutes of Health.; P.
Lieberman has served as a consultant and/or speaker to Dey Laboratories,
Novartis, Schering-Plough, AstraZenica, Merck, TEVA, Pfizer, MEDA,
Alcon, Genentech, Intelliject, and the Food Allergy and Anaphylaxis
Network. He is past president of the American Academy of Allergy,
Asthma, and Immunology.; L. C. Schneider has served as a
consultant/clinical advisor for the Food Allergy Initiative. She has
received funding/grant support from a variety of not-for-profit research
foundations, as well as Novartis and the National Institutes of Health.;
R. A. Simon has served as a speaker for Dey Laboratories, Genentech,
GlaxoSmithKline, Merck, Novartis, and the US Food and Drug
Administration.; F. E. R. Simons holds a patent on "Fast-disintegrating
epinephrine tablets for sublingual administration." She is a
past-president of the American Academy of Allergy, Asthma, and
Immunology and of the Canadian Society of Allergy and Clinical
Immunology. She is a member of the advisory boards of Dey, Intelliject,
and ALK-Abello. She has received funding/grant support from AllerGen,
the Canadian Allergy, Asthma and Immunology Foundation/Anaphylaxis
Canada, and the Canadian Institutes of Health Research.; S. J. Teach has
served as a speaker for AstraZeneca. He has received funding/grant
support from the AstraZeneca Foundation, Aventis, the Child Health
Center Board, the CNMC Research Advisory Council, the National
Association of Chain Drug Stores Foundation, the National Institutes of
Health (National Institute of Allergy and Infectious Diseases; National
Heart, Lung, and Blood Institute), Novartis/Genentech, the Robert Woods
Johnson Foundation, the US Centers for Disease Control and Prevention,
the US Public Health Service, and the Washington, DC, Department of
Health.
NR 1
TC 399
Z9 409
U1 12
U2 36
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 DEC
PY 2010
VL 126
IS 6
BP 1105
EP 1118
DI 10.1016/j.jaci.2010.10.008
PG 14
WC Allergy; Immunology
SC Allergy; Immunology
GA 689RZ
UT WOS:000284947800005
PM 21134568
ER
PT J
AU Melendez, SN
Hanning, I
Han, J
Nayak, R
Clement, AR
Wooming, A
Hererra, P
Jones, FT
Foley, SL
Ricke, SC
AF Melendez, S. N.
Hanning, I.
Han, J.
Nayak, R.
Clement, A. R.
Wooming, A.
Hererra, P.
Jones, F. T.
Foley, S. L.
Ricke, S. C.
TI Salmonella enterica isolates from pasture-raised poultry exhibit
antimicrobial resistance and class I integrons
SO JOURNAL OF APPLIED MICROBIOLOGY
LA English
DT Article
DE integron; pasture; poultry; resistance; Salmonella
ID FIELD GEL-ELECTROPHORESIS; ESCHERICHIA-COLI; ANTIBIOTIC-RESISTANCE;
VIRULENCE PLASMIDS; ORGANIC CHICKENS; UNITED-STATES; SEROVAR HEIDELBERG;
CAMPYLOBACTER SPP.; RETAIL STORES; ENTERITIDIS
AB Aims: While considerable foodborne pathogen research has been conducted on conventionally produced broilers and turkeys, few studies have focused on free-range (organic) or pastured poultry. The current surveillance study was designed to isolate, identify and genetically characterize Salmonella from pastured poultry farm environment and from retail samples.
Methods and Results: In this study, 59 isolates were collected from two pastured poultry farms (n = 164; pens, feed, water and insect traps) and retail carcasses (n = 36) from a local natural foods store and a local processing plant. All isolates were serotyped and analysed phenotypically (antimicrobial resistance profiles) and genotypically (DNA fingerprints, plasmid profiles and integron analysis). Salmonella enterica was detected using standard microbiological methods. Salmonella Kentucky was the most prevalent serotype detected from the sampled sources (53%), followed by Salmonella Enteritidis (24%), Bareilly (10%), Mbandaka (7%), Montevideo (5%) or Newport (2%). All isolates were resistant to sulfisoxazole and novobiocin, and the majority (40/59) possessed class I integrons shown by PCR detection. Each Salmonella serotype elicited a distinct pulsed-field gel electrophoresis fingerprint profile, and unique differences were observed among the serotypes.
Conclusions: The findings of this study show that Salmonella serotypes isolated from pasture-raised poultry exhibit antimicrobial resistance and class I integrons.
Significance and Impact of the Study: This study demonstrates that despite the cessation of antibiotic usage in poultry production, antibiotic resistant Salmonella may still be recovered from the environment and poultry products.
C1 [Hanning, I.] Univ Arkansas, Dept Food Sci, Div Agr, Fayetteville, AR 72704 USA.
[Han, J.; Nayak, R.; Foley, S. L.] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Jones, F. T.] Univ Arkansas, Dept Poultry Sci, Fayetteville, AR 72701 USA.
RP Hanning, I (reprint author), Univ Arkansas, Dept Food Sci, Div Agr, 2650 N Young Ave, Fayetteville, AR 72704 USA.
EM ihanning@uark.edu
FU USDA/CSREES NIFSI [406-2008 51110]
FX This study was funded by the USDA/CSREES NIFSI grant no. 406-2008 51110.
NR 60
TC 30
Z9 31
U1 1
U2 16
PU WILEY-BLACKWELL
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 1364-5072
J9 J APPL MICROBIOL
JI J. Appl. Microbiol.
PD DEC
PY 2010
VL 109
IS 6
BP 1957
EP 1966
DI 10.1111/j.1365-2672.2010.04825.x
PG 10
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 679OI
UT WOS:000284170300012
PM 20722876
ER
PT J
AU Sangal, V
Harbottle, H
Mazzoni, CJ
Helmuth, R
Guerra, B
Didelot, X
Paglietti, B
Rabsch, W
Brisse, S
Weill, FX
Roumagnac, P
Achtman, M
AF Sangal, Vartul
Harbottle, Heather
Mazzoni, Camila J.
Helmuth, Reiner
Guerra, Beatriz
Didelot, Xavier
Paglietti, Bianca
Rabsch, Wolfgang
Brisse, Sylvain
Weill, Francois-Xavier
Roumagnac, Philippe
Achtman, Mark
TI Evolution and Population Structure of Salmonella enterica Serovar
Newport
SO JOURNAL OF BACTERIOLOGY
LA English
DT Article
ID FIELD GEL-ELECTROPHORESIS; HORIZONTAL GENE-TRANSFER; SEQUENCE TYPING
DATA; AMPC BETA-LACTAMASE; MULTIDRUG-RESISTANT; SEROTYPE NEWPORT;
SUBSPECIES-I; SPECTRUM CEPHALOSPORINS; STAPHYLOCOCCUS-AUREUS;
PHYLOGENETIC NETWORKS
AB Salmonellosis caused by Salmonella enterica serovar Newport is a major global public health concern, particularly because S. Newport isolates that are resistant to multiple drugs (MDR), including third-generation cephalosporins (MDR-AmpC phenotype), have been commonly isolated from food animals. We analyzed 384 S. Newport isolates from various sources by a multilocus sequence typing (MLST) scheme to study the evolution and population structure of the serovar. These were compared to the population structure of S. enterica serovars Enteritidis, Kentucky, Paratyphi B, and Typhimurium. Our S. Newport collection fell into three lineages, Newport-I, Newport-II, and Newport-III, each of which contained multiple sequence types (STs). Newport-I has only a few STs, unlike Newport-II or Newport-III, and has possibly emerged recently. Newport-I is more prevalent among humans in Europe than in North America, whereas Newport-II is preferentially associated with animals. Two STs of Newport-II encompassed all MDR-AmpC isolates, suggesting recent global spread after the acquisition of the bla(CMY-2) gene. In contrast, most Newport-III isolates were from humans in North America and were pansusceptible to antibiotics. Newport was intermediate in population structure to the other serovars, which varied from a single monophyletic lineage in S. Enteritidis or S. Typhimurium to four discrete lineages within S. Paratyphi B. Both mutation and homologous recombination are responsible for diversification within each of these lineages, but the relative frequencies differed with the lineage. We conclude that serovars of S. enterica provide a variety of different population structures.
C1 [Mazzoni, Camila J.; Achtman, Mark] Natl Univ Ireland Univ Coll Cork, Environm Res Inst, Cork, Ireland.
[Mazzoni, Camila J.; Achtman, Mark] Natl Univ Ireland Univ Coll Cork, Dept Microbiol, Cork, Ireland.
[Sangal, Vartul; Mazzoni, Camila J.; Roumagnac, Philippe; Achtman, Mark] Max Planck Inst Infect Biol, Dept Mol Biol, D-10117 Berlin, Germany.
[Sangal, Vartul] Univ Strathclyde, Strathclyde Inst Pharm & Biomed Sci, Glasgow G4 0RE, Lanark, Scotland.
[Harbottle, Heather] US FDA, Ctr Vet Med, Laurel, MD 20708 USA.
[Helmuth, Reiner; Guerra, Beatriz] BfR Fed Inst Risk Assessment, Natl Salmonella Reference Lab, Berlin, Germany.
[Didelot, Xavier] Univ Oxford, Dept Stat, Oxford OX1 3TG, England.
[Paglietti, Bianca] Univ Sassari, Dept Biomed Sci, I-07100 Sassari, Italy.
[Rabsch, Wolfgang] Robert Koch Inst, Natl Reference Ctr Salmonellae & Other Enter, Wernigerode, Germany.
[Weill, Francois-Xavier] Inst Pasteur, Unite Bacteries Pathogenes Enter, F-75724 Paris, France.
[Roumagnac, Philippe] Ctr Cooperat Int Rech Agron Dev, UMR BGPI, F-34398 Montpellier 5, France.
RP Achtman, M (reprint author), Natl Univ Ireland Univ Coll Cork, Environm Res Inst, Lee Rd, Cork, Ireland.
EM m.achtman@ucc.ie
RI Didelot, Xavier/H-1608-2013; Mazzoni, Camila/L-3441-2014;
OI Didelot, Xavier/0000-0003-1885-500X; Sangal, Vartul/0000-0002-7405-8446;
PAGLIETTI, Bianca/0000-0002-2568-0642; Weill,
Francois-Xavier/0000-0001-9941-5799
FU Science Foundation of Ireland [05/FE1/B882]; National Institutes of
Health [R01 GM084318-01A1]; Federal Institute for Risk Assessment
[BfR-45-004]; Med-Ved-Net (European Union)
FX This work was partly supported by grants 05/FE1/B882 (Science Foundation
of Ireland), R01 GM084318-01A1 (National Institutes of Health), and
BfR-45-004 (Federal Institute for Risk Assessment) and by the
Med-Ved-Net (European Union-funded Network of Excellence for the
Prevention and Control of Zoonoses).
NR 67
TC 48
Z9 48
U1 2
U2 13
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0021-9193
J9 J BACTERIOL
JI J. Bacteriol.
PD DEC
PY 2010
VL 192
IS 24
BP 6465
EP 6476
DI 10.1128/JB.00969-10
PG 12
WC Microbiology
SC Microbiology
GA 686IQ
UT WOS:000284690400018
PM 20935094
ER
PT J
AU Joseph, F
AF Joseph, Francesca
TI Pediatric Cardiovascular Device Registries-The Need for Such Data And
The Potential Impact
SO JOURNAL OF CARDIOVASCULAR TRANSLATIONAL RESEARCH
LA English
DT Editorial Material
ID CARDIOLOGY
C1 US FDA, Silver Spring, MD 20993 USA.
RP Joseph, F (reprint author), US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM francesca.joseph@fda.hhs.gov
NR 6
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1937-5387
J9 J CARDIOVASC TRANSL
JI J. Cardiovasc. Transl. Res.
PD DEC
PY 2010
VL 3
IS 6
SI SI
BP 597
EP 599
DI 10.1007/s12265-010-9196-4
PG 3
WC Cardiac & Cardiovascular Systems; Medicine, Research & Experimental
SC Cardiovascular System & Cardiology; Research & Experimental Medicine
GA 687LK
UT WOS:000284779800001
PM 20585915
ER
PT J
AU Patel-Raman, SM
Chen, EA
AF Patel-Raman, Sonna M.
Chen, Eric A.
TI Past, Present, and Future Regulatory Aspects of Ventricular Assist
Devices
SO JOURNAL OF CARDIOVASCULAR TRANSLATIONAL RESEARCH
LA English
DT Article
DE Ventricular assist devices; Mechanical circulatory support; FDA;
Regulatory
ID HEART-TRANSPLANTATION; SUPPORT; NOVACOR; SYSTEM; THORATEC; BRIDGE
AB The development of ventricular assist devices (VADs) for the treatment of heart failure has been ongoing since the National Heart Lung and Blood Institute (NHLBI) initiated the artificial heart program in 1964. The primary goal was to develop VADs and total artificial hearts for both temporary (short-term) and long-term use. Due to a small target population and the inability to blind patients and clinicians, the Food and Drug Administration (FDA) has recognized the challenges of conducting trials with these invasive devices. In an effort to address those challenges, FDA has accepted a variety of clinical trial designs to collect the data required to evaluate safety and effectiveness data in different patient groups. This article will provide a detailed discussion of the past, present, and future FDA regulatory considerations for VADs.
C1 [Patel-Raman, Sonna M.; Chen, Eric A.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Patel-Raman, SM (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave,WO66-1255, Silver Spring, MD 20993 USA.
EM sonna.patel@fda.hhs.gov
NR 8
TC 3
Z9 3
U1 0
U2 2
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1937-5387
J9 J CARDIOVASC TRANSL
JI J. Cardiovasc. Transl. Res.
PD DEC
PY 2010
VL 3
IS 6
SI SI
BP 600
EP 603
DI 10.1007/s12265-010-9225-3
PG 4
WC Cardiac & Cardiovascular Systems; Medicine, Research & Experimental
SC Cardiovascular System & Cardiology; Research & Experimental Medicine
GA 687LK
UT WOS:000284779800002
PM 21046301
ER
PT J
AU Koutchma, T
Song, Y
Setikaite, I
Juliano, P
Barbosa-Canovas, GV
Dunne, CP
Patazca, E
AF Koutchma, Tatiana
Song, Yoonseok
Setikaite, Ilona
Juliano, Pablo
Barbosa-Canovas, Gustavo V.
Dunne, C. Patrick
Patazca, Eduardo
TI PACKAGING EVALUATION FOR HIGH-PRESSURE HIGH-TEMPERATURE STERILIZATION OF
SHELF-STABLE FOODS
SO JOURNAL OF FOOD PROCESS ENGINEERING
LA English
DT Article
ID BARRIER
AB The integrity of flexible packages during high-pressure (HP) sterilization is of critical importance to the safety and shelf life of food products. For HP-sterilization, packaged products need to be preheated to a target temperature before HP processing. Preheating efficiency can be affected by the packaging material utilized. The objectives were to quantify the impact of packaging materials on the rate of heat penetration into foods during preheating, and to evaluate the effects of preheating and HP processing (at 688 MPa and 121C) on package integrity, oxygen permeability and mechanical properties for commercially available packaging materials. Commercial scrambled egg patties were vacuum-sealed in pouches. Four plastic-laminated materials (nylon/coextruded ethylene-vinyl alcohol, nylon/polypropylene [PP], polyethylene terephthalate [PET]/aluminum oxide/casted PP [CPP] and PET/polyethylene) and two aluminum foil-laminated pouches (PET/aluminum [Al]/CPP and nylon/Al/PP) were tested. Selected packaging materials also were evaluated after thermal retort (TR) treatment and HP low temperature processing. The results demonstrated that foil-laminated materials provided shorter preheating time than thinner polymeric materials. HP treatment at high temperatures (HP-HT) increased seal strength of foil-laminated pouches. However, the HP-HT process did not significantly contribute to changes in seal strength of plastic-laminated pouches. It was found that the HP-HT process altered the oxygen barrier of the composite packaging materials. However, the increase in permeability observed during the HP-HT process was attributed to thermal damage occurring during preheating. TR processing increased oxygen permeability to a higher extent than HP-HT processing. It was concluded that the selected packaging materials could provide the required oxygen barrier for HP-HT treated shelf-stable foods.
C1 [Koutchma, Tatiana; Setikaite, Ilona; Patazca, Eduardo] IIT, Summit Argo, IL 60501 USA.
[Song, Yoonseok] US FDA, Natl Ctr Food Safety & Technol, Summit Argo, IL 60501 USA.
[Setikaite, Ilona] Quaker Tropicana Gatorade PepsiCo, Barrington, IL USA.
[Juliano, Pablo; Barbosa-Canovas, Gustavo V.] Washington State Univ, Dept Biol Syst Engn, Pullman, WA 99164 USA.
[Juliano, Pablo] Food Sci Australia, Innovat Foods Ctr, Werribee, Vic 3030, Australia.
[Dunne, C. Patrick] USA, Res Dev & Engn Command, Natick, MA 01760 USA.
RP Koutchma, T (reprint author), Agr & Agri Food Canada, 93 Stone Rd W, Guelph, ON N1G 5C9, Canada.
EM koutchmat@agr.gc.ca
RI Juliano, Pablo/H-9251-2013
OI Juliano, Pablo/0000-0002-7425-8085
NR 19
TC 14
Z9 15
U1 4
U2 26
PU WILEY-BLACKWELL PUBLISHING, INC
PI MALDEN
PA COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA
SN 0145-8876
J9 J FOOD PROCESS ENG
JI J. Food Process Eng.
PD DEC
PY 2010
VL 33
IS 6
BP 1097
EP 1114
DI 10.1111/j.1745-4530.2008.00328.x
PG 18
WC Engineering, Chemical; Food Science & Technology
SC Engineering; Food Science & Technology
GA 689XH
UT WOS:000284963700008
ER
PT J
AU Fleischman, GJ
Badvela, MK
Rehkopf, A
Stewart, CM
AF Fleischman, Gregory J.
Badvela, Mani K.
Rehkopf, Andre
Stewart, Cynthia M.
TI Thermal Death Time Measurement Using Thin Flexible Sleeves: A New
Experimental Approach for Determining Microbial Destruction Kinetics in
Fluids of Arbitrary Viscosity
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
AB The thermal death time kinetics of Salmonella Enteritidis (SE) was measured in buffer, egg yolk, and albumen using thin layer plastic sleeves. The sleeves allowed for the loading and sampling of liquids of high or unusual viscosity, as in the case of yolk and albumen, and accepted relatively large volumes (2 to 3 ml) of fluid. The sleeves maintained the volume of the fluid in a thin layer and could be easily handled for heat exposure. The thin layer maintained one-dimensional heat transfer and minimized temperature gradients, thus preventing parts of the fluid from experiencing different heating rates. A representative strain of SE associated with an egg-based salmonellosis outbreak was used in this study. The D- and z-values of the chosen strain, H7037, were measured in buffer, yolk, and albumen. In buffer, SE had the following mean (+/- standard deviation) D-values: D(55 degrees C) = 3.51 +/- 0.30 min, D(57 degrees C) = 1.75 +/- 0.13 min, and D(60 degrees C) = 0.25 +/- 0.06 min. In yolk, D(58 degrees C) = 0.90 +/- 0.05, D(60 degrees C) = 0.26 +/- 0.03, and D(62 degrees C) = 0.20 +/- 0.02. In albumen, D(55 degrees C) = 1.26 +/- 0.31, D(56 degrees C) = 0.68 +/- 0.10, and D(57 degrees C) = 0.44 +/- 0.04. The z-values for for SE calculated from these D-values were 4.29 +/- 0.39 degrees C in buffer, 6.12 +/- 0.26 degrees C in yolk, and 4.63 +/- 1.14 degrees C in albumen. The sleeves allowed one consistent approach to determining thermal death time kinetics regardless of viscosity.
C1 [Fleischman, Gregory J.] US FDA, Summit Argo, IL 60501 USA.
[Badvela, Mani K.; Rehkopf, Andre; Stewart, Cynthia M.] Natl Ctr Food Safety & Technol, IIT, Summit Argo, IL 60501 USA.
RP Fleischman, GJ (reprint author), US FDA, 6502 S Archer Rd, Summit Argo, IL 60501 USA.
EM gregory.fleischman@fda.hhs.gov
FU U.S. Food and Drug Administration [FD-000431]; National Center for Food
Safety and Technology [FD-000431]
FX The authors gratefully acknowledge the efforts of Claudia Rodriguez in
overseeing the microbiological aspects of this work. This paper was
supported by Cooperative Agreement FD-000431 from the U.S. Food and Drug
Administration and the National Center for Food Safety and Technology.
NR 7
TC 1
Z9 1
U1 1
U2 3
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD DEC
PY 2010
VL 73
IS 12
BP 2301
EP 2305
PG 5
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 692RJ
UT WOS:000285172500023
PM 21219753
ER
PT J
AU Ohmann, EL
Brooks, MM
Webber, SA
Girnita, DM
Ferrell, RE
Burckart, GJ
Chinnock, R
Canter, C
Addonizio, L
Bernstein, D
Kirklin, JK
Naftel, DC
Zeevi, A
AF Ohmann, Erin L.
Brooks, Maria M.
Webber, Steven A.
Girnita, Diana M.
Ferrell, Robert E.
Burckart, Gilbert J.
Chinnock, Richard
Canter, Charles
Addonizio, Linda
Bernstein, Daniel
Kirklin, James K.
Naftel, David C.
Zeevi, Adriana
TI Association of genetic polymorphisms and risk of Late
post-transplantation infection in pediatric heart recipients
SO JOURNAL OF HEART AND LUNG TRANSPLANTATION
LA English
DT Article
DE pediatric heart transplant; bacteria infection; viral infection; genetic
polymorphism
ID GRANZYME-B; TRANSPLANT RECIPIENTS; INTERFERON-GAMMA; ACUTE REJECTION;
OTITIS-MEDIA; FREQUENCY; GENOTYPE; CHILDREN; SUSCEPTIBILITY; ARTHRITIS
AB BACKGROUND Late infections are common causes of morbidity and mortality after pediatric heart transplantation In this multicenter study from 6 centers we investigated the association between genetic polymorphisms (GPs) in immune response genes and late post-transplantation infections in 524 patients
METHODS Late infection was defined as a clinical infectious process occuring >60 days after transplantation and requiring hospitalization intravenous antimicrobial therapy or a life-threatening infection requiring oral therapy All patients provided a blood sample for GP analyses of 18 GPs in cytokine, growth factor and effector molecule genes by single specific pnmer-polymerase chain reaction and/or sequencing Significant associations in univariable analyses were tested m multivariable Cox regression models
RESULTS Late infection was common, with 48 7% of patients expenencing >= 1 late infection 25 2% had >= 1 late bacterial infection and 30 5% had >= 1 late viral infection Older age at transplantation was a protective factor for late infection, both bactenal and viral (hazard ratio [HR] 0 89-092 per 1 year age increase, p < 0 001) Adjusting for age, race and transplant etiology, late bactenal infection was associated with HMOX1 A + 326G AG and GG genotypes (HR 241 95% confidence interval [CI] 1 35-430 p = 0 003) and GZMB A-295G AA genotype (HR 1 47, 95% CI, 1 03-2 1, p = 0 036) Late viral mfection was associated with FAS A-670G GG genotype (FIR 1 42,95% CI, 1 00-2 00, p = 0 050) in the adjusted model and with CTL44 A+49G AA and AG genotypes (HR, 1 49 95% CI 1 02-2 19 p = 0 041) m umvariable analysis
CONCLUSION We found an association between late bacterial infection and GP of HMOX1 which may control macrophage activation A weaker association was also found between late viral infection and GP of CTL44 a regulator of T-cell activation This represents progress toward understanding the clinical and genetic risk factors of outcomes after transplantation J Heart Lung Transplant 2010 29 1342-51 (C) 2010 International Society for Heart and Lung Transplantation All rights reserved
C1 [Zeevi, Adriana] Univ Pittsburgh, Dept Pathol, Div Transplant Pathol, Pittsburgh, PA 15261 USA.
[Ohmann, Erin L.; Webber, Steven A.] Univ Pittsburgh, Dept Pediat, Div Cardiol, Pittsburgh, PA 15261 USA.
[Brooks, Maria M.] Univ Pittsburgh, Dept Epidemiol, Pittsburgh, PA 15261 USA.
[Ferrell, Robert E.] Univ Pittsburgh, Dept Human Genet, Pittsburgh, PA 15261 USA.
[Burckart, Gilbert J.] US FDA, Off Translat Sci, Off Clin Pharmacol, Silver Spring, MD USA.
[Chinnock, Richard] Loma Linda Univ, Dept Pediat, Loma Linda, CA 92350 USA.
[Canter, Charles] Washington Univ, St Louis Childrens Hosp, Sch Med, Dept Pediat Cardiol, St Louis, MO 63110 USA.
[Addonizio, Linda] Columbia Univ, Dept Pediat, Div Cardiol, New York Presbyterian Hosp, New York, NY 10027 USA.
[Bernstein, Daniel] Stanford Univ, Lucile Packard Childrens Hosp, Div Pediat Cardiol, Palo Alto, CA 94304 USA.
[Kirklin, James K.; Naftel, David C.] Univ Alabama, Dept Surg, Birmingham, AL 35294 USA.
RP Zeevi, A (reprint author), Univ Pittsburgh, Dept Pathol, Div Transplant Pathol, W1551 Biomed Sci Tower, Pittsburgh, PA 15261 USA.
OI Chinnock, Richard/0000-0002-9814-1762; Brooks, Maria/0000-0002-2030-7873
FU National Heart Lung and Blood Institute, National Institutes of Health
[5P50 HL 074 732-05]; University of Pittsburgh School of Medicine; Dons
Duke Clinical Research Fellowship
FX This work was supported by grant 5P50 HL 074 732-05 from the National
Heart Lung and Blood Institute, National Institutes of Health Erin L
Ohmann is supported by funding from Dean Arthur S Levine, MD, and the
Clinical Scientist Training Program at the University of Pittsburgh
School of Medicine, and by the Dons Duke Clinical Research Fellowship
program
NR 35
TC 5
Z9 5
U1 0
U2 1
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1053-2498
J9 J HEART LUNG TRANSPL
JI J. Heart Lung Transplant.
PD DEC
PY 2010
VL 29
IS 12
BP 1342
EP 1351
DI 10.1016/j.healun.2010.07.013
PG 10
WC Cardiac & Cardiovascular Systems; Respiratory System; Surgery;
Transplantation
SC Cardiovascular System & Cardiology; Respiratory System; Surgery;
Transplantation
GA 693JP
UT WOS:000285220700004
PM 20869265
ER
PT J
AU Zhang, HH
Song, KM
Rabin, RL
Hill, BJ
Perfetto, SP
Roederer, M
Douek, DC
Siegel, RM
Farber, JM
AF Zhang, Hongwei H.
Song, Kaimei
Rabin, Ronald L.
Hill, Brenna J.
Perfetto, Stephen P.
Roederer, Mario
Douek, Daniel C.
Siegel, Richard M.
Farber, Joshua M.
TI CCR2 Identifies a Stable Population of Human Effector Memory CD4(+) T
Cells Equipped for Rapid Recall Response
SO JOURNAL OF IMMUNOLOGY
LA English
DT Article
ID MONOCYTE CHEMOATTRACTANT PROTEIN-1; CYTOMEGALOVIRUS-SPECIFIC CD4(+);
PRIMARY IMMUNE-RESPONSE; VIRUS TYPE-1 INFECTION; EPSTEIN-BARR-VIRUS;
LYMPH-NODE; L-SELECTIN; PHENOTYPIC CHARACTERIZATION; DIFFERENTIAL
REGULATION; INTERLEUKIN (IL)-2
AB Because T cells act primarily through short-distance interactions, homing receptors can identify colocalizing cells that serve common functions. Expression patterns for multiple chemokine receptors on CD4(+) T cells from human blood suggested a hierarchy of receptors that are induced and accumulate during effector/memory cell differentiation. We characterized CD4(+)CD45RO(+) T cells based on expression of two of these receptors, CCR5 and CCR2, the principal subsets being CCR5(-)CCR2(-) (similar to 70%), CCR5(+)CCR2(-) (similar to 25%), and CCR5(+)CCR2(+) (similar to 5%). Relationships among expression of CCR5 and CCR2 and CD62L, and the subsets' proliferation histories, suggested a pathway of progressive effector/memory differentiation from the CCR5(-)CCR2(-) to CCR5(+)CCR2(-) to CCR5(+)CCR2(+) cells. Sensitivity and rapidity of TCR-mediated activation, TCR signaling, and effector cytokine production by the subsets were consistent with such a pathway. The subsets also showed increasing responsiveness to IL-7, and the CCR5(+)CCR2(+) cells were CD127(bright) and invariably showed the greatest response to tetanus toxoid. CCR5(+)CCR2(+) cells also expressed the largest repertoire of chemokine receptors and migrated to the greatest number of chemokines. By contrast, the CCR5(+)CCR2(-) cells had the greatest percentages of regulatory T cells, activated/cycling cells, and CMV-reactive cells, and were most susceptible to apoptosis. Our results indicate that increasing memory cell differentiation can be uncoupled from susceptibility to death, and is associated with an increase in chemokine responsiveness, suggesting that vaccination (or infection) can produce a stable population of effector-capable memory cells that are highly enriched in the CCR5(+)CCR2(+) subset and ideally equipped for rapid recall responses in tissue. The Journal of Immunology, 2010, 185: 6646-6663.
C1 [Siegel, Richard M.; Farber, Joshua M.] NIAMSD, Autoimmun Branch, NIH, Bethesda, MD 20892 USA.
[Zhang, Hongwei H.; Song, Kaimei; Farber, Joshua M.] NIAID, Inflammat Biol Sect, Lab Mol Immunol, Bethesda, MD 20892 USA.
[Hill, Brenna J.; Douek, Daniel C.] NIAID, Human Immunol Sect, Bethesda, MD 20892 USA.
[Perfetto, Stephen P.; Roederer, Mario] NIAID, Vaccine Res Ctr, ImmunoTechnol Sect, Bethesda, MD 20892 USA.
[Rabin, Ronald L.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Farber, JM (reprint author), NIAMSD, Autoimmun Branch, NIH, Bldg 10,Room 11N-112,10 Ctr Dr, Bethesda, MD 20892 USA.
EM jfarber@niaid.nih.gov
OI Siegel, Richard/0000-0001-5953-9893
FU National Institute of Allergy and Infectious Diseases, National
Institutes of Health
FX This work was supported by the Intramural Research Program of the
National Institute of Allergy and Infectious Diseases, National
Institutes of Health.
NR 80
TC 17
Z9 19
U1 0
U2 3
PU AMER ASSOC IMMUNOLOGISTS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-1767
J9 J IMMUNOL
JI J. Immunol.
PD DEC 1
PY 2010
VL 185
IS 11
BP 6646
EP 6663
DI 10.4049/jimmunol.0904156
PG 18
WC Immunology
SC Immunology
GA 681KJ
UT WOS:000284311500030
PM 20980630
ER
PT J
AU Marcelin, G
Bland, HM
Negovetich, NJ
Sandbulte, MR
Ellebedy, AH
Webb, AD
Griffin, YS
DeBeauchamp, JL
McElhaney, JE
Webby, RJ
AF Marcelin, Glendie
Bland, Hilliary M.
Negovetich, Nicholas J.
Sandbulte, Matthew R.
Ellebedy, Ali H.
Webb, Ashley D.
Griffin, Yolanda S.
DeBeauchamp, Jennifer L.
McElhaney, Janet E.
Webby, Richard J.
TI Inactivated Seasonal Influenza Vaccines Increase Serum Antibodies to the
Neuraminidase of Pandemic Influenza A(H1N1) 2009 Virus in an
Age-Dependent Manner
SO JOURNAL OF INFECTIOUS DISEASES
LA English
DT Article
ID H1N1; ASSOCIATION; PROTECTION; INFECTION; MICE
AB Levels of preexisting antibodies to the hemagglutinin of pandemic influenza A(H1N1) 2009 (hereafter pandemic H1N1) virus positively correlate with age. The impact of contemporary seasonal influenza vaccines on establishing immunity to other pandemic H1N1 proteins is unknown. We measured serum antibodies to the neuraminidase (NA) of pandemic H1N1 in adults prior to and after vaccination with seasonal trivalent inactivated influenza vaccines. Serum antibodies to pandemic H1N1 NA were observed in all age groups; however, vaccination elevated levels of pandemic H1N1 NA antibodies predominately in elderly individuals (age, >= 60 years). Therefore, contemporary seasonal vaccines likely contribute to reduction of pandemic H1N1-associated disease in older individuals.
C1 [Marcelin, Glendie; Bland, Hilliary M.; Negovetich, Nicholas J.; Ellebedy, Ali H.; Webb, Ashley D.; Griffin, Yolanda S.; DeBeauchamp, Jennifer L.; Webby, Richard J.] St Jude Childrens Hosp, Dept Infect Dis, Memphis, TN 38105 USA.
[Sandbulte, Matthew R.] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
[McElhaney, Janet E.] Univ Connecticut, Sch Med, Dept Immunol, Farmington, CT USA.
[McElhaney, Janet E.] Univ British Columbia, Dept Med, Vancouver, BC, Canada.
RP Webby, RJ (reprint author), St Jude Childrens Hosp, Dept Infect Dis, 262 Danny Thomas Pl,Mail Stop 330, Memphis, TN 38105 USA.
EM richard.webby@stjude.org
FU National Institute of Allergy and Infectious Diseases
[HHSN266200700005C, R01 AI68265]; Canadian Institutes of Health
Research; American Lebanese Syrian Associated Charities;
GlaxoSmithKline; University of Connecticut Health Center; Vancouver
Coastal Health Research Institute
FX Financial support: National Institute of Allergy and Infectious Diseases
(contract HHSN266200700005C and grant R01 AI68265); Canadian Institutes
of Health Research; American Lebanese Syrian Associated Charities;
GlaxoSmithKline (investigator-initiated contract to J.E.M.).; We
acknowledge Adrianus C. M. Boon for editorial assistance and the
research teams supporting the influenza projects at the University of
Connecticut Health Center and Vancouver Coastal Health Research
Institute. We thank the World Health Oranization Global Influenza
Surveillance Network for providing the H1N1 viruses.
NR 15
TC 29
Z9 29
U1 0
U2 1
PU OXFORD UNIV PRESS INC
PI CARY
PA JOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA
SN 0022-1899
J9 J INFECT DIS
JI J. Infect. Dis.
PD DEC 1
PY 2010
VL 202
IS 11
BP 1634
EP 1638
DI 10.1086/657084
PG 5
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 675BU
UT WOS:000283799900004
PM 20979454
ER
PT J
AU Dair, BJ
Saylor, DM
Cargal, TE
French, GR
Kennedy, KM
Casas, RS
Guyer, JE
Warren, JA
Kim, CS
Pollack, SK
AF Dair, Benita J.
Saylor, David M.
Cargal, T. Eric
French, Grace R.
Kennedy, Kristen M.
Casas, Rachel S.
Guyer, Jonathan E.
Warren, James A.
Kim, Chang-Soo
Pollack, Steven K.
TI The Effect of Substrate Material on Silver Nanoparticle Antimicrobial
Efficacy
SO JOURNAL OF NANOSCIENCE AND NANOTECHNOLOGY
LA English
DT Article
DE Nanoparticle; Antimicrobial; Medical Device; Coating; Polymer
ID ION
AB With the advent of nanotechnology, silver nanoparticles increasingly are being used in coatings, especially in medical device applications, to capitalize on their antimicrobial properties. The attractiveness of nanoparticulate silver systems is the expected increased antimicrobial efficacy relative to their bulk counterparts, which may be attributed to an increased silver ion (Ag(+)) solubility, and hence availability, that arises from capillarity effects in small, nanometer-sized particles. However, a change of the material upon which the antimicrobial nanoparticulate silver is deposited (herein called "substrate") may affect the availability of Ag+ ions and the intended efficacy of the device. We utilize both theory and experiment to determine the effect of substrate on ion release from silver particles in electrochemical environments and find that substrate surface charge, chemical reactivity or affinity of the surface for Ag+ ions, and wettability of the surface all affect availability of Ag+ ions, and hence antimicrobial efficacy. It is also observed that with time of exposure to deionized water, Ag+ ion release increases to a maximum value at 5 min before decreasing to undetectable levels, which is attributed to coarsening of the nanoparticles, and which subsequently reduces the solubility and availability of Ag+ ions. This coarsening phenomenon is also predicted by the theoretical considerations and has been confirmed experimentally by transmission electron microscopy.
C1 [Dair, Benita J.; Saylor, David M.; Cargal, T. Eric; French, Grace R.; Kennedy, Kristen M.; Casas, Rachel S.; Kim, Chang-Soo; Pollack, Steven K.] FDA Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Chem & Mat Sci, Silver Spring, MD 20993 USA.
[Guyer, Jonathan E.; Warren, James A.] NIST, Mat Sci & Engn Labs, Div Met, Gaithersburg, MD 20899 USA.
RP Dair, BJ (reprint author), FDA Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Div Chem & Mat Sci, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
RI Warren, James/B-1698-2008; Guyer, Jonathan/M-5165-2016;
OI Warren, James/0000-0001-6887-1206; Guyer, Jonathan/0000-0002-1407-6589;
Casas, Rachel/0000-0003-2848-3107
NR 15
TC 12
Z9 13
U1 1
U2 12
PU AMER SCIENTIFIC PUBLISHERS
PI STEVENSON RANCH
PA 25650 NORTH LEWIS WAY, STEVENSON RANCH, CA 91381-1439 USA
SN 1533-4880
J9 J NANOSCI NANOTECHNO
JI J. Nanosci. Nanotechnol.
PD DEC
PY 2010
VL 10
IS 12
BP 8456
EP 8462
DI 10.1166/jnn.2010.3566
PG 7
WC Chemistry, Multidisciplinary; Nanoscience & Nanotechnology; Materials
Science, Multidisciplinary; Physics, Applied; Physics, Condensed Matter
SC Chemistry; Science & Technology - Other Topics; Materials Science;
Physics
GA 672XQ
UT WOS:000283621400080
PM 21121354
ER
PT J
AU Stumbo, PJ
Weiss, R
Newman, JW
Pennington, JA
Tucker, KL
Wiesenfeld, PL
Illner, AK
Klurfeld, DM
Kaput, J
AF Stumbo, Phyllis J.
Weiss, Rick
Newman, John W.
Pennington, Jean A.
Tucker, Katherine L.
Wiesenfeld, Paddy L.
Illner, Anne-Kathrin
Klurfeld, David M.
Kaput, Jim
TI Web-Enabled and Improved Software Tools and Data Are Needed to Measure
Nutrient Intakes and Physical Activity for Personalized Health Research
SO JOURNAL OF NUTRITION
LA English
DT Article
ID HEART-RATE-VARIABILITY; FOOD FREQUENCY QUESTIONNAIRE; DIETARY
ASSESSMENT; HUMAN METABOLOME; SYSTEMS BIOLOGY; HIGH-THROUGHPUT;
FATTY-ACIDS; IDENTIFICATION; NUTRIGENOMICS; CHALLENGES
AB Food intake physical activity (PA) and genetic makeup each affect health and each factor influences the impact of the other 2 factors Nutrigenomics describes interactions between genes and environment Knowledge about the interplay between environment and genetics would be improved if experimental designs included measures of nutrient intake and PA Lack of familiarity about how to analyze environmental variables and ease of access to tools and measurement instruments are 2 deterrents to these combined studies This article describes the state of the art for measuring food intake and PA to encourage researchers to make their tools better known and more available to workers in other fields Information presented was discussed during a workshop on this topic sponsored by the USDA NIH and FDA in the spring of 2009 J Nutr 140 2104-2115 2010
C1 [Stumbo, Phyllis J.] Univ Iowa, Inst Clin & Translat Sci, Iowa City, IA 52242 USA.
[Weiss, Rick] Viocare Inc, Princeton, NJ 08542 USA.
[Newman, John W.] ARS, USDA, Western Human Nutr Res Ctr, Davis, CA 95616 USA.
[Pennington, Jean A.] NIH, Div Nutr Res Coordinat, Bethesda, MD 20892 USA.
[Tucker, Katherine L.] Northeastern Univ, Dept Hlth Sci, Boston, MA 02115 USA.
[Wiesenfeld, Paddy L.] US FDA, Div Toxicol, Off Appl Res & Safety Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
[Illner, Anne-Kathrin] German Inst Human Nutr, Dept Epidemiol, D-14558 Potsdam, Nuthetal, Germany.
[Klurfeld, David M.] USDA ARS, Beltsville, MD 20705 USA.
[Kaput, Jim] US FDA, Natl Ctr Toxicol Res, Div Personalized Nutr & Med, Jefferson, AR 72079 USA.
RP Stumbo, PJ (reprint author), Univ Iowa, Inst Clin & Translat Sci, Iowa City, IA 52242 USA.
RI Tucker, Katherine/A-4545-2010;
OI Tucker, Katherine/0000-0001-7640-662X
FU FDA/National Center for Toxicological Research/Division of Personalized
Nutrition and Medicine NIH; USDA
FX Supported by FDA/National Center for Toxicological Research/Division of
Personalized Nutrition and Medicine NIH and USDA
NR 91
TC 16
Z9 16
U1 1
U2 4
PU AMER SOC NUTRITION-ASN
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD DEC
PY 2010
VL 140
IS 12
BP 2104
EP 2115
DI 10.3945/jn.110.128371
PG 12
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 692AG
UT WOS:000285123300001
PM 20980656
ER
PT J
AU Wang, C
Daniels, MJ
Scharfstein, DO
Land, S
AF Wang, C.
Daniels, M. J.
Scharfstein, D. O.
Land, S.
TI A Bayesian Shrinkage Model for Incomplete Longitudinal Binary Data With
Application to the Breast Cancer Prevention Trial
SO JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION
LA English
DT Article
DE Informative drop-out; Intermittent missingness; Prior elicitation
ID PATTERN-MIXTURE-MODELS; SEMIPARAMETRIC NONRESPONSE MODELS;
LOGISTIC-REGRESSION MODELS; INFORMATIVE DROP-OUT; MISSING DATA; REPEATED
OUTCOMES; SELECTION BIAS; NONIGNORABLE NONRESPONSE;
SENSITIVITY-ANALYSIS; RESPONSE DATA
AB We consider inference in randomized longitudinal studies with missing data that is generated by skipped clinic visits and loss to followup. In this setting, it is well known that full data estimands are not identified unless unverified assumptions are imposed. We assume a non-future dependence model for the drop-out mechanism and partial ignorability for the intermittent missingness. We posit an exponential tilt model that links nonidentifiable distributions and distributions identified under partial ignorability. This exponential tilt model is indexed by nonidentified parameters, which are assumed to have an informative prior distribution, elicited from subject-matter experts. Under this model, full data estimands are shown to be expressed as functionals of the distribution of the observed data. To avoid the curse of dimensionality, we model the distribution of the observed data using a Bayesian shrinkage model. In a simulation study, we compare our approach to a fully parametric and a fully saturated model for the distribution of the observed data. Our methodology is motivated by, and applied to, data from the Breast Cancer Prevention Trial.
C1 [Wang, C.; Daniels, M. J.] Univ Florida, Dept Stat, Gainesville, FL 32611 USA.
[Wang, C.] US FDA, Div Biostat, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
[Scharfstein, D. O.] Johns Hopkins Univ, Dept Biostat, Bloomberg Sch Publ Hlth, Baltimore, MD 21205 USA.
[Land, S.] Univ Pittsburgh, Dept Biostat, Pittsburgh, PA 15213 USA.
RP Wang, C (reprint author), Univ Florida, Dept Stat, Gainesville, FL 32611 USA.
EM mdaniels@stat.ufl.edu
FU NIH [R01-CA85295, U10-CA37377, U10-CA69974, R01 AI078835, P30MH086043,
R01HL79457]
FX C. Wang was Ph.D. Student, Department of Statistics, University of
Florida, Gainesville, FL 32611, and is Mathematical Statistician,
Division of Biostatistics, Center for Devices and Radiological Health,
Food and Drug Administration, Silver Spring, MD 20993. M. J. Daniels is
Professor and Chair, Department of Statistics, University of Florida,
Gainesville, FL 32611 (E-mail: mdaniels@stat.ufl.edu). D. O. Scharfstein
is Professor, Department of Biostatistics, Johns Hopkins University
Bloomberg School of Public Health, Baltimore, MD 21205. S. Land is
Research Associate Professor, Department of Biostatistics, University of
Pittsburgh, Pittsburgh, PA 15213. This research was supported by NIH
grants R01-CA85295, U10-CA37377, U10-CA69974, R01 AI078835, P30MH086043,
and R01HL79457. The authors are grateful to oncologist Patricia Ganz at
UCLA for providing her expertise for the MNAR analysis.
NR 66
TC 9
Z9 9
U1 0
U2 7
PU AMER STATISTICAL ASSOC
PI ALEXANDRIA
PA 732 N WASHINGTON ST, ALEXANDRIA, VA 22314-1943 USA
SN 0162-1459
J9 J AM STAT ASSOC
JI J. Am. Stat. Assoc.
PD DEC
PY 2010
VL 105
IS 492
BP 1333
EP 1346
DI 10.1198/jasa.2010.ap09321
PG 14
WC Statistics & Probability
SC Mathematics
GA 710VU
UT WOS:000286545900005
PM 21516191
ER
PT J
AU Zuurbier, L
Homminga, I
Calvert, V
Winkel, MLT
Buijs-Gladdines, JGCAM
Kooi, C
Smits, WK
Sonneveld, E
Veerman, AJP
Kamps, WA
Horstmann, M
Petricoin, EF
Pieters, R
Meijerink, JPP
AF Zuurbier, L.
Homminga, I.
Calvert, V.
Winkel, M. L. Te
Buijs-Gladdines, J. G. C. A. M.
Kooi, C.
Smits, W. K.
Sonneveld, E.
Veerman, A. J. P.
Kamps, W. A.
Horstmann, M.
Petricoin, E. F., III
Pieters, R.
Meijerink, J. P. P.
TI NOTCH1 and/or FBXW7 mutations predict for initial good prednisone
response but not for improved outcome in pediatric T-cell acute
lymphoblastic leukemia patients treated on DCOG or COALL protocols
SO LEUKEMIA
LA English
DT Article
DE pediatric T-ALL; NOTCH1; FBXW7; TLX3; prednisone response; outcome
AB Aberrant activation of the NOTCH1 pathway by inactivating and activating mutations in NOTCH1 or FBXW7 is a frequent phenomenon in T-cell acute lymphoblastic leukemia (T-ALL). We retrospectively investigated the relevance of NOTCH1/FBXW7 mutations for pediatric T-ALL patients enrolled on Dutch Childhood Oncology Group (DCOG) ALL7/8 or ALL9 or the German Co-Operative Study Group for Childhood Acute Lymphoblastic Leukemia study (COALL-97) protocols. NOTCH1-activating mutations were identified in 63% of patients. NOTCH1 mutations affected the heterodimerization, the juxtamembrane and/or the PEST domains, but not the RBP-J-kappa-associated module, the ankyrin repeats or the transactivation domain. Reverse-phase protein microarray data confirmed that NOTCH1 and FBXW7 mutations resulted in increased intracellular NOTCH1 levels in primary T-ALL biopsies. Based on microarray expression analysis, NOTCH1/FBXW7 mutations were associated with activation of NOTCH1 direct target genes including HES1, DTX1, NOTCH3, PTCRA but not cMYC. NOTCH1/FBXW7 mutations were associated with TLX3 rearrangements, but were less frequently identified in TAL1- or LMO2-rearranged cases. NOTCH1-activating mutations were less frequently associated with mature T-cell developmental stage. Mutations were associated with a good initial in vivo prednisone response, but were not associated with a superior outcome in the DCOG and COALL cohorts. Comparing our data with other studies, we conclude that the prognostic significance for NOTCH1/FBXW7 mutations is not consistent and may depend on the treatment protocol given. Leukemia (2010) 24, 2014-2022; doi:10.1038/leu.2010.204; published online 23 September 2010
C1 [Meijerink, J. P. P.] Erasmus Univ, Sophia Childrens Hosp, Dept Pediat Oncol Hematol, Med Ctr,ZH, NL-3015 GJ Rotterdam, Netherlands.
[Calvert, V.; Petricoin, E. F., III] George Mason Univ, Ctr Appl Prote & Mol Med, Manassas, VA USA.
[Sonneveld, E.; Veerman, A. J. P.; Kamps, W. A.] Dutch Childhood Oncol Grp, The Hague, Netherlands.
[Kamps, W. A.] Univ Groningen, Univ Med Ctr Groningen, Beatrix Childrens Hosp, Dept Pediat Oncol, Groningen, Netherlands.
[Horstmann, M.] German Cooperat Study Grp Childhood Acute Lymphob, Hamburg, Germany.
[Horstmann, M.] Univ Med Ctr Hamburg Eppendorf, Res Inst Childrens Canc Ctr Hamburg, Clin Pediat Hematol & Oncol, Hamburg, Germany.
[Petricoin, E. F., III] NCI, FDA Clin Prote Program, US FDA, Bethesda, MD USA.
RP Meijerink, JPP (reprint author), Erasmus Univ, Sophia Childrens Hosp, Dept Pediat Oncol Hematol, Med Ctr,ZH, Room Sp2456,Dr Molewaterpl 60, NL-3015 GJ Rotterdam, Netherlands.
EM j.meijerink@erasmusmc.nl
RI Meijerink, Jules/D-4393-2017
OI Meijerink, Jules/0000-0002-6860-798X
FU Stichting Kinderen Kankervrij (KiKa) [KiKa 2007-012, KiKa 2008-029];
Dutch Cancer Society Dutch Cancer Society (KWF-EMCR) [2006-3500]; German
Jose Carreras Leukemia Foundation [SP 04/03]
FX LZ and WKS were financed by the Stichting Kinderen Kankervrij (KiKa;
Grant no. KiKa 2007-012). IH was financed by the Dutch Cancer Society
Dutch Cancer Society (KWF-EMCR 2006-3500) CK was financed by KiKa (Grant
no. KiKa 2008-029). We thank the German Jose Carreras Leukemia
Foundation (Grant no. SP 04/03 to MH).
NR 44
TC 64
Z9 66
U1 0
U2 6
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 0887-6924
EI 1476-5551
J9 LEUKEMIA
JI Leukemia
PD DEC
PY 2010
VL 24
IS 12
BP 2014
EP 2022
DI 10.1038/leu.2010.204
PG 9
WC Oncology; Hematology
SC Oncology; Hematology
GA 695OF
UT WOS:000285380900005
PM 20861909
ER
PT J
AU Park, S
Jennings, R
Liu, HM
Badano, A
Myers, K
AF Park, Subok
Jennings, Robert
Liu, Haimo
Badano, Aldo
Myers, Kyle
TI A statistical, task-based evaluation method for three-dimensional x-ray
breast imaging systems using variable-background phantoms
SO MEDICAL PHYSICS
LA English
DT Article
ID POWER-LAW NOISE; CONE-BEAM CT; DIGITAL TOMOSYNTHESIS;
COMPUTER-SIMULATION; SIGNAL-DETECTION; MONTE-CARLO; MODEL; OBSERVER;
OPTIMIZATION; MAMMOGRAPHY
AB Purpose: For the last few years, development and optimization of three-dimensional (3D) x-ray breast imaging systems, such as digital breast tomosynthesis (DBT) and computed tomography, have drawn much attention from the medical imaging community, either academia or industry. However, there is still much room for understanding how to best optimize and evaluate the devices over a large space of many different system parameters and geometries. Current evaluation methods, which work well for 2D systems, do not incorporate the depth information from the 3D imaging systems. Therefore, it is critical to develop a statistically sound evaluation method to investigate the usefulness of inclusion of depth and background-variability information into the assessment and optimization of the 3D systems.
Methods: In this paper, we present a mathematical framework for a statistical assessment of planar and 3D x-ray breast imaging systems. Our method is based on statistical decision theory, in particular, making use of the ideal linear observer called the Hotelling observer. We also present a physical phantom that consists of spheres of different sizes and materials for producing an ensemble of randomly varying backgrounds to be imaged for a given patient class. Lastly, we demonstrate our evaluation method in comparing laboratory mammography and three-angle DBT systems for signal detection tasks using the phantom's projection data. We compare the variable phantom case to that of a phantom of the same dimensions filled with water, which we call the uniform phantom, based on the performance of the Hotelling observer as a function of signal size and intensity.
Results: Detectability trends calculated using the variable and uniform phantom methods are different from each other for both mammography and DBT systems.
Conclusions: Our results indicate that measuring the system's detection performance with consideration of background variability may lead to differences in system performance estimates and comparisons. For the assessment of 3D systems, to accurately determine trade offs between image quality and radiation dose, it is critical to incorporate randomness arising from the imaging chain including background variability into system performance calculations. (C) 2010 American Association of Physicists in Medicine. [DOI: 10.1118/1.3488910]
C1 [Park, Subok; Jennings, Robert; Badano, Aldo; Myers, Kyle] OSEL CDRH FDA, Div Imaging Appl Math, Silver Spring, MD 20993 USA.
[Liu, Haimo] Univ Maryland, College Pk, MD 20742 USA.
RP Park, S (reprint author), OSEL CDRH FDA, Div Imaging Appl Math, Silver Spring, MD 20993 USA.
EM subok.park@fda.hhs.gov
OI badano, aldo/0000-0003-3712-6670
FU National Institute of Biomedical Imaging and Bioengineering at the
National Institutes of Health
FX The authors would like to thank Robert Leimbach and Hugo de las Heras,
respectively, for initial and additional phantom measurements, Rongping
Zeng for her help on implementing analytical x-ray projections of the 3D
spheres, and Iacovos Kyprianou for his support on the use of the cone
beam laboratory. This work was supported in part by the National
Institute of Biomedical Imaging and Bioengineering at the National
Institutes of Health through an intramural grant to the Center for
Devices and Radiological Health, FDA, as well as the FDA's Office of
Women's Health.
NR 48
TC 29
Z9 29
U1 0
U2 6
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 DEC
PY 2010
VL 37
IS 12
BP 6253
EP 6270
DI 10.1118/1.3488910
PG 18
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 701UR
UT WOS:000285849400016
PM 21302782
ER
PT J
AU Sun, JC
Schnackenberg, LK
Pence, L
Bhattacharyya, S
Doerge, DR
Bowyer, JF
Beger, RD
AF Sun, Jinchun
Schnackenberg, Laura K.
Pence, Lisa
Bhattacharyya, Sudeepa
Doerge, Daniel R.
Bowyer, John F.
Beger, Richard D.
TI Metabolomic analysis of urine from rats chronically dosed with
acrylamide using NMR and LC/MS
SO METABOLOMICS
LA English
DT Article
DE Metabolomics; Acrylamide; Pattern Recognition; Energy Metabolism;
Glutathione Biosynthesis
ID DNA ADDUCT FORMATION; FISCHER-344 RATS; GLYCERALDEHYDE-3-PHOSPHATE
DEHYDROGENASE; DRINKING-WATER; GLYCIDAMIDE; TOXICITY; MICE;
GENOTOXICITY; TOXICOKINETICS; SPECTROSCOPY
AB Acrylamide (AA) is known to cause neurotoxicity, genotoxicity, reproductive, and carcinogenic effects in rodents and neurotoxicity in humans. A metabolomics study of urine samples from rats dosed with acrylamide for 14 days was undertaken to understand the mechanisms of and develop biomarkers for acrylamide-induced toxicity. NMR-based and LC/MS-based metabolomics methods were used to analyze metabolites in urine samples. Three mercapturic acid conjugates of acrylamide were detected using exact mass and principal component analysis (PCA) of urine samples. NMR analysis showed an increase in creatine and a decrease in taurine throughout the dosing period. Results showed that citric acid cycle metabolites were down-regulated later in the dosing period. Further, many amino acids were also up-regulated during the study and may be related to the weight loss observed in this study. Taken together, the data suggest that both LC/MS-based and NMR-based metabolomics analysis can detect changes in endogenous metabolites related to glutathione, TCA cycle, and amino acid metabolism induced by AA administration over a 2 week dosing period.
C1 [Sun, Jinchun; Schnackenberg, Laura K.; Pence, Lisa; Bhattacharyya, Sudeepa; Beger, Richard D.] US FDA, Ctr Metabol, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Doerge, Daniel R.] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[Bowyer, John F.] US FDA, Div Neurotoxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Beger, RD (reprint author), US FDA, Ctr Metabol, Div Syst Biol, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM Richard.Beger@fda.hhs.gov
NR 43
TC 6
Z9 8
U1 1
U2 27
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 1573-3882
J9 METABOLOMICS
JI Metabolomics
PD DEC
PY 2010
VL 6
IS 4
BP 550
EP 563
DI 10.1007/s11306-010-0225-8
PG 14
WC Endocrinology & Metabolism
SC Endocrinology & Metabolism
GA 676UO
UT WOS:000283944300009
ER
PT J
AU Valentine, CR
Delongchamp, RR
Pearce, MG
Rainey, HF
Dobrovolsky, VN
Malling, HV
Heflich, RH
AF Valentine, Carrie R.
Delongchamp, Robert R.
Pearce, Mason G.
Rainey, Heather F.
Dobrovolsky, Vasily N.
Malling, Heinrich V.
Heflich, Robert H.
TI In vivo mutation analysis using the Phi X174 transgenic mouse and
comparisons with other transgenes and endogenous genes
SO MUTATION RESEARCH-REVIEWS IN MUTATION RESEARCH
LA English
DT Review
DE Transgenic mice; Somatic cell mutation; Germ cell mutation; Mutation
frequency; Single-burst analysis
ID PAROXYSMAL-NOCTURNAL HEMOGLOBINURIA; MISMATCH REPAIR DEFICIENCY;
ENU-INDUCED MUTATION; BIG BLUE(R) MICE; ESCHERICHIA-COLI; SPLENIC
LYMPHOCYTES; MUTANT FREQUENCIES; MAMMALIAN-CELLS; NUCLEOTIDE-SEQUENCE;
INDUCED MUTAGENESIS
AB The Phi X174 transgenic mouse was first developed as an in vivo Ames test, detecting base pair substitution (bps) at a single bp in a reversion assay. A forward mutational assay was also developed, which is a gain of function assay that also detects bps exclusively. Later work with both assays focused on establishing that a mutation was fixed in vivo using single-burst analysis: determining the number of mutant progeny virus from an electroporated cell by dividing the culture into aliquots before scoring mutants. We review results obtained from single-burst analysis, including testing the hypothesis that high mutant frequencies (MFs) of G:C to A:T mutation recovered by transgenic targets include significant numbers of unrepaired G:T mismatches. Comparison between the Phi X174 and lad transgenes in mouse spleen indicates that the spontaneous bps mutation frequency per nucleotide (mf(n)) is not significantly lower for Phi X174 than for lacl; the response to ENU is also comparable. For the lad transgene, the spontaneous bps mf(n) is highly age-dependent up to 12 weeks of age and the linear trend extrapolates at conception to a frequency close to the human bps mf(n) per generation of 1.7 x 10(-8). Unexpectedly, we found that the lad somatic (spleen) bps mf(n) per cell division at early ages was estimated to be the same as for the human germ-line. The bps mf(n) in bone marrow for the gpt transgene is comparable to spleen for the lad and Phi X174 transgenes. We conclude that the G:C to A:T transition is characteristic of spontaneous in vivo mutation and that the MFs measured in these transgenes at early ages reflect the expected accumulation of in vivo mutation typical of endogenous mammalian mutation rates. However, spontaneous and induced mf(n)s per nucleotide for the cif gene in spleen are 5-10 times higher than for these other transgenes. Published by Elsevier B.V.
C1 [Valentine, Carrie R.; Pearce, Mason G.; Rainey, Heather F.; Dobrovolsky, Vasily N.; Heflich, Robert H.] Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
[Delongchamp, Robert R.] Univ Arkansas Med Sci, Dept Epidemiol, Coll Publ Hlth, Little Rock, AR 72205 USA.
[Malling, Heinrich V.] NIEHS, Mammalian Mutagenesis Grp, Toxicol Lab, Environm Toxicol Program, Res Triangle Pk, NC 27709 USA.
RP Heflich, RH (reprint author), Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, 3900 NCTR Rd,HFT-120, Jefferson, AR 72079 USA.
EM robert.heflich@fda.hhs.gov
NR 87
TC 3
Z9 3
U1 0
U2 3
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1383-5742
J9 MUTAT RES-REV MUTAT
JI Mutat. Res.-Rev. Mutat. Res.
PD DEC
PY 2010
VL 705
IS 3
BP 205
EP 216
DI 10.1016/j.mrrev.2010.07.001
PG 12
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 701HF
UT WOS:000285808300006
PM 20637298
ER
PT J
AU Cote, TR
Xu, K
Pariser, AR
AF Cote, Timothy R.
Xu, Kui
Pariser, Anne R.
TI Accelerating orphan drug development
SO NATURE REVIEWS DRUG DISCOVERY
LA English
DT Editorial Material
C1 [Cote, Timothy R.; Xu, Kui] US FDA, Off Commissioner, Off Orphan Prod Dev, Silver Spring, MD 20993 USA.
[Pariser, Anne R.] US FDA, Ctr Drug Evaluat & Res, Off New Drugs, Silver Spring, MD 20993 USA.
RP Cote, TR (reprint author), US FDA, Off Commissioner, Off Orphan Prod Dev, Silver Spring, MD 20993 USA.
EM timothy.cote@fda.hhs.gov
NR 6
TC 19
Z9 19
U1 0
U2 12
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 1474-1776
J9 NAT REV DRUG DISCOV
JI Nat. Rev. Drug Discov.
PD DEC
PY 2010
VL 9
IS 12
BP 901
EP 902
DI 10.1038/nrd3340
PG 2
WC Biotechnology & Applied Microbiology; Pharmacology & Pharmacy
SC Biotechnology & Applied Microbiology; Pharmacology & Pharmacy
GA 688SE
UT WOS:000284871900001
PM 21119719
ER
PT J
AU Banoo, S
Bell, D
Bossuyt, P
Herring, A
Mabey, D
Poole, F
Smith, PG
Sriram, N
Wongsrichanalai, C
Linke, R
O'Brien, R
Perkins, M
Cunningham, J
Matsoso, P
Nathanson, CM
Olliaro, P
Peeling, RW
Ramsay, A
AF Banoo, Shabir
Bell, David
Bossuyt, Patrick
Herring, Alan
Mabey, David
Poole, Freddie
Smith, Peter G.
Sriram, N.
Wongsrichanalai, Chansuda
Linke, Ralf
O'Brien, Rick
Perkins, Mark
Cunningham, Jane
Matsoso, Precious
Nathanson, Carl Michael
Olliaro, Piero
Peeling, Rosanna W.
Ramsay, Andy
CA TDR Diagnostics Evaluation Expert
TI Evaluation of diagnostic tests for infectious diseases: general
principles
SO NATURE REVIEWS MICROBIOLOGY
LA English
DT Article
ID ACCURACY; MEDICINE
C1 [Banoo, Shabir] Med Control Council S Africa, Pretoria, South Africa.
[Bell, David] WHO, Reg Off Western Pacific, Manila, Philippines.
[Bossuyt, Patrick] Univ Amsterdam, Acad Med Ctr, Dept Clin Epidemiol & Biostat, NL-1105 AZ Amsterdam, Netherlands.
[Herring, Alan] Univ Bristol, Sch Vet, Bristol, Avon, England.
[Mabey, David] London Sch Hyg & Trop Med, Clin Res Unit, London WC1, England.
[Poole, Freddie] US FDA, Div Microbiol Devices, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
[Smith, Peter G.] London Sch Hyg & Trop Med, Infect Dis Epidemiol Unit, London WC1, England.
[Sriram, N.] Tulip Grp Co, Goa, India.
[Wongsrichanalai, Chansuda] US Naval Med Res Unit 2, Jakarta, Indonesia.
[Linke, Ralf; O'Brien, Rick; Perkins, Mark] Fdn Innovat Diagnost FIND, Geneva, Switzerland.
[Cunningham, Jane; Matsoso, Precious; Nathanson, Carl Michael; Olliaro, Piero; Peeling, Rosanna W.; Ramsay, Andy] WHO, UNICEF UNDP World Bank WHO Special Programme Res, CH-1211 Geneva, Switzerland.
RP Banoo, S (reprint author), Med Control Council S Africa, Pretoria, South Africa.
EM peelingr@who.int
RI Bossuyt, Patrick/B-4557-2016
OI Bossuyt, Patrick/0000-0003-4427-0128
NR 16
TC 34
Z9 34
U1 0
U2 7
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 1740-1526
J9 NAT REV MICROBIOL
JI Nat. Rev. Microbiol.
PD DEC
PY 2010
SU S
BP S17
EP S27
DI 10.1038/nrmicro1523
PG 11
WC Microbiology
SC Microbiology
GA 687BM
UT WOS:000284748800004
ER
PT J
AU Cohen, MH
Johnson, JR
Chattopadhyay, S
Tang, SH
Justice, R
Sridhara, R
Pazdur, R
AF Cohen, Martin H.
Johnson, John R.
Chattopadhyay, Somesh
Tang, Shenghui
Justice, Robert
Sridhara, Rajeshwari
Pazdur, Richard
TI Approval Summary: Erlotinib Maintenance Therapy of Advanced/Metastatic
Non-Small Cell Lung Cancer (NSCLC)
SO ONCOLOGIST
LA English
DT Article
DE Erlotinib; Non-small cell lung cancer; Maintenance treatment
ID III RANDOMIZED-TRIAL; PHASE-III; THYMIDYLATE SYNTHASE; PLUS CARBOPLATIN;
1ST-LINE TREATMENT; BEVACIZUMAB; PACLITAXEL; GEMCITABINE
AB On April 16, 2010, the U. S. Food and Drug Administration (FDA) approved erlotinib tablets (Tarceva (R); OSI Pharmaceuticals, Inc., Melville, NY) for maintenance treatment of patients with stage IIIB/IV non-small cell lung cancer (NSCLC) whose disease had not progressed after four cycles of platinum-based first-line chemotherapy.
In total, 889 patients received either erlotinib (150 mg) or placebo once daily. Progression-free survival (PFS), in all patients and in patients with epidermal growth factor receptor (EGFR)(+) tumors by immuno-histochemistry (IHC), was the primary efficacy endpoint. Overall survival (OS) was a secondary sponsor endpoint but was the primary regulatory endpoint.
Median PFS times were 2.8 months and 2.6 months in the erlotinib and placebo arms, respectively (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.62-0.82; p < .001). Median OS times were 12.0 months and 11.0 months, favoring erlotinib (HR, 0.81; 95% CI, 0.70-0.95). The PFS and OS HRs in patients with EGFR(+) tumors by IHC were 0.69 (95% CI, 0.58-0.82) and 0.77 (95% CI, 0.64-0.93), respectively. The PFS and OS HRs in patients with EGFR(-) tumors by IHC were 0.77 (95% CI, 0.51-1.14) and 0.91 (95% CI, 0.59-1.38), respectively.
Following disease progression, 57% of placebo-treated patients received additional chemotherapy, compared with 47% of erlotinib-treated patients. Fourteen percent of placebo-treated patients received erlotinib or gefitinib, 31% received docetaxel, and 14% received pemetrexed. In total, 59% of placebo-treated patients who received treatment received FDA approved second-line NSCLC drugs.
The most common adverse reactions in patients receiving erlotinib were rash and diarrhea. The Oncologist 2010;15:1344-1351
C1 [Cohen, Martin H.; Johnson, John R.; Chattopadhyay, Somesh; Tang, Shenghui; Justice, Robert; Sridhara, Rajeshwari; Pazdur, Richard] US FDA, Off Oncol Drug Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Cohen, MH (reprint author), US FDA, Off Oncol Drug Prod, Ctr Drug Evaluat & Res, White Oak Campus,10903 New Hampshire Ave,Bldg 22, Silver Spring, MD 20993 USA.
EM martin.cohen@fda.hhs.gov
FU AstraZeneca; Lilly; Pfizer; ImClone
FX Reviewer "A" discloses research funding from AstraZeneca, Lilly, Pfizer,
and ImClone.
NR 21
TC 32
Z9 32
U1 1
U2 1
PU ALPHAMED PRESS
PI DURHAM
PA 318 BLACKWELL ST, STE 260, DURHAM, NC 27701-2884 USA
SN 1083-7159
J9 ONCOLOGIST
JI Oncologist
PD DEC
PY 2010
VL 15
IS 12
BP 1344
EP 1351
DI 10.1634/theoncologist.2010-0257
PG 8
WC Oncology
SC Oncology
GA 699SK
UT WOS:000285682900013
PM 21148614
ER
PT J
AU Cohen, MH
Cortazar, P
Justice, R
Pazdur, R
AF Cohen, Martin H.
Cortazar, Patricia
Justice, Robert
Pazdur, Richard
TI Approval Summary: Pemetrexed Maintenance Therapy of Advanced/Metastatic
Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)
SO ONCOLOGIST
LA English
DT Article
DE Pemetrexed; Non-small cell lung cancer; Maintenance treatment
ID PHASE-III TRIAL; THYMIDYLATE SYNTHASE; RANDOMIZED TRIAL; CHEMOTHERAPY;
CISPLATIN; GEMCITABINE; HISTOLOGY; DURATION
AB On July 2, 2009, the U.S. Food and Drug Administration approved pemetrexed injection (Alimta (R) Injection; Eli Lilly and Company, Indianapolis, IN) for maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinumbased doublet induction chemotherapy.
A double-blind study of pemetrexed plus best supportive care versus placebo plus best supportive care was conducted. Pemetrexed, 500 mg/m(2) i.v., was administered every 21 days until disease progression. Folic acid, vitamin B12, and a corticosteroid were given to all study patients.
There were 663 randomized patients (pemetrexed, 441; placebo, 222). Treatments were well balanced with respect to baseline disease characteristics and stratification factors.
The median overall survival (OS) time for intent-to-treat (ITT) patients was 13.4 months for patients receiving pemetrexed and 10.6 months for those receiving placebo (hazard ratio [HR] 0.79; 95% confidence interval [CI], 0.65-0.95; p = .012). Median OS times were 15.5 months versus 10.3 months for patients with nonsquamous histologies receiving pemetrexed and placebo, respectively (HR, 0.70; 95% CI, 0.56-0.88). The median OS time in patients with squamous histology receiving pemetrexed was 9.9 months, versus 10.8 months for those receiving placebo (HR, 1.07; 95% CI, 0.77-1.50). A significantly longer progression- free survival interval for both the ITT and nonsquamous patient populations receiving pemetrexed maintenance therapy was also observed.
The most common (>5%) adverse reactions in patients receiving pemetrexed were hematologic toxicity, an increase in hepatic enzymes, fatigue, gastrointestinal toxicity, sensory neuropathy, and skin rash. The Oncologist 2010;15:1352-1358
C1 [Cohen, Martin H.; Cortazar, Patricia; Justice, Robert; Pazdur, Richard] US FDA, Off Oncol Drug Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Cohen, MH (reprint author), US FDA, Off Oncol Drug Prod, Ctr Drug Evaluat & Res, White Oak Campus,10903 New Hampshire Ave,Bldg 22, Silver Spring, MD 20993 USA.
EM martin.cohen@fda.hhs.gov
NR 23
TC 27
Z9 27
U1 0
U2 0
PU ALPHAMED PRESS
PI DURHAM
PA 318 BLACKWELL ST, STE 260, DURHAM, NC 27701-2884 USA
SN 1083-7159
J9 ONCOLOGIST
JI Oncologist
PD DEC
PY 2010
VL 15
IS 12
BP 1352
EP 1358
DI 10.1634/theoncologist.2010-0224
PG 7
WC Oncology
SC Oncology
GA 699SK
UT WOS:000285682900014
PM 21148615
ER
PT J
AU Dal Pan, GJ
AF Dal Pan, Gerald J.
TI Commentary on "Secondary Use of Electronic Health Record Data:
Spontaneous Triggered Adverse Drug Event Reporting" by Linder et al.
SO PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
LA English
DT Editorial Material
C1 US FDA, Silver Spring, MD USA.
RP Dal Pan, GJ (reprint author), US FDA, Silver Spring, MD USA.
EM gerald.dalpan@fda.hhs.gov
NR 0
TC 4
Z9 4
U1 0
U2 0
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 1053-8569
J9 PHARMACOEPIDEM DR S
JI Pharmacoepidemiol. Drug Saf.
PD DEC
PY 2010
VL 19
IS 12
BP 1216
EP 1217
DI 10.1002/pds.2050
PG 2
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
GA 699JO
UT WOS:000285659900002
PM 20981885
ER
PT J
AU Shaw, PM
Zineh, I
AF Shaw, Peter M.
Zineh, Issam
TI Generating and weighing evidence in drug development and regulatory
decision making: 5th US FDA-DIA workshop on pharmacogenomics
SO PHARMACOGENOMICS
LA English
DT Article
DE co-development; diagnostics; DNA sampling; drug labels; pharmaceutical
company; pharmacogenetics; pharmacogenomics; prospective/retrospective
analysis; regulatory; US FDA; workshop
AB The 5th US FDA-Drug Industry Association (DIA) workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making', contained four major topics (tracks): 'Learning from Labels and Label Changes: How to Build Pharmacogenomics into Drug Development Programs'; 'Enabling Pharmacogenomic Clinical Trials Through Sampling'; 'Designing Pharmacogenomics Studies to be Fit for Purpose'; and 'Co-Development of Drugs and Diagnostics'. The meeting was attended by approximately 200 professionals, primarily involved in drug development and healthcare delivery. Several critical elements drove the success of the meeting: it was recognized that the enriched conversation at this workshop between regulators and drug developers was driven with less inhibition than before and with a greater scientific focus on the issues. Multiple examples in the field and broader collective experience helped more in-depth thinking of the pros and cons of implementing pharmacogenetic/genetic approaches during drug development, in the current environment. It was also noted that this field is still developing and nascent as illustrated by the paucity of actual diagnostic drug co-development examples. Furthermore, the complexities of conducting pharmacogenetic research in global drug-development programs was acknowledged as was the need for rigorous research designs and methodologies despite these challenges.
C1 [Shaw, Peter M.] Merck & Co Inc, Pharmacogenet & Mol Profiling, West Point, PA 19486 USA.
[Zineh, Issam] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Shaw, PM (reprint author), Merck & Co Inc, Pharmacogenet & Mol Profiling, POB 4,770 Sumneytown Pike,WP53B-120, West Point, PA 19486 USA.
EM peter_show3@merck.com
NR 4
TC 3
Z9 3
U1 0
U2 1
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1462-2416
J9 PHARMACOGENOMICS
JI Pharmacogenomics
PD DEC
PY 2010
VL 11
IS 12
SI SI
BP 1629
EP 1635
DI 10.2217/PGS.10.142
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 742VS
UT WOS:000288974000001
PM 21142905
ER
PT J
AU Surh, LC
Pacanowski, MA
Haga, SB
Hobbs, S
Lesko, LJ
Gottlieb, S
Papaluca-Amati, M
Patterson, SD
Hughes, AR
Kim, MJ
Close, SL
Mosteller, M
Zineh, I
Dechairo, B
Cohen, NA
AF Surh, Linda C.
Pacanowski, Michael A.
Haga, Susanne B.
Hobbs, Stuart
Lesko, Lawrence J.
Gottlieb, Scott
Papaluca-Amati, Marisa
Patterson, Scott D.
Hughes, Arlene R.
Kim, Myong-Jin
Close, Sandra L.
Mosteller, Michael
Zineh, Issam
Dechairo, Bryan
Cohen, Nadine A.
TI Learning from product labels and label changes: how to build
pharmacogenomics into drug-development programs
SO PHARMACOGENOMICS
LA English
DT Article
DE biomarkers; genetic tests; pharmacogenetics; pharmacogenomics; product
label; summary of product characteristics; US prescribing information
ID COLORECTAL-CANCER; WARFARIN
AB The 2010 US FDA-Drug Industry Association (DIA) Pharmacogenomics (PGx) Workshop follows a series that began in 2002 bringing together multidisciplinary experts spanning regulatory authorities, medical research, healthcare and industry. This report summarizes the 'Building PGx into Labels' sessions from the workshop, which discussed the critical elements in developing PGx outcomes leading to product labels that inform efficacy and/or safety. Examples were drawn from US prescribing information, which integrated PGx knowledge into medical decisions (e.g., panitumumab, warfarin and clopidogrel). Attendees indicated the need for broader dialog and for guidelines on evidentiary considerations for PGx to be included into product labels. Also discussed was the understanding of appropriate PGx placement on labels; how to encourage adoption by medical communities of label recommendations on PGx tests; and, given the global nature of drug development, worldwide considerations including European Summary of Product Characteristics.
C1 [Surh, Linda C.] GlaxoSmithKline Inc, Global Regulatory Affairs, Res Triangle Pk, NC 27709 USA.
[Pacanowski, Michael A.; Lesko, Lawrence J.; Kim, Myong-Jin; Zineh, Issam] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
[Haga, Susanne B.] Duke Univ, Inst Genome Sci & Policy, Durham, NC 27706 USA.
[Hughes, Arlene R.; Mosteller, Michael] GlaxoSmithKline Inc, Genet, Res Triangle Pk, NC USA.
[Gottlieb, Scott] Amer Enterprise Inst Publ Policy Res, Washington, DC 20036 USA.
[Papaluca-Amati, Marisa] European Med Agcy, London, England.
[Patterson, Scott D.] Amgen Inc, Mol Sci, Thousand Oaks, CA USA.
[Close, Sandra L.] Eli Lilly & Co, BioMed, Indianapolis, IN USA.
RP Surh, LC (reprint author), GlaxoSmithKline Inc, Global Regulatory Affairs, Res Triangle Pk, NC 27709 USA.
EM lcsurh@gmail.com
NR 8
TC 11
Z9 11
U1 0
U2 4
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1462-2416
J9 PHARMACOGENOMICS
JI Pharmacogenomics
PD DEC
PY 2010
VL 11
IS 12
SI SI
BP 1637
EP 1647
DI 10.2217/PGS.10.138
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 742VS
UT WOS:000288974000002
PM 21142906
ER
PT J
AU Warner, A
Nelsen, A
Bhathena, A
FitzGerald, K
Gilardi, S
Kelso, E
Knoppers, B
McLeod, HL
Nelson, R
Uyama, Y
Weisman, J
Rudman, A
AF Warner, Amelia
Nelsen, Anita
Bhathena, Anahita
FitzGerald, Kevin
Gilardi, Sandra
Kelso, Ellen
Knoppers, Bartha
McLeod, Howard L.
Nelson, Robert
Uyama, Yoshi
Weisman, Jennifer
Rudman, Allen
TI Enabling pharmacogenomic clinical trials through sampling
SO PHARMACOGENOMICS
LA English
DT Article
DE clinical trials; drug development; international coordination;
pharmacogenomics; regulatory; sample collection
AB Discussion and output from the US FDA and the pharmaceutical industry from the Drug Information Association/FDA 5th Workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making'. A major topic area at the 5th FDA/Industry Workshop on Pharmacogenomics, February 2-4, 2010 in Bethseda (MD, USA), was enabling pharmacogenomic clinical trials through collection of future use samples. The importance of the collection of samples with permission for future analyses was affirmed by both industry and the FDA. In addition, current barriers for the collection of such samples were detailed and possible solutions for overcoming barriers at sites, as well as globally within countries, were discussed. The importance of international concordance on collection of these samples was emphasized, and potential areas for industry to harmonize sample collection practices. A standalone workshop on issues related to sampling was determined to be a key step for solving issues related to future use sample collection during drug development.
C1 [Warner, Amelia] Merck Res Labs, N Wales, PA 19454 USA.
[Nelsen, Anita] GlaxoSmithKline Inc, Res Triangle Pk, NC 27709 USA.
[Bhathena, Anahita] Abbott Labs, Abbott Pk, IL 60064 USA.
[FitzGerald, Kevin] Georgetown Univ, Washington, DC 20057 USA.
[Gilardi, Sandra] Bristol Myers Squibb Co, Pennington, NJ 08534 USA.
[Kelso, Ellen] Goodwyn Inst Review Board, Cincinnati, OH 45242 USA.
[Knoppers, Bartha] McGill Univ, Montreal, PQ H3A 1A4, Canada.
[McLeod, Howard L.] Univ N Carolina, Chapel Hill, NC 27599 USA.
[Nelson, Robert; Rudman, Allen] US FDA, Silver Spring, MD 20993 USA.
[Uyama, Yoshi] Japanese Pharmaceut & Med Devices Agcy, Tokyo 1000013, Japan.
[Weisman, Jennifer] Off Civil Rights, Silver Spring, MD 20993 USA.
RP Warner, A (reprint author), Merck Res Labs, 351 N Sumneytown Pike,UG4D-34, N Wales, PA 19454 USA.
EM amelia.warner@merck.com
NR 2
TC 3
Z9 3
U1 0
U2 0
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1462-2416
J9 PHARMACOGENOMICS
JI Pharmacogenomics
PD DEC
PY 2010
VL 11
IS 12
SI SI
BP 1649
EP 1654
DI 10.2217/PGS.10.139
PG 6
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 742VS
UT WOS:000288974000003
PM 21142907
ER
PT J
AU Burns, DK
Hughes, AR
Power, A
Wang, SJ
Patterson, SD
AF Burns, Daniel K.
Hughes, Arlene R.
Power, Aidan
Wang, Sue-Jane
Patterson, Scott D.
TI Designing pharmacogenomic studies to be fit for purpose
SO PHARMACOGENOMICS
LA English
DT Article
DE abacavir; biomarkers; cetuximab; HLA-B*5701; KRAS; panitumumab;
pharmacogenomics; prospective-retrospective
ID METASTATIC COLORECTAL-CANCER; HUMAN-LEUKOCYTE ANTIGEN-B-ASTERISK-5701;
ABACAVIR HYPERSENSITIVITY REACTIONS; HLA-B REGION; K-RAS;
GENETIC-VARIATIONS; CLINICAL-OUTCOMES; ASSOCIATION; HLA-B-ASTERISK-5701;
MUTATIONS
AB The 2010 US FDA-Drug Industry Association (DIA) Pharmacogenomics Workshop, the fifth in a series of meetings that begun in 2002, brought together multidisciplinary experts from regulatory authorities, medical research, healthcare and drug development. This article summarizes the 'Designing Pharmacogenomic Studies to be Fit for Purpose' track in which considerations regarding the use of retrospective and prospective studies were examined in relation to their ability to influence treatment decisions and labeling for drugs. The aim of the session, using real-world examples (KRAS/panitumumab and HLA-B*5701/abacavir), was to identify good scientific principles that would guide the design of studies to identify subgroups of responders during development programs (including marketed drugs), which could subsequently be used to guide treatment decisions.
C1 [Patterson, Scott D.] Amgen Inc, Med Sci, Thousand Oaks, CA 91320 USA.
[Burns, Daniel K.] Duke Univ, Deane Drug Discovery Inst, R David Thomas Execut Training Ctr, Durham, NC 27708 USA.
[Hughes, Arlene R.] Genet GlaxoSmithKline, Res Triangle Pk, NC 27709 USA.
[Power, Aidan] Pfizer Inc, Mol Med, PharmaTherapeut Res, Groton, CT 06340 USA.
[Wang, Sue-Jane] US FDA, Off Biostat, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Wang, Sue-Jane] Johns Hopkins Univ, Baltimore, MD 21218 USA.
RP Patterson, SD (reprint author), Amgen Inc, Med Sci, 1 Amgen Ctr Dr,MS 38-3-A, Thousand Oaks, CA 91320 USA.
EM spatters@amgen.com
NR 46
TC 5
Z9 5
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 1462-2416
J9 PHARMACOGENOMICS
JI Pharmacogenomics
PD DEC
PY 2010
VL 11
IS 12
SI SI
BP 1657
EP 1667
DI 10.2217/PGS.10.140
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 742VS
UT WOS:000288974000004
PM 21142908
ER
PT J
AU Hinman, LM
Carl, KM
Spear, BB
Salerno, RA
Becker, RL
Abbott, BM
Kelly, JF
Mansfield, E
Katz, RG
Harper, C
Day, SP
Pacanowski, MA
Pignato, W
AF Hinman, Lois M.
Carl, Kevin M.
Spear, Brian B.
Salerno, Ronald A.
Becker, Robert L.
Abbott, Brian M.
Kelly, James F.
Mansfield, Elizabeth
Katz, Russell G.
Harper, Courtney
Day, Stephen P.
Pacanowski, Michael A.
Pignato, William
TI Development and regulatory strategies for drug and diagnostic
co-development
SO PHARMACOGENOMICS
LA English
DT Article
DE biomarkers; co-development pharmacogenomics; companion diagnostics;
drug/diagnostic
ID LUMIRACOXIB
AB At the 5th FDA-Drug Industry Association (DIA) Workshop on 'Pharmacogenomics in Drug Development and Regulatory Decision Making', track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit risk paradigm for new drugs.
C1 [Hinman, Lois M.] Novartis Pharmaceut, E Hanover, NJ 07939 USA.
Abbott Labs, Abbott Pk, IL 60064 USA.
US FDA, CDRH, Rockville, MD 20857 USA.
AstraZeneca, Wilmington, DE USA.
Roche Mol Systs, Alameda, CA USA.
[Pignato, William] Novartis Mol Diagnost, Cambridge, MA USA.
RP Hinman, LM (reprint author), Novartis Pharmaceut, 1 Hth Plaza, E Hanover, NJ 07939 USA.
EM lois.hinman@novartis.com
NR 6
TC 9
Z9 9
U1 1
U2 5
PU FUTURE MEDICINE LTD
PI LONDON
PA UNITEC HOUSE, 3RD FLOOR, 2 ALBERT PLACE, FINCHLEY CENTRAL, LONDON, N3
1QB, ENGLAND
SN 1462-2416
J9 PHARMACOGENOMICS
JI Pharmacogenomics
PD DEC
PY 2010
VL 11
IS 12
SI SI
BP 1669
EP 1675
DI 10.2217/PGS.10.141
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 742VS
UT WOS:000288974000005
PM 21142909
ER
PT J
AU Soldin, OP
Soldin, SJ
Vinks, AA
Younis, I
Landy, HJ
AF Soldin, Offie P.
Soldin, Steven J.
Vinks, Alexander A.
Younis, Islam
Landy, Helain J.
TI Longitudinal Comparison of Thyroxine Pharmacokinetics Between Pregnant
and Nonpregnant Women: A Stable Isotope Study
SO THERAPEUTIC DRUG MONITORING
LA English
DT Article
DE levothyroxine LT4; Thyroid; gestation; clinical pharmacology; thyroid
disorder/drug therapy/physiopathology/hypothyroidism
ID TANDEM MASS-SPECTROMETRY; THYROID-HORMONE TRANSPORTERS; REFERENCE
INTERVALS; MENSTRUAL-CYCLE; DISEASE; TRIIODOTHYRONINE; REPLACEMENT;
BRAIN; HYPOTHYROIDISM; DEFICIENCY
AB The treatment of maternal hypothyroidism presents clinicians with a unique challenge, because dosing regimens previously developed and validated for nonpregnant women cannot be easily extrapolated to dosing in pregnancy. Thyroid hormone requirement increases by 20% to 40% early during pregnancy, persisting throughout gestation. Accordingly, women with treated hypothyroidism need to increase their levothyroxine dose to prevent maternal hypothyroidism and the associated impaired cognitive development and increased fetal mortality. We investigated the pharmacokinetic properties of levothyroxine during pregnancy through the use of a novel, traceable form of levothyroxine. The objective was to conduct a longitudinal study to determine whether levothyroxine pharmacokinetics differ in the pregnant versus nonpregnant state. We used a unique C-13-levothyroxine-tracer method to distinguish between endogenous and exogenous levothyroxine and studied the pharmacokinetics of a single oral dose of levothyroxine using tandem mass spectrometry. Moreover, we were able to detect single dose amounts of the drug, in picogram/mL concentrations. The area under the curve was 23.0 ng*h/mL in pregnancy and 14.8 ng*h/mL in nonpregnant women (P < 0.03) with median serum half-lives of 32.1 hours and 24.1 hours, respectively (P < 0.04). Further research involves the measurement of free thyroxine on these samples using tandem mass spectrometry. Future work should focus on the mechanisms responsible for the gestational differences in pharmacokinetics and whether these should necessitate dose schedule changes in pregnancy.
C1 [Soldin, Offie P.] Georgetown Univ, Med Ctr, Dept Med, Washington, DC 20007 USA.
[Soldin, Offie P.] Georgetown Univ, Med Ctr, Dept Oncol, Washington, DC 20007 USA.
[Soldin, Offie P.] Georgetown Univ, Med Ctr, Dept Physiol, Washington, DC 20007 USA.
[Soldin, Offie P.] Georgetown Univ, Med Ctr, Dept Biophys, Washington, DC 20007 USA.
[Soldin, Steven J.] Georgetown Univ, Dept Pharmacol, Washington, DC USA.
[Soldin, Steven J.] Georgetown Univ, Bioanalyt Core Lab, Washington, DC USA.
[Vinks, Alexander A.] Univ Cincinnati, Cincinnati Childrens Hosp Med Ctr, Div Clin Pharmacol, Cincinnati, OH USA.
[Vinks, Alexander A.] Univ Cincinnati, Cincinnati Childrens Hosp Med Ctr, Pediat Pharmacol Res Unit, Cincinnati, OH USA.
[Vinks, Alexander A.] Univ Cincinnati, Dept Pediat, Cincinnati, OH 45221 USA.
[Younis, Islam] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Bethesda, MD 20014 USA.
[Landy, Helain J.] Georgetown Univ Hosp, Dept Obstet & Gynecol, Washington, DC 20007 USA.
RP Soldin, OP (reprint author), Lombardi Comprehens Canc Ctr, Dept Med, LL S-166, Washington, DC 20057 USA.
EM os35@georgetown.edu
FU National Institutes of Health/National Institute of Child Health and
Human Development (NIH/NICHD) [5U10HD0478925]; Office of Research on
Women's Health; GCRC at Georgetown University Medical Center; NIH/NICHD
Pediatric Pharmacology Research Unit [5U10HD037249-10]; National
Institutes of Health National Center for Research Resources
[M01RR-023942]
FX O.P.S. is supported by a National Institutes of Health/National
Institute of Child Health and Human Development (NIH/NICHD) supplement
to the Obstetric-Fetal Pharmacology Research Unit Network Grant
5U10HD0478925, funds from the Office of Research on Women's Health, and
by the GCRC at Georgetown University Medical Center. A.A.V.'s
contribution was supported in part by NIH/NICHD Pediatric Pharmacology
Research Unit grant 5U10HD037249-10 (AAV).; This project was conducted
through the General Clinical Research Center at Georgetown University
and supported by the National Institutes of Health National Center for
Research Resources, Grant M01RR-023942.
NR 35
TC 2
Z9 2
U1 0
U2 1
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, PA 19103 USA
SN 0163-4356
EI 1536-3694
J9 THER DRUG MONIT
JI Ther. Drug Monit.
PD DEC
PY 2010
VL 32
IS 6
BP 767
EP 773
DI 10.1097/FTD.0b013e3181f12fe5
PG 7
WC Medical Laboratory Technology; Pharmacology & Pharmacy; Toxicology
SC Medical Laboratory Technology; Pharmacology & Pharmacy; Toxicology
GA 678TI
UT WOS:000284103400015
PM 20962709
ER
PT J
AU Boorman, GA
Wolf, DC
Francke-Carroll, S
Maronpot, RR
AF Boorman, Gary A.
Wolf, Douglas C.
Francke-Carroll, Sabine
Maronpot, Robert R.
TI Pathology Peer Review
SO TOXICOLOGIC PATHOLOGY
LA English
DT Editorial Material
DE toxicologic pathology; safety assessment; quality assurance
C1 [Boorman, Gary A.] Covance Inc, Vienna, VA USA.
[Wolf, Douglas C.] US EPA, Res Triangle Pk, NC 27711 USA.
[Francke-Carroll, Sabine] US FDA, College Pk, MD USA.
[Maronpot, Robert R.] Maronpot Consulting LLC, Raleigh, NC USA.
RP Boorman, GA (reprint author), Covance Inc, Vienna, VA USA.
NR 0
TC 3
Z9 3
U1 0
U2 0
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0192-6233
J9 TOXICOL PATHOL
JI Toxicol. Pathol.
PD DEC
PY 2010
VL 38
IS 7
BP 1009
EP 1010
DI 10.1177/0192623310385361
PG 2
WC Pathology; Toxicology
SC Pathology; Toxicology
GA 800QM
UT WOS:000293378600001
PM 21248323
ER
PT J
AU Soni, MG
Thurmond, TS
Miller, ER
Spriggs, T
Bendich, A
Omaye, ST
AF Soni, Madhu G.
Thurmond, T. Scott
Miller, Edgar R., III
Spriggs, Tracey
Bendich, Adrianne
Omaye, Stanley T.
TI Safety of Vitamins and Minerals: Controversies and Perspective
SO TOXICOLOGICAL SCIENCES
LA English
DT Editorial Material
DE antioxidants; safety; vitamins; minerals; supplements; toxicity
ID RANDOMIZED CONTROLLED-TRIAL; LONG-TERM SUPPLEMENTATION; BETA-CAROTENE;
CARDIOVASCULAR-DISEASE; ALPHA-TOCOPHEROL; WOMENS HEALTH; LUNG-CANCER;
ANTIOXIDANT; PREVENTION; FLAVONOIDS
AB Available information suggests that currently over 47% of males and 59% of females use dietary supplements for health benefits, and the number of users is rapidly increasing. However, numerous studies published over more than a decade have linked some supplements (including vitamins E, C, D, A, and B, as well as selenium) to no health benefits or even to adverse health effects. Recent studies with negative results, which drew media attention, include the following: a 2008 study on the ability of vitamin E and selenium to lower the risk of prostate cancer was halted amidst fear of potential harm; vitamin C may do more harm than good as it may protect cancer cells; intake of vitamins E and C by 15,000 male physicians for 10 years had no health benefits. In contrast, there are compelling cause and effect data linking the use of folic acid with consistent and significant reductions in fetal adverse pregnancy outcomes, demonstrating no beneficial effects of calcium and vitamin D supplements in improving bone strength and reducing fractures. These equivocal and conflicting findings on the effects of supplements on health outcomes have left consumers confused about their benefits and wary of the possible adverse effects of vitamin and mineral supplementation. The objectives of this session are to characterize the current state of the science as it relates to the impact of vitamin and mineral supplementation on human health, review the statutory and regulatory perspective of vitamin use from a safety perspective, assess the credibility of meta-analysis in the safety assessment of vitamins, and elicit the mechanisms of these interactions-pro-oxidant versus antioxidant effects and beneficial versus adverse effects.
C1 [Omaye, Stanley T.] Univ Nevada, Dept Nutr, Reno, NV 89557 USA.
[Soni, Madhu G.] Soni & Associates Inc, Vero Beach, FL USA.
[Thurmond, T. Scott] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
[Miller, Edgar R., III] Johns Hopkins Med Inst, Welch Ctr Prevent Epidemiol & Clin Res, Baltimore, MD 21205 USA.
[Spriggs, Tracey; Bendich, Adrianne] GlaxoSmithkline Consumer Healthcare, Parsippany, NJ USA.
RP Omaye, ST (reprint author), Univ Nevada, Dept Nutr, Mail Stop 142, Reno, NV 89557 USA.
EM omaye@unr.edu
NR 49
TC 28
Z9 30
U1 3
U2 14
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1096-6080
J9 TOXICOL SCI
JI Toxicol. Sci.
PD DEC
PY 2010
VL 118
IS 2
BP 348
EP 355
DI 10.1093/toxsci/kfq293
PG 8
WC Toxicology
SC Toxicology
GA 682WB
UT WOS:000284432600003
PM 20861067
ER
PT J
AU Wang, T
Jacobson-Kram, D
Pilaro, AM
Lapadula, D
Jacobs, A
Brown, P
Lipscomb, J
McGuinn, WD
AF Wang, Tao
Jacobson-Kram, David
Pilaro, Anne M.
Lapadula, Daniel
Jacobs, Abigail
Brown, Paul
Lipscomb, John
McGuinn, William David
TI ICH Guidelines: Inception, Revision, and Implications for Drug
Development
SO TOXICOLOGICAL SCIENCES
LA English
DT Editorial Material
ID TOXICITY; ASSAY; TRANSFORMATION; CARCINOGENS
C1 [Wang, Tao] Nova Pharmaceut Corp, Preclin Safety, Emeryville, CA 94608 USA.
[Jacobson-Kram, David; Pilaro, Anne M.; Jacobs, Abigail; Brown, Paul; McGuinn, William David] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
[Lapadula, Daniel] Novartis Pharmaceut, Preclin Safety, E Hanover, NJ 07936 USA.
[Lipscomb, John] US EPA, Natl Ctr Environm Assessment, Cincinnati, OH 45268 USA.
RP Wang, T (reprint author), Nova Pharmaceut Corp, Preclin Safety, 4560 Horton St,M-S 4-6, Emeryville, CA 94608 USA.
EM tao.wang@novartis.com
NR 16
TC 8
Z9 8
U1 0
U2 3
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1096-6080
J9 TOXICOL SCI
JI Toxicol. Sci.
PD DEC
PY 2010
VL 118
IS 2
BP 356
EP 367
DI 10.1093/toxsci/kfq286
PG 12
WC Toxicology
SC Toxicology
GA 682WB
UT WOS:000284432600004
PM 20861066
ER
PT J
AU Yu, XF
Dhakal, IB
Beggs, M
Edavana, VK
Williams, S
Zhang, XM
Mercer, K
Ning, BT
Lang, NP
Kadlubar, FF
Kadlubar, S
AF Yu, Xinfeng
Dhakal, Ishwori B.
Beggs, Marjorie
Edavana, Vineetha Koroth
Williams, Suzanne
Zhang, Xuemei
Mercer, Kelly
Ning, Baitang
Lang, Nicholas P.
Kadlubar, Fred F.
Kadlubar, Susan
TI Functional Genetic Variants in the 3 '-Untranslated Region of
Sulfotransferase Isoform 1A1 (SULT1A1) and Their Effect on Enzymatic
Activity
SO TOXICOLOGICAL SCIENCES
LA English
DT Article
DE SULT1A1; genotype; phenotype; pharmacogenetics
ID BREAST-CANCER PATIENTS; PHENOL SULFOTRANSFERASE; HUMAN GENOME;
HUMAN-LIVER; HAPLOTYPE RECONSTRUCTION; LINKAGE DISEQUILIBRIUM;
PARTIAL-PURIFICATION; ASSAY CONDITIONS; PST ACTIVITY; ASSOCIATION
AB Sulfotransferase isoform 1A1 (SULT1A1) is the most highly expressed hepatic sulfotransferase and is involved in the biotransformation of a wide variety of endo- and xenobiotics. A common single nucleotide polymorphism (SNP) in the coding region of SULT1A1, several proximal promoter SNPs, and copy number variation (CNV) are associated with altered enzymatic activity, but these variants do not fully account for the observed variation of SULT1A1 activity in human populations. In order to identify additional SNPs modulating SULT1A1 activity, we examined the 3'-untranslated region (UTR) of SULT1A1 in 97 liver samples. Direct sequencing revealed that two SNPs in the 3'-UTR (902A > G [rs6839] and 973C > T [rs1042157]) and one SNP in the 3'-flanking region (1307G > A [rs4788068]) were common. These SNPs are in absolute linkage disequilibrium with each other and in tight linkage with SULT1A1*1/2 (linkage coefficient D' 0.83) and are significantly associated with SULT1A1 messenger RNA (p = 0.001, 0.029, 0.021) and enzymatic activity (p = 0.022, 0.012, 0.027). We then examined the collective effects of 3'-UTR SNPs, SULT1A1*1/2, and CNV on SULT1A1 activity in 498 Caucasian and 127 African-American subjects by haplotype analysis. This analysis revealed that SULT1A1*1/2 does not contribute to the variation in SULT1A1 enzymatic activity when the 3'-UTR SNPs are included in the statistical model. Two major haplotypes (ACG and GTA) were significantly correlated with SULT1A1 activity, and when stratified by copy number, the SULT1A1 3'-UTR SNPs remain significantly associated with SULT1A1 enzymatic activity in Caucasians, but not in African-Americans. Subsequent functional characterization revealed that a microRNA, miR-631, regulates SULT1A1 expression in a genotype-specific manner.
C1 [Yu, Xinfeng; Dhakal, Ishwori B.; Beggs, Marjorie; Edavana, Vineetha Koroth; Williams, Suzanne; Zhang, Xuemei; Mercer, Kelly; Kadlubar, Fred F.; Kadlubar, Susan] Univ Arkansas Med Sci, Coll Med, Div Med Genet, Little Rock, AR 72205 USA.
[Ning, Baitang] Natl Ctr Toxicol Res, Div Personalized Nutr & Med, Jefferson, AR 72079 USA.
[Lang, Nicholas P.] Univ Arkansas Med Sci, Coll Med, Dept Surg, Little Rock, AR 72205 USA.
RP Kadlubar, S (reprint author), Univ Arkansas Med Sci, Coll Med, Div Med Genet, 4301 W Markham,580, Little Rock, AR 72205 USA.
EM sakadlubar@uams.edu
FU National Cancer Institute at the National Institutes of Health
[R01CA128897]; National Center for Research Resources [1UL1RR029884];
Susan G. Komen for the Cure [BCTR0707584]
FX National Cancer Institute at the National Institutes of Health
(R01CA128897); National Center for Research Resources (award number
1UL1RR029884); Susan G. Komen for the Cure (BCTR0707584).
NR 42
TC 30
Z9 31
U1 0
U2 0
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1096-6080
J9 TOXICOL SCI
JI Toxicol. Sci.
PD DEC
PY 2010
VL 118
IS 2
BP 391
EP 403
DI 10.1093/toxsci/kfq296
PG 13
WC Toxicology
SC Toxicology
GA 682WB
UT WOS:000284432600007
PM 20881232
ER
PT J
AU Fux, E
Gonzalez-Gil, S
Lunven, M
Gentien, P
Hess, P
AF Fux, Elie
Gonzalez-Gil, Sonsoles
Lunven, Michel
Gentien, Patrick
Hess, Philipp
TI Production of diarrhetic shellfish poisoning toxins and pectenotoxins at
depths within and below the euphotic zone
SO TOXICON
LA English
DT Article
DE Marine toxins; Dinophysis acuta; LC-MS; Passive sampling; SPATT; Okadaic
acid; Dinophysistoxin-2; Pectenotoxin-2
ID DINOFLAGELLATE DINOPHYSIS-ACUMINATA; LC-MS/MS ANALYSIS; OKADAIC ACID;
NEW-ZEALAND; LIQUID-CHROMATOGRAPHY; MARINE-PHYTOPLANKTON;
MASS-SPECTROMETRY; LIPOPHILIC TOXINS; BALTIC SEA; ACUTA
AB During a 10 day survey in the CelticSea near the Irish South-West coast (July 2007), Dinophysis acuta was observed in large numbers. The deployment of a profiler allowed for the identification of a D. acuta thin layer that reached 1910 cells/L The aim of the study was to investigate if the bloom that occurred in low light environment was viable, dividing, actively producing toxins and if the toxin profile changed over a short term period. Several large concentrates of phytoplankton samples were obtained over a 14 h period, from evening to morning, by pumping Dinophysis from specific depths. In addition, D. acuta was collected in complete darkness at 81 m depth by concentrating 120 L of water. The cells were extracted and their toxin profiles were established by liquid chromatography - mass spectrometry (LC-MS). Passive samplers were deployed in a nearby location for 6 days at 30, 50, 70 and 110 m depth, and the toxin profiles were determined by LC-MS as above. The toxin profiles obtained in phytoplankton samples and in the SPATT were compared and correlated well. Sample concentrates and SPATT results suggested that toxic D. acuta occurred and produced similar toxin profiles at all water depths, including below the euphotic zone. (C) 2010 Elsevier Ltd. All rights reserved.
C1 [Fux, Elie; Hess, Philipp] Biotoxin Chem Marine Inst, Galway, Ireland.
[Gonzalez-Gil, Sonsoles] Inst Espanol Oceanog, Ctr Oceanog Vigo, Vigo, Spain.
[Lunven, Michel; Gentien, Patrick] IFREMER, Ctr Brest, F-29280 Plouzane, France.
RP Fux, E (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 1 Iberville Dr, Dauphin Isl, AL 36528 USA.
EM elie.fux@marine.ie
RI Hess, Philipp/G-1761-2010; Gonzalez-Gil, Sonsoles/M-2515-2014
OI Hess, Philipp/0000-0002-9047-1345;
FU Marine Institute; BIOTOX; EU [514074]
FX The Marine Institute and BIOTOX (EU funded project 514074 under FP 6)
have provided funds for this study. The authors also would like Dr
Juliette Smith from Woods Hole Oceanographic Institute for her valuable
comments on this manuscript.
NR 34
TC 11
Z9 11
U1 1
U2 17
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0041-0101
J9 TOXICON
JI Toxicon
PD DEC
PY 2010
VL 56
IS 8
BP 1487
EP 1496
DI 10.1016/j.toxicon.2010.09.007
PG 10
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 685YQ
UT WOS:000284664400021
PM 20888853
ER
PT J
AU Boada, LD
Zumbado, M
Luzardo, OR
Almeida-Gonzalez, M
Plakas, SM
Granade, HR
Abraham, A
Jester, ELE
Dickey, RW
AF Boada, Luis D.
Zumbado, Manuel
Luzardo, Octavio R.
Almeida-Gonzalez, Maira
Plakas, Steven M.
Granade, Hudson R.
Abraham, Ann
Jester, Edward L. E.
Dickey, Robert W.
TI Ciguatera fish poisoning on the West Africa Coast: An emerging risk in
the Canary Islands (Spain)
SO TOXICON
LA English
DT Article
DE Ciguatera; Outbreak; Ciguatoxins; Lesser amberjack; Canary Islands
ID NEUROTOXINS; TOXINS
AB Ciguatera fish poisoning (CFP) is endemic in certain tropical and subtropical regions of the world. CFP had not been described on the West Africa Coast until a 2004 outbreak in the Canary Islands. In 2008-2009, two additional outbreaks of ciguatera occurred. Individuals afflicted had consumed lesser amberjack (Seriola rivoliana) captured from nearby waters. Caribbean ciguatoxin-1 (C-CTX-1) was confirmed in fish samples by LC-MS/MS. Ciguatoxic fish in this region may pose a new health risk for the seafood consumer. (C) 2010 Elsevier Ltd. All rights reserved.
C1 [Boada, Luis D.; Zumbado, Manuel; Luzardo, Octavio R.; Almeida-Gonzalez, Maira] Univ Las Palmas Gran Canaria, Hlth Sci Ctr, Dept Clin Sci, Toxicol Unit, Las Palmas Gran Canaria 35080, Spain.
[Plakas, Steven M.; Granade, Hudson R.; Abraham, Ann; Jester, Edward L. E.; Dickey, Robert W.] US FDA, Gulf Coast Seafood Lab, Dauphin Isl, AL USA.
RP Boada, LD (reprint author), Univ Las Palmas Gran Canaria, Hlth Sci Ctr, Dept Clin Sci, Toxicol Unit, POB 550, Las Palmas Gran Canaria 35080, Spain.
EM ldominguez@dcc.ulpgc.es
RI Zumbado, Manuel/B-4495-2010; Dominguez-Boada, Luis/L-5577-2015;
OI Almeida Gonzalez, Maira/0000-0003-2410-4659; Dominguez-Boada,
Luis/0000-0002-0195-4565; P. Luzardo, Octavio/0000-0002-4153-3028
NR 17
TC 21
Z9 22
U1 1
U2 5
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0041-0101
J9 TOXICON
JI Toxicon
PD DEC
PY 2010
VL 56
IS 8
BP 1516
EP 1519
DI 10.1016/j.toxicon.2010.07.021
PG 4
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 685YQ
UT WOS:000284664400025
PM 20692274
ER
PT J
AU Kwekel, JC
Desai, VG
Moland, CL
Branham, WS
Fuscoe, JC
AF Kwekel, Joshua C.
Desai, Varsha G.
Moland, Carrie L.
Branham, William S.
Fuscoe, James C.
TI Age and sex dependent changes in liver gene expression during the life
cycle of the rat
SO BMC GENOMICS
LA English
DT Article
ID DRUG-METABOLIZING-ENZYMES; TRANSCRIPTION FACTORS; MOUSE-LIVER;
CLINICAL-PHARMACOLOGY; UNITED-STATES; GROWTH; INJURY; CYTOCHROME-P450;
CARCINOGENICITY; POLYMORPHISMS
AB Background: Age-and sex-related susceptibility to adverse drug reactions and disease is a key concern in understanding drug safety and disease progression. We hypothesize that the underlying suite of hepatic genes expressed at various life cycle stages will impact susceptibility to adverse drug reactions. Understanding the basal liver gene expression patterns is a necessary first step in addressing this hypothesis and will inform our assessments of adverse drug reactions as the liver plays a central role in drug metabolism and biotransformation. Untreated male and female F344 rats were sacrificed at 2, 5, 6, 8, 15, 21, 52, 78, and 104 weeks of age. Liver tissues were collected for histology and gene expression analysis. Whole-genome rat microarrays were used to query global expression profiles.
Results: An initial list of differentially expressed genes was selected using criteria based upon p-value (p < 0.05) and fold-change (+/- 1.5). Three dimensional principal component analyses revealed differences between males and females beginning at 2 weeks with more divergent profiles beginning at 5 weeks. The greatest sex-differences were observed between 8 and 52 weeks before converging again at 104 weeks. K-means clustering identified groups of genes that displayed age-related patterns of expression. Various adult aging-related clusters represented gene pathways related to xenobiotic metabolism, DNA damage repair, and oxidative stress.
Conclusions: These results suggest an underlying role for genes in specific clusters in potentiating age-and sex-related differences in susceptibility to adverse health effects. Furthermore, such a comprehensive picture of life cycle changes in gene expression deepens our understanding and informs the utility of liver gene expression biomarkers.
C1 [Kwekel, Joshua C.; Desai, Varsha G.; Moland, Carrie L.; Branham, William S.; Fuscoe, James C.] US FDA, Ctr Funct Genom, Div Syst Biol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Kwekel, JC (reprint author), US FDA, Ctr Funct Genom, Div Syst Biol, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM joshua.kwekel@fda.hhs.gov; james.fuscoe@fda.hhs.gov
FU U.S. Department of Energy; U.S. Food and Drug Administration
FX The thoughtful comments and critical reviews from Drs. Tao Han, Leming
Shi, and William Salminen are greatly appreciated. JCK was supported in
part by an appointment to the Research 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. The findings and conclusions presented in this article
are the authors and do not necessarily reflect those of the Food and
Drug Administration.
NR 58
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U1 0
U2 3
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 30
PY 2010
VL 11
AR 675
DI 10.1186/1471-2164-11-675
PG 15
WC Biotechnology & Applied Microbiology; Genetics & Heredity
SC Biotechnology & Applied Microbiology; Genetics & Heredity
GA 700TD
UT WOS:000285766300001
PM 21118493
ER
PT J
AU Hammad, TA
Mosholder, AD
AF Hammad, Tarek A.
Mosholder, Andrew D.
TI Suicide and antidepressants Beware extrapolation from ecological data
SO BRITISH MEDICAL JOURNAL
LA English
DT Letter
ID WARNINGS
C1 [Hammad, Tarek A.; Mosholder, Andrew D.] Food & Drug Adm, Ctr Drug Evaluat & Res, Off Surveillance & Epidemiol, Div Epidemiol, Silver Spring, MD 20993 USA.
RP Hammad, TA (reprint author), Food & Drug Adm, Ctr Drug Evaluat & Res, Off Surveillance & Epidemiol, Div Epidemiol, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Tarek.Hammad@fda.hhs.gov
NR 5
TC 1
Z9 1
U1 1
U2 4
PU BMJ PUBLISHING GROUP
PI LONDON
PA BRITISH MED ASSOC HOUSE, TAVISTOCK SQUARE, LONDON WC1H 9JR, ENGLAND
SN 1756-1833
J9 BRIT MED J
JI Br. Med. J.
PD NOV 30
PY 2010
VL 341
AR c6844
DI 10.1136/bmj.c6844
PG 2
WC Medicine, General & Internal
SC General & Internal Medicine
GA 691OG
UT WOS:000285090100003
PM 21118884
ER
PT J
AU Zhao, N
Zidan, A
Tawakkul, M
Sayeed, VA
Khan, M
AF Zhao, Na
Zidan, Ahmed
Tawakkul, Mobin
Sayeed, Vilayat A.
Khan, Mansoor
TI Tablet splitting: Product quality assessment of metoprolol succinate
extended release tablets
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Article
DE Tablet splitting; Quality assessment; Near infrared mapping
ID NEAR-INFRARED SPECTROSCOPY; NIR SPECTROSCOPY; PHARMACEUTICAL
APPLICATIONS; REFLECTANCE SPECTRA; CONTENT UNIFORMITY; BLEND UNIFORMITY;
IDENTIFICATION; CHEMOMETRICS; VARIABILITY; EXCIPIENTS
AB Metoprolol succinate extended release tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. Despite the flexibility that controlled release pellets may offer, segregation is one of the challenges that commonly occur during tableting for such drug delivery system. Since all commercial metoprolol succinate extended release tablets are scored, they are deemed suitable for splitting. The present study was aimed at utilizing an innovative technology to determine the dose uniformity for split tablets. Four marketed drug products consisting of innovator and generics were evaluated for effect of splitting on weight, assay and content uniformity. Novel analytical tool such as near infrared (NIR) chemical imaging was used to visualize the distribution of metoprolol succinate and functional excipients on the surfaces of the marketed tablets. The non-homogeneous distribution of directly compressed metoprolol succinate beads on the surface of the tablets as well as the split intersection explained the large variation in the split tablets' weight and content uniformity results. The obtained results indicated the usefulness of NIR chemical imaging to determine the need for content uniformity studies for certain split tablets. Published by Elsevier B.V.
C1 [Zhao, Na; Zidan, Ahmed; Tawakkul, Mobin; Khan, Mansoor] US FDA, Div Prod Qual Res, Off Testing & Res, CDER, Rockville, MD 20857 USA.
[Sayeed, Vilayat A.] US FDA, Div Chem Review, Off Gener Drugs, CDER, Rockville, MD 20857 USA.
[Zidan, Ahmed] Zagazig Univ, Fac Pharm, Zagazig, Egypt.
RP Khan, M (reprint author), 10903 New Hampshire Ave,WO 64, Silver Spring, MD 20993 USA.
EM Mansoor.khan@fda.hhs.gov
RI Zidan, Ahmed/I-1147-2012
FU critical path programs; Office of Generic Drugs
FX Funding from critical path programs and Office of Generic Drugs is
gratefully acknowledged.
NR 29
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U1 1
U2 16
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
J9 INT J PHARMACEUT
JI Int. J. Pharm.
PD NOV 30
PY 2010
VL 401
IS 1-2
BP 25
EP 31
DI 10.1016/j.ijpharm.2010.09.004
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 693KJ
UT WOS:000285222700004
PM 20849940
ER
PT J
AU Zhou, Y
Li, N
Choi, FFK
Qiao, CF
Song, JZ
Li, SL
Liu, X
Cai, ZW
Fu, PP
Lin, G
Xu, HX
AF Zhou, Yan
Li, Na
Choi, Franky Fung-Kei
Qiao, Chun-Feng
Song, Jing-Zheng
Li, Song-Lin
Liu, Xin
Cai, Zong-Wei
Fu, Peter P.
Lin, Ge
Xu, Hong-Xi
TI A new approach for simultaneous screening and quantification of toxic
pyrrolizidine alkaloids in some potential pyrrolizidine
alkaloid-containing plants by using ultra performance liquid
chromatography-tandem quadrupole mass spectrometry
SO ANALYTICA CHIMICA ACTA
LA English
DT Article
DE Pyrrolizidine alkaloids (PAs); UPLC-TQ-MS; Precursor ion scan (PIS);
Multiple reaction monitoring (MRM); Parasenecio species; Senecio species
ID MEDICINAL-PLANTS; N-OXIDES
AB A rapid, but sensitive and selective method for simultaneous screening and quantification of toxic pyrrolizidine alkaloids (PAs) by ultra performance liquid-chromatography (UPLC) coupled with tandem mass spectrometry (MS/MS) on a tandem quadrupole mass spectrometer (TQ-MS) is described. This was accomplished by incorporating the precursor ion scan (PIS) acquisition and multiple reaction monitoring (MRM) acquisition in the same UPLC-MS/MS run. Notably, the developed PIS approach for detecting two pairs of characteristic product ions at m/z 120/138 or 168/150, allowed specific identification of toxic retronecine and otonecine types PAs. This PIS method is highly sensitive with over 10-fold sensitivity improvement upon previously published LC-MS method. Moreover, this new approach is suitable for high sample throughput and was applied to the screening and quantifying toxic PAs in 22 samples collected from seven Parasenecio species and four Senecio species. In addition, coupling the MRM with PIS approach generated quantitative results equivalent to those obtained by conventional MRM-only approach. This coupled MRM with PIS approach could provide both qualitative and quantitative results without the need of repetitive analyses. (C) 2010 Elsevier B.V. All rights reserved.
C1 [Li, Na; Lin, Ge] Chinese Univ Hong Kong, Sch Biomed Sci, Hong Kong, Hong Kong, Peoples R China.
[Zhou, Yan; Choi, Franky Fung-Kei; Qiao, Chun-Feng; Song, Jing-Zheng; Li, Song-Lin; Liu, Xin; Xu, Hong-Xi] Hong Kong Jockey Club Inst Chinese Med, Shatin, Hong Kong, Peoples R China.
[Cai, Zong-Wei] Hong Kong Baptist Univ, Dept Chem, Hong Kong, Hong Kong, Peoples R China.
[Fu, Peter P.] Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Lin, G (reprint author), Chinese Univ Hong Kong, Sch Biomed Sci, Hong Kong, Hong Kong, Peoples R China.
EM linge@cuhk.edu.hk; xuhongxi@hkjcicm.org
OI Cai, Zongwei/0000-0002-8724-7684
FU Hong Kong Jockey Club Charities Trust [JCICM-15-07]
FX This research was supported by the Hong Kong Jockey Club Charities Trust
(JCICM-15-07). The authors are grateful to Dr. Karl Lo of Waters Corp.
The contents of this article do not necessarily reflect the views and
policies of the U.S. Food & Drug Administration. The mentioning of trade
names and commercial products does not constitute endorsement or
recommendation for use.
NR 26
TC 33
Z9 38
U1 6
U2 39
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0003-2670
J9 ANAL CHIM ACTA
JI Anal. Chim. Acta
PD NOV 29
PY 2010
VL 681
IS 1-2
BP 33
EP 40
DI 10.1016/j.aca.2010.09.011
PG 8
WC Chemistry, Analytical
SC Chemistry
GA 682GO
UT WOS:000284389600005
PM 21035600
ER
PT J
AU Le Nouen, C
Hillyer, P
Munir, S
Winter, CC
McCarty, T
Bukreyev, A
Collins, PL
Rabin, RL
Buchholz, UJ
AF Le Nouen, Cyril
Hillyer, Philippa
Munir, Shirin
Winter, Christine C.
McCarty, Thomas
Bukreyev, Alexander
Collins, Peter L.
Rabin, Ronald L.
Buchholz, Ursula J.
TI Effects of Human Respiratory Syncytial Virus, Metapneumovirus,
Parainfluenza Virus 3 and Influenza Virus on CD4+T Cell Activation by
Dendritic Cells
SO PLOS ONE
LA English
DT Article
ID T-HELPER TYPE-1; IN-VITRO; YOUNG-CHILDREN; DIFFERENTIAL RESPONSE;
FLOW-CYTOMETRY; CILIATED CELLS; TRACT DISEASE; HUMAN NAIVE; INFECTION;
LYMPHOCYTES
AB Background: Human respiratory syncytial virus (HRSV), and to a lesser extent human metapneumovirus (HMPV) and human parainfluenza virus type 3 (HPIV3), re-infect symptomatically throughout life without antigenic change, suggestive of incomplete immunity. One causative factor is thought to be viral interference with dendritic cell (DC)-mediated stimulation of CD4+ T cells.
Methodology, Principal Findings: We infected human monocyte-derived DC with purified HRSV, HMPV, HPIV3, or influenza A virus (IAV) and compared their ability to induce activation and proliferation of autologous CD4+ T cells in vitro. IAV was included because symptomatic re-infection without antigenic change is less frequent, suggesting that immune protection is more complete and durable. We examined virus-specific memory responses and superantigen-induced responses by multiparameter flow cytometry. Live virus was more stimulatory than inactivated virus in inducing DC-mediated proliferation of virus-specific memory CD4+ T cells, suggesting a lack of strong suppression by live virus. There were trends of increasing proliferation in the order: HMPV, HRSV, HPIV3, IAV, and greater production of interferon-gamma c and tumor necrosis factor-alpha by proliferating cells in response to IAV, but differences were not significant. Exposure of DC to HRSV, HPIV3, or IAV reduced CD4+ T cell proliferation in response to secondary stimulus with superantigen, but the effect was transitory and greatest for IAV. T cell cytokine production was similar, with no evidence of Th2 or Th17 skewing.
Conclusions, Significance: Understanding the basis for the ability of HRSV in particular to symptomatically re-infect without significant antigenic change is of considerable interest. The present results show that these common respiratory viruses are similar in their ability to induce DC to activate CD4+ T cells. Thus, the results do not support the common model in which viral suppression of CD4+ T cell activation and proliferation by HRSV, HMPV, and HPIV3 is a major factor in the difference in re-infectability compared to IAV.
C1 [Le Nouen, Cyril; Munir, Shirin; Winter, Christine C.; McCarty, Thomas; Bukreyev, Alexander; Collins, Peter L.; Buchholz, Ursula J.] NIAID, Infect Dis Lab, NIH, Bethesda, MD 20892 USA.
[Hillyer, Philippa; Rabin, Ronald L.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Le Nouen, C (reprint author), NIAID, Infect Dis Lab, NIH, Bethesda, MD 20892 USA.
EM ubuchholz@niaid.nih.gov
OI Tripp, Ralph/0000-0002-2924-9956
FU NIAID, NIH
FX This research was supported by the Intramural Research Program of the
NIAID, NIH. Disclaimer: The views expressed in this report are the
personal opinions of the authors and are not the official opinion of the
U.S. Food and Drug Administration, the National Institutes of Health, or
the Department of Health and Human Services. The funders had no role in
study design, data collection and analysis, decision to publish, or
preparation of the manuscript.
NR 60
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U1 1
U2 7
PU PUBLIC LIBRARY SCIENCE
PI SAN FRANCISCO
PA 185 BERRY ST, STE 1300, SAN FRANCISCO, CA 94107 USA
SN 1932-6203
J9 PLOS ONE
JI PLoS One
PD NOV 29
PY 2010
VL 5
IS 11
AR e15017
DI 10.1371/journal.pone.0015017
PG 14
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 686HD
UT WOS:000284686500016
PM 21124776
ER
PT J
AU Hadwiger, ME
Trehy, ML
Ye, W
Moore, T
Allgire, J
Westenberger, B
AF Hadwiger, Michael E.
Trehy, Michael L.
Ye, Wei
Moore, Terry
Allgire, James
Westenberger, Benjamin
TI Identification of amino-tadalafil and rimonabant in electronic cigarette
products using high pressure liquid chromatography with diode array and
tandem mass spectrometric detection
SO JOURNAL OF CHROMATOGRAPHY A
LA English
DT Article
DE E-cigarettes; Electronic cigarettes; HPLC; Mass spectrometry; Multi mode
ionization; MS; Rimonabant; Amino tadalafil
ID SYNTHETIC PHOSPHODIESTERASE-5 INHIBITORS; HERBAL DIETARY-SUPPLEMENT;
LC-ESI-MS; STRUCTURE ELUCIDATION; ADULTERANT; ANALOG
AB A high-pressure liquid chromatography-diode array detection and multi-mode ionization tandem mass spectrometry (HPLC-DAD-MMI-MS/MS) method was used to identify amino-tadalafil and rimonabant in electronic cigarette (e-cigarette) cartridges Amino-tadalafil is a drug analogue of the commercially approved Cialis (TM) (i e tadalafil) Rimonabant is a drug that was at one time approved for weight loss in Europe (although approval has been retracted) but not in the United States In addition poor quality control over the e-cigarette products analyzed here is shown by the presence of nicotine in products labeled as containing no nicotine or by the presence of significant amounts of rimonabant oxidative degradant in e-cigarette products containing rimonabant Identification was accomplished by comparing the retention time of relevant peaks in the sample with those of standard compounds in addition to comparison of the UV spectra mass spectra and/or product ion mass spectra Published by Elsevier B V
C1 [Hadwiger, Michael E.; Trehy, Michael L.; Ye, Wei; Moore, Terry; Allgire, James; Westenberger, Benjamin] Food & Drug Adm, Div Pharmaceut Anal, St Louis, MO 63101 USA.
RP Hadwiger, ME (reprint author), Food & Drug Adm, Div Pharmaceut Anal, 1114 Market St, St Louis, MO 63101 USA.
NR 11
TC 46
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U1 2
U2 43
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0021-9673
J9 J CHROMATOGR A
JI J. Chromatogr. A
PD NOV 26
PY 2010
VL 1217
IS 48
BP 7547
EP 7555
DI 10.1016/j.chroma.2010.10.018
PG 9
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 686BS
UT WOS:000284672400012
PM 20980012
ER
PT J
AU Kim, DH
Ilev, IK
AF Kim, D. -H.
Ilev, I. K.
TI Simple confocal thickness gauge based on fibre-optic confocal sensor for
non-contact measurement
SO ELECTRONICS LETTERS
LA English
DT Article
ID OPTICAL COHERENCE TOMOGRAPHY; REFRACTIVE-INDEX; TISSUE
AB A simple non-contact thickness measurement method based on a dual-confocal microscope has been developed and tested. A reference comparison method was adapted for calibration of the system. The high accuracy potential of the method was demonstrated by measuring the thickness of transparent samples and a non-transparent soft biological sample. Lensed-tip fibre-optic confocal sensors were tested for the method.
C1 [Kim, D. -H.; Ilev, I. K.] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA.
RP Kim, DH (reprint author), US FDA, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
NR 7
TC 3
Z9 3
U1 0
U2 1
PU INST ENGINEERING TECHNOLOGY-IET
PI HERTFORD
PA MICHAEL FARADAY HOUSE SIX HILLS WAY STEVENAGE, HERTFORD SG1 2AY, ENGLAND
SN 0013-5194
J9 ELECTRON LETT
JI Electron. Lett.
PD NOV 25
PY 2010
VL 46
IS 24
BP 1594
EP 1595
DI 10.1049/el.2010.3048
PG 2
WC Engineering, Electrical & Electronic
SC Engineering
GA 684WB
UT WOS:000284584600012
ER
PT J
AU Wang, W
Castelan-Vega, JA
Jimenez-Alberto, A
Vassell, R
Ye, ZP
Weiss, CD
AF Wang, Wei
Castelan-Vega, Juan A.
Jimenez-Alberto, Alicia
Vassell, Russell
Ye, Zhiping
Weiss, Carol D.
TI A mutation in the receptor binding site enhances infectivity of 2009
H1N1 influenza hemagglutinin pseudotypes without changing antigenicity
SO VIROLOGY
LA English
DT Article
DE hemagglutinin; influenza A 2009 H1N1 virus; pseudotype neutralization;
hemagglutinin pseudotypes; influenza A antigenicity; influenza
infectivity
ID PANDEMIC INFLUENZA; AVIAN INFLUENZA; IN-VIVO; MOLECULAR-DYNAMICS;
LENTIVIRAL VECTOR; GENE DELIVERY; VIRUS ENTRY; NEURAMINIDASE;
SPECIFICITY; MICE
AB The 2009 H1N1 pandemic highlights the need to better understand influenza A infectivity and antigenicity. Relative to other recent seasonal H1N1 influenza strains, the 2009 H1N1 virus grew less efficiently in eggs, which hindered efforts to rapidly supply vaccine. Using lentiviral pseudotypes bearing influenza hemagglutinin (HA-pseudotypes) we evaluated a glutamine to arginine mutation at position 223 (Q223R) and glycosylation at residue 276 in HA for their effects on infectivity and neutralization. Q223R emerged during propagation in eggs and lies in the receptor binding site. We found that the Q223R mutation greatly enhanced infectivity of HA-pseudotypes in human cells, which was further augmented by inclusion of the viral neuraminidase (NA) and M2 proteins. Loss of glycosylation at residue 276 did not alter infectivity. None of these modifications affected neutralization. These findings provide information for increasing 2009 H1N1HA-pseudotype titers without altering antigenicity and offer insights into receptor use. Published by Elsevier Inc.
C1 [Weiss, Carol D.] US FDA, Immunoregulat Lab, CBER, HFM 466, Bethesda, MD 20892 USA.
[Ye, Zhiping] US FDA, Ctr Biol Evaluat & Res, Lab Resp Viral Dis, Bethesda, MD 20892 USA.
RP Weiss, CD (reprint author), US FDA, Immunoregulat Lab, CBER, HFM 466, Bldg 29,Room 532,29 Lincoln Dr, Bethesda, MD 20892 USA.
EM carol.weiss@fda.hhs.gov
RI Weiss, Carol/F-6438-2011
OI Weiss, Carol/0000-0002-9965-1289
FU FDA; CDW; COTEPABE (Instituto Politecnico Nacional, Mexico); CONACYT
FX We thank the following persons for generously supplying key reagents for
these studies: Galina Vodieko and Christine Anderson (FDA, Bethesda, MD)
for sheep reference antisera; Dr. Kanta Subbarao (NIH, Bethesda, MD) for
ferret A/California/04/2009 antiserum; and Dr. Gary Nabel (NIH,
Bethesda, MD) for CMV/R 8 kappa B and HIV-luciferase expression vectors.
We are also grateful to Drs. Vladimir Lugostev and Judy Beeler (FDA,
Bethesda, MD) for critical review of the manuscript and Dr. Juan Luis
Arciniega (FDA, Bethesda, MD) for providing laboratory space for some of
this research. This work was supported by institutional research funds
from the FDA for WW, JC-V, AJ-A, RV, ZY, and CDW and from COTEPABE
(Instituto Politecnico Nacional, Mexico) and CONACYT for JC-V and AJ-A.
NR 42
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Z9 18
U1 0
U2 2
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 NOV 25
PY 2010
VL 407
IS 2
BP 374
EP 380
DI 10.1016/j.virol.2010.08.027
PG 7
WC Virology
SC Virology
GA 671DJ
UT WOS:000283480100023
PM 20869738
ER
PT J
AU Glierova, H
Panigaj, M
Semberova, J
Janouskova, O
Dvorakova, E
Zivny, J
Holada, K
AF Glierova, Hana
Panigaj, Martin
Semberova, Jana
Janouskova, Olga
Dvorakova, Eva
Zivny, Jan
Holada, Karel
TI Impairment of Erythropoiesis In Inbred Cellular Prion Protein Deficient
Mice
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Glierova, Hana; Panigaj, Martin; Janouskova, Olga; Dvorakova, Eva; Holada, Karel] Charles Univ Prague, Inst Microbiol & Immunol, Fac Med 1, Prague, Czech Republic.
[Semberova, Jana] CBER FDA, Div Hematol, Rockville, MD USA.
[Zivny, Jan] Charles Univ Prague, Inst Pathol Physiol, Fac Med 1, Prague, Czech Republic.
RI Panigaj, Martin/G-6492-2013; Janouskova, Olga/H-4110-2014
OI Janouskova, Olga/0000-0002-1365-6274
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 844
EP 844
PG 1
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662202255
ER
PT J
AU Kimchi-Sarfaty, C
Simhadri, VL
Kopelman, D
Friedman, A
Edwards, N
Javaid, A
Okunji, C
Komar, A
Sauna, Z
Katagiri, N
AF Kimchi-Sarfaty, Chava
Simhadri, Vijaya L.
Kopelman, David
Friedman, Adam
Edwards, Nathan
Javaid, Atiq
Okunji, Chinyere
Komar, Anton
Sauna, Zuben
Katagiri, Nobuko
TI The Synonymous V107V Mutation In Factor IX Is Not So Silent and May
Cause Hemophilia R In Patients
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Kimchi-Sarfaty, Chava; Simhadri, Vijaya L.; Kopelman, David; Friedman, Adam; Edwards, Nathan; Javaid, Atiq; Okunji, Chinyere; Sauna, Zuben; Katagiri, Nobuko] US FDA, Div Hematol, CBER, Bethesda, MD 20014 USA.
[Komar, Anton] Cleveland State Univ, Cleveland, OH 44115 USA.
NR 0
TC 1
Z9 1
U1 0
U2 1
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 906
EP 906
PG 1
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662202420
ER
PT J
AU Entin, I
Yaccoby, S
Zhining, W
Shaughnessy, J
Barlogie, B
Epstein, J
AF Entin, Igor
Yaccoby, Shmuel
Zhining, Wen
Shaughnessy, John, Jr.
Barlogie, Bart
Epstein, Joshua
TI Myeloma Cell Interaction with Osteoclasts and Mesenchymal Stem Cells
Reveals Genes Associated with Post Relapse Survival
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Entin, Igor; Yaccoby, Shmuel; Shaughnessy, John, Jr.; Barlogie, Bart; Epstein, Joshua] Univ Arkansas Med Sci, Myeloma Inst Res & Therapy, Little Rock, AR 72205 USA.
[Zhining, Wen] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 1220
EP 1220
PG 1
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662203289
ER
PT J
AU Lacerda, SH
Semberova, J
Holada, K
Simakova, O
Simak, J
AF Lacerda, Silvia H.
Semberova, Jana
Holada, Karel
Simakova, Olga
Simak, Jan
TI Carbon Nanotubes Activate Store Operated Calcium Entry (SOCE) In Human
Platelets Manifested by STIM1 Capping
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Lacerda, Silvia H.; Simak, Jan] US FDA, Lab Cellular Hematol, CBER, Rockville, MD 20857 USA.
[Semberova, Jana] Inst Care Mother & Child, Prague, Czech Republic.
[Holada, Karel] Charles Univ Prague, Inst Microbiol & Immunol, Fac Med 1, Prague, Czech Republic.
[Simakova, Olga] NIH, Dept Lab Med, Ctr Clin, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 3
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 1311
EP 1311
PG 1
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662203521
ER
PT J
AU Gelderman-Fuhrmann, M
Farrell, J
Panigaj, M
Holada, K
Vostal, J
AF Gelderman-Fuhrmann, Monique
Farrell, John
Panigaj, Martin
Holada, Karel
Vostal, Jaroslav
TI Deletion of the Prion Protein Does not Affect Erythropoiesis in a Mouse
Model of Beta-Thalassemia.
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Gelderman-Fuhrmann, Monique; Farrell, John; Vostal, Jaroslav] FDA CBER OBRR, Lab Cellular Hematol, Rockville, MD USA.
[Panigaj, Martin; Holada, Karel] Charles Univ Prague, Inst Immunol & Microbiol, Fac Med 1, Prague, Czech Republic.
RI Panigaj, Martin/G-6492-2013
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 1318
EP 1318
PG 1
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662203544
ER
PT J
AU Gelderman-Fuhrmann, M
Chi, X
Zhi, L
Vostal, J
AF Gelderman-Fuhrmann, Monique
Chi, Xuan
Zhi, Li
Vostal, Jaroslav
TI UVB Light Exposed Human Platelets Mediate Acute Lung Injury In a
Two-Event Mouse Model of Transfusion.
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Gelderman-Fuhrmann, Monique; Chi, Xuan; Zhi, Li; Vostal, Jaroslav] FDA CBER OBRR, Lab Cellular Hematol, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 1374
EP 1374
PG 1
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662203685
ER
PT J
AU Rao, SS
Ketha, KMV
Atreya, CD
AF Rao, Shilpakala Sainath
Ketha, Krishna Mohan V.
Atreya, Chintamani D.
TI Staphylococcus Aureus Detection In Platelets Using Short Synthetic
Peptides Derived From Phage-Displayed Random Peptide Libraries Coupled
with Quantum-Dot Nanocrystals.
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Rao, Shilpakala Sainath; Ketha, Krishna Mohan V.] US FDA, Lab Cellular Hematol, CBER, Bethesda, MD 20014 USA.
NR 0
TC 1
Z9 1
U1 1
U2 3
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 1375
EP 1376
PG 2
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662203690
ER
PT J
AU Ketha, KMV
Rao, SS
Atreya, CD
AF Ketha, Krishna Mohan V.
Rao, Shilpakala Sainath
Atreya, Chintamani D.
TI Combinatorial Antimicrobicidal Peptides Exhibit Enhanced Activity
Against Bacterial Contaminants In Stored Platelet Concentrates (PCs)
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Ketha, Krishna Mohan V.; Atreya, Chintamani D.] CBER Food & Drug Adm, Lab Cellular Hematol, Bethesda, MD 20014 USA.
[Rao, Shilpakala Sainath] CBER FDA, Div Hematol, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 488
EP 489
PG 2
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662201227
ER
PT J
AU Zhi, L
Chi, X
Gelderman-Fuhrmann, M
Vostal, J
AF Zhi, Li
Chi, Xuan
Gelderman-Fuhrmann, Monique
Vostal, Jaroslav
TI Protein Kinase C Mediates UVB Light Induced Changes in Human Platelets
that Lead to Inflammation In a Two-Event Animal Model of Transfusion
Mediated Acute Lung Injury.
SO BLOOD
LA English
DT Meeting Abstract
CT 52nd Annual Meeting of the American-Society-of-Hematology (ASH)
CY DEC 04-07, 2010
CL Orlando, FL
SP Amer Soc Hematol
C1 [Zhi, Li; Chi, Xuan; Gelderman-Fuhrmann, Monique; Vostal, Jaroslav] FDA CBER OBRR, Lab Cellular Hematol, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD NOV 19
PY 2010
VL 116
IS 21
BP 1375
EP 1375
PG 1
WC Hematology
SC Hematology
GA 752BH
UT WOS:000289662203689
ER
PT J
AU Neverov, A
Chumakov, K
AF Neverov, Alexander
Chumakov, Konstantin
TI Massively parallel sequencing for monitoring genetic consistency and
quality control of live viral vaccines
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
DE mutant quantification; quasispecies; sequence heterogeneity; vaccine
safety; neurovirulence
ID ORAL POLIOVIRUS VACCINE; GEL-ELECTROPHORESIS; NEUROVIRULENCE TEST;
IN-VITRO; VIRUS; RNA; STRAIN; POLIOMYELITIS; POPULATIONS; MICROEVOLUTION
AB Intrinsic genetic instability of RNA viruses may lead to the accumulation of revertants during manufacture of live viral vaccines, requiring rigorous quality control to ensure vaccine safety. Each lot of oral poliovirus vaccine (OPV) is tested for neurovirulence in animals and also for the presence of neurovirulent revertants. Mutant analysis by PCR and restriction enzyme cleavage (MAPREC) is used to measure the frequency of neurovirulent mutations at the 5' untranslated region (UTR) of the viral genome that correlate with the level of neurovirulence determined by the monkey neurovirulence test. However, MAPREC can only monitor mutations at a few genomic loci and miss mutations at other sites that could adversely affect vaccine quality. Here we propose to use massively parallel sequencing (MPS) for sensitive detection and quantification of all mutations in the entire genome of attenuated viruses. Analysis of vaccine samples and reference preparations demonstrated a perfect agreement with MAPREC results. Quantitative MPS analysis of validated reference preparations tested by MAPREC produced identical results, suggesting that the method could take advantage of the existing reference materials and be used as a replacement for the MAPREC procedure in lot release of OPV. Patterns of mutations present at a low level in vaccine preparations were characteristic of seed viruses used for their manufacture and could be used for identification of individual batches. This approach may represent the ultimate tool for monitoring genetic consistency of live viral vaccines.
C1 [Neverov, Alexander; Chumakov, Konstantin] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
RP Chumakov, K (reprint author), US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
EM konstantin.chumakov@fda.hhs.gov
FU Food and Drug Administration
FX We thank Dr. Ellie Ehrenfeld, Dr. Steven Rubin, and Dr. Keith Peden for
reading the manuscript. The work was supported by funds from the Food
and Drug Administration's intramural research program.
NR 39
TC 28
Z9 30
U1 0
U2 3
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 NOV 16
PY 2010
VL 107
IS 46
BP 20063
EP 20068
DI 10.1073/pnas.1012537107
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 680UT
UT WOS:000284261800083
PM 21041640
ER
PT J
AU Rahman, Z
Zidan, AS
Khan, MA
AF Rahman, Ziyaur
Zidan, Ahmed S.
Khan, Mansoor A.
TI Risperidone solid dispersion for orally disintegrating tablet: Its
formulation design and non-destructive methods of evaluation
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Article
DE Risperidone; Methyl-beta-cyclodextrin; Solid dispersion; Orally
disintegrating tablet
ID NEAR-INFRARED SPECTROSCOPY; DRY EMULSION TABLET; REFLECTANCE SPECTRA;
BETA-CYCLODEXTRIN; IN-VITRO; COMPLEXATION; DISSOLUTION; BIOAVAILABILITY;
REGRESSION; DELIVERY
AB The focus of present investigation was to assess the utility of non-destructive techniques in the evaluation of risperidone solid dispersions (SD) with methyl-beta-cyclodextrin (MBCD) and subsequent incorporation of the SD into orally disintegrating tablets (ODT) for a faster release of risperidone. The SD was prepared by a solvent evaporation method and evaluated by scanning electron microscopy (SEM), Fourier transform infrared (FTIR), near infrared spectroscopy (NIR), NIR-chemical imaging (NIR-CI), powder X-ray diffraction (PXRD) and differential scanning calorimetry (DSC). DSC and XRD analysis indicated that crystallinity of SD has reduced significantly. FTIR showed no interaction between risperidone and MBCD. Partial least square (PLS) was applied to the NIR data for the construction of chemometric models to determine both components of the SD. Good correlations were obtained for calibration and prediction as indicated by correlation coefficients >0.9965. The model was more accurate and less biased in predicting the MBCD than risperidone as indicated by its lower mean accuracy and mean bias values. SD-3 (risperidone:MBCD, 1:3) was incorporated into ODT tablets containing diluent (D-mannitol, FlowLac (R) 100 or galenIQ (TM)-721) and superdisintegrant (Kollidon (R) CL-SF, Ac-Di-Sol or sodium starch glycolate). Disintegration time, T(50) and T(90) were decreased in the formulations containing mannitol and Kollidon (R) CL-SF, but increased with galenIQ (TM)-721 and sodium starch glycolate, respectively. NIR-CI images confirmed the homogeneity of SD and ODT formulations. Published by Elsevier B.V.
C1 [Rahman, Ziyaur; Zidan, Ahmed S.; Khan, Mansoor A.] US FDA, DPQR, CDER, Silver Spring, MD 20993 USA.
RP Khan, MA (reprint author), US FDA, DPQR, CDER, LS Bldg 64,Room 1070,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Mansoor.Khan@fda.hhs.gov
RI Zidan, Ahmed/I-1147-2012;
OI Rahman, Ziyaur/0000-0002-0402-825X
FU Oak Ridge Institute for Science and Education (ORISE)
FX The authors would like to thank the Oak Ridge Institute for Science and
Education (ORISE) for supporting post doctoral research program.
NR 49
TC 29
Z9 30
U1 1
U2 20
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
J9 INT J PHARMACEUT
JI Int. J. Pharm.
PD NOV 15
PY 2010
VL 400
IS 1-2
BP 49
EP 58
DI 10.1016/j.ijpharm.2010.08.025
PG 10
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 675KP
UT WOS:000283829900008
PM 20801200
ER
PT J
AU Hailemariam, K
Iwasaki, K
Huang, BW
Sakamoto, K
Tsuji, Y
AF Hailemariam, Kiros
Iwasaki, Kenta
Huang, Bo-Wen
Sakamoto, Kensuke
Tsuji, Yoshiaki
TI Transcriptional regulation of ferritin and antioxidant genes by HIPK2
under genotoxic stress
SO JOURNAL OF CELL SCIENCE
LA English
DT Article
DE HIPK2; ATF1; Phosphorylation; Ferritin; Genotoxic stress; Transcription
ID INTERACTING PROTEIN KINASE-2; ELEMENT-BINDING PROTEIN; INDUCIBLE
FACTOR-I; RESPONSIVE ELEMENT; OXIDATIVE STRESS; H-GENE; ACTIVATES
TRANSCRIPTION; MEDIATED TRANSCRIPTION; INDUCED APOPTOSIS; HYPOXIC
RESPONSE
AB ATF1 (activating transcription factor 1), a stimulus-induced CREB family transcription factor, plays important roles in cell survival and proliferation. Phosphorylation of ATF1 at Ser63 by PKA (cAMP-dependent protein kinase) and related kinases was the only known post-translational regulatory mechanism of ATF1. Here, we found that HIPK2 (homeodomain-interacting protein kinase 2), a DNA-damage-responsive nuclear kinase, is a new ATF1 kinase that phosphorylates Ser198 but not Ser63. ATF1 phosphorylation by HIPK2 activated ATF1 transcription function in the GAL4-reporter system. ATF1 is a transcriptional repressor of ferritin H, the major intracellular iron storage gene, through an ARE (antioxidant-responsive element). HIPK2 overrode the ATF1-mediated ARE repression in a kinase-activity-dependent manner in HepG2 cells. Furthermore, DNA-damage-inducing agents doxorubicin, etoposide and sodium arsenite induced ferritin H mRNA expression in HIPK2(+/+) MEF cells, whereas it was significantly impaired in HIPK2(-/-) MEF cells. Induction of other ARE-regulated detoxification genes such as NQO1 (NADPH quinone oxidoreductase 1), GST (glutathione S-transferase) and HO1 (heme oxygenase 1) by genotoxic stress was also decreased in HIPK2-deficient cells. Taken together, these results suggest that HIPK2 is a new ATF1 kinase involved in the regulation of ferritin H and other antioxidant detoxification genes in genotoxic stress conditions.
C1 [Hailemariam, Kiros; Iwasaki, Kenta; Huang, Bo-Wen; Sakamoto, Kensuke; Tsuji, Yoshiaki] N Carolina State Univ, Dept Environm & Mol Toxicol, Raleigh, NC 27695 USA.
[Hailemariam, Kiros] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Iwasaki, Kenta] Nagoya Univ, Sch Med, Dept Appl Immunol, Showa Ku, Nagoya, Aichi 4668550, Japan.
RP Tsuji, Y (reprint author), N Carolina State Univ, Dept Environm & Mol Toxicol, Campus Box 7633, Raleigh, NC 27695 USA.
EM yoshiaki_tsuji@ncsu.edu
FU National Institutes of Health [DK-60007, ES-007046, DK-60007S]; North
Carolina State University
FX We are grateful to Eric J. Huang at University of California San
Francisco for providing us with the HIPK2 wild-type and knockout MEF
cells. We thank M. Lienhard Schmitz at Justus-Liebig University, Germany
for HIPK2 plasmids. We thank Jun Ninomiya-Tsuji at North Carolina State
University for plasmids and discussion. This work was supported in part
by National Institutes of Health research grant DK-60007 to Y.T. K.H.
was supported by the National Institutes of Health training grant
ES-007046 and the National Institutes of Health minority supplement
grant DK-60007S. B.-W.H. was supported by North Carolina State
University Research Assistant Fellowship. Deposited in PMC for release
after 12 months.
NR 68
TC 21
Z9 23
U1 0
U2 2
PU COMPANY OF BIOLOGISTS LTD
PI CAMBRIDGE
PA BIDDER BUILDING CAMBRIDGE COMMERCIAL PARK COWLEY RD, CAMBRIDGE CB4 4DL,
CAMBS, ENGLAND
SN 0021-9533
J9 J CELL SCI
JI J. Cell Sci.
PD NOV 15
PY 2010
VL 123
IS 22
BP 3863
EP 3871
DI 10.1242/jcs.073627
PG 9
WC Cell Biology
SC Cell Biology
GA 675BM
UT WOS:000283798600005
PM 20980392
ER
PT J
AU Heather, A
Nina, R
Emilio, P
Dwight, F
Rashmi, R
Derese, G
Paul, P
Svetlana, G
Yi-Wen, C
Ingrid, L
Kanneboyina, N
AF Heather M, Alger
Nina, Raben
Emilio, Pistilli
Dwight, Francia
Rashmi, Rawat
Derese, Getnet
Paul, Plotz
Svetlana, Ghimbovschi
Yi-Wen, Chen
Ingrid, Lundberg
Kanneboyina, Nagaraju
TI The role of Tumor Necrosis Factor-alpha-Related Apoptosis Inducing
Ligand (TRAIL) in mediating muscle fiber damage in myositis
SO JOURNAL OF NEUROIMMUNOLOGY
LA English
DT Meeting Abstract
CT 10th Congress of the International-Society-of-Neuroimmunology (ISNI)
CY OCT 26-30, 2010
CL Sitges, SPAIN
SP Int Soc Neuroimmunol
C1 [Heather M, Alger; Dwight, Francia; Svetlana, Ghimbovschi; Yi-Wen, Chen; Kanneboyina, Nagaraju] Childrens Natl Med Ctr, Dept Med Genet, Washington, DC 20010 USA.
[Nina, Raben; Paul, Plotz] NIAMSD, NIH, Bethesda, MD 20892 USA.
[Emilio, Pistilli] Univ Penn, Penn Muscle Inst, Philadelphia, PA 19104 USA.
[Rashmi, Rawat] US FDA, Silver Spring, MD USA.
[Derese, Getnet] Johns Hopkins Univ, Baltimore, MD USA.
[Ingrid, Lundberg] Karolinska Univ Hosp Solna, Dept Med, Rheumatol Unit, Stockholm, Sweden.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0165-5728
J9 J NEUROIMMUNOL
JI J. Neuroimmunol.
PD NOV 15
PY 2010
VL 228
IS 1-2
SI SI
BP 206
EP 206
PG 1
WC Immunology; Neurosciences
SC Immunology; Neurosciences & Neurology
GA 673WH
UT WOS:000283694400585
ER
PT J
AU Southworth, MR
Temple, R
AF Southworth, Mary Ross
Temple, Robert
TI Interaction of Clopidogrel and Omeprazole
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Letter
C1 [Southworth, Mary Ross; Temple, Robert] US FDA, Silver Spring, MD USA.
RP Southworth, MR (reprint author), US FDA, Silver Spring, MD USA.
NR 1
TC 9
Z9 9
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
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD NOV 11
PY 2010
VL 363
IS 20
BP 1977
EP 1977
DI 10.1056/NEJMc1012022
PG 1
WC Medicine, General & Internal
SC General & Internal Medicine
GA 678CR
UT WOS:000284047600036
PM 21067412
ER
PT J
AU Schlessinger, S
Kokko, K
Fratkin, J
Butt, F
Hawxby, A
Todaro, M
Henderson, H
Seawright, A
Parker, C
Byers, P
Gonzalez-Peralta, R
Kayler, L
Fauerbach, L
Lawrence, R
Haafiz, A
Stanek, D
Hammond, R
Thoroughman, D
Pippen, T
Johnson, S
Mahle, W
Lyon, G
Laporte, K
Kanter, K
Ivey, M
Arnold, K
Lance, S
Navarro-Almario, E
Farnon, E
Kuehnert, M
Shieh, W
Paddock, C
Zaki, S
Drew, C
Schmitz, A
Sejvar, J
Sriram, R
Visvesvara, G
Beach, M
Yoder, J
Roy, S
Qvarnstrom, Y
Bandea, R
daSilva, A
Bosserman, E
Budge, P
Lutterloh, E
AF Schlessinger, S.
Kokko, K.
Fratkin, J.
Butt, F.
Hawxby, A.
Todaro, M.
Henderson, H.
Seawright, A.
Parker, C.
Byers, P.
Gonzalez-Peralta, R.
Kayler, L.
Fauerbach, L.
Lawrence, R.
Haafiz, A.
Stanek, D.
Hammond, R.
Thoroughman, D.
Pippen, T.
Johnson, S.
Mahle, W.
Lyon, G., III
Laporte, K.
Kanter, K.
Ivey, M.
Arnold, K.
Lance, S.
Navarro-Almario, E.
Farnon, E.
Kuehnert, M.
Shieh, W.
Paddock, C.
Zaki, S.
Drew, C.
Schmitz, A.
Sejvar, J.
Sriram, R.
Visvesvara, G.
Beach, M.
Yoder, J.
Roy, S.
Qvarnstrom, Y.
Bandea, R.
daSilva, A.
Bosserman, E.
Budge, P.
Lutterloh, E.
TI Balamuthia mandrillaris Transmitted Through Organ
Transplantation-Mississippi, 2009 (Reprinted from vol 59, pg 1165-1170,
2010)
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Reprint
C1 [Schlessinger, S.] Mississippi Organ Recovery Agcy, Flowood, MS USA.
[Kokko, K.; Fratkin, J.; Butt, F.; Hawxby, A.; Todaro, M.; Henderson, H.; Seawright, A.; Parker, C.] Univ Mississippi, Med Ctr, University, MS 38677 USA.
[Gonzalez-Peralta, R.; Kayler, L.; Fauerbach, L.; Lawrence, R.; Haafiz, A.] Univ Florida, Shands Hosp, Gainesville, FL 32611 USA.
[Mahle, W.; Lyon, G., III; Laporte, K.; Kanter, K.] Emory Univ, Childrens Healthcare Atlanta, Atlanta, GA 30322 USA.
[Navarro-Almario, E.] US FDA, Rockville, MD 20857 USA.
[Budge, P.; Lutterloh, E.] CDC, EIS, Atlanta, GA 30333 USA.
RP Schlessinger, S (reprint author), Mississippi Organ Recovery Agcy, Flowood, MS USA.
NR 1
TC 0
Z9 0
U1 0
U2 2
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60654-0946 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD NOV 10
PY 2010
VL 304
IS 18
BP 2008
EP 2012
PG 4
WC Medicine, General & Internal
SC General & Internal Medicine
GA 677OB
UT WOS:000284000600010
ER
PT J
AU Resnic, FS
Gross, TP
Marinac-Dabic, D
Loyo-Berrios, N
Donnelly, S
Normand, SLT
Matheny, ME
AF Resnic, Frederic S.
Gross, Thomas P.
Marinac-Dabic, Danica
Loyo-Berrios, Nilsa
Donnelly, Sharon
Normand, Sharon-Lise T.
Matheny, Michael E.
TI Automated Surveillance to Detect Postprocedure Safety Signals of
Approved Cardiovascular Devices
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Article
ID INTERVENTIONAL CARDIOLOGY; RANDOMIZED-TRIAL; MEDICAL DEVICE; STENTS;
CATHETERIZATION; COMPLICATIONS; METAANALYSIS; REGISTRY; HOLES; RISK
AB Context Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.
Objective To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices.
Design, Setting, and Patients Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts.
Main Outcome Measure Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered.
Results We evaluated 74 427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of post-procedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device.
Conclusion Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices. JAMA. 2010;304(18):2019-2027 www.jama.com
C1 [Resnic, Frederic S.; Donnelly, Sharon] Brigham & Womens Hosp, Boston, MA 02115 USA.
[Normand, Sharon-Lise T.] Harvard Univ, Sch Med, Dept Hlth Care Policy, Boston, MA 02115 USA.
[Gross, Thomas P.; Marinac-Dabic, Danica; Loyo-Berrios, Nilsa] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA.
[Normand, Sharon-Lise T.] Harvard Univ, Sch Publ Hlth, Dept Biostat, Boston, MA 02115 USA.
[Matheny, Michael E.] Tennessee Valley Healthcare Syst, Vet Adm Med Ctr, Nashville, TN USA.
[Matheny, Michael E.] Vanderbilt Univ, Med Ctr, Nashville, TN USA.
RP Resnic, FS (reprint author), Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA.
EM fresnic@partners.org
FU Boston Scientific Inc; Abbott Vascular Inc; Cordis Corp; St Jude
Medical; Medicines Company; National Library of Medicine [NIH
R01-LM008142]; US Food and Drug Administration [HHSF 223200830058C];
Veterans Administration Health Services Research and Development Service
[CDP 09-387]; Division of Healthcare Quality and Statistics,
Massachusetts Department of Public Health
FX Dr Resnic and Dr Matheny reported filing a patent application, currently
under review at the US Patent Office, for several key analytic
components of the DELTA surveillance system; the intellectual property
rights of Drs Resnic and Matheny (current and former employees of
Brigham and Women's Hospital) related to the development of DELTA are
assigned to the institution, and Partners Healthcare, the parent
organization of Brigham and Women's Hospital, retains partial rights for
DELTA use and licensing. Neither Dr Resnic nor Dr Matheny have
previously received or anticipate any financial compensation, stock
options, income, or ownership in DELTA, Coping Systems, or any other
related commercial entity. Dr Resnic reported receiving modest
consulting income from Boston Scientific Inc, Abbott Vascular Inc,
Cordis Corp, and St Jude Medical and receiving research grants from The
Medicines Company. No other authors reported dislosures.; This study was
funded, in part, by grants from the National Library of Medicine (NIH
R01-LM008142) and the US Food and Drug Administration (HHSF
223200830058C) as well as from the Veterans Administration Health
Services Research and Development Service (CDP 09-387).; The National
Institutes of Health, the Veterans Administration Health Services
Research and Development Service, and the US Food and Drug
Administration had no role in the design and conduct of the study; the
collection, management, analysis, and interpretation of the data; or the
preparation, review, or approval of the manuscript. However, the
preliminary proposed study protocol was provided to the Veterans
Administration Health Services Research and Development Service and the
US Food and Drug Administration as part of the original grant and
contract application process.; We acknowledge the significant system
development and technical contributions of Richard Cope, BS, and Susan
Robbins, BS, of Coping Systems Inc, Andover, Massachusetts. Coping
Systems was a subcontractor to Brigham and Women's Hospital, and neither
Mr Cope nor Ms Robbins received extra compensation for their
contributions; Mr Cope is part owner of Coping Systems and is also named
on the patent application filed by Dr Resnic and Dr Matheny. We also
acknowledge the support of the Division of Healthcare Quality and
Statistics, Massachusetts Department of Public Health.
NR 33
TC 35
Z9 35
U1 0
U2 5
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60654-0946 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD NOV 10
PY 2010
VL 304
IS 18
BP 2019
EP 2027
DI 10.1001/jama.2010.1633
PG 9
WC Medicine, General & Internal
SC General & Internal Medicine
GA 677OB
UT WOS:000284000600020
PM 21063011
ER
PT J
AU Nakashima, H
Fujisawa, T
Husain, SR
Puri, RK
AF Nakashima, Hideyuki
Fujisawa, Toshio
Husain, Syed R.
Puri, Raj K.
TI Interleukin-13 receptor alpha 2 DNA prime boost vaccine induces tumor
immunity in murine tumor models
SO JOURNAL OF TRANSLATIONAL MEDICINE
LA English
DT Article
ID THERAPEUTIC CANCER VACCINES; REGULATORY T-CELLS; IL-13 RECEPTOR;
FUNCTIONAL-CHARACTERIZATION; PSEUDOMONAS EXOTOXIN; MAMMARY-TUMOR;
CLASS-II; IN-VIVO; PROTEIN; CHAIN
AB Background: DNA vaccines represent an attractive approach for cancer treatment by inducing active T cell and B cell immune responses to tumor antigens. Previous studies have shown that interleukin-13 receptor alpha 2 chain (IL-13R alpha 2), a tumor-associated antigen is a promising target for cancer immunotherapy as high levels of IL-13R alpha 2 are expressed on a variety of human tumors. To enhance the effectiveness of DNA vaccine, we used extracellular domain of IL-13R alpha 2 (ECD alpha 2) as a protein-boost against murine tumor models.
Methods: We have developed murine models of tumors naturally expressing IL-13R alpha 2 (MCA304 sarcoma, 4T1 breast carcinoma) and D5 melanoma tumors transfected with human IL-13R alpha 2 in syngeneic mice and examined the antitumor activity of DNA vaccine expressing IL-13R alpha 2 gene with or without ECD alpha 2 protein mixed with CpG and IFA adjuvants as a boost vaccine.
Results: Mice receiving IL-13R alpha 2 DNA vaccine boosted with ECD alpha 2 protein were superior in exhibiting inhibition of tumor growth, compared to mice receiving DNA vaccine alone, in both prophylactic and therapeutic vaccine settings. In addition, prime-boost vaccination significantly prolonged the survival of mice compared to DNA vaccine alone. Furthermore, ECD alpha 2 booster vaccination increased IFN-gamma production and CTL activity against tumor expressing IL-13R alpha 2. The immunohistochemical analysis showed the infiltration of CD4 and CD8 positive T cells and IFN-gamma-induced chemokines (CXCL9 and CXCL10) in regressing tumors of immunized mice. Finally, the prime boost strategy was able to reduce immunosuppressive CD4(+) CD25(+) Foxp3(+) regulatory T cells (Tregs) in the spleen and tumor of vaccinated mice.
Conclusion: These results suggest that immunization with IL-13R alpha 2 DNA vaccine followed by ECD alpha 2 boost mixed with CpG and IFA adjuvants inhibits tumor growth in T cell dependent manner. Thus our results show an enhancement of efficacy of IL-13R alpha 2 DNA vaccine with ECD alpha 2 protein boost and offers an exciting approach in the development of new DNA vaccine targeting IL-13R alpha 2 for cancer immunotherapy.
C1 [Nakashima, Hideyuki; Fujisawa, Toshio; Husain, Syed R.; Puri, Raj K.] US FDA, Tumor Vaccines & Biotechnol Branch, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Puri, RK (reprint author), US FDA, Tumor Vaccines & Biotechnol Branch, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, NIH Bldg 29B,Room 2NN20,29 Lincoln Dr,MSC 4555, Bethesda, MD 20892 USA.
EM raj.puri@fda.hhs.gov
NR 44
TC 9
Z9 10
U1 0
U2 1
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1479-5876
J9 J TRANSL MED
JI J. Transl. Med.
PD NOV 10
PY 2010
VL 8
AR 116
DI 10.1186/1479-5876-8-116
PG 14
WC Medicine, Research & Experimental
SC Research & Experimental Medicine
GA 686NH
UT WOS:000284702500001
PM 21067607
ER
PT J
AU Rao, VA
Klein, SR
Bonar, SJ
Zielonka, J
Mizuno, N
Dickey, JS
Keller, PW
Joseph, J
Kalyanaraman, B
Shacter, E
AF Rao, V. Ashutosh
Klein, Sarah R.
Bonar, Spencer J.
Zielonka, Jacek
Mizuno, Naoko
Dickey, Jennifer S.
Keller, Paul W.
Joseph, Joy
Kalyanaraman, Balaraman
Shacter, Emily
TI The Antioxidant Transcription Factor Nrf2 Negatively Regulates Autophagy
and Growth Arrest Induced by the Anticancer Redox Agent Mitoquinone
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID SUBSTRATE ADAPTER PROTEIN; MALIGNANT GLIOMA-CELLS; CANCER-CELLS;
TARGETED ANTIOXIDANTS; OXIDATIVE DAMAGE; ARSENIC TRIOXIDE;
TOPOISOMERASE-I; DT-DIAPHORASE; MCF-7 CELLS; DNA-DAMAGE
AB Mitoquinone (MitoQ) is a synthetically modified, redox-active ubiquinone compound that accumulates predominantly in mitochondria. We found that MitoQ is 30-fold more cytotoxic to breast cancer cells than to healthy mammary cells. MitoQ treatment led to irreversible inhibition of clonogenic growth of breast cancer cells through a combination of autophagy and apoptotic cell death mechanisms. Relatively limited cytotoxicity was seen with the parent ubiquinone coenzyme Q(10). Inhibition of cancer cell growth by MitoQ was associated with G(1)/S cell cycle arrest and phosphorylation of the checkpoint kinases Chk1 and Chk2. The possible role of oxidative stress in MitoQ activity was investigated by measuring the products of hydroethidine oxidation. Increases in ethidium and dihydroethidium levels, markers of one-electron oxidation of hydroethidine, were observed at cytotoxic concentrations of MitoQ. Keap1, an oxidative stress sensor protein that regulates the antioxidant transcription factor Nrf2, underwent oxidation, degradation, and dissociation from Nrf2 in MitoQ-treated cells. Nrf2 protein levels, nuclear localization, and transcriptional activity also increased following MitoQ treatment. Knockdown of Nrf2 caused a 2-fold increase in autophagy and an increase in G(1) cell cycle arrest in response to MitoQ but had no apparent effect on apoptosis. The Nrf2-regulated enzyme NQO1 is partly responsible for controlling the level of autophagy. Keap1 and Nrf2 act as redox sensors for oxidative perturbations that lead to autophagy. MitoQ and similar compounds should be further evaluated for novel anticancer activity.
C1 [Rao, V. Ashutosh; Klein, Sarah R.; Bonar, Spencer J.; Dickey, Jennifer S.; Shacter, Emily] US FDA, Biochem Lab, Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
[Zielonka, Jacek; Joseph, Joy; Kalyanaraman, Balaraman] Med Coll Wisconsin, Free Radical Res Ctr, Milwaukee, WI 53226 USA.
[Mizuno, Naoko; Keller, Paul W.] NIAMSD, Struct Biol Res Lab, NIH, Bethesda, MD 20892 USA.
RP Rao, VA (reprint author), 29 Lincoln Dr,Bldg 29A,Rm 2A-09,HFD-122, Bethesda, MD 20892 USA.
EM ashutosh.rao@fda.hhs.gov; emily.shacter@fda.hhs.gov
RI Zielonka, Jacek/N-9546-2014
OI Zielonka, Jacek/0000-0002-2524-0145
FU NIAMS; NCI; National Institutes of Health [RO1CA125112, RO1CA136799]
FX This work was supported in part by National Institutes of Health
Intramural Research Programs of NIAMS and NCI and by National Institutes
of Health Grants RO1CA125112 and RO1CA136799.
NR 58
TC 62
Z9 63
U1 0
U2 12
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD NOV 5
PY 2010
VL 285
IS 45
BP 34447
EP 34459
DI 10.1074/jbc.M110.133579
PG 13
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 673KL
UT WOS:000283659100019
PM 20805228
ER
PT J
AU Jha, KN
Wong, L
Zerfas, PM
De Silva, RS
Fan, YX
Spiridonov, NA
Johnson, GR
AF Jha, Kula N.
Wong, Lily
Zerfas, Patricia M.
De Silva, Rukman S.
Fan, Ying-Xin
Spiridonov, Nikolay A.
Johnson, Gibbes R.
TI Identification of a Novel HSP70-binding Cochaperone Critical to
HSP90-mediated Activation of Small Serine/Threonine Kinase
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID HSP90 CHAPERONE MACHINERY; MOLECULAR CHAPERONES; SIGNAL-TRANSDUCTION;
MALE-INFERTILITY; PROTEIN-KINASES; CO-CHAPERONE; BINDING; CELL;
SPERMATOGENESIS; RECEPTOR
AB We previously reported the identification of small serine/threonine kinase (SSTK) that is expressed in postmeiotic germ cells, associates with HSP90, and is indispensable for male fertility. Sperm from SSTK-null mice cannot fertilize eggs in vitro and are incapable of fusing with eggs that lack zona pellucida. Here, using the yeast two-hybrid screen, we have discovered a novel SSTK-interacting protein (SIP) that is expressed exclusively in testis. The gene encoding SIP is restricted to mammals and encodes a 125-amino acid polypeptide with a predicted tetratricopeptide repeat domain. SIP is co-localized with SSTK in the cytoplasm of spermatids as they undergo restructuring and chromatin condensation, but unlike SSTK, is not retained in the mature sperm. SIP binds to SSTK with high affinity (K-d similar to 10 nM), and the proteins associate with each other when co-expressed in cells. In vitro, SIP inhibited SSTK kinase activity, whereas the presence of SIP in cells resulted in enzymatic activation of SSTK without affecting Akt or MAPK activity. SIP was found to be associated with cellular HSP70, and analyses with purified proteins revealed that SIP directly bound HSP70. Importantly, SSTK recruited SIP onto HSP90, and treatment of cells with the specific HSP90 inhibitor, 17-allylamino-17-demethoxygeldanamycin, completely abolished SSTK catalytic activity. Hence, these findings demonstrate that HSP90 is essential for functional maturation of the kinase and identify SIP as a cochaperone that is critical to the HSP90-mediated activation of SSTK.
C1 [Jha, Kula N.; Wong, Lily; De Silva, Rukman S.; Fan, Ying-Xin; Spiridonov, Nikolay A.; Johnson, Gibbes R.] US FDA, Chem Lab, Div Therapeut Prot, Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
[Zerfas, Patricia M.] NIH, Div Vet Resources, Bethesda, MD 20892 USA.
RP Johnson, GR (reprint author), US FDA, Chem Lab, Div Therapeut Prot, Ctr Drug Evaluat & Res, 29 Lincoln Dr,Bldg 29A,HFD 122, Bethesda, MD 20892 USA.
EM gibbes.johnson@fda.hhs.gov
RI Spiridonov, Nikolay/B-6287-2014
NR 39
TC 3
Z9 6
U1 0
U2 3
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD NOV 5
PY 2010
VL 285
IS 45
BP 35180
EP 35187
DI 10.1074/jbc.M110.134767
PG 8
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 673KL
UT WOS:000283659100091
PM 20829357
ER
PT J
AU Kilcoyne, J
Fux, E
AF Kilcoyne, Jane
Fux, Elie
TI Strategies for the elimination of matrix effects in the liquid
chromatography tandem mass spectrometry analysis of the lipophilic
toxins okadaic acid and azaspiracid-1 in molluscan shellfish
SO JOURNAL OF CHROMATOGRAPHY A
LA English
DT Article
DE Lipophilic marine biotoxins; Azaspiracid; Okadaic acid; LC-MS; On-line
SPE; Matrix effects
ID SINGLE-LABORATORY VALIDATION; MYTILUS-EDULIS; SPORTS DRINKS; SOFT
DRINKS; PERFORMANCE; MUSSELS; RESIDUES
AB Considerable efforts are being made worldwide to replace in vivo assays with instrumental methods of analysis for the monitoring of marine biotoxins in shellfish Analysis of these compounds by the preferred technique of liquid chromatography tandem mass spectrometry (LC-MS/MS) is challenged by matrix effects associated with the shellfish tissues In methods validation assessment of matrix interferences is imperative to ensure the validity and accuracy of results being produced Matrix Interferences for the analysis of okadaic acid (OA) and azaspiracid 1 (AZA1) were assessed using acidic methods on electrospray triple stage quadrupole (TSQ) and hybrid quadrupole time of flight (QToF) instruments by the use of matrix matched standards for different tissue types Using an acidic method no matrix interference and suppression was observed on the TSQ for OA and AZA1 respectively whilst the opposite was observed on the QToF matrix enhancement for OA and no matrix interference for AZA1 The suppression of AZAs on the TSQ was found to be due to interfering compounds being carried over from previous injections The degree of suppression is very much dependant on the tissue type ranging from 15 to 70% Several strategies were evaluated to eliminate these interferences including the partitioning of the extract with hexane optimisation of the chromatographic method and the use of on-line SPE Hexane clean up did not have any impact on matrix effects The use of an alkaline method and a modified acidic method eliminated matrix suppression for AZA1 on the TSQ instrument while an on-line SPE method proved to be effective for matrix enhancement of OA on the QToF (C) 2010 Elsevier B V All rights reserved
C1 [Kilcoyne, Jane] Marine Inst Renville, Oranmore, Galway, Ireland.
[Fux, Elie] US FDA, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
RP Kilcoyne, J (reprint author), Marine Inst Renville, Oranmore, Galway, Ireland.
OI Kilcoyne, Jane/0000-0002-1219-7731
FU Department of Agriculture Fisheries and Food
FX This work was carried out as part of the national Irish biotoxin
monitoring programme which is funded by the Department of Agriculture
Fisheries and Food
NR 39
TC 29
Z9 30
U1 3
U2 26
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0021-9673
J9 J CHROMATOGR A
JI J. Chromatogr. A
PD NOV 5
PY 2010
VL 1217
IS 45
BP 7123
EP 7130
DI 10.1016/j.chroma.2010.09.020
PG 8
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 677EX
UT WOS:000283973000015
PM 20926091
ER
PT J
AU Stang, PE
Ryan, PB
Racoosin, JA
Overhage, JM
Hartzema, AG
Reich, C
Welebob, E
Scarnecchia, T
Woodcock, J
AF Stang, Paul E.
Ryan, Patrick B.
Racoosin, Judith A.
Overhage, J. Marc
Hartzema, Abraham G.
Reich, Christian
Welebob, Emily
Scarnecchia, Thomas
Woodcock, Janet
TI Advancing the Science for Active Surveillance: Rationale and Design for
the Observational Medical Outcomes Partnership
SO ANNALS OF INTERNAL MEDICINE
LA English
DT Article
ID SAFETY SURVEILLANCE; CLAIMS DATA; EVENTS; CARE; ALGORITHMS; DATABASE;
NETWORK; RECORDS
AB The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.
C1 [Stang, Paul E.] Johnson & Johnson, Pharmaceut Res & Dev, Titusville, NJ 08560 USA.
Fdn Natl Inst Hlth, Bethesda, MD USA.
GlaxoSmithKline, Res Triangle Pk, NC USA.
Univ N Carolina, Eshelman Sch Pharm, Chapel Hill, NC USA.
US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
Regenstrief Inst Hlth Care, Indianapolis, IN 46202 USA.
Indiana Univ, Sch Med, Indianapolis, IN USA.
Univ Florida, Coll Pharm, Gainesville, FL USA.
Digital Aurora, Manchester, VT USA.
RP Stang, PE (reprint author), Johnson & Johnson, Pharmaceut Res & Dev, 1125 Trenton Harbourton Rd,POB 200,MS K304, Titusville, NJ 08560 USA.
EM PStang@its.jnj.com
OI Overhage, Joseph/0000-0003-0223-0195
FU Foundation for the National Institutes of Health
FX The OMOP is funded by the Foundation for the National Institutes of
Health, with contributions from a consortium of 17 organizations
(Appendix Table, available at www.annals.org). Three members of the
research team (Dr. Stang, Mr. Ryan, and Dr. Racoosin) serve in-kind and
are not compensated for their participation.
NR 35
TC 133
Z9 134
U1 1
U2 15
PU AMER COLL PHYSICIANS
PI PHILADELPHIA
PA INDEPENDENCE MALL WEST 6TH AND RACE ST, PHILADELPHIA, PA 19106-1572 USA
SN 0003-4819
EI 1539-3704
J9 ANN INTERN MED
JI Ann. Intern. Med.
PD NOV 2
PY 2010
VL 153
IS 9
BP 600
EP 606
DI 10.7326/0003-4819-153-9-201011020-00010
PG 7
WC Medicine, General & Internal
SC General & Internal Medicine
GA 673MH
UT WOS:000283667000007
PM 21041580
ER
PT J
AU Abbasi, F
Degheidy, HA
Marti, GE
AF Abbasi, Fatima
Degheidy, Heba A.
Marti, Gerald E.
TI CONSENSUS DESCRIPTION OF BICLONAL MBL
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Meeting Abstract
CT 25th Annual Meeting of the International-Clinical-Cytometry-Society
CY OCT 01-05, 2010
CL Houston, TX
SP Int Clin Cytometry Soc
C1 [Abbasi, Fatima; Degheidy, Heba A.; Marti, Gerald E.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1552-4949
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD NOV
PY 2010
VL 78B
IS 6
BP 390
EP 390
PG 1
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 677BW
UT WOS:000283965100006
ER
PT J
AU Degheidy, HA
Venzon, DJ
Farooqui, MZH
Abbasi, F
Arthur, DC
Wiestner, A
Stevenson, MAS
Marti, GE
AF Degheidy, Heba A.
Venzon, David J.
Farooqui, Mohammed Z. H.
Abbasi, Fatima
Arthur, Dian C.
Wiestner, Adrian
Stevenson, M. A. Stetler
Marti, Gerald E.
TI ONE STEP METHOD TOWARD STANDARDIZATION OF ZAP-70 EXPRESSION ANALYSIS IN
CLL.
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Meeting Abstract
CT 25th Annual Meeting of the International-Clinical-Cytometry-Society
CY OCT 01-05, 2010
CL Houston, TX
SP Int Clin Cytometry Soc
C1 [Degheidy, Heba A.; Abbasi, Fatima; Arthur, Dian C.; Stevenson, M. A. Stetler; Marti, Gerald E.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Venzon, David J.] NCI, Biostat & Data Management Sect, Rockville, MD USA.
[Farooqui, Mohammed Z. H.; Wiestner, Adrian] NHLBI, NIH, Bethesda, MD 20892 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1552-4949
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD NOV
PY 2010
VL 78B
IS 6
BP 393
EP 393
PG 1
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 677BW
UT WOS:000283965100016
ER
PT J
AU Degheidy, HA
Venzon, D
Farooqui, MZH
Abbasi, F
Arthur, DC
Wiestner, A
Stevenson, MAS
Marti, GE
AF Degheidy, Heba A.
Venzon, David
Farooqui, Mohammed Z. H.
Abbasi, Fatima
Arthur, Diane C.
Wiestner, Adrian
Stevenson, M. A. Stetler
Marti, Gerald E.
TI COMBINED ANALYSIS OF ZAP-70,CD38,CD69,CD26,CD49D,CD27 AS A PREDICTOR FOR
IGVH MUTATIONAL STATUS IN CLL
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Meeting Abstract
CT 25th Annual Meeting of the International-Clinical-Cytometry-Society
CY OCT 01-05, 2010
CL Houston, TX
SP Int Clin Cytometry Soc
C1 [Degheidy, Heba A.; Abbasi, Fatima; Arthur, Diane C.; Stevenson, M. A. Stetler; Marti, Gerald E.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Venzon, David] NCI, Biostat & Data Management Sect, Rockville, MD USA.
[Farooqui, Mohammed Z. H.; Wiestner, Adrian] NHLBI, NIH, Bethesda, MD 20892 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1552-4949
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD NOV
PY 2010
VL 78B
IS 6
BP 393
EP 394
PG 2
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 677BW
UT WOS:000283965100017
ER
PT J
AU Degheidy, HA
Venzon, DJ
Farooqui, MZH
Abbasi, F
Arthur, DC
Wiestner, A
Stevenson, MAS
Marti, GE
AF Degheidy, Heba A.
Venzon, David J.
Farooqui, Mohammed Z. H.
Abbasi, Fatima
Arthur, Diane C.
Wiestner, Adrian
Stevenson, M. A. Stetler
Marti, Gerald E.
TI ZAP-70 ANALYSIS IN CLL USING TWO DIFFERENT MONOCLONAL ANTIBODIES
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Meeting Abstract
CT 25th Annual Meeting of the International-Clinical-Cytometry-Society
CY OCT 01-05, 2010
CL Houston, TX
SP Int Clin Cytometry Soc
C1 [Degheidy, Heba A.; Abbasi, Fatima; Arthur, Diane C.; Stevenson, M. A. Stetler; Marti, Gerald E.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Venzon, David J.] NCI, Biostat & Data Management Sect, Rockville, MD USA.
[Farooqui, Mohammed Z. H.; Wiestner, Adrian] NHLBI, NIH, Bethesda, MD 20892 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1552-4949
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD NOV
PY 2010
VL 78B
IS 6
BP 394
EP 394
PG 1
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 677BW
UT WOS:000283965100018
ER
PT J
AU Degheidy, HA
Gadalla, SM
Farooqui, MZH
Abbasi, F
Arthur, DC
Wiestner, A
Stevenson, MAS
Marti, GE
AF Degheidy, Heba A.
Gadalla, Shahinaz M.
Farooqui, Mohammed Z. H.
Abbasi, Fatima
Arthur, Diane C.
Wiestner, Adrian
Stevenson, M. A. Stetler
Marti, Gerald E.
TI BCL-2: BIOMARKER FOR 13Q14 DELETION STATUS IN CLL
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Meeting Abstract
CT 25th Annual Meeting of the International-Clinical-Cytometry-Society
CY OCT 01-05, 2010
CL Houston, TX
SP Int Clin Cytometry Soc
C1 [Degheidy, Heba A.; Abbasi, Fatima; Arthur, Diane C.; Stevenson, M. A. Stetler; Marti, Gerald E.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
[Gadalla, Shahinaz M.] NCI, Div Canc Epidemiol & Genet, Rockville, MD USA.
[Farooqui, Mohammed Z. H.; Wiestner, Adrian] NHLBI, NIH, Bethesda, MD 20892 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1552-4949
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD NOV
PY 2010
VL 78B
IS 6
BP 394
EP 395
PG 2
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 677BW
UT WOS:000283965100019
ER
PT J
AU Justice, R
Ibrahim, A
Murgo, A
Pazdur, R
AF Justice, R.
Ibrahim, A.
Murgo, A.
Pazdur, R.
TI The point of view of FDA
SO EJC SUPPLEMENTS
LA English
DT Meeting Abstract
CT 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics
CY NOV 16-19, 2010
CL Berlin, GERMANY
C1 [Justice, R.; Ibrahim, A.; Murgo, A.; Pazdur, R.] US FDA, Off Oncol Drug Prod, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 1359-6349
J9 EJC SUPPL
JI EJC Suppl.
PD NOV
PY 2010
VL 8
IS 7
BP 20
EP 20
DI 10.1016/S1359-6349(10)71736-5
PG 1
WC Oncology
SC Oncology
GA 735ZU
UT WOS:000288460100034
ER
PT J
AU Dunne, J
Margaryants, L
Murphy, MD
Myers, AM
Avant, D
Rodriguez, WJ
AF Dunne, Julia
Margaryants, Lala
Murphy, M. Dianne
Myers, Ann M.
Avant, Debbie
Rodriguez, William J.
TI Globalization Facilitates Pediatric Drug Development in the 21st Century
SO DRUG INFORMATION JOURNAL
LA English
DT Article
DE Globalization; Pediatric clinical trial; FDA
ID OFF-LABEL; CHILDREN; TRIALS
AB Introduction: US legislation, supported by strengthened ethical frameworks and improved trial design, has produced significant increases in the number of pediatric clinical trials. This has global implications. Method: We reviewed all submissions of pediatric data received by the US FDA from 2002 to 2007 in response to new FDA pediatric initiatives. Results: Although 54% of the trials were multinational, the US dominated as a trial location. The European Union and Latin America followed. Few trials specifically studied neonates, infants, and toddlers. Conclusion: Although most pediatric drug programs are global, the United States remains the dominant location for pediatric trials. This distribution differs for adult trials. The balance may change in the future. EU and FDA regulators should continue to discuss coordinated approaches to minimize unnecessary pediatric trials and to optimize trial design, safety, and conduct so that the limited pediatric populations available are enrolled only in ethically implemented, scientifically important trials.
C1 [Dunne, Julia; Murphy, M. Dianne; Myers, Ann M.; Avant, Debbie; Rodriguez, William J.] US FDA, Off Pediat Therapeut, Silver Spring, MD 20993 USA.
[Margaryants, Lala] Sci Ctr Drug & Med Technol Expertise, Yerevan, Armenia.
RP Dunne, J (reprint author), US FDA, Off Pediat Therapeut, 10903 New Hampshire Ave,Bldg 32,Room 5154, Silver Spring, MD 20993 USA.
EM julia.dunne@fda.hhs.gov
NR 16
TC 4
Z9 5
U1 0
U2 2
PU DRUG INFORMATION ASSOC
PI HORSHAM
PA 800 ENTERPRISE ROAD, SUITE 200, HORSHAM, PA 19044-3595 USA
SN 0092-8615
J9 DRUG INF J
JI Drug Inf. J.
PD NOV
PY 2010
VL 44
IS 6
BP 757
EP 765
PG 9
WC Health Care Sciences & Services; Pharmacology & Pharmacy
SC Health Care Sciences & Services; Pharmacology & Pharmacy
GA 678ZV
UT WOS:000284130100012
ER
PT J
AU Oakley, MS
Majam, V
Majajan, B
McCutchan, T
Aravind, L
Kumar, S
AF Oakley, Miranda S.
Majam, Victoria
Majajan, Babita
McCutchan, Thomas
Aravind, L.
Kumar, Sanjai
TI MOLECULAR DETERMINANTS OF EXPERIMENTAL CEREBRAL MALARIA IN THE BRAIN AND
CIRCULATION
SO AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
LA English
DT Meeting Abstract
CT 59th Annual Meeting of the
American-Society-of-Tropical-Medicine-and-Hygiene (ASTMH)
CY NOV 03-07, 2010
CL Atlanta, GA
SP Amer Soc Trop Med & Hyg (ASTMH)
C1 [Oakley, Miranda S.; Majam, Victoria; Majajan, Babita; Kumar, Sanjai] US FDA, Rockville, MD 20857 USA.
[McCutchan, Thomas; Aravind, L.] NIH, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC TROP MED & HYGIENE
PI MCLEAN
PA 8000 WESTPARK DR, STE 130, MCLEAN, VA 22101 USA
SN 0002-9637
J9 AM J TROP MED HYG
JI Am. J. Trop. Med. Hyg.
PD NOV
PY 2010
VL 83
IS 5
SU S
MA 425
BP 127
EP 127
PG 1
WC Public, Environmental & Occupational Health; Tropical Medicine
SC Public, Environmental & Occupational Health; Tropical Medicine
GA 832QF
UT WOS:000295819700426
ER
PT J
AU Anez, G
Chancey, CJ
Grinev, A
Morales-Betoulle, ME
Rios, M
AF Anez, German
Chancey, Caren J.
Grinev, Andriyan
Morales-Betoulle, Maria E.
Rios, Maria
TI PHYLOGENETIC ANALYSIS OF AN ISOLATE OF DENGUE VIRUS TYPE 2 FROM
GUATEMALA, 2009
SO AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
LA English
DT Meeting Abstract
CT 59th Annual Meeting of the
American-Society-of-Tropical-Medicine-and-Hygiene (ASTMH)
CY NOV 03-07, 2010
CL Atlanta, GA
SP Amer Soc Trop Med & Hyg (ASTMH)
C1 [Anez, German; Chancey, Caren J.; Grinev, Andriyan; Rios, Maria] US FDA, Bethesda, MD 20014 USA.
[Morales-Betoulle, Maria E.] Univ Valle Guatemala, Guatemala City, Guatemala.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC TROP MED & HYGIENE
PI MCLEAN
PA 8000 WESTPARK DR, STE 130, MCLEAN, VA 22101 USA
SN 0002-9637
J9 AM J TROP MED HYG
JI Am. J. Trop. Med. Hyg.
PD NOV
PY 2010
VL 83
IS 5
SU S
MA 512
BP 154
EP 154
PG 1
WC Public, Environmental & Occupational Health; Tropical Medicine
SC Public, Environmental & Occupational Health; Tropical Medicine
GA 832QF
UT WOS:000295819700513
ER
PT J
AU Chancey, C
Lee-Stroka, A
Rios, M
AF Chancey, Caren
Lee-Stroka, Agnes
Rios, Maria
TI WEST NILE VIRUS BINDS TO RED BLOOD CELLS OF SEVERAL VERTEBRATE SPECIES
SO AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
LA English
DT Meeting Abstract
CT 59th Annual Meeting of the
American-Society-of-Tropical-Medicine-and-Hygiene (ASTMH)
CY NOV 03-07, 2010
CL Atlanta, GA
SP Amer Soc Trop Med & Hyg (ASTMH)
C1 [Chancey, Caren; Rios, Maria] Food & Drug Adm CBER, Bethesda, MD USA.
[Lee-Stroka, Agnes] NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC TROP MED & HYGIENE
PI MCLEAN
PA 8000 WESTPARK DR, STE 130, MCLEAN, VA 22101 USA
SN 0002-9637
J9 AM J TROP MED HYG
JI Am. J. Trop. Med. Hyg.
PD NOV
PY 2010
VL 83
IS 5
SU S
MA 1060
BP 316
EP 316
PG 1
WC Public, Environmental & Occupational Health; Tropical Medicine
SC Public, Environmental & Occupational Health; Tropical Medicine
GA 832QF
UT WOS:000295819701427
ER
PT J
AU deVore, NC
Huynh, S
Dobrovolskaia, EN
Slater, JE
AF deVore, Nicolette C.
Huynh, Susan
Dobrovolskaia, Ekaterina N.
Slater, Jay E.
TI Multiplex microbead measurements for the characterization of cat and
ragweed allergen extracts
SO ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY
LA English
DT Article
ID FEL-D-I; POTENCY; IGE; STABILITY; POLLEN; PURIFICATION; INFORMATION;
REACTIVITY; ANTIBODIES; EXPOSURE
AB Background: Current assays for allergen extracts can measure either overall potency or the levels of individual allergens.
Objective: To develop a multiplex allergen extract potency assay (MAEPA) for allergen extracts that can concurrently measure individual allergens and characterize the overall allergen levels in the mixture.
Methods: Six anti-Fel d 1 and 6 anti-Amb a 1 recombinant antibodies were generated and were covalently bound to carboxy-labeled beads. Antibody-bound beads were then used to measure Fel d 1 and Amb a 1 levels in commercial cat hair and short ragweed pollen (SRP) extracts, respectively, using bead-based flow cytometry. These major allergen levels were compared with those obtained using a conventional antibody-based method. Allergen levels were calculated by comparing the half-maximal effective concentrations of dose-response curves analyzed using 4-parameter fits. Bead-antibody pairs were tested to determine whether the presence of additional bead-antibody pairs affected the apparent potency of the extract.
Results: Allergen contents of cat hair and SRP extracts determined using the MAEPA and anti-Fel d 1 and anti-Amb a 1 antibodies were comparable with potencies determined using conventional methods. Cross-interference from the concurrent use of multiple beads was minimal. Six lots of cat hair extract and 6 lots of SRP extract were tested.
Conclusions: The MAEPA, a bead-based assay using recombinant antibodies, accurately determined Fel d 1 levels in cat hair allergenic extracts and Amb a 1 levels in SRP extracts. The results of this assay are reproducible and are consistent with data obtained using conventional methods. Ann Allergy Asthma Immunol. 2010;105:351-358.
C1 [deVore, Nicolette C.; Huynh, Susan; Dobrovolskaia, Ekaterina N.; Slater, Jay E.] US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Slater, JE (reprint author), US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike,HFM-422, Rockville, MD 20852 USA.
EM Jay.Slater@fda.hhs.gov
FU Center for Biologics Evaluation and Research, US Food and Drug
Administration
FX This study was supported by the Center for Biologics Evaluation and
Research, US Food and Drug Administration.
NR 26
TC 5
Z9 5
U1 0
U2 2
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1081-1206
J9 ANN ALLERG ASTHMA IM
JI Ann. Allergy Asthma Immunol.
PD NOV
PY 2010
VL 105
IS 5
BP 351
EP 358
DI 10.1016/j.anai.2010.09.026
PG 8
WC Allergy; Immunology
SC Allergy; Immunology
GA 701PO
UT WOS:000285834000006
PM 21055660
ER
PT J
AU Gnjidic, D
Le Couteur, DG
Abernethy, DR
Hilmer, SN
AF Gnjidic, Danijela
Le Couteur, David G.
Abernethy, Darrell R.
Hilmer, Sarah N.
TI A Pilot Randomized Clinical Trial Utilizing the Drug Burden Index to
Reduce Exposure to Anticholinergic and Sedative Medications in Older
People
SO ANNALS OF PHARMACOTHERAPY
LA English
DT Article
DE anticholinergic and sedative medications; older adults; prescribing
practices
ID RISK-INCREASING DRUGS; PRESCRIPTION DRUGS; PHYSICAL FUNCTION;
WITHDRAWAL; FALLS; PERCEPTIONS; POPULATION; DECLINE; ADULTS; WOMEN
AB BACKGROUND: The drug burden index (DBI) is an evidence-based tool that utilizes pharmacologic principles to calculate an individual's total exposure to anticholinergic and sedative medications. Higher DBI has been associated with functional impairment in observational studies of older people.
OBJECTIVE: To assess the impact of providing information about DBI to general practitioners (GPs) on prescribing for older people.
METHODS: This was a cluster randomized controlled trial with 3 months of follow-up. Participants were volunteers aged >= 70 years, living in self-care retirement villages in Sydney, Australia. The study intervention involved a letter and phone call to GPs, using DBI to prompt them to consider cessation or dose reduction of anticholinergic and sedative medications. The primary study outcome was to assess the impact of information about DBI on prescribing practices of the GPs.
RESULTS: A total of 115 participants were enrolled, 57 in the intervention group (from 6 sites) and 58 in the control group (from 6 sites). At baseline, 19 of 57 participants in the intervention group and 31 of 58 participants in the control group had a DBI >0 (p < 0.05). At follow-up, a DBI change was observed in 16 participants. DBI decreased in 12 participants, 6 (32%) in the intervention group, and 6 (19%) in the control group. GPs identified the following barriers to reducing anticholinergic and sedative drugs: uncomfortable altering prescriptions initiated by specialists; unable to influence patients' attitudes; unaware of patients' medications and strong clinical indication.
CONCLUSIONS: The intervention targeting GPs' prescribing practices was less effective than anticipated in reducing anticholinergic and sedative drug exposure, and barriers were identified. Future studies should explore multidisciplinary interventions, engaging patients, specialists, GPs, and pharmacists.
C1 [Gnjidic, Danijela] Univ Sydney, Dept Clin Pharmacol, Sydney Med Sch, St Leonards, NSW, Australia.
[Le Couteur, David G.] Concord Hosp, Ctr Educ & Res Ageing, Concord, NSW, Australia.
[Abernethy, Darrell R.] US FDA, Silver Spring, MD USA.
RP Gnjidic, D (reprint author), Univ Sydney, Dept Clin Pharmacol, Sydney Med Sch, St Leonards, NSW, Australia.
EM dgnjidic@med.usyd.edu.au
OI Hilmer, Sarah/0000-0002-5970-1501
FU Geoff and Elaine Penney Ageing Research Unit
FX This study was supported by Geoff and Elaine Penney Ageing Research
Unit.
NR 28
TC 26
Z9 27
U1 1
U2 7
PU HARVEY WHITNEY BOOKS CO
PI CINCINNATI
PA PO BOX 42696, CINCINNATI, OH 45242 USA
SN 1060-0280
J9 ANN PHARMACOTHER
JI Ann. Pharmacother.
PD NOV
PY 2010
VL 44
IS 11
BP 1725
EP 1732
DI 10.1345/aph.1P310
PG 8
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 679XX
UT WOS:000284195200004
PM 20876826
ER
PT J
AU Johnson, CN
Flowers, AR
Noriea, NF
Zimmerman, AM
Bowers, JC
DePaola, A
Grimes, DJ
AF Johnson, C. N.
Flowers, A. R.
Noriea, N. F., III
Zimmerman, A. M.
Bowers, J. C.
DePaola, A.
Grimes, D. J.
TI Relationships between Environmental Factors and Pathogenic Vibrios in
the Northern Gulf of Mexico
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID OYSTERS CRASSOSTREA-VIRGINICA; PARAHAEMOLYTICUS DENSITIES; CHESAPEAKE
BAY; TDH-GENE; VULNIFICUS; WATER; CHOLERAE; COAST; COEFFICIENT;
TEMPERATURE
AB Although autochthonous vibrio densities are known to be influenced by water temperature and salinity, little is understood about other environmental factors associated with their abundance and distribution. Densities of culturable Vibrio vulnificus containing vvh (V. vulnificus hemolysin gene) and V. parahaemolyticus containing tlh (thermolabile hemolysin gene, ubiquitous in V. parahaemolyticus), tdh (thermostable direct hemolysin gene, V. parahaemolyticus pathogenicity factor), and trh (tdh-related hemolysin gene, V. parahaemolyticus pathogenicity factor) were measured in coastal waters of Mississippi and Alabama. Over a 19-month sampling period, vibrio densities in water, oysters, and sediment varied significantly with sea surface temperature (SST). On average, tdh-to-tlh ratios were significantly higher than trh-to-tlh ratios in water and oysters but not in sediment. Although tlh densities were lower than vvh densities in water and in oysters, the opposite was true in sediment. Regression analysis indicated that SST had a significant association with vvh and tlh densities in water and oysters, while salinity was significantly related to vibrio densities in the water column. Chlorophyll a levels in the water were correlated significantly with vvh in sediment and oysters and with pathogenic V. parahaemolyticus (tdh and trh) in the water column. Furthermore, turbidity was a significant predictor of V. parahaemolyticus density in all sample types (water, oyster, and sediment), and its role in predicting the risk of V. parahaemolyticus illness may be more important than previously realized. This study identified (i) culturable vibrios in winter sediment samples, (ii) niche-based differences in the abundance of vibrios, and (iii) predictive signatures resulting from correlations between environmental parameters and vibrio densities.
C1 [Flowers, A. R.; Noriea, N. F., III; Zimmerman, A. M.; Grimes, D. J.] Univ So Mississippi, Gulf Coast Res Lab, Ocean Springs, MS 39564 USA.
[Johnson, C. N.] Louisiana State Univ, Dept Environm Sci, Baton Rouge, LA 70803 USA.
[Bowers, J. C.] US FDA, College Pk, MD USA.
[DePaola, A.] US FDA, Gulf Coast Seafood Lab, Dauphin Isl, AL USA.
RP Grimes, DJ (reprint author), Univ So Mississippi, Gulf Coast Res Lab, 703 E Beach Dr, Ocean Springs, MS 39564 USA.
EM jay.grimes@usm.edu
FU NOAA Oceans and Human Health Initiative [NA-04-OAR4600214]; NSF
[EF-0813285]; NSF-NIH; NASA [NNX09AR57G]
FX This research was supported by a NOAA Oceans and Human Health Initiative
grant (NA-04-OAR4600214), by NSF grant EF-0813285 as part of the joint
NSF-NIH Ecology of Infectious Diseases program, and by a NASA grant
(NNX09AR57G).
NR 40
TC 78
Z9 78
U1 1
U2 25
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 NOV
PY 2010
VL 76
IS 21
BP 7076
EP 7084
DI 10.1128/AEM.00697-10
PG 9
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 670PM
UT WOS:000283439800013
PM 20817802
ER
PT J
AU David, DE
Lynne, AM
Han, J
Foley, SL
AF David, Donna E.
Lynne, Aaron M.
Han, Jing
Foley, Steven L.
TI Evaluation of Virulence Factor Profiling in the Characterization of
Veterinary Escherichia coli Isolates
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID ANTIMICROBIAL RESISTANCE; GENES; STRAINS; CALVES; IDENTIFICATION;
BACTERIA; ONTARIO; TRAITS; CATTLE; PIGS
AB Escherichia coli has been used as an indicator organism for fecal contamination of water and other environments and is often a commensal organism in healthy animals, yet a number of strains can cause disease in young or immunocompromised animals. In this study, 281 E. coli isolates from bovine, porcine, chicken, canine, equine, feline, and other veterinary sources were analyzed by BOXA1R PCR and by virulence factor profiling of 35 factors to determine whether they had utility in identifying the animal source of the isolates. The results of BOXA1R PCR analysis demonstrated a high degree of diversity; less than half of the isolates fell into one of 27 clusters with at least three isolates (based on 90% similarity). Nearly 60% of these clusters contained isolates from more than one animal source. Conversely, the results of virulence factor profiling demonstrated clustering by animal source. Three clusters, named Bovine, Chicken, and Porcine, based on discriminant components analysis, were represented by 90% or more of the respective isolates. A fourth group, termed Companion, was the most diverse, containing at least 84% of isolates from canine, feline, equine, and other animal sources. Based on these results, it appears that virulence factor profiling may have utility, helping identify the likely animal host species sources of certain E. coli isolates.
C1 [Han, Jing] US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
[David, Donna E.; Lynne, Aaron M.; Foley, Steven L.] Marshfield Clin Res Fdn, Marshfield, WI 54449 USA.
[Lynne, Aaron M.; Foley, Steven L.] Sam Houston State Univ, Dept Biol Sci, Huntsville, TX USA.
RP Foley, SL (reprint author), US FDA, Div Microbiol, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM steven.foley@fda.hhs.gov
FU Marshfield Clinic Research Foundation; U.S. Food and Drug
Administration; Oak Ridge Institute for Science and Education
FX We thank the Marshfield Clinic Research Foundation and the U.S. Food and
Drug Administration for financial support of the research. Jing Han is
supported through the Oak Ridge Institute for Science and Education.
NR 30
TC 6
Z9 6
U1 1
U2 4
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD NOV
PY 2010
VL 76
IS 22
BP 7509
EP 7513
DI 10.1128/AEM.00726-10
PG 5
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 675PX
UT WOS:000283843900018
PM 20889790
ER
PT J
AU Sachdeva, A
Defibaugh-Chavaz, SLH
Day, JB
Zink, D
Sharma, SK
AF Sachdeva, Amita
Defibaugh-Chavaz, Stephanie L. H.
Day, James B.
Zink, Donald
Sharma, Shashi K.
TI Detection and Confirmation of Clostridium botulinum in Water Used for
Cooling at a Plant Producing Low-Acid Canned Foods
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID NEUROTOXIN; STRAIN; TOXIN
AB Our laboratory tested water samples used for cooling low-acid canned foods at a canning facility under investigation by the U. S. Food and Drug Administration. We used an enzyme-linked immunosorbent assay with digoxigenin-labeled antibodies (DIG-ELISA) and real-time PCR as screening methods and confirmed the presence of neurotoxin-producing Clostridium botulinum in the samples by mouse bioassay.
C1 [Sachdeva, Amita; Defibaugh-Chavaz, Stephanie L. H.; Day, James B.; Zink, Donald; Sharma, Shashi K.] US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Sharma, SK (reprint author), US FDA, Ctr Food Safety & Appl Nutr, CPK1,HFS 712,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM shashi.sharma@fda.hhs.gov
NR 14
TC 6
Z9 6
U1 0
U2 10
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD NOV
PY 2010
VL 76
IS 22
BP 7653
EP 7657
DI 10.1128/AEM.00820-10
PG 5
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 675PX
UT WOS:000283843900037
PM 20889791
ER
PT J
AU Mossoba, MM
Al-Khaldi, SF
Schoen, B
Yakes, BJ
AF Mossoba, Magdi M.
Al-Khaldi, Sufian F.
Schoen, Brianna
Yakes, Betsy Jean
TI Nanoparticle Probes and Mid-Infrared Chemical Imaging for DNA Microarray
Detection
SO APPLIED SPECTROSCOPY
LA English
DT Article
DE DNA microarrays; Mid-infrared chemical imaging; Nanoparticles
ID SINGLE-STRANDED-DNA; CLOSTRIDIUM-PERFRINGENS; GENE-EXPRESSION; GOLD
SURFACES; HYBRIDIZATION; SPECTROSCOPY; IDENTIFICATION; AMPLIFICATION;
ALKANETHIOLS; ATTACHMENT
AB To date most mid-infrared spectroscopic studies have been limited, due to lack of sensitivity, to the structural characterization of a single oligonucleotide probe immobilized over the entire surface of a gold-coated slide or other infrared substrate. By contrast, widely used and commercially available glass slides and a microarray spotter that prints approximately 120-mu m-diameter DNA spots were employed in the present work. To our knowledge, mid-infrared chemical imaging (IRCI) in the external reflection mode has been applied in the present study for the first time to the detection of nanostructure-based DNA microarrays spotted on glass slides. Alkyl amine-modified oligonucleotide probes were immobilized on glass slides that had been prefunctionalized with succinimidyl ester groups. This molecular fluorophore-free method entailed the binding of gold-nanoparticle-streptavidin conjugates to biotinylated DNA targets. Hybridization was visualized by the silver enhancement of gold nanoparticles. The adlayer of silver, selectively hound only to hybridized spots in a microarray, formed the external reflective infrared substrate that was necessary for the detection of DNA hybridization by IRCI in the present proof-of-concept study. IRCI made it possible to discriminate between diffuse and specular external reflection modes. The promising qualitative results are presented herein, and the implications for quantitative determination of DNA microarrays are discussed.
C1 [Mossoba, Magdi M.; Yakes, Betsy Jean] US FDA, Div Analyt Chem, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
[Al-Khaldi, Sufian F.; Schoen, Brianna] US FDA, Div Microbiol, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Mossoba, MM (reprint author), US FDA, Div Analyt Chem, Off Regulatory Sci, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM magdi.mossoba@fda.hhs.gov
RI Yakes, Betsy/K-2646-2012
NR 50
TC 3
Z9 3
U1 3
U2 14
PU SOC APPLIED SPECTROSCOPY
PI FREDERICK
PA 5320 SPECTRUM DRIVE SUITE C, FREDERICK, MD 21703 USA
SN 0003-7028
J9 APPL SPECTROSC
JI Appl. Spectrosc.
PD NOV
PY 2010
VL 64
IS 11
BP 1191
EP 1198
DI 10.1366/000370210793335007
PG 8
WC Instruments & Instrumentation; Spectroscopy
SC Instruments & Instrumentation; Spectroscopy
GA 681FO
UT WOS:000284297000001
PM 21073786
ER
PT J
AU Grajkowski, A
Cieslak, J
Gapeev, A
Schindler, C
Beaucage, SL
AF Grajkowski, Andrzej
Cieslak, Jacek
Gapeev, Alexei
Schindler, Christian
Beaucage, Serge L.
TI Convenient Synthesis of a Propargylated Cyclic (3 '-5 ') Diguanylic Acid
and Its "Click" Conjugation to a Biotinylated Azide
SO BIOCONJUGATE CHEMISTRY
LA English
DT Article
ID C-DI-GMP; I INTERFERON RESPONSE; ACETOBACTER-XYLINUM; CELLULOSE
SYNTHESIS; TERMINAL ALKYNES; PROTECTING GROUP; SOLID-PHASE; ANALOGS;
MOLECULE; DNA
AB The ribonucleoside building block, N(2)-isobutyryl-2'-O-propargyl-3'-O-levulinyl guanosine, was prepared from commercial N(2)-isobutyryl-5'-O-(4,4'-dimethoxytrityl)-2'-O-propargyl guanosine in a yield of 91%. The propargylated guanylyl(3'-5')guanosine phosphotriester was synthesized from the reaction of N(2)-isobutyryl-2'-O-propargyl-3'-O-levulinyl guanosine with N(2)-isobutyryl-5'-O-(4,4'-dimethoxytrityl)-2'-O-tert-butyldimethylsilyl-3'-O-[(2-cyanoethyl)-N, N-diisopropylaminophosphinyl] guanosine and isolated in a yield of 88% after P(III) oxidation, 3'-/5'-deprotection, and purification. The propargylated guanylyl(3'-5')guanosine phosphotriester was phosphitylated using 2-cyanoethyl tetraisopropylphosphordiamidite and 1H-tetrazole and was followed by an in situ intramolecular cyclization to give a propargylated c-di-GMP triester, which was isolated in a yield of 40% after P(III) oxidation and purification. Complete N-deacylation of the guanine bases and removal of the 2-cyanoethyl phosphate protecting groups from the propargylated c-di-GMP triester were performed by treatment with aqueous ammonia at ambient temperature. The final 2'-desilylation reaction was effected by exposure to triethylammonium trihydrofluoride affording the desired propargylated c-di-GMP diester, the purity of which exceeded 95%. Biotinylation of the propargylated c-di-GMP diester was easily accomplished through its cycloaddition reaction with a biotinylated azide derivative under click conditions to produce the biotinylated c-di-GMP conjugate of interest in an isolated yield of 62%.
C1 [Grajkowski, Andrzej; Cieslak, Jacek; Beaucage, Serge L.] Ctr Drug Evaluat & Res, Food & Drug Adm, Div Therapeut Prot, Bethesda, MD 20892 USA.
[Schindler, Christian] Columbia Univ, Dept Microbiol & Immunol, New York, NY 10032 USA.
[Gapeev, Alexei] Univ Maryland Baltimore Cty, Dept Chem & Biochem, Baltimore, MD 21250 USA.
RP Grajkowski, A (reprint author), Ctr Drug Evaluat & Res, Food & Drug Adm, Div Therapeut Prot, 8800 Rockville Pike, Bethesda, MD 20892 USA.
EM Andrzej.Grajkowski@fda.hhs.gov
FU NIH [R21 ES016835, RO1 AI058211]
FX This work was supported in part by NIH grants R21 ES016835 and RO1
AI058211 (CS.).
NR 26
TC 12
Z9 13
U1 2
U2 13
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 1043-1802
J9 BIOCONJUGATE CHEM
JI Bioconjugate Chem.
PD NOV
PY 2010
VL 21
IS 11
BP 2147
EP 2152
DI 10.1021/bc1003857
PG 6
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Chemistry, Multidisciplinary; Chemistry, Organic
SC Biochemistry & Molecular Biology; Chemistry
GA 680AT
UT WOS:000284203200025
PM 20942415
ER
PT J
AU Antunes, AMM
Godinho, ALA
Martins, IL
Oliveira, MC
Gomes, RA
Coelho, AV
Beland, FA
Marques, MM
AF Antunes, Alexandra M. M.
Godinho, Ana L. A.
Martins, Ines L.
Oliveira, M. Conceicao
Gomes, Ricardo A.
Coelho, Ana V.
Beland, Frederick A.
Marques, M. Matilde
TI Protein Adducts As Prospective Biomarkers of Nevirapine Toxicity
SO CHEMICAL RESEARCH IN TOXICOLOGY
LA English
DT Article
ID REVERSE-TRANSCRIPTASE INHIBITOR; INDUCED SKIN RASH; PERFORMANCE
LIQUID-CHROMATOGRAPHY; TANDEM MASS-SPECTROMETRY; TO-CHILD TRANSMISSION;
METABOLIC-ACTIVATION; COVALENT BINDING; DRUG-REACTIONS; HUMAN-ALBUMIN;
SINGLE
AB Nevirapine (NVP) is a non-nucleoside reverse transcriptase inhibitor used against human immunodeficiency virus type-1 (HIV-1), mostly to prevent mother-to-child HIV-1 transmission in developing countries. Despite its clinical efficacy, NVP administration is associated with a variety of toxic responses that include hepatotoxicity and skin rash. Although the reasons for the adverse effects of NVP administration are still unclear, increasing evidence supports the involvement of metabolic activation to reactive electrophiles. In particular, Phase II activation of the NVP metabolite 12-hydroxy-NVP is thought to mediate NVP binding to bionucleophiles, which may be at the onset of toxicity. In the present study, we investigated the nature and specific locations of the covalent adducts produced in human serum albumin and human hemoglobin by reaction in vitro with the synthetic model electrophile 12-mesyloxy-NVP, used as a surrogate for the Phase II metabolite 12-sulfoxy-NVP. Multiple sites of modification were identified by two different mass spectrometry-based methodologies, liquid chromatography electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) and matrix-assisted laser desorption ionization tandem mass spectrometry (MALDI-TOF-TOF-MS). These two distinct methodologies, which in some instances afforded complementary information, allowed the identification of multiple adducts involving cysteine, lysine, tryptophan, histidine, serine, and the N-terminal valine of hemoglobin. Tryptophan, which is not a common site of covalent protein modification, was the NVP-modified amino acid residue detected in the two proteins and consistently identified by both LC-ESI-MS/MS and MALDI-TOF-TOF-MS. The propensity of tryptophan to react with the NVP-derived electrophile is further emphasized by the fact that human serum albumin possesses a single tryptophan residue, which suggests a remarkable selectivity that may be useful for biomonitoring purposes. Likewise, the NVP adduct with the terminal valine of hemoglobin, detected by LC-ESI-MS/MS after N-alkyl Edman degradation, appears as an easily assessed marker of NVP binding to proteins. Our results demonstrate the merits and complementarity of the two MS-based methodologies for the characterization of protein binding by NVP and suggest a series of plausible biomarkers of NVP toxicity that should be useful in the monitoring of toxicity effects in patients administered NVP.
C1 [Antunes, Alexandra M. M.; Godinho, Ana L. A.; Martins, Ines L.; Oliveira, M. Conceicao; Marques, M. Matilde] Univ Tecn Lisbon, Inst Super Tecn, Ctr Quim Estrutural, P-1049001 Lisbon, Portugal.
[Gomes, Ricardo A.; Coelho, Ana V.] Univ Nova Lisboa, Inst Tecnol Quim & Biol, P-2781901 Oeiras, Portugal.
[Beland, Frederick A.] Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Antunes, AMM (reprint author), Univ Tecn Lisbon, Inst Super Tecn, Ctr Quim Estrutural, Complexo 1,Av Rovisco Pais, P-1049001 Lisbon, Portugal.
EM alexandra.antunes@ist.utl.pt; matilde.marques@ist.utl.pt
RI Gomes, Ricardo/E-8379-2012; Oliveira, Maria Conceicao/H-8263-2012;
Coelho, Ana/H-8885-2012; Marques, M. Matilde/E-2535-2012; PTMS,
RNEM/C-1589-2014; Antunes, Alexandra/B-7871-2009; Varela Coelho,
Ana/O-3977-2014;
OI Gomes, Ricardo/0000-0001-7155-0059; Oliveira, Maria
Conceicao/0000-0002-3068-4920; Marques, M. Matilde/0000-0002-7526-4962;
Antunes, Alexandra/0000-0003-1827-7369; Varela Coelho,
Ana/0000-0001-8700-8934; Lanca Martins, Ines/0000-0003-0797-7642;
Coelho, Ana/0000-0002-6143-4203
FU Fundacao para a Ciencia e a Tecnologia (FCT), Portugal; FEDER
[POCI/56582/QUI/2004, PPCDT/QUI/56582/2004]; FCT [SFRH/BPD/41037/2007];
National Center for Toxicological Research/Food and Drug Administration
[224-93-0001]; National Institute for Environmental Health Sciences
[224-93-0001]
FX This work was supported in part by a research grant from Fundacao para a
Ciencia e a Tecnologia (FCT), Portugal and FEDER (POCI/56582/QUI/2004;
PPCDT/QUI/56582/2004), by a postdoctoral fellowship from FCT to R.A.G.
(SFRH/BPD/41037/2007), and by Interagency Agreement No. 224-93-0001
between the National Center for Toxicological Research/Food and Drug
Administration and the National Institute for Environmental Health
Sciences/National Toxicology Program. The LC-MS equipment used in this
work is located at the IST-UTL node of the Portuguese National Mass
Spectrometry Network (RNEM) and was acquired within the framework of the
National Re-equipment Program sponsored by FCT. The opinions expressed
in this paper do not necessarily represent those of the U.S. Food and
Drug Administration.
NR 52
TC 32
Z9 32
U1 0
U2 16
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0893-228X
J9 CHEM RES TOXICOL
JI Chem. Res. Toxicol.
PD NOV
PY 2010
VL 23
IS 11
BP 1714
EP 1725
DI 10.1021/tx100186t
PG 12
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Toxicology
SC Pharmacology & Pharmacy; Chemistry; Toxicology
GA 681DJ
UT WOS:000284290500011
PM 20809596
ER
EF