Food and Drug Administration

Summary

Organization: Food and Drug Administration
Country: USA

Top Publications

  1. pmc Anti-West Nile virus activity of in vitro expanded human primary natural killer cells
    Mingjie Zhang
    Laboratory of Molecular Virology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20892, USA
    BMC Immunol 11:3. 2010
  2. ncbi Genomic hypomethylation is specific for preneoplastic liver in folate/methyl deficient rats and does not occur in non-target tissues
    Igor P Pogribny
    Division of Biochemical Toxicology, FDA National Center for Toxicological Research, NCTR, 3900 NCTR Road, Jefferson, AR 72079, USA
    Mutat Res 548:53-9. 2004
  3. ncbi Formation and analysis of heterocyclic aromatic amine-DNA adducts in vitro and in vivo
    Robert J Turesky
    Division of Chemistry, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079, USA
    J Chromatogr B Analyt Technol Biomed Life Sci 802:155-66. 2004
  4. ncbi Immunization with meningococcal polysaccharide-tetanus toxoid conjugate induces polysaccharide-reactive T cells in mice
    Subramanian Muthukkumar
    Division of Monoclonal Antibodies, Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, USA
    Vaccine 22:1290-9. 2004
  5. ncbi Effects of on-board and dockside handling on the formation of biogenic amines in mahimahi (Coryphaena hippurus), skipjack tuna (Katsuwonus pelamis), and yellowfin tuna (Thunnus albacares)
    Walter F Staruszkiewicz
    US Food and Drug Administration, Washington Seafood Laboratory, 8301 Muirkirk Road, Laurel, Maryland 20708, USA
    J Food Prot 67:134-41. 2004
  6. ncbi Signal pathway profiling of ovarian cancer from human tissue specimens using reverse-phase protein microarrays
    Julia D Wulfkuhle
    Center for Cancer Research, National Cancer Institute NIH, Building 29A Room 2B20, 8000 Rockville Pike, Bethesda, MD 20892, USA
    Proteomics 3:2085-90. 2003
  7. ncbi Aberration analyses needed for FDA evaluation of safety and effectiveness of wavefront-guided refractive surgical devices
    Bruce A Drum
    Division of Ophthalmic and ENT Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Boulevard, HFZ 460, Rockville, MD 20850, USA
    J Refract Surg 19:S588-91. 2003
  8. ncbi Are all monitoring boundaries equally ethical?
    Susan S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Control Clin Trials 24:585-8. 2003
  9. ncbi CpG DNA as a vaccine adjuvant
    Dennis M Klinman
    Section of Retroviral Immunology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA
    Expert Rev Vaccines 2:305-15. 2003
  10. ncbi Relative risks of reported serious injury and death associated with hemostasis devices by gender
    Dale R Tavris
    Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ 541, Rockville, MD 20850, USA
    Pharmacoepidemiol Drug Saf 12:237-41. 2003

Detail Information

Publications62

  1. pmc Anti-West Nile virus activity of in vitro expanded human primary natural killer cells
    Mingjie Zhang
    Laboratory of Molecular Virology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20892, USA
    BMC Immunol 11:3. 2010
    ..The expanded NK cells were tested for their ability to inhibit WNV infection in vitro...
  2. ncbi Genomic hypomethylation is specific for preneoplastic liver in folate/methyl deficient rats and does not occur in non-target tissues
    Igor P Pogribny
    Division of Biochemical Toxicology, FDA National Center for Toxicological Research, NCTR, 3900 NCTR Road, Jefferson, AR 72079, USA
    Mutat Res 548:53-9. 2004
    ..They also demonstrate that DNA hypomethylation is localized to tissue that undergoes carcinogenesis, and is not altered in non-target tissues...
  3. ncbi Formation and analysis of heterocyclic aromatic amine-DNA adducts in vitro and in vivo
    Robert J Turesky
    Division of Chemistry, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079, USA
    J Chromatogr B Analyt Technol Biomed Life Sci 802:155-66. 2004
    ..In this review, the principal methods to synthesize and characterize DNA adducts, and the methods applied to measure HAA-DNA adduct in vitro and vivo are discussed...
  4. ncbi Immunization with meningococcal polysaccharide-tetanus toxoid conjugate induces polysaccharide-reactive T cells in mice
    Subramanian Muthukkumar
    Division of Monoclonal Antibodies, Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, USA
    Vaccine 22:1290-9. 2004
    ..The data suggest that multivalent repeating epitopes on PS antigen (Ag) can overcome the need for MHC restricted interactions, but not the requirement for cell-cell contact...
  5. ncbi Effects of on-board and dockside handling on the formation of biogenic amines in mahimahi (Coryphaena hippurus), skipjack tuna (Katsuwonus pelamis), and yellowfin tuna (Thunnus albacares)
    Walter F Staruszkiewicz
    US Food and Drug Administration, Washington Seafood Laboratory, 8301 Muirkirk Road, Laurel, Maryland 20708, USA
    J Food Prot 67:134-41. 2004
    ..The study also demonstrated that histidine decarboxylase activity was retained in some frozen samples of fish and could result in further increases in histamine on thawing...
  6. ncbi Signal pathway profiling of ovarian cancer from human tissue specimens using reverse-phase protein microarrays
    Julia D Wulfkuhle
    Center for Cancer Research, National Cancer Institute NIH, Building 29A Room 2B20, 8000 Rockville Pike, Bethesda, MD 20892, USA
    Proteomics 3:2085-90. 2003
    ....
  7. ncbi Aberration analyses needed for FDA evaluation of safety and effectiveness of wavefront-guided refractive surgical devices
    Bruce A Drum
    Division of Ophthalmic and ENT Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Boulevard, HFZ 460, Rockville, MD 20850, USA
    J Refract Surg 19:S588-91. 2003
    Manufacturers of refractive surgical lasers are seeking Food and Drug Administration (FDA) approval for refractive surgery based on wavefront measurements rather than manifest refractions...
  8. ncbi Are all monitoring boundaries equally ethical?
    Susan S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Control Clin Trials 24:585-8. 2003
  9. ncbi CpG DNA as a vaccine adjuvant
    Dennis M Klinman
    Section of Retroviral Immunology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA
    Expert Rev Vaccines 2:305-15. 2003
    ..Ongoing clinical studies indicate that CpG oligodeoxynucleotides are safe and well-tolerated when administered as adjuvants to humans and in some cases increase vaccine-induced immune responses...
  10. ncbi Relative risks of reported serious injury and death associated with hemostasis devices by gender
    Dale R Tavris
    Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ 541, Rockville, MD 20850, USA
    Pharmacoepidemiol Drug Saf 12:237-41. 2003
    ..To assess relative risks by gender of reported serious injuries and deaths associated with the use of hemostasis devices, stratified by year of report, type of injury, and type of device...
  11. pmc Impact of antimicrobial resistance on regulatory policies in veterinary medicine: status report
    Linda Tollefson
    Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA
    AAPS PharmSci 4:E37. 2002
    ..The US Food and Drug Administration's (FDA's) goal in resolving the public health impact arising from the use of antimicrobial drugs in ..
  12. pmc Adverse drug event monitoring at the Food and Drug Administration
    Syed Rizwanuddin Ahmad
    Division of Drug Risk Evaluation, Office of Drug Safety, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD 20857, USA
    J Gen Intern Med 18:57-60. 2003
    The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market...
  13. ncbi Classification of a polycyclic aromatic hydrocarbon-metabolizing bacterium, Mycobacterium sp. strain PYR-1, as Mycobacterium vanbaalenii sp. nov
    Ashraf A Khan
    Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
    Int J Syst Evol Microbiol 52:1997-2002. 2002
    ..nov. is proposed...
  14. ncbi Development of vaccines for bio-warfare agents
    S R Rosenthal
    Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, CBER FDA, Rockville, Maryland 20852, USA
    Dev Biol (Basel) 110:99-105. 2002
    ..FDA resources exist to assist vaccine developers with regard to the novel challenges posed in the dinical development of these products...
  15. ncbi Correlation of DNA adduct formation and riddelliine-induced liver tumorigenesis in F344 rats and B6C3F1 mice [Cancer Lett. 193 (2003) 119-125
    Ming W Chou
    Division of Biochemical Toxicology, National Center for Toxicological Research, Jefferson, AR 72079, USA
    Cancer Lett 207:119-25. 2004
    ..These results indicate that the levels of riddelliine-induced DNA adducts in specific populations of liver cells correlate with the preferential induction of liver hemangiosarcomas by riddelliine...
  16. ncbi Confirmation of the allergenic peanut protein, Ara h 1, in a model food matrix using liquid chromatography/tandem mass spectrometry (LC/MS/MS)
    Kevin J Shefcheck
    Center for Food Safety and Nutrition, Food and Drug Administration, College Park, Maryland 20740, USA
    J Agric Food Chem 52:2785-90. 2004
    ..This method provides an unambiguous means of confirming the presence of the peanut allergen, Ara h 1, in foods and can easily be modified to detect other food allergens...
  17. ncbi Lessons from Kitty Hawk: from feasibility to routine clinical use for the field of proteomic pattern diagnostics
    Emanuel F Petricoin
    FDA NCI Clinical Proteomics Program, Office of Cell and Gene Therapies, CBER, FDA, Bethesda, MD 20892, USA
    Proteomics 4:2357-60. 2004
    ..We reflect on the important lessons gleaned from the Wright brothers' attempts at controlled heavier-than-air flight as a model for perseverance and a view to the very near future for proteomic pattern diagnostics...
  18. ncbi Analysis of strategies to successfully vaccinate infants in developing countries against enterotoxigenic E. coli (ETEC) disease
    Richard I Walker
    Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20851 1448, USA
    Vaccine 25:2545-66. 2007
    ..However, a Product Development Partnership to overcome this hurdle could accelerate the time lines towards when control of ETEC disease in DCs is substantially closer...
  19. ncbi Determination of usnic acid in lichen toxic to elk by liquid chromatography with ultraviolet and tandem mass spectrometry detection
    John A G Roach
    Center for Food Safety and Applied Nutrition, U S Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740, USA
    J Agric Food Chem 54:2484-90. 2006
    ..The combination of UV quantification and MS confirmation provides a reliable analytical method for measuring usnic acid levels in plant material...
  20. ncbi Biological activity of residual cell-substrate DNA
    K Peden
    Division of Viral Products, OVRR, CBER, FDA, Bethesda, MD 20892, USA
    Dev Biol (Basel) 123:45-53; discussion 55-73. 2006
    ..In this paper, we discuss our approaches to address this issue and describe some preliminary work...
  21. ncbi Applications of real-time immuno-polymerase chain reaction (rt-IPCR) for the rapid diagnoses of viral antigens and pathologic proteins
    Janet Barletta
    University of Maryland Baltimore, 725 W Lombard St, Baltimore, MD 21201, USA
    Mol Aspects Med 27:224-53. 2006
    ..With further standardization and validation, rt-IPCR has the potential to become the most analytically sensitive method available for the detection of proteins...
  22. ncbi FDA perspectives on supplement use by patients on antithrombotic therapy
    Myong Jin Kim
    Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, HFD 870, Rockville, MD 20857, USA
    Thromb Res 117:197-200; discussion 201-7. 2005
  23. ncbi Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen
    Bhupinder S Mann
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 11:5671-7. 2005
    To present the basis of the decision of the Food and Drug Administration to grant accelerated approval for letrozole for extended adjuvant treatment of early-stage breast cancer in postmenopausal women after completion of adjuvant ..
  24. ncbi Toxicological aspects of the South American herbs cat's claw (Uncaria tomentosa) and Maca (Lepidium meyenii) : a critical synopsis
    Luis G Valerio
    Division of Biotechnology and GRAS Notice Review, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, U S Food and Drug Administration, College Park, Maryland 20740, USA
    Toxicol Rev 24:11-35. 2005
    ....
  25. ncbi Critical path workshop on the development of cellular and gene therapy products
    Eda T Bloom
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Mol Ther 12:5-8. 2005
  26. ncbi Feasibility of immunodiagnostic devices for the detection of ricin, amanitin, and T-2 toxin in food
    Eric A E Garber
    Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods, Division of Natural Products, 5100 Paint Branch Parkway, College Park, Maryland 20740, USA
    J Food Prot 68:1294-301. 2005
    ..Competitive ELISAs, which typically have unacceptably high background reactions with food samples, successfully detected amanitin and T-2 toxin...
  27. ncbi IV-IVC for topically applied preparations--a critical evaluation
    Vinod P Shah
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Eur J Pharm Biopharm 60:309-14. 2005
    ..In the scientific arena, it is difficult to obtain a classical IV-IVC even for orally administered products and is more so difficult for topically administered drug products...
  28. ncbi A dynamic simulation of bisphenol A dosimetry in neuroendocrine organs
    Joseph C Hutter
    Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20852, USA
    Toxicol Ind Health 20:29-40. 2004
    ..Route differences in tissue uptake were directly related to the competition between transfer and binding reactions during the absorption phase...
  29. ncbi U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 11:12-9. 2005
    ..The present review, based on a safety and efficacy report submitted on December 20, 2002, summarizes data applicable to the conversion of these three CML indications to full approval status...
  30. ncbi Viral safety evaluation of plasma-derived therapeutic products
    M Farshid
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    Dev Biol (Basel) 118:11-5. 2004
    ....
  31. ncbi Regulatory philosophy for comparability protocols
    M Moos
    FDA CBER, Rockville, MD 20852 1448, USA
    Dev Biol (Basel) 109:53-6. 2002
    ..Other parts of this strategy include thorough product characterization during development,...adherence to Good Manufacturing Practices, a validated manufacturing process, raw materials testing, in-process testing," and so forth...
  32. ncbi Implications of the new FDA/CDER immunotoxicology guidance for drugs
    Kenneth L Hastings
    Division of Special Pathogen and Immunologic Drug Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, 20857, USA
    Int Immunopharmacol 2:1613-8. 2002
    ..In this review, the essential points of the new FDA/CDER guidance document will be discussed, especially with respect to promotion of research into issues such as drug allergy...
  33. ncbi Feasibility of a defined microflora challenge method for evaluating the efficacy of foodborne Listeria monocytogenes selective enrichments
    A D Hitchins
    Center for Food Safety and Applied Nutrition, U S Food and Drug Administration, Washington, DC 20204 0001, USA
    J Food Prot 63:1064-70. 2000
    ..monocytogenes recovery was 2.2 x 10(6) or higher for the Food and Drug Administration one-step enrichments and 0...
  34. ncbi Liquid chromatography/mass spectrometry for timely response in regulatory analyses: identification of pentobarbital in dog food
    D N Heller
    U S Food and Drug Administration, Center for Veterinary Medicine, Laurel, Maryland 20708, USA
    Anal Chem 72:2711-6. 2000
    ..This work demonstrates the utility of LC/MS for rapid regulatory response, provided there is a framework of quality assurance checks...
  35. ncbi Use of microbial data for hazard analysis and critical control point verification--Food and Drug Administration perspective
    J E Kvenberg
    Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Washington, DC 20204, USA
    J Food Prot 63:810-4. 2000
    ..The verification audits demonstrate that all control measures have been applied as designed in the HACCP plan. Although auditing HACCP records is the primary means of verification, microbial sampling can play an important role as well...
  36. ncbi An evaluation of l-ephedrine neurotoxicity with respect to hyperthermia and caudate/putamen microdialysate levels of ephedrine, dopamine, serotonin, and glutamate
    J F Bowyer
    Division of Neurotoxicology, National Center for Toxicological Research, Jefferson, Arkansas 72079, USA
    Toxicol Sci 55:133-42. 2000
    ....
  37. ncbi Progress of a half century in the study of the Luria-Delbrück distribution
    Q Zheng
    Division of Biometry and Risk Assessment, National Center for Toxicological Research, Jefferson, AR 72079 9502, USA
    Math Biosci 162:1-32. 1999
    ..This review emphasizes basic principles which not only help to unify existing results but also allow for a few useful extensions. In addition, the review offers a historical perspective and some new explanations of divergent moments...
  38. ncbi Dietary vitamin E and beta-carotene sources influence vitamin A and E storage in young rats fed marginal and adequate vitamin E
    M Y Jenkins
    Office of Food Labeling, US Food and Drug Administration, Laurel, MD 20708, USA
    Nutr Cancer 34:235-41. 1999
    ..The roles of the two vitamin E sources in alpha-tocopherol metabolism are not equivalent. These data indicate that vitamin A source influences the magnitude of the tissue vitamin A and E changes in response to the two vitamin E sources...
  39. ncbi Cloning and expression in Escherichia coli of an azoreductase gene from Clostridium perfringens and comparison with azoreductase genes from other bacteria
    F Rafii
    Division of Microbiology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR 72079, USA
    J Basic Microbiol 39:29-35. 1999
    ..perfringens is conserved in some anaerobes and facultative anaerobes, but not in others, and that different types of azoreductase genes must be found in other anaerobic bacteria...
  40. ncbi Template preparation for PCR and RFLP of amplification products for the detection and identification of Cyclospora sp. and Eimeria spp. Oocysts directly from raspberries
    K C Jinneman
    Seafood Products Research Center, U S Food and Drug Administration, Bothell, Washington 98041, USA
    J Food Prot 61:1497-503. 1998
    ..cayetanensis and the Eimeria spp. are 94 to 96% similar in the amplified region, but the amplification products from the two genera were distinguished using an RFLP analysis with the restriction enzyme MnlI...
  41. ncbi Chemicals mutagenic in Salmonella typhimurium strain TA1535 but not in TA100
    M J Prival
    Genetic Toxicology Branch HFS 236, Food and Drug Administration, Washington, DC 20204, USA
    Mutat Res 412:251-60. 1998
    ..typhimurium assay...
  42. pmc Phages infecting Vibrio vulnificus are abundant and diverse in oysters (Crassostrea virginica) collected from the Gulf of Mexico
    A DePaola
    Gulf Coast Seafood Laboratory, U S Food and Drug Administration, Dauphin Island, Alabama 36528, USA
    Appl Environ Microbiol 64:346-51. 1998
    ..vulnificus. Results from this study indicate that a morphologically diverse group of phages which infect V. vulnificus is abundant and widely distributed in oysters from estuaries bordering the northeastern Gulf of Mexico...
  43. ncbi Arylamine-DNA adduct conformation in relation to mutagenesis
    F A Beland
    Division of Biochemical Toxicology, National Center for Toxicological Research, Jefferson, AR 72079, USA
    Mutat Res 376:13-9. 1997
    ..This increase in biological activity may be due in part to the greater propensity of ortho alkylated adducts to adopt a syn conformation...
  44. ncbi DNA polymerases delta and epsilon in developing and aging rat brain
    D R Prapurna
    Neurobiochemistry Laboratory, School of Life Sciences, University of Hyderabad Hyderabad, India
    Int J Dev Neurosci 15:67-73. 1997
    ..The data suggest that the rat brain is equipped with a sustained DNA repair capacity throughout the life span...
  45. ncbi Ontogeny of estrogen receptor messenger ribonucleic acid expression in the postnatal rat uterus
    R B Fishman
    National Center for Toxicological Research, U S Food and Drug Administration, Department of Health and Human Services, Jefferson, Arkansas 72079, USA
    Biol Reprod 55:1221-30. 1996
    ....
  46. ncbi Influence of antipsychotic, antiemetic, and Ca(2+) channel blocker drugs on the cellular accumulation of the anticancer drug daunorubicin: P-glycoprotein modulation
    S Ibrahim
    Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, Maryland 20857, USA
    J Pharmacol Exp Ther 295:1276-83. 2000
    ....
  47. ncbi Correlation of blood cholinesterase levels with toxicity of sarin in rats
    J F Young
    National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas 72079 9502, USA
    J Toxicol Environ Health A 62:161-74. 2001
    ..Neither plasma or erythrocyte baseline cholinesterase levels nor relative or absolute cholinesterase decline values could be used as predictors of mortality from sarin administration in rats...
  48. ncbi Inter-species differences in drug properties
    J M Collins
    Laboratory of Clinical Pharmacology, Food and Drug Administration, 4 Research Court, Room 314, Rockville, MD 20850, USA
    Chem Biol Interact 134:237-42. 2001
    ..Continued focus should be placed upon the application of comparative interspecies data for prospective design of animal experiments and retrospective interpretation of animal findings in terms of the potential for human risk and benefit...
  49. ncbi Determination of chloral hydrate and its metabolites in blood plasma by capillary gas chromatography with electron capture detection
    Thomas C Schmitt
    Department of Health and Human Services, FDA Division of Chemistry, HFT 230, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079 9502, USA
    J Chromatogr B Analyt Technol Biomed Life Sci 780:217-24. 2002
    ..1 microg/ml for TCA. Detector response to TCA and TCE were shown to be linear in the range of 3.125-200 microg/ml (r> or =0.9996). For CH, the response fits a second-order equation in this same range (r=0.99994)..
  50. ncbi Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the vaccine: Adverse Event Reporting System
    Robert Ball
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    J Clin Epidemiol 55:819-24. 2002
    ..Development and application of case definitions for other adverse events reported after vaccination should enhance the value of vaccine safety databases. Published by Elsevier Science Inc...
  51. ncbi The progression of neuronal, myelin, astrocytic, and immunological changes in the rat brain following exposure to aurothioglucose
    Larry C Schmued
    Department of Neurotoxicology, National Center for Toxicological Research FDA, Jefferson, AR 72079, USA
    Brain Res 949:171-7. 2002
    ..The results of this study help resolve the mechanism of ATG toxicity as reflected by a cascade of pathologies that is consistent with disparate cell types exhibiting specific changes at specific times...
  52. ncbi Modeling the bidirectional reflectance of emissive displays
    Aldo Badano
    Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, Maryland 20857, USA
    Appl Opt 41:3847-52. 2002
    ..I show that emissive FPDs with thin-film organic layers on reflective substrates can exhibit a predominant specular peak broadened by short-range light scattering...
  53. ncbi Efficacy of sanitation and cleaning methods in a small apple cider mill
    Susanne E Keller
    U S Food and Drug Administration, National Center for Food Safety and Technology, Summit Argo, Illinois 60501, USA
    J Food Prot 65:911-7. 2002
    ..The data presented in this study suggest that current sanitary practices within a typical small cider facility are insufficient to remove potential pathogens...
  54. ncbi An integrated "4-phase" approach for setting endocrine disruption screening priorities--phase I and II predictions of estrogen receptor binding affinity
    L Shi
    R O W Sciences, Inc, Jefferson, AR 72079, USA
    SAR QSAR Environ Res 13:69-88. 2002
    ..We believe that the same integrated scheme will be equally applicable to endpoints of other endocrine disrupting mechanisms, e.g. androgen receptor binding...
  55. pmc Dissection of human immunodeficiency virus type 1 entry with neutralizing antibodies to gp41 fusion intermediates
    Hana Golding
    Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg 29A Room 1A21, 8800 Rockville Pike, Bethesda, MD 20892, USA
    J Virol 76:6780-90. 2002
    ..They also indicate that six-helix bundles can form prior to fusion and that the lag time before fusion occurs may include the time needed to accumulate preformed six-helix bundles at the fusion site...
  56. ncbi Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancer
    Martin H Cohen
    Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 8:665-9. 2002
    ..In 1998, letrozole was approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer in postmenopausal women, with hormone receptor ..
  57. ncbi IL-23: a cytokine that acts on memory T cells
    David M Frucht
    Laboratory of Cell Biology, Division of Monoclonal Antibodies, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA
    Sci STKE 2002:pe1. 2002
    ..More functions that distinguish IL-23 from IL-12 are likely to be uncovered as soon as the other component(s) of the IL-23 receptor are molecularly cloned and characterized...
  58. ncbi Effect of polymorphism in the human glutathione S-transferase A1 promoter on hepatic GSTA1 and GSTA2 expression
    B F Coles
    Division of Molecular Epidemiology, National Center for Toxicological Research, Jefferson, Arkansas 72079 9502, USA
    Pharmacogenetics 11:663-9. 2001
    ....
  59. ncbi Estimation of the average burst size of Phix174 am3, cs70 for use in mutation assays with transgenic mice
    R R Delongchamp
    Division of Biometry and Risk Assessment, National Center for Toxicological Research, Jefferson, Arkansas, USA
    Environ Mol Mutagen 37:356-60. 2001
    ..The observed plaque counts were adequately fit by this approximation. Environ. Mol. Mutagen. 37:356-360, 2001 Published 2001 Wiley-Liss, Inc...
  60. ncbi UV doses of Americans
    D E Godar
    US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20852, USA
    Photochem Photobiol 73:621-9. 2001
    ..S. vacation (7800 J/m2). Thus, we can now assess the risks of UV-related health effects for Americans...
  61. ncbi Sex hormones as immunomodulators in health and disease
    D Verthelyi
    Retroviral Immunology Section, Center for Biologics Evaluation and Research, Food and Drug Administration, Building 29A, Rm 3 D 2, Bethesda, MD 20892, USA
    Int Immunopharmacol 1:983-93. 2001
    ..Understanding the physiology of the interaction between sex hormones and immune function and its potential pathological consequences may provide insight into the autoimmune diseases and new directions for their treatment...
  62. ncbi Are current hydrophone low frequency response standards acceptable for measuring mechanical/cavitation indices?
    G R Harris
    US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20852, USA
    Ultrasonics 34:649-54. 1996
    ..For example, for a 3.5 MHz transducer, the hydrophone should have a lower cut-off frequency of less than 350 kHz, which at present constitutes a challenge because of the lack of commercial hydrophones calibrated below 1 MHz...