Food and Drug Administration

Summary

Organization: Food and Drug Administration
Country: USA

Top Publications

  1. doi Development and validation of a magneto-hydrodynamic solver for blood flow analysis
    W Kainz
    Center for Devices and Radiological Health, FDA, Silver Spring, MD, USA
    Phys Med Biol 55:7253-61. 2010
  2. doi Using phiX174 DNA as an exogenous reference for measuring mitochondrial DNA copy number
    Meagan B Myers
    Division of Genetic and Reproductive Toxicology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR 72079, USA
    Biotechniques 47:867-9. 2009
  3. doi Scientific and regulatory perspectives on metabolizing enzyme-transporter interplay and its role in drug interactions: challenges in predicting drug interactions
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Mol Pharm 6:1766-74. 2009
  4. doi Analysis of polyhexamethylene biguanide in multipurpose contact lens solutions
    Anne D Lucas
    US Food and Drug Administration, Center for Devices and Radiological Health, OSEL DB, Silver Spring, MD 20993, USA
    Talanta 80:1016-9. 2009
  5. doi Adherence and weight loss outcomes associated with food-exercise diary preference in a military weight management program
    Laura E Shay
    Uniformed Services University of Health Sciences, Bethesda, Maryland 20814, United States
    Eat Behav 10:220-7. 2009
  6. doi Vibration effects of lab equipment on dissolution testing with USP paddle method
    Zongming Gao
    Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, Missouri 63101, USA
    J Pharm Sci 99:403-12. 2010
  7. ncbi Prevalence of select psychiatric diagnoses in long-term care: 1997-2007
    Joseph E Regan
    Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 1850, USA
    Health Care Financ Rev 30:105-14. 2008
  8. ncbi Compendia and anticancer therapy under Medicare
    Katherine Tillman
    Centers for Medicare and Medicaid Services, Baltimore, Maryland, USA
    Ann Intern Med 150:348-50. 2009
  9. pmc The salivary gland transcriptome of the neotropical malaria vector Anopheles darlingi reveals accelerated evolution of genes relevant to hematophagy
    Eric Calvo
    Section of Vector Biology, Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD 20852, USA
    BMC Genomics 10:57. 2009
  10. doi Expanding the role of health services research as a tool to reduce the public health burden of alcohol use disorders
    Peter J Delany
    Substance Abuse and Mental Health Services Administration, Rockville, Maryland 20857, USA
    Subst Use Misuse 43:1729-46. 2008

Detail Information

Publications62

  1. doi Development and validation of a magneto-hydrodynamic solver for blood flow analysis
    W Kainz
    Center for Devices and Radiological Health, FDA, Silver Spring, MD, USA
    Phys Med Biol 55:7253-61. 2010
    ..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...
  2. doi Using phiX174 DNA as an exogenous reference for measuring mitochondrial DNA copy number
    Meagan B Myers
    Division of Genetic and Reproductive Toxicology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR 72079, USA
    Biotechniques 47:867-9. 2009
    ....
  3. doi Scientific and regulatory perspectives on metabolizing enzyme-transporter interplay and its role in drug interactions: challenges in predicting drug interactions
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Mol Pharm 6:1766-74. 2009
    ..Finally, the discussion will focus on the need to leverage current knowledge to obtain more meaningful drug interaction information...
  4. doi Analysis of polyhexamethylene biguanide in multipurpose contact lens solutions
    Anne D Lucas
    US Food and Drug Administration, Center for Devices and Radiological Health, OSEL DB, Silver Spring, MD 20993, USA
    Talanta 80:1016-9. 2009
    ..5% RSD. Storage and stability studies indicated that storage of MPS with PHMB for chemical analysis are not temperature dependent, but are affected by the composition of the container in which the contact lens solution is stored...
  5. doi Adherence and weight loss outcomes associated with food-exercise diary preference in a military weight management program
    Laura E Shay
    Uniformed Services University of Health Sciences, Bethesda, Maryland 20814, United States
    Eat Behav 10:220-7. 2009
    ..2% vs. 43.4%, p=.015) and exercise (60.6% vs. 31.2%, p=.001). Though no difference was seen between groups on weight management outcomes, these results suggest that diary preference affects adherence to diary use...
  6. doi Vibration effects of lab equipment on dissolution testing with USP paddle method
    Zongming Gao
    Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, Missouri 63101, USA
    J Pharm Sci 99:403-12. 2010
    ..In the frequency range studied, root mean square (RMS) acceleration values above 0.01 g, in either vertical or horizontal direction, typically affected dissolution results...
  7. ncbi Prevalence of select psychiatric diagnoses in long-term care: 1997-2007
    Joseph E Regan
    Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 1850, USA
    Health Care Financ Rev 30:105-14. 2008
    ..This information is collected from two groups of beneficiaries: those living in the community and those living in facilities. Information is obtained on specific medical diagnoses and conditions for beneficiaries residing in a facility...
  8. ncbi Compendia and anticancer therapy under Medicare
    Katherine Tillman
    Centers for Medicare and Medicaid Services, Baltimore, Maryland, USA
    Ann Intern Med 150:348-50. 2009
    ....
  9. pmc The salivary gland transcriptome of the neotropical malaria vector Anopheles darlingi reveals accelerated evolution of genes relevant to hematophagy
    Eric Calvo
    Section of Vector Biology, Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD 20852, USA
    BMC Genomics 10:57. 2009
    ..Here we present and analyze data from a comprehensive salivary gland (SG) transcriptome of the neotropical malaria vector Anopheles darlingi (subgenus Nyssorhynchus)...
  10. doi Expanding the role of health services research as a tool to reduce the public health burden of alcohol use disorders
    Peter J Delany
    Substance Abuse and Mental Health Services Administration, Rockville, Maryland 20857, USA
    Subst Use Misuse 43:1729-46. 2008
    ..The paper concludes by outlining some of the steps taken by NIAAA to further the continuing development of alcohol health services research...
  11. doi Brain region-specific neurodegenerative profiles showing the relative importance of amphetamine dose, hyperthermia, seizures, and the blood-brain barrier
    John F Bowyer
    Division of Neurotoxicology, National Center for Toxicological Research, Jefferson, Arkansas, USA
    Ann N Y Acad Sci 1139:127-39. 2008
    ....
  12. ncbi Trends in out-of-pocket healthcare costs among older community-dwelling Medicare beneficiaries
    Gerald F Riley
    Office of Research, Development, and Information, Centers for Medicare and Medicaid Services, Baltimore, MD 21244, USA
    Am J Manag Care 14:692-6. 2008
    ..To describe trends in out-of-pocket healthcare costs, including insurance premiums, for older Medicare beneficiaries living in the community...
  13. ncbi Toxicity and detection of ricin and abrin in beverages
    Eric A E Garber
    U S Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Regulatory Science, College Park, Maryland 20740, USA
    J Food Prot 71:1875-83. 2008
    ..Enzyme-linked immunosorbent assays of the samples administered by i.p. injection indicated a decrease in detectable toxin at 0.5 microg/ml...
  14. doi Imaging as a tumor biomarker in oncology drug trials for lung cancer: the FDA perspective
    N Petrick
    National Institute of Biomedical Imaging and Bioengineering Center for Devices and Radiological Health Laboratory for the Assessment of Medical Imaging Systems, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 84:523-5. 2008
    The US Food and Drug Administration (FDA) is committed to working with the oncology community to expedite the drug evaluation process in view of the many promising new oncology drugs under laboratory development and the time and expense ..
  15. doi Recent changes in Medicaid policy and their possible effects on mental health services
    Jeffrey A Buck
    Center for Mental Health Services, Substance Abuse and Mental Health Services Administration, Rockville, MD 20857, USA
    Psychiatr Serv 60:1504-9. 2009
    ..These changes will likely affect state mental health systems, mental health providers, and the nature of service delivery...
  16. doi Exogenously expressed human Ku70 stabilizes Ku80 in Xenopus oocytes and induces heterologous DNA-PK catalytic activity
    Jyotshnabala Kanungo
    Institute of Molecular Medicine and Genetics, Medical College of Georgia, Augusta, GA 30912, USA
    Mol Cell Biochem 338:291-8. 2010
    ....
  17. doi Preweaning behaviors, developmental landmarks, and acrylamide and glycidamide levels after pre- and postnatal acrylamide treatment in rats
    Sherry A Ferguson
    Division of Neurotoxicology, National Center for Toxicological Research FDA, United States
    Neurotoxicol Teratol 32:373-82. 2010
    ..These data extend those of our previous study (Garey et al., 2005 [14]) and demonstrate that overt preweaning neurobehavioral effects are apparent in rats exposed to acrylamide pre- and postnatally, but only at the highest doses tested...
  18. pmc Two new ArrayTrack libraries for personalized biomedical research
    Joshua Xu
    Z Tech Corporation, ICF International company at NCTR, National Center for Toxicological Research, 3900 NCTR Rd, Jefferson, AR 72079, USA
    BMC Bioinformatics 11:S6. 2010
    ..An efficient data mining strategy and a set of sophisticated tools are necessary to help better understand and utilize the findings from genetic association studies...
  19. doi Lactational transfer of bisphenol A in Sprague-Dawley rats
    Daniel R Doerge
    Division of Biochemical Toxicology, National Center for Toxicological Research, U S Food and Drug Administration, 3900 NCRT Road, Jefferson, AR 72079, USA
    Toxicol Lett 199:372-6. 2010
    ..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...
  20. doi Pharmacometrics 2020
    Jogarao V S Gobburu
    Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    J Clin Pharmacol 50:151S-157S. 2010
    ..These goals should be of significance to all stakeholders who have a vested interest in drug development and therapeutics. The future of pharmacometrics depends on how well we all can deliver on the strategic goals...
  21. doi Oncomutations as biomarkers of cancer risk
    Barbara L Parsons
    Division of Genetic and Reproductive Toxicology, National Center for Toxicological Research, Jefferson, Arkansas 72079, USA
    Environ Mol Mutagen 51:836-50. 2010
    ..Future research opportunities using oncomutation as an endpoint are described, including rodent to human extrapolation, dose-response assessment, and personalized medicine...
  22. doi Use of parenteral iron products and serious anaphylactic-type reactions
    Diane K Wysowski
    Office of Surveillance and Epidemiology, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    Am J Hematol 85:650-4. 2010
    ..Voluntary reports submitted to the Food and Drug Administration show anaphylactic reactions and symptoms for the four parenteral iron products...
  23. pmc A resource for the assessment of lung nodule size estimation methods: database of thoracic CT scans of an anthropomorphic phantom
    Marios A Gavrielides
    Division of Imaging and Mathematics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U S Food and Drug Administration, Silver Spring, MD, USA
    Opt Express 18:15244-55. 2010
    ..This resource complements public databases of clinical data and will contribute towards the development of procedures that will maximize the utility of CT imaging for lung cancer screening and tumor therapy evaluation...
  24. doi Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions
    Francesca Dolcimascolo
    FDA, Silver Spring, MD, USA
    J Cardiovasc Transl Res 2:147-9. 2009
    The advancement of pediatric medical devices is an important challenge currently facing the Food and Drug Administration and the medical community. In this manuscript, the challenges are described and possible solutions presented.
  25. doi Regulatory use of computational toxicology tools and databases at the United States Food and Drug Administration's Office of Food Additive Safety
    Kirk B Arvidson
    US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, HFS 275, 5100 Paint Branch Parkway, College Park, MD 20740, USA
    Expert Opin Drug Metab Toxicol 6:793-6. 2010
    ..In this article, we provide an overview of the programs used in OFAS as well as a perspective on how to apply multiple QSAR tools in the review process of a new food-contact substance...
  26. ncbi Population pharmacokinetics with a very small sample size
    Iftekhar Mahmood
    Office of Blood Review and Research, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville Pike, MD 20852, USA
    Drug Metabol Drug Interact 24:259-74. 2009
    ..The population PK study with sparse sampling scheme may be useful for PK studies in neonates and very young children and in subjects with rare diseases where sample size is small...
  27. ncbi Enzyme-linked immunosorbent assay detection of melamine in infant formula and wheat food products
    Eric A E Garber
    Division of Bioanalytical Chemistry, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, U S Food and Drug Administration, College Park, Maryland 20740, USA
    J Food Prot 73:701-7. 2010
    ..5 microg/g, respectively. The ELISA kits provide an effective alternative for the analysis of samples suspected of containing melamine without relying on extensive sample preparation or expensive instrumentation...
  28. doi DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA
    Lawrence J Lesko
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, HFD 850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Pharmacogenomics 11:507-12. 2010
    ....
  29. pmc PCR-based method for targeting 16S-23S rRNA intergenic spacer regions among Vibrio species
    Maria Hoffmann
    Division of Microbiology, Office of Regulatory Science Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD 20740, USA
    BMC Microbiol 10:90. 2010
    ..Consequently, it is of paramount importance to have a method which is able to reliably and efficiently differentiate the numerous Vibrio species...
  30. doi How the US Food and Drug Administration evaluates the scientific evidence for health claims
    Kathleen C Ellwood
    Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, U S Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, USA
    Nutr Rev 68:114-21. 2010
    ..Several court decisions directed the US Food and Drug Administration (FDA) to provide for dietary supplement claims not meeting the significant scientific agreement ..
  31. doi Determination of iodide and thiocyanate in powdered milk and infant formula by on-line enrichment ion chromatography with photodiode array detection
    Richard A Niemann
    Center for Food Safety and Applied Nutrition, US Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, USA
    J Chromatogr A 1200:193-7. 2008
    ..2 mg/kg LOQ); iodide was found at 0.3-1.3mg/kg (0.04 mg/kg LOQ). In 13 dry milk samples, thiocyanate was found at 27-38 mg/kg (1 mg/kg LOQ), and iodide was found at 1.8-3.2 mg/kg (0.2 mg/kg LOQ)...
  32. doi Screening biomaterials for stimulation of nitric oxide-mediated inflammation
    Daniel B Lyle
    Division of Biology, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, FDA, 10903 New Hampshire Ave, Silver Spring, Maryland 20993 0002, USA
    J Biomed Mater Res A 90:82-93. 2009
    ..7 may serve as a convenient in vitro system to routinely screen biomaterials for potentially harmful macrophage-mediated inflammation whereby the safety of implanted medical devices might be compromised...
  33. ncbi Issues with statistical risks for testing methods in noninferiority trial without a placebo ARM
    H M James Hung
    Division of Biometrics I, Office of Biostatistics, OTS CDER, FDA, Silver Spring, MD 20993 0002, USA
    J Biopharm Stat 17:201-13. 2007
    ..For the indirect statistical inference, the practical utility of any method that controls only the across-trial Type I error rate at a fixed small level is limited...
  34. ncbi FDA's review of scientific evidence for health claims
    Barbara Schneeman
    Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD, USA
    J Nutr 137:493-4. 2007
    ..In order to meet its statutory responsibility for evaluation of health claims, the agency has developed guidelines for review of scientific evidence in support of a health claim...
  35. pmc Substrate competition studies using whole-cell accumulation assays with the major tripartite multidrug efflux pumps of Escherichia coli
    Christopher A Elkins
    Division of Microbiology, National Center for Toxicological Research, 3900 NCTR Drive, Jefferson, AR 72079 9502, USA
    Antimicrob Agents Chemother 51:923-9. 2007
    ..In addition, our study has extended the range of substrates recognized by the AcrAB- and EmrAB-TolC systems...
  36. ncbi Structure elucidation of a novel analogue of sildenafil detected as an adulterant in an herbal dietary supplement
    John C Reepmeyer
    US Food and Drug Administration, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA
    J Pharm Biomed Anal 43:1615-21. 2007
    ..The compound, named methisosildenafil, is a novel synthetic analogue of sildenafil in which the N-methylpiperazine moiety has been replaced with 2,6-dimethylpiperazine...
  37. ncbi A regulatory perspective on issues and approaches in characterizing human metabolites
    Karen L Davis-Bruno
    US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, Maryland 20993, USA
    Chem Res Toxicol 19:1561-3. 2006
    ..A discussion of the need for, and the adequacy of, the assessment of human drug metabolites with specific regard to their potential as mediators of toxicity is presented from a regulatory perspective...
  38. ncbi Changes in financial burdens for health care: national estimates for the population younger than 65 years, 1996 to 2003
    Jessica S Banthin
    Division of Modeling and Simulation, Center for Financing, Access and Cost Trends, Agency for Healthcare Research and Quality, US Department of Health and Human Services, Rockville, MD 20850, USA
    JAMA 296:2712-9. 2006
    ..Policymakers as well as physicians need to understand how rapidly rising health care costs are affecting specific groups of patients...
  39. ncbi Rapid quantitative and qualitative confirmatory method for the determination of monofluoroacetic acid in foods by liquid chromatography-mass spectrometry
    G O Noonan
    US Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, USA
    J Chromatogr A 1139:271-8. 2007
    ..8microg/L) was sufficient to confirm the presence of MFA in all spiked matrices. Repeatability tests at the low spiking levels yielded RSDs of approximately 7% for all matrices analyzed...
  40. ncbi Impact of microarray data quality on genomic data submissions to the FDA
    Felix W Frueh
    US Food and Drug Administration, Office of Clinical Pharmacology, Center for Drug Evaluationand Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA
    Nat Biotechnol 24:1105-7. 2006
  41. ncbi Simian foamy virus infection by whole-blood transfer in rhesus macaques: potential for transfusion transmission in humans
    Arifa S Khan
    Laboratory of Retrovirus Research, Division of Viral Products, Center for Biologics Evaluation and Research, U S Food and Drug Administration, Bethesda, Maryland, USA
    Transfusion 46:1352-9. 2006
    ..The persistence of infectious virus in peripheral blood mononuclear cells (PBMNC) and the recent identification of some infected blood donors has raised safety concerns regarding potential virus transmission by blood transfusion...
  42. ncbi Use of nontraditional animals for evaluation of pharmaceutical products
    Abigail Jacobs
    Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Expert Opin Drug Metab Toxicol 2:345-9. 2006
    ..Use of nontraditional animal species may be proposed by a drug sponsor to a reviewing division with supporting data and reasons for using a particular species...
  43. ncbi Stability profiles of drug products extended beyond labeled expiration dates
    Robbe C Lyon
    Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD 941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 0002, USA
    J Pharm Sci 95:1549-60. 2006
    ..The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years...
  44. ncbi National estimates for mental health mutual support groups, self-help organizations, and consumer-operated services
    Ingrid D Goldstrom
    Substance Abuse and Mental Health Services Administration, U S Department of Health and Human Services, Rockville, MD 20857, USA
    Adm Policy Ment Health 33:92-103. 2006
    ..The array of services and supports provided within each of these types (MSG, SHO, COS) is reported, and implications for the President's New Freedom Commission on Mental Health recommendations are explicated...
  45. ncbi Interoperability: the key to the future health care system
    David J Brailer
    U S Department of Health and Human Services, Washington, DC, USA
    Health Aff (Millwood) . 2005
    ..The paper by Jan Walker and colleagues highlights some of these benefits. One critical question is whether the adoption of EMRs needs to wait for interoperability standards or whether it can proceed efficiently without them...
  46. ncbi First-generation blood substitutes: what have we learned? Biochemical and physiological perspectives
    Abdu I Alayash
    Center for Biologics Evaluation and Research, Food and Drug Administration, Laboratory of Biochemistry and Vascular Biology, Division of Hematology, National Institutes of Health Campus, Bethesda, MD 20892, USA
    Expert Opin Biol Ther 7:665-75. 2007
    ..Here the authors provide an overview of their research experiences, novel insights into the molecular basis of toxicities of these products and some lessons learned...
  47. ncbi Reliable comfort and meaningfulness at a sustainable cost
    Joanne Lynn
    Quality Measurement and Health Assessment Group, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Baltimore, Maryland 21244 1850, USA
    J Palliat Med 10:660-4. 2007
  48. ncbi An observational study of cholecystectomy in patients receiving tegaserod
    Allen Brinker
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Drug Saf 30:581-8. 2007
    ..Registrational studies of patients treated with tegaserod for irritable bowel syndrome (IBS) suggest an increased risk for cholecystectomy versus treatment with placebo...
  49. doi Modeling microstructure development and release kinetics in controlled drug release coatings
    David M Saylor
    Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, Maryland 20903, USA
    J Pharm Sci 98:169-86. 2009
    ....
  50. doi Modifications and insights into a method for the analysis of the nitrogen mustard mechlorethamine by high-performance liquid chromatography
    John C Reepmeyer
    United States Food and Drug Administration, Center for Drug Evaluation and Research, Office of Phamaceutical Science, Division of Pharmaceutical Analysis, FDA, 1114 Market Street, Room 1002, St Louis, MO 63101, USA
    Anal Chim Acta 616:78-84. 2008
    ..The method has been extended to the analysis of mechlorethamine in aqueous solutions...
  51. doi Motive for nonmedical use of prescription pain relievers in the national survey on drug use and health
    James D Colliver
    Division of Population Surveys, Office of Applied Studies, Substance Abuse and Mental Health Services Administration, Rockville, Maryland 20857, USA
    J Pain 9:487-9; discussion 494-6. 2008
  52. doi Survey of furan in heat processed foods by headspace gas chromatography/mass spectrometry and estimated adult exposure
    Kim M Morehouse
    Food and Drug Administration CFSAN, College Park, MD 20740, USA
    Food Addit Contam Part A Chem Anal Control Expo Risk Assess 25:259-64. 2008
    ..15 microg kg(-1) body weight day(-1)). Estimates of mean exposure to furan for different subpopulations were calculated. For consumers 2 years and older, the intake is estimated to be about 0.2 microg kg(-1) body weight day(-1)...
  53. doi Multiclass determination and confirmation of antibiotic residues in honey using LC-MS/MS
    Mayda I Lopez
    Center for Veterinary Medicine, U S Food and Drug Administration, 8401 Muirkirk Road, Laurel, Maryland 20708, USA
    J Agric Food Chem 56:1553-9. 2008
    ..The evaluation of matrix effects caused by honey of different floral origin is presented...
  54. pmc In vitro model of colonization resistance by the enteric microbiota: effects of antimicrobial agents used in food-producing animals
    R Doug Wagner
    National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR 72079, USA
    Antimicrob Agents Chemother 52:1230-7. 2008
    ..The results of this study suggest that direct assessment of the effects of antimicrobial drugs on colonization resistance in an in vitro model can be useful in determining ADI values...
  55. ncbi Drug release phenomena within a hydrophobic starch acetate matrix: FTIR mapping of tablets after in vitro dissolution testing
    Jari Pajander
    Department of Pharmaceutics, University of Kuopio, P O Box 1627, FI 70211 Kuopio, Finland
    J Pharm Sci 97:3367-78. 2008
    ..Mapping showed that caffeine became localized in the lower part of the tablet unlike riboflavin. The hydrodynamic conditions during the in vitro release test might contribute to this differentiation...
  56. ncbi Vibration effects on dissolution tests with USP apparatuses 1 and 2
    Zongming Gao
    Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, Missouri 63101, USA
    J Pharm Sci 97:3335-43. 2008
    ..The importance of vibration to dissolution test results depends on the vibration source, product being tested and the apparatus type...
  57. ncbi Statistics for risk assessment of chemical carcinogens
    James J Chen
    Division of Personalized Nutrition and Medicine, National Center for Toxicological Research, Jefferson, Arkansas 72079, USA
    J Environ Sci Health C Environ Carcinog Ecotoxicol Rev 25:281-312. 2007
    ..This paper reviews statistical principles and procedures for qualitative and quantitative approaches to human risk assessment...
  58. ncbi Comparison of delivery characteristics from a combination metered-dose inhaler using the Andersen cascade impactor and the next generation pharmaceutical impactor
    Changning Guo
    U S Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, Room 1002, St Louis, Missouri 63101, USA
    J Pharm Sci 97:3321-34. 2008
    ....
  59. ncbi Use of multitoxin immunoaffinity columns for determination of aflatoxins and ochratoxin A in ginseng and ginger
    Mary W Trucksess
    U S Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740, USA
    J AOAC Int 90:1042-9. 2007
    ....
  60. ncbi Indication and use of drug products used to treat attention-deficit/hyperactivity disorder: a cross-sectional study with inference on the likelihood of treatment in adulthood
    Allen Brinker
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Child Adolesc Psychopharmacol 17:328-33. 2007
    ..We analyzed cross-sectional prescription claims data and data from a national survey of office-based physicians for further inference on the likelihood of treatment with ADHD medications into adulthood...
  61. ncbi Analysis of food for toxic elements
    Stephen G Capar
    U S Food and Drug Administration, Center for Food Safety and Applied Nutrition, Harvey W Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740 3835, USA
    Anal Bioanal Chem 389:159-69. 2007
    ..The topics covered include contamination control, analytical sample treatment and the common analytical techniques used for food analysis...
  62. ncbi QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies
    Leming Shi
    US Food and Drug Administration, Center for Toxicoinformatics, Division of Systems Toxicology, National Center for Toxicological Research, HFT 020, 3900 NCTR Road, Jefferson, AR 72079, USA
    Expert Rev Mol Diagn 4:761-77. 2004
    ..The US Food and Drug Administration has been proactive in promoting the use of pharmacogenomic data in drug development and has issued a ..

Research Grants4

  1. INITIATION OF VIRUS SPECIFIC CD8+ T CELL RESPONSES
    Maryna Eichelberger; Fiscal Year: 2002
    ..This proposal is designed as an essential step towards the development of more effective influenza vaccine. ..
  2. Accelerated Viral Inhibition Assay
    Maryna Eichelberger; Fiscal Year: 2006
    ....
  3. Using Clinically-Enhanced Claims Data to Guide Selection of Coronary Procedures
    HAROLD KILBURN; Fiscal Year: 2010
    ....
  4. Using Clinically-Enhanced Claims Data to Guide Treatment of Acute Heart Failure
    Mark Sonneborn; Fiscal Year: 2010
    ..The database will be used to conduct a study of the comparative effectiveness of different drug treatments of patients hospitalized with acute worsening of congestive heart failure. ..