united states food and drug administration

Summary

Summary: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.

Top Publications

  1. ncbi Selective publication of antidepressant trials and its influence on apparent efficacy
    Erick H Turner
    Department of Psychiatry, Oregon Health and Science University, Portland, OR, USA
    N Engl J Med 358:252-60. 2008
  2. pmc Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration
    Irving Kirsch
    Department of Psychology, University of Hull, Hull, United Kingdom
    PLoS Med 5:e45. 2008
  3. ncbi Drug-target network
    Muhammed A Yildirim
    Center for Cancer Systems Biology CCSB, Harvard Medical School, 44 Binney St, Boston, Massachusetts 02115, USA
    Nat Biotechnol 25:1119-26. 2007
  4. pmc Serotonin and depression: a disconnect between the advertisements and the scientific literature
    Jeffrey R Lacasse
    Florida State University College of Social Work, Tallahassee, Florida, United States of America
    PLoS Med 2:e392. 2005
  5. pmc Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system
    Toshiyuki Sakaeda
    Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan
    PLoS ONE 6:e28124. 2011
  6. ncbi Cardiovascular, ocular and bone adverse reactions associated with thiazolidinediones: a disproportionality analysis of the US FDA adverse event reporting system database
    Domenico Motola
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Drug Saf 35:315-23. 2012
  7. ncbi A review of patient-reported outcome labels in the United States: 2006 to 2010
    Ari Gnanasakthy
    Novartis Pharmaceuticals Corporation, East Hannover, NJ 07936, USA
    Value Health 15:437-42. 2012
  8. ncbi Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions
    Manfred Hauben
    Department of Risk Management Strategy, Pfizer Inc, New York, New York 10017, USA
    Drug Saf 32:99-110. 2009
  9. ncbi Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
    Ana Szarfman
    Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Drug Saf 25:381-92. 2002
  10. pmc Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS
    Kaori Kadoyama
    Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606 8501, Japan
    J Exp Clin Cancer Res 30:93. 2011

Detail Information

Publications271 found, 100 shown here

  1. ncbi Selective publication of antidepressant trials and its influence on apparent efficacy
    Erick H Turner
    Department of Psychiatry, Oregon Health and Science University, Portland, OR, USA
    N Engl J Med 358:252-60. 2008
    ..Selective publication of clinical trials--and the outcomes within those trials--can lead to unrealistic estimates of drug effectiveness and alter the apparent risk-benefit ratio...
  2. pmc Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration
    Irving Kirsch
    Department of Psychology, University of Hull, Hull, United Kingdom
    PLoS Med 5:e45. 2008
    ..The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials...
  3. ncbi Drug-target network
    Muhammed A Yildirim
    Center for Cancer Systems Biology CCSB, Harvard Medical School, 44 Binney St, Boston, Massachusetts 02115, USA
    Nat Biotechnol 25:1119-26. 2007
    ..Significant differences in distance were found between etiological and palliative drugs. A recent trend toward more rational drug design was observed...
  4. pmc Serotonin and depression: a disconnect between the advertisements and the scientific literature
    Jeffrey R Lacasse
    Florida State University College of Social Work, Tallahassee, Florida, United States of America
    PLoS Med 2:e392. 2005
  5. pmc Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system
    Toshiyuki Sakaeda
    Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan
    PLoS ONE 6:e28124. 2011
    ....
  6. ncbi Cardiovascular, ocular and bone adverse reactions associated with thiazolidinediones: a disproportionality analysis of the US FDA adverse event reporting system database
    Domenico Motola
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Drug Saf 35:315-23. 2012
    ..The risk of myocardial infarction, macular oedema and bone fractures associated with thiazolidinediones (TZDs) has been extensively investigated...
  7. ncbi A review of patient-reported outcome labels in the United States: 2006 to 2010
    Ari Gnanasakthy
    Novartis Pharmaceuticals Corporation, East Hannover, NJ 07936, USA
    Value Health 15:437-42. 2012
    ....
  8. ncbi Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions
    Manfred Hauben
    Department of Risk Management Strategy, Pfizer Inc, New York, New York 10017, USA
    Drug Saf 32:99-110. 2009
    ..This definition and its accompanying flowchart should inform decision making in considering benefits and harms caused by pharmacological and nonpharmacological interventions...
  9. ncbi Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
    Ana Szarfman
    Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Drug Saf 25:381-92. 2002
    ..The application of these tools may ultimately improve usage recommendations...
  10. pmc Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS
    Kaori Kadoyama
    Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606 8501, Japan
    J Exp Clin Cancer Res 30:93. 2011
    ..The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide...
  11. ncbi Drug-induced torsades de pointes: data mining of the public version of the FDA Adverse Event Reporting System (AERS)
    Elisabetta Poluzzi
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Pharmacoepidemiol Drug Saf 18:512-8. 2009
    ..To investigate spontaneous reports of TdP present in the public version of the FDA Adverse Event Reporting System (AERS) in the light of what is already known on their TdP-liability...
  12. pmc Platinum agent-induced hypersensitivity reactions: data mining of the public version of the FDA adverse event reporting system, AERS
    Toshiyuki Sakaeda
    Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan
    Int J Med Sci 8:332-8. 2011
    ..Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm the platinum agent-associated mild, severe, and lethal hypersensitivity reactions...
  13. pmc Gadolinium-enhanced cardiovascular magnetic resonance: administered dose in relationship to United States Food and Drug Administration (FDA) guidelines
    Marcelo S Nacif
    Radiology and Imaging Sciences National Institutes of Health Clinical Center, Bethesda, MD, USA
    J Cardiovasc Magn Reson 14:18. 2012
    ..The relationship of gadolinium dose warnings (due to nephrogenic systemic fibrosis) announced in 2008 to gadolinium dosing regimens was also examined...
  14. ncbi Serious adverse drug events reported to the Food and Drug Administration, 1998-2005
    Thomas J Moore
    Institute for Safe Medication Practices, 1800 Byberry Rd, Ste 810, Huntingdon Valley, PA 19006, USA
    Arch Intern Med 167:1752-9. 2007
    ..The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers...
  15. pmc Mining FDA drug labels using an unsupervised learning technique--topic modeling
    Halil Bisgin
    Department of Information Science, University of Arkansas at Little Rock, 2801 S, University Ave, Little Rock, AR 72204 1099, USA
    BMC Bioinformatics 12:S11. 2011
    ..Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive...
  16. pmc Aspirin- and clopidogrel-associated bleeding complications: data mining of the public version of the FDA adverse event reporting system, AERS
    Takao Tamura
    Kinki University Nara Hospital, Nara, Japan
    Int J Med Sci 9:441-6. 2012
    ....
  17. ncbi The US Orphan Drug Act: rare disease research stimulator or commercial opportunity?
    Olivier Wellman-Labadie
    Division of Dermatology, Department of Medicine, University of British Columbia, 835 West 10th Ave, Vancouver, BC, Canada
    Health Policy 95:216-28. 2010
    ..This study investigates issues associated with the United States Orphan Drug Act...
  18. ncbi Drug repositioning for orphan diseases
    Divya Sardana
    Department of Computer Science, University of Cincinnati, OH, USA
    Brief Bioinform 12:346-56. 2011
    ..In this study, we will review some of these issues and the current methodologies adopted or proposed to overcome them and translate chemical and biological discoveries into safe and effective orphan disease therapeutics...
  19. ncbi Beta-lactam antibiotics offer neuroprotection by increasing glutamate transporter expression
    Jeffrey D Rothstein
    Department of Neurology, Johns Hopkins University, Baltimore, Maryland 21287, USA
    Nature 433:73-7. 2005
    ..Thus these studies provide a class of potential neurotherapeutics that act to modulate the expression of glutamate neurotransmitter transporters via gene activation...
  20. pmc Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants
    Kelly Posner
    Division of Child and Adolescent Psychiatry, Columbia University New York State Psychiatric Institute, New York, NY 10032, USA
    Am J Psychiatry 164:1035-43. 2007
    ....
  21. ncbi Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action
    Diane K Wysowski
    Division of Drug Risk Evaluation, Food and Drug Administration, White Oak, Bldg 22, Room 3424, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    Arch Intern Med 167:1414-9. 2007
    ..Warfarin sodium is widely used and causes bleeding; a review might suggest the need for regulatory action by the US Food and Drug Administration (FDA)...
  22. 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 FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk...
  23. ncbi 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
    ..To help differentiate risk among the parenteral iron products, the brand name of the product always should be provided on medical records, death certificates, and adverse drug reaction reports...
  24. ncbi Evaluation of the United States Food and Drug Administration-approved scoring and test system of HER-2 protein expression in breast cancer
    P Birner
    The Institute of Clinical Pathology, University of Vienna Medical School, A 1090 Vienna, Austria
    Clin Cancer Res 7:1669-75. 2001
    ..growth factor receptor (HER)-2 oncogene protein overexpression of breast cancer tissue by the United States Food and Drug Administration (FDA)-approved HercepTest and grading system (negative, 0 or 1+; weakly positive, 2+; strongly ..
  25. ncbi United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up
    Donald R Sanders
    Center for Clinical Research, Chicago, Illinois, USA
    Ophthalmology 111:1683-92. 2004
    ..To report on 3-year postoperative safety and efficacy outcomes with the Myopic Implantable Collamer Lens (ICL)...
  26. ncbi Detection of systemic hypersensitivity to drugs using standard guinea pig assays
    James L Weaver
    Office of Testing and Research, Division of Applied Pharmacology Research, Center for Drug Evaluation and Research CDER, MOD 1, 8301 Muirkirk Rd, Laurel, MD 20708, USA
    Toxicology 193:203-17. 2003
    ..No statistically significant associations between human data and GP test results were observed. These data suggest that standard GP assays have limited ability to predict human systemic hypersensitivity potential for pharmaceuticals...
  27. ncbi Timing of new black box warnings and withdrawals for prescription medications
    Karen E Lasser
    Department of Medicine, Cambridge Hospital, Cambridge, MA 02139, USA
    JAMA 287:2215-20. 2002
    ..Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs...
  28. ncbi United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy
    Robert C Kane
    Division of Drug Oncology Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0004, USA
    Clin Cancer Res 12:2955-60. 2006
    ..The FDA analysis of the trial data and bortezomib's regulatory development are summarized here...
  29. pmc Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting
    Carlo Piccinni
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Diabetes Care 34:1369-71. 2011
    ..To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications...
  30. ncbi Clinical trials in children
    Patrina H Y Caldwell
    Centre for Kidney Research, The Children s Hospital at Westmead, New South Wales, Australia
    Lancet 364:803-11. 2004
    ..In this review, we explore issues relating to trial participation for children and suggest some strategies for improving the conduct of clinical trials involving children...
  31. ncbi FDA-approved drug labeling for the study of drug-induced liver injury
    Minjun Chen
    Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
    Drug Discov Today 16:697-703. 2011
    ..The method is transparent and reproducible with a potential to serve as a common practice to study the DILI of marketed drugs for supporting drug discovery and biomarker development...
  32. ncbi Drug-versus-drug adverse event rate comparisons: a pilot study based on data from the US FDA Adverse Event Reporting System
    Alan M Hochberg
    ProSanos Corporation, Harrisburg, Pennsylvania 17101, USA
    Drug Saf 32:137-46. 2009
    ..The accuracy of comparative AERS-based data mining has been questioned, but has not been systematically studied...
  33. ncbi Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group
    Paul Gallo
    Novartis Pharmaceuticals, East Hanover, NJ 07936, USA
    J Biopharm Stat 16:275-83; discussion 285-91, 293-8, 311-2. 2006
    ..Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation...
  34. ncbi Black box warning for topical calcineurin inhibitors and the death of common sense
    Alan B Fleischer
    Department of Dermatology, Wake Forest University School of Medicine, Winston Salem, NC, USA
    Dermatol Online J 12:2. 2006
    ..This commentary is designed to provide a clinical viewpoint regarding the Food and Drug Administration (FDA) and its recent decision to imposed a "black box warning" on the topical calcineurin inhibitors, pimecrolimus and tacrolimus...
  35. ncbi A study of warning letters issued to institutional review boards by the United States Food and Drug Administration
    Katrina A Bramstedt
    Research Subject Advocacy Program, General Clinical Research Center, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA
    Clin Invest Med 27:316-23. 2004
    This study explores the ethical issues contained in warning letters (WLs) issued to institutional review boards (IRBs) by the United States Food and Drug Administration (FDA).
  36. ncbi An experimental investigation of masking in the US FDA adverse event reporting system database
    Hsin Wei Wang
    Computational Sciences Centre of Emphasis, Pfizer Global Research and Development, Cambridge, Massachusetts, USA
    Drug Saf 33:1117-33. 2010
    ....
  37. ncbi Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: investigation from the United States Food and Drug Administration adverse event reporting system database
    Pranav K Gandhi
    Department of Pharmacy Practice, School of Pharmacy, South College, Knoxville, Tennessee 37919, USA
    Pharmacotherapy 32:902-9. 2012
    ..To investigate reports of thrombotic events associated with the use of C1 esterase inhibitor products in patients with hereditary angioedema in the United States...
  38. ncbi Signals of progressive multifocal leukoencephalopathy for immunosuppressants: a disproportionality analysis of spontaneous reports within the US Adverse Event Reporting System (AERS)
    Niklas Schmedt
    BIPS Institute for Epidemiology and Prevention Research, Germany
    Pharmacoepidemiol Drug Saf 21:1216-20. 2012
    ..We aimed to study signals of PML for immunosuppressants using a disproportionality analysis of spontaneous adverse event reports...
  39. pmc The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases
    Brigitta E Miyamoto
    Kakkis EveryLife Foundation For Rare Diseases, 77 Digital Drive, Suite 210, Novato, CA 94949, USA
    Orphanet J Rare Dis 6:49. 2011
    ..Many rare diseases have not utilized AA due to the difficulty in gaining acceptance of novel surrogate endpoints in untreated rare diseases...
  40. ncbi Adverse event profile of tigecycline: data mining of the public version of the U.S. Food and Drug Administration adverse event reporting system
    Kaori Kadoyama
    Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Japan
    Biol Pharm Bull 35:967-70. 2012
    ..The adverse events suggested were in agreement with information provided by the manufacturer, suggesting that off-label use hardly results in unexpected adverse events, presumably due to usage with extreme caution...
  41. ncbi Medical device recalls and the FDA approval process
    Diana M Zuckerman
    National Research Center for Women and Families, Washington, DC 20036, USA
    Arch Intern Med 171:1006-11. 2011
    ..The second standard is intended for devices that the FDA deems to involve low or moderate risk...
  42. pmc Tobacco packaging and labeling policies under the U.S. Tobacco Control Act: research needs and priorities
    David Hammond
    Department of Health Studies and Gerontology, University of Waterloo, 200 University Avenue West, Waterloo, Ontario, N2L 3G1, Canada
    Nicotine Tob Res 14:62-74. 2012
    ..S. Food and Drug Administration authority to regulate tobacco products. The current paper reviews the provisions for packaging and labeling, including the existing evidence and research priorities...
  43. ncbi Evolution of the physicochemical properties of marketed drugs: can history foretell the future?
    Bernard Faller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Drug Discov Today 16:976-84. 2011
    ..In this new territory, semi-empirical rules derived from knowledge accumulated from historic, older molecules are not necessarily valid and different liabilities become more prominent...
  44. ncbi Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials
    Cheerag D Upadhyaya
    Department of Neurological Surgery, University of California, San Francisco, California, USA
    J Neurosurg Spine 16:216-28. 2012
    ..These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials...
  45. ncbi Erythropoietin, the FDA, and oncology
    Robert Steinbrook
    N Engl J Med 356:2448-51. 2007
  46. ncbi Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study
    Andrew P Prayle
    University of Nottingham, Division of Child Health, School of Clinical Sciences, Queens Medical Centre, Nottingham NG7 2UH, UK
    BMJ 344:d7373. 2012
    ..gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation...
  47. ncbi New and existing oils and fats used in products with reduced trans-fatty acid content
    Maria Teresa Tarrago-Trani
    Department of Biochemistry, Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA
    J Am Diet Assoc 106:867-80. 2006
    ....
  48. ncbi Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS)
    Emily Jane Woo
    US Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland 20852, USA
    Drug Saf 31:667-74. 2008
    ..Stratified empirical Bayesian (EB) methods have been compared with crude, but not stratified, proportional reporting ratios (PRRs) in their performance on adverse event data...
  49. pmc Lessons learned from the contamination of heparin
    Haiying Liu
    Department of Chemistry, Rensselaer Polytechnic Institute, Troy, New York 12180, USA
    Nat Prod Rep 26:313-21. 2009
    ..Effective assays, which can detect both known and unknown contaminants, are required to monitor the quality of heparin. Safer and better-regulated processes are needed for heparin production...
  50. ncbi Initial results of endothelial cell counts after Artisan lens for phakic eyes: an evaluation of the United States Food and Drug Administration Ophtec Study
    Mihai Pop
    Michel Pop Clinics, Montreal, Canada
    Ophthalmology 111:309-17. 2004
    ..To evaluate the endothelial cell count change in eyes implanted with the iris-claw phakic Artisan lens for treatment of moderate to high myopia...
  51. ncbi Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years
    M Miles Braun
    Office of Orphan Products Development, US Food and Drug Administration, Silverspring, Maryland 20993, USA
    Nat Rev Drug Discov 9:519-22. 2010
    ..The implications of such findings for future development and marketing of therapies for rare diseases are discussed...
  52. pmc A systematic approach to biomarker discovery; preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"
    Lisa H Butterfield
    Department of Medicine, Division of Hematology Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15213, USA
    J Transl Med 6:81. 2008
    ..Society for the Biological Therapy of Cancer (iSBTc) has initiated in collaboration with the United States Food and Drug Administration (FDA) a programmatic look at innovative avenues for the identification of relevant parameters to ..
  53. ncbi Understanding the complexity of trans fatty acid reduction in the American diet: American Heart Association Trans Fat Conference 2006: report of the Trans Fat Conference Planning Group
    Robert H Eckel
    University of Colorado at Denver and Health Sciences Center, USA
    Circulation 115:2231-46. 2007
    ..The conference demonstrated the value of collaboration between the food industry and health and nutrition professionals, and this conference model should be used to address other food development, processing, and/or technology issues...
  54. ncbi Antimicrobials and the risk of torsades de pointes: the contribution from data mining of the US FDA Adverse Event Reporting System
    Elisabetta Poluzzi
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Drug Saf 33:303-14. 2010
    ..In this context, the US FDA Adverse Event Reporting System (AERS) is an important source of information, which can be applied to the analysis of TdP liability of marketed drugs...
  55. ncbi Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration
    Nicole R Hartnell
    College of Pharmacy, Dalhousie University, Halifax, Nova Scotia, Canada
    Pharmacotherapy 24:743-9. 2004
    ..To validate or refute a widely accepted epidemiologic phenomenon known as the Weber effect by replicating Weber's original observation by using drugs that were marketed in the United States and using reports from a U.S. database...
  56. ncbi The role of databases in drug postmarketing surveillance
    E M Rodriguez
    Division of Drug Risk Evaluation II, Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, HFD 440, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 10:407-10. 2001
    This paper describes the role of databases used for postmarketing surveillance of drugs at the United States Food and Drug Administration (FDA)...
  57. pmc Publication of clinical trials supporting successful new drug applications: a literature analysis
    Kirby Lee
    Department of Clinical Pharmacy, University of California San Francisco, San Francisco, California, USA
    PLoS Med 5:e191. 2008
    ....
  58. ncbi Gender in the pharmacy: does it matter?
    Jocelyn Kaiser
    Science 308:1572. 2005
  59. ncbi Clinical trials in Russia and Eastern Europe: recruitment and quality
    P Platonov
    Lund University, Lund, Sweden
    Int J Clin Pharmacol Ther 41:277-80. 2003
    ..To review the current situation of clinical trials in Russia and Eastern Europe...
  60. ncbi Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database
    Arif Khan
    Northwest Clinical Research Center, Bellevue, Washington, USA
    J Clin Psychopharmacol 22:40-5. 2002
    ..Early discontinuation was more frequent among patients whose mean initial HAM-D scores were higher. These data may help inform the design of future antidepressant clinical trials...
  61. pmc Responsiveness and minimal important differences for patient reported outcomes
    Dennis A Revicki
    Center for Health Outcomes Research, United BioSource Corporation, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814, USA
    Health Qual Life Outcomes 4:70. 2006
    ..Responsiveness and MID must be demonstrated and documented for the particular study population, and these measurement characteristics are needed for PRO labeling and promotional claims...
  62. ncbi Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence
    Jonathan M Spergel
    Curr Allergy Asthma Rep 6:270-4. 2006
    ..To date, studies from clinical trials, systemic absorption, and post-marketing surveillance show no evidence for this systemic immunosuppression or increased risk for any malignancy...
  63. pmc Omeprazole- and esomeprazole-associated hypomagnesaemia: data mining of the public version of the FDA Adverse Event Reporting System
    Takao Tamura
    Kinki University Nara Hospital, Nara, Japan
    Int J Med Sci 9:322-6. 2012
    ..In this study, the reports submitted to the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) were evaluated to assess omeprazole and esomeprazole in terms of susceptibility to hypomagnesaemia...
  64. ncbi Computational toxicology approaches at the US Food and Drug Administration
    Chihae Yang
    Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD, USA
    Altern Lab Anim 37:523-31. 2009
    For over a decade, the United States Food and Drug Administration (US FDA) has been engaged in the applied research, development, and evaluation of computational toxicology methods used to support the safety evaluation of a diverse set of ..
  65. ncbi Expanding the black box - depression, antidepressants, and the risk of suicide
    Richard A Friedman
    Psychopharmacology Clinic, Weill Cornell Medical College, New York, USA
    N Engl J Med 356:2343-6. 2007
  66. pmc Adverse event profiles of 5-fluorouracil and capecitabine: data mining of the public version of the FDA Adverse Event Reporting System, AERS, and reproducibility of clinical observations
    Kaori Kadoyama
    Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606 8501, Japan
    Int J Med Sci 9:33-9. 2012
    ..The safety profiles of oral fluoropyrimidines were compared with 5-fluorouracil (5-FU) using adverse event reports (AERs) submitted to the Adverse Event Reporting System, AERS, of the US Food and Drug Administration (FDA)...
  67. ncbi Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial
    R Doyle Stulting
    Department of Ophthalmology, Emory University, Atlanta, Georgia 30342, USA
    Ophthalmology 115:464-472.e1. 2008
    ..To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia...
  68. ncbi Prospects for productivity
    Bruce Booth
    McKinsey and Company, 55 East 52nd Street, New York, NY 10055, USA
    Nat Rev Drug Discov 3:451-6. 2004
  69. ncbi Dangers of rosuvastatin identified before and after FDA approval
    Sidney M Wolfe
    Lancet 363:2189-90. 2004
  70. pmc Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?
    John P A Ioannidis
    Clinical Trials and Evidence Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine and the Biomedical Research Institute, Foundation for Research and Technology Hellas, Ioannina, Greece
    Philos Ethics Humanit Med 3:14. 2008
    ....
  71. ncbi A pre-marketing ALT signal predicts post-marketing liver safety
    Cynthia A Moylan
    Division of Gastroenterology and Hepatology, Duke University, Durham, NC 27710, USA
    Regul Toxicol Pharmacol 63:433-9. 2012
    ..A cut-off of 1.2% increase in ALT ≥ 3× ULN in treated versus placebo groups provides an easily calculated method for predicting post-marketing liver safety...
  72. ncbi Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low
    Dongyi Du
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA
    Health Aff (Millwood) 31:1022-9. 2012
    ..The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events...
  73. pmc Biclustering of adverse drug events in the FDA's spontaneous reporting system
    R Harpaz
    Department of Biomedical Informatics, Columbia University Medical Center, New York, New York, USA
    Clin Pharmacol Ther 89:243-50. 2011
    ....
  74. pmc Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection
    John L Chollet
    Ther Rx Corporation, St Louis, MO 63146, USA
    Drug Dev Ind Pharm 38:540-9. 2012
    ..These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable...
  75. pmc Pharmacy compounding primer for physicians: prescriber beware
    Sarah Sellers
    q Vigilance LLC, North Barrington, IL 60010, USA
    Drugs 72:2043-50. 2012
    ..While representing a US perspective, underlying principles apply globally in the setting of magistral and extemporaneous formulations produced outside national regulatory frameworks...
  76. ncbi Examination of pharmacists' intention to report serious adverse drug events (ADEs) to the FDA using the theory of planned behavior
    Paul Gavaza
    Department of Pharmaceutical, Social and Administrative Sciences, Appalachian College of Pharmacy, 1060 Dragon Road, Oakwood, VA 24631, USA
    Res Social Adm Pharm 7:369-82. 2011
    ..However, underreporting of serious ADEs is a common problem. Little is known about pharmacists' decision making with respect to ADE reporting...
  77. pmc Adverse event profiles of platinum agents: data mining of the public version of the FDA adverse event reporting system, AERS, and reproducibility of clinical observations
    Toshiyuki Sakaeda
    Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606 8501, Japan
    Int J Med Sci 8:487-91. 2011
    ..Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm platinum agent-associated adverse events, and to clarify the rank-order of these drugs in terms of susceptibility...
  78. ncbi Influence of the MedDRA hierarchy on pharmacovigilance data mining results
    Ronald K Pearson
    ProSanos Corporation, Harrisburg, PA 17102, USA
    Int J Med Inform 78:e97-e103. 2009
    ..To compare the results of drug safety data mining with three different algorithms, when adverse events are identified using MedDRA Preferred Terms (PT) vs. High Level Terms (HLT) vs. Standardised MedDRA Queries (SMQ)...
  79. ncbi Prospective data mining of six products in the US FDA Adverse Event Reporting System: disposition of events identified and impact on product safety profiles
    Steven Bailey
    Global Safety Surveillance and Epidemiology, Wyeth, Collegeville, Pennsylvania, USA
    Drug Saf 33:139-46. 2010
    ..Specifically, the utility in identifying new safety signals and the resources required to do so have not been elucidated...
  80. ncbi Pediatric drug labeling: improving the safety and efficacy of pediatric therapies
    Rosemary Roberts
    Office of Counter Terrorism and Pediatric Drug Development, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20855, USA
    JAMA 290:905-11. 2003
    ..In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA), which encouraged pediatric drug development by providing an incentive in the form of additional marketing exclusivity...
  81. ncbi Pimecrolimus and tacrolimus: the US FDA public health advisory
    S Maddin
    Division of Dermatology, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
    Skin Therapy Lett 10:1-3. 2005
  82. ncbi Report criticizes lack of FDA oversight
    Mike Mitka
    JAMA 296:920-2. 2006
  83. ncbi Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration
    Barbara M Davit
    Division of Bioequivalence II, Office of Generic Drugs, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Derwood, MD 20855, USA
    Ann Pharmacother 43:1583-97. 2009
    ..Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies...
  84. ncbi Insomnia medication: do published studies reflect the complete picture of efficacy and safety?
    Taina Mattila
    Medicines Evaluation Board, The Hague, The Netherlands
    Eur Neuropsychopharmacol 21:500-7. 2011
    ..EPARs/FDA reviews provide a more unbiased view of the benefit-risk balance of insomnia and other medications and hence these documents should be consulted by e.g. authors of meta-analyses and of treatment guidelines...
  85. ncbi A study of warning letters issued to clinical investigators by the United States Food and Drug Administration
    Katrina A Bramstedt
    Research Subject Advocacy Program, General Clinical Research Center, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA
    Clin Invest Med 27:129-34. 2004
    ..This study explores the ethical issues contained in warning letters issued to clinical researchers by the Food and Drug Administration (FDA) in the USA...
  86. ncbi Experts look for ways to lessen impact of drug shortages and discontinuations
    Tracy Hampton
    JAMA 298:727-8. 2007
  87. ncbi [Nephrogenic systemic fibrosis (NSF)--implications for radiology]
    H J Michaely
    Institut fur Klinische Radiologie, Klinikum Mannheim der Universität Heidelberg, Theodor Kutzer Ufer 1 3, 68167 Mannheim, Deutschland
    Radiologe 47:785-93. 2007
    ..Other Gd-containing contrast agents should only be administered after thorough assessment of the indication and with minimized Gd dose. In the USA, the FDA has issued a black box warning for Gd-containing contrast agents...
  88. ncbi Riata implantable cardioverter-defibrillator lead failure: analysis of explanted leads with a unique insulation defect
    Robert G Hauser
    Minneapolis Heart Institute Foundation, Minneapolis, MN, USA
    Heart Rhythm 9:742-9. 2012
    ....
  89. ncbi Analgesics for acute pain: Meeting the United States Food and Drug Administration's requirements for proof of efficacy
    Derry Ridgway
    Lineberry Research Associates, Research Triangle Park, NC, USA
    Clin J Pain 20:123-32. 2004
    To examine the United States Food and Drug Administration's (FDA) standards for reviews of the scientific basis for efficacy claims for newly approved oral analgesics.
  90. ncbi U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States
    Deborah A Wing
    Department of Obstetrics Gynecology, University of California, Irvine, Orange, California 92868, USA
    Obstet Gynecol 115:825-33. 2010
    ..These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed...
  91. ncbi Iloperidone redux: a dissection of the Drug Approval Package for this newly commercialised second-generation antipsychotic
    L Citrome
    Department of Psychiatry, New York University School of Medicine and the Nathan S Kline Institute for Psychiatric Research, Orangeburg, NY, USA
    Int J Clin Pract 64:707-18. 2010
    ..To describe the contents of a Drug Approval Package and to describe the efficacy and safety of iloperidone for the treatment of schizophrenia...
  92. pmc An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences
    Aaron S Kesselheim
    Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
    Milbank Q 89:450-502. 2011
    ..With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market...
  93. ncbi "Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk
    Shirley Murphy
    US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Counter Terrorism and Pediatric Drug Development, Silver Spring, MD 20993, USA
    J Allergy Clin Immunol 117:34-9. 2006
    ..A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted...
  94. ncbi Safety and efficacy of rosuvastatin
    Gunnar O Olsson
    Lancet 364:135. 2004
  95. pmc Diet & nutrition: hyperactive ingredients?
    Julia R Barrett
    Environ Health Perspect 115:A578. 2007
  96. pmc ArrayTrack--supporting toxicogenomic research at the U.S. Food and Drug Administration National Center for Toxicological Research
    Weida Tong
    Center for Toxicoinformatics, Division of Biometry and Risk Assessment, National Center for Toxicological Research, U S Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
    Environ Health Perspect 111:1819-26. 2003
    ..Using ArrayTrack, we can select an analysis method from the TOOL and apply the method to selected microarray data stored in the MicroarrayDB; the analysis results can be linked directly to gene information in the LIB...
  97. ncbi What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling
    Mary E Willy
    Office of Drug Safety, Food and Drug Administration, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 13:201-6. 2004
    ..The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States...
  98. ncbi Safety in numbers--monitoring risk in approved drugs
    Susan Okie
    N Engl J Med 352:1173-6. 2005
  99. ncbi Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting System
    John A Clark
    United BioSource Corporation, Lexington, MA 02420, USA
    Pharmacoepidemiol Drug Saf 19:107-14. 2010
    ..To review topical bovine thrombin spontaneous adverse event (AE) reports that were forwarded to the US Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) between January 1986 and December 2006...
  100. ncbi Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics
    Henry Rodriguez
    National Cancer Institute Food and Drug Administration Interagency Oncology Task Force on Molecular Diagnostics, National Institutes of Health, Bethesda, MD 20892, USA
    Clin Chem 56:237-43. 2010
    ....
  101. ncbi Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration
    Fred E Regnier
    Department of Chemistry, Purdue University, West Lafayette, IN, USA
    Clin Chem 56:165-71. 2010
    ..Submissions provided a mutually beneficial way for members of the proteomics and regulatory communities to identify the analytical issues that the field should address when developing protein-based multiplex clinical assays...

Research Grants74

  1. DINUCLEOTIDE ISOMER AS A NOVEL ANTIVIRAL
    Radhakrishnan P Iyer; Fiscal Year: 2010
    ..Further continuing studies, in Phase II SBIR application, could lead to an Investigational New Drug Application with USFDA and follow-up clinical trials. ..
  2. Elucidating a novel molecular biomarker for castration-resistant prostate cancer
    Nima Sharifi; Fiscal Year: 2013
    ..survival benefit conferred by abiraterone acetate, which blocks CYP17A1 and was approved by the United States Food and Drug Administration in April 2011 for the treatment of CRPC, is the best evidence for the necessity of androgen ..
  3. Characterization and Treatment of the Scarred Vocal Fold
    Nathan Welham; Fiscal Year: 2013
    ..Retinoic acid is approved for clinical use by the United States Food and Drug Administration, holds demonstrated efficacy as an antifibrotic agent in other organ systems, and is therefore ..
  4. Acute Ischemia Monitor Utilizing Subcutaneous Electrodes
    Bruce Hopenfeld; Fiscal Year: 2013
    ..completion of this aim will be shown when the entire system passes all tests required to obtain United States Food and Drug Administration approval for a clinical safety trial...
  5. Compact Hydrogen Peroxide Sensor for Sterilization Cycle Monitoring
    Krishnan Parameswaran; Fiscal Year: 2013
    ....
  6. Cooperative steroidogenic inhibition for treatment of advanced prostate cancer
    Nima Sharifi; Fiscal Year: 2013
    ..Initial or acquired resistance to abiraterone acetate, which was approved by the United States Food and Drug Administration in April 2011 for the treatment of CRPC, has now become the next hurdle to overcome...
  7. Neural Stem Cell Mediated CE-CPT11 Therapy for Neuroblastoma
    Karen S Aboody; Fiscal Year: 2013
    ..Our goal is to submit an Investigational New Drug application to the United States Food and Drug Administration by the end of the 4 year funding period, and to receive approval to initiate first-in-human ..
  8. Can Consumers and Audiologists Detect Ear Disease Prior to Hearing Aid Use?
    David Zapala; Fiscal Year: 2013
    PROJECT SUMMARY/ABSTRACT Current United States Food and Drug Administration (FDA) policies for adults seeking to purchase hearing aids balance two potentially conflicting healthcare objectives: (1) ensure public safety by detecting ..
  9. Virginia shellfish growing area examination, inspection, and investigations enhan
    KEITH SKILES; Fiscal Year: 2013
    ..These improvements will address many of the United States Food and Drug Administration's goals to provide modern and innovative approaches in risk assessment, inspection and ..
  10. Azithromycin Combination Therapy in Resistant Malaria
    Charles Knirsch; Fiscal Year: 2000
    ..MILESTONE 4: file a supplemental New Drug Application to the United States Food and Drug Administration for the use of azithromycin drug combinations for the treatment of P falciparum malaria, ..
  11. Food Inspection Innovation
    HECTOR F GONZALEZ; Fiscal Year: 2013
    ..objectives: Capacity Building and Workforce development and this will also enhance our capability to fulfill the United States Food and Drug Administration Voluntary National Retail Food Regulatory Program Standards.
  12. Clinical Accommodation Measurement
    Adrian Glasser; Fiscal Year: 2010
    ..The first so called accommodative intraocular lens received United States Food and Drug Administration (FDA) approval in November 2003, and FDA clinical trials are currently underway for scleral ..
  13. AZITHROMYCIN TREATMENT FOR DRUG-RESISTANT MALARIA
    Jonathan Berman; Fiscal Year: 2000
    ..The research plan will lead to United States Food and Drug Administration approval of azithromycin as a drug combination of treatment of drug-resistant Plasmodium ..
  14. Wide Dynamic Range Hydrogen Peroxide Sensor for Sterilization Cycle Development
    WILLIAM KESSLER; Fiscal Year: 2007
    ..unreadable] [unreadable] [unreadable]..
  15. THERAPY FOR ALPHA-1 ANTITRYPSIN DEFECIENCY
    GORDON SNIDER; Fiscal Year: 1999
    ..Representatives of the United States Food and Drug Administration and the National Institutes of Health will participate as well...
  16. INTRACORNEAL LENS FOR THE CORRECTION OF HYPEROPIA
    ALOK NIGAM; Fiscal Year: 2003
    ..abstract_text> ..
  17. BIOEFFECTS OF GAS BODY ACTIVATION IN MEDICAL ULTRASOUND
    Douglas Miller; Fiscal Year: 2009
    ..This project will examine bioeffects in cells and tissues and show how to safely use ultrasound contrast agents in diagnostic imaging. ..
  18. CHARACTERIZATION & SAFETY TESTING OF CLINICAL RETROVIRUS
    JEFFREY OSTROVE; Fiscal Year: 2000
    ..used in the clinical trial conform to the safety standards set by regulatory requirements of the United States Food and Drug Administration. One of the target diseases for such gene therapy trials is the inherited immune system ..
  19. Automated Electrocardiography and Blood Sampling
    Candice Kissinger; Fiscal Year: 2003
    ..A recent addition to the tests requested by the United States Food and Drug Administration (FDA) is an assessment of the potential for any new drug, and all of its known metabolites, to ..
  20. Develop/Reversible Intrafallopian Contraception Device
    Richard Grant; Fiscal Year: 2005
    ..Commercialization of this device would be expected to command a significant share of the $3 billion contraceptive market. ..
  21. HTLV SUPPLEMENTAL TESTING DEVICE
    JAMES HENGST; Fiscal Year: 2002
    ..Since there are no other devices approved by the USFDA, nor are there likely to be, we expect to capture essentially all of the U.S. market and a significant share outside the U.S. ..
  22. Pharmacotherapy for Minor Depression
    Robert Howland; Fiscal Year: 2004
    ..The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD. ..
  23. H2N PEPTIDE VACCINES--PATIENTS WI/H2N EXPRESSING CANCERS
    MARY DISIS; Fiscal Year: 1999
    ..The investigation has been approved for human study by both the United States Food and Drug Administration (FDA IND BB-6524, Disis P.I.) and the University of Washington
  24. Pharmacogenetics and Cardiovascular Events
    Bruce Psaty; Fiscal Year: 2006
    ..The primary defense is replication: we would therefore welcome collaboration from others in the Pharmacogenetics Network in validation efforts. ..
  25. Genome-wide case-only study of antihypertensive drug-gene interactions
    Bruce M Psaty; Fiscal Year: 2010
    ....
  26. Hormone Replacement Therapy and Prothrombotic Variants
    Bruce Psaty; Fiscal Year: 2005
    ..Power for primary and secondary aims is excellent. Information from this project may help physicians counsel women about HRT to maximize either effectiveness, or safety, or both. ..
  27. ANTIHYPERTENSIVE DRUG/GENE INTERACTIONS AND CV EVENTS
    Bruce Psaty; Fiscal Year: 2004
    ..58 (the difference between an odds ratio of 0.46 and 0.79 in subjects with and without the variant, respectively). Power for other primary aims is excellent; power for secondary aims is good to excellent. ..
  28. MUTATIONS, HORMONE THERAPY, AND VENOUS THROMBOEMBOLISM
    Bruce Psaty; Fiscal Year: 2001
    ....
  29. Trends in and Outcomes of Medication Use in Older Adults
    Bruce Psaty; Fiscal Year: 2004
    ..abstract_text> ..
  30. WGA Study to Identify Genetic Variants Associated with CV Events in CHS
    Bruce Psaty; Fiscal Year: 2009
    ..The proposed three-part study is efficient, has excellent power to detect small to modest-sized hazard ratios, provides a large sample of WG scans for aim 2, and includes an external replication. (End of Abstract) ..
  31. Antidepressant Treatment and Suicidality: Biostatistical/Methodological Solutions
    Robert Gibbons; Fiscal Year: 2006
    ..Collaboration with members of the VA (Cunningham, Valenstein), Kaiser Permanente (Clarke, Gullion), PHARMO (Erkens) and the Indian Health Service (Perez) is an integral part of the proposal. [unreadable] [unreadable] [unreadable]..
  32. An Exploratory Center for Obesity Research (RMI)
    Adam Drewnowski; Fiscal Year: 2006
    ..By promoting interagency collaborations, these efforts will help the NIH develop a roadmap on how to effectively translate research findings into national, state, and local health policy. [unreadable] [unreadable]..
  33. Antidepressant Use and Suicide
    Susan Busch; Fiscal Year: 2009
    ..The significance of this project lies in its potential to help clinicians and policymakers assess and manage competing risk and benefit claims. ..
  34. Early Diagnosis of Neonatal Candidiasis
    Daniel Benjamin; Fiscal Year: 2008
    ..abstract_text> ..
  35. Clinical Predictors of Antiretroviral Failure
    Daniel Benjamin; Fiscal Year: 2003
    ..abstract_text> ..
  36. Mixed-Effects ZIP Models--Mental Health Service Research
    Robert Gibbons; Fiscal Year: 2004
    ..abstract_text> ..
  37. DYNAMIC TECHNIQUES FOR TREATMENT EFFECTIVENESS ANALYSES
    ANDREW LEON; Fiscal Year: 2008
    ..In summary, this interdisciplinary project will inform methodologists about the proposed data analytic strategy and inform clinicians about effectiveness of treatments for PD, BDD, and bipolar depression. ..
  38. Transporter-Enzyme Interplay Evaluation via Microfluidiic HTS Cell Culture Device
    Leslie Benet; Fiscal Year: 2008
    ..unreadable] [unreadable] [unreadable]..
  39. Mycophenylate mofetil for treatment of chronic GVHD
    Paul Martin; Fiscal Year: 2008
    ..unreadable] [unreadable] [unreadable] [unreadable] [unreadable]..
  40. Exploring Attitudes About Data Disclosure and Data-Sharing in Genomics Research
    Susanne Haga; Fiscal Year: 2008
    ..The success of large-scale genomics research initiatives will depend on the support and participation of the public and therefore, their views are critically important to obtain. [unreadable] [unreadable] [unreadable]..
  41. TREATMENT OF SMOKELESS TOBACCO USERS
    Dorothy Hatsukami; Fiscal Year: 2008
    ..PERFORMANCE SITE ========================================Section End=========================================== ..
  42. TOBACCO EXPOSURE REDUCTION
    Dorothy Hatsukami; Fiscal Year: 2008
    ..The results of research from this TTURC will provide the scientific basis for urgent policy, public education, and regulatory efforts to reduce tobacco harm. ..
  43. Enhanced Prescription Drug Label Design to Improve Patient Understanding and Use
    Michael S Wolf; Fiscal Year: 2010
    ..This study will advance the science related to Rx labeling practices. Findings will directly inform clinical practice and state and federal policies for improving patient medication information and safety. ..
  44. Innovative Interventions for Smoking Cessation
    Dorothy K Hatsukami; Fiscal Year: 2010
    ..The results of this study will provide useful information on directions to pursue to improve our pharmacotherapies and behavioral treatments and to better understand the various aspects of addiction. ..
  45. Innate Effectors of rAls3p-N Anti-Candida Vaccine
    Brad J Spellberg; Fiscal Year: 2010
    ..PNS 398/2590 (Rev. 11/07) Page - Continuation Format Page ..
  46. Adrenergic Antagonism During Murine Candidiasis
    Brad Spellberg; Fiscal Year: 2008
    ..For these reasons, the potential for adrenergic antagonism to act as an effective immunotherapy is highly meritorious of investigation in this training application. ..
  47. Function & Fate of Alloantigen-specific CD8 Cell in GVHD
    Paul Martin; Fiscal Year: 2005
    ..The studies proposed in this application will help clarify the critical functions and fate of specific donor CD8 cell population that cause GVHD. ..
  48. Psychobiology of IV Naloxone & Lactate in Normals
    Donald Klein; Fiscal Year: 2005
    ..This would further validate this model. It may also suggest new approaches to anti-panic agents, such as mixed opiate agonist-antagonist. ..
  49. VIRUS PHOTOINACTIVATION--DIMETHYLMETHYLENE BLUE IN RBC
    Stephen Wagner; Fiscal Year: 2004
    ..abstract_text> ..
  50. Medication Management Decisions in Schizophrenia
    Mark Olfson; Fiscal Year: 2003
    ..The results will inform quality improvement programs by identifying key modifiable determinants of the quality of medication management in the community treatment of schizophrenia. ..
  51. ESCAPE Mechanistic Substudies
    Robert Califf; Fiscal Year: 2003
    ..Catecholamines are also being collected at baseline and 3 months. In addition, the ESCAPE investigators are all ready capturing detailed demographic, clinical, and physiological information as part of the protocol for the primary study. ..
  52. ACYLCOA FORMATION--COVALENT BINDING, PHARMACOKINETICS
    Leslie Benet; Fiscal Year: 2002
    ....
  53. TEMPORALLY CONTROLLED DEPLETION OF ALLOREACTIVE T CELLS
    Paul Martin; Fiscal Year: 2002
    ..Results of these preclinical studies will help to assess the potential risks and benefits of using similar approaches to prevent GVHD in human marrow transplantation. ..
  54. USE OF CANCER SCREENING IN A MANAGED CARE ENVIRONMENT
    Kathryn Phillips; Fiscal Year: 2002
    ..The findings will therefore have implications not only for the types of screening examined in this study but also for other health care services. ..
  55. UTILIZATION AND COST EFFECTIVENESS OF NEW HIV TESTS
    Kathryn Phillips; Fiscal Year: 2001
    ..abstract_text> ..
  56. Acellular vaccines against Francisella tularensis
    Wayne Conlan; Fiscal Year: 2005
    ..It is expected that the findings from the proposed studies will be applicable to the development of acellular vaccines against other intracellular respiratory pathogens such as Mycobacterium tuberculosis, and Chlamydia pneumoniae. ..
  57. Interventions for Tobacco Dependent Adolescents
    Dorothy Hatsukami; Fiscal Year: 2005
    ....
  58. Screening for Colorectal Cancer: An Integrated Approach
    Kathryn Phillips; Fiscal Year: 2007
    ..We will focus particularly on the influence of (a) utilization rates (Aim #1) and (b) patient preferences for current and new screening methods (Aim #2). ..
  59. DIETARY OBESITY
    George Bray; Fiscal Year: 2007
    ..We now propose these well founded, important and exciting studies which will provide critical new insights into anatomical, physiological and molecular mechanisms by which high levels of dietary fat induce obesity. ..
  60. Outcomes of Sleep Disorders in Older Men-Palo Alto
    Marcia Stefanick; Fiscal Year: 2007
    ..We will also supplement the bank of MrOS specimens to allow for testing of future hypotheses concerning the role of sleep in the development of age-related diseases and conditions. ..
  61. Nasal Delivery of Naltrexone for Treatment of Alcoholism
    Daniel Wermeling; Fiscal Year: 2006
    ..The long-term goal of this work is to develop and commercialize nasal delivered NTX for the treatment of alcoholism. [unreadable] [unreadable] [unreadable]..
  62. PHASE III TRIAL OF TETRATHIOMOLYBDATE IN PRIMARY BILIAR*
    George Brewer; Fiscal Year: 2007
    ..Abstract Not Provided ..
  63. EPIDEMIOLOGY OF BRAIN ABNORMALITIES IN FEBRILE SEIZURES
    Dale Hesdorffer; Fiscal Year: 2002
    ..Answers to these questions may improve the clinical management of subgroups of children at risk for long-term disability so that future at-risk children can benefit from early interventions. ..
  64. An Automated System to Monitor Medical Device Safety
    Frederic Resnic; Fiscal Year: 2009
    ..This approach can be readily extended to monitor the safety of technologies outside of interventional cardiology as outcomes data repositories become available. ..
  65. Symptom Cluster Assessment and Intervention Trial
    Andrea M Barsevick; Fiscal Year: 2010
    ....
  66. Dectection of occult mediastinal lymph node mestastases
    Michael Wallace; Fiscal Year: 2007
    ..In the R33 component of the grant application these criteria will be prospectively evaluated and correlated with clinical outcome in a second, larger cohort of patients. ..
  67. Vaccine therapy of congenital adrenal Hyperplasia
    Scott Rivkees; Fiscal Year: 2003
    ..We also anticipate being able to extend this novel approach to the treatment of other receptor-mediated endocrine disorders, such as hyperthyroidism. ..
  68. Randomized Trial of EUS Neurolysis in Pancreas Cancer
    Michael Wallace; Fiscal Year: 2006
    ..The primary outcome will be a reduction in pain at 1 month. Secondary outcomes will include the durability of pain control, quality of life, narcotic use and narcotic side effects. [unreadable] [unreadable]..
  69. PHASE RESPONSE CURVES FOR EXERCISE AND BRIGHT LIGHT
    DANIEL KRIPKE; Fiscal Year: 2002
    ..Resultant circadian phases will then be determined to compute the phase response curves, in order to examine interactions of stimulus (exercise vs. light), age, and gender on circadian responsiveness. ..
  70. DEFENSIN AND THE PATHOGENESIS OF ATHEROSCLEROSIS
    Douglas Cines; Fiscal Year: 2002
    ..Finally, the interaction between endogenous defensin and endogenous Lp(a) will be examined in a novel transgenic mouse than overexpresses both human defensin and human Lp(a). ..
  71. VERIFICATION OF CIRCADIAN ABNORMALITIES IN AGING
    DANIEL KRIPKE; Fiscal Year: 2002
    ....
  72. AFP-BASED PRIME-BOOST IMMUNOTHERAPY OF HCC
    LISA BUTTERFIELD; Fiscal Year: 2006
    ..These proposed studies will permit us to determine the immunological impact of a plasmid prime-adenoviral boost directed towards a self tumor antigen and to define mechanisms of antigen presentation. ..