postmarketing product surveillance

Summary

Summary: Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.

Top Publications

  1. ncbi Quantitative methods in pharmacovigilance: focus on signal detection
    Manfred Hauben
    Safety Evaluation and Epidemiology, Pfizer Inc, New York, New York 10021, USA
    Drug Saf 26:159-86. 2003
  2. ncbi Drug safety. Gaps in the safety net
    Jennifer Couzin
    Science 307:196-8. 2005
  3. ncbi Use of health care databases in pharmacoepidemiology
    Sean Hennessy
    Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, 19104 6021, USA
    Basic Clin Pharmacol Toxicol 98:311-3. 2006
  4. ncbi Vioxx's history and the need for better procedures and better testing
    Margaret Gilhooley
    Seton Hall Law School, USA
    Seton Hall Law Rev 37:941-68. 2007
  5. ncbi Potential determinants of drug-drug interaction associated dispensing in community pharmacies
    Matthijs L Becker
    National Institute of Public Health and the Environment, Bilthoven, The Netherlands
    Drug Saf 28:371-8. 2005
  6. pmc Investigation of false positive results with an oral fluid rapid HIV-1/2 antibody test
    Krishna Jafa
    Division of HIV AIDS Prevention, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
    PLoS ONE 2:e185. 2007
  7. ncbi Postmarketing surveillance for human teratogenicity: a model approach
    C D Chambers
    Department of Pediatrics, University of California, San Diego, CA 92103 8446, USA
    Teratology 64:252-61. 2001
  8. ncbi An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. VAERS Working Group
    J A Singleton
    Vaccine Safety and Development Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
    Vaccine 17:2908-17. 1999
  9. ncbi Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database
    Robert G Hauser
    Minneapolis Heart Institute Foundation, Minnesota 55407, USA
    Heart Rhythm 1:399-405. 2004
  10. ncbi Safety of reagents for infection testing: results of the market surveillance by the Federal Institute for Drugs and Medicinal Devices until end 2006
    R Siekmeier
    Federal Institute for Drugs and Medical Devices BfArM, Bonn, Germany
    J Physiol Pharmacol 59:629-43. 2008

Detail Information

Publications237 found, 100 shown here

  1. ncbi Quantitative methods in pharmacovigilance: focus on signal detection
    Manfred Hauben
    Safety Evaluation and Epidemiology, Pfizer Inc, New York, New York 10021, USA
    Drug Saf 26:159-86. 2003
    ..Understanding the theoretical basis of these methods should enhance the effective assessment and possible implementation of these techniques by drug safety professionals...
  2. ncbi Drug safety. Gaps in the safety net
    Jennifer Couzin
    Science 307:196-8. 2005
  3. ncbi Use of health care databases in pharmacoepidemiology
    Sean Hennessy
    Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, 19104 6021, USA
    Basic Clin Pharmacol Toxicol 98:311-3. 2006
    ....
  4. ncbi Vioxx's history and the need for better procedures and better testing
    Margaret Gilhooley
    Seton Hall Law School, USA
    Seton Hall Law Rev 37:941-68. 2007
  5. ncbi Potential determinants of drug-drug interaction associated dispensing in community pharmacies
    Matthijs L Becker
    National Institute of Public Health and the Environment, Bilthoven, The Netherlands
    Drug Saf 28:371-8. 2005
    ..Further assessment of the relation between these determinants and the dispensing of DDIs and of the relation between DDI-associated dispensing and patient harm is recommended...
  6. pmc Investigation of false positive results with an oral fluid rapid HIV-1/2 antibody test
    Krishna Jafa
    Division of HIV AIDS Prevention, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
    PLoS ONE 2:e185. 2007
    ..From August 2004-June 2005, we investigated a sudden increase in false-positive results occurring in a performance study of OraQuick oral-fluid rapid HIV tests in Minnesota...
  7. ncbi Postmarketing surveillance for human teratogenicity: a model approach
    C D Chambers
    Department of Pediatrics, University of California, San Diego, CA 92103 8446, USA
    Teratology 64:252-61. 2001
    ..The purpose of this report is to outline a complementary approach that can be used in addition to other more established methods to provide the most comprehensive evaluation of prenatal exposures with respect to teratogenicity...
  8. ncbi An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. VAERS Working Group
    J A Singleton
    Vaccine Safety and Development Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
    Vaccine 17:2908-17. 1999
    ..The acceptability, sensitivity and representativeness of VAERS are unknown. The study of vaccine safety is complicated by underreporting, erroneous reporting, frequent multiple exposures and multiple outcomes...
  9. ncbi Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database
    Robert G Hauser
    Minneapolis Heart Institute Foundation, Minnesota 55407, USA
    Heart Rhythm 1:399-405. 2004
    ..The aim of this study was to understand the causes of implantable cardioverter defibrillator (ICD) failure and complications so that adverse events, including unnecessary death, can be prevented...
  10. ncbi Safety of reagents for infection testing: results of the market surveillance by the Federal Institute for Drugs and Medicinal Devices until end 2006
    R Siekmeier
    Federal Institute for Drugs and Medical Devices BfArM, Bonn, Germany
    J Physiol Pharmacol 59:629-43. 2008
    ..The results and experience obtained since 1999 suggest that the system for post marketing surveillance of IVD is an established tool to ensure product safety even though the current system can be further optimised...
  11. ncbi [Safety of high risk in vitro diagnostic medical devices : international and national measures]
    J Halbauer
    Paul Ehrlich Institut, Referat Pharmakovigilanz II, Paul Ehrlich Strasse 51 59, 63225, Langen, Deutschland
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 52:610-8. 2009
    ..However, the current system can be further optimized...
  12. ncbi Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing
    Laura G Wesolowski
    Division of HIV AIDS Prevention, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA
    AIDS 20:1661-6. 2006
    ..Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid...
  13. ncbi Opening Pandora's pillbox: using modern information tools to improve drug safety
    Scott Gottlieb
    American Enterprise Institute in Washington, DC, USA
    Health Aff (Millwood) 24:938-48. 2005
    ..New incentives will be needed to entice payers and product developers to work on building a broader, more robust system for collecting data on drug safety...
  14. ncbi Clinical study of the laser sheath for lead extraction: the total experience in the United States
    Charles L Byrd
    Broward General Medical Center, Fort Lauderdale, Florida, USA
    Pacing Clin Electrophysiol 25:804-8. 2002
    ..Success is independent of laser sheath size. Major complications can be expected in < 2% of patients, and occur more often during an investigator's early experience...
  15. ncbi Pregnancy exposure registries
    Dianne L Kennedy
    Pregnancy Labeling Task Force, US Food and Drug Administration, Rockville, Maryland 20874, USA
    Drug Saf 27:215-28. 2004
    ..Successful recruitment of an adequate number of exposed pregnancies, aggressive follow-up, and complete and accurate ascertainment of pregnancy outcome are critical attributes of a well-designed registry...
  16. ncbi Evaluating the use of Drotrecogin alfa (activated) in adult severe sepsis: a Canadian multicenter observational study
    Salmaan Kanji
    Department of Pharmacy, The Ottawa Hospital, Ottawa Health Research Institute, 501 Smyth Road, Room 1818, H1H 8L6, Ottawa, ON, Canada
    Intensive Care Med 33:517-23. 2007
    ..The purpose of this study was to characterize the usage patterns and clinical outcomes of DAA in Ontario and Quebec over a 1-year period...
  17. ncbi Teratogenicity of recently introduced medications in human pregnancy
    W Y Lo
    Department of Medical Genetics, University of British Columbia, Vancouver, Canada
    Obstet Gynecol 100:465-73. 2002
    ..To determine how long it takes after a new drug is marketed to establish whether or not its use by pregnant women is likely to pose a substantial teratogenic risk...
  18. ncbi Safety, scrutiny and conflicts: assessing the fallout and lessons learned from pharmaceuticals
    Raymond J Lanzafame
    Photomed Laser Surg 23:1-2. 2005
  19. ncbi Data from regulatory studies: What do they tell? What don't they tell?
    E Ben-Menachem
    Department of Clinical Neuroscience, Sahlgrenska Academy, Goteborg University, Goteborg, Sweden
    Acta Neurol Scand Suppl 181:21-5. 2005
    ..By complementing regulatory evidence with real-life clinical experience, a comprehensive assessment of the risks and benefits of an AED can be made...
  20. ncbi Perspectives on the use of data mining in pharmaco-vigilance
    June Almenoff
    GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Drug Saf 28:981-1007. 2005
    ..The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues...
  21. ncbi Remarks of the Acting FDA Commissioner: FDLI's 48th annual conference
    Lester M Crawford
    Food and Drug Administration FDA, Rockville, MD, USA
    Food Drug Law J 60:99-102. 2005
  22. ncbi Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care
    Lawrence R Schiller
    Digestive Health Associates of Texas, Baylor University Medical Center, Dallas, Texas 75246, USA
    Am J Gastroenterol 103:815-9. 2008
    ..The absence of this sort of consultation leaves physicians with serious limitations on their abilities to take care of patients...
  23. ncbi Curbing industry sponsor's incentive to design post-approval trials that are suboptimal for informing prescribers but more likely than optimal designs to yield favorable results
    Benjamin P Falit
    Seton Hall Law Rev 37:969-1049. 2007
  24. ncbi Serious infections associated with anticytokine therapies in the rheumatic diseases
    Jon T Giles
    Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    J Intensive Care Med 19:320-34. 2004
    ..In addition, relevant animal data illustrating potential mechanistic roles for TNF-alpha in host responses to infection are also reviewed...
  25. pmc Medicine. Moving toward transparency of clinical trials
    Deborah A Zarin
    National Library of Medicine, National Institutes of Health, U S Department of Health and Human Services, Bethesda, MD 20894, USA
    Science 319:1340-2. 2008
  26. ncbi Are novel drugs more risky for patients than less novel drugs?
    Mary K Olson
    School of Public Health, Yale University, New Haven, CT 06520, USA
    J Health Econ 23:1135-58. 2004
    ..These results suggest that novel drugs pose greater risk of serious ADRs for patients relative to less novel drugs...
  27. ncbi Postmarketing surveillance of potentially fatal reactions to oncology drugs: potential utility of two signal-detection algorithms
    Manfred Hauben
    Pfizer Inc, 150 E 42nd Street, New York, NY 10017, USA
    Eur J Clin Pharmacol 60:747-50. 2004
    ....
  28. ncbi Safety in numbers--monitoring risk in approved drugs
    Susan Okie
    N Engl J Med 352:1173-6. 2005
  29. ncbi Devices, drugs, and the Food and Drug Administration: increasing implications for ischemic stroke
    Anthony J Furlan
    Department of Neurology, University of Massachusetts Medical School, Worcester, Mass 01605 2982, USA
    Stroke 36:398-9. 2005
  30. ncbi A surveillance method for the early identification of idiosyncratic adverse drug reactions
    Fatma A Etwel
    Department of Medicine, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada
    Drug Saf 31:169-80. 2008
    ..Pemoline was withdrawn from the market 30 years later because of fatal hepatotoxicity associated with its use...
  31. pmc Drug withdrawals from the Canadian market for safety reasons, 1963-2004
    Joel Lexchin
    School of Health Policy and Management, York University, Emergency Department, University Health Network, Toronto, ON
    CMAJ 172:765-7. 2005
  32. ncbi FDA guidance document on monitoring delayed adverse events a good first start
    David A Williams
    Mol Ther 12:991-2. 2005
  33. ncbi COX-2 inhibitors and the heart: putting risk in perspective
    Rodel V Bobadilla
    Midlands Cardiology Associates in Columbia, SC, USA
    Adv Nurse Pract 13:48-50. 2005
  34. ncbi [Science, marketing and pharmacovigilance: the example of topical calcineurin inhibitors]
    C Paul
    Ann Dermatol Venereol 134:817-21. 2007
  35. ncbi Regulatory experts debate FDA's authority
    Donna Young
    Am J Health Syst Pharm 64:910, 912. 2007
  36. ncbi The risk of risk reduction: can postmarket surveillance pose more risk than benefit?
    Ralph F Hall
    University of Minnesota Baker and Daniels LLP, Indianapolis, Indiana, and Washington, DC and MR3 Medical, LLC, USA
    Food Drug Law J 62:473-92. 2007
  37. ncbi Red sky in the morning: modifying prescription drug labels as a result of postmarket surveillance
    Jill D Jacobson
    Bowman and Brooke LLP, Richmond, VA, USA
    Food Drug Law J 62:529-46. 2007
  38. ncbi U.S. postmarketing pharmacovigilance compliance in the midst of regulatory uncertainty
    Stephen A Goldman
    Stephen A Goldman Consulting Services, L L C, Morris Plains, N J, USA
    Food Drug Law J 62:513-28. 2007
  39. ncbi Pharmaceutical postmarket review: fact or fiction?
    Stephen J Schanz
    Department of Management, Innovation and Entrepreneurship at the College of Management at North Caroline State University, USA
    Food Drug Law J 62:493-500. 2007
  40. ncbi Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval
    Jeffrey S Borer
    Division of Cardiovascular Pathophysiology, Weill Medical College of Cornell University, 47 East 88th Street, New York, NY 10128 1152, USA
    Eur Heart J 28:1904-9. 2007
    ....
  41. ncbi The US drug safety system: role of the pharmaceutical industry
    Brent R Gibson
    United States Army Medical Department Center and School, Ft Sam Houston, TX, USA
    Pharmacoepidemiol Drug Saf 17:110-4. 2008
    ..In light of continuing concerns about drug safety and pending legislation, this original perspective provides an important context...
  42. ncbi Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems
    Stephen P Glasser
    University of Alabama at Birmingham, Division of Prev Medicine, 1717 11th Ave S, MT638, Birmingham, AL 35205 4731, USA
    J Clin Pharmacol 47:1074-86. 2007
    ..The authors discuss the different types of study designs that are common under the phase IV terminology and provide some examples. They also discuss the use of registries and self-reporting of adverse events using the MedWatch System...
  43. ncbi Is that product safe? How to guarantee the integrity of medical supplies and tell staff about recalls
    Lee Ann Runy
    Hosp Health Netw 81:6 p following 46, 2. 2007
    ..And it pays special attention to the ways hospitals can disseminate recall notices out to all affected staff as quickly and thoroughly as possible...
  44. ncbi Illusions of objectivity and a recommendation for reporting data mining results
    Manfred Hauben
    Department of Medicine, New York University School of Medicine, Valhalla, NY, USA
    Eur J Clin Pharmacol 63:517-21. 2007
    ..Our objective is to compare the data mining results on pre-selected drug-event combinations (DECs) between two commonly used software programs using similar protocols...
  45. ncbi Confidentiality laws and secrecy in medical research: improving public access to data on drug safety
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Boston, Massachusetts, USA
    Health Aff (Millwood) 26:483-91. 2007
    ..We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs...
  46. ncbi Consumer groups look to improve adverse event reporting systems
    Brian Vastag
    J Natl Cancer Inst 97:1804-5. 2005
  47. ncbi Reform of drug regulation--beyond an independent drug-safety board
    Wayne A Ray
    Center for Education and Research on Therapeutics, Vanderbilt University School of Medicine, Nashville, USA
    N Engl J Med 354:194-201. 2006
  48. ncbi Schroeder Lecture. Worst pills, best pills
    Sidney M Wolfe
    Public Citizen s Health Research Group, USA
    Health Matrix Clevel 16:785-96. 2006
  49. ncbi Statin safety: an appraisal from the adverse event reporting system
    Michael H Davidson
    Rush University Medical Center, Chicago, Illinois, USA
    Am J Cardiol 97:32C-43C. 2006
    ..Postrosuvastatin AE reporting patterns were comparable to those seen with other statins and did not resemble cerivastatin...
  50. ncbi Reports of hyperkalemia after publication of RALES--a pharmacovigilance study
    Manfred Hauben
    Risk Management Strategy, Pfizer Inc, New York, NY 10017, USA
    Pharmacoepidemiol Drug Saf 15:775-83. 2006
    ..e. multi-item gamma Poisson shrinker [MGPS] and proportional reporting ratios [PRRs]) to spontaneous reporting system (SRS) data to determine if these DMAs could have provided an earlier indication of a possible hyperkalemia safety issue...
  51. ncbi FDA post-marketing safety decisions
    Donald F Klein
    New York State Psychiatric Institute, Columbia University, New York, NY 10032, USA
    J Clin Psychiatry 67:1305-6. 2006
  52. ncbi Strategy for surveillance of adverse drug events
    Roselie A Bright
    Surveillance and Data Analysis Branch in the Division of Compliance Risk Management and Surveillance, Office of Compliance, Center for Drug Evaluation and Research, U S Food and Drug Administration, USA
    Food Drug Law J 62:605-16. 2007
  53. ncbi Federal Drug Administration authority and the emergency nurse: implications for patient safety
    Angela Hackenschmidt
    Emergency Department, San Francisco General Hospital Medical Center, San Francisco, CA 94110, USA
    J Emerg Nurs 32:449-50. 2006
  54. ncbi The drug safety system conundrum
    Thomas N Tiedt
    Med Tox Group, Lakewood Ranch, FL, USA
    Food Drug Law J 62:547-558. 2007
  55. ncbi Cause and effect? Assessing postmarketing safety studies as evidence of causation in products liability cases
    Lance L Shea
    Fulbright and Jaworski L L P, Washington, DC, USA
    Food Drug Law J 62:445-72. 2007
  56. 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...
  57. ncbi FDA attempting to overcome major roadblocks in monitoring drug safety
    Sarah L Zielinski
    J Natl Cancer Inst 97:872-3. 2005
  58. ncbi Safety surveillance in drug development: understanding the process and its implications for nephrology nursing
    Susan Browar
    Luitpold Pharmaceuticals, Inc, Shirley, NY, USA
    Nephrol Nurs J 29:143-50. 2002
    ..This article explains the pre- and post-marketing phases of drug development and describes the post-marketing safety surveillance of all FDA-approved drugs...
  59. ncbi Automated support for pharmacovigilance: a proposed system
    Roselie A Bright
    Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ 541, Rockville, MD 20850, USA
    Pharmacoepidemiol Drug Saf 11:121-5. 2002
    ....
  60. ncbi From pharmacovigilance to pharmacoperformance
    Jonathan Peachey
    PwC Consulting, Pharmaceutical Consulting Practice, London, United Kingdom
    Drug Saf 25:399-405. 2002
    ..better structures, processes and technological platforms in place to cope with a big increase in throughput is only a short-term solution yet is it enough to fulfil the objective in the long-term of ensuring compliance and patient safety?..
  61. ncbi The impact of FDA reform
    Janet Trunzo
    AdvaMed, Washington, District of Columbia, USA
    Med Device Technol 14:36-7. 2003
    ..The changes introduced by the Medical Device User Fee and Modernisation Act should ensure a timely and effective review process. The impact of some of the reforms is discussed here...
  62. ncbi Toward improved adverse event/suspected adverse drug reaction reporting
    Robert Gross
    Pharmacoepidemiol Drug Saf 12:89-91. 2003
  63. ncbi Droperidol, QT prolongation, and sudden death: what is the evidence?
    Louise W Kao
    Division of Medical Toxicology, Indiana University School of Medicine, Indianapolis, IN, USA
    Ann Emerg Med 41:546-58. 2003
    ..We sought to examine the evidence of a causal association suggested by the black box warning to aid clinicians in their risk-benefit analyses regarding further use of droperidol...
  64. doi FDA turns to electronic "sentinel" to flag prescription drug safety problems
    Bridget M Kuehn
    JAMA 300:156-7. 2008
  65. ncbi Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project
    Lisa A Ladewski
    Veterans Affairs Midwest Center for Health and Policy Research, Lakeside Division, Northwestern University Medical Center, Chicago, IL 60611, USA
    J Clin Oncol 21:3859-66. 2003
    ..To describe the clinical findings, occurrence rates, causality evidence, and dissemination media for serious cancer drug-associated adverse drug reactions (ADRs) reported in the postmarketing setting...
  66. ncbi How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers
    P Fleuranceau-Morel
    Drug Safety Departement, Schering S A, Lys Lez Lannoy, France
    Pharmacoepidemiol Drug Saf 11:37-44. 2002
    ..Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters...
  67. ncbi The major role of clinicians in the discovery of off-label drug therapies
    Harold J Demonaco
    Massachusetts Institute of Technology Sloan School of Management, Cambridge, Massachusetts 02114, USA
    Pharmacotherapy 26:323-32. 2006
    ..S. Patent and Trademark Office...
  68. ncbi An overview of drug development in the United States and current challenges
    Sharon Wyatt Moore
    Medical and Regulatory Affairs, Clinical Trial Management Services, Inc, Bristol, TN 37620, USA
    South Med J 96:1244-55; quiz 1256. 2003
    ..Although the ultimate goal is to bring safer and more effective medical products to patients in a timely manner, multiple challenges face those who participate in drug development...
  69. doi Prescription drugs, products liability, and preemption of tort litigation
    Catherine D DeAngelis
    JAMA 300:1939-41. 2008
  70. ncbi Reported adverse drug events in infants and children under 2 years of age
    Thomas J Moore
    Center for Health Services Research and Policy, George Washington University School of Public Health and Health Services, Washington, DC 20006, USA
    Pediatrics 110:e53. 2002
    ..To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration...
  71. ncbi The medical dictionary for regulatory activities (MedDRA)
    E G Brown
    Medicines Control Agency, London, England
    Drug Saf 20:109-17. 1999
    ....
  72. ncbi Effectiveness of risk management plans: a case study of pemoline using pharmacy claims data
    Elaine H Morrato
    University of Colorado at Denver and Health Sciences Center, Denver, CO, USA
    Pharmacoepidemiol Drug Saf 16:104-12. 2007
    ..To assess the effectiveness of a pharmaceutical risk management plan using pemoline as a case study and pharmacy claims as the data source...
  73. ncbi Errors in the approval process and post-marketing evaluation of drotrecogin alfa (activated) for the treatment of severe sepsis
    Daniele Poole
    Department of Anaesthesia and Intensive Care, S Martino Hospital, Belluno, Italy
    Lancet Infect Dis 9:67-72. 2009
    ..The case of the approval and post-marketing evaluation of drotrecogin alfa, we believe, shows that the current drug regulation system needs reforming...
  74. ncbi Safety concerns about alosetron
    Michael Camilleri
    Arch Intern Med 162:100-1. 2002
  75. ncbi A comparison of reported gastrointestinal and thromboembolic events between rofecoxib and celecoxib using observational data
    Rachna Kasliwal
    Drug Safety Research Unit, Southampton, UK
    Drug Saf 28:803-16. 2005
    ....
  76. ncbi Controlling type I error rate for fast track drug development programmes
    Weichung J Shih
    University of Medicine and Dentistry of New Jersey, 335 George Street, Liberty Plaza Room 3456, New Brunswick, NJ 08903, USA
    Stat Med 22:665-75. 2003
    ..In this paper we will discuss the concept of two kinds of type I errors, namely, the 'conditional approval' and the 'final approval' type I errors, and propose statistical methods for controlling them in a new drug submission process...
  77. ncbi Medical physicists should not encourage or participate in off-label, non-FDA-approved uses of intravascular brachytherapy devices. For the proposition
    Shirish K Jani
    Scripps Clinic, Radiation Oncology Division, La Jolla, California 92037, USA
    Med Phys 29:2128-9. 2002
  78. ncbi Clinicians say they're twisting in wind during FDA review of SSRIs
    Linda Watts Jackim
    Behav Healthc Tomorrow 13:31-4. 2004
  79. ncbi Thwarting nonconformity: CAPA vs. preventive action
    Michael Hoffman
    Hoffman Regulatory and Quality Consulting
    Biomed Instrum Technol 41:390-2. 2007
  80. pmc Drug safety without borders: concerns about bupropion
    Barbara Mintzes
    CMAJ 167:447. 2002
  81. ncbi Betahistine: a retrospective synopsis of safety data
    Sabine Jeck-Thole
    Solvay Pharmaceuticals, Hannover, Germany
    Drug Saf 29:1049-59. 2006
    ..In summary, clinical and postmarketing studies have revealed a good safety profile of betahistine that was confirmed by the safety surveillance data presented...
  82. ncbi Validation
    A Isaacs
    Doyen Medipharm Ltd, Barton, UK
    Med Device Technol 12:38, 40. 2001
    ..Validation is often considered to be a complex process that is arduous to implement. This article describes recommended validation techniques and answers frequently asked questions on how to validate machines and processes...
  83. ncbi Postmarketing surveillance rates of uveitis and scleritis with bisphosphonates among a national veteran cohort
    Dustin D French
    VISN 8 Patient Safety Center of Inquiry, James A Haley Hospital, Tampa, FL 33613, USA
    Retina 28:889-93. 2008
    ..Uveitis and scleritis are the most serious ocular side effects of bisphosphonate therapy. The purpose of this study was to determine the 6-month rates of uveitis/scleritis following dispensing of bisphosphonates in a large veteran cohort...
  84. pmc Food and Drug Administration regulation of in vitro diagnostic devices
    Elizabeth Mansfield
    Office of In Vitro Diagnostic Device Evaluation and Safety, Food and Drug Administration, Rockville, Maryland, USA
    J Mol Diagn 7:2-7. 2005
    ..We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation...
  85. ncbi Safety profile of esomeprazole: results of a prescription-event monitoring study of 11 595 patients in England
    Miranda Davies
    Drug Safety Research Unit, Southampton, UK
    Drug Saf 31:313-23. 2008
    ..This study aims to monitor the safety of esomeprazole prescribed in the primary care setting in England using prescription-event monitoring (PEM)...
  86. ncbi [Patient influence in drug imputability: a report of 17 cases]
    Céline Flattet
    Therapie 59:645-9. 2004
  87. ncbi Applications of metabolomics in drug discovery and development
    David S Wishart
    Departments of Biological Science and Computing Science, University of Alberta, Edmonton, Alberta, Canada
    Drugs R D 9:307-22. 2008
    ....
  88. ncbi A systematic review of the safety of kava extract in the treatment of anxiety
    Clare Stevinson
    Department of Complementary Medicine, University of Exeter, Exeter, United Kingdom
    Drug Saf 25:251-61. 2002
    ..Serious adverse events have been reported and further research is required to determine the nature and frequency of such events...
  89. ncbi Citalopram and suicidality in adult major depression and anxiety disorders
    Anders G Pedersen
    Drug Development, H Lundbeck A S, Ottiliavej 9, DK 2500 Valby Copenhagen, Denmark
    Nord J Psychiatry 60:392-9. 2006
    ..However, the patients in these clinical trials represent a selected group, as those patients with a significant risk of suicide were excluded at trial onset...
  90. pmc Mixed-effects Poisson regression analysis of adverse event reports: the relationship between antidepressants and suicide
    Robert D Gibbons
    Center for Health Statistics, University of Illinois at Chicago, 1601 W Taylor, Chicago, IL 60612, U S A
    Stat Med 27:1814-33. 2008
    ..We recommend improvements to the existing AERS system, which are likely to improve its public health value as an early warning system...
  91. ncbi Etanercept: an overview of its role in the treatment of psoriasis
    Malini Patel Galindo
    Center for Clinical Studies, 6655 Travis 120, Houston, TX 77030, USA
    Expert Opin Drug Metab Toxicol 4:305-10. 2008
    ..Psoriasis is a chronic and disabling disease affecting patients' quality of life...
  92. ncbi FDA's response to food, dietary supplement, and cosmetic adverse events
    Linda Bren
    FDA Consum 37:12-3. 2003
  93. ncbi Drug use investigation (DUI) and prescription-event monitoring in Japan (J-PEM)
    K Tanaka
    Department of Medical Affairs, Health Insurance Bureau, Ministry of Health and Welfare, Japan
    Pharmacoepidemiol Drug Saf 10:653-8. 2001
    ....
  94. ncbi The drug safety review process
    J Somberg
    Am J Ther 14:119. 2007
  95. ncbi Osteonecrosis and bisphosphonates: correlation versus causation
    Harry C Schwartz
    J Oral Maxillofac Surg 62:763-4. 2004
  96. ncbi Moxonidine: a review of safety and tolerability after seven years of clinical experience
    M Schachter
    Department of Clinical Pharmacology, St Mary s Hospital, London, UK
    J Hypertens Suppl 17:S37-9. 1999
    ..Moxonidine may improve aspects of glucose and lipid metabolism. In conclusion, moxonidine is a safe as well as an effective antihypertensive, with considerably improved patient tolerability compared to the older sympatholytics...
  97. ncbi A postmarketing surveillance study of fasudil treatment after aneurysmal subarachnoid hemorrhage
    Yoshio Suzuki
    Department of Neurosurgery, Nagoya Daini Red Cross Hospital, Nagoya 466 8650, Japan
    Surg Neurol 68:126-31; discussion 131-2. 2007
    ..The aim of the present study was, first, to assess safety of fasudil (Eril; Asahi Kasei Pharma Corp, Tokyo, Japan) and, second, to investigate whether the effects of fasudil in the phase 3 trial could be reproduced in a PMS study...
  98. ncbi Efficacy and safety of nifedipine GITS in Chinese patients with hypertension--a post-marketing surveillance study
    Yong Huo
    Beijing University First Hospital, Beijing, China
    Blood Press Suppl 1:18-23. 2007
    ..This post-marketing surveillance study assessed the efficacy, safety and tolerability of the treatment with nifedipine GITS (gastro-intestinal therapeutic system) in hypertensive patients under normal daily practice conditions in China...
  99. ncbi Postmarketing surveillance and reporting of adverse drug events
    Rebecca K Baer
    S D J Med 57:13-4. 2004
  100. ncbi Effectiveness, tolerability, and safety of ziprasidone in patients with schizophrenia or schizoaffective disorder: results of a multi-centre observational trial
    Duerten Kudla
    Centre for Psychosocial Medicine, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Martinistr 52, 20246 Hamburg, Germany
    Eur Psychiatry 22:195-202. 2007
    ..Secondary objectives included quality of life, subjective well-being, tolerability, and safety...
  101. ncbi A multicenter, open-label study of the efficacy and safety of ciclopirox nail lacquer solution 8% for the treatment of onychomycosis in patients with diabetes
    C Seebacher
    Hospital Dresden-Friedrichstadt, Dresden, Germany
    Cutis 68:17-22. 2001
    ..Ciclopirox nail lacquer is safe and effective for the topical treatment of onychomycosis in patients with diabetes and produced results similar to those observed in the general population...

Research Grants67

  1. CLINICAL RESEARCH CURRICULUM
    BRIAN STROM; Fiscal Year: 2004
    ..I. and co-PI s in the three distinct aspects of Clinical Research targeted by this program represent particular features of this proposal. ..
  2. FAAH GENE MUTATIONS: RISK FACTORS IN DRUG USE/ADDICTION
    JACK SIPE; Fiscal Year: 2006
    ..abstract_text> ..
  3. GERIATRIC CLINICAL EPIDEMIOLOGY TRAINING GRANT
    STEVEN HALBERT; Fiscal Year: 2007
    ..g., clinical trials, case control, cohort research, etc.), and the faculties' commitment to collaborative research. [unreadable] [unreadable]..
  4. 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. ..
  5. Molecular Genetics of Inattention in Australia
    THEODORE CICERO; Fiscal Year: 2009
    ..This will be at a marked cost savings due to the employment of existing well-characterized samples and the long history of collaborative studies between investigators from Australia and the United States. ..
  6. ENDOCANNABINOID BIOMARKERS OF OBESITY USING INTEGRATED GENOMICS AND METABOLOMICS
    JACK SIPE; Fiscal Year: 2008
    ..unreadable] [unreadable] [unreadable]..
  7. OPIATE ENDOCRINE INTERACTIONS--DEVELOPMENTAL ASPECTS
    THEODORE CICERO; Fiscal Year: 2003
    ..The proposed animal studies could establish whether gender differences exist and if these differences are based on inherent, first-order biological differences between the sexes. ..
  8. Postprandial glycemic response to 4-week low and high glycemic load diets
    Marian Neuhouser; Fiscal Year: 2008
    ..unreadable] [unreadable] [unreadable]..
  9. EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION
    Samuel Stanley; Fiscal Year: 2004
    ..The CNRU will bring together a wide group of researchers providing a synergistic environment to enhance translational and clinical neuroscience research at Washington University in St. Louis. ..
  10. 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. ..
  11. Diet and Genetic Risks for Prostate Cancer
    Marian Neuhouser; Fiscal Year: 2005
    ..To date, there are 718 confirmed cases of primary prostatic carcinoma. This proposed study will provide important information about prostate cancer etiology and suggest new strategies for prevention and control. ..
  12. Screening for Addiction Risk in Chronic Opioid Therapy
    Stephen Butler; Fiscal Year: 2005
    ..Substantial Phase III support has been committed by Endo Pharmaceuticals. The resulting measure should be reliable, valid, and easy to use in practice settings. ..
  13. Pharmacotherapy for opioid and cocaine dependence
    Bruce Rounsaville; Fiscal Year: 2005
    ..4. To examine depression as a predictor of response. 5. To examine three month follow-up status after completing the treatment trial for continuation in treatment, abstinence from illicit drugs, and depressive symptoms. ..
  14. Mechanisms of influenza NA drug resistance
    Jennifer L McKimm Breschkin; Fiscal Year: 2010
    ....
  15. USE OF ANTIOXIDANT SUPPLEMENTS AND OXIDATIVE DNA DAMAGE
    Marian Neuhouser; Fiscal Year: 2006
    ..unreadable] [unreadable] [unreadable]..
  16. Genome-wide case-only study of antihypertensive drug-gene interactions
    Bruce M Psaty; Fiscal Year: 2010
    ....
  17. Lipoxygenases in Atherosclerosis
    Garret FitzGerald; Fiscal Year: 2007
    ..Overall, these studies will illuminate the importance of lipoxygenase pathways in macrophages in relation to atherosclerotic disease. ..
  18. Mechanisms of beta-blocker induced improvements in asthma
    RICHARD AGUSTIN BOND; Fiscal Year: 2010
    ..Using a murine antigen driven 3=(n' 0 moo +L' 0p., >_E Off' :.(n ECM (II :.. O-0 o-- (Q' 6C' 0-: ..
  19. Signal Detection for Prescription Opioid Outbreaks
    Stephen Butler; Fiscal Year: 2008
    ..This system should be perceived by stakeholders as highly valuable. Thus, we believe this product has enormous commercial viability and public health importance. [unreadable] [unreadable] [unreadable] [unreadable]..
  20. PGP Regulation of Antipsychotic Exposure and Effects
    C Devane; Fiscal Year: 2008
    ..The results of this research will provide support for translational studies in humans to refine treatment guidelines for the use of this class of medications in severely mentally ill patients. ..
  21. NICHD Institutional Training for Pediatricians
    Kathryn Edwards; Fiscal Year: 2007
    ..3.) Evaluate the success of the training program through both process and outcomes evaluation. (4.) Implement continuous quality improvement procedures that will enhance the PPOR components, curriculum, and overall program. ..
  22. TARDIVE DYSKINESIA INCIDENCE AND ATYPICAL ANTIPSYCHOTIC
    Scott Woods; Fiscal Year: 2004
    ..The existence of a previous sample at the same site provides a useful additional comparison group. Methods including sample ascertainment and TD assessment are closely modeled after the original work. ..
  23. TRAINING IN FUNCTIONAL IMAGING AND ALCOHOL WITHDRAWAL
    DONALD MYRICK; Fiscal Year: 2004
    ....
  24. Mixed-Effects ZIP Models--Mental Health Service Research
    Robert Gibbons; Fiscal Year: 2004
    ..abstract_text> ..
  25. DOUBLE-BLIND CONTROLLED TRIAL OF NIGRAL GRAFTING IN PD
    C Olanow; Fiscal Year: 2003
    ..abstract_text> ..
  26. MULTIMEDIA SMOKING CESSATION FOR ALCOHOLIC CLIENTS
    Stephen Butler; Fiscal Year: 2002
    ..If a computerized, affordable smoking cessation program can be shown, in field trials, to have demonstrable efficacy, the commercial potential can be extraordinary. ..
  27. Pharmacogenetics of Methadone
    C Devane; Fiscal Year: 2003
    ..This study will form the basis for subsequent studies which should provide a more rational basis for dosing of methadone in pregnant addicts. ..
  28. WEB-BASED MANAGEMENT TRAINING: ADDICTION-RESOURCES.COM
    Stephen Butler; Fiscal Year: 2003
    ..An analogue field trial will examine, in contrast to a written booklet and wait-list control, the website's effectiveness in facilitating managers to more use of clinical data in decision-making. ..
  29. MECHANISMS OF CARDIOTOXICITY OF ANTIPSYCHOTIC DRUGS
    David Flockhart; Fiscal Year: 2001
    ....
  30. STATINS AND NON-CARDIAC ENDPOINTS
    Beatrice Golomb; Fiscal Year: 2003
    ....
  31. MR PREDICTORS OF RESPONSE TO HAART IN HIV DEMENTIA
    Joseph Berger; Fiscal Year: 2004
    ..It will also open novel avenues for exploring the differential sensitivities of these pathways to HAART, and suggest unique therapeutic options. ..
  32. TREATMENT OF PANIC DISORDER--LONG TERM STRATEGIES
    Scott Woods; Fiscal Year: 2003
    ..Thus, we are proposing to add these aims. ..
  33. ASI-MV.net: A Prescription Medication Monitoring Tool
    Stephen Butler; Fiscal Year: 2006
    ..Phase II will fully develop the ASI-MV.net website and establish its reliability and validity. The ASI-MV.net will be an innovative solution to problems collecting product-specific addictions data in real time. [unreadable] [unreadable]..
  34. NIAMS Muiltidisciplinary Clinical Research Center in...
    Richard Deyo; Fiscal Year: 2006
    ..It will require computer modeling, based on precedents in MR-PET scanning. We will determine if surgeons will accept the synthesized images as a replacement for CT-myelography for purposes of surgical planning. ..
  35. Consumer Influences of Treatment of Depression
    Richard Kravitz; Fiscal Year: 2004
    ..e., should DTCA be further regulated?) while also contributing to our understanding of the social influences on diagnosis and treatment of depression in primary care settings. ..
  36. Neurodevelopmental Effects of Antiepileptic Drugs II
    Kimford Meador; Fiscal Year: 2009
    ..The NEAD study has an invaluable cohort, and the results of this continuation proposal will impact the clinical management of women receiving these medications, and improve the health of their children. ..
  37. Gene Targets of NKX 2.5 in the Conduction System
    Melvin Scheinman; Fiscal Year: 2004
    ..MinK and HCN-1) in the pathogenesis of arrhythmias in the ventricular restricted knockout mouse model. This will be done by using in-situ hybridization and immunohistochemistry to follow the pattern of expression of these ion channels. ..
  38. Nanostenting Hydrogels for Sinus Surgery
    RICHARD ORLANDI; Fiscal Year: 2004
    ..The results of these Phase I studies will determine the feasibility and the optimal chemical properties of a nanostenting HA gel for human trials. ..
  39. Disclosing Conflict of Interest to Research Participants
    Jeremy Sugarman; Fiscal Year: 2008
    ..abstract_text> ..
  40. Pain Assessment Interview and Clinical Advisory System
    Stephen Butler; Fiscal Year: 2008
    ..Thus, we believe this product has enormous commercial viability and public health importance. [unreadable] [unreadable] [unreadable] [unreadable]..
  41. NEUROSCIENCE OF HIV CONFERENCE
    Joseph Berger; Fiscal Year: 2002
    ..Dr. Brian Wigdahl, international co-chair of the ISNV, is a co-investigator on this grant. ..
  42. ANALYSIS OF MULTIPLE INFORMANT DATA IN PSYCHIATRY
    SHARON LISE TERESA NORMAND; Fiscal Year: 2010
    ..These novel and innovative methods will improve the assessment of treatment effects and will contribute to improving the health of the population. ..
  43. 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. ..
  44. West Nile Virus: Epidemiology and Mosquito Competence
    Alan D T Barrett; Fiscal Year: 2010
    ..S. during the 2006-2011 transmission seasons;3. Investigate the mechanism of attenuation of neuroinvasiveness of mouse attenuated WNV isolates;4. Correlate WNV phenotype in vertebrate cells with mosquito vector infection. ..
  45. The impact of the pneumococcal conjugate vaccine on pneumonia hospitalizations
    CARLOS GRIJALVA; Fiscal Year: 2008
    ..We propose the use of NIS and SID for the evaluation of the pneumococcal conjugate vaccination program, using an innovative approach. [unreadable] [unreadable] [unreadable] [unreadable]..
  46. Integrating Aging and Cancer Research
    Robert Wallace; Fiscal Year: 2007
    ..Remaining activities include program administration, including ongoing planning and evaluation activities, and provision of variously sized pilot grants to promote research in the areas selected for development. ..
  47. A Chinese Adaptation of the ASI-Multimedia Version
    Stephen Butler; Fiscal Year: 2004
    ..The final product will be marketed as part of our extensive suite of substance abuse-related, multimedia tools. ..
  48. Computerized ASI Follow-up and Outcome System
    Stephen Butler; Fiscal Year: 2004
    ..Client acceptance will be evaluated along with correspondence between the IVR and traditional ASI administration. Phase II will evaluate the system's validity, capacity to produce acceptable response rates, and cost-effectiveness. ..
  49. Intravenous Cocaine Discrimination in Humans
    Chris Ellyn Johanson; Fiscal Year: 2004
    ..If successful, this will be an efficient paradigm for examining the ability of compounds to attenuate the effects of cocaine in humans and may lead to a successful pharmacological treatment for cocaine abuse/dependence. ..
  50. 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]..
  51. JCV Virus Expression in Oropharynx and HIV
    Joseph Berger; Fiscal Year: 2004
    ..This line of investigation would add credence to an oropharyngeal mechanism of JCV transmission and may ultimately lead to the clinical identification of an acute illness attributable to this pathogen. ..
  52. Internet Monitoring Of Prescription Drug Abuse
    Stephen Butler; Fiscal Year: 2006
    ..Phase II will see development of a full prototype of PRISM and demonstration of its reliability and internal and external validity. [unreadable] [unreadable] [unreadable] [unreadable]..
  53. MODELING TREATMENT USE & EFFECTIVENESS IN MENTAL ILLNESS
    Sharon Lise Normand; Fiscal Year: 2007
    ..The methodological advances from this research will enable researchers, policy makers, and methodologists to better characterize factors impacting technology innovation/exnovation and to expand the inferences for usual care. ..
  54. 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) ..
  55. A Computerized Adaptive Testing Version of the ASI
    Stephen Butler; Fiscal Year: 2007
    ..The availability of this new tool should enhance the quality and reduce the cost of research and treatment in the substance abuse area. [unreadable] [unreadable] [unreadable] [unreadable]..
  56. HIV Neuroprotection Workshop
    Joseph Berger; Fiscal Year: 2004
    ..The proposed conference is the first of its kind to highlight neuroprotection in HIV CNS and PNS disorders. By coupling this meeting with the International Symposium on Neurovirology this synergy can be exploited. ..
  57. Trends in and Outcomes of Medication Use in Older Adults
    Bruce Psaty; Fiscal Year: 2004
    ..abstract_text> ..
  58. Brain Imaging of Tobacco Craving Using fMRI
    Chris Ellyn Johanson; Fiscal Year: 2003
    ..Finally, because nicotine dependence is a prototypic addiction, this research should provide a model for similar research with other drug dependencies. ..
  59. 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. ..
  60. 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. ..
  61. 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. ..
  62. A Spanish Adaptation of the ASI-Multimedia Version
    Stephen Butler; Fiscal Year: 2002
    ..Due to its reliability and low cost, we believe the ASI-MV could become the "Gold Standard" addictions assessment. Under such a circumstance, a Spanish adaptation would enjoy widespread use and profitability. ..
  63. AIDS MALIGNANCY CONSORTIUM
    Joseph Sparano; Fiscal Year: 2005
    ..abstract_text> ..