Open AccessEvaluation of Serious Adverse Drug Reactions
Author(s) -
Charles L. Bennett,
Jonathan R. Nebeker,
Paul R. Yarnold,
Cara C. Tigue,
David A. Dorr,
June M. McKoy,
Beatrice J. Edwards,
John F. Hurdle,
Dennis P. West,
Denys T. Lau,
Cara Angelotta,
Sigmund A. Weitzman,
Steven M. Belknap,
Benjamin Djulbegović,
Martin S. Tallman,
Timothy M. Kuzel,
Al B. Benson,
Andrew M. Evens,
Steven Trifilio,
D. Mark Courtney,
Dennis W. Raisch
Publication year - 2007
Publication title -
archives of internal medicine
Language(s) - English
Resource type - Journals
eISSN - 1538-3679
pISSN - 0003-9926
DOI - 10.1001/archinte.167.10.1041
Subject(s) - medicine , postmarketing surveillance , drug reaction , food and drug administration , adverse effect , adverse drug reaction , drug , medical emergency , emergency medicine , pharmacology
The Food and Drug Administration (FDA) and pharmaceutical manufacturers conduct most postmarketing pharmaceutical safety investigations. These efforts are frequently based on data mining of databases. In 1998, investigators initiated the Research on Adverse Drug events And Reports (RADAR) project to investigate reports of serious adverse drug reactions (ADRs) and prospectively obtain information on these cases. We compare safety efforts for evaluating serious ADRs conducted by the FDA and pharmaceutical manufacturers vs the RADAR project.
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