PharmacyPharmacologyClinical PharmacologyPharmaceutical ToxicologyPharmacovigilanceAdverse Drug Event DetectionAdverse Drug Reaction DetectionAdverse Drug Reaction ReportingAdverse Drug ReactionsAdverse Event ReportingDrug Safety MonitoringAdverse Drug Reaction AnalysisAdverse Drug Reaction EpidemiologyAdverse Drug Reaction SurveillanceAdverse Reactions ReportingPhase Iv Clinical TrialsPhase Iv TrialsRegulatory Reporting MechanismsSuspected Adverse Drug Reaction Reporting
Following a Food and Drug Administration review of three major phase IV studies involving from 7,607 to 22,653 persons, it was determined that none of the studies resulted in the detection of new adverse drug reactions (ADRs). For two of the three drugs studied, new ADRs were identified after approval. The discovery of these new ADRs was attributed to physician case reports obtained through concurrently operating spontaneous reporting mechanisms. (<i>JAMA</i>1983;249:2226-2228)
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The Discovery of Drug-Induced Illness
Hershel Jick · New England Journal of Medicine · 1977 · 97 citations
Evaluation of a Worldwide Spontaneous Reporting System With Cimetidine
Thomas G. Davis · JAMA · 1980 · 57 citations