Ascertainment of Side Effects in Psychopharmacologic Clinical Trials
Since the era of modern pharmacologic treatment of psychiatric disorders began in the mid-1950s, much progress has been made in techniques to assess the efficacy of proposed therapeutic agents. This has come about for a variety of reasons including the amendment to the U.S. Food, Drug, and Cosmetics Law in 1962 that requires proof of efficacy before marketing of prescription medications is permitted. Assessment or proof of safety prior to marketing had been a requirement for many years.
KeywordsAdverse Drug Reaction Adverse Health Event Efficacy Assessment Intercurrent Illness Drug Surveillance
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