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Clinical Evaluation of Analgesics

Executive Summary

FDA announces the availability of its "Guideline for the Clinical Evaluation of Analgesic Drugs." The guideline incorporates changes proposed by the American Society for Clinical Pharmacology and Therapeutics to a November 1979 guideline on the same subject ("The Pink Sheet" Nov. 19, 1990, T&G-1) and includes suggested pain models, suggestions on pharmacokinetic and pharmacodynamic data to be collected, and recommendations for recording onset of analgesic effect, peak effect and duration of effect.
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PS022282

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