Pharmacovigilance - Rationale Information obtained prior to first marketing is inadequate to cover all aspects of drug safety: tests in animals are insufficiently predictive of human safety, tests in animals are insufficiently predictive of human safety, in clinical trials patients are selected and limited in number, in clinical trials patients are selected and limited in number, conditions of use in trials differ from those in clinical practice, conditions of use in trials differ from those in clinical practice, duration of trials is limited duration of trials is limited information about rare but serious adverse reactions, chronic toxicity, use in special groups or drug interactions is often not available.
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