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U.S. Department of Health and Human Services


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Characterization of New Drug’s Safety Profile Before Marketing

Friedman MA et al. JAMA 1999; 281(18):1728–1734


  • Most drugs approved by FDA with average of 1500 patient exposures
  • Some drugs have rare toxicity profiles (bromfenac hepatotoxicity 1 in 20,000 patients)
  • For drugs with rare toxicity, more than 100,000 patients must be exposed to generate a signal i.e. after drug is marketed


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