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