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| Characterization of New Drug’s |
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| Safety Profile Before Marketing |
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| § | Most drugs approved by FDA with average |
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| of 1500 patient exposures |
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| § | Some drugs have rare toxicity profiles |
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| (bromfenac hepatotoxicity 1 in 20,000 |
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| patients) |
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| § | For drugs with rare toxicity, more than |
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| 100,000 patients must be exposed to generate |
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| a signal i.e. after drug is marketed |
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