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What does the FDAs Safety Testing of Drug Metabolites guidance say?

April 26, 2017FDAs guidance

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What does the FDAs Safety Testing of Drug Metabolites guidance say?

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The guidance document states that the FDA “strongly recommend in vivo metabolic evaluation in humans be performed as early as possible”. Metabolites that raise a safety concern are those produced in humans at greater than 10% of parent drug systemic exposure at steady state.