FDA Guidance Urges Metabolite Testing Early In Drug Development Process

25 Feb 2008
News

Jamie Hammon jamie.hammon@informa.com

Executive Summary

A new FDA guidance encourages evaluation of metabolites as early in the drug development process as is feasible, as metabolites that appear only in human plasma or at disproportionately higher levels in humans than in animals will require nonclinical toxicity studies and such studies should be done before large-scale clinical trials

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FDA Guidance Urges Metabolite Testing Early In Drug Development Process

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