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Human Drug Metabolism Earlier - International Clinical Trials Autumn 2008

Date Posted: 27 Nov 2008 Summary: Earlier Metabolism Information derisks later stages of development Download:  ICT Autumn 2008 Metabolism Studies RCG,GL.pdf Download

"Understanding which drug metabolites are formed in humans both qualitatively and quantitatively is of fundamental importance in the drug development process, especially if any of the formed metabolites are pharmacologically active or toxic. The new FDA guidance on Safety Testing of Drug Metabolites is particularly focused on situations where the safety of drug metabolites may need to be determined in non-clinical studies because these metabolites are either only identified in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard non-clinical toxicology testing."

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