Guidance for Industry Safety Testing of Drug Metabolites
by FDA Center for Drug Evaluation and Research
This FDA CDER guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The safety of drug metabolites may need to be determined in nonclinical studies because these metabolites are either identified only in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard nonclinical toxicology testing.
| Published: | 2008 |
| Format: | |
| Length: | 14 pages |
| Type: | White paper |
| Language: | English |
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