Monday, February 18, 2008
New FDA MIST Guidance
FDA Guidance for Industry: Safety Testing of Drug Metabolites, February 2008
Click here to download the document.
EXCERPT:
1. IntroductionThis 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.