Guidance for Industry on Safety Testing of Drug Metabolites; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Safety Testing of Drug Metabolites." This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. It also provides recommendations on the timing and type of nonclinical studies that should be conducted to investigate the potential for clinical toxicity of drug metabolites. This guidance applies to small molecule nonbiologic drug products under development. This guidance finalizes the draft guidance published on June 6, 2005.