Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 15.2.20081 Min. Lesezeit
Guidance for Industry on Safety Testing of Drug Metabolites; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
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 This guidance finalizes the draft guidance published on June 6, 2005.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →