An industry perspective on tiered approach to the investigation of metabolites in drug development

摘要: Background: A tiered approach to drug metabolite measurement and identification is often used industry wide fulfill regulatory requirements specified in recent US FDA European Medicines Agency guidance. Although this strategy structured its intent it can be customized address unique challenges which may arise during early late development activities. These unconventional methods applied at any stage facilitate characterization. Results: Two case studies are described NVS 1 2. 1: plasma concentrations, measured using a radiolabeled MS-response factor exploratory method, were comparable those from validated bioanalytical method. The 2 example showed how vitro analysis helped characterize an unexpectedly abundant circulating M3. Conclusion: incorporating many aspects of conventional flexible analytical methodologies pulled together questions surrounding cha...