期刊
DRUG METABOLISM REVIEWS
卷 40, 期 3, 页码 447-463出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/03602530802186561
关键词
major human metabolites; unique human metabolites; FDA draft guidance; metabolite safety testing
A Draft Guidance for Industry on Safety Testing of Drug Metabolites was released by FDA in 2005. According to these recommendations, there may be instances when the safety profile of human metabolites may mandate their direct safety testing in animals prior to registration and approval of new molecular entity. In response to this evolving regulatory environment, pragmatic and scientifically driven approaches should be used to assess which (if any) metabolites may require direct safety testing in animals. A specific Lilly case study highlights a strategic approach for evaluation of unique and major human metabolites of a drug in Phase 2 development.
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