Luffer-Atlas Debra
Department of Drug Disposition, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
Drug Metab Rev. 2008;40(3):447-63. doi: 10.1080/03602530802186561.
A Draft Guidance for Industry on "Safety Testing of Drug Metabolites" was released by FDA in 2005.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.
美国食品药品监督管理局（FDA）于2005年发布了一份关于“药物代谢物安全性测试”的行业指导草案。根据这些建议，在某些情况下，人体代谢物的安全性概况可能要求在新分子实体注册和批准之前对其进行直接的动物安全性测试。为应对这种不断变化的监管环境，应采用务实且以科学为导向的方法来评估哪些（如果有的话）代谢物可能需要进行直接的动物安全性测试。礼来公司的一个具体案例研究突出了在2期开发中评估药物独特且主要的人体代谢物的一种策略性方法。
