摘要
生物利用度(bioavailability,BA)和生物等效性(bioequivalence,BE)研究是新药研发过程中评价药物质量和桥接安全性、有效性数据的重要手段。最近,美国食品药品监督管理局(FDA)对新药申请(包括新药上市申请(NDA)和新药临床申请(IND))中有关BA/BE研究的指导原则进行了更新。本文着重将新药BA/BE研究指导原则的内容与更新前内容作对比,介绍其主要变更要点,为新药研究提供参考。
Bioavailability （BA） and Bioequivalence （BE） studies are critical methods in new drug evalua- tion during new drug development procedure, which can bridge safety and efficacy data from the previous studies to the current proposed Product. Recently, U.S. Food and Drug Administration （FDA） has updated guidance for BA/BE studies in INDs/NDAs. In this article, major changes in requirements for BA/BE studies in INDs/NDAs and NDA supplements were discerned by comparing newly published version to the one before revision. Hope this can be of any help to the new drug development.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第8期932-935,共4页
Chinese Journal of New Drugs
