鼻用制剂生物等效性指导原则的介绍分析  

Introduction and analysis of bioequivalence guidances for nasal preparations

作　　者：刘倩[1] 南楠[1] 张广超 许鸣镝[1] LIU Qian;NAN Nan;ZHANG Guang-chao;XU Ming-di(National Institute for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国临床药理学杂志》2022年第13期1558-1563,共6页The Chinese Journal of Clinical Pharmacology

基　　金：国家重点研发计划基金资助项目(2020YFE0201700)。

摘　　要：制剂生物等效性试验是评价仿制药内在质量的关键之一。美国食品药品监督管理局颁布的“特定品种生物等效性指导原则”中,对鼻用制剂如何进行生物等效性试验提出相应要求,其要点包括试验设计、种类、检测指标、生物豁免原则等,以上指南对我国正在开展的仿制药质量与疗效一致性评价工作有着重要的借鉴意义。Bioequivalence(BE) study is one of the critical factors for evaluating the inherent quality of generic drug products. U.S. Food and Drug Administration(FDA) issued guidance on Bioequivalence Recommendations for Specific Products related with nasal preparations were studied and analyzed. Recommendations were analyzed from multiple aspects, including study design, selection of bioequivalence subjects, dosage, analytes to measure, waiver request of in vivo testing, in vitro test etc. These guidances have important inspiration of the agreement evaluation of generic drug products in China.

关 键 词：生物等效性试验 指导原则 参比制剂 鼻用制剂 仿制药质量与疗效一致性评价 

分 类 号：R97[医药卫生—药品]