为了保证吸入制剂原研药和仿制药体内体外生物等效性，美国食品药品监督管理局（FDA）颁布的指导原则中明确要求对吸入制剂体外非临床研究数据采用群体生物等效性统计分析方法。综述了FDA对吸入制剂体外群体生物等效性研究方面的建议，统计方法原理，相关参数的计算及等效性判断标准并阐述了国外文献的研究实例，旨在为我国吸入制剂仿制药的体外等效性统计方法学研究提供合理可靠的依据。

In order to ensure the in vivo and in vitro bioequivalence of test and reference inhaled drug products, data from in vitro non-clinical studying performance characteristics of the population bioequivalence statistical test explicitly required by the US Food and Drug Administration (FDA) guidelines for inhaled drug products. This article summarizes the FDA's recommendations on in vitro population bioequivalence for inhaled drug products, the principles of statistical methods, the calculation of relevant parameters, the criteria for equivalence determination and examples of foreign literature studies. The purpose is to provide a reasonable and reliable scientific basis of in vitro statistical equivalence methodology for inhaled generic drugs in China.

国家科技部重大专项（2017ZX09201002）