為了保證吸入制劑原研藥和仿制藥體內(nèi)體外生物等效性，美國食品藥品監(jiān)督管理局（FDA）頒布的指導(dǎo)原則中明確要求對吸入制劑體外非臨床研究數(shù)據(jù)采用群體生物等效性統(tǒng)計(jì)分析方法。綜述了FDA對吸入制劑體外群體生物等效性研究方面的建議，統(tǒng)計(jì)方法原理，相關(guān)參數(shù)的計(jì)算及等效性判斷標(biāo)準(zhǔn)并闡述了國外文獻(xiàn)的研究實(shí)例，旨在為我國吸入制劑仿制藥的體外等效性統(tǒng)計(jì)方法學(xué)研究提供合理可靠的依據(jù)。

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.

國家科技部重大專項(xiàng)（2017ZX09201002）