研究美國食品藥品監(jiān)督管理局（FDA）對以體外結(jié)合試驗作為生物等效性評價指標(biāo)的仿制藥品種，分析其關(guān)鍵質(zhì)量屬性及生物等效性試驗的要求及相關(guān)指導(dǎo)原則，并結(jié)合文獻(xiàn)數(shù)據(jù)和FDA審評情況總結(jié)了需要關(guān)注的問題，以期為此類產(chǎn)品的開發(fā)提供有益的參考，為我國該類仿制藥研發(fā)和正在開展的仿制藥質(zhì)量和療效一致性評價提供技術(shù)支持。

To study the requirements and relevant guiding principles of Food and Drug Administration on the generic drugs with in vitro binding test as the bioequivalence evaluation index, and analyze the key quality attributes and bioequivalence test requirements. The bioequivalence guidance issued by FDA and the important considerations of some published articles are summarized. To guide the development and consistency evaluation of these preparations and to have important inspiration of the agreement evaluation of generic drug products in China.

國家“重大新藥創(chuàng)制”科技重大專項資助項目（2017ZX09101001）