隨著科學(xué)認(rèn)知的不斷深入，為縮短藥品的批準(zhǔn)上市時(shí)間，不同藥品監(jiān)管機(jī)構(gòu)相繼出臺(tái)了人體生物等效性豁免的相關(guān)法規(guī)及技術(shù)文件，旨在通過體外研究來(lái)替代體內(nèi)試驗(yàn)。總結(jié)和比較國(guó)內(nèi)外相關(guān)指導(dǎo)原則對(duì)速釋口服固體劑型的仿制藥藥學(xué)研究的要求，重點(diǎn)關(guān)注存在的差異之處，探討背后的科學(xué)原因，并在最終經(jīng)國(guó)際人用藥品注冊(cè)技術(shù)協(xié)調(diào)委員會(huì)協(xié)調(diào)一致的過程中得到思考和啟示，以期增加仿制藥被豁免體內(nèi)試驗(yàn)的成功率、進(jìn)而降低仿制藥的開發(fā)成本，但同時(shí)亦能保證其質(zhì)量和療效與參比制劑一致，真正實(shí)現(xiàn)其臨床可替代性。

With the deepening of scientific cognition, in order to shorten the time of the drug marketed process, different regulatory agencies have successively issued relevant regulations and guidance on biowaivers (BE) to replace in vivo BE study with in vitro tests. This paper is aimed to summarize and compare the requirements of relevant guidances at home and abroad for generic pharmaceutical research of immediate-release oral solid dosage forms, focuse on the differences, explore the possible scientific reasons behind, and finally get thinking and inspiration in the process of coordination by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), expected to increase the success rate of generics being waived in vivo study, thus reducing the development cost of generic drugs. Meanwhile, the quality and efficacy of generics is ensured that consistent with reference products, so as to truly realize their clinical substitutability.

R944.2