生物等效性是仿制藥一致性評價的重要階段。以藥效學參數(shù)為終點指標評價生物等效性方法逐漸引發(fā)關(guān)注。在藥動學方法無法實施或藥動學參數(shù)無法靈敏地體現(xiàn)兩藥差異的情況下，選擇合理的藥效學參數(shù)作為終點指標可有效地評價藥品之間的差異。參考相關(guān)指南、法規(guī)及文獻，系統(tǒng)地闡述藥效學方法的適用條件，根據(jù)量效曲線選擇終點指標，終點參數(shù)分析以及具體藥物方法設(shè)計等，為相關(guān)研究提供參考和幫助。

Bioequivalence (BE) is an important stage in the consistency evaluation of generic drugs. The method of evaluating bioequivalence by using pharmacodynamic parameters as the endpoint index has gradually attracted attention. When the pharmacokinetic method cannot be implemented or the pharmacokinetic parameters cannot reflect the difference between the two drugs sensitively, choosing reasonable pharmacodynamic parameters as the endpoint can effectively evaluate the difference between the drugs. With reference to relevant guidelines, regulations and literature, this article systematically expounds the applicable conditions of pharmacodynamic methods, selects endpoint indicators according to the dose-response curve, analyzes endpoint parameters, and designs specific drug methods, etc., to provide reference and help for related research.

R969.1

皖南醫(yī)學院弋磯山醫(yī)院科技創(chuàng)新團隊“攀峰”培育計劃項目（KPF2019016）