等效性评价方法研究现状

目的：阐明生物等效性与临床等效性的研究现状及发展方向。方法：介绍新药等效性评价方法的原理，生物等效性分析方法的新进展包括总体或(和)个体生物等效性和多变量生物等效性检验的方法，以及临床等效性中等效界值、目标参数及有待解决的问题，并结合实例进行论述。结论：等效性评价的基本方法已得到推广使用，但在应用上还存在很大的可塑性，不利于新药审评标准的把握，应加强等效性评价方法的正确应用与发展。

Current Status of Equivalence Analysis Methods

Objective: To clarify the current research status and the future direction of the bioequivalence test and clinical equivalence. Methods: The principle of the equivalence test, new progresses of bioequivalence including population/individual bioequivalence and statistical tests for multivariate bioequivalence, some important issues concerning the therapeutic equivalence including equivalence margin, primary endpoint of trials, and some other problems to be solved were introduced in the analysis. Conclusion: The basic method of the equivalence test has been accepted; however, there are still some issues to be solved in application. It is important to facilitate the reasonable employment and development of equivalence.