仿制药等效性与一致性评价受到了国内外工业界和学术界的广泛重视。传统上，原研药与仿制药间要求具有平均等效性，但这可能将导致变异度不同、不具有群体等效性或个体等效性的仿制药被批准，由于不具有处方选择性和用药可交换性，上市后给临床应用带来困难。因此，群体等效性和个体等效性的概念逐渐受到重视。本研究将针对生物利用度和生物等效性研究，提出加权检验法和联合检验法，用于高效、便利地进行群体等效性和个体等效性的检验；参考FDA和EMA的有关指导原则，结合我国仿制药物评价的现状，提出适合我国的等效性临床试验等效标准确定方法。采用理论推导、计算机模拟试验评价所提出方法的性质，并结合真实数据提出相应标准的确定和方法的选择策略。课题的顺利实施将为我国仿制药一致性评价的实施和审评提供方法参考、理论依据和软件支持，有利于疗效相当、价格优越的仿制药进入我国市场，提高我国人民的健康水平，促进民族制药工业的发展。

Evaluations of the equivalence between the brand name drug and its generic drug has drawn the attentions from both the industry and the academia. Traditionally, it is required that the generic drug should be in average bioequivalence with the brand name drug. However, this may lead to the approval of the generic drugs with different variations than the brand name drug. Due to the absence of the population and individual equivalence, the generic drug would not have prescribability and switchability with the brand name drug, resulting in the difficulties on clinical administration..Thus, increasingly importance has been attached to the concepts of population and individual bioequivalence. In this study, we will propose a weighted test and a simultaneous test for the evaluations of the population and individual equivalences. By evaluating the FDA and EMA’s guidances, we will propose the criterion for the establishment of the equivalence limits based on the present status of China’s bioequivalence clinical trials. Theoretical investigations and extensive simulations will be conducted to evaluate the performance of the proposed methods. Real world datasets from equivalence clinical trials in China will be used to propose the strategies for the establishment of the equivalence criteria and the selection of the appropriate methods. .The present study will provide methodology and theoretical references, as well as software supports to the conductions and reviews of the bioequivalence trials in China. It will facilitate the research and review processes of the generic drugs with equivalence effects but cheaper prices. We believe people’s health level and domestic pharmaceutical industry will also gain benefits from the study.