两阶段生物等效性研究目前已得到多个国家生物等效性指南的认可，但在实施两阶段生物等效性研究时如何在控制I类错误的基础上保证目标把握度是很大的挑战。对目前国内外文献发表的两阶段设计生物等效性研究方法加以综述，详细介绍了文献方法的研究策略、检验水准的校正方法、样本量再估算等，为国内药品申办者在开展两阶段生物等效性研究提供参考。

Two-stage designs for the assessment of bioequivalence have been recently accepted in various regulatory authorities. However, controlling type I error rates around 5% at targeted power is still a great challenge for applying two-stage method. This paper reviewed the feature of present designs of the two-stage bioequivalence. The decision tree, nominal significance level, and sample size recalculation in previously published methods were also introduced in detail, which would be referential for domestic sponsors in the study of two-stage design bioequivalence.

国家自然科学基金面上项目（81173134）；安徽省卫生厅医学科研重点项目（2010A013）