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在生物等效性(BE)研究中,因多种原因,会经常遇到重复BE研究的问题.对这类情况如何进行BE统计分析,目前并没有指导原则可以参考.本文基于2阶段统计分析的原理,对不同情况下,重复BE研究中α值(Ⅰ类错误)的消耗问题进行了探讨,并给出了示例.期望通过α值的调整,确保重复BE研究中的Ⅰ类错误不超过法规限度要求.“,”In the bioequivalence (BE) studies,repeated BE tests are often encountered due to many reasons. How to carry out such kind of tests,currently,no guideline could be referenced. Based on the two - stage design,α spending (type Ⅰ error) was investigated in the repeated bioequivalence studies under various situations,and example was given for demonstration purpose. It is expected type Ⅰ error be kept under the regulatory requirements by means of adoption of different α values during the repeated BE tests.