仿制药生物等效性试验样本量估算探讨

Sample size calculation for average bioequivalence studies of generic drugs

随着我国仿制药质量与疗效一致性评价的全面开展,平均生物等效性研究作为一致性评价的重点内容将迎来高峰,对于平均生物等效性研究如何确定合适的样本量(即受试者的数量)既是关键又是难点。本文综述了国内外对平均生物等效性研究样本量的法规要求,探讨了平均生物等效性试验样本量的影响因素、估算方法、预试验的作用等问题,以期能够对平均生物等效性研究样本量的确定提供建议。

As the full conduction of correspondence evaluation of generic drugs in China, average bioequivalence studies as the focus correspondence evaluation will increase in the near future, so how to get an appropriate sample size for average bioequivalence studies is very important and also difficult. This paper reviewed and summarized the domestic and abroad regulations and guidelines on sa factors that determine sample size, how to calculate sample size, effect mple size of bioequivalence studies. The of pre-bioequivalence studies and other issues were discussed. Finally, some suggestions were provided on sample size calculation for average bioequivalence studies.