对药物制剂平均生物等效性试验样本量的探讨

Sample size in average bioequivalence test of pharmaceutical preparations

在以药动学参数为终点的平均生物等效性试验中样本量是非常重要的,本研究综述了国内外对平均生物等效性试验样本量的法规要求,探讨了平均生物等效性试验样本量的影响因素、估算方法、对试验结果的影响等问题,提出了确定平均生物等效性试验样本量的建议。

Sample size is very important in average bioequivalence tests which use pharmacokinetic parameters as endpoints. In this paper,the registration requirements on sample size,both at home and abroad,were summarized. The influencing factors and calculation methods of sample size,the effect of sample size on the test results,and other problems of average bioequivalence tests were also discussed. Finally,some suggestions on determination of the sample size in average bioequivalence tests were proposed.