生物等效性试验通过受试制剂与参比制剂主要药代动力学参数药时曲线下面积(AUC)、Cmax均值之比的90%置信区间与规定的限度相比较,进行等效性评估。本研究对等效性评估的统计学原理及平行、配对、2×2双交叉试验的(1-2α)%置信区间计算方法进行了整理和举例。这些试验设计可以通过成组/配对t检验或ANOVA计算出受试制剂与参比制剂均值之差的标准误,进而计算均值之比的置信区间。 Bioequivalence test Equivalence assessment was performed by comparing the 90% confidence intervals for the area under the curve (AUC) and the mean Cmax for the pharmacokinetic parameters of the test formulation with the reference pharmacokinetic parameters. In this study, the statistical principle of equivalence evaluation and the calculation method of (1-2α)% confidence interval in parallel, paired and 2 × 2 double crossover trials were summarized and exemplified. These trial designs can calculate the standard error of the difference between the mean value of the test formulation and the reference formulation by grouping / paired t-test or ANOVA to calculate the confidence interval of the mean ratio.