在生物等效研究中,美国药典收录的《体内生物等效性研究的指导性文件》把双处理交叉设计作为标准统计步骤。20年来,各国普遍采用两种处理、两周期的随机交叉实验设计,通过多因素方差分析、双单侧t检验和计算90%置信区间来评价药物间的生物等效性。近年来,EXCEL由于其 In the bioequivalence study, the “guidelines for in vivo bioequivalence studies” included in the United States Pharmacopeia treat dual-treatment crossover design as a standard statistical step. Twenty years ago, two treatment and two-period randomized crossover experimental designs were widely adopted in all countries to evaluate the bioequivalence among drugs by multivariate analysis of variance, double unilateral t-test and 90% confidence interval. In recent years, EXCEL due to it