Diletti E, Hauschke D, Steinijans V W
Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.
Int J Clin Pharmacol Ther Toxicol. 1992;30 Suppl 1:S51-8.
The statistical analysis of bioequivalence assessment has been consolidated in recent years through the work of Schuirmann [1987], Westlake [1988] and Hauschke et al. [1990], and this has been reflected in the CPMP Note for Guidance on Bioavailability and Bioequivalence and in the joint recommendations of the APV (International Association for Pharmaceutical Technology) and ZL (Central Laboratories of German Pharmacists) during a recent workshop in support of EC-Guidelines [Blume et al. 1990]. Since the decision procedure based on the inclusion of the shortest 90%-confidence interval in the bioequivalence range is the procedure of choice, and as this is equivalent to the two one-sided tests procedure, the sample size determination is based on the power of the latter. Following the approach of Phillips [1990] for the additive model, corresponding nomograms for the more relevant multiplicative model are given in this paper for various ratios of the expected means for test and reference and various coefficients of variation.
近年来，通过舒尔曼（1987年）、韦斯特莱克（1988年）以及豪施克等人（1990年）的工作，生物等效性评估的统计分析得到了整合，这一点已在欧洲药品审评委员会《生物利用度和生物等效性指导原则》以及在最近一次支持欧盟指南的研讨会上，由APV（国际制药技术协会）和ZL（德国药剂师中央实验室）联合提出的建议中得到体现[布卢姆等人，1990年]。由于基于将最短90%置信区间纳入生物等效性范围的决策程序是首选程序，并且由于这等同于双向单侧检验程序，所以样本量的确定是基于后者的效能。遵循菲利普斯（1990年）针对加法模型的方法，本文针对各种试验品与参比品预期均值的比率以及各种变异系数，给出了更为相关的乘法模型的相应列线图。
