Chow S C, Peace K E, Shao J
Biostatistics Department, Bristol-Myers Squibb Company, Plainsboro, New Jersey 08536.
J Biopharm Stat. 1991;1(2):193-203. doi: 10.1080/10543409108835018.
In many bioavailability/bioequivalence studies, the distributions of responses such as AUC and Cmax are often positively skewed and exhibit a lack of homogeneity of variances. In this situation, a logarithmic transformation is usually considered for reduction of skewness and achievement of an additive model with relatively homogeneous variance. In this paper, consideration is given to a multiplicative model based on empirical evidence. A method is proposed using individual subject ratios for assessing the bioequivalence of two different formulations. This method is then subsequently extended to several commonly used crossover experiments.
在许多生物利用度/生物等效性研究中，诸如AUC和Cmax等响应的分布通常呈正偏态，并且表现出方差缺乏齐性。在这种情况下，通常会考虑进行对数变换以减少偏度并实现具有相对齐性方差的加法模型。本文基于经验证据考虑了一个乘法模型。提出了一种使用个体受试者比率来评估两种不同制剂生物等效性的方法。该方法随后被扩展到几个常用的交叉试验。
