Assessment of bioequivalence using a multiplicative model.
Journal Article (Journal Article)
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.
- Chow, SC; Peace, KE; Shao, J
Volume / Issue
- 1 / 2
Start / End Page
- 193 - 203
International Standard Serial Number (ISSN)
Digital Object Identifier (DOI)