Assessment of bioequivalence using a multiplicative model.

Abstract

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.

Cite this paper

@article{Chow1991AssessmentOB, title={Assessment of bioequivalence using a multiplicative model.}, author={Shein - Chung Chow and Karl E. Peace and J L Shao}, journal={Journal of biopharmaceutical statistics}, year={1991}, volume={1 2}, pages={193-203} }