Assessment of bioequivalence using a multiplicative model.

Published

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.

Full Text

Duke Authors

Cited Authors

  • Chow, SC; Peace, KE; Shao, J

Published Date

  • 1991

Published In

Volume / Issue

  • 1 / 2

Start / End Page

  • 193 - 203

PubMed ID

  • 1844696

Pubmed Central ID

  • 1844696

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1080/10543409108835018

Language

  • eng

Conference Location

  • England