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 consideredfor reduction of skew-ness 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.
Original language | American English |
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Journal | Journal of Biopharmaceutical Statistics |
Volume | 1 |
DOIs | |
State | Published - 1991 |
Disciplines
- Public Health
- Biostatistics
Keywords
- Bioavailability
- Bioequivalence
- Individual subject ratios
- Multiplicative model