Assessment of Bioequivalence Using a Multiplicative Model

Shein chung Chow, Karl E. Peace, Jun Shao

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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 languageAmerican English
JournalJournal of Biopharmaceutical Statistics
Volume1
DOIs
StatePublished - 1991

Disciplines

  • Public Health
  • Biostatistics

Keywords

  • Bioavailability
  • Bioequivalence
  • Individual subject ratios
  • Multiplicative model

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