Evaluation of log-transformation in assessing bioequivalence
Journal
Communications in Statistics - Theory and Methods
Journal Volume
23
Journal Issue
2
Pages
421-434
Date Issued
1994
Author(s)
Abstract
The question of whether we should use log-transformed data in assessing bioequivalence between two formulations is studied through a simulation. Under a 2x2 crossover design with different combinations of sample size and intrasubject variability, we examine the impacts of different scales of the data on the conclusion of bioequivalence as well as on the level of significance and power. We also investigate the distributions of AUC and Cmax when the joint distribution of plasma concentrations is either multivariate normal or lognormal. A comparison between population bioequivalence of average bioavailability and individual bioequivalence under a lognormal distribution is also given. © 1994, Taylor & Francis Group, LLC. All rights reserved.
Type
journal article