Two-Stage Adaptive Designs for Three-Treatment Bioequivalence Studies.

ABSTRACT: Bioequivalence (BE) studies are most often conducted as crossover trials, and therefore establishing their required sample size necessitates specification of the within-person variance. Given that this specification is often difficult in practice, there has been great interest in recent years in the use of adaptive designs for BE trials. However, while numerous methods for this have now been presented, their focus has been solely on two-treatment BE studies. In some instances, it will be desired to incorporate more than a single test and reference formulation into a BE trial. It would therefore be useful to establish methodology for the design of adaptive multi-treatment BE trials, to acquire the benefits in the two-treatment setting in this more complex situation. Here, we achieve this fo

SUBMITTER: Grayling MJ 

PROVIDER: S-EPMC7612189 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature