A sequential bioequivalence design with a potential ethical advantage.

ABSTRACT: This paper introduces a two-stage approach for evaluation of bioequivalence, where, in contrast to the designs of Diane Potvin and co-workers, two stages are mandatory regardless of the data obtained at stage 1. The approach is derived from Potvin's method C. It is shown that under circumstances with relatively high variability and relatively low initial sample size, this method has an advantage over Potvin's approaches in terms of sample sizes while controlling type I error rates at or below 5% with a minute occasional trade-off in power. Ethically and economically, the method may thus be an attractive alternative to the Potvin designs. It is also shown that when using the method introduced here, average total sample sizes are rather independent of initial sample size. Finally, it is show

SUBMITTER: Fuglsang A 

PROVIDER: S-EPMC4070248 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature