Sequential bioequivalence trial designs with increased power and controlled type I error rates.

ABSTRACT: Methods to implement two-stage designs in two-treatment, two-sequence, and two-period crossover bioequivalence studies have only recently been developed. The two-stage methods have so far only been described for a targeted study power of 80%. Since it is sometimes desirable to increase the targeted power to 90%, this study identifies sets of alphas that work for the recently developed two-stage methods while controlling type I error rates around 5% for assumed geometric mean test/reference ratios of 0.90 and 0.95 at targeted power of 90%, and provides a characterization of the methods in terms of the resulting sample sizes and power. Depending on the actual variability and the chosen sample size at stage 1, the actual power will be between 83% and 100%. The previously characterised methods

SUBMITTER: Fuglsang A 

PROVIDER: S-EPMC3691437 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature