On statistical power for average bioequivalence testing under replicated crossover designs.
Journal Article (Journal Article)
In its recent guidance on bioequivalence, the U.S. Food and Drug Administration (FDA) recommends a two-sequence, four-period (2 x 4) replicated crossover design be used for assessment of population and individual bioequivalence [FDA. Guidance for Industry on Statistical Approaches to Establishing Bioequivalence; Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, MD, 2001]. The recommended replicated crossover design not only allows estimates of both the inter-subject and the intra-subject variabilities and the variability due to subject-by-formulation interaction, but also provides an assessment of average bioequivalence (ABE). In this article, power function for assessment of ABE under a general replicated crossover design (i.e., a 2 x 2m replicated crossover design) based on the traditional analysis of variance model and the mixed effects model as suggested by the FDA are studied. It is found that the power of a 2 x 2m replicated crossover design depends upon the variability due to subject-by-formulation interaction and the number of replicates. Based on the derived power function, formula for sample size calculation for assessment of ABE under a 2 x 2m replicated crossover design is also provided.
Full Text
Duke Authors
Cited Authors
- Wan, H; Chow, S-C
Published Date
- August 2002
Published In
Volume / Issue
- 12 / 3
Start / End Page
- 295 - 309
PubMed ID
- 12448572
International Standard Serial Number (ISSN)
- 1054-3406
Digital Object Identifier (DOI)
- 10.1081/bip-120014560
Language
- eng
Conference Location
- England