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The AAPS Journal

, Volume 16, Issue 3, pp 373–378 | Cite as

Sequential Bioequivalence Approaches for Parallel Designs

  • Anders FuglsangEmail author
Research Article

Abstract

Regulators in EU, USA and Canada allow the use of two-stage approaches for evaluation of bioequivalence. The purpose of this paper is to evaluate such designs for parallel groups using trial simulations. The methods developed by Diane Potvin and co-workers were adapted to parallel designs. Trials were simulated and evaluated on basis of either equal or unequal variances between treatment groups. Methods B and C of Potvin et al., when adapted for parallel designs, protected well against type I error rate inflation under all of the simulated scenarios. Performance characteristics of the new parallel design methods showed little dependence on the assumption of equality of the test and reference variances. This is the first paper to describe the performance of two-stage approaches for parallel designs used to evaluate bioequivalence. The results may prove useful to sponsors developing formulations where crossover designs for bioequivalence evaluation are undesirable.

KEY WORDS

bioequivalence parallel power sequential designs type I errors 

Notes

ACKNOWLEDGMENTS

Thanks to Helmut Schütz and Detlew Labes who provided valuable input.

Supplementary material

12248_2014_9571_MOESM1_ESM.pdf (59 kb)
ESM 1 (PDF 58 kb)
12248_2014_9571_MOESM2_ESM.pdf (68 kb)
ESM 2 (PDF 67 kb)
12248_2014_9571_MOESM3_ESM.pdf (74 kb)
ESM 3 (PDF 73 kb)

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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  1. 1.HaderslevDenmark

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