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The AAPS Journal

, Volume 16, Issue 6, pp 1292–1297 | Cite as

Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies

  • Helmut Schütz
  • Detlew Labes
  • Anders Fuglsang
Research Article

Abstract

It is difficult to validate statistical software used to assess bioequivalence since very few datasets with known results are in the public domain, and the few that are published are of moderate size and balanced. The purpose of this paper is therefore to introduce reference datasets of varying complexity in terms of dataset size and characteristics (balance, range, outlier presence, residual error distribution) for 2-treatment, 2-period, 2-sequence bioequivalence studies and to report their point estimates and 90% confidence intervals which companies can use to validate their installations. The results for these datasets were calculated using the commercial packages EquivTest, Kinetica, SAS and WinNonlin, and the non-commercial package R. The results of three of these packages mostly agree, but imbalance between sequences seems to provoke questionable results with one package, which illustrates well the need for proper software validation.

KEY WORDS

bioequivalence crossover software validation 

Supplementary material

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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  1. 1.Consultancy Services for Bioequivalence and Bioavailability StudiesViennaAustria
  2. 2.Cooperative Clinical Drug Research and Development AGHoppegartenGermany
  3. 3.Fuglsang PharmaHaderslevDenmark

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