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The online version of this article (doi:10.1208/s1224-6) contains supplementary material, which is available to authorized users. A proposal is made for the results that should be used as validation targets. Where results could be obtained across all packages, one showed questionable results when datasets contained unequal group sizes ( Kinetica). Not all software packages provide functionality for the assumption of unequal variances (EquivTest, Kinetica), and not all packages can handle datasets with more than 1000 subjects per group ( WinNonlin). Insofar as possible, datasets were evaluated with and without the assumption of equal variances for the construction of a 90% confidence interval. This paper puts a total 11 datasets into the public domain along with proposed consensus obtained via evaluations from six different software packages ( R, SAS, WinNonlin, OpenOffice Calc, Kinetica, EquivTest). In order to help companies qualify and validate the software used to evaluate bioequivalence trials with two parallel treatment groups, this work aims to define datasets with known results. If this is the case it is usually found in the full download archive itself.ДЎ2248_2014_9704_MOESM25_ESM.tif (29K) Abstract

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