Due to different approximations of the degrees of freedom, slight differences were observed in two software packages for Method B in highly incomplete datasets. ![]() For the estimation of CV wR and Method A, all software packages produced results that are in agreement across all datasets. The datasets were evaluated by seven different software packages according to methods proposed by the European Medicines Agency. A proposal is made for results that should be used as validation targets. This paper releases 30 reference datasets into the public domain along with proposed consensus results. In order to help companies qualify and validate the software used to evaluate bioequivalence trials in a replicate design intended for average bioequivalence with expanding limits, this work aims to define datasets with known results.
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