Equivalence testing for similarity in bioassays using bioequivalence criteria on the relative bioactivity

This article provides a general equivalence approach to evaluate similarity that is directly related to bioequivalence on the relative bioactivity of the standard and test preparations. Bioequivalence on the relative bioactivity can only be guaranteed for positive (only nonblanks) and finite dose intervals. The approach is demonstrated on 4 case studies in which we also show how to calculate a sample size and how to investigate the power of equivalence on similarity.

Source: Pharmaceutical Statistics - September 1, 2017 Category: Statistics Authors: Corine Balj é‐Volkers, Thembile Mzolo, Erik Talens, Pieta IJzerman‐Boon, Edwin Van den Heuvel Tags: MAIN PAPER Source Type: research