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Title:	Carryover negligibility and relevance in bioequivalence studies
Author:	Ocaña i Rebull, Jordi; Sánchez Olavarría, María Pilar; Carrasco Jordan, Josep Lluís
Other authors:	Universitat de Barcelona
Abstract:	The carryover effect is a recurring issue in the pharmaceutical field. It may strongly influence the final outcome of an average bioequivalence study. Testing a null hypothesis of zero carryover is useless: not rejecting it does not guarantee the non-existence of carryover, and rejecting it is not informative of the true degree of carryover and its influence on the validity of the final outcome of the bioequivalence study. We propose a more consistent approach: even if some carryover is present, is it enough to seriously distort the study conclusions or is it negligible? This is the central aim of this paper, which focuses on average bioequivalence studies based on 2×2 crossover designs and on the main problem associated with carryover: type I error inflation. We propose an equivalence testing approach to these questions and suggest reasonable negligibility or relevance limits for carryover. Finally, we illustrate this approach on some real datasets.
Subject(s):	-Salut -Estadística -Health -Statistics
Rights:	(c) John Wiley & Sons, 2015
Document type:	Article Article - Accepted version
Published by:	John Wiley & Sons
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