Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/67135
Title: Carryover negligibility and relevance in bioequivalence studies
Author: Ocaña i Rebull, Jordi
Sánchez Olavarría, María Pilar
Carrasco Jordan, Josep Lluís
Keywords: Salut
Estadística
Health
Statistics
Issue Date: 14-Jul-2015
Publisher: John Wiley & Sons
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.
Note: Versió postprint del document publicat a: http://dx.doi.org/10.1002/pst.1699
It is part of: Pharmaceutical Statistics, 2015, vol. 14, num. 5, p. 400-408
Related resource: http://dx.doi.org/10.1002/pst.1699
URI: http://hdl.handle.net/2445/67135
ISSN: 1539-1604
Appears in Collections:Articles publicats en revistes (Genètica, Microbiologia i Estadística)

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