Bayesian modeling of multivariate average bioequivalence Journal Article


Authors: Ghosh, P.; Gonen, M.
Article Title: Bayesian modeling of multivariate average bioequivalence
Abstract: Bioequivalence trials are usually conducted to compare two or more formulations of a drug. Simultaneous assessment of bioequivalence on multiple endpoints is called multivariate bioequivalence. Despite the fact that some tests for multivariate bioequivalence are suggested, current practice usually involves univariate bioequivalence assessments ignoring the correlations between the endpoints such as AUC and Cmax. In this paper we develop a semiparametric Bayesian test for bioequivalence under multiple endpoints. Specifically, we show how the correlation between the endpoints can be incorporated in the analysis and how this correlation affects the inference. Resulting estimates and posterior probabilities 'borrow strength' from one another where the amount and the direction of the strength borrowed are determined by the prior correlations. The method developed is illustrated using a real data set. Copyright © 2007 John Wiley & Sons, Ltd.
Keywords: clinical trial; area under the curve; bayes theorem; drug dosage form comparison; mathematical model; statistical analysis; data interpretation, statistical; probability; models, statistical; cross-sectional studies; multivariate analysis; maximum plasma concentration; biological availability; drug formulation; erythromycin; markov chain monte carlo; average bioequivalence; crossover design; gibbs sampling; mixture of dirichlet process prior; erthrocin; bioequivalence; therapeutic equivalency
Journal Title: Statistics in Medicine
Volume: 27
Issue: 13
ISSN: 0277-6715
Publisher: John Wiley & Sons  
Date Published: 2008-06-15
Start Page: 2402
End Page: 2419
Language: English
DOI: 10.1002/sim.3160
PUBMED: 18095275
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 3" - "Export Date: 17 November 2011" - "CODEN: SMEDD" - "Source: Scopus"
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  1. Mithat Gonen
    1028 Gonen