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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Use of Bayesian Methods for Multivariate Bioequivalence Measures

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Author(s):
Molina de Souza, Roberto [1] ; Achcar, Jorge Alberto [1] ; Martinez, Edson Zangiacomi [1]
Total Authors: 3
Affiliation:
[1] Univ Sao Paulo, Fac Med Ribeirao Preto, Dept Social Med, BR-14049900 Ribeirao Preto, SP - Brazil
Total Affiliations: 1
Document type: Journal article
Source: Journal of Biopharmaceutical Statistics; v. 19, n. 1, p. 42-66, 2009.
Web of Science Citations: 3
Abstract

In this paper, we introduce a Bayesian analysis for bioequivalence data assuming multivariate pharmacokinetic measures. With the introduction of correlation parameters between the pharmacokinetic measures or between the random effects in the bioequivalence models, we observe a good improvement in the bioequivalence results. These results are of great practical interest since they can yield higher accuracy and reliability for the bioequivalence tests, usually assumed by regulatory offices. An example is introduced to illustrate the proposed methodology by comparing the usual univariate bioequivalence methods with multivariate bioequivalence. We also consider some usual existing discrimination Bayesian methods to choose the best model to be used in bioequivalence studies. (AU)

FAPESP's process: 07/01594-0 - Statistics on bioequivalence: guarantee in quality of generic drug
Grantee:Roberto Molina de Souza
Support Opportunities: Scholarships in Brazil - Master