Use of Bayesian Methods for Multivariate Bioequivalence Measures

Autor(es)

Molina de Souza, Roberto ^[1] ; Achcar, Jorge Alberto ^[1] ; Martinez, Edson Zangiacomi ^[1]

Afiliação do(s) autor(es)

^[1] Univ Sao Paulo, Fac Med Ribeirao Preto, Dept Social Med, BR-14049900 Ribeirao Preto, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Journal of Biopharmaceutical Statistics; v. 19, n. 1, p. 42-66, 2009.
• Citações Web of Science: 3

Resumo

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)

• Processo FAPESP: 07/01594-0 - Estatística em bioequivalência: garantia na qualidade do medicamento genérico
• Beneficiário: Roberto Molina de Souza
• Modalidade de apoio: Bolsas no Brasil - Mestrado