Bioeqivalence: Bayesian methods

Roberto Molina de SOUZA[1]

Edson Zangiacomi MARTINEZ1

Jorge Alberto ACHCAR1

Josmar MAZUCHELI[2]

§    ABSTRACT: Bioequivalence trials are used to guarantee the security in the interchangeability between drugs, making possible the generic drug propagation in the market, being thus of extreme importance for the pharmaceutical industry. Amongst the stages of a bioequivalence trial, the stage statistics is the conclusive one of the study. This article, presents one brief revision on studies of bioequivalence, the methods of average and individual bioequivalence and the analysis statistics under the approach of average bioequivalence in according to ANVISA and, as an alternative, Bayesian approach of the analysis. The hypothetical data available in the Manual of good practical in bioavailability presented for the ANVISA had been used for the application of the classic and Bayesian approaches for the evaluation of average bioequivalence.

§    KEYWORDS: Average bioequivalence; Bayesian analysis; individual bioequivalence; bioavailability.

 



[1] Departamento de Medicina Social, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo – FMRP/USP, Ribeirão Preto, SP, Brasil. E-mail: rmolina.souza@gmail.com / edson@fmrp.usp.br / achcar@fmrp.usp.br

[2] Departamento de Estatística, Universidade Estadual de Maringá – UEM, Maringá, PR, Brasil. E-mail: jmazucheli@uem.br