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Activity Number: 233
Type: Contributed
Date/Time: Monday, August 3, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303687
Title: Making Decisions in Bioequivalence Studies: A Statistical Contribution
Author(s): Arminda L. Siqueira*+ and Daniela M. Braga and Paula R. Chellini
Companies: Universidade Federal de Minas Gerais and Agência Nacional de Saúde Suplementar - Ministério da Saúde and Centro de Pesquisa em Biotecnologia
Address: Departamento de Estatística - ICEx, Belo Horizonte, International, 31270901, Brazil
Keywords: Bioequivalence study ; Crossover designs ; Pharmacokinetic variables
Abstract:

Bioequivalence studies are required for comparing generic drugs to a reference product that has been already placed in the market. Pharmacokinetic measures (e.g. area under the curve and maximum concentration) must be analyzed. Generally, the study is conducted with healthy volunteers following the 2x2 crossover design, although higher order crossover designs are sometimes recommended, for instance when the variability is high. For the success of a bioequivalence study, correct decisions need to be made regarding the number of volunteers, design and schedule of blood samples, etc. We discuss practical issues related to the planning and analysis of data and present results, obtained from both analytical formulas and simulation studies, which can be used as guidelines to making good decisions in bioequivalence studies.

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