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Bayesian approach to average bioequivalence using Bayes' factor.
Ghosh, Pulak; Khattree, Ravindra.
Afiliación
  • Ghosh P; Department of Mathematics and Statistics, Oakland University, Rochester, Michigan 48309-4485, USA. pghosh@oakland.edu
J Biopharm Stat ; 13(4): 719-34, 2003 Nov.
Article en En | MEDLINE | ID: mdl-14584718
In recent years, bioavailability studies for assessment of bioequivalence between two or more drug formulations have become very popular in drug development. However the current practice for the assessment of bioequivalence suffers from certain serious drawbacks. For example, sometimes these tests fail to control the consumer's risk. In this article a new methodology based on the application of Bayes' factor for solving the average bioequivalence problem is proposed. We compare our approach with the existing methods by using real data sets from the Food and Drug Administration (FDA). Results are further explored using simulation studies.
Asunto(s)
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Equivalencia Terapéutica / Modelos Estadísticos / Teorema de Bayes Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: J Biopharm Stat Asunto de la revista: FARMACOLOGIA Año: 2003 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Equivalencia Terapéutica / Modelos Estadísticos / Teorema de Bayes Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: J Biopharm Stat Asunto de la revista: FARMACOLOGIA Año: 2003 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido