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Technical Proposal:

icon Pan American Network on Drug Regulatory Harmonization. Working Group on BE. Framework for implementation of equivalence requirements for pharmaceutical products. Document approved in the V Conference for Drug Regulatory Harmonization. Buenos Aires, Argentina. 17 - 19 November, 2008 (326.45 kB)

Studies:

iconImplementación de Estudios de Bioequivalencia en las Américas Estudio Diagnóstico.(Spanish)

iconDiagnostic on Implementation of BE Studies

Educational Activities

Bioequivalence Educational activities were identified as a priority strategy. An update on seminars, implementation, and educational material are provided.

-Seminars implemented

-Program content of Educational Seminars

-Educational Modules prepared by the FDA (only in Spanish)

Módulo 1. 1 Temas Generales. Curso de Biodisponibilidad y Bioequivalencia

Módulo 1.2. Temas Generales. Curso de Biodisponibilidad y Bioequivalencia

Módulo 2.1. FDA y la prueba de disolución

Módulo 2.2, Establecimiento de especificaciones de disolución y dispensas Biofarmacéuticas

Módulo 2.3 Desarrollo, evaluación y aplicación de las correlaciones In Vitro - In Vivo Módulo

Módulo 2.4 Sistema de clasificación Biofarmacéutica



Last Updated on Tuesday, 26 April 2011 09:30

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