Working Group Bioequivalence Working Group

Mission

The working group should contribute to harmonized bioequivalence criteria TO PROMOTE the interchangeability of pharmaceutical products in the Americas.

Objectives

1. To develop scientific based criteria for the products that need studies of BE in vitro and/or in vivo and for those do not require it;
2. To develop prioritized lists of pharmaceutical products in which the studies of BE in vivo are necessary;
3. To develop a list of the products of pharmaceutical products where the studies of BE in vivo are not necessary;
4. To develop a list of comparators for BE studies to be used in the region of Americas;
5. To formulate recommendations and guidelines of interpretation, evaluation, and application of the scientific principles of BE;
6. To promote and to develop educational training activities in the countries of the Americas on the application of BE principles;
7. To promote implementation of BE of pharmaceutical products in the Americas;
8. To include in training programs the share of experiences in the execution of studies of BE in the Americas;
9. To develop a set of indicators to evaluate the implementation of BE studies in the Americas

Working Group Bioequivalence Directory

They are groups of experts in areas that have been identified as priorities for the drug regulatory harmonization. Members are selected by the Steering Committee and confirmed by the regulatory authorities of the respective countries. Whenever possible, Working Groups (WG) should have at least one representative for each of the five sub-regional blocs of the Americas.

Academics and other experts can be members of the WG. Its main objectives include the implementation of diagnostic studies in order to identify the differences among the countries regarding the implementation of internationals standards and to define the necessary strategies for technical cooperation; analyze international guidelines and prepare harmonized proposal in their areas to be considered for the conference for its implementation in the region.

Members

• Justina Molzon, Coordinator. Center for Evaluation and Research. USFDA. (United States of America)
• Ricardo Bolaños, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. (Argentina)
• Tatiana Lowande, Gerência Geral de Medicamentos, Agência Nacional de Vigilância Sanitária - ANVISA. (Brazil)
• Alexis Aceituno. Instituto de Salud Pública de Chile
• Maggi Kabbad, Instituto Nacional de Higiene Rafael Rangel (Venezuela)
• Vinod Shaw. Consultant of The United States Pharmacopeia (USP).
• Salomon Stavchansky, College of Pharmacy, Division of Pharmaceutics (United States of America)
• Conrad Pereira. Therapeutic Products Directorate, Health Canada. Canada
• Sanchez Aida. (Resource Person) FDA Division of Bioequivalence
• Graciela Salazar Vargas. Consejo. Ministerio de Salud. (Costa Rica)
• Silvia Giarcovich. ALIFAR

Secretariat

• Nelly Marín. Pan American Health Organization. PAHO/Washington

Former Members

• Brazil: Silvia Sorpirtis. Profesora asociada de la escuela de farmacia de la Universidad de São Paulo, consultora en BE de ANVISA.
• Canada: Norman Pound, Health Canadá and John Gordon Health Canadá
• Chile: Ana María Concha. Pamela Milla, and Regina Pezoa Reyes. Instituto de Salud Pública Chile
• Costa Rica: Lidiete Fonseca. Escuela de farmacia Universidad de Costa Rica.
• United States Pharmacopeia (USP): Roger Williams. Executive Vicepresident. Chief Executive Officer, and Margareth Marques.
• Venezuela: Irene Goncalves. Instituto Nacional de Higiene Rafael Rangel
• FIFARMA. Vivian Trespalacios, and Loreta Marquez Bristol-Myer Squibb

Former Secretariat

Rosario Dalesio. Pan American Health Organization. PAHO/Washington  

Technical Proposal

• pdf 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

• Implementación de Estudios de Bioequivalencia en las Américas Estudio Diagnóstico.(Spanish)
• Diagnostic 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

Meetings and Minutes

• Seventh Meeting, Montevideo, 21-24 May, 2006
• Sixth Meeting. Panama, 8-11 August 2005
• Fifth Meeting, Antigua Guatemala, 28-30 April, 2004
• Fourth Meeting, Mexico City, 4-5, August, 2003
• Third Meeting, Brasilia 14-15 February, 2003
• Second Meeting, Caracas 3-4 December, 2001
• First Meeting, Washington, D.C., 14 September, 2001

Conclusions and recommendations

• Document of Conclusions and recommendations. IV Pan American Network for Drug Regulatory Harmonization (PANDRH): Dominican Republic. 2-4 March 2005.