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Bioequivalence and Bioavailability Working Group

Bioequivalence and Bioavailability Working Group. BE/BA Working Group. Contact Person : Justina Molzon (FDA) Topic Lead : Lizzie Sanchez (FDA) ALIFAR: Silvia Giarcovich Argentina: Ricardo Bolaños Brazil: Silvia Storpitis Canada: Conrad Pereira Chile: Regina Pezoa Reyes

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Bioequivalence and Bioavailability Working Group

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  1. Bioequivalence andBioavailability Working Group

  2. BE/BA Working Group • Contact Person: Justina Molzon (FDA) • Topic Lead: Lizzie Sanchez (FDA) • ALIFAR: Silvia Giarcovich • Argentina: Ricardo Bolaños • Brazil: Silvia Storpitis • Canada:Conrad Pereira • Chile: Regina Pezoa Reyes • Costa Rica: Lidiette Fonseca • FIFARMA: Loreta Marquez/Janeth Mora • Venezuela: Irene Goncalves • USP: Vinod Shaw • University of Texas: Salomon Stavchansky • PAHO Secretariat: Rosario D’Alessio >>Nelly Marin

  3. September 14, 2000—Washington, DC 3rd Conference April 24-26, 2002 December 3-4, 2002—Caracas, Venezuela February 14-15, 2003—Brasilia, Brazil August 11-12, 2003—Mexico City, Mexico April 28-30, 2004—Antigua, Guatemala 4th Conference March 2-4, 2005 August 8-10, 2005—Panama May 21-24, 2006—Montevideo, Uruguay BE Working Group Meetings

  4. Prioritized Objectives Approved4th Conference 1. Develop science based criteria for products requiring in vitro and/or in vivo BE studies and those not requiring BE studies 2. Develop prioritized lists (core nucleus and recommended) of those pharmaceutical products where in vivo BE studies are necessary 3. Develop a list of pharmaceutical products where in vivo BE studies are not necessary

  5. Prioritized Objectives Approved4th Conference 4. Develop a list of comparator drug products for use in the Americas region 5.Develop recommendations and guidelines for the interpretation, evaluation and application of science based bioequivalence principles. 6.Promote and assist in education and training in countries of the Americas to implement bioequivalence principles

  6. Prioritized Objectives Approved4th Conference 7.Promote bioequivalence of pharmaceutical products in the countries of the Americas 8.Adjust training programs to share regulatory experience in implementing BE within the framework of the PANDRH 9.Develop indicators to evaluate implementation of BE in the Americas

  7. Recommendations by 4th Conference • WG/BE to complete the DRAFT document and to ensure that a FINAL version of the document is presented at the next (V) Pan American Conference on Drug Regulatory Harmonization • WG/BE to prepare a progress report on the implementation of BE studies in the Americas, to be presented at the next Conference

  8. Finalized Document • Framework for Implementation of Equivalence Requirements for Pharmaceutical Products • Posted for comment on PANDRH Website • The document underwent many revisions. Most notably the WG adopted the scientific documents prepared by WHO on bioequivalence so those sections were eliminated. • The document focuses on strategies for implementing BE studies • Decision tree to guide in implementing equivalence studies • WG reviewed comments from the public received by the Secretariat and prepared the final version to be considered by the PANDRH Conference for adoption

  9. Comparator Product • The WGanalyzed the need for a comparator product • The WG designed a decision tree for determining comparator products • The decision tree was included in the document to assist NDRA in selecting a comparator products

  10. Training in Bioequivalence • WG will consider courses or other training activities already in the market for possible sponsorship from PAHO, in which PANDRH document should be given special consideration • Countries are encouraged to continue promoting implementation of training courses jointly with universities and other international agencies, and inform the Secretariat on those being implemented

  11. Training in Statistics • Dr. Ricardo Bolaños proposed an educational seminar focusing on statistics • WG Members considered this a priority subject for countries implementing BE • Assistance of specialized organizations such as AAPS and other DRA would be helpful in implementing the program

  12. Proposals to the Conference

  13. Proposals • The Conference adopt the document: Framework for Implementation of Equivalence Requirements for Pharmaceutical Products • The conference recommend training to promote implementation by the NDRA • On the document • On bioequivalence and statistics • The Conference recommend the development of indicators to evaluate implementation of BE in the Americas

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