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 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

BE Working Group Meetings September 14, 2000 — Washington, DC 3 rd 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

Prioritized Objectives Approved 4 th 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

Prioritized Objectives Approved 4 th 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

Prioritized Objectives Approved 4 th 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

Recommendations by 4 th 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

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

Comparator Product The WG analyzed 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

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

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

Proposals to the Conference

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