Bioequivalence andBioavailability Working Group

BE/BA Working Group

Contact Person: Justina Molzon (FDA)Topic Lead: Lizzie Sanchez (FDA)ALIFAR: Silvia GiarcovichArgentina: Ricardo BolaosBrazil: Silvia StorpitisCanada: Conrad PereiraChile: Regina Pezoa ReyesCosta Rica: Lidiette FonsecaFIFARMA: Loreta Marquez/Janeth Mora Venezuela: Irene Goncalves USP: Vinod Shaw University of Texas: Salomon StavchanskyPAHO Secretariat: Rosario DAlessio >>Nelly Marin

BE Working Group MeetingsSeptember 14, 2000Washington, DC3rd Conference April 24-26, 2002December 3-4, 2002Caracas, VenezuelaFebruary 14-15, 2003Brasilia, BrazilAugust 11-12, 2003Mexico City, MexicoApril 28-30, 2004Antigua, Guatemala4th Conference March 2-4, 2005August 8-10, 2005PanamaMay 21-24, 2006Montevideo, Uruguay

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 studies2.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 Approved4th Conference4. 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 Approved4th Conference7.Promote bioequivalence of pharmaceutical products in the countries of the Americas8.Adjust training programs to share regulatory experience in implementing BE within the framework of the PANDRH9.Develop indicators to evaluate implementation of BE in the Americas

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 HarmonizationWG/BE to prepare a progress report on the implementation of BE studies in the Americas, to be presented at the next Conference

Finalized DocumentFramework for Implementation of Equivalence Requirements for Pharmaceutical ProductsPosted for comment on PANDRH WebsiteThe 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 ProductThe WG analyzed the need for a comparator product The WG designed a decision tree for determining comparator productsThe decision tree was included in the document to assist NDRA in selecting a comparator products

Training in BioequivalenceWG 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 StatisticsDr. Ricardo Bolaos proposed an educational seminar focusing on statisticsWG Members considered this a priority subject for countries implementing BEAssistance of specialized organizations such as AAPS and other DRA would be helpful in implementing the program

Proposals to the Conference

ProposalsThe Conference adopt the document: Framework for Implementation of Equivalence Requirements for Pharmaceutical ProductsThe conference recommend training to promote implementation by the NDRAOn the documentOn bioequivalence and statisticsThe Conference recommend the development of indicators to evaluate implementation of BE in the Americas

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