Mission

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

Objectives

• 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;
• To develop prioritized lists of pharmaceutical products in which the studies of BE in vivo are necessary;
• To develop a list of the products of pharmaceutical products where the studies of BE in vivo are not necessary;
• To develop a list of comparators for BE studies to be used in the region of Americas;
• To formulate recommendations and guidelines of interpretation, evaluation, and application of the scientific principles of BE;
• To promote and to develop educational training activities in the countries of the Americas on the application of BE principles;
• To promote implementation of BE of pharmaceutical products in the Americas;
• To include in training programs the share of experiences in the execution of studies of BE in the Americas;
• To develop a set of indicators to evaluate the implementation of BE studies in the Americas

   

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