Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

Abstract

The workshop “Bioequivalence, Biopharmaceutics Classification System, and Beyond” was held May 21–23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

DOI: 10.1208/s12248-008-9040-9
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@article{Polli2008SummaryWR, title={Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond}, author={James E. Polli and Bertil Abrahamsson and Lawrence Yu and Gordon L Amidon and John M. Baldoni and Jack Cook and Paul H Fackler and Kerry J. Hartauer and Gordon Johnston and Steve L. Krill and Robert A. Lipper and Waseem A. Malick and Vinod P. Shah and Duxin Sun and Helen N. Winkle and Yunhui Wu and Hua Zhang}, journal={The AAPS Journal}, year={2008}, volume={10}, pages={373-379} }