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

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 o...

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Bibliographic Details
Published in:The AAPS journal 2008-06, Vol.10 (2), p.373-379
Main Authors: Polli, James E., Abrahamsson, Bertil S. I., Yu, Lawrence X., Amidon, Gordon L., Baldoni, John M., Cook, Jack A., Fackler, Paul, Hartauer, Kerry, Johnston, Gordon, Krill, Steve L., Lipper, Robert A., Malick, Waseem A., Shah, Vinod P., Sun, Duxin, Winkle, Helen N., Wu, Yunhui, Zhang, Hua
Format: Article
Language:English
Subjects:
B.S. Abrahamsson
BCS and Beyond
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biopharmaceutics - classification
Biopharmaceutics - legislation & jurisprudence
Biotechnology
Congresses as Topic
Drug Design
Drugs, Generic - chemistry
Drugs, Generic - classification
Drugs, Generic - pharmacokinetics
FARMACI
Guest Editors: J.E. Polli
Humans
L.X. Yu
Meeting Report Theme: Bioequivalence
Meeting Report Theme: Bioequivalence, BCS and Beyond / Guest Editors: J.E. Polli, B.S. Abrahamsson, L.X. Yu
Pharmacology/Toxicology
PHARMACY
Therapeutic Equivalency
United States
United States Food and Drug Administration
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Summary: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.
ISSN:1550-7416
1550-7416
DOI:10.1208/s12248-008-9040-9