Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2008 Jun;10(2):373-9.
doi: 10.1208/s12248-008-9040-9. Epub 2008 Aug 5.

Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond

James E Polli  1 , Bertil S I Abrahamsson, Lawrence X Yu, Gordon L Amidon, John M Baldoni, Jack A Cook, Paul Fackler, Kerry Hartauer, Gordon Johnston, Steve L Krill, Robert A Lipper, Waseem A Malick, Vinod P Shah, Duxin Sun, Helen N Winkle, Yunhui Wu, Hua Zhang
Affiliations

Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond

James E Polli et al. AAPS J. 2008 Jun.

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.

PubMed Disclaimer

References

    1. Guidance for Industry, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. August 2000, CDER/FDA. http://www.fda.gov/cder/guidance/3618fnl.htm (accessed 12/15/07)
    1. Polli J. E., Yu L. X., Cook J. A., Amidon G. L., Borchardt R. T., Burnside B. A., Burton P. S., Chen M.-L., Conner D. P., Faustino J., Hawi A. A., Hussain A. S., Joshi H. N., Kwei G., Lee V. H. L., Lesko L. J., Lipper R. A., Loper A. E., Nerurkar S. G., Polli J. W., Sanvordeker D. R., Taneja R., Uppoor R. S., Vattikonda C. S., Wilding I., Zhang G. Summary workshop report: biopharmaceutics classification system—implementation challenges and extension opportunities. J. Pharm. Sci. 2004;93:1375–1381. doi: 10.1002/jps.20064. - DOI - PubMed
    1. Critical Path Opportunities Report. March 2006, FDA. http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_report.pdf (accessed 12/15/07)
    1. J. E. Polli. In vitro studies are sometimes better than conventional human in vivo studies in assessing bioequivalence for immediate-release solid oral dosage forms. AAPS J. in press (2008). - PMC - PubMed
    1. M. S. Ku. Use of the biopharmaceutical classification system in early drug development. AAPS J. in press (2008). - PMC - PubMed

MeSH terms

LinkOut - more resources