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.
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References
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)
J. E. Polli, L. X. Yu, J. A. Cook, G. L. Amidon, R. T. Borchardt, B. A. Burnside, P. S. Burton, M.-L. Chen, D. P. Conner, J. Faustino, A. A. Hawi, A. S. Hussain, H. N. Joshi, G. Kwei, V. H. L. Lee, L. J. Lesko, R. A. Lipper, A. E. Loper, S. G. Nerurkar, J. W. Polli, D. R. Sanvordeker, R. Taneja, R. S. Uppoor, C. S. Vattikonda, I. Wilding, and G. Zhang. Summary workshop report: biopharmaceutics classification system—implementation challenges and extension opportunities. J. Pharm. Sci. 93:1375–1381 (2004).
Critical Path Opportunities Report. March 2006, FDA. http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_report.pdf (accessed 12/15/07)
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).
M. S. Ku. Use of the biopharmaceutical classification system in early drug development. AAPS J. in press (2008).
J. A. Cook, W. Addicks, and Y. H. Wu. Application of the biopharmaceutical classification system in clinical drug development—an industrial view. AAPS J. in press (2008).
S. Stavchansky. Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility–low permeability drugs (BCS-Class 3). AAPS J. in press (2008).
Guidance for Industry, Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations. September 1997, CDER/FDA. http://www.fda.gov/cder/guidance/1306fnl.pdf (accessed 12/15/07)
L. X. Yu. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharm. Res. 25:781–791 (2008).
W. W. Lee, P.Dickinson, P. Stott, A. Townsend, J. Smart, P. Ghahramani, T. Hammett, L. Billett, S. Behn, R. Gibb, and B. Abrahamsson. Clinical relevance of dissolution testing in quality by design. AAPS J. in press (2008).
M. Tubic-Grozdanis, M. Bolger, and P. Langguth. Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds. AAPS J. 10:213–216.
K. A. Lentz. Current methods for predicting human food effect. AAPS J. in press (2008).
B. Davit, D. P. Conner, B. Fabian-Fritsch, S. H. Haidar, X. Jiang, D. T. Patel, P. R. Seo, K. Suh, and C. L. Thompson. Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications. AAPS J. 10:213–226 (2008).
Critical Path Opportunities for Generic Drugs. May 2007, CDER/FDA.http://www.fda.gov/oc/initiatives/criticalpath/reports/generic.html (accessed 12/15/07)
R. A. Lionberger. FDA critical path initiatives: opportunities for generic drug development. AAPS J. 10:103–109.
L. X. Yu, A. Raw, R. A. Lionberger. U.S. FDA Question-based review for generic drugs: A new pharmaceutical quality assessment system. J. Generic Med. 4:239–248 (2007).
L. Lee, R. A. Lionberger, L. X. Yu, C. Mundkur, G. Munro, G. Johnston, and J. C. Famulare. FDA Office of Generic Drugs’ pharmaceutical quality initiative: progress and feedback on question-based review. Pharm. Eng. 27:52–61 (2007).
Anonymous. “Annex 7: Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability”. In WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fortieth Report; WHO: Geneva, Switzerland, 2006, pp. 347–390. http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf (accessed 12/15/07)
Committee for Proprietary Medicinal Products. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. July 2001, EMEA. http://www.emea.europa.eu/pdfs/human/qwp/140198enfin.pdf (accessed 12/15/07)
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Opinions expressed in this report are those of the authors (LXY and HNW) and do not necessarily reflect the views or policies of the FDA.
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Polli, J.E., Abrahamsson, B.S.I., Yu, L.X. et al. Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond. AAPS J 10, 373–379 (2008). https://doi.org/10.1208/s12248-008-9040-9
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DOI: https://doi.org/10.1208/s12248-008-9040-9