The Biopharmaceutics Classification System (BCS) and Biowaivers Focus Group is part of FIP’s Special Interest Group on Regulatory Sciences. Our mission is to
- Provide a global, independent platform for scientific discussion among academia, industry and regulators on the possibilities and the limitations of biowaivers for in vivo bioequivalence studies;
- Stimulate optimisation of biowaiver methods;
- Contribute to harmonisation of the application of BCS-based biowaivers;
- Provide leadership in educating scientists worldwide about the BCS Biowaiver and how it fits into the determination of bioequivalence.
In order to achieve our mission, we:
- Work to produce biowaiver monographs
- Share expertise with regulatory agencies
- Hold workshops and other events
- Conduct research
Sharing expertise: Our group reviewed and commented on the following draft US Food and Drug Administration guidance on Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms based on a Biopharmaceutics Classification System in 2015.
Research: Current research is centred around three areas: how to apply the biowaiver to fixed-dose combination products; impact of excipients on bioequivalence (using retrospective analysis of bioequivalent and not bioequivalent products) and added value of the BCS-based biowaiver to public health. Several members of the focus group are participating in a European initiative to streamline pharmaceutical development, the Orbito Project.
Who we are
The group is chaired by Prof. Jennifer Dressman. Members are:
- Bertil Abrahamsson, AstraZeneca,Sweden: email@example.com
- Rodrigo Cristofoletti, National Health Surveillance Agency (ANVISA), Brazil: firstname.lastname@example.org
- Jennifer Dressman, University Frankfurt, Germany (chair): email@example.com
- Peter Langguth, University Mainz, Germany: firstname.lastname@example.org
- Mehul Mehta, Food and Drug Administration, Mehul.email@example.com
- Alan Parr, Bioceutics LLC, USA: A.Parr.BioCeutics@gmail.com
- James Polli, University Maryland, USA: firstname.lastname@example.org
- Vinod P. Shah, USA: email@example.com
- Tomokazu Tajiri, Astellas, Japan: firstname.lastname@example.org
For more information on this focus group, please contact Prof. Dressman at RegulatorySciences@fip.org.
If you’re interested in organising a workshop with support from FIP and the SIG BCS, email Paula Cohen at email@example.com