Focus Group on BCS (Biopharmaceutics Classification System) and Biowaiver
Chair: Prof. Jennifer Dressman
BCS and Biowaivers is a Focus Group that belongs to the Special Interest Group on Regulatory Sciences.
- Provide a worldwide and independent platform for scientific discussion among academia, industry and regulators on the possibilities and the limitations of biowaivers for in vivo bioequivalence studies.
- Stimulate development of new biowaver methods.
- Bertil Abrahamsson, AstraZeneca, Sweden: firstname.lastname@example.org (photo: click here)
- Rodrigo Cristofoletti, National Health Surveillance Agency (ANVISA), Brazil: email@example.com (photo: click here)
- Jennifer Dressman, University Frankfurt, Germany (chair): firstname.lastname@example.org (photo: click here)
- Peter Langguth, University Mainz, Germany: email@example.com (photo: click here)
- Mehul Mehta, Food and Drug Administration, Mehul.firstname.lastname@example.org (photo: click here)
- Alan Parr, GlaxoSmithKline, USA: email@example.com (photo: click here)
- James Polli, University Maryland, USA: firstname.lastname@example.org (photo: click here)
- Vinod P. Shah, USA: email@example.com (photo: click here)
In constant memory of: Dirk Barends, Founder of the Focus Group
Please click here to view a short tribute to Dirk Barends and his contributions to the Focus Group
Biowaiver monographs are literature reviews, in which publicly available data are gathered and organized to address the question of whether a biowaiver can be recommended for a new formulation of that API. Parameters and points discussed are: solubility and permeability, dissolution of dosage forms, pharmacokinetics, the therapeutic use and therapeutic window of the API, data on excipient interactions and problems with bioavailability and/or bioequivalence. For more information and a list of available monographs: click here.
Sharing expertise with Regulatory agencies
The SIG on BCS & Biowaivers reviewed and commented on the following draft guidelines:
With Health Canada:
Our comments (click here) on the draft guidelines Conduct and Analysis of Comparative Bioavailability Studies (click here) and Comparative Bioavailability Standards: Formulations used for Systemic Effects (click here).
Important International Regulatory documents
For an overview of links to important international regulatory documents, click here
An International Symposium on Bioequivalence was held in August 2012 in Thailand. Please click on the report for more information.
Interested in organizing a workshop with support from FIP & and the SIG BCS?
Contact the FIP Scientific Secretary Prof. Henk de Jong via firstname.lastname@example.org
Peter Langguth & Marlies Kubbinga run BIOTHREE, carried out at the Dutch National Institute for Public Health and the Environment (RIVM) and the Johannes Gutenberg University of Mainz, and co-sponsored by the Pharmaceutical Quality Research Institute (PQRI) and the FIP, to develop a comparative in vitro permeability test, to become a second surrogate in vitro bioequivalence test, in addition to comparative in vitro dissolution testing.
Several members of the Focus group participate in a European initiative to streamline pharmaceutical development. A link to this pan-European research project can be found under http://www.orbitoproject.eu/.