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 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 optimization of biowaiver methods.
- Contribute to harmonization 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
- Bertil Abrahamsson, AstraZeneca, Sweden: email@example.com (photo: click here)
- Rodrigo Cristofoletti, National Health Surveillance Agency (ANVISA), Brazil: firstname.lastname@example.org (photo: click here)
- Jennifer Dressman, University Frankfurt, Germany (chair): email@example.com (photo: click here)
- Peter Langguth, University Mainz, Germany: firstname.lastname@example.org (photo: click here)
- Mehul Mehta, Food and Drug Administration, Mehul.email@example.com (photo: click here)
- Alan Parr, Bioceutics LLC, USA: A.Parr.BioCeutics@gmail.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)
- Tomokazu Tajiri, Astellas, Japan: firstname.lastname@example.org (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
26-27 September 2017
Oral Biopharmaceutics Tools: What's new and what's coming?
26-27 April 2017
Workshop Panamericano: Implementación de Bioexenciones basadas en el Sistema de Clasificación Biofarmacéutica
Facultad de Química, Pontificia Universidad Católica de Chile
15-16 September 2016
The Global Bioequivalence Harmonisation Initiative (GBHI) 2nd Conference, Washington DC USA
Initiated by the EUFEPS Bioavailability and Biopharmaceutics Network, it will be organised by EUFEPS and AAPS in collaboration – following on the successful GBHI 1st Conference held in 2015 in Amsterdam NL. For scope and aim, preliminary programme, speakers and other contributors to it, and registration and accommodation information, see the GBHI Conference site e.g. at: http://www.eufeps.org which will be up running soon.
Interested in organizing a workshop with support from FIP and the SIG BCS?
Contact the FIP Scientific Secretary Prof. Giovanni Pauletti via email@example.com
Current research is centered 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 the value-added of the BCS based biowaiver to public health.
Further, several members of the Focus group are participating in a European initiative to streamline pharmaceutical development. A link to this pan-European research project can be found under http://www.orbitoproject.eu/.
Publications resulting from the project BIOTHREE, co-sponsored by the Pharmaceutical Quality Research Institute (PQRI) and the FIP, and carried out under the supervision of Peter Langguth to develop a comparative in vitro permeability test which could serve as a second surrogate in vitro bioequivalence test, along with comparative in vitro dissolution testing, are listed here.