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.

Mission:

  • 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.

 

Members:

 

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


Activities:

Biowaiver monographs

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

 

Workshops/events

International Symposium on Bioequivalence (August 2012)

An International Symposium on Bioequivalence was held in August 2012 in Thailand. Please click on the report for more information.

19 May - 20 May 2015 Bioavailability/Bioequivalence, Dissolution Testing and Biowaivers, Prague, Czech Republic (click here)

17 Aug - 19 Aug 2015 6th Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit, Chicago, US  (click here)

15 Sep - 17 Sep 2015 2nd MENA Conference on Bioequivalence, Biowaivers, Bioanalysis, Dissolution and Biosimilar, Amman, Jordan  (click here)

 

Interested in organizing a workshop with support from FIP & and the SIG BCS?
Contact the FIP Scientific Secretary Prof. Henk de Jong via paula@fip.org

 

Research

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/.