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 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

 

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 FDA: 
Our comments (click here) on the draft guidance on Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms based on a Biopharmaceutics Classification System (click here).

 

Important International Regulatory documents

For an overview of links to important international regulatory documents, click here

 

Workshops/events

 

8-9 June 2017

Disso India 2017 - Mumbai 2017
International Symposium
The Leela, Mumbai, Andheri Kurla Road, Sahar, Mumbai, Mahara

 

26-27 September 2017

Nürnberg, Germany 
Oral Biopharmaceutics Tools: What's new and what's coming? 
http://www.apv-mainz.de/en/seminare/events/event/seminar/6695/ 

  

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

 

Research

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.