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Our comments (click here) on the draft guidance on Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms based on a Biopharmaceutics Classification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


12-13 April 2018

Amsterdam, Netherlands
Global Bioequivalence Harmonization Initiative
http://eufeps.org/conferences/3rd_GBHI  

This 3rd conference of the Global Bioequivalence Harmonization Initiative will take place in Amsterdam, The Netherlands, from April 12-13, 2018.

Topics of this conference were selected by an International Scientific Planning Committee with the intention of identifying differences with realistic chances for harmonization based on the scientific state of the art. To achieve this objective, the BE-related topics selected for discussion include the necessity of multiple dose studies in BE testing, the BE assessment of transdermal patches including adhesion and skin sensitization / irritation studies and BE of liposomal parenteral preparations. Moreover, aspects which remained still unresolved in the previous conference will be taken up again with the intention to achieve further consensus.

Based on the positive experience with the first GBHI conference 2015 in Amsterdam and the subsequent conference 2016 in Rockville/USA, the Scientific Committee expects intensive discussions between the regulatory scientists of the involved Agencies and the auditorium. Attendees may receive useful information for advanced designing of BE programs to find acceptance in all regions. 

 

 

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.