BCS (Biopharmaceutics Classification System) and Biowaiver

Chair: Prof. Jennifer Dressman

Please note that, as of September 2011, BCS and Biowaivers is a Focus Group that falls under the SIG 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:

  • Bertil Abrahamsson, AstraZeneca, Sweden: bertil.abrahamsson@astrazeneca.com
  • Dirk Barends, RIVM, the Netherlands: dirk.barends@rivm.nl
  • Jennifer Dressman, University Frankfurt, Germany (co-chair): dressman@em.uni-frankfurt.de
  • Peter Langguth, University Mainz, Germany: langguth@mail.uni-mainz.de 
  • Alan Parr, GlaxoSmithKline, USA: alan.f.parr@gsk.com
  • James Polli, University Maryland, USA:  jpolli@rx.umaryland.edu
  • Vinod P. Shah, FIP Scientific Secretary, USA: dr.vpshah@comcast.net
  • Chikako Yomota, National Institute of Health Science, Japan: yomota@nihs.go.jp

Click HERE for a picture taken at one of the last face-to-face meetings, Scheveningen, The Netherlands, 20/21 April 2008.

From left to right, back: Bertil Abrahamsson, Peter Langguth, Dirk Barends;
front: James Polli, Jennifer Dressman, Vinod P. Shah. (missing: Chikako Yomota and Alan Parr)

 

Coming events:

Facilitating Oral Product Development and reducing regulatory Burden through Novel Approaches to Assess Bioavailability/Bioequivalence. Workshop organised by the American Association of Pharmaceutical Scientists (AAPS) on October 22-23, 2011, in Washington DC (USA).

Click here for more information on this workshop.

 

Activities:

Biowaiver monographs

Biowaiver monographs are literature reviews, gathering and organising publicly available data to be taken into consideration whether a biowaiver can be recommended for a new formulation of that API. Discussed are: solubility, pharmacokinetics and permeability, dissolution of dosage forms, 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

Interested to organise a workshop with support from FIP & and the SIG BCS?
Contact the FIP Scientific Secretary Dr. Vinod P. Shah at paula@fip.org

 

Research

Dirk Barends & Peter Langguth run BIOTHREE, carried out at the Dutch National Institute for Public Health and the Environment (RIVM) and the Johannes Gutenberg University of Mainz, and 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.