BCS (Biopharmaceutics Classification System) and Biowaiver

Biowaiver Public Forum | SIG BCS Biowaiver Annual Report 2009-2010

Co-chairs: Dr Dirk Barends and Prof. Jennifer Dressman

Mission:
Providing a worldwide and independent platform for scientific discussion between academia, industry and regulato
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, Netherlands (co-chair): dirk.barends@rivm.nl
Jennifer Dressman, University Frankfurt, Germany: 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.

Activities:
Biowaiver monographs
The FIP-BPS Special Interest Group (SIG) Biopharmaceutics Classification System (BCS) and Biowaiver under the leadership
Dirk Barends of the Dutch National Institute for Public Health and the Environment (RIVM) has started to collect publicly av
information for Essential Medical Drug Products based on the Biopharmaceutical Classification System (BCS). This activity
supported by WHO and refers to the FDA Guidance of possible biowaivers for class 1 drugs of the BCS. The collected infor
is critically reviewed and published as monographs in Journal of Pharmaceutical Sciences. They are also made available on
FIP Website below. By now, more than 25 monographs are published and more data on class 1 (and class 3) drugs will foll
The selection of possible drug candidates is based on the "Essential Drug List" of WHO in order to assist especially develo
countries in getting easy approval by means of a "biowaiver" of generic drug products which belong to class 1 of BCS whic
taken up in the database.

These monographs are essentially literature reviews, gathering and organising relevant data to be taken into consideratio
whether a biowaiver can be recommended for a new formulation of that API. Discussed are: solubility, pharmacokinetics a
permeability, dissolution of dosage forms, the therapeutic use and therapeutic window of the API, data on excipient intera
and problems with bioavailability and/or bioequivalence.
The monographs have no formal regulatory status, but represent the best scientific opinions currently available. They are
published in the Journal of Pharmaceutical Science but can also be downloaded free of charge by clicking on the link in th
below. It is foreseen to update the monographs with addenda if new data becomes available.
Acetaminophen = Paracetamol (click here)
Acetazolamide (click here)
International Pharmaceutical Federation (FIP)
The global federation of national associations representing 2 million
pharmacists and pharmaceutical scientists around the world.
Read more about us .
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Aciclovir (click here)
Amitriptyline Hydrochloride (click here)
Atenolol (click here)
Chloroquine Phosphate (click here)
Chloroquine Sulfate (click here)
Chloroquine Hydrochloride (click here)
Cimetidine (click here)
Ciprofloxacin hydrochloride (accepted for publication)
Diclofenac potassium (click here)
Diclofenac sodium (click here)
Doxycycline Hyclate (click here)
Ethambutol Dihydrochloride (click here)
Furosemide (click here)
Ibuprofen (click here)
Isoniazid (click here)
Mefloquine HCl (accepted for publication)
Metronidazole (submitted for publication)
Metoclopramide Hydrochloride (click here)
Prednisolone (click here)
Prednisone (click here)
Propranolol Hydrochloride (click here)
Pyrazinamide (click here)
Quinidine sulphate (click here)
Ranitidine Hydrochloride (click here)
Rifampicin (click here)
Verapamil Hydrochloride (click here)

Click here for the progress table, showing the monographs in preparation and their first authors.
Are you interested in writring a biowaiver monograph also? Contact the corresponding author of the series at
dirk.barends@rivm.nl. For guidance to writing such a monograph, click here.
Do you have data not yet covered in one of these Biowaiver Monographs? Or comments? Or general comments on biowaiv
biowaiving? TheDiscussion Forum on Biowaiver Monographs which is open to everybody, invites you to post your addition
data and comments to specific monographs, or make general comments!

Sharing expertise
With WHO
Groupe BCS participated in drafting WHO guidelines:
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeab
Technical Report Series, No 937, 40th Report, Annex 7 of WHO Expert committee on specifications for pharmaceu
preparations. http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf.

Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-relea
solid oral dosage forms. Technical Report Series, No 937, 40th Report, Annex 8 of WHO Expert committee on
specifications for pharmaceutical preparations. http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf.

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

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8/11/2010 http://www.fip.org/bcs
PO Box 84200
2508 AE The Hague
The Netherlands
Andries Bickerweg 5
2517 JP The Hague
The Netherlands
Tel.
Fax:
Research
Dirk Barends & Peter Langguth run a research project BIOTHREE, sponsored by 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 dissolutio
testing.
Are you interested in participating in this project? Contact the project leader of BIOTHREE at dirk.barends@rivm.nl.

We work with:
World Health Organization
UNESCO
World Health Professions Alliance
Regional Pharmaceutical Forums
All our partners
On this Site:
About FIP
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Site Map
Contact Details:
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