Annual Reports

Annual Report 2009-2010

Name

The name of the SIG was changed in: SIG on BCS & Biowaiver

Membership

The SIG has now 8 members: 3 academic members, 2 industrial members, 2 with a regulatory affiliation + the Scientific Secretary of FIP, 3 having residence in the USA, 2 in Germany, one in Japan, 1 in Sweden 1 and 1 in The Netherlands.

Plans for 2010 - Finding a member from the FDA.

Activities

Biowaiver monographs
Accepted:
• Doxycycline Hyclate
• Furosemide
Submitted
• Ciprofloxacin
• Mefloquine HCl

Feedback mechanism on Biowaiver monographs

The Discussion Forum was launched. We hoped to get new data, not covered by the published monographs. This is yet not so, the Discussion Forum tend to become more a Question & Answer Forum. In any case, this Forum may become an important platform for exchange of views and data on biowaiving.

Contribution in AAPS Newsmagazine

In the March issue of the AAPS Newsmagazine, Vinod Shah will publish a contribution: Biowaiver Monographs of WHO Essential Medicines, in which also the Feedback mechanism on Biowaiver monographs by the Discussion Forum will be announced.

Plans for 2010:

Submissions of:
• Nifedipine
• Carbamazepine
• Metronidazole
• Stavudin
• Zidovudin
• Levofloxacin
• Important new data will be used to write Addenda to the already published Monographs.
• Write a review: Biowaiver Monographs 2004 -2009 - What have we learned?
• Start preparing a book with published monographs +Addenda, on the occasion of FIP`s centennial in 2012.

 

Lecturing & Workshops

Annual World Congress of Pharmacy and Pharmaceutical Science, Istanbul 2009.
The SIG organised a session : Understanding of the dissolution testing and IVIVC.

Plans for 2010

Annual World Congress of Pharmacy and Pharmaceutical Science, Lisboa 2010
The SIG prepared a session: Biowaiver Monographs - What have we learned?

PSWC 2010 Pre-Satellite Workshop
Dressman and Shah participate in a PSWC 2010 Pre-Satellite Workshop on Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource and Complex Drug Products, organised by AAPS, EUFEPS & FIP.

Plans for 2011
We hope to succeed in organizing a Workshop on biowaiving in Japan in March 2011,

Research

Biothree
BIOTHREE is a research project of RIVM (National Institute of Public Health and the Environment) of The Netherlands, in cooperation with the University of Mainz and supported by FIP. BIOTHREE will develop comparative in vitro permeability testing as a surrogate BE test, in addition to comparative in vitro dissolution testing already now in use.
We succeed in receiving continuous sponsoring from the directorate of the RIVM, and found d the PQRI willing to sponsor the clinical study, planned early 2010. In 2010, preparatory work was done, and the model compound and formulations selected. There is good fine-tuning with the study performed by Jim Polli commissioned by the FDA.

Plans for 2010
Formulations development & manufacturing. In-vitro tests. Literature review.

International disharmony with respect to regulations on Biowaivers.
Large international disharmony exist with respect to biowaivers regulations. Considering that the FIP is an independent platform for scientific discussion, the SIG will compare the present regulations with the state-of-the art of science and started with cutinizing the current differences and similarities in the regulations.

Plans for 2010
Working out a practical strategy to reach that goal.

 

Annual Report 2008-2009

Mission

The mission of the SIG remained unchanged:

  • Providing a worldwide and independent platform for scientific discussion between academia, industry and regulators on the possibilities and the limitations of biowaivers for in vivo bioequivalence studies.
  • Stimulate the development of new biowaiver methods.

 

Membership

Dr. Chikako Yomota, of the National Institute of Health Science, Japan, became member of the SIG  in the autumn of 2008.
With the membership of Dr. Yomota, the SIG has now members from every region participating in ICH: USA, EU and Japan. Also, the membership of Dr. Yomota strengthens the regulatory input in the SIG, providing a better balance between SIG members from academia, regulatory agencies and industry.

Working procedure

  • Regular teleconferences.
  • Annual face-to-face meeting
  • Open meeting during the FIP World Congress
  • Other face-to-face meetings where possible (e.g. at congresses)

 

Activities

Biowaiver monographs

The biowaiver monographs are literature reviews on drug substances on WHO Essential Medicines List. One drug substance is reviewed pro monograph following a risk analysis approach. First authors write a draft monograph, which is reviewed internally by a team of co-authors:

  • Amidon: University of Michigan
  • Barends: RIVM; project leader & corresponding author of the series
  • Dressman: Goethe University, Frankfurt
  • Junginger: Naresuan University, Thailand
  • Kopp: WHO
  • Midha: University of Saskatchewan, FIP president
  • Shah: FIP Scientific Secretary
  • Stavchansky: University of Texas


Each monograph concludes to yes/no for a biowaiver, and, if yes, what restrictions are to be applied. The monographs are published as an outcome of an FIP activity in J Pharm Sci, after peer- review. The monographs consider the present regulations, but are not bound to any of these regulations and also serves as an evaluation of the present regulations.
Once accepted for publication, they are downloadable, free of charge, from www.fip.org/bcs.

 

Published 2008

  • Ethambutol
  • Acetazolamide
  • Aciclovir
  • Metoclopramide
  • Pyrazinamide


Accepted for publication 2008

  • Diclofenac
  • Rifampicin
  • Quinidine

 

Submitted 2008

  • Furosemide
  • Ciprofloxacin and Nifedipine, planned for 2008, were not finalized.
  • During 2008, also “early view” monographs became posted on the FIP webpage.
  • A contribution was issued to FIP`s Newsletter: Biowaiver monographs downloadable from FIP website.

 

Plans for 2009:

  • Submission of the Ciprofloxacin, Nifedipine and Doxycycline monographs
  • Re-vitalization of some monographs that got stuck during preparation.
  • A possibility to post new data, not covered by the published monographs, on the webpage of SIG.
  • New data will be used to write Addenda to the monographs.
  • Write a review: Biowaiver Monographs 2004 -2009 – What have we learned?
  • Start preparing a book with published monographs +Addenda on the occasion of FIP`s centennial in 2012.


Sharing expertise

Commenting on the draft EMEA Note for Guidance on bioequivalence
Prof Dressman took up the task organizing a comment from the FIP-SIG, with respect to the biowaiver aspects of the document.


Workhops

Bio-International 2008 October 2008, London.

Two members of the SIG participate in programme committee and three members of the SIG presented.

Annual World Congress of Pharmacy and Pharmaceutical Science, Istanbul 2009.

The SIG participated in developing session: Understanding of the dissolution testing and IVIVC.

Annual World Congress of Pharmacy and Pharmaceutical Science, Lisboa 2010

The SIG is in progress organising a session: Biowaiver Monographs – What have we learned?

 

Reseach

Biothree

BIOTHREE is a research project of RIVM (National Institute of Public Health and the Environment) of The Netherlands, in cooperation with the University of Mainz and supported by FIP. BIOTHREE will develop comparative in vitro permeability testing as in vitro BE test, in addition to comparative in vitro dissolution testing already now in use.  A Ph.D. student, Marlies Kubbinga, will start in January 2009; finalization of this project is expected mid 2011.

 

Plans for 2009:

  • Literature review and publishing the results of the review.
  • Selection, manufacturing and in vitro testing of the model formulations
  • Allocate sponsoring for the in vivo testing in 2010.