Federation Internationale Pharmaceutique, Board of Pharmaceutical
Sciences,
Special Interest Group on Bioavailability/Bioequivalence (FIP-BPS-SIG
BA/BE) Co-chairs
email correspondence to: shahvi@cder.fda.gov
Federation Internationale
Pharmaceutique (FIP, International Pharmaceutical Federation)
is a world wide federation of national pharmaceutical professional
and scientific associations and has its mission to represent and
serve pharmacy and pharmaceutical sciences around the globe. FIP
represents both pharmacists and pharmaceutical scientists world-wide.
The practicing pharmacists are organized through the Board of
Pharmaceutical Practice (BPP) and the pharmaceutical scientists
through the Board of Pharmaceutical Sciences (BPS).
Under the umbrella of BPS, one of the major activities undertaken
was to address various issues in the area of Bioavailability (BA)
and Bioequivalence (BE). Very often, these are controversial issues
and need scientific input from academia, industry and regulators.
This was achieved by holding Bio-International Conferences under
the chairmanship of Dr. Kamal K. Midha. These conferences provided
an open forum to discuss BA/BE issues. The first Bio-International
conference was held in 1989.
In 1994, FIP-BPS established a Special Interest Group (SIG)
to address several issues in the area of bioavailability/ bioequivalence
(BA/BE). The first chair of SIG BA/BE was Dr.Henning Blume. The
current chair of SIG - BA/BE is Dr. Vinod P. Shah. There are two
active working groups (WG) in SIG BA/BE, the Dissolution WG and
the Biopharmaceutics Classification System (BCS) WG. Other WGs
can be formed as needed. SIG BA/BE actively participates in bio-international
meetings. The next Bio-International conference is being planned
for October 8-10, 2003 in London.
As a part of FIP-BPS initiatives jointly developed with American
Association of Pharmaceutical Scientists (AAPS), SIG BA/BE participated
actively in International Regulatory and Educational Bioequivalence
Workshops in Cairo, Egypt (2000); Jerusalem, Israel (2000); Bangkok,
Thailand (2000); Taipei, Taiwan (2000); Seoul, Korea (2000); Potchefstroom,
South Africa (2001); and Santiago, Chile (2002). The next such
workshop is planned for November 20-21, 2002 in Quito, Ecuador.
Future similar workshops are planned in other developing countries.
Dissolution WG:
The Co-Chairs of Dissolution WG are Drs. Martin Siewert and Vinod
P. Shah. Members of the group are from academia, industry and
regulatory authorities. The major activity of the group has been
to develop dissolution guidelines, resolve complex issues related
to dissolution and create harmonization. The WG has developed
"FIP Guidelines for Dissolution Testing of Solid Oral Products".
The WG is currently working on developing guidelines for dissolution/
in vitro release of special/novel dosage forms. After organizing
two workshops in London (1999) and in Frankfurt (2001) in this
area, the WG has published draft Guidelines White paper
(Dissolution Technologies; 9/1: 6-11, 2002) . The WG members also
chaired the AAPS workshop on special dosage forms in September
2002 to get input from scientists from USA, and are in the process
of finalizing the white paper. The aim is to come-up with the
finalized FIP guideline for special/novel dosage forms in the
first quarter of 2003.
The Dissolution WG has also initiated "Hands-On-Dissolution"
workshops to provide proper training for performing important
tests such as dissolution, in order to improve the quality of
the drug products. Such workshops were held in Australia (1999)
and two in India (2001). These workshops also have been very successful.
The goal is to collaborate with WHO and take this type of workshop
to developing countries. The Hands-On-Dissolution workshops are
planned for Thailand (Bangkok) and Vietnam in March 2003 and in
China for May 2003.
Biopharmaceutics Classification System (BCS) WG:
The Co-Chairs for BCS WG are Drs. Hans Junginger and Vinod
P. Shah. The WG had organized an international workshop on 'BCS
Scientific and Regulatory Aspects in Practice' in London,
2001. Other important activities of the WG include (1) developing
a standardized protocol for Caco2 studies and (2) data mining
related to solubility, permeability, absorption and dissolution
data. The purpose of this exercise is to identify when a regulatory
'bio-waiver' is appropriate.
The Steering committee for the SIG - BA/BE activities consist
of Drs. Kamal K. Midha, Vinod P. Shah, Y Sugiyama (or his representative),
Hans Junginger and the co-chairs of the WGs. In order to increase
interactions within WGs and among interested members in the BA/BE
discipline, SIG BA/BE general meeting is usually held at the time
of FIP annual congress, and is open to all interested scientists.
At the last meeting in Nice on September 3, 2002 more than
70 people from several countries participated and discussed several
issues related to BA/BE and dissolution.
One of the issue that was raised was bridging and integrating
the dissolution activities between BCS and international reference
standard. This will be the next focus of SIG BA/BE.