SIG-BA/BE: Its Structure, Functions and Activities

Vinod P. Shah,* Martin Siewert, and Hans Junginger

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.