What are the regulatory sciences?
The regulatory sciences represent the scientific underpinning of guidances prepared by various regulatory agencies to provide sponsors of new drugs and new drug products with the information they need to apply for a marketing authorisation. The regulatory sciences encompass a wide scope of activities, ranging from laboratory work to support drug product quality through pharmacokinetics and pharmacodynamics to post-marketing surveillance. The Special Interest Group on Regulatory Sciences focuses on bioavailability, bioequivalence, bridging studies, biowaiver and drug release aspects of the regulatory sciences through its focus groups.
About us and our objectives
The aim of the SIG on Regulatory Sciences is to advance and shape the pharmaceutical sciences of the future, and to provide modern medicines to patients worldwide.
How we work
The regulatory sciences special interest group has a broad scientific scope, encompassing four focus groups. The chair of the special interest group is Prof. Jennifer Dressman (Germany). The focus groups are as follow:
- Dissolution/In vitro release (chaired by Dr Horst-Dieter Friedel);
- Biopharmaceutics classification system (BCS) and Biowaivers (chaired by Prof. Jennifer Dressman);
- Bioavailability/Bioequivalence (chaired by Prof. Shinji Yamashita); and
- Clinical bridging studies (chaired by Dr Oliver Hu).
Address global issues in these areas;The major aims of the four focus groups are to:
- Organise and participate in national, regional and international professional conferences;
- Develop position papers and publish in referred journals; develop and publish special BCS monographs that can be used to facilitate biowaivers;
- Conduct educational regulatory workshops in developing countries;
- Facilitate global harmonisation in certain regulatory areas;
- Be at the forefront of cutting-edge science; and, overall,
- Be responsive in the field of pharmaceutical sciences.
- The third conference of the Global Bioequivalence Harmonisation Initiative was held in Amsterdam, Netherlands, in April 2018. Topics were selected by an International Scientific Planning Committee with the intention of identifying differences with realistic chances for harmonisation based on the scientific state of the art. Bioequivalence-related topics selected for discussion included the necessity of multiple dose studies in BE testing, the BE assessment of transdermal patches including adhesion and skin sensitisation/irritation studies and BE of liposomal parenteral preparations.
- Publication of the "FIP Guidelines for Dissolution Testing of Solid Oral Products" in the Journal of Pharmaceutical Sciences 107, 2995 (2018)
- Submission of comments for the ICH M9 document (Biopharmaceutics Classification System-based Biowaivers) on behalf of FIP to ICH.
- The Focus Group Bioavailability and Bioequivalence co-organized the 3rd International Symposium on BA/BE of Oral Drug Products: Biopharmaceutics meets Galenics (BA/BE 2018) in Lisbon, Portugal, October 11 & 12 (Thu-Fri), 2018.
For more information on this special interest group, please contact Prof. Dressman at RegulatorySciences@fip.org.