The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference
Blume Hh, Minesh P. Mehta, Gerald Beuerle, Angelica Dorantes, Georg Hempel, Wenlei Jiang, A. Kovar, Jieon Lee, Henrike Potthast, Barbara Schug, Anne Seidlitz, Nilufer Tampal, Y-C Tsang, J Walstab, Jan Welink
Abstract
International Conference on Global Bioequivalence Harmonisation Initiative (GBHI) that was co-organised by the European Federation of Pharmaceutical Sciences (EUFEPS) and the American Association of Pharmaceutical Scientists (AAPS). The goal of the GBHI conference is to offer the most informative and up to date science and regulatory thinking of bioequivalence (BE) in global drug development to support the intended process of a scientific global harmonisation. The workshop provided an open forum for pharmaceutical scientists from academia, industry and regulatory agencies to discuss three BE topics of interest, (a) BE assessment for long-acting injectables and implants, (b) necessity of fed BE studies for immediate-release products and (c) procedures to demonstrate equivalence of orally inhaled products. Moreover, in keynote lectures, a potential road map to an international BE reference product was discussed, and visions and perspectives for future global BE harmonisation activities have been presented. The meeting delivered a cutting-edge insight into the topics in an interactive and at the same time focused way.