5th Conference of the Global Bioequivalence Harmonization Initiative (GBHI)
The fifths conference of the GBHI meeting series was held on September 28 - 29, 2022 in Amsterdam, The Netherlands.
The main topics of the conference included:
Fed vs fasted studies for immediate release dosage forms: relevance of excipients, disintegration/dissolution specificities, drug substance properties and physiological GI conditions - new findings shall help achieve harmonisation
Statistical considerations for BE assessment: replicate design for BE of Highly Variable Drugs, two-stage design and PK modelling as supportive tools for BE assessment
Topical products: Scientifically-based approaches for a waiver of clinical endpoint trials
Narrow therapeutic index drugs: study design and acceptance criteria
Here you can download the final version of the program.
The scientific and planning committee members:
| Mehul Mehta, US-FDA, Washington, USA (Chair) | Andreas Kovar, Sanofi, Frankfurt, Germany |
| Barbara Schug, SocraTec R&D, Oberursel, Germany (Chair) | Janet König, BfArM, Bonn, Germany |
| Erem Bilensoy, Hacettepe University, Ankara, Turkey | Henning Blume, SocraTec C&S, Oberursel, Germany |
| Gerald Beuerle, Teva - Ratiopharm, Ulm/Germany | Anne Seidlitz, University of Greifswald, Germany |
| Jack Cook, Pfizer, Lyme, USA | Nilufer Tampal, US-FDA, Silver Spring, USA |
| Sebastian Haertter, Boehringer Ingelheim, Germany | Yu-Chung Tsang, Apotex, Toronto, Canada |
| Georg Hempel, University Münster, Münster, Germany | Jan Welink, MEB, Utrecht, The Netherlands |
| Wenlei Jiang, US-FDA, Silver Spring, USA | Clive Wilson, Strathclyde University, Glasgow, Scotland |
Conference Report
The conference report was published at the European Journal of Pharmaceutical Sciences (Eur J Pharm Sci) in November 2023. Here you can download the article: