1st Conference of the Global Bioequivalence Harmonization Initiative (GBHI)
The first conference of the GBHI meeting series was held on March 23 - 24, 2015 in Amsterdam, The Netherlands.
The main topics of the conference included:
Introductory session - Why a global bioequivalence harmonisation initiative now?
Applicability BCS-based biowaiver: requirements and conditions
Bioequivalence assessments of different strengths: presuppositions for extrapolation and bracketing
Fasted vs. fed administration in bioequivalence studies for immediate release dosage forms
Here you can download the final version of the program.
The scientific and planning committee members:
| Mei-Ling Chen, US-FDA, Rockville, USA (Chair) | Andreas Kovar, Sanofi, Frankfurt, Germany |
| Henning Blume, SocraTec C&S, Oberursel, Germany (Chair) | Henrike Potthiast, BfArM, Bonn, Germany |
| Eva Brendel, EB Pharmacokinetics Consulting, Solingen, Germany | Barbara Schug, SocraTec R&D, Oberursel, Germany |
| Gerald Beuerle, Teva - Ratiopharm, Ulm/Germany | G. Hochhaus, University of Florida, Gainesville, Germany |
| A. Dzierbicki, Polpharma, Gdansk, Poland | Thomas Salmonson, MPA, Uppsala, Sweden |
| Hans H. Lindén, EUFEPS, Sweden | Yu-Chung Tsang, Apotex, Toronto, Canada |
| T.A. Shepard, MRHA, London, UK | S. Yokohama, Sawai Pharmaceutical Co, Japan |
| S. Yamashita, Setsunan University, Osaka, Japan | C. Yomota, National Institute of Health Science, Tokyo, Japan |
| C. Scheerans, Bayer HealthCare, Wuppertal, Germany | H. Pei, Union Medical College Hospital, Peking, China |
| Jack Cook, Pfizer, Groton, 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 January 2018. Here you can download the article: