2nd Conference of the Global Bioequivalence Harmonization Initiative (GBHI)
The second conference of the GBHI meeting series was held on September 15 - 16, 2016 in Rockville, USA.
The main topics of the conference included:
Outcome Summary and Tying up loose ends of GBHI Conference 2015 in Amsterdam
Prodrugs and Compounds with pre-systemic extraction
Scaling procedure and adaptive design(s) in be assessment of highly variable drugs
Exclusion of PK data in be assessment of IR and MR products
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 Potthast, BfArM, Bonn, Germany |
| Barbara M. Davit, Merck Research Laboratories, Whitehouse Station N.J., USA | Barbara Schug, SocraTec R&D, Oberursel, Germany |
| Gerald Beuerle, Teva - Ratiopharm, Ulm/Germany | Mehul Mehta, U.S. Food and Drug Administration, Silver Spring, Md., USA |
| Andrzej Dzierbicki, Polpharma, Gdansk, Poland | Hans H. Linden, EUFEPS, Stockholm, Sweden |
| Angelica Dorantes, U.S. Food and Drug Administration, Silver Spring, Md., USA | Yu-Chung Tsang, Apotex, Toronto, Canada |
| Larissa Lapteva, U.S. Food and Drug Administration, Silver Spring, Md., USA | Jan Welink, Medicines Evaluation Board, Utrecht, NL |
| Nilufer Tampal, U.S. Food and Drug Administration, Silver Spring, Md., USA |
Conference Report
The conference report was published at the European Journal of Pharmaceutical Sciences (Eur J Pharm Sci) in January 2019. Here you can download the article: