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Eur J Pharm Sci. 2018 Jan 1;111:153-157. doi: 10.1016/j.ejps.2017.09.047. Epub 2017 Sep 28.

The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.

Author information

1
U.S. Food and Drug Administration, MD, USA. Electronic address: Meiling.Chen@fda.hhs.gov.
2
SocraTec C&S GmbH, Oberursel, Germany.
3
Teva, Germany.
4
Merck Research Laboratories, NJ, USA.
5
U.S. Food and Drug Administration, MD, USA.
6
BfArM, Bonn, Germany.
7
SocraTec R&D GmbH, Oberursel, Germany.
8
Apotex Inc. Toronto, Canada.
9
University of Greifswald, Greifswald, Germany.
10
Medicines Evaluation Board, The Netherlands.

Abstract

Bioequivalence (BE) is considered one of the key questions in new and generic drug product development and registration worldwide. However, the regulations and jurisdiction vary from country to country and continent to continent. Harmonization of regulatory requirements and criteria for BE determination may avoid unnecessary repetition of BE studies and minimize drug exposure to humans. Harmonization around the globe may be achieved by a better understanding of scientific principles and expectations from different regulatory authorities. To facilitate global harmonization, the Network on Bioavailability and Biopharmaceutics (BABP) under the European Federation for Pharmaceutical Sciences (EUFEPS) launched a Global Bioequivalence Harmonization Initiative (GBHI) several years ago. This international conference was the first in a series of workshops organized by EUFEPS/BABP under GBHI. The workshop provided a forum for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on selected BE issues in the hope of identifying common ground and arriving at a harmonized view on these topics.

KEYWORDS:

Bioavailability; Bioequivalence; Biopharmaceutics; Global harmonization; Regulatory requirements; Regulatory standards

PMID:
28964950
DOI:
10.1016/j.ejps.2017.09.047
[Indexed for MEDLINE]

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