The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.
Eur J Pharm Sci
; 111: 153-157, 2018 Jan 01.
Article
de En
| MEDLINE
| ID: mdl-28964950
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.
Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Pharmacocinétique
/
Préparations pharmaceutiques
/
Agrément de médicaments
Type d'étude:
Guideline
/
Prognostic_studies
Pays/Région comme sujet:
America do norte
Langue:
En
Journal:
Eur J Pharm Sci
Sujet du journal:
FARMACIA
/
FARMACOLOGIA
/
QUIMICA
Année:
2018
Type de document:
Article