The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference.

Bioavailability Bioequivalence Fed/fasted, IR formulations Global harmonisation Long-acting injectables and implants Orally-inhaled drug products Regulatory standards

Journal

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
ISSN: 1879-0720
Titre abrégé: Eur J Pharm Sci
Pays: Netherlands
ID NLM: 9317982

Informations de publication

Date de publication:
01 Dec 2021
Historique:
received: 19 05 2021
revised: 19 08 2021
accepted: 30 08 2021
pubmed: 5 9 2021
medline: 18 11 2021
entrez: 4 9 2021
Statut: ppublish

Résumé

This report provides a summary of the 4

Identifiants

pubmed: 34481066
pii: S0928-0987(21)00290-6
doi: 10.1016/j.ejps.2021.105987
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

105987

Informations de copyright

Copyright © 2021. Published by Elsevier B.V.

Auteurs

Blume Hh (B)

SocraTec C&S GmbH, Oberursel, Germany. Electronic address: Henning.Blume@socratec-foundation.de.

Mehta M (M)

U.S. Food and Drug Administration, Silver Spring, MD, United States.

Beuerle G (B)

Teva GmbH, Ulm, Germany.

Dorantes A (D)

U.S. Food and Drug Administration, Silver Spring, MD, United States.

Hempel G (H)

University of Muenster, Muenster, Germany.

Jiang W (J)

U.S. Food and Drug Administration, Silver Spring, MD, United States.

Kovar A (K)

Sanofi-Aventis Deutschland GmbH, Frankfurt/Main, Germany.

Lee J (L)

U.S. Food and Drug Administration, Silver Spring, MD, United States.

Potthast H (P)

BfArM, Bonn, Germany (until October 2020).

Schug B (S)

SocraTec R&D GmbH, Oberursel/Erfurt, Germany.

Seidlitz A (S)

University of Greifswald, Greifswald, Germany.

Tampal N (T)

U.S. Food and Drug Administration, Silver Spring, MD, United States.

Y-C Tsang (YC)

Apotex Inc. Toronto, Canada.

Walstab J (W)

SocraTec R&D GmbH, Oberursel/Erfurt, Germany.

Welink J (W)

Medicines Evaluation Board, Utrecht, The Netherlands.

Classifications MeSH