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Acceleration of new medicines–CMC lessons learned from emergency use authorizations

Authors :
James Bernstein
Kim Huynh-Ba
Patrick Lynch
Thomas Oliver
Reza Oliyai
Scott W. Roberts
Andrea Schirmer
David Schwinke
Kin Tang
Jessica Ursin
Source :
AAPS Open, Vol 10, Iss 1, Pp 1-7 (2024)
Publication Year :
2024
Publisher :
SpringerOpen, 2024.

Abstract

Abstract The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on July 15, 2022, to provide a forum to discuss industry and regulator CMC challenges associated with emergency use authorizations.

Details

Language :
English
ISSN :
23649534
Volume :
10
Issue :
1
Database :
Directory of Open Access Journals
Journal :
AAPS Open
Publication Type :
Academic Journal
Accession number :
edsdoj.9928b46a96fc4ac4a379cb5a91c7fc4c
Document Type :
article
Full Text :
https://doi.org/10.1186/s41120-023-00089-2