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

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2024年3月4日

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James Bernstein,
Kim Huynh-Ba,
Patrick Lynch,
Thomas Oliver,
Reza Oliyai,
Scott W. Roberts,
Andrea Schirmer,
David Schwinke,
Kin Tang,
Jessica Ursin

摘要

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.