加快新药开发--从紧急使用授权中汲取的经验教训

AAPS Open Pub Date : 2024-03-04 DOI:10.1186/s41120-023-00089-2

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

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摘要

美国制药科学家协会 (AAPS) 化学、制造和控制 (CMC) 社区于 2022 年 7 月 15 日举办了一次虚拟小组讨论会，提供了一个讨论与紧急使用授权相关的行业和监管机构 CMC 挑战的论坛。

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

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.

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AAPS Open

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