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

• Hlavní autoři: James Bernstein (Autor), Kim Huynh-Ba (Autor), Patrick Lynch (Autor), Thomas Oliver (Autor), Reza Oliyai (Autor), Scott W. Roberts (Autor), Andrea Schirmer (Autor), David Schwinke (Autor), Kin Tang (Autor), Jessica Ursin (Autor)
• Médium: Kniha
• Vydáno: SpringerOpen, 2024-03-01T00:00:00Z.
• Témata: article
• On-line přístup: Connect to this object online.

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.