James Bernstein, Kim Huynh-Ba, Patrick Lynch, Thomas Oliver, Reza Oliyai, Scott W. Roberts, Andrea Schirmer, David Schwinke, Kin Tang, Jessica Ursin
{"title":"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","doi":"10.1186/s41120-023-00089-2","DOIUrl":null,"url":null,"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.","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"2012 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"AAPS Open","FirstCategoryId":"1","ListUrlMain":"https://doi.org/10.1186/s41120-023-00089-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.
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