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

{"title":"加快新药开发--从紧急使用授权中汲取的经验教训","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":"{\"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}","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

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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

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.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

AAPS Open

自引率

0.00%

发文量