please see our prior blog post, “FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development.” The first discussion paper, “Artificial Intelligence in Drug Manufacturing,” was issued by the Center for Drug ...
此前的2023年3月和5月,FDA发布了两份讨论文件《Artificial Intelligence in Drug Manufacturing》和《Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products》,征求业内意见。参见FDA发布两份讨论文件,探讨如何在药物开发和制造中应用AI 2024年2月28日,FDA局长Robert Ca...
今天给大家介绍一篇由ZhaoyiChen, JiangBian等人2020年12月24日发表在Drug Discovery Today上的一篇综述文章” Applications of artificial intelligence in drug development using real-world data”。FDA一直在积极推动真实世界数据(RWD, real-world data )在药物开发中的应用。RWD可以产生重要的真实世界证据,反映治疗方...
参考文献:[1] For a summary and analysis of FDA’s first discussion paper, which focused on the use of AI in drug manufacturing, please see our prior blog post, “FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development.” The first dis...
2023年3月2日,FDA药品审评和研究中心(CDER)发布了《药物制造中的人工智能(Artificial Intelligence in Drug Manufacturing)》讨论文件。 文中,CDER对人工智能用于药物制造的范围、背景、术语和与人工智能相关的领域进行了介绍,并提出了以下问题: 1.你认为哪些人工智能应用会被用于药品生产?
参考文献:[1] For a summary and analysis of FDA’s first discussion paper, which focused on the use of AI in drug manufacturing, please see our prior blog post, “FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development.” The first dis...
[1] Artificial Intelligence in Drug Manufacturing. Retrieved March 3, 2023, from https://www.fda.gov/media/165743/download?utm_medium=email&utm_source=govdelivery [2] CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Pro...
▲CDER批准新药中孤儿药的比例呈现上升趋势(图片来源:FDA官网) CDER还与C-Path组织合作,在ARC项目中启动了三个新的子项目,促进针对溶酶体疾病、罕见神经退行性疾病、和α1-抗胰蛋白酶缺乏症(AATD)的新药研发。 https://www.fda.gov/drugs/news-events-human-drugs/cder-continues-advance-rare-disease-drug-deve...
参考资料: [1] Artificial Intelligence in Drug Manufacturing. Retrieved March 3, 2023, from https://www.fda.gov/media/165743/download?utm_medium=email&utm_source=govdelivery [2] CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures...
2023年3月2日,FDA药品审评和研究中心(CDER)发布了《药物制造中的人工智能(Artificial Intelligence in Drug Manufacturing)》讨论文件。 文中,CDER对人工智能用于药物制造的范围、背景、术语和与人工智能相关的领域进行了介绍,并提出了以下问题: 该文件属于其此前提出的监管先进制造评估框架 (FRAME) 计划的一部分,公众...