這集聽了很想睡...
最近很多領悟,人生很多事情都是因果,你怎麼選擇和成就自己的樣子,也都是因果
科學也是因果,做什麼實驗,得到什麼結果;科學研究的價值與必要性就是因果鏈。
前面講太長了,如果不想聽可以跳到20分鐘後..
這集其實是要聊 US FDA的文件:
Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions
接續EP125, 187.201,聊到的ASME V&V40, 來聊US FDA 出的CM&S的可信度評估指引
"Credibility"可信度,就是說我們怎麼建立自己的模型的可信度,來說服FDA相信我們的CM&S的結果。
"Animal Model"這個名詞將在各種研究中慢慢消失..
我們一起好好把in silico testing做好,接續動物實驗,掌握可信度評估的因果基礎
ASME V&V 40:
V V 40 - Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices
https://www.asme.org/codes-standards/find-codes-standards/assessing-credibility-of-computational-modeling-through-verification-and-validation-application-to-medical-devices
FDA CM&S Credibility Guidance:
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions
留言告訴我你對這一集的想法: https://open.firstory.me/user/ckssiau1vq5ic082295g8on9d/comments
✎ 留言: podcast.biomeder.com/contact-us
📧 Email: media@biomeder.com
《生醫人生旅歷》podcast.biomeder.com
《BioMeder生醫人網摘》biomeder.com