EP221-科學和人生都是因果!告別動物實驗，FDA的醫材虛擬測試可信度指引

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 #CM&S #VV40 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: [email protected] 《生醫人生旅歷》podcast.biomeder.com   《BioMeder生醫人網摘》biomeder.com Powered by Firstory Hosting

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