EP251-新藥不再靠動物實驗?FDA如何驗證下一代實驗技術(2026草稿指引）

這一集來分享2026/3/19 US FDA發佈的-General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry (DRAFT GUIDANCE)。注意:這份文件目前只是草稿指引，也在收集公眾評論。可能之後會有所改變。你可以聽到:NAMs-我們正站在歷史的轉折點上Validation與Qualification的不同?Validation四大核心要素(COU, Human Biological Relevance,Technical Characterization,Fit for Purpose)這份草稿的公眾評論整理#NAMs＃新方法學＃新測試方法學＃非動物實驗＃驗證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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EP251-新藥不再靠動物實驗?FDA如何驗證下一代實驗技術(2026草稿指引）

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