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Pharmews
Pharmews
61 episodes
1 week ago
国内医药正在发生的,What happens in Chinese pharmaceuticals. https://www.pharmews.xyz
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Science
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All content for Pharmews is the property of Pharmews and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
国内医药正在发生的,What happens in Chinese pharmaceuticals. https://www.pharmews.xyz
Show more...
Science
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S1E56 基于动物法则的药物注册技术指导原则
Pharmews
38 minutes 39 seconds
3 years ago
S1E56 基于动物法则的药物注册技术指导原则
某些用于治疗或预防由化学、生物、放射、核物质引起的严重威胁人体生命健康的疾病的药物因开展人体有效性试验不符合伦理或现场试验不可行,无法按常规思路开展临床有效性试验获得人体有效性数据申报上市,需基于“动物法则(Animal Rule)”进行药物注册。为了科学开展该类药物的有效性评价和正确应用动物法则,推动该类药物上市,我中心组织起草了《基于动物法则的药物注册技术指导原则》,现在中心网站予以公示。
Pharmews
国内医药正在发生的,What happens in Chinese pharmaceuticals. https://www.pharmews.xyz