FDA立新规矩,昭衍新药受伤

健识局
11 Apr

4 月 10 日,FDA宣布了一项颠覆性政策:计划在单抗和其他药物的开发过程中,逐步淘汰动物实验,转而采用基于AI的计算模型、实验室培养的人体类器官等方法作为替代。这项政策将立即在新药临床试验申请(IND)中实施。从FDA的表述来看,逐步取消动物实验是深思熟虑的。对于患者来说,用这些新方法能让新产品发现更高效更安全性。对于动物来说,也不用再遭临床试验的折磨,每年可能有包括狗和猴在内的数千只动物得以...

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