药物临床研究有效性综合分析指导原则(征求意见稿)

2021-09-16 国家药品监督管理局药品审评中心(CDE) CDE

按照ICH M4通用技术文档(CTD)要求,为了指导申办者对药物临床研究进行有效性综合分析,以尽可能全面系统地展现药物的有效性特征,药品审评中心组织起草了《药物临床研究有效性综合分析指导原则(征求意见

中文标题:

药物临床研究有效性综合分析指导原则(征求意见稿)

发布日期:

2021-09-16

简要介绍:

按照ICH M4通用技术文档(CTD)要求,为了指导申办者对药物临床研究进行有效性综合分析,以尽可能全面系统地展现药物的有效性特征,药品审评中心组织起草了《药物临床研究有效性综合分析指导原则(征求意见稿)》,现公开征求意见。欢迎各界提出宝贵意见和建议,并请及时反馈给我们。

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