体重控制药物临床试验技术指导原则

2021-12-08 国家药品监督管理局药品审评中心(CDE) CDE

近年来,我国超重和肥胖患者数量显著增加,对于超重和肥胖患者的体重控制成为迫切的临床需求。为鼓励和推动体重控制药物研发,规范临床研究设计和相关技术要求,药审中心组织制定了《体重控制药物临床试验技术指导原

中文标题:

体重控制药物临床试验技术指导原则

发布日期:

2021-12-08

简要介绍:

近年来,我国超重和肥胖患者数量显著增加,对于超重和肥胖患者的体重控制成为迫切的临床需求。为鼓励和推动体重控制药物研发,规范临床研究设计和相关技术要求,药审中心组织制定了《体重控制药物临床试验技术指导原则》(见附件)。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》(药监综药管〔2020〕9号)要求,经国家药品监督管理局审查同意,现予发布,自发布之日起施行。

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    2021-12-10 微探

    vvvv

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    2021-12-09 微探

    学习学习

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