放射性体内诊断药物非临床研究技术指导原则(征求意见稿)

2020-08-28 国家药品监督管理局药品审评中心(CDE) CDE

随着核医学、分子影像学和药学等各学科的发展,我国放射性体内诊断药物的研发日趋活跃。与一般治疗药物相比,放射性体内诊断药物的非临床研究具有特殊性,但目前国内缺乏针对此类药物非临床研究的技术指导原则。

中文标题:

放射性体内诊断药物非临床研究技术指导原则(征求意见稿)

发布日期:

2020-08-28

简要介绍:

随着核医学、分子影像学和药学等各学科的发展,我国放射性体内诊断药物的研发日趋活跃。与一般治疗药物相比,放射性体内诊断药物的非临床研究具有特殊性,但目前国内缺乏针对此类药物非临床研究的技术指导原则。
       为推动和规范我国放射性体内诊断药物的研发,我中心起草了《放射性体内诊断药物非临床研究技术指导原则》,经中心内部讨论,并征求部分专家意见,现形成征求意见稿。
       我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议,并及时反馈给我们,以便后续完善。征求意见时限为自发布之日起一个月。
       您的反馈意见请发到以下联系人的邮箱:
       联系人:李艾芳,光红梅
       联系方式:liaf@cde.org.cn,guanghm@cde.org.cn
       感谢您的参与和大力支持。
                                                                                                                           国家药品监督管理局药品审评中心
                                                                                                                                         2020年8月27日

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《放射性体内诊断药物非临床研究技术指导原则(征求意见稿)》.docx
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#插入话题
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    2021-02-12 ddrrrr13

    看看

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    2020-10-03 ms8000000775044569

    红红火火

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    2020-10-03 ms8000000775044569

    哈哈哈哈

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    2020-10-03 ms8000000775044569

    哈哈哈哈

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