抗肿瘤药联合治疗临床试验技术指导原则(2020年)

2020-12-30 国家药品监督管理局药品审评中心(CDE) NMPA

为鼓励抗肿瘤创新药研发,进一步规范抗肿瘤药联合用药临床试验设计,在国家药品监督管理局的部署下,药审中心组织制定了《抗肿瘤药联合治疗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

中文标题:

抗肿瘤药联合治疗临床试验技术指导原则(2020年)

发布日期:

2020-12-30

简要介绍:

为鼓励抗肿瘤创新药研发,进一步规范抗肿瘤药联合用药临床试验设计,在国家药品监督管理局的部署下,药审中心组织制定了《抗肿瘤药联合治疗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。
       特此通告。
                                                                                                                           国家药品监督管理局药品审评中心
                                                                                                                                         2020年12月30日

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评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1180672, encodeId=583b11806e2d5, content=非常期待, beContent=null, objectType=guider, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d25a5516768, createdName=一己怀, createdTime=Tue Jan 04 23:47:59 CST 2022, time=2022-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959593, encodeId=1a8f9595930b, content=非常期待, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=adbf5474917, createdName=ms6000000798860771, createdTime=Thu Apr 22 21:45:26 CST 2021, time=2021-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=946141, encodeId=692894614128, content=及时, beContent=null, objectType=guider, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://q.qlogo.cn/qqapp/101296147/F6ACA602293B51DFBD3C177D2FADBE65/100, createdBy=e1681996783, createdName=回到起点, createdTime=Sun Mar 07 12:56:55 CST 2021, time=2021-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924409, encodeId=6d109244098c, content=很好,有指导意义!, beContent=null, objectType=guider, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=33ac5447033, createdName=ms3000000728156085, createdTime=Sat Feb 13 10:19:23 CST 2021, time=2021-02-13, status=1, ipAttribution=)]
    2022-01-04 一己怀

    非常期待

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1180672, encodeId=583b11806e2d5, content=非常期待, beContent=null, objectType=guider, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d25a5516768, createdName=一己怀, createdTime=Tue Jan 04 23:47:59 CST 2022, time=2022-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959593, encodeId=1a8f9595930b, content=非常期待, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=adbf5474917, createdName=ms6000000798860771, createdTime=Thu Apr 22 21:45:26 CST 2021, time=2021-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=946141, encodeId=692894614128, content=及时, beContent=null, objectType=guider, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://q.qlogo.cn/qqapp/101296147/F6ACA602293B51DFBD3C177D2FADBE65/100, createdBy=e1681996783, createdName=回到起点, createdTime=Sun Mar 07 12:56:55 CST 2021, time=2021-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924409, encodeId=6d109244098c, content=很好,有指导意义!, beContent=null, objectType=guider, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=33ac5447033, createdName=ms3000000728156085, createdTime=Sat Feb 13 10:19:23 CST 2021, time=2021-02-13, status=1, ipAttribution=)]
    2021-04-22 ms6000000798860771

    非常期待

    0

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    2021-03-07 回到起点

    及时

    0

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    2021-02-13 ms3000000728156085

    很好,有指导意义!

    0