抗肿瘤药临床试验影像评估程序标准技术指导原则(2021年)

2021-01-14 国家药品监督管理局药品审评中心(CDE) NMPA

为规范和指导当前抗肿瘤新药临床试验过程中影像学相关的设计和实施,提高影像学相关终点的评价质量,为行业提供技术参考,在国家药品监督管理局的部署下,药审中心组织制定了《抗肿瘤药临床试验影像评估程序标准技术

中文标题:

抗肿瘤药临床试验影像评估程序标准技术指导原则(2021年)

发布日期:

2021-01-14

简要介绍:

为规范和指导当前抗肿瘤新药临床试验过程中影像学相关的设计和实施,提高影像学相关终点的评价质量,为行业提供技术参考,在国家药品监督管理局的部署下,药审中心组织制定了《抗肿瘤药临床试验影像评估程序标准技术指导原则》(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
                                                                                                                                         2021年1月14日

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#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1180680, encodeId=a6d1118068007, content= 国家药品监督管理局药品审评中心, beContent=null, objectType=guider, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d25a5516768, createdName=一己怀, createdTime=Tue Jan 04 23:48:41 CST 2022, time=2022-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010969, encodeId=9935101096993, content=没有积分还有别的方法下载吗, beContent=null, objectType=guider, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ebee5583205, createdName=ms8000001936450913, createdTime=Tue Aug 24 14:46:48 CST 2021, time=2021-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959970, encodeId=843b9599e0c9, content=积分不多怎么看?, beContent=null, objectType=guider, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2c41889281, createdName=ms6762542768160387, createdTime=Sat Apr 24 09:36:56 CST 2021, time=2021-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924026, encodeId=b408924026c8, content=受益匪浅, beContent=null, objectType=guider, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/560f15a0277d43b6a97093df9d0bd9c6/495b8d7c43964f24a256a019fb92ab8e.jpg, createdBy=4aac5114077, createdName=1461fe16m02, createdTime=Wed Feb 10 09:58:48 CST 2021, time=2021-02-10, status=1, ipAttribution=)]
    2022-01-04 一己怀

    国家药品监督管理局药品审评中心

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1180680, encodeId=a6d1118068007, content= 国家药品监督管理局药品审评中心, beContent=null, objectType=guider, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d25a5516768, createdName=一己怀, createdTime=Tue Jan 04 23:48:41 CST 2022, time=2022-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010969, encodeId=9935101096993, content=没有积分还有别的方法下载吗, beContent=null, objectType=guider, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ebee5583205, createdName=ms8000001936450913, createdTime=Tue Aug 24 14:46:48 CST 2021, time=2021-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959970, encodeId=843b9599e0c9, content=积分不多怎么看?, beContent=null, objectType=guider, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2c41889281, createdName=ms6762542768160387, createdTime=Sat Apr 24 09:36:56 CST 2021, time=2021-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924026, encodeId=b408924026c8, content=受益匪浅, beContent=null, objectType=guider, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/560f15a0277d43b6a97093df9d0bd9c6/495b8d7c43964f24a256a019fb92ab8e.jpg, createdBy=4aac5114077, createdName=1461fe16m02, createdTime=Wed Feb 10 09:58:48 CST 2021, time=2021-02-10, status=1, ipAttribution=)]
    2021-08-24 ms8000001936450913

    没有积分还有别的方法下载吗

    0

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    2021-04-24 ms6762542768160387

    积分不多怎么看?

    0

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    2021-02-10 1461fe16m02

    受益匪浅

    0