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DIA 2021：抗肿瘤联合用药开发策略考量

2021-05-23 CDE 周明 DIA年会

肿瘤
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如何从临床亟需角度出发，提高现有抗肿瘤治疗的临床获益是当下新药开发的热点。CDE 基于国内临床开发的现状，于2020年12月30日正式发布了

如何从临床亟需角度出发，提高现有抗肿瘤治疗的临床获益是当下新药开发的热点。CDE 基于国内临床开发的现状，于2020年12月30日正式发布了《抗肿瘤药联合治疗临床试验技术指导原则》从监管层面厘清生物医药行业在实际开发过程潜在误区和欠规范之处。同时CDE也借助业内专业会议平台，从多个维度分享监管部门针对国内临床开发的审评考量，特别是为了规避大量资源浪费的同质化开发，在监管层面提出“关门效应”基准。     本分享内容版权属于DIA年会讲者，CDE周明先生。   声明/Disclaimer： 上述演讲内容，仅为演讲者个人专业观点，与受聘和所属单位无关； 本演讲材料包括幻灯素材属于演讲者的个人知识产权，受所在国版权法律保护，经所有者许可方能使用。演讲者对演讲材料保留所有权力。 The above materias/slides shared during the DIA meeting are the professional viewpoints expressed by presenter, should not be attt

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1639767, encodeId=7ade1639e670d, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Sat Oct 23 17:20:35 CST 2021, time=2021-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1514304, encodeId=0c36151430463, content=<a href='/topic/show?id=9d7c80e14b3' target=_blank style='color:#2F92EE;'>#联合用药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80714, encryptionId=9d7c80e14b3, topicName=联合用药)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue May 25 05:20:35 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967955, encodeId=28ba96e9557b, content=好好学习！, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sun May 23 17:06:05 CST 2021, time=2021-05-23, status=1, ipAttribution=)]
    2021-10-23 ms9608593228839890

    #DIA#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1639767, encodeId=7ade1639e670d, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Sat Oct 23 17:20:35 CST 2021, time=2021-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1514304, encodeId=0c36151430463, content=<a href='/topic/show?id=9d7c80e14b3' target=_blank style='color:#2F92EE;'>#联合用药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80714, encryptionId=9d7c80e14b3, topicName=联合用药)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue May 25 05:20:35 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967955, encodeId=28ba96e9557b, content=好好学习！, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sun May 23 17:06:05 CST 2021, time=2021-05-23, status=1, ipAttribution=)]
    2021-05-25 zhouqu_8

    #联合用药#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1639767, encodeId=7ade1639e670d, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Sat Oct 23 17:20:35 CST 2021, time=2021-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1514304, encodeId=0c36151430463, content=<a href='/topic/show?id=9d7c80e14b3' target=_blank style='color:#2F92EE;'>#联合用药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80714, encryptionId=9d7c80e14b3, topicName=联合用药)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue May 25 05:20:35 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=967955, encodeId=28ba96e9557b, content=好好学习！, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sun May 23 17:06:05 CST 2021, time=2021-05-23, status=1, ipAttribution=)]
    2021-05-23 jyzxjiangqin

    好好学习！

    0

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