晚期肝细胞癌临床试验终点技术指导原则

2020-12-01 国家药品监督管理局药品审评中心(CDE) CDE

为指导在我国晚期肝细胞癌中的药物临床研发,提供可参考的技术标准,在国家药品监督管理局的部署下,药审中心组织制定了《晚期肝细胞癌临床试验终点技术指导原则》(见附件)。根据《国家药监局综合司关于印发药品技

中文标题:

晚期肝细胞癌临床试验终点技术指导原则

发布日期:

2020-12-01

简要介绍:

为指导在我国晚期肝细胞癌中的药物临床研发,提供可参考的技术标准,在国家药品监督管理局的部署下,药审中心组织制定了《晚期肝细胞癌临床试验终点技术指导原则》(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11月26日

征求意见稿见:晚期肝细胞癌临床试验终点技术指导原则(征求意见稿)

相关资料下载:
[AttachmentFileName(sort=1, fileName=晚期肝细胞癌临床试验终点技术指导原则.pdf)] GetToolGuiderByIdResponse(projectId=1, id=8bb271c00202206c, title=晚期肝细胞癌临床试验终点技术指导原则, enTitle=, guiderFrom=CDE, authorId=0, author=, summary=为指导在我国晚期肝细胞癌中的药物临床研发,提供可参考的技术标准,在国家药品监督管理局的部署下,药审中心组织制定了《晚期肝细胞癌临床试验终点技术指导原则》(见附件)。根据《国家药监局综合司关于印发药品技, cover=, journalId=0, articlesId=null, associationId=1936, associationName=国家药品监督管理局药品审评中心(CDE), associationIntro=国家药品监督管理局药品审评中心(CDE), copyright=0, guiderPublishedTime=Tue Dec 01 00:00:00 CST 2020, originalUrl=, linkOutUrl=, content=<p>为指导在我国晚期肝细胞癌中的药物临床研发,提供可参考的技术标准,在国家药品监督管理局的部署下,药审中心组织制定了《晚期肝细胞癌临床试验终点技术指导原则》(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。<br />&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 特此通告。<br />&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 国家药品监督管理局药品审评中心<br />&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2020年11月26日</p> <p>征求意见稿见:<a href="https://www.medsci.cn/guideline/show_article.do?id=3e4bd1c00196aede" target="_blank" rel="noopener">晚期肝细胞癌临床试验终点技术指导原则(征求意见稿)</a></p>, tagList=[TagDto(tagId=357, tagName=肝细胞癌)], categoryList=[CategoryDto(categoryId=5, categoryName=肿瘤科, tenant=100), CategoryDto(categoryId=67, categoryName=研究设计与统计, tenant=100), CategoryDto(categoryId=85, categoryName=指南&解读, tenant=100), CategoryDto(categoryId=20620, categoryName=肿瘤医学网, tenant=100), CategoryDto(categoryId=21100, categoryName=达仁堂循证e学界, tenant=100)], articleKeywordId=0, articleKeyword=, articleKeywordNum=6, guiderKeywordId=0, guiderKeyword=, guiderKeywordNum=6, haveAttachments=1, attachmentList=null, guiderType=0, guiderArea=指导原则, guiderLanguage=0, guiderRegion=3, opened=0, paymentType=, paymentAmount=10, recommend=0, recommendEndTime=null, sticky=0, stickyEndTime=null, allHits=2278, appHits=146, showAppHits=0, pcHits=415, showPcHits=2132, likes=1, shares=93, comments=3, approvalStatus=1, publishedTime=Mon Dec 07 11:26:19 CST 2020, publishedTimeString=2020-12-01, pcVisible=1, appVisible=1, editorId=4754896, editor=fbzhang, waterMark=0, formatted=0, memberCards=[], isPrivilege=0, deleted=0, version=2, createdBy=null, createdName=fbzhang, createdTime=Mon Dec 07 11:26:15 CST 2020, updatedBy=4754896, updatedName=fbzhang, updatedTime=Sat Jan 06 14:02:42 CST 2024, courseDetails=[], otherVersionGuiders=[], isGuiderMember=false, ipAttribution=, attachmentFileNameList=[AttachmentFileName(sort=1, fileName=晚期肝细胞癌临床试验终点技术指导原则.pdf)])
晚期肝细胞癌临床试验终点技术指导原则.pdf
下载请点击:
评论区 (3)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=911400, encodeId=bbd9911400dc, content=晚期肝细胞癌临床试验终点技术指导原则, beContent=null, objectType=guider, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Dec 27 21:07:13 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=908914, encodeId=cd489089147b, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a6c24111761, createdName=13bd9e1fm68暂无昵称, createdTime=Thu Dec 17 19:04:11 CST 2020, time=2020-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=906570, encodeId=dbd69065e044, content=学习去, beContent=null, objectType=guider, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=64795439197, createdName=ms4000001378802702, createdTime=Thu Dec 10 07:43:51 CST 2020, time=2020-12-10, status=1, ipAttribution=)]
    2020-12-27 oo902

    晚期肝细胞癌临床试验终点技术指导原则

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=911400, encodeId=bbd9911400dc, content=晚期肝细胞癌临床试验终点技术指导原则, beContent=null, objectType=guider, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Dec 27 21:07:13 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=908914, encodeId=cd489089147b, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a6c24111761, createdName=13bd9e1fm68暂无昵称, createdTime=Thu Dec 17 19:04:11 CST 2020, time=2020-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=906570, encodeId=dbd69065e044, content=学习去, beContent=null, objectType=guider, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=64795439197, createdName=ms4000001378802702, createdTime=Thu Dec 10 07:43:51 CST 2020, time=2020-12-10, status=1, ipAttribution=)]
    2020-12-17 13bd9e1fm68暂无昵称

    学习了

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=911400, encodeId=bbd9911400dc, content=晚期肝细胞癌临床试验终点技术指导原则, beContent=null, objectType=guider, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Dec 27 21:07:13 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=908914, encodeId=cd489089147b, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a6c24111761, createdName=13bd9e1fm68暂无昵称, createdTime=Thu Dec 17 19:04:11 CST 2020, time=2020-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=906570, encodeId=dbd69065e044, content=学习去, beContent=null, objectType=guider, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=64795439197, createdName=ms4000001378802702, createdTime=Thu Dec 10 07:43:51 CST 2020, time=2020-12-10, status=1, ipAttribution=)]
    2020-12-10 ms4000001378802702

    学习去

    0