免疫细胞治疗产品药学研究与评价技术指导原则(试行)

2022-05-31 国家药品监督管理局药品审评中心(CDE) 国家药监局药审中心

为规范和指导免疫细胞治疗产品的药学研发、生产和注册,在国家药品监督管理局的部署下,药审中心组织制定了《免疫细胞治疗产品药学研究与评价技术指导原则(试行)》。

中文标题:

免疫细胞治疗产品药学研究与评价技术指导原则(试行)

发布日期:

2022-05-31

简要介绍:

为规范和指导免疫细胞治疗产品的药学研发、生产和注册,在国家药品监督管理局的部署下,药审中心组织制定了《免疫细胞治疗产品药学研究与评价技术指导原则(试行)》。

相关资料下载:
[AttachmentFileName(sort=1, fileName=免疫细胞治疗产品药学研究与评价技术指导原则(试行).pdf)] GetToolGuiderByIdResponse(projectId=1, id=397ae1c002a5e1c6, title=免疫细胞治疗产品药学研究与评价技术指导原则(试行), enTitle=, guiderFrom=国家药监局药审中心, authorId=0, author=, summary=为规范和指导免疫细胞治疗产品的药学研发、生产和注册,在国家药品监督管理局的部署下,药审中心组织制定了《免疫细胞治疗产品药学研究与评价技术指导原则(试行)》。, cover=https://img.medsci.cn/20220531/1653987433817_5579292.jpg, 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 May 31 00:00:00 CST 2022, originalUrl=, linkOutUrl=, content=<p>为规范和指导免疫细胞治疗产品的药学研发、生产和注册,在国家药品监督管理局的部署下,药审中心组织制定了《免疫细胞治疗产品药学研究与评价技术指导原则(试行)》。</p>, tagList=[TagDto(tagId=45082, tagName=免疫细胞治疗)], categoryList=[CategoryDto(categoryId=5, categoryName=肿瘤, tenant=100), CategoryDto(categoryId=85, categoryName=指南&解读, 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=1, paymentType=, paymentAmount=0, recommend=0, recommendEndTime=null, sticky=0, stickyEndTime=null, allHits=2674, appHits=34, showAppHits=0, pcHits=319, showPcHits=2640, likes=0, shares=8, comments=4, approvalStatus=1, publishedTime=Wed Jun 01 15:26:00 CST 2022, publishedTimeString=2022-05-31, pcVisible=1, appVisible=1, editorId=0, editor=FUNNYMAN, waterMark=0, formatted=0, memberCards=[], isPrivilege=0, deleted=0, version=3, createdBy=null, createdName=FUNNYMAN, createdTime=Tue May 31 17:00:10 CST 2022, updatedBy=6459136, updatedName=艺玮, updatedTime=Sat Jan 06 04:23:47 CST 2024, courseDetails=[], otherVersionGuiders=[], isGuiderMember=false, ipAttribution=, attachmentFileNameList=[AttachmentFileName(sort=1, fileName=免疫细胞治疗产品药学研究与评价技术指导原则(试行).pdf)])
免疫细胞治疗产品药学研究与评价技术指导原则(试行).pdf
下载请点击:
评论区 (3)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1241561, encodeId=534e12415619c, content=<a href='/topic/show?id=4834291364d' target=_blank style='color:#2F92EE;'>#免疫细胞治疗#</a><a href='/topic/show?id=3e26e794600' target=_blank style='color:#2F92EE;'>#细胞治疗#</a>, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29136, encryptionId=4834291364d, topicName=免疫细胞治疗), TopicDto(id=77946, encryptionId=3e26e794600, topicName=细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Sun Aug 28 15:03:03 CST 2022, time=2022-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1225177, encodeId=5a0012251e718, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210830/6e21298998ee404a98a9f9f18d4fd636/6dfb1526eb8d47dba5515dd0709385e8.jpg, createdBy=dc685586392, createdName=onebutton, createdTime=Wed Jun 08 12:15:01 CST 2022, time=2022-06-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1224664, encodeId=3b9d122466443, content=学习学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=c40a6387446, createdName=ms3000000376140643, createdTime=Mon Jun 06 07:11:53 CST 2022, time=2022-06-06, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1241561, encodeId=534e12415619c, content=<a href='/topic/show?id=4834291364d' target=_blank style='color:#2F92EE;'>#免疫细胞治疗#</a><a href='/topic/show?id=3e26e794600' target=_blank style='color:#2F92EE;'>#细胞治疗#</a>, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29136, encryptionId=4834291364d, topicName=免疫细胞治疗), TopicDto(id=77946, encryptionId=3e26e794600, topicName=细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Sun Aug 28 15:03:03 CST 2022, time=2022-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1225177, encodeId=5a0012251e718, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210830/6e21298998ee404a98a9f9f18d4fd636/6dfb1526eb8d47dba5515dd0709385e8.jpg, createdBy=dc685586392, createdName=onebutton, createdTime=Wed Jun 08 12:15:01 CST 2022, time=2022-06-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1224664, encodeId=3b9d122466443, content=学习学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=c40a6387446, createdName=ms3000000376140643, createdTime=Mon Jun 06 07:11:53 CST 2022, time=2022-06-06, status=1, ipAttribution=)]
    2022-06-08 onebutton

    学习

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1241561, encodeId=534e12415619c, content=<a href='/topic/show?id=4834291364d' target=_blank style='color:#2F92EE;'>#免疫细胞治疗#</a><a href='/topic/show?id=3e26e794600' target=_blank style='color:#2F92EE;'>#细胞治疗#</a>, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29136, encryptionId=4834291364d, topicName=免疫细胞治疗), TopicDto(id=77946, encryptionId=3e26e794600, topicName=细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Sun Aug 28 15:03:03 CST 2022, time=2022-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1225177, encodeId=5a0012251e718, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210830/6e21298998ee404a98a9f9f18d4fd636/6dfb1526eb8d47dba5515dd0709385e8.jpg, createdBy=dc685586392, createdName=onebutton, createdTime=Wed Jun 08 12:15:01 CST 2022, time=2022-06-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1224664, encodeId=3b9d122466443, content=学习学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=c40a6387446, createdName=ms3000000376140643, createdTime=Mon Jun 06 07:11:53 CST 2022, time=2022-06-06, status=1, ipAttribution=)]
    2022-06-06 ms3000000376140643

    学习学习

    0