儿科用药临床药理学研究技术指导原则

2020-12-31 国家药品监督管理局药品审评中心(CDE) NMPA

为了促进儿童药品研发,进一步明确儿科用药临床药理学技术要求,药审中心组织制定了《儿科用药临床药理学研究技术指导原则》(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

中文标题:

儿科用药临床药理学研究技术指导原则

发布日期:

2020-12-31

简要介绍:

 为了促进儿童药品研发,进一步明确儿科用药临床药理学技术要求,药审中心组织制定了《儿科用药临床药理学研究技术指导原则》(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31日

相关资料下载:
[AttachmentFileName(sort=1, fileName=66.pdf)] GetToolGuiderByIdResponse(projectId=1, id=deea41c0020519b8, title=儿科用药临床药理学研究技术指导原则, enTitle=, guiderFrom=NMPA, authorId=0, author=, summary= 为了促进儿童药品研发,进一步明确儿科用药临床药理学技术要求,药审中心组织制定了《儿科用药临床药理学研究技术指导原则》(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, 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=Thu Dec 31 00:00:00 CST 2020, originalUrl=, linkOutUrl=, content=<p>&nbsp;为了促进儿童药品研发,进一步明确儿科用药临床药理学技术要求,药审中心组织制定了《儿科用药临床药理学研究技术指导原则》(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12月31日</p>, tagList=[TagDto(tagId=89, tagName=儿科)], categoryList=[CategoryDto(categoryId=11, categoryName=药械, 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=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=30, recommend=0, recommendEndTime=null, sticky=0, stickyEndTime=null, allHits=2128, appHits=72, showAppHits=0, pcHits=368, showPcHits=2056, likes=1, shares=2, comments=8, approvalStatus=1, publishedTime=Wed Feb 10 16:05:01 CST 2021, publishedTimeString=2020-12-31, pcVisible=1, appVisible=1, editorId=4754896, editor=fbzhang, waterMark=0, formatted=0, memberCards=[], isPrivilege=0, deleted=0, version=3, createdBy=null, createdName=fbzhang, createdTime=Tue Feb 09 14:20:57 CST 2021, updatedBy=4754896, updatedName=fbzhang, updatedTime=Sat Jan 06 18:16:32 CST 2024, courseDetails=[], otherVersionGuiders=[], isGuiderMember=false, ipAttribution=, attachmentFileNameList=[AttachmentFileName(sort=1, fileName=66.pdf)])
66.pdf
下载请点击:
评论区 (7)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1079038, encodeId=359d10e90388a, content=好好学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0f46397345, createdName=ms4000000579154068, createdTime=Sat Dec 11 13:26:47 CST 2021, time=2021-12-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1078541, encodeId=9c1110e85414d, content=好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36886394392, createdName=ms3000001448366925, createdTime=Thu Dec 09 19:23:36 CST 2021, time=2021-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062669, encodeId=099010626699e, content=看看, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbed5643540, createdName=ms8000000657117688, createdTime=Thu Oct 21 18:47:49 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=972119, encodeId=eb009e2119e0, content=非常好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1465517364, createdName=ms3000001377143229, createdTime=Wed Jun 09 11:30:41 CST 2021, time=2021-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970723, encodeId=14549e07238b, content=需要这个内容, beContent=null, objectType=guider, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d6935421065, createdName=ms4000000079207461, createdTime=Fri Jun 04 00:35:51 CST 2021, time=2021-06-04, status=1, ipAttribution=)]
    2021-12-11 ms4000000579154068

    好好学习

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1079038, encodeId=359d10e90388a, content=好好学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0f46397345, createdName=ms4000000579154068, createdTime=Sat Dec 11 13:26:47 CST 2021, time=2021-12-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1078541, encodeId=9c1110e85414d, content=好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36886394392, createdName=ms3000001448366925, createdTime=Thu Dec 09 19:23:36 CST 2021, time=2021-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062669, encodeId=099010626699e, content=看看, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbed5643540, createdName=ms8000000657117688, createdTime=Thu Oct 21 18:47:49 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=972119, encodeId=eb009e2119e0, content=非常好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1465517364, createdName=ms3000001377143229, createdTime=Wed Jun 09 11:30:41 CST 2021, time=2021-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970723, encodeId=14549e07238b, content=需要这个内容, beContent=null, objectType=guider, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d6935421065, createdName=ms4000000079207461, createdTime=Fri Jun 04 00:35:51 CST 2021, time=2021-06-04, status=1, ipAttribution=)]
    2021-12-09 ms3000001448366925

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1079038, encodeId=359d10e90388a, content=好好学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0f46397345, createdName=ms4000000579154068, createdTime=Sat Dec 11 13:26:47 CST 2021, time=2021-12-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1078541, encodeId=9c1110e85414d, content=好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36886394392, createdName=ms3000001448366925, createdTime=Thu Dec 09 19:23:36 CST 2021, time=2021-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062669, encodeId=099010626699e, content=看看, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbed5643540, createdName=ms8000000657117688, createdTime=Thu Oct 21 18:47:49 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=972119, encodeId=eb009e2119e0, content=非常好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1465517364, createdName=ms3000001377143229, createdTime=Wed Jun 09 11:30:41 CST 2021, time=2021-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970723, encodeId=14549e07238b, content=需要这个内容, beContent=null, objectType=guider, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d6935421065, createdName=ms4000000079207461, createdTime=Fri Jun 04 00:35:51 CST 2021, time=2021-06-04, status=1, ipAttribution=)]
    2021-10-21 ms8000000657117688

    看看

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1079038, encodeId=359d10e90388a, content=好好学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0f46397345, createdName=ms4000000579154068, createdTime=Sat Dec 11 13:26:47 CST 2021, time=2021-12-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1078541, encodeId=9c1110e85414d, content=好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36886394392, createdName=ms3000001448366925, createdTime=Thu Dec 09 19:23:36 CST 2021, time=2021-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062669, encodeId=099010626699e, content=看看, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbed5643540, createdName=ms8000000657117688, createdTime=Thu Oct 21 18:47:49 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=972119, encodeId=eb009e2119e0, content=非常好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1465517364, createdName=ms3000001377143229, createdTime=Wed Jun 09 11:30:41 CST 2021, time=2021-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970723, encodeId=14549e07238b, content=需要这个内容, beContent=null, objectType=guider, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d6935421065, createdName=ms4000000079207461, createdTime=Fri Jun 04 00:35:51 CST 2021, time=2021-06-04, status=1, ipAttribution=)]
    2021-06-09 ms3000001377143229

    非常好

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1079038, encodeId=359d10e90388a, content=好好学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0f46397345, createdName=ms4000000579154068, createdTime=Sat Dec 11 13:26:47 CST 2021, time=2021-12-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1078541, encodeId=9c1110e85414d, content=好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36886394392, createdName=ms3000001448366925, createdTime=Thu Dec 09 19:23:36 CST 2021, time=2021-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062669, encodeId=099010626699e, content=看看, beContent=null, objectType=guider, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbed5643540, createdName=ms8000000657117688, createdTime=Thu Oct 21 18:47:49 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=972119, encodeId=eb009e2119e0, content=非常好, beContent=null, objectType=guider, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1465517364, createdName=ms3000001377143229, createdTime=Wed Jun 09 11:30:41 CST 2021, time=2021-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970723, encodeId=14549e07238b, content=需要这个内容, beContent=null, objectType=guider, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d6935421065, createdName=ms4000000079207461, createdTime=Fri Jun 04 00:35:51 CST 2021, time=2021-06-04, status=1, ipAttribution=)]
    2021-06-04 ms4000000079207461

    需要这个内容

    0