FDA 指南:新生血管性年龄相关性黄斑变性的开发治疗药物

2023-02-24 美国食品和药品监督管理局 FDA 发表于安徽省

本指南旨在就资格标准、试验设计注意事项和疗效终点向申办者提供建议,以提高临床试验数据质量,并提高治疗新生血管性年龄相关性黄斑变性药物开发计划的效率。

中文标题:

FDA 指南:新生血管性年龄相关性黄斑变性的开发治疗药物

英文标题:

Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Guidance for Industry

发布日期:

2023-02-24

简要介绍:

本指南旨在就资格标准、试验设计注意事项和疗效终点向申办者提供建议,以提高临床试验数据质量,并提高治疗新生血管性年龄相关性黄斑变性药物开发计划的效率。

相关资料下载:
[AttachmentFileName(sort=1, fileName=FDA 指南:新生血管性年龄相关性黄斑变性的开发治疗药物.pdf)] GetToolGuiderByIdResponse(projectId=1, id=9763a1c00300e072, title=FDA 指南:新生血管性年龄相关性黄斑变性的开发治疗药物, enTitle=Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Guidance for Industry, guiderFrom=FDA, authorId=0, author=, summary=本指南旨在就资格标准、试验设计注意事项和疗效终点向申办者提供建议,以提高临床试验数据质量,并提高治疗新生血管性年龄相关性黄斑变性药物开发计划的效率。, cover=https://img.medsci.cn/Random/diagnostic-form-in-hospital-conceptual-image-7JAH3GT.jpg, journalId=0, articlesId=null, associationId=486, associationName=美国食品和药品监督管理局, associationIntro=美国食品和药品监督管理局是美国公共卫生及服务部的一个代理商,其由委员会办公室和4个监督核心功能理事机构组成。, copyright=0, guiderPublishedTime=Fri Feb 24 00:00:00 CST 2023, originalUrl=, linkOutUrl=, content=<p><span style="color: #333333;">本指南旨在就资格标准、试验设计注意事项和疗效终点向申办者提供建议,以提高临床试验数据质量,并提高治疗新生血管性年龄相关性黄斑变性药物开发计划的效率。</span></p>, tagList=[TagDto(tagId=66391, tagName=新生血管性年龄相关性黄斑变性)], categoryList=[CategoryDto(categoryId=18, categoryName=儿科, tenant=100), CategoryDto(categoryId=32, categoryName=眼科, 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=66391, articleKeyword=新生血管性年龄相关性黄斑变性, articleKeywordNum=6, guiderKeywordId=66391, guiderKeyword=新生血管性年龄相关性黄斑变性, guiderKeywordNum=6, haveAttachments=1, attachmentList=null, guiderType=0, guiderArea=指南, guiderLanguage=1, guiderRegion=1, opened=0, paymentType=, paymentAmount=10, recommend=0, recommendEndTime=null, sticky=0, stickyEndTime=null, allHits=11422, appHits=51, showAppHits=0, pcHits=257, showPcHits=11369, likes=1, shares=7, comments=2, approvalStatus=1, publishedTime=Sat Mar 04 17:24:00 CST 2023, publishedTimeString=2023-02-24, pcVisible=1, appVisible=1, editorId=0, editor=FUNNYMAN, waterMark=0, formatted=0, memberCards=[], isPrivilege=0, deleted=0, version=4, createdBy=null, createdName=FUNNYMAN, createdTime=Mon Feb 27 19:24:59 CST 2023, updatedBy=2427819, updatedName=梁丽玲, updatedTime=Fri Jan 05 22:43:36 CST 2024, courseDetails=[], otherVersionGuiders=[], isGuiderMember=false, ipAttribution=安徽省, attachmentFileNameList=[AttachmentFileName(sort=1, fileName=FDA 指南:新生血管性年龄相关性黄斑变性的开发治疗药物.pdf)])
FDA 指南:新生血管性年龄相关性黄斑变性的开发治疗药物.pdf
下载请点击:
评论区 (2)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=2120171, encodeId=819821201e1fb, content=牛, beContent=null, objectType=guider, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b73a8592456, createdName=ms7000001533030902, createdTime=Fri Mar 17 17:16:34 CST 2023, time=2023-03-17, status=1, ipAttribution=山西省), GetPortalCommentsPageByObjectIdResponse(id=2120169, encodeId=5fb921201694a, content=前沿,厉害, beContent=null, objectType=guider, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b73a8592456, createdName=ms7000001533030902, createdTime=Fri Mar 17 17:13:48 CST 2023, time=2023-03-17, status=1, ipAttribution=山西省)]
    2023-03-17 ms7000001533030902 来自山西省

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2120171, encodeId=819821201e1fb, content=牛, beContent=null, objectType=guider, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b73a8592456, createdName=ms7000001533030902, createdTime=Fri Mar 17 17:16:34 CST 2023, time=2023-03-17, status=1, ipAttribution=山西省), GetPortalCommentsPageByObjectIdResponse(id=2120169, encodeId=5fb921201694a, content=前沿,厉害, beContent=null, objectType=guider, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b73a8592456, createdName=ms7000001533030902, createdTime=Fri Mar 17 17:13:48 CST 2023, time=2023-03-17, status=1, ipAttribution=山西省)]
    2023-03-17 ms7000001533030902 来自山西省

    前沿,厉害

    0

拓展阅读

法瑞西单抗再添新适应症,为中国新生血管性AMD患者带来新的曙光

这是继不久前获批的糖尿病黄斑水肿(DME)后,法瑞西单抗在国内获得的第二项适应症,有望为我国nAMD患者提供全新的治疗选择。

2017 UK专家共识建议:阿柏西普治疗新生血管性年龄相关性黄斑变性

新生血管性年龄相关性黄斑变性是一种急性发作的慢性渐进性眼疾病,主要影响中心视力。本文主要针对临床应用阿柏西普治疗提出指导建议。