经眼玻璃体给药药物的研究进展及非临床研究的考虑要点

2023-02-24 国家药品监督管理局药品审评中心(CDE) 药学学报 发表于安徽省

对于该类眼科产品,目前国内外尚无明确的非临床研究技术指导原则和规范可循。本文结合审评实践和已上市产品的研发案例,梳理了经眼玻璃体给药药物的研究进展及非临床研究评价考虑要点,以期为该类药物的研究评价提供

中文标题:

经眼玻璃体给药药物的研究进展及非临床研究的考虑要点

发布日期:

2023-02-24

简要介绍:

近年来,随着眼科治疗药物的发展,玻璃体作为眼科疾病尤其是眼底病药物治疗的通道,为以湿性年龄相关性黄斑变性(wet age-related macular degeneration, wAMD)为代表的各种脉络膜新生血管性疾病、眼底病并发的黄斑水肿、葡萄膜炎等疾病的治疗开辟了新的治疗途径。经眼玻璃体给药的药物主要包括眼用抗血管内皮生长因子(vascular endothelial growth factor, VEGF)类注射剂、微纤溶酶及激素等。对于该类眼科产品,目前国内外尚无明确的非临床研究技术指导原则和规范可循。本文结合审评实践和已上市产品的研发案例,梳理了经眼玻璃体给药药物的研究进展及非临床研究评价考虑要点,以期为该类药物的研究评价提供参考。

相关资料下载:
[AttachmentFileName(sort=1, fileName=经眼玻璃体给药药物的研究进展及非临床研究的考虑要点_付淑军.pdf)] GetToolGuiderByIdResponse(projectId=1, id=82f761c0030061e1, title=经眼玻璃体给药药物的研究进展及非临床研究的考虑要点, enTitle=, guiderFrom=药学学报, authorId=0, author=, summary=对于该类眼科产品,目前国内外尚无明确的非临床研究技术指导原则和规范可循。本文结合审评实践和已上市产品的研发案例,梳理了经眼玻璃体给药药物的研究进展及非临床研究评价考虑要点,以期为该类药物的研究评价提供, cover=https://img.medsci.cn/20221109/1668025636625_4754896.webp, 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=Fri Feb 24 00:00:00 CST 2023, originalUrl=, linkOutUrl=, content=<p><span style="color: #666666;">近年来,随着眼科治疗药物的发展,玻璃体作为眼科疾病尤其是眼底病药物治疗的通道,为以湿性年龄相关性黄斑变性(wet age-related macular degeneration, wAMD)为代表的各种脉络膜新生血管性疾病、眼底病并发的黄斑水肿、葡萄膜炎等疾病的治疗开辟了新的治疗途径。经眼玻璃体给药的药物主要包括眼用抗血管内皮生长因子(vascular endothelial growth factor, VEGF)类注射剂、微纤溶酶及激素等。对于该类眼科产品,目前国内外尚无明确的非临床研究技术指导原则和规范可循。本文结合审评实践和已上市产品的研发案例,梳理了经眼玻璃体给药药物的研究进展及非临床研究评价考虑要点,以期为该类药物的研究评价提供参考。</span></p>, tagList=[TagDto(tagId=472268, tagName=玻璃体给药)], categoryList=[CategoryDto(categoryId=11, categoryName=药械, 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=472268, articleKeyword=玻璃体给药, articleKeywordNum=6, guiderKeywordId=472268, guiderKeyword=玻璃体给药, guiderKeywordNum=6, haveAttachments=1, attachmentList=null, guiderType=0, guiderArea=其它, guiderLanguage=0, guiderRegion=3, opened=0, paymentType=, paymentAmount=10, recommend=0, recommendEndTime=null, sticky=0, stickyEndTime=null, allHits=6568, appHits=26, showAppHits=0, pcHits=299, showPcHits=6541, likes=0, shares=5, comments=3, approvalStatus=1, publishedTime=Thu Mar 02 13:14:00 CST 2023, publishedTimeString=2023-02-24, pcVisible=1, appVisible=1, editorId=0, editor=lixiang, waterMark=0, formatted=0, memberCards=[], isPrivilege=0, deleted=0, version=3, createdBy=null, createdName=lixiang, createdTime=Mon Feb 27 13:16:12 CST 2023, updatedBy=2427819, updatedName=梁丽玲, updatedTime=Fri Jan 05 16:12:30 CST 2024, courseDetails=[], otherVersionGuiders=[], isGuiderMember=false, ipAttribution=安徽省, attachmentFileNameList=[AttachmentFileName(sort=1, fileName=经眼玻璃体给药药物的研究进展及非临床研究的考虑要点_付淑军.pdf)])
经眼玻璃体给药药物的研究进展及非临床研究的考虑要点_付淑军.pdf
下载请点击:
评论区 (2)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=2120174, encodeId=c97321201e43a, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b73a8592456, createdName=ms7000001533030902, createdTime=Fri Mar 17 17:18:51 CST 2023, time=2023-03-17, status=1, ipAttribution=山西省), GetPortalCommentsPageByObjectIdResponse(id=2117218, encodeId=74ec211e21872, content=学习了,感谢!, beContent=null, objectType=guider, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f2d08264621, createdName=ms3000002109107555, createdTime=Thu Mar 02 13:37:10 CST 2023, time=2023-03-02, status=1, ipAttribution=四川省)]
    2023-03-17 ms7000001533030902 来自山西省

    学习了

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2120174, encodeId=c97321201e43a, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b73a8592456, createdName=ms7000001533030902, createdTime=Fri Mar 17 17:18:51 CST 2023, time=2023-03-17, status=1, ipAttribution=山西省), GetPortalCommentsPageByObjectIdResponse(id=2117218, encodeId=74ec211e21872, content=学习了,感谢!, beContent=null, objectType=guider, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f2d08264621, createdName=ms3000002109107555, createdTime=Thu Mar 02 13:37:10 CST 2023, time=2023-03-02, status=1, ipAttribution=四川省)]
    2023-03-02 ms3000002109107555 来自四川省

    学习了,感谢!

    0