治疗部分发作的癫痫药物:从成人到2岁的小儿患者的疗效探索(FDA指南)

2019-10-31 美国食品和药品监督管理局

治疗部分发作的癫痫药物:从成人到2岁的小儿患者的疗效探索

中文标题:

治疗部分发作的癫痫药物:从成人到2岁的小儿患者的疗效探索(FDA指南)

英文标题:

Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry

发布日期:

2019-10-31

简要介绍:

治疗部分发作的癫痫药物:从成人到2岁的小儿患者的疗效探索

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治疗部分发作的癫痫药物:从成人到2岁的小儿患者的疗效探索(FDA指南)
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  1. [GetPortalCommentsPageByObjectIdResponse(id=975825, encodeId=0a129e58256d, content=指南阐述了FDA当前关于临床开发项目的思路,这些项目可以支持对2岁及以上儿童患者用于成人部分性癫痫发作治疗的药物的疗效进行外推。没有用药推荐, beContent=null, objectType=guider, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=764b5528533, createdName=王真真, createdTime=Tue Jun 22 16:01:16 CST 2021, time=2021-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=912448, encodeId=9d1691244860, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q3auHgzwzM6tia9pyZiaPziaeLHadUZP17uiav8DTro6peFy5lvuO5EjYrG4ButKWVynGX1CUFFBbXhib9bjE77pkHw/132, createdBy=41785253089, createdName=医路前行4231, createdTime=Thu Dec 31 08:23:54 CST 2020, time=2020-12-31, status=1, ipAttribution=)]
    2021-06-22 王真真

    指南阐述了FDA当前关于临床开发项目的思路,这些项目可以支持对2岁及以上儿童患者用于成人部分性癫痫发作治疗的药物的疗效进行外推。没有用药推荐

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=975825, encodeId=0a129e58256d, content=指南阐述了FDA当前关于临床开发项目的思路,这些项目可以支持对2岁及以上儿童患者用于成人部分性癫痫发作治疗的药物的疗效进行外推。没有用药推荐, beContent=null, objectType=guider, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=764b5528533, createdName=王真真, createdTime=Tue Jun 22 16:01:16 CST 2021, time=2021-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=912448, encodeId=9d1691244860, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q3auHgzwzM6tia9pyZiaPziaeLHadUZP17uiav8DTro6peFy5lvuO5EjYrG4ButKWVynGX1CUFFBbXhib9bjE77pkHw/132, createdBy=41785253089, createdName=医路前行4231, createdTime=Thu Dec 31 08:23:54 CST 2020, time=2020-12-31, status=1, ipAttribution=)]
    2020-12-31 医路前行4231

    学习了

    0