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FDA拒绝睾酮替代药物

2018-05-10 MedSci MedSci原创

睾酮替代药物
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美国的监管机构已经拒绝了Lipocine的Tlando，这是一种雄激素替代疗法，用于成年男性的性机能减退。美国食品和药物管理局在一封完整的回复信中表示，目前这种治疗方式无法获得批准。CRL概述了重新提交之前需要解决的四个问题。首先，公司必须确定血清采血管中睾酮十一烷酸酯离体转化为睾酮的程度，以确认数据的可靠性。此外，通过动态血压监测研究，必须获得确切的证据，确定Tlando是否会导致性功能减退症男


美国的监管机构已经拒绝了Lipocine的Tlando，这是一种雄激素替代疗法，用于成年男性的性机能减退。

美国食品和药物管理局在一封完整的回复信中表示，目前这种治疗方式无法获得批准。
CRL概述了重新提交之前需要解决的四个问题。

首先，公司必须确定血清采血管中睾酮十一烷酸酯离体转化为睾酮的程度，以确认数据的可靠性。

此外，通过动态血压监测研究，必须获得确切的证据，确定Tlando是否会导致性功能减退症男性的血压升高。

Lipocine还应验证Cmax数据的可靠性，并确定适当的终止标准，以确定那些应停止使用该疗法的患者。

该公司表示，对这一决定感到失望，但在此前的咨询委员会会议之后，发现的不足之处就在其预期范围之内，它现在将要求与FDA召开会议，进一步评估其缺陷，并就未来可能获得批准的方式达成一致。


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  1. [GetPortalCommentsPageByObjectIdResponse(id=1688731, encodeId=8a5e1688e3114, content=<a href='/topic/show?id=d18ee3102f0' target=_blank style='color:#2F92EE;'>#睾酮替代药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73102, encryptionId=d18ee3102f0, topicName=睾酮替代药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4b8128623936, createdName=12498a1cm76暂无昵称, createdTime=Fri Aug 03 22:17:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=314070, encodeId=e14f3140e0fd, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri May 11 08:08:01 CST 2018, time=2018-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=314018, encodeId=7f08314018c0, content=文章不错!认真学习!, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=55e02077924, createdName=1881f188c8m, createdTime=Fri May 11 06:50:00 CST 2018, time=2018-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=314017, encodeId=e41631401e6f, content=太棒了, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=55e02077924, createdName=1881f188c8m, createdTime=Fri May 11 06:49:44 CST 2018, time=2018-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=313927, encodeId=f8e331392e7e, content=美国的监管机构已经拒绝了Lipocine的Tlando.这是一种雄激素替代疗法.用于成年男性的性机能减退., beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Thu May 10 23:02:23 CST 2018, time=2018-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=313917, encodeId=4db731391efd, content=不错的文章值得拥有, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Thu May 10 22:42:27 CST 2018, time=2018-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=313911, encodeId=38fe313911ed, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Thu May 10 22:21:49 CST 2018, time=2018-05-10, status=1, ipAttribution=)]
    2018-08-03 12498a1cm76暂无昵称

    #睾酮替代药物#

    0

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    2018-05-11 yfjms

    学习

    0

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    2018-05-11 1881f188c8m

    文章不错!认真学习!

    0

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    2018-05-11 1881f188c8m

    太棒了

    0

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    2018-05-10 有备才能无患

    美国的监管机构已经拒绝了Lipocine的Tlando.这是一种雄激素替代疗法.用于成年男性的性机能减退.

    0

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    2018-05-10 1e1b8538m79(暂无匿称)

    不错的文章值得拥有

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    2018-05-10 131****2916

    不错的文章值得推荐

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