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EMEA关于药物相互作用研究指南

2014-03-13 光红梅 审评四部 审评七室

药代动力学指南
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   本指南说明应与下列文件结合使用。●   CPMP关于GCP的指南●   CPMP关于生物利用度和生物等效性研究的指南●   CPMP关于人体药代动力学研究的指南●   CPMP关于分析方法验证的指南●   CPMP关于医疗产品申请上市许可的临床试验的生物统计方法学的指南

本指南说明应与下列文件结合使用。 ●   CPMP关于GCP的指南 ●   CPMP关于生物利用度和生物等效性研究的指南 ●   CPMP关于人体药代动力学研究的指南 ●   CPMP关于分析方法验证的指南 ●   CPMP关于医疗产品申请上市许可的临床试验的生物统计方法学的指南 ●   CPMP关于手性活性物质研究的指南 ●   CPMP关于新药动物药代动力学和代谢试验安全性评估的安全性指南 ●   CPMP关于多次给药毒性研究的安全性指南 ●   CPMP关于单次给药毒性研究的安全性指南 ●   CPMP关于儿童医疗产品临床研究的指南 ●   CPMP关于复方药物的指南 1．概述      在药代动力学（特别是药物的代谢）和药效学领域，药物相互作用研究的焦点已经从特别的试验观察转变为设计合理的试验。根据药物的结构、理化特性以

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    2014-04-17 medscijoin

    #相互作用#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1909172, encodeId=748419091e20f, content=<a href='/topic/show?id=8039e2512e8' target=_blank style='color:#2F92EE;'>#相互作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72512, encryptionId=8039e2512e8, topicName=相互作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f73a255, createdName=medscijoin, createdTime=Thu Apr 17 11:32:00 CST 2014, time=2014-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1471495, encodeId=050414e14954f, content=<a href='/topic/show?id=c0132410554' target=_blank style='color:#2F92EE;'>#互作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24105, encryptionId=c0132410554, topicName=互作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dc87121468, createdName=ylz8405, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1510874, encodeId=cb1215108e477, content=<a href='/topic/show?id=36b86e19b2' target=_blank style='color:#2F92EE;'>#EMEA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6719, encryptionId=36b86e19b2, topicName=EMEA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7310265615, createdName=xiaoyang_ambs, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585009, encodeId=bd521585009f9, content=<a href='/topic/show?id=61888e8231b' target=_blank style='color:#2F92EE;'>#药物相互作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87823, encryptionId=61888e8231b, topicName=药物相互作用)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5d4517099766, createdName=liao1625, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=)]
    2014-03-15 ylz8405

    #互作#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1909172, encodeId=748419091e20f, content=<a href='/topic/show?id=8039e2512e8' target=_blank style='color:#2F92EE;'>#相互作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72512, encryptionId=8039e2512e8, topicName=相互作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f73a255, createdName=medscijoin, createdTime=Thu Apr 17 11:32:00 CST 2014, time=2014-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1471495, encodeId=050414e14954f, content=<a href='/topic/show?id=c0132410554' target=_blank style='color:#2F92EE;'>#互作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24105, encryptionId=c0132410554, topicName=互作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dc87121468, createdName=ylz8405, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1510874, encodeId=cb1215108e477, content=<a href='/topic/show?id=36b86e19b2' target=_blank style='color:#2F92EE;'>#EMEA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6719, encryptionId=36b86e19b2, topicName=EMEA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7310265615, createdName=xiaoyang_ambs, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585009, encodeId=bd521585009f9, content=<a href='/topic/show?id=61888e8231b' target=_blank style='color:#2F92EE;'>#药物相互作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87823, encryptionId=61888e8231b, topicName=药物相互作用)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5d4517099766, createdName=liao1625, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=)]
    2014-03-15 xiaoyang_ambs

    #EMEA#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1909172, encodeId=748419091e20f, content=<a href='/topic/show?id=8039e2512e8' target=_blank style='color:#2F92EE;'>#相互作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72512, encryptionId=8039e2512e8, topicName=相互作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f73a255, createdName=medscijoin, createdTime=Thu Apr 17 11:32:00 CST 2014, time=2014-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1471495, encodeId=050414e14954f, content=<a href='/topic/show?id=c0132410554' target=_blank style='color:#2F92EE;'>#互作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24105, encryptionId=c0132410554, topicName=互作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dc87121468, createdName=ylz8405, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1510874, encodeId=cb1215108e477, content=<a href='/topic/show?id=36b86e19b2' target=_blank style='color:#2F92EE;'>#EMEA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6719, encryptionId=36b86e19b2, topicName=EMEA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7310265615, createdName=xiaoyang_ambs, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585009, encodeId=bd521585009f9, content=<a href='/topic/show?id=61888e8231b' target=_blank style='color:#2F92EE;'>#药物相互作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87823, encryptionId=61888e8231b, topicName=药物相互作用)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5d4517099766, createdName=liao1625, createdTime=Sat Mar 15 10:32:00 CST 2014, time=2014-03-15, status=1, ipAttribution=)]
    2014-03-15 liao1625

    #药物相互作用#

    0

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