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药品II期临床研究方案格式

2013-04-16 MedSci MedSci原创

II期药品方案
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第一部分  药品Ⅱ期临床试验方案体例格式 一、方案指南： 试验概览 1．  题目封页 2．  申办者研究者签字页 3．  试验方案目录 4．  试验方案摘要 5．  试验研究流程图 二、方案正文： 试验方案题目 1.        

第一部分  药品Ⅱ期临床试验方案体例格式 一、方案指南： 试验概览 1．  题目封页 2．  申办者研究者签字页 3．  试验方案目录 4．  试验方案摘要 5．  试验研究流程图 二、方案正文： 试验方案题目 1.         立题依据 2.         试验背景 3.         试验目的 4.         试验设计 4.1. 试验设计 4.2. 病例数的估算（样本含量） 4.3. 随机分组方法与设计 4.4. 对照与参比 4.5. 盲法的要求和设计 5.         病例选择 5.1. 诊断标准 5

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    2013-11-25 医生2402

    #I期临床#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1652691, encodeId=d5d6165269124, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Mon Nov 25 10:46:00 CST 2013, time=2013-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649951, encodeId=b234164995194, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Sun Nov 03 08:46:00 CST 2013, time=2013-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688735, encodeId=bd531688e3585, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed May 29 00:46:00 CST 2013, time=2013-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524535, encodeId=3de81524535e0, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Thu Apr 18 08:46:00 CST 2013, time=2013-04-18, status=1, ipAttribution=)]
    2013-11-03 huiwelcome

    #II期临床研究#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1652691, encodeId=d5d6165269124, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Mon Nov 25 10:46:00 CST 2013, time=2013-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649951, encodeId=b234164995194, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Sun Nov 03 08:46:00 CST 2013, time=2013-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688735, encodeId=bd531688e3585, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed May 29 00:46:00 CST 2013, time=2013-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524535, encodeId=3de81524535e0, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Thu Apr 18 08:46:00 CST 2013, time=2013-04-18, status=1, ipAttribution=)]
    2013-05-29 ms8543593053280928

    #研究方案#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1652691, encodeId=d5d6165269124, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Mon Nov 25 10:46:00 CST 2013, time=2013-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649951, encodeId=b234164995194, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Sun Nov 03 08:46:00 CST 2013, time=2013-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688735, encodeId=bd531688e3585, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed May 29 00:46:00 CST 2013, time=2013-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524535, encodeId=3de81524535e0, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Thu Apr 18 08:46:00 CST 2013, time=2013-04-18, status=1, ipAttribution=)]
    2013-04-18 guihongzh

    #II期临床#

    0