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    你的位置： 首页 > IT圈 > ICH-E10-临床试验中对照组的选择和相关问题-20000720

    ICH-E10-临床试验中对照组的选择和相关问题-20000720

    IT圈 admin 62浏览 0评论

    2024年4月7日发(作者：俎幼霜)

    ICH

    E10

    现行第四阶段版本

    2000年7月20日

    该指导原则由相应的ICH专家工作组制定，按照ICH

    进程，已通过药品监管机构讨论。在ICH进程第四阶段，最

    终草案被推荐给欧盟、日本和美国的管理机构采纳。

    i

    E10

    首次编码 历史 日期 重新编码

    2005年11月

    E10 由指导委员会根据

    第二阶段程序批准，

    并公开征求意见。

    1999年5月7

    日

    E10

    目前第四阶段版本

    E10 由大会根据第四阶段

    程序批准，并建议三个

    ICH监管实体采纳。

    2000年7月

    20日

    E10

    ii

    2024年4月7日发(作者：俎幼霜)

    ICH

    E10

    现行第四阶段版本

    2000年7月20日

    该指导原则由相应的ICH专家工作组制定，按照ICH

    进程，已通过药品监管机构讨论。在ICH进程第四阶段，最

    终草案被推荐给欧盟、日本和美国的管理机构采纳。

    i

    E10

    首次编码 历史 日期 重新编码

    2005年11月

    E10 由指导委员会根据

    第二阶段程序批准，

    并公开征求意见。

    1999年5月7

    日

    E10

    目前第四阶段版本

    E10 由大会根据第四阶段

    程序批准，并建议三个

    ICH监管实体采纳。

    2000年7月

    20日

    E10

    ii

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    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
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    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730351750)
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    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730351750)
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    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
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    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
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    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730371460)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730371460)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730585898)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730585898)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730633132)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730633132)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730677309)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730677309)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730737374)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730737374)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730738132)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730738132)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730739500)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730739500)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730760682)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730760682)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730819306)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730819306)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1095, humandate(1730843292)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(26))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)
    Error[2]: Trying to access array offset on value of type int, File: /www/wwwroot/www.usbmi.com/xiunophp/xiunophp.min.php, Line: 54
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 1096, humandate(1730843292)
    File: /www/wwwroot/www.usbmi.com/tmp/model_thread.func.php, Line: 662, well_thread_format(array(27))
    File: /www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm, Line: 249, well_thread_find_asc(array(20) , 20)
    File: /www/wwwroot/www.usbmi.com/tmp/route_read.php, Line: 204, include(/www/wwwroot/www.usbmi.com/tmp/view_template_d8_htm_read.htm)
    File: /www/wwwroot/www.usbmi.com/tmp/index.inc.php, Line: 129, include(/www/wwwroot/www.usbmi.com/tmp/route_read.php)
    File: /www/wwwroot/www.usbmi.com/index.php, Line: 29, include(/www/wwwroot/www.usbmi.com/tmp/index.inc.php)

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