{"id":115255,"date":"2019-06-11T12:19:00","date_gmt":"2019-06-11T04:18:10","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/115255\/"},"modified":"2019-06-11T12:18:13","modified_gmt":"2019-06-11T04:18:13","slug":"b464de46c2","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/115255\/","title":{"rendered":"\u56fd\u5bb6\u836f\u76d1\u5c40\u5c31ICH E2B\uff08R3\uff09\u6307\u5bfc\u539f\u5219\u516c\u5f00\u5f81\u6c42\u610f\u89c1"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">5\u670828\u65e5\uff0c\u56fd\u5bb6\u836f\u76d1\u5c40\u53d1\u5e03\u901a\u77e5\uff0c\u5c31ICH\uff08\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff09\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u4e2d\u7684<span style=\"color: rgb(75, 110, 177);box-sizing: border-box;\">\u300aE2B\uff08R3\uff09\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u4f20\u8f93\u7684\u6570\u636e\u5143\u7d20\u300b<\/span>\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cE2B\uff08R3\uff09\u201d\uff09\u76f8\u5173\u6587\u4ef6\u5411\u793e\u4f1a\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;box-sizing: border-box;\"><img class=\"raw-image\"     style=\"vertical-align: middle;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/06\/8-1560226691.jpg\" alt=\"\u56fd\u5bb6\u836f\u76d1\u5c40\u5c31ICH E2B\uff08R3\uff09\u6307\u5bfc\u539f\u5219\u516c\u5f00\u5f81\u6c42\u610f\u89c1\" title=\"\u56fd\u5bb6\u836f\u76d1\u5c40\u5c31ICH E2B\uff08R3\uff09\u6307\u5bfc\u539f\u5219\u516c\u5f00\u5f81\u6c42\u610f\u89c1\"  \/><\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u901a\u77e5\u663e\u793a\uff0cE2B\uff08R3\uff09\u7684\u4e24\u4e2a\u76f8\u5173\u6587\u4ef6<strong style=\"box-sizing: 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\/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">E2B\uff08R3\uff09\u662f\u4e2d\u56fd\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u52a0\u5165ICH\u540e\u51b3\u5b9a\u9002\u7528\u7684\u4e94\u4e2aICH\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u4e4b\u4e00\uff0c\u7528\u4e8e<span style=\"color: rgb(75, 110, 177);box-sizing: border-box;\">\u63a8\u8fdb\u6301\u6709\u4eba\u5411\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u6280\u672f\u673a\u6784\u9012\u4ea4\u836f\u54c1\u4e0a\u5e02\u540e\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\u3002<\/span><\/p>\n<p style=\"box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"box-sizing: border-box;\">\u4e0a\u8ff0\u6307\u5357\u6587\u4ef6\u662f\u4f9d\u636eE2B\uff08R3\uff09\u6307\u5357\u548c\u4e2d\u56fd\u836f\u54c1\u76d1\u7ba1\u8981\u6c42\u7f16\u5236\uff0c\u63cf\u8ff0\u4e86\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\u7535\u5b50\u4f20\u8f93\u4e2d\u6570\u636e\u5143\u7d20\u9879\u76ee\u3001\u5143\u7d20\u7f16\u7801\u89c4\u5219\u3001\u5143\u7d20\u95f4\u903b\u8f91\u6821\u9a8c\u5173\u7cfb\u4ee5\u53ca\u4f20\u8f93\u6807\u51c6\u7b49\u5185\u5bb9\uff0c\u4ee5\u4fc3\u8fdb\u4e0a\u5e02\u540e\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\u5728\u4e0d\u540c\u673a\u6784\u4e4b\u95f4\u5171\u4eab\u548c\u4ea4\u6362\u3002\u76ee\u7684\u662f\u4e3a\u6307\u5bfc\u6301\u6709\u4eba\u4ee5 E2B\uff08R3\uff09\u683c\u5f0f\u9012\u4ea4\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\uff0c<span style=\"color: rgb(75, 110, 177);box-sizing: 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border-box;\">\n<section style=\"font-size: 15px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u636e\u4e86\u89e3\uff0c2017\u5e746\u6708\uff0c\u6211\u56fd\u836f\u76d1\u90e8\u95e8\u6b63\u5f0f\u52a0\u5165ICH\uff0c\u6210\u4e3a\u5168\u7403\u7b2c8\u4e2a\u76d1\u7ba1\u673a\u6784\u6210\u5458\u30022018\u5e746\u6708\uff0c\u56fd\u5bb6\u836f\u76d1\u5c40\u6210\u4e3aICH\u7ba1\u59d4\u4f1a\u6210\u5458\u3002\u6309\u7167ICH\u89c4\u5b9a\uff0c\u5b9e\u65bd3\u4e2a\u4e00\u7ea7\u6307\u5bfc\u539f\u5219\u662f\u6210\u4e3aICH\u6210\u5458\u7684\u5fc5\u8981\u6761\u4ef6\uff1b\u5b8c\u5168\u5b9e\u65bd1\u4e2a\u3001\u90e8\u5206\u5b9e\u65bd4\u4e2a\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u662f\u6210\u4e3a\u7ba1\u59d4\u4f1a\u6210\u5458\u7684\u6761\u4ef6\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u52a0\u5165ICH\u540e\uff0c\u56fd\u5bb6\u836f\u76d1\u90e8\u95e8\u4e8e2018\u5e741\u6708\u53d1\u5e03\u4e86\u300a\u5173\u4e8e\u9002\u7528\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u7684\u516c\u544a\u300b\uff082018\u5e74\u7b2c10\u53f7\uff09\uff0c\u51b3\u5b9a\u9002\u7528\u300aM4\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09\u300b\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cM4\u201d\uff09\u3001\u300aE2A\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\u300b\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cE2A\u201d\uff09\u3001\u300aE2D\uff1a\u4e0a\u5e02\u540e\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\u300b\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cE2D\u201d\uff09\u3001\u300aM1\uff1a\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09\u300b\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cM1\u201d\uff09\u548cE2B\uff08R3\uff09\u4e94\u4e2aICH 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border-box;\">\n<section style=\"display: inline-block;width: 546px;vertical-align: top;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"margin-bottom: -10px;text-align: left;font-size: 13px;transform: translate3d(3px, 0px, 0px);box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"padding-right: 8px;padding-left: 8px;height: 2em;line-height: 2em;display: inline-block;vertical-align: top;background-color: rgb(75, 110, 177);color: rgb(255, 255, 255);font-size: 15px;text-align: center;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">2018\u5e745\u67081\u65e5\u8d77<\/p>\n<\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 0px;border-left: 1em solid rgb(75, 110, 177);font-size: 16px;box-sizing: border-box;border-top: 1em solid transparent !important;border-bottom: 1em solid transparent !important;\"><\/section>\n<section style=\"width: 0px;border-right: 0.6em solid rgb(2, 32, 99);border-top: 0.6em solid rgb(2, 32, 99);box-sizing: border-box;border-left: 0.6em solid transparent !important;border-bottom: 0.6em solid transparent !important;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"padding-left: 16px;display: inline-block;width: 546px;vertical-align: top;border-width: 0px;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"padding-left: 10px;display: inline-block;width: 530px;vertical-align: top;border-left: 2px dashed rgb(160, 160, 160);border-bottom-left-radius: 0px;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u671f\u95f4\u62a5\u544a\u4e25\u91cd\u4e14\u975e\u9884\u671f\u7684\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u9002\u7528E2A\u3001M1\u53caE2B\uff08R3\uff09\uff1b<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;width: 546px;vertical-align: top;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"margin-bottom: -10px;text-align: left;font-size: 13px;transform: translate3d(3px, 0px, 0px);box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"padding-right: 8px;padding-left: 8px;height: 2em;line-height: 2em;display: inline-block;vertical-align: top;background-color: rgb(75, 110, 177);color: rgb(255, 255, 255);font-size: 15px;text-align: center;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">2018\u5e747\u67081\u65e5\u8d77<\/p>\n<\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 0px;border-left: 1em solid rgb(75, 110, 177);font-size: 16px;box-sizing: border-box;border-top: 1em solid transparent !important;border-bottom: 1em solid transparent !important;\"><\/section>\n<section style=\"width: 0px;border-right: 0.6em solid rgb(2, 32, 99);border-top: 0.6em solid rgb(2, 32, 99);box-sizing: border-box;border-left: 0.6em solid transparent !important;border-bottom: 0.6em solid transparent !important;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"padding-left: 16px;display: inline-block;width: 546px;vertical-align: top;border-width: 0px;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"padding-left: 10px;display: inline-block;width: 530px;vertical-align: top;border-left: 2px dashed rgb(160, 160, 160);border-bottom-left-radius: 0px;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u62a5\u544a\u4e0a\u5e02\u540e\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u9002\u7528E2D\uff1b2019\u5e747\u67081\u65e5\u8d77\uff0c\u62a5\u544a\u4e0a\u5e02\u540e\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u53ef\u9002\u7528M1\u53caE2B\uff08R3\uff09\uff1b<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;width: 546px;vertical-align: top;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"margin-bottom: -10px;text-align: left;font-size: 13px;transform: translate3d(3px, 0px, 0px);box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"padding-right: 8px;padding-left: 8px;height: 2em;line-height: 2em;display: inline-block;vertical-align: top;background-color: rgb(75, 110, 177);color: rgb(255, 255, 255);font-size: 15px;text-align: center;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">2022\u5e747\u67081\u65e5\u8d77<\/p>\n<\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 0px;border-left: 1em solid rgb(75, 110, 177);font-size: 16px;box-sizing: border-box;border-top: 1em solid transparent !important;border-bottom: 1em solid transparent !important;\"><\/section>\n<section 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src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/06\/2-1560226692.jpeg\" alt=\"\u56fd\u5bb6\u836f\u76d1\u5c40\u5c31ICH E2B\uff08R3\uff09\u6307\u5bfc\u539f\u5219\u516c\u5f00\u5f81\u6c42\u610f\u89c1\" title=\"\u56fd\u5bb6\u836f\u76d1\u5c40\u5c31ICH E2B\uff08R3\uff09\u6307\u5bfc\u539f\u5219\u516c\u5f00\u5f81\u6c42\u610f\u89c1\"  \/><\/section>\n<\/section>\n<\/section>\n<section  style=\"font-size: 16px;letter-spacing: 1px;white-space: normal;box-sizing: border-box;\">\n<section style=\"margin-top: 10px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: bottom;width: 65.5188px;box-sizing: border-box;\">\n<section  style=\"box-sizing: border-box;\">\n<section style=\"text-align: center;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;width: 52.4125px;box-sizing: border-box;\"><img class=\"raw-image\"     style=\"vertical-align: middle;width: 52.4125px;box-sizing: border-box;\" 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