{"id":6265,"date":"2018-06-12T01:00:00","date_gmt":"2018-07-27T09:13:06","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e7%a0%94%e7%a9%b6%e4%b8%ad%e7%a6%bb%e7%be%a4%e5%80%bc%e7%9a%84%e4%b8%80%e8%88%ac%e8%80%83%e8%99%91\/"},"modified":"2018-07-27T17:13:07","modified_gmt":"2018-07-27T09:13:07","slug":"%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e7%a0%94%e7%a9%b6%e4%b8%ad%e7%a6%bb%e7%be%a4%e5%80%bc%e7%9a%84%e4%b8%80%e8%88%ac%e8%80%83%e8%99%91","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/6265\/","title":{"rendered":"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u79bb\u7fa4\u503c\u7684\u4e00\u822c\u8003\u8651"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin: 10px 0%;box-sizing: border-box;\">\n<section class=\"\" style=\"display: inline-block;width: 100%;vertical-align: top;padding: 15px;border-width: 2px;border-radius: 0px;border-style: solid;border-color: rgb(227, 227, 227);background-position: -5.6181% -1.1911%;background-repeat: repeat;background-size: 14.3537%;background-attachment: scroll;background-image: url('http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress3-1532682787.png');box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: justify;color: rgb(34, 34, 34);line-height: 2;box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\uff08Bioequivalence\uff0cBE\uff09\u662f\u8bc4\u4ef7\u540c\u4e00\u836f\u7269\u4e0d\u540c\u5236\u5242\u95f4\u5dee\u5f02\u53ca\u4eff\u5236\u836f\u4e0e\u539f\u7814\u5236\u5242\u95f4\u53ef\u66ff\u6362\u6027\u7684\u91cd\u8981\u65b9\u6cd5\u3002\u8fd1\u5e74\u6765\uff0c\u6211\u56fd\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u8d28\u91cf\u5f97\u5230\u4e86\u5f88\u5927\u7a0b\u5ea6\u7684\u63d0\u5347\uff0c\u4f46\u8fd1\u671f\u63d0\u4ea4\u7684\u7533\u62a5\u8d44\u6599\u4e2d\u9646\u7eed\u51fa\u73b0\u4e0d\u5408\u7406\u5254\u9664\u201c\u79bb\u7fa4\u503c\u201d\u7b49\u7684\u95ee\u9898\uff0c\u5982\u4f55\u5bf9\u8fd9\u4e9b\u65b0\u95ee\u9898\u505a\u51fa\u79d1\u5b66\u5408\u7406\u7684\u8bc4\u4ef7\u662f\u6211\u4eec\u5ba1\u8bc4\u5f53\u524d\u9636\u6bb5\u9762\u4e34\u7684\u65b0\u7684\u6311\u6218\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"text-align: right;margin: -50px 0% 10px;box-sizing: border-box;\">\n<section class=\"\" style=\"max-width: 100%;vertical-align: middle;display: inline-block;width: 30%;overflow: hidden !important;box-sizing: border-box;\"><img     style=\"vertical-align: middle;width: 100%;box-sizing: border-box;\" width=\"100%\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress9-1532682787.jpg\" alt=\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u79bb\u7fa4\u503c\u7684\u4e00\u822c\u8003\u8651\" title=\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u79bb\u7fa4\u503c\u7684\u4e00\u822c\u8003\u8651\"  \/><\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"display: inline-block;vertical-align: top;box-sizing: border-box;\">\n<section style=\"width: 45px;height: 5px;margin-left: auto;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section class=\"\" style=\"margin-top: -3px;margin-bottom: -3px;transform: rotate(0deg);border-width: 1px;border-style: solid;border-color: rgb(0, 0, 0);padding-left: 8px;padding-right: 8px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u4e00\u3001\u79bb\u7fa4\u503c\u7684\u5224\u5b9a<\/strong><\/p>\n<\/section>\n<section style=\"width: 45px;height: 5px;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><br  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 0.5em;margin-bottom: 0.5em;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section style=\"width: 20px;height: 20px;float: left;border-top: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-top: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<section style=\"margin-top: -20px;margin-bottom: -20px;box-sizing: border-box;\">\n<section class=\"\" style=\"border-width: 2px;border-style: dotted;border-color: rgb(233, 233, 233);padding: 10px 20px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\uff0c\u79bb\u7fa4\u503c\u901a\u5e38\u4e3a\u4e00\u4e2a\u6216\u591a\u4e2a\u8840\u836f\u6d53\u5ea6\u6d4b\u5b9a\u503c\u6216\u836f\u4ee3\u52a8\u529b\u5b66\uff08Pharmacokinetics\uff0cPK\uff09\u53c2\u6570\u4e0e\u7814\u7a76\u4e2d\u5176\u4ed6\u53d7\u8bd5\u8005\u76f8\u5e94\u7ed3\u679c\u660e\u663e\u4e0d\u4e00\u81f4\u7684\u6570\u636e\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u5982\u5728\u8840\u836f\u6d53\u5ea6\u68c0\u6d4b\u8fc7\u7a0b\u4e2d\u6709\u65f6\u4f1a\u51fa\u73b0\u4e00\u4e2a\u6216\u591a\u4e2a\u6d53\u5ea6\u70b9\u8fdc\u8fdc\u9ad8\u4e8e\u6216\u4f4e\u4e8e\u524d\u540e\u6d53\u5ea6\u70b9\u7684\u60c5\u51b5\uff0c\u5373\u901a\u5e38\u6240\u8bf4\u7684\u201c\u8df3\u70b9\u201d\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">PK\u53c2\u6570\u5f02\u5e38\u4e3b\u8981\u8868\u73b0\u4e3a\u4e00\u4e2a\u6216\u591a\u4e2a\u53d7\u8bd5\u8005\u670d\u7528\u67d0\u4e00\u5236\u5242\uff08\u53d7\u8bd5\u5236\u5242\u6216\u53c2\u6bd4\u5236\u5242\uff09\u540e\u7684\u836f\u65f6\u66f2\u7ebf\u4e0b\u9762\u79ef\uff08Area under the curve\uff0cAUC\uff09\u6216\u6700\u5927\u8840\u836f\u6d53\u5ea6\uff08<span style=\"font-size: 16px;\"><span style=\"text-indent: 37px;font-family: \u4eff\u5b8b;\">C<\/span><sub style=\"text-indent: 37px;\"><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1;vertical-align: sub;\">max<\/span><\/sub><\/span><span style=\"text-indent: 37px;\">\uff09\u4e0e\u53e6\u4e00\u5468\u671f\u6216\u5176\u4ed6\u53d7\u8bd5\u8005\u7684\u7ed3\u679c\u76f8\u6bd4\u5dee\u5f02\u8f83\u5927\u3002<\/span><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u79bb\u7fa4\u503c\u7684\u51fa\u73b0\u53ef\u80fd\u662f\u5236\u5242\u8d28\u91cf\u4e0d\u5747\u4e00\u3001\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u65b9\u6848\u504f\u79bb\u6216\u6837\u672c\u68c0\u6d4b\u65f6\u7684\u64cd\u4f5c\u5931\u8bef\u7b49\u539f\u56e0\u9020\u6210\u7684\u3002\u4f46\u662f\uff0c\u7531\u4e8e\u79bb\u7fa4\u503c\u662f\u5728\u6837\u672c\u68c0\u6d4b\u5b8c\u6210\u3001\u751a\u81f3\u662f\u7edf\u8ba1\u5206\u6790\u5b8c\u6210\u540e\u53d1\u73b0\u7684\uff0c\u4e5f\u53ef\u80fd\u5b58\u5728\u7814\u7a76\u8005\u4e3b\u89c2\u5224\u5b9a\u56e0\u7d20\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"width: 20px;height: 20px;float: left;border-bottom: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-bottom: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" 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 class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"display: inline-block;vertical-align: top;box-sizing: border-box;\">\n<section style=\"width: 45px;height: 5px;margin-left: auto;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section class=\"\" style=\"margin-top: -3px;margin-bottom: -3px;transform: rotate(0deg);border-width: 1px;border-style: solid;border-color: rgb(0, 0, 0);padding-left: 8px;padding-right: 8px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u4e8c\u3001\u51fa\u73b0\u79bb\u7fa4\u503c\u7684\u539f\u56e0<\/strong><\/p>\n<\/section>\n<section style=\"width: 45px;height: 5px;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><br  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 0.5em;margin-bottom: 0.5em;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section style=\"width: 20px;height: 20px;float: left;border-top: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-top: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<section style=\"margin-top: -20px;margin-bottom: -20px;box-sizing: border-box;\">\n<section class=\"\" style=\"border-width: 2px;border-style: dotted;border-color: rgb(233, 233, 233);padding: 10px 20px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><span style=\"color: rgb(45, 69, 152);box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">1. \u5236\u5242\u8d28\u91cf\u95ee\u9898<\/strong><\/span><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u8bd5\u9a8c\u6240\u7528\u5236\u5242\u53ef\u80fd\u5b58\u5728\u6279\u5185\u6216\u6279\u95f4\u5747\u4e00\u6027\u5dee\u7684\u60c5\u51b5\uff0c\u4f8b\u5982\uff0c\u53d7\u8bd5\u8005\u670d\u7528\u67d0\u79cd\u7f13\u91ca\u5236\u5242\u800c\u4ea7\u751f\u4e0d\u5bfb\u5e38\u7684\u9ad8\u6216\u8005\u4f4e\u7684\u54cd\u5e94\uff0c\u8fd9\u79cd\u79bb\u7fa4\u503c\u7684\u51fa\u73b0\u53ef\u80fd\u662f\u7531\u4e8e\u7f13\u91ca\u5236\u5242\u8d28\u91cf\u4e0d\u5747\u4e00\uff0c\u5bfc\u81f4\u5728\u67d0\u4e2a\u6216\u67d0\u4e9b\u53d7\u8bd5\u8005\u51fa\u73b0\u5242\u91cf\u7a81\u91ca\u6216\u7531\u4e8e\u5305\u88ab\u56e0\u7d20\u963b\u6b62\u836f\u7269\u7684\u6eb6\u89e3\u800c\u4ea7\u751f\u5236\u5242\u91ca\u653e\u5f02\u5e38\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\"><span style=\"color: rgb(45, 69, 152);box-sizing: border-box;\">2. \u65b9\u6848\u504f\u79bb\u5bfc\u81f4\u7684\u79bb\u7fa4\u503c<\/span><\/strong><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u7531\u4e8e\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u53d7\u8bd5\u8005\u6709\u610f\u5410\u836f\u7b49\u884c\u4e3a\uff0c\u53ef\u80fd\u5bfc\u81f4\u53d7\u8bd5\u8005\u672a\u670d\u836f\u6216\u670d\u836f\u5242\u91cf\u504f\u4f4e\uff0c\u6216\u670d\u836f\u540e\u7531\u4e8e\u5236\u5242\u672c\u8eab\u5b58\u5728\u7684\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u5455\u5410\u6216\u4e25\u91cd\u8179\u6cfb\uff0c\u5bfc\u81f4\u836f\u7269\u66b4\u9732\u91cf\u51cf\u5c11\uff0c\u4ece\u800c\u4ea7\u751f\u79bb\u7fa4\u503c\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u68c0\u6d4b\u65f6\u7531\u4e8e\u4e2a\u522b\u6837\u672c\u5904\u7406\u6216\u5206\u6790\u68c0\u6d4b\u8fc7\u7a0b\u4e2d\u53d1\u751f\u65b9\u6848\u504f\u79bb\u6216\u51fa\u73b0\u5931\u8bef\uff0c\u5bfc\u81f4\u5f85\u6d4b\u7269\u6700\u7ec8\u68c0\u6d4b\u7ed3\u679c\u4e0d\u51c6\u786e\uff0c\u4e5f\u53ef\u80fd\u4ea7\u751f\u79bb\u7fa4\u503c\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><span style=\"color: rgb(45, 69, 152);box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">3. \u53d7\u8bd5\u8005\u4e0e\u5236\u5242\u76f8\u4e92\u4f5c\u7528<\/strong><\/span><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u53ef\u80fd\u5728\u5c11\u6570\u4e2a\u4f53\u4e2d\u7531\u4e8e\u53d7\u8bd5\u8005\u548c\u5236\u5242\u7684\u76f8\u4e92\u4f5c\u7528\uff0c\u5bfc\u81f4\u8fd9\u4e9b\u4e2a\u4f53\u5bf9\u4e24\u79cd\u5236\u5242\u7684\u76f8\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u4e0e\u591a\u6570\u7fa4\u4f53\u76f8\u6bd4\u660e\u663e\u4e0d\u540c\uff0c\u5c3d\u7ba1\u8fd9\u4e24\u79cd\u5236\u5242\u53ef\u80fd\u5728\u5927\u591a\u6570\u4e2a\u4f53\u4e2d\u662f\u751f\u7269\u7b49\u6548\u7684\uff0c\u4f46\u5bf9\u4e8e\u8fd9\u4e9b\u5c11\u6570\u4e2a\u4f53\u6765\u8bf4\uff0c\u8fd9\u4e24\u79cd\u5236\u5242\u5e76\u4e0d\u663e\u793a\u751f\u7269\u7b49\u6548\u6027<span style=\"font-size: 14px;\"><sup><span style=\"vertical-align: super;\">[1]<\/span><\/sup><\/span>\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"width: 20px;height: 20px;float: left;border-bottom: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-bottom: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" 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 class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"display: inline-block;vertical-align: top;box-sizing: border-box;\">\n<section style=\"width: 45px;height: 5px;margin-left: auto;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section class=\"\" style=\"margin-top: -3px;margin-bottom: -3px;transform: rotate(0deg);border-width: 1px;border-style: solid;border-color: rgb(0, 0, 0);padding-left: 8px;padding-right: 8px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u4e09\u3001\u5bf9\u79bb\u7fa4\u503c\u7684\u4e00\u822c\u8003\u8651<\/strong><\/p>\n<\/section>\n<section style=\"width: 45px;height: 5px;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><br  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 0.5em;margin-bottom: 0.5em;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section style=\"width: 20px;height: 20px;float: left;border-top: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-top: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<section style=\"margin-top: -20px;margin-bottom: -20px;box-sizing: border-box;\">\n<section class=\"\" style=\"border-width: 2px;border-style: dotted;border-color: rgb(233, 233, 233);padding: 10px 20px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><span style=\"color: rgb(45, 69, 152);box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">1. \u57fa\u672c\u8003\u8651<\/strong><\/span><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u867d\u7136\u76ee\u524d\u7528\u4e8e\u5224\u5b9a\u79bb\u7fa4\u503c\u7684\u7edf\u8ba1\u5b66\u65b9\u6cd5\u6709\u5f88\u591a\uff0c\u4f46\u662f\u5373\u4f7f\u5728\u7edf\u8ba1\u5b66\u9a8c\u8bc1\u7684\u57fa\u7840\u4e0a\uff0c\u4e5f\u4e0d\u80fd\u7b80\u5355\u5730\u8ba4\u4e3a\u67d0\u4e2a\u7ed3\u679c\u88ab\u5224\u5b9a\u4e3a\u79bb\u7fa4\u503c\u5c31\u53ef\u4ee5\u76f4\u63a5\u5254\u9664\u3002\u56e0\u4e3a\u4e0d\u5408\u7406\u5254\u9664\u79bb\u7fa4\u503c\u53ef\u80fd\u4f1a\u5bfc\u81f4\u539f\u6765\u4e0d\u7b49\u6548\u7684\u7ed3\u679c\u53d8\u6210\u7b49\u6548\uff0c\u4ece\u800c\u4f7f\u7814\u7a76\u7ed3\u8bba\u4e3a\u751f\u7269\u7b49\u6548\u7684\u5236\u5242\u5b58\u5728\u6f5c\u5728\u4e0d\u7b49\u6548\u98ce\u9669\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u6211\u56fd\u53d1\u5e03\u7684\u300a\u751f\u7269\u6837\u54c1\u5b9a\u91cf\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219\u300b<span style=\"font-size: 14px;\"><sup><span style=\"vertical-align: super;\">[2]<\/span><\/sup><\/span>\u4e25\u683c\u89c4\u5b9a\uff0c\u5bf9\u4e8e\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\uff0c\u901a\u5e38\u4e0d\u80fd\u63a5\u53d7\u7531\u4e8e\u836f\u52a8\u5b66\u7406\u7531\u91cd\u65b0\u5206\u6790\u8bd5\u9a8c\u6837\u54c1\u3002\u540c\u6837\u5730\uff0cFDA\u300a\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u4e2d\u8981\u6c42<span style=\"font-size: 14px;\"><sup><span style=\"vertical-align: super;\">[1]<\/span><\/sup><\/span>\uff0c\u5728\u5236\u5242\u5931\u8d25\u7684\u60c5\u51b5\u4e0b\uff0c\u53d7\u8bd5\u5236\u5242\u6216\u53c2\u6bd4\u5236\u5242\u90fd\u6709\u53ef\u80fd\u4f1a\u51fa\u73b0\u79bb\u7fa4\u503c\u3002\u4f46\u662f\uff0c\u5c31\u4e9a\u7fa4\u800c\u8a00\uff0c\u5373\u4f7f\u5728\u53c2\u6bd4\u5236\u5242\u4e0a\u89c2\u5bdf\u5230\u4e0d\u5bfb\u5e38\u7684\u54cd\u5e94\uff0c\u4ecd\u7136\u53ef\u80fd\u4f1a\u62c5\u5fc3\u4e24\u79cd\u5236\u5242\u7f3a\u4e4f\u53ef\u66ff\u6362\u6027\u3002\u7279\u522b\u662f\u5bf9\u4e8e\u975e\u91cd\u590d\u8bbe\u8ba1\u8bd5\u9a8c\uff0c\u901a\u5e38\u4e0d\u5efa\u8bae\u57fa\u4e8e\u4e0a\u8ff0\u539f\u56e0\u5254\u9664\u79bb\u7fa4\u503c\u3002\u4f7f\u7528\u91cd\u590d\u7684\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u8bbe\u8ba1\u7684\u91cd\u65b0\u6d4b\u8bd5\u7279\u5f81\u5e94\u8be5\u80fd\u5bf9\u662f\u5426\u5220\u9664\u79bb\u7fa4\u503c\u8d77\u5230\u6307\u793a\u4f5c\u7528\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u82e5\u8ba4\u4e3a\u67d0\u4e2a\u6570\u636e\u70b9\u4e3a\u79bb\u7fa4\u503c\uff0c\u5176\u539f\u56e0\u5e94\u8be5\u5177\u6709\u7edf\u8ba1\u4e0a\u7684\u8bf4\u670d\u529b\uff0c\u5e76\u4e14\u5982\u679c\u53ef\u80fd\u7684\u8bdd\uff0c\u5e94\u5728\u65b9\u6848\u4e2d\u9884\u5148\u89c4\u5b9a\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">EMA\u300a\u5173\u4e8e\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u6307\u5bfc\u539f\u5219\u300b<span style=\"font-size: 14px;\"><sup><span style=\"vertical-align: super;\">[3]<\/span><\/sup><\/span>\u4e2d\u8981\u6c42\uff0c\u4ec5\u4ec5\u57fa\u4e8e\u7edf\u8ba1\u5b66\u5206\u6790\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u539f\u56e0\u5254\u9664\u6570\u636e\u662f\u4e0d\u88ab\u5141\u8bb8\u7684\uff0c\u56e0\u4e3a\u4e0d\u53ef\u80fd\u5c06\u5236\u5242\u6548\u5e94\u4e0e\u5176\u4ed6\u5f71\u54cd\u836f\u4ee3\u52a8\u529b\u5b66\u7684\u5f71\u54cd\u56e0\u7d20\u533a\u5206\u5f00\u6765\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><span style=\"color: rgb(45, 69, 152);box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">2. \u7279\u6b8a\u60c5\u51b5<\/strong><\/span><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u79bb\u7fa4\u503c\u53ef\u80fd\u662f\u7531\u4e8e\u610f\u5916\u4e8b\u4ef6\uff0c\u5982\u6280\u672f\u7f3a\u9677\u5f15\u8d77\u7684\uff0c\u5982\u53d1\u751f\u6b64\u7c7b\u7279\u6b8a\u60c5\u51b5\uff0c\u7533\u8bf7\u4eba\u5e94\u8be5\u63d0\u4f9b\u8db3\u591f\u7684\u79d1\u5b66\u8bc1\u636e\u6765\u8bc1\u660e\u3002EMA\u300a\u5173\u4e8e\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u6307\u5bfc\u539f\u5219\u300b<span style=\"font-size: 14px;\"><sup><span style=\"vertical-align: super;\">[3]<\/span><\/sup><\/span>\u4e2d\u5bf9\u4e8e\u51e0\u79cd\u7279\u6b8a\u60c5\u51b5\u7684\u5904\u7406\u65b9\u5f0f\u4f5c\u4e86\u8f83\u4e3a\u5177\u4f53\u7684\u89c4\u5b9a\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\uff081\uff09\u670d\u7528\u53c2\u6bd4\u5236\u5242\u7684\u53d7\u8bd5\u8005\u7f3a\u4e4f\u4efb\u4f55\u53ef\u6d4b\u6d53\u5ea6\u6216\u53ea\u6709\u975e\u5e38\u4f4e\u7684\u8840\u6d46\u6d53\u5ea6\u3002\u5982\u679cAUC\u5c0f\u4e8e\u53c2\u6bd4\u5236\u5242AUC\u51e0\u4f55\u5747\u503c\u76845\uff05\uff08\u5e94\u6392\u9664\u79bb\u7fa4\u503c\u53d7\u8bd5\u8005\u7684\u6570\u636e\uff09\uff0c\u5219\u8ba4\u4e3a\u53d7\u8bd5\u8005\u5177\u6709\u975e\u5e38\u4f4e\u7684\u8840\u6d46\u6d53\u5ea6\u3002\u57fa\u4e8e\u6b64\u539f\u56e0\u6392\u9664\u6570\u636e\u53ea\u4f1a\u5728\u7279\u6b8a\u60c5\u51b5\u4e0b\u88ab\u63a5\u53d7\uff0c\u5e76\u4e14\u5ba1\u8bc4\u53ef\u80fd\u5bf9\u8bd5\u9a8c\u7684\u6709\u6548\u6027\u63d0\u51fa\u8d28\u7591\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\uff082\uff09\u53d7\u8bd5\u8005\u7684\u57fa\u7ebf\u6d53\u5ea6\u975e\u96f6\u4e14&gt; 5\uff05&nbsp;<span style=\"font-size: 16px;text-align: justify;text-indent: 37px;font-family: \u4eff\u5b8b;\">C<\/span><sub style=\"text-align: justify;white-space: normal;text-indent: 37px;\"><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1;vertical-align: sub;\">max<\/span><\/sub>\uff0c\u8fd9\u4e9b\u6570\u636e\u5e94\u4ece\u751f\u7269\u7b49\u6548\u6027\u8ba1\u7b97\u4e2d\u5254\u9664\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">EMA\u4e00\u4efd\u5173\u4e8e\u6c28\u6c2f\u5730\u5e73\/\u7f2c\u6c99\u5766\u7684\u5ba1\u8bc4\u62a5\u544a\u4e2d<span style=\"font-size: 14px;\"><sup><span style=\"vertical-align: super;\">[4]<\/span><\/sup><\/span>\uff0c\u76d1\u7ba1\u673a\u6784\u63a5\u53d7\u4e86\u7531\u4e8e\u4e0a\u8ff0\u7b2c\u4e00\u79cd\u60c5\u51b5\u800c\u5254\u9664\u53d7\u8bd5\u8005\u7684\u7814\u7a76\u7ed3\u679c\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><span style=\"color: rgb(45, 69, 152);box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">3. \u518d\u7ed9\u836f\u7814\u7a76<\/strong><\/span><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u7533\u8bf7\u4eba\u6000\u7591\u53d7\u8bd5\u8005\u670d\u836f\u65f6\u51fa\u73b0\u65b9\u6848\u504f\u79bb\uff0c\u5e0c\u671b\u901a\u8fc7\u5bf9\u5b58\u5728\u79bb\u7fa4\u503c\u7684\u53d7\u8bd5\u8005\u91cd\u65b0\u7ed9\u836f\uff0c\u5e76\u91cd\u65b0\u8fdb\u884c\u8840\u6837\u91c7\u96c6\u548c\u8840\u836f\u6d53\u5ea6\u68c0\u6d4b\uff0c\u4ee5\u8bc1\u5b9e\u5254\u9664\u79bb\u7fa4\u503c\u7684\u5408\u7406\u6027\u3002FDA\u8ba4\u4e3a\uff0c\u5982\u679c\u518d\u7ed9\u836f\u7814\u7a76\u5305\u62ec\u53ef\u7591\u53d7\u8bd5\u8005\u548c\u4e00\u5b9a\u6bd4\u4f8b\u7684\u6765\u81ea\u9996\u6b21BE\u7814\u7a76\u7684\u53d7\u8bd5\u8005\u4f5c\u4e3a\u5bf9\u7167\uff0c\u4e14\u53d7\u8bd5\u8005\u7684\u4f8b\u6570\u5e94\u80fd\u4f7f\u518d\u7ed9\u836f\u7814\u7a76\u5177\u6709\u4e00\u5b9a\u7684\u628a\u63e1\u5ea6\uff0c\u5219\u53ef\u4ee5\u901a\u8fc7\u518d\u7ed9\u836f\u7684\u65b9\u5f0f\u6765\u8bc1\u660e\u7279\u6b8a\u539f\u56e0\u5f15\u8d77\u7684\u79bb\u7fa4\u503c\u3002\u82e5\u53ef\u7591\u53d7\u8bd5\u8005\u5728\u518d\u7ed9\u836f\u7814\u7a76\u4e2d\u663e\u793a\u6b63\u5e38\u54cd\u5e94\uff0c\u5219\u53ef\u4ee5\u8bc1\u5b9e\u5728\u9996\u6b21BE\u7814\u7a76\u4e2d\u54cd\u5e94\u786e\u5b9e\u5f02\u5e38\uff0c\u5e76\u63a5\u53d7\u4ece\u539fBE\u7814\u7a76\u4e2d\u5254\u9664\u79bb\u7fa4\u503c\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">EMA\u5bf9\u518d\u7ed9\u836f\u7814\u7a76\u5219\u6709\u4e0d\u540c\u7684\u8ba4\u8bc6\u3002\u5728OVERVIEW OF COMMENTS RECEIVED ON DRAFT GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE<span style=\"font-size: 14px;\"><sup><span style=\"vertical-align: super;\">[5]<\/span><\/sup><\/span>\u4e2d\u663e\u793a\uff0c\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u7ecf\u836f\u4ee3\u52a8\u529b\u5b66\u5206\u6790\u540e\u4f1a\u53d1\u73b0\u4e00\u4e9b\u54cd\u5e94\u5f02\u5e38\u7684\u8840\u6d46\u6837\u672c\uff0c\u5373\u4f7f\u5728\u6574\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5e76\u6ca1\u6709\u62a5\u9053\u8fc7\u4efb\u4f55\u7684\u4e8b\u4ef6\uff0c\u4e5f\u4f1a\u5b58\u5728\u53d7\u8bd5\u8005\u672a\u541e\u54bd\u836f\u54c1\u7684\u53ef\u80fd\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u5e94\u8be5\u53ef\u4ee5\u8fdb\u884c\u91cd\u65b0\u7ed9\u836f\u7814\u7a76\uff0c\u4ee5\u8bc1\u660e\u521d\u59cb\u7814\u7a76\u7684\u79bb\u7fa4\u503c\uff0c\u5e76\u6839\u636e\u91cd\u65b0\u7ed9\u836f\u7814\u7a76\u7684\u7ed3\u679c\u4ece\u8bc4\u4ef7\u4e2d\u5254\u9664\u8be5\u53d7\u8bd5\u8005\u3002\u4f46\u5bf9\u4e8e\u4ee5\u4e0a\u5efa\u8bae\uff0cEMA\u6700\u7ec8\u5f97\u51fa\u7684\u7ed3\u8bba\u4e3a\uff1a\u76ee\u524d\u6682\u4e0d\u652f\u6301\u518d\u7ed9\u836f\u7814\u7a76\uff0c\u56e0\u4e3a\u67d0\u4e2a\u7ed3\u679c\u5728\u91cd\u65b0\u7ed9\u836f\u65f6\u672a\u91cd\u73b0\u5e76\u4e0d\u610f\u5473\u7740\u8fd9\u4e2a\u7ed3\u679c\u662f\u4e0d\u771f\u5b9e\u7684\u3002EMA\u5e76\u4e0d\u671f\u671b\u6bcf\u6b21\u90fd\u4f1a\u6709\u540c\u6837\u7684\u7ed3\u679c\u3002\u4efb\u4f55\u4fa7\u91cd\u4e8e\u5c06\u5177\u6709\u8f83\u5927\u5dee\u5f02\u7684\u7ed3\u679c\u4f5c\u4e3a\u6392\u65a5\u76ee\u6807\u7684\u65b9\u6cd5\u90fd\u4f1a\u589e\u52a0\u9519\u8bef\u5730\u663e\u793a\u7b49\u6548\u6027\u7684\u53ef\u80fd<span style=\"font-size: 14px;\"><sup><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1;vertical-align: super;\">[5]<\/span><\/sup><\/span>\u3002\u8fd9\u4e0e\u6211\u56fd\u6307\u5bfc\u539f\u5219\u4e2d\u901a\u5e38\u4e0d\u80fd\u63a5\u53d7\u7531\u4e8e\u836f\u52a8\u5b66\u7406\u7531\u91cd\u65b0\u5206\u6790\u8bd5\u9a8c\u6837\u54c1\u7684\u89c4\u5b9a\u662f\u4e00\u81f4\u7684\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"width: 20px;height: 20px;float: left;border-bottom: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-bottom: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" 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 class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"display: inline-block;vertical-align: top;box-sizing: border-box;\">\n<section style=\"width: 45px;height: 5px;margin-left: auto;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section class=\"\" style=\"margin-top: -3px;margin-bottom: -3px;transform: rotate(0deg);border-width: 1px;border-style: solid;border-color: rgb(0, 0, 0);padding-left: 8px;padding-right: 8px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u56db\u3001\u4e0d\u5408\u7406\u5254\u9664\u73b0\u8c61\u4e3e\u4f8b<\/strong><\/p>\n<\/section>\n<section style=\"width: 45px;height: 5px;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><br  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 0.5em;margin-bottom: 0.5em;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section style=\"width: 20px;height: 20px;float: left;border-top: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-top: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<section style=\"margin-top: -20px;margin-bottom: -20px;box-sizing: border-box;\">\n<section class=\"\" style=\"border-width: 2px;border-style: dotted;border-color: rgb(233, 233, 233);padding: 10px 20px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u53d1\u73b0\uff0c\u76ee\u524d\u7533\u62a5\u8d44\u6599\u4e2d\u5b58\u5728\u4e00\u4e9b\u4e0d\u5408\u7406\u5254\u9664\u6570\u636e\u7684\u73b0\u8c61\uff0c\u4ee5\u67d0\u79cd\u4e0d\u6070\u5f53\u7684\u7406\u7531\u5254\u9664\u4e3b\u89c2\u4e0a\u8ba4\u4e3a\u4e0d\u5408\u7406\u7684\u6570\u636e\uff0c\u4ece\u800c\u8fbe\u5230\u8bd5\u9a8c\u7ed3\u679c\u7b26\u5408\u751f\u7269\u7b49\u6548\u6027\u6807\u51c6\u7684\u76ee\u7684\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u5982\uff1a\u67d0BE\u7814\u7a76\u62a5\u544a\u4e2d\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242&nbsp;<span style=\"font-size: 16px;text-align: justify;text-indent: 37px;font-family: \u4eff\u5b8b;\">C<\/span><sub style=\"text-align: justify;white-space: normal;text-indent: 37px;\"><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1;vertical-align: sub;\">max<\/span><\/sub>\u51e0\u4f55\u5747\u503c\u4e4b\u6bd4\u768490%\u7f6e\u4fe1\u533a\u95f4\u4e3a96.2%~124.3%\uff0c\u4f46\u7814\u7a76\u4ee5\u67d0\u53d7\u8bd5\u8005\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\uff08\u836f\u540e4\u5c0f\u65f6\uff09\u51fa\u73b0\u4f4e\u8840\u7cd6\u670d\u7528\u4e86\u5de7\u514b\u529b\u4e3a\u7531\uff0c\u5254\u9664\u4e86\u8be5\u4f8b\u53d7\u8bd5\u8005\uff08T<span style=\"font-size: 16px;\"><sub style=\"text-indent: 37px;\"><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1;vertical-align: sub;\">max<\/span><\/sub><\/span><span style=\"text-indent: 37px;\">\u4e3a3\u5c0f\u65f6\uff09\u7684\u5168\u90e8\u6570\u636e\uff0c\u5c06\u8be5\u53d7\u8bd5\u8005\u6570\u636e\u91cd\u65b0\u7eb3\u5165\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790\uff0c\u7ed3\u679c\u663e\u793a\uff0c\u4e24\u5236\u5242<\/span><span style=\"text-indent: 37px;font-size: 16px;font-family: \u4eff\u5b8b;\">C<\/span><sub style=\"text-indent: 37px;\"><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1;vertical-align: sub;\">max<\/span><\/sub><span style=\"text-indent: 37px;\">\u51e0\u4f55\u5747\u503c\u4e4b\u6bd4\u768490%\u7f6e\u4fe1\u533a\u95f4\u4e3a99.7%~126.7%\uff0c\u663e\u7136\u4e24\u5236\u5242\u5b58\u5728\u4e0d\u7b49\u6548\u98ce\u9669\u3002<\/span><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u53e6\u4e00BE\u7814\u7a76\u62a5\u544a\u4e2d\u4ee5\u67d0\u53d7\u8bd5\u8005\u8bd5\u9a8c\u7ed3\u675f\u540e\u5c3f\u6db2\u7ea2\u7ec6\u80de\u4e00\u4e2a\u201c+\u201d\u4e3a\u7531\uff0c\u672a\u5c06\u8be5\u53d7\u8bd5\u8005\u6570\u636e\u7eb3\u5165BE\u5206\u6790\u96c6\uff0cAUC\u548c<span style=\"text-indent: 37px;font-family: \u4eff\u5b8b;font-size: 19px;\"><\/span><span style=\"text-align: justify;\">&nbsp;<\/span><span style=\"font-size: 16px;text-align: justify;text-indent: 37px;font-family: \u4eff\u5b8b;\">C<\/span><sub style=\"text-align: justify;white-space: normal;text-indent: 37px;\"><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1;vertical-align: sub;\">max<\/span><\/sub><sub style=\"text-indent: 37px;\"><span style=\"font-family:\u5fae\u8f6f\u96c5\u9ed1;font-size:21px;vertical-align:sub;\"><\/span><\/sub><span style=\"text-indent: 37px;\">\u5747\u7b26\u5408\u751f\u7269\u7b49\u6548\u6807\u51c6\u3002\u4f46\u5ba1\u8bc4\u53d1\u73b0\uff0c\u8be5\u53d7\u8bd5\u8005\u7b5b\u9009\u671f\u5c31\u51fa\u73b0\u4e86\u5c3f\u6db2\u7ea2\u7ec6\u80de\u4e00\u4e2a\u201c+\u201d\uff0c\u5374\u672a\u5c06\u5176\u5254\u9664\uff0c\u8be5\u53d7\u8bd5\u8005\u5b8c\u6210\u4e86\u5168\u90e8\u8bd5\u9a8c\u3002\u5c06\u8be5\u53d7\u8bd5\u8005\u6570\u636e\u91cd\u65b0\u7eb3\u5165\u5e76\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\uff0c\u7ed3\u679c\u663e\u793a\uff0c\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242AUC\u51e0\u4f55\u5747\u503c\u4e4b\u6bd4\u768490%\u7f6e\u4fe1\u533a\u95f4\u4e3a76.4%~114.1%\uff0c\u56e0\u6b64\u5ba1\u8bc4\u4e0d\u80fd\u63a5\u53d7\u4e24\u5236\u5242\u751f\u7269\u7b49\u6548\u7684\u7ed3\u8bba\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"width: 20px;height: 20px;float: left;border-bottom: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-bottom: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" 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 class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"display: inline-block;vertical-align: top;box-sizing: border-box;\">\n<section style=\"width: 45px;height: 5px;margin-left: auto;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section class=\"\" style=\"margin-top: -3px;margin-bottom: -3px;transform: rotate(0deg);border-width: 1px;border-style: solid;border-color: rgb(0, 0, 0);padding-left: 8px;padding-right: 8px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u4e94\u3001\u7ed3\u8bed<\/strong><\/p>\n<\/section>\n<section style=\"width: 45px;height: 5px;line-height: 5px;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><br  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 0.5em;margin-bottom: 0.5em;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section style=\"width: 20px;height: 20px;float: left;border-top: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-top: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<section style=\"margin-top: -20px;margin-bottom: -20px;box-sizing: border-box;\">\n<section class=\"\" style=\"border-width: 2px;border-style: dotted;border-color: rgb(233, 233, 233);padding: 10px 20px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u5bf9\u4e8e\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u7684\u79bb\u7fa4\u503c\u5e94\u5f53\u975e\u5e38\u8c28\u614e\uff0c\u5982\u679c\u5236\u5242\u53ef\u80fd\u672c\u8eab\u5e76\u4e0d\u7b49\u6548\uff0c\u4e0d\u6392\u9664\u5b58\u5728\u7533\u8bf7\u4eba\u4e3b\u89c2\u5730\u9009\u62e9\u548c\u6392\u9664\u6f5c\u5728\u79bb\u7fa4\u503c\u4ece\u800c\u6539\u53d8\u751f\u7269\u7b49\u6548\u6027\u7ed3\u8bba\u7684\u53ef\u80fd\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u901a\u5e38\u60c5\u51b5\u4e0b\uff0c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u4e0d\u5efa\u8bae\u5254\u9664\u79bb\u7fa4\u503c\u3002\u5bf9\u67d0\u4e9b\u7279\u6b8a\u60c5\u51b5\u4e0b\u53ef\u80fd\u771f\u5b9e\u5b58\u5728\u7684\u79bb\u7fa4\u503c\u4e88\u4ee5\u8ba4\u53ef\uff0c\u5e76\u4e0d\u610f\u5473\u7740\u53ef\u4ee5\u968f\u610f\u57fa\u4e8e\u836f\u52a8\u5b66\u539f\u56e0\u5254\u9664\u6570\u636e\u3002\u4e0d\u5408\u7406\u5254\u9664\u79bb\u7fa4\u503c\uff0c\u4f7f\u539f\u672c\u4e0d\u7b49\u6548\u7684\u5236\u5242\u5f97\u51fa\u76f8\u53cd\u7684\u7ed3\u8bba\uff0c\u53ef\u80fd\u7ed9\u516c\u4f17\u7528\u836f\u5b89\u5168\u5e26\u6765\u6781\u5927\u98ce\u9669\u3002<\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"clear: none;white-space: normal;box-sizing: border-box;\">\u7533\u8bf7\u4eba\u5e94\u5728\u5f00\u5c55\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u524d\u8fdb\u884c\u5145\u5206\u7684\u5236\u5242\u7814\u7a76\uff0c\u786e\u4fdd\u5236\u5242\u8d28\u91cf\u5747\u4e00\u3001\u53ef\u63a7\uff0c\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u5e94\u4e25\u683c\u63a7\u5236\u8bd5\u9a8c\u8d28\u91cf\uff0c\u628a\u63a7\u597d\u6bcf\u4e00\u4e2a\u7ec6\u8282\uff0c\u5c3d\u91cf\u907f\u514d\u8bd5\u9a8c\u504f\u79bb\uff0c\u624d\u80fd\u5728\u6839\u672c\u4e0a\u907f\u514d\u79bb\u7fa4\u503c\u7684\u51fa\u73b0\uff0c\u786e\u4fdd\u8bd5\u9a8c\u6570\u636e\u7684\u53ef\u9760\u6027\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"width: 20px;height: 20px;float: left;border-bottom: 2px solid rgb(45, 69, 152);border-left: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"width: 20px;height: 20px;float: right;border-bottom: 2px solid rgb(45, 69, 152);border-right: 2px solid rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" 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 class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u53c2\u8003\u6587\u732e:<br style=\"box-sizing: border-box;\"  \/><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section class=\"\" style=\"padding-left: 8px;padding-bottom: 8px;box-sizing: border-box;\">\n<section style=\"border-width: 1px;border-style: solid;border-color: rgb(192, 200, 209);box-sizing: border-box;\">\n<section style=\"height: 8px;width: 100%;border-right: 1px solid rgb(192, 200, 209);transform: rotate(45deg);-webkit-transform: rotate(45deg);-moz-transform: rotate(45deg);-o-transform: rotate(45deg);transform-origin: right top 0px;-webkit-transform-origin: right top 0px;-moz-transform-origin: right top 0px;-o-transform-origin: right top 0px;margin-bottom: 4px;border-top-color: rgb(192, 200, 209);border-bottom-color: rgb(192, 200, 209);border-left-color: rgb(192, 200, 209);box-sizing: border-box;\"><\/section>\n<section class=\"\" style=\"background-color: rgb(255, 255, 255);margin: -7px 4px -8px -6px;border-width: 1px;border-style: solid;border-color: rgb(192, 200, 209);padding: 10px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"font-size: 14px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">[1] Statistical Approaches to Establishing Bioequivalence. https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm070244.pdf. January 2001.<\/p>\n<p style=\"box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"box-sizing: border-box;\">[2] \u300a9012 \u751f\u7269\u6837\u54c1\u5b9a\u91cf\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219\u300b. \u4e2d\u56fd\u836f\u51782015\u5e74\u7248. 363-368.<\/p>\n<p style=\"box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"box-sizing: border-box;\">[3] GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2010\/01\/WC500070039.pdf.&nbsp;01\/08\/2010.<\/p>\n<p style=\"box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"box-sizing: border-box;text-align: left;\">[4] Assessment report Amlodipine\/Valsartan Mylan. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Public_assessment_report\/human\/004037\/WC500204384.pdf.&nbsp;28 January 2016.<\/p>\n<p style=\"box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"box-sizing: border-box;\">[5] OVERVIEW OF COMMENTS RECEIVED ON DRAFT GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE CPMP\/EWP\/QWP\/1401\/98 REV. 1. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2010\/02\/WC500073572.pdf.&nbsp;10\/02\/2010<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: right;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u7edf\u8ba1\u4e0e\u4e34\u5e8a\u836f\u7406\u5b66\u90e8\u4f9b\u7a3f\uff09<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"box-sizing: border-box;\" >\n<section class=\"\" style=\"margin-top: 0.5em;margin-bottom: 0.5em;text-align: center;box-sizing: border-box;\"><img class=\"\"     style=\"width: 100%;max-height: 1.2em !important;box-sizing: border-box;\" width=\"100%\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress6-1532682787.png\" alt=\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u79bb\u7fa4\u503c\u7684\u4e00\u822c\u8003\u8651\" title=\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u79bb\u7fa4\u503c\u7684\u4e00\u822c\u8003\u8651\"  \/> <\/p>\n<section class=\"\" style=\"width: 0.6em;height: 0.6em;margin: -0.9em auto 0.9em;box-sizing: border-box;\">\n<section style=\"width: 100%;height: 100%;margin-left: 1px;border-radius: 100%;background-color: rgb(45, 69, 152);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<blockquote class='keep-source'>\n<p>\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a                         \u4e2d\u56fd\u836f\u5ba1                      <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\uff08Bioequivalence\uff0cBE\uff09\u662f\u8bc4\u4ef7\u540c\u4e00\u836f\u7269\u4e0d\u540c\u5236\u5242\u95f4\u5dee\u5f02\u53ca\u4eff\u5236\u836f\u4e0e\u539f\u7814\u5236\u5242\u95f4\u53ef\u66ff\u6362\u6027\u7684 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6266,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/6265"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=6265"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/6265\/revisions"}],"predecessor-version":[{"id":6270,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/6265\/revisions\/6270"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/6266"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=6265"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=6265"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=6265"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}