{"id":98099,"date":"2019-02-25T00:00:50","date_gmt":"2019-05-17T08:13:03","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98099\/"},"modified":"2019-05-17T16:13:07","modified_gmt":"2019-05-17T08:13:07","slug":"7c5d14a558","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98099\/","title":{"rendered":"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section style=\"box-sizing: border-box;font-size: 16px;\">\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 15px;height: 15px;margin-left: auto;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\">\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\">\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<section style=\"margin-top: -15px;background-color: rgb(255, 129, 36);padding: 10px;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"text-align: center;color: rgb(255, 255, 255);font-size: 20px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"width: 15px;height: 15px;margin-top: -15px;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\">\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\">\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"width: 5px;height: 5px;float: left;background-color: rgb(255, 255, 255);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"text-align: center;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">Generating Model Integrated Evidence for Generic Drug Development and Assessment<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;text-align: center;box-sizing: border-box;\"><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/2-1558080784.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<section style=\"display: inline-block;vertical-align: top;max-width: 100%;border-radius: 3px 3px 0px 0px;margin-right: 3px;margin-left: 3px;background-color: rgb(255, 129, 36);color: rgb(255, 255, 255);font-size: 18px;padding-left: 6px;padding-right: 6px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u6765\u6e90<\/strong><\/p>\n<\/section>\n<p><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/4-1558080784.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/section>\n<section style=\"width: 100%;font-size: 0px;margin-top: -2px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 100%;margin-right: -6px;margin-left: -6px;border-bottom: 2px solid rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"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;\">Clinical Pharmacology &amp; Therapeutics | 2019,<\/p>\n<p style=\"box-sizing: border-box;\">IF=6.544<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;text-align: center;box-sizing: border-box;\"><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/9-1558080784.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<section style=\"display: inline-block;vertical-align: top;max-width: 100%;border-radius: 3px 3px 0px 0px;margin-right: 3px;margin-left: 3px;background-color: rgb(255, 129, 36);color: rgb(255, 255, 255);font-size: 18px;padding-left: 6px;padding-right: 6px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u4f5c\u8005<\/strong><\/p>\n<\/section>\n<p><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/7-1558080784.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/section>\n<section style=\"width: 100%;font-size: 0px;margin-top: -2px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 100%;margin-right: -6px;margin-left: -6px;border-bottom: 2px solid rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"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;\">Liang Zhao1, Myong-Jin Kim1, Lei Zhang2 , Robert Lionberger2<\/p>\n<p style=\"box-sizing: border-box;\">1. \u7f8e\u56fdFDA\uff0cCDER\uff0c\u4eff\u5236\u836f\u529e\u516c\u5ba4OGD\uff0c\u7814\u7a76\u4e0e\u6807\u51c6\u5316\u529e\u516c\u5ba4ORS\u7684\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21\u90e8\u95e8QMM<\/p>\n<p style=\"box-sizing: border-box;\">&nbsp;2. \u7f8e\u56fdFDA\uff0cCDER\uff0c\u4eff\u5236\u836f\u529e\u516c\u5ba4OGD\uff0c\u7814\u7a76\u4e0e\u6807\u51c6\u5316\u529e\u516c\u5ba4ORS<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;text-align: center;box-sizing: border-box;\"><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/8-1558080784.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<section style=\"display: inline-block;vertical-align: top;max-width: 100%;border-radius: 3px 3px 0px 0px;margin-right: 3px;margin-left: 3px;background-color: rgb(255, 129, 36);color: rgb(255, 255, 255);font-size: 18px;padding-left: 6px;padding-right: 6px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u7ffb\u8bd1<\/strong><\/p>\n<\/section>\n<p><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/4-1558080785.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/section>\n<section style=\"width: 100%;font-size: 0px;margin-top: -2px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 100%;margin-right: -6px;margin-left: -6px;border-bottom: 2px solid rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"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;\">\u56e2\u961f<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;text-align: center;box-sizing: border-box;\"><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/5-1558080785.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<section style=\"display: inline-block;vertical-align: top;max-width: 100%;border-radius: 3px 3px 0px 0px;margin-right: 3px;margin-left: 3px;background-color: rgb(255, 129, 36);color: rgb(255, 255, 255);font-size: 18px;padding-left: 6px;padding-right: 6px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u5bfc\u8bfb<\/strong><\/p>\n<\/section>\n<p><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/4-1558080785-1.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/section>\n<section style=\"width: 100%;font-size: 0px;margin-top: -2px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 100%;margin-right: -6px;margin-left: -6px;border-bottom: 2px solid rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u672c\u6587\u9610\u8ff0\u4e86FDA\u91c7\u7528\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u8054\u7528\u6a21\u578b\u6574\u5408\u5b9e\u8bc1MIE\u7684\u65b9\u6cd5\u4fc3\u8fdb\u4eff\u5236\u836f\u5ba1\u6279\u7684\u76d1\u7ba1\u51b3\u7b56\u6216\u5f00\u53d1BE\u65b0\u7684\u8bc4\u4ef7\u6307\u6807\u3002\u53ea\u6709\u901a\u8fc7\u5145\u5206\u77e5\u8bc6\u548c\u4fe1\u606f\u9a8c\u8bc1\u548c\u786e\u8ba4\u540e\u7684\u6a21\u578b\uff08\u5982\u751f\u7406\u836f\u4ee3\u52a8\u529b\u5b66PBPK\uff0c\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP\uff09\u624d\u80fd\u6210\u4e3aMIE\uff0c\u5e76\u7528\u4e8e\u76d1\u7ba1\u51b3\u7b56\u3002\u6b64\u5916\uff0c\u8fd8\u4ecb\u7ecd\u4e86\u51e0\u4e2a\u5e94\u7528\u5b9e\u4f8b\u6765\u8bf4\u660eQMM\u5728\u4eff\u5236\u836f\u5ba1\u6279\u4e2d\u7684\u5b9e\u7528\u6027\u548c\u5f71\u54cd\u3002<\/p>\n<p style=\"box-sizing: border-box;text-align: center;\"><strong>FDA \u5728\u76d1\u7ba1\u4e2d\u4f7f\u7528\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM \u7684\u90e8\u5206\u6848\u4f8b(\u81f32018\uff09<\/strong><\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/9-1558080785.jpg\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;text-align: center;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;max-width: 100%;border-radius: 3px 3px 0px 0px;margin-right: 3px;margin-left: 3px;background-color: rgb(255, 129, 36);color: rgb(255, 255, 255);font-size: 18px;padding-left: 6px;padding-right: 6px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u6458\u8981<\/strong><\/p>\n<\/section>\n<p><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/4-1558080786.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/section>\n<section style=\"width: 100%;font-size: 0px;margin-top: -2px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 100%;margin-right: -6px;margin-left: -6px;border-bottom: 2px solid rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21\u7406\u5ff5\uff08QMM\uff0cQuantitative methods and modeling\uff09\u5305\u62ec\u5f88\u591a\u53ef\u4f9b\u4f7f\u7528\u7684\u5de5\u5177\uff0c\u9488\u5bf9\u4eff\u5236\u836f\u9886\u57df\uff0c\u6700\u5173\u952e\u7684\u5de5\u5177\u662f\u57fa\u4e8e\u751f\u7406\u5b66\u7684\u6a21\u578b\u548c\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66\u3002\u7f8e\u56fdFDA\u4f7f\u7528\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u65e5\u76ca\u589e\u591a\uff0c\u7528\u4e8e\u4fc3\u8fdb\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u5ba1\u8bc4\uff0c\u5e76\u4e14\u5728\u751f\u7269\u7b49\u6548\u6027BE\u8bc4\u4f30\u7684\u73b0\u4ee3\u5316\u8fdb\u7a0b\u4e2d\u53d1\u6325\u5173\u952e\u7684\u4f5c\u7528\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u5c40\u90e8\u4f5c\u7528\u836f\u54c1\uff0c\u5176\u4ed6\u7c7b\u578b\u7684\u590d\u6742\u836f\u54c1\uff0c\u8c03\u91ca\u56fa\u4f53\u53e3\u670d\u5236\u5242MR\u3002QMM\u5df2\u7528\u4e8e\u534f\u52a9\u5f00\u53d1\u4ee5\u4e0b\u7684\u65b9\u6cd5\uff1a\u65b0\u7684BE\u8bc4\u4ef7\u65b9\u6cd5\uff0c\u53ea\u6709\u4f53\u5916\u6570\u636e\u7684BE\u8bc4\u4ef7\u65b9\u6cd5\uff0c\u57fa\u4e8e\u98ce\u9669\u7684\u8bc4\u4f30\u65b9\u6cd5\u3002QMM\u672a\u6765\u7684\u53d1\u5c55\u65b9\u5411\u662f\u5c06\u6a21\u578b\u548c\u8bd5\u9a8c\u8bc1\u636e\u6216\u865a\u62dfBE\u8bd5\u9a8c\u6574\u5408\u8d77\u6765\uff0c\u4ece\u800c\u6700\u5927\u7a0b\u5ea6\u5730\u4e3a\u4eff\u5236\u836f\u7684\u6279\u51c6\u63d0\u4f9b\u5173\u952e\u7684\u4fe1\u606f\u3002\u603b\u800c\u8a00\u4e4b\uff0cQMM\u662f\u5b9e\u73b0\u4eff\u5236\u836f\u5f00\u53d1\uff0cBE\u8bc4\u4f30\uff0c\u76d1\u7ba1\u6cd5\u89c4\u51b3\u7b56\u73b0\u4ee3\u5316\u4e0d\u53ef\u6216\u7f3a\u7684\u65b9\u6cd5\u3002\u672c\u6587\u5c06\u901a\u8fc7\u6cd5\u89c4\u76d1\u7ba1\u5b9e\u4f8b\u9610\u8ff0QMM\u662f\u5982\u4f55\u5b9e\u73b0\u4ee5\u4e0b\u9886\u57df\u7684\u73b0\u4ee3\u5316\uff1a\u4fc3\u8fdb\u4eff\u5236\u836f\u7684\u5f00\u53d1\uff0c\u89e3\u51b3BE\u8bc4\u4f30\u4e2d\u7684\u6311\u6218\uff0c\u652f\u6301\u76d1\u7ba1\u7684\u51b3\u7b56\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;text-align: center;box-sizing: border-box;\"><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/1-1558080786.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<section style=\"display: inline-block;vertical-align: top;max-width: 100%;border-radius: 3px 3px 0px 0px;margin-right: 3px;margin-left: 3px;background-color: rgb(255, 129, 36);color: rgb(255, 255, 255);font-size: 18px;padding-left: 6px;padding-right: 6px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u6b63 \u6587<\/strong><\/p>\n<\/section>\n<p><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/1-1558080786-1.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/section>\n<section style=\"width: 100%;font-size: 0px;margin-top: -2px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 100%;margin-right: -6px;margin-left: -6px;border-bottom: 2px solid rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 0.55em;margin-bottom: 0.55em;font-size: 12px;box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;height: 3em;color: rgb(249, 110, 87);width: 3em;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(255, 129, 36);background-color: rgb(255, 255, 255);box-sizing: border-box;\">\n<section style=\"line-height: 1.5;font-size: 22px;color: rgb(255, 129, 36);text-align: center;box-sizing: border-box;\">\n<p style=\"clear: none;box-sizing: border-box;\">1<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"float: left;margin-top: -2.9em;margin-left: 0.1em;line-height: 2.9em;border-radius: 1.5em;background-color: rgb(255, 129, 36);box-sizing: border-box;min-height: 2.9em !important;\">\n<section style=\"padding-right: 10px;padding-left: 2em;margin-left: 5px;float: left;display: inline-block;vertical-align: top;font-size: 18px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u6982\u8ff0<\/strong><\/p>\n<\/section>\n<\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5728\u6cd5\u89c4\u76d1\u7ba1\u5ba1\u8bc4\u4e2d\uff0c\u65b0\u836f\u80fd\u5426\u8fdb\u4e00\u6b65\u5f00\u53d1\u548c\u83b7\u6279\u53d6\u51b3\u4e8e\u662f\u5426\u6709\u8db3\u591f\u7684\u4f53\u5916\u548c\u4f53\u5185\u8bc1\u636e\uff0c\u4ee5\u652f\u6301\u836f\u54c1\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u4eff\u5236\u836f\u7684\u5ba1\u6279\u5219\u9700\u8981\u6709\u5145\u5206\u7684\u8bc1\u636e\u6765\u8bc1\u660e\u4e0e\u539f\u7814\u836f\u5177\u6709\u7b49\u6548\u6027\u3002\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u53ef\u52a0\u901f\u65b0\u836f\u548c\u4eff\u5236\u836f\u7684\u836f\u54c1\u5f00\u53d1\u548c\u76d1\u7ba1\u5ba1\u8bc4\u8fdb\u7a0b\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u7528\u4e8e\u65b0\u836f\u548c\u4eff\u5236\u836f\u7684\u5f00\u53d1\u548c\u5ba1\u6279\u8fc7\u7a0b\u4e2d\u7684\u6570\u636e\u6a21\u578b\uff0c\u53ef\u5c06\u5176\u7406\u89e3\u6210\u662f\u4e00\u5957\u77e5\u8bc6\u7ba1\u7406\u4f53\u7cfb\uff0c\u5b83\u5c06\u836f\u54c1\u7684\u6240\u6709\u76f8\u5173\u7684\u79d1\u5b66\u8ba4\u77e5\u548c\u73b0\u6709\u6570\u636e\u6574\u5408\u8d77\u6765\uff0c\u5305\u62ec\u5236\u5242\u5904\u65b9\uff0c\u4f53\u5916\/\u4f53\u5185\u91ca\u653e\uff0c\u836f\u4ee3\u52a8\u529b\u5b66\uff08PK\uff09\uff0c\u836f\u6548\u5b66\uff08PD\uff09\uff0c\u4e34\u5e8a\u6548\u5e94\u3002QMM\u8fd9\u95e8\u5b66\u79d1\u65e2\u8981\u6784\u5efa\u8fd9\u4e9b\u6a21\u578b\uff0c\u8fd8\u9700\u8981\u901a\u8fc7\u4f7f\u7528\u8fd9\u4e9b\u6a21\u578b\u6765\u8f85\u52a9\u6cd5\u89c4\u76d1\u7ba1\u548c\u4e1a\u52a1\u7684\u51b3\u7b56\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"color: rgb(255, 129, 36);font-size: 18px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">1.1 QMM\u5728\u65b0\u836f\u5f00\u53d1\u4e2d\u7684\u5e94\u7528<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5982\u56fe1\u6240\u793a\uff0c\u5bf9\u4e8e\u65b0\u836f\u5f00\u53d1\uff0c\u6570\u636e\u8f74\u6db5\u76d6\u4e86\u65b0\u53d1\u6574\u4e2a\u8fc7\u7a0b\u4e2d\u83b7\u53d6\u5230\u7684\u4fe1\u606f\u548c\u6570\u636e\uff0c\u5305\u62ec\u4e86\u539f\u6599\u836fAPI\uff0c\u5236\u5242\u5904\u65b9\uff0c\u4f53\u5916\u6eb6\u51fa\uff0c\u4f53\u5185\u9776\u5411\u91ca\u653e\u66f2\u7ebf\uff0c\u836f\u7269\u5728\u52a8\u7269\u548c\u4eba\u4f53\u5185\u7684PK\uff0cPD\u6548\u5e94\uff0c\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u4e34\u5e8a\u7ec8\u70b9\u6548\u5e94\u3002\u56fe\u4e2d\u4e0d\u540c\u6570\u636e\u96c6\u4e4b\u95f4\u7684\u5173\u7cfb\u5c06\u901a\u8fc7\u6a21\u578b\u8fdb\u884c\u63cf\u8ff0\uff0c\u8fd9\u4e9b\u6a21\u578b\u7684\u5e94\u7528\u53ef\u52a0\u901f\u76d1\u7ba1\u51b3\u7b56\uff0c\u5e76\u7528\u4e8e\u4f18\u5316\u83b7\u53d6\u5230\u7684\u6570\u636e\u3002<\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/9-1558080786.jpg\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<p style=\"box-sizing: border-box;text-align: center;\"><strong><span style=\"font-size: 14px;box-sizing: border-box;\">\u56fe1 \u6574\u5408\u4e86\u6a21\u578b\u7684\u65b0\u836f\u5f00\u53d1<\/span><\/strong><\/p>\n<p style=\"box-sizing: border-box;text-align: center;\"><strong><span style=\"font-size: 14px;box-sizing: border-box;\">x\u8f74\u4ee3\u8868\u836f\u54c1\u7814\u53d1\u7684\u65f6\u95f4; y\u8f74\u4ee3\u8868\u65b0\u836f\u7684\u4e34\u5e8a\u7597\u6548\u53ef\u4fe1\u5ea6\u3002\u4ece\u4e0b\u5230\u4e0a\u7684\u4e09\u6761\u7ebf\u5206\u522b\u4ee3\u8868\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u6a21\u578b\u8f74\uff0c\u6570\u636e\u8f74\u548c\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u8f74\u3002\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u8f74\u91c7\u7528\u865a\u7ebf\uff0c\u8fd9\u8868\u793a\u76d1\u7ba1\u51b3\u7b56\u9690\u85cf\u7740\u4e00\u5b9a\u7684\u7f6e\u4fe1\u5ea6\u3002\u4ece\u8fd9\u4e2a\u89d2\u5ea6\u6765\u770b\uff0c\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u5c06\u63a8\u8fdb\u4e34\u5e8a\u7ed3\u679c\u7684\u6570\u636e\u548c\u77e5\u8bc6\u8c31\u7684\u5b9a\u91cf\u5173\u7cfb\u6574\u5408\u8d77\u6765\u3002<\/span><\/strong><\/p>\n<p style=\"box-sizing: border-box;\">2017\u5e74\u5904\u65b9\u836f\u62a5\u8005\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA VI\uff09\u4e0b\u7684\u6a21\u578b\u5f15\u5bfc\u7684\u836f\u7269\u5f00\u53d1\uff08MIDD\uff0cModel-informed drug development\uff09\uff0c\u5021\u5bfc\u91c7\u7528\u8fd9\u4e9b\u6a21\u578b\u6765\u964d\u4f4e\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u4e0d\u786e\u5b9a\u6027\uff0c\u6210\u672c\uff0c\u65f6\u95f4\uff0c\u6d88\u8017\u548c\u5931\u8d25\u7387\u3002\u901a\u8fc7\u6765\u81ea\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u7684\u6570\u636e\uff0c\u642d\u5efa\u7fa4\u4f53PK\u6a21\u578b\uff0c\u5242\u91cf\/\u66b4\u9732-\u54cd\u5e94\u5173\u7cfb\u6a21\u578b\uff0c\u751f\u7269\u6a21\u578b\uff0c\u7edf\u8ba1\u6a21\u578b\uff0c\u8fd9\u4e9b\u6a21\u578b\u7684\u76ee\u6807\u662f\u4e3a\u836f\u7269\u5f00\u53d1\u548c\u76d1\u7ba1\u51b3\u7b56\u63d0\u4f9b\u5f15\u5bfc\u3002\u8bd5\u70b9\u8ba1\u5212\u4e3a\u836f\u54c1\u5f00\u53d1\u65b9\u548cFDA\u63d0\u4f9b\u4e86\u53cc\u65b9\u8ba8\u8bba\u548c\u63d0\u5efa\u8bae\u7684\u673a\u4f1a\uff0c\u5305\u62ec\u8ba8\u8bbaMIDD\u65b9\u6cd5\u5982\u4f55\u5e94\u7528\u5728\u836f\u54c1\u5f00\u53d1\u548c\u76d1\u7ba1\u8bc4\u4f30\u4e2d\uff0c\u5e76\u5c31\u7279\u5b9aMIDD\u65b9\u6cd5\u5982\u4f55\u5728\u7279\u5b9a\u836f\u54c1\u5f00\u53d1\u9879\u76ee\u4e2d\u4f7f\u7528\u63d0\u51fa\u5efa\u8bae1\u3002\u6a21\u578b\u5f15\u5bfc\u7684\u836f\u7269\u5f00\u53d1MIDD\u7684\u76f4\u63a5\u6536\u76ca\u5305\u62ec\u53ef\u51cf\u5c11\u989d\u5916\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8981\u6c42\uff0c\u51cf\u5c11\u4e34\u5e8a\u7814\u7a76\u4e2d\u53d7\u8bd5\u60a3\u8005\u7684\u6570\u91cf\uff0c\u6307\u5bfc\u7ed9\u836f\u5242\u91cf\u548c\u7ed9\u836f\u65b9\u6848\u7684\u9009\u62e9\uff0c\u8bc6\u522b\u5165\u9009\u7684\u53d7\u8bd5\u60a3\u8005\u7fa4\u4f53\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u6a21\u578b\u5f15\u5bfc\u7684\u836f\u7269\u5f00\u53d1MIDD\u662f\u6307\u5bfc\u836f\u7269\u5f00\u53d1\u7684\u6709\u529b\u5de5\u5177\uff0c\u53ef\u652f\u6301\u836f\u7269\u5f00\u53d1\u548c\u5ba1\u8bc4\u7684\u51b3\u7b56\u3002\u5176\u5e94\u7528\u7684\u8303\u56f4\u4e0e\u6570\u636e\u7684\u5145\u8db3\u6027\u548c\u73b0\u62e5\u6709\u77e5\u8bc6\u7684\u7a0b\u5ea6\u5bc6\u5207\u76f8\u5173\uff0c\u5e76\u4e14\u53ef\u4ee5\u7528\u4e8e\u89e3\u91ca\u6570\u636e\u548c\u8fdb\u884c\u7ed3\u679c\u7684\u5916\u63a8\u3002\u7136\u800c\uff0c\u5efa\u6a21\u548c\u6a21\u62df\u751f\u6210\u7684\u6570\u636e\u5e76\u4e0d\u80fd\u66ff\u4ee3\u65b0\u836f\u7533\u8bf7\uff08NDA\uff09\u9636\u6bb5\u4e2d\u8981\u6c42\u7684\u4e34\u5e8a\u5b9e\u8bc1\u6570\u636e\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">1.2 QMM\u5728\u4eff\u5236\u836f\u5f00\u53d1\u4e2d\u7684\u5e94\u7528<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5bf9\u4e8e\u4eff\u5236\u836f\uff0c\u6279\u51c6\u7684\u5173\u952e\u4f9d\u636e\u662f\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\uff0c21CFR\u00a7314.3\uff08b\uff09\u4e2d\u7684BE\u5b9a\u4e49\u4e3a\u201c\u5728\u8bbe\u8ba1\u5408\u7406\u7684\u8bd5\u9a8c\u7814\u7a76\u4e2d\uff0c\u76f8\u4f3c\u7684\u6761\u4ef6\u4e0b\u7ed9\u4e88\u76f8\u540c\u6469\u5c14\u5242\u91cf\u7684\u836f\u6548\u7b49\u6548\u6216\u836f\u7269\u66ff\u4ee3\u7269\u65f6\uff0c\u5230\u8fbe\u4f5c\u7528\u90e8<span style=\"letter-spacing: 0px;box-sizing: border-box;\">\u4f4d\u7684\u6d3b\u6027\u6210\u5206\uff08active ingredient\uff09\u6216\u6d3b\u6027\u90e8\u5206(Active moiety)\u7684\u901f\u7387\u548c\u7a0b\u5ea6\u65e0\u663e\u8457\u5dee\u5f02\u201d\u3002<\/span><\/p>\n<p style=\"box-sizing: border-box;\">\u81ea\u4ece1984\u5e74\u9881\u5e03\u836f\u54c1\u4ef7\u683c\u7ade\u4e89\u4e0e\u4e13\u5229\u671f\u8865\u507f\u6cd5\uff08Hatch-Waxman\u6cd5\u6848\uff09\u4ee5\u67652-4\uff0cFDA\u5df2\u7ecf\u5f88\u597d\u5730\u5efa\u7acb\u4e86BE\u6307\u5bfc\u539f\u5219\u3002\u7533\u529e\u65b9\u5fc5\u987b\u7528\u6700\u51c6\u786e\uff0c\u6700\u654f\u611f\u53ca\u91cd\u73b0\u6027\u597d\u7684\u65b9\u6cd5\u8bba\u8bc1\u6240\u5f00\u53d1\u836f\u54c1\u7684\u751f\u7269\u5229\u7528\u5ea6BA\u6216\u751f\u7269\u7b49\u6548\u6027BE\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u4eff\u5236\u836f\u7533\u8bf7\u4e2d\uff0c\u8bc1\u660e\u53d7\u8bd5\u5236\u5242BE\u7684\u65b9\u6cd5\u5305\u62ec\u4f53\u5916\u8bd5\u9a8c\uff0c\u4ee5PK\u4e3a\u7ec8\u70b9\uff0c\u4ee5PD\u4e3a\u7ec8\u70b9\uff0c\u5bf9\u6bd4\u4e34\u5e8a\u7ec8\u70b9\u7814\u7a76\uff0c\u5176\u4e2d\u4ee5PK\u4e3a\u7ec8\u70b9\u7684\u7814\u7a76\u662f\u6700\u5e38\u7528\u7684BE\u8bc4\u4f30\u8bd5\u9a8c\uff0c\u8fd9\u662f\u56e0\u4e3a\u5927\u591a\u6570\u836f\u54c1\u662f\u901a\u8fc7\u5438\u6536\u5165\u4f53\u5faa\u73af\u800c\u5230\u8fbe\u4f5c\u7528\u90e8\u4f4d\u7684\uff0c\u901a\u8fc7\u4f53\u5faa\u73afPK\u53ef\u53cd\u6620\u836f\u7269\u5728\u4f5c\u7528\u90e8\u4f4d\u7684\u9012\u9001\u3002\u5f53\u65e0\u6cd5\u901a\u8fc7PK\u7814\u7a76\u8fdb\u884cBE\u8bc4\u4f30\u6216\u83b7\u53d6\u7684\u7ed3\u679c\u4e0d\u80fd\u5145\u5206\u8bc1\u660e\u662f\u5426BE\u65f6\uff0c\u5219\u9700\u4f7f\u7528\u975ePK\u7ec8\u70b9\u7684\u4e34\u5e8a\u7814\u7a76\u6765\u5efa\u7acb\u4e0eBE\u7684\u76f8\u5173\u6027\u30022003\u5e74\uff0c\u201c\u533b\u7597\u4fdd\u9669\u5904\u65b9\u836f\uff0c\u6539\u5584\u548c\u73b0\u4ee3\u5316\u6cd5\u6848\u201d\u4fee\u8ba2\u4e86\u201c\u8054\u90a6\u98df\u54c1\uff0c\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u201d\u7b2c505\uff08j\uff09\uff088\uff09\uff08A\uff09\uff08ii\uff09\u8282\uff0c\u89c4\u5b9a\u201c[f]\u6216\u975e\u5438\u6536\u5165\u8840\u7684\u836f\u7269\uff0c\u53ef\u901a\u8fc7\u79d1\u5b66\u6709\u6548\u7684\u6d4b\u91cf\u65b9\u6cd5\u6765\u8bc4\u4f30\u5176\u751f\u7269\u5229\u7528\u5ea6\uff0c\u4ee5\u53cd\u6620\u6d3b\u6027\u6210\u5206\u6216\u6cbb\u7597\u6210\u5206\u5230\u8fbe\u836f\u7269\u4f5c\u7528\u90e8\u4f4d\u7684\u901f\u7387\u548c\u7a0b\u5ea6\u3002\u201d<\/p>\n<p style=\"box-sizing: border-box;\">\u5f53\u524d\uff0c\u8bb8\u591a\u79d1\u5b66\u548c\u76d1\u7ba1\u7684\u6311\u6218\u4e0e\u4f7f\u7528\u975ePK\u7ec8\u70b9\u8fdb\u884cBE\u8bc4\u4f30\u6709\u5173\u3002\u4f8b\u5982\uff0c\u4f7f\u7528\u5bf9\u6bd4PD\u7814\u7a76\u4e3a\u7ec8\u70b9\u6216\u4ee5\u4e34\u5e8a\u7814\u7a76\u4e3a\u7ec8\u70b9\u7684\u65b9\u6cd5\u5f88\u53ef\u80fd\u5bf9\u68c0\u6d4b\u5236\u5242\u7684\u5dee\u5f02\u5e76\u4e0d\u654f\u611f\uff0c\u540c\u65f6\u5728\u65f6\u95f4\uff0c\u4eba\u529b\u8d44\u6e90\uff0c\u8d44\u91d1\u6295\u5165\u65b9\u9762\u90fd\u8f83\u9ad8\u3002\u800c\u91c7\u7528\u4f53\u5916\u65b9\u6cd5\u8fdb\u884cBE\u8bc4\u4f30\u65f6\uff0c\u4e5f\u9762\u4e34\u5982\u4f55\u8bc6\u522b\u4f53\u5916\u6d4b\u8bd5\u7684\u53c2\u6570\u4e0eBE\u8bc4\u4f30\u6807\u51c6\u7684\u4e34\u5e8a\u76f8\u5173\u6027\u4e0a\u7684\u5de8\u5927\u79d1\u5b66\u6311\u6218\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u5728\u5e2e\u52a9\u4eff\u5236\u836f\u5f00\u53d1\u4eba\u5458\u548c\u4eff\u5236\u836f\u5ba1\u8bc4\u4eba\u5458\u89e3\u51b3\u8fd9\u4e9b\u6311\u6218\u65f6\uff0c\u53d1\u6325\u7740\u5173\u952e\u4f5c\u7528\u3002\u5bf9\u4e8e\u4eff\u5236\u836f\u4f01\u4e1a\uff0cQMM\u5c06\u6709\u5229\u4e8e\u5236\u5242\u5904\u65b9\u548c\u5de5\u827a\u7684\u8bbe\u8ba1\uff0c\u4f53\u5185BE\u8bd5\u9a8c\u7684\u8bbe\u8ba1\uff0c\u66ff\u4ee3BE\u9014\u5f84\u521b\u65b0\u7684\u8bc4\u4f30\u3002<\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/1-1558080786.jpg\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<p style=\"box-sizing: border-box;text-align: center;\"><strong><span style=\"font-size: 14px;box-sizing: border-box;\">\u56fe2 \u6574\u5408\u4e86\u6a21\u578b\u7684\u836f\u7269\u5f00\u53d1\u5728\u4eff\u5236\u836f\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u3002<\/span><\/strong><\/p>\n<p style=\"box-sizing: border-box;text-align: center;\"><strong><span style=\"font-size: 14px;box-sizing: border-box;\">x\u8f74\u8868\u793a\u4eff\u5236\u836f\u7684\u7814\u53d1\u65f6\u95f4; y\u8f74\u8868\u793a\u4eff\u5236\u836fBE\u7684\u7f6e\u4fe1\u5ea6\u3002\u673a\u4f1a\u533a\u57df\u8868\u793a\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u65b9\u6cd5\u6709\u53ef\u80fd\u6210\u4e3a\u66ff\u4ee3\u5ba1\u8bc4\u8d44\u6599\u4e2d\u4f53\u5185PK\u7ec8\u70b9\u548c\/\u6216\u5bf9\u6bd4\u4e34\u5e8a\u7ec8\u70b9\u7684BE\u7814\u7a76\u7684\u5173\u952e\u4fe1\u606f\uff0c\u5e76\u4e14\u4f7f\u4ec5\u901a\u8fc7\u4f53\u5916BE\u8bd5\u9a8c\u8bc4\u4f30\u5c31\u83b7\u5f97\u4eff\u5236\u836f\u6279\u51c6\u6210\u4e3a\u53ef\u80fd\u3002<\/span><\/strong><\/p>\n<p style=\"box-sizing: border-box;\">\u4e0e\u65b0\u53d1\u76f8\u6bd4\uff0c\u4eff\u5236\u836fBE\u8bc4\u4f30\u7684\u5efa\u7acb\u5728\u6570\u636e\u8f74\u4e0a\u5b58\u5728\u4e09\u4e2a\u5dee\u5f02\u3002\u5982\u56fe2\u6240\u793a\uff0c\u65b0\u5236\u5242\u5904\u65b9\u53ca\u8f85\u6599\uff0cPK 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style=\"box-sizing: 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5\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u7684\u5173\u952e\u65f6\u673a\u662f\u5229\u7528\u6a21\u578b\u8bc6\u522b\u4e0d\u5fc5\u8981\u6216\u4e0d\u654f\u611f\u7684\u4f53\u5185\u7814\u7a76\uff0c\u5e76\u4e3a\u4eff\u5236\u836f\u5f00\u53d1\u9879\u76ee\u7684BE\u4f53\u5916\u65b9\u6cd5\u63d0\u4f9b\u652f\u6301\u3002\u540e\u9762\u7684\u6848\u4f8b\u8bf4\u660e\u5b9a\u91cf\u7684\u5efa\u6a21\u662f\u4eff\u5236\u836f\u5f00\u53d1\u548c\u6279\u51c6\u7684\u5173\u952e\u6865\u63a5\u3002\u5728\u8fd9\u65b9\u9762\uff0cFDA\u7684\u5efa\u6a21\u4eba\u5458\u901a\u8fc7\u5229\u7528\u6240\u6709\u76f8\u5173\u836f\u7269\u5f00\u53d1\u9879\u76ee\u4e2d\u6240\u79ef\u7d2f\u7684\u5927\u91cf\u4fe1\u606f\uff0c\u4ee5\u652f\u6301\u7279\u5b9a\u836f\u54c1\u6307\u5bfc\u539f\u5219\uff08PSG\uff09\u7684\u5236\u5b9a\u548cBE\u521b\u65b0\u65b9\u6cd5\u7684\u5efa\u7acb\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 0.55em;margin-bottom: 0.55em;font-size: 12px;box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;height: 3em;color: rgb(249, 110, 87);width: 3em;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(255, 129, 36);background-color: rgb(255, 255, 255);box-sizing: border-box;\">\n<section style=\"line-height: 1.5;font-size: 18px;color: rgb(255, 129, 36);text-align: center;box-sizing: border-box;\">\n<p style=\"clear: none;box-sizing: border-box;\">2<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"float: left;margin-top: -2.9em;margin-left: 0.1em;line-height: 2.9em;border-radius: 1.5em;background-color: rgb(255, 129, 36);box-sizing: border-box;min-height: 2.9em !important;\">\n<section style=\"padding-right: 10px;padding-left: 2em;margin-left: 5px;float: left;display: inline-block;vertical-align: top;font-size: 18px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">QMM\u5728\u4eff\u5236\u836f\u5f00\u53d1\u548c\u83b7\u6279\u4e2d\u7684\u597d\u5904\uff0c\u5e94\u7528\u8303\u56f4\u548c\u5de5\u5177<\/strong><\/p>\n<\/section>\n<\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">ANDA\u4f1a\u8bae\u5e0c\u671b\u5728\u4eff\u5236\u836f\u5f00\u53d1\u7684\u65e9\u671f\u5c31\u8ba9\u6f5c\u5728\u7684\u7533\u62a5\u65b9\u7684\u9884\u671f\u6cd5\u89c4\u6709\u6e05\u6670\u7684\u8ba4\u77e5\uff0c\u4ece\u800c\u5e2e\u52a9\u7533\u62a5\u65b9\u5f00\u53d1\u51fa\u66f4\u5b8c\u6574\u7684\u7533\u62a5\u6750\u6599\uff0c\u4fc3\u8fdb\u66f4\u6709\u6548\u548c\u66f4\u6709\u5f71\u54cd\u7684\u5ba1\u8bc4\u8fdb\u7a0b\uff0c\u5e76\u51cf\u5c11\u4eff\u5236\u836f\u83b7\u6279\u6d41\u7a0b\u4e2d\u5ba1\u8bc4\u7684\u5468\u671f\u6570\u91cf\u3002\u5728\u9884-ANDA\u4f1a\u8bae\u4e2d\uff0c\u53ef\u770b\u5230FDA\u4f7f\u7528\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u4ee5\u652f\u6301\u4eff\u5236\u836f\u5f00\u53d1\u9879\u76ee\u7684\u8d8b\u52bf\u6b63\u5728\u589e\u52a0\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u5305\u542b\u4e24\u4e2a\u7ef4\u5ea6\uff1a\u5de5\u5177\u96c6\u548c\u5e94\u7528\u9886\u57df\u3002\u76ee\u524d\u6709\u4e09\u79cd\u5173\u952e\u5de5\u5177\u7ec4\u5e2e\u52a9FDA\u4eff\u5236\u836f\u9879\u76ee\u76d1\u7ba1\u5b9e\u73b0\u73b0\u4ee3\u5316\u3002\u8fd9\u4e9b\u5de5\u5177\u7ec4\u5305\u62ec\uff1a\uff08i\uff09\u9488\u5bf9\u53e3\u670d\u548c\u975e\u53e3\u670d\u836f\u7269\u7684\u751f\u7406\u836f\u4ee3\u52a8\u529b\u5b66PBPK\u6a21\u578b\uff0c\u5b83\u53ef\u4e86\u89e3\u836f\u7269\u5728\u4f53\u5185\u7684\u91ca\u653e\u7279\u5f81\uff0c\u5438\u6536\u7279\u5f81\uff0c\u836f\u7269\u5728\u4f53\u5185\u4e0d\u540c\u533a\u57df\u7684\u5206\u5e03\u7279\u5f81; \uff08ii\uff09\u7531\u7fa4\u4f53PK\uff0cPK-PD\u548c\u66b4\u9732-\u54cd\u5e94\u6a21\u578b\u4e09\u79cd\u65b9\u6cd5\u7ec4\u6210\u7684\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP10; 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border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">2.1&nbsp;<span style=\"letter-spacing: 0px;box-sizing: border-box;\">\u751f\u7406\u836f\u4ee3\u52a8\u529b\u5b66PBPK\u6a21\u578b<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">PBPK\u662f\u4e00\u79cd\u6570\u5b66\u5efa\u6a21\u65b9\u6cd5\uff0c\u7528\u4e8e\u9884\u6d4b\u5316\u5b66\u5408\u6210\u6216\u5929\u7136\u4ea7\u7269\u5728\u4eba\u548c\u52a8\u7269\u4f53\u5185\u7684\u5438\u6536\uff0c\u5206\u5e03\uff0c\u4ee3\u8c22\u548c\u6392\u6cc4\u3002\u5b83\u53ef\u7528\u4e8e\u9884\u6d4b\u4eba\u4f53\u5faa\u73af\u8840\u6db2\/\u8840\u6e05\u7684\u836f\u7269\u6d53\u5ea6\uff0c\u4ee5\u53ca\u611f\u5174\u8da3\u7684\u7ec4\u7ec7\uff0c\u5668\u5b98\u548c\/\u6216\u4f5c\u7528\u90e8\u4f4d\u7684\u5c40\u90e8\u836f\u7269\u6d53\u5ea6\u66f2\u7ebf\u3002\u6b64\u5916\uff0cPBPK\u8fd8\u53ef\u4ee5\u4f5c\u4e3a\u865a\u62df\u4eba\u7fa4\u6a21\u62df\u7684\u5efa\u6a21\u7cfb\u7edf17,18\u3002\u53e3\u670d\u5438\u6536\u6a21\u578b\u7684PBPK\u6a21\u578b\u5df2\u7ecf\u5f97\u5230\u4e86FDA\u548c\u4eff\u5236\u836f\u884c\u4e1a\u7684\u5145\u5206\u7814\u7a76\u548c\u5546\u4e1a\u531619,20\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u975e\u53e3\u670d\u5438\u6536\u6a21\u578b\u8fd8\u5904\u4e8e\u65e9\u671f\u53d1\u5c55\u9636\u6bb5\uff0c\u4f46\u975e\u53e3\u670d\u5438\u6536\u6a21\u578b\u5bf9\u4e8e\u8bc4\u4ef7\u5c40\u90e8\u4f5c\u7528\u7684\u836f\u7269\u7684\u7b49\u6548\u6027\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5728\u65b0\u836f\u5f00\u53d1\u4e2d\uff0cPBPK\u6a21\u578b\u5df2\u5e7f\u6cdb\u7528\u4e8e\u8bc4\u4f30\u513f\u79d1\u548c\u5176\u4ed6\u7279\u5b9a\u4eba\u7fa4\u7684\u836f\u7269\u76f8\u4e92\u4f5c\u7528DDI\u548c\u5242\u91cf\u8c03\u657421\u3002\u6a21\u578b\u7684\u7f6e\u4fe1\u5ea6\u5c06\u968f\u7740\u5bf9\u673a\u4f53\u77e5\u8bc6\u7684\u4f9d\u8d56\u7a0b\u5ea6\u7684\u63d0\u9ad8\u800c\u964d\u4f4e\u3002\u4f8b\u5982\uff0cPBPK\u6a21\u578b\u5728\u8bc4\u4f30\u5728\u7814\u836f\u7269IND\u4f5c\u4e3a\u4ee3\u8c22\u9176\u5e95\u7269\u7684DDI\u53d1\u751f\u7684\u53ef\u80fd\u6027\u65b9\u9762\u7684\u9884\u6d4b\u6027\u80fd\u5df2\u7ecf\u5f88\u597d\uff0c\u7279\u522b\u662f\u88abCPY3A\u548c2D6\u4ecb\u5bfc\u7684\u4ee3\u8c2222\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u5bf9\u4e8e\u5efa\u6a21\u4eba\u5458\u6765\u8bf4\uff0c\u901a\u8fc7PBPK\u4e86\u89e3\u836f\u7269\u5438\u6536\u548c\u5c40\u90e8\u5668\u5b98\u7684\u836f\u7269\u6d53\u5ea6\u4ecd\u9762\u4e34\u5f88\u5927\u7684\u6311\u6218\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5bf9\u53e3\u670d\u836f\u54c1\u7684\u5438\u6536\u5efa\u6a21\u901a\u5e38\u9700\u7406\u89e3\u4e09\u79cd\u7c7b\u578b\u7684\u53c2\u6570\uff1a\u539f\u6599\u836f\u7684\u4fe1\u606f\uff0c\u836f\u54c1\uff08\u5236\u5242\uff09\u7684\u4fe1\u606f\u548c\u751f\u7406\u53c2\u6570\uff0c\u4ee5\u8868\u5f81\u836f\u7269\u5728\u80c3\u80a0\u9053\u4e2d\u7684\u751f\u7406\u73af\u5883\u3002\u8fd9\u4e9b\u53c2\u6570\u53ef\u4f30\u7b97\u836f\u7269\u5438\u6536\u7684\u901f\u7387\u548c\u7a0b\u5ea6\u6216\u836f\u7269\u8fdb\u5165\u4f53\u5faa\u73af\u7684BA\u3002\u836f\u7269\u5438\u6536\u540e\uff0c\u53ef\u901a\u8fc7\u4f20\u7edf\u7684\u4e00\u623f\u5ba4\u6216\u4e8c\u623f\u5ba4\u6a21\u578b\u7684\u53c2\u6570\u9884\u6d4b\u9759\u8109\u6ce8\u5c04\u7ed9\u836f\u540e\u7684PK\u66f2\u7ebf\u3002<\/p>\n<p style=\"box-sizing: border-box;\">PBPK\u6a21\u578b\u4e0d\u4f46\u53ef\u7528\u4e8e\u6a21\u62df\u53e3\u670d\u836f\u7269\u5438\u6536\uff0c\u8fd8\u53ef\u7528\u4e8e\u6a21\u62df\u5c40\u90e8\u4f5c\u7528\u662f\u836f\u54c1\u5728\u4f5c\u7528\u90e8\u4f4d\u7684\u836f\u7269\u6d53\u5ea6\u3002\u7528\u4e8e\u5c40\u90e8\u4f5c\u7528\u836f\u54c1\u7684PBPK\u6a21\u578b\u6d89\u53ca\u4e24\u79cd\u7c7b\u578b\u7684\u53c2\u6570\u3002\u4e00\u7c7b\u662fAPI\u548c\u5236\u5242\u7684\u7279\u5f02\u53c2\u6570\uff0c\u53e6\u4e00\u79cd\u662f\u4eba\u4f53\u7cfb\u7edf\u7684\u7279\u5f02\u53c2\u6570\u3002API\u548c\u5236\u5242\u7684\u7279\u5f02\u53c2\u6570\u5305\u62ec\u539f\u6599\u836f\u7684\u7279\u6027\uff0c\u5236\u5242\u4fe1\u606f\uff08\u5373\u5236\u5242\u7684\u5927\u5c0f\uff0c\u7c7b\u578b\uff0c\u6210\u5206\u548c\u836f\u7269\u91ca\u653e\u673a\u5236\uff09\uff0c\u4ee5\u53ca\u5177\u6709\u751f\u7269\u76f8\u5173\u6027\u4ecb\u8d28\u4e0b\u7684\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u3002\u4eba\u4f53\u7cfb\u7edf\u7684\u7279\u5f02\u53c2\u6570\u7528\u4e8e\u63cf\u8ff0\u76f8\u5173\u7684\u751f\u7406\u7cfb\u7edf\uff0c\u6362\u53e5\u8bdd\u8bf4\uff0c\u8fd9\u4e9b\u53c2\u6570\u7528\u4e8e\u8868\u5f81\u611f\u5174\u8da3\u7684\u865a\u62df\u5668\u5b98\u3002\u5bf9\u4e8e\u53e3\u670d\u5438\u6536\u7684\u836f\u7269\u6216\u80c3\u80a0\u9053\u5c40\u90e8\u4f5c\u7528\u7684\u836f\u54c1\uff0c\u751f\u7406\u7cfb\u7edf\u4e3b\u8981\u6307\u80c3\u80a0\u9053\u7cfb\u7edf\u3002\u5bf9\u4e8e\u5c40\u90e8\u4f5c\u7528\u7684\u836f\u54c1\uff0cPBPK\u6a21\u578b\u5c06\u6d89\u53ca\u5e7f\u6cdb\u7684\u751f\u7406\u7cfb\u7edf\uff0c\u4f8b\u5982\uff0c\u5c40\u90e8\u4f5c\u7528\u6216\u5168\u8eab\u4f5c\u7528\u7684\u9f3b\u5185\u7ed9\u836f\u7cfb\u7edf\uff1b\u6df7\u60ac\u6db2\uff0c\u8f6f\u818f\uff0c\u4e73\u6db2\u7684\u773c\u90e8\u7ed9\u836f\u7cfb\u7edf\uff1b\u5b9a\u91cf\u5438\u6536\u5668\u6216\u5e72\u7c89\u5438\u5165\u5668\u7684\u80ba\u90e8\u7ed9\u836f\u7cfb\u7edf\uff1b\u8d34\u5242\uff0c\u4e73\u6db2\uff0c\u8f6f\u818f\u548c\u971c\u5242\u7684\u76ae\u80a4\u7ed9\u836f\u7cfb\u7edf\u3002<\/p>\n<p style=\"box-sizing: border-box;\">PBPK\u6a21\u578b\u7684\u4f7f\u7528\u9886\u57df\u53ef\u5206\u4e3a\u56db\u4e2a\u4e3b\u8981\u9886\u57df\u30021\uff09\u5b83\u6709\u52a9\u4e8e\u6307\u5bfc\u4f53\u5185BE\u7814\u7a76\u7684\u66ff\u4ee3\u65b9\u6848\uff0c\u5305\u62ec\u62d3\u5c55BCS I\u7c7b\u836f\u54c1\u4ee5\u5916\u7684\u751f\u7269\u836f\u5242\u5b66\u5206\u7c7b\u7cfb\u7edfBCS\u8c41\u514d5\uff1b\u5f53\u67d0\u4e9b\u7279\u5b9a\u6761\u4ef6\u4e0b\u6eb6\u51fa\u7ed3\u679c\u65e0\u6cd5\u8fdb\u884c\u6709\u6548\u7684\u6bd4\u8f83\u65f6\uff0c\u5c06\u4f53\u5185BE\u8bd5\u9a8c\u7ed3\u679c\u6865\u63a5\u5230\u836f\u54c1\u7684\u989d\u5916\u7ed9\u836f\u89c4\u683c\u4e0a\uff0c\u5e76\u8bc1\u660e\u8be5\u4f53\u5916BE\u65b9\u6cd5\u7684\u5408\u7406\u6027\u30022\uff09\u901a\u8fc7PBPK\u6a21\u578b\u5efa\u7acb\u5c40\u90e8\u4f5c\u7528\u836f\u54c1\u786e\u5b9aBE\u7684\u8bc4\u4ef7\u6307\u6807\u6216\u5177\u6709\u4e34\u5e8a\u76f8\u5173\u6027\u7684Q3\u53c2\u657023\u30023\uff09PBPK\u6a21\u578b\u53ef\u7528\u4e8e\u652f\u6301\u5177\u6709\u4e34\u5e8a\u76f8\u5173\u6027\u7684\u6eb6\u51fa\u89c4\u8303\u7684\u5efa\u7acb\uff0c\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u786e\u5b9a\uff0c\u91ca\u653e\u673a\u5236\u53d8\u66f4\u540e\u7684\u98ce\u9669\u8bc4\u4f3024\u30024\uff09PBPK\u6a21\u578b\u53ef\u786e\u4fdd\u6240\u6709\u60a3\u8005\u6216\u5728\u7279\u6b8a\u6761\u4ef6\u4f7f\u7528\u836f\u54c1\u65f6\u7684\u6cbb\u7597\u7b49\u6548\u6027\uff0c\u800c\u65e0\u9700\u989d\u5916\u7684\u7814\u7a76\u3002\u4f8b\u5982\uff0c\u7528PBPK\u6a21\u578b\u8bc4\u4f30\u9152\u7cbe\u5242\u91cf\u503e\u6cfb\u7684\u5f71\u54cd\uff0c\u540c\u670d\u7528\u8d28\u5b50\u6cf5\u6291\u5236\u5242\uff08PPI\uff09\u7684\u5f71\u54cd\uff0c\u75be\u75c5\u72b6\u51b5\u548c\u7279\u5b9a\u4eba\u7fa4\u5bf9BE\u7684\u5f71\u54cd25\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">2.2 \u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP\u6a21\u578b<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP\u6a21\u578b\u662f\u4e00\u79cd\u4f7f\u7528\u5e7f\u6cdb\u7684\u65b9\u6cd5\uff0c\u5728\u65b0\u836f\u548c\u4eff\u5236\u836f\u5f00\u53d1\u4e2d\u8d77\u7740\u5173\u952e\u4f5c\u7528\u3002\u901a\u5e38\uff0c\u4e34\u5e8a\u836f\u7406\u5b66\u7684\u76ee\u6807\u662f\u7814\u7a76\u836f\u7269\u5728\u4eba\u4f53\u4e2d\u7684\u5404\u79cd\u89c2\u6d4b\u7684\u54cd\u5e94\uff0c\u9610\u660e\u836f\u7269\u4f5c\u7528\u7684\u673a\u5236\u548c\u5bfc\u81f4\u53c2\u6570\u53d8\u5f02\u7684\u6765\u6e90\u3002QCP\u4f5c\u4e3a\u4e34\u5e8a\u836f\u7406\u5b66\u7684\u4e00\u90e8\u5206\uff0c\u5b83\u4e3aPD\u6548\u5e94\u548c\u4e34\u5e8a\u54cd\u5e94\u7684\u91cf\u5316\u6307\u6807\uff0c\u589e\u52a0\u4e86\u8d28\u91cf\uff0c\u4f53\u79ef\u7684\u53ef\u6d4b\u91cf\u548c\u6570\u503c\u610f\u4e4926\u3002<\/p>\n<p style=\"box-sizing: border-box;\">QCP\u5728\u57fa\u4e8e\u98ce\u9669\u7684BE\u8bc4\u4f30\u65b9\u6cd5\u4e2d\u53d1\u6325\u5173\u952e\u4f5c\u7528\uff0c\u5df2\u7528\u4e8e\u7a84\u6cbb\u7597\u6307\u6570\u836f\u7269\u7684\u5206\u7c7b\uff0c\u957f\u6548\u6ce8\u5c04\u5242\u7684BE\u6307\u6807\uff0c\u4ee5PD\u4e3a\u7ec8\u70b9\/\u9274\u5b9a\u751f\u7269\u6807\u5fd7\u7269\u7684BE\u8bc4\u4f30\uff0c\u4ee5PK\u4e3a\u7ec8\u70b9\u7684BE\u6307\u6807\u7684\u786e\u8ba4\uff0c\u5305\u62ecpAUC\u7684\u63a8\u8350\u3002\u57fa\u4e8eQCP\u7684\u6a21\u62df\u8fd8\u7528\u4e8e\u7ba1\u7406\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u7814\u7a76\uff0c\u5f15\u5bfcBE\u7814\u7a76\u7684\u8bbe\u8ba1\uff0c\u8bc4\u4f30\u4f7f\u7528\u5bf9\u6bd4\u4e34\u5e8a\u7ec8\u70b9\u8fdb\u884c\u5c40\u90e8\u4f5c\u7528\u548c\/\u6216\u590d\u6742\u836f\u54c1\u8fdb\u884cBE\u7684\u8bc4\u4f30\u3002\u7fa4\u4f53PK\u5efa\u6a21\u6280\u672f\u53ef\u9488\u5bf9PK\u91c7\u6837\u7a00\u758f\u7684\u836f\u7269\uff0c\u5f00\u53d1\u5176\u57fa\u4e8e\u6a21\u578b\u7684BE\u8bc4\u4f30\u3002Meta\u5206\u6790\u53ef\u7528\u4e8e\u8bc4\u4ef7\u65b0\u836f\u7533\u8bf7NDA\u548c\u4eff\u5236\u836f\u7533\u8bf7ANDA\u4e2dBE\u8bc4\u4f30\u65b9\u6cd5\u7684\u9002\u7528\u6027\uff0c\u5e76\u901a\u8fc7\u4f7f\u7528\u771f\u5b9e\u6570\u636e\u6765\u4f30\u7b97\u5b9e\u9645\u7684\u7814\u7a76\u80fd\u529b\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u4e0d\u540c\u7684QMM\u65b9\u6cd5\u968f\u7740\u65b0\u836f\u6216\u4eff\u5236\u836f\u7684\u5f00\u53d1\u8fdb\u7a0b\u800c\u4e0d\u65ad\u88ab\u5f00\u53d1\u51fa\u6765\uff0c\u5e76\u5e7f\u6cdb\u5e94\u7528\u4e0e\u836f\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u3002\u4f8b\u5982\uff0c\u9488\u5bf9ANDA\u7684BE\u8bc4\u4f30\u5f00\u53d1\u7684\u7279\u5b9a\u65b9\u6cd5\uff0c\u4e5f\u53ef\u7528\u4e8e\u8bc4\u4f30505(b)(2)\u548c505(b)(1)\u5728\u4e0a\u5e02\u524d\/\u4e0a\u5e02\u540e\uff0c\u56e0\u5236\u5242\u5904\u65b9\u7684\u53d8\u66f4\uff0c\u751f\u4ea7\u5de5\u827a\u7684\u53d8\u66f4\uff0c\u751f\u4ea7\u5730\u70b9\u7684\u53d8\u66f4\u662f\u5426\u5bfc\u81f4BE\u7684\u53d8\u66f4\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"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;\"><strong style=\"box-sizing: border-box;\"><span style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">2.3&nbsp;&nbsp;<\/span><\/strong><strong style=\"letter-spacing: 0px;box-sizing: border-box;\"><span style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\u5176\u4ed6\u7528\u4e8e\u4eff\u5236\u836f\u7684\u65b0\u65b9\u6cd5\uff1a\u5927\u6570\u636e\uff0c\u673a\u5668\u5b66\u4e60\uff0c\u4eba\u5de5\u667a\u80fd<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u6211\u4eec\u751f\u6d3b\u5728\u5927\u6570\u636e\u7684\u65f6\u4ee3\uff0c\u5fc5\u987b\u5229\u7528\u5927\u6570\u636e\u5206\u6790\u4e3a\u4eff\u5236\u836f\u9879\u76ee\u5e26\u6765\u7684\u597d\u5904\u3002\u9664\u4e86QCP\u548cPBPK\u65b9\u6cd5\u5916\uff0c\u7f8e\u56fdFDA\u8fd8\u5e94\u7528\u5927\u6570\u636e\u5206\u6790\u4fc3\u8fdb\u4f20\u7edf\u7684\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP\u6216\u751f\u7406\u836f\u4ee3\u52a8\u529b\u5b66PBPK\u65b9\u6cd5\u7684\u9769\u65b011\uff0c\u5f00\u53d1\u51fa\u65b0\u65b9\u6cd5\u4ee5\u6ee1\u8db3ANDA\u5ba1\u8bc4\u4e2d\u65b0\u51fa\u73b0\u7684\u9700\u6c42\uff0c\u4f8b\u5982\uff0c\u8bc4\u4f30\u590d\u6742\u836f\u54c1\u7684\u7b49\u6548\u602712\uff0c\u5728\u5047\u8bbe\u6709\u591a\u79cd\u5206\u5e03\u6a21\u578b\u7684\u57fa\u7840\u4e0a\u8bc4\u4f30\u7c92\u5f84\u5206\u5e03\uff0c\u91c7\u7528\u771f\u5b9e\u4e16\u754c\u6216\u533b\u7597\u7d22\u8d54\u7684\u6570\u636e\u8bc4\u4f30\u5df2\u4e0a\u5e02\u4eff\u5236\u836f\u4e0e\u539f\u7814\u836f\u7684\u7597\u6548\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">2.4 \u8054\u7528QMM\u65b9\u6cd5\u548c\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u65b9\u6cd5\u4ee5\u4fc3\u8fdb\u836f\u54c1\u7684\u6279\u51c6<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u53ef\u4ee5\u6574\u5408\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP\u548c\u751f\u7406\u836f\u4ee3\u52a8\u529b\u5b66PBPK\u6a21\u578b\u8fdb\u884c\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u7814\u7a76\uff0c\u8fd9\u662f\u4eff\u5236\u836f\u8bc4\u4f30\u9886\u57df\u7684\u6838\u5fc3\u5e94\u7528\u3002\u53ef\u7528\u7c7b\u4f3c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6a21\u62df\u6280\u672f\u8fdb\u884cVBE\u7814\u7a76\uff0c\u5e76\u8bc4\u4f30\u66ff\u4ee3\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u6027\u80fd\u3002\u4ec0\u4e48\u662fVBE\u7814\u7a76\uff0c\u5b83\u5177\u6709\u54ea\u4e9b\u7279\u5f81\uff1f\u5728\u4eff\u5236\u836f\u5f00\u53d1\u4e2d\uff0cVBE\u5c06\u901a\u8fc7\u6a21\u578b\u6765\u8bc4\u4f30\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u4e4b\u95f4PK\u548c\u4e34\u5e8a\u7597\u6548\u7684\u76f8\u4f3c\u6027\u548c\u6f5c\u5728\u5dee\u5f02\u3002VBE\u6a21\u578b\u5e94\u5177\u5907\u8c03\u6574\u7684\u5236\u5242\u5904\u65b9\u53d8\u91cf\u7684\u529f\u80fd\uff0c\u4ee5\u4ee3\u8868\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u4e4b\u95f4\u7684\u5dee\u5f02\u3002\u6a21\u578b\u53ef\u4ea7\u751f\u7528\u4e8e\u865a\u62dfBE\u7814\u7a76\u7684\u4eba\u7fa4\uff0c\u901a\u8fc7QCP\u6a21\u578b\u6bd4\u8f83\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5728\u8fd9\u4e9b\u4eba\u7fa4\u4e2d\u7684\u6027\u80fd\uff0c\u5e76\u8bc4\u4ef7\u8fd9\u4e24\u79cd\u5236\u5242\u5728\u4f53\u5185\u7684\u76f8\u4f3c\u7a0b\u5ea6\u3002\u901a\u5e38\u9700\u8981\u8fdb\u884c\u591a\u6b21\u6a21\u62df\u7814\u7a76\uff0c\u4ee5\u4f30\u7b97\u4e24\u79cd\u5236\u5242BE\u6210\u529f\u6216\u5931\u8d25\u7684\u6982\u7387\uff0c\u5e76\u786e\u5b9a\u63a7\u5236\u7b2c\u4e00\u7c7b\u548c\u7b2c\u4e8c\u7c7b\u9519\u8bef\u7684\u6837\u672c\u91cf\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\uff08MIE\uff0cModel integrated evidence\uff09\u7684\u4f7f\u7528\uff0c\u5982VBE\u7814\u7a76\u7ed3\u679c\uff0c\u4e0d\u4ec5\u662f\u4e3a\u4e86\u5b9e\u65bd\u4e00\u9879\u5173\u952e\u7684\u7814\u7a76\uff0c\u4e5f\u662f\u4ee5\u4e0b\u65b9\u9762\u7684\u5173\u952e\u8bc1\u636e\uff1a\uff08i\uff09\u836f\u54c1\u7684\u6279\u51c6\uff0c\u6216\uff08ii\uff09\u7ed3\u5408\u6709\u751f\u7269\u76f8\u5173\u6027\u7684\u4f53\u5916BE\u8bd5\u9a8c\uff0c\u4ee5\u652f\u6301\u66ff\u4ee3\u63a8\u8350\u7684\u5e38\u89c4\u4f53\u5185\u7814\u7a76\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u4ee5PK\u4e3a\u7ec8\u70b9\uff0c\u4ee5PD\u4e3a\u7ec8\u70b9\u6216\u4ee5\u5bf9\u6bd4\u4e34\u5e8a\u4e3a\u7ec8\u70b9\u7684\u7814\u7a76\u3002\u6839\u636e\u9884\u671f\u5efa\u6a21\u7684\u76ee\u7684\uff0cMIE\u9700\u5bf9\u77e5\u8bc6\u548c\u6a21\u578b\u9884\u6d4b\u6027\u80fd\u8fdb\u884c\u9002\u5f53\u7684\u96c6\u6210\u3002\u6bcf\u4e2a\u6a21\u578b\u90fd\u9700\u505a\u4e24\u4e2a\u6846\u67b6\u7684\u5047\u8bbe\uff0c\u7b2c\u4e00\u4e2a\u662f\u7ed3\u6784\u6846\u67b6\uff0c\u5b83\u5c06\u8fc4\u4eca\u4e3a\u6b62\u83b7\u5f97\u7684\u6240\u6709\u673a\u7406\u548c\u7ecf\u9a8c\u6027\u77e5\u8bc6\u548c\u4f53\u9a8c\u8fdb\u884c\u6574\u5408\uff0c\u7b2c\u4e8c\u4e2a\u662f\u7edf\u8ba1\u6846\u67b6\uff0c\u5b83\u5c06\u4e0d\u540c\u7c7b\u578b\u7684\u53d8\u5f02\u6027\u8fdb\u884c\u7279\u5f81\u5316\uff0c\u6bd4\u5982\u6b8b\u5dee\uff0c\u4e2a\u4f53\u5185\u7684\u53d8\u5f02\uff0c\u4e2a\u4f53\u95f4\u7684\u53d8\u5f02\uff0c\u4e2a\u4f53\u968f\u65f6\u95f4\u7684\u53d8\u5f02\uff0c\u548c\/\u6216\u8bd5\u9a8c\u95f4\u7684\u53d8\u5f02\u3002\u53ea\u6709\u901a\u8fc7\u79d1\u5b66\u548c\u77e5\u8bc6\u76f8\u7ed3\u5408\u5e76\u901a\u8fc7\u5df2\u6709\u6570\u636e\u7684\u5145\u5206\u652f\u6301\uff0c\u9a8c\u8bc1\uff0c\u786e\u8ba4\u540e\u7684\u4fe1\u606f\u624d\u80fd\u5f52\u7c7b\u4e3aMIE\uff0c\u5e76\u7528\u4e8e\u76d1\u7ba1\u51b3\u7b56\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u53ea\u6709\u4ee5\u4e0b\u4fe1\u606f\u548c\u77e5\u8bc6\u90fd\u5145\u5206\u65f6\uff0c\u624d\u80fd\u5c06MIE\u7528\u4e8e\u836f\u54c1\u5ba1\u6279\u4e2d\uff0c\u5305\u62ec\u6cbb\u7597\u7684\u6548\u679c\uff0c\u66b4\u9732-\u54cd\u5e94\u5173\u7cfb\u7684\u91cf\u5316\uff0c\u836f\u7269\u5438\u6536\u7684\u5efa\u6a21\uff0c\u5177\u6709\u751f\u7269\u9884\u6d4b\u6027\u7684\u4f53\u5916\u65b9\u6cd5\uff0c\u548c\/\u6216\u5b58\u5728\u836f\u7269\u5728\u4f5c\u7528\u90e8\u4f4d\u7684\u66b4\u9732\u6a21\u578b\u3002\u53ef\u5728\u4eff\u5236\u836f\u5f00\u53d1\u548c\u6279\u51c6\u4e2d\u5148\u5b9e\u65bdMIE\uff0c\u56e0\u4e3a\u539f\u7814\u836f\u5728\u4e0a\u5e02\u524d\u548c\u4e0a\u5e02\u540e\u7684\u9636\u6bb5\u90fd\u79ef\u7d2f\u4e86\u66f4\u591a\u7684\u4fe1\u606f\u548c\u77e5\u8bc6\u3002\u540e\u9762\u7684\u6848\u4f8b\u5c06\u8fdb\u4e00\u6b65\u8bf4\u660e\u5728\u4eff\u5236\u836f\u5f00\u53d1\u548c\u6279\u51c6\u4e2d\u5b9e\u65bdMIE\u7684\u6b65\u9aa4\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 0.55em;margin-bottom: 0.55em;font-size: 12px;box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;height: 3em;color: rgb(249, 110, 87);width: 3em;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(255, 129, 36);background-color: rgb(255, 255, 255);box-sizing: border-box;\">\n<section style=\"line-height: 1.5;font-size: 18px;color: rgb(255, 129, 36);text-align: center;box-sizing: border-box;\">\n<p style=\"clear: none;box-sizing: border-box;\">3<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"float: left;margin-top: -2.9em;margin-left: 0.1em;line-height: 2.9em;border-radius: 1.5em;background-color: rgb(255, 129, 36);box-sizing: border-box;min-height: 2.9em !important;\">\n<section style=\"padding-right: 10px;padding-left: 2em;margin-left: 5px;float: left;display: inline-block;vertical-align: top;font-size: 18px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">QMM\u5bf9\u836f\u54c1\u8bc4\u5ba1\uff0c\u6307\u5bfc\u539f\u5219\u5236\u5b9a\uff0c\u836f\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u76d1\u7ba1\u5f71\u54cd<\/strong><\/p>\n<\/section>\n<\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5728\u7f8e\u56fd\u4eff\u5236\u836f\u4f01\u4e1a\u6536\u8d39\u6cd5\u6848\uff08GDUFA\uff09\u76d1\u7ba1\u79d1\u5b66\u8ba1\u5212\u7684\u652f\u6301\u4e0b\uff0c\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u65b9\u6cd5\u5df2\u5e7f\u6cdb\u5e94\u7528\u4e8e\u4eff\u5236\u836f\u5f00\u53d1\u548c\u76d1\u7ba1\u5ba1\u8bc4\u7684\u4e0d\u540c\u9636\u6bb5\u3002\u672c\u8282\u5c06\u901a\u8fc7\u4e00\u4e9b\u6848\u4f8b\u6765\u8bf4\u660eQMM\u5bf9\u7279\u5b9a\u836f\u54c1\u6307\u5bfc\u539f\u5219PSG\u5236\u5b9a\u7684\u5b9e\u7528\u6027\u548c\u5f71\u54cd\uff0c\u5e76\u89e3\u51b3ANDA\u5ba1\u8bc4\u671f\u95f4\u54a8\u8be2\u4e2d\u51fa\u73b0\u7684\u95ee\u9898\u548c\u7591\u8651\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">3.1 \u6a21\u578b\u5f15\u5bfc\u7684\u4f53\u5916\u65b9\u6cd5\u5f00\u53d1\u548c\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u8bc4\u4f30<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: 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style=\"box-sizing: border-box;\">\u7ed3\u679c\u8868\u660e\uff0c\u7528\u4e8e\u6c22\u53ef\u916e\u9152\u77f3\u9178\u6c22\u76d0ER\u7247\u7684IVIVC\u6a21\u578b\u662f\u53ef\u884c\u7684\uff0c\u5e76\u4e14\u65b0\u5f00\u53d1\u7684\u4f53\u5916\u4eba\u5de5\u5480\u56bc\u65b9\u6cd5\u53ef\u6709\u52a9\u4e8e\u9884\u6d4b\u6c22\u53ef\u916e\u9152\u77f3\u9178\u6c22\u76d0ER\u7247\u5480\u56bc\u5e76\u53e3\u670d\u541e\u54bd\u7684\u4f53\u5185\u884c\u4e3a\u3002<\/p>\n<p style=\"box-sizing: border-box;\">PBPK\u5efa\u6a21\u8fd8\u53ef\u5f15\u5bfc\u836f\u54c1\u8d28\u91cf\u89c4\u8303\u7684\u5efa\u7acb\u3002\u6700\u8fd1\u7684\u4e00\u4e2a\u6848\u4f8b\u662f\u666e\u62c9\u683c\u96f7\u76d0\u9178\u76d0\u7247\u5242\u7684\u76d0\u578b-\u78b1\u578b\u8f6c\u5316\u7a0b\u5ea6\u7684\u89c4\u8303\u3002\u5728\u751f\u4ea7\u8fc7\u7a0b\u6216\u5b58\u50a8\u671f\u95f4\u666e\u62c9\u683c\u96f7\u76d0\u4f1a\u8f6c\u5316\u6210\u6e38\u79bb\u78b1\uff0c\u800c\u5bfc\u81f4\u54c1\u8d28\u4e0d\u5747\u5300\u3002\u7531\u4e8e\u666e\u62c9\u683c\u96f7\u76d0\u9178\u76d0\u5728\u80c3\u80a0\u9053pH\u8303\u56f4\u5185\u7684\u6eb6\u89e3\u5ea6\u9ad8\u4e8e\u666e\u62c9\u683c\u96f7\u78b1\u7684\u6eb6\u89e3\u5ea6\uff0c\u56e0\u6b64\u5728\u5065\u5eb7\u53d7\u8bd5\u8005\u80c3pH&gt; 6\u65f6\u7ed9\u836f\uff0c\u8fd9\u65f6\u6eb6\u89e3\u5ea6\u662f\u5438\u6536\u901f\u7387\u7684\u9650\u5236\u6b65\u9aa4\uff0c\u666e\u62c9\u683c\u96f7\u76d0\u9178\u76d0\u4e0e\u666e\u62c9\u683c\u96f7\u78b1\u76f8\u6bd4\uff0c\u5c06\u83b7\u5f97\u66f4\u9ad8\u7684BA29\u3002\u670d\u7528\u8d28\u5b50\u6cf5\u6291\u5236\u5242PPI\u7684\u53d7\u8bd5\u8005\u80c3pH\u503c\u5c06\u5347\u9ad8\uff0c\u636e\u62a5\u9053\uff0c\u8f6c\u5316\u6210\u6e38\u79bb\u78b1\u7684\u7a0b\u5ea6\u8d8a\u9ad8\u5c06\u5bfc\u81f4\u751f\u7269\u4e0d\u7b49\u6548\u7684\u53ef\u80fd\u6027\u5347\u9ad8\uff0c\u56e0\u6b64\u8fd9\u79cd\u62c5\u5fe7\u5728\u5ba1\u8bc4\u4e2d\u4e5f\u5347\u9ad830\u3002\u901a\u8fc7PBPK\u5efa\u6a21\u8bc4\u4f30\u666e\u62c9\u683c\u96f7\u76d0\u9178\u76d0\u836f\u54c1\u76d0\u8f6c\u5316\u78b1\u7684\u6570\u91cf\u5bf9\u670d\u7528PPI\u5065\u5eb7\u53d7\u8bd5\u8005BE\u7684\u5f71\u54cd31\u3002\u901a\u8fc7\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u6a21\u62df\u4fdd\u5b88\u60c5\u51b5\u4e0b\u5b58\u5728\u7684\u4e0d\u786e\u5b9a\u6027\u56e0\u7d20\uff0c\u7ed3\u679c\u8868\u660e\uff0c\u5f53\u666e\u62c9\u683c\u96f7\u76d0\u4e2d\u7684\u6e38\u79bb\u78b1&lt;20%\u65f6\uff0c\u5c31\u53ef\u786e\u4fdd\u8be5\u4eff\u5236\u836f\u4f53\u5185\u662fBE\u7684\uff0c\u5305\u62ec\u670d\u7528\u8d28\u5b50\u6cf5\u6291\u5236\u5242PPI\u7684\u53d7\u8bd5\u8005\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">3.2 \u57fa\u4e8e\u6a21\u578b\u786e\u5b9aBE\u8bc4\u4f30\u4e2d\u7684PK\u6307\u6807<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">PBPK\u53ef\u7528\u4e8e\u5efa\u7acbpAUC\u4e0e\u80c3\u80a0\u9053\u5c40\u90e8\u5438\u6536\u90e8\u4f4d\u7684\u5173\u7cfb\u3002PBPK\u5efa\u6a21\u5de5\u4f5c\u5bfc\u81f4\u80c3\u80a0\u9053\u5c40\u90e8\u4f5c\u7528\u7684\u7f8e\u6c99\u62c9\u55eaER\u80f6\u56ca\u91c7\u7528\u63a8\u8350\u7684pAUC\u8fdb\u884cBE\u8bc4\u4f30\uff0c\u800c\u4e0d\u662f\u91c7\u7528\u4ee5\u5bf9\u6bd4\u4e34\u5e8a\u4e3a\u7ec8\u70b9\u7684BE\u8bd5\u9a8c\u3002\u7f8e\u6c99\u62c9\u55eaER\u80f6\u56ca\uff08\u4ee5Pentasa\u548cApriso\u6279\u51c6\u4e0a\u5e02\uff09\u9002\u7528\u4e8e\u6e83\u75a1\u6027\u7ed3\u80a0\u708e\u60a3\u8005\uff0c\u5728\u80c3\u80a0\u9053\u4e0b\u7aef\u7684\u5c40\u90e8\u7c98\u819c\u53d1\u708e\u8868\u9762\u53d1\u6325\u5c40\u90e8\u4f5c\u752832\u3002\u4e3a\u4e86\u786e\u8ba4\u7f8e\u6c99\u62c9\u55ea\u5728\u5c40\u90e8\u80c3\u80a0\u9053\u7684\u6d53\u5ea6\u662f\u5426\u53ef\u4ee5\u901a\u8fc7\u4f53\u5faa\u73af\u7684PK\u66f2\u7ebf\u83b7\u5f97\uff0c\u91c7\u7528PBPK\u8fdb\u884c\u5efa\u6a21\u4e0e\u6a21\u62df\u4ee5\u9884\u6d4b\u7f8e\u6c99\u62c9\u55eaER\u80f6\u56ca\u7ed9\u836f\u540e\u5728\u7ed3\u80a0\u4e2d\u7684\u836f\u7269\u6d53\u5ea6\u3002\u7528\u9759\u8109\u6ce8\u5c04\uff0c\u53e3\u670d\uff0c\u76f4\u80a0\u7ed9\u836f\u7684\u7f8e\u6c99\u62c9\u55ea\u5236\u5242\u5bf9\u5e94\u7684PK\u6570\u636e\u9a8c\u8bc1PBPK\u6a21\u578b\u3002\u53d1\u73b0\u7ed3\u80a0\u7684\u66b4\u9732\u91cf\u4e0eAUC3-t\u9ad8\u5ea6\u76f8\u5173\u3002\u6700\u7ec8\u5728\u7279\u5b9a\u836f\u54c1\u6307\u5bfc\u539f\u5219PSG\u4e2d\u63a8\u8350\u4e86\u8be5pAUC\uff0c\u53d6\u4ee3\u4e86\u4ee5\u5bf9\u6bd4\u4e34\u5e8a\u4e3a\u7ec8\u70b9\u7684\u7814\u7a76\u3002FDA\u7684\u4eff\u5236\u836f\u529e\u516c\u5ba4\uff08OGD\uff09\u8fd8\u4e0e\u5bc6\u6b47\u6839\u5927\u5b66\u7b7e\u8ba2\u5408\u540c\uff0c\u5bc6\u6b47\u6839\u5927\u5b66\u7528\u7f8e\u6c99\u62c9\u55ea\u836f\u54c1\u8fdb\u884c\u4f53\u5185\u63d2\u7ba1\u7684PK\u7814\u7a7633\u3002\u6570\u636e\u5206\u6790\u8868\u660e\u4f53\u5faa\u73af\u548c\u5c40\u90e8\u80c3\u80a0\u9053\u7684\u836f\u7269\u6d53\u5ea6\u4e4b\u95f4\u5b58\u5728\u76f8\u5173\u6027\u3002\u5df2\u63a8\u8350\u7c7b\u4f3c\u7684BE\u8bd5\u9a8c\u7528\u4e8e\u7f8e\u6c99\u62c9\u55ea\u7684\u5176\u4ed6\u5242\u578b\u7684\u7814\u7a76\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u54cc\u7532\u916f\u662f\u4e00\u79cd\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u5174\u594b\u5242\uff0c\u662f\u6cbb\u7597\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u7684\u6ce8\u610f\u529b\u7f3a\u9677\/\u591a\u52a8\u969c\u788d\u7684\u6700\u5e7f\u6cdb\u7684\u836f\u54c1\u3002\u6839\u636ePK\u66f2\u7ebf\u4e0e\u54cc\u7532\u916f\u836f\u54c1\u4e34\u5e8a\u6548\u679c\u4e4b\u95f4\u7684\u5bc6\u5207\u5173\u7cfb34\uff0c\u91c7\u7528\u6574\u5408\u57fa\u4e8e\u6a21\u578b\u7684\u65b9\u6cd5\u8bc4\u4f30PK\u548cPD\u53d8\u5316\uff0c\u4ee5\u53cd\u6620\u54cc\u7532\u916f\u836f\u54c1\uff08\u5982\u7b2c\u4e8c\u4ee3ER\uff09\u4e0d\u540c\u5236\u5242\u7684\u6f5c\u5728\u53d8\u5f02\u3002\u8fd9\u79cd\u57fa\u4e8e\u6a21\u578b\u7684\u65b9\u6cd5\u7684\u5173\u952e\u7ec4\u6210\u5982\u4e0b\uff1a\uff08i\uff09\u4f53\u5185\u5916\u76f8\u5173\u6027IVIVC\u7684\u8bc4\u4f30\uff0c\uff08ii\uff09\u901a\u8fc7\u57fa\u4e8e\u751f\u7406\u5b66\u7684\u5438\u6536\u5efa\u6a21\u8868\u5f81\u54cc\u7532\u916f\u836f\u54c1\u7684PK\uff0c\u4ee5\u53ca\uff08iii\uff09\u91c7\u7528\u8fde\u63a5\u54cc\u7532\u916f\u66b4\u9732-PD\u54cd\u5e94\u7684\u6a21\u578b\u8fdb\u884c\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u8fdb\u884c\u6a21\u62df35\u3002\u5047\u5b9a\u5404\u79cd\u54cc &nbsp;\u7532\u916f\u836f\u54c1\u7684PK\u5dee\u5f02\u80fd\u53cd\u6620\u4e34\u5e8a\u610f\u4e49\uff0c\u6bd4\u8f83\u5404\u79cdBE\u6307\u6807\u7684\u654f\u611f\u5ea6\u3002VBE\u6a21\u62df\u7ed3\u679c\u8868\u660e\uff0c\u4e0e\u5e38\u89c4\u5cf0\u503c\u8840\u6d46\u6d53\u5ea6\u548cAUC\u6307\u6807\u76f8\u6bd4\uff0cpAUC\u53c2\u6570\u5728\u68c0\u6d4b\u5177\u6709\u4e34\u5e8a\u76f8\u5173\u6027\u7684\u5236\u5242\u5dee\u5f02\u548cPK\u53d8\u5316\u66f4\u654f\u611f\u3002\u603b\u4e4b\uff0c\u56e0\u4e3a\u76f4\u63a5\u7684PK \/ PD\u5173\u7cfb\u4ee5\u53ca\u5f31\u52bf\u513f\u79d1\u4eba\u7fa4\u9700\u957f\u671f\u670d\u7528\u8be5\u836f\uff0c\u6211\u4eec\u5728\u76f8\u5e94\u7684\u7279\u5b9a\u836f\u54c1\u6307\u5bfc\u539f\u5219PSG\u4e2d\u63a8\u8350\u4f7f\u7528pAUC\uff0c\u4ee5\u786e\u4fdd\u836f\u7269\u5728\u5177\u6709\u4e34\u5e8a\u76f8\u5173\u6027\u7684\u7a97\u53e3\u5185\u6d53\u5ea6-\u65f6\u95f4\u548cBE\u6709\u53ef\u6bd4\u602734,35\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">3.3 \u589e\u5f3a\u57fa\u4e8e\u5bf9\u6bd4PD\u7ec8\u70b9\u6216\u4e34\u5e8a\u7ec8\u70b9\u4f53\u5185\u7814\u7a76\u8bc4\u4f30BE\u7684\u65b9\u6cd5<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u4e0e\u4e34\u5e8a\u7ec8\u70b9\u76f8\u6bd4\uff0c\u4ee5PD\u4e3a\u7ec8\u70b9\u5e76\u4e0d\u662f\u4e34\u5e8a\u7597\u6548\u7684\u76f4\u63a5\u8861\u91cf\u6307\u6807\uff0c\u800c\u662f\u8861\u91cf\u201c\u836f\u7269\u5bf9\u8eab\u4f53\u7684\u4f5c\u7528\u201d\u7684\u6307\u6807\uff0c\u4ee5PD\u4e3a\u7ec8\u70b9\u4f7f\u7528\u751f\u7269\u6807\u5fd7\u7269\u6216\u5176\u4ed6\u4e34\u5e8a\u7ed3\u679c\uff08\u6839\u636e\u5176\u4f5c\u7528\u673a\u5236\uff09\u53cd\u6620\u836f\u7269\u5728\u4f53\u5185\u7684\u6d3b\u6027\u3002\u5728\u53e3\u8154\u5438\u5165\u836f\u54c1\u7684PSG\u4e2d\u63a8\u8350\u4f7f\u7528\u4ee5PD\u4e3a\u7ec8\u70b9\u7684BE\u8bc4\u4ef7\u65b9\u6cd5\uff0c\u4f8b\u5982\uff0c\u4e00\u79d2\u949f\u7528\u529b\u547c\u6c14\u91cf\uff08FEV1\uff09\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5efa\u8bae\u91c7\u7528\u5242\u91cf-\u7f29\u653e\u6bd4\u4f8b\u5206\u6790\u6765\u8bc4\u4f30\u6c99\u4e01\u80fa\u9187\u5438\u5165\u836f\u54c1PD\u7684\u76f8\u5e9436\u3002\u9488\u5bf9PD\u6d4b\u91cf\u4e2d\u663e\u793a\u51fa\u975e\u7ebf\u6027\u7684\u5242\u91cf-\u54cd\u5e94\u5173\u7cfb\u7684\u60c5\u51b5\uff0cFDA\u6839\u636e\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u76f8\u5bf9BA\u5236\u5b9a\u4e86\u8be5\u65b9\u6cd5\u7528\u4e8eBE\u7684\u8bc4\u4ef737\u3002\u7136\u800c\uff0c\u5728ANDA\u7684\u76d1\u7ba1\u5ba1\u8bc4\u4e2d\uff0c\u53d1\u73b0\u5230\u7684\u63d0\u4ea4\u8d44\u6599\u4e2d\u5242\u91cf-\u7f29\u653e\u6bd4\u4f8b\u5206\u6790\u5728\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u5b58\u5728\u4e0d\u4e00\u81f4\u6027\uff0c\u4f8b\u5982\uff0c\u83b7\u53d6\u539f\u59cb\u6570\u636e\u7684\u65b9\u6cd5\u4e0d\u540c\uff0c\u7edf\u8ba1\u5efa\u6a21\u7b97\u6cd5\u7684\u4e0d\u540c\uff0c\u7f3a\u5931\u6570\u636e\u5904\u7406\u7684\u4e0d\u540c\u3002FDA\u6700\u8fd1\u4fee\u8ba2\u4e86PSG\uff0c\u76ee\u7684\u5728\u4e8e\u4f7f\u5efa\u6a21\u8fc7\u7a0b\u7edf\u4e00\uff0c\u5e76\u63d0\u9ad8\u5efa\u6a21\u65b9\u6cd5\u7684\u6027\u80fd\u3002\u4e3a\u4e86\u786e\u4fdd\u4fee\u8ba2\u7684\u79d1\u5b66\uff0cFDA\u901a\u8fc7\u5efa\u6a21\u548c\u6a21\u62df\u8bc4\u4f30\u5404\u79cd\u6280\u672f\u56e0\u7d20\u5bf9\u5242\u91cf-\u7f29\u653e\u6bd4\u4f8b\u5206\u6790\u7ed3\u679c\u7684\u5f71\u54cd\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5efa\u6a21\u7ed3\u679c\u8868\u660e\u5728\u8fdb\u884c\u5242\u91cf-\u7f29\u653e\u6bd4\u4f8b\u5206\u6790\u65f6\uff0c\u975e\u7ebf\u6027\u6df7\u5408\u6548\u5e94\uff08NLME\uff09\u7b97\u6cd5\u91c7\u7528\u6c47\u603b\u7684\u4e2a\u4f53\u6570\u636e\u6bd4\u91c7\u7528\u5e73\u5747\u6570\u636e\u6709\u4f18\u52bf\uff0c\u8fd9\u662f\u56e0\u4e3a\u975e\u7ebf\u6027\u6df7\u5408\u6548\u5e94NLME\u7b97\u6cd5\u53ef\u4ee5\u5c06\u6240\u6709\u4e2a\u4f53\u6c34\u5e73\u7684\u4fe1\u606f\u90fd\u7eb3\u5165\u6a21\u578b\uff0c\u5e76\u7528\u4e8e\u8868\u5f81\u836f\u54c1\u7684\u6027\u80fd38\u3002FDA\u7684\u5efa\u6a21\u5de5\u4f5c\u5bfc\u81f4\u4e86\u4fee\u8ba2\u7248\u7684PSG\u4e2d\u63a8\u8350\u4f7f\u7528NLME\u65b9\u6cd5\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><span style=\"color: rgb(255, 129, 36);box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">3.4 \u4f7f\u7528PBPK \/ QCP\u6a21\u578b\u51cf\u5c11\u4ee5PK\u4e3a\u7ec8\u70b9\uff0c\u6bd4\u8f83PD\u7ec8\u70b9\uff0c\u6bd4\u8f83\u4e34\u5e8a\u7ec8\u70b9\u7684BE\u8bc4\u4ef7\u7814\u7a76\u7684\u8d1f\u62c5<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u542b\u6709\u5de6\u7094\u8bfa\u5b55\u916e\u7684\u957f\u6548\u5bab\u5185\u8282\u80b2\u7cfb\u7edf\uff08IUS\uff09\u5177\u6709\u957f\u8fbe5\u5e74\u7684\u907f\u5b55\u6548\u679c\uff0c\u7528\u4e8e\u5973\u6027\u4f7f\u7528IUS\u4f5c\u4e3a\u907f\u5b55\u65b9\u6cd5\u4e14\u6708\u7ecf\u91cd\u5ea6\u51fa\u8840\u7684\u6cbb\u7597\u3002\u7531\u4e8eIUS\u5728\u5b50\u5bab\u5185\u662f\u5c40\u90e8\u9012\u9001\u5de6\u7094\u8bfa\u5b55\u916e\u7684\uff0c\u56e0\u6b64\u5e38\u89c4\u4ee5PK\u4e3a\u7ec8\u70b9\u7684BE\u65b9\u6cd5\u4e0d\u8db3\u4ee5\u8bc4\u4f30\u5de6\u7094\u8bfa\u5b55\u916eIUS\u7684\u6cbb\u7597\u7b49\u6548\u6027\u3002\u6b64\u5916\uff0c\u8003\u8651\u5230\u8be5\u836f\u54c1\u76ee\u6807\u662f\u8ba9\u5de6\u7094\u8bfa\u5b55\u916e\u7684\u91ca\u653e\u957f\u8fbe5\u5e74\uff0c\u6301\u7eed5\u5e74\u7684\u5bf9\u6bd4\u4e34\u5e8a\u7ec8\u70b9BE\u7814\u7a76\u5728\u5b9e\u9645\u4e2d\u662f\u4e0d\u592a\u53ef\u884c\u7684\u3002\u56e0\u6b64\uff0c\u6211\u4eec\u63a2\u7d22\u4e86\u66ff\u4ee3\u7684BE\u7814\u7a76\u8bbe\u8ba1\uff0c\u6d89\u53ca\u836f\u54c1\u7684Q3\u7279\u5f81\u548c\u57fa\u4e8eIUS\u89c4\u5b9a\u65f6\u95f4\u5185\u5de6\u7094\u8bfa\u5b55\u916e\u6b8b\u7559\u91cf\u7684\u77ed\u671fBE\u7814\u7a76\u3002\u901a\u8fc7\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP\u7684\u5efa\u6a21\u548c\u6a21\u62df\uff0c\u6211\u4eec\u5f00\u53d1\u4e86\u4e00\u79cd\u66ff\u4ee3\u7684BE\u65b9\u6cd5\uff0c\u5c06BE\u7814\u7a76\u6301\u7eed\u65f6\u95f4\u4ece5\u5e74\u7f29\u77ed\u81f31\u5e74\uff0c\u5e76\u5efa\u8baeIUS\u5de6\u7094\u8bfa\u5b55\u916e\u5728\u7b2c1\u5e74\u7684\u6b8b\u7559\u91cf\u8981\u63a7\u5236\u5728BE\u9650\u5b9a\u8303\u56f4\u7684(95\u2013105%)\u5185\uff0c\u4ee5\u786e\u4fdd\u7b2c\u4e94\u5e74\u8fd8\u80fd\u7ef4\u6301\u572890\uff05BE\u7f6e\u4fe1\u533a\u95f4CI\uff0cBE\u9650\u5b9a\u8303\u56f4\u572880-125\uff05\u4e4b\u95f4\u3002\u8fd9\u53ef\u80fd\u4f1a\u4fc3\u4f7f\u5de6\u7094\u8bfa\u5b55\u916eIUS\u7684\u4eff\u5236\u836f\u4f01\u4e1a\u53c2\u4e0e\u5230\u8be5\u7ade\u4e89\u4e2d39\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406\u5b66QCP\u53ef\u7528\u4e8e\u786e\u5b9aBE\u8bc4\u4f30\u7684\u7814\u7a76\u7ec8\u70b9\u3002\u4f0a\u7ef4\u83cc\u7d20\u5916\u7528\u4e73\u818f\u662f\u4e00\u79cd\u72ec\u7279\u7684\u5c40\u90e8\u836f\u54c1\uff0c\u4f53\u5faa\u73af\u53ef\u68c0\u6d4b\u5230\u836f\u7269\u6d53\u5ea6\u3002\u4f0a\u7ef4\u83cc\u7d20\u5438\u6536\u5165\u4f53\u5faa\u73af\u7684\u9650\u901f\u6b65\u9aa4\u662f\u5982\u4f55\u5feb\u901f\u900f\u8fc7\u591a\u5c42\u8868\u76ae\u5e76\u8fdb\u5165\u771f\u76ae\uff0c\u8fd9\u662f\u836f\u7269\u4f5c\u7528\u7684\u90e8\u4f4d\u4e14\u4f0a\u7ef4\u83cc\u7d20\u5728\u8be5\u90e8\u4f4d\u5438\u6536\u8fdb\u5165\u4f53\u5faa\u73af\u4e2d\u3002\u56e0\u6b64\uff0c\u4f0a\u7ef4\u83cc\u7d20\u4f53\u5faa\u73af\u7684\u66b4\u9732\u91cf\u53ef\u80fd\u4e0e\u80fd\u5230\u8fbe\u4f5c\u7528\u90e8\u4f4d\u7684\u4f0a\u7ef4\u83cc\u7d20\u7684\u91cf\u76f8\u5173\u3002\u4e3a\u6b64\uff0c\u6211\u4eec\u8fdb\u884c\u4e86\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u6a21\u62df\uff0c\u5e76\u5b9a\u91cf\u6bd4\u8f83\u4ee5PK\u4e3a\u7ec8\u70b9\u548c\u5bf9\u6bd4\u4e34\u5e8a\u7ec8\u70b9\u4e24\u79cd\u65b9\u6cd5\u5728BE\u7814\u7a76\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u68c0\u6d4b\u4e0d\u540c\u5236\u5242\u5dee\u5f02\u7684\u654f\u611f\u5ea6\u3002VBE\u7814\u7a76\u8868\u660e\uff0c\u4e0e\u5bf9\u6bd4\u4e34\u5e8a\u7ec8\u70b9\u7684BE\u5e73\u884c\u8bd5\u9a8c\u8bbe\u8ba1\u76f8\u6bd4\uff0c\u53cc\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\u7684PK\u7814\u7a76\u5728\u68c0\u6d4b\u5236\u5242\u5dee\u5f02\u65b9\u9762\u66f4\u654f\u611f\u3002\u6b64\u5916\uff0cPK\u7814\u7a76\u6240\u9700\u8981\u7684\u53d7\u8bd5\u8005\u4f8b\u6570\u66f4\u5c11\uff0c\u7814\u7a76\u6301\u7eed\u65f6\u95f4\u66f4\u77ed\u3002\u6839\u636e\u8fd9\u4e9b\u7ed3\u679c\uff0c\u5f53\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5728\u8d28\u91cf\u548c\u542b\u91cf\u4e0a\u662f\u76f8\u540c\u7684\uff0c\u7269\u7406\u5316\u5b66\u6027\u8d28\u662f\u76f8\u4f3c\u7684\uff0c\u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u8868\u660e\u836f\u7269\u6709\u7b49\u6548\u7684\u91ca\u653e\u901f\u7387\uff0c\u4f53\u5916\u6e17\u900f\u8bd5\u9a8c\u663e\u793a\u6709\u7b49\u6548\u7684\u836f\u7269\u6e17\u900f\u901f\u7387\/\u7a0b\u5ea6\u65f6\uff0c\u6211\u4eec\u63a8\u8350\u8fd9\u6837\u7684\u836f\u54c1\u91c7\u7528\u4ee5PK\u4e3a\u7ec8\u70b9\u8fdb\u884cBE\u7814\u7a76\u3002\u4eff\u5236\u836f\u7533\u8bf7\u65b9\u4e5f\u53ef\u4ee5\u9009\u62e9\u4ee5\u5bf9\u6bd4\u4e34\u5e8a\u4e3a\u7ec8\u70b9\u8fdb\u884cBE\u7814\u7a7640\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u6a21\u578b\u8fd8\u652f\u6301\u5f53\u836f\u54c1\u4e0d\u540c\u89c4\u683c\u51fa\u73b0\u4e0d\u540c\u7684\u91ca\u653e\u66f2\u7ebf\u65f6\uff0c\u4f4e\u89c4\u683c\u836f\u54c1\u4e0d\u9700\u8fdb\u884c\u4f53\u5185PK\u7684BE\u7814\u7a76\u3002\u4f8b\u5982\uff0c\u8f83\u4f4e\u89c4\u683c\u7684\u5965\u6614\u5e03\u5b81\u7684\u91ca\u653e\u66f2\u7ebf\u4e0e\u9ad8\u89c4\u683c\u7684\u4e0d\u540c\uff0c\u4f46\u4f4e\u89c4\u683c\u5e76\u6ca1\u6709\u8fdb\u884c\u4f53\u5185BE\u7814\u7a76\u3002\u91c7\u7528PBPK\u6a21\u578b\u8bc4\u4f30\u6839\u636e\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u662f\u5426\u6709\u751f\u7269\u4e0d\u7b49\u6548\u7684\u98ce\u9669\uff0c\u6839\u636e\u57fa\u4e8ePBPK\u6a21\u578b\u7684\u4f53\u5916-\u4f53\u5185\u5173\u7cfbIVIVR\u6a21\u578b\u7684\u8bc4\u4f30\u7ed3\u679c\uff0c\u4e0d\u5efa\u8bae\u5730\u89c4\u683c\u7684\u5965\u6614\u5e03\u5b81\u8fdb\u884c\u4f53\u5185BE\u7814\u7a7641,42\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"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;\"><strong style=\"box-sizing: border-box;\"><span style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">3.5 \u57fa\u4e8e\u6a21\u578b\u8bc4\u4f30\u751f\u7269\u4e0d\u7b49\u6548\u6027\u7684\u98ce\u9669\uff0c\u4ee5\u89e3\u51b3\u5ba1\u8bc4\u4e2d\u7684\u54a8\u8be2<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5efa\u6a21\u548c\u6a21\u62df\u53ef\u7528\u4e8e\u8bc4\u4f30\u5bf9\u6f5c\u5728\u4e0dBE\u7684\u62c5\u5fe7\u3002\u91c7\u7528PBPK\u6a21\u578b\u5bf9\u836f\u7269\u7684\u5438\u6536\u8fdb\u884c\u5efa\u6a21\u548c\u6a21\u62df\uff0c\u7528\u4e8e\u6d4b\u91cf\u76f8\u5bf9\u9ad8\u6f6e\u6e7f\u73af\u5883\u4e0b\u534e\u6cd5\u6797\u7ed3\u6676\u5305\u5408\u7269\u5f62\u5f0f\u4e2d\u5f02\u4e19\u9187\u7684\u6d41\u5931\u91cf\uff0c\u6d4b\u9a8c\u9178\u6027pH\u6761\u4ef6\u4e0b\u6eb6\u51fa\u53d8\u6162\u540e\u5bf9\u534e\u6cd5\u6797\u94a0\u7247\u7684PK\u662f\u5426\u6709\u663e\u8457\u7684\u5f71\u54cd\uff0c\u6a21\u578b\u7684\u8f93\u5165\u53c2\u6570\u4e3a\u5236\u5242\u5904\u65b9\u56e0\u5b50\u6216\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u3002<\/p>\n<p style=\"box-sizing: border-box;\">\u57fa\u4e8e\u6a21\u578b\u7684\u654f\u611f\u6027\u5206\u6790\u8868\u660e\u534e\u6cd5\u6797PK\u5bf9pH 4.5\u4e0b\u7684\u6eb6\u89e3\u5ea6\uff0c\u7c92\u5f84\uff0c\u5bc6\u5ea6\u6216\u6eb6\u51fa\u901f\u7387\u90fd\u4e0d\u654f\u611f\u3002\u4f46\u5176PK\u53d7pH 6.8\u4e0b\u7684\u6eb6\u51fa\u901f\u7387\u7684\u5f71\u54cd\uff0c\u5e76\u53ef\u4f5c\u4e3a\u836f\u7269\u76f8\u5bf9\u91cf\u7684\u6548\u80fd\u6d4b\u91cf\u3002\u5982\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u7814\u7a76\u7ed3\u679c\u6240\u793a\uff0c\u5982\u53d7\u6f6e\u964d\u89e3\u7684\u534e\u6cd5\u6797\u94a0\u7247\u5728pH4.5\u4e2d\u6eb6\u51fa\u53d8\u6162\u800c\u5728pH6.8\u4e2d\u6eb6\u51fa\u8ddf\u672a\u964d\u89e3\u7684\u76f8\u4f3c\uff0c\u5219\u53d7\u6f6e\u964d\u89e3\u4e0e\u672a\u964d\u89e3\u7684\u534e\u6cd5\u6797\u94a0\u7247\u5c06\u4e0dBE\u3002\u964d\u89e3\u7684\u7247\u5242\u6307\u7684\u662f\u5bb6\u5ead\u6d74\u5ba4\u5178\u578b\u5b58\u50a8\u6761\u4ef6\u4e0b\u7684\u7247\u5242\uff0c\u4ee3\u8868\u4e86\u6700\u5dee\u4e14\u4e0d\u63a8\u8350\u7684\u836f\u54c1\u50a8\u5b58\u73af\u5883\uff08\u4f8b\u598240\u2103\/ 75\uff05\u76f8\u5bf9\u6e7f\u5ea6\u4e0b24\u5c0f\u65f6\uff09\u3002\u968f\u540e\u5728\u5065\u5eb7\u53d7\u8bd5\u8005\u4e2d\u5f00\u5c55\u56db\u4ea4\u53c9\u5355\u5242\u91cf\u8bbe\u8ba1\u8bd5\u9a8c\uff0c\u5176BE\u7814\u7a76\u7684\u4f53\u5185PK\u7ed3\u679c\u8bc1\u5b9e\u4e86\u4e4b\u524d\u7684PK\u6a21\u62df\u9884\u6d4b\u7ed3\u679c43\u3002<\/p>\n<p style=\"box-sizing: border-box;\">PBPK\u8fd8\u7528\u4e8e\u8bc4\u4f30\u76d0\u9178\u6587\u62c9\u6cd5\u8f9bER\u5236\u5242\u56e0\u91ca\u653e\u673a\u5236\u53d8\u66f4\u5e26\u6765\u7684\u98ce\u9669\uff0c\u4ece\u6e17\u900f\u6cf5\u7247\u53d8\u66f4\u4e3a\u53ef\u6253\u5f00\u578b\u9aa8\u67b6\u7247\u3002FDA\u6279\u51c6\u4e86\u91c7\u7528\u53ef\u6253\u5f00\u578b\u9aa8\u67b6\u7247\u91ca\u653e\u673a\u5236\u7684\u76d0\u9178\u6587\u62c9\u6cd5\u8f9bER\u53e3\u670d\u5236\u5242\uff0c\u8fd9\u4e0e\u53c2\u6bd4\u5236\u5242\u91c7\u7528\u7684\u662f\u63a8-\u62c9\u5f0f\u7684\u6e17\u900f\u6cf5\u91ca\u653e\u673a\u5236\u4e0d\u540c\u3002BE\u7684\u98ce\u9669\u662f\u8ddf\u836f\u54c1\u9009\u62e9\u7684\u91ca\u653e\u6a21\u5f0f\u662f\u5426\u6070\u5f53\u76f8\u5173\u7684\uff0c\u5982\u91ca\u653e\u9700\u731b\u7136\u6253\u5f00\u65f6\u51fa\u73b0\u4e86\u5ef6\u8fdf\uff0c\u8fd9\u79cd\u4e0d\u9002\u5f53\u7684\u91ca\u653e\u6a21\u5f0f\u5c06\u5bfc\u81f4\u9884\u671fPK\u66f2\u7ebf\u7684\u53d8\u5316\u3002\u91c7\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684PBPK\u5438\u6536\u6a21\u578b\uff0c\u6a21\u62df\u6e17\u900f\u6cf5\u6216\u53ef\u6253\u5f00\u578b\u9aa8\u67b6\u7684\u76d0\u9178ER\u6587\u62c9\u6cd5\u8f9b\u7247\u5242\u5355\u6b21\u7ed9\u836f\u540e\u7684PK\u66f2\u7ebf\uff0c\u5728\u9884\u6d4b\u7684PK\u66f2\u7ebf\u7684\u57fa\u7840\u4e0a\uff0c\u5f53\u4f7f\u7528\u7684\u836f\u7269\u7684\u5ef6\u8fdf\u91ca\u653e\u65f6\u95f4\uff08lag time\uff09\u57280\u52304\u5c0f\u65f6\u4e4b\u95f4\u53d8\u5316\u65f6\uff0c\u53ef\u6253\u5f00\u578b\u9aa8\u67b6\u7684\u76d0\u9178ER\u6587\u62c9\u6cd5\u8f9b\u7247\u524290%\u7684\u7f6e\u4fe1\u533a\u95f4CI\u5185\u7684\u8840\u6d46\u5cf0\u503c\u6d53\u5ea6\u548cAUCt\u5728BE\u63a5\u53d7\u9650\u5ea6\u5185\uff08\u537380-125\uff05\uff09\uff0c\u91c7\u7528\u6700\u5e38\u7528\u6eb6\u51fa\u6761\u4ef6\u7684\u6eb6\u51fa\u66f2\u7ebf\uff0c\u7ed3\u679c\u63d0\u793a\u83b7\u6279\u7684\u53ef\u6253\u5f00\u578b\u9aa8\u67b6\u7684\u76d0\u9178ER\u6587\u62c9\u6cd5\u8f9bER\u7247\u5242\u7684BE\u98ce\u9669\u4e3b\u8981\u6765\u81ea\u5236\u5242\u524d\u671f\u7684\u91ca\u653e\u5ef6\u8fdf44\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">3.6 \u6a21\u578b\u6574\u5408\u5b9e\u8bc1MIE\u5728\u4eff\u5236\u836f\u83b7\u6279\u4e2d\u7684\u5e94\u7528&nbsp;<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u4e34\u5e8a\u836f\u7406QCP\u5efa\u6a21\u7ed3\u679c\u4e00\u65e6\u7ecf\u8fc7\u5145\u5206\u7684\u9a8c\u8bc1\uff0c\u5c31\u53ef\u4f5c\u4e3a\u7528\u4e8e\u836f\u7269\u83b7\u6279\u7684\u6a21\u578b\u6574\u5408\u5b9e\u8bc1MIE\u3002\u6eb4\u83ab\u5c3c\u5b9a\u51dd\u80f6\u5c40\u90e8\u7ed9\u836f\u4f5c\u4e3aNDA\u7684\u83b7\u6279\u4e3b\u8981\u4f9d\u8d56\u4e8e\u7597\u6548\u7ec8\u70b9\uff0c\u5373\u4e0d\u540c\u65f6\u95f4\u70b9\u7684\u7ec4\u5408\u6210\u529f\u7387\u3002\u6839\u636e\u4e34\u5e8a\u533b\u751f\u548c\u60a3\u8005\u5728\u56db\u4e2a\u65f6\u95f4\u70b9\uff08\u7b2c29\u5929\u76843,6,9,12\u5c0f\u65f6\uff09\u6d4b\u91cf\u7684\u4e94\u70b9\u8bc4\u4ef7\u6307\u6807\u5747\u5f97\u5230\u4e24\u7ea7\u6539\u5584\u7684\u53d7\u8bd5\u8005\u6bd4\u4f8b\u6765\u8fdb\u884c\u8bc4\u4f30\u7684\u3002FDA\u63a8\u8350\u4eff\u5236\u836f\u5f00\u53d1\u7684\u4ee5\u5bf9\u6bd4\u4e34\u5e8a\u4e3a\u7ec8\u70b9\u7684BE\u7814\u7a76\uff0c\u5176\u4e2d\u4ee5\u7b2c15\u5929\u7684\u56db\u4e2a\u65f6\u95f4\u70b9\u4e3a\u9996\u8981\u8003\u5bdf\u70b9\uff0c\u6b21\u8981\u8003\u5bdf\u7684\u65f6\u95f4\u70b9\u4e3a\u7b2c\u4e00\u5929\u7684\u7ec8\u70b945\u3002\u8fd1\u671f\u7684ANDA\u7533\u8bf7\u4e2d\uff0c\u5f53\u5bf9\u6bd4\u4e34\u5e8a\u7814\u7a76\u4e2d\u7684\u65f6\u95f4\u70b9\u4e0e\u76d1\u7ba1\u90e8\u95e8\u63a8\u8350\u7684\u65f6\u95f4\u70b9\u5e76\u4e0d\u4e00\u81f4\u65f6\uff0c\u5f15\u53d1\u7684\u76d1\u7ba1\u8ba8\u8bba\u4e3a\uff1a\u6839\u636e\u73b0\u6709\u7684\u4e34\u5e8a\u54cd\u5e94\u6570\u636e\u662f\u5426\u53ef\u6a21\u62dfBE\u7814\u7a76\u4e2d\u672a\u5f00\u5c55\u7814\u7a76\u7684\u65f6\u95f4\u70b9\uff1f\u901a\u8fc7\u5efa\u6a21\u65b9\u6cd5\u5f97\u5230\u7684\u6570\u636e\u662f\u5426\u53ef\u4ee5\u7528\u4e8e\u652f\u6301ANDA\u6279\u51c6\u7684\u76d1\u7ba1\u51b3\u7b56\uff1f<\/p>\n<p style=\"box-sizing: border-box;\">\u5148\u4f7f\u7528\u539f\u59cbNDA\u7684\u6570\u636e\u5f00\u53d1\u66b4\u9732-\u54cd\u5e94\u6a21\u578b\uff0c\u7136\u540e\u5728\u5df2\u901a\u8fc7\u9a8c\u8bc1\u7684\u6a21\u578b\u4e0a\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6a21\u62df\u3002\u53ef\u89c6\u5316\u7684\u9884\u6d4b\u7ed3\u679c\u8868\u660e\u8be5\u6a21\u578b\u53ef\u5f88\u597d\u5730\u63cf\u8ff0ANDA\u7b2c1\u5929\u548c\u7b2c15\u5929\u7684ANDA\u7684\u8bd5\u9a8c\u7ed3\u679c\u3002\u63a5\u7740\uff0c\u91c7\u7528\u8be5\u6a21\u578b\u9884\u6d4b\u8d85\u8fc7\u539f\u7814\u7a76\u4e2d\u672a\u5f00\u5c55\u7814\u7a76\u7684\u65f6\u95f4\u70b9\u7684\u836f\u7269\u6548\u80fd\uff0c\u6a21\u578b\u8986\u76d6\u4e86\u7b2c15\u5929\u6240\u7814\u7a76\u7684\u65f6\u95f4\u70b9\u3002\u901a\u8fc7\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u7684\u6a21\u62df\uff0c\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5728-0.20\u81f30.20\u7684\u533a\u95f4\u5185\uff0c\u672a\u5f00\u5c55\u7814\u7a76\u7684\u65f6\u95f4\u70b9\u7684\u533a\u5206\u529b\u7684\u6210\u529f\u7387\u5177\u6709\u7ea690%\u7684CI\u3002FDA\u5f00\u5c55\u7684\u8fd9\u9879\u6a21\u62df\uff0c\u4e3a\u8be5ANDA\u7533\u8bf7\u521d\u6b65\u6279\u51c6\u7684\u51b3\u7b56\u63d0\u4f9b\u4e86\u652f\u6301\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 0.55em;margin-bottom: 0.55em;font-size: 12px;box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;height: 3em;color: rgb(249, 110, 87);width: 3em;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(255, 129, 36);background-color: rgb(255, 255, 255);box-sizing: border-box;\">\n<section style=\"line-height: 1.5;font-size: 22px;color: rgb(255, 129, 36);text-align: center;box-sizing: border-box;\">\n<p style=\"clear: none;box-sizing: border-box;\">4<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"float: left;margin-top: -2.9em;margin-left: 0.1em;line-height: 2.9em;border-radius: 1.5em;background-color: rgb(255, 129, 36);box-sizing: border-box;min-height: 2.9em !important;\">\n<section style=\"padding-right: 10px;padding-left: 2em;margin-left: 5px;float: left;display: inline-block;vertical-align: top;font-size: 18px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u5728\u4eff\u5236\u836f\u5f00\u53d1\u548c\u5ba1\u8bc4\u4e2d\u7684\u524d\u666f<\/strong><\/p>\n<\/section>\n<\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"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;\"><span style=\"color: rgb(255, 129, 36);box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\"><span style=\"font-size: 18px;box-sizing: border-box;\">4.1 \u91c7\u7528\u751f\u7406\u836f\u4ee3\u52a8\u529b\u5b66PBPK\u6a21\u578b\u548c\u5b9a\u91cf\u836f\u7406QCP\u6a21\u578b\u534f\u52a9ANDA\u836f\u54c1\u7684\u5f00\u53d1\uff0c\u5305\u62ec\u652f\u6301\u5236\u836f\u4f01\u4e1a\u5bfb\u627e\u65b0\u7684BE\u66ff\u4ee3\u65b9\u6cd5<\/span><\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5982\u56fe1\u6240\u793a\uff0c\u5efa\u6a21\u548c\u6a21\u62df\u5df2\u5e7f\u6cdb\u5e94\u7528\u4e8e\u65b0\u836f\u5f00\u53d1\u7684\u4e0d\u540c\u9636\u6bb5\uff0c\u4e3b\u8981\u5e94\u7528\u9886\u57df\uff1a\u9996\u6b21\u4eba\u4f53PK\u66f2\u7ebf\u7684\u9884\u6d4b\uff0c\u7ed9\u836f\u5242\u91cf\u548c\u7ed9\u836f\u65b9\u6848\u7684\u4f18\u5316\uff0cPK \/ PD 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style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 18px;color: rgb(255, 129, 36);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">4.2 GDUFA II\u8ba1\u5212\u4e0b\u5efa\u7acbQMM\u5de5\u5177\u94fe<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">FDA\u7684GDUFA I\u548cGDUFA II\u8ba1\u5212\u5df2\u8d44\u52a9\u4e86\u9488\u5bf9\u4eff\u5236\u836f\u5f00\u53d1\u548c\u5ba1\u6279\u7684QMM\u5de5\u5177\u96c6\u7684\u79d1\u5b66\u7814\u7a76\u4e0e\u5f00\u53d1\u3002\u901a\u8fc7\u5bf9QMM\u91cd\u70b9\u7814\u7a76\u7684\u57fa\u91d1\u8d44\u52a9\u548c\u5408\u540c\u7b7e\u7f72\uff0cGDUFA 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title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/7-1558080787.jpg\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\"><span style=\"font-size: 14px;box-sizing: 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border-box;\">\u5bf9\u4e8e\u900f\u76ae\u7684\u4eff\u5236\u836f\uff0cGDUFA\u8d44\u52a9\u7814\u7a76\u7684\u91cd\u70b9\u5728\u4e8e\u6539\u5584\u5efa\u6a21\u5de5\u5177\u7684\u5b9a\u91cf\u6027\u80fd\uff0c\u8fd9\u4e9b\u5efa\u6a21\u5de5\u5177\u7528\u4e8e\u63cf\u8ff0API\u5236\u6210\u6cbb\u7597\u76ae\u80a4\u75c5\u7684\u5236\u5242\u5728\u900f\u8fc7\u76ae\u80a4\u65f6\u7684\u5438\u6536\u3002\u76ee\u524d\uff0c\u7814\u7a76\u76ee\u6807\u662f\u5f00\u53d1\u9884\u6d4b\u5f71\u54cd\u76ae\u80a4\u5c40\u90e8\u4f5c\u7528\u548c\u900f\u76ae\u5242\u578b\u4f53\u5185\u6027\u80fd\u7684\u5173\u952e\u5236\u5242\u5c5e\u6027\u7684\u5efa\u6a21\u4e0e\u6a21\u62df\u5de5\u5177\uff0c\u8fd9\u4e9b\u5de5\u5177\u53ef\u7528\u4e8e\u9884\u6d4b\u865a\u62df\u5065\u5eb7\u53d7\u8bd5\u8005\u548c\u865a\u62df\u75c5\u4eba\u53d7\u8bd5\u8005\u7684\u900f\u76ae\u60c5\u51b5\u3002\u8fd9\u4e9b\u6a21\u578b\u63d0\u9ad8\u4e86\u865a\u62df\u751f\u7269\u7b49\u6548\u6027VBE\u548cBE\u8bc4\u4f30\u7684\u9884\u6d4b\u6027\u80fd\uff0c\u4ece\u800c\u53ef\u66ff\u4ee3\u4f53\u5185BE\u7814\u7a7647\u3002<\/p>\n<p style=\"box-sizing: 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style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 0.55em;margin-bottom: 0.55em;font-size: 12px;box-sizing: border-box;\">\n<section style=\"display: inline-block;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;height: 3em;color: rgb(249, 110, 87);width: 3em;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(255, 129, 36);background-color: rgb(255, 255, 255);box-sizing: border-box;\">\n<section style=\"line-height: 1.5;font-size: 18px;color: rgb(255, 129, 36);text-align: center;box-sizing: border-box;\">\n<p style=\"clear: none;box-sizing: border-box;\">5<br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"float: left;margin-top: -2.9em;margin-left: 0.1em;line-height: 2.9em;border-radius: 1.5em;background-color: rgb(255, 129, 36);box-sizing: border-box;min-height: 2.9em !important;\">\n<section style=\"padding-right: 10px;padding-left: 2em;margin-left: 5px;float: left;display: inline-block;vertical-align: top;font-size: 18px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u7ed3\u8bed<\/strong><\/p>\n<\/section>\n<\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u5b9a\u91cf\u65b9\u6cd5\u4e0e\u5efa\u6a21QMM\u7684\u5e94\u7528\u5305\u62ec\u7814\u7a76\u65b0\u7684BE\u6307\u6807\uff0c\u7528\u4e8e\u4f53\u5faa\u73af\u548c\u5c40\u90e8\u4f5c\u7528\u836f\u54c1\uff0c\u590d\u6742\u836f\u54c1\u548c\u8c03\u91ca\u5236\u5242\u7684PBPK\u6a21\u578b\u6280\u672f\u7684\u6539\u8fdb\uff0c\u57fa\u4e8e\u6a21\u578b\u7684BE\u8bc4\u4f30\uff0c\u836f\u54c1\u4e0a\u5e02\u540e\u7684\u8bc4\u4f30\uff0c\u57fa\u4e8e\u98ce\u9669\u7684\u8bc4\u4f30\u3002QMM\u901a\u5e38\u7528\u4e8e\u7279\u5b9a\u836f\u54c1\u6307\u5bfc\u539f\u5219PSG\u5efa\u7acb\u7684\u5236\u5b9a\uff0c\u89e3\u51b3\u6cd5\u89c4\u76d1\u7ba1\u4e2d\u51fa\u73b0\u7684\u95ee\u9898\u4ee5\u53ca\u534f\u52a9ANDA\u7684\u5ba1\u8bc4\u51b3\u7b56\u3002<\/p>\n<p style=\"box-sizing: 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2em;margin-left: 5px;float: left;display: inline-block;vertical-align: top;font-size: 18px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u81f4\u8c22<\/strong><\/p>\n<\/section>\n<\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"line-height: 2;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u611f\u8c22\u6765\u81ea\u7f8e\u56fdFDA\u7684\u836f\u7269\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3CDER\u7684\u4eff\u5236\u836f\u529e\u516c\u5ba4OGD\u7684\u5b9a\u91cf\u65b9\u6cd5\u548c\u6a21\u578b\u90e8\u95e8\u7684\u79d1\u5b66\u5bb6\u4eec\uff0c\u4ed6\u4eec\u63d0\u4f9b\u4e86\u8be5\u9879\u76ee\u7684\u6848\u4f8b\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;text-align: center;box-sizing: border-box;\"><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/2-1558080787.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/p>\n<section style=\"display: inline-block;vertical-align: top;max-width: 100%;border-radius: 3px 3px 0px 0px;margin-right: 3px;margin-left: 3px;background-color: rgb(255, 129, 36);color: rgb(255, 255, 255);font-size: 18px;padding-left: 6px;padding-right: 6px;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u53c2\u8003\u6587\u732e<\/p>\n<\/section>\n<p><img     style=\"display: inline-block;vertical-align: bottom;width: 0.8em;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/4-1558080787.png\" alt=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\" title=\"\u8bd1\u6587|FDA\u901a\u8fc7\u6a21\u578b\u6574\u5408\u5b9e\u8bc1\u7684\u65b9\u6cd5\u63d0\u5347\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e0e\u8bc4\u4f30\"  \/><\/section>\n<section style=\"width: 100%;font-size: 0px;margin-top: -2px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;width: 100%;margin-right: -6px;margin-left: -6px;border-bottom: 2px solid rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<section style=\"display: inline-block;vertical-align: top;margin-top: -2px;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(255, 129, 36);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"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;\">\u8be6\u89c1PDF\u7248\u539f\u6587\u6216\u8bd1\u6587\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-right: 0%;margin-left: 0%;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: top;height: 2em;padding-right: 0.5em;padding-left: 0.5em;line-height: 2em;background-color: rgb(255, 204, 128);text-align: center;color: rgb(91, 57, 30);box-sizing: border-box;\">\n<p style=\"box-sizing: 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style=\"border-bottom: 1px solid rgb(95, 156, 239);width: 100%;box-sizing: border-box;\"><\/section>\n<section style=\"margin-top: -3px;box-sizing: border-box;\">\n<section style=\"float: left;width: 5px;height: 5px;margin-left: -5px;border-radius: 100%;background-color: rgb(95, 156, 239);box-sizing: border-box;\"><\/section>\n<section style=\"float: right;width: 5px;height: 5px;margin-right: -5px;border-radius: 100%;background-color: rgb(95, 156, 239);box-sizing: border-box;\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<section style=\"border-radius: 1em;display: inline-block;vertical-align: top;background-image: linear-gradient(to right, rgb(9, 82, 180) 0%, rgb(237, 64, 151) 100%);height: 1.8em;line-height: 1.8em;padding-left: 12px;padding-right: 12px;color: rgb(255, 255, 255);margin-top: -1em;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: 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