{"id":42951,"date":"2024-09-04T09:00:00","date_gmt":"2024-09-04T07:00:00","guid":{"rendered":"https:\/\/kymos.com\/news\/ich-m10-%e4%b8%8e-ema-%e5%92%8c-fda-%e6%97%a2%e5%be%80%e7%94%9f%e7%89%a9%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e6%8c%87%e5%8d%97%e7%9a%84%e6%af%94%e8%be%83\/"},"modified":"2024-09-04T09:00:00","modified_gmt":"2024-09-04T07:00:00","slug":"ich-m10-%e4%b8%8e-ema-%e5%92%8c-fda-%e6%97%a2%e5%be%80%e7%94%9f%e7%89%a9%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e6%8c%87%e5%8d%97%e7%9a%84%e6%af%94%e8%be%83","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/ich-m10-%e4%b8%8e-ema-%e5%92%8c-fda-%e6%97%a2%e5%be%80%e7%94%9f%e7%89%a9%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e6%8c%87%e5%8d%97%e7%9a%84%e6%af%94%e8%be%83\/","title":{"rendered":"ICH M10 \u4e0e EMA \u548c FDA \u65e2\u5f80\u751f\u7269\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\u7684\u6bd4\u8f83"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\u5c3d\u7ba1 ICH \u53d1\u5e03\u5173\u4e8e\u836f\u7269\u548c\u6d3b\u6027\u7269\u8d28\u8d28\u91cf\u8bc4\u4f30\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\uff08ICH Q2\uff09\u7684\u5efa\u8bae\u5df2\u6709 25 \u5e74\u4e4b\u4e45\uff0c\u4f46\u76f4\u5230\u6700\u8fd1\uff082022-2023 \u5e74\uff09\uff0c\u6211\u4eec\u624d\u83b7\u5f97\u4e86\u4e00\u4efd\u6db5\u76d6\u751f\u7269\u57fa\u8d28\u4e2d\u836f\u7269\u548c\u5206\u6790\u7269\u9a8c\u8bc1\u4e0e\u5206\u6790\u7684\u534f\u8c03\u6307\u5357\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4e0e\u836f\u7269\u6216\u6210\u54c1\u5236\u5242\u4e0d\u540c\uff0c\u8fd9\u4e9b\u57fa\u8d28\u5177\u6709\u6781\u9ad8\u7684\u590d\u6742\u6027\uff0c\u4e14\u5b58\u5728\u663e\u8457\u7684\u4e2a\u4f53\u6216\u4e2a\u4f53\u95f4\u5dee\u5f02\u3002\u56e0\u6b64\uff0cICH M10 \u662f\u4e00\u9879\u975e\u5e38\u91cd\u8981\u7684\u534f\u8c03\u6210\u679c\uff0c\u76ee\u524d\u5df2\u88ab FDA \u548c EMA \u91c7\u7528\u5e76\u5b9e\u65bd\uff0c\u5176\u4ed6\u76d1\u7ba1\u673a\u6784\u548c\u7ba1\u7406\u90e8\u95e8\u4e5f\u6b63\u5728\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8003\u8651\u5230\u8fd9\u4e00\u70b9\uff0c\u6211\u4eec\u7684\u751f\u7269\u5206\u6790\u90e8\u95e8\u4e0e\u8d28\u91cf\u4fdd\u8bc1\u90e8\u95e8\u5408\u4f5c\uff0c\u5bf9\u65e7\u6307\u5357\u4e2d\u5bf9\u751f\u7269\u5206\u6790\u7814\u7a76\u5f71\u54cd\u6700\u5927\u7684\u4e3b\u8981\u5173\u952e\u70b9\u548c\u5dee\u5f02\u8fdb\u884c\u4e86\u603b\u7ed3\u4e0e\u5f52\u7eb3\u3002<\/span><\/p>\n<h2>\u5f15\u8a00\u4e0e\u8303\u56f4<\/h2>\n<p><span style=\"font-size: 14pt;\">ICH M10 \u63cf\u8ff0\u4e86\u9884\u671f\u7528\u4e8e\u652f\u6301\u76d1\u7ba1\u51b3\u7b56\u7684\u751f\u7269\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\uff0c\u5e76\u4e3a\u6b64\u89c4\u5b9a\u4e86\u8fd9\u4e9b\u6307\u5357\u9002\u7528\u7684\u7279\u5b9a\u8303\u56f4\u3002\u8fd9\u4e9b\u7814\u7a76\u5305\u62ec\uff1a <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u4f5c\u4e3a\u4e34\u5e8a\u7814\u7a76\u66ff\u4ee3\u7814\u7a76\u8fdb\u884c\u7684\u975e\u4e34\u5e8a\u6bd2\u4ee3\u52a8\u529b\u5b66 (TK) \u7814\u7a76\u548c\u836f\u4ee3\u52a8\u529b\u5b66 (PK) \u7814\u7a76<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u76d1\u7ba1\u7533\u62a5\u4e2d\u6240\u6709\u9636\u6bb5\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08\u5305\u62ec\u6bd4\u8f83\u751f\u7269\u5229\u7528\u5ea6\/\u751f\u7269\u7b49\u6548\u6027 (BA\/BE) \u7814\u7a76\uff09\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u901a\u5e38\u6307\u9075\u5faa GLP \u6216 GCP \u7684\u7814\u7a76<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u751f\u7269\u6807\u5fd7\u7269\u9664\u975e\u662f\u7814\u7a76\u7684\u4e3b\u8981\u7ec8\u70b9\uff0c\u5426\u5219\u4e0d\u5c5e\u4e8e\u672c\u6307\u5357\u8303\u56f4\u3002\u751f\u7269\u57fa\u8d28\u5305\u62ec\u8840\u6db2\u3001\u8840\u6e05\u3001\u8840\u6d46\u4ee5\u53ca\u5176\u4ed6\u4f53\u6db2\u6216\u7ec4\u7ec7\u3002 <\/span><\/p>\n<h2>\u4e00\u822c\u539f\u5219<\/h2>\n<h3><strong><span style=\"font-size: 14pt;\">\u65b9\u6cd5\u5f00\u53d1<\/span><\/strong><\/h3>\n<p><span style=\"font-size: 14pt;\">\u5173\u4e8e\u65b9\u6cd5\u5f00\u53d1\uff0c\u65b0\u7684 ICH M10 \u5927\u90e8\u5206\u501f\u9274\u4e86\u4ee5\u5f80\u7684 FDA \u6307\u5357\u3002\u65b9\u6cd5\u5f00\u53d1\u5e94\u786e\u5b9a\u65b9\u6cd5\u7684\u8bbe\u8ba1\u3001\u64cd\u4f5c\u6761\u4ef6\u3001\u5c40\u9650\u6027\u4ee5\u53ca\u9488\u5bf9\u5176\u9884\u671f\u7528\u9014\u7684\u9002\u7528\u6027\uff0c\u5e76\u786e\u4fdd\u5176\u5df2\u51c6\u5907\u597d\u8fdb\u884c\u9a8c\u8bc1\u3002 <\/span><\/p>\n<h3><strong><span style=\"font-size: 14pt;\">\u5168\u9a8c\u8bc1<\/span><\/strong><\/h3>\n<p><span style=\"font-size: 14pt;\">ICH M10 \u5728 EMA \u548c FDA \u4e4b\u524d\u7684\u6307\u5357\u57fa\u7840\u4e0a\uff0c\u8fdb\u4e00\u6b65\u9610\u8ff0\u4e86\u4f55\u65f6\u9700\u8981\u5bf9\u751f\u7269\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u5168\u9a8c\u8bc1<\/span>\u3002<\/p>\n<h2>\u8272\u8c31\u5206\u6790<\/h2>\n<h3><span style=\"font-size: 14pt;\"><strong>\u9a8c\u8bc1<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">ICH M10 \u4e3a\u8272\u8c31\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u4e2d\u7684\u6bcf\u4e2a\u8981\u7d20\u63d0\u4f9b\u4e86\u989d\u5916\u7684\u7ec6\u8282\u548c\u6307\u5bfc\uff0c\u5e76\u5728\u65b0\u6307\u5357\u4e2d\u5bf9\u5176\u4e2d\u4e00\u4e9b\u8981\u7d20\u8fdb\u884c\u4e86\u6269\u5c55\uff0c\u751a\u81f3\u521b\u5efa\u4e86\u65b0\u7ae0\u8282\u3002\u6211\u4eec\u7684\u56e2\u961f\u603b\u7ed3\u4e86\u4e0e EMA\/FDA \u65e2\u5f80\u6307\u5357\u76f8\u6bd4\u7684\u5173\u952e\u90e8\u5206\u548c\u5dee\u5f02\uff1a <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u5728\u65b0\u7684 ICH M10 \u4e2d\uff0c<strong>\u9009\u62e9\u6027 (Selectivity)<\/strong> \u5df2\u4e0e\u4e13\u5c5e\u6027 (Specificity) \u5206\u5f00<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u57fa\u8d28\u6548\u5e94 (ME)\uff1a<\/strong> \u5173\u4e8e\u57fa\u8d28\u6548\u5e94\uff0cICH M10 \u63d0\u4f9b\u4e86\u6bd4\u4ee5\u5f80 EMA \u548c FDA \u66f4\u7cbe\u786e\u7684\u6307\u5bfc\uff0c\u5efa\u8bae\u5bf9\u8bc4\u4f30\u7684\u6bcf\u4e2a\u5355\u72ec\u57fa\u8d28\u6765\u6e90\/\u6279\u6b21\u8fdb\u884c\u51c6\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6\u6d4b\u5b9a<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u5173\u4e8e <strong>A&#038;P (\u51c6\u786e\u5ea6\u4e0e\u7cbe\u5bc6\u5ea6)<\/strong>\uff0cICH M10 \u5728 EMA \u548c FDA \u7684\u57fa\u7840\u4e0a\u8fdb\u884c\u4e86\u6269\u5c55\uff0c\u5e76\u7ed3\u5408\u4e86\u5b83\u4eec\u7684\u4e00\u4e9b\u5efa\u8bae\u3002\u6700\u91cd\u8981\u7684\u4e00\u70b9\u662f\uff0c\u7528\u4e8e\u8fd9\u4e9b\u8bc4\u4f30\u7684\u6807\u51c6\u66f2\u7ebf\u5e94\u5728\u81f3\u5c11\u4e00\u4e2a\u5206\u6790\u6279\u4e2d\u4f7f\u7528\u65b0\u9c9c\u914d\u5236\u7684\u6821\u51c6\u6807\u51c6\u54c1\u3002\u5982\u679c\u5176\u4ed6\u5206\u6790\u6279\u4e2d\u672a\u4f7f\u7528\u65b0\u9c9c\u914d\u5236\u7684\u6821\u51c6\u6807\u51c6\u54c1\uff0c\u5219\u5e94\u8bc1\u660e\u51b7\u51bb\u6821\u51c6\u6807\u51c6\u54c1\u7684\u7a33\u5b9a\u6027\u3002  <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u7a33\u5b9a\u6027\uff1a<\/strong> ICH M10 \u8fdb\u4e00\u6b65\u9610\u8ff0\u4e86 EMA\/FDA \u65e2\u5f80\u6307\u5357\u4e2d\u7684\u5185\u5bb9\uff0c\u5e76\u5bf9\u751f\u7269\u57fa\u8d28\u4e2d\u5206\u6790\u7269\u3001\u5904\u7406\u540e\u6837\u54c1\u4ee5\u53ca\u50a8\u5907\u6db2\u548c\u5de5\u4f5c\u6db2\u7684\u7a33\u5b9a\u6027\u63d0\u51fa\u4e86\u5177\u4f53\u5efa\u8bae\u3002<\/span><\/li>\n<\/ul>\n<h3><strong><span style=\"font-size: 14pt;\">\u7814\u7a76\u6837\u54c1\u5206\u6790<\/span><\/strong><\/h3>\n<p><span style=\"font-size: 14pt;\">ICH M10 \u89c4\u5b9a\uff0c\u7814\u7a76\u6837\u54c1\u7684\u5206\u6790\u53ef\u5728\u9a8c\u8bc1\u5b8c\u6210\u540e\u8fdb\u884c\uff08\u6b64\u65f6\u6570\u636e\u5df2\u63d0\u4ea4\u81f3\u76d1\u7ba1\u673a\u6784\uff09\uff0c\u4f46\u540c\u65f6\u4e5f\u7406\u89e3\u67d0\u4e9b\u53c2\u6570\u53ef\u80fd\u4f1a\u5728\u7a0d\u540e\u9636\u6bb5\u5b8c\u6210\u3002ICH M10 \u5728\u53c2\u6570\u548c\u7a0b\u5e8f\u4e0a\u57fa\u672c\u4fdd\u6301\u4e0d\u53d8\uff0c\u4ec5\u6709\u7ec6\u5fae\u53d8\u5316\u548c\u5c11\u91cf\u8865\u5145\u3002 <\/span><\/p>\n<h2>\u914d\u4f53\u7ed3\u5408\u5206\u6790<\/h2>\n<h3><span style=\"font-size: 14pt;\"><strong>\u5173\u952e\u8bd5\u5242<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\u6211\u4eec\u7684\u56e2\u961f\u603b\u7ed3\u4e86\u5173\u4e8e\u914d\u4f53\u7ed3\u5408\u5206\u6790\u5173\u952e\u8bd5\u5242\u4e0e EMA\/FDA \u65e2\u5f80\u6307\u5357\u7684\u4e3b\u8981\u5dee\u5f02\uff1a<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u6807\u51c6\u5bf9\u7167\u54c1\uff1a<\/strong> \u4e0e EMA\/FDA \u4e00\u6837\uff0cICH M10 \u4e0d\u8981\u6c42\u4e00\u7ea7\u6807\u51c6\u54c1\u3002\u5173\u4e8e CoA \u548c\u6807\u51c6\u5bf9\u7167\u54c1\u6709\u6548\u671f\u3001\u6821\u51c6\u66f2\u7ebf\u4f7f\u7528\u540c\u4e00\u6279\u6b21\u4ee5\u53ca\u6279\u6b21\u66f4\u6362\u7684\u4fe1\u606f\u548c\u5efa\u8bae\u4e0e\u65e2\u5f80\u6307\u5357\u4e00\u81f4\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u5173\u952e\u8bd5\u5242\uff1a<\/strong> \u5efa\u8bae\u57fa\u4e8e EMA\/FDA\uff0c\u4f46\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8fd9\u4e9b\u5173\u952e\u8bd5\u5242\u7684\u7a33\u5b9a\u6027\u6d4b\u8bd5\u5e94\u57fa\u4e8e\u5176\u5728\u751f\u7269\u5206\u6790\u4e2d\u7684\u8868\u73b0\uff0c\u5e76\u53c2\u8003\u8bd5\u5242\u50a8\u5b58\u6761\u4ef6\u7684\u4e00\u822c\u6307\u5bfc\uff0c\u4e14\u53ef\u4ee5\u5ef6\u957f\u81f3\u4f9b\u5e94\u5546\u63d0\u4f9b\u7684\u6709\u6548\u671f\u4e4b\u5916\u3002<\/span><\/li>\n<\/ul>\n<h3><strong><span style=\"font-size: 14pt;\">\u9a8c\u8bc1<\/span><\/strong><\/h3>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u4e13\u5c5e\u6027\uff1a<\/strong> ICH M10 \u7ef4\u6301\u4e86 EMA\/FDA \u5173\u4e8e\u4e13\u5c5e\u6027\u7a0b\u5e8f\u548c\u63a5\u53d7\u6807\u51c6\u7684\u76f8\u540c\u5efa\u8bae\uff0c\u4f46\u6307\u51fa\u5982\u679c\u5b58\u5728\u4ea4\u53c9\u53cd\u5e94\uff0c\u5fc5\u987b\u8bc4\u4f30\u5176\u5f71\u54cd\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u9009\u62e9\u6027\uff1a<\/strong> ICH M10 \u6307\u51fa\uff0c\u57fa\u8d28\u53ef\u80fd\u542b\u6709\u975e\u7279\u5f02\u6027\u57fa\u8d28\u6210\u5206\uff0c\u53ef\u80fd\u4f1a\u5e72\u6270\u76ee\u6807\u5206\u6790\u7269\u3002\u76f8\u6bd4\u8fc7\u53bb\uff0c\u4e00\u4e9b\u6269\u5c55\u5efa\u8bae\u5305\u62ec\u5206\u6790\u4f4e\u7aef\u7684\u9009\u62e9\u6027\u3001\u52a0\u6807\u6c34\u5e73\u4ee5\u53ca\u76f8\u5173\u4eba\u7fa4\u60c5\u51b5\u4e0b\u7684\u6700\u5c11\u60a3\u8005\u6570\u91cf\u3002\u63a5\u53d7\u6807\u51c6\u4fdd\u6301\u4e0d\u53d8\u3002  <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u6807\u51c6\u66f2\u7ebf\u548c\u8303\u56f4\uff1a<\/strong> \u5173\u4e8e\u6807\u51c6\u66f2\u7ebf\u548c\u8303\u56f4\uff0cICH M10 \u4e0e\u65e2\u5f80\u6307\u5357\u57fa\u672c\u4e00\u81f4\uff0c\u4f46\u4e5f\u6307\u51fa\u6700\u597d\u4f7f\u7528\u65b0\u9c9c\u914d\u5236\u7684\u6821\u51c6\u6807\u51c6\u54c1\u3002\u63a5\u53d7\u6807\u51c6\u76f8\u540c\uff0c\u4ec5\u6709\u7ec6\u5fae\u7684\u6269\u5c55\u70b9\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u51c6\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6\uff1a<\/strong> \u8fd9\u4e9b\u53c2\u6570\u7684\u4e3b\u8981\u533a\u522b\u5728\u4e8e\uff0cICH M10 \u5efa\u8bae QC \u6837\u54c1\u5e94\u901a\u8fc7\u5728\u57fa\u8d28\u4e2d\u52a0\u6807\u5236\u5907\uff0c\u5e76\u5728\u9884\u671f\u7684\u7814\u7a76\u6837\u54c1\u6761\u4ef6\u4e0b\u50a8\u5b58\u3002\u5b83\u8fd8\u589e\u52a0\u4e86\u4e00\u4e2a\u65b0\u7684 QC \u5236\u5907\u6d53\u5ea6\u6c34\u5e73\uff08\u4e2d\u6d53\u5ea6\uff0c\u7ea6\u5728\u51e0\u4f55\u5e73\u5747\u503c\u9644\u8fd1\uff09\uff0c\u5e76\u5efa\u8bae\u5e94\u4f7f\u7528\u76f8\u540c\u7684\u5206\u6790\u6279\u548c\u6570\u636e\u8bc4\u4f30\u51c6\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6\u3002\u63a5\u53d7\u6807\u51c6\u57fa\u4e8e EMA \u548c FDA\u3002  <\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u7a00\u91ca\u7ebf\u6027\u4e0e\u94a9\u72b6\u6548\u5e94\uff1a<\/strong> \u6211\u4eec\u53ef\u4ee5\u770b\u5230\u4e0e EMA\/FDA \u76f8\u540c\u7684\u5efa\u8bae\uff08\u4e24\u8005\u7684\u534f\u8c03\uff09\uff0c\u5e76\u6709\u5c11\u91cf\u8865\u5145\u3002\u5728\u63a5\u53d7\u6807\u51c6\u65b9\u9762\uff0cICH M10 \u5efa\u8bae\u7814\u7a76\u6837\u54c1\u5206\u6790\u671f\u95f4\u91c7\u7528\u7684\u7a00\u91ca\u500d\u6570\u5e94\u5728\u9a8c\u8bc1\u671f\u95f4\u8bc4\u4f30\u7684\u7a00\u91ca\u500d\u6570\u8303\u56f4\u5185\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u7a33\u5b9a\u6027\uff1a<\/strong> ICH M10 \u89c4\u5b9a\u7a33\u5b9a\u6027\u5e94\u6db5\u76d6\u5904\u7406\u548c\u50a8\u5b58\u6761\u4ef6\uff0c\u4e14\u7a33\u5b9a\u6027\u6837\u54c1\u5e94\u6db5\u76d6\u7814\u7a76\u6837\u54c1\u7684\u6574\u4e2a\u6d53\u5ea6\u8303\u56f4\u3002\u5bf9\u4e8e\u751f\u7269\u836f\u7269\uff0c\u65b0\u6307\u5357\u8865\u5145\u8bf4\u53ef\u4ee5\u91c7\u7528\u62ec\u53f7\u6cd5\uff08\u5728\u4e24\u4e2a\u6e29\u5ea6\u70b9\u4e4b\u95f4\uff09\uff0c\u5173\u4e8e\u7a0b\u5e8f\u548c\u63a5\u53d7\u6807\u51c6\u7684\u5efa\u8bae\u4e0e\u534f\u8c03\u540e\u7684\u5185\u5bb9\u4e00\u81f4\u3002 <\/span><\/li>\n<\/ul>\n<h3><span style=\"font-size: 14pt;\"><strong>\u7814\u7a76\u6837\u54c1\u5206\u6790<\/strong><\/span><\/h3>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u5206\u6790\u6279<\/strong>\uff1a\u5206\u6790\u6279\u7684\u7ec4\u6210\u548c QC \u5728\u6279\u4e2d\u7684\u653e\u7f6e\u4e0e EMA\/FDA \u76f8\u540c\uff0c\u5f53\u5206\u6790\u591a\u4e2a\u677f\u65f6\uff0c\u6bcf\u4e2a\u677f\u5e94\u5305\u542b\u4e00\u5957\u5355\u72ec\u7684\u6821\u51c6\u6807\u51c6\u54c1\u548c QC\u3002<\/span><\/li>\n<\/ul>\n<p style=\"padding-left: 40px;\"><span style=\"font-size: 14pt;\">ICH M10 \u7684\u4e00\u4e2a\u5173\u952e\u70b9\u662f QC \u5e94\u6db5\u76d6\u9884\u671f\u7684\u7814\u7a76\u6837\u54c1\u6d53\u5ea6\u8303\u56f4\u3002\u6b64\u5916\u8fd8\u6307\u51fa\uff0c\u5141\u8bb8\u8fdb\u884c\u5355\u5b54\u5206\u6790\uff08\u9a8c\u8bc1\u548c\u7814\u7a76\u6837\u54c1\u5747\u53ef\uff09\u3002 <\/span><\/p>\n<p style=\"padding-left: 40px;\"><span style=\"font-size: 14pt;\">\u5173\u4e8e\u6807\u51c6\u66f2\u7ebf\u548c\u63a5\u53d7\u6807\u51c6\uff0cICH M10 \u662f EMA \u548c FDA \u7684\u534f\u8c03\u4ea7\u7269\uff0c\u6240\u6709\u5408\u683c\u5206\u6790\u6279\u4e2d QC \u7684\u603b\u5e73\u5747\u51c6\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6\u5e94\u5728\u6bcf\u4e2a\u6d53\u5ea6\u6c34\u5e73\u4e0a\u8fdb\u884c\u8ba1\u7b97\uff0c\u5e76\u5728\u5206\u6790\u62a5\u544a\u4e2d\u4f53\u73b0\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u7814\u7a76\u6837\u54c1\u590d\u6d4b<\/strong>\uff1a\u5173\u4e8e\u590d\u6d4b\u7684\u539f\u56e0\u3001\u6807\u51c6\u548c\u6837\u54c1\u6570\u91cf\uff0c\u5efa\u8bae\u4e0e EMA\/FDA \u4e00\u81f4\u3002ICH M10 \u89c4\u5b9a\uff0c\u6837\u54c1\u7684\u5206\u6790\u5e94\u57fa\u4e8e\u4e0e\u521d\u59cb\u5206\u6790\u76f8\u540c\u7684\u6bcf\u4e2a\u7814\u7a76\u6837\u54c1\u5b54\u6570\u3002 <\/span><\/li>\n<\/ul>\n<h2><strong>\u5b9e\u6d4b\u6837\u54c1\u590d\u6d4b (ISR)<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u6839\u636e ICH M10\uff0cISR \u65e8\u5728\u9a8c\u8bc1\u62a5\u544a\u7684\u6837\u54c1\u5206\u6790\u7269\u6d53\u5ea6\u7684\u53ef\u9760\u6027\uff0c\u5e76\u5e94\u5728 EMA \u548c FDA \u89c4\u5b9a\u7684\u60c5\u5f62\u4e0b\u6267\u884c\uff0c\u8fd9\u4e9b\u60c5\u5f62\u73b0\u5df2\u5728\u65b0\u6307\u5357\u4e2d\u5408\u5e76\u5e76\u534f\u8c03\u3002\u7814\u7a76\u7c7b\u578b\u3001\u6570\u91cf\u3001\u6837\u54c1\u9009\u62e9\u548c\u8ba1\u7b97\u65b9\u5f0f\u4fdd\u6301\u4e0d\u53d8\u3002 <\/span><\/p>\n<h2>\u7ed3\u8bba<\/h2>\n<p><span style=\"font-size: 14pt;\">\u5982\u672c\u6587\u7efc\u8ff0\u6240\u793a\uff0cICH M10 \u4e3a\u751f\u7269\u5206\u6790\u7814\u7a76\u63d0\u4f9b\u4e86\u4e00\u4e2a\u534f\u8c03\u7684\u6846\u67b6\uff0c\u8be5\u6846\u67b6\u5df2\u88ab FDA \u548c EMA \u5b9e\u65bd\uff0c\u5e76\u5df2\u6210\u4e3a\u5206\u6790\u751f\u7269\u57fa\u8d28\u4e2d\u836f\u7269\u548c\u5206\u6790\u7269\u7684\u6807\u51c6\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u81ea\u6211\u4eec\u91c7\u7528\u8fd9\u4e00\u65b0\u6307\u5357\u4ee5\u6765\uff0c\u5ba2\u6237\u5bf9\u65b0\u7248\u9a8c\u8bc1\u65b9\u6848\u548c\u6837\u54c1\u5206\u6790\u65b9\u6848\u7684\u53cd\u9988\u975e\u5e38\u79ef\u6781\uff0c\u786e\u8ba4\u4e86\u6211\u4eec\u7684\u65b9\u6cd5\u548c\u7a0b\u5e8f\u7b26\u5408 ICH M10 \u8981\u6c42\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5982\u679c\u60a8\u9700\u8981\u5173\u4e8e\u6b64\u65b0\u6307\u5357\u7684\u66f4\u591a\u4fe1\u606f\u6216\u5bf9\u60a8\u7684\u9879\u76ee\u6709\u4efb\u4f55\u534f\u52a9\u9700\u6c42\uff0c\u8bf7\u8054\u7cfb <a href=\"mailto:quotes@kymos.com\" data-wpel-link=\"internal\">quotes@kymos.com<\/a>\u3002\u6211\u4eec\u5c06\u7aed\u8bda\u4e3a\u60a8\u63d0\u4f9b\u8be6\u7ec6\u7684\u54a8\u8be2\u4e0e\u652f\u6301\u3002 <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u5c3d\u7ba1 ICH \u53d1\u5e03\u5173  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":42956,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[383],"tags":[62],"class_list":["post-42951","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-383","tag-joan"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ICH M10 \u6307\u5357\uff1a\u751f\u7269\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1<\/title>\n<meta name=\"description\" content=\"Kymos \u96c6\u56e2\u5df2\u91c7\u7528\u6700\u65b0\u7684 ICH \u534f\u8c03\u6307\u5357 M10\u300a\u751f\u7269\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u53ca\u7814\u7a76\u6837\u54c1\u5206\u6790\u300b\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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