{"id":48377,"date":"2026-10-14T11:42:41","date_gmt":"2026-10-14T09:42:41","guid":{"rendered":"https:\/\/kymos.com\/news\/%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e5%bc%80%e5%8f%91%ef%bc%9aaqbd-%e6%96%b9%e6%b3%95\/"},"modified":"2026-10-14T11:42:41","modified_gmt":"2026-10-14T09:42:41","slug":"%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e5%bc%80%e5%8f%91%ef%bc%9aaqbd-%e6%96%b9%e6%b3%95","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e5%bc%80%e5%8f%91%ef%bc%9aaqbd-%e6%96%b9%e6%b3%95\/","title":{"rendered":"\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\uff1aAQbD \u65b9\u6cd5"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\u5206\u6790\u65b9\u6cd5\u9700\u8981\u4e3a\u5176\u9884\u671f\u7528\u9014\u63d0\u4f9b\u53ef\u9760\u7684\u7ed3\u679c\uff0c\u4f46\u5f00\u53d1\u4e00\u79cd\u5728\u7279\u5b9a\u6761\u4ef6\u4e0b\u8fd0\u884c\u7684\u65b9\u6cd5\uff0c\u5e76\u4e0d\u7b49\u540c\u4e8e\u7406\u89e3\u8be5\u65b9\u6cd5\u5728\u8fd9\u4e9b\u6761\u4ef6\u53d1\u751f\u53d8\u5316\u65f6\u7684\u8868\u73b0\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u79cd\u533a\u522b\u662f <strong>ICH Q14<\/strong> \u4e2d\u63cf\u8ff0\u7684\u589e\u5f3a\u578b\u5206\u6790\u7a0b\u5e8f\u5f00\u53d1\u65b9\u6cd5\u7684\u6838\u5fc3\u3002\u8be5\u6307\u5357\u81ea 2024 \u5e74 6 \u6708\u8d77\u5728\u6b27\u76df\u751f\u6548\uff0c\u4e3a\u5f00\u53d1\u548c\u7ef4\u62a4\u5206\u6790\u7a0b\u5e8f\u63d0\u4f9b\u4e86\u4e00\u4e2a\u57fa\u4e8e\u79d1\u5b66\u548c\u98ce\u9669\u7684\u6846\u67b6\uff0c\u662f\u5bf9\u6d89\u53ca\u9a8c\u8bc1\u7684 <strong>ICH Q2(R2)<\/strong> \u7684\u8865\u5145\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u5206\u6790\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1 (AQbD)<\/strong> \u901a\u5e38\u7528\u4e8e\u63cf\u8ff0 <strong>\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u539f\u5219\u5728\u5206\u6790\u7a0b\u5e8f\u5f00\u53d1\u4e2d\u7684\u5e94\u7528<\/strong>\u3002AQbD \u65b9\u6cd5\u4e0d\u4ec5\u4ec5\u5173\u6ce8\u83b7\u5f97\u5408\u9002\u7684\u5206\u6790\u6761\u4ef6\uff0c\u8fd8\u65e8\u5728\u5efa\u7acb\u5bf9\u5f71\u54cd\u65b9\u6cd5\u6027\u80fd\u56e0\u7d20\u7684\u7ed3\u6784\u5316\u7406\u89e3\uff0c\u5e76\u5229\u7528\u8fd9\u4e9b\u77e5\u8bc6\u6765\u652f\u6301\u4f18\u5316\u3001\u63a7\u5236\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><em>\u6ce8\uff1a<\/em> <em>\u5728\u672c\u6587\u4e2d\uff0c\u4e3a\u4e86\u4fbf\u4e8e\u9605\u8bfb\uff0c\u201c\u5206\u6790\u65b9\u6cd5\u201d\u548c\u201c\u5206\u6790\u7a0b\u5e8f\u201d\u4ea4\u66ff\u4f7f\u7528\uff0c\u5c3d\u7ba1 ICH Q14 \u6b63\u5f0f\u4f7f\u7528\u7684\u662f\u201c\u5206\u6790\u7a0b\u5e8f\u201d\u4e00\u8bcd\u3002<\/em><\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u4ec0\u4e48\u662f\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u4e2d\u7684 AQbD\uff1f<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>ICH Q14<\/strong> \u533a\u5206\u4e86\u5206\u6790\u7a0b\u5e8f\u5f00\u53d1\u7684 <strong>\u5e38\u89c4\u65b9\u6cd5\u548c\u589e\u5f3a\u578b\u65b9\u6cd5<\/strong>\u3002\u5e38\u89c4\u65b9\u6cd5\u4ecd\u7136\u662f\u5f00\u53d1\u5206\u6790\u65b9\u6cd5\u7684\u516c\u8ba4\u65b9\u5f0f\u3002\u589e\u5f3a\u578b\u65b9\u6cd5\u5219\u589e\u52a0\u4e86\u80fd\u591f\u66f4\u6df1\u5165\u7406\u89e3\u5206\u6790\u7a0b\u5e8f\u53c2\u6570\u4e0e\u5206\u6790\u6027\u80fd\u4e4b\u95f4\u5173\u7cfb\u7684\u8981\u7d20\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u79cd\u533a\u522b\u5f88\u91cd\u8981\u3002<strong>AQbD<\/strong> \u5e76\u4e0d\u662f\u8981\u53d6\u4ee3\u4f20\u7edf\u7684\u5206\u6790\u5f00\u53d1\uff0c<strong>ICH Q14<\/strong> \u4e5f\u6ca1\u6709\u8981\u6c42\u6bcf\u4e2a\u5206\u6790\u7a0b\u5e8f\u90fd\u5fc5\u987b\u4f7f\u7528\u589e\u5f3a\u578b\u65b9\u6cd5\u8fdb\u884c\u5f00\u53d1\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u76f8\u53cd\uff0c<strong>\u589e\u5f3a\u578b\u65b9\u6cd5\u63d0\u4f9b\u4e86\u4e00\u4e2a\u6846\u67b6\uff0c\u53ef\u4ee5\u6839\u636e\u7a0b\u5e8f\u7684\u9700\u8981\u3001\u73b0\u6709\u7684\u5148\u9a8c\u77e5\u8bc6\u548c\u9884\u671f\u7684\u751f\u547d\u5468\u671f\u7b56\u7565\u6765\u5e94\u7528\u3002<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5728\u5b9e\u9645\u64cd\u4f5c\u4e2d\uff0c\u5173\u6ce8\u70b9\u4ece\u7b80\u5355\u5730\u8be2\u95ee\uff1a<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u201c\u8fd9\u4e2a\u65b9\u6cd5\u6709\u6548\u5417\uff1f\u201d<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8f6c\u53d8\u4e3a\u540c\u65f6\u8be2\u95ee\uff1a<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u201c\u8fd9\u4e2a\u65b9\u6cd5\u9700\u8981\u8fbe\u5230\u4ec0\u4e48\u76ee\u6807\uff1f\u54ea\u4e9b\u56e0\u7d20\u4f1a\u5f71\u54cd\u5176\u6027\u80fd\uff1f\u5728\u54ea\u4e9b\u6761\u4ef6\u4e0b\u6211\u4eec\u53ef\u4ee5\u8bc1\u660e\u5b83\u59cb\u7ec8\u7b26\u5408\u8981\u6c42\uff1f\u201d<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u4e9b\u989d\u5916\u7684\u7406\u89e3\u968f\u540e\u53ef\u7528\u4e8e\u5efa\u7acb\u9002\u5f53\u7684\u64cd\u4f5c\u8303\u56f4\uff0c\u652f\u6301\u63a7\u5236\u7b56\u7565\uff0c\u5e76\u4e3a\u5206\u6790\u7a0b\u5e8f\u751f\u547d\u5468\u671f\u7684\u540e\u7eed\u9636\u6bb5\u63d0\u4f9b\u66f4\u5f3a\u5927\u7684\u77e5\u8bc6\u5e93\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u5efa\u7acb\u5bf9\u65b9\u6cd5\u6027\u80fd\u7684\u66f4\u597d\u7406\u89e3<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u57fa\u4e8e <strong>AQbD \u7684\u5f00\u53d1<\/strong> \u9996\u5148\u8981\u5b9a\u4e49\u5206\u6790\u7a0b\u5e8f\u9700\u8981\u5b9e\u73b0\u7684\u76ee\u6807\u3002<\/span><\/p>\n<ol>\n<li><span style=\"font-size: 14pt;\"><strong> \u5206\u6790\u76ee\u6807\u6982\u8c8c (ATP)<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\"><strong>\u5206\u6790\u76ee\u6807\u6982\u8c8c (ATP)<\/strong> \u5b9a\u4e49\u4e86\u5206\u6790\u7a0b\u5e8f\u7684\u9884\u671f\u7528\u9014\u3001\u5f85\u6d4b\u4ea7\u54c1\u5c5e\u6027\u4ee5\u53ca\u9884\u671f\u7684\u6027\u80fd\u6807\u51c6\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5b83\u901a\u8fc7\u5efa\u7acb\u8bc4\u4f30\u5f00\u53d1\u51b3\u7b56\u7684\u76ee\u6807\uff0c\u4e3a\u5f00\u53d1\u63d0\u4f9b\u4e86\u57fa\u7840\u3002<\/span><\/p>\n<ol start=\"2\">\n<li><span style=\"font-size: 14pt;\"><strong> \u77e5\u8bc6\u548c\u98ce\u9669\u8bc4\u4f30<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\u4e00\u65e6\u786e\u5b9a\u4e86\u9884\u671f\u6027\u80fd\uff0c\u5c31\u53ef\u4ee5\u5229\u7528 <strong>\u5148\u9a8c\u77e5\u8bc6\u548c\u98ce\u9669\u8bc4\u4f30\u6765\u8bc6\u522b\u53ef\u80fd\u5f71\u54cd\u6027\u80fd\u7684\u5206\u6790\u7a0b\u5e8f\u53c2\u6570\u3002<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u6839\u636e\u7a0b\u5e8f\u7684\u4e0d\u540c\uff0c\u8fd9\u4e9b\u53c2\u6570\u53ef\u80fd\u6d89\u53ca\u5206\u6790\u6761\u4ef6\u3001\u6750\u6599\u3001\u4eea\u5668\u6216\u6837\u54c1\u5236\u5907\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u76ee\u7684\u4e0d\u4ec5\u4ec5\u662f\u8bc6\u522b\u5c3d\u53ef\u80fd\u591a\u7684\u53d8\u91cf\uff0c\u800c\u662f\u6839\u636e\u5176\u5bf9\u5206\u6790\u6027\u80fd\u7684\u6f5c\u5728\u5f71\u54cd\uff0c\u786e\u5b9a <strong>\u54ea\u4e9b\u53c2\u6570\u9700\u8981\u8fdb\u4e00\u6b65\u7814\u7a76\u3002<\/strong><\/span><\/p>\n<ol start=\"3\">\n<li><span style=\"font-size: 14pt;\"><strong> \u521d\u6b65\u5f00\u53d1<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\u968f\u540e\u53ef\u4ee5\u901a\u8fc7\u521d\u6b65\u7684\u5b9e\u9a8c\u5ba4\u7814\u7a76\u6765 <strong>\u5efa\u7acb\u5408\u9002\u7684\u5206\u6790\u6761\u4ef6\u5e76\u5f00\u53d1\u521d\u6b65\u65b9\u6cd5\u3002<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u4e3a\u66f4\u7cfb\u7edf\u7684\u8c03\u67e5\u548c\u4f18\u5316\u63d0\u4f9b\u4e86\u8d77\u70b9\u3002<\/span><\/p>\n<ol start=\"4\">\n<li><span style=\"font-size: 14pt;\"><strong> \u4e13\u5c5e\u6027\u548c\u5f3a\u5236\u964d\u89e3<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\u5bf9\u4e8e\u9700\u8981\u7a33\u5b9a\u6027\u6307\u793a\u80fd\u529b\u7684\u7a0b\u5e8f\uff0c\u53ef\u4ee5\u5c06\u9002\u5f53\u7684\u5f3a\u5236\u964d\u89e3\u7814\u7a76\u7eb3\u5165\u5f00\u53d1\u4e2d\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u7834\u574f\u6027\u8bd5\u9a8c\u6709\u52a9\u4e8e\u8bc4\u4f30\u4e13\u5c5e\u6027\u5e76\u8bc6\u522b\u53ef\u80fd\u9700\u8981\u8fdb\u4e00\u6b65\u4f18\u5316\u7684\u964d\u89e3\u76f8\u5173\u5206\u79bb<\/strong>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u5e76\u975e\u6bcf\u4e2a\u5206\u6790\u7a0b\u5e8f\u7684\u5f3a\u5236\u6027\u6b65\u9aa4\u3002\u5176\u76f8\u5173\u6027\u53d6\u51b3\u4e8e\u65b9\u6cd5\u7684\u9884\u671f\u7528\u9014\u548c\u4ea7\u54c1\u7684\u7279\u6027\u3002 <\/span><\/p>\n<ol start=\"5\">\n<li><span style=\"font-size: 14pt;\"><strong> \u5b9e\u9a8c\u8bbe\u8ba1\u548c\u65b9\u6cd5\u4f18\u5316<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\u652f\u6301\u589e\u5f3a\u578b\u65b9\u6cd5\u7684\u5de5\u5177\u4e4b\u4e00\u662f <strong>\u5b9e\u9a8c\u8bbe\u8ba1 (DoE)<\/strong>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u901a\u8fc7\u9002\u5f53\u8bbe\u8ba1\u7684\u5b9e\u9a8c\uff0c\u53ef\u4ee5\u7814\u7a76\u76f8\u5173\u5206\u6790\u7a0b\u5e8f\u53c2\u6570\u7684\u5f71\u54cd\u4ee5\u53ca\uff08\u5728\u9002\u7528\u65f6\uff09\u5b83\u4eec\u7684\u76f8\u4e92\u4f5c\u7528\uff0c\u800c\u4e0d\u662f\u4e00\u6b21\u53ea\u7814\u7a76\u4e00\u4e2a\u53c2\u6570\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u6240\u5f97\u6570\u636e\u53ef\u4ee5\u4e3a <strong>\u4f18\u5316\u4ee5\u53ca\u7406\u89e3\u4e0d\u540c\u6761\u4ef6\u5982\u4f55\u5f71\u54cd\u5206\u6790\u6027\u80fd\u63d0\u4f9b\u66f4\u7cfb\u7edf\u7684\u57fa\u7840\u3002<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u91cd\u8981\u7684\u662f\uff0c<strong>ICH Q14<\/strong> \u5e76\u6ca1\u6709\u5f3a\u5236\u8981\u6c42\u6bcf\u4e2a\u589e\u5f3a\u578b\u5206\u6790\u7a0b\u5e8f\u90fd\u5fc5\u987b\u8fdb\u884c DoE\u3002\u5b83\u5c06\u5355\u53d8\u91cf\u6216\u591a\u53d8\u91cf\u5b9e\u9a8c\u53ca\u5efa\u6a21\u63cf\u8ff0\u4e3a\u53ef\u6839\u636e\u9700\u8981\u4f7f\u7528\u7684\u8981\u7d20\u3002 <\/span><\/p>\n<ol start=\"6\">\n<li><span style=\"font-size: 14pt;\"><strong> \u65b9\u6cd5\u53ef\u64cd\u4f5c\u8bbe\u8ba1\u533a\u57df (MODR)<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\u901a\u8fc7\u5b9e\u9a8c\u4ea7\u751f\u7684\u77e5\u8bc6\u53ef\u7528\u4e8e\u5efa\u7acb\u9002\u5f53\u7684\u53c2\u6570\u8303\u56f4\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5728\u9002\u7528\u60c5\u51b5\u4e0b\uff0c\u8fd9\u53ef\u4ee5\u5305\u62ec <strong>\u65b9\u6cd5\u53ef\u64cd\u4f5c\u8bbe\u8ba1\u533a\u57df (MODR)<\/strong>\uff1a\u76f8\u5173\u5206\u6790\u7a0b\u5e8f\u53c2\u6570\u8303\u56f4\u7684\u7ec4\u5408\uff0c\u5728\u6b64\u8303\u56f4\u5185\u5df2\u8bc1\u660e\u8be5\u7a0b\u5e8f\u7b26\u5408\u9884\u5b9a\u4e49\u7684\u6027\u80fd\u8981\u6c42\u3002<\/span><\/p>\n<ol start=\"7\">\n<li><span style=\"font-size: 14pt;\"><strong> \u5206\u6790\u7a0b\u5e8f\u63a7\u5236\u7b56\u7565<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\"><strong>\u5f00\u53d1\u77e5\u8bc6\u968f\u540e\u53ef\u4ee5\u8f6c\u5316\u4e3a\u5206\u6790\u7a0b\u5e8f\u63a7\u5236\u7b56\u7565<\/strong>\uff0c\u5305\u62ec\u9002\u5f53\u7684\u53c2\u6570\u8bbe\u5b9a\u70b9\u6216\u8303\u56f4\u4ee5\u53ca\u76f8\u5173\u7684\u7cfb\u7edf\u9002\u7528\u6027\u6807\u51c6\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u5c06\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u77e5\u8bc6\u4e0e\u5e38\u89c4\u4f7f\u7528\u5206\u6790\u7a0b\u5e8f\u65f6\u5c06\u5e94\u7528\u7684\u6761\u4ef6\u8054\u7cfb\u8d77\u6765\u3002<\/span><\/p>\n<ol start=\"8\">\n<li><span style=\"font-size: 14pt;\"><strong> \u8bb0\u5f55\u5f00\u53d1\u77e5\u8bc6<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\u6700\u540e\uff0c\u5f00\u53d1\u5de5\u4f5c\u9700\u8981\u4ee5\u4e00\u79cd\u4e0d\u4ec5\u8bb0\u5f55\u6700\u7ec8\u65b9\u6cd5\uff0c\u800c\u4e14\u8bb0\u5f55\u5176\u80cc\u540e\u79d1\u5b66\u4f9d\u636e\u7684\u65b9\u5f0f\u8fdb\u884c\u5f52\u6863\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4e00\u4efd\u5168\u9762\u7684\u5f00\u53d1\u62a5\u544a\u53ef\u4ee5\u5c06\u5f00\u53d1\u6570\u636e\u3001\u7edf\u8ba1\u8bc4\u4f30\u3001\u5173\u952e\u6280\u672f\u51b3\u7b56\u4ee5\u53ca\u6700\u7ec8\u5206\u6790\u7a0b\u5e8f\u53ca\u5176\u64cd\u4f5c\u6761\u4ef6\u7684\u5408\u7406\u6027\u8bf4\u660e\u6574\u5408\u5728\u4e00\u8d77\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u8fd9\u662f Kymos \u5728\u5176\u5185\u90e8 AQbD \u5f00\u53d1\u6d41\u7a0b\u4e2d\u91c7\u7528\u7684\u7ed3\u6784\u3002<\/strong> \u7531\u6b64\u4ea7\u751f\u7684\u5f00\u53d1\u5305\u65e8\u5728\u652f\u6301\u540e\u7eed\u7684\u9a8c\u8bc1\u3001\u65b9\u6cd5\u8f6c\u79fb\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>ICH Q14 \u4e0e\u5206\u6790\u7a0b\u5e8f\u751f\u547d\u5468\u671f<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>ICH Q14<\/strong> \u4e2d\u7684\u5173\u952e\u6982\u5ff5\u4e4b\u4e00\u662f <strong>\u5206\u6790\u7a0b\u5e8f\u751f\u547d\u5468\u671f<\/strong>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u8be5\u6307\u5357\u8ba4\u8bc6\u5230\u5206\u6790\u7a0b\u5e8f\u7684\u5f00\u53d1\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u662f\u76f8\u4e92\u5173\u8054\u7684<\/strong>\uff0c\u5e76\u4e14\u5404\u9879\u6d3b\u52a8\u7684\u987a\u5e8f\u548c\u7a0b\u5ea6\u53ef\u80fd\u4f1a\u6839\u636e\u9884\u671f\u7528\u9014\u548c\u5f00\u53d1\u65b9\u6cd5\u800c\u6709\u6240\u4e0d\u540c\u3002\u591a\u9879\u6d3b\u52a8\u4e5f\u53ef\u80fd\u540c\u65f6\u8fdb\u884c\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u610f\u5473\u7740 <strong>\u5f00\u53d1\u5de5\u4f5c\u7684\u4ef7\u503c\u5e76\u4e0d\u4ec5\u9650\u4e8e\u786e\u5b9a\u6700\u7ec8\u5206\u6790\u6761\u4ef6\u7684\u90a3\u4e00\u523b<\/strong>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u77e5\u8bc6\u6709\u52a9\u4e8e\u66f4\u597d\u5730\u7406\u89e3\uff1a<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u54ea\u4e9b\u53c2\u6570\u5bf9\u65b9\u6cd5\u6027\u80fd\u7684\u5f71\u54cd\u6700\u5927<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u8fd9\u4e9b\u53c2\u6570\u7684\u53d8\u5316\u5982\u4f55\u5f71\u54cd\u5206\u6790\u7a0b\u5e8f<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u54ea\u4e9b\u64cd\u4f5c\u8303\u56f4\u5177\u6709\u79d1\u5b66\u5408\u7406\u6027<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u5e38\u89c4\u4f7f\u7528\u671f\u95f4\u54ea\u4e9b\u63a7\u5236\u662f\u76f8\u5173\u7684<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u5f53\u9700\u8981\u53d8\u66f4\u65f6\u5982\u4f55\u7ba1\u7406\u7a0b\u5e8f<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u4e9b\u77e5\u8bc6\u7684\u6c47\u7f16\u53ef\u4ee5\u4e3a <strong>\u65b9\u6cd5\u751f\u547d\u5468\u671f\u7684\u540e\u7eed\u9636\u6bb5\u63d0\u4f9b\u66f4\u575a\u5b9e\u7684\u57fa\u7840<\/strong>\uff0c\u5305\u62ec\u9a8c\u8bc1\u3001\u8f6c\u79fb\u3001\u5e38\u89c4\u4f7f\u7528\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>AQbD \u4e0e\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1<\/strong><\/span><\/h2>\n<p><strong><span style=\"font-size: 14pt;\">AQbD \u5e76\u4e0d\u80fd\u53d6\u4ee3\u5206\u6790\u7a0b\u5e8f\u9a8c\u8bc1\u3002<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>ICH Q14 \u6d89\u53ca\u5206\u6790\u7a0b\u5e8f\u5f00\u53d1\uff0c\u800c ICH Q2(R2) \u5219\u63d0\u4f9b\u4e86\u9a8c\u8bc1\u6846\u67b6<\/strong>\u3002\u8fd9\u4e24\u4efd\u6307\u5357\u662f\u4e92\u8865\u7684\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u540c\u65f6\uff0c\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u6570\u636e\u53ef\u4ee5\u4e3a\u9a8c\u8bc1\u7b56\u7565\u505a\u51fa\u8d21\u732e\u3002<strong>ICH Q14<\/strong> \u6307\u51fa\uff0c\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u6570\u636e\uff08\u4f8b\u5982\u6765\u81ea DoE \u7814\u7a76\u7684\u7a33\u5065\u6027\u6570\u636e\uff09\u53ef\u7528\u4f5c\u76f8\u5173\u5206\u6790\u7a0b\u5e8f\u6027\u80fd\u7279\u6027\u9a8c\u8bc1\u6570\u636e\u7684\u4e00\u90e8\u5206\uff0c\u8fd9\u610f\u5473\u7740\u67d0\u4e9b\u7814\u7a76\u4e0d\u4e00\u5b9a\u9700\u8981\u91cd\u590d\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u521b\u9020\u4e86\u4e00\u4e2a\u66f4\u5177\u5173\u8054\u6027\u7684\u8fc7\u7a0b\uff1a<strong>\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u79d1\u5b66\u7406\u89e3\u53ef\u4ee5\u4e3a\u9a8c\u8bc1\u7b56\u7565\u63d0\u4f9b\u4fe1\u606f<\/strong>\uff0c\u800c\u4e0d\u662f\u5728\u5f00\u53d1\u9636\u6bb5\u7ed3\u675f\u540e\u5c31\u88ab\u675f\u4e4b\u9ad8\u9601\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u652f\u6301\u5206\u6790\u7a0b\u5e8f\u751f\u547d\u5468\u671f\u7ba1\u7406<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u5f53\u5728\u4ea7\u54c1\u751f\u547d\u5468\u671f\u540e\u671f\u9700\u8981\u8fdb\u884c\u53d8\u66f4\u65f6\uff0c<strong>\u5bf9\u5206\u6790\u7a0b\u5e8f\u53c2\u6570\u7684\u66f4\u597d\u7406\u89e3\u4e5f\u4f1a\u53d8\u5f97\u975e\u5e38\u6709\u4ef7\u503c<\/strong>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4f8b\u5982\uff0c\u589e\u5f3a\u578b\u5f00\u53d1\u65b9\u6cd5\u53ef\u4ee5\u652f\u6301\u79d1\u5b66\u5408\u7406\u7684\u64cd\u4f5c\u8303\u56f4\u7684\u5b9a\u4e49\uff0c\u5e76\u4e3a\u5206\u6790\u7a0b\u5e8f\u5efa\u7acb\u9002\u5f53\u7684\u6761\u4ef6\u3002 <strong>ICH Q14 \u5c06\u8fd9\u79cd\u589e\u5f3a\u7684\u7406\u89e3\u4e0e\u751f\u547d\u5468\u671f\u7ba1\u7406\u4e2d\u66f4\u5927\u7684\u7075\u6d3b\u6027\u4ee5\u53ca\u67d0\u4e9b\u6279\u51c6\u540e\u53d8\u66f4\u7684\u7ba1\u7406\u8054\u7cfb\u8d77\u6765\u3002<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u5e76\u4e0d\u610f\u5473\u7740\u901a\u8fc7 AQbD \u5f00\u53d1\u7684\u65b9\u6cd5\u4f1a\u81ea\u52a8\u6d88\u9664\u76d1\u7ba1\u8981\u6c42\u6216\u907f\u514d\u672a\u6765\u7684\u53d8\u66f4\u3002\u76f8\u53cd\uff0c\u5f00\u53d1\u77e5\u8bc6\u548c\u79d1\u5b66\u5408\u7406\u7684\u8303\u56f4\u53ef\u4ee5\u4e3a\u8bc4\u4f30\u548c\u7ba1\u7406\u8fd9\u4e9b\u53d8\u66f4\u63d0\u4f9b\u66f4\u5f3a\u5927\u7684\u57fa\u7840\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u540c\u6837\u7684\u539f\u5219\u4e5f\u9002\u7528\u4e8e\u5206\u6790\u7a0b\u5e8f\u8f6c\u79fb\u3002<\/strong> \u5f53\u9700\u8981\u5728\u53e6\u4e00\u4e2a\u5b9e\u9a8c\u5ba4\u6216\u5728\u4e0d\u540c\u7684\u64cd\u4f5c\u6761\u4ef6\u4e0b\u5b9e\u65bd\u7a0b\u5e8f\u65f6\uff0c\u4e00\u4e2a\u5176\u76f8\u5173\u53c2\u6570\u3001\u6027\u80fd\u8981\u6c42\u548c\u64cd\u4f5c\u8303\u56f4\u90fd\u5f97\u5230\u5145\u5206\u7406\u89e3\u7684\u65b9\u6cd5\u53ef\u4ee5\u63d0\u4f9b\u66f4\u5b8c\u6574\u7684\u77e5\u8bc6\u5e93\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u5728\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u5efa\u7acb\u79d1\u5b66\u7406\u89e3<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>\u589e\u5f3a\u578b\u5206\u6790\u5f00\u53d1\u7684\u7ed3\u679c\u662f\u5f97\u5230\u4e00\u4e2a\u7531\u5bf9\u5176\u6027\u80fd\u7684\u6df1\u5165\u7406\u89e3\u6240\u652f\u6301\u7684\u65b9\u6cd5\u3002<\/strong> \u5f00\u53d1\u8fc7\u7a0b\u53ef\u4ee5\u4ea7\u751f\u5173\u4e8e\u4e3a\u4ec0\u4e48\u8981\u9009\u62e9\u7279\u5b9a\u6761\u4ef6\u3001\u54ea\u4e9b\u53d8\u91cf\u4f1a\u5f71\u54cd\u65b9\u6cd5\u3001\u5b83\u4eec\u5982\u4f55\u76f8\u4e92\u4f5c\u7528\u4ee5\u53ca\u7a0b\u5e8f\u53ef\u4ee5\u5728\u4f55\u5904\u53ef\u9760\u8fd0\u884c\u7684\u77e5\u8bc6\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u4e9b\u77e5\u8bc6\u5728\u5f00\u53d1\u5b8c\u6210\u540e\u4ecd\u7136\u6709\u7528\u3002 <strong>\u5206\u6790\u7a0b\u5e8f\u5728\u9a8c\u8bc1\u3001\u8f6c\u79fb\u548c\u5e38\u89c4\u4f7f\u7528\u671f\u95f4\uff0c\u4ee5\u53ca\u5728\u751f\u547d\u5468\u671f\u540e\u671f\u5f15\u5165\u53d8\u66f4\u65f6\uff0c\u90fd\u9700\u8981\u4fdd\u6301\u5176\u9884\u671f\u7528\u9014\u7684\u9002\u7528\u6027\u3002<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5f00\u53d1\u671f\u95f4\u8fdb\u884c\u7684\u98ce\u9669\u8bc4\u4f30\u3001\u5b9e\u9a8c\u7814\u7a76\u3001\u7edf\u8ba1\u8bc4\u4f30\u548c\u64cd\u4f5c\u8303\u56f4\u5b9a\u4e49\u4e3a\u5728\u8fd9\u4e9b\u9636\u6bb5\u7ba1\u7406\u65b9\u6cd5\u63d0\u4f9b\u4e86\u79d1\u5b66\u4f9d\u636e\u3002\u7531\u6b64\u4ea7\u751f\u7684\u77e5\u8bc6\u8fd8\u53ef\u4ee5\u4e3a\u63a7\u5236\u7b56\u7565\u63d0\u4f9b\u4fe1\u606f\uff0c\u5e76\u5728\u5206\u6790\u7a0b\u5e8f\u9700\u8981\u6f14\u53d8\u65f6\u5e2e\u52a9\u8bc4\u4f30\u53d8\u66f4\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5bf9\u4e8e\u652f\u6301\u836f\u7269\u5f00\u53d1\u548c\u8d28\u91cf\u63a7\u5236\u7684\u5206\u6790\u7a0b\u5e8f\uff0c\u8fd9\u79cd\u751f\u547d\u5468\u671f\u89c6\u89d2\u662f ICH Q14 \u4e2d\u63cf\u8ff0\u7684\u589e\u5f3a\u578b\u65b9\u6cd5\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u5728 Kymos \u5b9e\u65bd AQbD<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>\u5728 Kymos\uff0cAQbD \u539f\u5219\u7684\u5b9e\u65bd\u59cb\u4e8e\u5bf9\u5f53\u524d\u5206\u6790\u5f00\u53d1\u6846\u67b6\u7684\u7814\u7a76\uff0c\u7279\u522b\u662f ICH Q14 \u548c ICH Q2(R2)<\/strong>\uff0c\u4ee5\u53ca\u76f8\u5173\u7684\u79d1\u5b66\u548c\u884c\u4e1a\u8d44\u6e90\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u6211\u4eec\u4f4d\u4e8e\u610f\u5927\u5229 Kymos 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