{"id":39789,"date":"2017-05-17T10:48:40","date_gmt":"2017-05-17T05:18:40","guid":{"rendered":"https:\/\/new.editage.cn\/insights\/%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e6%8c%87%e5%8d%97%ef%bc%9a%e5%a6%82%e4%bd%95%e9%81%bf%e5%85%8d%e6%97%a0%e6%b3%95%e9%87%8d%e5%a4%8d%e7%9a%84%e7%a0%94%e7%a9%b6%e7%bb%93%e6%9e%9c"},"modified":"2026-01-07T16:22:58","modified_gmt":"2026-01-07T10:52:58","slug":"fen-xi-fang-fa-yan-zheng-zhi-nan-ru-he-bi-mian-wu-fa-chong-fu-de-yan-jiu-jie-guo-he-che-gao-2770","status":"publish","type":"post","link":"https:\/\/www.editage.cn\/insights\/fen-xi-fang-fa-yan-zheng-zhi-nan-ru-he-bi-mian-wu-fa-chong-fu-de-yan-jiu-jie-guo-he-che-gao-2770\/","title":{"rendered":"\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\uff1a\u5982\u4f55\u907f\u514d\u65e0\u6cd5\u91cd\u590d\u7684\u7814\u7a76\u7ed3\u679c\u548c\u64a4\u7a3f"},"content":{"rendered":"

\u5728\u6784\u5efa\u81ea\u5df1\u7684\u79d1\u7814\u751f\u6daf\u65f6\uff0c\u7279\u522b\u662f\u5728\u786c\u79d1\u5b66\u548c\u5176\u4ed6\u79d1\u5b66\u6216\u5de5\u7a0b\u76f8\u5173\u9886\u57df\uff0c\u8fdb\u884c\u5b9e\u9645\u7684\u7814\u7a76\u53ea\u4e0d\u8fc7\u662f\u8fc7\u7a0b\u7684\u4e00\u4e2a\u6b65\u9aa4\u3002\u5728\u8fdb\u884c\u4efb\u4f55\u9700\u8981\u6536\u96c6\u786c\u6570\u636e\u7684 R&D \u5de5\u4f5c\u524d\uff0c\u4e00\u5b9a\u8981\u6709\u6570\u636e\u6536\u96c6\u7b56\u7565\uff0c\u901a\u5e38\u79f0\u4e3a\u7814\u7a76\u65b9\u6cd5 (research method)\u3002\u7814\u7a76\u65b9\u6cd5\u5305\u542b\u6267\u884c\u5b9e\u9a8c\u5e76\u5bfc\u51fa\u6709\u6548\u6570\u636e\u7684\u7279\u5b9a\u65b9\u6cd5\uff0c\u4e14\u5728\u53d1\u8868\u524d\u8981\u80fd\u591f\u91cd\u590d\u6216\u91cd\u73b0\u3002\u5c0f\u5fc3\u89c4\u5212\u548c\u6267\u884c\u7814\u7a76\u662f\u79d1\u7814\u4eba\u5458\u7684\u8d23\u4efb\uff0c\u5982\u6b64\u624d\u80fd\u5f97\u5230\u53ef\u4ee5\u501f\u7531\u6807\u51c6\u9a8c\u8bc1\u65b9\u6cd5\u91cd\u590d\u3001\u91cd\u73b0\u548c\u9a8c\u8bc1\u7684\u6570\u636e\u3002\u7531\u4e8e\u5927\u90e8\u5206\u7684 R&D \u90fd\u5305\u542b\u4e00\u4e9b\u5206\u6790\u65b9\u6cd5\uff0c\u5373\u4fbf\u662f\u751f\u7269\u5b66\u3001\u751f\u7269\u5316\u5b66\u3001\u751f\u7269\u533b\u5b66\u4f1a\u5176\u4ed6\u79cd\u7c7b\u7684\u7814\u7a76\u4e5f\u662f\u5982\u6b64\uff0c\u5927\u90e8\u5206\u7684\u7814\u7a76\u6700\u7ec8\u90fd\u8981\u4f9d\u9760\u6536\u96c6\u5230\u53ef\u7528\u7684\u6709\u6548\u5206\u6790\u6570\u636e\u3002<\/p>\n

\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1<\/strong> (Analytical Method Validation, AMV)<\/strong><\/p>\n

\u65b9\u6cd5\u9a8c\u8bc1\u8ddf\u8fbe\u5230\u5927\u4f17\u6240\u63a5\u53d7\u7684\u7ec4\u7ec7\u6240\u89c4\u5b9a\u7684\u7279\u5b9a\u6807\u51c6\u6761\u4ef6\u7684\u6700\u7ec8\u4f18\u5316\u65b9\u6cd5\u6709\u5173\uff0c\u8fd9\u4e9b\u5355\u4f4d\u5305\u542b International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use) \u5206\u6790\u65b9\u6cd5\u6216\u662f ICH<\/a>\u3002ICH \u57fa\u672c\u4e0a\u5305\u542b\u76d1\u7ba1\u5355\u4f4d\u4ee5\u53ca\u5236\u836f\u548c\u751f\u7269\u5236\u836f\u4ea7\u4e1a\u6240\u63d0\u4f9b\u5206\u6790\u65b9\u6cd5\u8be5\u5982\u4f55\u9a8c\u8bc1\u7684\u610f\u89c1\u3002\u5728\u4e00\u4e9b ICH \u6587\u6863\u4e2d\uff0c\u8fd9\u4e9b\u53ef\u63a5\u53d7\u7684\u9a8c\u8bc1\u8fd9\u4e9b\u65b9\u6cd5\u7684\u505a\u6cd5\u501f\u7531\u7b7e\u7f72\u4eba\u5458\u540c\u610f\uff0c\u7136\u540e\u518d\u7531\u56fd\u9645\u5236\u836f\u5355\u4f4d\uff08FDA\u3001EMA\u3001JPA \u7b49\uff09\u91c7\u7528\uff0c\u5982\u6b64\u89c4\u8303\u4e00\u822c\u5904\u65b9\u836f\u7684\u6279\u51c6\u548c\u9500\u552e\u3002\u8fd9\u4e9b\u6307\u5357\u5e76\u4e0d\u9002\u7528\u4e8e\u975e\u5904\u65b9\u836f\u54c1\uff0c\u8fd9\u90e8\u5206\u76ee\u524d\u8fd8\u6ca1\u6709\u4efb\u4f55\u76f8\u5173\u89c4\u8303\u3002AMV \u6709\u5f88\u591a\u65b9\u9762\uff0c\u4f8b\u5982\u91cd\u590d\u6027\u3001\u91cd\u73b0\u6027\u3001\u7a33\u5065\u6027\u3001\u8010\u7528\u6027\u3001\u7cfb\u7edf\u9002\u7528\u6027\u3001\u68c0\u6d4b\u9650\u5236\u548c\u5b9a\u91cf\u9650\u5236\u7b49\u7b49\u4e4b\u5916\u8fd8\u6709\u5f88\u591a\u3002\u4e0d\u8fc7\uff0c\u5982\u679c\u56de\u5f52\u5230\u57fa\u672c\u9762\u4e0a\u6765\u770b\uff0cAMV \u662f\u8981\u4fdd\u8bc1\u6700\u540e\u7684\u4efb\u4f55\u5206\u6790\u79d1\u7814\u65b9\u6cd5\u7684\u5408\u6cd5\u6027\u3001\u53ef\u7528\u6027\u548c\u91cd\u73b0\u6027\uff0c\u6700\u7ec8\u53ef\u4f9b\u5236\u836f\u6216\u751f\u7269\u5236\u836f\u548c\u76d1\u7ba1\u5355\u4f4d\u4f7f\u7528\u3002\u4efb\u4f55\u60f3\u8981\u53d6\u5f97\u76d1\u7ba1\u5355\u4f4d\u7684\u52a8\u7269\u7814\u7a76\u3001\u4eba\u7c7b\u4e34\u5e8a\u7814\u7a76\u53ca\u8425\u9500\u8bb8\u53ef\u7684\u516c\u53f8\u90fd\u9700\u8981\u9075\u5b88\u8fd9\u4e9b ICH \u6307\u5357\uff0c\u4f46\u5982\u679c\u4e2a\u4eba\u60f3\u8981\u6295\u7a3f\u53d1\u8868\u5230\u4e16\u754c\u4e0a\u4efb\u4f55\u671f\u520a\uff0c\u5c31\u4e0d\u9700\u8981\u9075\u5b88\u8fd9\u4e9b\u89c4\u5b9a\u3002\u4e8b\u5b9e\u4e0a\uff0c\u671f\u520a\u3001\u7f16\u8f91\u6216\u662f\u5ba1\u7a3f\u4eba\u4e0d\u4f1a\u8981\u6c42\u4f5c\u8005\u9075\u5b88\u4efb\u4f55\u4f7f\u7528 AMV \u7684\u6307\u5357\u3002<\/p>\n

\u867d\u7136\u9664\u4e86 ICH \u5916\u8fd8\u6709\u5176\u4ed6\u7ec4\u7ec7\u51b3\u5b9a\u4f55\u4e3a\u9a8c\u8bc1\u65b9\u6cd5\uff0c\u4f46 ICH \u8fd8\u662f\u6700\u53d7\u8ba4\u53ef\u7684\u6307\u5357\u3002ICH \u89c4\u5b9a\u6240\u6709\u5236\u836f\u548c\u751f\u7269\u5236\u836f\u5b9e\u8df5\u3001\u516c\u53f8\u548c\u4e3b\u8981\u7684\u76d1\u7ba1\u5355\u4f4d\uff0c\u5305\u542b\u7f8e\u56fd FDA\u3002\u9664\u4e86 ICH \u5916\uff0c\u7f8e\u56fd\u56fd\u5bb6\u6807\u6ce8\u6280\u672f\u7814\u7a76\u6240 (National Institute of Standards and Technology, NIST) \u548c\u591a\u4e2a\u671f\u520a\u79d1\u7814\u7ec4\u7ec7 (IVT\/JVT) \u4e5f\u6709\u81ea\u5df1\u7684\u4e00\u5957\u6307\u5357\uff0c\u89c4\u8303\u5f00\u53d1\u548c\u5e94\u7528\u9a8c\u8bc1\u65b9\u6cd5\u3002Institute of Validation Technology<\/a> (IVT) \u662f\u77e5\u540d\u7684\u79c1\u4eba\u7ec4\u7ec7\uff0c\u4e13\u95e8\u5904\u7406\u9a8c\u8bc1\u6848\u4ef6\u3002\u8be5\u7ec4\u7ec7\u5b9a\u671f\u51fa\u7248\u7ecf\u8fc7\u5ba1\u67e5\u7684\u957f\u671f\u5728\u7ebf\u671f\u520a\u300aJournal of Validation Technology\u300b(JVT)\uff0c\u8be5\u671f\u520a\u51e0\u4e4e\u5168\u90e8\u90fd\u5728\u8c08\u5404\u79cd\u9a8c\u8bc1\u8bae\u9898\u3002<\/p>\n

\u6709\u8bb8\u591a\u4e66\u7c4d\u3001\u671f\u520a\u3001\u7efc\u8ff0\u6587\u7ae0\u3001\u6742\u5fd7\u548c\u7f51\u7ad9\u90fd\u4e13\u95e8\u8ba8\u8bba AMV\uff0c\u4f8b\u5982\u4f60\u53ef\u4ee5\u8f7b\u677e\u5728\u5728\u7ebf\u627e\u5230\u7edf\u8ba1\u65b9\u6cd5\u9a8c\u8bc1 ICH \u6307\u5357<\/a>\u3002\u5982\u679c\u6709\u4eba\u4f7f\u7528\u8ddf ICH \u6307\u5357\u6709\u5173\u7684\u5173\u952e\u8bcd<\/a>\u641c\u7d22\u00a0AMV\uff0c\u90a3\u4e48\u5b9e\u8d28\u4e0a\u8ddf\u8fd9\u4e2a\u6709\u5173\u3001\u7531\u5176\u4ed6\u76d1\u7ba1\u5355\u4f4d\u53d1\u884c\u7684\u6240\u6709\u6587\u732e\u90fd\u4f1a\u8dd1\u51fa\u6765\u3002\u79d1\u7814\u4eba\u5458\u90fd\u8be5\u77e5\u9053\u8fd9\u4e9b\u57fa\u672c\u51c6\u5219\uff0c\u624d\u80fd\u5728\u6295\u7a3f\u524d\u4e3a\u81ea\u5df1\u7684\u65b9\u6cd5\u8fdb\u884c AMV\u3002\u4e0d\u8fc7\uff0c\u4f60\u4e5f\u8981\u77e5\u9053\u7b26\u5408\u5236\u836f\u76d1\u7ba1\u5355\u4f4d\u6838\u51c6\u7684\u65b9\u6cd5\u9a8c\u8bc1\u5e76\u4e0d\u4e00\u5b9a\u4e0e\u5176\u4ed6\u4ea7\u4e1a\u6216\u7ec4\u7ec7\u4e00\u81f4\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u5927\u90e8\u5206\u505a AMV \u7684\u79d1\u7814\u4eba\u5458\u90fd\u662f\u4f7f\u7528 ICH \u6307\u5357\uff0c\u4e0d\u8fc7\uff0c\u53ea\u6709\u5236\u836f\u548c\u751f\u7269\u5236\u836f\u4ea7\u4e1a\u5728\u7f8e\u56fd\u6216\u6d77\u5916\u5411\u76d1\u7ba1\u5355\u4f4d\u9001\u5ba1\u6216\u7533\u8bf7\u65f6\uff0c\u624d\u771f\u6b63\u9700\u8981\u9075\u5b88\u8fd9\u4e9b\u89c4\u5b9a\u3002\u76ee\u524d\u4e16\u754c\u4e0a\u8fd8\u6ca1\u6709\u4efb\u4f55\u671f\u520a\u5728\u6295\u7a3f\u65f6\u6709\u4efb\u4f55\u7c7b\u4f3c\u7684\u8981\u6c42\u3002\u8fd9\u90fd\u662f\u4f5c\u8005\u4e2a\u4eba\u7279\u522b\u6307\u5b9a\u7684\u51b3\u5b9a\uff0c\u6216\u8bb8\u5ba1\u7a3f\u4eba\u4e5f\u53ef\u4ee5\u51b3\u5b9a\uff0c\u4f46\u901a\u5e38\u4e0d\u4f1a\u3002\u7ed9\u79d1\u7814\u4f5c\u8005\u7684\u6307\u5357\u4ece\u6ca1\u6709\u8ba8\u8bba\u8fc7 ICH \u6216 AMV \u8981\u6c42\u3002<\/p>\n

\u4ee5\u4e0b\u662f ICH \u6307\u5357\u4e2d\u5bf9\u6267\u884c AMV \u7684\u57fa\u672c\u8981\u70b9\uff1a<\/p>\n

1. <\/strong>\u91cd\u590d\u6027\u548c\u91cd\u73b0\u6027<\/strong><\/p>\n

\u4efb\u4f55\u6bd4\u8f83\u65b0\u7684\u5316\u5b66\u3001\u751f\u7269\u3001\u751f\u7269\u533b\u5b66\u3001\u836f\u7528\u6216\u533b\u5b66\u7528\u7684\u5206\u6790\u65b9\u6cd5\u90fd\u9700\u8981\u7b26\u5408 AMV \u57fa\u672c\u8981\u6c42\u3002\u5927\u90e8\u5206\u7684\u79d1\u7814\u5de5\u4f5c\u90fd\u4f1a\u6536\u96c6\u786c\u6570\u636e\uff0c\u4e5f\u5c31\u662f\u6709\u5e73\u5747\u503c\u7684\u6570\u5b57\uff0c\u8fd8\u6709\u5e73\u5747\u6570\u504f\u5dee\u503c\uff0c\u4f8b\u5982\u6807\u51c6\u5dee (standard deviation, SD)\u3001\u76f8\u5bf9\u6807\u51c6\u504f\u5dee (relative standard deviation, RSD)\u3001\u767e\u5206\u542b\u91cf\u7684\u76f8\u5bf9\u6807\u51c6\u504f\u5dee (percent relative standard deviation, %RSD)\u3001\u53d8\u5f02\u7cfb\u6570 (coefficient of variation, CV)\u7b49\u3002\u6240\u6709\u7684\u53d1\u8868\u6587\u7ae0\u90fd\u8be5\u8868\u793a\u6bcf\u4e00\u4e2a\u6570\u503c\u91cd\u590d\u7684\u6b21\u6570\uff0c\u901a\u5e38\u90fd\u7528 n \u7f29\u5199\u8868\u793a\uff0c\u6839\u636e FDA \u89c4\u5b9a\uff0cn \u4e0d\u5f97\u5c0f\u4e8e 3\uff0c\u6700\u597d\u662f\u5927\u4e8e\u7b49\u4e8e 6\u3002<\/p>\n

\u6240\u6709\u5ba1\u7a3f\u4eba\u548c\u671f\u520a\u7f16\u8f91\u5e94\u8be5\u90fd\u4e0d\u4f1a\u63a5\u53d7\u5355\u70b9\u6570\u636e\u7684\u79d1\u7814\u8bba\u6587\u3002\u5c3d\u7ba1 ICH \u6807\u51c6\u5e76\u4e0d\u9002\u7528\u671f\u520a\u53d1\u8868\uff0c\u4f46\u662f\u6bcf\u4e00\u4f4d\u5ba1\u7a3f\u4eba\u901a\u5e38\u9700\u8981\u5b9a\u4e49\u8981\u5305\u542b\u4ec0\u4e48\u6837\u7684 AMV\u3002\u56e0\u6b64\uff0c\u5927\u90e8\u5206\u7684\u671f\u520a\u6216\u7f16\u8f91\u5728\u8fd9\u65b9\u9762\u6ca1\u6709\u4efb\u4f55\u8bf4\u660e\uff0c\u6240\u4ee5\u5927\u4f53\u800c\u8a00\uff0c\u4e00\u5207\u90fd\u770b\u4e0d\u540c\u7684\u4f5c\u8005\u548c\u5ba1\u7a3f\u4eba\u505a\u4ec0\u4e48\u4e0d\u540c\u7684\u51b3\u5b9a\u3002<\/p>\n

\u8fd8\u6709\uff0c\u5982\u679c\u4f60\u6295\u7a3f\u4e00\u7bc7 n=1 \u7684\u6587\u7ae0\u7ed9\u4efb\u4f55\u671f\u520a\uff0c\u5bf9\u4f60\u7684\u5de5\u4f5c\u53ef\u80fd\u6709\u8d1f\u9762\u5f71\u54cd\u3002\u6211\u60f3\u8981\u5f3a\u8c03\uff0c\u5c31\u6211\u6240\u77e5\u8303\u56f4\u5185\uff0c\u4ece\u6765\u90fd\u6ca1\u6709\u4efb\u4f55\u5206\u6790\u671f\u520a\u660e\u786e\u8bf4\u660e\u6216\u89c4\u5b9a\u8fd9\u4e9b\u9a8c\u8bc1\u8981\u6c42\u3002\u6ca1\u6709\u4efb\u4f55\u671f\u520a\u628a ICH \u7684 AMV \u6307\u5357\u5217\u5165\u6295\u7a3f\u89c4\u5b9a\u4e2d\uff0c\u8fd9\u4e00\u4e2a\u91cd\u8981\u7684\u70b9\u5c31\u7559\u7ed9\u4f5c\u8005\u548c\u5ba1\u7a3f\u4eba\u81ea\u5df1\u51b3\u5b9a\u4f5c\u8005\u5728 AMV \u6307\u5357\u90e8\u5206\u8981\u505a\u5230\u4ec0\u4e48\u7a0b\u5ea6\u3002<\/p>\n

\u6bcf\u4e00\u4e2a\u5206\u6790\u6570\u636e\u7684\u8868\u683c\u90fd\u4e00\u5b9a\u8981\u6709\u6bcf\u4e00\u4e2a\u5e73\u5747\u6570\u7684\u91cd\u590d\u6b21\u6570\u4ee5\u53ca\u53ef\u91cd\u590d\u6027\u6216\u662f n=\u91cd\u590d\u6b21\u6570\u6570\u503c\uff0c\u4e5f\u8be5\u6709\u8fd9\u4e9b\u6570\u503c\u4e0e\u5176\u4ed6\u6570\u503c\u6709\u591a\u76f8\u8fd1\u7684\u8bf4\u660e\uff0c\u5982 SD\u3001%RSD \u548c\u5176\u4ed6\u6570\u503c\u3002\u5982\u679c\u7814\u7a76\u5de5\u4f5c\u6709\u786e\u5b9e\u505a\u597d\uff0c\u8fd9\u4e9b\u6570\u503c\u504f\u5dee\u8bf4\u660e\u5e94\u8be5\u5f88\u5c0f\uff0c\u4e00\u822c\u5c0f\u4e8e 1-2%\uff0c\u8fd9\u8868\u793a\u4e0d\u9519\u7684\u53ef\u91cd\u590d\u6027\u3002<\/p>\n

\u867d\u7136\u5176\u4ed6\u4eba\u4e5f\u6709\u53ef\u80fd\u4f7f\u7528\u8ddf\u539f\u4f5c\u540c\u6837\u7684\u65b9\u6cd5\u3001\u4eea\u5668\u3001\u4e13\u4e1a\u548c\u80fd\u529b\u91cd\u73b0\uff0c\u4f46\u6240\u6709\u6570\u503c\u7684\u91cd\u590d\u6027\u901a\u5e38\u662f\u7531\u4e2a\u4eba\u64cd\u4f5c\u7684\u3002\u53ef\u91cd\u590d\u6027\u901a\u5e38\u6709\u539f\u5148\u7684\u79d1\u5b66\u5bb6\u8fdb\u884c\u6d4b\u8bd5\uff0c\u7136\u540e\u7531\u5176\u4ed6\u5177\u5907\u76f8\u540c\u5b9e\u529b\u7684\u4eba\uff0c\u5728\u4e0d\u540c\u5b9e\u9a8c\u5ba4\u4f7f\u7528\u76f8\u540c\u7684\u65b9\u6cd5\u3001\u4eea\u5668\u3001\u8bd5\u5242\u3001\u5316\u5b66\u836f\u5242\u7b49\u7b49\u8fdb\u884c\u590d\u5236\u91cd\u73b0\uff0c\u7531\u6b64\u8ba9\u4e0d\u540c\u7684\u5b9e\u9a8c\u5ba4\u6f14\u793a\u6574\u4f53\u91cd\u73b0\u6027\u3002\u5c31\u6570\u91cf\u4e0a\u6765\u770b\uff0c\u8fd9\u4e9b\u6570\u5b57\u5e94\u8be5\u90fd\u6709\u5c11\u4e8e\u51e0\u4e2a RSD \u6216 %RSD \u767e\u5206\u6bd4\u7684\u8bef\u5dee\u3002\u56e0\u4e3a\u76ee\u524d\u6ca1\u6709\u79d1\u7814\u671f\u520a\u8981\u6c42\u4f5c\u8005\u8981\u6f14\u793a\u91cd\u73b0\u6027\uff0c\u6709\u5f88\u591a\u4f5c\u8005\u8ddf\u5ba1\u7a3f\u4eba\u4e0d\u76f8\u4fe1\u8981\u8ba9\u7814\u7a76\u8ba4\u4e3a\u53ef\u63a5\u53d7\u4e14\u503c\u5f97\u53d1\u8868\uff0c\u5e94\u8be5\u8981\u5305\u542b\u8fd9\u4e9b\u4e1c\u897f\u5728\u6295\u7a3f\u8bba\u6587\u4e4b\u4e2d\u3002\u8ba9\u6211\u7528\u522b\u79cd\u8bf4\u6cd5\u5728\u8bf4\u4e00\u6b21\u8fd9\u53e5\u8bdd\u5427\uff0c\u4e0d\u7ba1\u671f\u520a\u89c4\u5b9a\u6216\u7f16\u8f91\u7684\u60f3\u6cd5\u5982\u4f55\uff0c\u5982\u679c\u4f5c\u8005\u4e0d\u5c1d\u8bd5 AMV\u3001\u91cd\u590d\u6027\u6216\u91cd\u73b0\u6027\uff0c\u6bcf\u4e00\u4e2a\u6570\u503c\u90fd\u53ea\u6709\u505a\u4e00\u6b21\uff0c\u8bba\u6587\u8fd8\u662f\u53ef\u4ee5\u53d1\u8868\u3002<\/p>\n

\u4e5f\u5c31\u662f\u8bf4\uff0c\u79d1\u5b66\u662f\u5960\u57fa\u5728\u5f00\u653e\u4e00\u4e2a\u4eba\u7684\u539f\u521b\u65b9\u6cd5\u7ed9\u5176\u4ed6\u5177\u6709\u7c7b\u4f3c\u6280\u80fd\u548c\u4e13\u4e1a\u7684\u4eba\uff0c\u8ba9\u5176\u4ed6\u4eba\u53ef\u4ee5\u8fd0\u7528\u8fd9\u4e9b\u65b9\u6cd5\u548c\u7ed3\u679c\u6570\u636e\u6765\u63a8\u8fdb\u81ea\u5df1\u7684 R&D\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u5982\u679c\u7ed3\u679c\u6700\u540e\u65e0\u6cd5\u91cd\u590d\uff0c\u6211\u76f8\u4fe1\u5b83\u4eec\u5c31\u4e0d\u5e94\u8be5\u53d1\u8868\u3002\u4e3a\u4ec0\u4e48\u5462\uff1f\u8fd9\u662f\u56e0\u4e3a\u8fd9\u4e9b\u4e0d\u80fd\u91cd\u590d\u7684\u65b9\u6cd5\u4f1a\u6d6a\u8d39\u5176\u4ed6\u79d1\u7814\u4eba\u5458\u7684\u65f6\u95f4\u3001\u7cbe\u529b\u3001\u8d44\u6e90\u548c\u91d1\u94b1\u3002\u65e0\u6cd5\u91cd\u73b0\u7684\u53d1\u8868\u6587\u7ae0\u5e94\u8be5\u8981\u88ab\u64a4\u7a3f\u5e76\u66dd\u5149\u5176\u9519\u8bef\u3002<\/p>\n

2. <\/strong>\u575a\u56fa\u6027\u548c\u8010\u7528\u6027<\/strong><\/p>\n

\u6210\u529f\u7684\u7814\u7a76\u5206\u6790\u65b9\u6cd5\u6709\u5f88\u591a\u8981\u7d20\uff0c\u4f8b\u5982\u575a\u56fa\u6027\u548c\u8010\u7528\u6027\u3002\u8fd9\u8868\u793a\u4e00\u4e2a\u65b9\u6cd5\u5373\u4f7f\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u6eb6\u5242\u7eaf\u5ea6\u3001\u8bd5\u5242\u6765\u6e90\u3001\u4eea\u5668\u5e74\u4ee3\u3001\u4eea\u5668\u6027\u8d28\u3001\u6c14\u538b\u7b49\u64cd\u4f5c\u53c2\u6570\u6709\u6240\u53d8\u5f02\uff0c\u8fd8\u662f\u80fd\u591f\u6210\u529f\u3002\u4e00\u4e2a\u597d\u7684\u65b9\u6cd5\u57280%RSD \u81f3\u4efb\u4f55\u6570\u503c\u504f\u5dee\u533a\u95f4 (+\/-) \u90fd\u80fd\u591f\u6b63\u5e38\u8fd0\u4f5c\uff0c\u4e00\u4e2a\u597d\u7684\u65b9\u6cd5\u7684\u6570\u503c\u6709\u5f88\u5c0f\u7684 %RSD\uff0c\u5bf9\u64cd\u4f5c\u53c2\u6570\u7684\u5c0f\u90e8\u5206\u53d8\u5f02\u90fd\u4e0d\u654f\u611f\u3002\u4e00\u4e2a\u4e0d\u597d\u7684\u65b9\u6cd5\u7684\u6570\u503c\u6709\u5f88\u5927\u7684 RSD \u6216 %RSD\uff0c\u800c\u4e14\u901a\u5e38\u5c40\u9650\u5728\u80fd\u63d0\u4f9b\u7cbe\u786e\u6570\u503c\u7684\u5b9e\u9a8c\u53c2\u6570\u4e2d\u3002<\/p>\n

\u53e6\u4e00\u65b9\u9762\uff0c\u4e00\u4e2a\u575a\u56fa\u7684\u65b9\u6cd5\u53ef\u4ee5\u7ecf\u8fc7\u591a\u6b21\u6d4b\u91cf\u6216\u4e0d\u540c\u7684\u64cd\u4f5c\u53c2\u6570\u4ecd\u5386\u4e45\u4e0d\u8870\uff0c\u8fd8\u662f\u80fd\u5f97\u51fa\u6709\u7528\u3001\u6709\u610f\u4e49\u800c\u4e14\u53ef\u4ee5\u91cd\u590d\u7684 RSD \u5f88\u5c0f\u7684\u6570\u636e\u3002\u5927\u90e8\u5206\u7684\u4eba\u90fd\u504f\u597d\u4f7f\u7528\u575a\u56fa\u8010\u7528\u4e14\u5b9e\u9645\u3001\u4e0d\u8d35\u53c8\u5f88\u597d\u8f6c\u79fb\u5230\u6709\u76f8\u4f3c\u6570\u636e\u548c RSD \u7684\u4e0d\u540c\u7fa4\u4f53\u3001\u5b9e\u9a8c\u5ba4\u7684\u65b9\u6cd5\u3002\u5b9e\u9645\u4e0a\u6ca1\u6709\u79d1\u7814\u8bba\u6587\u6709\u8ba8\u8bba\u8fc7\u81ea\u5df1\u7814\u7a76\u7684\u575a\u56fa\u6027\u548c\u8010\u7528\u6027\uff0c\u9664\u975e\u4ed6\u4eec\u6709\u9075\u5b88 ICH \u6307\u5357\uff0c\u4ed6\u4eec\u901a\u4ea7\u53ea\u6709\u63d0\u5230\u4e00\u7ec4\uff08\u4f18\u5316\u8fc7\u7684\uff09\u5b9e\u9a8c\u53c2\u6570\uff0c\u8fd9\u4e9b\u53c2\u6570\u662f\u53d6\u5f97\u6240\u6709\u6216\u5927\u90e8\u5206\u6587\u7ae0\u4e2d\u5448\u73b0\u7684\u6570\u636e\uff0c\u4f46\u4ed6\u4eec\u4ece\u4e0d\u8ba8\u8bba\u575a\u56fa\u6027\u548c\u8010\u7528\u6027\u8fd9\u4e9b\u91cd\u8981\u7684\u60f3\u6cd5\u3002<\/p>\n

3. <\/strong>\u7cfb\u7edf\u9002\u7528\u6027<\/strong><\/p>\n

\u4f60\u7684\u65b9\u6cd5\u6700\u540e\u8fd8\u662f\u8981\u6709\u7cfb\u7edf\u9002\u7528\u6027\u6d4b\u8bd5\uff0c\u4e5f\u5c31\u662f\u8bf4\uff0c\u5fc5\u987b\u8981\u80fd\u5c55\u793a\u51fa\u8fd9\u4e2a\u65b9\u6cd5\u9002\u5408\u9884\u671f\u6d4b\u91cf\u3002\u8fd9\u9700\u8981\u4f60\u7684\u5b9e\u9645\u6837\u672c\u4e2d\uff0c\u5728\u5df2\u77e5\u6c34\u5e73\u8981\u6709\u81f3\u5c11\u4e24\u7ec4\u6216\u4ee5\u4e0a\u7684\u8bd5\u5242\u7cfb\u7edf\u9002\u7528\u6027\u6807\u51c6\uff0c\u5bf9\u6bd4\u4e00\u4e2a\u8bd5\u5242\uff0c\u4e5f\u5c31\u662f\u5df2\u7ecf\u627e\u51fa\u4e14\u5b9a\u91cf\u7684\u5b9e\u9645\u5206\u6790\u3002\u63a5\u7740\uff0c\u4e00\u5b9a\u8981\u5217\u51fa\u8fd9\u4e2a\u6807\u51c6\uff0c\u505a\u4e3a\u57fa\u51c6\u7ebf\u89e3\u51b3\u53e6\u4e00\u4e2a\u8bd5\u5242\u5728\u8be5\u6807\u51c6\u6837\u672c\u533a\u95f4\u7684\u5206\u6790\u7269\u9ad8\u5cf0\u3002\u6b64\u5916\uff0c\u5206\u6790\u7269\u9ad8\u5cf0\u4e00\u5b9a\u8981\u80fd\u591f\u4ee5\u6807\u51c6\u3001\u5b9a\u91cf\u65b9\u6cd5\u7684\u9ad8\u7cbe\u786e\u5ea6\u548c\u51c6\u786e\u5ea6\u88ab\u8fa8\u8bc6\u4e14\u5b9a\u91cf\u3002\u4e0d\u8fc7\uff0c\u771f\u6b63\u7684\u5b9a\u91cf\u7814\u7a76\u90fd\u662f\u9996\u5148\u8fdb\u884c\u7cfb\u7edf\u9002\u7528\u7814\u7a76\uff0c\u8fd9\u6837\u5206\u5f00\u8fdb\u884c\u7684\u7cfb\u7edf\u9002\u7528\u6027\u662f\u5728\u88ab\u5b9e\u9645\u6837\u672c\u6d4b\u91cf\u524d\uff0c\u8bc1\u660e\u4f60\u7684\u5206\u6790\u7cfb\u7edf\u6b63\u786e\u8fd0\u4f5c\u7684\u7406\u60f3\u65b9\u5f0f\u3002\u867d\u7136\u5927\u90e8\u5206\u7684\u5b66\u672f R&D \u6ca1\u6709\u7528\u7cfb\u7edf\u9002\u7528\u6027\u6837\u672c\uff0c\u4f46\u5728\u8bb8\u591a\u4ea7\u4e1a\u7814\u7a76\u4e2d\uff0c\u8fd9\u662f\u5728\u4f7f\u7528\u771f\u5b9e\u6837\u672c\u524d\u5fc5\u5907\u7684\u6761\u4ef6\u3002<\/p>\n

4. AMV <\/strong>\u5176\u4ed6\u65b9\u9762\uff1a\u51c6\u786e\u5ea6<\/strong> (accuracy)<\/strong>\u3001\u7cbe\u786e\u5ea6<\/strong> (precision)<\/strong>\u3001\u68c0\u6d4b\u9650\u5236\u7b49<\/strong><\/p>\n

\u597d\u7684\u5206\u6790\u65b9\u6cd5\u8fd8\u9700\u8981\u5177\u5907\u54ea\u4e9b\u6761\u4ef6\uff0c\u5e2e\u4f60\u6536\u96c6\u4f60\u6240\u9009\u62e9\u9886\u57df\u7684\u6570\u636e\u5462\uff1f\u6709\u4e2a\u7b80\u5355\u5bb9\u6613\u8bbe\u7f6e\u3001\u5bb9\u6613\u6559\u7ed9\u65b0\u7528\u6237\u3001\u5bb9\u6613\u7ef4\u62a4\u3001\u7a33\u5b9a\u64cd\u4f5c\u3001\u6709\u8ba1\u7b97\u673a\u63a7\u5236\u5e76\u4e14\u80fd\u5feb\u901f\u53d6\u5f97\u6570\u636e\u7684\u65b9\u6cd5\u662f\u6bcf\u4e2a\u4eba\u90fd\u60f3\u8981\u7684\uff0c\u5f53\u79d1\u5b66\u5206\u6790\u65b9\u6cd5\u80fd\u8fbe\u5230\u4e0a\u8ff0\u7406\u60f3\u6807\u51c6\u65f6\uff0c\u79d1\u5b66\u80fd\u8fdb\u5c55\u5f97\u66f4\u5feb\u3002\u4e00\u822c\u4eba\u4f1a\u60f3\u8981\u53ef\u4ee5\u63d0\u4f9b\u9ad8\u51c6\u786e\u5ea6\u7684\u6570\u636e\uff08\u4e5f\u5c31\u662f\u6709\u5b9e\u9645\u5206\u6790\u6c34\u5e73\u7684\u4e00\u81f4\u6d4b\u91cf\uff09\u3001\u6bcf\u4e2a\u6d4b\u91cf\u7686\u7cbe\u786e\uff08\u5c0f RSD\uff09\u3001\u53ea\u9488\u5bf9\u7279\u5b9a\u5206\u6790\u7269\uff08\u53ea\u8fa8\u8ba4\u3001\u91cf\u5316\u7279\u5b9a\u5206\u6790\u7269\uff09\u3001\u4f4e\u68c0\u6d4b\u4e0e\u91cf\u5316\u9650\u5236\u3001\u7ebf\u6027\u8303\u56f4\u5927\uff0c\u8fd8\u6709\uff0c\u5f3a\u5927\u7684\u6570\u636e\u7684\u65b9\u6cd5\u3002\u4e0a\u9762\u63d0\u5230\u7684\u6240\u6709\u7279\u6027\u57fa\u672c\u4e0a\u90fd\u8be5\u6db5\u76d6\u5728\u65b9\u6cd5\u4e2d\uff0c\u5e76\u4e14\u8fd0\u7528\u5728\u4f60\u81ea\u5df1\u8fd8\u6709\u5176\u4ed6\u4eba\u7684\u6d4b\u91cf\u4e2d\u3002<\/p>\n

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\u4f60\u7684\u672a\u6765\u4e5f\u662f\uff1f\u4e0d\u662f\u5417\uff1f<\/p>\n","protected":false},"excerpt":{"rendered":"

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