{"id":11694,"date":"2018-07-23T01:00:00","date_gmt":"2018-07-30T04:06:47","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/%e5%ae%9e%e9%aa%8c%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e7%9a%8431%e4%b8%aa%e6%a6%82%e5%bf%b5%ef%bc%8c%e4%b8%8d%e6%98%af%e6%af%8f%e4%b8%aa%e5%ae%9e%e9%aa%8c%e4%ba%ba%e9%83%bd%e4%bc%9a%e3%80%90%e5%88%86\/"},"modified":"2018-07-30T12:06:47","modified_gmt":"2018-07-30T04:06:47","slug":"%e5%ae%9e%e9%aa%8c%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e7%9a%8431%e4%b8%aa%e6%a6%82%e5%bf%b5%ef%bc%8c%e4%b8%8d%e6%98%af%e6%af%8f%e4%b8%aa%e5%ae%9e%e9%aa%8c%e4%ba%ba%e9%83%bd%e4%bc%9a%e3%80%90%e5%88%86","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/11694\/","title":{"rendered":"\u5b9e\u9a8c\u65b9\u6cd5\u9a8c\u8bc1\u768431\u4e2a\u6982\u5ff5\uff0c\u4e0d\u662f\u6bcf\u4e2a\u5b9e\u9a8c\u4eba\u90fd\u4f1a\u3010\u5206\u4eab+\u6536\u85cf\u3011"},"content":{"rendered":"
\n

1.\u65b9\u6cd5\u786e\u8ba4Method Validation<\/span><\/strong><\/p>\n

\u5b9e\u9a8c\u5ba4\u901a\u8fc7\u8bd5\u9a8c\uff0c\u63d0\u4f9b\u5ba2\u89c2\u6709\u6548\u8bc1\u636e\u8bc1\u660e\u7279\u5b9a\u68c0\u6d4b\u65b9\u6cd5\u6ee1\u8db3\u9884\u671f\u7684\u7528\u9014\u3002<\/span><\/p>\n

\u6ce8\uff1a\u65b9\u6cd5\u786e\u8ba4\u5e94\u5f53\u5efa\u7acb\u65b9\u6cd5\u7684\u6027\u80fd\u7279\u6027\u548c\u4f7f\u7528\u7684\u9650\u5236\u6761\u4ef6\uff0c\u5e76\u8bc6\u522b\u5f71\u54cd\u65b9\u6cd5\u6027\u80fd\u7684\u56e0\u7d20\u53ca\u5f71\u54cd\u7a0b\u5ea6\uff0c\u786e\u5b9a\u65b9\u6cd5\u6240\u9002\u7528\u7684\u57fa\u4f53\uff0c\u4ee5\u53ca\u65b9\u6cd5\u7684\u6b63\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6<\/span><\/h2>\n

 <\/p>\n

2.\u65b9\u6cd5\u9a8c\u8bc1Method Verification<\/span><\/strong><\/h2>\n

\u5b9e\u9a8c\u5ba4\u901a\u8fc7\u6838\u67e5\uff0c\u63d0\u4f9b\u5ba2\u89c2\u6709\u6548\u8bc1\u636e\u8bc1\u660e\u6ee1\u8db3\u65b9\u6cd5\u89c4\u5b9a\u7684\u8981\u6c42\u3002<\/span><\/h2>\n

  <\/h2>\n

3.\u5b9e\u9a8c\u5ba4\u5185\u65b9\u6cd5\u786e\u8ba4In-house Method Validation<\/span><\/strong><\/h2>\n

\u5728\u4e00\u4e2a\u5b9e\u9a8c\u5ba4\u5185\uff0c\u5728\u5408\u7406\u7684\u65f6\u95f4\u95f4\u9694\u5185\uff0c\u7528\u4e00\u79cd\u65b9\u6cd5\u5728\u9884\u5b9a\u6761\u4ef6\u4e0b\u5bf9\u76f8\u540c\u6216\u4e0d\u540c\u6d4b\u8bd5\u6837\u54c1\u8fdb\u884c\u7684\u5206\u6790\u5b9e\u9a8c\uff0c\u4ee5\u8bc1\u660e\u7279\u5b9a\u68c0\u6d4b\u65b9\u6cd5\u6ee1\u8db3\u9884\u671f\u7684\u7528\u9014\u3002<\/span><\/h2>\n

 <\/p>\n

4.\u5b9e\u9a8c\u5ba4\u95f4\u65b9\u6cd5\u786e\u8ba4Interlaboratory MethodValidation<\/span><\/strong><\/h2>\n

\u5728\u4e24\u4e2a\u6216\u591a\u4e2a\u5b9e\u9a8c\u5ba4\u4e4b\u95f4\u5b9e\u65bd\u7684\u65b9\u6cd5\u786e\u8ba4\u3002\u5b9e\u9a8c\u5ba4\u4f9d\u7167\u9884\u5b9a\u6761\u4ef6\u7528\u76f8\u540c\u65b9\u6cd5\u5bf9\u76f8\u540c\u6837\u54c1\u7684\u6d4b\u5b9a\uff0c\u4ee5\u8bc1\u660e\u7279\u5b9a\u68c0\u6d4b\u65b9\u6cd5\u6ee1\u8db3\u9884\u671f\u7684\u7528\u9014\u3002<\/span><\/h2>\n

 <\/p>\n

5.\u5b9a\u6027\u65b9\u6cd5Qualitative Method<\/span><\/strong><\/span><\/h2>\n

\u6839\u636e\u7269\u8d28\u7684\u5316\u5b66\u3001\u751f\u7269\u6216\u7269\u7406\u6027\u8d28\u5bf9\u5176\u8fdb\u884c\u9274\u5b9a\u7684\u5206\u6790\u65b9\u6cd5\u3002<\/span><\/h2>\n

 <\/p>\n

6.\u5b9a\u91cf\u65b9\u6cd5Quantitative Method<\/span><\/strong><\/span><\/h2>\n

\u6d4b\u5b9a\u88ab\u5206\u6790\u7269\u7684\u8d28\u91cf\u6216\u8d28\u91cf\u5206\u6570\u7684\u5206\u6790\u65b9\u6cd5\uff0c\u53ef\u7528\u9002\u5f53\u5355\u4f4d\u7684\u6570\u503c\u8868\u793a\u3002<\/span><\/h2>\n

 <\/h2>\n

7.\u786e\u8bc1\u65b9\u6cd5Confirmatory Method<\/span><\/strong><\/h2>\n

\u80fd\u63d0\u4f9b\u5168\u90e8\u6216\u90e8\u5206\u4fe1\u606f\uff0c\u5e76\u660e\u786e\u5b9a\u6027\uff0c\u5728\u5fc5\u8981\u65f6\u53ef\u5728\u5173\u6ce8\u7684\u6d53\u5ea6\u6c34\u5e73\u4e0a\u8fdb\u884c\u5b9a\u91cf\u7684\u65b9\u6cd5\u3002<\/span><\/h2>\n

 <\/p>\n

8.\u7b5b\u9009\u65b9\u6cd5Screening Method<\/span><\/strong><\/h2>\n

\u5177\u6709\u5904\u7406\u5927\u91cf\u6837\u54c1\u7684\u80fd\u529b\uff0c\u7528\u4e8e\u68c0\u6d4b\u4e00\u79cd\u7269\u8d28\u6216\u4e00\u7ec4\u7269\u8d28\u5728\u6240\u5173\u6ce8\u7684\u6d53\u5ea6\u6c34\u5e73\u4e0a\u662f\u5426\u5b58\u5728\u7684\u65b9\u6cd5\u3002\u8fd9\u4e9b\u65b9\u6cd5\u7528\u4e8e\u7b5b\u9009\u5927\u91cf\u6837\u54c1\u53ef\u80fd\u7684\u9633\u6027\u7ed3\u679c\uff0c\u5e76\u7528\u6765\u907f\u514d\u5047\u9634\u6027\u7ed3\u679c\u3002\u6b64\u7c7b\u65b9\u6cd5\u6240\u83b7\u5f97\u7684\u68c0\u6d4b\u7ed3\u679c\u901a\u5e38\u4e3a\u5b9a\u6027\u7ed3\u679c\u6216\u534a\u5b9a\u91cf\u7ed3\u679c\u3002<\/span><\/h2>\n

 <\/h2>\n

9.\u5bb9\u8bb8\u9650Permitted Limit\uff0cPL<\/span><\/strong><\/h2>\n

\u5bf9\u67d0\u4e00\u5b9a\u91cf\u7279\u6027\u89c4\u5b9a\u548c\u8981\u6c42\u7684\u7269\u8d28\u9650\u503c\uff0c\u5982\uff1a\u6700\u5927\u6b8b\u7559\u9650\u3001\u6700\u9ad8\u5141\u8bb8\u6d53\u5ea6\u6216\u5176\u5b83\u6700\u5927\u5bb9\u8bb8\u91cf\u7b49\u3002<\/span><\/h2>\n

 <\/h2>\n

10.\u5173\u6ce8\u6d53\u5ea6\u6c34\u5e73Level of Interest<\/span><\/strong><\/h2>\n

\u5bf9\u5224\u65ad\u6837\u54c1\u4e2d\u7269\u8d28\u6216\u5206\u6790\u7269\u662f\u5426\u7b26\u5408\u6cd5\u89c4\u89c4\u5b9a\u548c\u8981\u6c42\u7684\u6709\u51b3\u5b9a\u6027\u610f\u4e49\u7684\u6d53\u5ea6\uff08\u5982\uff1a\u5bb9\u8bb8\u9650\u6d53\u5ea6\uff09<\/span><\/h2>\n

 <\/h2>\n

11.\u9009\u62e9\u6027 Selectivity<\/span><\/strong><\/h2>\n

\u6d4b\u91cf\u7cfb\u7edf\u6309\u89c4\u5b9a\u7684\u6d4b\u91cf\u7a0b\u5e8f\u4f7f\u7528\u5e76\u63d0\u4f9b\u4e00\u4e2a\u6216\u591a\u4e2a\u88ab\u6d4b\u91cf\u7684\u6d4b\u5f97\u7684\u91cf\u503c\u65f6\uff0c\u6bcf\u4e2a\u88ab\u6d4b\u91cf\u7684\u503c\u4e0e\u5176\u4ed6\u88ab\u6d4b\u91cf\u6216\u6240\u7814\u7a76\u7684\u73b0\u8c61\u3001\u7269\u4f53\u6216\u7269\u8d28\u4e2d\u7684\u5176\u4ed6\u91cf\u65e0\u5173\u7684\u7279\u6027\u3002<\/span><\/h2>\n

  <\/h2>\n

12.\u57fa\u8d28\u6548\u5e94Matrix Effect<\/span><\/strong><\/h2>\n

\u5316\u5b66\u5206\u6790\u4e2d\uff0c\u57fa\u8d28\u6307\u7684\u662f\u6837\u54c1\u4e2d\u88ab\u5206\u6790\u7269\u4ee5\u5916\u7684\u7ec4\u5206\u3002\u57fa\u8d28\u5e38\u5e38\u5bf9\u5206\u6790\u7269\u7684\u5206\u6790\u8fc7\u7a0b\u6709\u663e\u8457\u7684\u5e72\u6270\uff0c\u5e76\u5f71\u54cd\u5206\u6790\u7ed3\u679c\u7684\u51c6\u786e\u6027\u3002\u4f8b\u5982\uff0c\u6eb6\u6db2\u7684\u79bb\u5b50\u5f3a\u5ea6\u4f1a\u5bf9\u5206\u6790\u7269\u6d3b\u5ea6\u7cfb\u6570\u6709\u5f71\u54cd\uff0c\u8fd9\u4e9b\u5f71\u54cd\u548c\u5e72\u6270\u88ab\u79f0\u4e3a\u57fa\u8d28\u6548\u5e94\u3002<\/span><\/h2>\n

 <\/h2>\n

13.\u7ebf\u6027\u8303\u56f4Linearity of Calibration<\/span><\/strong><\/h2>\n

\u5bf9\u4e8e\u5206\u6790\u65b9\u6cd5\u800c\u8a00\uff0c\u7528\u7ebf\u6027\u8ba1\u7b97\u6a21\u578b\u6765\u5b9a\u4e49\u4eea\u5668\u54cd\u5e94\u4e0e\u6d53\u5ea6\u7684\u5173\u7cfb\uff0c\u8be5\u8ba1\u7b97\u6a21\u578b\u7684\u5e94\u7528\u8303\u56f4\u3002<\/span><\/h2>\n

 <\/h2>\n

14.\u68c0\u51fa\u9650Limit of Detection\uff0cLOD<\/span><\/strong><\/h2>\n

\u7531\u7ed9\u5b9a\u6d4b\u91cf\u7a0b\u5e8f\u83b7\u5f97\u7684\u6d4b\u5f97\u7684\u91cf\u503c\uff0c\u5176\u5bf9\u7269\u8d28\u4e2d\u4e0d\u5b58\u5728\u67d0\u79cd\u6210\u5206\u7684\u8bef\u5224\u6982\u7387\u4e3ab\uff0c\u5bf9\u7269\u8d28\u4e2d\u5b58\u5728\u67d0\u79cd\u6210\u5206\u7684\u8bef\u5224\u6982\u7387\u4e3aa\u3002<\/span><\/h2>\n

\u6ce81\uff1a\u56fd\u9645\u7406\u8bba\u5316\u5b66\u548c\u5e94\u7528\u5316\u5b66\u8054\u5408\u4f1a\uff08IUPAC\uff09\u63a8\u8350a\u548cb\u7684\u9ed8\u8ba4\u503c\u4e3a0.05\u3002<\/span><\/h2>\n

\u6ce82\uff1a\u68c0\u51fa\u9650\u5f80\u5f80\u5206\u4e3a\u4e24\u79cd:\u65b9\u6cd5\u68c0\u51fa\u9650\u548c\u4eea\u5668\u68c0\u51fa\u9650<\/span><\/h2>\n

 <\/h2>\n

15.\u65b9\u6cd5\u68c0\u51fa\u9650\uff08Method Detection Limit\uff0cMDL\uff09<\/span><\/strong><\/h2>\n

\u7528\u7279\u5b9a\u65b9\u6cd5\u53ef\u9760\u5730\u5c06\u5206\u6790\u7269\u6d4b\u5b9a\u4fe1\u53f7\u4ece\u7279\u5b9a\u57fa\u4f53\u80cc\u666f\u4e2d\u8bc6\u522b\u6216\u533a\u5206\u51fa\u6765\u65f6\uff0c\u5206\u6790\u7269\u7684\u6700\u4f4e\u6d53\u5ea6\u6216\u6700\u4f4e\u91cf\u3002<\/span><\/h2>\n

 <\/h2>\n

16.\u4eea\u5668\u68c0\u51fa\u9650\uff08Instrumental Detection Limit\uff0cIDL\uff09<\/span><\/strong><\/h2>\n

\u4eea\u5668\u80fd\u53ef\u9760\u5730\u5c06\u5206\u6790\u7269\u4fe1\u53f7\u4ece\u4eea\u5668\u80cc\u666f\uff08\u566a\u97f3\uff09\u4e2d\u8bc6\u522b\u6216\u533a\u5206\u51fa\u6765\u65f6\u5206\u6790\u7269\u7684\u6700\u4f4e\u6d53\u5ea6\u6216\u6700\u4f4e\u91cf\u3002<\/span><\/h2>\n

 <\/h2>\n

17.\u5b9a\u91cf\u9650Limit of Quantification\uff0cLOQ<\/span><\/strong><\/span><\/h2>\n

\u6837\u54c1\u4e2d\u88ab\u6d4b\u7ec4\u5206\u80fd\u88ab\u5b9a\u91cf\u6d4b\u5b9a\u7684\u6700\u4f4e\u6d53\u5ea6\u6216\u6700\u4f4e\u91cf\uff0c\u6b64\u65f6\u7684\u5206\u6790\u7ed3\u679c\u5e94\u80fd\u786e\u4fdd\u4e00\u5b9a\u7684\u6b63\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6\u3002<\/span><\/h2>\n

 <\/h2>\n

18.\u7cbe\u5bc6\u5ea6 Precision<\/span><\/strong><\/h2>\n

\u5728\u89c4\u5b9a\u6761\u4ef6\u4e0b\uff0c\u5bf9\u540c\u4e00\u6216\u7c7b\u4f3c\u88ab\u6d4b\u5bf9\u8c61\u91cd\u590d\u6d4b\u91cf\u6240\u5f97\u793a\u503c\u6216\u6d4b\u5f97\u7684\u91cf\u503c\u95f4\u7684\u4e00\u81f4\u7a0b\u5ea6<\/span><\/h2>\n

 <\/h2>\n

19.\u7075\u654f\u5ea6 Sensitivity<\/span><\/strong><\/h2>\n

\u6d4b\u91cf\u7cfb\u7edf\u7684\u793a\u503c\u53d8\u5316\u9664\u4ee5\u76f8\u5e94\u88ab\u6d4b\u91cf\u7684\u91cf\u503c\u53d8\u5316\u6240\u5f97\u7684\u5546\u3002<\/span><\/h2>\n

\u6ce81\uff1a\u6d4b\u91cf\u7cfb\u7edf\u7684\u7075\u654f\u5ea6\u53ef\u80fd\u53d6\u51b3\u4e8e\u88ab\u6d4b\u91cf\u7684\u91cf\u503c\u3002<\/span><\/h2>\n

\u6ce82\uff1a\u6240\u8003\u8651\u7684\u88ab\u6d4b\u91cf\u7684\u91cf\u503c\u53d8\u5316\u5e94\u5927\u4e8e\u6d4b\u91cf\u7cfb\u7edf\u7684\u5206\u8fa8\u529b\u3002<\/span><\/h2>\n

  <\/h2>\n

20.\u6d4b\u91cf\u533a\u95f4 Measuringinterval<\/span><\/strong><\/h2>\n

\u5728\u89c4\u5b9a\u6761\u4ef6\u4e0b\uff0c\u7531\u5177\u6709\u4e00\u5b9a\u7684\u4eea\u5668\u7684\u6d4b\u91cf\u4e0d\u786e\u5b9a\u5ea6\u7684\u6d4b\u91cf\u4eea\u5668\u6216\u6d4b\u91cf\u7cfb\u7edf\u80fd\u591f\u6d4b\u91cf\u51fa\u7684\u4e00\u7ec4\u540c\u7c7b\u91cf\u7684\u91cf\u503c\u3002<\/span><\/h2>\n

\u6ce81\uff1a\u5728\u67d0\u4e9b\u9886\u57df\uff0c\u6b64\u672f\u8bed\u4e5f\u79f0\u201c\u6d4b\u91cf\u8303\u56f4\u201d\u3002<\/span><\/h2>\n

\u6ce82\uff1a\u6d4b\u91cf\u533a\u95f4\u7684\u4e0b\u9650\u4e0d\u5e94\u4e0e\u201c\u68c0\u51fa\u9650\u201d\u76f8\u6df7\u6dc6\u3002<\/span><\/h2>\n

  <\/h2>\n

21.\u91cd\u590d\u6027\u6d4b\u91cf\u6761\u4ef6 Repeatability Conditionof Measurement  <\/span><\/strong><\/h2>\n

\u76f8\u540c\u6d4b\u91cf\u7a0b\u5e8f\u3001\u76f8\u540c\u64cd\u4f5c\u8005\u3001\u76f8\u540c\u6d4b\u91cf\u7cfb\u7edf\u3001\u76f8\u540c\u64cd\u4f5c\u6761\u4ef6\u548c\u76f8\u540c\u5730\u70b9\uff0c\u5e76\u5728\u77ed\u65f6\u95f4\u5185\u5bf9\u540c\u4e00\u6216\u76f8\u7c7b\u4f3c\u7684\u88ab\u6d4b\u5bf9\u8c61\u91cd\u590d\u6d4b\u91cf\u7684\u4e00\u7ec4\u6d4b\u91cf\u6761\u4ef6<\/span><\/h2>\n

 <\/span><\/h2>\n

22.\u91cd\u590d\u6027 Repeatability<\/span><\/strong><\/h2>\n

\u5728\u4e00\u7ec4\u91cd\u590d\u6027\u6d4b\u91cf\u6761\u4ef6\u4e0b\u7684\u6d4b\u91cf\u7cbe\u5bc6\u5ea6\u3002<\/span><\/h2>\n

  <\/h2>\n

23.\u518d\u73b0\u6027\u6d4b\u91cf\u6761\u4ef6 Reproducibility Conditionof Measurement<\/span><\/strong><\/h2>\n

\u4e0d\u540c\u5730\u70b9\u3001\u4e0d\u540c\u64cd\u4f5c\u8005\u3001\u4e0d\u540c\u6d4b\u91cf\u7cfb\u7edf\uff0c\u5bf9\u540c\u4e00\u6216\u76f8\u7c7b\u4f3c\u88ab\u6d4b\u5bf9\u8c61\u91cd\u590d\u6d4b\u91cf\u7684\u4e00\u7ec4\u6d4b\u91cf\u6761\u4ef6\u3002<\/span><\/h2>\n

  <\/h2>\n

24.\u518d\u73b0\u6027 Reproducibility<\/span><\/strong><\/h2>\n

\u5728\u518d\u73b0\u6027\u6d4b\u91cf\u6761\u4ef6\u4e0b\u7684\u6d4b\u91cf\u7cbe\u5bc6\u5ea6\u3002<\/span><\/h2>\n

 <\/h2>\n

25.\u81ea\u7531\u5ea6 Degrees of Freedom<\/span><\/strong><\/span><\/h2>\n

\u548c\u7684\u9879\u6570\u51cf\u53bb\u548c\u4e2d\u8bf8\u9879\u6570\u7684\u7ea6\u675f\u6570\u3002<\/span><\/h2>\n

  <\/h2>\n

26.\u6b63\u786e\u5ea6 Trueness<\/span><\/strong><\/h2>\n

\u65e0\u7a77\u591a\u6b21\u91cd\u590d\u6d4b\u91cf\u6240\u5f97\u6d4b\u5f97\u7684\u91cf\u503c\u7684\u5e73\u5747\u503c\u4e0e\u4e00\u4e2a\u53c2\u8003\u91cf\u503c\u95f4\u7684\u4e00\u81f4\u7a0b\u5ea6\u3002<\/span><\/h2>\n

 <\/h2>\n

 27.\u504f\u501a bias<\/span><\/strong><\/h2>\n

\u7cfb\u7edf\u6d4b\u91cf\u8bef\u5dee\u7684\u4f30\u8ba1\u503c\u3002<\/span><\/h2>\n

 <\/h2>\n

28.\u6807\u51c6\u6dfb\u52a0Standard Addition<\/span><\/strong><\/h2>\n

\u6309\u7167\u540c\u4e00\u4e2a\u65b9\u6cd5\u5b9e\u65bd\u68c0\u6d4b\u65f6\uff0c\u5c06\u6d4b\u8bd5\u6837\u54c1\u5206\u6210\u4e24\u4e2a\u6216\u66f4\u591a\u90e8\u5206\u3002\u4e00\u90e8\u5206\u8fdb\u884c\u5e38\u89c4\u5206\u6790\uff0c\u5176\u5b83\u90e8\u5206\u5728\u5206\u6790\u524d\u52a0\u5165\u5df2\u77e5\u91cf\u7684\u6807\u51c6\u5206\u6790\u7269\u3002\u52a0\u5165\u7684\u6807\u51c6\u5206\u6790\u7269\u7684\u91cf\u5e94\u662f\u6837\u54c1\u4e2d\u5206\u6790\u7269\u4f30\u8ba1\u542b\u91cf\u76842\uff5e5\u500d\uff0c\u4e5f\u53ef\u4ee5\u662f\u6309\u7167\u65b9\u6cd5\u5b9a\u91cf\u9650\u3001\u5bb9\u8bb8\u9650\u7b49\u63a8\u7b97\u7684\u6807\u51c6\u5206\u6790\u7269\u7684\u91cf\u3002\u6807\u51c6\u6dfb\u52a0\u53ef\u7528\u4e8e\u8861\u91cf\u65b9\u6cd5\u56de\u6536\u7387\u53ef\u80fd\u53d7\u6d4b\u5b9a\u6837\u54c1\u4e2d\u5206\u6790\u7269\u7684\u542b\u91cf\u548c\u57fa\u8d28\u7b49\u56e0\u7d20\u5f71\u54cd\uff0c\u4e5f\u53ef\u7528\u4e8e\u8bc4\u4f30\u5728\u5b9a\u91cf\u9650\u3001\u5bb9\u8bb8\u9650\u7b49\u6c34\u5e73\u4e0a\u7684\u6b63\u786e\u5ea6\u3002<\/span><\/h2>\n

 <\/h2>\n

29.\u56de\u6536\u7387Recovery<\/span><\/strong><\/h2>\n

\u5c06\u5df2\u77e5\u6d53\u5ea6\u7684\u5206\u6790\u7269\u52a0\u5230\u6837\u54c1\u4e2d\uff0c\u6309\u7167\u9884\u5b9a\u7684\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u68c0\u6d4b\uff0c\u6d4b\u5f97\u7684\u5b9e\u9645\u6d53\u5ea6\u51cf\u53bb\u539f\u5148\u672a\u6dfb\u52a0\u5206\u6790\u7269\u65f6\u6837\u54c1\u7684\u6d4b\u5b9a\u6d53\u5ea6\uff0c\u5e76\u9664\u4ee5\u6240\u6dfb\u52a0\u6d53\u5ea6\u7684\u767e\u5206\u7387\u3002<\/span><\/h2>\n

\u6ce81\uff1a\u5728\u6ca1\u6709\u6709\u8bc1\u6807\u51c6\u7269\u8d28\u7684\u60c5\u51b5\u4e0b\uff0c\u56de\u6536\u7387\u53ef\u7528\u4e8e\u65b9\u6cd5\u786e\u8ba4\u8fc7\u7a0b\u3002<\/span><\/h2>\n

\u6ce82\uff1a\u5b9a\u4e49\u4e2d\u7684\u6dfb\u52a0\u6d53\u5ea6\u4e3a\u6dfb\u52a0\u7269\u5728\u6837\u54c1\u4e2d\u7684\u8ba1\u7b97\u6d53\u5ea6\u3002<\/span><\/h2>\n

 <\/h2>\n

30.\u51c6\u786e\u5ea6 Accuracy<\/span><\/strong><\/h2>\n

\u88ab\u6d4b\u91cf\u7684\u6d4b\u5f97\u7684\u91cf\u503c\u4e0e\u5176\u771f\u503c\u95f4\u7684\u4e00\u81f4\u7a0b\u5ea6\u3002<\/span><\/h2>\n

\u6ce81\uff1a\u6982\u5ff5\u201c\u6d4b\u91cf\u51c6\u786e\u5ea6\u201d\u4e0d\u662f\u4e00\u4e2a\u91cf\uff0c\u4e5f\u4e0d\u7ed9\u51fa\u91cf\u7684\u6570\u503c\u3002\u5f53\u6d4b\u91cf\u7ed9\u51fa\u8f83\u5c0f\u7684\u6d4b\u91cf\u8bef\u5dee\u65f6\uff0c\u8be5\u6d4b\u91cf\u66f4\u51c6\u786e\u3002<\/span><\/h2>\n

\u6ce82\uff1a\u672f\u8bed\u201c\u6d4b\u91cf\u51c6\u786e\u5ea6\u201d\u4e0d\u5e94\u7528\u4e8e\u8868\u793a\u201c\u6d4b\u91cf\u6b63\u786e\u5ea6\u201d\uff0c\u201c\u6d4b\u91cf\u7cbe\u5bc6\u5ea6\u201d\u4e0d\u5e94\u7528\u4e8e\u8868\u793a\u201c\u6d4b\u91cf\u51c6\u786e\u5ea6\u201d\uff0c\u5c3d\u7ba1\u6d4b\u91cf\u51c6\u786e\u5ea6\u4e0e\u8fd9\u4e24\u4e2a\u6982\u5ff5\u6709\u5173\u3002<\/span><\/h2>\n

\u6ce83\uff1a\u6d4b\u91cf\u51c6\u786e\u5ea6\u6709\u65f6\u88ab\u7406\u89e3\u4e3a\u8d4b\u4e88\u88ab\u6d4b\u91cf\u7684\u6d4b\u5f97\u7684\u91cf\u503c\u4e4b\u95f4\u7684\u4e00\u81f4\u7a0b\u5ea6\u3002
<\/span><\/h2>\n

 <\/p>\n

31.\u7a33\u5065\u5ea6Ruggedness<\/span><\/strong><\/h2>\n

\u5b9e\u9a8c\u6761\u4ef6\u53d8\u5316\u5bf9\u5206\u6790\u65b9\u6cd5\u7684\u5f71\u54cd\u7a0b\u5ea6\u3002\u8fd9\u4e9b\u6761\u4ef6\u5728\u65b9\u6cd5\u4e2d\u89c4\u5b9a\uff0c\u6216\u6839\u636e\u89c4\u5b9a\u7a0d\u52a0\u6539\u52a8\uff0c\u5305\u62ec\u6837\u54c1\u79cd\u7c7b\u3001\u57fa\u8d28\u3001\u4fdd\u5b58\u6761\u4ef6\u3001\u73af\u5883\u6216\u6837\u54c1\u5236\u5907\u6761\u4ef6\u7b49\u3002\u6240\u6709\u5728\u5b9e\u8df5\u4e2d\u53ef\u80fd\u5f71\u54cd\u5206\u6790\u7ed3\u679c\u7684\u5b9e\u9a8c\u6761\u4ef6\uff08\u4f8b\u5982\uff0c\u8bd5\u5242\u7a33\u5b9a\u6027\u3001\u6837\u54c1\u7ec4\u6210\u3001pH\u3001\u6e29\u5ea6\u7b49\uff09\u7684\u4efb\u4f55\u53d8\u5316\u90fd\u5e94\u5f53\u6307\u660e\u3002<\/span><\/h2>\n


<\/p>\n

<\/span><\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/p>\n

<\/p>\n
\u7248\u6743\u58f0\u660e<\/strong><\/section>\n

<\/span><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/section>\n


<\/p>\n

\n
\n
\n
\n

<\/span>\u514d\u8d23\u58f0\u660e\uff1a\u6587\u7ae0<\/span>\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\u3002\u5982\u6d89\u53ca\u4f5c\u54c1\u5185\u5bb9\u3001\u7248\u6743\u548c\u5176\u5b83\u95ee\u9898\uff0c\u8bf7\u8ddf\u6211\u4eec\u8054\u7cfb\u5220\u9664\uff01\u6587\u7ae0\u5185\u5bb9\u4e3a\u4f5c\u8005\u4e2a\u4eba\u89c2\u70b9,\u5e76\u4e0d\u4ee3\u8868\u672c\u516c\u4f17\u53f7\u8d5e\u540c\u6216\u652f\u6301\u5176\u89c2\u70b9\u3002\u672c\u516c\u4f17\u53f7\u62e5\u6709\u5bf9\u6b64\u58f0\u660e\u7684\u6700\u7ec8\u89e3\u91ca\u6743\u3002<\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n

   \u5728\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u8f6c\u79fb\u786e\u8ba4\u4e2d\u5927\u5bb6\u9047\u5230\u7684\u95ee\u9898\uff0c\u8fd9\u91cc\u5c0f\u7f16\u4e3a\u5927\u5bb6\u63a8\u8350\u4e00\u4e2a\u4f1a\u8bae\uff0c\u80fd\u591f\u89e3\u51b3\u60a8\u7684\u7591\u95ee\uff01\uff01\uff01<\/span><\/p>\n


<\/p>\n<\/h2>\n


<\/p>\n


<\/p>\n

\n
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8\u67084\u65e5<\/span><\/strong>(\u661f\u671f\u516d)<\/span><\/strong>9:00-<\/span><\/strong>12:00 <\/span><\/strong>13:30-16:30<\/span><\/strong><\/span><\/p>\n

\u4e00\u3001\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb<\/span><\/span><\/strong><\/p>\n

1.<\/span><\/strong>\u6cd5\u89c4\u5bf9\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u6709\u4ec0\u4e48\u8981\u6c42\uff1f<\/span><\/span><\/strong><\/p>\n

ICH\u6307\u5bfc\u539f\u5219\u4e2d\u5bf9\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u8981\u6c42<\/span><\/p>\n

FDA\u6709\u54ea\u4e9b\u6587\u4ef6\u6765\u6307\u5bfc\u6211\u4eec\u8fdb\u884c\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb<\/span><\/p>\n

WHO\u6709\u4ec0\u4e48\u8981\u6c42<\/span><\/p>\n

USP\u7684\u5177\u4f53\u8981\u6c42\u6709\u54ea\u4e9b<\/span><\/p>\n

\u65b0\u7248\u836f\u5178\u7684\u8981\u6c42<\/span><\/span><\/p>\n

FDA\u7684\u8b66\u544a\u4fe1\u4e2d\u5982\u4f55\u5f3a\u8c03\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u91cd\u8981\u6027<\/span><\/p>\n

2.<\/span><\/strong>\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u53ef\u4ee5\u9009\u62e9\u7684\u65b9\u6848\u6709\u54ea\u4e9b\uff1f<\/span><\/span><\/strong><\/p>\n

\u5bf9\u540c\u4e00\u6279\u6837\u54c1\u5728\u8f6c\u79fb\u548c\u88ab\u8f6c\u79fb\u65b9\u8fdb\u884c\u540c\u65f6\u68c0\u9a8c\uff0c\u8fdb\u884c\u7ed3\u679c\u6bd4\u8f83<\/span><\/span><\/p>\n

\u53cc\u65b9\u8bd5\u9a8c\u5ba4\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u5171\u540c\u9a8c\u8bc1<\/span><\/span><\/p>\n

\u88ab\u8f6c\u79fb\u65b9\u5b9e\u9a8c\u5ba4\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u90e8\u5206\u6216\u5168\u9a8c\u8bc1<\/span><\/span><\/p>\n

\u4ec0\u4e48\u6761\u4ef6\u4e0b\u5206\u6790\u65b9\u6cd5\u65e0\u9700\u8f6c\u79fb\u8fc7\u7a0b<\/span><\/span><\/p>\n

3.<\/span><\/strong>\u5e38\u89c1\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u79cd\u7c7b\u4ee5\u53ca\u5728\u8f6c\u79fb\u8fc7\u7a0b\u4e2d\u7684\u6ce8\u610f\u4e8b\u9879<\/span><\/span><\/strong><\/p>\n

\u542b\u91cf\u7c7b\u5305\u62ec\u6eb6\u51fa\u7684\u8f6c\u79fb<\/span><\/span><\/p>\n

\u6709\u5173\u7269\u8d28\u65b9\u6cd5\u7684\u8f6c\u79fb\uff0c\u5206\u9650\u5ea6\u6cd5\u8f6c\u79fb\u548c\u5b9a\u91cf\u6cd5\u8f6c\u79fb<\/span><\/span><\/p>\n

\u8f6c\u79fb\u6837\u54c1\u7684\u9009\u62e9<\/span><\/span><\/p>\n

\u8f6c\u79fb\u65b9\u6848\u548c\u62a5\u544a\u7684\u4e66\u5199<\/span><\/span><\/p>\n

\u51fa\u73b0\u504f\u5dee\u6216\u6ca1\u6709\u8fbe\u5230\u9884\u671f\u8bbe\u5b9a\u7684\u63a5\u53d7\u6807\u51c6\u600e\u4e48\u529e<\/span><\/span><\/p>\n

4.<\/span><\/strong>\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u5b9e\u4f8b\u8bf4\u660e<\/span><\/span><\/strong><\/p>\n

\u516c\u53f8\u8f6c\u79fb<\/span>SOP\u7684\u5236\u5b9a<\/span><\/p>\n

\u65f6\u95f4\u7d27\u8feb\u7684\u6761\u4ef6\u4e0b\u65b9\u6cd5\u8f6c\u79fb\u5b9e\u4f8b<\/span><\/span><\/p>\n

\u5bf9\u65b9\u5b9e\u9a8c\u5ba4\u4eba\u624b\u548c\u7ecf\u9a8c\u4e0d\u8db3\u7684\u65b9\u6cd5\u8f6c\u79fb\u4e3e\u4f8b<\/span><\/span><\/p>\n

\u8f6c\u79fb\u5931\u8d25\u5b9e\u4f8b\u8bf4\u660e<\/span><\/span><\/p>\n

\u4e8c\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u548c\u786e\u8ba4<\/span><\/span><\/strong><\/p>\n

1\u56fd\u5bb6\u6807\u51c6GB\/T\u300a\u5408\u683c\u8bc4\u5b9a \u5316\u5b66\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u548c\u9a8c\u8bc1\u6307\u5357\u300b\u89e3\u8bfb<\/span><\/p>\n

2\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\u548c\u786e\u8ba4\u7684\u9002\u7528\u8303\u56f4\u3001\u76ee\u7684\u548c\u53d1\u8d77\u65f6\u673a\uff0c\u603b\u4f53\u8981\u6c42\uff1b<\/span><\/p>\n

3\u54ea\u4e9b\u65b9\u6cd5\u505a\u9a8c\u8bc1\uff0c\u54ea\u4e9b\u65b9\u6cd5\u505a\u786e\u8ba4\uff1f<\/span><\/p>\n

4\u836f\u5178\u6807\u51c6\u65b9\u6cd5\u662f\u5426\u6bcf\u4e2a\u7269\u6599\u7684\u68c0\u9a8c\u9879\u76ee\u90fd\u8981\u9a8c\u8bc1\u6216\u786e\u8ba4\uff1f<\/span><\/p>\n

5\u65b9\u6cd5\u786e\u8ba4\u5e94\u8be5\u600e\u4e48\u505a\uff1f<\/span><\/p>\n

\u4e09\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u3001\u65b9\u6cd5\u8f6c\u79fb\u548c\u65b9\u6cd5\u786e\u8ba4\u7684\u8054\u7cfb\u548c\u533a\u522b<\/span><\/span><\/strong><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a\u738b\u8001\u5e08<\/span>  \u6c5f\u82cf\u7701\u98df\u54c1\u836f\u54c1\u68c0\u9a8c\u9662\u526f\u9662\u957f\uff0c\u535a\u58eb\uff0c\u4e3b\u4efb\u836f\u5e08\uff0c\u4e2d\u56fd\u836f\u5178\u7406\u5316\u4e13\u4e1a\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u4e2d\u56fd\u836f\u5927\u517c\u804c\u6559\u6388\uff0c\u535a\u5bfc\u3002\u4e3b\u6301\u5b8c\u6210\u591a\u9879\u56fd\u5bb6\u79d1\u6280\u652f\u6491\u8ba1\u5212\u548c\u81ea\u7136\u79d1\u5b66\u57fa\u91d1\u7b49\u8bfe\u9898\uff0c\u53d1\u8868\u8bba\u6587\u4e00\u767e\u4f59\u7bc7\uff1b\u4e3b\u7f16\u4e13\u8457\u300a\u836f\u54c1\u68c0\u9a8c\u300b\u4e00\u90e8\uff0c\u53c2\u7f16\u4e13\u8457\u6570\u90e8\u3002<\/span><\/span><\/strong><\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/section>\n<\/section>\n<\/section>\n
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8\u67085\u65e5<\/span><\/strong>(\u661f\u671f\u65e5)<\/span><\/strong>9:00-12:00  <\/span><\/strong>1<\/span><\/strong>3<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0-1<\/span><\/strong>6<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0<\/span><\/strong><\/p>\n

\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u6cd5\u89c4\u8981\u6c42<\/span><\/span><\/strong><\/p>\n

1\u65b9\u6cd5\u9a8c\u8bc1\u9075\u5faa\u7684\u6cd5\u89c4<\/span><\/p>\n

2\u5efa\u7acb\u8d28\u91cf\u6807\u51c6\u65f6\u65b9\u6cd5\u7684\u9a8c\u8bc1<\/span><\/p>\n

3\u751f\u4ea7\u5de5\u827a\u53d8\u66f4\u3001\u5236\u5242\u7ec4\u5206\u53d8\u66f4\u3001\u5206\u6790\u65b9\u6cd5\u4fee\u8ba2\u65f6\u7684\u9a8c\u8bc1<\/span><\/p>\n

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\u4e09\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/strong><\/span><\/p>\n

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\u56db\u3001\u8054\u7cfb\u65b9\u5f0f<\/span> <\/span><\/span><\/strong><\/p>\n

\u8054<\/span> \u7cfb<\/span> \u4eba\uff1a\u6f58\u6613<\/span>      panyi2010@126.com   <\/span><\/span><\/strong><\/p>\n

   \u7535    \u8bdd\uff1a13522766753 \uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/span><\/strong><\/p>\n


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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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