{"id":5791,"date":"2018-06-12T01:00:00","date_gmt":"2018-07-27T08:46:20","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e6%b5%85%e6%9e%90%e7%a8%b3%e5%ae%9a%e6%80%a7%e8%af%95%e9%aa%8c%e4%b8%adoot%e7%9a%84%e7%a1%ae%e8%ae%a4%e6%96%b9%e6%b3%95\/"},"modified":"2018-07-27T16:46:23","modified_gmt":"2018-07-27T08:46:23","slug":"%e6%b5%85%e6%9e%90%e7%a8%b3%e5%ae%9a%e6%80%a7%e8%af%95%e9%aa%8c%e4%b8%adoot%e7%9a%84%e7%a1%ae%e8%ae%a4%e6%96%b9%e6%b3%95","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/5791\/","title":{"rendered":"\u6d45\u6790\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5"},"content":{"rendered":"
\n

\"\u6d45\u6790\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5\"<\/p>\n

\u258d<\/span><\/strong><\/span><\/strong><\/span>\u6765\u6e90\uff1a\u592a\u9633\u6797<\/span><\/span><\/p>\n

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

\n
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\"\u6d45\u6790\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5\"<\/section>\n
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\u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1\u7406\u8d44\u6df1\u4e13\u5bb6\uff0c\u591a\u5bb6\u5236\u836f\u516c\u53f8\u987e\u95ee\uff0c\u836f\u5b66\u7855\u58eb\u3002\u56fd\u5bb6\u5de5\u827a\u6838\u5bf9\u672a\u96e8\u7ef8\u7f2a\u4e4b\u9645\uff0c\u6210\u529f\u89e3\u51b3\u4e86\u591a\u5bb6\u5728\u4ea7\u4ea7\u54c1\u5904\u65b9\u3001\u5de5\u827a\u95ee\u9898\u3002\u5904\u65b9\u5de5\u827a\u7684\u4e8c\u6b21\u5f00\u53d1\uff0c\u514d\u8d39\u54a8\u8be2\uff0c\u5168\u7a0b\u4fdd\u5bc6\u3002\u90ae\u7bb1\uff1a1193686015@qq.com\u3002<\/span><\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n

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


<\/em><\/p>\n

1 OOT \u7b80\u4ecb<\/strong><\/p>\n

1.1 OOT\u7684\u5b9a\u4e49<\/strong><\/p>\n

OOT\uff08Out of Trend\uff09\u7ed3\u679c\uff0c\u53c8\u79f0\u4e3a\u8d85\u8d8b\u52bf\u7ed3\u679c\uff0c\u662f\u6307\u8d85\u51fa\u4e86\u7cfb\u7edf\u8d8b\u52bf\u4f46\u4ecd\u5728\u8d28\u91cf\u6807\u51c6\u9650\u5ea6\u5185\u7684\u7ed3\u679c\u3002\u5728\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2d\uff0c\u7cfb\u7edf\u8d8b\u52bf\u662f\u6307\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7ed3\u679c\u7684\u6b63\u5e38\u6ce2<\/p>\n

\u52a8\u8303\u56f4\u3002\u800c\u7cfb\u7edf\u8d8b\u52bf\u7684\u5efa\u7acb\u65e2\u53ef\u901a\u8fc7\u4e0e\u5176\u4ed6\u6279\u6b21\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7ed3\u679c\u7684\u6bd4\u8f83\u800c\u5f97\uff0c\u4e5f\u53ef\u7ecf\u5bf9\u5148\u524d\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7ed3\u679c\u7684\u5206\u6790\u800c\u5f97\u3002<\/p>\n

1.2 OOT\u4e0eOOS\u7684\u533a\u522b<\/strong><\/p>\n

\u6839\u636eICH\u7684\u5b9a\u4e49\uff0c\u504f\u5dee\uff08Deviation\uff09\u662f\u6307\u5bf9\u6279\u51c6\u6307\u4ee4\uff08\u751f\u4ea7\u5de5\u827a\u89c4\u7a0b\u3001\u5c97\u4f4d\u64cd\u4f5c\u6cd5\u548c\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\u7b49\uff09\u6216\u89c4\u5b9a\u6807\u51c6\u7684\u4efb\u4f55\u504f\u79bb [1] \u3002OOT\u7ed3\u679c\u548cOOS\u7ed3\u679c\u5747\u5c5e\u504f\u5dee\uff0c\u4f46\u4e24\u8005\u504f\u79bb\u7a0b\u5ea6\u4e0d\u540c\u3002OOS \u7ed3\u679c\u662f\u6307\u5728\u68c0\u9a8c\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u7684\u4efb\u4f55\u504f\u79bb\u6807\u51c6\uff08\u5305\u62ec\u836f\u54c1\u7533\u62a5\u6807\u51c6\u3001DMF\u4e2d\u7533\u62a5\u6807\u51c6\u3001\u836f\u5178\u6807\u51c6\u548c\u4f01\u4e1a\u5185\u63a7\u6807\u51c6\uff09\u7684\u7ed3\u679c [2] \uff1b\u800cOOT\u7ed3\u679c\u5219\u5c5e\u8d85\u51fa\u4e86\u6b63\u5e38\u6ce2\u52a8\u8303\u56f4\u4f46\u672a\u504f\u79bb\u4efb\u4f55\u6807\u51c6\u3002\u6545OOT\u7ed3\u679c\u4e0eOOS\u7ed3\u679c\u7684\u672c\u8d28\u533a\u522b\u5728\u4e8e\u662f\u5426\u504f\u79bb\u4e86\u4efb\u4f55\u6807\u51c6\u3002<\/p>\n

1.3 OOT\u786e\u8ba4\u7684\u5fc5\u8981\u6027<\/strong><\/p>\n

\u5982\u4eca\uff0cOOT\u95ee\u9898\u8d8a\u6765\u8d8a\u5f97\u5230\u5404\u56fd\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u5236\u836f\u754c\u7684\u5173\u6ce8\u3002\u65e0\u8bba\u4ece\u76d1\u7ba1\u89d2\u5ea6\u8fd8\u662f\u5546\u4e1a\u89d2\u5ea6\uff0c\u786e\u8ba4\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2d\u7684OOT\u7ed3\u679c\u5747\u662f\u5341\u5206\u6709\u5fc5\u8981\u7684\uff1a\u4ece\u76d1\u7ba1\u89d2\u5ea6\u6765\u770b\uff0cFDA\u6307\u51faOOT\u7ed3\u679c\u7684\u786e\u8ba4\u5df2\u7ecf\u6210\u4e3a\u4e0a\u5e02\u836f\u54c1\u76d1\u6d4b\u7684\u91cd\u8981\u90e8\u5206\uff0c\u73b0\u5df2\u6709\u591a\u5bb6\u5236\u836f\u4f01\u4e1a\u63a5\u5230FDA\u7684483\u8868\u683c\u8981\u6c42\u5176\u5efa\u7acb\u5173\u4e8e\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7ed3\u679c\u7684\u786e\u8ba4\u548c\u8c03\u67e5\u7684\u4e66\u9762\u6587\u4ef6 [3] \u3002<\/p>\n

\u6b64\u5916\uff0cFDA\u53d1\u5e03\u4e86OOS\u8c03\u67e5\u7684\u5de5\u4e1a\u6307\u5357\uff0c\u8981\u6c42\u5236\u836f\u4f01\u4e1a\u5728\u8bc4\u4ef7\u5206\u6790\u7ed3\u679c\u548c\u6279\u653e\u884c\u51b3\u5b9a\u65f6\u5e94\u5f53\u8003\u8651\u4ea7\u54c1\u7684\u5386\u53f2\u6570\u636e\uff0c\u5e76\u5728\u6b64\u57fa\u7840\u4e0a\u8fdb\u884c\u8d8b\u52bf\u5206\u6790\u4ee5\u9884\u6d4b\u672a\u6765OOS\u7ed3\u679c\u7684\u53ef\u80fd\u6027 [4] \u3002<\/p>\n

\u4ece\u5546\u4e1a\u89d2\u5ea6\u6765\u770b\uff0c\u5bf9\u7a33\u5b9a\u6027\u6570\u636e\u8fdb\u884cOOT\u786e\u8ba4\u6709\u7740\u91cd\u8981\u7684\u5546\u4e1a\u610f\u4e49\u3002\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u5728\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u65f6\u53ef\u4ee5\u4f5c\u4e3a\u8bc1\u660e\u4ea7\u54c1\u6709\u6548\u671f\u7684\u4f9d\u636e\u3002\u6b64\u5916\uff0c\u8bb8\u591a\u516c\u53f8\u5229\u7528\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u5236\u5b9a\u4ea7\u54c1\u7684\u5185\u63a7\u6807\u51c6\uff0c\u786e\u4fdd\u5728\u6574\u4e2a\u6709\u6548\u671f\u5185\u59cb\u7ec8\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u3002\u6b64\u65f6\u7a33\u5b9a\u6027\u6570\u636e\u5c31\u7528\u4e8e\u4f30\u8ba1\u4ea7\u54c1\u5728\u6709\u6548\u671f\u5185\u8d28\u91cf\u53d8\u5316\uff0c\u4e0d\u540c\u6279\u6b21\u76f8\u540c\u4ea7\u54c1\u8d28\u91cf\u7684\u4e00\u81f4\u6027\u548c\u542b\u91cf\u7684\u53d8\u5f02\u6027\u3002\u56e0\u6b64\uff0c\u786e\u8ba4\u4efb\u4f55\u504f\u79bb\u9884\u671f\u8d8b\u52bf\u4e4b\u5916\u7684\u6570\u636e\u5c31\u53d8\u5f97\u975e\u5e38\u6709\u5fc5\u8981\uff0c\u56e0\u4e3aOOT\u6570\u636e\u5fc5\u5c06\u5bf9\u6240\u8981\u8fdb\u884c\u7684\u76f8\u5173\u8ba1\u7b97\u4ea7\u751f\u91cd\u5927\u5f71\u54cd\uff0c\u4f7f\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u5404\u9879\u5e94\u7528\u7684\u6548\u679c\u5927\u6253\u6298\u6263\u3002<\/p>\n

2 OOT \u786e\u8ba4\u6982\u8ff0<\/strong><\/p>\n

2.1 OOT\u786e\u8ba4\u65b9\u6cd5\u5b66<\/strong><\/p>\n

OOT\u786e\u8ba4\u9996\u5148\u9700\u8981\u89e3\u51b3\u7684\u662f\u786e\u8ba4\u6807\u51c6\u7684\u95ee\u9898\uff0c\u786e\u5b9a\u5982\u4f55\u8fdb\u884c\u6570\u636e\u5bf9\u6bd4\u4ece\u800c\u5f97\u51fa\u4f55\u4e3a\u9884\u671f\u7ed3\u679c\u3002\u76ee\u524d\uff0c\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7684OOT\u786e\u8ba4\u7684\u57fa\u672c\u65b9\u6cd5\u6709\u4e24\u79cd\uff1a\u4e00\u79cd\u4e3a\u6279\u5185\u6bd4\u8f83\u6cd5\uff0c\u662f\u901a\u8fc7\u5bf9\u6bd4\u540c\u4e00\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6279\u6b21\u7684\u7ed3\u679c\uff0c\u4ee5\u5224\u65ad\u8be5\u6279\u8be5\u65f6\u95f4\u70b9\u7684\u7ed3\u679c\u4e0e\u5148\u524d\u65f6\u95f4\u70b9\u7684\u7ed3\u679c\u662f\u5426\u6709\u76f8\u540c\u7684\u8d8b\u52bf\uff1b\u53e6\u4e00\u79cd\u4e3a\u6279\u95f4\u6bd4\u8f83\u6cd5\uff0c\u662f\u901a\u8fc7\u5bf9\u6bd4\u4ee5\u5f80\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6279\u6b21\u7684\u7ed3\u679c\uff0c\u4ee5\u5224\u65ad\u8be5\u6279\u5728\u5404\u65f6\u95f4\u70b9\u7684\u7ed3\u679c\u4e0e\u540c\u4e00\u4ea7\u54c1\u7684\u5176\u4ed6\u6279\u6b21\u5728\u76f8\u5e94\u65f6\u95f4\u70b9\u7684\u7ed3\u679c\u662f\u5426\u6709\u76f8\u540c\u7684\u8d8b\u52bf\u3002\u8fd9\u4e24\u79cdOOT\u786e\u8ba4\u7684\u57fa\u672c\u65b9\u6cd5\u6240\u9700\u91c7\u7528\u7684\u7edf\u8ba1\u65b9\u6cd5\u5404\u4e0d\u76f8\u540c\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u6279\u5185\u6bd4\u8f83\u6cd5\u6bd4\u6279\u95f4\u6bd4\u8f83\u6cd5\u5728\u5b9e\u9645\u64cd\u4f5c\u8fc7\u7a0b\u4e2d\u7684\u5e94\u7528\u96be\u5ea6\u66f4\u5927\uff0c\u56e0\u4e3a\u4e00\u822c\u6279\u5185\u6bd4\u8f83\u65f6\u6240\u80fd\u53c2\u8003\u7684\u6570\u636e\u76f8\u5bf9\u8f83\u5c11\uff0c\u5c24\u5176\u662f\u5bf9\u4e8e\u5904\u4e8e\u7a33\u5b9a\u6027\u8bd5\u9a8c\u524d\u671f\u7684\u6570\u636e\u70b9\u3002\u76ee\u524d\uff0cOOT\u786e\u8ba4\u4e2d\u662f\u4f18\u5148\u91c7\u7528\u6279\u5185\u6bd4\u8f83\u6cd5\u8fd8\u662f\u6279\u95f4\u6bd4\u8f83\u6cd5\u5c1a\u672a\u8fbe\u6210\u5171\u8bc6\uff0c\u5b9e\u9645\u5e94\u7528\u7684\u8fc7\u7a0b\u4e2d\u5e94\u89c6\u5177\u4f53\u60c5\u51b5\u800c\u5b9a\u3002<\/p>\n

2.2 \u73b0\u6709\u65b9\u6cd5\u6982\u8ff0<\/strong><\/p>\n

\u76ee\u524d\u5728\u836f\u54c1\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2d\u5e7f\u6cdb\u4f7f\u7528\u7684\u7528\u4e8e\u786e\u8ba4OOT\u7ed3\u679c\u7684\u65b9\u6cd5\u5305\u62ec\uff1a\uff081\uff09\u8fde\u7eed\u4e09\u4e2a\u7ed3\u679c\u8d85\u51fa\u67d0\u4e00\u9650\u5ea6\uff1b\uff082\uff09\u8fde\u7eed\u7ed3\u679c\u4e4b\u95f4\u7684\u5dee\u5f02\u8d85\u8fc7\u4e86\u5148\u524d\u7ed3\u679c\u4e0e\u8d28\u91cf\u6807\u51c6\u5dee\u5f02\u7684\u4e00\u534a\uff1b\uff083\uff09\u7ed3\u679c\u8d85\u51fa\u4e86\u6700\u521d\u7ed3\u679c\u7684\u00b15\uff05\uff1b\uff084\uff09\u7ed3\u679c\u8d85\u51fa\u4e86\u4e4b\u524d\u7ed3\u679c\u76843\uff05\uff1b\uff085\uff09\u7ed3\u679c\u8d85\u51fa\u4e86\u4e4b\u524d\u6240\u6709\u7ed3\u679c\u5e73\u5747\u503c\u7684\u00b15\uff05 [3] \u3002<\/p>\n

\u4ee5\u4e0a\u7684\u4f18\u70b9\u5728\u4e8e\u6613\u4e8e\u7406\u89e3\u548c\u5e94\u7528\uff0c\u5e76\u4e14\u901a\u5e38\u65e0\u9700\u5bf9\u6bcf\u4e00\u65f6\u95f4\u70b9\u5747\u8bbe\u5b9a\u76f8\u5e94\u7684\u9650\u5ea6\u3002\u4f46\u662f\uff0c\u8fd9\u4e9b\u65b9\u6cd5\u7684\u6700\u5927\u7f3a\u9677\u5728\u4e8e\u7f3a\u4e4f\u7edf\u8ba1\u5b66\u7406\u8bba\u4f9d\u636e\uff0cOOT\u786e\u8ba4\u6807\u51c6\u7684\u5236\u5b9a\u8fc7\u4e8e\u7ecf\u9a8c\u5316\u3002\u6b64\u5916\uff0cOOT\u7684\u786e\u8ba4\u6807\u51c6\u8fd8\u4f1a\u968f\u7279\u6b8a\u60c5\u51b5\u7684\u6570\u636e\u7684\u53d8\u5316\u800c\u53d8\u5316\uff0c\u7f3a\u4e4f\u4e00\u5b9a\u7684\u7a33\u5b9a\u6027\uff0c\u53ef\u80fd\u4f1a\u5bfc\u81f4\u9ad8\u53d8\u5f02\u6027\u6570\u636e\u5bb9\u6613\u51fa\u73b0\u5047\u9633\u6027OOT\u7ed3\u679c\uff0c\u800c\u4f4e\u53d8\u5f02\u6027\u6570\u636e\u5bb9\u6613\u51fa\u73b0\u5047\u9634\u6027OOT\u7ed3\u679c\u3002\u4e0d\u4ec5\u5982\u6b64\uff0c\u5176\u4e2d\u90e8\u5206\u65b9\u6cd5\u662f\u5c06\u73b0\u5728\u7ed3\u679c\u4e0e\u53e6\u4e00\u53c2\u7167\u7ed3\u679c\u8fdb\u884c\u6bd4\u8f83\u3002<\/p>\n

\u5982\u679c\u53c2\u7167\u7ed3\u679c\u4e0d\u51c6\u786e\uff0c\u8fd9\u6837\u7684\u6bd4\u8f83\u53ef\u80fd\u4e0d\u80fd\u51c6\u786e\u53cd\u6620\u73b0\u5728\u7ed3\u679c\u662f\u5426\u4e3aOOT\u3002\u56e0\u6b64\uff0c\u5bf9\u4e8eOOT\u7ed3\u679c\u7684\u786e\u8ba4\uff0c\u65b9\u6cd5\u5b66\u5fc5\u987b\u5efa\u7acb\u5728\u7edf\u8ba1\u5b66\u539f\u7406\u7684\u57fa\u7840\u4e0a\uff0c\u786e\u8ba4\u6807\u51c6\u5e94\u5f53\u79d1\u5b66\u5408\u7406\u3002<\/p>\n

3 \u57fa\u4e8e\u7edf\u8ba1\u5b66\u539f\u7406\u7684 OOT \u786e\u8ba4<\/strong><\/p>\n

3.1 \u56de\u5f52\u63a7\u5236\u56fe\u6cd5<\/strong><\/p>\n

3.1.1 \u63a7\u5236\u56fe\u539f\u7406<\/strong><\/p>\n

\u63a7\u5236\u56fe\uff08Control Chart\uff09\uff0c\u53c8\u79f0\u4e3a\u7ba1\u7406\u56fe\uff0c\u4e3a\u6839\u636e\u5047\u8bbe\u68c0\u9a8c\u539f\u7406\u6784\u9020\u7684\u4e00\u79cd\u56fe\uff0c\u662f\u7528\u4e8e\u5224\u65ad\u548c\u9884\u62a5\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u8d28\u91cf\u72b6\u51b5\u662f\u5426\u53d1\u751f\u5f02\u5e38\u6ce2\u52a8\u7684\u4e00\u79cd\u6709\u6548\u65b9\u6cd5 [5] \u3002<\/p>\n

\u63a7\u5236\u56fe\u7531\u7f8e\u56fd\u7684\u4f11\u54c8\u7279\uff08W.A.Shewhart\uff09\u4e8e1924\u5e74\u9996\u521b\uff0c\u56e0\u5176\u7528\u6cd5\u7b80\u5355\u3001\u6548\u679c\u826f\u597d\u3001\u4fbf\u4e8e\u638c\u63e1\uff0c\u56e0\u800c\u9010\u6e10\u6210\u4e3a\u8d28\u91cf\u7ba1\u7406\u4e2d\u4e00\u79cd\u91cd\u8981\u7684\u5de5\u5177\u3002\u8d28\u91cf\u7ba1\u7406\u4e2d\uff0c\u8fc7\u7a0b\u8d28\u91cf\u7279\u6027\u503cX\u901a\u5e38\u4e3a\u8ba1\u91cf\u503c\u6570\u636e\uff0c\u4e14\u670d\u4ece\u6b63\u6001\u5206\u5e03\uff0c\u5373X \u223dN\uff08\u03bc<\/span>\uff0c\u03c3 2 \uff09\u3002\u5bf9\u4e8e\u6b63\u6001\u5206\u5e03\u6709p\uff3b\uff08\u03bc<\/span>\uff0d3\u03c3\uff09\uff1cX\uff1c\uff08\u03bc<\/span>\uff0b3\u03c3\uff09\uff3d\uff1d 0.997 3\uff0c\u56e0\u6b64\u53ef\u7528\u6700\u5e38\u89c1\u76843\u03c3\u539f\u5219\u786e\u5b9a\u63a7\u5236\u56fe\u7684\u63a7\u5236\u7ebf\uff08Control Lines\uff09\uff0c\u5176\u4e2d\u4e2d\u5fc3\u7ebf\uff08Central Line\uff09\u4e3a\u03bc<\/span>\uff0c\u4e0a<\/p>\n

\u63a7\u9650\uff08UpperControlLine\uff09\u4e3a\u03bc<\/span>\uff0b3\u03c3\uff0c\u4e0b\u63a7\u9650\uff08LowerControlLine\uff09\u4e3a\u03bc<\/span>\uff0d3\u03c3\u3002\u5f53\u7136\uff0c\u5b9e\u9645\u5e94\u7528\u8fd8\u53ef\u4ee5\u6839\u636e\u6240\u9700\u7f6e\u4fe1\u6c34\u5e73\u9009\u53d6\u03c3\u7684\u4e58\u6570\u3002<\/p>\n

3.1.2 \u56de\u5f52\u63a7\u5236\u56fe\u6cd5\u539f\u7406<\/strong><\/p>\n

\u56de\u5f52\u63a7\u5236\u56fe\uff08Regression Control Chart\uff09\u662f\u5728\u5bf9\u5386\u53f2\u6570\u636e\u6309\u7167\u4e00\u5b9a\u7684\u56de\u5f52\u65b9\u6cd5\u5efa\u7acb\u5de5\u827a\u6a21\u578b\u7684\u57fa\u7840\u4e0a\uff0c\u4f9d\u636e\u5047\u8bbe\u68c0\u9a8c\u539f\u7406\u6784\u9020\u7684\u4e00\u79cd\u63a7\u5236\u56fe\u3002\u5728\u7a33\u5b9a\u6027\u8bd5\u9a8cOOT\u786e\u8ba4\u4e2d\uff0c\u901a\u5e38\u91c7\u7528\u6700\u5c0f\u4e8c\u4e58\u6cd5\u62df\u5408\u5386\u53f2\u6570\u636e\uff0c\u4ece\u800c\u5efa\u7acb\u4e00\u5143\u7ebf\u6027\u6a21\u578b\u5e76\u4ee5\u6b64\u4f5c\u4e3a\u4e2d\u5fc3\u7ebf\uff0c\u7136\u540e\u6839\u636e\u4e00\u5b9a\u7f6e\u4fe1\u6c34\u5e73\u5efa\u7acb\u4e0a\u3001\u4e0b\u63a7\u5236\u9650\u3002\u8be5\u6cd5\u8981\u6c42\u5047\u5b9a\u6240\u6709\u6570\u636e\u7b26\u5408\u6b63\u6001\u5206\u5e03\u4e14\u76f8\u4e92\u72ec\u7acb\uff0c\u5e76\u5728\u6574\u4e2a\u76d1\u6d4b\u5468\u671f\u5185\u53d8\u5f02\u6027\u6052\u5b9a\u6216\u8fd1\u4f3c\u6052\u5b9a\uff0c\u6279\u95f4\u6bd4\u8f83\u6cd5\u65f6\u8fd8\u8981\u6c42\u6240\u6709\u6279\u6b21\u5177\u4f53\u6709\u76f8\u540c\u7684\u7ebf\u6027\u659c\u7387\u3002<\/p>\n

\u56de\u5f52\u63a7\u5236\u56fe\u6cd5\u9002\u7528\u4e8e\u6279\u5185\u6570\u636e\u548c\u6279\u95f4\u6570\u636e\u7684\u6bd4\u8f83\u3002\u5bf9\u4e8e\u6279\u5185\u6bd4\u8f83\uff0c\u56de\u5f52\u7ebf\u62df\u5408\u8be5\u6279\u6b21\u7684\u6570\u636e\uff1b\u5bf9\u4e8e\u6279\u4e4b\u95f4\u7684\u6bd4\u8f83\uff0c\u56de\u5f52\u7ebf\u62df\u5408\u5047\u8bbe\u6709\u76f8\u540c\u659c\u7387\u4f46\u53ef\u4e3a\u4e0d\u540c\u6279\u622a\u8ddd\u7684\u7279\u5b9a\u4ea7\u54c1\u7684\u5386\u53f2\u6570\u636e\u3002\u5728\u4f7f\u7528\u56de\u5f52\u63a7\u5236\u56fe\u6cd5\u65f6\uff0c\u9700\u8981\u5bf9\u622a\u8ddd\u3001\u659c\u7387\u548c\u5747\u65b9\u8bef\u5dee\u5e73\u65b9\u6839\u8fdb\u884c\u4f30\u8ba1\u3002\u5bf9\u4e8e\u67d0\u4e00\u7279\u5b9a\u6279\u6b21\u5728\u7279\u5b9a\u65f6\u95f4\u70b9\u7684\u9884\u671f\u7ed3\u679c\u7684\u4f30\u8ba1\u503c\u53ef\u4ee5\u6309\u7167\u4ee5\u4e0b\u516c\u5f0f\u8ba1\u7b97\uff1a\u9884\u671f\u7ed3\u679c\uff1d\u622a\u8ddd\uff0b\u659c\u7387\u00d7\u65f6\u95f4\u3002<\/strong><\/p>\n

\u800c\u7279\u5b9a\u65f6\u95f4\u70b9\u7684\u4e0a\u3001\u4e0b\u63a7\u5236\u9650\u5219\u53ef\u4f9d\u636e\u4e0b\u9762\u516c\u5f0f\u8ba1\u7b97\uff1a\u9884\u671f\u7ed3\u679c\u00b1k\u00d7s\u3002\u5176\u4e2d\uff0ck\u662f\u7f6e\u4fe1\u4e58\u6570\uff0c\u4e3a\u6839\u636e\u6240\u9700\u7f6e\u4fe1\u6c34\u5e73\u800c\u786e\u5b9a\u7684\u6b63\u6001\u5206\u4f4d\u6570\uff08k\uff1d1\uff0c\u7f6e\u4fe1\u6c34\u5e73p\uff1d95.44\uff05\uff1bk\uff1d2\uff0cp\uff1d99.73\uff05\uff1bk\uff1d3\uff0c\u7f6e\u4fe1\u6c34\u5e73p\uff1d99.999 998\uff05\uff09\uff1bs\u4e3a\u56de\u5f52\u4e2d\u6570\u636e\u7684\u5747\u65b9\u8bef\u5dee\uff08MSE\uff09\u7684\u5e73\u65b9\u6839\u3002<\/p>\n

\u5728\u7279\u5b9a\u65f6\u95f4\u70b9\u4e2d\uff0c\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u70b9\u5904\u4e8e\u4e0a\u8ff0\u4e0a\u3001\u4e0b\u63a7\u5236\u9650\u4e4b\u5185\u65f6\u5219\u8ba4\u4e3a\u662f\u53ef\u63a7\u7684\uff0c\u4e0d\u5c5e\u4e8eOOT\u7ed3\u679c\uff1b\u800c\u5f53\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u70b9\u5904\u4e8e\u4e0a\u3001\u4e0b\u63a7\u5236\u9650\u4e4b\u5916\u65f6\uff0c\u5219\u8be5\u70b9<\/p>\n

\u5c5e\u4e8eOOT\u7ed3\u679c\uff0c\u9700\u8981\u5bf9\u5176\u8fdb\u884c\u6df1\u5165\u8c03\u67e5\u4ee5\u786e\u5b9a\u4ea7\u751f\u8d8b\u52bf\u504f\u79bb\u7684\u539f\u56e0\u3002\u5728\u56de\u5f52\u63a7\u5236\u56fe\u6cd5\u4e2d\uff0c\u53ef\u4ee5\u901a\u8fc7\u7f6e\u4fe1\u4e58\u6570k\u7684\u9009\u62e9\u6765\u786e\u5b9a\u4e0a\u3001\u4e0b\u63a7\u5236\u9650\u7684\u5bbd\u5ea6\uff0c\u8fdb\u800c\u63a7\u5236\u51fa\u73b0\u5047<\/p>\n

\u9633\u6027\u7ed3\u679c\u548c\u5047\u9634\u6027\u7ed3\u679c\u7684\u6982\u7387\u3002<\/p>\n

3.1.3 \u56de\u5f52\u63a7\u5236\u56fe\u6cd5\u5e94\u7528\u793a\u4f8b<\/strong><\/p>\n

\u67d0\u6279\u836f\u54c1\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2d\u524d18\u4e2a\u6708\u7684\u542b\u91cf\u6d4b\u5b9a\u6570\u636e\uff08\u5747\u5728\u8d28\u91cf\u6807\u51c6\u9650\u5ea6\u5185\uff09\u89c1\u88681\u5de6\u534a\u90e8\u5206\uff0c\u5176\u4e2d\u524d12\u4e2a\u6708\u671f\u95f4\u7684\u6570\u636e\u7528\u4e8e\u8bbe\u5b9a\u8be5\u6279\u7684\u56de\u5f52\u63a7\u5236\u56fe\u7684\u4e0a\u3001\u4e0b\u63a7\u5236\u9650\u5ea6\u3002\u6839\u636e\u6700\u5c0f\u4e8c\u4e58\u6cd5\u56de\u5f52\u7684\u539f\u7406\uff0c\u4f7f\u7528EXCEL\u8ba1\u7b97\u5f97\u5230\u56de\u5f52\u65b9\u7a0b\u7684\u622a\u8ddd\u3001\u659c\u7387\u548c\u5747\u65b9\u8bef\u5dee\u5e73\u65b9\u6839\u7684\u4f30\u8ba1\u503c\uff08\u5982\u88681\u4e2d\u90e8\uff09\uff0c\u5e76\u7531\u6b64\u5f97\u5230\u4e2d\u5fc3\u7ebf\u56de\u5f52\u6a21\u578b\u65b9\u7a0bR\uff1d – 0.14T\uff0b100.98\u548c\u8ba1\u7b97\u5404\u65f6\u95f4\u70b9\u7684\u9884\u671f\u7ed3\u679cR*\u3002\u7136\u540e\u518d\u4f9d\u636e99.73%\u7684\u7f6e\u4fe1\u6c34\u5e73\u9009\u62e9\u7f6e\u4fe1\u4e58\u6570k\u4e3a3\uff0c\u518d\u6839\u636e\u65b9\u7a0bR*\u00b1ks\u53ef\u5f97\u5230\u4e0a\u63a7\u9650\u56de\u5f52\u65b9\u7a0b\uff1aR\uff1d – 0.14T\uff0b104.31\u548c\u4e0b\u63a7\u5236\u9650\u56de\u5f52\u65b9\u7a0b\uff1aR\uff1d – 0.14T\uff0b97.65\u3002\u5c06\u4e2d\u5fc3\u7ebf\u3001\u4e0a\u63a7\u7ebf\u548c\u4e0b\u63a7\u7ebf\u7684\u4e09\u4e2a\u56de\u5f52\u65b9\u7a0b\u5728\u540c\u4e00\u5750\u6807\u56fe\u5185\u4f5c\u51fa\uff08\u56fe1\uff09\uff0c\u5e76\u5747\u5411\u524d\u9884\u6d4b\u82e5\u5e72\u4e2a\u5468\u671f\uff08\u598210\u4e2a\u6708\uff09\u3002\u6700\u540e\u53c2\u7167\u56de\u5f52\u63a7\u5236\u56fe\uff08\u56fe1\uff09\uff0c\u53ef\u4ee5\u786e\u8ba4\u7b2c18\u4e2a\u6708\u7684\u6570\u636e\u70b9\uff08\u56fe1\u4e2d\u65b9\u5f62\u70b9\uff09\u4e0d\u5728\u4e0a\u3001\u4e0b\u63a7\u5236\u7ebf\u5185\uff0c\u5e94\u5f53\u5224\u5b9a\u8be5\u542b\u91cf\u6d4b\u5b9a\u7ed3\u679c\u4e3aOOT\u7ed3\u679c [6] \u3002<\/p>\n

\"\u6d45\u6790\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5\"<\/p>\n

\"\u6d45\u6790\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5\"<\/p>\n

3.2 \u65f6\u95f4\u70b9\u6cd5<\/strong><\/p>\n

3.2.1 \u65f6\u95f4\u70b9\u6cd5\u539f\u7406<\/strong><\/p>\n

\u65f6\u95f4\u70b9\u6cd5\uff08By Time Point Method\uff09\u7684\u539f\u7406\u4e3a\u4f9d\u636e\u5176\u4ed6\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6279\u6b21\u5728\u540c\u4e00\u65f6\u95f4\u70b9\u7684\u7a33\u5b9a\u6027\u6570\u636e\u6765\u5224\u65ad\u8be5\u65f6\u95f4\u70b9\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7ed3\u679c\u662f\u5426\u5728\u9884\u671f\u8d8b\u52bf\u5185\u3002\u8be5\u6cd5\u8981\u6c42\u5047\u5b9a\u6240\u6709\u6570\u636e\u7b26\u5408\u6b63\u6001\u5206\u5e03\u4e14\u76f8\u4e92\u72ec\u7acb\u3002<\/p>\n

\u5728\u65f6\u95f4\u70b9\u6cd5\u4e2d\uff0c\u5176\u4ed6\u6279\u6b21\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u7528\u4ee5\u786e\u5b9a\u5404\u4e2a\u7a33\u5b9a\u6027\u8bd5\u9a8c\u65f6\u95f4\u70b9\u7684\u5bb9\u8bb8\u533a\u95f4\uff08ToleranceInterval\uff09\u3002\u5bb9\u8bb8\u533a\u95f4\u7684\u786e\u5b9a\u9700\u8981\u8ba1\u7b97\u5404\u65f6\u95f4\u70b9\u7684\u7a33\u5b9a\u6027\u6570\u636e\u7684\u5e73\u5747\u503cx\u548c\u6807\u51c6\u5dees\uff0c\u5e76\u4f9d\u636e\u6240\u9700\u7f6e\u4fe1\u6c34\u5e73\u786e\u5b9a\u7f6e\u4fe1\u4e58\u6570k\uff08\u53d6\u503c\u540c\u56de\u5f52\u63a7\u5236\u56fe\u6cd5\uff09\u3002\u5bb9\u8bb8\u533a\u95f4\u7684\u8ba1\u7b97\u53ef\u4ee5\u6309\u7167\u516c\u5f0f\uff1ax\u00b1ks\u3002\u56e0\u6b64\uff0c\u5bb9\u8bb8\u533a\u95f4\u7684\u5bbd\u5ea6\u5219\u7531\u7528\u4e8e\u533a\u95f4\u8ba1\u7b97\u7684\u6279\u6b21\u7684\u6570\u91cf\u3001\u6240\u9009\u7f6e\u4fe1\u6c34\u5e73\u548c\u671f\u671b\u8986\u76d6\u8303\u56f4\u51b3\u5b9a\u3002\u5982\u5f53\u524d\u6240\u8fdb\u884c\u6279\u6b21\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7ed3\u679c\u8d85\u51fa\u4e86\u5f53\u524d\u65f6\u95f4\u70b9\u7684\u5bb9\u8bb8\u533a\u95f4\uff0c\u5219\u8be5\u7ed3\u679c\u53ef\u88ab\u8ba4\u5b9a\u4e3aOOT\u7ed3\u679c\u3002<\/p>\n

\u65f6\u95f4\u70b9\u6cd5\u7684\u4f18\u70b9\u5728\u4e8e\u65e0\u9700\u5047\u8bbe\u836f\u54c1\u964d\u89e3\u66f2\u7ebf\u7684\u5f62\u72b6\uff0c\u9002\u7528\u4e8e\u4e0d\u540c\u65f6\u95f4\u70b9\u836f\u54c1\u7279\u6027\u7684\u53d8\u5f02\u6027\u4e0d\u540c\u7684\u60c5\u51b5\uff0c\u5e76\u4e14\u53ef\u4ee5\u9009\u62e9\u4e0d\u540c\u7684\u7f6e\u4fe1\u6c34\u5e73\u548c\u8986\u76d6\u8303\u56f4\u4ee5\u6ee1\u8db3\u7279\u5b9a\u4ea7\u54c1\u7684OOT\u786e\u8ba4\u8981\u6c42\u3002\u4f46\u662f\uff0c\u5982\u679c\u73b0\u6709\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u4e0d\u662f\u5728\u540d\u4e49\u65f6\u95f4\u70b9\u8fdb\u884c\u6d4b\u8bd5\u7684\uff0c\u65f6\u95f4\u70b9\u6cd5\u7684\u5e94\u7528\u5c31\u4f1a\u51fa\u73b0\u4e00\u4e9b\u95ee\u9898\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u4f7f\u7528\u540d\u4e49\u65f6\u95f4\u70b9\u4e4b\u524d\u6216<\/p>\n

\u4e4b\u540e\u7684\u6570\u636e\u8ba1\u7b97\u7684\u5bb9\u8bb8\u533a\u95f4\u53ea\u80fd\u7528\u4f5c\u8fd1\u4f3c\u503c\uff0c\u800c\u8fd1\u4f3c\u503c\u7684\u9002\u7528\u6027\u5219\u53d6\u51b3\u4e8e\u6570\u636e\u7684\u53d8\u5316\u7387\u3002<\/p>\n

3.2.2 \u65f6\u95f4\u70b9\u6cd5\u5e94\u7528\u793a\u4f8b<\/strong><\/p>\n

\u5728\u67d0\u6279\u836f\u54c1\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7684\u542b\u91cf\u6d4b\u5b9a\u6570\u636e\uff08\u5747\u5728\u8d28\u91cf\u6807\u51c6\u9650\u5ea6\u5185\uff0c\u5982\u88682\uff09\u7684OOT\u786e\u8ba4\u4e2d\uff0c\u9009\u53d6\u4e4b\u524d\u4e94\u6279\u76f8\u540c\u836f\u54c1\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7684\u542b\u91cf\u6d4b\u5b9a\u6570\u636e\uff08\u5747\u5728\u8d28\u91cf\u6807\u51c6\u9650\u5ea6<\/p>\n

\u5185\uff0c\u5982\u88683\uff09\u4f5c\u4e3a\u7528\u4e8e\u8ba1\u7b97\u5bb9\u8bb8\u533a\u95f4\u7684\u5386\u53f2\u6279\u6b21\uff0c\u5206\u522b\u8ba1\u7b97\u8fd9\u4e94\u6279\u836f\u54c1\u542b\u91cf\u6d4b\u5b9a\u7ed3\u679c\u5728\u5404\u65f6\u95f4\u70b9\uff080\uff5e24\u6708\uff09\u7684\u5747\u503cx\u548c\u6807\u51c6\u5dees \uff08\u89c1\u88683\u53f3\u4fa7\uff09\uff0c\u7136\u540e\u6839\u636ex\u00b1ks \uff08\u5176\u4e2d\u7f6e\u4fe1\u4e58\u6570k\uff1d6\uff0c\u7f6e\u4fe1\u6c34\u5e73p\uff1d99.999 998\uff05\uff09\u8ba1\u7b97\u5404\u65f6\u95f4\u70b9\u7684\u5bb9\u8bb8\u533a\u95f4\u7684\u4e0a\u63a7\u9650\u548c\u4e0b\u63a7\u9650\uff08\u5982\u88682\u4e2d\u90e8\uff09\u3002\u5c06\u6240\u6709\u6570\u636e\u70b9\u4f5c\u4e8e\u4e00\u56fe\u4e2d\u5f97\u5230\u8be5\u6279\u836f\u54c1\u7528\u4e8eOOT\u786e\u8ba4\u7684\u65f6\u95f4\u70b9\u6cd5\u56fe\uff08\u5982\u56fe2\uff09[7] \u3002\u56fe\u4e2d\u65b9\u5f62\u7a7a\u5fc3\u70b9\u4e3a\u7528\u4e8eOOT\u786e\u8ba4\u7684\u6570\u636e\u70b9\uff0c\u5706\u5f62\u5b9e\u5fc3\u70b9\u4e3a\u5bb9\u8bb8\u533a\u95f4\u7684\u6570\u636e\u70b9\uff0c\u5706\u5f62\u7a7a\u5fc3\u70b9\u4e3a\u7528\u4e8e\u8ba1\u7b97\u5bb9\u8bb8\u533a\u95f4\u7684\u5386\u53f2\u6279\u6b21\u6570\u636e\u70b9\u3002\u6839\u636e\u65f6\u95f4\u70b9\u6cd5\u56fe\u53ef\u4ee5\u5f97\u51fa\uff0c\u8be5\u6279\u7684\u7b2c18\u4e2a\u6708\u548c\u7b2c24\u4e2a\u6708\u7684\u7ed3\u679c\u5904\u4e8e\u5bb9\u8bb8\u533a\u95f4\u4e4b\u5916\uff0c\u6545\u53ef\u8ba4\u5b9a\u4e24\u7ed3\u679c\u4e3aOOT\u7ed3\u679c\u3002<\/p>\n

\"\u6d45\u6790\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5\"<\/p>\n

\"\u6d45\u6790\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5\"<\/p>\n

\n

4 \u7ed3\u8bed<\/strong><\/p>\n

\u603b\u7684\u6765\u8bf4\uff0c\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2dOOT\u7684\u786e\u8ba4\u65b9\u6cd5\u4e0d\u5e94\u8be5\u592a\u8fc7\u590d\u6742\uff0c\u5e94\u5f53\u5728\u7b26\u5408\u7edf\u8ba1\u5b66\u539f\u7406\u7684\u57fa\u7840\u4e0a\u5c3d\u53ef\u80fd\u8fdb\u884c\u7b80\u5316\uff0c\u4f46\u4e5f\u4e0d\u53ef\u4f7f\u7528\u76ee\u524d\u8fd9\u4e9b\u8fc7\u4e8e\u7b80\u5316\u4e14\u7f3a\u4e4f\u7edf\u8ba1\u5b66\u4f9d\u636e\u7684\u65b9\u6cd5\u3002\u5728\u5bf9\u836f\u54c1\u8d28\u91cf\u8981\u6c42\u8d8a\u6765\u8d8a\u4e25\u683c\u7684\u5f53\u4eca\uff0c\u5728\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2d\u4ec5\u4ec5\u5efa\u7acbOOS\u786e\u8ba4\u548c\u8c03\u67e5\u7684\u4e66\u9762\u6587\u4ef6\u662f\u4e0d\u591f\u7684\uff0c\u53ea\u6709\u5efa\u7acbOOT\u786e\u8ba4\u548c\u8c03\u67e5\u7684\u4e66\u9762\u89c4\u7a0b\u624d\u80fd\u6839\u636eOOT\u786e\u8ba4\u7684\u7ed3\u679c\u5728\u53d1\u751fOOS\u4e4b\u524d\u627e\u51fa\u53d1\u751f\u504f\u79bb\u7684\u6839\u6e90\uff0c\u4ece\u800c\u8fdb\u4e00\u6b65\u63d0\u5347\u836f\u54c1\u7684\u8d28\u91cf\u3002<\/p>\n

\uff3b\u53c2\u8003\u6587\u732e\uff3d<\/p>\n

[1]\u6881\u6bc5.\u836f\u54c1\u751f\u4ea7\u7684\u504f\u5dee\u5206\u6790[J].\u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1\uff0c2008\uff0c29(1)\uff1a37\uff5e40<\/p>\n

[2]\u6881\u6bc5.\u836f\u54c1\u751f\u4ea7OOS\u8c03\u67e5[J].\u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1\uff0c2008\uff0c29(2)\uff1a28\uff5e31<\/p>\n

[3]PhRMA CMC Statistics and Stability Expert Teams.Identification of Out-of-Trend Stability Results.Pharmaceutical Technology,2003\uff1a38\uff5e52<\/p>\n

[4]FDA.Guidance for industry:Investigating Out ofSpecification \uff08OOS\uff09TestResultsforPharmaceuticalProduction[EB\/OL].http:\/\/www.fda.gov\/downloads\/<\/p>\n

Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm070287.pdf<\/p>\n

[5]\u5c24\u5efa\u65b0\uff0c\u675c\u5b66\u7f8e\uff0c\u5f20\u5efa\u540c.\u8d28\u91cf\u7ba1\u7406\u5b66[M].\u5317\u4eac\uff1a\u79d1\u5b66\u51fa\u7248\u793e\uff0c2008.7\uff1a168<\/p>\n

[6]\u5f20\u540c\u53cb\uff0c\u8d3e\u65b0\u7ae0.\u7edf\u8ba1\u8fc7\u7a0b\u63a7\u5236\u4e2d\u7684\u56de\u5f52\u63a7\u5236\u56fe\u6280\u672f[J].\u56fa\u4f53\u7535\u5b50\u5b66\u7814\u7a76\u4e0e\u8fdb\u5c55\uff0c2001\uff0c21(3)\uff1a330\uff5e333<\/p>\n

[7] ICH.Q1E\uff1aEvaluation of Stability Data [EB\/OL].http:\/\/www.ich.org\/LOB\/media\/MEDIA415.pdf<\/p>\n


<\/p>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5236\u836f\u5de5\u7a0b\u8bba\u575b <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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