{"id":39149,"date":"2018-08-15T01:00:00","date_gmt":"2018-09-17T06:28:40","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e3%80%90%e6%94%b6%e8%97%8f%e3%80%91%e9%ab%98%e5%8f%98%e5%bc%82%e8%8d%af%e7%89%a9%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e8%af%95%e9%aa%8c%e5%8f%8a%e9%87%8f%e5%8c%96%e8%af%84%e4%bb%b7\/"},"modified":"2018-09-17T14:28:45","modified_gmt":"2018-09-17T06:28:45","slug":"%e3%80%90%e6%94%b6%e8%97%8f%e3%80%91%e9%ab%98%e5%8f%98%e5%bc%82%e8%8d%af%e7%89%a9%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e8%af%95%e9%aa%8c%e5%8f%8a%e9%87%8f%e5%8c%96%e8%af%84%e4%bb%b7","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/39149\/","title":{"rendered":"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7"},"content":{"rendered":"
\n

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\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"<\/p>\n

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<\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u662f\u65b0\u836f\u7814\u53d1\u8fc7\u7a0b\u4e2d\u8bc4\u4ef7\u836f\u54c1\u8d28\u91cf\u548c\u6865\u63a5\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u6570\u636e\u7684\u91cd\u8981\u624b\u6bb5\u3002\u5728\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u4e2d\uff0c\u4e00\u822c\u901a\u8fc7\u6bd4\u8f83\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u76f8\u5bf9\u751f\u7269\u5229\u7528\u5ea6\uff0c\u6839\u636e\u9009\u5b9a\u7684\u836f\u52a8\u5b66\u53c2\u6570\u548c\u9884\u8bbe\u7684\u63a5\u53d7\u9650\uff0c\u5bf9\u4e24\u8005\u7684\u751f\u7269\u7b49\u6548\u6027\u505a\u51fa\u5224\u5b9a\u3002\u8840\u836f\u6d53\u5ea6-\u65f6\u95f4\u66f2\u7ebf\u4e0b\u9762\u79ef(area under the curve, AUC)\u53cd\u6620\u66b4\u9732\u7684\u7a0b\u5ea6\uff0c\u5cf0\u6d53\u5ea6(Cmax)\u548c\u8fbe\u5cf0\u65f6\u95f4\uff08Tmax\uff09\u662f\u53d7\u5230\u5438\u6536\u901f\u5ea6\u5f71\u54cd\u7684\u53c2\u6570\u3002\u5982\u679c\u542b\u6709\u76f8\u540c\u6d3b\u6027\u7269\u8d28\u7684\u4e24\u79cd\u836f\u54c1\u836f\u5242\u5b66\u7b49\u6548\u6216\u836f\u5242\u5b66\u53ef\u66ff\u4ee3\uff0c\u5e76\u4e14\u5b83\u4eec\u5728\u76f8\u540c\u6469\u5c14\u5242\u91cf\u4e0b\u7ed9\u836f\u540e\uff0c\u751f\u7269\u5229\u7528\u5ea6(\u5438\u6536\u901f\u5ea6\u548c\u7a0b\u5ea6\uff09\u843d\u5728\u9884\u5b9a\u7684\u63a5\u53d7\u9650\u5ea6\u5185\uff0c\u5219\u88ab\u8ba4\u4e3a\u751f\u7269\u7b49\u6548\u3002\u8bbe\u7f6e\u8fd9\u4e9b\u9650\u5ea6\u4ee5\u4fdd\u8bc1\u4e0d\u540c\u5236\u5242\u4e2d\u836f\u7269\u7684\u4f53\u5185\u884c\u4e3a\u76f8\u5f53\uff0c\u5373\u4e24\u79cd\u5236\u5242\u6709\u76f8\u4f3c\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n


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\n

\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b2015\u5e74\u7248\u7b2c4\u90e8\u300a\u836f\u7269\u5236\u5242\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u300b\u6307\u51fa\uff1a\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u6027\u836f\u7269\uff0c\u5982\u679c\u8ba4\u4e3aCmax\u5dee\u5f02\u8f83\u5927\u4f46\u5bf9\u4e8e\u4e34\u5e8a\u7684\u5f71\u54cd\u4e0d\u5927\uff0c\u57fa\u4e8e\u4e34\u5e8a\u7684\u5145\u5206\u7406\u7531\uff0c\u5219\u53ef\u653e\u5bbd\u63a5\u53d7\u8303\u56f4\uff0cCmax\u7684\u53ef\u4ee5\u63a5\u53d7\u7684\u6700\u5bbd\u8303\u56f4\u4e3a69.84%~143.19%\u30022015\u5e74CFDA\u9881\u5e03\u7684\u300a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\u6307\u51fa\uff1a\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\uff0c\u53ef\u6839\u636e\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\uff0c\u5c06\u7b49\u6548\u6027\u8bc4\u4ef7\u6807\u51c6\u4f5c\u9002\u5f53\u6bd4\u4f8b\u7684\u8c03\u6574\u3002\u56fd\u5185\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u5c1a\u65e0\u4e13\u9879\u7684\u6307\u5bfc\u539f\u5219 , \u9ec4\u94a6\u7b49\u6307\u51fa\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u662f\u4e00\u4e2a\u6bd4\u8f83\u590d\u6742\u7684\u95ee\u9898\uff0c\u540c\u65f6\u4e5f\u662f\u4e00\u4e2a\u5f15\u4eba\u5173\u6ce8\u7684\u73b0\u5b9e\u8bfe\u9898\u3002\u672c\u6587\u53c2\u8003\u56fd\u5185\u5916\u6cd5\u89c4\u3001\u6307\u5bfc\u539f\u5219\u53ca\u6587\u732e\uff0c\u65e8\u5728\u5bf9\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\u8fdb\u884c\u7cfb\u7edf\u9610\u8ff0\u3002<\/p>\n


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1.\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u95ee\u9898\u7684\u590d\u6742\u6027<\/span><\/strong><\/span><\/p>\n<\/section>\n

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1.1\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u5b9a\u4e49<\/span><\/section>\n<\/blockquote>\n

\u9ad8\u53d8\u5f02\u836f\u7269(highly variable drug)\u662f\u6307\u6709\u4e00\u4e2a\u6216\u591a\u4e2a\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u6307\u6807\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u6027(within-subject coefficient of variation\uff0cCV)\u226530%\u7684\u836f\u7269\u5236\u5242<\/span>\u3002FDA\u7edf\u8ba1\u76842003\u5e74\u52302005\u5e74\u4e4b\u95f4212\u9879\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u4e2d\u670933\u9879\u9ad8\u53d8\u5f02\u6027\u836f\u7269<\/span>\u3002\u5982\u679c\u91c7\u7528\u5e38\u89c4\u4f8b\u6570\u7684\u53d7\u8bd5\u8005\u8bc4\u4ef7\u4f1a\u9020\u6210\u628a\u63e1\u5ea6\u592a\u5c0f\uff0cII\u7c7b\u9519\u8bef\u7684\u53ef\u80fd\u6027\u5927\uff0c\u5bb9\u6613\u628a\u7b49\u6548\u5236\u5242\u5224\u4e3a\u4e0d\u7b49\u6548\u3002\u4e0d\u91c7\u7528\u5927\u91cf\u53d7\u8bd5\u8005\u5f88\u96be\u53bb\u8bc4\u4ef7\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\uff0c\u4f46\u5165\u7ec4\u8f83\u591a\u7684\u53d7\u8bd5\u8005\u9996\u5148\u4f1a\u5e26\u6765\u4f26\u7406\u5b66\u7684\u95ee\u9898\uff0c\u5065\u5eb7\u53d7\u8bd5\u8005\u65e0\u6cd5\u4ece\u8bd5\u9a8c\u4e2d\u53d7\u76ca\uff0c\u5176\u6b21\u589e\u52a0\u4e86\u8bd5\u9a8c\u6210\u672c\u548c\u8bd5\u9a8c\u8fd0\u884c\u7ba1\u7406\u7684\u96be\u5ea6(\u56e0\u8bd5\u9a8c\u6761\u4ef6\u7684\u9650\u5236\u4e0d\u80fd\u540c\u65f6\u5165\u7ec4\u5168\u90e8\u53d7\u8bd5\u8005\uff0c\u4e34\u5e8a\u64cd\u4f5c\u53ef\u884c\u6027\u964d\u4f4e)<\/span>\u3002<\/span>
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\u56fe1\u663e\u793a\u4e86\u4e24\u79cd\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u7ed3\u679c\uff0c\u836f\u7269A\u662f\u6b63\u5e38\u53d8\u5f02\uff0c\u836f\u7269B\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u8f83\u5927\uff0c\u56fe\u4e2d X\u8f74\u4e0a80%~125%\u4ee3\u8868\u7740\u751f\u7269\u7b49\u6548\u9650\uff0c\u8fd9\u4e24\u4e2a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\uff0c\u53c2\u6bd4\u4e0e\u53d7\u8bd5\u5236\u5242\u836f\u52a8\u5b66\u53c2\u6570\uff08Cmax\u3001AUC\uff09\u7684\u51e0\u4f55\u5747\u6570\u6bd4\uff08GMR\uff09\u5747\u63a5\u8fd1\u4e8e1\uff0c\u5bf9\u4e8e\u836f\u7269A\uff0c GMR\u768490%\u7f6e\u4fe1\u533a\u95f4\u5728\u751f\u7269\u7b49\u6548\u9650\u8303\u56f4\u5185\uff0c\u7b49\u6548\u6027\u6210\u7acb\u3002\u800c\u836f\u54c1B\uff0c\u5176GMR\u7684 90%\u7684\u7f6e\u4fe1\u533a\u95f4\u4e0d\u7b26\u5408\u751f\u7269\u7b49\u6548\u9650\uff0c\u7b49\u6548\u6027\u4e0d\u6210\u7acb\u3002\u867d\u7136\u836f\u7269B\u7684 GMR\u63a5\u8fd1\u4e8e1\uff0c\u8bf4\u660e\u8bd5\u9a8c\u5236\u5242\u53ef\u80fd\u662f\u4e00\u4e2a\u57fa\u4e8e\u826f\u597d\u8bbe\u8ba1\uff0c\u5728\u4f53\u5185\u4e0e\u53c2\u6bd4\u5236\u5242\u884c\u4e3a\u4e00\u81f4\u7684\u4ea7\u54c1\uff0c\u4f46\u5fc5\u987b\u589e\u52a0\u53d7\u8bd5\u8005\u4f8b\u6570\u624d\u80fd\u4f7f\u836f\u54c1B\u7b26\u5408\u751f\u7269\u7b49\u6548\u9650\u3002<\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"<\/p>\n


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1.2 \u9020\u6210\u9ad8\u53d8\u5f02\u7684\u76f8\u5173\u56e0\u7d20<\/span><\/section>\n<\/blockquote>\n

\u5927\u90e8\u5206\u9ad8\u53d8\u5f02\u836f\u7269\u4e3a\u751f\u7269\u836f\u5242\u5b66\u5206\u7c7b\u4e2d\u76842\u7c7b\u62164\u7c7b\uff0c\u8fd9\u7c7b\u836f\u7269\u5177\u6709\u6eb6\u89e3\u5ea6\u4f4e\u3001\u9996\u8fc7\u6548\u5e94\u5927\u3001\u751f\u7269\u5229\u7528\u5ea6\u4f4e\u3001\u9178\u4e0d\u7a33\u5b9a\u6027\u9ad8\u3001\u4eb2\u8102\u6027\u9ad8\u7b49\u7279\u6027\u3002\u9664\u4e86\u836f\u7269\u672c\u8eab\u7684\u56e0\u7d20\uff0c\u5236\u5242\u56e0\u7d20\u548c\u996e\u98df\u65f6\u95f4\u4e5f\u53ef\u5f71\u54cd\u836f\u7269\u7684\u53d8\u5f02\u6027\uff0c\u8fd9\u4e9b\u836f\u7269\u7684\u8840\u836f\u6d53\u5ea6\u975e\u5e38\u7684\u4f4e\uff0c\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u51c6\u786e\u5730\u63cf\u8ff0\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96be\u5ea6\u8f83\u5927\u3002\u5e38\u89c1\u7684\u9ad8\u53d8\u5f02\u836f\u7269\u5305\u62ec\u6297\u6291\u90c1\u836f\u963f\u5f0b\u7f8e\u62c9\u6c40\u3001\u6fc0\u7d20\u7c7b\u836f\u7269\u9ec4\u4f53\u916e\u3001\u9499\u901a\u9053\u963b\u6ede\u5242\u7ef4\u62c9\u5e15\u7c73\u7b49\u3002<\/p>\n


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\u9ad8\u53d8\u5f02\u4eff\u5236\u836f\u7269\u7684\u7533\u8bf7\u53ef\u80fd\u4f1a\u56e0\u4e00\u6b21\u5931\u8d25\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u4e0d\u4e88\u6279\u51c6\uff0c\u9700\u8981\u91cd\u590d\u591a\u6b21\u4f53\u5185\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u76f4\u81f3\u8fbe\u5230\u8981\u6c42\u3002\u8fd9\u4e0d\u4ec5\u4ec5\u4f1a\u5e26\u6765\u4f26\u7406\u95ee\u9898\uff0c\u800c\u4e14\u4f1a\u589e\u52a0\u836f\u7269\u7814\u53d1\u7684\u6210\u672c\uff0c\u6700\u7ec8\u5c06\u4f1a\u52a0\u91cd\u75c5\u4eba\u7684\u7528\u836f\u6210\u672c\u3002\u5982\u679c\u91c7\u7528\u5e38\u89c4\u4f8b\u6570\u7684\u53d7\u8bd5\u8005\u8bc4\u4ef7\u4f1a\u9020\u6210\u628a\u63e1\u5ea6\u592a\u5c0f\uff0cII\u7c7b\u9519\u8bef\u7684\u53ef\u80fd\u6027\u5927\uff0c\u91c7\u7528\u5e38\u89c4\u7684\u53cc\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\u548c80%~125%\u7684\u751f\u7269\u7b49\u6548\u9650\uff0c\u4e24\u5468\u671f\u5747\u670d\u7528\u53c2\u6bd4\u5236\u5242\uff0c\u90fd\u6709\u53ef\u80fd\u5f97\u5230\u4e0d\u7b49\u6548\u6027\u7ed3\u8bba\uff0c\u8fd9\u79cd\u60c5\u51b5\u5df2\u7ecf\u5728\u6c2f\u4e19\u55ea\u548c\u7ef4\u62c9\u5e15\u7c73\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u4e2d\u88ab\u8bc1\u5b9e\u3002\u7531\u6b64\u53ef\u89c1\uff0c\u666e\u901a\u7684\u6cd5\u89c4\u5df2\u4e0d\u9002\u7528\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u3002<\/p>\n


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2.\u56fd\u9645\u4e0a\u5173\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u91c7\u7eb3\u7684\u6cd5\u89c4<\/span><\/strong><\/span><\/p>\n<\/section>\n

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\u5173\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u7684\u63a2\u8ba8\u5728\u56fd\u5185\u56fd\u9645\u4f1a\u8bae\u4e2d\u8ba8\u8bba\u4e86\u5f88\u591a\u5e74\u30022004\u5e74\uff0cFDA\u8003\u8651\u662f\u5426\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u91c7\u7eb3\u4e00\u79cd\u56fa\u5b9a\u7684\u65b9\u6cd5\u8fdb\u884c\u8bc4\u4ef7\u3002\u540c\u5e744\u6708\uff0cFDA\u4eff\u5236\u836f\u90e8\u95e8\uff08FDA\u2019s office of generic drugs ,OGD)\u6210\u7acb\u4e86\u5173\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6700\u4f18\u65b9\u6848\u7814\u7a76\u7684\u4e34\u5e8a\u836f\u5b66\u54a8\u8be2\u59d4\u5458\u4f1a\u3002\u968f\u540e\u6536\u96c6\u4e86\u5173\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u89e3\u51b3\u65b9\u6cd5\u7684\u5404\u79cd\u63d0\u8bae\uff0c\u5305\u62ec\u91c7\u7528\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u3001\u591a\u5242\u91cf\u7a33\u6001\u8bc4\u4ef7\u3001\u6210\u7ec4\u5e8f\u8d2f\u7814\u7a76\u7b49\u3002\u6700\u540e\u7ecf\u8fc7\u7b5b\u9009\u8003\u8651\u91c7\u7eb3\u7528\u91cd\u590d\u53c2\u6bd4\u5236\u5242\u6cd5\u8ba1\u7b97\u4e2a\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u53d8\u5f02\u6027\uff0c\u7b49\u6548\u965080%~125%\u6269\u5927\u523070%~143%\u3002FDA\u7684\u4eff\u5236\u836f\u7269\u90e8\u95e8\u968f\u540e\u505a\u4e86\u4eff\u771f\u7814\u7a76\u6765\u9a8c\u8bc1\u65b9\u6848\u662f\u5426\u53ef\u884c\uff0c\u5e76\u6210\u7acb\u4e86\u4e00\u4e2a\u5de5\u4f5c\u5c0f\u7ec4\u53bb\u7814\u7a76\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u3002\u57fa\u4e8e\u4eff\u771f\u7814\u7a76\u7684\u7ed3\u679c\uff0c\u57282006\u5e744\u6708\u5de5\u4f5c\u5c0f\u7ec4\u63d0\u51fa\u4e86\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u65b9\u6848\u3002FDA\u7684\u4eff\u5236\u836f\u90e8\u95e8\u7ecf\u591a\u65b9\u9762\u8003\u8651\u6700\u7ec8\u51b3\u5b9a\u5bf9\u9ad8\u53d8\u5f02\u836f\u7269\u91c7\u7528\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u65b9\u6848\u3002\u5e76\u4e8e2010\u5e74\u53d1\u5e03\u4e86\u7b2c1\u4e2a\u5c5e\u4e8e\u9ad8\u53d8\u5f02\u836f\u54c1(\u9ec4\u4f53\u916e\u80f6\u56ca)\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219(\u8349\u6848)\u3002\u5728FDA\u63d0\u51fa\u65b9\u6848\u4e4b\u540e\uff0cEMA\u4e8e2010\u5e74\u4e5f\u51fa\u53f0\u4e86\u76f8\u5e94\u7684\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7684\u6cd5\u89c4\u3002\u5747\u5229\u7528\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u5bf9\u53c2\u6570\u751f\u7269\u7b49\u6548\u9650\u4f5c\u6bd4\u4f8b\u5316\u8c03\u6574\uff0c\u5747\u8981\u6c42\u5bf9\u53c2\u6bd4\u5236\u5242\u662f\u91cd\u590d\u8bbe\u8ba1\u3002\u4e0b\u9762\u6211\u4eec\u5177\u4f53\u4ecb\u7ecd\u4e24\u4e2a\u6743\u5a01\u6307\u5357\u4e2d\u751f\u7269\u7b49\u6548\u9650\u754c\u503c\u8c03\u6574\u7684\u516c\u5f0f\u4ee5\u53ca\u76f8\u5e94\u6837\u672c\u542b\u91cf\u7684\u4f30\u7b97\u65b9\u6cd5\u3002<\/p>\n

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<\/section>\n
2.1  FDA\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u91c7\u7eb3\u7684\u65b9\u6cd5<\/span><\/section>\n

\u3000\u3000<\/span><\/p><\/blockquote>\n

\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027(reference-scaled average bioequivalence\uff0cRSABE)\u5bf9\u4e8eAUC\u548cCmax\u7b49\u6548\u6027\u8bc4\u4f30\u5982\u4e0b\u5f0f1\uff1a  <\/span><\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\" ……….(1)<\/span><\/p>\n

\u00b5T\u4e3a\u53d7\u8bd5\u5236\u5242\u836f\u52a8\u5b66\u53c2\u6570\u5bf9\u6570\u8f6c\u5316\u540e\u7684\u7fa4\u4f53\u5747\u503c\uff0c\u00b5R\u4e3a\u53c2\u6bd4\u5236\u5242\u836f\u52a8\u5b66\u53c2\u6570\u5bf9\u6570\u8f6c\u5316\u540e\u7684\u7fa4\u4f53\u5747\u503c\uff0c\u03c3WR\u4ee3\u8868\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u6807\u51c6\u5dee\uff0c\u03b8S=\uff08ln1.25)2 \/\u03c32WO\uff0c\u5e76\u4e14\u03c3WO\u662f\u7ba1\u7406\u673a\u6784\uff08regulatory agency\uff09\u9884\u5148\u8bbe\u5b9a\u7684\u5e38\u6570\u3002\u5728\u8fd9\u4e2a\u6a21\u578b\u4e2d\u03bcT-\u03bcR\u7684\u7b49\u6548\u9650\u5982\u5f0f2\uff1a<\/p>\n

 <\/span>\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"……….(2)<\/span><\/p>\n

FDA\u5c06\u03c3WO\u7684\u503c\u8bbe\u4e3a0.25\u3002 FDA\u968f\u540e\u5bf9\u6b64\u65b9\u6848\u63d0\u51fa\u4e862\u70b9\u8865\u5145\u8bf4\u660e\uff1a<\/p>\n

\uff081\uff09\u5f53\u03c3WR\u5927\u4e8e\u6216\u7b49\u4e8e0.294\uff08\u5373CV\u226530%)\u65f6\u91c7\u7528\u6bd4\u4f8b\u5747\u5316\u751f\u7269\u7b49\u6548\u6027\u3002<\/p>\n

\uff082\uff09\u70b9\u4f30\u8ba1\u7684\u8303\u56f4\u57280.8~1.25\uff0c\u5373\u8981\u6c42Cmax\u548cAUC\u7684GMR\u57280.8~1.25\u8303\u56f4\u5185\u3002\u4f7f\u7528\u70b9\u4f30\u8ba1\u8303\u56f4\u4f1a\u63d0\u9ad8\u533b\u751f\u548c\u60a3\u8005\u5bf9\u4eff\u5236\u836f\u54c1\u7684\u4fe1\u4efb\u3002<\/p>\n

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2.2 EMA<\/span><\/section>\n<\/blockquote>\n

\u5f53\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u53d8\u5f02\u5927\u4e8e\u6216\u7b49\u4e8e\u9884\u5148\u8bbe\u5b9a\u7684\u503c(CVWR\u4e3a30%\uff0c\u5373\u4e2a\u4f53\u5185\u6807\u51c6\u5deeSWR=0.294\uff09\u65f6\uff0c\u53ef\u4ee5\u7528\u4ee5\u4e0b\u516c\u5f0f\uff083\uff09\u6bd4\u4f8b\u5316\u3002<\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"……….(3)<\/span><\/p>\n

\u03c3WO\u662f\u9884\u5148\u8bbe\u5b9a\u7684\u6807\u51c6\u5dee\uff0c\u7531\u76d1\u7ba1\u673a\u6784\u8bbe\u7f6e\u3002SWR\u4ee3\u8868\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u6807\u51c6\u5dee\uff0c\u4e0eFDA\u63d0\u51fa\u7684\u516c\u5f0f\u03c3WR\u662f\u76f8\u540c\u53c2\u6570\u3002-0.223\u548c+0.223\u5373\u4e3aln0.8\u548cln1.25\uff0c\u8fd9\u610f\u5473\u7740\u53ef\u6839\u636eSWR\u503c\u7684\u5927\u5c0f\u6765\u76f8\u5e94\u6269\u5927\u751f\u7269\u7b49\u6548\u9650\u3002\u5728\u516c\u5f0f4 \u4e2d\u5c060.223\/\u03c3WO\u662f\u5b9a\u4e49\u4e3a\u5e38\u6570k\u3002\uff1a<\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\" ……….(4)<\/span><\/p>\n

\u3000\u3000\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\u548c\u53c2\u6bd4\u5236\u5242\u4e2a\u4f53\u5185\u6807\u51c6\u5dee\u7684\u6362\u7b97\u516c\u5f0f\u89c1\u516c\u5f0f5\uff1a<\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"……….(5)<\/span><\/p>\n

EMA\u8bbe\u5b9a\u03c3WO = 0.294\uff0c\u6839\u636e\u516c\u5f0f4\u53ef\u8ba1\u7b97\u5e38\u6570k\u4e3a0.760\u3002EMA\u89c4\u5b9a\u7684\u6269\u5927\u7684\u751f\u7269\u7b49\u6548\u9650\u516c\u5f0f\u5982\u5f0f6\uff1a<\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"…….(6)<\/span><\/p>\n

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2.3  EMA\u548cFDA\u7684\u5bf9\u6bd4<\/span><\/section>\n<\/blockquote>\n

\u56fe2 FDA\u548cEMA\u751f\u7269\u7b49\u6548\u9650\u968f\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\u53d8\u5316\u5bf9\u6bd4<\/span><\/strong><\/p><\/blockquote>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\" <\/span><\/p><\/blockquote>\n


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

\u76f8\u540c\u70b9<\/strong>\uff1a\u5bf9\u6bd4FDA\u548cEMEA\u4e24\u4e2a\u6743\u5a01\u6307\u5357\uff0c\u90fd\u662f\u6839\u636e\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u6027\u5bf9\u751f\u7269\u7b49\u6548\u9650\u8303\u56f4\u8fdb\u884c\u8c03\u6574\uff1b\u5747\u8981\u6c42\u5bf9\u53c2\u6bd4\u5236\u5242\u662f\u91cd\u590d\u8bbe\u8ba1\uff0c\u90e8\u5206\u91cd\u590d\u4e09\u5468\u671f\u4e09\u5e8f\u5217\u8bbe\u8ba1\uff08TRR\u3001 RTR\u3001 RRT\uff09\u3001\u5b8c\u5168\u91cd\u590d\u56db\u5468\u671f\u4e24\u5e8f\u5217\u8bbe\uff08TRTR\u3001RTRT\uff09\u90fd\u662f\u53ef\u63a5\u53d7\u7684\uff1b\u4e24\u6307\u5357\u5747\u8981\u6c42\u53c2\u6570\u7684GMR\u4ecd\u5fc5\u987b\u843d\u5728\u4f20\u7edf\u7684\u7b49\u6548\u9650\u8303\u56f4\u5185\uff0880.00%~125.00%\uff09\u3002<\/p>\n


<\/p>\n

\u533a\u522b<\/strong>\uff1a\uff081\uff092010\u5e74EMA\u89c4\u5b9a\u7684\u6307\u5357\u66f4\u503e\u5411\u4e8e3\u5468\u671f\u8bd5\u9a8c[17]\uff0c\u8ba4\u4e3a4\u5468\u671f\u552f\u4e00\u7684\u4f18\u70b9\u662f\u80fd\u591f\u8ba1\u7b97\u8bd5\u9a8c\u7ec4\u7684\u53d8\u5f02\u6027\uff0c\u4f46\u662f\u8bd5\u9a8c\u7ec4\u7684\u53d8\u5f02\u6027\u5728\u63d0\u51fa\u7684\u65b9\u6cd5\u4e2d\u4e0d\u88ab\u7528\u5230\u3002\u8fd9\u79cd\u5bf93\u5468\u671f\u91cd\u590d\u8bbe\u8ba1\u7684\u503e\u5411\u6027\u5728FDA\u6307\u5357\u4e2d\u6ca1\u6709\u88ab\u63d0\u53ca\u3002\uff082\uff09\u6bd4\u8f83\u516c\u5f0f\uff082\uff09\u548c\uff083\uff09\uff0c\u5dee\u522b\u4ec5\u5728\u4e8e\u5bf9\u03c3<\/span>WO<\/span>\u8bbe\u5b9a\u7684\u4e0d\u540c\uff0cFDA\u662f\u6839\u636e\u6570\u7406\u4eff\u771f\u6a21\u62df\uff0c\u5c06\u5e38\u6570\u03c3<\/span>WO<\/span>\u8bbe\u4e3a0.25\uff0c\u800cEMA\u5c06\u03c3<\/span>WO<\/span>\u8bbe\u4e3a0.294\u3002<\/span> \uff083\uff09FDA\u89c4\u5b9a\u53ef\u5c06RSABE\u7b49\u6548\u7f6e\u4fe1\u533a\u95f4\u7684\u8c03\u6574\u5e94\u7528\u4e8e\u53c2\u6570AUC\u548cC<\/span>max<\/span>\u3002\u800cEMA\u53ea\u5c06RSABE\u7b49\u6548\u7f6e\u4fe1\u533a\u95f4\u7684\u8c03\u6574\u5e94\u7528\u4e8eC<\/span>max<\/span>\u3002<\/span>\uff084\uff09FDA\u89c4\u5b9a\u7531\u53d8\u5f02\u7cfb\u6570\u4ece30%\u5f00\u59cb\u4f7f\u7528\u8fd9\u4e2a\u65b9\u6cd5\uff0c\u4e14\u03c3<\/span>WO<\/span>\u8bbe\u4e3a0.25\uff0c\u6545\u53d8\u5316\u66f2\u7ebf\u662f\u4e0d\u8fde\u7eed\u7684\u3002\u8fd9\u4e0eEMA\u63d0\u51fa\u7684RSABE\u65b9\u6cd5\u4e0d\u540c\uff0cEMA\u8bbe\u5b9a\u7684\u03c3<\/span>WO<\/span>\u503c\u4e3a0.294\uff08\u5f53\u53d8\u5f02\u7cfb\u6570\u4e3a30%\uff0c\u8ba1\u7b97\u7684\u03c3<\/span>WR<\/span>\u503c\u4e3a0.294\uff09\uff0c\u53d8\u5316\u66f2\u7ebf\u662f\u8fde\u7eed\u7684\u3002<\/span>\uff085\uff09EMA\u91c7\u7528RSABE\u7b49\u6548\u7f6e\u4fe1\u533a\u95f4\u7684\u8c03\u6574\u6700\u5bbd\u53ea\u523069.84%~143.19%\uff0c\u5f53CV\u8d85\u51fa50%\uff0cCV\u5347\u9ad8\uff0c\u4f46\u7f6e\u4fe1\u533a\u95f4\u4e0d\u518d\u653e\u5bbd\uff0c\u800cFDA\u4e2d\u6ca1\u6709\u8fd9\u4e00\u9650\u5236\u3002\u56fe3\u4e2d\u53ef\u4ee5\u770b\u51faFDA\u89c4\u5b9a\u7684\u751f\u7269\u7b49\u6548\u9650\u8303\u56f4\u8981\u6bd4EMA\u89c4\u5b9a\u8303\u56f4\u8981\u5bbd\u3002<\/span><\/p>\n

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2.4  \u56fd\u9645\u6307\u5357\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u76f8\u4f3c\u548c\u4e0d\u540c\u70b9<\/span><\/section>\n<\/blockquote>\n
\n

<\/span><\/section>\n<\/blockquote>\n

\u5404\u56fd\u5728\u6cd5\u89c4\u4e2d\u7528\u5404\u79cd\u5404\u6837\u7684\u65b9\u6cd5\u51cf\u5c11\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u4e2d\u53d7\u8bd5\u8005\u4f8b\u6570\u7684\u9009\u62e9\u3002\u65e5\u672c\u3001\u65b0\u52a0\u5761\u3001\u4e1c\u76df\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u7684\u76f8\u5e94\u6307\u5357\u4e2d\u5efa\u8bae\u91c7\u7528\u7a33\u6001\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u51cf\u5c11\u53d8\u5f02\u6027\uff0c\u65e5\u672c\u6cd5\u89c4\u540c\u65f6\u63d0\u51fa\u53ef\u5bf9\u9ad8\u53d8\u5f02\u836f\u7269\u91c7\u7528\u7a33\u5b9a\u540c\u4f4d\u7d20\u7684\u65b9\u6cd5\uff0c\u4f46\u8fd9\u6216\u8bb8\u9700\u8981\u5927\u91cf\u7684\u53d7\u8bd5\u8005\u4f8b\u6570\u3002EMA\u548c\u7f8e\u56fdFDA\u6307\u5357\u63a8\u8350\u4f7f\u7528\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\uff0c\u7528RSABE\u8fd9\u79cd\u65b9\u6cd5\uff0c\u53c2\u6bd4\u5236\u5242\u5fc5\u987b\u670d\u75282\u6b21\u6765\u786e\u5b9a\u4e2a\u4f53\u5185\u53d8\u5f02\u6027\uff0c\u7b49\u6548\u9650\u7684\u8303\u56f4\u968f\u7740\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u800c\u5b9a\u3002\u53e6\u5916\uff0cEMA\u6cd5\u89c4\u53ea\u5728Cmax\u4e2d\u91c7\u7528RSABE\uff0c\u800c\u7f8e\u56fd\u6cd5\u89c4\u5bf9\u4e8eAUC\u548cCmax\u90fd\u91c7\u7528RSABE\u3002\u6fb3\u5927\u5229\u4e9a\u91c7\u7528EMA\u7684\u65b9\u6cd5\u3002\u52a0\u62ff\u5927\u6cd5\u89c4\u6ca1\u6709\u523b\u610f\u533a\u5206\u9ad8\u53d8\u5f02\u836f\u7269\u3002<\/p><\/blockquote>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"<\/p>\n

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

3.\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u95ee\u9898<\/span><\/strong><\/span><\/p>\n<\/section>\n

<\/section>\n
<\/section>\n<\/section>\n<\/blockquote>\n


<\/p>\n

\n
<\/section>\n
<\/section>\n
<\/section>\n
3.1  FDA\u548cEMA\u5173\u4e8e\u6837\u672c\u91cf\u4f30\u7b97<\/span><\/section>\n<\/blockquote>\n

\u968f\u7740\u4e2a\u4f53\u53d8\u5f02\u6027\u7684\u589e\u52a0\uff0c\u5728\u4ea4\u53c9\u8bbe\u8ba1\u4e2d\u7684\u53d7\u8bd5\u8005\u4f8b\u6570\u4e5f\u8981\u76f8\u5bf9\u589e\u52a0\u3002\u5047\u8bbe\u5176\u4ed6\u56e0\u7d20\u4fdd\u6301\u4e0d\u53d8\uff0c\u56e0\u6b64\uff0c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97\u53d6\u51b3\u4e8e\u68c0\u9a8c\u6c34\u51c6\u3001\u68c0\u9a8c\u6548\u80fd\u3001\u836f\u4ee3\u53c2\u6570\u6307\u6807\uff08AUC\u3001Cmax \u7b49\uff09\u7684\u4e2a\u4f53\u53d8\u5f02\u548c\u8bd5\u9a8c\u836f\u548c\u53c2\u6bd4\u836f\u5f85\u8bc4\u4ef7\u836f\u4ee3\u53c2\u6570\u6307\u6807\u7684\u5dee\u503c\u53ca\u8bbe\u5b9a\u7684\u7b49\u6548\u9650\u503c\u3002\u5982\u4e0b\u5f0f7\uff1a<\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\" ……….(7)<\/span><\/p>\n

ne\uff1a\u4e24\u5468\u671f\u4ea4\u53c9\u8bd5\u9a8c\u6240\u9700\u8981\u7684\u6837\u672c\u4f8b\u6570<\/p>\n

n\uff1a\u9884\u8bd5\u9a8c\u7684\u6837\u672c\u91cf<\/p>\n

CV\uff1a\u53d8\u5f02\u7cfb\u6570<\/p>\n

v\uff1a\u751f\u7269\u7b49\u6548\u9650\uff08\u4ee5\u5bf9\u6570\u503c\u8868\u793a\uff09<\/p>\n

\u03b4\uff1a\u8bd5\u9a8c\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u5dee\u5f02\uff08\u4ee5\u51e0\u4f55\u5747\u6570\u6bd4\u7684\u5bf9\u6570\u503c\u8868\u793a\uff09<\/p>\n

\u03b1\uff1a\u68c0\u9a8c\u6c34\u51c6\uff0c\u53c8\u79f0\u663e\u8457\u6027\u6c34\u5e73\uff0c\u901a\u5e38\u53d65%\uff0c\u662f\u72af\u7b2cI\u7c7b\u9519\u8bef\u7684\u6982\u7387\u3002<\/p>\n

\u03b2\uff1a\u03b2\u662f\u72af\u7b2c\u2161\u7c7b\u9519\u8bef\u7684\u6982\u7387\uff0c\u4e5f\u5c31\u662f\u628a\u5b9e\u9645\u6709\u6548\u8bef\u5224\u4e3a\u65e0\u6548\u7684\u6982\u7387\u30021-\u03b2\u8868\u793a\u68c0\u9a8c\u6548\u80fd\uff1b\u5373\u628a\u63e1\u5ea6\u7684\u5927\u5c0f\uff0c\u4e00\u822c\u4e0d\u5c0f\u4e8e80%\u3002<\/p>\n

\u3000\u3000<\/span><\/p>\n

\u53ef\u6839\u636ene\u7ed3\u679c\u6765\u4f30\u8ba1\u53c2\u6bd4\u5236\u5242\u91cd\u590d\u8bbe\u8ba1\u7684BE\u7814\u7a76\u6837\u672c\u91cf\uff0c\u5176\u4e2d\u90e8\u5206\u91cd\u590d\u7684\u4e09\u5468\u671f\u8bbe\u8ba1\u6837\u672c\u91cf\u4e00\u822c\u4e3ane\u7684\u56db\u5206\u4e4b\u4e09\uff0c\u800c\u5b8c\u5168\u91cd\u590d\u7684\u56db\u5468\u671f\u8bd5\u9a8c\u8bbe\u8ba1\u6837\u672c\u91cf\u4e00\u822c\u4e3ane\u7684\u4e8c\u5206\u4e4b\u4e00\u3002<\/p>\n

\u8ba1\u7b97\u6b65\u9aa4\u5982\u4e0b\uff1a<\/p>\n

\uff081\uff09\u8ba1\u7b97\u53c2\u6bd4\u5236\u5242\u4e2a\u4f53\u6807\u51c6\u5deeSWR\uff0c\u53ef\u7528\u4ee5\u4e0b\u516c\u5f0f8\u8ba1\u7b97\uff1a<\/p>\n

 \"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"<\/span>……….(8)<\/span><\/p>\n

\uff082\uff09\u6839\u636e\u524d\u9762\u516c\u5f0f2\u6216\u516c\u5f0f6\u8ba1\u7b97\u751f\u7269\u7b49\u6548\u9650\uff1b<\/p>\n

\uff083\uff09 \u6839\u636e\u516c\u5f0f9\u548c10\u5206\u522b\u8ba1\u7b97EMA\u548cFDA\u7684\u4ee5\u5bf9\u6570\u503c\u8868\u793a\u7684\u751f\u7269\u7b49\u6548\u9650\uff1b<\/p>\n

     v=0.76*SWR……….(9)<\/p>\n

     v=0.893*SWR……….(10)<\/p>\n

\uff084\uff09\u03b4\u5206\u522b\u7528\u516c\u5f0f11\u8ba1\u7b97\uff1b<\/p>\n

    \u03b4=|ln(GMR)|……….(11)<\/p>\n

\uff085\uff09\u4ee3\u5165\u4e8c\u5468\u671f\u4ea4\u53c9\u5b9e\u9a8c\u516c\u5f0f7\u5373<\/span>\u53ef\u5f97ne\uff1b<\/p>\n

\uff086\uff09\u636e\u5177\u4f53\u8bd5\u9a8c\u8bbe\u8ba1\u7c7b\u578b\u4f30\u8ba1\u6837\u672c\u91cf\u3002<\/p>\n


<\/p>\n

\u53c2\u8003Phani\u6587\u732e\u4e2d\u7ed9\u51fa\u7684\u8868\u683c\uff0c\u672c\u6587\u7ed9\u51fa\u4e8680%\u68c0\u9a8c\u6548\u80fd\u56db\u5468\u671f\u8bd5\u9a8c\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97\u7684\u8868\u683c\uff0c\u6309EMA\u548cFDA\u6307\u5357\u8981\u6c4280%\u68c0\u9a8c\u6548\u80fd\u56db\u5468\u671f\u4ea4\u53c9\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97\u8868\u5206\u522b\u89c1\u88682\u548c\u88683\uff0c\u4e09\u5468\u671f\u6837\u672c\u91cf\u53ef\u6839\u636e\u516c\u5f0f\u81ea\u884c\u63a8\u7b97\u3002\u6587\u732e21\u4e2d\u8fd8\u63d0\u4f9b\u4e8690%\u68c0\u9a8c\u6548\u80fd\u4e09\u5468\u671f\u6216\u56db\u5468\u671f\u91cd\u590d\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97\u8868\u683c\uff0c\u8bfb\u8005\u53ef\u6839\u636e\u9700\u8981\u81ea\u884c\u53c2\u8003\u3002<\/p>\n

\u88682  FDA\u5173\u4e8e\u56db\u5468\u671f\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97<\/span><\/strong><\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"
<\/p>\n


<\/p>\n

\u88683  EMA\u5173\u4e8e\u56db\u5468\u671f\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97<\/span><\/strong><\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"
<\/p>\n

\n

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<\/section>\n
<\/section>\n
3.2  FDA\u548cEMA\u6837\u672c\u4f30\u7b97\u7684\u533a\u522b\u4e0e\u8054\u7cfb<\/span><\/section>\n<\/blockquote>\n

\u4ece\u4e0a\u8ff0\u8868\u683c\u53ef\u4ee5\u53d1\u73b0FDA\u76f8\u8f83\u4e8eEMA\u9700\u8981\u53d7\u8bd5\u8005\u4f8b\u6570\u66f4\u5c11\u3002FDA\u66f4\u6709\u5229\u4e8e\u7533\u529e\u65b9\u7684\u9700\u6c42\uff0c\u56fe3\u662fFDA\u548cEMA\u5728\u53d8\u5f02\u7cfb\u6570\u5927\u4e8e\u7b49\u4e8e30%\u65f6\u7684\u6837\u672c\u542b\u91cf\u9700\u8981\u3002\u56fe3\u4e5f\u663e\u793a\u4e86\u5728\u53d8\u5f02\u5ea6\u5c0f\u4e8e30%\u7684\u6837\u672c\u542b\u91cf\u4f30\u7b97\uff0c\u5728\u53d8\u5f02\u7cfb\u6570\u5c0f\u4e8e30%\uff0c\u6837\u672c\u542b\u91cf\u968f\u7740\u53d8\u5f02\u7cfb\u6570\u589e\u52a0\u800c\u589e\u52a0\uff0c\u53d8\u5f02\u5ea6\u8d85\u8fc730%\u91c7\u7528\u6bd4\u4f8b\u5316\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\uff0c\u5f53GMR=1.0\u65f6\uff0c\u6837\u672c\u542b\u91cf\u53d8\u5316\u5f88\u5c0f\u3002\u5f53GMR\u504f\u79bb1.0\uff0c\u4f8b\u59821.1\u65f6\uff0c\u6837\u672c\u542b\u91cf\u968f\u7740\u53d8\u5f02\u7cfb\u6570\u589e\u52a0\u800c\u51cf\u5c11\u3002<\/p>\n


<\/p>\n

\u5728EMA\u4e2d\u5f53CV=30%\u65f6\uff0c\u4e0d\u7ba1\u91c7\u7528\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u8fd8\u662f\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u6837\u672c\u542b\u91cf\u662f\u4e0d\u53d8\u7684\u3002\u76f8\u53cd\uff0c\u5728FDA\u4e2d\u5f53CV=30%\u7684\u65f6\u5019\uff0c\u6837\u672c\u542b\u91cf\u662f\u53d8\u5316\u7684\uff0c\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u9700\u8981\u7684\u53d7\u8bd5\u8005\u4f8b\u6570\u662f\u5927\u4e8e\u6bd4\u4f8b\u5316\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u7684\u3002FDA\u63d0\u51fa\u7684\u6cd5\u89c4\u53ef\u80fd\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\u5b58\u5728\u66f4\u5927\u7684\u6d88\u8d39\u8005\u98ce\u9669\u3002<\/p>\n

\u7531FDA\u548cEMA\u63d0\u51fa\u7684\u6837\u672c\u542b\u91cf\u4f30\u7b97\u7684\u7279\u5f81\u8fdb\u4e00\u6b65\u53ef\u53d1\u73b0\uff0c\u4e24\u6837\u672c\u542b\u91cf\u7684\u5dee\u5f02\u968f\u7740\u53d8\u5f02\u5ea6\u7684\u589e\u52a0\u800c\u51cf\u5c11\u3002\u662f\u56e0\u4e3a\u5728FDA\u4e2d\u51e0\u4f55\u5747\u503c\u6bd4\u9650\u5ea6\u5f71\u54cd\u7b49\u6548\u9650\u8303\u56f4\u6bd4EMA\u7684\u5927\u3002\u5f53\u53d8\u5f02\u5ea6\u5927\u4e8e50%\u65f6\uff0cEMA\u4e2d\u968f\u7740\u53d8\u5f02\u5ea6\u7684\u589e\u52a0\u6837\u672c\u542b\u91cf\u589e\u52a0\u7684\u901f\u5ea6\u662f\u9ad8\u4e8eFDA\u7684\uff0c\u56e0\u4e3aEMA\u4e2d\u53d8\u5f02\u5ea6\u5927\u4e8e50%\u65f6\uff0c\u751f\u7269\u7b49\u6548\u9650\u662f\u4e0d\u53d8\u7684\uff0c\u800cFDA\u6ca1\u6709\u8fd9\u6837\u4e00\u4e2a\u9650\u5236\u3002<\/p>\n

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

\u56fe3 FDA\u548cEMA\u6837\u672c\u542b\u91cf\u968f\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\u53d8\u5316\u7684\u6bd4\u8f83\u56fe<\/span><\/strong><\/p>\n


<\/p>\n

\"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"
<\/span><\/p>\n


<\/p>\n

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

3.3\u6837\u672c\u4f30\u7b97\u4e3e\u4f8b<\/span><\/p><\/blockquote>\n

\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97\u95ee\u9898\u540c\u6837\u662f\u4e00\u4e2a\u590d\u6742\u4e14\u8feb\u5207\u7684\u73b0\u5b9e\u95ee\u9898\uff0c\u672c\u6587\u53c2\u8003Phani\u63d0\u51fa\u7684\u6837\u672c\u542b\u91cf\u4f30\u7b97\u65b9\u6cd5\uff0c\u7ed9\u51fa\u4e86\u516c\u5f0f\u6cd5\u3001\u67e5\u8868\u6cd5\u53ca\u8f6f\u4ef6\u6cd5\u4e09\u79cd\u65b9\u6cd5\u89e3\u51b3\u9ad8\u53d8\u5f02\u836f\u7269\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u9700\u8981\u7684\u6837\u672c\u4f8b\u6570\u95ee\u9898\u3002\u4ee5\u4e0b\u63d0\u51fa\u4e00\u4e2a\u5047\u8bbe\u5e76\u4e14\u7ed9\u51fa\u4e86\u6837\u672c\u4f30\u7b97\u65b9\u6cd5\u5b9e\u4f8b\u3002<\/p>\n


<\/p>\n

\u3010\u5b9e\u4f8b\u3011<\/strong>  \u5047\u5982\u5728\u8fdb\u884c\u4e00\u4e2a\u8bd5\u9a8c\u836f\u7269\u7684BE\u9884\u8bd5\u9a8c\u4e2d\uff0c\u9884\u8bd5\u9a8c\u7684\u6837\u672c\u6570\u662f12\u4f8b\uff0c\u5f97\u5230\u53c2\u6570Cmax\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570CV\u4e3a0.32\uff0c\u9884\u8bd5\u9a8c\u5f97\u5230\u7684Cmax\u7684\u51e0\u4f55\u5747\u6570\u6bd4\u4e3a0.95\uff0c\u90a3\u4e48\u5982\u679c\u8fdb\u884c\u4e00\u4e2a\u56db\u4ea4\u53c9\uff08\u03b1\u4e3a0.05\u3001\u03b2\u4e3a0.20\uff09\u7684BE\u6b63\u5f0f\u7814\u7a76\uff0c\u81f3\u5c11\u9700\u8981\u591a\u5c11\u6837\u672c\u91cf\u3002<\/p>\n

\u6839\u636e\u516c\u5f0f\u8ba1\u7b97\u6b65\u9aa4\u5982\u4e0b\uff1a<\/p>\n

\u6839\u636eFDA\u7684\u6cd5\u89c4\u8981\u6c42\uff1a<\/p>\n

    \n
  • \n

    \u5df2\u77e5\uff1aCV=0.32   <\/p>\n<\/li>\n

  • \n

    \u7531\u516c\u5f0f8\u53ef\u5f97\u5230SWR=0.312<\/p>\n<\/li>\n

  • \n

    \u7531\u516c\u5f0f2\u53ef\u5f97\u5230BE\u7b49\u6548\u754c\u503c\u53ef\u653e\u5bbd\u81f3[0.757 ,1.32]<\/p>\n<\/li>\n

  • \n

    \u7531\u516c\u5f0f10\u300111\u53ef\u5f97\u5230V=0.892*0.312=0.278<\/p>\n<\/li>\n

  • \n

    \u03b4 =|ln(0.95)|= 0.0513<\/p>\n<\/li>\n

  • \n

    t(\u03b1,2n-2),t(\u03b2,2n-2)\u503c\u5206\u522b\u4e3a1.71\u30010.858<\/p>\n<\/li>\n

  • \n

    \u7528\u516c\u5f0f\u5373\u5f97\u5230ne=25.973\u224826<\/p>\n<\/li>\n

  • \n

    \u7531\u4e8e\u662f\u56db\u5468\u671f\u4ea4\u53c9\u8bd5\u9a8c  \u6545n\u224813<\/p>\n<\/li>\n

  • \n

    \u540c\u7406\u6839\u636eEMA\u7684\u6cd5\u89c4\u8981\u6c42\uff1a<\/p>\n<\/li>\n

  • \n

    \u7528\u516c\u5f0f\u5373\u5f97\u5230ne=39.245<\/p>\n<\/li>\n

  • \n

    \u7531\u4e8e\u662f\u56db\u5468\u671f\u4ea4\u53c9\u8bd5\u9a8c  \u6545n\u224820<\/p>\n<\/li>\n

  • \n

    \u6240\u9700\u6837\u672c\u542b\u91cf\u4e3a20\u3002<\/p>\n<\/li>\n

  • \n

    \u67e5\u88682\u548c\u88683\u53ef\u77e5\uff1a<\/p>\n<\/li>\n

  • \n

    \u5f53CV=32%\u65f6<\/p>\n<\/li>\n

  • \n

    \u67e5FDA\u5173\u4e8e\u56db\u5468\u671f\u8bd5\u9a8c\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97\u8868\u683c\u53ef\u77e5\uff1an=13  \u4e0e\u8ba1\u7b97\u7ed3\u679c\u4e00\u81f4<\/p>\n<\/li>\n

  • \n

    \u67e5EMA\u5173\u4e8e\u56db\u5468\u671f\u8bd5\u9a8c\u8bd5\u9a8c\u6837\u672c\u542b\u91cf\u4f30\u7b97\u8868\u683c\u53ef\u77e5\uff1an=20  \u4e0e\u8ba1\u7b97\u7ed3\u679c\u4e00\u81f4<\/p>\n<\/li>\n<\/ul>\n


    <\/p>\n

    \u6211\u4eec\u4e5f\u53ef\u901a\u8fc7\u4e00\u4e9b\u7edf\u8ba1\u5b66\u8f6f\u4ef6\u6765\u5bf9\u6837\u672c\u91cf\u8fdb\u884c\u8ba1\u3002PASS\uff0c nQuery\uff0cS + \u548c SAS \u7b49\u8f6f\u4ef6\u90fd\u53ef\u8ba1\u7b97\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7684\u6837\u672c\u91cf\u3002\u4e0b\u9762\u4ee5PASS\u4e3a\u4f8b\uff0c\u4ecb\u7ecd\u901a\u8fc7\u8f6f\u4ef6\u8ba1\u7b97\u7684\u6b65\u9aa4\u3002\u6211\u4eec\u4ecd\u662f\u901a\u8fc7\u4e24\u5468\u671f\u53cc\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u6837\u672c\u91cf\u6765\u4f30\u7b97\u4f30\u8ba1\u53c2\u6bd4\u5236\u5242\u91cd\u590d\u8bbe\u8ba1\u7684BE\u7814\u7a76\u6837\u672c\u91cf\u3002<\/p>\n


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

    \u8fd0\u884cPASS\u8f6f\u4ef6\uff0c\u9009\u62e9\u201cmeans\u201d \u2192 \u201ctwo means\u201d\u2192\u201c2\u00d72Cross-Over designs\u201d \u2192 \u201cEquivalence Tests using Ratios\u201d\u51fa\u73b0\u5982\u56fe4\u6240\u793a\u7a97\u53e3\uff0c\u7136\u540e\u5728\u201cfind\uff08solve for\uff09\u201d\u9009\u62e9\u201cN\u201d\uff0c\u5373\u8ba1\u7b97\u6837\u672c\u542b\u91cf\uff1b\u9009\u62e9power=0.8\u3001\u03b1=0.05\uff1bRU\uff08\u7b49\u6548\u6807\u51c6\u4e0a\u9650\uff09\u9009\u62e91.321\uff08\u6839\u636e\u516c\u5f0f2\u7b97\u51fa\uff09\uff0cRL\uff08\u7b49\u6548\u6807\u51c6\u4e0b\u9650\uff09\u9009\u62e90.757\uff08\u6839\u636e\u516c\u5f0f2\u7b97\u51fa\uff09\uff1bR1\uff08True Ratio\uff09\u4e3a0.95\uff1bCOV\uff08Coefficient of Variation\uff0c\u53d8\u5f02\u7cfb\u6570\uff09\u586b\u51650.32\u3002\u9009\u62e9\u6216\u586b\u597d\u4ee5\u4e0a\u6570\u5b57\u540e\uff0c\u5355\u51fb\u201crun\u201d\u8fd0\u884c\u3002\u8fd0\u884c\u7ed3\u679c\u5982\u56fe5\u6240\u793a\uff0c\u6309FDA\u7b49\u6548\u9650\u8ba1\u7b972\u5468\u671f\u6837\u672c\u542b\u91cf\u4f30\u8ba1\u7ed3\u679c\u4e3a27\u4f8b\uff0c\u56db\u5468\u671f\u5373\u4e3a13\u4f8b\u3002<\/p>\n


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

    \u5982\u4e0a\u6cd5\u6309EMA\u7b49\u6548\u9650\u8303\u56f4RU\uff08\u7b49\u6548\u6807\u51c6\u4e0a\u9650\uff09\u9009\u62e91.268\uff08\u6839\u636e\u516c\u5f0f2\u7b97\u51fa\uff09\uff0cRL\uff08\u7b49\u6548\u6807\u51c6\u4e0b\u9650\uff09\u9009\u62e90.789\uff08\u6839\u636e\u516c\u5f0f2\u7b97\u51fa\uff09\u5982\u56fe6\u8ba1\u7b972\u5468\u671f\u6837\u672c\u542b\u91cf\u4e3a38\u4f8b\uff0c\u56db\u5468\u671f\u4e3a19\u4f8b\u3002\u4e0e\u516c\u5f0f\u6cd5\u548c\u67e5\u8868\u7684\u7ed3\u679c\u57fa\u672c\u4e00\u81f4\u3002<\/p>\n


    <\/p>\n

    \u56fe4 \u6839\u636eFDA\u89c4\u5b9a\u7684\u7b49\u6548\u9650\u8ba1\u7b97\u7684\u6837\u672c\u542b\u91cf\u7ed3\u679c<\/span><\/strong><\/span><\/p>\n

    \"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\" <\/span><\/p>\n

    \u56fe5  \u6839\u636eEMA\u89c4\u5b9a\u7684\u7b49\u6548\u9650\u8ba1\u7b97\u7684\u6837\u672c\u542b\u91cf\u7ed3\u679c<\/span><\/strong><\/span><\/p>\n

    \"\u3010\u6536\u85cf\u3011\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u53ca\u91cf\u5316\u8bc4\u4ef7\"
     <\/span><\/p>\n

    \u4ee5\u4e0a\u4e09\u79cd\u8ba1\u7b97\u7684\u7ed3\u679c\u6709\u5c11\u8bb8\u7684\u5dee\u5f02\u662f\u56e0\u4e3a\u8f6f\u4ef6\u6837\u672c\u91cf\u4f30\u7b97\u65f6\u6ca1\u6709\u8003\u8651\u9884\u8bd5\u9a8c\u7684\u4f8b\u6570\u3002\u836f\u5b66\u5de5\u4f5c\u8005\u5728\u4ee5\u540e\u8fdb\u884c\u9ad8\u53d8\u5f02\u836f\u7269\u6837\u672c\u542b\u91cf\u4f30\u7b97\u65f6\u53ef\u4ee5\u53c2\u8003\u4ee5\u4e0a\u4efb\u4f55\u4e00\u79cd\u65b9\u6cd5\u5bf9\u6837\u672c\u91cf\u8fdb\u884c\u4f30\u7b97\u3002\u9700\u8981\u6ce8\u610f\u7684\u5730\u65b9\u662f\uff0c\u672c\u6587\u4ecb\u7ecd\u7684\u6837\u672c\u91cf\u4f30\u7b97\u662f\u57fa\u4e8e\u7edf\u8ba1\u5b66\u8003\u8651\u6240\u9700\u7eb3\u5165\u7684\u6700\u4f4e\u6837\u672c\u91cf\uff0c\u5728\u5b9e\u9645\u65b9\u6848\u8bbe\u8ba1\u4e2d\u8fd8\u5e94\u8003\u8651\u5230\u8bd5\u9a8c\u4e2d\u53d7\u8bd5\u8005\u8131\u843d\u7684\u53ef\u80fd\u6027\uff0c\u4ee5\u53ca\u836f\u76d1\u90e8\u95e8\u6cd5\u89c4\u6240\u8bbe\u5b9a\u7684\u6700\u4f4e\u6837\u672c\u8981\u6c42\uff0c\u4e00\u822c\u9700\u8981\u7b5b\u9009\u9002\u5f53\u591a\u4e00\u4e9b\u7684\u53d7\u8bd5\u8005\u5165\u7ec4\u8bd5\u9a8c\u3002<\/p>\n


    <\/p>\n

    \u7efc\u4e0a\u6240\u8ff0\uff0c\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8bc4\u4ef7\u662f\u4e00\u4e2a\u6bd4\u8f83\u590d\u6742\u7684\u95ee\u9898\uff0c\u540c\u65f6\u4e5f\u662f\u4e00\u4e2a\u5f15\u4eba\u5173\u6ce8\u7684\u73b0\u5b9e\u8bfe\u9898\u3002FDA\u548cEMA\u6240\u63d0\u51fa\u7684RSABE\u6cd5\u662f\u6839\u636e\u53c2\u6bd4\u5236\u5242\u4e2a\u4f53\u53d8\u5f02\u5bf9\u7b49\u6548\u9650\u8fdb\u884c\u6bd4\u4f8b\u5316\u8c03\u6574\uff0c\u53ef\u907f\u514d\u7eb3\u5165\u8fc7\u591a\u53d7\u8bd5\u8005\u53c2\u52a0\u8bd5\u9a8c\uff0c\u964d\u4f4e\u8bd5\u9a8c\u6210\u672c\uff0c\u63d0\u9ad8\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53ef\u64cd\u4f5c\u6027\u3002\u4f46\u5173\u4e8e\u5177\u4f53\u7684\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u56fd\u5185\u76ee\u524d\u5c1a\u65e0\u4e13\u95e8\u7684\u6307\u5bfc\u539f\u5219, \u836f\u76d1\u90e8\u95e8\u672a\u51fa\u53f0\u76f8\u5e94\u8bc4\u4ef7\u7ec6\u5219\uff0c\u8fd8\u9700\u5927\u91cf\u8bd5\u9a8c\u57fa\u7840\u4e0e\u7406\u8bba\u7684\u7ed3\u5408\uff0c\u9700\u8981\u66f4\u52a0\u6df1\u5165\u7ec6\u81f4\u7684\u7814\u7a76\u548c\u63a2\u8ba8\u3002\u56e0\u6b64\u6ce8\u518c\u7533\u8bf7\u4eba\u548c\u4e34\u5e8a\u7814\u7a76\u5355\u4f4d\u5728\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u524d\u9700\u8981\u5145\u5206\u638c\u63e1\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u8be6\u7ec6\u7684\u836f\u7269\u4ee3\u8c22\u60c5\u51b5\u53ca\u5176\u4e2a\u4f53\u5185\u7684\u53d8\u5f02\u60c5\u51b5\uff0c \u5224\u522b\u7814\u7a76\u7684\u836f\u7269\u6709\u6ca1\u6709\u9ad8\u53d8\u5f02\u7684\u5c5e\u6027\u3002 \u5982\u679c\u662f\u9ad8\u53d8\u5f02\u836f\u7269\uff0c\u8fd8\u9700\u4e86\u89e3\u836f\u7269\u7684\u5b89\u5168\u8303\u56f4\uff0c\u5982\u679c\u8ba4\u4e3aCmax\u5dee\u5f02\u8f83\u5927\u5bf9\u4e8e\u4e34\u5e8a\u7684\u5f71\u54cd\u4e0d\u5927\uff0c\u57fa\u4e8e\u4e34\u5e8a\u7684\u5145\u5206\u7406\u7531\uff0c\u5219\u53ef\u4ee5\u653e\u5bbdCmax\u7b49\u6548\u63a5\u53d7\u8303\u56f4\uff0c\u9274\u4e8eEMA\u7684\u65b9\u6cd5\u66f4\u52a0\u4e25\u683c\uff0c\u56fd\u5185\u7533\u8bf7\u4eba\u5728\u8fdb\u884c\u9ad8\u53d8\u5f02\u4eff\u5236\u836fBE\u7814\u7a76\u4e2d\u5e94\u5c3d\u91cf\u91c7\u7528EMA\u7684\u6807\u51c6\uff0c\u5e76\u9009\u62e9\u5408\u9002\u7684\u6837\u672c\u542b\u91cf\u8fdb\u884c\u7814\u7a76\u3002<\/p>\n


    <\/p>\n

    \u8feb\u5207\u5e0c\u671b\u56fd\u5bb6\u6709\u5173\u90e8\u95e8\u65e9\u65e5\u51fa\u53f0\u66f4\u52a0\u79d1\u5b66\u89c4\u8303\u7684\u6307\u5357\u5bf9\u9ad8\u53d8\u5f02\u836f\u7269\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8fdb\u6307\u5bfc\uff0c\u4e3a\u56fd\u5185\u4e34\u5e8a\u7814\u7a76\u5355\u4f4d\u89e3\u51b3\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u95ee\u9898\u63d0\u4f9b\u53ef\u91c7\u7eb3\u7684\u65b9\u6cd5, \u4ece\u800c\u66f4\u52a0\u79d1\u5b66\u53ef\u9760\u5730\u8bc4\u4ef7\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u3002<\/p>\n

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


    <\/p>\n

    \u6587\u7ae0\u6765\u6e90\uff1a\u4eff\u5236\u836f\u8bba\u575b\uff0c\u836f\u7814\u7f16\u8f91\u6574\u7406<\/span><\/em><\/p>\n


    <\/p>\n

    \n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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