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    \u5728\u65f6\u9694\u8fd14\u5e74\u540e\uff0c\u56fd\u52a1\u9662\u518d\u63d0\u8fd9\u4e2a\u5de5\u4f5c\uff0c\u540c\u65f6\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u81ea\u67e5\u7c7b\u4f3c\uff0c\u4eba\u6c11\u65e5\u62a5\u914d\u5408\u53d1\u6587\u5ba3\u4f20\uff0c\u800c\u8fdb\u51652016\u5e74\uff0c\u56fd\u52a1\u9662\u3001CFDA\u5bc6\u96c6\u3001\u9ad8\u9891\u51fa\u53f0\u76f8\u5173\u7ec6\u8282\u5de5\u4f5c\u63a8\u8fdb\u6b64\u9879\u5de5\u4f5c\uff0c\u53ef\u4ee5\u770b\u51fa\u76d1\u7ba1\u5c42\u5bf9\u4e8e\u63d0\u9ad8\u56fd\u5185\u4eff\u5236\u836f\u8d28\u91cf\u7684\u51b3\u5fc3\u3002\u5f53\u524d\u9636\u6bb5\u7684\u5177\u4f53\u4efb\u52a1\uff0c\u662f2018\u5e74\u5e95\u8981\u5b8c\u62102007\u5e7410\u67081\u65e5\u524d\u6279\u51c6\u7684\u300a\u56fd\u5bb6\u57fa\u672c\u836f\u7269\u76ee\u5f55\u300b\u4e2d\u5316\u5b66\u836f\u54c1\u4eff\u5236\u836f\u53e3\u670d\u56fa\u4f53\u5236\u5242\u7684\u8d28\u91cf\u4e00\u81f4\u6027\u8bc4\u4ef7\u3002<\/p>\n\n\n\n

    \u6211\u4eec\u518d\u6765\u770b\u770b\u7f8e\u56fd\u7684\u4eff\u5236\u836f\u76d1\u7ba1<\/strong><\/p>\n\n\n\n

    \u4e0a\u4e16\u7eaa60\u5e74\u4ee3\uff0c\u7f8e\u56fd\u201c\u53cd\u5e94\u505c\u201d\u4e8b\u4ef6\u7206\u53d1\uff0c\u968f\u540e\u7f8e\u56fd\u901a\u8fc7\u300aKefauver-Harris\u836f\u54c1\u4fee\u6b63\u6848\u300b\u7b2c\u4e00\u6b21\u89c4\u5b9aNDA\u5fc5\u987b\u5305\u542b\u5bf9\u4e8e\u836f\u7269\u6709\u6548\u6027\u7684\u201c\u5b9e\u8d28\u6027\u8bc1\u636e\u201d\uff0c\u5728\u6b64\u4e4b\u524d\u5e76\u672a\u5bf9\u836f\u54c1\u672c\u8eab\u7684\u6709\u6548\u6027\u8fdb\u884c\u5f3a\u5236\u8981\u6c42\u3002\u968f\u540e\u57281966\u5e74FDA\u5b9e\u65bd\u836f\u6548\u8bc4\u4ef7\u9879\u76ee\uff08Drug Efficacy Study Implementation\uff09\uff0c\u7528\u4e09\u5e74\u5b8c\u6210\u4e8624\u5e74\uff081938\uff5e1962\uff09\u5185\u6279\u51c6\u76843443\u4e2a\u836f\u54c1\u6709\u6548\u6027\u8bc4\u4ef7\u3002\u6700\u7ec8\u7ed3\u679c\u786e\u8bc12225\u4e2a\u54c1\u79cd\u6709\u6548\uff0864.62%\uff09\u30011051\u4e2a\u54c1\u79cd\u65e0\u6548\uff0830.53%\uff09\u3001167\u4e2a\u54c1\u79cd\u65e0\u7ed3\u679c\uff084.85%\uff09\u3002FDA\u5bf9\u4eff\u5236\u836f\u7684\u76d1\u7ba1\u8981\u6c42\u662f\u4ee5\u4e0e\u539f\u7814\u836f\u6cbb\u7597\u7b49\u6548\u4e3a\u76ee\u6807\uff0c\u6cbb\u7597\u7b49\u6548=\u836f\u5b66\u7b49\u6548+\u751f\u7269\u7b49\u6548\u3002\u5728\u836f\u5b66\u7b49\u6548\u7684\u57fa\u7840\u4e0a\uff0c\u5904\u65b9\u5f00\u53d1\u5fc5\u987b\u57fa\u4e8eBE\u8bd5\u9a8c\u3002\u5b9e\u9645\u4e0a\u76ee\u524dCFDA\u6b63\u5728\u8fdb\u884c\u7684\u4e00\u7cfb\u5217\u6539\u9769\u6b63\u662f\u6548\u4effFDA\u7684\u76d1\u7ba1\u65b9\u6cd5\uff0c\u56e0\u6b64\u6b64\u756a\u5bf9\u4eff\u5236\u836f\u4e00\u81f4\u6027\u7684\u8bc4\u4ef7\u51e0\u7ecf\u5468\u6298\u6700\u7ec8\u786e\u5b9a\u4ee5BE\u8bd5\u9a8c\u4f5c\u4e3a\u6700\u7ec8\u8861\u91cf\u6807\u51c6\u3002<\/p>\n\n\n\n

    \u6211\u4eec\u53ef\u4ee5\u5f97\u51fa\u7ed3\u8bba\uff0c\u4eff\u5236\u836f\u7684\u4e0a\u5e02\u4f1a\u7ecf\u8fc7CFDA\u4e43\u81f3FDA\u7684\u4e25\u683c\u628a\u5173\uff0c\u8fd9\u610f\u5473\u7740\uff0c\u4eff\u5236\u836f\u662f\u7ecf\u8fc7\u5ba1\u6279\u7684\u3001\u6cd5\u5f8b\u8bb8\u53ef\u7684\uff0c\u4e0d\u7b49\u540c\u4e8e\u98df\u54c1\u6216\u5bb6\u7528\u54c1\u5f53\u4e2d\u5f88\u591a\u201c\u4f4e\u8d28\u4f4e\u6548\u201d\u7684\u4eff\u5236\u54c1\uff0c\u66f4\u4e0d\u662f\u5047\u5192\u4f2a\u52a3\u3002\u5bf9\u4e8e\u5f88\u591a\u8d1f\u62c5\u4e0d\u8d77\u6602\u8d35\u7684\u539f\u7814\u836f\u7684\u60a3\u8005\uff0c\u4eff\u5236\u836f\u7684\u51fa\u73b0\u4f7f\u5f97\u4ed6\u4eec\u4e5f\u80fd\u4eab\u53d7\u73b0\u4ee3\u533b\u5b66\u8fdb\u6b65\u7684\u6210\u679c\u3002<\/p>\n\n\n\n

    \u6700\u540e\uff0c\u6211\u4eec\u5bf9\u6bd4\u4e00\u4e0bFDA\u548cCFDA\u5bf9\u4eff\u5236\u836f\u836f\u6548\u8ba4\u8bc1\u7684\u6807\u51c6\uff1a<\/strong><\/p>\n\n\n\n

    FDA\u8981\u6c42\u5236\u836f\u516c\u53f8\u8bc1\u660e\u4eff\u5236\u836f\u53ef\u4ee5\u88ab\u5b8c\u5168\u66ff\u4ee3<\/strong>\uff0c\u5e76\u63d0\u4f9b\u4e0e\u5176\u590d\u5236\u7684\u54c1\u724c\u836f\u76f8\u540c\u7684\u4e34\u5e8a\u76ca\u5904\u3002\u836f\u54c1\u516c\u53f8\u63d0\u4ea4\u7684\u7f29\u5199\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09\u5fc5\u987b\u4ee5\u4e0b\u5217\u65b9\u5f0f\u663e\u793a\u4eff\u5236\u836f\u4e0e\u54c1\u724c\u7248\u76f8\u540c\uff1a\u4eff\u5236\u836f\u4e2d\u7684\u6d3b\u6027\u6210\u5206\u4e0e\u54c1\u724c\u836f\/\u521b\u65b0\u836f\u76f8\u540c\u3002\u8be5\u4eff\u5236\u836f\u5177\u6709\u76f8\u540c\u7684\u5f3a\u5ea6<\/strong>\uff0c\u4f7f\u7528\u9002\u5e94\u75c7\uff0c\u5f62\u5f0f\uff08\u4f8b\u5982\u7247\u5242\u6216\u6ce8\u5c04\u5242\uff09\u548c\u7ed9\u836f\u9014\u5f84\uff08\u4f8b\u5982\u53e3\u670d\u6216\u5c40\u90e8\uff09\u3002\u8be5\u4eff\u5236\u836f\u662f\u5728\u4e0e\u540d\u724c\u836f\u76f8\u540c\u7684\u4e25\u683c\u6807\u51c6\u4e0b\u5236\u9020\u7684\u3002FDA\u5ba1\u67e5\u516c\u53f8\u9500\u552e\u4eff\u5236\u836f\u7684\u7533\u8bf7\u6709\u516b\u4e2a\u4e3b\u8981\u90e8\u5206\uff1a\u5fc5\u987b\u6709FDA\u6279\u51c6\u7684\u54c1\u724c\u836f\u7269\u4f5c\u4e3a\u62df\u8bae\u901a\u7528\u836f\u7269\u7684\u53c2\u8003\u3002\u901a\u7528\u7269\u5fc5\u987b\u5177\u6709\u4e0e\u8be5\u53c2\u8003\u4ea7\u54c1\u76f8\u540c\u7684\u6d3b\u6027\u6210\u5206\u6216\u6210\u5206\u4ee5\u53ca\u76f8\u540c\u7684\u6807\u8bb0\u5f3a\u5ea6\u3002\u5b83\u5fc5\u987b\u5177\u6709\u76f8\u540c\u7684\u5242\u578b \u2013 \u7247\u5242\uff0c\u8d34\u5242\u548c\u6db2\u4f53\u662f\u5242\u578b\u7684\u5b9e\u4f8b\u3002\u5fc5\u987b\u4ee5\u76f8\u540c\u7684\u65b9\u5f0f\u7ed9\u836f\uff0c\u4f8b\u5982\uff0c\u4f5c\u4e3a\u836f\u4e38\u541e\u54bd\u6216\u4f5c\u4e3a\u6ce8\u5c04\u7ed9\u836f\u3002<\/p>\n\n\n\n

    FDA\u4eff\u5236\u836f\u8ba1\u5212\u8fdb\u884c\u4e25\u683c\u5ba1\u67e5\uff0c\u4ee5\u786e\u4fdd\u4eff\u5236\u836f\u7b26\u5408\u8fd9\u4e9b\u8981\u6c42\u3002<\/strong>\u6b64\u5916\uff0cFDA\u6bcf\u5e74\u5bf9\u5236\u9020\u5de5\u5382\u8fdb\u884c3,500\u6b21\u68c0\u67e5\uff0c\u786e\u4fdd\u7b26\u5408\u8be5\u673a\u6784\u5173\u4e8e\u826f\u597d\u751f\u4ea7\u89c4\u8303\u7684\u89c4\u5b9a\u3002FDA\u5de5\u4f5c\u4eba\u5458\u8fd8\u6301\u7eed\u76d1\u63a7\u836f\u54c1\uff0c\u786e\u4fdd\u4f9b\u5e94\u94fe\u5404\u4e2a\u5c42\u9762\u7684\u836f\u54c1\uff0c\u4ece\u6d3b\u6027\u836f\u7269\u6210\u5206\uff08API\uff09\u5230\u9500\u552e\u7ed9\u6d88\u8d39\u8005\u7684\u4ea7\u54c1\uff0c\u90fd\u662f\u5b89\u5168\uff0c\u6709\u6548\u548c\u9ad8\u8d28\u91cf\u7684\u3002\u5982\u679c\u62a5\u544a\u60a3\u8005\u6709\u526f\u4f5c\u7528\u6216\u5176\u4ed6\u53cd\u5e94\uff0cFDA\u4f1a\u8fdb\u884c\u8c03\u67e5\uff0c\u5e76\u5728\u9002\u5f53\u60c5\u51b5\u4e0b\uff0c\u53ef\u80fd\u9700\u8981\u66f4\u6539\u836f\u7269\uff08\u5305\u62ec\u54c1\u724c\u540d\u79f0\u548c\u4eff\u5236\u836f\uff09\u7684\u4f7f\u7528\u6216\u5236\u9020\u65b9\u5f0f\u3002<\/p>\n\n\n\n

    CFDA\u300a\u56fd\u52a1\u9662\u5173\u4e8e\u6539\u9769\u836f\u54c1\u533b\u7597\u5668\u68b0\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u7684\u610f\u89c1\u300b<\/strong>\u4e4b\u7b2c\u516d\u6761\uff1a\u5c06\u4eff\u5236\u836f\u7531\u73b0\u884c\u7684\u201c\u4eff\u5df2\u6709\u56fd\u5bb6\u6807\u51c6\u7684\u836f\u54c1\u201d\u8c03\u6574\u4e3a\u201c\u4eff\u4e0e\u539f\u7814\u836f\u54c1\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u7684\u836f\u54c1\u201d\u3002\u6839\u636e\u4e0a\u8ff0\u539f\u5219\uff0c\u8c03\u6574\u836f\u54c1\u6ce8\u518c\u5206\u7c7b\u3002\u4eff\u5236\u836f\u5ba1\u8bc4\u5ba1\u6279\u8981\u4ee5\u539f\u7814\u836f\u54c1\u4f5c\u4e3a\u53c2\u6bd4\u5236\u5242\uff0c\u786e\u4fdd\u65b0\u6279\u51c6\u7684\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e0e\u539f\u7814\u836f\u54c1\u4e00\u81f4<\/strong>\u3002<\/p>\n\n\n\n

    \u6211\u4eec\u53ef\u4ee5\u5f97\u51fa\u7ed3\u8bba\uff1a\u7ecf\u8fc7FDA\u6216CFDA\u5ba1\u6838\u7684\u4eff\u5236\u836f\uff0c\u5927\u90e8\u5206\u662f\u53ef\u4ee5\u66ff\u4ee3\u539f\u7814\u836f\u7684\u4f7f\u7528\u5f97\u3002<\/strong><\/p>\n\n\n\n

    \u90a3\u4e48\uff0c\u4e3a\u4ec0\u4e48\u5f88\u591a\u60a3\u8005\u5728\u5b9e\u9645\u4f7f\u7528\u8fc7\u7a0b\u4e2d\uff0c\u4e34\u5e8a\u836f\u6548\uff0c\u4eff\u5236\u836f\u5c31\u662f\u4e0d\u5982\u539f\u7814\u836f\u5462\uff1f<\/strong><\/p>\n\n\n\n

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    \n

    \u5316\u5b66\u836f\u7269\u5236\u5242\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\uff0c\u901a\u5e38\u91c7\u7528\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\uff08Average bioequivalence, ABE\uff09\u65b9\u6cd5\uff0c\u7b49\u6548\u6807\u51c6\u4e3a\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u4e3b\u8981\u836f\u52a8\u5b66\u53c2\u6570\uff08AUC\u548cCmax<\/sub>\uff09\u51e0\u4f55\u5747\u503c\u6bd4\u768490%\u7f6e\u4fe1\u533a\u95f4\u843d\u572880.00%~125.00%\u8303\u56f4\u5185<\/strong>\u3002<\/p>\n<\/blockquote>\n\n\n\n

    \u57fa\u4e8e\u4eff\u5236\u836f\u7684\u7597\u6548\u5dee\u5f02\uff0c\u5370\u5ea6\u836f\u76f4\u90ae\u5efa\u8bae\u4ee5\u4e0b\u60c5\u51b5\u4e0d\u9002\u5408\u7528\u4eff\u5236\u836f\u66ff\u4ee3\u539f\u7814\u836f\uff1a<\/strong><\/p>\n\n\n\n

      \n
    1. \u5371\u6025\u75be\u75c5\u3001\u5371\u6025\u60a3\u8005\u548c\u5371\u6025\u65f6\u6240\u9700\u7684\u836f\u7269\uff1b<\/li>\n\n\n\n
    2. \u6cbb\u7597\u6307\u6570\u72ed\u7a84\u7684\u836f\u7269\uff1b<\/li>\n\n\n\n
    3. \u4e0d\u6613\u63a7\u5236\u7684\u60a3\u8005  (\u5982\u766b\u75eb\u3001\u7cbe\u795e\u75c5\u3001\u8840\u6db2\u75c5\u3001\u5fc3\u8111\u8840\u7ba1\u75c5\u3001\u4e25\u91cd\u611f\u67d3\u7b49)  \uff1b<\/li>\n\n\n\n
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