{"id":120822,"date":"2019-11-06T09:28:05","date_gmt":"2020-04-21T00:46:18","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/120822\/"},"modified":"2020-04-21T08:46:19","modified_gmt":"2020-04-21T00:46:19","slug":"deef52bba9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/120822\/","title":{"rendered":"\u6ce8\u610f\uff01\u8fd9\u4e9b\u6ce8\u5c04\u5242\u9700\u8981\u505aBE\u6216\u8005\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\uff01"},"content":{"rendered":"
\n

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\u5173\u8054\u9605\u8bfb\uff1a<\/strong><\/span><\/p>\n

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\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09 <\/span><\/strong><\/span><\/section>\n


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\u4e8c\u3001\u836f\u5b66\u7814\u7a76<\/span><\/strong><\/strong><\/span><\/h1>\n

\u6839\u636e\u300a\u5316\u5b66\u836f\u54c1\u6ce8\u5c04\u5242\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\u300b\uff0c\u7279\u6b8a\u6ce8\u5c04\u5242\u4e00\u81f4\u6027\u8bc4\u4ef7\u5728\u6309\u7167\u4e0a\u8ff0\u6280\u672f\u8981\u6c42\u5f00\u5c55\u7814\u7a76\u7684\u540c\u65f6\uff0c\u8fd8\u9700\u6839\u636e\u7279\u6b8a\u6ce8\u5c04\u5242\u7684\u7279\u70b9\uff0c\u53c2\u7167<\/span>FDA\u3001<\/span>EMA<\/span>\u53d1\u5e03\u7684\u7279\u6b8a\u5236\u5242\u76f8\u5173\u6280\u672f\u8981\u6c42\uff0c\u79d1\u5b66\u8bbe\u8ba1\u8bd5\u9a8c\u3002<\/span><\/span><\/span>\u5efa\u8bae\u5173\u6ce8\u4ee5\u4e0b\u95ee\u9898\uff1a<\/span><\/p>\n

\uff08\u4e00\uff09\u5904\u65b9\u5de5\u827a<\/span><\/p>\n

\u5904\u65b9\u539f\u5219\u4e0a\u5e94\u4e0e\u53c2\u6bd4\u5236\u5242\u4e00\u81f4\uff0c\u5efa\u8bae\u5bf9\u8f85\u6599\u7684\u578b\u53f7\u53ca\u53ef\u80fd\u5f71\u54cd\u6ce8\u5c04\u5242\u4f53\u5185\u884c\u4e3a\u7684\u8f85\u6599\u7684<\/span>CQA\u8fdb\u884c\u7814\u7a76\u3002<\/span><\/span><\/p>\n

\u7279\u6b8a\u6ce8\u5c04\u5242\u7684\u751f\u4ea7\u5de5\u827a\u53ef\u80fd\u5f71\u54cd\u836f\u7269\u4f53\u5185\u884c\u4e3a\uff0c\u9700\u6df1\u5165\u7814\u7a76\uff1b\u5bf9\u4e8e\u91c7\u7528\u65e0\u83cc\u5de5\u827a\u751f\u4ea7\u7684\u7279\u6b8a\u6ce8\u5c04\u5242\uff0c\u9700\u7279\u522b\u6ce8\u610f\u5404\u751f\u4ea7\u6b65\u9aa4\u7684\u65e0\u83cc\u4fdd\u8bc1\u63aa\u65bd\u548c\u9a8c\u8bc1\u3002<\/span><\/p>\n

\u6ce8\u518c\u6279\u548c\u5546\u4e1a\u6279\u7684\u751f\u4ea7\u5de5\u827a\u53ca\u6279\u91cf\u539f\u5219\u4e0a\u5e94\u4fdd\u6301\u4e00\u81f4\u3002<\/span>\u6ce8\u518c\u6279\u6837\u54c1\u6279\u91cf\u53c2\u7167\u53d1\u5e03\u7684\u300a\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09\u300b\u6267\u884c\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u8d28\u91cf\u7814\u7a76<\/span><\/p>\n

\u8003\u5bdf\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u53ef\u80fd\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u4ee5\u4e0b\u5185\u5bb9\uff1a\u7406\u5316\u6027\u8d28\uff08<\/span>\u5982\u6027\u72b6\uff0c\u9ecf\u5ea6\uff0c\u6e17\u900f\u538b\u6469\u5c14\u6d53\u5ea6\uff0c<\/span>pH<\/span>\u503c<\/span>\/<\/span>\u9178\u78b1\u5ea6\u7b49\uff09<\/span>\uff0c<\/span>Zeta\u7535\u4f4d\uff0c\u7c92\u5b50\u5f62\u6001\uff0c\u7c92\u5f84\u53ca\u5206\u5e03\uff08\u5982<\/span>D<\/span><\/span>10<\/span><\/sub>\uff0c<\/span>D<\/span>50<\/span><\/sub>\uff0c<\/span>D<\/span>90<\/span><\/sub>\u7b49\uff09\uff0c\u4f53\u5916\u6eb6\u51fa<\/span>\/\u91ca\u653e\u884c\u4e3a\uff0c\u6e38\u79bb\u548c\u7ed3\u5408\u836f\u7269\uff0c\u836f\u7269\u6676\u578b\u548c\u7ed3\u6676\u5f62\u6001\u3002<\/span><\/span><\/span><\/p>\n

\u539f\u5219\u4e0a\u5e94\u63d0\u4f9b\u81f3\u5c11<\/span>3\u6279\u6b21\u53c2\u6bd4\u5236\u5242\u6837\u54c1\u7684\u8d28\u91cf\u5bf9\u6bd4\u8003\u5bdf\u6570\u636e\u3002<\/span><\/span><\/p>\n

\uff08\u4e09\uff09\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027<\/span>\u7814\u7a76<\/span>\/\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8003\u8651<\/span><\/span><\/span><\/p>\n

\u5e94\u91c7\u7528\u5546\u4e1a\u6279\u91cf\u7684\u6837\u54c1\u8fdb\u884c\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027<\/span>\u7814\u7a76\u548c<\/span>\/\u6216\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/span><\/span><\/p>\n

\u5bf9\u4e8e<\/span>FDA\u6216EMA<\/span>\u5df2\u516c\u5e03<\/span>\u6307\u5bfc\u539f\u5219\u7684\u7279\u5b9a\u6ce8\u5c04\u5242\u54c1\u79cd\uff0c\u5efa\u8bae\u53c2\u7167\u5176\u6280\u672f\u8981\u6c42\u5f00\u5c55\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u5bf9\u6bd4\u7814\u7a76\u3002<\/span><\/span><\/p>\n

\u4e09\u3001\u975e\u4e34\u5e8a\u7814\u7a76<\/span><\/strong><\/span><\/h1>\n

\u4e0e\u666e\u901a\u6ce8\u5c04\u5242\u4e0d\u540c\uff0c\u7279\u6b8a\u6ce8\u5c04\u5242\u8fdb\u5165\u4f53\u5185\u540e\u901a\u5e38\u5b58\u5728\u91ca\u836f\u8fc7\u7a0b\u548c\u4f53\u6db2\u6210\u5206\u5438\u9644\u7b49\u56e0\u7d20\uff0c\u56e0\u6b64\uff0c\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5904\u65b9\u548c\u5de5\u827a\u7684\u5dee\u5f02\u53ef\u80fd\u5bfc\u81f4\u836f\u7269\u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u884c\u4e3a\u53d1\u751f\u6539\u53d8\uff0c\u4ece\u800c\u5e26\u6765\u6709\u6548\u6027\u548c\u6bd2\u6027\u7684\u53d8\u5316\uff0c\u800c\u4ec5\u51ed\u836f\u5b66\u4f53\u5916\u5bf9\u6bd4\u7814\u7a76\u5f80\u5f80\u4e0d\u8db3\u4ee5\u5145\u5206\u53cd\u6620\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u4f53\u5185\u884c\u4e3a\u7684\u5dee\u5f02\u3002<\/span>\u57fa\u4e8e\u4e0a\u8ff0\u8003\u8651\uff0c\u5728\u5f00\u5c55\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6216\u4e34\u5e8a<\/span>\u8bd5\u9a8c\u524d\uff0c\u5e94\u9009\u62e9\u5408\u9002\u7684\u52a8\u7269\u79cd\u5c5e\u8fdb\u884c\u975e\u4e34\u5e8a\u836f\u4ee3\u52a8\u529b\u5b66\u5bf9\u6bd4\u7814\u7a76\uff0c\u4ee5\u5145\u5206\u63d0\u793a\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5728\u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u884c\u4e3a<\/span>\u548c<\/span>\/\u6216<\/span><\/span>\u5728<\/span>\u836f\u6548<\/span>\/\u6bd2\u6027\u9776\u5668\u5b98\u5206\u5e03\u7684\u4e00\u81f4\u6027\u3002<\/span><\/span><\/span><\/p>\n

\u9274\u4e8e\u901a\u5e38\u53ea\u6709\u4ece\u5236\u5242\u4e2d\u91ca\u653e\u51fa\u6765\u7684\u836f\u7269\u624d\u80fd\u5728\u4f53\u5185\u53d1\u6325\u6d3b\u6027\uff0c\u5efa\u8bae\u5728\u6d4b\u5b9a\u8840\u836f\u6d53\u5ea6\u65f6\u5206\u522b\u6d4b\u5b9a\u8d1f\u8f7d\u836f\u7269\u548c\u91ca\u653e\u836f\u7269\u7684\u6d53\u5ea6\u3002<\/span><\/p>\n

\u56db\u3001<\/span><\/strong>\u4e34\u5e8a<\/span><\/strong>\u7814\u7a76<\/span><\/strong><\/span><\/h1>\n

\u5728\u7814\u7a76\u8bc4\u4f30\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5728\u836f\u5b66\u53ca\u975e\u4e34\u5e8a\u4e0a\u5177\u6709\u4e00\u81f4\u6027\u7684\u57fa\u7840\u4e0a\uff0c\u65b9\u53ef\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\u3002\u4e34\u5e8a\u7814\u7a76\u901a\u5e38\u5e94\u91c7\u7528\u9010\u6b65\u9012\u8fdb\u7814\u7a76\u7b56\u7565\uff0c\u5e94\u9996\u5148\u8fdb\u884c\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\uff0c\u5fc5\u8981\u65f6\u5f00\u5c55\u8fdb\u4e00\u6b65\u7684\u4e34\u5e8a\u7814\u7a76\u3002<\/span><\/p>\n

\uff08<\/span><\/strong>\u4e00\uff09\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76<\/span><\/strong><\/span><\/h2>\n

\u5efa\u7acb\u5177\u6709\u533a\u5206\u529b\u7684\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u65b9\u6cd5\u3002<\/span>\u4e00\u822c\u8981\u6c42\u548c\u8bd5\u9a8c\u8bbe\u8ba1\u53ef\u53c2<\/span>\u7167\u300a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\u548c\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u7b49\u76f8\u5173\u6307\u5bfc\u539f\u5219\u3002<\/span>\u5177\u4f53\u7814\u7a76\u5efa\u8bae\u5173\u6ce8\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/span><\/p>\n

\u7814\u7a76\u8bbe\u8ba1\uff1a<\/span><\/strong><\/strong>\u901a\u5e38\u91c7\u7528\u968f\u673a\u3001\u5355\u6b21\u7ed9\u836f\u3001\u4ea4\u53c9\u7814\u7a76\u8bbe\u8ba1\u3002<\/span><\/span>\u7279\u6b8a\u60c5\u51b5\u4e0b\uff0c\u5e94\u57fa\u4e8e\u836f\u7269\u7279\u70b9\u3001\u9002\u5e94\u75c7\u4eba\u7fa4\u7b49\u9009\u62e9\u5408\u7406\u7684\u7814\u7a76\u8bbe\u8ba1\u3002<\/span><\/p>\n

\u53d7\u8bd5\u8005\uff1a<\/span><\/strong><\/strong>\u901a\u5e38\u91c7\u7528\u5065\u5eb7\u53d7\u8bd5\u8005\u3002<\/span><\/span>\u5f53\u5165\u9009\u5065\u5eb7\u53d7\u8bd5\u8005\u53c2\u4e0e\u8bd5\u9a8c\u53ef\u80fd\u9762\u4e34\u5b89\u5168\u6027\u65b9\u9762\u7684\u98ce\u9669\u65f6\uff0c\u5efa\u8bae<\/span>\u9009\u62e9\u8bd5\u9a8c\u836f\u7269\u7684\u62df\u5b9a\u9002\u5e94\u75c7\u60a3\u8005\u3002<\/span><\/p>\n

\u6837\u672c\u91cf\uff1a<\/span><\/strong><\/strong>\u5165\u9009\u53d7\u8bd5\u8005\u7684\u4f8b\u6570\u5e94\u4f7f\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u5177\u6709\u8db3\u591f\u7684\u7edf\u8ba1\u5b66\u6548\u529b\u3002<\/span><\/span><\/p>\n

\u68c0\u6d4b\u7269\u8d28\uff1a<\/span><\/strong><\/strong>\u7279\u6b8a\u6ce8\u5c04\u5242\u6d3b\u6027\u7269\u8d28\u5728\u4f53\u5185\u5982\u540c\u65f6\u5b58\u5728\u591a\u79cd\u5f62\u6001\uff0c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u5e94\u5145\u5206\u8003\u8651\u5404\u79cd\u5f62\u6001\u836f\u7269\u5bf9\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u5f71\u54cd\uff0c\u7ed3\u5408\u836f\u7269\u7279\u70b9\u9009\u62e9\u79d1\u5b66\u3001\u5408\u7406\u7684\u68c0\u6d4b\u7269\u8d28\u3002<\/span><\/span>\u68c0\u6d4b\u65b9\u6cd5\u9700\u7ecf\u8fc7\u5145\u5206\u9a8c\u8bc1\uff0c\u5e76\u5bf9\u76ee\u6807\u68c0\u6d4b\u7269\u8d28\u5177\u6709\u8db3\u591f\u533a\u5206\u529b\uff0c\u5bf9\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u5dee\u5f02\u5177\u6709\u8db3\u591f\u7075\u654f\u5ea6\u3002<\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u6307\u6807\uff1a<\/span><\/strong><\/strong>\u5e94\u63d0\u4f9b\u5305\u62ec\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684<\/span>AUC<\/span>0-t<\/span><\/sub>\u3001<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\u3001<\/span>C<\/span>max<\/span><\/sub>\u51e0\u4f55\u5747\u503c\u3001\u51e0\u4f55\u5747\u503c\u6bd4\u503c\u53ca\u5176<\/span>90%\u7f6e\u4fe1\u533a\u95f4\u7b49\u3002<\/span><\/span><\/span>\u7279\u6b8a\u60c5\u51b5\u4e0b\uff08\u5982\uff1a\u5fae\u7403\u7b49\uff09\uff0c\u53ef\u80fd\u9700\u8981\u589e\u52a0\u90e8\u5206\u66b4\u9732\u91cf\u6307\u6807\u6765\u89c2\u6d4b\u65e9\u671f\u66b4\u9732\u91cf\u6216\u7279\u5b9a\u65f6\u6bb5\u7684\u66b4\u9732\u91cf\u3002<\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u7684\u63a5\u53d7\u6807\u51c6\uff1a<\/span><\/strong><\/strong>\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u5bf9\u4e8e\u4e3b\u8981\u7ec8\u70b9\u6307\u6807\uff0c\u4e0a\u8ff0\u53c2\u6570\u51e0\u4f55\u5747\u503c\u6bd4\u503c\u7684<\/span>90%\u7f6e\u4fe1\u533a\u95f4\u6570\u503c\u5e94\u4e0d\u4f4e\u4e8e<\/span>80.00%<\/span>\uff0c\u4e14\u4e0d\u8d85\u8fc7<\/span>125.00%<\/span>\u3002<\/span><\/span><\/span><\/p>\n

\u9884\u8bd5\u9a8c\uff1a<\/span><\/strong><\/strong>\u6b63\u5f0f\u8bd5\u9a8c\u4e4b\u524d\uff0c\u53ef\u5728\u5c11\u6570\u53d7\u8bd5\u8005\u4e2d\u8fdb\u884c\u9884\u8bd5\u9a8c\uff0c\u7528\u4ee5\u9a8c\u8bc1\u5206\u6790\u65b9\u6cd5\uff08\u5305\u62ec\u5bf9\u68c0\u6d4b\u7269\u8d28\u7684\u533a\u5206\u529b\uff09\u3001\u8bc4\u4f30\u53d8\u5f02\u7a0b\u5ea6\u3001\u4f18\u5316\u91c7\u6837\u65f6\u95f4\uff0c\u4ee5\u53ca\u83b7\u5f97\u5176\u4ed6\u76f8\u5173\u4fe1\u606f\u3002<\/span><\/span>\u9884\u8bd5\u9a8c\u7684\u6570\u636e\u4e0d\u80fd\u7eb3\u5165\u6700\u7ec8\u7edf\u8ba1\u5206\u6790\u3002<\/span><\/p>\n

\u5176\u4ed6\uff1a<\/span><\/strong><\/span><\/p>\n

\u6ce8\u518c\u7533\u62a5\u65f6\uff0c\u9664\u4e86\u5e94\u6ee1\u8db3\u73b0\u884c\u7684\u76f8\u5173\u7533\u62a5\u8d44\u6599\u8981\u6c42\u4e4b\u5916\uff0c\u8fd8\u5e94\u57fa\u4e8e\u4ea7\u54c1\u7279\u70b9\uff0c\u5bf9\u76f8\u5173\u5173\u952e\u95ee\u9898\u7684\u79d1\u5b66\u5408\u7406\u6027\u8fdb\u884c\u5145\u5206\u8bba\u8bc1\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u8bd5\u9a8c\u8bbe\u8ba1\u3001\u53d7\u8bd5\u8005\u9009\u62e9\u3001\u6837\u672c\u91cf\u3001\u68c0\u6d4b\u7269\u8d28\u3001\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u6307\u6807\u7b49\u3002<\/span><\/p>\n

\u4ee5\u836f\u6548\u5b66\u6307\u6807\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u53c2\u7167\u76f8\u5173\u6307\u5bfc\u539f\u5219\u6267\u884c\u3002<\/span><\/p>\n

\u7279\u6b8a\u60c5\u51b5\u65f6\uff0c\u53ef\u4e8b\u5148\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u3002<\/span><\/p>\n

\uff08\u4e8c<\/span><\/strong>\uff09\u968f\u673a\u5bf9\u7167\u4e34\u5e8a<\/span><\/strong>\u8bd5\u9a8c<\/span><\/strong><\/span><\/h2>\n

\u662f\u5426\u9700\u8981\u8fdb\u884c\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e94\u57fa\u4e8e\u836f\u7269\u7279\u70b9\uff0c\u4ee5\u53ca\u524d\u671f\u836f\u5b66\u3001\u975e\u4e34\u5e8a\u3001\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7ed3\u679c\u7b49\u8ba8\u8bba\u786e\u5b9a\u3002<\/span>\u5bf9\u4e8e<\/span>\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7ed3\u679c\u663e\u793a\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u4e0d\u7b49\u6548\u7684\uff0c\u7533\u8bf7\u4eba\u5e94\u5bf9\u53d7\u8bd5\u5236\u5242\u5904\u65b9\u5de5\u827a\u8fdb\u4e00\u6b65\u4f18\u5316\uff0c\u91cd\u65b0\u5f00\u5c55\u5bf9\u6bd4\u7814\u7a76\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u4ee5\u4e0b\u60c5\u51b5\uff08\u4e0d\u9650\u4e8e\uff09\uff0c\u5efa\u8bae\u5f00\u5c55\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\uff0c\u8bc1\u660e\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u7b49\u6548\u6027\uff1a<\/span><\/p>\n

\uff081\uff09 \u7f3a\u4e4f\u51c6\u786e\u53ef\u9760\u7684\u751f\u7269\u6837\u672c\u6d4b\u5b9a\u65b9\u6cd5\uff0c\u65e0\u6cd5\u901a\u8fc7\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u8bc4\u4ef7\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u662f\u5426\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002<\/span><\/span><\/p>\n

\uff082\uff09 \u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7ed3\u679c\u663e\u793a\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5b58\u5728\u5dee\u5f02\uff0c\u4e14\u5c1a\u4e0d\u786e\u5b9a\u8be5\u5dee\u5f02\u662f\u5426\u4f1a\u5bf9\u836f\u7269\u7684\u5b89\u5168\u6709\u6548\u6027\u4ea7\u751f\u660e\u663e\u5f71\u54cd\u3002<\/span><\/span><\/p>\n

\uff083\uff09 \u4f53\u5faa\u73af\u4e2d\u7684\u836f\u7269\u6d53\u5ea6\u4e0e\u7597\u6548\u6216\u5b89\u5168\u6027\u76f8\u5173\u6027\u8f83\u5dee\uff0c\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e0d\u8db3\u4ee5\u8bc4\u4ef7\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u7597\u6548\u3001\u5b89\u5168\u6027\u4e00\u81f4\u3002<\/span><\/span><\/p>\n

\u5bf9\u4e8e\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u60c5\u51b5\uff0c\u5efa\u8bae\u4e8b\u5148\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u53c2\u8003\u6587\u732e<\/span><\/strong><\/span><\/h1>\n

1. \uff08\u539f\uff09\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3<\/span>.\u300a\u5df2\u6709\u56fd\u5bb6\u6807\u51c6\u5316\u5b66\u836f\u54c1\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff08<\/span>2007<\/span>\u5e74<\/span>8<\/span>\u6708\uff09<\/span><\/span><\/p>\n

2. \u300a\u5316\u5b66\u836f\u54c1\u6ce8\u5c04\u5242\u57fa\u672c\u6280\u672f\u8981\u6c42\uff08\u8bd5\u884c\uff09\u300b\uff08\u56fd\u98df\u836f\u76d1\u6ce8<\/span>[2008]7\u53f7\uff09<\/span><\/span><\/p>\n

3. \uff08\u539f\uff09\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40<\/span>.\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\uff08<\/span>2016<\/span>\u5e74\u7b2c<\/span>61<\/span>\u53f7\u901a\u544a\uff09<\/span><\/span><\/p>\n

4. \u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u7535\u5b50\u520a\u7269<\/span>.\u300a\u5bf9\u5df2\u6709\u56fd\u5bb6\u6807\u51c6\u7684\u9776\u5411\u4e73\u5242\u54c1\u79cd\u4e34\u5e8a\u8bd5\u9a8c\u7684\u57fa\u672c\u8003\u8651\u300b\uff08<\/span>2005<\/span>\u5e74<\/span>11<\/span>\u6708\uff09<\/span><\/span><\/p>\n

5. \uff08\u539f\uff09\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3<\/span>.\u300a\u5df2\u4e0a\u5e02\u5316\u5b66\u4eff\u5236\u836f\uff08\u6ce8\u5c04\u5242\uff09\u4e00\u81f4\u6027\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\u300b\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09<\/span><\/span><\/p>\n

6. \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3<\/span>.\u300a\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09\u300b\uff082018\u5e746<\/span>\u6708\uff09<\/span><\/span><\/p>\n


<\/p>\n

1. European Medicines Agency. Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product. EMA\/CHMP\/806058\/2009\/Rev. 02.2013<\/span><\/p>\n

2. Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. April 2018<\/span><\/p>\n

3. Food and Drug Administration. Draft Guidance on Amphotericin B: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/psg\/Amphotericin%20B_%20Liposomal%20injection_RLD%20050740_RV01-16.pdf<\/span><\/p>\n

4. Food and Drug Administration. Draft Guidance on Doxorubicin Hydrochloride: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/psg\/Doxorubicin%20Hydrochloride_draft_Injection%20injec%20lipo_RLD%2050718_RC09-18.pdf<\/span><\/p>\n

5. Food and Drug Administration. Draft Guidance on Leuprolide Acetate: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/psg\/Leuprolide_acetate_inj_19732_20011_20263_RV02-14.pdf<\/span><\/p>\n

6. Food and Drug Administration. Draft Guidance on Leuprolide Acetate: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/psg\/Leuprolide_acetate_inj_20517_20708_RV02-14.pdf<\/span><\/p>\n

7. Food and Drug Administration. Draft Guidance on Propofol: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/psg\/Propofol_injectable%20injection_RLD%2019627_RC06-16.pdf<\/span><\/p>\n

8. European Medicines Agency. Committee for Medicinal Products for Human use (CHMP). Guideline on the investigation of bioequivalence. CPMP\/EWP\/QWP\/1401\/98 Rev.1\/Corr<\/span><\/p>\n


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

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