{"id":98232,"date":"2019-03-08T00:00:50","date_gmt":"2019-05-17T08:13:39","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98232\/"},"modified":"2019-05-17T16:13:41","modified_gmt":"2019-05-17T08:13:41","slug":"794f74bcc3","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98232\/","title":{"rendered":"\u6d45\u6790\u7f8e\u56fdFDA \u52a8\u7269\u6cd5\u5219\u7684\u57fa\u672c\u539f\u7406"},"content":{"rendered":"
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\u6d45\u6790\u7f8e\u56fdFDA \u52a8\u7269\u6cd5\u5219\u7684\u57fa\u672c\u539f\u7406<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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Analysis on Basic Principle of Animal \uff32ule of FDA<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e2d\u56fd\u836f\u5b66\u6742\u5fd7\uff0c2019 \u5e741 \u6708\u7b2c54 \u5377\u7b2c1 \u671f<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4f59\u73ca\u73ca\uff0c\u5c39\u534e\u9759\uff0c\u738b\u5e86\u5229\uff0c\u80e1\u6653\u654f<\/p>\n

 \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u76ee\u7684\uff1a\u6982\u8ff0\u52a8\u7269\u6cd5\u5219\u7684\u4e3b\u8981\u5185\u5bb9\uff0c\u4e3a\u4e1a\u754c\u5177\u4f53\u5b9e\u65bd\u52a8\u7269\u6cd5\u5219\u63d0\u4f9b\u53c2\u8003\u3002\u65b9\u6cd5\u57fa\u4e8e\u672c\u6587\u5206\u6790\uff0c\u9610\u8ff0\u52a8\u7269\u6cd5\u5219\u7684\u57fa\u672c\u539f\u7406\u548c\u6280\u672f\u8981\u70b9\u3002<\/span><\/p>\n

\u7ed3\u679c\uff1a\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40( FDA) \u9488\u5bf9\u6cbb\u7597\u6216\u9884\u9632\u4e25\u91cd\u5a01\u80c1\u751f\u547d\u7684\u5316\u5b66\u836f\u7269\u6216\u751f\u7269\u5236\u54c1( \u5305\u62ec\u75ab\u82d7) \uff0c\u56e0<\/span>\u4f26\u7406\u9053\u5fb7\u6216\u4e0d\u53ef\u64cd\u4f5c\u6027\u7b49\u539f\u56e0\u65e0\u6cd5\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u8bd5\u9a8c\u5ba1\u6279\u548c\u6ce8\u518c\uff0c\u5236\u5b9a\u4e86\u52a8\u7269\u6cd5\u5219\uff0c\u5373\u53ef\u4f9d\u636e\u9002\u5f53\u7684\u52a8\u7269\u6709\u6548\u6027\u8bd5\u9a8c\u83b7\u5f97<\/span>\u7684\u6570\u636e\u53ca\u5176\u4ed6\u652f\u6301\u6027\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6279\u51c6\u8be5\u836f\u7269\u4e0a\u5e02\u3002\u7b14\u8005\u4ecb\u7ecd\u4e86\u52a8\u7269\u6cd5\u5219\u7684\u57fa\u672c\u539f\u7406\uff0c\u5f00\u5c55\u5173\u952e\u6027\u52a8\u7269\u836f\u6548\u8bd5\u9a8c\u7684\u6280\u672f\u8981<\/span>\u70b9\uff0c\u5206\u6790\u5916\u63a8\u4eba\u4f53\u6709\u6548\u5242\u91cf\u7684\u7b56\u7565\u3002<\/span><\/p>\n

\u7ed3\u8bba\uff1a\u52a8\u7269\u6cd5\u5219\u4e3a\u90a3\u4e9b\u201c\u76f8\u5f53\u53ef\u80fd( resonably likely) \u201d\u5177\u6709\u4e34\u5e8a\u83b7\u76ca\uff0c\u4f46\u5f00\u5c55\u4eba\u4f53\u6709\u6548\u6027<\/span>\u8bd5\u9a8c\u4e0d\u7b26\u5408\u4f26\u7406\u6216\u4e0d\u53ef\u884c\u7684\u5019\u9009\u836f\u7269\uff0c\u63d0\u4f9b\u4e86\u4e00\u79cd\u65b0\u7684\u6ce8\u518c\u9014\u5f84\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6b63 \u6587<\/strong><\/p>\n<\/section>\n

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\u5f53\u4eba\u7c7b\u4e3a\u5f00\u53d1\u67d0\u4e9b\u7279\u5b9a\u7684\u7528\u4e8e\u6cbb\u7597\u6216\u9884\u9632\u4e25\u91cd\u5a01\u80c1\u751f\u547d\u75be\u75c5\u7684\u836f\u7269\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u8bd5\u9a8c\u65f6\uff0c\u53ef\u80fd<\/span>\u9700\u8981\u5bf9\u5065\u5eb7\u53d7\u8bd5\u8005\u4f7f\u7528\u81f4\u6b7b\u6027\u6216\u80fd\u591f\u5bfc\u81f4\u6c38\u4e45\u6027\u635f<\/span>\u4f24\u7684\u6bd2\u6027\u7269\u8d28\u6216\u5fae\u751f\u7269\u3002<\/span><\/p>\n

\u7531\u4e8e\u4e0a\u8ff0\u539f\u56e0\u5bfc\u81f4\u4eba\u4f53\u4e34<\/span>\u5e8a\u6709\u6548\u6027\u8bd5\u9a8c\u7684\u5f00\u5c55\u4e0d\u7b26\u5408\u4f26\u7406\u6216\u4e0d\u53ef\u884c\u65f6\uff0c\u5ba1\u8bc4<\/span>\u673a\u6784\u53ef\u80fd\u4f9d\u636e\u201c\u52a8\u7269\u6cd5\u5219\u201d\uff0c\u4f9d\u636e\u201c\u9002\u5f53\u7684( appropriate)<\/span>\u52a8\u7269\u6709\u6548\u6027\u8bd5\u9a8c\u201d\u83b7\u5f97\u7684\u6570\u636e\u53ca\u5176\u4ed6\u652f\u6301\u6027\u6570<\/span>\u636e\u6279\u51c6\u8be5\u836f\u7269\u4e0a\u5e02\u3002<\/span><\/p>\n

\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/span>( FDA) \u7684CDE\uff32 \u548cCBE\uff32 \u4e8e2002 \u5e747 \u67081 \u65e5\u9996\u6b21\u53d1<\/span>\u5e03\u201cProduct Development Under the Animal \uff32ule Guidance <\/span>for Industry\u201d\uff0c\u5373\u52a8\u7269\u6cd5\u5219\uff0c\u4e4b\u540e\u4e8e2015 \u5e7410 \u6708<\/span>\u8fdb\u884c\u4e86\u4fee\u8ba2\uff3b1\uff3d\u3002<\/span><\/p>\n

\u7b14\u8005\u5c06\u7b80\u8981\u4ecb\u7ecd\u52a8\u7269\u6cd5\u5219\u7684\u57fa\u672c\u4fe1<\/span>\u606f\u548c\u6280\u672f\u8981\u6c42\uff0c\u4e5f\u5c06\u5305\u62ec\u5982\u4f55\u4f9d\u636e\u52a8\u7269\u6570\u636e\u6307\u5bfc\u4e34\u5e8a<\/span>\u7ed9\u836f\u5242\u91cf\u9009\u62e9\u548c\u63a8\u6d4b\u4e34\u5e8a\u6709\u6548\u6027\u65b9\u9762\u7684\u5185\u5bb9\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

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\u603b\u4f53\u4ecb\u7ecd<\/strong><\/p>\n<\/section>\n<\/section>\n

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1.1 \u76ee\u7684<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5bf9\u75ab<\/span>\u82d7\u6765\u8bf4\uff0c\u5219\u662f\u7528\u52a8\u7269\u514d\u75ab\u53cd\u5e94\u5bf9\u5e94\u7684\u751f\u5b58\u7387\u6c34\u5e73\u5916<\/span>\u63a8\u4eba\u8fbe\u5230\u76f8\u540c\u514d\u75ab\u53cd\u5e94\u6c34\u5e73\u65f6\u7684\u9884\u671f\u4fdd\u62a4\u6548\u529b\uff0c\u4ee5<\/span>\u53ca\u9009\u62e9\u5408\u9002\u7684\u4eba\u4f53\u4fdd\u62a4\u5242\u91cf\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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1. 2 \u9002\u7528\u5bf9\u8c61<\/span><\/strong><\/span>
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1. 3 \u9002\u7528\u6761\u4ef6<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u91c7\u7528\u52a8\u7269\u6cd5\u5219\u8bc4\u4ef7\u6709\u6548\u6027\u7684\u836f\u7269\uff0c\u5176\u4e34\u5e8a\u5b89\u5168\u6027\u8bd5<\/span>\u9a8c\u4ecd\u5e94\u6ee1\u8db3\u65b0\u836f\u5b89\u5168\u6027\u8bc4\u4ef7\u7684\u8981\u6c42\u3002<\/span><\/p>\n

\u52a8\u7269\u6cd5\u5219\u4e0d\u9002\u7528\u4e8e\u53ef\u7528\u66ff\u4ee3\u7ec8\u70b9\u6216\u9664\u751f\u5b58\u7387\/<\/span>\u6b7b\u4ea1\u7387\u4ee5\u5916\u7684\u5176\u4ed6\u4e34\u5e8a\u7ec8\u70b9\u6307\u6807\u8bc4\u4ef7\u6709\u6548\u6027\uff0c\u4f9d\u636e<\/span>\u4e0a\u8ff0\u7ec8\u70b9\u7684\u6709\u6548\u6027\u7ed3\u679c\u53ef\u88ab\u6709\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02\u7684<\/span>\u60c5\u51b5\u3002<\/span><\/p>\n

\u52a8\u7269\u6cd5\u5219\u4e0d\u5e94\u6210\u4e3a\u836f\u7269\u4e0a\u5e02\u7814\u7a76\u7684\u6377\u5f84\u3002\u76f8\u53cd\uff0c\u7531\u4e8e\u88ab\u8bc4\u4ef7\u75ab\u82d7\u6216\u836f\u7269\u7684\u79cd\u7c7b\u3001\u7528\u6cd5\u3001\u9002\u5e94\u8bc1\u3001\u75c5<\/span>\u539f\u611f\u67d3\u9014\u5f84\u3001\u75ab\u82d7\u4fdd\u62a4\u673a\u5236\u7b49\u65b9\u9762\u5747\u6709\u5dee\u5f02\uff0c\u6bcf\u4e2a\u5fc5<\/span>\u987b\u4f9d\u9760\u201c\u52a8\u7269\u6cd5\u5219\u201d\u8bc4\u4ef7\u6709\u6548\u6027\u7684\u6848\u4f8b\u90fd\u8981\u6c42\u7814\u7a76<\/span>\u8005\u5177\u5907\u8f83\u9ad8\u7684\u5236\u8ba2\u79d1\u5b66\u6709\u6548\u8bd5\u9a8c\u65b9\u6848\u7684\u80fd\u529b\u3002<\/span><\/p>\n

\u751f\u7269\u5236\u54c1( \u5305\u62ec\u75ab\u82d7) \u4f9d\u636e\u52a8\u7269\u6cd5\u5219\u83b7\u5f97\u7684\u52a8\u7269\u6570\u636e\u652f\u6301\u5176\u6709\u6548\u6027\uff0c\u9700\u6ee1\u8db3\u4ee5\u4e0b\u51e0\u4e2a\u524d\u63d0\uff0c\u540c\u65f6\u4ecd<\/span>\u9700\u5f00\u5c55\u4e34\u5e8a\u5b89\u5168\u6027\u8bd5\u9a8c\u3002<\/span><\/p>\n

\u2460\u76ee\u6807\u75be\u75c5\u7684\u6bd2\u6027\u75c5\u7406\u673a<\/span>\u5236\u4ee5\u53ca\u53d7\u8bd5\u7269\u9884\u9632\u6216\u6cbb\u7597\u7684\u4f5c\u7528\u673a\u5236\u660e\u786e\u3002<\/span><\/p>\n

\u2461\u5e94\u5728<\/span>\u4e00\u4e2a\u4ee5\u4e0a\u52a8\u7269\u79cd\u5c5e\u4e2d\u5f00\u5c55\u6709\u6548\u6027\u8bd5\u9a8c\uff0c\u5e76\u4e14\u52a8\u7269\u53cd<\/span>\u5e94\u53ef\u5916\u63a8\u5230\u4eba\u7c7b\u3002\u5982\u679c\u4ec5\u4f7f\u7528\u4e00\u79cd\u52a8\u7269\u6a21\u578b\uff0c\u5219\u8be5<\/span>\u6a21\u578b\u987b\u4e3a\u7ecf\u5145\u5206\u8ba4\u53ef\u7684\uff0c\u80fd\u5f88\u597d\u5730\u9884\u6d4b\u4eba\u4f53\u53cd\u5e94\u7684<\/span>\u6a21\u578b\u3002<\/span><\/p>\n

\u2462\u52a8\u7269\u836f\u6548\u7ec8\u70b9\u6307\u6807\u5e94\u660e\u786e\u4e0e\u4eba\u7684\u4e34\u5e8a\u83b7\u76ca<\/span>\u76f8\u5173\uff0c\u901a\u5e38\u662f\u589e\u52a0\u751f\u5b58\u7387\u6216\u964d\u4f4e\u6b7b\u4ea1\u7387\uff0c\u4e0d\u80fd\u4ec5\u8003\u5bdf<\/span>\u66ff\u4ee3\u7ec8\u70b9\u6307\u6807\u3002<\/span><\/p>\n

\u2463\u52a8\u7269\u836f\u6548\u548c\u836f\u52a8\u5b66\u6570\u636e\uff0c\u6216\u6587\u732e<\/span>\u8d44\u6599( \u53ef\u80fd\u5305\u542b\u90e8\u5206\u80fd\u591f\u83b7\u5f97\u7684\u4eba\u4f53\u6570\u636e) \uff0c\u5e94\u8db3\u591f<\/span>\u652f\u6301\u63a8\u7b97\u51fa\u4eba\u4f53\u6709\u6548\u5242\u91cf\u3002<\/span><\/p>\n

\u5bf9\u75ab\u82d7\u6765\u8bf4\uff0c\u5728\u62df\u5b9a\u7684<\/span>\u4eba\u63a5\u79cd\u5242\u91cf\u4e0b\u8bf1\u5bfc\u7684\u4eba\u4f53\u514d\u75ab\u53cd\u5e94\u5e94\u8fbe\u5230\u88ab\u6709\u6548\u4fdd<\/span>\u62a4\u7684\u52a8\u7269\u4f53\u5185\u7684\u514d\u75ab\u53cd\u5e94\u6c34\u5e73\u3002<\/span><\/p>\n

FDA \u5728\u4f9d\u636e\u52a8\u7269\u6cd5\u5219\u6279\u51c6\u836f\u7269\u65f6\u53ef\u80fd\u9644\u52a0\u4ee5\u4e0b\u8981\u6c42:<\/span><\/p>\n

 \u2460\u4e00\u65e6\u75ab\u60c5\u6216\u751f\u7269\u707e\u5bb3\u4e8b\u4ef6\u7206\u53d1\uff0c\u5e94\u5f00\u5c55\u4eba<\/span>\u4f53\u6709\u6548\u6027\u4e34\u5e8a\u8bd5\u9a8c\u548c\u514d\u75ab\u539f\u6027\u7814\u7a76\u3002\u7533\u8bf7\u4eba\u5e94\u62df\u8ba2<\/span>\u5207\u5b9e\u53ef\u884c\u7684\u4e34\u5e8a\u6709\u6548\u6027\u8bd5\u9a8c\u7814\u7a76\u65b9\u6848\uff0c\u5728\u7533\u8bf7\u751f\u4ea7<\/span>\u65f6\u4e00\u5e76\u63d0\u4ea4\u3002<\/span><\/p>\n

\u2461\u5236\u8ba2\u5177\u4f53\u63aa\u65bd\u786e\u4fdd\u7528\u836f\u5b89\u5168\u3002\u62df\u8ba2<\/span>\u8ba1\u5212\u5bf9\u53ef\u80fd\u53c2\u4e0e\u836f\u7269\u4f7f\u7528\u5404\u73af\u8282\u7684\u4eba\u5458\u8fdb\u884c\u7279\u6b8a\u5b89<\/span>\u5168\u6027\u57f9\u8bad\uff0c\u5f00\u5c55\u4e0a\u5e02\u540e\u8ddf\u8e2a\u8c03\u67e5\u6216\u4fdd\u5b58\u8bb0\u5f55\u7b49\u3002<\/span><\/p>\n

\u2462<\/span>\u8bf4\u660e\u4e66\u4e2d\u5e94\u8bf4\u660e\u836f\u7269\u7531\u4e8e\u4f26\u7406\u6216\u53ef\u884c\u6027\u95ee\u9898\u65e0\u6cd5\u5f00<\/span>\u5c55\u4eba\u4f53\u6709\u6548\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ec5\u6709\u52a8\u7269\u6709\u6548\u6027\u8bd5\u9a8c\u6570\u636e<\/span>\u652f\u6301\u4e0a\u5e02\u3002\u5728\u8bf4\u660e\u4e66\u4e2d\u8fd8\u5e94\u6ce8\u660e\u836f\u7269\u7684\u5176\u4ed6\u4fe1\u606f\uff0c<\/span>\u5982\u7528\u6cd5\u7528\u91cf\u3001\u7981\u5fcc\u8bc1\u3001\u53ef\u9884\u6d4b\u7684\u5b89\u5168\u6027\u98ce\u9669\u548c\u4e0d\u826f\u53cd<\/span>\u5e94\u7b49\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

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

\n
\n

\u751f\u7269\u8c41\u514d\u5e94\u6ce8\u610f\u7684\u95ee\u9898<\/strong><\/p>\n<\/section>\n<\/section>\n

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

2.1 \u8bbe\u8ba1\u539f\u5219<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u4f9d\u636e\u52a8\u7269\u6cd5\u5219\u5f00\u5c55\u7684\u652f\u6301\u836f\u7269\u4e0a\u5e02\u7684\u5173\u952e\u6709\u6548\u6027\u8bd5\u9a8c\u5e94\u4e25\u683c\u9075\u5faaGLP\uff0c\u5e76\u6ee1\u8db3\u201c\u5145\u5206\u4e25\u683c\u5bf9\u7167\u201d<\/span>( adequate and well-controlled) \u7684\u539f\u5219\u3002<\/span><\/p>\n

\u8bd5\u9a8c\u673a\u6784\u5e94<\/span>\u5177\u6709\u64cd\u4f5c\u5927\u52a8\u7269( \u975e\u4eba\u7075\u957f\u7c7b\u52a8\u7269) \u7684\u80fd\u529b\uff0c\u5e76\u4e14\u5177<\/span>\u5907\u6ee1\u8db3\u6240\u9700\u751f\u7269\u5b89\u5168\u7ea7\u522b\u7684\u50a8\u5b58\u6761\u4ef6\u3002<\/span><\/p>\n

\u9f13\u52b1\u5728\u5f00\u5c55\u4eba\u4f53\u2160\u671f\u548c\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u540c\u6b65\u5f00\u5c55\u52a8\u7269\u9884\u8bd5\u9a8c\uff0c\u63a2\u7d22\u548c\u786e\u5b9a\u52a8\u7269\u6709\u6548\u6027\u8bd5\u9a8c\u7684\u91cd<\/span>\u8981\u53c2\u6570\u3002<\/span><\/p>\n

\u4ee5\u75ab\u82d7\u4e3a\u4f8b\uff0c\u5728\u9884\u8bd5\u9a8c\u4e2d\u53ef\u63a2\u7d22\u52a8\u7269\u7684\u514d<\/span>\u75ab\u7a0b\u5e8f\u3001\u653b\u6bd2\u5242\u91cf\u3001\u653b\u6bd2\u65f6\u95f4\u4ee5\u53ca\u91c7\u8840\u68c0\u6d4b\u65f6\u95f4\u7b49<\/span>\u53c2\u6570\u3002<\/span><\/p>\n

\u8bd5\u9a8c\u5e94\u6a21\u62df\u53d7\u8bd5\u836f\u7269\u7684\u4e34\u5e8a\u4f7f\u7528\u60c5\u51b5\uff0c\u6700\u5927\u7a0b\u5ea6\u7684\u83b7\u53d6\u4e0e\u4eba\u4f53\u6709\u6548\u6027\u8bd5\u9a8c\u5177\u6709\u76f8\u4f3c\u610f\u4e49\u7684\u52a8\u7269\u6570<\/span>\u636e; \u5efa\u8bae\u4f7f\u7528\u4e24\u4e2a\u6027\u522b\u7684\u6210\u5e74\u52a8\u7269; \u52a8\u7269\u7684\u5e74\u9f84\u548c\u514d<\/span>\u75ab\u72b6\u6001\u5e94\u548c\u76ee\u6807\u4eba\u7fa4\u5177\u6709\u76f8\u5173\u6027; \u52a8\u7269\u7684\u7ed9\u836f\u9014\u5f84<\/span>\u5e94\u4e0e\u4eba\u7ed9\u836f\u9014\u5f84\u4e00\u81f4\u3002<\/p>\n

\u51e0\u4e4e\u6240\u6709\u9700\u8981\u6839\u636e\u52a8\u7269\u6cd5\u5219\u5f00\u5c55\u8bd5\u9a8c\u7684\u836f\u7269\uff0c\u5f88\u5c11\u80fd\u5177\u5907\u4e0e\u9633\u6027\u5bf9\u7167\u836f\u5bf9\u6bd4\u8fbe\u5230\u975e\u52a3\u6548\u4ece\u800c\u8bc1\u660e<\/span>\u6709\u6548\u7684\u6761\u4ef6\u3002<\/span><\/p>\n

\u56e0\u6b64\uff0c\u8bd5\u9a8c\u591a\u91c7\u7528\u968f\u673a\u3001\u76f2\u6cd5\u3001\u5b89\u6170\u5242<\/span>\u5bf9\u7167\u4ee5\u8bc1\u660e\u4f18\u6548\u7684\u8bd5\u9a8c\u65b9\u6848\u3002\u4f46\u662f\uff0c\u5982\u679c\u80fd\u627e\u5230\u9488<\/span>\u5bf9\u76f8\u540c\u9002\u5e94\u8bc1\u3001\u4e14\u836f\u6548\u5df2\u7ecf\u8fc7\u76f8\u540c\u52a8\u7269\u79cd\u5c5e\u9a8c\u8bc1\u7684<\/span>\u4e0a\u5e02\u836f\u7269\uff0c\u5219\u5e94\u5728\u5b89\u6170\u5242\u5bf9\u7167\u7684\u57fa\u7840\u4e0a\u52a0\u5165\u9633\u6027\u5bf9<\/span>\u7167\u836f\u7ec4\uff0c\u9a8c\u8bc1\u8bd5\u9a8c\u7cfb\u7edf\u7684\u654f\u611f\u6027\u3002<\/span><\/p>\n

\u8bd5\u9a8c\u65b9\u6848\u5e94\u5236\u8ba2\u52a8\u7269\u5165\u6392\u6807\u51c6\uff0c\u9884\u5148\u8bbe\u8ba1\u7edf\u8ba1<\/span>\u65b9\u6cd5\u3002\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u5e94\u8bc4\u4ef7\u836f\u7269\u66b4\u9732\u91cf\u548c\u6548\u5e94\u4e4b\u95f4\u7684<\/span>\u5173\u7cfb( exposure \/response) \uff0c\u63a2\u7d22\u4eba\u4f53\u6709\u6548\u5242\u91cf; \u8bbe\u8ba1<\/span>\u7ed9\u836f\u65f6\u7a0b\u5e94\u8003\u8651\u5230\u76ee\u6807\u9002\u5e94\u8bc1\u8003\u5bdf\u7684\u7ec8\u70b9\u6307\u6807\uff0c\u6062<\/span>\u590d\u671f\u5e94\u8db3\u591f\u89c2\u5bdf\u505c\u836f\u540e\u6216\u590d\u53d1\u65f6\u7ec8\u70b9\u6307\u6807\u7684\u53d8\u5316\u3002<\/span><\/p>\n

\u8bd5\u9a8c\u8bc4\u4f30\u6761\u4ef6\u5e94\u80fd\u5ba2\u89c2\u53cd\u6620\u5f53\u524d\u7684\u4e34\u5e8a\u6cbb\u7597\u5b9e\u9645\u60c5\u51b5\u3002\u5373\u5728\u7814\u53d1\u65e9\u671f\u5c31\u5e94\u8bc4\u4ef7\u786e\u5b9a\u836f\u7269\u4e34\u5e8a\u6cbb\u7597<\/span>\u662f\u5426\u9700\u8981\u8f85\u52a9\u652f\u6301\u6cbb\u7597\u3002\u5982\u9700\u914d\u5408\u652f\u6301\u6cbb\u7597\uff0c\u5219\u836f<\/span>\u7269\u6cbb\u7597\u7ec4\u548c\u5b89\u6170\u5242\u7ec4\u5e94\u7ed9\u4e88\u76f8\u540c\u7684\u652f\u6301\u6cbb\u7597\u65b9\u6848\u3002<\/span><\/p>\n

\u5728\u8bbe\u8ba1\u7edf\u8ba1\u65b9\u6848\u65f6\u5e94\u540c\u65f6\u8003\u8651\u5230\u52a8\u7269\u63a5\u53d7\u652f\u6301\u6cbb\u7597\u53ef\u80fd\u5bf9\u836f\u4ee3\u548c\u6709\u6548\u6027\u7ec8\u70b9\u4ea7\u751f\u6f5c\u5728\u5f71\u54cd\u3002\u5e94\u8003\u5bdf\u4e34<\/span>\u5e8a\u5b58\u5728\u5408\u5e76\u7528\u836f\u65f6\u7684\u836f\u7269-\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u3002<\/span><\/p>\n

\u5bf9\u75ab\u82d7\u6765\u8bf4\uff0c\u52a8\u7269\u6cd5\u5219\u9002\u7528\u4e8e\u66b4\u9732\u524d\u548c\u66b4\u9732\u540e<\/span>\u63a5\u79cd\u7684\u75ab\u82d7\u3002\u75ab\u82d7\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u4e00\u822c\u6027\u539f\u5219\u5305\u62ec: \u66b4<\/span>\u9732\u540e\u63a5\u79cd\u75ab\u82d7\u901a\u5e38\u5e94\u5728\u75c5\u539f\u66b4\u9732\u540e\u7acb\u5373\u63a5\u79cd\uff0c\u8bbe\u7f6e<\/span>\u7684\u52a8\u7269\u63a5\u79cd\u65f6\u95f4\u5e94\u4e0e\u4eba\u4e34\u5e8a\u514d\u75ab\u63a5\u79cd\u65f6\u95f4\u76f8\u5173\uff0c\u75ab<\/span>\u82d7\u5728\u52a8\u7269\u4f53\u5185\u8bf1\u5bfc\u7684\u514d\u75ab\u53cd\u5e94\u5e94\u53ef\u5916\u63a8\u5230\u4eba\u3002<\/span><\/p>\n

\u66b4\u9732<\/span>\u540e\u514d\u75ab\u53ef\u501f\u9274\u66b4\u9732\u524d\u9884\u9632\u63a5\u79cd\u7684\u52a8\u7269\u6570\u636e( \u5c24\u5176\u662f<\/span>\u836f\u4ee3\u548c\u514d\u75ab\u53cd\u5e94\u5cf0\u503c) \u3002<\/span><\/p>\n

\u4e34\u5e8a\u5b9e\u8df5\u4e2d\u66b4\u9732\u540e\u63a5\u79cd\u75ab<\/span>\u82d7\u5e38\u8054\u5408\u6297\u83cc\u6cbb\u7597\u6216\u5176\u4ed6\u8054\u5408\u6cbb\u7597\uff0c\u52a8\u7269\u836f\u6548\u8bd5\u9a8c<\/span>\u4e2d\u5e94\u6ce8\u610f\u8003\u5bdf\u8054\u5408\u6cbb\u7597\u5bf9\u75ab\u82d7\u514d\u75ab\u6548\u679c\u7684\u5f71\u54cd\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2.2 \u4e34\u5e8a\u8bd5\u9a8c\u548c\u52a8\u7269\u8bd5\u9a8c\u7684\u9636\u6bb5\u6027<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u6865\u63a5\u52a8\u7269\u6570\u636e\u548c\u4eba\u4f53\u6570\u636e\u6700\u7ec8\u83b7\u5f97\u5173\u952e\u6027\u836f\u6548\u8bd5\u9a8c\u7684\u201c\u4eba\u5316\u5242\u91cf\u201d\u662f\u4e00\u4e2a\u8fed\u4ee3\u7684\u8fc7\u7a0b\u3002\u5373\u2160\u671f\u4eba<\/span>\u4f53\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u53ef\u7528\u4e8e\u6307\u5bfc\u52a8\u7269\u9884\u8bd5\u9a8c\u7684\u5242\u91cf\u9009<\/span>\u62e9\uff0c\u800c\u52a8\u7269\u9884\u8bd5\u9a8c\u6570\u636e\u53c8\u53ef\u53cd\u8fc7\u6765\u6307\u5bfc\u2161\u671f\u4eba\u4f53\u8bd5<\/span>\u9a8c\u7684\u5242\u91cf\u9009\u62e9\uff0c\u52a8\u7269\u548c\u4eba\u4f53\u8bd5\u9a8c\u7684\u6570\u636e\u7684\u5173\u7cfb\u662f\u4e92\u76f8\u652f\u6301\u3001\u4e92\u4e3a\u4f9d\u636e\u7684\uff3b4\uff3d\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2. 3 \u52a8\u7269\u79cd\u5c5e\u7684\u9009\u62e9<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u5e94\u6839\u636e\u6bcf\u4e2a\u53d7\u8bd5\u7269\u7684\u5177\u4f53\u60c5\u51b5\u9009\u62e9\u52a8\u7269\u79cd\u5c5e\u3002\u9996\u5148\u5e94\u660e\u786e\u53d7\u8bd5\u836f\u7269\u7684\u4f5c\u7528\u673a\u5236\uff0c\u6bd4\u8f83\u53d7\u8bd5\u836f\u7269\u5728<\/span>\u76ee\u6807\u52a8\u7269\u6a21\u578b\u548c\u4eba\u4f53\u7684\u4f5c\u7528\u673a\u5236\u7684\u5dee\u5f02\u3002<\/span><\/p>\n

\u76ee\u6807\u52a8\u7269<\/span>\u6a21\u578b\u5e94\u5177\u6709\u4e0e\u4eba\u4f53\u76f8\u4f3c\u7684\u53d1\u75c5\u673a\u5236\u3002\u7406\u60f3\u7684\u52a8\u7269\u6a21<\/span>\u578b\u5e94\u8868\u73b0\u51fa\u4e0e\u4eba\u4f53\u76f8\u4f3c\u7684\u75c5\u7406\u751f\u7406\u3001\u75be\u75c5\u8fdb\u7a0b\u3001\u75c7\u72b6<\/span>\u548c\u5bbf\u4e3b\u514d\u75ab\u53cd\u5e94\u3002<\/span><\/p>\n

\u5728\u8fd9\u6837\u7684\u52a8\u7269\u6a21\u578b\u4e2d\u83b7\u5f97\u7684\u836f\u6548<\/span>\u8bd5\u9a8c\u7ed3\u679c\u624d\u80fd\u66f4\u5408\u7406\u7684\u63a8\u6d4b\u836f\u7269\u5bf9\u4eba\u4f53\u7684\u6cbb\u7597\u4f5c<\/span>\u7528\u3002<\/span><\/p>\n

\u53d7\u8bd5\u836f\u7269\u5728\u4eba\u548c\u52a8\u7269\u4f53\u5185\u7684\u6cbb\u7597\u6216\u4fdd\u62a4\u673a\u5236\u4e5f<\/span>\u5e94\u6709\u76f8\u5173\u6027\u3002<\/span><\/p>\n

FDA \u8ba4\u4e3a\uff0c\u5728\u4e24\u4e2a\u52a8\u7269\u79cd\u5c5e\u4e0a\u83b7\u5f97\u7684\u76f8\u4e92\u652f\u6301\u7684\u836f\u6548\u7ed3\u679c\u6bd4\u4e00\u4e2a\u52a8\u7269\u79cd\u5c5e\u66f4\u6709\u610f\u4e49\u3002<\/span><\/p>\n

\u5982\u679c\u4ec5\u5728\u4e00<\/span>\u4e2a\u52a8\u7269\u79cd\u5c5e\u5f00\u5c55\u836f\u6548\u8bd5\u9a8c\uff0c\u5219\u53ef\u80fd\u6709\u5fc5\u8981\u5728\u8be5\u52a8\u7269<\/span>\u6a21\u578b\u4e0a\u8fdb\u4e00\u6b65\u5f00\u5c55\u786e\u8bc1\u6027\u8bd5\u9a8c\uff0c\u6709\u6761\u4ef6\u65f6\u786e\u8bc1\u6027\u8bd5<\/span>\u9a8c\u6700\u597d\u5728\u4e0d\u540c\u5b9e\u9a8c\u5ba4\u5f00\u5c55\u3002\u5982\u679c\u836f\u7269\u4e0a\u5e02\u540e\u53ef\u83b7\u5f97<\/span>\u4eba\u6709\u6548\u6027\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff0c\u5219\u76f8\u540c\u52a8\u7269\u79cd\u5c5e\u7684\u518d\u6b21\u786e<\/span>\u8bc1\u8bd5\u9a8c\u53ef\u4ee5\u8c41\u514d\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2.4 \u7528\u4e8e\u653b\u6bd2\u7684\u7269\u8d28<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u901a\u5e38\u662f\u75c5\u6bd2\u6bd2\u682a\u6216\u7ec6\u83cc\u7b49\uff0c\u5e94\u5f53\u662f\u5177\u6709\u4e34\u5e8a\u4ee3\u8868\u6027\u7684\u6d41\u884c\u81f4\u75c5\u539f( disease cause strain) \u3002\u5e94\u5efa\u7acb\u7a33<\/span>\u5b9a\u7684\u68c0\u6d4b\u65b9\u6cd5\uff0c\u5b9a\u91cf\u68c0\u6d4b\u653b\u6bd2\u7269\u8d28\u7684\u5242\u91cf( \u75c5\u6bd2\u91cf)<\/span>\u548c\u7eaf\u5ea6\u7b49\u3002\u5e94\u9009\u62e9\u4e0e\u4eba\u4f53\u5b9e\u9645\u611f\u67d3\u9014\u5f84\u4e00\u81f4\u7684\u66b4\u9732<\/span>\u9014\u5f84\u8fdb\u884c\u653b\u6bd2\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2. 5 \u836f\u6548\u7ec8\u70b9\u6307\u6807<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u52a8\u7269\u836f\u6548\u8bd5\u9a8c\u7684\u7ec8\u70b9\u6307\u6807\u5e94\u9009\u62e9\u90a3\u4e9b\u4e0e\u4eba\u4e34\u5e8a\u83b7\u76ca\u660e\u786e\u76f8\u5173\u7684\u6307\u6807\uff0c\u5982\u63d0\u9ad8\u751f\u5b58\u7387\u6216\u964d\u4f4e\u6b7b\u4ea1\u7387\uff0c<\/span>\u800c\u4e0d\u5e94\u4ec5\u8003\u5bdf\u66ff\u4ee3\u7ec8\u70b9\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2. 6 \u5242\u91cf\u9009\u62e9<\/span><\/strong>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2. 6. 1 \u5316\u836f\u548c\u751f\u7269\u5236\u54c1<\/strong><\/p>\n

\u5728\u786e\u5b9a\u52a8\u7269\u5173\u952e\u6027\u836f\u6548\u8bd5\u9a8c\u7684\u5242\u91cf\u524d\uff0c\u9996\u5148\u5e94\u5f00\u5c55\u52a8\u7269\u5242\u91cf\u63a2\u7d22\u8bd5\u9a8c\uff0c\u660e\u786e<\/span>\u52a8\u7269\u4f53\u5185\u7684\u836f\u7269\u66b4\u9732\u91cf-\u6548\u5e94\u5173\u7cfb\u3002\u63a2\u7d22\u6027\u52a8\u7269\u8bd5<\/span>\u9a8c\u5e94\u81f3\u5c11\u8bbe\u7f6e3 \u4e2a\u5242\u91cf\uff0c\u5e76\u6709\u5408\u9002\u7684\u68af\u5ea6\u95f4\u9694\uff0c\u4fbf\u4e8e<\/span>\u63cf\u7ed8\u7279\u5f81\u66b4\u9732\u91cf-\u6548\u5e94\u66f2\u7ebf\uff0c\u786e\u5b9a\u6700\u5927\u836f\u6548\u5242\u91cf\u3002<\/span><\/p>\n

\u6700<\/span>\u5927\u836f\u6548\u5242\u91cf\u662f\u6307\u836f\u6548( \u5982\u751f\u5b58\u7387) \u968f\u7740\u5242\u91cf\u589e\u52a0\u800c<\/span>\u589e\u5927\u81f3\u836f\u6548\u5e73\u53f0\u65f6\uff0c\u5373\u4f7f\u7ee7\u7eed\u589e\u52a0\u7ed9\u836f\u5242\u91cf\uff0c\u836f\u6548\u4e0d<\/span>\u518d\u589e\u5927\u65f6\u7684\u6700\u5c0f\u5242\u91cf\u3002\u52a8\u7269\u5173\u952e\u6027\u836f\u6548\u8bd5\u9a8c\u7684\u591a\u4e2a<\/span>\u7ed9\u836f\u5242\u91cf\u4e2d\u5e94\u81f3\u5c11\u5305\u542b\u4e00\u4e2a\u6700\u5927\u836f\u6548\u5242\u91cf\uff3b1\uff0c5<\/span>\uff3d\u3002<\/span><\/p>\n

\u7531\u4e8e\u836f\u7269\u5438\u6536\u7684\u79cd\u5c5e\u5dee\u5f02\uff0c\u4eba\u548c\u52a8\u7269\u4f53\u5185\u836f\u7269\u6d53\u5ea6\u968f\u65f6\u95f4\u53d8\u5316\u7684\u8fc7\u7a0b( \u5e38\u7528\u836f-\u65f6\u66f2\u7ebf\u8868\u793a) \u53ef\u80fd<\/span>\u6709\u660e\u663e\u5dee\u5f02\u3002<\/span><\/p>\n

\u5728\u8fd9\u6837\u7684\u60c5\u51b5\u4e0b\uff0c\u9700\u8c03\u6574\u52a8\u7269\u7ed9\u836f\u5242<\/span>\u91cf\u548c\/\u6216\u7ed9\u836f\u7a0b\u5e8f\uff0c\u4f7f\u52a8\u7269\u7684\u836f-\u65f6\u66f2\u7ebf\u66f4\u63a5\u8fd1\u4e8e\u4eba\uff0c<\/span>\u4f7f\u52a8\u7269\u4f53\u5185\u7684\u836f\u7269\u66b4\u9732\u836f\u4ee3\u53c2\u6570( \u5982\u5cf0\u6d53\u5ea6\u3001\u8fbe\u5cf0<\/span>\u65f6\u95f4) \u66f4\u63a5\u8fd1\u4e8e\u4eba\uff0c\u4ece\u800c\u66f4\u597d\u7684\u6307\u5bfc\u836f\u7269\u7528\u4e8e\u4eba\u4f53<\/span>\u6709\u6548\u5242\u91cf\u7684\u9009\u62e9\u3002<\/span><\/p>\n

\u6309\u4eba\u4f53\u5185\u836f-\u65f6\u66f2\u7ebf\u7279\u5f81\u8c03\u6574\u540e\u7684\u52a8\u7269\u7ed9\u836f\u5242\u91cf\u88ab\u79f0\u4e3a\u201c\u4eba\u5316\u5242\u91cf\u201d( humanized <\/span>dose) \u3002<\/span><\/p>\n

\u5982\u56fe\u4f8b\u6240\u793a\uff0c\u67d0\u836f\u7269\u5728\u52a8\u7269\u4f53\u5185\u7684\u4ee3\u8c22\u534a\u8870<\/span>\u671f\u77ed\uff0c\u5355\u6b21\u7ed9\u836f\u540e\u7684\u836f-\u65f6\u66f2\u7ebf\u7279\u5f81\u548c\u4eba\u4f53\u5b58\u5728\u660e\u663e<\/span>\u5dee\u5f02\u3002\u5f53\u8c03\u6574\u52a8\u7269\u7684\u7ed9\u836f\u7a0b\u5e8f\uff0c\u7531\u5355\u6b21\u7ed9\u836f\u53d8\u4e3a\u4e24<\/span>\u6b21\u7ed9\u836f\u540e\uff0c\u52a8\u7269\u4f53\u5185\u836f\u7269\u6d53\u5ea6\u7684\u8fbe\u5cf0\u65f6\u95f4\u548c\u7cfb\u7edf\u66b4<\/span>\u9732\u65f6\u95f4\u66f4\u63a5\u8fd1\u4eba\u4f53\u3002\u89c1\u56fe1\u3002<\/span><\/p>\n

\"\u6d45\u6790\u7f8e\u56fdFDA<\/p>\n

2. 6. 2 \u75ab\u82d7\u7684\u5242\u91cf\u9009\u62e9<\/strong><\/p>\n

\u75ab\u82d7\u2160\u671f\u6216\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\u901a\u5e38\u5df2\u5728\u5065\u5eb7\u4eba\u4e2d\u83b7\u5f97\u4e86\u4e00\u4e9b\u4eba\u4f53\u514d\u75ab\u53cd\u5e94\u7684\u6570<\/span>\u636e\u3002<\/span><\/p>\n

\u5728\u52a8\u7269\u836f\u6548\u9884\u8bd5\u9a8c\u4e2d\u5e94\u7740\u91cd\u8003\u5bdf\u75ab\u82d7\u63a5\u79cd\u5242\u91cf<\/span>\u548c\u514d\u75ab\u53cd\u5e94\u4e4b\u95f4\u7684\u5173\u7cfb\u3002\u52a8\u7269\u5173\u952e\u6709\u6548\u6027\u8bd5\u9a8c\u91c7\u7528<\/span>\u7684\u63a5\u79cd\u5242\u91cf\u6240\u8bf1\u5bfc\u51fa\u7684\u52a8\u7269\u514d\u75ab\u53cd\u5e94\uff0c\u5e94\u80fd\u57fa\u672c\u8fbe<\/span>\u5230\u4eba\u4f53\u514d\u75ab\u53cd\u5e94\u7684\u7a0b\u5ea6\uff0c\u8fd9\u4e2a\u5242\u91cf\u88ab\u79f0\u4f5c\u75ab\u82d7\u7684<\/span>\u201c\u4eba\u5316\u5242\u91cf\u201d\u3002<\/span><\/p>\n

\u901a\u8fc7\u52a8\u7269\u5173\u952e\u6027\u8bd5\u9a8c\u9009\u62e9\u7684\u63a5\u79cd\u5242<\/span>\u91cf\u3001\u514d\u75ab\u9014\u5f84\u3001\u514d\u75ab\u7a0b\u5e8f\u53ef\u80fd\u4e0d\u540c? \u901a\u8fc7\u5e38\u89c4\u624b\u6bb5\u9884<\/span>\u6d4b\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4eba\u4f53\u7ed9\u836f\u65b9\u6848\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

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

\n
\n

\u52a8\u7269\u5173\u952e\u6027\u8bd5\u9a8c\u6570\u636e\u7684\u5916\u63a8<\/strong><\/p>\n<\/section>\n<\/section>\n

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

3. 1 \u5916\u63a8\u4eba\u4f53\u7ed9\u836f\u5242\u91cf<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u9009\u62e9\u4eba\u4e34\u5e8a\u7ed9\u836f\u5242\u91cf\u4e3b\u8981\u53c2\u8003\u52a8\u7269PK\/PD \u6570\u636e\uff0c\u5e94\u9996\u5148\u660e\u786e\u836f\u6548\u5242\u91cf\u4e0b\u52a8\u7269\u7684PK\/PD \u548c\u4eba\u4f53<\/span>PK\/PD \u7279\u5f81\uff0c\u6839\u636ePK\/PD \u6570\u636e\u9009\u62e9\u52a8\u7269\u5173\u952e\u836f\u6548<\/span>\u8bd5\u9a8c\u4e2d\u91c7\u7528\u7684\u836f\u6548\u5242\u91cf\uff0c\u6700\u7ec8\u6307\u5bfc\u4e34\u5e8a\u4eba\u4f53\u7ed9\u836f\u5242<\/span>\u91cf\u7684\u9009\u62e9\u3002<\/p>\n

\u4eba\u4f53\u5242\u91cf\u7684\u9009\u62e9\u65b9\u5f0f\u4e3b\u8981\u6709\u4ee5\u4e0b\u51e0\u79cd\uff0c\u5e94\u6839\u636e\u53d7\u8bd5\u836f\u7269\u7684\u5177\u4f53\u60c5\u51b5\uff0c\u6311\u9009\u5408\u9002\u7684\u5242\u91cf\u5916\u63a8<\/span>\u65b9\u6cd5\u3002<\/span><\/p>\n

\u5176\u4e00<\/strong>\uff0c\u82e5\u53d7\u8bd5\u836f\u7269\u7684\u4f5c\u7528\u673a\u5236\u4e3a\u76f4\u63a5\u4f5c\u7528\u4e8e\u75c5\u56e0\u6216\u81f4\u75c5\u56e0\u7d20\uff0c\u800c\u4e0d\u662f\u901a\u8fc7\u4f5c\u7528\u4e8e\u5bbf\u4e3b\u8d77\u6548\uff0c\u53ef\u76f4\u63a5<\/span>\u7528\u4f53\u5916\u8bd5\u9a8c\u4e2d\u9776\u90e8\u4f4d\u6709\u6548\u836f\u7269\u66b4\u9732\u6d53\u5ea6\u6307\u5bfc\u52a8\u7269\u548c<\/span>\u4eba\u5242\u91cf\u7684\u9009\u62e9\u3002\u4f8b\u5982\uff0c\u6297\u83cc\u836f\u4f53\u5916\u836f\u654f\u8bd5\u9a8c\u53ef\u8003\u5bdf<\/span>\u836f\u7269\u7684PD \u7279\u5f81\uff0c\u83b7\u5f97\u6700\u4f4e\u6291\u83cc\u6d53\u5ea6MIC\u3002\u5728\u975e\u4e34<\/span>\u5e8a\u52a8\u7269\u8bd5\u9a8c\u4e2d\u53ef\u660e\u786e\u4e0e\u836f\u6548\u76f8\u5173\u7684\u4e00\u4e9bPK\/PD \u6307<\/span>\u6807\uff0c\u5982cmax \/MIC \u6bd4\u4f8b\u3001AUC \/MIC \u6bd4\u4f8b\u3001MIC \u4ee5\u4e0a\u6709\u6548<\/span>\u6d53\u5ea6\u7ef4\u6301\u65f6\u95f4\uff0c\u7528\u8fd9\u4e9b\u53c2\u6570\u6307\u5bfc\u52a8\u7269\u548c\u4eba\u4f53\u836f\u6548\u5242<\/span>\u91cf\u7684\u9009\u62e9\u3002<\/span><\/p>\n

\u5176\u4e8c<\/strong>\u3001\u82e5\u53d7\u8bd5\u836f\u7269\u66fe\u6279\u51c6\u7528\u4e8e\u5176\u4ed6\u9002\u5e94\u8bc1\uff0c\u53ef\u6839\u636e\u5df2\u83b7\u5f97\u7684\u4eba\u4f53PK\/PD \u6570\u636e\u6307\u5bfc\u52a8\u7269\u836f\u6548\u5242\u91cf\u7684<\/span>\u9009\u62e9\uff0c\u518d\u8fdb\u4e00\u6b65\u7528\u52a8\u7269\u836f\u6548\u8bd5\u9a8c\u83b7\u5f97\u7684\u6570\u636e\u53cd\u8fc7\u6765<\/span>\u6307\u5bfc\u76ee\u6807\u9002\u5e94\u8bc1\u4eba\u4e34\u5e8a\u5242\u91cf\u7684\u9009\u62e9\u3002\u4f8b\u5982\uff0c\u6cbb\u7597\u80ba<\/span>\u708e\u7684\u67d0\u4e0a\u5e02\u6297\u83cc\u836f\u7269\uff0c\u660e\u786e\u7684\u4eba\u4f53\u66b4\u9732\u91cf-\u53cd\u5e94\u5173\u7cfb<\/span>\u53ef\u6307\u5bfc\u652f\u6301\u9f20\u75ab\u80ba\u708e\u9002\u5e94\u8bc1\u52a8\u7269\u5173\u952e\u836f\u6548\u8bd5\u9a8c\u7684\u5242<\/span>\u91cf\u9009\u62e9\uff0c\u4ee5\u8bc4\u4ef7\u52a8\u7269\u5728\u201c\u4eba\u5316\u5242\u91cf\u201d\u4e0b\u7684\u6709\u6548\u6027\u3002\u5728<\/span>\u4e00\u4e9b\u60c5\u51b5\u4e0b\uff0c\u6839\u636e\u52a8\u7269\u8bd5\u9a8c\u6570\u636e\u786e\u5b9a\u7684\u76ee\u6807\u9002\u5e94\u8bc1<\/span>\u7684\u836f\u6548\u5242\u91cf\u53ef\u80fd\u4e0d\u540c\u4e8e\u5df2\u6279\u51c6\u9002\u5e94\u8bc1\u3002<\/span><\/p>\n

\u5176\u4e09<\/strong>\u3001\u5728\u52a8\u7269\u836f\u6548\u8bd5\u9a8c\u4e2d\u8003\u5bdf\u4e0e\u836f\u7269\u4f5c\u7528\u673a\u5236\u548c\u4e34\u5e8a\u83b7\u76ca\u76f4\u63a5\u76f8\u5173\u836f\u6548\u7ec8\u70b9\u6307\u6807\uff0c\u5982\u4e00\u4e9b\u751f\u7269\u6807<\/span>\u8bb0\u7269\uff0c\u4e5f\u53ef\u7528\u4e8e\u6307\u5bfc\u4eba\u4f53\u5242\u91cf\u7684\u9009\u62e9\u3002\u5373\uff0c\u4e34\u5e8a\u5242\u91cf<\/span>\u5e94\u4f7f\u4eba\u4f53\u5185\u7684\u4e0a\u8ff0\u836f\u6548\u7ec8\u70b9\u6307\u6807\u8fbe\u5230\u7ecf\u52a8\u7269\u836f\u6548\u8bd5<\/span>\u9a8c\u9a8c\u8bc1\u7684\u8d77\u6548\u8303\u56f4\u5185\u3002<\/span><\/p>\n

\u5176\u56db<\/strong>\u3001\u5f53\u9047\u5230\u53d7\u8bd5\u836f\u7269\u5728\u52a8\u7269\u4f53\u5185\u7684\u66b4\u9732\/\u6548\u5e94\u5173\u7cfb\u5df2\u7ecf\u5efa\u7acb\uff0c\u4f46\u7f3a\u4e4f\u5408\u9002\u7684\u751f\u7269\u6807\u8bb0\u7269\u53ef\u4f5c\u4e3a\u6865<\/span>\u63a5\u7ec8\u70b9\u6307\u6807\u65f6\uff0c\u82e5\u6ca1\u6709\u5176\u4ed6\u7684\u66ff\u4ee3\u65b9\u6cd5\uff0c\u5728\u5145\u5206\u4e86\u89e3<\/span>\u52a8\u7269\u66b4\u9732\/\u6548\u5e94\u5173\u7cfb\u3001\u52a8\u7269\u6700\u5927\u836f\u6548\u5242\u91cf\u4e0b\u7684\u66b4\u9732<\/span>\u91cf\u3001\u4eba\u4f53\u6700\u5927\u7ed9\u836f\u5242\u91cf\u4e0b\u66b4\u9732\u91cf\u7684\u524d\u63d0\u4e0b\uff0c\u53ef\u91c7\u53d6\u4e00<\/span>\u79cd\u66f4\u4fdd\u5b88\u7684\u65b9\u5f0f\u9009\u62e9\u4eba\u4f53\u7ed9\u836f\u5242\u91cf\u3002\u5373\u901a\u8fc7\u76f4\u63a5\u6bd4<\/span>\u8f83\u4eba\u548c\u52a8\u7269\u66b4\u9732\u91cf\u7684\u836f\u4ee3\u53c2\u6570( \u5982AUC\u3001Cmax\u3001Cmin\u3001<\/span>Css<\/span>) \u9009\u62e9\u4e34\u5e8a\u7ed9\u836f\u5242\u91cf\u3002\u5177\u4f53\u65b9\u6cd5\u89c1\u56fe2\uff0c\u9634\u5f71\u90e8\u5206<\/span>\u836f-\u65f6\u66f2\u7ebf\u8868\u793a\u7684\u662f3 \u4e2a\u5242\u91cf( \u5747\u4e3a\u53ef\u8010\u53d7\u5242\u91cf) \u53d7<\/span>\u8bd5\u836f\u7269\u7ed9\u836f\u540e\uff0c\u4eba\u4f53\u7cfb\u7edf\u66b4\u9732\u91cf\u968f\u65f6\u95f4\u53d8\u5316\u7684\u60c5\u51b5\u3002<\/span><\/p>\n

\"\u6d45\u6790\u7f8e\u56fdFDA<\/p>\n

\u7ebf\u6761\u4ee3\u8868\u52a8\u7269\u4e2a\u4f53\u5728\u63a5\u53d7\u836f\u6548\u5242\u91cf\u540e\u7684\u836f\u7269\u66b4\u9732\u60c5<\/span>\u51b5\u3002\u901a\u8fc7\u6bd4\u8f83\u53ef\u89c1\uff0c\u5242\u91cf3 \u7684\u4eba\u4f53\u66b4\u9732Cmax<\/span>\u548cAUC<\/span>\u5747\u8d85\u8fc7\u52a8\u7269\u4e2a\u4f53\uff0c\u53ef\u9009\u62e9\u5242\u91cf3 \u4f5c\u4e3a\u7406\u60f3\u7684\u4eba\u7ed9\u836f<\/span>\u5242\u91cf\u3002<\/span><\/p>\n

\u82e5\u8be5\u53d7\u8bd5\u836f\u7269\u7684\u836f\u6548\u4e0d\u662f\u4e0e\u836f\u7269\u5cf0\u6d53\u5ea6\u76f4\u63a5<\/span>\u76f8\u5173\uff0c\u5219\u5242\u91cf2 \u4e5f\u662f\u8ba4\u4e3a\u662f\u5408\u9002\u7684\u4eba\u4f53\u5242\u91cf\u3002\u867d\u7136\u6b64<\/span>\u65f6\u5242\u91cf2 \u7684\u5cf0\u6d53\u5ea6\u53ef\u80fd\u4f4e\u4e8e\u52a8\u7269\u5cf0\u6d53\u5ea6\uff0c\u4f46\u5176AUC<\/span>\u5747\u660e\u663e\u9ad8\u4e8e\u6bcf\u4e2a\u52a8\u7269\u4e2a\u4f53\u3002\u5242\u91cf1 \u7684\u66b4\u9732\u91cf\u5c0f\u4e8e\u52a8<\/span>\u7269\u836f\u6548\u5242\u91cf\u7684\u66b4\u9732\u91cf\uff0c\u4e0d\u662f\u5408\u9002\u7684\u4eba\u7ed9\u836f\u5242\u91cf\u3002<\/p>\n

\u5728\u4e0e\u76d1\u7ba1\u90e8\u95e8\u8ba8\u8bba\u540e\uff0c\u52a8\u7269\u66b4\u9732\u91cf\u5916\u63a8\u4eba\u4f53\u7ed9<\/span>\u836f\u5242\u91cf\u4e5f\u53ef\u91c7\u7528\u5176\u4ed6\u65b9\u6cd5\uff0c\u5982PK \u6a21\u578b\u3001PK\/PD \u6a21<\/span>\u578b\u3001\u751f\u7406\u836f\u52a8\u6a21\u578b(physiologically-basedpharmacokinetic <\/span>modeling\uff0cPBPK) \u3001\u6216\u7fa4\u4f53\u836f\u52a8\u5b66\u6a21\u578b( population <\/span>modeling) \u7b49\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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3. 2 \u63a8\u6d4b\u75ab\u82d7\u4e34\u5e8a\u4fdd\u62a4\u6548\u529b<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

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\u5728\u5047\u8bbe\u52a8\u7269\u548c\u4eba\u7684\u6297\u4f53\u4fdd\u62a4\u6548\u529b\u65e0\u79cd\u5c5e\u5dee\u5f02\u7684\u524d\u63d0\u4e0b\uff0c\u53ef\u901a\u8fc7\u8003\u5bdf\u75ab\u82d7\u8bf1\u5bfc\u7684\u52a8\u7269\u514d\u75ab\u53cd\u5e94\u6307\u6807( \u5982\u751f\u5b58\u7387) \uff0c\u91c7\u7528\u53ef\u53cd\u6620\u673a\u4f53\u514d\u75ab\u53cd\u5e94\u6c34\u5e73\u7684\u6307\u6807( \u5982\u6297\u4f53\u6ef4\u5ea6) \u6865\u63a5\u52a8\u7269\u548c\u4eba\u4f53\u7684\u4fdd\u62a4\u6548\u529b\uff0c\u6700\u7ec8\u91cf\u5316\u9884\u6d4b\u75ab\u82d7\u7684\u4e34\u5e8a\u4fdd\u62a4\u7387\u3002<\/span><\/p>\n

\u5e94\u5168\u9762\u5206\u6790\u75ab\u82d7\u7684\u4fdd\u62a4\u4f5c\u7528\u673a\u5236\u5c5e\u4e8e\u4f53\u6db2\u514d\u75ab\u6216\u662f\u7ec6\u80de\u514d\u75ab\uff0c\u5145\u5206\u8bba\u8bc1\u7ec8\u70b9\u6307\u6807\u7684\u9009\u62e9\u3002<\/span><\/p>\n

\u82e5\u75ab\u82d7\u7684\u4fdd\u62a4\u673a\u5236\u5305\u62ec\u4f53\u6db2\u514d\u75ab\u548c\u7ec6\u80de\u514d\u75ab\uff0c\u6a21\u578b\u52a8\u7269\u5e94\u80fd\u88ab\u8bf1\u5bfc\u51fa\u4e0e\u4eba\u4f53\u53cd\u5e94\u76f8\u4f3c\u7684\u4f53\u6db2\u514d\u75ab\u548c\u7ec6\u80de\u514d\u75ab\u7ec8\u70b9\u6307\u6807\u7684\u6539\u53d8\u3002<\/span><\/p>\n

\u5e94\u9009\u62e9\u80fd\u76f4\u89c2\u53cd\u6620\u75ab\u82d7\u4fdd\u62a4\u6548\u529b\u7684\u7ec8\u70b9\u6307\u6807\u4f5c\u4e3a\u6865\u63a5\u7684\u5173\u952e\u6709\u6548\u6027\u6307\u6807\u3002\u5bf9\u591a\u6297\u539f\u7ec4\u5206\u75ab\u82d7\u6765\u8bf4\uff0c\u5355\u4e2a\u514d\u75ab\u53cd\u5e94\u7ec8\u70b9\u6307\u6807\u53ef\u80fd\u4e0d\u80fd\u5168\u9762\u53cd\u6620\u75ab\u82d7\u8bf1\u5bfc\u51fa\u7684\u4eba\u4f53\u514d\u75ab\u4fdd\u62a4\u53cd\u5e94\u3002<\/span><\/p>\n

\u90a3\u4e48\u5e94\u6839\u636e\u75ab\u82d7\u7684\u7279\u6027\u9009\u62e9\u6865\u63a5\u65b9\u6cd5\uff0c\u53ef\u80fd\u9700\u8981\u8003\u5bdf\u591a\u4e2a\u514d\u75ab\u53cd\u5e94\u6307\u6807\u7528\u4e8e\u6865\u63a5\u3002<\/span><\/p>\n

\u4ee5\u4e0b\u662f\u7528\u52a8\u7269\u4fdd\u62a4\u529b\u6570\u636e\u6865\u63a5\u4eba\u4f53\u6548\u529b\u7684\u7b80\u5316\u6848\u4f8b\u4ecb\u7ecd\u3002\u8be5\u6848\u4f8b\u4e2d\u7684\u53d7\u8bd5\u75ab\u82d7\u7cfb\u5355\u4e00\u6297\u539f\u6210\u5206\u75ab\u82d7\uff0c\u4e3b\u8981\u4fdd\u62a4\u4f5c\u7528\u673a\u5236\u662f\u8bf1\u5bfc\u4f53\u6db2\u514d\u75ab\u3002<\/span><\/p>\n

\u524d\u671f\u7814\u7a76\u5df2\u7ecf\u663e\u793a\u4e86\u8be5\u75ab\u82d7\u8bf1\u5bfc\u4f53\u5185\u6297\u4f53\u6c34\u5e73\u548c\u4fdd\u62a4\u529b\u5177\u6709\u663e\u8457\u7684\u76f8\u5173\u6027\u3002\u8bd5\u9a8c\u9996\u5148\u9009\u62e9\u52a8\u7269\u63a5\u79cd\u75ab\u82d7\u540e\u7684\u5408\u9002\u65f6\u95f4\u68c0\u6d4b\u514d\u75ab\u53cd\u5e94\u3002<\/span><\/p>\n

\u4e4b\u540e\uff0c\u7ed9\u4e88\u52a8\u7269\u9884\u9632\u63a5\u79cd\u540e\u8fdb\u884c\u653b\u6bd2\uff0c\u8bc4\u4f30\u52a8\u7269\u4fdd\u62a4\u7387\u548c\u5728\u4f53\u5185\u6297\u4f53\u6c34\u5e73\u4e4b\u95f4\u5173\u7cfb( \u56fe3A) \u3002<\/span><\/p>\n

\"\u6d45\u6790\u7f8e\u56fdFDA<\/p>\n

A-\u514d\u75ab\u52a8\u7269\u653b\u6bd2\u540e\u7684\u751f\u5b58\u7387\u4e0e\u7279\u5f02\u6027\u6297\u4f53\u6ef4\u5ea6\u7684\u5173\u7cfb\u66f2\u7ebf; <\/span><\/strong><\/p>\n

B- \u4e34\u5e8a\u6297\u4f53\u6ef4\u5ea6\u9006\u5411\u7d2f\u79ef\u5206\u5e03\u66f2\u7ebf\u3002<\/span><\/strong><\/p>\n

\u6a2a\u8f74\u4e3a\u5bf9\u6570\u8f6c\u6362\u540e\u7684\u6297\u4f53\u6ef4\u5ea6\u6216\u6d53\u5ea6\uff0c\u7eb5\u8f74\u4e3a\u81f3\u5c11\u8fbe\u5230\u67d0\u4e2a\u6297\u4f53\u6c34\u5e73\u7684\u53d7\u8bd5\u8005\u4e2a\u4f53\u6240\u5360\u6bd4\u4f8b\uff3b4\uff3d\u3002<\/span><\/strong><\/p>\n

\u4eba\u4f53\u63a5\u79cd\u75ab\u82d7\u540e\u7684\u6297\u4f53\u53cd\u5e94\u5728\u4e34\u5e8a\u8bd5\u9a8c\u7684\u514d\u75ab\u539f\u6027\u7814\u7a76\u4e2d\u8003\u5bdf\u3002\u7406\u8bba\u9006\u5411\u7d2f\u8ba1\u5206\u5e03\u66f2\u7ebf( \u56fe3B)\u663e\u793a\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4eba\u4f53\u63a5\u79cd\u75ab\u82d7\u540e\u7684\u6297\u4f53\u6ef4\u5ea6\u6c34\u5e73\u4e0e\u4ea7\u751f\u81f3\u5c11\u67d0\u6297\u4f53\u6c34\u5e73\u7684\u4eba\u7fa4\u6bd4\u4f8b( \u7d2f\u8ba1\u9891\u7387%) \u4e4b<\/span>\u95f4\u7684\u5173\u7cfb\u6839\u636e\u56fe3A \u548cB \u4e2d\u6240\u793a\u6570\u636e\uff0c\u6211\u4eec\u5927\u81f4\u53ef\u4ee5\u63a8\u6d4b\u53d7\u8bd5\u75ab\u82d7\u7684\u63a5\u79cd\u53ef\u8bf1\u5bfc\u7ea685% \u53d7\u8bd5\u8005\u4f53\u5185\u4ea7\u751f\u514d\u75ab\u53cd\u5e94\u7684\u6297\u4f53\u6c34\u5e73\u53ef\u4ea7\u751f\u81f3\u5c1170% \u7684\u4fdd\u62a4\u7387\u3002<\/span><\/p>\n

\u6b64\u5916\uff0c\u76f4\u63a5\u5916\u63a8\u52a8\u7269\u6297\u4f53\u6c34\u5e73\u5230\u4eba\uff0c\u8981\u6c42\u7528\u4e8e\u68c0\u6d4b\u52a8\u7269\u548c\u4eba\u4f53\u6297\u4f53\u6c34\u5e73\u7684\u65b9\u6cd5\u4e0d\u53d7\u79cd\u5c5e\u5dee\u5f02\u7684\u5f71\u54cd\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

\n
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\u52a8\u7269\u6cd5\u5219\u7684\u610f\u4e49<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u52a8\u7269\u6cd5\u5219\u4e3a\u90a3\u4e9b\u201c\u76f8\u5f53\u53ef\u80fd( resonably likely)\u201d\u5177\u6709\u4e34\u5e8a\u83b7\u76ca\uff0c\u4f46\u5f00\u5c55\u4eba\u4f53\u6709\u6548\u6027\u8bd5\u9a8c\u4e0d\u7b26\u5408<\/span>\u4f26\u7406\u6216\u4e0d\u53ef\u884c\u7684\u836f\u7269\uff0c\u63d0\u4f9b\u4e86\u4e00\u79cd\u65b0\u7684\u6ce8\u518c\u9014\u5f84\uff0c<\/span>\u4f46\u52a8\u7269\u6cd5\u5219\u4e0d\u662f\u836f\u7269\u4e0a\u5e02\u7814\u7a76\u7684\u6377\u5f84\uff0c\u76f8\u53cd\uff0c\u7531\u4e8e<\/span>\u88ab\u8bc4\u4ef7\u75ab\u82d7\u6216\u836f\u7269\u7684\u79cd\u7c7b\u3001\u7528\u6cd5\u3001\u9002\u5e94\u8bc1\u3001\u75c5\u539f\u611f\u67d3\u9014\u5f84\u3001\u75ab\u82d7\u4fdd\u62a4\u673a\u5236\u7b49\u65b9\u9762\u5747\u6709\u5dee\u5f02\uff0c\u4f9d\u636e\u201c\u52a8<\/span>\u7269\u6cd5\u5219\u201d\u8bc4\u4ef7\u836f\u7269\u6709\u6548\u6027\u5bf9\u4e8e\u7814\u53d1\u8005\u548c\u76d1\u7ba1\u673a\u6784<\/span>\u90fd\u662f\u4e00\u79cd\u6311\u6218\u3002<\/span><\/p>\n

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\"\u6d45\u6790\u7f8e\u56fdFDA<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

\u6d45\u6790\u7f8e\u56fdFDA \u52a8\u7269\u6cd5\u5219\u7684\u57fa\u672c\u539f\u7406 Analysis on Basic Principle of Animal […]<\/p>\n","protected":false},"author":1,"featured_media":98233,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98232"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=98232"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98232\/revisions"}],"predecessor-version":[{"id":98248,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98232\/revisions\/98248"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/98233"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=98232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=98232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=98232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}