{"id":107781,"date":"2019-05-08T00:00:50","date_gmt":"2019-05-17T09:18:54","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/107781\/"},"modified":"2019-05-17T17:19:01","modified_gmt":"2019-05-17T09:19:01","slug":"7dbab3ff46","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/107781\/","title":{"rendered":"\u5f3a\u70c8\u63a8\u8350|\u6297\u4f53\u836f\u6cd5\u89c4\u89e3\u8bfb\u53ca\u4e13\u5229\u8003\u91cf"},"content":{"rendered":"
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\u6297\u4f53\u836f\u6cd5\u89c4\u89e3\u8bfb\u53ca\u4e13\u5229\u8003\u91cf<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u65f6\u95f4\uff1a2019\u5e745\u670825-26\u65e5<\/strong><\/p>\n

\u5730\u70b9\uff1a\u4e0a\u6d77<\/strong><\/p>\n

\u8d39\u7528\uff1a6800\/\u4eba<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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01<\/section>\n
\u6297\u4f53\u836f\u56fd\u5185\u7533\u62a5\u3001\u6ce8\u518c<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u25c7 \u6297\u4f53\u836f\u56fd\u5185\u6ce8\u518c\u3001\u7533\u62a5\u6cd5\u89c4\u548c\u8981\u6c42<\/span><\/p>\n

\u25c7 \u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u548cICH-CTD\u683c\u5f0f\u7533\u62a5\u6750\u6599\u7684\u64b0\u5199<\/span><\/p>\n

\u25c7 \u6848\u4f8b\u5206\u6790<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u5f3a\u70c8\u63a8\u8350|\u6297\u4f53\u836f\u6cd5\u89c4\u89e3\u8bfb\u53ca\u4e13\u5229\u8003\u91cf\"<\/section>\n<\/section>\n
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\u5468\u6674\u7476<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6cf0\u683c\u533b\u836f <\/span><\/p>\n

\u6ce8\u518c\u90e8\u603b\u76d1<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u66fe\u4efb<\/span>\u8f89\u745e\u5168\u7403\u836f\u54c1\u5b89\u5168\u53ca\u6cd5\u89c4\u8fd0\u8425\u90e8\u95e8\u4e9a\u592a\u836f\u54c1\u6ce8\u518c\u7ecf\u7406<\/span><\/strong>\uff0c\u4e3b\u8981\u8d1f\u8d23\u4e9a\u592a\u5730\u533a\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u8fd0\u8425\u7ba1\u7406\uff0c\u62e5\u6709\u4e30\u5bcc\u7684CTD\u683c\u5f0f\u548ceCTD\u683c\u5f0f\u7684\u7533\u62a5\u6ce8\u518c\u7ecf\u9a8c\u3002\u5728\u6b64\u4e4b\u524d\uff0c\u62c5\u4efb<\/span>\u836f\u660e\u751f\u7269\u6cd5\u89c4\u4e8b\u52a1\u90e8\u6ce8\u518c\u7ecf\u7406<\/span><\/strong>\uff0c\u53c2\u4e0e\u591a\u4e2a\u5355\u6297\u3001\u53cc\u6297\u3001ADC\u836f\u54c1\u7684\u7814\u53d1\u6ce8\u518c\uff0c\u5728\u751f\u7269\u5236\u54c1\u6ce8\u518c\u65b9\u9762\u6709\u4e30\u5bcc\u7ecf\u9a8c\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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02<\/section>\n
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\u25c7 \u4e0d\u540c\u56fd\u5bb6\u548c\u5730\u533a\u7684\u7533\u62a5\u6cd5\u89c4\u53ca\u7533\u62a5\u6e20\u9053<\/span><\/p>\n

\u25c7 \u7533\u62a5\u6750\u6599\u64b0\u5199<\/span><\/p>\n

\u25c7 \u6848\u4f8b\u5206\u6790<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u5f3a\u70c8\u63a8\u8350|\u6297\u4f53\u836f\u6cd5\u89c4\u89e3\u8bfb\u53ca\u4e13\u5229\u8003\u91cf\"<\/section>\n<\/section>\n
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\u675c\u65b0<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u963f\u8bfa\u533b\u836f <\/span><\/p>\n

\u9ad8\u7ea7\u526f\u603b\u88c1<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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       <\/span>\u524dFDA\u7684CMC\u5ba1\u8bc4\u4e13\u5bb6<\/span><\/strong>\uff0c<\/span>\u836f\u54c1\u6ce8\u518c\u76d1\u7ba1\u4e8b\u52a1\u4e13\u5bb6\uff0c\u540e\u5c31\u804c\u4e8e\u5b89\u4e07\u7279\u3001\u60e0\u6c0f\u3001\u8bfa\u534e\u3001BMS, NPS\u7b49\u5236\u836f\u516c\u53f8\uff0c\u591a\u6b21\u7ecf\u5386\u5e76\u8d2d\u548c\u88ab\u5e76\u8d2d\uff0c\u5177\u6709\u72ec\u7279\u7684<\/span>\u7f8e\u56fdFDA\u548c\u5de5\u4e1a\u754c\u76f8\u7ed3\u5408\u7684\u836f\u54c1\u6ce8\u518c\u76d1\u7ba1\u7ecf\u9a8c<\/span><\/strong>\uff0c\u6df1\u77e5FDA\u548c\u5168\u7403\u5bf9\u836f\u54c1\u5f00\u53d1\uff0c\u751f\u4ea7\uff0c\u8d28\u91cf\u7ba1\u7406\uff0c\u4e34\u5e8a\u8bbe\u8ba1\u548c\u8bd5\u9a8c\u7684\u6cd5\u89c4\u3002<\/span><\/p>\n

\u66fe\u5728\u7f8e\u56fdFDA\u548c\u5236\u836f\u4f01\u4e1aAventis-Pastuer, Wyeth, Novartis, BMS, NPS, Actinium pharma\u548c Advaxis\u5de5\u4f5c\u3002\u76ee\u524d\uff0c\u4ed6\u662fAdali Nortye USA Inc \u6ce8\u518c\u76d1\u7ba1\u7684\u9ad8\u7ea7\u526f\u603b\u88c1\u3002\u66fe\u5728\u91cd\u5e86\u897f\u5357\u5927\u5b66\u548c\u4e2d\u56fd\u519c\u4e1a\u90e8\u5de5\u4f5c\u3002<\/span><\/p>\n


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03<\/section>\n
\u6297\u4f53\u836f\u6cd5\u89c4\u5e94\u7528<\/span><\/strong><\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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\u25c7 \u6297\u4f53\u836f\u6ce8\u518c\u7533\u62a5\u6cd5\u89c4\u65b9\u9762\u7684\u7279\u522b\u5173\u6ce8<\/span><\/p>\n

\u25c7 \u4ece\u5408\u89c4\u7684\u89d2\u5ea6\u8003\u91cf\u6297\u4f53\u53d1\u9636\u6bb5\u7684\u8fc7\u7a0b\u7ba1\u7406\u4e0e\u63a7\u5236<\/span><\/p>\n

\u25c7 \u6297\u4f53\u836f\u4f01\u4e1a\u6cd5\u89c4\u90e8\u95e8\u4e0e\u7814\u53d1\u90e8\u95e8\u95f4\u6c9f\u901a<\/span><\/p>\n

\u25c7 \u6848\u4f8b\u5206\u6790<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u5f3a\u70c8\u63a8\u8350|\u6297\u4f53\u836f\u6cd5\u89c4\u89e3\u8bfb\u53ca\u4e13\u5229\u8003\u91cf\"<\/section>\n<\/section>\n
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\u9648\u671d\u534e<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u8f89\u745e <\/span><\/p>\n

\u526f\u603b\u88c1\u3001\u4e2d\u56fd\u836f\u7269\u5f00\u53d1\u90e8\u8d1f\u8d23\u4eba<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u9996\u90fd\u533b\u79d1\u5927\u5b66\uff0c\u4e34\u5e8a\u533b\u5b66\u4e13\u4e1a\u3002\u66fe\u5728\u5317\u4eac\u5929\u575b\u533b\u9662\u548c\u5317\u4eac\u666e\u4ec1\u533b\u9662\u62c5\u4efb\u4e09\u5e74\u5185\u79d1\u533b\u751f\u3002<\/span><\/p>\n

\u73b0\u62c5\u4efb<\/span>\u8f89\u745e\u4e2d\u56fd\u836f\u7269\u5f00\u53d1\u90e8\u8d1f\u8d23\u4eba<\/span><\/strong>\uff0c\u8d1f\u8d23\u7ec4\u5efa\u5408\u89c4\u3001\u6709\u6548\u548c\u9ad8\u6548\u8fd0\u8425\u7684\u7814\u53d1\u7ec4\u7ec7\uff0c\u5e76\u534f\u8c03\u5168\u7403\u56e2\u961f\uff0c\u987a\u5229\u5b9e\u73b0\u5728\u4e2d\u56fd\u7684\u4ea7\u54c1\u6ce8\u518c\u76ee\u6807\u3002\u9886\u5bfc\u8de8\u90e8\u95e8\u7684\u4e2d\u56fd\u7814\u53d1\u7ec4\u7ec7\uff0c\u5305\u62ec\u4e34\u5e8a\u79d1\u5b66\u3001\u6cd5\u89c4\u4e8b\u52a1\u3001\u7814\u53d1\u8fd0\u4f5c\u3001\u4e34\u5e8a\u836f\u7406\u53ca\u9879\u76ee\u7ba1\u7406\u3002<\/span><\/p>\n

\u66fe\u4efb<\/span>\u4fe1\u8fbe\u751f\u7269\u9996\u5e2d\u533b\u5b66\u5b98<\/span><\/strong>\uff0c\u8d1f\u8d23<\/span>\u7aef\u5230\u7aef\u7684\u4e34\u5e8a\u7814\u53d1\u548c\u8d28\u91cf\u7ba1\u7406\u3001\u4ee5\u53ca\u4e0a\u5e02\u540e\u533b\u5b66\u53ca\u836f\u7269\u8b66\u6212\u652f\u6301<\/span><\/strong>\u3002\u5728\u6b64\u4e4b\u524d\uff0c\u66fe\u5728\u8f89\u745e\u5de5\u4f5c18\u5e74\uff0c\u4ece2015-2017\u5e74\uff0c\u4efb\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u548c\u4ea7\u54c1\u7ec4\u5408\u7ba1\u7406\u90e8\u95e8\u7684\u8d1f\u8d23\u4eba\uff1b\u66fe\u4f9b\u804c\u4e8e\u8f89\u745e\u4e2d\u56fd\u7814\u53d1\u4e2d\u5fc3\uff0c\u8f89\u745e\u4e2d\u56fd\u533b\u5b66\u90e8\uff0c\u79ef\u7d2f\u4e86\u5927\u91cf\u7684\u6807\u51c6\u64cd\u4f5c\u6d41\u7a0b\uff08SOP\uff09\u3001\u57f9\u8bad\u53ca\u6d41\u7a0b\u6267\u884c\u65b9\u9762\u7684\u7ecf\u9a8c\u3002<\/span><\/p>\n


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04<\/section>\n
\u6297\u4f53\u836f\u4e13\u5229\u89e3\u8bfb\u53ca\u5e03\u5c40\u7b56\u7565<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

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 \u25c7 \u751f\u7269\u533b\u836f\u4e13\u5229\u4fdd\u62a4\u7b56\u7565<\/span><\/p>\n

 \u25c7 \u751f\u7269\u533b\u836f\u4e13\u5229\u5e03\u5c40\u4e0e\u64b0\u5199<\/span><\/p>\n

 \u25c7 \u751f\u7269\u533b\u836f\u4e13\u5229\u8bc9\u8bbc\u53ca\u5e94\u5bf9<\/span><\/p>\n

 \u25c7 \u6848\u4f8b\u5206\u6790<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u5f3a\u70c8\u63a8\u8350|\u6297\u4f53\u836f\u6cd5\u89c4\u89e3\u8bfb\u53ca\u4e13\u5229\u8003\u91cf\"<\/section>\n<\/section>\n
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\u674e\u514b\u5b81<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u7f8e\u56fdDuane Morris LLP<\/span><\/p>\n

\u5408\u4f19\u4eba\u517c\u4e2d\u56fd\u77e5\u8bc6\u4ea7\u6743\u4e1a\u52a1\u7ec4\u4e3b\u7ba1<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5357\u4eac\u5927\u5b66\uff0c\u7406\u5b66\u5b66\u58eb\uff1b\u5a01\u65af\u5eb7\u8f9b\u5927\u5b66\uff0c\u5206\u5b50\u751f\u7269\u5b66\u535a\u58eb\uff1b\u5a01\u65af\u5eb7\u8f9b\u5927\u5b66\u6cd5\u5b66\u9662\uff0c\u8363\u8a89\u6cd5\u5b66\u535a\u58eb\u3002 <\/span><\/p>\n

\u62e5\u670920\u591a\u5e74<\/strong><\/span>\u4e2d\u7f8e\u77e5\u8bc6\u4ea7\u6743\u548c\u5546\u4e1a\u6cd5\u5f8b<\/span><\/strong>\u7684\u6267\u4e1a\u7ecf\u9a8c<\/strong>\uff0c\u670d\u52a1\u7684\u5ba2\u6237\u6db5\u76d6\u4e86\u521d\u521b\u516c\u53f8\u5230500\u5f3a\u4f01\u4e1a\uff0c\u534f\u52a9\u5ba2\u6237\u5c06<\/strong><\/span>\u7ba1\u7406\u77e5\u8bc6\u4ea7\u6743\u8d44\u4ea7\u4f5c\u4e3a\u5176\u7efc\u5408\u7ade\u4e89\u6218\u7565\u7684\u7ec4\u6210\u90e8\u5206<\/span><\/strong>\u3002\u5728\u4ee5\u4e0b\u65b9\u9762\u62e5\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\uff1a\u5236\u5b9a\u5168\u9762\u7684\u77e5\u8bc6\u4ea7\u6743\u6218\u7565\uff1b\u5728\u6295\u8d44\u4ea4\u6613\u4e2d\u5229\u7528\u77e5\u8bc6\u4ea7\u6743\u8d44\u4ea7\uff1b\u5728\u6cd5\u9662\u548c\u884c\u653f\u673a\u6784\u6267\u884c\u77e5\u8bc6\u4ea7\u6743\uff1b\u89e3\u51b3\u56f0\u96be\u7684\u8425\u4e1a\u81ea\u7531\u5e72\u6270\uff1b\u8c08\u5224\u8bb8\u53ef\u534f\u8bae\uff1b\u5e76\u6709\u6548\u5730\u5229\u7528\u73b0\u6709\u77e5\u8bc6\u4ea7\u6743\u7ec4\u5408\u4ee5\u52a0\u5f3a\u5ba2\u6237\u7684\u7ade\u4e89\u5730\u4f4d\u3002 <\/span><\/p>\n

\u7f8e\u56fd\u5546\u4f1a\u3001\u8bb8\u53ef\u8d38\u6613\u5de5\u4f5c\u8005\u534f\u4f1a\u3001\u7f8e\u56fd\u79d1\u5b66\u4fc3\u8fdb\u4f1a\u548c\u4e2d\u56fd\u77e5\u8bc6\u4ea7\u6743\u6cd5\u534f\u4f1a\u7684\u6210\u5458\u3002<\/span><\/p>\n


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05<\/section>\n
\u6297\u4f53\u836f\u4e13\u5229\u7b56\u7565<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u25c7 \u5f53\u524d\u6297\u4f53\u836f\u4e13\u5229\u5f62\u5f0f\u53ca\u7ade\u4e89\u6001\u52bf<\/span><\/p>\n

\u25c7 \u6297\u4f53\u836f\u7acb\u9879\u4e2d\u4e13\u5229\u98ce\u9669\u53d1\u73b0\u548c\u5e94\u5bf9<\/span><\/p>\n

\u25c7 \u6848\u4f8b\u5206\u6790<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5f20\u7424<\/span><\/strong><\/span><\/p>\n


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TiPLab IP Strategy\u8054\u5408\u521b\u59cb\u4eba\u3001\u751f\u7269\u533b\u836f\u9886\u57df\u6267\u884c\u5408\u4f19\u4eba\u3002<\/span><\/p>\n

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2\u3001\u7535\u8111\u7aef\u8bf7\u590d\u5236\u4e0b\u65b9\u94fe\u63a5\u8fdb\u884c\u62a5\u540d<\/span><\/strong>
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3. \u8054\u7cfb\u54a8\u8be2\uff1a<\/span><\/strong>
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\u8bf7\u6ce8\u660e\uff1a\u59d3\u540d+\u7814\u7a76\u65b9\u5411\uff01<\/strong><\/span><\/p>\n

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\u6297\u4f53\u836f\u6cd5\u89c4\u89e3\u8bfb\u53ca\u4e13\u5229\u8003\u91cf \u65f6\u95f4\uff1a2019\u5e745\u670825-26\u65e5 \u5730\u70b9\uff1a\u4e0a\u6d77 \u8d39\u7528\uff1a6800\/\u4eba 01 \u6297\u4f53\u836f\u56fd\u5185\u7533 […]<\/p>\n","protected":false},"author":1,"featured_media":107782,"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\/107781"}],"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=107781"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/107781\/revisions"}],"predecessor-version":[{"id":107797,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/107781\/revisions\/107797"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/107782"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=107781"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=107781"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=107781"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}