{"id":42943,"date":"2022-10-28T07:17:15","date_gmt":"2022-10-28T05:17:15","guid":{"rendered":"https:\/\/kymos.com\/news\/fda-%e5%85%b3%e4%ba%8e%e5%af%a1%e6%a0%b8%e8%8b%b7%e9%85%b8%e7%96%97%e6%b3%95%e7%9a%84%e6%96%b0%e6%8c%87%e5%8d%97%e8%8d%89%e6%a1%88\/"},"modified":"2022-10-28T07:17:15","modified_gmt":"2022-10-28T05:17:15","slug":"fda-%e5%85%b3%e4%ba%8e%e5%af%a1%e6%a0%b8%e8%8b%b7%e9%85%b8%e7%96%97%e6%b3%95%e7%9a%84%e6%96%b0%e6%8c%87%e5%8d%97%e8%8d%89%e6%a1%88","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/fda-%e5%85%b3%e4%ba%8e%e5%af%a1%e6%a0%b8%e8%8b%b7%e9%85%b8%e7%96%97%e6%b3%95%e7%9a%84%e6%96%b0%e6%8c%87%e5%8d%97%e8%8d%89%e6%a1%88\/","title":{"rendered":"FDA \u5173\u4e8e\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u7684\u65b0\u6307\u5357\u8349\u6848"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">2022 \u5e74 6 \u6708\uff0cFDA \u53d1\u5e03\u4e86\u4e00\u4efd\u5173\u4e8e<strong>\u201c<\/strong><strong>\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u5f00\u53d1\u7684\u4e34\u5e8a\u836f\u7406\u5b66\u8003\u8651\u56e0\u7d20\u201d<\/strong>\u7684\u65b0\u6307\u5357\u8349\u6848\u3002\u8be5\u6307\u5357\u63d0\u4f9b\u4e86\u76f8\u5173\u5efa\u8bae\uff0c\u4ee5\u534f\u52a9\u4e1a\u754c\u5f00\u53d1\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u3002\u8fd9\u7ed9\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u7684\u5f00\u53d1\u5546\u548c\u5236\u9020\u5546\u5e26\u6765\u4e86\u65b0\u7684\u6311\u6218\u3002<strong>Kymos \u5be1\u6838\u82f7\u9178\u90e8\u95e8\u7ecf\u7406 Maria Fauth<\/strong> \u89e3\u91ca\u4e86\u65b0\u6307\u5357\u7684\u5185\u5bb9\u4ee5\u53ca Kymos \u5982\u4f55\u652f\u6301\u60a8\u5b9e\u65bd\u8be5\u6307\u5357\u3002 <\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u201c\u65b0\u7684 FDA \u6307\u5357\u8349\u6848\u4fa7\u91cd\u4e8e<strong>\u9488\u5bf9<\/strong><strong>\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u836f\u6548\u5b66\u548c\u5b89\u5168\u6027\u8bc4\u4f30\u7684\u5efa\u8bae<\/strong>\u3002\u6211\u4eec Kymos \u53ef\u4ee5\u4e3a\u5ba2\u6237\u5728\u6240\u6709\u8fd9\u4e9b\u6d3b\u52a8\u4e2d\u63d0\u4f9b\u652f\u6301\uff0c\u201dMaria Fauth \u9996\u5148\u8fdb\u884c\u4e86\u6982\u8ff0\u3002 <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u7684\u5f00\u53d1\u5728\u8bb8\u591a\u65b9\u9762\u9075\u5faa\u5c0f\u5206\u5b50\u6216\u751f\u7269\u5236\u5242\u7684\u836f\u7269\u5f00\u53d1\u6d41\u7a0b\u3002\u7136\u800c\uff0c\u4e0e\u5c0f\u5206\u5b50\u6216\u751f\u7269\u4ea7\u54c1\u76f8\u6bd4\uff0c\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u5177\u6709\u67d0\u4e9b\u9700\u8981\u8003\u8651\u7684\u72ec\u7279\u7279\u5f81\u3002\u4f8b\u5982\uff0c\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u7684\u8840\u6d46\u836f\u4ee3\u52a8\u529b\u5b66\u53ef\u80fd\u65e0\u6cd5\u53cd\u6620\u9776\u7ec4\u7ec7\u7684\u5206\u5e03\u3001\u836f\u6548\u5b66\u3001\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u3002  <\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">Maria Fauth \u6982\u8ff0\u4e86 <strong>Kymos \u5982\u4f55\u5728\u8fd9\u4e00\u5f00\u53d1\u9636\u6bb5\u4e3a\u60a8\u63d0\u4f9b\u4fbf\u5229<\/strong>\uff1a\u201c\u9996\u5148\uff0c\u6211\u4eec\u53ef\u4ee5\u6839\u636e GLP\uff0c\u4f7f\u7528\u6742\u4ea4 ELISA \u6216 LC-MS\/MS \u751f\u7269\u5206\u6790\u65b9\u6cd5<strong>\u6d4b\u5b9a\u8840\u6d46\u6d53\u5ea6<\/strong>\u3002\u7136\u540e\uff0c\u6211\u4eec\u4f7f\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684 WinNonLin \u8f6f\u4ef6\u8fdb\u884c<strong>\u836f\u4ee3\u52a8\u529b\u5b66\u8bc4\u4f30<\/strong>\u3002\u5982\u679c\u8840\u6d46\u836f\u4ee3\u52a8\u529b\u5b66\u6570\u636e\u4e0d\u8db3\uff0c\u6211\u4eec Kymos \u8fd8\u53ef\u4ee5\u4f7f\u7528\u5148\u8fdb\u7684 ECLA \u7cfb\u7edf\u5feb\u901f\u8f7b\u677e\u5730<strong>\u91cf\u5316\u6240\u9700\u7684\u836f\u6548\u5b66\u751f\u7269\u6807\u5fd7\u7269<\/strong>\u3002\u201d  <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">\u4e8b\u5b9e\u4e0a\uff0c\u6574\u4e2a\u65c5\u7a0b\u6b63\u662f\u4ece\u8fd9\u79cd\u751f\u7269\u6807\u5fd7\u7269\u6d4b\u5b9a\u5f00\u59cb\u7684\u3002<\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u201c\u591a\u5e74\u524d\u6211\u4eec\u5c31\u610f\u8bc6\u5230\u4e86\u5bf9\u53ef\u91cd\u590d\u751f\u7269\u5206\u6790\u65b9\u6cd5\u7684\u9700\u6c42\uff0c\u5e76\u4ed8\u8bf8\u884c\u52a8\uff0c\u201dMaria Fauth \u89e3\u91ca\u9053\u3002\u201c\u65e9\u5728 2017 \u5e74\uff0c\u6211\u4eec\u5c31\u5f00\u59cb\u901a\u8fc7 qPCR \u5f00\u53d1\u5e76\u9a8c\u8bc1\u9002\u7528\u4e8e\u4e0d\u540c\u7ec4\u7ec7\u548c\u751f\u7269\u4f53\u6db2\u4e2d\u751f\u7269\u6807\u5fd7\u7269 miRNA \u7684\u7b26\u5408 GLP \u6807\u51c6\u7684\u751f\u7269\u5206\u6790\u65b9\u6cd5\u3002\u5728\u6b64\u540e\u7684\u51e0\u5e74\u91cc\uff0c\u6211\u4eec\u5c06\u8303\u56f4\u6269\u5927\u5230\u4e86\u5176\u4ed6\u6838\u9178\u548c\u5e94\u7528\u9886\u57df\u3002\u73b0\u5728\u6211\u4eec\u611f\u5230\u81ea\u5df1\u7684\u505a\u6cd5\u5f97\u5230\u4e86\u80af\u5b9a\uff0c\u56e0\u4e3a <strong>FDA \u5728\u8fd9\u4efd\u65b0\u6307\u5357\u4e2d\u660e\u786e\u6307\u51fa\u4e86\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u751f\u7269\u5206\u6790\u65b9\u6cd5\u7684\u5fc5\u8981\u6027<\/strong>\u3002\u201d   <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">\u7136\u800c\uff0cFDA \u66f4\u8fdb\u4e00\u6b65\u3002\u5728\u65b0\u6307\u5357\u8349\u6848\u4e2d\uff0c\u4ed6\u4eec\u5f3a\u8c03\u65b0\u7684\u5316\u5b66\u4fee\u9970\u548c\u5176\u4ed6<strong>\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u53ef\u80fd\u4f1a\u5f15\u53d1\u4e0d\u826f\u514d\u75ab\u53cd\u5e94<\/strong>\u3002\u56e0\u6b64\uff0c\u5bf9\u5be1\u6838\u82f7\u9178\uff0c\u7279\u522b\u662f\u5bf9\u8f7d\u4f53\u6210\u5206\u4ee5\u53ca\u4e0e\u86cb\u767d\u8d28\u9776\u5411\u914d\u4f53\u7ed3\u5408\u7684\u5be1\u6838\u82f7\u9178\u7f00\u5408\u7269\u8fdb\u884c\u514d\u75ab\u6d4b\u5b9a\u662f\u5fc5\u4e0d\u53ef\u5c11\u7684\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u9488\u5bf9 FDA \u7684\u5efa\u8bae\uff0cMaria Fauth \u7b80\u8981\u6982\u8ff0\u4e86 Kymos \u5728\u514d\u75ab\u539f\u6027\u65b9\u9762\u7684\u4e30\u5bcc\u7ecf\u9a8c\u3002<\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u201c\u6211<strong>\u4eec\u6709\u4e24\u4e2a\u7ad9\u70b9\uff0c\u5206\u522b\u4f4d\u4e8e\u5df4\u585e\u7f57\u90a3\u548c\u6cd5\u5170\u514b\u798f\uff0c\u4e13\u95e8\u4ece\u4e8b\u514d\u75ab\u539f\u6027\u6d4b\u5b9a\u3002<\/strong>\u6211\u7ecf\u9a8c\u4e30\u5bcc\u7684\u540c\u4e8b\u5df2\u51c6\u5907\u597d\u534f\u52a9\u60a8\u89e3\u51b3\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u51fa\u73b0\u7684\u4efb\u4f55\u514d\u75ab\u539f\u6027\u95ee\u9898\u3002\u201d<\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">\u603b\u4e4b\uff0cKymos \u7684\u6574\u4e2a\u56e2\u961f\u5f88\u4e50\u610f\u5c31\u6307\u5357\u7684\u5b9e\u65bd\u4e3a\u60a8\u63d0\u4f9b\u54a8\u8be2\uff0c\u5e76\u652f\u6301\u60a8\u7684\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u5f00\u53d1\u3002\u5982\u9700\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u901a\u8fc7 <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a> \u4e0e\u6211\u4eec\u8054\u7cfb\u3002<strong>\u60a8\u8fd8\u53ef\u4ee5\u5728 11 \u6708 16 \u65e5\u81f3 18 \u65e5\u4e8e\u5965\u5730\u5229\u7ef4\u4e5f\u7eb3\u4e3e\u884c\u7684 TIDES \u4f1a\u8bae\u4e0a\u4e0e Maria Fauth \u672c\u4eba\u89c1\u9762\u3002<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4e3a\u65b9\u4fbf\u8d77\u89c1\uff0c\u60a8\u53ef\u4ee5\u5728<a href=\"https:\/\/www.fda.gov\/media\/159414\/download\" data-wpel-link=\"external\">\u6b64\u5904<\/a>\u627e\u5230\u5b8c\u6574\u7684\u6307\u5357\u3002<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>2022 \u5e74 6 \u6708  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":42945,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[381,383],"tags":[],"class_list":["post-42943","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc","category-383"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u5be1\u6838\u82f7\u9178\u7597\u6cd5 | FDA \u65b0\u6307\u5357<\/title>\n<meta name=\"description\" content=\"\u4e86\u89e3\u66f4\u591a\u5173\u4e8e 2022 \u5e74 6 \u6708\u53d1\u5e03\u7684 FDA \u5be1\u6838\u82f7\u9178\u7597\u6cd5\u65b0\u6307\u5357\u8349\u6848\u7684\u4fe1\u606f\u3002\u7acb\u5373\u63a2\u7d22\uff01\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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