{"id":42967,"date":"2024-05-31T11:19:59","date_gmt":"2024-05-31T09:19:59","guid":{"rendered":"https:\/\/kymos.com\/news\/%e9%80%8f%e7%9a%ae%e6%b5%8b%e8%af%95%ef%bc%9a%e9%80%8f%e7%9a%ae%e8%b4%b4%e5%89%82%e7%9a%84%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/"},"modified":"2024-05-31T11:19:59","modified_gmt":"2024-05-31T09:19:59","slug":"%e9%80%8f%e7%9a%ae%e6%b5%8b%e8%af%95%ef%bc%9a%e9%80%8f%e7%9a%ae%e8%b4%b4%e5%89%82%e7%9a%84%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e9%80%8f%e7%9a%ae%e6%b5%8b%e8%af%95%ef%bc%9a%e9%80%8f%e7%9a%ae%e8%b4%b4%e5%89%82%e7%9a%84%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/","title":{"rendered":"\u900f\u76ae\u6d4b\u8bd5\uff1a\u900f\u76ae\u8d34\u5242\u7684\u5206\u6790\u4e0e\u8d28\u91cf\u63a7\u5236"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\u900f\u76ae\u8d34\u5242\uff0c\u53c8\u79f0\u900f\u76ae\u7ed9\u836f\u7cfb\u7edf (TDDS)\uff0c\u65e8\u5728\u901a\u8fc7\u76ae\u80a4\u76f4\u63a5\u5c06\u6d3b\u6027\u7269\u8d28\u4ee5\u6301\u4e45\u4e14\u6052\u5b9a\u7684\u901f\u7387\u8f93\u9001\u5230\u8840\u6db2\u4e2d\u3002\u7531\u4e8e\u5176\u72ec\u7279\u7684\u5c5e\u6027\uff0c\u5728\u63a7\u5236\u5176\u8d28\u91cf\u3001\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u65f6\u9762\u4e34\u7740\u4e0d\u540c\u7684\u6311\u6218\u3002\u5728\u672c\u6587\u4e2d\uff0c\u6211\u4eec\u5c06\u63a2\u8ba8\u5176\u5de5\u4f5c\u673a\u5236\u3001\u76d1\u7ba1\u8981\u6c42\uff0c\u4ee5\u53ca Kymos \u96c6\u56e2\u5982\u4f55\u534f\u52a9\u60a8\u8fdb\u884c\u8d28\u91cf\u63a7\u5236\u548c\u5206\u6790\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u900f\u76ae\u8d34\u5242\u7531\u591a\u5c42\u7ed3\u6784\u7ec4\u6210\uff0c\u901a\u5e38\u5305\u62ec\u836f\u7269\u8d2e\u5e93\u3001\u63a7\u5236\u819c\u3001\u7c98\u5408\u5c42\u548c\u4fdd\u62a4\u886c\u57ab\u3002\u5f53\u8d34\u5242\u5e94\u7528\u4e8e\u76ae\u80a4\u65f6\uff0c\u4e00\u79cd\u6216\u591a\u79cd\u6d3b\u6027\u7269\u8d28\u4ece\u8d2e\u5e93\u4e2d\u91ca\u653e\uff0c\u901a\u8fc7\u63a7\u5236\u819c\u548c\u7c98\u5408\u5c42\u6269\u6563\uff0c\u7136\u540e\u7a7f\u900f\u5b8c\u6574\u7684\u76ae\u80a4\u5230\u8fbe\u5168\u8eab\u5faa\u73af\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4e0e\u4ec5\u65e8\u5728\u5f71\u54cd\u7ed9\u836f\u533a\u57df\u7684\u5916\u7528\u4ea7\u54c1\u4e0d\u540c\uff0c\u900f\u76ae\u8d34\u5242\u65e8\u5728\u4ea7\u751f\u5168\u8eab\u6548\u5e94\uff0c\u56e0\u6b64\u5728\u76ee\u7684\u3001\u673a\u5236\u548c\u914d\u65b9\u590d\u6742\u6027\u65b9\u9762\u6709\u6240\u4e0d\u540c\u3002\u6b63\u56e0\u5982\u6b64\uff0c\u5728\u5206\u6790\u5916\u7528\u4ea7\u54c1\u65f6\uff0c\u4f53\u5916\u91ca\u653e\u6d4b\u8bd5 (IVRT) \u548c\u4f53\u5916\u6e17\u900f\u6d4b\u8bd5 (IVPT) \u53ef\u80fd\u5141\u8bb8\u8df3\u8fc7\u4e34\u5e8a\u7814\u7a76\uff08<a href=\"https:\/\/www.ema.europa.eu\/en\/quality-equivalence-topical-products-scientific-guideline\" data-wpel-link=\"external\">2018 \u5e74 EMA \u5173\u4e8e\u201c\u5916\u7528\u4ea7\u54c1\u8d28\u91cf\u548c\u7b49\u6548\u6027\u201d\u7684\u6307\u5357\u8349\u6848<\/a>\uff09\uff0c\u4f46\u5728\u5904\u7406\u900f\u76ae\u8d34\u5242\u65f6\uff0cIVRT \u548c IVPT \u4e0d\u80fd\u66ff\u4ee3\u4e34\u5e8a\u90e8\u5206\u3002 <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u900f\u76ae\u8d34\u5242\u7684\u76d1\u7ba1\u6982\u51b5\u4e0e\u6d4b\u8bd5<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u5982\u524d\u6240\u8ff0\uff0c\u7531\u4e8e\u5176\u7279\u6027\uff0c\u76d1\u7ba1\u673a\u6784\u5df2\u5b9a\u4e49\u4e86\u5408\u9002\u7684\u6d4b\u8bd5\u6765\u8868\u5f81\u548c\u63a7\u5236\u900f\u76ae\u8d34\u5242\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027 (CQA)\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4e3b\u8981\u7684\u53c2\u8003\u6846\u67b6\u7531\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4e8e 2014 \u5e74\u53d1\u5e03\uff1a<em><a href=\"https:\/\/www.ema.europa.eu\/en\/quality-transdermal-patches-scientific-guideline\" data-wpel-link=\"external\">\u300a\u900f\u76ae\u8d34\u5242\u8d28\u91cf\u6307\u5357 (EMA\/CHMP\/608924\/2014)\u300b<\/a><\/em>\u3002\u8be5\u6587\u4ef6\u9488\u5bf9\u900f\u76ae\u7ed9\u836f\u7cfb\u7edf\u7684\u65b0\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff0c\u5e76\u6982\u8ff0\u4e86\u4e3a\u786e\u4fdd\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u8d28\u91cf\u800c\u5fc5\u987b\u8bc4\u4f30\u7684\u5fc5\u8981\u6d4b\u8bd5\u548c CQA\u3002\u8be5\u6587\u4ef6\u7ed3\u5408\u76f8\u5173\u7684\u836f\u5178\u5355\u884c\u672c\u4ee5\u53ca ICH \u548c CHMP\/CVMP \u6307\u5357\uff0c\u6784\u6210\u4e86\u6211\u4eec\u900f\u76ae\u8d34\u5242\u670d\u52a1\u76ee\u5f55\u7684\u57fa\u7840\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Kymos \u96c6\u56e2\u5728\u900f\u76ae\u8d34\u5242\u836f\u7269\u4ea7\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u63d0\u4f9b\u5168\u9762\u652f\u6301\uff0c\u4ece\u914d\u65b9\u3001\u5f00\u53d1\u548c\u7a33\u5b9a\u6027\u5230\u5e38\u89c4\u5206\u6790\u548c\u91cd\u65b0\u914d\u65b9\u3002\u6211\u4eec\u62e5\u6709\u5206\u6790 EMA \u6307\u5357\u4e2d\u63d0\u5230\u7684 CQA \u7684\u7ecf\u9a8c\uff0c\u4f8b\u5982\u5e38\u89c4\u8d28\u91cf\u63a7\u5236\u5206\u6790\uff08\u542b\u91cf\u6d4b\u5b9a\u3001\u6709\u5173\u7269\u8d28\u3001\u5916\u89c2\u7b49\uff09\u3001\u6b8b\u7559\u6eb6\u5242\u6d4b\u5b9a\u3001\u6d3b\u6027\u7269\u8d28\u7ed3\u6676\u3001\u63d0\u53d6\u7269\u548c\u6d78\u51fa\u7269\u6d4b\u8bd5\u3001IVRT \u548c IVPT\uff0c\u4ee5\u53ca\u7c98\u9644\u6027\u80fd\u7b49\u7279\u5b9a\u7684\u900f\u76ae\u8d34\u5242\u6d4b\u8bd5\u3002 <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u900f\u76ae\u8d34\u5242\u7684 CMC \u4e0e\u8d28\u91cf\u63a7\u5236\u6d4b\u8bd5<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u8d28\u91cf\u63a7\u5236\u548c CMC \u5206\u6790\u5bf9\u4e8e\u786e\u4fdd\u900f\u76ae\u8d34\u5242\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u81f3\u5173\u91cd\u8981\u3002\u5e94\u5bf9\u5305\u62ec TDDS \u5728\u5185\u7684\u6240\u6709\u5242\u578b\u8fdb\u884c\u7684\u5408\u9002\u6d4b\u8bd5\u5305\u62ec\uff1a <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u542b\u91cf\u6d4b\u5b9a\uff1a<\/strong>\u6d4b\u5b9a\u900f\u76ae\u8d34\u5242\u4e2d\u7684\u836f\u7269\u542b\u91cf\uff0c\u786e\u4fdd\u5176\u7b26\u5408\u89c4\u5b9a\u7684\u6d3b\u6027\u7269\u8d28\u6d53\u5ea6\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u5916\u89c2\uff1a<\/strong>\u8bc4\u4f30\u900f\u76ae\u8d34\u5242\u7684\u89c6\u89c9\u548c\u7269\u7406\u7279\u6027\uff0c\u4ee5\u786e\u4fdd\u5176\u7b26\u5408\u8981\u6c42\u7684\u6807\u51c6\u3002\u5728 TDDS \u7684\u7279\u5b9a\u60c5\u51b5\u4e0b\uff0c\u5b83\u5305\u62ec\u989c\u8272\u6216\u5f62\u72b6\u7b49\u4e00\u822c\u5c5e\u6027\uff0c\u4f46\u4e5f\u5305\u62ec\u7c98\u5408\u57fa\u8d28\u6216\u91ca\u653e\u886c\u57ab\u8131\u79bb\u7b49\u7279\u5b9a\u5c5e\u6027\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u6709\u5173\u7269\u8d28\uff1a<\/strong>\u8bc6\u522b\u6742\u8d28\u548c\u964d\u89e3\u4ea7\u7269\uff0c\u5e76\u786e\u4fdd\u5176\u542b\u91cf\u5728\u53ef\u63a5\u53d7\u7684\u8303\u56f4\u5185\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u6b64\u5916\uff0c\u6211\u4eec\u8fd8\u6709\u9488\u5bf9\u900f\u76ae\u8d34\u5242\u7684\u7279\u5b9a QC \u5206\u6790\uff0c\u8fd9\u4e9b\u5206\u6790\u5177\u6709\u7279\u6b8a\u6027\u6216\u91cd\u8981\u6027\uff1a<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u6d3b\u6027\u7269\u8d28\u7ed3\u6676\uff1a<\/strong>\u7ed3\u6676\u5f62\u6210\u662f\u4e00\u79cd\u8d28\u91cf\u7f3a\u9677\uff0c\u56e0\u4e3a\u5b83\u4f1a\u51cf\u5c11\u53ef\u4f9b\u91ca\u653e\u5e76\u88ab\u76ae\u80a4\u5438\u6536\u7684\u6d3b\u6027\u7269\u8d28\u6570\u91cf\uff0c\u4ece\u800c\u5f71\u54cd\u8d34\u5242\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u8fdb\u884c\u7ed3\u6676\u6d4b\u5b9a\u7684\u5b9a\u6027\u5206\u6790\u81f3\u5173\u91cd\u8981\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u6b8b\u7559\u6eb6\u5242\uff1a<\/strong>\u6b8b\u7559\u6eb6\u5242\u7684\u68c0\u6d4b\u548c\u5b9a\u91cf\u5728\u900f\u76ae\u8d34\u5242\u4e2d\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u5b83\u4eec\u53ef\u80fd\u4f1a\u5f71\u54cd\u7c98\u9644\u529b\u548c\u6e17\u900f\u589e\u5f3a\uff0c\u5e76\u4e14\u53ef\u80fd\u9700\u8981\u6bd4 ICH Q3C \u4e2d\u66f4\u4e25\u683c\u7684\u9650\u5236\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u63d0\u53d6\u7269\u548c\u6d78\u51fa\u7269\uff1a<\/strong>\u7531\u4e8e\u900f\u76ae\u8d34\u5242\u5242\u578b\u7684\u6027\u8d28\uff0c\u68c0\u6d4b\u5728\u6eb6\u5242\u5b58\u5728\u4e0b\u53ef\u80fd\u4ece\u591a\u5c42\u7ed3\u6784\u3001\u836f\u7269\u8d2e\u5e93\u548c\u521d\u7ea7\u5305\u88c5\u4e2d\u63d0\u53d6\u51fa\u7684\u63d0\u53d6\u7269\uff0c\u4ee5\u53ca\u6e17\u5165\u836f\u7269\u4ea7\u54c1\u4e2d\u7684\u6c61\u67d3\u7269\u81f3\u5173\u91cd\u8981\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u7c98\u9644\u6027\u80fd\uff1a<\/strong>\u900f\u76ae\u8d34\u5242\u7279\u6709\u7684\u7c98\u9644\/\u5185\u805a\u6027\u80fd\u5e94\u8fdb\u884c\u8868\u5f81\u5e76\u5f97\u5230\u4ee4\u4eba\u6ee1\u610f\u7684\u63a7\u5236\uff0c\u4ee5\u786e\u4fdd\u8d34\u5242\u5728\u6240\u9700\u7684\u65f6\u95f4\u5185\u4fdd\u6301\u9644\u7740\u5728\u76ae\u80a4\u4e0a\u3002\u8fd9\u4e9b\u5305\u62ec\u5265\u79bb\u529b\u6d4b\u8bd5\u3001\u7c98\u5408\u5f3a\u5ea6\u6d4b\u8bd5\u3001\u521d\u7c98\u529b\u6d4b\u8bd5\u7b49\u5206\u6790\uff0cKymos \u53ef\u4ee5\u4f7f\u7528\u76f8\u5173\u8bbe\u5907\u8c03\u6574\u5e76\u5b9e\u65bd\u8fd9\u4e9b\u65b9\u6cd5\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u5fae\u751f\u7269\u5b66\uff1a<\/strong>\u6839\u636e\u5e94\u7528\u60c5\u51b5\uff0c\u65e0\u83cc\u6d4b\u8bd5\u81f3\u5173\u91cd\u8981\uff0c\u8fd8\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u5fae\u751f\u7269\u5206\u6790\u548c\u7279\u5b9a\u75c5\u539f\u4f53\u8c03\u67e5\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u4f53\u5916\u91ca\u653e\u6d4b\u8bd5 (IVRT)\/\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\uff1a<\/strong>\u4e3a\u4e86\u6ee1\u8db3\u4e00\u81f4\u4e14\u53d7\u63a7\u7684\u836f\u7269\u8f93\u9001\u6240\u9700\u7684\u6280\u672f\u89c4\u8303\uff0c\u5fc5\u987b\u6d4b\u91cf\u8d34\u5242\u7684\u836f\u7269\u91ca\u653e\u901f\u7387\u3002\u6b63\u5982 EMA \u6307\u5357\u6240\u8ff0\uff0c\u5728\u5904\u7406 TDDS \u65f6\uff0c\u4f53\u5916\u91ca\u653e\u548c\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\u88ab\u63cf\u8ff0\u4e3a\u540c\u4e00\u79cd\u5206\u6790\u65b9\u6cd5\u3002\u8be5\u6d4b\u8bd5\u4f7f\u7528 Kymos \u7684 2 \u7c7b\u6868\u6cd5\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\u4eea\u8fdb\u884c\uff0c\u8be5\u4eea\u5668\u91c7\u7528\u4e13\u7528\u819c\u4ee5\u9632\u6b62\u8d34\u5242\u5728\u6eb6\u51fa\u4ecb\u8d28\u4e2d\u6f02\u6d6e\u3002\u5bf9\u4e8e\u7279\u5b9a\u5e94\u7528\uff0c\u8fd8\u63d0\u4f9b\u5782\u76f4\u6269\u6563 Franz \u6269\u6563\u6c60\u3002   <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u4f53\u5916\u6e17\u900f\u6d4b\u8bd5 (IVPT)\uff1a<\/strong>\u8fd9\u4e9b\u7814\u7a76\u6d89\u53ca\u5728\u5408\u6210\u819c\u6216\u751f\u7269\u819c\u4e0a\u6d4b\u8bd5\u8d34\u5242\uff0c\u4ee5\u6d4b\u91cf\u836f\u7269\u7a7f\u900f\u76ae\u80a4\u7684\u60c5\u51b5\uff0c\u5e76\u4e14\u6839\u636e\u6307\u5357\uff0c\u53ef\u4ee5\u5728\u914d\u65b9\u5f00\u53d1\u9636\u6bb5\u3001\u7a33\u5b9a\u6027\u7814\u7a76\u4ee5\u53ca\u836f\u7269\u4ea7\u54c1\u8f85\u6599\u53d1\u751f\u4efb\u4f55\u53d8\u5316\u540e\u8fdb\u884c\u3002\u5728 Kymos\uff0c\u6b64\u9879\u6d4b\u8bd5\u88ab\u7528\u4f5c\u836f\u7269\u4ea7\u54c1\u7684\u6027\u80fd\u6307\u6807\uff0c\u4f7f\u7528\u5782\u76f4\u6269\u6563 Franz \u6269\u6563\u6c60\u5e76\u9075\u5faa 2018 \u5e74 EMA \u6307\u5357\u8349\u6848\u4e2d\u66f4\u65b0\u7684\u65b9\u6cd5\u8fdb\u884c\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u7a33\u5b9a\u6027\u7814\u7a76\uff1a<\/strong>EMA 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14pt;\">\u7528\u4e8e\u6cbb\u7597\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u3001\u5e15\u91d1\u68ee\u75c5\u3001\u9000\u884c\u6027\u8fc7\u7a0b\u7b49\u7684\u836f\u7269\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u7cbe\u795e\u7c7b\u836f\u7269<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u75bc\u75db\u6cbb\u7597\u836f\u7269<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u907f\u5b55\u836f<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u7528\u4e8e\u6212\u70df\u7684\u5c3c\u53e4\u4e01<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u6fc0\u7d20\u7597\u6cd5<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u6655\u52a8\u75c5\uff08\u4e1c\u83a8\u83ea\u78b1\uff09<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u5982\u679c\u60a8\u9700\u8981 CMC \u6216\u751f\u7269\u5206\u6790\u9879\u76ee\u65b9\u9762\u7684\u534f\u52a9\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\u6216\u53d1\u9001\u7535\u5b50\u90ae\u4ef6\u81f3 <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a>\u3002 <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u900f\u76ae\u8d34\u5242\uff0c\u53c8\u79f0\u900f\u76ae\u7ed9  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":42968,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[381,383],"tags":[67],"class_list":["post-42967","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc","category-383","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u900f\u76ae\u6d4b\u8bd5\uff1a\u900f\u76ae\u8d34\u5242\u7684\u8d28\u91cf\u63a7\u5236<\/title>\n<meta name=\"description\" content=\"\u4e86\u89e3\u900f\u76ae\u8d34\u5242\u7684\u5de5\u4f5c\u673a\u5236\u3001\u76d1\u7ba1\u8981\u6c42\uff0c\u4ee5\u53ca Kymos 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