{"id":42957,"date":"2024-11-15T09:19:20","date_gmt":"2024-11-15T08:19:20","guid":{"rendered":"https:\/\/kymos.com\/news\/ema-%e5%85%b3%e4%ba%8e%e5%a4%96%e7%94%a8%e4%ba%a7%e5%93%81%e7%9a%84%e6%96%b0%e6%8c%87%e5%8d%97%ef%bc%9a%e5%af%b9-ivrt-%e5%92%8c-ivpt-%e7%9a%84%e5%bd%b1%e5%93%8d\/"},"modified":"2024-11-15T09:19:20","modified_gmt":"2024-11-15T08:19:20","slug":"ema-%e5%85%b3%e4%ba%8e%e5%a4%96%e7%94%a8%e4%ba%a7%e5%93%81%e7%9a%84%e6%96%b0%e6%8c%87%e5%8d%97%ef%bc%9a%e5%af%b9-ivrt-%e5%92%8c-ivpt-%e7%9a%84%e5%bd%b1%e5%93%8d","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/ema-%e5%85%b3%e4%ba%8e%e5%a4%96%e7%94%a8%e4%ba%a7%e5%93%81%e7%9a%84%e6%96%b0%e6%8c%87%e5%8d%97%ef%bc%9a%e5%af%b9-ivrt-%e5%92%8c-ivpt-%e7%9a%84%e5%bd%b1%e5%93%8d\/","title":{"rendered":"EMA \u5173\u4e8e\u5916\u7528\u4ea7\u54c1\u7684\u65b0\u6307\u5357\uff1a\u5bf9 IVRT \u548c IVPT \u7684\u5f71\u54cd"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4e8e 2024 \u5e74 10 \u6708\u5ba3\u5e03\u901a\u8fc7\u4e86\u5907\u53d7\u671f\u5f85\u7684\u5173\u4e8e\u5916\u7528\u4ea7\u54c1\u8d28\u91cf\u548c\u7b49\u6548\u6027\u7684\u6307\u5357\u3002\u6700\u7ec8\u6587\u4ef6\u4e8e 2018 \u5e74\u8d77\u8349\uff0c\u5c06\u4e8e 2025 \u5e74 4 \u6708\u6b63\u5f0f\u751f\u6548\uff0c\u5b98\u65b9\u540d\u79f0\u4e3a\u201c<a href=\"https:\/\/www.ema.europa.eu\/en\/quality-equivalence-locally-applied-locally-acting-cutaneous-products-scientific-guideline#current-version-8664\" data-wpel-link=\"external\">\u5c40\u90e8\u5e94\u7528\u3001\u5c40\u90e8\u4f5c\u7528\u76ae\u80a4\u4ea7\u54c1\u8d28\u91cf\u548c\u7b49\u6548\u6027\u6307\u5357<\/a>\u201d\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u6211\u4eec\u7684 IVRT &#038; IVPT \u548c\u8d28\u91cf\u4fdd\u8bc1\u90e8\u95e8\u603b\u7ed3\u4e86 EMA \u6307\u5357\u4e2d\u4e0e IVRT \u548c IVPT \u76f8\u5173\u7684\u6700\u91cd\u8981\u65b9\u9762\uff0c\u5c06\u5176\u5206\u4e3a\u8d28\u91cf\u5efa\u8bae\u548c\u6cbb\u7597\u7b49\u6548\u6027\u90e8\u5206\u3002\u6700\u540e\uff0c\u4ed6\u4eec\u5206\u4eab\u4e86 Kymos \u96c6\u56e2\u81ea 2018 \u5e74\u8be5\u6307\u5357\u8349\u6848\u53d1\u5e03\u4ee5\u6765\uff0c\u9075\u5faa\u8be5\u6307\u5357\u5f00\u5c55\u5de5\u4f5c\u7684\u7ecf\u9a8c\u3002 <\/span><\/p>\n<h2><strong>2024 \u5e74 EMA \u5173\u4e8e\u5916\u7528\u4ea7\u54c1\u7684\u65b0\u6307\u5357\u662f\u4ec0\u4e48\uff1f<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u987e\u540d\u601d\u4e49\uff0c\u8be5\u6307\u5357\u6d89\u53ca\u5c40\u90e8\u5e94\u7528\u548c\u5c40\u90e8\u4f5c\u7528\u7684\u76ae\u80a4\u7528\u836f\uff0c\u4f46\u4e5f\u53ef\u80fd\u4e0e\u5176\u4ed6\u4ea7\u54c1\u76f8\u5173\uff0c\u5982\u8033\u7528\u6216\u773c\u7528\u5236\u5242\uff0c\u4ee5\u53ca\u5c40\u90e8\u4f5c\u7528\u7684\u9634\u9053\u4ea7\u54c1\u3002\u8fd9\u9879\u65b0\u6cd5\u89c4\u5206\u4e3a\u8d28\u91cf\u548c\u7b49\u6548\u6027\u5efa\u8bae\uff0c\u5e76\u5f15\u5165\u4e86\u66f4\u7ed3\u6784\u5316\u7684\u76ae\u80a4\u4ea7\u54c1\u8bc4\u4f30\u65b9\u6cd5\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5173\u4e8e\u7b49\u6548\u6027\u7684\u7b2c\u4e8c\u90e8\u5206\u4e0d\u9002\u7528\u4e8e\u751f\u7269\u5236\u54c1\u3001\u8349\u836f\u5236\u54c1\u3001\u901a\u8fc7\u4e34\u5e8a\u8bd5\u9a8c\u8bc1\u660e\u7597\u6548\u7b49\u6548\u6027\u7684\u4ea7\u54c1\uff0c\u4ee5\u53ca\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5242\u578b\u4e0d\u540c\u7684\u4ea7\u54c1\u3002\u5728\u5904\u7406<a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e9%80%8f%e7%9a%ae%e6%b5%8b%e8%af%95\/\" data-wpel-link=\"internal\">\u5168\u8eab\u5438\u6536\u5242\u578b\uff08\u5982\u900f\u76ae\u8d34\u5242\uff09<\/a>\u65f6\uff0c\u8fd9\u4e00\u6392\u9664\u6761\u6b3e\u5c24\u4e3a\u91cd\u8981\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u901a\u8fc7\u8fd9\u4e9b\u6700\u65b0\u7684\u66f4\u65b0\uff0cEMA \u5f3a\u8c03\u4e86\u4e00\u79cd\u66f4\u7ed3\u6784\u5316\u3001\u5faa\u5e8f\u6e10\u8fdb\u7684\u65b9\u6cd5\uff0c\u65e8\u5728\u7b80\u5316\u8bc1\u660e\u6cbb\u7597\u7b49\u6548\u6027\u7684\u8fc7\u7a0b\uff0c\u91cd\u70b9\u5173\u6ce8\u4f53\u5916\uff08\u4f53\u5916\u91ca\u653e\u8bd5\u9a8c\u6216 IVRT\uff0c\u4ee5\u53ca\u4f53\u5916\u6e17\u900f\u8bd5\u9a8c\u6216 IVPT\uff09\u548c\u836f\u4ee3\u52a8\u529b\u5b66 (PK) \u65b9\u6cd5\uff0c\u8fd9\u4e9b\u65b9\u6cd5\u4e3a\u4e34\u5e8a\u7814\u7a76\u63d0\u4f9b\u4e86\u8282\u7701\u6210\u672c\u4e14\u9ad8\u6548\u7684\u66ff\u4ee3\u65b9\u6848\u3002<\/span><\/p>\n<h2><strong>\u5916\u7528\u4ea7\u54c1\u7684\u8d28\u91cf\u5efa\u8bae<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u8be5\u6307\u5357\u4e2d\u7684\u8d28\u91cf\u5efa\u8bae\u9002\u7528\u4e8e\u65b0\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff0c\u4ee5\u53ca\u4e0d\u53d7\u5176\u4ed6\u6307\u5357\u6216\u76f8\u5173\u836f\u5178\u6807\u51c6\u6db5\u76d6\u7684\u4ea7\u54c1\u7684\u4e0a\u5e02\u540e\u53d8\u66f4\u3002\u5173\u4e8e IVRT \u548c IVPT\uff0c\u8be5\u6307\u5357\u6700\u76f8\u5173\u7684\u65b9\u9762\u5305\u62ec\uff1a <\/span><\/p>\n<h4><span style=\"text-decoration: underline;\"><span style=\"font-size: 14pt;\"><strong>\u836f\u7269\u7814\u53d1<\/strong><\/span><\/span><\/h4>\n<ul>\n<li>\n<h4><strong><span style=\"font-size: 14pt;\">\u5904\u65b9\u7814\u53d1<\/span><\/strong><\/h4>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u5904\u65b9\u7814\u53d1\u5e94\u4e0e QTTP\uff08\u8d28\u91cf\u76ee\u6807\u4ea7\u54c1\u6982\u51b5\uff09\u4fdd\u6301\u4e00\u81f4\uff0c\u5e76\u8fdb\u884c\u9002\u5f53\u7684\u6d4b\u8bd5\u4ee5\u8868\u5f81\u548c\u63a7\u5236 CQA\uff08\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff09\uff0c\u5982\u7ed9\u836f\u4fbf\u5229\u6027\u3001\u4f7f\u7528\u671f\u9650\u4ee5\u53ca\u6eb6\u51fa\u5ea6\u3001IVRT \u548c\uff08\u5982\u9002\u7528\uff09IVPT \u7b49\u4ea7\u54c1\u6027\u80fd\u3002<\/span><\/p>\n<ul>\n<li>\n<h4><strong><span style=\"font-size: 14pt;\">\u4ea7\u54c1\u8868\u5f81<\/span><\/strong><\/h4>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u8868\u5f81\u5bf9\u4e8e\u4fc3\u8fdb\u751f\u547d\u5468\u671f\u7ba1\u7406\u4ee5\u53ca\uff08\u5fc5\u8981\u65f6\uff09\u4ea7\u54c1\u7b49\u6548\u6027\u662f\u5fc5\u4e0d\u53ef\u5c11\u7684\u3002\u5173\u952e\u6027\u80fd\u6d4b\u8bd5\u5e94\u5305\u62ec\u6df7\u60ac\u5242\u7684\u6eb6\u51fa\u5ea6\u3001IVRT\uff0c\u4ee5\u53ca\uff08\u5fc5\u8981\u65f6\uff09IVPT\u3002\u5e94\u8bc1\u660e\u4ea7\u54c1\u6027\u80fd\u5728\u50a8\u5b58\u671f\u95f4\u4fdd\u6301\u7a33\u5b9a\u3002  <\/span><\/p>\n<h4><span style=\"font-size: 14pt;\"><strong><span style=\"text-decoration: underline;\">\u63a7\u5236\u7b56\u7565<\/span><\/strong><\/span><\/h4>\n<p><span style=\"font-size: 14pt;\">\u5e94\u5bf9\u836f\u7269\u91ca\u653e\u63a7\u5236\u81f3\u5173\u91cd\u8981\u7684 CQA \u8fdb\u884c\u4ed4\u7ec6\u7ba1\u7406\uff0c\u5e76\u8fdb\u884c IVRT \u548c IVPT\uff08\u5982\u76f8\u5173\uff09\u7b49\u6d4b\u8bd5\u3002\u5982\u679c\u8bc1\u660e\u5176\u4ed6\u53c2\u6570\uff08\u5982\u663e\u5fae\u955c\u68c0\u67e5\u3001DSC\u3001\u6d41\u53d8\u5b66\uff09\u5728\u63a7\u5236\u836f\u7269\u91ca\u653e\u65f6\u66f4\u5177\u533a\u5206\u6027\uff0c\u5219\u53ef\u4ee5\u4f7f\u7528\u8fd9\u4e9b\u53c2\u6570\u3002\u6b64\u5916\uff0c\u89c4\u683c\u4e2d\u5305\u542b\u7684\u4efb\u4f55\u6027\u80fd\u6d4b\u8bd5\u9650\u5ea6\uff08\u5982\u6eb6\u51fa\u5ea6\u3001IVRT\uff09\u5fc5\u987b\u901a\u8fc7\u53c2\u8003\u5df2\u8bc1\u660e\u7597\u6548\u548c\u5b89\u5168\u6027\u7684\u4e34\u5e8a\u6279\u6b21\u6765\u8bc1\u660e\u5176\u5408\u7406\u6027\u3002  <\/span><\/p>\n<h4><span style=\"font-size: 14pt;\"><strong><span style=\"text-decoration: underline;\">\u7a33\u5b9a\u6027\u8ba1\u5212<\/span><\/strong><\/span><\/h4>\n<p><span style=\"font-size: 14pt;\">\u7a33\u5b9a\u6027\u6d4b\u8bd5\u5fc5\u987b\u786e\u4fdd\u4ea7\u54c1\u5728\u4e00\u6bb5\u65f6\u95f4\u5185\u7684\u8d28\u91cf\u548c\u6709\u6548\u6027\uff0c\u901a\u8fc7 IVRT \u6216\u5176\u4ed6\u6027\u80fd\u6d4b\u8bd5\u786e\u8ba4\u8d27\u67b6\u671f\u7684\u4e00\u81f4\u6027\u3002<\/span><\/p>\n<h2><strong>\u5916\u7528\u4ea7\u54c1\u7684\u7b49\u6548\u6027\u5efa\u8bae <\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u672c\u6307\u5357\u7684\u8fd9\u4e00\u90e8\u5206\u9002\u7528\u4e8e\u5e0c\u671b\u8bc1\u660e\u4e0e\u73b0\u6709\u836f\u7269\u5177\u6709\u6cbb\u7597\u7b49\u6548\u6027\u7684\u65b0\u76ae\u80a4\u4ea7\u54c1\u3002\u5728\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\u540e\uff0c\u5982\u679c\u9884\u671f\u5bf9\u8d28\u91cf\u3001\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u6709\u6f5c\u5728\u5f71\u54cd\uff0c\u5b83\u4e5f\u9002\u7528\u4e8e\u4e0a\u5e02\u540e\u53d8\u66f4\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8be5\u6307\u5357\u8fd8\u660e\u786e\u6307\u51fa\uff0c\u201c\u5982\u679c\u7533\u8bf7\u4f9d\u8d56\u6587\u732e\u6765\u8bc1\u660e\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u5219\u6587\u732e\u7684\u76f8\u5173\u6027\u5e94\u901a\u8fc7\u4e0e\u6587\u732e\u4e2d\u63cf\u8ff0\u7684\u4ea7\u54c1\u7684\u7b49\u6548\u6027\u6865\u63a5\u6570\u636e\u6765\u652f\u6301\u201d\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5982\u524d\u6240\u8ff0\uff0cEMA \u5efa\u8bae\u91c7\u7528\u5faa\u5e8f\u6e10\u8fdb\u7684\u65b9\u6cd5\u6765\u8bc1\u660e\u7b49\u6548\u6027\u3002\u8fd9\u4f7f\u5f97\u5236\u836f\u5546\u80fd\u591f\u9884\u5148\u77e5\u9053\u5bf9\u5176\u4ea7\u54c1\uff08\u7b80\u5355\u5236\u5242\u5982\u6eb6\u6db2\u6216\u51dd\u80f6\uff0c\u6216\u590d\u6742\u5236\u5242\u5982\u4e73\u5242\uff09\u8fdb\u884c\u54ea\u4e9b\u6d4b\u8bd5\uff0c\u5176\u4e3b\u8981\u76ee\u6807\u662f\u8df3\u8fc7\u5b8c\u6574\u7684\u4e34\u5e8a\u7814\u7a76\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5728\u51b3\u5b9a\u9009\u62e9\u54ea\u79cd\u65b9\u6cd5\u548c\u51b3\u7b56\u6811\u65f6\uff0cEMA \u4f1a\u8003\u8651\u76ae\u80a4\u4ea7\u54c1\u7684\u5b9a\u6027\u7ec4\u6210\u3001\u5b9a\u91cf\u7ec4\u6210\u4ee5\u53ca\u7269\u7406\u5316\u5b66\u548c\u7ed3\u6784\u8868\u5f81\uff1a<\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17702\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline.png\" alt=\"\u6839\u636e EMA \u6307\u5357\u6539\u7f16\u7684\u5faa\u5e8f\u6e10\u8fdb\u65b9\u6cd5\u4e2d\u7684\u51b3\u7b56\u6811\u9009\u62e9\" width=\"579\" height=\"407\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27579%27%20height%3D%27407%27%20viewBox%3D%270%200%20579%20407%27%3E%3Crect%20width%3D%27579%27%20height%3D%27407%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-200x141.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-300x211.png 300w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-400x282.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-600x423.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-768x541.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-800x563.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-1024x721.png 1024w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline.png 1200w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 579px) 100vw, 579px\" \/><\/p>\n<p style=\"text-align: center;\"><em>\u56fe 1) \u6839\u636e EMA \u6307\u5357\u6539\u7f16\u7684\u5faa\u5e8f\u6e10\u8fdb\u65b9\u6cd5\u4e2d\u7684\u51b3\u7b56\u6811\u9009\u62e9<\/em><\/p>\n<p><span style=\"font-size: 14pt;\">\u7136\u540e\uff0c\u6839\u636e\u8fd9\u4e9b\u8003\u8651\u56e0\u7d20\uff0c\u5faa\u5e8f\u6e10\u8fdb\u7684\u65b9\u6cd5\u5982\u4e0b\u9762\u7684\u51b3\u7b56\u6811\u6240\u793a\uff0c\u6700\u7ec8\u5bfc\u81f4\u53ef\u63a5\u53d7\u7684\u6865\u63a5\u6216\u62d2\u7edd\uff1a<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u51b3\u7b56\u6811 1\uff1a\u5b9a\u6027\u548c\u5b9a\u91cf\u7ec4\u6210\u76f8\u540c\uff0c\u4e14\u7269\u7406\u5316\u5b66\u548c\u7ed3\u6784\u8868\u5f81\u76f8\u540c<\/strong><\/span><\/p>\n<p><strong><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17712\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1.png\" alt=\"EMA \u6307\u5357\u4e2d\u7684\u51b3\u7b56\u6811 1\" width=\"618\" height=\"579\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27618%27%20height%3D%27579%27%20viewBox%3D%270%200%20618%20579%27%3E%3Crect%20width%3D%27618%27%20height%3D%27579%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-200x187.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-300x281.png 300w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-400x375.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-600x562.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-768x719.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-800x749.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-1024x959.png 1024w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1.png 1169w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 618px) 100vw, 618px\" \/><\/strong><\/p>\n<p style=\"text-align: center;\"><em>\u56fe 2) EMA \u6307\u5357\u4e2d\u7684\u51b3\u7b56\u6811 1<\/em><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u51b3\u7b56\u6811 2\uff1a\u5b9a\u6027\u548c\u5b9a\u91cf\u7ec4\u6210\u6709\u5fae\u5c0f\u5dee\u5f02\uff0c\u548c\/\u6216\u7269\u7406\u5316\u5b66\u548c\u7ed3\u6784\u8868\u5f81\u6709\u5fae\u5c0f\u5dee\u5f02<\/strong><\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17704\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline.png\" alt=\"EMA \u6307\u5357\u4e2d\u7684\u51b3\u7b56\u6811 2\" width=\"610\" height=\"344\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27610%27%20height%3D%27344%27%20viewBox%3D%270%200%20610%20344%27%3E%3Crect%20width%3D%27610%27%20height%3D%27344%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-200x113.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-300x169.png 300w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-400x225.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-600x338.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-768x433.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-800x451.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-1024x577.png 1024w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline.png 1194w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 610px) 100vw, 610px\" \/><\/p>\n<p style=\"text-align: center;\"><em>\u56fe 3) EMA \u6307\u5357\u4e2d\u7684\u51b3\u7b56\u6811 2<\/em><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u51b3\u7b56\u6811 3\uff1a\u5b9a\u6027\u548c\u5b9a\u91cf\u7ec4\u6210\u4e0d\u540c\uff0c\u4e14\u7269\u7406\u5316\u5b66\u548c\u7ed3\u6784\u8868\u5f81\u4e0d\u540c<\/strong><\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17708\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline.png\" alt=\"EMA \u6307\u5357\u4e2d\u7684\u51b3\u7b56\u6811 3\" width=\"357\" height=\"377\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27357%27%20height%3D%27377%27%20viewBox%3D%270%200%20357%20377%27%3E%3Crect%20width%3D%27357%27%20height%3D%27377%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-200x211.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-284x300.png 284w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-400x422.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-600x634.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-768x811.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline.png 786w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 357px) 100vw, 357px\" \/><\/p>\n<p style=\"text-align: center;\"><em>\u56fe 4) EMA \u6307\u5357\u4e2d\u7684\u51b3\u7b56\u6811 3<\/em><\/p>\n<p><span style=\"font-size: 14pt;\">\u4ece\u8fd9\u4e9b\u51b3\u7b56\u6811\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u6839\u636e\u4ea7\u54c1\u4e4b\u95f4\u7684\u76f8\u4f3c\u6027\uff0cEMA \u63d0\u4f9b\u4e86\u5236\u9020\u5546\u5e94\u8003\u8651\u7684\u4e0d\u540c\u5faa\u5e8f\u6e10\u8fdb\u65b9\u6cd5\u3002<\/span><\/p>\n<h2><strong>Kymos \u96c6\u56e2\u5728 IVRT \u548c IVPT \u7814\u7a76\u65b9\u9762\u7684\u7ecf\u9a8c<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Kymos \u96c6\u56e2\u62e5\u6709\u4e00\u652f\u81ea 2017 \u5e74\u4ee5\u6765\u4e00\u76f4\u81f4\u529b\u4e8e\u836f\u7269\u91ca\u653e\u548c\u5916\u7528\u4ea7\u54c1\u6280\u672f\u7684\u4e13\u4e1a\u56e2\u961f\uff0c\u5728 IVRT \u548c IVPT \u7814\u7a76\u65b9\u9762\u62e5\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\u3002\u6211\u4eec\u7684\u65b9\u6cd5\u662f\u6839\u636e 2018 \u5e74\u8be5\u6307\u5357\u7684\u8349\u6848\u7248\u672c\u5f00\u53d1\u7684\uff0c\u6211\u4eec\u7684\u79d1\u5b66\u5bb6\u5df2\u7ecf\u719f\u6089\u4e86\u8fd9\u4e00\u6700\u7ec8\u7248\u672c\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u6211\u4eec\u5c06\u836f\u7269\u91ca\u653e\u548c\u7ecf\u76ae\u5438\u6536\u670d\u52a1\u76ee\u5f55\u5206\u4e3a\u4e24\u5927\u7c7b\uff1a<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>IVRT\uff1a<\/strong>\u6211\u4eec\u4f7f\u7528\u4eba\u5de5\u819c\u6d4b\u91cf\u836f\u7269\u91ca\u653e\u91cf\u548c\u901f\u7387\uff0c\u4ee5\u5f00\u53d1\u548c\u9a8c\u8bc1\u4e0d\u540c\u5236\u5242\u7684\u65b9\u6cd5\u3002<\/span><span style=\"font-size: 14pt;\">\u8fd9\u4e9b\u65b9\u6cd5\u53ef\u7528\u4e8e\u8bc4\u4f30\u7b49\u6548\u6027\u7684\u5bf9\u6bd4\u7814\u7a76\uff0c\u4e5f\u53ef\u7528\u4e8e\u751f\u4ea7\u6279\u6b21\u7684\u8d28\u91cf\u63a7\u5236\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>IVPT\uff1a<\/strong>\u6211\u4eec\u4f7f\u7528\u76ae\u80a4\u6837\u672c\u6d4b\u91cf\u900f\u76ae\u6e17\u900f\u91cf\u3001\u901a\u91cf\u7387\u548c\u5c42\u5206\u5e03\uff0c\u7528\u4e8e\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002<\/span><span style=\"font-size: 14pt;\">\u6211\u4eec\u8fd8\u53ef\u4ee5\u901a\u8fc7\u7ecf\u76ae\u5438\u6536\u7814\u7a76\u534f\u52a9\u4f18\u5316\u548c\u6bd4\u8f83\u5236\u5242\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u6211\u4eec\u7684\u5b9e\u9a8c\u5ba4\u662f\u6b27\u6d32\u5c11\u6570\u51e0\u5bb6\u80fd\u591f\u4f7f\u7528\u6700\u65b0\u7684\u81ea\u52a8\u5316 Hanson \u5782\u76f4\u6269\u6563 Phoenix \u4eea\u5668\uff08Franz \u7ec6\u80de\u6d4b\u8bd5\uff09\u4e3a\u76ae\u80a4\u4ea7\u54c1\u63d0\u4f9b GLP \u548c GMP \u8ba4\u8bc1\u7ecf\u76ae\u5438\u6536\u6d4b\u5b9a\u7684\u8bbe\u65bd\u4e4b\u4e00\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u51ed\u501f\u5bf9\u65b0\u6307\u5357\u7684\u6df1\u523b\u7406\u89e3\uff0c\u6211\u4eec\u7684\u79d1\u5b66\u56e2\u961f\u968f\u65f6\u51c6\u5907\u652f\u6301\u5ba2\u6237\u5b8c\u6210\u4ece\u5904\u65b9\u7814\u53d1\u5230\u65b0\u4e0a\u5e02\u7533\u8bf7\u7684\u76d1\u7ba1\u63d0\u4ea4\uff0c\u540c\u65f6\u4e5f\u652f\u6301\u5e0c\u671b\u6309\u7167 EMA \u5faa\u5e8f\u6e10\u8fdb\u65b9\u6cd5\u8bc1\u660e\u4e0e\u73b0\u6709\u836f\u7269\u7b49\u6548\u7684\u76ae\u80a4\u4ea7\u54c1\u3002<\/span><\/p>\n<h2><strong>\u7ed3\u8bba<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">EMA \u5173\u4e8e\u5916\u7528\u4ea7\u54c1\u8d28\u91cf\u548c\u7b49\u6548\u6027\u7684\u65b0\u6307\u5357\u7684\u901a\u8fc7\uff0c\u662f\u5411\u66f4\u534f\u8c03\u3001\u66f4\u7ed3\u6784\u5316\u7684\u6b64\u7c7b\u836f\u7269\u5206\u6790\u65b9\u6cd5\u8fc8\u51fa\u7684\u4e00\u5927\u6b65\u3002\u5176\u4f7f\u7528 IVRT \u548c IVPT \u7b49\u6280\u672f\u8bc1\u660e\u7b49\u6548\u6027\u7684\u5faa\u5e8f\u6e10\u8fdb\u5efa\u8bae\uff0c\u7b80\u5316\u4e86\u5c06\u65b0\u4eff\u5236\u836f\u63a8\u5411\u5e02\u573a\u7684\u8fc7\u7a0b\uff0c\u65e0\u9700\u8fdb\u884c\u6602\u8d35\u4e14\u8017\u65f6\u7684\u4e34\u5e8a\u7814\u7a76\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4f5c\u4e3a IVRT \u548c IVPT \u9886\u57df\u7684\u9886\u5148 CRO\uff0cKymos \u96c6\u56e2\u53ca\u5176\u56e2\u961f\u968f\u65f6\u51c6\u5907\u5728\u6bcf\u4e00\u6b65\u4e3a\u5ba2\u6237\u548c\u5408\u4f5c\u4f19\u4f34\u63d0\u4f9b\u652f\u6301\uff0c\u786e\u4fdd\u5728\u6700\u65b0\u6307\u5357\u4e0b\u987a\u5229\u83b7\u5f97\u6b27\u6d32\u5e02\u573a\u6279\u51c6\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5982\u679c\u60a8\u9700\u8981\u6709\u5173 EMA \u6307\u5357\u7684\u66f4\u591a\u4fe1\u606f\u6216\u5728\u7ecf\u76ae\u5438\u6536\u9879\u76ee\u65b9\u9762\u9700\u8981\u4efb\u4f55\u534f\u52a9\uff0c\u8bf7\u8054\u7cfb <a href=\"mailto:commercial@kymos.com\" 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