{"id":1487,"date":"2023-10-02T10:52:00","date_gmt":"2023-10-02T02:52:00","guid":{"rendered":"https:\/\/vcro.online\/cn\/?p=1487"},"modified":"2024-07-12T11:59:19","modified_gmt":"2024-07-12T03:59:19","slug":"%e6%a0%b8%e9%85%b8%e8%8d%af%e7%89%a9%e7%9a%84%e4%b8%b4%e5%ba%8a%e8%80%83%e8%99%91-ii","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1487","title":{"rendered":"\u6838\u9178\u836f\u7269\u7684\u4e34\u5e8a\u8003\u8651-II"},"content":{"rendered":"\n<p>\u9762\u5bf9\u9010\u6e10\u589e\u52a0\u7684\u5be1\u6838\u82f7\u9178\u836f\u7269\uff0cFDA\u7279\u522b\u9488\u5bf9\u5b89\u5168\u6027\u90e8\u5206\u8fdb\u884c\u4e86\u8f83\u8be6\u7ec6\u7684\u6307\u5f15\u3002\u7531\u4e8e\u5be1\u6838\u82f7\u9178\u836f\u7269\u7684\u79cd\u7c7b\u7e41\u591a\uff0c\u5bfc\u81f4\u7597\u6548\u7684\u673a\u8f6c\u4e0e\u6295\u9012\u76ee\u6807\u4e5f\u90fd\u4e0d\u540c\uff0c\u6545FDA\u5f3a\u70c8\u5efa\u8bae\u53c2\u8003ICH E14 Clinical Evaluation of QT\/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs\u6240\u8ff0\u4e4b\u5185\u5bb9\uff0c\u5236\u5b9a\u9488\u5bf9QT\/QTc\u5ef6\u957f\u7684\u98ce\u9669\u8bc4\u4f30\u4e0e\u76d1\u6d4b\u8ba1\u753b\uff0c\u5e76\u5118\u65e9\u4e0eFDA\u8fdb\u884c\u6c9f\u901a\u8ba8\u8bba\u3002<br>&nbsp; &nbsp; \u5728\u5be1\u6838\u82f7\u9178\u836f\u7269\u5bfc\u81f4\u514d\u75ab\u53cd\u5e94\u7684\u98ce\u9669\u90e8\u5206\uff0c\u53ef\u80fd\u6765\u81ea\u4e8e\u4fee\u9970\u8fc7\u7684\u6838\u9178\u9aa8\u67b6\u3001\u5916\u6765\u6838\u9178\u5e8f\u5217\u3001\u6216\u662f\u6838\u9178\u4e0e\u8f7d\u4f53\u7ed3\u5408\u540e\u4ea7\u751f\u7684\u65b0\u6297\u539f\u7b49\u3002\u6b64\u5916\uff0c\u5728\u8bbe\u8ba1\u5be1\u6838\u82f7\u9178\u836f\u7269\u7684\u65e9\u671f\u9636\u6bb5\u65f6\uff0c\u5c31\u5e94\u4e8b\u5148\u6392\u9664\u5df2\u77e5\u4f1a\u4fc3\u8fdb\u514d\u75ab\u53cd\u5e94\u4e4b\u7ed3\u6784\u5982CpG\u7b49\u3002\u76f8\u5173\u514d\u75ab\u53cd\u5e94\u8bc4\u4f30\uff0c\u53ef\u53c2\u8003FDA guidance&nbsp;\u3002<br>&nbsp; &nbsp; \u53e6\u5916\uff0c\u5be1\u6838\u82f7\u9178\u836f\u7269\u662f\u5426\u4f1a\u56e0\u4e3a\u5176\u7279\u6b8a\u7684\u836f\u52a8\u5b66\u4e0e\u836f\u7406\u5b66\uff0c\u5bf9\u809d\u810f\u4e0e\u80be\u810f\u7b49\u5668\u5b98\u9020\u6210\u4f24\u5bb3\uff0c\u4ea6\u987b\u5118\u65e9\u5728\u975e\u4e34\u5e8a\u9636\u6bb5\u4e0e\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u91d0\u6e05\u3002\u5bf9\u809d\u810f\u800c\u8a00\uff0c\u4f1a\u63a5\u53d7\u7edd\u5927\u90e8\u5206\u7ecf\u7531\u7cfb\u7edf\u5168\u8eab\u6027\u7ed9\u4e88\u7684\u836f\u7269\uff0c\u6545\u6b64\u7c7b\u836f\u7269\u5bf9\u809d\u529f\u80fd\u4e4b\u5f71\u54cd\u4ea6\u662f\u5fc5\u987b\u88ab\u91d0\u6e05\u7684\u3002\u6b64\u5916\u4ea6\u6709\u7814\u7a76\u6307\u51fa\u7ea6\u670930%\u7684\u5be1\u6838\u82f7\u9178\u836f\u7269\u662f\u672a\u7ecf\u4ee3\u8c22\u5373\u88ab\u80be\u810f\u6392\u51fa\uff0c\u6545\u80be\u529f\u80fd\u4e0d\u5168\u662f\u5426\u9002\u7528\u5be1\u6838\u82f7\u9178\u836f\u7269\u4e5f\u662f\u9700\u8981\u88ab\u8ba8\u8bba\u7684\u91cd\u70b9\u3002<\/p>\n\n\n\n<p>\u8be6\u60c5\u8bf7\u53c2\u9605FDA Guidance for Industry<\/p>\n\n\n<figure class=\"wp-block-post-featured-image\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/10\/cf85fa0a-b4a1-495b-b162-71d6333bc880.jpg\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"\" style=\"object-fit:cover;\" srcset=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/10\/cf85fa0a-b4a1-495b-b162-71d6333bc880.jpg 1024w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/10\/cf85fa0a-b4a1-495b-b162-71d6333bc880-300x300.jpg 300w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/10\/cf85fa0a-b4a1-495b-b162-71d6333bc880-150x150.jpg 150w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/10\/cf85fa0a-b4a1-495b-b162-71d6333bc880-768x768.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>","protected":false},"excerpt":{"rendered":"<p>\u9762\u5bf9\u9010\u6e10\u589e\u52a0\u7684\u5be1\u6838\u82f7\u9178\u836f\u7269\uff0cFDA\u7279\u522b\u9488\u5bf9\u5b89\u5168\u6027\u90e8\u5206\u8fdb\u884c\u4e86\u8f83\u8be6\u7ec6\u7684\u6307\u5f15\u3002\u7531\u4e8e\u5be1\u6838\u82f7\u9178\u836f\u7269\u7684\u79cd\u7c7b\u7e41\u591a\uff0c\u5bfc\u81f4\u7597\u6548\u7684 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1605,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-1487","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - 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