{"id":1501,"date":"2023-03-27T10:58:00","date_gmt":"2023-03-27T02:58:00","guid":{"rendered":"https:\/\/vcro.online\/cn\/?p=1501"},"modified":"2024-07-12T13:29:44","modified_gmt":"2024-07-12T05:29:44","slug":"%e7%be%8e%e5%9b%bd%e9%a3%9f%e5%93%81%e8%8d%af%e5%93%81%e7%ae%a1%e7%90%86%e5%b1%80%e4%ba%8e%e7%bd%95%e8%a7%81%e7%96%be%e7%97%85%e5%9f%ba%e5%9b%a0%e6%b2%bb%e7%96%97%e4%ba%a7%e5%93%81%e4%b9%8b%e7%ae%a1-2","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1501","title":{"rendered":"\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\u4e8e\u7f55\u89c1\u75be\u75c5\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u4e4b\u7ba1\u7406\u7b56\u7565-l"},"content":{"rendered":"\n<p>\u7f8e\u56fd\u56fd\u5bb6\u536b\u751f\u7814\u7a76\u9662(NIH)\u5b9a\u4e49\u7f55\u89c1\u75be\u75c5\u4e3a\u7f79\u75c5\u4eba\u6570\u4f4e\u4e8e\u4e8c\u5341\u4e07\u7f8e\u56fd\u5c45\u6c11\u4e4b\u75be\u75c5\u6216\u72b6\u6001\u3002\u6839\u636e\u7edf\u8ba1\uff0c\u76ee\u524d\u6709\u5c06\u8fd1\u4e03\u5343\u79cd\u7684\u75be\u75c5\u88ab\u767b\u8f7d\u3002\u8fd9\u4e9b\u75be\u75c5\u4e2d\uff0c\u9ad8\u8fbe\u767e\u5206\u4e4b\u516b\u5341\u4e3a\u5355\u4e00\u57fa\u56e0\u7f3a\u9677\u9020\u6210\uff0c\u662f\u975e\u5e38\u9002\u5408\u4ee5\u57fa\u56e0\u7597\u6cd5\u8fdb\u884c\u6cbb\u7597\u3002\u5bf9\u6b64US FDA\u4e8e2020\u5e741\u6708\u9881\u5e03\u7f55\u89c1\u75be\u75c5\u4eba\u7c7b\u57fa\u56e0\u6cbb\u7597\u4ea7\u4e1a\u6307\u5f15(Human Gene Therapy for Rare Diseases &#8211; Guidance for Industry)\uff0c\u5e0c\u671b\u4ee5\u6b64\u52a0\u901f\u7f55\u89c1\u75be\u75c5\u6cbb\u7597\u7684\u53d1\u5c55\u3002<br>&nbsp; &nbsp; &nbsp; \u4e8e\u5316\u5b66\u3001\u5236\u9020\u4e0e\u7ba1\u5236(CMC)\u90e8\u5206\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40(US FDA)\u5f3a\u70c8\u5efa\u8bae\u5f00\u53d1\u5382\u5546\u4e8e\u7814\u53d1\u65e9\u671f\u5373\u4e0e\u96b6\u5c5e\u4e8e\u836f\u7269\u8bc4\u4f30\u66a8\u7814\u7a76\u4e2d\u5fc3\u4e0b\u7684\u7ec4\u7ec7\u53ca\u65b0\u5174\u7597\u6cd5\u529e\u516c\u5ba4(Office of Tissues and Advanced Therapies)\u8fdb\u884c\u54a8\u8be2\u6c9f\u901a\uff0c\u5e76\u9488\u5bf9\u4e2a\u522b\u5236\u5242\u7279\u6027\u53d1\u5c55\u5408\u9002\u7684\u89c4\u683c\u6807\u51c6\u4e0e\u68c0\u6d4b\u65b9\u5f0f\uff0c\u4ee5\u5229\u540e\u7eed\u836f\u7269\u5f00\u53d1\u53ca\u5236\u7a0b\u8fc7\u7a0b\u4e2d\u5bf9\u4e8e\u6700\u7ec8\u4ea7\u7269\u4e0d\u8bba\u662f\u89c4\u683c\u6216\u8d28\u91cf\u4e0a\u7684\u6709\u6548\u63a7\u5236\u3002<br>&nbsp; &nbsp; &nbsp; \u4e8e\u975e\u4e34\u5e8a\u8bd5\u9a8c\u90e8\u5206\uff0c\u5176\u4e3b\u8981\u76ee\u6807\u5305\u62ec\uff1a1)\u786e\u7acb\u836f\u7269\u751f\u7269\u4f53\u5185\u6d3b\u6027\u5242\u91cf\u8303\u56f4\uff1b2)\u51b3\u5b9a\u521d\u59cb\u4e34\u5e8a\u836f\u7269\u5242\u91cf\u6c34\u5e73\u3001\u5242\u91cf\u9012\u589e\u8ba1\u5212\u53ca\u7ed9\u836f\u65b9\u6848\uff1b3)\u5efa\u7acb\u53ef\u884c\u4e14\u76f8\u5bf9\u5b89\u5168\u7684\u4e34\u5e8a\u7ed9\u836f\u9014\u5f84\uff1b4)\u5efa\u7acb\u6cbb\u7597\u76ee\u6807\u65cf\u7fa4\u53c2\u6570\uff1b5)\u786e\u7acb\u6cbb\u7597\u6f5c\u5728\u6bd2\u6027\u4e0e\u751f\u7406\u53c2\u6570\u53d8\u5316\u8303\u56f4\u7b495\u9879\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u82e5\u5f00\u53d1\u4e4b\u57fa\u56e0\u7597\u6cd5\u8ba1\u5212\u4e8e\u513f\u7ae5\u65cf\u7fa4\u5c55\u5f00\u9996\u6b21\u4eba\u4f53\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4e14\u8be5\u7597\u6cd5\u672a\u5728\u6210\u4eba\u65cf\u7fa4\u76f8\u540c\u75be\u75c5\u5177\u6709\u7597\u6548\u6570\u636e\u65f6\uff0c\u975e\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5bf9\u4e8e\u53d7\u8bd5\u8005\u5177\u6709\u76f4\u63a5\u9884\u671f\u597d\u5904\u7684\u8bd5\u9a8c\u7ed3\u679c\u5c06\u683c\u5916\u88ab\u91cd\u89c6\u3002<\/p>\n\n\n\n<p>\u5ef6\u4f38\u9605\u8bfb:<br>U.S. FDA. Human Gene Therapy for Rare Diseases &#8211; Guidance for Industry. Jan. 2020.<\/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\/03\/b6d2ba0b-e7c6-4fd5-b440-ff76c569c50f.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\/03\/b6d2ba0b-e7c6-4fd5-b440-ff76c569c50f.jpg 1024w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/03\/b6d2ba0b-e7c6-4fd5-b440-ff76c569c50f-300x300.jpg 300w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/03\/b6d2ba0b-e7c6-4fd5-b440-ff76c569c50f-150x150.jpg 150w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2023\/03\/b6d2ba0b-e7c6-4fd5-b440-ff76c569c50f-768x768.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u56fd\u5bb6\u536b\u751f\u7814\u7a76\u9662(NIH)\u5b9a\u4e49\u7f55\u89c1\u75be\u75c5\u4e3a\u7f79\u75c5\u4eba\u6570\u4f4e\u4e8e\u4e8c\u5341\u4e07\u7f8e\u56fd\u5c45\u6c11\u4e4b\u75be\u75c5\u6216\u72b6\u6001\u3002\u6839\u636e\u7edf\u8ba1\uff0c\u76ee\u524d\u6709\u5c06\u8fd1\u4e03\u5343\u79cd\u7684 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1628,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-1501","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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