{"id":1962,"date":"2025-02-03T17:04:14","date_gmt":"2025-02-03T09:04:14","guid":{"rendered":"https:\/\/www.vcro.com.tw\/tw\/?p=1962"},"modified":"2025-02-05T17:53:49","modified_gmt":"2025-02-05T09:53:49","slug":"%e9%97%9c%e6%96%bccgt%e7%94%a2%e5%93%81%e7%9a%84%e5%89%8d%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a9%97%e8%80%83%e9%87%8f-%e7%89%a9%e7%a8%ae%e3%80%81%e6%af%92%e7%90%86%e8%a9%a6%e9%a9%97%e3%80%81%e7%94%9f","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=1962","title":{"rendered":"\u95dc\u65bcCGT\u7522\u54c1\u7684\u524d\u81e8\u5e8a\u8a66\u9a57\u8003\u91cf – \u7269\u7a2e\u3001\u6bd2\u7406\u8a66\u9a57\u3001\u751f\u7269\u5206\u5e03\u3001\u5291\u91cf\u8f49\u63db"},"content":{"rendered":"\n
\"VCRO<\/figure>\n\n\n\n
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\u7528\u65bc\u81e8\u5e8a\u7684CGT\u7522\u54c1\u7684\u8d77\u59cb\u5291\u91cf\u6c34\u5e73\u901a\u5e38\u662f\u6839\u64da\u5728\u75be\u75c5\u52d5\u7269\u6a21\u578b\u4e2d\u9032\u884c\u7684\u975e\u81e8\u5e8aPOC\u7814\u7a76\u4e2d\u7522\u54c1\u7684\u751f\u7269\u6d3b\u6027\u78ba\u5b9a\u7684\uff0c\u540c\u6642\u4e5f\u9700\u5f97\u5230\u975e\u81e8\u5e8a\u5b89\u5168\u6027\u7814\u7a76\u7684\u652f\u6301\u3002\u5728POC\u548c\u6bd2\u7406\u5b78\u7814\u7a76\u4e2d\uff0c\u5c0d\u6bcf\u7a2e\u63a5\u53d7\u76ee\u6a19\u81e8\u5e8a\u7522\u54c1\uff08\u6216\u985e\u4f3c\u7522\u54c1\uff09\u7d66\u85e5\u7684\u52d5\u7269\u7269\u7a2e\u90fd\u61c9\u78ba\u5b9a\u5176\u5291\u91cf\u63a8\u7b97\u65b9\u6cd5\u548c\u5b89\u5168\u6027\u3002<\/p>\n<\/details>\n\n\n\n

\u4f86\u6e90\uff1aFDA Frequently Asked Questions \u2014 Developing Potential Cellular and Gene Therapy Products \uff08Nov, 2024)<\/a><\/p>\n\n\n\n

VCRO \u80fd\u5920\u5e6b\u52a9\u60a8\u6e96\u5099\u7b26\u5408\u6a19\u6e96\u7684\u6280\u8853\u6587\u4ef6\uff0c\u4e26\u91cf\u8eab\u8a02\u505a\u6700\u7b26\u5408\u60a8\u76ee\u6a19\u7684\u81e8\u5e8a\u8a66\u9a57\u7814\u7a76\u65b9\u6848\uff0c\u9084\u80fd\u4ee3\u8868\u60a8\u8207\u76e3\u7ba1\u6a5f\u69cb\u9032\u884c\u6e9d\u901a\u5354\u8abf\uff0c\u4ee5\u7372\u5f97\u6700\u6709\u5229\u689d\u4ef6\u7684\u6279\u51c6\uff1b\u5728\u8a66\u9a57\u968e\u6bb5\uff0c\u53ca\u6642\u76e3\u6e2c\u60a8\u7684\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\uff0c\u4ee5\u78ba\u4fdd\u5176\u6e96\u78ba\u6027\u548c\u53ef\u9760\u6027\u3002<\/p>\n\n\n\n

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\u7121\u8ad6\u60a8\u7684\u7522\u54c1\u662f\u5c0f\u5206\u5b50\u5316\u85e5\u3001\u751f\u7269\u88fd\u5291\u3001\u690d\u7269\u65b0\u85e5\u3001\u7d30\u80de\u6cbb\u7642\u3001\u57fa\u56e0\u6cbb\u7642\u3001\u91ab\u7642\u5668\u6750\u6216\u8907\u5408\u5f0f\u7522\u54c1\uff0c\u5728\u5176\u767c\u5c55\u904e\u7a0b\u4e2d\u7684\u5404\u500b\u8a55\u4f30\u968e\u6bb5\uff0c\u5305\u62ec\u5316\u5b78\u88fd\u9020\u63a7\u5236\u3001\u524d\u81e8\u5e8a\u8207\u81e8\u5e8a\u8b70\u984c\uff0c\u6211\u5011\u90fd\u53ef\u4ee5\u63d0\u4f9b\u5c08\u696d\u7684\u8aee\u8a62\u670d\u52d9\u3002<\/p>\n\n\n\n

\u6211\u5011\u5c07\u91dd\u5c0d\u60a8\u7684\u56f0\u96e3\u9ede\u9032\u884c\u8a73\u7d30\u5206\u6790\uff0c\u627e\u51fa\u5dee\u8ddd\u4e26\u63d0\u4f9b\u6709\u6548\u7684\u89e3\u6c7a\u65b9\u6848\uff0c\u70ba\u60a8\u5236\u5b9a\u6700\u6709\u5229\u7684\u958b\u767c\u7b56\u7565\u3002<\/p>\n\n\n\n

\u6211\u5011\u7684\u5c08\u5bb6\u5718\u968a\u6709\u8c50\u5bcc\u7684\u8207\u76e3\u7ba1\u55ae\u4f4d\u6e9d\u901a\u7d93\u9a57\uff0c\u5305\u62ec\u5354\u52a9\u6216\u4ee3\u8868\u5ba2\u6236\u9032\u884c\u5404\u5f0f\u6b63\u5f0f\u6e9d\u901a\u6703\u8b70\uff08\u5982\u53f0\u7063CDE \u8aee\u8a62\u6703\u8b70\u3001 US FDA pre-IND \u3001 Interact \u6703\u8b70\u7b49\uff09 \uff0c\u6211\u5011\u5b70\u6089\u76e3\u7ba1\u6a5f\u69cb\u5c0d\u5404\u985e\u7522\u54c1\u7684\u95dc\u6ce8\u91cd\u9ede\u8207\u8b70\u984c\uff0c\u80fd\u5e6b\u52a9\u60a8\u8207\u76e3\u7ba1\u6a5f\u95dc\u9032\u884c\u6700\u6709\u6548\u7684\u6e9d\u901a\uff0c\u4e26\u9054\u6210\u5c0d\u60a8\u6700\u6709\u5229\u7684\u6c7a\u8b70\u5171\u8b58\u3002<\/p>\n\n\n\n

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