{"id":733,"date":"2024-06-13T16:07:54","date_gmt":"2024-06-13T08:07:54","guid":{"rendered":"http:\/\/10.0.20.30:8080\/wordpress4\/?page_id=733"},"modified":"2025-01-22T16:34:05","modified_gmt":"2025-01-22T08:34:05","slug":"%e4%b8%8a%e6%b5%b7%e7%b6%ad%e5%b7%9e","status":"publish","type":"page","link":"https:\/\/www.vcro.com.tw\/cn\/?page_id=733","title":{"rendered":"\u4e0a\u6d77\u7ef4\u5dde\u533b\u836f\u79d1\u6280\u6709\u9650\u516c\u53f8"},"content":{"rendered":"\n

\u4e0a\u6d77\u7ef4\u5dde\u533b\u836f\u79d1\u6280\u6709\u9650\u516c\u53f8\u662f\u7ef4\u5dde\u751f\u7269\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\u7684\u5b50\u516c\u53f8\u6210\u7acb\u4e8e2020\u5e74\uff0c\u5e76\u5728\u540c\u5e74\u6210\u4e3a\u4e2d\u56fd\u56fd\u5185\u524d\u4e94\u5927\u836f\u5382\u4e4b\u4e00\u7684\u5408\u683c\u4f9b\u8d27\u5546\uff0c\u4e0e\u591a\u5bb6\u4e2d\u56fd\u836f\u4f01\u5408\u4f5c\u8fdb\u884c\u4e2d\u7f8e\u53cc\u62a5\u3002\u6211\u4eec\u5df2\u7d2f\u79ef50\u591a\u9879 US FDA IND \u59d4\u6258\u9879\u76ee\uff0c\u6db5\u76d6\u5316\u836f\u3001\u690d\u7269\u836f\u3001\u751f\u7269\u5236\u5242\u53ca 505b2 \u7684\u7f8e\u56fd\u7533\u62a5\u6210\u5c31\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u6d89\u53ca\u8840\u6db2\u80bf\u7624\u3001\u611f\u67d3\u3001\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u3001\u5fc3\u8840\u7ba1\u7cfb\u7edf\u3001\u80a0\u80c3\u9053\u7cfb\u7edf\u7b49\u591a\u4e2a\u9886\u57df\uff0c\u9001\u4ef6\u901a\u8fc7\u7387\u8fbe95%\u4ee5\u4e0a\u3002<\/p>\n\n\n\n

<\/p>\n\n\n\n

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\n

\u5bf9\u4e8e\u5927\u9646\u7533\u529e\u65b9\u6d77\u5916\u6ce8\u518c\u4e34\u5e8a\u7b56\u7565\uff0cVCRO<\/span> \u80fd\u63d0\u4f9b\u66f4\u4f18\u5316\u7684\u89e3\u51b3\u65b9\u6848\uff0c\u5305\u542b<\/p>\n<\/blockquote>\n\n\n\n

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\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u6d77\u5916\u751f\u4ea7\u5e03\u5c40\uff0c\u53ca\u6ce8\u518c\u4e34\u5e8a\u7b49\u4fbf\u5229\u9014\u5f84<\/h2>\n\n\n\n
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\u89e3\u51b3\u4ea7\u54c1\u4eba\u79cd\u5dee\u5f02\u5bfc\u81f4\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8d44\u6599\u5dee\u5f02<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u5927\u9646\u7ec6\u80de\u7c7b\u4ea7\u54c1\u79bb\u5883\u7ba1\u63a7<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u8fdb\u4e00\u6b65\u5c06\u5927\u9646\u4ea7\u54c1\u52a0\u901f\u671d\u5411\u6d77\u5916\u53d1\u5c55<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u5584\u4e8e\u4e0e\u76d1\u7ba1\u5355\u4f4d\u6c9f\u901a<\/h2>\n\n\n\n
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\u6709\u591a\u6b21\u80fd\u5c06\u7b2c\u4e00\u6b21\u4eba\u4f53\u4f7f\u7528\u7684\u4ea7\u54c1\u76f4\u63a5\u8fdb\u5165 Phase I, II \u8fde\u505a\uff0c\u751a\u81f3\u662f\u76f4\u63a5\u8fdb\u5165 Phase II, III<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u4f18\u826f\u7684\u6d77\u5916\u4e34\u5e8a\u8fd0\u8425\u56e2\u961f\uff0c\u4fbf\u5229\u7533\u529e\u65b9\u6d77\u5916\u5f00\u5c55\u4e34\u5e8a<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u6267\u884c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u533b\u9662\u7b5b\u9009\u3001\u4e34\u5e8a\u8bd5\u9a8c PI \u8bc4\u4f30\u3001\u4f26\u7406\u6279\u4ef6\u7684\u7533\u8bf7\u7b49\u3002\u90fd\u80fd\u5728\u5145\u5206\u7b26\u5408\u5404\u5730\u7684\u6cd5\u89c4\u53ca\u8d28\u91cf\u9700\u6c42\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u5bf9\u4e8e\u524d\u6cbf\u4ea7\u54c1\u7684\u5f00\u53d1\u80fd\u529b<\/h2>\n\n\n\n
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<\/path><\/svg><\/div><\/div>\n<\/div>\n\n\n\n
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VCRO \u4e13\u957f\u4e8e\u4e0e\u65b0\u521b\u516c\u53f8\u643a\u624b\u5408\u4f5c\uff0c\u4ece\u524d\u4e34\u5e8a\u8fdb\u5165\u5230\u4eba\u4f53\u5b9e\u9a8c\uff0c\u5c24\u5176\u662f\u524d\u6cbf\u4ea7\u54c1\u7684\u5f00\u53d1<\/p>\n<\/div>\n<\/div>\n\n\n\n

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<\/path><\/svg><\/div><\/div>\n<\/div>\n\n\n\n
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VCRO \u65e9\u57282018\u5e74\u5c31\u6210\u529f\u7533\u62a5\u83b7\u6279\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1 FDA IND \u3002\u5c24\u5176\u662f\u5982\u4f55\u8854\u63a5\u7533\u62a5 CDE \u7684\u9879\u76ee\u76f4\u63a5\u9012\u4ea4 FDA IND<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u5e7f\u5927\u7684\u6d77\u5916\u5f00\u53d1\u80fd\u529b<\/h2>\n\n\n\n
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\n
\n
<\/path><\/svg><\/div><\/div>\n<\/div>\n\n\n\n
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VCRO \u662f\u6781\u5c11\u6570\u80fd\u62e5\u6709 in-house \u56e2\u961f\u8fdb\u884c\u7f8e\u56fd\u53ca\u6b27\u6d32\u7684\u6ce8\u518c\u4e34\u5e8a\u9879\u76ee<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u534f\u52a9\u5927\u9646\u5ba2\u6237\u5c3d\u901f\u7ecf\u4ea7\u54c1\u56fd\u9645\u5316<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

VCRO \u5728\u7ec6\u80de\u6cbb\u7597\u9886\u57df\u5df2\u6709\u903e20\u5e74\u7684\u6295\u5165\uff0c\u7d2f\u79ef\u4e86\u8fd140\u4ef6\u7ec6\u80de\u6cbb\u7597\u59d4\u6258\u6848\uff0c\u6db5\u76d6\u514d\u75ab\u7ec6\u80de\u4e0e\u5e72\u7ec6\u80de\u4ea7\u54c1\uff0c\u6d89\u53ca\u5e7f\u6cdb\u7684\u533b\u7597\u9886\u57df\uff0c\u5982\u764c\u75c7\u3001\u9aa8\u79d1\u3001\u809d\u80c6\u80a0\u80c3\u79d1\u3001\u773c\u79d1\u3001\u76ae\u80a4\u79d1\u7b49\u3002\u6211\u4eec\u4e3a\u5ba2\u6237\u63d0\u4f9b\u4ece\u65e9\u671f\u4ea7\u54c1\u7814\u53d1\u7b56\u7565\u5e03\u5c40\u3001\u6cd5\u89c4\u9014\u5f84\u3001\u524d\u4e34\u5e8a\u4e0e\u4ea7\u54c1 CMC \u5236\u7a0b\u54a8\u8be2\uff0c\u5230\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u8bbe\u8ba1\u3001 Pre IND \u54a8\u8be2\u4f1a\u8bae\u3001 IND \u6587\u4ef6\u51c6\u5907\u4e0e\u9012\u4ea4\uff0c\u76f4\u81f3\u4e34\u5e8a\u8bd5\u9a8c\u6267\u884c\u7684\u5b8c\u6574\u670d\u52a1\u3002\u901a\u8fc7\u6211\u4eec\u4e30\u5bcc\u7684\u5b9e\u52a1\u7ecf\u9a8c\uff0c\u4e0e\u60a8\u643a\u624b\u8fbe\u6210\u6700\u7ec8\u76ee\u6807\u3002<\/p>\n\n\n\n

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