{"id":213,"date":"2024-06-04T15:40:30","date_gmt":"2024-06-04T07:40:30","guid":{"rendered":"http:\/\/localhost\/wordpress4\/?page_id=213"},"modified":"2025-01-22T16:27:17","modified_gmt":"2025-01-22T08:27:17","slug":"%e9%86%ab%e5%ad%b8%e4%ba%8b%e5%8b%99","status":"publish","type":"page","link":"https:\/\/www.vcro.com.tw\/tw\/?page_id=213","title":{"rendered":"\u91ab\u5b78\u4e8b\u52d9"},"content":{"rendered":"\n
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\u91ab\u5b78\u4e8b\u52d9<\/h2>\n\n\n\n
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\u91ab\u5b78\u4e8b\u52d9\u5718\u968a\u4f5c\u70ba VCRO<\/span> \u7684\u6838\u5fc3\u5718\u968a<\/p>\n\u7531\u591a\u4f4d\u570b\u5167\u5916\u77e5\u540d\u5b78\u5e9c\u7684\u751f\u6280\u3001\u91ab\u5b78\u3001\u85e5\u5b78\u78a9\u535a\u58eb\u5c08\u5bb6\u7d44\u6210\uff0c\u64c1\u6709\u8c50\u5bcc\u7684\u5b78\u7814\u8207\u7522\u696d\u754c\u4e4b\u7814\u7a76\u958b\u767c\u7d93\u9a57<\/cite><\/blockquote>\n\n\n\n

\"\u5b64\u5152\u85e5,odd,Orphan<\/figure>\n\n\n\n
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\u91ab\u5b78\u4e8b\u52d9\u5718\u968a\u719f\u7a14\u53f0\u7063\u3001\u7f8e\u570b\u8207\u4e2d\u570b\u5927\u9678\u7684\u85e5\u54c1\u3001\u91ab\u6750\u6cd5\u898f\u4e26\u7d2f\u7a4d\u4e8620\u9918\u5e74\u7684\u6210\u529f\u7d93\u9a57\uff0c\u5354\u52a9\u904e\u5c0f\u5206\u5b50\u85e5\u7269\u3001\u690d\u7269\u85e5\u3001\u7d30\u80de\u7642\u6cd5\u3001\u751f\u7269\u88fd\u5291\u3001\u57fa\u56e0\u6cbb\u7642\u3001\u91ab\u7642\u5668\u6750\u4e43\u81f3\u85e5\u54c1\u8207\u91ab\u6750\u5408\u4f75\u7522\u54c1\u7684\u958b\u767c\uff0c\u6211\u5011\u81f4\u529b\u65bc\u63a8\u52d5\u5275\u65b0\u4e26\u7406\u89e3\u60a8\u7522\u54c1\u7684\u7368\u7279\u6027\uff0c\u9700\u8981\u7684\u662f\u5ba2\u88fd\u5316\u7684\u89e3\u6c7a\u65b9\u6848\u3002<\/p>\n\n\n\n

\u56e0\u6b64\uff0c\u6211\u5011\u6703\u6839\u64da\u60a8\u7684\u5177\u9ad4\u9700\u6c42\u63d0\u4f9b\u91cf\u8eab\u8a02\u88fd\u7684\u5efa\u8b70\u548c\u652f\u6301\uff0c\u8b93\u60a8\u5f9e\u524d\u81e8\u5e8a\u968e\u6bb5\u9032\u5165\u81e8\u5e8a\u968e\u6bb5\u76f4\u81f3\u6700\u7d42\u53d6\u5f97\u7522\u54c1\u8a31\u53ef\u8b49\u7684\u904e\u7a0b\u4e2d\u6709\u5b8c\u6574\u7684\u5354\u52a9\uff0c\u5f15\u9818\u60a8\u8de8\u8d8a\u7814\u767c\u548c\u5e02\u5834\u5316\u7684\u5404\u500b\u9580\u6abb\uff0c\u5728\u6fc0\u70c8\u7684\u5e02\u5834\u7af6\u722d\u4e2d\u53d6\u5f97\u512a\u52e2\uff0c\u966a\u4f34\u60a8\u8d70\u5411\u6210\u529f\u3002<\/p>\n\n\n\n

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\u6211\u5011\u80fd\u505a\u4ec0\u9ebc<\/strong><\/strong><\/p>\nVCRO<\/span> \u91ab\u5b78\u4e8b\u52d9\u5718\u968a\u81f4\u529b\u65bc\u70ba\u7522\u54c1\u958b\u767c\u63d0\u4f9b\u5168\u65b9\u4f4d\u7684\u6cd5\u898f\u8aee\u8a62\uff0c\u5354\u52a9\u60a8\u7a81\u7834\u958b\u767c\u74f6\u9838\uff0c\u4e26\u5236\u5b9a\u6700\u4f73\u7684\u958b\u767c\u7b56\u7565<\/cite><\/blockquote>\n\n\n\n

VCRO \u80fd\u5920\u5e6b\u60a8\u88fd\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

\u6211\u5011\u7684\u5c08\u5bb6\u5718\u968a\u5c07\u5354\u52a9\u60a8\u5206\u6790\u548c\u89e3\u8b80\u53ca\u5c55\u73fe\u7814\u7a76\u7d50\u679c\uff0c\u5e6b\u52a9\u60a8\u505a\u51fa\u6709\u5229\u65bc\u85e5\u7269\u958b\u767c\u548c\u5e02\u5834\u51c6\u5165\u7684\u95dc\u9375\u6c7a\u7b56\uff0c\u78ba\u4fdd\u60a8\u7684\u7814\u7a76\u7b26\u5408\u79d1\u5b78\u6a19\u6e96\u3001\u6cd5\u898f\u8981\u6c42\u4ee5\u53ca\u8a2d\u5b9a\u7684\u76ee\u6a19\u3002<\/p>\n\n\n\n

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\u958b\u767c\u7b56\u7565\u8aee\u8a62<\/strong><\/strong><\/strong><\/p>\n<\/div>\n<\/div>\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<\/div>\n<\/div>\n\n\n\n

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\u6cd5\u898f\u4ee3\u8868\u6e9d\u901a<\/strong><\/strong><\/strong><\/strong><\/strong><\/p>\n<\/div>\n<\/div>\n\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 (\u5982\u53f0\u7063 CDE \u8aee\u8a62\u6703\u8b70\u3001 US FDA pre-IND<\/a> \u3001 Interact \u6703\u8b70\u7b49) \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\u65bc\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<\/div>\n<\/div>\n\n\n\n

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IND\u6e96\u5099\u8207\u7533\u8acb<\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n

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VCRO \u7684\u91ab\u5b78\u4e8b\u52d9\u5718\u968a\u7531\u4f86\u81ea\u81e8\u5e8a\u3001\u975e\u81e8\u5e8a\u3001\u76e3\u7ba1\u4e8b\u52d9\u4ee5\u53ca\u5316\u5b78\u3001\u88fd\u9020\u548c\u63a7\u5236 (CMC) \u7b49\u591a\u500b\u9818\u57df\u7684\u5c08\u696d\u4eba\u58eb\u7d44\u6210\uff0c\u8c50\u5bcc\u7684\u79d1\u5b78\u3001\u6cd5\u898f\u77e5\u8b58\u52a0\u4e0a\u7d2f\u7a4d\u5927\u91cf\u5728\u7f8e\u570b\u3001\u53f0\u7063\u7684\u6210\u529f\u7533\u5831\u5be6\u6230\u7d93\u9a57\uff0c\u6211\u5011\u662f\u60a8\u653b\u514b\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57 (IND) \u7533\u8acb\u7684\u95dc\u9375\u95dc\u5361\u4e0a\u52dd\u7387\u6700\u9ad8\u7684\u8ecd\u5e2b\uff0c\u8b93\u60a8\u8d0f\u5728\u81e8\u5e8a\u958b\u767c\u7684\u8d77\u8dd1\u7dda\u4e0a\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u81e8\u5e8a\u8a66\u9a57\u898f\u5283<\/strong><\/strong><\/strong><\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n

\n

VCRO \u91ab\u5b78\u4e8b\u52d9\u5718\u968a\u64c1\u6709\u8c50\u5bcc\u7684\u591a\u985e\u578b\u7522\u54c1\u7684\u958b\u767c\u7d93\u9a57\uff0c\u8ca0\u8cac\u904e\u5404\u671f\u5225\u81e8\u5e8a\u8a66\u9a57\u7684\u898f\u5283\uff0c\u9069\u61c9\u75c7\u66f4\u5305\u62ec\u764c\u75c7\u3001\u795e\u7d93\u75be\u75c5\u3001\u514d\u75ab\u75be\u75c5\u3001\u5fc3\u8840\u7ba1\u75be\u75c5\u3001\u611f\u67d3\u75be\u75c5\u3001\u76ae\u819a\u75c5\u3001\u6838\u5b50\u91ab\u5b78\u3001\u5a66\u79d1\u75be\u75c5\u3001\u75bc\u75db\u63a7\u5236\u3001\u773c\u79d1\u3001\u85e5\u7269\u6210\u766e\u7b49\u6578\u5341\u9805\u9818\u57df\uff0c\u6211\u5011\u64c5\u9577\u6839\u64da\u5ba2\u6236\u7684\u9700\u6c42\u8207\u76ee\u6a19\uff0c\u8a2d\u8a08\u6700\u7b26\u5408\u671f\u5f85\u7684\u81e8\u5e8a\u7814\u7a76\u65b9\u6848\uff0c\u9ad8\u6548\u63a8\u9032\u60a8\u7684\u6574\u9ad4\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u6280\u8853\u6587\u4ef6\u64b0\u5beb<\/strong><\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n

\n

VCRO \u91ab\u5b78\u4e8b\u52d9\u5718\u968a\u64c1\u6709\u64b0\u5beb\u4e0d\u540c\u985e\u578b\u7522\u54c1\u6280\u8853\u6587\u4ef6\u7684\u8c50\u5bcc\u7d93\u9a57\uff0c\u80fd\u5920\u78ba\u4fdd\u6587\u4ef6\u7684\u6e96\u78ba\u6027\u548c\u5b8c\u6574\u6027\uff0c\u6211\u5011\u7684\u6280\u8853\u6587\u4ef6\u64b0\u5beb\u5747\u9075\u5faa\u570b\u969b\u91ab\u85e5\u6cd5\u898f\u5354\u548c\u6703 (ICH) \u4e4b\u901a\u7528\u6280\u8853\u6587\u4ef6\u683c\u5f0f\uff0c\u7b26\u5408\u5168\u7403\u5404\u5927\u90e8\u5206\u76e3\u7ba1\u6a5f\u69cb\u5305\u62ec\u53f0\u7063\u3001\u7f8e\u570b\u3001\u6b50\u76df\u53ca\u4e2d\u570b\u5927\u9678\u7684\u8981\u6c42\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u6cd5\u898f\u4ee3\u8868\u9001\u4ef6<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n

\n

VCRO \u64c1\u6709\u591a\u4f4d\u5be6\u6230\u7d93\u9a57\u8c50\u5bcc\u7684\u6cd5\u898f\u5c08\u5bb6\uff0c\u80fd\u5920\u5f9e\u76e3\u7ba1\u6a5f\u95dc\u7684\u89d2\u5ea6\u70ba\u60a8\u63d0\u4f9b\u6700\u6e96\u78ba\u7684\u8a66\u9a57\u7533\u8acb\u6216\u7522\u54c1\u8a3b\u518a\u7684\u65b9\u5411\u8207\u7b56\u7565\u3002<\/p>\n\n\n\n

\u9664\u4e86\u6280\u8853\u4e0a\u7684\u512a\u52e2\u8207\u8c50\u539a\u7684\u8cc7\u6b77\uff0c\u6211\u5011\u8207\u76e3\u7ba1\u6a5f\u95dc\u4ea6\u4fdd\u6301\u826f\u597d\u4e14\u4e92\u4fe1\u7684\u6e9d\u901a\u7ba1\u9053\uff0c\u5e6b\u52a9\u60a8\u7e2e\u77ed\u4e26\u52a0\u901f\u5be9\u67e5\u7684\u6642\u9593\u8207\u904e\u7a0b\uff0c\u662f\u60a8\u5728\u9700\u8981\u6975\u5ea6\u6b63\u78ba\u6027\u8207\u6e96\u78ba\u6027\u7684\u5197\u9577\u9001\u4ef6\u7533\u8acb\u904e\u7a0b\u4e2d\u7684\u6700\u4f73\u5f8c\u76fe\uff0c\u5e6b\u52a9\u60a8\u9806\u5229\u901a\u904e\u6bcf\u500b\u5be9\u6279\u968e\u6bb5\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u6211\u5011\u7684\u7279\u8272\u7279\u8cea<\/strong><\/strong><\/p>\n<\/blockquote>\n\n\n\n

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  • \u5f15\u9818\u524d\u6cbf<\/u><\/strong>
    VCRO \u8fd130\u5e74\u4f86\u7684\u5ba2\u6236\u59cb\u7d42\u8d70\u5728\u65b0\u85e5\u958b\u767c\u7684\u6700\u524d\u6cbf\uff0c\u81f4\u529b\u65bc\u6700\u65b0\u6cbb\u7642\u9818\u57df\u7684\u7522\u54c1\u958b\u767c\uff0c\u6211\u5011\u4e0d\u65b7\u8ffd\u8e64\u5168\u7403\u91ab\u5b78\u548c\u79d1\u6280\u7684\u6cd5\u898f\u52d5\u614b\u8207\u89c0\u9ede\uff0c\u4fdd\u6301\u8207\u5168\u7403\u9818\u5148\u5be9\u67e5\u6a5f\u69cb\u7684\u7dca\u5bc6\u806f\u7e6b\uff0c\u70ba\u6211\u5011\u7684\u5ba2\u6236\u63d0\u4f9b\u6700\u524d\u77bb\u7684\u89e3\u6c7a\u65b9\u6848\u3002<\/li>\n<\/ul>\n\n\n\n
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    • \u95dc\u5fc3\u966a\u4f34<\/u><\/strong><\/u><\/strong>
      \u6211\u5011\u6df1\u77e5\u6bcf\u4e00\u500b\u7814\u7a76\u9805\u76ee\u80cc\u5f8c\u7684\u52aa\u529b\u548c\u671f\u671b\uff0c\u56e0\u6b64\u6211\u5011\u81f4\u529b\u65bc\u8207\u5ba2\u6236\u5efa\u7acb\u7dca\u5bc6\u7684\u5408\u4f5c\u5925\u4f34\u95dc\u4fc2\u3002\u6211\u5011\u7684\u5718\u968a\u4e0d\u50c5\u50c5\u662f\u63d0\u4f9b\u6280\u8853\u652f\u6301\uff0c\u66f4\u95dc\u5fc3\u6bcf\u500b\u9805\u76ee\u7684\u9032\u5c55\u548c\u76ee\u6a19\uff0c\u96a8\u6642\u6e96\u5099\u89e3\u7b54\u60a8\u7684\u5404\u7a2e\u7591\u554f\u4e26\u63d0\u4f9b\u6700\u5207\u8eab\u7684\u5efa\u8b70\uff0c\u5728\u6bcf\u4e00\u500b\u968e\u6bb5\u63d0\u4f9b\u5168\u65b9\u4f4d\u7684\u652f\u6301\uff0c\u8207\u60a8\u4e00\u540c\u9762\u5c0d\u5404\u7a2e\u56f0\u96e3\u3002<\/li>\n<\/ul>\n\n\n\n
        \n
      • \u5805\u6301\u5c08\u696d<\/u><\/strong><\/u><\/strong><\/u><\/strong>
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            \n

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            \n\n\n\n

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