{"id":17336,"date":"2023-02-22T11:06:59","date_gmt":"2023-02-22T03:06:59","guid":{"rendered":"https:\/\/www.nikyang.com\/?p=17336"},"modified":"2023-02-22T11:09:04","modified_gmt":"2023-02-22T03:09:04","slug":"procos-case","status":"publish","type":"post","link":"https:\/\/www.nikyang.com\/automated-solution\/procos-case\/","title":{"rendered":"\u62c6\u89e3 Procos \u52a0\u901f API \u5de5\u827a\u5f00\u53d1\u7684\u79d8\u7b08"},"content":{"rendered":"\t\t
\u539f\u6599\u836f\u5728\u533b\u836f\u4ea7\u4e1a\u4e2d\u5404\u4e2a\u73af\u8282\u4e2d\u90fd\u5341\u5206\u5173\u952e\uff0c\u5c24\u5176\u5728\u9879\u76ee\u8fdb\u5165\u4e34\u5e8a\u9636\u6bb5\u540e\uff0c\u5bf9\u539f\u6599\u836f\u7684\u9700\u6c42\u66f4\u5927\u3002\u539f\u6599\u836f\u7684\u751f\u4ea7\u8fc7\u7a0b\u5341\u5206\u590d\u6742\uff0c\u800c\u4e14\u5bb9\u6613\u53d7\u73af\u5883\u53c2\u6570\u5982: \u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u538b\u529b\u7b49\u7b49\u7684\u5f71\u54cd\uff0c\u6709\u4e9b\u539f\u6750\u6599\u66f4\u6709\u4e00\u5b9a\u5371\u9669\u6027\uff0c\u56e0\u6b64\u5728\u8fdb\u884c\u539f\u6599\u836f\u7684\u6269\u5927\u5de5\u827a\u65f6\uff0c\u9664\u4e86\u8981\u8003\u8651\u5176\u8d28\u91cf\u3001\u7ecf\u6d4e\u6548\u76ca\u5916\uff0c\u66f4\u8981\u8003\u8651\u5176\u5b89\u5168\u6027\u3002\u901a\u8fc7\u53cd\u5e94\u7b5b\u9009\u8fdb\u884c\u539f\u6599\u836f\u7684\u5de5\u827a\u5f00\u53d1\uff0c\u53ef\u4ee5\u5bfb\u627e\u6700\u4f73\u7684\u53cd\u5e94\u6761\u4ef6\u3001\u6700\u4f73\u7684\u50ac\u5316\u4f53\u7cfb\uff0c\u5b9e\u73b0\u53cd\u5e94\u9009\u62e9\u6027\u7684\u4f18\u5316\uff0c\u5e76\u83b7\u5f97\u5c3d\u53ef\u80fd\u4f4e\u7684\u6742\u8d28\u542b\u91cf\u76ee\u6807\u4ea7\u7269\u3002<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t \u4e3a\u4e86\u5e94\u5bf9\u4ee5\u4e0a\u7684\u6311\u6218\uff0cProcos S.p.A \u516c\u53f8\u53bb\u5e74\u5e74\u521d\u5c31\u6b63\u5f0f\u5ba3\u5e03\u5e94\u7528 Chemspeed \u81ea\u52a8\u7814\u53d1\u7cfb\u7edf\uff0c\u4f5c\u4e3a\u7814\u53d1\u56e2\u961f\u4f7f\u7528\u7684\u5de5\u5177\uff0c\u4ee5\u4f18\u5316\u652f\u6301 NDA (New Drug Application – \u65b0\u836f\u7533\u8bf7) \u9879\u76ee\u7684\u5de5\u4f5c\u901f\u5ea6\u3002<\/p> Procos S.p.A \u516c\u53f8\u662f\u4e00\u5bb6\u5408\u540c\u5f00\u53d1\u673a\u6784 (CDMO)\uff0c\u4ece\u4e8b\u6d3b\u6027\u836f\u7269\u6210\u5206 (API)\u3001\u9ad8\u7ea7\u4e2d\u95f4\u4f53\u548c\u76f8\u5173\u670d\u52a1\u7684\u5f00\u53d1\u3001\u653e\u5927\u548c\u751f\u4ea7\u3002<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t “\u501f\u52a9 Chemspeed \u8fd9\u9879\u5148\u8fdb\u7684\u6280\u672f\uff0c\u5c06\u8fdb\u4e00\u6b65\u63d0\u9ad8 API \u5f00\u53d1\u548c\u63d0\u4ea4\u7ed9\u76f8\u5173\u76d1\u7ba1\u673a\u6784 (\u5982 FDA) \u7684\u65f6\u95f4\u3002\u6b64\u5916\uff0c\u5b83\u8fd8\u5c06\u52a0\u5feb\u65b0\u836f\u7533\u8bf7\u7684\u65f6\u95f4\u8868\u3001\u589e\u52a0\u8bd5\u9a8c\u7684\u6570\u91cf\uff0c\u4ee5\u53ca\u62a5\u544a\u9075\u5faa\u884c\u4e1a\u6307\u5357\u7684\u6570\u636e\uff0c\u5305\u62ec 21 CFR \u7b2c 11 \u90e8\u5206\u3002”<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\u539f\u6599\u836f
\u5de5\u827a\u5f00\u53d1 <\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\tProcos S.p.A\u00a0 <\/strong>\u516c\u53f8\u900f\u9732<\/h6>