\u9488\u5bf9\u4e34\u5e8a\u524d\u3001\u4e34\u5e8a\u548c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684 GLP \u8ba4\u8bc1\u548c GCP \u5408\u89c4\u751f\u7269\u5206\u6790<\/p>\n<\/div>
Kymos \u96c6\u56e2\u4e13\u6ce8\u4e8e\u4e16\u754c\u7ea7\u7684\u5c0f\u5206\u5b50\u751f\u7269\u5206\u6790\uff0c\u63d0\u4f9b\u5168\u9762\u7684\u670d\u52a1\uff0c\u4ece\u5feb\u901f\u7684\u4f53\u5185\u548c\u4f53\u5916 ADMET \u7b5b\u9009\u5230\u4e34\u5e8a\u524d\u6bd2\u4ee3\u52a8\u529b\u5b66\u3001\u751f\u7269\u5229\u7528\u5ea6\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u3001\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u7814\u7a76\uff0c\u4ee5\u53ca\u5305\u62ec\u9996\u6b21\u4eba\u4f53\u8bd5\u9a8c\u548c\u5242\u91cf\u9012\u589e\u7814\u7a76\u5728\u5185\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n
\u6211\u4eec\u7684\u751f\u7269\u5206\u6790\u4e13\u5bb6\u5728\u5168\u9762\u7ba1\u7406 I \u81f3 IV \u671f\u5c0f\u5206\u5b50\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u751f\u7269\u5206\u6790\u4ee5\u53ca\u4eff\u5236\u836f\u751f\u7269\u7b49\u6548\u6027\u65b9\u9762\u7ecf\u9a8c\u4e30\u5bcc\u3002\u6211\u4eec\u662f\u4e00\u5bb6\u901a\u8fc7 GLP \u8ba4\u8bc1\u4e14\u7b26\u5408 GCP \u6807\u51c6\u7684\u8de8\u56fd CRO\uff0c\u5728\u670d\u52a1\u5404\u79cd\u5ba2\u6237\u7fa4\u4f53\u65b9\u9762\u62e5\u6709\u5e7f\u6cdb\u7ecf\u9a8c\uff0c\u5305\u62ec\uff1a <\/p>\n<\/div>
\u52a8\u7269\u4fdd\u5065\u516c\u53f8<\/strong>\uff0c\u9700\u8981\u6b8b\u7559\u6d88\u51cf\u7814\u7a76\u3002<\/p>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\u670d\u52a1<\/p>\n<\/div><\/div><\/div>\u6211\u4eec\u7684\u670d\u52a1\u76ee\u5f55\u5305\u62ec\uff1a<\/h2><\/div><\/i><\/i><\/span>\u5c0f\u5206\u5b50\u4e34\u5e8a\u524d\u7814\u7a76<\/span><\/a><\/h3><\/div>\n\n\u4f7f\u7528 Phoenix WinNonlin\u00ae \u8fdb\u884c\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u751f\u7269\u6807\u5fd7\u7269\/\u836f\u6548\u5b66\u548c\u6bd2\u4ee3\u52a8\u529b\u5b66\u7684\u8ba1\u7b97\u4e0e\u7edf\u8ba1<\/span><\/li>\n\u4ee3\u8c22\u7269\u9274\u5b9a\u4e0e\u5b9a\u91cf<\/span><\/li>\n\u62e5\u6709\u5927\u591a\u6570\u52a8\u7269\u6a21\u578b\u7684\u7ecf\u9a8c\uff0c\u5305\u62ec\u5927\u9f20\u3001\u5c0f\u9f20\u3001\u5154\u5b50\u3001\u5c0f\u578b\u732a\u3001\u732b\u3001\u72d7\u3001\u975e\u4eba\u7075\u957f\u7c7b\u52a8\u7269\u3001\u732a\u3001\u725b\u3001\u7f8a\u3001\u5bb6\u79bd\u548c\u9a6c<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/i><\/i><\/span>\u5c0f\u5206\u5b50\u4e34\u5e8a\u7814\u7a76<\/span><\/a><\/h3><\/div>\n\nI-IV \u671f\u836f\u4ee3\u52a8\u529b\u5b66\uff0c\u5305\u62ec\u9996\u6b21\u4eba\u4f53\u5242\u91cf\u9012\u589e\u7814\u7a76<\/li>\n\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u7814\u7a76<\/li>\n\u751f\u7269\u6807\u5fd7\u7269\u548c\u836f\u6548\u5b66\u7684\u9274\u5b9a\u4e0e\u5b9a\u91cf<\/li>\n\u4e0e\u9075\u5faa EMA\/FDA\/ANVISA \u6307\u5357\u7684\u77e5\u540d\u6b27\u6d32\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u4e2d\u5fc3\u5408\u4f5c\uff0c\u5f00\u5c55\u5168\u9762\u7684\u4eff\u5236\u836f\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/i><\/i><\/span>\u7ecf\u76ae\u5438\u6536<\/span><\/a><\/h3><\/div>\n\n\u4f53\u5916\u7ecf\u76ae\u5438\u6536\u7814\u7a76\uff0c\u6d4b\u8bd5\u4f5c\u4e3a\u5c40\u90e8\u836f\u7269\u7684\u5c0f\u5206\u5b50\u5982\u4f55\u901a\u8fc7\u76ae\u80a4\u8868\u9762\u548c\u5408\u6210\u819c\u5438\u6536\u53ca\u5206\u89e3\u3002<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/i><\/i><\/span>\u6b8b\u7559\u6d88\u51cf\u7814\u7a76<\/span><\/a><\/h3><\/div>\n\n\u4e0e\u6218\u7565\u5408\u4f5c\u4f19\u4f34\u5171\u540c\u8fdb\u884c\u4e34\u5e8a\u524d\u5b9e\u9a8c\u548c\u52a8\u7269\u9972\u517b\u7684\u5168\u9762\u7814\u7a76\u7ba1\u7406<\/li>\n\u9488\u5bf9\u5404\u79cd\u52a8\u7269\u6a21\u578b\u548c\u590d\u6742\u57fa\u8d28\uff08\u5982\u809d\u810f\u3001\u8102\u80aa\u3001\u808c\u8089\u3001\u5927\u8111\u3001\u725b\u5976\u3001\u8702\u871c\u6216\u9e21\u86cb\uff09\u7684\u517d\u836f\u9a8c\u8bc1<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/i><\/i><\/span>\u5438\u6536\u7814\u7a76<\/span><\/a><\/h3><\/div>\n\n\u81b3\u98df\u8865\u5145\u5242\u548c\u690d\u7269\u836f\u7684\u5438\u6536\u7814\u7a76\uff0c\u6d4b\u91cf\u5176\u5728\u751f\u7269\u4f53\u5185\u7684\u6548\u679c\u548c\u5438\u6536\u7387<\/li>\n\u5728\u81b3\u98df\u8865\u5145\u5242\u3001\u533b\u7597\u5668\u68b0\u548c\u690d\u7269\u836f\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\u5177\u6709\u5c0f\u5206\u5b50\u751f\u7269\u5206\u6790\u7684\u4e13\u4e1a\u77e5\u8bc6<\/li>\n\u4e13\u6ce8\u4e8e\u4e3a\u5177\u6709\u6311\u6218\u6027\u7684\u57fa\u8d28\u3001\u4f4e\u5b9a\u91cf\u4e0b\u9650 (LOQ) \u548c\u591a\u79cd\u5206\u6790\u7269\u5f00\u53d1\u590d\u6742\u7684\u751f\u7269\u5206\u6790\u65b9\u6cd5<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\u4e00\u7ad9\u5f0f\u670d\u52a1<\/p>\n<\/div><\/div><\/div>\u4e34\u5e8a\u524d\u3001\u4e34\u5e8a\u548c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u4e00\u7ad9\u5f0f\u89e3\u51b3\u65b9\u6848<\/h2><\/div><\/div><\/div>Kymos \u96c6\u56e2\u4e0e\u6211\u4eec\u7684\u8054\u76df\u4f19\u4f34\u5145\u5206\u534f\u4f5c\uff0c\u63d0\u4f9b\u9ad8\u8d28\u91cf\u6807\u51c6\u3001\u7d27\u51d1\u7684\u5de5\u671f\u548c\u6781\u5177\u7ade\u4e89\u529b\u7684\u4ef7\u683c\uff0c\u5728\u4ee5\u4e0b\u9886\u57df\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u670d\u52a1\uff1a<\/p>\n<\/div><\/div><\/div>\u4e34\u5e8a\u7814\u7a76\u7ba1\u7406<\/h3><\/h4><\/div>\n\u65b9\u6848\u64b0\u5199<\/li>\n\u63d0\u4ea4\u81f3\u4f26\u7406\u59d4\u5458\u4f1a\u548c\u76d1\u7ba1\u673a\u6784<\/li>\n\u4fdd\u9669\u7b7e\u7ea6<\/li>\n\u4e34\u5e8a\u4e2d\u5fc3\u7ba1\u7406\u4e0e\u76d1\u67e5<\/li>\n\u7814\u7a76\u6267\u884c<\/li>\n\u6837\u672c\u8fd0\u8f93\u4e0e\u50a8\u5b58<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/span><\/a><\/span>\u8054\u7cfb\u6211\u4eec<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>\u7814\u7a76\u62a5\u544a<\/h3><\/h4><\/div>\nPhoenix WinNonlin\u00ae \u6570\u636e\u5206\u6790<\/li>\n\u836f\u4ee3\u52a8\u529b\u5b66\u62a5\u544a<\/li>\n\u6700\u7ec8\u4e34\u5e8a\u62a5\u544a<\/li>\n\u6839\u636e\u5f53\u5c40\u8981\u6c42\u7684\u7279\u5b9a\u62a5\u544a<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/span><\/a><\/span>\u8054\u7cfb\u6211\u4eec<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>\u751f\u7269\u5206\u6790<\/h3><\/h4><\/div>\n\u7528\u4e8e\u5c0f\u5206\u5b50\u3001\u4eff\u5236\u836f\u7684 LC-MS\/MS \u548c HRMS<\/li>\n\u7528\u4e8e\u91d1\u5c5e\/\u6709\u673a\u91d1\u5c5e\u5206\u6790\u7684 ICP-MS<\/li>\n\u7528\u4e8e\u5c0f\u80bd\u7684 ELISA\u3001ECLA \u548c RIA<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/span><\/a><\/span>\u8054\u7cfb\u6211\u4eec<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>\u652f\u6301\u6d3b\u52a8<\/h3><\/h4><\/div>\nIMPD \u64b0\u5199\u6216\u5ba1\u67e5<\/li>\n\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u5206\u6790\u6d4b\u8bd5<\/li>\n\u6eb6\u51fa\u66f2\u7ebf\u6bd4\u8f83<\/li>\n\u5bf9\u7167\u54c1\u548c\u6d4b\u8bd5\u4ea7\u54c1\u7684\u8fdb\u53e3<\/li>\n\u6279\u6b21\u68c0\u6d4b\u548c\u6279\u6b21\u653e\u884c<\/li>\n\u7ed9\u836f\u6eb6\u6db2\/\u5236\u5242\u7684\u7406\u5316\u5206\u6790<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/span><\/a><\/span>\u8054\u7cfb\u6211\u4eec<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\u6211\u4eec\u63d0\u4f9b\u5e7f\u6cdb\u7684\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u751f\u7269\u5206\u6790\u65b9\u6cd5\u5217\u8868*<\/h2><\/div>\r\n
\u670d\u52a1<\/p>\n<\/div>
\u4e00\u7ad9\u5f0f\u670d\u52a1<\/p>\n<\/div>
Kymos \u96c6\u56e2\u4e0e\u6211\u4eec\u7684\u8054\u76df\u4f19\u4f34\u5145\u5206\u534f\u4f5c\uff0c\u63d0\u4f9b\u9ad8\u8d28\u91cf\u6807\u51c6\u3001\u7d27\u51d1\u7684\u5de5\u671f\u548c\u6781\u5177\u7ade\u4e89\u529b\u7684\u4ef7\u683c\uff0c\u5728\u4ee5\u4e0b\u9886\u57df\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u670d\u52a1\uff1a<\/p>\n<\/div><\/div><\/div>
\u8054\u7cfb\u6211\u4eec<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>
\u8054\u7cfb\u6211\u4eec<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>