{"id":42589,"date":"2024-09-30T08:31:33","date_gmt":"2024-09-30T06:31:33","guid":{"rendered":"https:\/\/kymos.com\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e9%80%8f%e7%9a%ae%e6%b5%8b%e8%af%95\/"},"modified":"2026-07-12T09:41:27","modified_gmt":"2026-07-12T07:41:27","slug":"%e9%80%8f%e7%9a%ae%e6%b5%8b%e8%af%95","status":"publish","type":"page","link":"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e9%80%8f%e7%9a%ae%e6%b5%8b%e8%af%95\/","title":{"rendered":"\u900f\u76ae\u6d4b\u8bd5"},"content":{"rendered":"

\u900f\u76ae\u6d4b\u8bd5<\/h1><\/div>

\u9488\u5bf9\u900f\u76ae\u8d34\u5242\u63d0\u4f9b\u4ece\u914d\u65b9\u5f00\u53d1\u5230\u5e38\u89c4\u5206\u6790\u7684\u7ecf GMP \u548c GLP \u8ba4\u8bc1\u7684\u7814\u7a76\u3002<\/p>\n<\/div>

\u54a8\u8be2\u4e13\u5bb6<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>

Kymos \u96c6\u56e2\u4e3a\u900f\u76ae\u8d34\u5242\u6216\u900f\u76ae\u7ed9\u836f\u7cfb\u7edf (TDDS) \u63d0\u4f9b\u7ecf GMP \u548c GLP \u8ba4\u8bc1\u7684\u7814\u7a76\uff0c\u5728\u5206\u6790\u548c\u8d28\u91cf\u63a7\u5236\u65b9\u9762\u62e5\u6709\u6df1\u539a\u7684\u4e13\u4e1a\u77e5\u8bc6\u3002\u8fd9\u4e9b\u5242\u578b\u65e8\u5728\u901a\u8fc7\u76ae\u80a4\u4ee5\u5168\u8eab\u3001\u6301\u4e45\u4e14\u6052\u5b9a\u7684\u65b9\u5f0f\u8f93\u9001\u6d3b\u6027\u7269\u8d28\uff0c\u5728\u8d28\u91cf\u3001\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u65b9\u9762\u63d0\u51fa\u4e86\u72ec\u7279\u7684\u6311\u6218\u3002 <\/p>\n

\u6211\u4eec\u7684\u4e13\u4e1a\u5b9e\u9a8c\u5ba4\u914d\u5907\u4e86\u6700\u5148\u8fdb\u7684\u6280\u672f\u548c\u5de5\u827a\uff0c\u6211\u4eec\u7ecf\u9a8c\u4e30\u5bcc\u7684\u4e13\u4e1a\u56e2\u961f\u9075\u5faa\u6700\u9ad8\u6807\u51c6\u548c\u76d1\u7ba1\u8981\u6c42\uff0c\u7814\u7a76\u4f9d\u636e\u5305\u62ec\u300a\u900f\u76ae\u8d34\u5242\u8d28\u91cf\u6307\u5357 (EMA\/CHMP\/608924\/2014)\u300b\u3001\u76f8\u5173\u836f\u5178\u4e13\u8bba\u4ee5\u53ca ICH \u548c CHMP\/CVMP \u6307\u5357\u3002<\/p>\n

\u6211\u4eec\u4e3a\u900f\u76ae\u8d34\u5242\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u63d0\u4f9b\u652f\u6301\uff0c\u4ece\u914d\u65b9\u3001\u5f00\u53d1\u548c\u7a33\u5b9a\u6027\u7814\u7a76\uff0c\u5230\u5e38\u89c4\u5206\u6790\u548c\u91cd\u65b0\u914d\u65b9\u3002<\/p>\n<\/div><\/div><\/div>

\"image<\/div><\/div><\/div><\/div>
<\/div><\/div>

\u670d\u52a1<\/p>\n<\/div>

<\/div><\/div>

\u900f\u76ae\u8d34\u5242\u7684 CMC \u4e0e\u8d28\u91cf\u63a7\u5236\u6d4b\u8bd5<\/h2><\/div><\/div><\/div>
<\/div><\/div>
\"transdermal<\/div><\/div>

\u5e38\u89c4\u8d28\u91cf\u63a7\u5236\u5206\u6790<\/h3><\/h1><\/div>