{"id":42722,"date":"2025-11-07T08:38:16","date_gmt":"2025-11-07T07:38:16","guid":{"rendered":"https:\/\/kymos.com\/news\/%e7%94%9f%e7%89%a9%e7%b1%bb%e4%bc%bc%e8%8d%af%e5%bc%80%e5%8f%91%ef%bc%9a%e4%bb%8e-iii-%e6%9c%9f%e4%b8%b4%e5%ba%8a%e5%88%b0%e5%88%86%e6%9e%90%e5%8f%af%e6%af%94%e6%80%a7%e5%8f%8a-pk-pd\/"},"modified":"2026-07-07T12:48:34","modified_gmt":"2026-07-07T10:48:34","slug":"%e7%94%9f%e7%89%a9%e7%b1%bb%e4%bc%bc%e8%8d%af%e5%bc%80%e5%8f%91%ef%bc%9a%e4%bb%8e-iii-%e6%9c%9f%e4%b8%b4%e5%ba%8a%e5%88%b0%e5%88%86%e6%9e%90%e5%8f%af%e6%af%94%e6%80%a7%e5%8f%8a-pk-pd","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e7%94%9f%e7%89%a9%e7%b1%bb%e4%bc%bc%e8%8d%af%e5%bc%80%e5%8f%91%ef%bc%9a%e4%bb%8e-iii-%e6%9c%9f%e4%b8%b4%e5%ba%8a%e5%88%b0%e5%88%86%e6%9e%90%e5%8f%af%e6%af%94%e6%80%a7%e5%8f%8a-pk-pd\/","title":{"rendered":"\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\uff1a\u4ece III \u671f\u4e34\u5e8a\u5230\u5206\u6790\u53ef\u6bd4\u6027\u53ca PK\/PD"},"content":{"rendered":"

\u5c3d\u7ba1\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u5f00\u53d1\u5386\u6765\u56f0\u96be\u3001\u6602\u8d35\u4e14\u8017\u65f6\uff0c\u4f46\u5b83\u4eec\u662f\u6539\u5584\u60a3\u8005\u83b7\u5f97\u6551\u547d\u751f\u7269\u7597\u6cd5\u7684\u89e3\u51b3\u65b9\u6848\u3002\u4f20\u7edf\u4e0a\uff0c\u9a8c\u8bc1\u6027 III \u671f\u6bd4\u8f83\u7597\u6548\u548c\u5b89\u5168\u6027 (CES) \u7814\u7a76\u88ab\u89c6\u4e3a\u6279\u51c6\u7684\u6807\u51c6\u8981\u6c42\uff0c\u4f46\u8fd9\u4e00\u60c5\u51b5\u6700\u8fd1\u53d1\u751f\u4e86\u53d8\u5316\u3002 <\/span><\/p>\n

2025 \u5e74\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u5747\u53d1\u5e03\u4e86\u91cd\u5927\u66f4\u65b0\uff0c\u786e\u8ba4\u5728\u5927\u591a\u6570\u60c5\u51b5\u4e0b\uff0c\u5c06\u4e0d\u518d\u9700\u8981\u9a8c\u8bc1\u6027 III \u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u53d6\u800c\u4ee3\u4e4b\u7684\u662f\uff0c\u7531\u836f\u4ee3\u52a8\u529b\u5b66 (PK) \u4ee5\u53ca\uff08\u5728\u76f8\u5173\u60c5\u51b5\u4e0b\uff09\u836f\u6548\u5b66 (PD) \u7814\u7a76\u652f\u6301\u7684\u7a33\u5065\u5206\u6790\u53ef\u6bd4\u6027\u6570\u636e\uff0c\u5c06\u6210\u4e3a\u751f\u7269\u7c7b\u4f3c\u836f\u7533\u62a5\u7684\u5fc5\u8981\u6807\u51c6\u3002 <\/span><\/p>\n

\u6838\u5fc3\u8981\u70b9 <\/strong><\/h2>\n
    \n
  • EMA \u548c FDA \u4e0d\u518d\u8981\u6c42\u5927\u591a\u6570\u751f\u7269\u7c7b\u4f3c\u836f\u8fdb\u884c\u6602\u8d35\u7684 III \u671f\u7597\u6548\u8bd5\u9a8c\u3002<\/span><\/li>\n
  • \u5206\u6790\u53ef\u6bd4\u6027\u3001PK\/PD \u7814\u7a76\u548c\u514d\u75ab\u539f\u6027\u6d4b\u8bd5\u73b0\u5728\u662f\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u7684\u6838\u5fc3<\/span><\/li>\n
  • \u5168\u7403\u76d1\u7ba1\u673a\u6784\u6b63\u8d8b\u4e8e\u4e00\u81f4\uff0c\u4ee5\u4fc3\u8fdb\u60a3\u8005\u83b7\u53d6\u836f\u7269\u5e76\u52a0\u901f\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u5f00\u53d1\u3002<\/span><\/li>\n
  • \u8fd9\u4e3a\u5f00\u53d1\u8005\u964d\u4f4e\u6210\u672c\u548c\u7f29\u77ed\u5468\u671f\u521b\u9020\u4e86\u673a\u4f1a\uff0c\u4f46\u4e5f\u5bf9\u7a33\u5065\u7684\u5206\u6790\u4ee5\u53ca\u667a\u80fd\u3001\u5feb\u901f\u7684\u5f00\u53d1\u89c4\u5212\u63d0\u51fa\u4e86\u66f4\u9ad8\u8981\u6c42\u3002<\/span><\/li>\n<\/ul>\n

    \u5728\u672c\u6587\u4e2d\uff0c\u6211\u4eec\u56de\u987e\u4e86\u8fd9\u4e9b\u76d1\u7ba1\u53d8\u5316\u5bf9\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u8005\u7684\u610f\u4e49\uff0c\u4e3a\u4ec0\u4e48\u5206\u6790\u53ef\u6bd4\u6027\u548c PK\/PD \u7814\u7a76\u73b0\u5728\u6210\u4e3a\u7126\u70b9\uff0c\u4ee5\u53ca Kymos \u96c6\u56e2\u5982\u4f55\u5e2e\u52a9\u4f01\u4e1a\u5e94\u5bf9\u8fd9\u4e00\u65b0\u7684\u5f00\u53d1\u8def\u5f84\u3002<\/span><\/p>\n

     <\/p>\n

    \u76d1\u7ba1\u53d8\u9769\uff1aEMA \u4e0e FDA \u7684\u4e00\u81f4\u6027<\/strong><\/h2>\n

    \u6839\u636e EMA \u7684\u300a\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u4e2d\u5b9a\u5236\u5316\u4e34\u5e8a\u65b9\u6cd5\u7684\u601d\u8003\u8bba\u6587\u8349\u6848\u300b<\/em>\uff0c\u901a\u8fc7\u8be6\u5c3d\u7684\u7814\u7a76\u8bc1\u660e\u7ed3\u6784\u3001\u529f\u80fd\u548c\u836f\u4ee3\u52a8\u529b\u5b66 (PK) \u7684\u9ad8\u5ea6\u76f8\u4f3c\u6027\uff0c\u53ef\u4ee5\u63a8\u65ad\u51fa\u4e34\u5e8a\u7597\u6548\u3002\u56e0\u6b64\uff0c\u7ed3\u6784\u3001\u529f\u80fd\u548c PK \u7684\u53ef\u6bd4\u6027\u6570\u636e\u662f\u751f\u7269\u7c7b\u4f3c\u836f\u6279\u51c6\u7684\u4e3b\u8981\u8981\u6c42\u3002\u4ec5\u5f53\u5316\u5408\u7269\u7684\u4f5c\u7528\u673a\u5236\u5c1a\u4e0d\u660e\u786e\uff0c\u6216\u5df2\u8bc6\u522b\u7684\u7ed3\u6784\u548c\u529f\u80fd\u5dee\u5f02\u53ef\u80fd\u5f71\u54cd\u4e34\u5e8a\u7ed3\u679c\u65f6\uff0c\u624d\u9700\u8981\u8fdb\u884c\u6bd4\u8f83\u4e34\u5e8a\u7597\u6548\u7814\u7a76 (CES)\u3002 <\/span><\/p>\n

    \u540c\u6837\uff0cFDA \u6700\u8fd1\u53d7\u7406\u4e86\u9996\u4e2a\u8c41\u514d\u5355\u514b\u9686\u6297\u4f53\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u7597\u6548\u7814\u7a76\u7684\u7533\u8bf7\u3002\u4e0e\u6b64\u540c\u65f6\uff0cFDA \u53d1\u5e03\u4e86\u300a\u6bd4\u8f83\u5206\u6790\u8bc4\u4f30\u53ca\u5176\u4ed6\u8d28\u91cf\u76f8\u5173\u8003\u8651\u56e0\u7d20\u300b<\/em>\u6307\u5357\uff0c\u5176\u4e2d\u8be6\u5c3d\u800c\u8be6\u7ec6\u5730\u63cf\u8ff0\u4e86\u8bc1\u660e\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u5176\u53c2\u7167\u4ea7\u54c1\u4e4b\u95f4\u65e0\u7f1d\u53ef\u6bd4\u6027\u7684\u5206\u6790\u8981\u6c42\u3002 <\/span><\/p>\n

    \u5728\u5b9e\u8df5\u4e2d\uff0c\u8fd9\u610f\u5473\u7740 CES \u7814\u7a76\u4e0d\u518d\u662f\u9ed8\u8ba4\u8981\u6c42\u3002\u76f8\u53cd\uff0c\u76d1\u7ba1\u673a\u6784\u73b0\u5728\u5e0c\u671b\u5f00\u53d1\u8005\u4f9d\u9760\u6765\u81ea\u5206\u6790\u6570\u636e\u3001\u529f\u80fd\u6d4b\u5b9a\u3001PK\/PD \u7814\u7a76\u548c\u514d\u75ab\u539f\u6027\u6d4b\u8bd5\u7684\u201c\u8bc1\u636e\u603b\u548c\u201d\u65b9\u6cd5\u6765\u786e\u7acb\u751f\u7269\u76f8\u4f3c\u6027\u3002\u9664 EMA \u548c FDA \u5916\uff0c\u4e16\u754c\u536b\u751f\u7ec4\u7ec7 (WHO) \u6216\u52a0\u62ff\u5927\u536b\u751f\u90e8\u7b49\u5176\u4ed6\u76d1\u7ba1\u673a\u6784\u4e5f\u5728\u4fee\u8ba2\u5176\u6307\u5357\u4ee5\u51cf\u5c11\u4e0d\u5fc5\u8981\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ece\u800c\u5efa\u7acb\u4e00\u4e2a\u534f\u8c03\u7684\u5168\u7403\u6846\u67b6\u3002 <\/span><\/p>\n

     <\/p>\n

    \u4ece III \u671f\u4e34\u5e8a\u5230\u5206\u6790\u4e0e PK\/PD
    \n<\/strong><\/h2>\n

    \u4e3a\u4f55\u91cd\u65b0\u8003\u8651 III \u671f\u7814\u7a76<\/strong><\/h3>\n

     <\/p>\n

    \u5927\u578b CES \u7814\u7a76\u5386\u6765\u8017\u8d39\u65f6\u95f4\u548c\u8d44\u6e90\uff0c\u9700\u8981\u6570\u767e\u540d\u60a3\u8005\u3001\u6602\u8d35\u7684\u53c2\u7167\u836f\u91c7\u8d2d\u4ee5\u53ca\u957f\u671f\u7684\u968f\u8bbf\u3002\u7136\u800c\uff0c\u76d1\u7ba1\u7ecf\u9a8c\u8868\u660e\uff0c\u7b26\u5408\u751f\u7269\u76f8\u4f3c\u6027\u6807\u51c6\u7684\u5019\u9009\u836f\u7269\u5728 III \u671f\u4e34\u5e8a\u4e2d\u6781\u5c11\u8868\u73b0\u51fa\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u5dee\u5f02\u3002 <\/span><\/p>\n

    \u56e0\u6b64\uff0c\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u7684\u65b0\u6807\u51c6\u7531\u4ee5\u4e0b\u90e8\u5206\u7ec4\u6210\uff1a<\/span><\/p>\n

    \u5206\u6790\u53ef\u6bd4\u6027<\/strong><\/span><\/p>\n

    \u5168\u9762\u7684\u7406\u5316\u548c\u529f\u80fd\u8868\u5f81\u662f\u57fa\u7840\u3002\u5f00\u53d1\u8005\u5fc5\u987b\uff1a <\/span><\/p>\n

      \n
    • \u8bc4\u4f30\u4e00\u7ea7\u81f3\u56db\u7ea7\u7ed3\u6784\u3001\u7ffb\u8bd1\u540e\u4fee\u9970\u4ee5\u53ca\u4ea7\u54c1\u76f8\u5173\u53d8\u4f53\u3002<\/span><\/li>\n
    • \u4f7f\u7528\u6b63\u4ea4\u7684\u3001\u6700\u5148\u8fdb\u7684\u5206\u6790\u65b9\u6cd5\u3002<\/span><\/li>\n
    • \u6d4b\u8bd5\u53c2\u7167\u4ea7\u54c1\u548c\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u591a\u4e2a\u6279\u6b21\uff0c\u4ee5\u4e86\u89e3\u53d8\u5f02\u6027\u3002<\/span><\/li>\n
    • \u5e94\u7528\u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6cd5\u6765\u8bc6\u522b\u5173\u952e\u8d28\u91cf\u5c5e\u6027 (CQA) \u5e76\u5c06\u5176\u4e0e\u4e34\u5e8a\u8868\u73b0\u8054\u7cfb\u8d77\u6765\u3002<\/span><\/li>\n<\/ul>\n

      PK \u548c PD \u7814\u7a76<\/strong><\/span><\/h3>\n

       <\/p>\n

      \u4eba\u4f53 PK \u7814\u7a76\u4ecd\u7136\u81f3\u5173\u91cd\u8981\uff0c\u901a\u5e38\u8bbe\u8ba1\u4e3a\u5355\u5242\u91cf\u4ea4\u53c9\u7814\u7a76\uff0c\u4ee5\u6bd4\u8f83\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u53c2\u7167\u4ea7\u54c1\u4e4b\u95f4\u7684\u5438\u6536\u548c\u6d88\u9664\u3002\u5982\u679c\u6709\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u66ff\u4ee3\u6807\u5fd7\u7269\uff0c\u5219\u53ef\u4ee5\u4f7f\u7528 PD \u7ec8\u70b9\u3002\u514d\u75ab\u539f\u6027\u6570\u636e\u901a\u5e38\u4e0e PK \u6570\u636e\u540c\u65f6\u6536\u96c6\u3002 <\/span><\/p>\n

      \u514d\u75ab\u539f\u6027\u8bc4\u4f30<\/strong><\/span><\/h3>\n

       <\/p>\n

      \u5fc5\u987b\u6d4b\u91cf\u7ed3\u5408\u548c\u4e2d\u548c\u6297\u836f\u7269\u6297\u4f53\uff08ADA\u3001NAb\uff09\uff0c\u4ee5\u6392\u9664\u53ef\u80fd\u5f71\u54cd\u7597\u6548\u6216\u5b89\u5168\u6027\u7684\u514d\u75ab\u53cd\u5e94\u3002\u76ee\u524d\u7684\u6307\u5357\u5efa\u8bae\u91c7\u7528\u5206\u5c42\u65b9\u6cd5\uff1a\u7b5b\u9009\u7ed3\u5408\u6297\u4f53\u3001\u9a8c\u8bc1\u6027\u6d4b\u8bd5\uff0c\u4ee5\u53ca\u5728\u9700\u8981\u65f6\u8fdb\u884c\u4e2d\u548c\u6d3b\u6027\u7684\u8868\u5f81\u3002 <\/span><\/p>\n

      \u8fd9\u4e09\u4e2a\u90e8\u5206\u5171\u540c\u63d0\u4f9b\u4e86\u8bc1\u660e\u751f\u7269\u76f8\u4f3c\u6027\u6240\u9700\u7684\u201c\u8bc1\u636e\u603b\u548c\u201d\uff0c\u65e0\u9700\u8fdb\u884c\u5927\u578b\u7597\u6548\u8bd5\u9a8c\u3002<\/span><\/p>\n

       <\/p>\n

      \u8fd9\u5bf9\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u8005\u610f\u5473\u7740\u4ec0\u4e48<\/strong><\/h2>\n

      \u8fd9\u4e00\u76d1\u7ba1\u53d8\u5316\u4e3a\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u8005\u6253\u5f00\u4e86\u65b0\u7684\u5927\u95e8\u5e76\u5e26\u6765\u4e86\u673a\u9047\uff0c\u4f46\u4e5f\u63d0\u9ad8\u4e86\u5728\u67d0\u4e9b\u9886\u57df\u7684\u671f\u671b\u3002\u4e00\u65b9\u9762\uff0c\u6446\u8131\u5f3a\u5236\u6027 III \u671f\u8bd5\u9a8c\u5c06\u52a0\u901f\u5f00\u53d1\u5e76\u6269\u5927\u751f\u7269\u7c7b\u4f3c\u836f\u5e02\u573a\u7684\u53c2\u4e0e\u5ea6\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u5b83\u5bf9\u5206\u6790\u6c34\u5e73\u63d0\u51fa\u4e86\u66f4\u9ad8\u8981\u6c42\uff0c\u9700\u8981\u66f4\u5468\u5bc6\u7684\u89c4\u5212\u4ee5\u53ca\u4e0e\u76d1\u7ba1\u673a\u6784\u7684\u7d27\u5bc6\u914d\u5408\u3002 <\/span><\/p>\n

      \u673a\u9047<\/strong><\/h3>\n
        \n
      • \u66f4\u4f4e\u7684\u6210\u672c\u548c\u66f4\u5feb\u7684\u5468\u671f\uff1a<\/strong> \u53d6\u6d88 III \u671f\u7814\u7a76\u53ef\u7f29\u77ed\u6570\u5e74\u7684\u5f00\u53d1\u65f6\u95f4\u3002<\/span><\/li>\n
      • \u66f4\u5927\u7684\u5e02\u573a\u53c2\u4e0e\u5ea6\uff1a<\/strong> \u4e2d\u5c0f\u578b\u751f\u7269\u5236\u836f\u516c\u53f8\u73b0\u5728\u53ef\u4ee5\u5728\u751f\u7269\u7c7b\u4f3c\u836f\u9886\u57df\u8fdb\u884c\u7ade\u4e89\u3002<\/span><\/li>\n
      • \u76d1\u7ba1\u660e\u786e\u6027\uff1a<\/strong> \u5168\u7403\u6307\u5357\u7684\u534f\u8c03\u4e00\u81f4\u4f7f\u5f00\u53d1\u8def\u5f84\u66f4\u5177\u53ef\u9884\u6d4b\u6027\u3002<\/span><\/li>\n
      • \u73b0\u5b9e\u6848\u4f8b\uff1a<\/strong> \u6700\u8fd1\u5df2\u6709\u51e0\u79cd\u751f\u7269\u7c7b\u4f3c\u836f\u5728\u6ca1\u6709 III \u671f\u8bd5\u9a8c\u7684\u60c5\u51b5\u4e0b\u83b7\u5f97\u6279\u51c6\uff0c\u8fd9\u8868\u660e\u7cbe\u7b80\u8def\u5f84\u4e0d\u4ec5\u662f\u7406\u8bba\u4e0a\u7684\uff0c\u800c\u4e14\u5df2\u88ab\u76d1\u7ba1\u673a\u6784\u4ed8\u8bf8\u5b9e\u65bd\u3002<\/span><\/li>\n<\/ul>\n

        \u65b0\u8981\u6c42<\/strong><\/h3>\n
          \n
        • \u66f4\u9ad8\u7684\u5206\u6790\u6807\u51c6\uff1a<\/strong> \u7075\u654f\u7684\u6b63\u4ea4\u65b9\u6cd5\u548c\u5168\u9762\u7684\u98ce\u9669\u8bc4\u4f30\u662f\u5f3a\u5236\u6027\u7684\u3002<\/span><\/li>\n
        • \u65e9\u671f\u89c4\u5212\uff1a<\/strong> \u5efa\u8bae\u5728\u5f00\u59cb\u5173\u952e\u6027\u7814\u7a76\u4e4b\u524d\u8fbe\u6210\u9884\u5148\u5546\u5b9a\u7684\u76f8\u4f3c\u6027\u8bc4\u4f30\u65b9\u6848\u3002<\/span><\/li>\n
        • \u7a33\u5065\u7684\u751f\u4ea7\u63a7\u5236\uff1a<\/strong> \u5546\u4e1a\u6279\u6b21\u7684\u4e00\u81f4\u6027\u5bf9\u4e8e\u652f\u6301\u76f8\u4f3c\u6027\u58f0\u660e\u81f3\u5173\u91cd\u8981\u3002<\/span><\/li>\n
        • \u76d1\u7ba1\u6c9f\u901a\uff1a<\/strong> \u5efa\u8bae\u5c3d\u65e9\u4e0e EMA \u6216 FDA \u8fdb\u884c\u79d1\u5b66\u54a8\u8be2\u4f1a\u8bae\uff0c\u4ee5\u5c31\u7814\u7a76\u8bbe\u8ba1\u8fbe\u6210\u4e00\u81f4\u5e76\u907f\u514d\u610f\u5916\u60c5\u51b5\u3002<\/span><\/span> <\/li>\n<\/ul>\n

          \u4f55\u65f6\u4ecd\u53ef\u80fd\u9700\u8981 III \u671f\u4e34\u5e8a<\/strong><\/h2>\n

          \u867d\u7136\u73b0\u5728\u7684\u9ed8\u8ba4\u9884\u671f\u662f\u201c\u65e0\u9700 CES\u201d\uff0c\u4f46\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\u4ecd\u53ef\u80fd\u8981\u6c42\u8fdb\u884c\u4e34\u5e8a\u7597\u6548\u8bd5\u9a8c\u3002\u5bf9\u4e8e\u4f5c\u7528\u673a\u5236\u4e0d\u660e\u786e\u6216\u590d\u6742\u7684\u836f\u7269\uff0c\u6216\u8005\u5728\u5206\u6790\u6570\u636e\u548c\u529f\u80fd\u6d4b\u5b9a\u4e0d\u8db3\u4ee5\u9884\u6d4b\u4e34\u5e8a\u8868\u73b0\u7684\u60c5\u51b5\u4e0b\uff0c\u53ef\u80fd\u4ecd\u9700\u8981 III \u671f\u7814\u7a76\u3002\u540c\u6837\uff0cPK \u7814\u7a76\u671f\u95f4\u51fa\u73b0\u7684\u610f\u5916\u514d\u75ab\u539f\u6027\u4fe1\u53f7\u4e5f\u53ef\u80fd\u9700\u8981\u989d\u5916\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u6570\u636e\u3002 <\/span><\/p>\n

           <\/p>\n

          Kymos \u96c6\u56e2\u5982\u4f55\u63d0\u4f9b\u5e2e\u52a9<\/strong><\/h2>\n

          Kymos \u96c6\u56e2\u63d0\u4f9b\u5168\u65b9\u4f4d\u7684\u670d\u52a1\uff0c\u652f\u6301\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u8005\u5e94\u5bf9\u8fd9\u4e00\u65b0\u7684\u76d1\u7ba1\u5f62\u52bf\uff1a<\/span><\/p>\n

            \n
          • \u5206\u6790\u53ef\u6bd4\u6027\uff1a<\/strong> \u5168\u9762\u7684 CMC \u8868\u5f81\uff0c\u5305\u62ec GMP \u6761\u4ef6\u4e0b\u7684\u7406\u5316\u3001\u529f\u80fd\u548c\u6548\u529b\u6d4b\u5b9a\u3002\u4e86\u89e3\u66f4\u591a\u5173\u4e8e\u6211\u4eec CMC \u5206\u6790\u670d\u52a1\u7684\u4fe1\u606f <\/span><\/li>\n
          • \u751f\u7269\u5206\u6790\u4e0e PK \u7814\u7a76\uff1a<\/strong> \u7531\u6211\u4eec\u4f4d\u4e8e\u897f\u73ed\u7259\u548c\u5fb7\u56fd\u7684\u5b9e\u9a8c\u5ba4\u63d0\u4f9b\u7b26\u5408 GLP \u6807\u51c6\u7684 PK \u548c\u514d\u75ab\u539f\u6027\u6d4b\u8bd5\uff08ADA\u3001NAb\uff09\u3002\u63a2\u7d22\u6211\u4eec\u7684\u514d\u75ab\u539f\u6027\u6d4b\u8bd5\u80fd\u529b <\/span><\/li>\n
          • \u96c6\u6210\u89e3\u51b3\u65b9\u6848\uff1a<\/strong> \u4e0e\u4e13\u4e1a\u4e34\u5e8a\u5355\u4f4d\u7684\u5408\u4f5c\u4f7f\u6211\u4eec\u80fd\u591f\u63d0\u4f9b\u5b8c\u6574\u7684 PK\/PD \u7814\u7a76\uff0c\u5c06\u4e34\u5e8a\u6267\u884c\u4e0e\u5185\u90e8\u751f\u7269\u5206\u6790\u76f8\u7ed3\u5408\u3002<\/span><\/li>\n
          • \u76d1\u7ba1\u4e13\u4e1a\u77e5\u8bc6\uff1a<\/strong> \u6211\u4eec\u7684\u56e2\u961f\u8bbe\u8ba1\u7b26\u5408 EMA\u3001FDA \u548c ICH \u6307\u5357\u7684\u9002\u7528\u6027\u7814\u7a76\uff0c\u786e\u4fdd\u60a8\u7684\u7ed3\u679c\u7b26\u5408\u7533\u62a5\u8981\u6c42\u3002<\/span><\/span> <\/li>\n<\/ul>\n

            \u7ed3\u8bba<\/strong><\/h2>\n

            \u8fd1\u5e74\u6765\u751f\u7269\u7c7b\u4f3c\u836f\u5e02\u573a\u53d1\u5c55\u8fc5\u901f\uff0c\u8fd9\u4e00\u53d8\u5316\u6807\u5fd7\u7740\u5176\u5f00\u53d1\u6a21\u5f0f\u7684\u8303\u5f0f\u8f6c\u79fb\u3002\u901a\u8fc7\u964d\u4f4e\u5927\u578b III \u671f\u8bd5\u9a8c\u7684\u91cd\u8981\u6027\uff0c\u76d1\u7ba1\u673a\u6784\u6b63\u5728\u5f3a\u8c03\u4e00\u79cd\u4ee5\u79d1\u5b66\u4e3a\u9a71\u52a8\u3001\u4ee5\u6548\u7387\u4e3a\u4e2d\u5fc3\u7684\u65b9\u6cd5\uff0c\u91cd\u70b9\u5173\u6ce8\u7a33\u5065\u7684\u5206\u6790\u548c\u667a\u80fd\u7684\u5f00\u53d1\u89c4\u5212\u3002 <\/span><\/p>\n

            \u8fd9\u4e00\u65b0\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u73af\u5883\u4e3a\u5f00\u53d1\u8005\u5e26\u6765\u4e86\u673a\u9047\uff0c\u4e5f\u51f8\u663e\u4e86\u4f9d\u9760 Kymos \u7b49\u503c\u5f97\u4fe1\u8d56\u7684\u5206\u6790\u5408\u4f5c\u4f19\u4f34\u7684\u91cd\u8981\u6027\u3002\u6211\u4eec\u7684\u6b27\u6d32\u5b9e\u9a8c\u5ba4\u63d0\u4f9b\u7aef\u5230\u7aef\u7684\u5206\u6790\u53ef\u6bd4\u6027\u3001\u751f\u7269\u5206\u6790\u548c PK\/PD \u80fd\u529b\uff0c\u6ee1\u8db3\u6240\u9700\u6807\u51c6\u3002 <\/span><\/p>\n

            \u8fd9\u4e9b\u4f18\u52bf\u5171\u540c\u4f7f\u6211\u4eec\u80fd\u591f\u5e2e\u52a9\u90a3\u4e9b\u9700\u8981\u6ee1\u8db3\u65b0\u671f\u671b\u3001\u7f29\u77ed\u4e0a\u5e02\u65f6\u95f4\u5e76\u4fdd\u6301\u76d1\u7ba1\u5408\u89c4\u6027\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\u8005\u3002<\/span><\/p>\n

            \u8bf7\u7acb\u5373\u8054\u7cfb\u6211\u4eec\uff0c\u8ba8\u8bba\u6211\u4eec\u5982\u4f55\u652f\u6301\u60a8\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u9879\u76ee\uff0c\u5e76\u5e2e\u52a9\u60a8\u5229\u7528\u6700\u65b0\u7684\u76d1\u7ba1\u66f4\u65b0\u3002<\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":8,"featured_media":42723,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[381,383],"tags":[67],"class_list":["post-42722","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc","category-383","tag-carles"],"acf":[],"yoast_head":"\n\u751f\u7269\u7c7b\u4f3c\u836f\u5f00\u53d1\uff1a\u4ece III \u671f\u4e34\u5e8a\u5230\u53ef\u6bd4\u6027\u7814\u7a76<\/title>\n<meta name=\"description\" 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content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Sandra Magdaleno\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@KymosGroup\" \/>\n<meta name=\"twitter:site\" content=\"@KymosGroup\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sandra Magdaleno\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u5206\" \/>\n<script type=\"application\/ld+json\" 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