{"id":41848,"date":"2018-08-09T01:00:00","date_gmt":"2018-09-17T06:56:17","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e6%b5%85%e8%b0%88%ef%bc%9aqbd%e5%9c%a8%e8%8d%af%e7%89%a9%e5%bc%80%e5%8f%91%e4%b8%ad%e7%9a%84%e5%ba%94%e7%94%a8-%e5%9f%b9%e4%bc%98%e7%b2%be%e9%80%89%e7%a0%94%e5%8f%91%e6%8a%80\/"},"modified":"2018-09-17T14:56:23","modified_gmt":"2018-09-17T06:56:23","slug":"%e6%b5%85%e8%b0%88%ef%bc%9aqbd%e5%9c%a8%e8%8d%af%e7%89%a9%e5%bc%80%e5%8f%91%e4%b8%ad%e7%9a%84%e5%ba%94%e7%94%a8-%e5%9f%b9%e4%bc%98%e7%b2%be%e9%80%89%e7%a0%94%e5%8f%91%e6%8a%80","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/41848\/","title":{"rendered":"\u6d45\u8c08\uff1aQbD\u5728\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u7814\u53d1\u6280\u672f\u7cfb\u521715"},"content":{"rendered":"
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\"\u6d45\u8c08\uff1aQbD\u5728\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u7814\u53d1\u6280\u672f\u7cfb\u521715\"<\/p>\n

\u56fe2  FDA\u201c\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u201d\u6a21\u578b<\/span><\/p>\n

<\/span><\/p>\n

\n
\n
\n
\n
\n

ICH~QbD~Q8&Q9&Q10&Q11<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u4e0a\u9762\u8bf4\u5230\uff0c\u5728FDA\u63d0\u51faQbD\u540e\uff0cICH\u8fc5\u901f\u5c06\u5176\u7eb3\u5165\u5230\u81ea\u5df1\u7684\u8d28\u91cf\u4f53\u7cfb\u5f53\u4e2d\u3002ICH\u5bf9QbD\u7684\u5b9a\u4e49\u4e3a\uff0c<\/span>\u201c\u4ee5\u53ef\u9760\u7684\u79d1\u5b66\u77e5\u8bc6\u4f5c\u4e3a\u57fa\u77f3\uff0c\u5bf9\u836f\u54c1\u8d28\u91cf\u7684\u98ce\u9669\u8fdb\u884c\u79d1\u5b66\u5408\u7406\u7684\u8bc4\u4f30\u548c\u63a7\u5236\uff0c\u5e76\u5f3a\u8c03\u5bf9\u4ea7\u54c1\u4e0e\u5de5\u827a\u7684\u6df1\u523b\u7406\u89e3\uff0c\u6700\u7ec8\u8fbe\u5230\u7406\u60f3\u7684\u8d28\u91cf\u76ee\u6807\uff0c\u8fd9\u662f\u4e00\u4e2a\u7cfb\u7edf\u7684\u7814\u53d1\u65b9\u6cd5\u201d\u3002<\/em><\/span><\/p>\n


<\/span><\/p>\n

2005\u5e74\uff0cICH\u53d1\u5e03\u76f8\u5173\u6307\u5357~\u5173\u4e8e\u836f\u7269\u5f00\u53d1\u7684Q8\u548c\u5173\u4e8e\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7684Q9\u3002\u5728Q8\u91cc\u7ed3\u5408\u8bd5\u9a8c\u8bbe\u8ba1(Designof Experiments\uff0cDoE)\u4ecb\u7ecd\u4e86\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1QbD\u548c\u8bbe\u8ba1\u7a7a\u95f4(Design Space\uff0cDS)\u7684\u6982\u5ff5\uff1bQ9\u4ecb\u7ecd\u4e86\u8d28\u91cf\u98ce\u9669\u63a7\u5236\u7684\u539f\u5219\u548c\u5728\u836f\u7269\u5f00\u53d1\u548c\u751f\u4ea7\u4e2d\u7684\u5e94\u7528\u5b9e\u4f8b\u30022008\u5e74\uff0cICH\u53d1\u5e03\u4e86\u5173\u4e8e\u5236\u836f\u8d28\u91cf\u4f53\u7cfb\u7684Q10\uff0c\u7cfb\u7edf\u5730\u4ecb\u7ecd\u4e86\u4ea7\u54c1\u751f\u547d\u5468\u671f\u8d28\u91cf\u76ee\u6807\u7684\u8bbe\u5b9a\u548c\u8fbe\u6210\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u266a\u266a\u266a~ ICH Q8<\/span><\/strong><\/span><\/p>\n

\u5305\u62ec\u4e24\u5927\u90e8\u5206\uff1a\u836f\u7269\u7814\u53d1(\u7b2c1\u90e8\u5206)\u53ca\u5176\u8865\u5145\u5185\u5bb9(\u7b2c2\u90e8\u5206)\uff0c\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u5728\u836f\u54c1\u53ca\u5176\u751f\u4ea7\u5de5\u827a\u7684\u7814\u53d1\u8fc7\u7a0b\u4e2d\u5982\u4f55\u5e94\u7528<\/span>\u79d1\u5b66\u7b56\u7565\u548c\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7b56\u7565<\/span>\u83b7\u53d6\u5bf9\u4ea7\u54c1\u548c\u751f\u4ea7\u5de5\u827a\u7684\u5168\u9762\u7406\u89e3\uff0c\u4ece\u800c\u4e3a<\/span>\u8bbe\u8ba1\u7a7a\u95f4\u3001\u8d28\u91cf\u6807\u51c6\u548c\u751f\u4ea7\u63a7\u5236<\/span>\u7b56\u7565\u7684\u5236\u8ba2\u63d0\u4f9b\u79d1\u5b66\u4f9d\u636e\uff0c\u5e76\u4e3a\u836f\u54c1\u8d28\u91cf\u7684\u98ce\u9669\u7ba1\u7406\u63d0\u4f9b\u575a\u5b9e\u57fa\u7840\u3002\u5176\u6838\u5fc3\u5185\u5bb9\u5373\u4e3aQbD\u3002\u5176\u4e2d\uff0cICH Q8\u7b2c1\u90e8\u5206\u5bf9\u4e8e\u53ef\u80fd\u5f71\u54cd\u836f\u54c1\u8d28\u91cf\u7684\u5404\u56e0\u7d20\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u9700\u8981\u8003\u5bdf\u7684\u5185\u5bb9\u8fdb\u884c\u4e86\u8be6\u7ec6\u6307\u5bfc\uff0c\u89c1\u4e0b\u8868\u3002<\/span><\/p>\n

\"\u6d45\u8c08\uff1aQbD\u5728\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u7814\u53d1\u6280\u672f\u7cfb\u521715\"<\/p>\n

\u266a\u266a\u266a~ ICH Q9<\/span><\/strong><\/span><\/p>\n

ICHQ9\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u662fQbD\u7cfb\u7edf\u7684\u6838\u5fc3\u7b56\u7565\u4e4b\u4e00\uff0c\u6709\u6548\u7684\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u91c7\u7528\u4e3b\u52a8\u7b56\u7565\u8bc6\u522b\u836f\u7269\u7814\u53d1\u548c\u751f\u4ea7\u9636\u6bb5\u7684\u6f5c\u5728\u8d28\u91cf\u95ee\u9898\u5e76\u52a0\u4ee5\u63a7\u5236\uff0c\u80fd\u591f\u66f4\u9ad8\u7a0b\u5ea6\u5730\u4fdd\u969c\u836f\u54c1\u7684\u9ad8\u8d28\u91cf\uff0c\u800c\u4e14\u8fd8\u6709\u52a9\u4e8e\u7ba1\u7406\u5f53\u5c40\u548c\u7533\u62a5\u4f01\u4e1a\u5747\u80fd\u66f4\u52a0\u79d1\u5b66\u3001\u6709\u6548\u5730\u8fdb\u884c\u98ce\u9669\u51b3\u7b56\u3002ICH Q9\u91cd\u70b9\u4ecb\u7ecd\u4e86\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7684\u539f\u5219\u548c\u5e38\u7528\u5206\u6790\u5de5\u5177\u3002\u5176\u4e2d\uff0c\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7684\u4e24\u4e2a\u91cd\u8981\u539f\u5219\u4e3a\uff1a\u4e00\u3001\u98ce\u9669\u8bc4\u4f30\u5e94\u8be5\u57fa\u4e8e\u79d1\u5b66\u5e76\u7528\u4e8e\u6700\u7ec8\u4fdd\u62a4\u60a3\u8005\u5229\u76ca\uff1b\u4e8c\u3001\u98ce\u9669\u7ba1\u7406\u7684\u6295\u5165\u5e94\u8be5\u4e0e\u98ce\u9669\u7b49\u7ea7\u5bf9\u5e94\uff0c\u98ce\u9669\u7b49\u7ea7\u8d8a\u9ad8\uff0c\u7ba1\u7406\u6295\u5165\u5e94\u8d8a\u5927\u3002\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u5e38\u89c4\u6b65\u9aa4\uff0c\u89c1\u4e0b\u8868\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u6d45\u8c08\uff1aQbD\u5728\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u7814\u53d1\u6280\u672f\u7cfb\u521715\"<\/p>\n

 <\/span>\u266a\u266a\u266a~ ICH Q10<\/span><\/strong><\/p>\n

\u836f\u54c1\u8d28\u91cf\u7cfb\u7edf (pharmaceutical quality system) ICH Q10\u8be6\u7ec6\u9610\u8ff0\u4e86\u5982\u4f55\u91c7\u7528QbD\u7684\u7406\u5ff5\u3001\u5e94\u7528\u79d1\u5b66\u7ba1\u7406\u548c\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u8fd9\u4e24\u5927\u6838\u5fc3\u5de5\u5177\u5efa\u7acb\u6709\u6548\u7684\u836f\u54c1\u8d28\u91cf\u7cfb\u7edf\u3002\u5176\u4e2d\uff0c\u79d1\u5b66\u7ba1\u7406\u4f9d\u636e\u5df2\u77e5\u7684\u79d1\u5b66\u77e5\u8bc6\u548c\u5728\u8be5\u836f\u54c1\u751f\u547d\u5468\u671f\u5185(\u836f\u7269\u7814\u53d1\u3001\u6280\u672f\u8f6c\u79fb\u3001\u5546\u4e1a\u5316\u751f\u4ea7\u548c\u4ea7\u54c1\u505c\u4ea7)\u83b7\u5f97\u7684\u5bf9\u4ea7\u54c1\u53ca\u5176\u5de5\u827a\u7684\u5168\u9762\u7406\u89e3\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u836f\u54c1\u8d28\u91cf\u7cfb\u7edf\u7684\u76ee\u6807\uff1a\u83b7\u5f97\u7b26\u5408\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\u8981\u6c42\u7684\u4ea7\u54c1\u3001\u5efa\u7acb\u5e76\u7ef4\u6301\u4ea7\u54c1\u7684\u53d7\u63a7\u72b6\u6001\u4ee5\u53ca\u4fc3\u8fdb\u4ea7\u54c1\u8d28\u91cf\u7684\u6301\u7eed\u6539\u8fdb\u3002\u836f\u54c1\u8d28\u91cf\u7cfb\u7edf\u7684\u8981\u7d20\u5305\u62ec\uff1a\u5de5\u827a\u6027\u80fd\u548c\u4ea7\u54c1\u8d28\u91cf\u7684\u76d1\u63a7\u7cfb\u7edf\u3001\u6821\u6b63\u548c\u9884\u9632\u63aa\u65bd\u7cfb\u7edf\u3001\u53d8\u66f4\u7ba1\u7406\u7cfb\u7edf\u4ee5\u53ca\u5de5\u827a\u6027\u80fd\u548c\u4ea7\u54c1\u8d28\u91cf\u7684\u7ba1\u7406\u56de\u987e\u3002\u5728\u4ea7\u54c1\u5468\u671f\u7684\u5404\u9636\u6bb5(\u836f\u7269\u7814\u53d1\u3001\u6280\u672f\u8f6c\u79fb\u3001\u5546\u4e1a\u5316\u751f\u4ea7\u548c\u4ea7\u54c1\u505c\u4ea7)\u5747\u9700\u8981\u8d2f\u5f7b\u5b9e\u65bd\u8fd94\u5927\u8981\u7d20\uff0c\u89c1\u4e0b\u8868\u3002<\/span><\/p>\n

\"\u6d45\u8c08\uff1aQbD\u5728\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u7814\u53d1\u6280\u672f\u7cfb\u521715\"<\/p>\n

\u266a\u266a\u266a~ ICH Q11<\/span><\/strong><\/span><\/p>\n

ICHQ11\u91cd\u70b9\u5173\u6ce8\u4e86\u539f\u6599\u836f\u7684\u5f00\u53d1\u548c\u5236\u9020\uff0c\u5236\u836f\u516c\u53f8\u5728\u5f00\u53d1\u539f\u6599\u836f\u8fc7\u7a0b\u4e2d\u53ef\u4ee5\u6309\u7167\u201c\u4f20\u7edf\u201d\u6216\u201c\u5f3a\u5316\u201d\u7684\u65b9\u6cd5\u6216\u8054\u5408\u4e24\u79cd\u65b9\u6cd5\u8fdb\u884c\u3002\u5728\u4f20\u7edf\u7684\u65b9\u6cd5\u4e2d\uff0c\u5bf9\u5de5\u827a\u53c2\u6570\u8bbe\u5b9a\u6570\u636e\u6216\u8005\u8303\u56f4\uff0c\u539f\u6599\u836f\u7684\u63a7\u5236\u7b56\u7565\u901a\u5e38\u662f\u57fa\u4e8e\u8fc7\u7a0b\u7684\u91cd\u590d\u6027\u548c\u6d4b\u8bd5\uff0c\u53ef\u4ee5\u6ee1\u8db3\u65e2\u5b9a\u7684\u9a8c\u6536\u6807\u51c6\u3002\u800c\u5f3a\u5316\u65b9\u6cd5\u66f4\u52a0\u5e7f\u6cdb\u5730\u4f7f\u7528\u98ce\u9669\u7ba1\u7406\u4ee5\u53ca\u79d1\u5b66\u77e5\u8bc6\u6765\u8bc6\u522b\u548c\u7406\u89e3\u5f71\u54cd\u5173\u952e\u8d28\u91cf\u5c5e\u6027(CQA)\u7684\u5de5\u827a\u53c2\u6570\u548c\u5355\u5143\u64cd\u4f5c\uff0c\u5e76\u5728\u539f\u6599\u836f\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u5e94\u7528\u6070\u5f53\u7684\u63a7\u5236\u7b56\u7565\uff0c\u5176\u4e2d\u4e5f\u5305\u62ec\u5efa\u7acb\u8bbe\u8ba1\u7a7a\u95f4(\u8be6\u60c5\u89c1\u4e0b\u8868)\u3002\u6839\u636e ICH Q11\uff0c\u5236\u9020\u5de5\u827a\u7684\u5f00\u53d1\u81f3\u5c11\u5e94\u5305\u62ec\uff1a\u8bc6\u522b\u4e0e\u539f\u6599\u836f\u76f8\u5173\u7684\u6f5c\u5728CQA\uff1b\u4f7f\u5f71\u54cd\u836f\u54c1\u8d28\u91cf\u7684\u8fd9\u4e9b\u7279\u70b9\u53ef\u4ee5\u7814\u7a76\u548c\u63a7\u5236\uff1b\u5b9a\u4e49\u4e00\u4e2a\u9002\u5f53\u7684\u5236\u9020\u8fc7\u7a0b\uff1b\u5b9a\u4e49\u63a7\u5236\u7b56\u7565\uff0c\u4ee5\u786e\u4fdd\u5de5\u827a\u8fc7\u7a0b\u548c\u539f\u6599\u836f\u8d28\u91cf\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u6d45\u8c08\uff1aQbD\u5728\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u7814\u53d1\u6280\u672f\u7cfb\u521715\"<\/p>\n

\n
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\n
\n
\n

\u5168\u7403\u5bf9Qbd\u7684\u7814\u7a76\u72b6\u6001<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u622a\u81f3\u53d1\u7a3f\uff0c\u7b14\u8005\u901a\u8fc7\u67e5\u8be2\u201csciencedirect\u201d\u7f51\u7ad9\uff0c\u5173\u952e\u8bcd\u8f93\u5165\u201cFDA QbD\u201d\u53d1\u73b0\uff0c2008\u5e74\u4e4b\u524d(\u5305\u542b2008)\uff0c\u6587\u732e\u91cf\u6781\u5c11\uff0c\u81ea2009\u5e74\u4e4b\u540e\uff0c\u6587\u732e\u91cf\u5f00\u59cb\u589e\u591a\uff0c\u5176\u4e2d\uff0c2011\u5e74\u4e4b\u540e\u660e\u663e\u589e\u591a\uff1b\u800c\u6587\u732e\u7c7b\u578b\u65b9\u9762\uff0c\u7efc\u8ff0\u3001\u7814\u7a76\u3001\u4e66\u7c4d\u7ae0\u8282\u76f8\u5bf9\u8f83\u591a\uff1b\u5173\u952e\u8bcd\u8f93\u5165\u201cICH QbD\u201d\uff0c\u8d8b\u52bf\u540c\u4e0a(\u8be6\u60c5\u89c1\u4e0b\u56fe)\uff1b\u800c\u5173\u952e\u8bcd\u8f93\u5165\u201cquality by design\u201d\u8fdb\u884c\u641c\u7d22\uff0c\u6587\u9650\u91cf\u5219\u76f8\u5bf9\u8f83\u4e3a\u5de8\u5927\uff0c2000\u5e74\u4e4b\u524d\u4fbf\u6709\u6570\u5341\u4e07\u6761\u76f8\u5173\u6587\u732e\uff0c\u8fd9\u5219\u8bf4\u660e\u4e24\u4e2a\u95ee\u9898\uff0c\u4e00\u4e2a\u662fQbD\u5728\u5168\u7403\u5404\u884c\u5404\u4e1a\u7684\u7814\u7a76\u4f7f\u7528\uff0c\u90fd\u662f\u5f88\u591a\u7684\uff0c\u53e6\u4e00\u4e2a\u5219\u8bf4\u660e\uff0c\u836f\u54c1\u884c\u4e1a\u5728\u5f15\u5165QbD\u7406\u8bba\u65b9\u9762\uff0c\u8fd8\u662f\u6709\u4e9b\u8fdf\u6ede\u4e86\u3002<\/span><\/p>\n

<\/span><\/p>\n

\"\u6d45\u8c08\uff1aQbD\u5728\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u5e94\u7528\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u7814\u53d1\u6280\u672f\u7cfb\u521715\"<\/p>\n

\n
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\n
\n
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FDA\u5173\u4e8eQbD\u7684CMC\u8bd5\u70b9\u8ba1\u5212<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u9996\u5148\uff0cFDA\u8ba4\u4e3a\uff0c\u867d\u7136QbD\u539f\u7406\u63d0\u51fa\u65f6\u95f4\u4e0d\u957f\uff0c\u4f46\u5b9e\u9645\u836f\u54c1\u7814\u53d1\u4f01\u4e1a\u5728\u836f\u54c1\u8d28\u91cf\u63a7\u5236\u8fc7\u7a0b\u4e2d\uff0c\u5df2\u8fdb\u884c\u4e86\u5f88\u591aQbD\u7684\u5b9e\u8df5\uff0c\u53ea\u662f\u672a\u66fe\u4e0a\u5347\u5230\u7406\u8bba\u7684\u9ad8\u5ea6\u30022005\u5e747\u6708\uff0cFDA\u7ec4\u7ec7\u4e86\u4e00\u9879CMC\u8bd5\u70b9\u8ba1\u5212(ChemicalManufacture and Control Pilot Program)\uff0c\u62db\u52df\u4e869\u4e2a\u4f01\u4e1a\u768411\u4e2a\u9879\u76ee\u8fdb\u884cQbD\u6ce8\u518c\u7533\u62a5\u8bd5\u70b9\uff0c\u5e0c\u671b\u63d0\u4f9b\u4e00\u5b9a\u7684\u673a\u4f1a\u4f7f\u5f97\u57fa\u4e8eQbD\u539f\u7406\u5f62\u6210\u7684\u8d28\u91cf\u63a7\u5236\u4fe1\u606f\u53ef\u5728\u6ce8\u518c\u7533\u62a5\u65f6\u63d0\u4ea4\uff0c\u540c\u65f6\u4e5f\u589e\u52a0FDA\u5bf9\u8be5\u4f53\u7cfb\u7684\u5b9e\u8df5\u8ba4\u8bc6\u3002<\/span><\/p>\n

\u5728\u8fd9\u4e00\u8fc7\u7a0b\u4e2d\uff0c\u201c\u5b87\u5b99\u5927\u836f\u5382\u201d\u8f89\u745e\u8868\u73b0\u7a81\u51fa\uff0c\u5176\u5728\u4f10\u5c3c\u514b\u5170\u5236\u5242(varenicline tablets)\u548c\u9a6c\u62c9\u97e6\u7f57\u5236\u5242(maraviroc tablets)\u7684\u65b0\u836f\u7533\u8bf7\u4e2d\u53c2\u4e0e\u4e86FDA\u7684CMC\u8bd5\u70b9\u8ba1\u5212\uff0c\u4e14\u5bf9\u4f10\u5c3c\u514b\u5170\u7684\u751f\u4ea7\u8fc7\u7a0b\u8fdb\u884c\u53d8\u66f4\uff0c\u4ece\u800c\u5b9e\u73b0\u4e86\u4e0a\u5e02\u540e\u76d1\u7ba1\u7684\u7075\u6d3b\u6027\uff0c\u8fd9\u4e00\u8ba1\u5212\u5728\u5f53\u65f6\u9884\u671f\u4e3a\u8f89\u745e\u8282\u77012\u4ebf\u7f8e\u5143\uff0c\u800c\u4f10\u5c3c\u514b\u5170\u5236\u5242\u548c\u9a6c\u62c9\u97e6\u7f57\u5236\u5242\u65b0\u836f\u7533\u8bf7\u6587\u4ef6\u4e2d\u6240\u63cf\u8ff0\u7684\u65b0\u7684QbD\u8303\u4f8b\uff0c\u4e0d\u4ec5\u589e\u52a0\u4e86\u79d1\u5b66\u7ec6\u8282\u548c\u5bf9\u751f\u4ea7\u8fc7\u7a0b\u7684\u7406\u89e3\uff0c\u4e5f\u63a8\u8fdb\u4e86\u7f8e\u56fd\u3001\u6b27\u6d32\u548c\u65e5\u6728\u7684\u76d1\u7ba1\u5ba1\u8bc4\u548c\u6279\u51c6\u3002<\/span><\/p>\n


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\u901a\u8fc7\u591a\u5e74\u5b9e\u8df5\u7ecf\u9a8c\u603b\u7ed3\uff0c\u5927\u90e8\u5206\u4f01\u4e1a\u90fd\u8ba4\u4e3aQbD\u7684\u5b9e\u65bd\uff0c\u4f7f\u5f97\u836f\u54c1\u751f\u547d\u5468\u671f\u7684\u6d41\u7a0b\u66f4\u52a0\u89c4\u8303\u5316\uff0c\u53ef\u4ee5\u5feb\u901f\u6709\u6548\u5730\u964d\u4f4e\u836f\u54c1\u751f\u547d\u5468\u671f\u7684\u7efc\u5408\u6210\u672c\uff0c\u52a0\u5feb\u836f\u54c1\u7684\u4e0a\u5e02\u8fdb\u7a0b\u3002\u4e14\u8981\u8fdb\u4e00\u6b65\u5f3a\u8c03\u7684\u662f\uff0cQbD\u7684\u7406\u60f3\u72b6\u6001\u662f\u4e00\u4e2a\u4e09\u8d62\u7ed3\u679c\uff1a\u5373\u5bf9\u751f\u4ea7\u8005\u6765\u8bf4\uff0c\u53ef\u4ee5\u51cf\u5c11\u76d1\u7ba1\u538b\u529b\u548c\u964d\u4f4e\u751f\u4ea7\u6210\u672c\uff1b\u5bf9\u76d1\u7ba1\u8005\u6765\u8bf4\uff0c\u53ef\u4ee5\u5728\u4e0d\u727a\u7272\u8d28\u91cf\u7684\u524d\u63d0\u4e0b\u51cf\u5c0f\u76d1\u7ba1\u538b\u529b\uff1b\u5bf9\u75c5\u4eba\u6765\u8bf4\uff0c\u53ef\u4ee5\u83b7\u5f97\u6709\u6548\u7684\u836f\u7269\uff0c\u4ea7\u54c1\u8d28\u91cf\u6709\u66f4\u597d\u7684\u4fdd\u8bc1\u3002<\/span><\/p>\n

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\u836f\u4f01\u5bf9QbD\u7684\u53cd\u5e94\u6001\u5ea6<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u9996\u5148\uff0c\u5ba2\u89c2\u5b58\u5728\u7684\u95ee\u9898\u662f\u201c\u901a\u5e38\u4e00\u4e2a\u65b0\u836f\u7684\u4e13\u5229\u4fdd\u62a4\u671f\u670910\u591a\u5e74\uff0c\u5728\u8fd9\u671f\u95f4\uff0c\u5c3d\u7ba1\u79d1\u5b66\u6280\u672f\u6709\u5f88\u5927\u7a81\u7834\uff0c\u4f46\u5236\u836f\u4f01\u4e1a\u51e0\u4e4e\u90fd\u4e0d\u613f\u610f\u6539\u8fdb\u5de5\u827a\u548c\u7ba1\u7406\u89c4\u7a0b\uff0c\u56e0\u4e3a\u8fd9\u4e9b\u65b9\u9762\u7684\u4fee\u6539\u5fc5\u987b\u5411FDA \u63d0\u51fa\u7533\u8bf7\uff0c\u65e2\u803d\u8bef\u65f6\u95f4\uff0c\u53c8\u6709\u98ce\u9669\u201d\uff1b\u4f46\u4e5f\u6709\u4e1a\u5185\u4eba\u58eb\u8ba4\u4e3a\uff0c\u201c\u8fd9\u5bf9\u5236\u836f\u4f01\u4e1a\u6765\u8bf4\u662f\u597d\u4e8b\uff0c\u53ef\u4ee5\u8282\u770120\uff05\uff5e50\uff05\u7684\u6210\u672c\uff0c\u4f46\u524d\u63d0\u662f\u4f01\u4e1a\u8981\u6295\u8d44\u4f5c\u5145\u5206\u7684QbD\u7814\u7a76\u201d\u3002<\/span><\/p>\n


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\u5728\u8fd9\u4e00\u8fc7\u7a0b\u4e2d\uff0c\u539f\u7814\u836f\u4ea7\u4e1a\u7684\u521b\u65b0\u8005\u4eec\u5bf9ICH Q8\u3001Q9\u548cQ10\u6cd5\u89c4\u7684\u4f18\u70b9\u4e0d\u65ad\u5730\u8fdb\u884c\u4e89\u8bba\uff1b\u800c\u76f8\u53cd\u7684\u662f\uff0c\u4f17\u591a\u4eff\u5236\u836f\u516c\u53f8\u5374\u5f88\u5c11\u8ba8\u8bbaICH Q8\u548cQ9\u7684\u4f18\u70b9\uff0c\u800c\u662f\u9ed8\u9ed8\u5730\u9886\u4f1aQbD\u7684\u539f\u5219\u5e76\u5c06\u5176\u5e94\u7528\u5230\u73b0\u6709\u7684\u5546\u4e1a\u6a21\u5f0f\u4e2d\u53bb\uff1b\u5982\u68af\u74e6\u3001\u8fc8\u5170\u7b49\u4e3b\u8981\u7684\u4eff\u5236\u836f\u5236\u9020\u5546\u901a\u8fc7\u6df1\u523b\u9886\u4f1aQbD\u3001PAT\u7b49\u6765\u4e89\u53d6\u5b9e\u73b0\u7b2c\u4e00\u4e2a\u7533\u62a5\u4eff\u5236\u836f\u7684ANDA\u6765\u83b7\u5f97\u7ade\u4e89\u4f18\u52bf\u3002<\/span><\/p>\n


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\u867d\u7136\uff0c\u7f8e\u56fd\u9ed8\u514b\u836f\u5382\u7684Januvia\u6210\u4e3a\u4e86\u7b2c\u4e00\u4e2a\u5e94\u7528QbD\u7406\u5ff5\u901a\u8fc7\u5ba1\u8bc4\u7684\u836f\u7269(2006)\u3002\u4f46\u8fd9\u91cc\u8fd8\u662f\u8981\u4ecb\u7ecd\u4e0b\u8f89\u745e…\u81eaQbD\u63a8\u5e7f\u4e4b\u540e\uff0c\u8f89\u745e\u516c\u53f8\u4fbf\u5c06QbD\u6982\u5ff5\u6027\u65b9\u6cd5\u5728\u5176RFT(RightFirst Time)\u8fc7\u7a0b\u4e2d\u5f97\u5230\u4f53\u73b0\u3002RFT\u4e8e2005\u5e74\u5728\u8f89\u745e\u5168\u516c\u53f8\u8303\u56f4\u5185\u5f00\u59cb\u63a8\u5e7f\uff0c\u901a\u8fc7RFT\u548cQbD\u76f8\u8f85\u76f8\u6210\u7684\u5e94\u7528\u5bf9\u5176\u6240\u6709\u9879\u76ee\u505a\u51fa\u8bc4\u4ef7\u3002RFT\u7684\u610f\u601d\u662f\u7b2c\u4e00\u6b21\u5c31\u505a\u5bf9\uff0c\u4e3b\u8981\u76ee\u7684\u662f\u5728\u201c\u53d1\u5c55\u5bf9\u751f\u4ea7\u8fc7\u7a0b\u7684\u7406\u89e3\u4ee5\u4fbf\u4e0d\u65ad\u6539\u8fdb\u201d\u3002\u751f\u4ea7\u8fc7\u7a0b\u7406\u89e3\u548c\u4ea7\u54c1\u77e5\u8bc6\u7684\u63d0\u9ad8\u53ef\u4ee5\u4f7f\u4ea7\u54c1\u5f97\u5230\u4e0d\u65ad\u6539\u8fdb\uff0c\u5e76\u63d0\u4f9b\u673a\u4f1a\u6765\u5229\u7528\u589e\u5f3a\u7684\u77e5\u8bc6\u5728\u76d1\u7ba1\u7533\u8bf7\u4e2d\u83b7\u76ca\u3002<\/span><\/p>\n


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\u8f89\u745e\u5728\u591a\u4e2a\u516c\u5f00\u8ba8\u8bba\u4f1a\u4e0a\u5c55\u793a\u4e86QbD\u7533\u62a5\u548c\u5176\u4ed6\u4ea7\u54c1\u7684\u5b9e\u4f8b\uff0c\u5206\u4eab\u4e86\u5728ICH\u5730\u533a\u7684\u7ecf\u9a8c\u548c\u6559\u8bad\uff0c\u5e76\u4e0e\u65b0\u5174\u5e02\u573a\u56fd\u5bb6(\u5305\u62ec\u4e2d\u56fd\u5728\u5185)\u7684\u76d1\u7ba1\u673a\u6784\u5c55\u5f00\u8ba8\u8bba\u3002\u8f89\u745e\u5bf9\u4e00\u4e9bQbD\u76d1\u7ba1\u8bf4\u660e\u8303\u4f8b\u7684\u5f62\u6210\u4f5c\u51fa\u4e86\u663e\u8457\u8d21\u732e\uff0c\u5305\u62ec\u6b27\u6d32\u5236\u836f\u5de5\u4e1a\u534f\u4f1a\u8054\u5408\u4f1a(EFPIA) MOCK P2\u4f8b\u8bc1\u6587\u4ef6(Examplain)\u548cMockS. 2\u6587\u4ef6\u3001\u65e5\u672cMock J-QOS(\u8d28\u91cf\u7efc\u8ff0)\u3002\u5728\u6b27\u6d32\u3001\u65e5\u672c\u3001\u6fb3\u5927\u5229\u4e9a\u548c\u65b0\u897f\u5170\uff0c\u4f10\u5c3c\u514b\u5170\u7247\u5242\u548c\u9a6c\u62c9\u97e6\u7f57\u7247\u5242\u7684QbD\u6ce8\u518c\u6587\u4ef6\u56e0\u6240\u63d0\u4f9b\u7684\u4fe1\u606f\u8bc1\u660e\u4e86\u5bf9\u751f\u4ea7\u8fc7\u7a0b\u7406\u89e3\u7684\u589e\u5f3a\u800c\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u7684\u8ba4\u53ef\u3002\u5728\u52a0\u62ff\u5927\uff0c\u8f89\u745e\u57fa\u4e8e\u79d1\u5b66\u98ce\u9669\u8bc4\u4ef7\u4e3a\u751f\u4ea7\u5de5\u827a\u8bbe\u8ba1\u7a7a\u95f4\u63d0\u4f9b\u4e86\u5408\u7406\u548c\u4ee4\u4eba\u4fe1\u670d\u7684\u89e3\u91ca\uff0c\u56e0\u6b64\u901a\u8fc7\u4e0e\u76d1\u7ba1\u90e8\u95e8\u7684\u8c08\u5224\u51cf\u5c11\u4e86\u76d1\u7ba1\u9650\u5236\u3002\u5728\u5feb\u901f\u9886\u4f1a\u3001\u5e94\u7528QbD\u4e4b\u540e\uff0c\u8f89\u745e\u4e5f\u8fce\u6765\u4e86\u5404\u65b9\u9762\u7684\u6536\u83b7\u3002<\/span><\/p>\n

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QbD\u5bf9\u4e8e\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u597d\u5904<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u8fd1\u4e24\u5e74\uff0c\u56fd\u5185\u836f\u54c1\u884c\u4e1a\u6700\u70ed\u7684\u5173\u952e\u8bcd\u975e\u201c\u4e00\u81f4\u6027\u201d\u83ab\u5c5e\uff0c\u800c\u5bf9\u4e8e\u4e00\u81f4\u6027\u8bc4\u4ef7\uff0cQbD\u5982\u5e94\u7528\u5f97\u5f53\uff0c\u662f\u6709\u975e\u5e38\u591a\u7684\u597d\u5904\u7684\u3002\u4e14\u4e0d\u5f97\u4e0d\u8bf4\uff0c\u524d\u4e9b\u5e74\u56fd\u5185\u4eff\u5236\u836f\u836f\u54c1\u8d28\u91cf\u826f\u83a0\u4e0d\u9f50\uff0c\u5f88\u5927\u4e00\u90e8\u5206\u7684\u539f\u56e0\u662f\u4f01\u4e1a\u4e0d\u613f\u610f\u5bf9\u4ea7\u54c1\u8fdb\u884c\u6df1\u5165\u7684\u7814\u7a76\uff0c\u53ea\u8981\u83b7\u5f97\u5408\u683c\u7684\u53c2\u6570\u5373\u53ef(\u800c\u8fd9\u4e2a\u6570\u636e\u7684\u6765\u6e90\u5c31\u591a\u79cd\u591a\u6837\u4e86…)\uff0c\u800c\u7c97\u7cd9\u7684\u7814\u53d1\u8fc7\u7a0b\u4e5f\u7ec8\u917f\u82e6\u679c…<\/span><\/p>\n


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QbD\u5728\u4e00\u81f4\u6027\u8bc4\u4ef7\u4e2d\u7684\u8fd0\u7528\u4e3b\u8981\u5206\u4e3a\u4ee5\u4e0b\u6b65\u9aa4\uff1a1\uff09\u6839\u636e\u53c2\u6bd4\u5236\u5242\u786e\u5b9a\u76ee\u6807\u4ea7\u54c1\u7684\u8d28\u91cf\u6982\u51b5\u548c\u8d28\u91cf\u53c2\u6570\uff1b2\uff09\u786e\u5b9a\u4ea7\u54c1\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u3001\u5173\u952e\u5de5\u827a\u53c2\u6570\uff1b3\uff09\u7814\u53d1\u751f\u4ea7\u5de5\u827a\u7684\u8bbe\u8ba1\u7a7a\u95f4\uff1b4\uff09\u5b9e\u884c\u5168\u9762\u8d28\u91cf\u63a7\u5236\uff0c\u6301\u7eed\u751f\u4ea7\u9ad8\u8d28\u91cf\u7684\u4ea7\u54c1\u3002\u5176\u597d\u5904\u4e3b\u8981\u6709\u4ee5\u4e0b\u51e0\u70b9\uff1a<\/span><\/p>\n


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\u2606\u5229\u4e8e\u7814\u53d1<\/span><\/strong><\/p>\n

\u7f3a\u4e4f\u6b63\u786e\u7684\u6d41\u7a0b\u662f\u5236\u7ea6\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u91cd\u8981\u56e0\u7d20\u4e4b\u4e00\u3002\u5728\u4e00\u5b9a\u65f6\u671f\u5185\uff0c\u4eff\u5236\u836f\u7814\u53d1\u662f\u57fa\u4e8e\u7b80\u5355\u5b9e\u9a8c\u6765\u786e\u5b9a\u521d\u6b65\u7684\u5904\u65b9\u548c\u5de5\u827a\uff0c\u7f3a\u4e4f\u89c4\u8303\u7684\u7814\u53d1\u6d41\u7a0b\u3002\u901a\u8fc7\u7814\u7a76\u5206\u6790\u53c2\u6bd4\u5236\u5242\u548c\u539f\u6599\u7279\u6027\uff0c\u8003\u5bdf\u5176\u5173\u952e\u7684\u8d28\u91cf\u5c5e\u6027\u4e0e\u539f\u8f85\u6599\u548c\u5de5\u827a\u53c2\u6570\u7684\u5173\u8054\u6027\uff0c\u786e\u5b9a\u6b63\u5e38\u7684\u64cd\u4f5c\u7a7a\u95f4\uff0c\u5728\u7814\u53d1\u9636\u6bb5\u5c31\u8bbe\u8ba1\u597d\u7a33\u5b9a\u3001\u9ad8\u6548\u7684\u5de5\u827a\u6d41\u7a0b\uff0c\u6709\u5229\u4e8e\u63d0\u9ad8\u4eff\u5236\u836fBE\u7684\u901a\u8fc7\u7387\u3002<\/span><\/p>\n


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\u5c0f\u5c0f\u611f\u89e6<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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