{"id":68,"date":"2016-07-16T11:09:47","date_gmt":"2016-07-16T03:09:47","guid":{"rendered":"http:\/\/www.t-med.cn\/en\/?p=68"},"modified":"2016-07-16T11:18:19","modified_gmt":"2016-07-16T03:18:19","slug":"check-the-fdas-six-new-trends-exclusive","status":"publish","type":"post","link":"https:\/\/www.t-med.cn\/en\/?p=68","title":{"rendered":"Check the FDA’s six new trends | Exclusive"},"content":{"rendered":"

2015\u5e742\u67086\u65e5\u7531Shana Leonard\u53d1\u8868\u4e8e\u76d1\u7ba1\u548c\u5408\u89c4\u4e0a<\/p>\n

\u52a0\u5f3a\u7684\u76d1\u7ba1\u5bfc\u81f4\u4e86\u66f4\u591a\u8ba9\u4eba\u754f\u60e7\u548c\u77db\u76fe\u7684\u5ba1\u67e5\u73af\u5883\u3002\u4ee5\u4e0b\u662f\u4f60\u4e3a\u4e0b\u4e00\u6b21\u5ba1\u67e5\u4f5c\u51c6\u5907\u65f6\u9700\u8981\u77e5\u9053\u7684\u516d\u4e2a\u8d8b\u52bf\u3002<\/p>\n

\u8fc7\u53bb\u4e00\u4e24\u5e74\u5185\u589e\u52a0\u7684\u76d1\u7ba1\u8feb\u4f7f\u8d28\u91cf\u3001\u76d1\u7ba1\u548c\u5408\u89c4\u90e8\u95e8\u6709\u5173\u4eba\u5458\u4fdd\u6301\u8b66\u89c9\u3002\u4fdd\u8bc1\u8d28\u91cf\u5e76\u6700\u7ec8\u4fdd\u62a4\u60a3\u8005\u548c\u7528\u6237\u662f\u4e00\u4ef6\u597d\u4e8b\u60c5\u3002\u7136\u800c\uff0c\u8fd9\u4e5f\u662f\u4e00\u4ef6\u5934\u75bc\u7684\u4e8b\uff0c\u7279\u522b\u662f\u9762\u5bf9\u589e\u52a0\u7684\u76d1\u7ba1\u9700\u6c42\u548c\u77db\u76fe\u7684\u76d1\u7ba1\u6761\u4ef6\u3002<\/p>\n

\"\"<\/p>\n

\u7136\u800c\u7528Dennett Kouri\u7684\u8bdd\u6765\u8bf4\uff0c\u51c6\u5907\u5de5\u4f5c\u7684\u5173\u952e\u5728\u4e8e\u57f9\u517b\u8d28\u91cf\u6587\u5316\uff0c\u800c\u4e0d\u662f\u57f9\u517b\u9075\u5b88\u89c4\u5219\u7684\u6587\u5316\u3002Kouri\u662fEdwards\u751f\u547d\u79d1\u5b66\u516c\u53f8\u8d28\u91cf\u3001\u76d1\u7ba1\u548c\u4e34\u5e8a\u8d44\u6df1\u603b\u76d1\uff0c\u4ed6\u57282\u670811\u65e5\u7684\u897f\u90e8MD&M\u5927\u4f1a\u4e0a\u5c06\u4f5c\u4e00\u573a\u9898\u4e3a\u201c\u968f\u65f6\u5e94\u5bf9\u4e0d\u4e00\u81f4\u7684\u68c0\u9a8c\u73af\u5883\u201d\u7684\u53d1\u8a00\uff0c\u89e3\u91ca\u8d28\u91cf\u6587\u5316\u662f\u4ee5\u7406\u5ff5\u4f53\u7cfb\u4e3a\u7279\u5f81\uff0c\u201c\u8fd9\u5c31\u662f\u6211\u4eec\u7684\u673a\u6784\u5982\u4f55\u5728\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8303\u56f4\u4e0b\u5f00\u5c55\u65e5\u5e38\u8fd0\u4f5c\uff0c\u201d\u800c\u4e0d\u662f\u597d\u50cf\u6bcf\u5929\u5728\u63a5\u8fd1\u8fd9\u79cd\u201c\u6211\u4eec\u6b63\u5728\u52aa\u529b\u4e3a\u4e0b\u4e00\u6b21\u68c0\u67e5\u505a\u51c6\u5907\u3002\u201d<\/p>\n

\u5728\u5efa\u7acb\u8d28\u91cf\u6587\u5316\u4e4b\u540e\uff0c\u4f01\u4e1a\u901a\u8fc7\u660e\u786e\u81ea\u5df1\u7684\u6a21\u5f0f\u548c\u8d8b\u52bf\u80fd\u66f4\u7075\u6d3b\u7684\u64cd\u4f5c\u591a\u53d8\u7684\u68c0\u67e5\u8fc7\u7a0b\uff0c\u8fd9\u4e9b\u68c0\u67e5\u8fc7\u7a0b\u5728\u8fd1\u51e0\u4e2a\u6708\u5df2\u7ecf\u6210\u4e3a\u4e86\u589e\u52a0\u7684\u76d1\u7ba1\u3002Kouri\u5c06\u76ee\u5149\u9501\u5b9a\u5728\u4ee5\u4e0b\u7684\u516d\u70b9\u3002<\/p>\n

1. \u5ba1\u67e5\u5458\u7684\u7ecf\u9a8c\u53c2\u5dee\u4e0d\u9f50<\/strong><\/p>\n

Kouri \u8bf4\u201c\u5728\u68c0\u67e5\u4e2d\u6700\u91cd\u8981\u5e76\u4e14\u6700\u96be\u4ee5\u9884\u77e5\u7684\u56e0\u7d20\u5c31\u662f\u8c01\u5728\u6267\u884c\u8fd9\u4e9b\u68c0\u67e5\uff0c\u8fc7\u53bb\u51e0\u5e74\uff0cFDA\u5c06\u7cbe\u529b\u96c6\u4e2d\u5728\u57f9\u517b\u65b0\u7684\u5ba1\u67e5\u5458\u8eab\u4e0a\uff0c\u4ee5\u786e\u4fdd\u4ed6\u4eec\u7684\u5de5\u4f5c\u80fd\u529b\u3002\u5c3d\u7ba1\u8fd9\u662f\u4e00\u4e2a\u597d\u7684\u8d8b\u52bf\uff0c\u8fd8\u662f\u5b58\u5728\u80fd\u529b\u6c34\u5e73\u4e0d\u540c\u7684\u5ba1\u67e5\u4eba\u5458\u5728\u6267\u884c\u68c0\u67e5\u3002\u201d<\/p>\n

\u56e0\u4e3a\u4f60\u65e0\u6cd5\u77e5\u9053\u5ba1\u67e5\u4eba\u5458\u662f\u65b0\u624b\u8fd8\u662f\u7ecf\u9a8c\u4e30\u5bcc\u7684\u8001\u624b\uff0c\u6839\u636eKouri\u7684\u8bdd\u6765\u8bf4\uff0c\u4f60\u5fc5\u987b\u201c\u505a\u6700\u5145\u5206\u7684\u51c6\u5907\u6765\u671f\u671b\u4e00\u4e2a\u597d\u7ed3\u679c\u3002\u201d\u57fa\u672c\u4e0a\u5230\u76ee\u524d\u4e3a\u6b62\uff0c\u7b80\u5355\u7684\u7ec3\u4e60\u89e3\u91ca\u7ec4\u7ec7\u548c\u6d41\u7a0b\u5c31\u50cf\u662f\u95e8\u5916\u6c49\u6216\u8005\u65b0\u624b\u3002\u5f53\u7136\uff0c\u5982\u679c\u662f\u6709\u7ecf\u9a8c\u7684\u5ba1\u67e5\u5458\uff0c\u53ef\u4ee5\u4fee\u6539\u7b56\u7565\u3002<\/p>\n

Kouri \u8fd8\u63d0\u5230\u628a\u4e00\u4e9b\u7ecf\u9a8c\u4e30\u5bcc\u7684\u5ba1\u67e5\u5458\u548c\u6ca1\u6709\u7ecf\u9a8c\u7684\u4e3b\u9898\u4e13\u5bb6\u7ed3\u5408\u5728\u4e00\u8d77\u662f\u4e00\u4e2a\u95ee\u9898\u3002\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u7ecf\u9a8c\u4e30\u5bcc\u7684\u9886\u5bfc\u662f\u5173\u952e\u3002\u201c\u8fd9\u4e9b\u9886\u5bfc\u80fd\u7ba1\u7406\u597d\u8ba8\u8bba\uff0c\u786e\u4fdd\u5bf9\u8bdd\u548c\u9762\u8bd5\u5bf9\u5ba1\u67e5\u5458\u6709\u5e2e\u52a9\uff0c\u5e76\u4e14\u5c3d\u5feb\u83b7\u5f97\u8981\u70b9\u3002\u201d<\/p>\n

2.\u52a0\u5f3a\u91c7\u8d2d\u63a7\u5236\u7684\u5ba1\u67e5<\/strong><\/p>\n

\u6839\u636eKouri\u7684\u89c2\u5bdf\uff0c\u201c\u6211\u8ba4\u4e3a\u4e0e\u8fc7\u53bb\u76f8\u6bd4\uff0c\u5bf9\u4f9b\u5e94\u5546\u6700\u521d\u7684\u9009\u62e9\u6807\u51c6\u548c\u8bc4\u4f30\u6709\u4e86\u66f4\u5927\u5173\u6ce8\u201d\u3002\u4ed6\u8865\u5145\u9053\uff0c\u5373\u4f7f\u4f9b\u5e94\u5546\u5df2\u7ecf\u548c\u516c\u53f8\u5408\u4f5c\u4e86\u4e00\u6bb5\u65f6\u95f4\uff0cFDA\u4e00\u76f4\u5728\u8d28\u7591\u6311\u9009\u7684\u6807\u51c6\uff0c\u5e76\u4e14\u8d28\u7591\u8fd9\u4e9b\u4f9b\u5e94\u5546\u662f\u5426\u6709\u6807\u51c6\u7684\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff0c\u8fd9\u4e2a\u7cfb\u7edf\u9002\u7528\u4e8e\u4ed6\u4eec\u6b63\u5728\u5bf9\u516c\u53f8\u4f9b\u5e94\u7684\u4e1c\u897f\u3002<\/p>\n

3.\u63d0\u9ad8\u5bf9\u5f7b\u5e95\u6027\u548c\u652f\u6301\u6587\u6863\u7684\u9884\u671f\u3002<\/strong><\/p>\n

FDA\u65f6\u523b\u5173\u6ce8\u8c03\u67e5\u7684\u5145\u5206\u6027\uff0c\u662f\u5426\u4e0e\u4e0d\u5408\u683c\u54c1\u7684\u95ee\u9898\u6709\u5173\uff0c\u4e0e\u9884\u9632\u7ea0\u6b63\u63aa\u65bd\u6709\u5173\u6216\u8005\u4e0e\u5176\u4ed6\u95ee\u9898\u6709\u5173\u3002\u9664\u4e86\u7a33\u5065\u7684\u8c03\u67e5\uff0cFDA\u8d8a\u6765\u8d8a\u9700\u8981\u5927\u91cf\u7684\u4e66\u9762\u6587\u6863\u6765\u8bb0\u5f55\u8c03\u67e5\u3002Kouri \u8bf4\u201c\u8fd9\u5c31\u50cf\u4e00\u4e2a\u53e4\u8001\u7684\u683c\u8a00\uff1a\u6ca1\u6709\u5199\u4e0b\u6765\u7684\u4e8b\u60c5\u5c31\u7b49\u4e8e\u6ca1\u6709\u53d1\u751f\u3002<\/p>\n

4. \u66f4\u52a0\u5f3a\u8c03\u53cd\u5e94\u548c\u8c03\u67e5\u7684\u53ca\u65f6\u6027<\/strong><\/p>\n

\u5ba1\u67e5\u5458\u4f20\u8fbe\u4e86\u660e\u786e\u7684\u4fe1\u606f\uff1a\u5fc5\u987b\u53ca\u65f6\u5904\u7406\u8d28\u91cf\u548c\u5408\u89c4\u95ee\u9898\uff0c\u7279\u522b\u662f\u5728\u9047\u5230\u6295\u8bc9\uff0c\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u548c\u5065\u5eb7\u5371\u5bb3\u8bc4\u4f30\u65f6\u3002<\/p>\n

5. \u65b0\u5174\u7126\u70b9\u5173\u6ce8\u5206\u9500\u4ea7\u54c1<\/strong><\/p>\n

Kouri \u8bf4\u201c\u6211\u4eec\u5df2\u7ecf\u53d1\u73b0\u6216\u8005\u5df2\u7ecf\u542c\u8bf4\u5ba1\u67e5\u5458\u8bd5\u56fe\u786e\u4fdd\u7ba1\u7406\u8ddf\u4e0a\u4e86\u65f6\u4ee3\uff0c\u4e3a\u4e86\u505a\u51fa\u6070\u5f53\u51b3\u5b9a\uff0c\u9700\u8981\u62ff\u51fa\u6240\u6709\u9700\u8981\u7684\u4fe1\u606f\u3002\u201d\u4ed6\u8bf4\u8865\u5145\u90a3\u4e9b\u8bc1\u636e\u6765\u652f\u6301\u8fd9\u6837\u7684\u58f0\u660e\u548c\u884c\u52a8\u662f\u6700\u57fa\u672c\u7684\u3002\u201c\u6240\u4ee5\uff0c\u8fd9\u91cc\u6240\u6709\u7684\u6d88\u606f\u5c31\u662f\u4e3a\u4e86\u8ba9\u4f01\u4e1a\u786e\u4fdd\u4ed6\u4eec\u51c6\u5907\u597d\u66f4\u6df1\u5165\u7684\u6295\u5165\u5230\u8d28\u91cf\u7ba1\u7406\u7684\u8bb0\u5f55\u4e2d\uff0c\u8fd9\u4e9b\u8bb0\u5f55\u5173\u4e8e\u9884\u9632\u7ea0\u6b63\u63aa\u65bd\u7684\u8bb0\u5f55\uff0c\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u7684\u8bb0\u5f55\uff0c\u4e0d\u7b26\u5408\u89c4\u8303\u7684\u8bb0\u5f55\u7b49\uff0c\u8fd9\u4e9b\u8bb0\u5f55\u90fd\u662f\u7740\u773c\u4e8e\u7ba1\u7406\u76d1\u7763\u7684\u5145\u5206\u6027\u3002\u201d<\/p>\n

6. \u8d8a\u6765\u8d8a\u591a\u7684\u5f3a\u8c03\u7ba1\u7406\u610f\u8bc6<\/strong><\/p>\n

\u5f53\u6d89\u53ca\u5230\u5e02\u573a\u4e0a\u6b63\u5728\u9500\u552e\u7684\u4ea7\u54c1\u7684\u95ee\u9898\uff0c\u884c\u4e1a\u4e13\u5bb6\u6ce8\u610f\u5230\u4e00\u4e2a\u6b63\u5728\u6539\u53d8\u7684\u6001\u5ea6\u3002FDA\u8d8a\u6765\u8d8a\u4e25\u5389\u7684\u8d23\u4ee4\u516c\u53f8\u8fdb\u884c\u6df1\u5165\u8c03\u67e5\u6765\u786e\u5b9a\u95ee\u9898\u7684\u6839\u6e90\uff0c\u4ece\u800c\u5f88\u5bb9\u6613\u628a\u95ee\u9898\u5546\u54c1\u4ece\u5546\u4e1a\u754c\u4e2d\u5254\u9664\u3002<\/p>\n

Kouri \u8868\u793a\u201c\u5728\u8fc7\u53bb\uff0c\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u826f\u597d\u7684\u8ddf\u8e2a\u8bb0\u5f55\u6bd4\u4e25\u683c\u9075\u5b88GMP\u8981\u6c42\u66f4\u53ef\u9760\u3002\u4f46\u662fFDA\u5df2\u7ecf\u66f4\u591a\u7684\u5411\u53e6\u4e00\u4e2a\u7acb\u573a\u8f6c\u53d8\uff0c\u90a3\u5c31\u662f\u5982\u679c\u4f60\u5728\u8fc7\u7a0b\u4e2d\u6ca1\u6709\u9075\u5b88GMP\uff0c\u4f60\u6ca1\u6709\u8bc1\u636e\u8bc1\u660e\u4f60\u9075\u7167\u4e86GMP\uff0c\u4ea7\u54c1\u5728\u5e02\u573a\u4e0a\u8868\u73b0\u826f\u597d\u8fd9\u6837\u7684\u4e8b\u5b9e\u4e0d\u4f1a\u518d\u51fa\u73b0\u3002\u201d<\/p>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

2015\u5e742\u67086\u65e5\u7531Shana Leonard\u53d1\u8868\u4e8e\u76d1\u7ba1\u548c\u5408\u89c4\u4e0a \u52a0\u5f3a\u7684\u76d1\u7ba1\u5bfc\u81f4\u4e86\u66f4\u591a\u8ba9\u4eba\u754f\u60e7\u548c\u77db\u76fe\u7684\u5ba1\u67e5\u73af\u5883\u3002\u4ee5\u4e0b\u662f\u4f60\u4e3a\u4e0b\u4e00\u6b21\u5ba1\u67e5\u4f5c\u51c6\u5907\u65f6\u9700\u8981\u77e5\u9053\u7684\u516d\u4e2a\u8d8b\u52bf\u3002 \u8fc7\u53bb\u4e00\u4e24\u5e74\u5185\u589e\u52a0\u7684\u76d1\u7ba1\u8feb\u4f7f\u8d28\u91cf\u3001\u76d1\u7ba1\u548c\u5408\u89c4\u90e8\u95e8\u6709\u5173\u4eba\u5458\u4fdd\u6301\u8b66\u89c9\u3002\u4fdd\u8bc1\u8d28\u91cf\u5e76\u6700\u7ec8\u4fdd\u62a4\u60a3\u8005\u548c\u7528\u6237\u662f\u4e00\u4ef6\u597d\u4e8b\u60c5\u3002\u7136\u800c\uff0c\u8fd9\u4e5f\u662f\u4e00\u4ef6\u5934\u75bc\u7684\u4e8b\uff0c\u7279\u522b\u662f\u9762\u5bf9\u589e\u52a0\u7684\u76d1\u7ba1\u9700\u6c42\u548c\u77db\u76fe\u7684\u76d1\u7ba1\u6761\u4ef6\u3002 \u7136\u800c\u7528Dennett 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