{"id":98436,"date":"2019-03-25T00:00:50","date_gmt":"2019-05-17T08:14:39","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98436\/"},"modified":"2019-05-17T16:14:40","modified_gmt":"2019-05-17T08:14:40","slug":"aca914736b","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98436\/","title":{"rendered":"\u53e3\u670d\u8c03\u91ca\u5236\u5242\u4e59\u9187\u8bf1\u5bfc\u5242\u91cf\u503e\u6cfb\u7684\u76d1\u7ba1\u8003\u8651"},"content":{"rendered":"
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\u6765\u6e90\uff1a<\/strong><\/span><\/p>\n


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\u7f16\u8005\u8bed<\/span><\/span><\/p>\n<\/section>\n

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\u516c\u4f17\u53f7\u4e2dMzwinsunny<\/span>\u66fe\u53d1\u8868\u8fc7\u300a\u6eb6\u51fa\u8bd5\u9a8c\u7684\u4f5c\u7528\u539f\u6765\u5982\u6b64\u5f3a\u5927\uff0c\u4e14\u770b<\/span>FDA<\/span>\u89c2\u70b9\uff01\u300b\u8bd1\u6587\uff0c\u539f\u82f1\u6587\u9898\u76ee\u4e3a<\/span>Dissolution Testing for Generic Drugs: An FDA Perspective<\/span>\u3002\u6587\u4e2d\u6709\u4e00\u8282\u5bf9\u8c03\u91ca\u5236\u5242\u4e59\u9187\u8bf1\u5bfc\u7684\u5242\u91cf\u503e\u6cfb\u505a\u4e86\u7b80\u8981\u4ecb\u7ecd\uff0c\u5305\u62ec\u505a\u5242\u91cf\u503e\u6cfb\u8bd5\u9a8c\u7684\u539f\u56e0\u3001<\/span>FDA<\/span>\u5bf9\u7533\u62a5\u54c1\u79cd\u7684\u8981\u6c42\u3001\u4f53\u5916\u5242\u91cf\u503e\u6cfb\u8bd5\u9a8c\u7684\u6eb6\u51fa\u6761\u4ef6\u7b49\u3002<\/span>
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CFDA<\/span>\u5728<\/span>2016<\/span>\u5e74<\/span>3<\/span>\u6708<\/span>18<\/span>\u65e5\u53d1\u5e03\u4e86\u516c\u544a\uff08<\/span>2016<\/span>\u5e74\u7b2c<\/span>61<\/span>\u53f7\uff09\uff0c\u5176\u9644\u4ef6\u300a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\u4e2d\u89c4\u5b9a\uff1a<\/span>\u996e\u7528\u542b\u9152\u7cbe\u7684\u996e\u6599\u53ef\u80fd\u4f1a\u5f71\u54cd\u836f\u7269\u81ea\u8c03\u91ca\u5236\u5242\u4e2d\u91ca\u653e\u3002\u9152\u7cbe\u4f1a\u6539\u53d8\u836f\u7269\u91ca\u653e\u7279\u6027\uff0c\u5bfc\u81f4\u836f\u7269\u8fc7\u5feb\u91ca\u653e\uff0c\u5e76\u6539\u53d8\u836f\u7269\u4f53\u5185\u66b4\u9732\u91cf\uff0c\u8fdb\u800c\u5f71\u54cd\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u5efa\u8bae\u7814\u53d1\u7f13\u91ca\u53e3\u670d\u56fa\u4f53\u5236\u5242\u65f6\u8fdb\u884c\u76f8\u5e94\u7684\u4f53\u5916\u7814\u7a76\uff0c\u4ee5\u8bc4\u4ef7\u5236\u5242\u5728\u4f53\u5185\u9152\u7cbe\u73af\u5883\u4e2d\u51fa\u73b0\u836f\u7269\u7a81\u91ca\u7684\u53ef\u80fd\u6027\u3002\u5e94\u8003\u5bdf\u5236\u5242\u5728\u4e0d\u540c\u6d53\u5ea6\u7684\u9152\u7cbe\u6eb6\u5a92\u4e2d\u7684\u91ca\u653e\u60c5\u51b5\u3002\u67d0\u4e9b\u7279\u5b9a\u60c5\u51b5\u4e0b\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u5236\u5242\u4e0e\u9152\u540c\u670d\u65f6\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002\u201d<\/span>\u8fd9\u4e2a\u6307\u5bfc\u539f\u5219\u7d27\u8ddf\u56fd\u5916\u7814\u7a76\u60c5\u51b5\uff0c\u586b\u8865\u4e86\u56fd\u5185\u591a\u5e74\u7684\u7a7a\u767d\uff0c\u5bf9\u8c03\u91ca\u5236\u5242\u4eff\u5236\u53d1\u3001\u6ce8\u518c\u7533\u62a5\u3001\u4e00\u81f4\u6027\u8bc4\u4ef7\u5177\u6709\u91cd\u8981\u610f\u4e49\u3002<\/span><\/p>\n


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\u4e3a\u4e86\u4f7f\u4e1a\u5185\u540c\u884c\u8fdb\u4e00\u6b65\u4e86\u89e3\u5242\u91cf\u503e\u6cfb\uff0c\u5bf9\u56fd\u5916\u76f8\u5173\u8d44\u6599\u8fdb\u884c\u4e86\u7ffb\u8bd1\u6574\u7406\uff0c\u5e0c\u671b\u5bf9\u5404\u4f4d\u6709\u6240\u5e2e\u52a9\uff0c\u540c\u65f6\u6b22\u8fce\u5404\u4f4d\u4e13\u5bb6\u3001\u540c\u884c\u5bf9\u76f8\u5173\u6307\u5357\u3001\u6280\u672f\u8981\u6c42\u3001\u5236\u5242\u5904\u65b9\u5de5\u827a\u5f00\u53d1\u8fdb\u884c\u63a2\u8ba8\u3002<\/span><\/p>\n<\/section>\n<\/section>\n

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\u539f\u6587\u6807\u9898<\/p>\n<\/section>\n

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Regulatory Considerations for Alcohol-Induced Dose <\/strong>Dumping of Oral Modified-Release <\/strong>Formulations<\/strong><\/span><\/p>\n

Thomas P. Friebe, Firouz Asgarzadeh, Ann Gray, Kevin Hughes, <\/strong>Johann-Philipp Hebestreit, Yvonne Rosiaux, Mahmud Yunis, Amina Faham<\/strong><\/span><\/p>\n<\/section>\n<\/blockquote>\n<\/section>\n


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\u5728\u8fc7\u53bb\u51e0\u5341\u5e74\u91cc\uff0c\u8c03\u91ca\uff08<\/span>MR<\/span>\uff09\u7cfb\u7edf\u5df2\u7ecf\u5f7b\u5e95\u6539\u53d8\u4e86\u539f\u6599\u836f\u7684\u7ed9\u836f\u65b9\u5f0f\u3002\u901a\u8fc7\u4fdd\u6301\u66f4\u4e00\u81f4\u7684\u8840\u836f\u6d53\u5ea6\uff0c\u60a3\u8005\u7684\u4f9d\u4ece\u6027\u5f97\u5230\u4e86\u6539\u5584\uff0c\u526f\u4f5c\u7528\u5f97\u5230\u4e86\u51cf\u5c11\uff0c\u4fc3\u8fdb\u4e86\u66f4\u6709\u6548\u7684\u6cbb\u7597\u3002\u7edd\u5927\u591a\u6570\u60a3\u8005\u53d7\u76ca\u4e8e\u8c03\u91ca\u5236\u5242\u7684\u836f\u7406\u4f18\u52bf\u548c\u670d\u7528\u7684\u65b9\u4fbf\u6027\u3002\u7136\u800c\uff0c\u5f53\u542b\u4e59\u9187\u7684\u996e\u6599\u4e0e\u8c03\u91ca\u836f\u7269\u540c\u670d\u65f6\uff0c\u6709\u4e00\u90e8\u5206\u60a3\u8005\u4f1a\u4ea7\u751f\u610f\u5916\u7684\u836f\u7269\u8fc7\u91cf\u3002\u7531\u4e8e\u836f\u7269\u4ece\u8c03\u91ca\u7cfb\u7edf\u4e2d\u7684\u91ca\u653e\u662f\u7531\u805a\u5408\u7269\u57fa\u8d28\u6216\u7531\u805a\u5408\u7269\u5305\u8863\u63a7\u5236\u7684\uff0c\u5982\u679c\u5236\u5242\u5728\u542b\u4e59\u9187\u7684\u6db2\u4f53\u4e2d\u6eb6\u89e3\uff0c\u91ca\u653e\u63a7\u5236\u5c31\u4f1a\u906d\u5230\u7834\u574f\uff0c\u5c31\u53ef\u80fd\u4f1a\u53d1\u751f\u5242\u91cf\u503e\u6cfb\uff08<\/span>Dose Dumping<\/span>\uff09\u3002<\/span><\/p>\n


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\u201c<\/span>\u5242\u91cf\u503e\u6cfb<\/span>\u201d<\/span>\u662f\u6307\u836f\u7269\u5728\u77ed\u65f6\u95f4\u5185\u5168\u90e8\u6216\u7edd\u5927\u90e8\u5206\u5feb\u901f\u91ca\u653e\uff08<\/span>1<\/span>\uff09\u3002\u57fa\u4e8e<\/span>API<\/span>\u7684\u6cbb\u7597\u6307\u6570\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u6027\u548c\u9002\u5e94\u75c7\uff0c\u53ef\u80fd\u4f1a\u5bfc\u81f4\u4e25\u91cd\u7684\u526f\u4f5c\u7528\u751a\u81f3\u81f4\u547d\u3002\u836f\u7269\u4e0e\u542b\u4e59\u9187\u996e\u6599\u540c\u670d\u800c\u5f15\u8d77\u7684\u5242\u91cf\u503e\u6cfb\uff0c\u79f0\u4e3a<\/span>\u201c<\/span>\u4e59\u9187\u8bf1\u5bfc\u7684\u5242\u91cf\u503e\u6cfb<\/span>\u201d<\/span>\uff08<\/span>ADD<\/span>\uff09\u3002<\/span><\/p>\n


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\u8c03\u91ca\u91ca\u653e\u2014\u2014\u6709\u76ca\uff0c\u4e5f\u6709\u98ce\u9669<\/p>\n<\/section>\n<\/section>\n<\/section>\n


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\u4e59\u9187\u996e\u6599\u6d88\u8d39\u904d\u53ca\u5168\u4e16\u754c\u5404\u5730\u3002\u67d0\u4e9b\u75c5\u4eba\uff0c\u5982\u60a3\u6709\u6162\u6027\u75bc\u75db\u6216\u6291\u90c1\u75c7\u7684\u4eba\uff0c\u6709\u53ef\u80fd\u503e\u5411\u4e8e\u91c7\u7528\u996e\u9152\u4f5c\u4e3a\u4e00\u79cd\u5904\u7406\u65b9\u5f0f\u6765\u5e94\u5bf9\u4ed6\u4eec\u7684\u75be\u75c5\uff0c\u8fd9\u662f\u56e0\u4e3a\u9152\u7684\u751f\u7406\u6548\u5e94\u4e0e\u9ebb\u9189\u5242\u7c7b\u4f3c\uff08<\/span>2<\/span>\uff09\u3002\u5c3d\u7ba1\u4ea7\u54c1\u8bf4\u660e\u4e66\u4e2d\u505a\u51fa\u4e86\u6709\u5173\u8b66\u544a\uff0c\u4f46\u662f\u5982\u679c\u60a3\u8005\u5c06\u836f\u54c1\u4e0e\u4e59\u9187\u996e\u6599\u540c\u65f6\u670d\u7528\uff0c\u5c31\u53ef\u80fd\u5bfc\u81f4\u610f\u5916\u7684<\/span>ADD<\/span>\u53d1\u751f\u3002\u867d\u7136\u4e8c\u8005\u5f88\u5c11\u540c\u65f6\u670d\u7528\uff0c\u4f46\u662f\u7531\u4e8e\u6b8b\u7559\u7684\u4e59\u9187\u5b58\u5728\uff0c<\/span>ADD<\/span>\u4ecd\u7136\u53ef\u80fd\u4f1a\u53d1\u751f\u3002\u5982\u679c\u4e00\u4e2a\u4eba\u6545\u610f\u4f7f\u7528\u9ad8\u6d53\u5ea6\u7684\u4e59\u9187\u996e\u6599\u4ece\u7f13\u91ca\u5236\u5242\u4e2d\u63d0\u53d6\u9ad8\u5242\u91cf\u7684<\/span>API<\/span>\uff08\u901a\u5e38\u662f\u963f\u7247\u7c7b\u9547\u75db\u836f\uff09\uff0c\u90a3\u4e48\u6545\u610f\u7684<\/span>ADD<\/span>\u5c31\u4f1a\u53d1\u751f\u3002<\/span><\/p>\n


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\u672c\u6587\u4e0d\u53bb\u5173\u6ce8\u8fd9\u79cd\u6545\u610f\u7684<\/span>ADD<\/span>\uff08\u5305\u62ec\u9632\u6ee5\u7528\u5904\u65b9\uff09\uff0c\u800c\u662f\u5f3a\u8c03\u8c03\u91ca\u5236\u5242\u5e94\u5177\u6709\u4e00\u4e2a\u6070\u5f53\u7684\u3001\u8010\u53d7\u7684\u5904\u65b9\u6765\u786e\u4fdd\u75c5\u4eba\u7684\u5b89\u5168\uff0c\u4f8b\u5982\uff0c\u5bf9\u4e8e\u7a84\u6cbb\u7597\u7a97\u836f\u7269\u3002<\/span>
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2005 <\/span>\u5e74\u7684<\/span>\u201cPalladone<\/span>\u4e8b\u4ef6<\/span>\u201d<\/span>\u4f7f\u76d1\u7ba1\u90e8\u95e8\u63d0\u9ad8\u4e86\u5bf9<\/span>ADD<\/span>\u7684\u8ba4\u8bc6\uff08<\/span>3<\/span>\uff0c<\/span>4<\/span>\uff09\u3002<\/span>Palladone<\/span>\u662f\u4e00\u4e2a\u6c22\u53ef\u916e\u7f13\u91ca\u80f6\u56ca\uff0c\u91c7\u7528\u7532\u57fa\u4e19\u70ef\u9178\u5171\u805a\u7269<\/span>B<\/span>\u578b\u548c\u4e59\u57fa\u7ea4\u7ef4\u7d20\uff08<\/span>5<\/span>\uff09\u4f5c\u4e3a\u63a7\u5236\u836f\u7269\u91ca\u653e\u7684\u6750\u6599\uff0c\u4e8c\u8005\u90fd\u6eb6\u4e8e\u4e59\u9187\u3002\u5728\u5065\u5eb7\u53d7\u8bd5\u8005\u4e2d\u8fdb\u884c\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u8868\u660e\uff0c\u5171\u540c\u670d\u7528<\/span>240ml<\/span>\uff08<\/span>8<\/span>\u76ce\u53f8\uff09<\/span>40%<\/span>\uff08<\/span>80<\/span>\u5ea6\uff09\u7684\u4e59\u9187\u996e\u6599\u548c<\/span>12mg<\/span>\u7684<\/span>palladone<\/span>\u80f6\u56ca\u540e\uff0c\u4e0e\u7528\u6c34\u670d\u7528\u76f8\u6bd4\uff0c\u4f1a\u5bfc\u81f4\u6c22\u5417\u5561\u916e\u7684\u5e73\u5747\u8840\u836f\u6d53\u5ea6\u63d0\u9ad8<\/span>6<\/span>\u500d\u3002\u8fd9\u4e48\u9ad8\u7684\u6d53\u5ea6\u53ef\u80fd\u662f\u81f4\u547d\u7684\uff08<\/span>6<\/span>\uff09\u3002\u56e0\u6b64\uff0c<\/span>Palladone<\/span>\u4ece\u7f8e\u56fd\u5e02\u573a\u64a4\u5e02\u4e86\u3002\u8fd9\u4e00\u4e8b\u4ef6\u968f\u540e\u50ac\u751f\u4e86\u65b0\u7684\u6307\u5357\uff0c\u8981\u6c42\u4f01\u4e1a\u5728\u8fdb\u884c\u5236\u5242\u5904\u65b9\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u5fc5\u987b\u8981\u8003\u8651<\/span>ADD<\/span>\u3002<\/span><\/p>\n


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\u76d1\u7ba1\u673a\u6784\u7684\u8003\u8651<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


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\u6b27\u76df\uff08<\/span>7-9<\/span>\uff09\uff0c\u7f8e\u56fd\uff08<\/span>1<\/span>\uff0c<\/span>10<\/span>\uff09\u548c\u5176\u4ed6\u56fd\u5bb6\uff08<\/span>11<\/span>\uff09\u7684\u76d1\u7ba1\u673a\u6784\u5df2\u7ecf\u63d0\u51fa\u4e86\u5173\u4e8e<\/span>ADD<\/span>\u7684\u6307\u5357\uff0c\u7136\u800c<\/span>ICH<\/span>\u5374\u8fd8\u6ca1\u6709\u63d0\u51fa\u3002\u8fc4\u4eca\u4e3a\u6b62\uff0c\u8fd8\u6ca1\u6709\u4e00\u4e2a\u76d1\u7ba1\u673a\u6784\u5c06\u6240\u6709<\/span>ADD<\/span>\u76f8\u5173\u8981\u6c42\u6c47\u603b\u5728\u540c\u4e00\u4efd\u6587\u4ef6\u4e2d\u3002<\/span><\/p>\n


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\u6b27\u76df <\/span><\/strong>\u6839\u636e\u6307\u5357\uff08<\/span>8<\/span>\uff09\u548c<\/span>EMA<\/span>\u8d28\u91cf\u5de5\u4f5c\u7ec4\uff08<\/span>QWP<\/span>\uff09\uff08<\/span>9<\/span>\uff09<\/span>Q&A<\/span>\u90e8\u5206\u8981\u6c42\uff0c\u5e94\u8fdb\u884c\u4e59\u9187\u5b58\u5728\u4e0b\u7684\u4f53\u5916\u8bd5\u9a8c\u3002\u7533\u8bf7\u4eba\u9700\u8981\u8bc4\u4f30\u6240\u6709\u7c7b\u578b\u8c03\u91ca\u5236\u5242\u5904\u65b9\u4e2d<\/span>API<\/span>\u975e\u9884\u671f\u91ca\u653e\u7684\u98ce\u9669\uff0c\u5982\u679c\u51fa\u73b0\u4e86<\/span>ADD<\/span>\u6216\u53ef\u80fd\u51fa\u73b0<\/span>ADD<\/span>\uff0c\u4ea7\u54c1\u5e94\u8be5\u91cd\u65b0\u8bbe\u8ba1\u5904\u65b9\u3002\u56fe<\/span>1<\/span>\u63d0\u4f9b\u4e86\u51b3\u7b56\u56fe\u3002<\/span><\/p>\n


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\"\u53e3\u670d\u8c03\u91ca\u5236\u5242\u4e59\u9187\u8bf1\u5bfc\u5242\u91cf\u503e\u6cfb\u7684\u76d1\u7ba1\u8003\u8651\"\u56fe<\/span>1. <\/span>\u57fa\u4e8e<\/span>EMA<\/span>\u6307\u5357\uff08<\/span>8<\/span>\uff0c<\/span>9<\/span>\uff09\u7684\u4e59\u9187\u8bf1\u5bfc\u5242\u91cf\u503e\u6cfb\uff08<\/span>ADD<\/span>\uff09\u98ce\u9669\u8bc4\u4f30<\/span><\/span><\/p>\n


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2011<\/span>\u5e74\uff0c\u4e00\u4efd<\/span>EMA<\/span>\u8bc4\u4f30\u62a5\u544a\uff08<\/span>12<\/span>\uff09\u8981\u6c42\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\uff08<\/span>MAH<\/span>\uff09\u63d0\u4f9b\u4ed6\u4eec\u963f\u7247\u7c7b\u4ea7\u54c1\u5bf9\u4e59\u9187\u654f\u611f\u6027\u7684\u6570\u636e\u3002\u5171\u6709<\/span>8<\/span>\u4e2a\u7533\u8bf7\u4eba\u63d0\u4ea4\u4e86<\/span>14<\/span>\u4e2a\u4ea7\u54c1\u7684\u6570\u636e\u3002\u7136\u800c\uff0c\u6bcf\u4e2a\u7533\u8bf7\u4eba\u91c7\u7528\u4e86\u4e0d\u540c\u6d53\u5ea6\u7684\u4e59\u9187\u8fdb\u884c\u8bc4\u4ef7\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u4e0d\u4f46\u65b9\u6cd5\u4e0d\u591f\u6709\u6548\uff0c\u800c\u4e14\u4f7f\u5ba1\u8bc4\u4eba\u5458\u5f88\u96be\u8fdb\u884c\u5224\u65ad\u548c\u6570\u636e\u6bd4\u8f83\u3002\u6700\u8fd1<\/span>EMA<\/span>\u516c\u5e03\u7684<\/span>Q&A<\/span>\uff08<\/span>9<\/span>\uff09\u4e2d\u63d0\u4f9b\u4e86\u6240\u9700\u6d53\u5ea6\u4e59\u9187\u7684\u5177\u4f53\u6307\u5357\u3002<\/span><\/p>\n


<\/p>\n


<\/p>\n

\u7f8e\u56fd\u3002<\/span><\/strong>2011<\/span>\u5e74\uff0c<\/span>FDA<\/span>\u4eff\u5236\u836f\u529e\u516c\u5ba4\uff08<\/span>OGD<\/span>\uff09\u5bf9\u4eff\u5236\u836f\u63d0\u4f9b\u4e86\u4e00\u4e2a\u7b80\u5355\u7684\u6d41\u7a0b\uff08<\/span>13<\/span>\uff0c<\/span>14<\/span>\uff09\u6765\u5e94\u5bf9<\/span>ADD<\/span>\uff0c\u89c1\u56fe<\/span>2<\/span>\u3002<\/span><\/p>\n


<\/p>\n


<\/p>\n

\"\u53e3\u670d\u8c03\u91ca\u5236\u5242\u4e59\u9187\u8bf1\u5bfc\u5242\u91cf\u503e\u6cfb\u7684\u76d1\u7ba1\u8003\u8651\"<\/p>\n


<\/p>\n

\u56fe<\/span>2<\/span>.<\/span>FDA<\/span>\u4e59\u9187\u8bf1\u5bfc\u7684\u5242\u91cf\u503e\u6cfb\uff08<\/span>ADD<\/span>\uff09\u5e94\u5bf9\u6d41\u7a0b<\/span>–<\/span>\u5173\u952e\u4eff\u5236\u836f\u5904\u65b9\uff08<\/span>13<\/span>\uff09<\/span><\/p>\n


<\/p>\n

2014<\/span>\u5e74\u4ee5\u6765\uff0c\u6709\u4e00\u4efd\u5de5\u4e1a\u6307\u5357\uff08<\/span>15<\/span>\uff09\u89c4\u5b9a\uff0c\u4f1a\u628a\u4e0d\u5145\u5206\u7684\u6eb6\u51fa\u6570\u636e\u4f5c\u4e3a\u7406\u7531\u6765\u62d2\u6536<\/span>ANDA<\/span>\u7533\u8bf7\u3002\u6b64\u5916\uff0c<\/span>FDA<\/span>\u5bf9\u4e8e\u4e00\u4e9b<\/span>API<\/span>\u63d0\u4f9b\u4e86\u8be6\u7ec6\u7684\u751f\u7269\u7b49\u6548\u6027\u6eb6\u51fa\u5efa\u8bae\uff08<\/span>16<\/span>\uff09\uff0c\u5982\u975e\u963f\u7247\u7c7b\u836f\u7269\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\uff08<\/span>17<\/span>\uff09\u3001\u53ef\u4e50\u5b9a\uff08<\/span>18<\/span>\uff09\u3001\u7f8e\u91d1\u521a\uff08<\/span>19<\/span>\uff09\uff0c\u4e8c\u7532\u53cc\u80cd\u548c\u897f\u4ed6\u5217\u6c40\u78f7\u9178\uff08<\/span>20<\/span>\uff09\uff0c\u66f2\u53f8\u6c2f\u94f5\uff08<\/span>21<\/span>\uff09\uff0c\u8fd9\u4e9b\u662f\u5e7f\u6cdb\u4f7f\u7528\u7684\u6cbb\u7597\u6162\u6027\u75be\u75c5\u7684\u836f\u7269\u3002\u901a\u5e38\u5bf9\u4e8e\u8fd9\u4e9b\u836f\u7269\uff0c\u4e59\u9187\u6d4b\u8bd5\u6d53\u5ea6\u9700\u8981\u8fbe\u5230<\/span>40%<\/span>\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

FDA<\/strong>\u548c<\/span><\/strong>EMA<\/strong>\u8981\u6c42\u6bd4\u8f83<\/span><\/strong>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

EMA<\/span>\u548c<\/span>FDA<\/span>\u5173\u4e8e<\/span>ADD<\/span>\u7684\u8981\u6c42\u5e76\u975e\u5b8c\u5168\u4e00\u81f4\uff0c\u6709\u65f6\u751a\u81f3\u76f8\u4e92\u77db\u76fe\u3002\u8868<\/span>1<\/span>\u663e\u793a\u4e86\u5b83\u4eec\u4e4b\u95f4\u7684\u5dee\u5f02\u4e3b\u8981\u5305\u62ec\u4e09\u65b9\u9762\u3002<\/span>FDA<\/span>\u8981\u6c42\u6eb6\u51fa\u8bd5\u9a8c\u4e2d\u91c7\u7528<\/span>40%<\/span>\u4e59\u9187\u4f5c\u4e3a\u4ecb\u8d28\uff0c\u800c<\/span>EMA<\/span>\u8981\u6c42<\/span>20%<\/span>\u3002\u5e94\u5f53\u8bf4\u660e\u7684\u662f\uff0c\u80c3\u4e2d\u5982\u679c\u8fbe\u5230<\/span>40%<\/span>\u7684\u4e59\u9187\u6d53\u5ea6\u9700\u8981\u6444\u5165<\/span>240ml<\/span>\u542b<\/span>56%<\/span>\u4e59\u9187\u7684\u996e\u6599\uff08\u57fa\u4e8e\u5df2\u6709<\/span>100ml<\/span>\u80c3\u6db2\u5b58\u5728\u4e8e\u80c3\u4e2d\uff09\uff08<\/span>4<\/span>\uff0c<\/span>22<\/span>\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u8fd9\u4e48\u5927\u7684\u4e59\u9187\u6444\u5165\u91cf\u5728\u6781\u7aef\u60c5\u51b5\u4e0b\u4f3c\u4e4e\u662f\u53ef\u4ee5\u5b9e\u73b0\u7684\uff0c\u5373<\/span>\u201c<\/span>\u9157\u9152<\/span>\u201d<\/span>\u3002\u6b64\u5916\uff0c\u4e59\u9187\u901a\u5e38\u5728<\/span>30<\/span>\u5206\u949f\u5185\u5728\u80c3\u80a0\u9053\u8fc5\u901f\u5438\u6536\u548c\u6d88\u9664\uff08<\/span>23<\/span>\uff09\u3002\u56e0\u6b64\uff0c\u5728\u4f53\u5916\u8981\u6c42\u5bf9<\/span>40%<\/span>\u4e59\u9187\u8010\u53d7\u4f3c\u4e4e\u66f4\u4e0e\u4e59\u9187\u6ee5\u7528\u76f8\u5173\uff0c\u800c<\/span>20%<\/span>\u4e59\u9187\u53ef\u80fd\u66f4\u63a5\u8fd1\u51fa\u73b0\u610f\u5916<\/span>ADD<\/span>\u7684\u60c5\u51b5\u3002<\/span><\/p>\n


<\/p>\n

EMA<\/span>\u548c<\/span>FDA<\/span>\u8981\u6c42\u4e4b\u95f4\u7684\u5dee\u5f02\u53ef\u80fd\u4f1a\u4f7f\u5904\u65b9\u8bbe\u8ba1\u5e08\u4f1a\u4ea7\u751f\u56f0\u60d1\uff0c\u4e0d\u77e5\u8be5\u9075\u5faa\u54ea\u4e2a\u3002\u7531\u4e8e\u8bb8\u591a\u5236\u836f\u516c\u53f8\u5728\u5168\u7403\u8303\u56f4\u5185\u7ecf\u8425\uff0c\u4ed6\u4eec\u4e0d\u5e0c\u671b\u5728\u4e0d\u540c\u5730\u533a\u5356\u4e0d\u540c\u5904\u65b9\u7684\u4ea7\u54c1\uff0c\u56e0\u6b64\u53ef\u80fd\u5f3a\u5236\u8981\u6c42\u5904\u65b9\u8bbe\u8ba1\u5e08\u5f00\u53d1\u51fa\u5bf9<\/span>40%<\/span>\u4e59\u9187\u8010\u53d7\u7684\u5904\u65b9\uff0c\u4e0d\u7ba1\u8fd9\u662f\u5426\u4e0e\u751f\u7406\u76f8\u5173\u3002\u8fd9\u5bf9\u5904\u65b9\u5f00\u53d1\u662f\u4e00\u4e2a\u660e\u663e\u7684\u6280\u672f\u969c\u788d\uff0c\u751a\u81f3\u53ef\u80fd\u963b\u788d\u6709\u4ef7\u503c\u7684\u836f\u7269\u7684\u63a8\u51fa\u3002<\/span>
<\/p>\n


<\/p>\n

\"\u53e3\u670d\u8c03\u91ca\u5236\u5242\u4e59\u9187\u8bf1\u5bfc\u5242\u91cf\u503e\u6cfb\u7684\u76d1\u7ba1\u8003\u8651\"<\/p>\n


<\/p>\n

\n
\n
\n

\u4e59\u9187\u654f\u611f\u6027\u8bc4\u4f30<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u539f\u6599\u836f\u548c<\/span>\/<\/span>\u6216\u8f85\u6599\u5bf9\u4e59\u9187\u654f\u611f\u5e76\u4e0d\u4e00\u5b9a\u610f\u5473\u7740\u5236\u5242\u4f1a\u53d1\u751f\u5242\u91cf\u503e\u6cfb\u3002\u5904\u65b9\u8bbe\u8ba1\u5e08\u9700\u8981\u8bc4\u4f30\u8fd9\u4e00\u654f\u611f\u7a0b\u5ea6\uff0c\u800c\u8fd9\u6837\u505a\u65f6\uff0c\u5904\u65b9\u8bbe\u8ba1\u5e08\u9700\u8981\u91c7\u7528\u5df2\u88ab\u666e\u904d\u63a5\u53d7\u7684\u5de5\u5177\u6216\u6307\u5357\u3002<\/span>N. Jedinger<\/span>\u7b49\u4eba\uff08<\/span>25<\/span>\uff09\u5c31\u5982\u4f55\u5e94\u5bf9\u8fd9\u4e2a\u95ee\u9898\u8ba8\u8bba\u4e86\u4e00\u4e9b\u6709\u610f\u4e49\u7684\u65b9\u6cd5\u6765\u51cf\u5c11<\/span>ADD<\/span>\u7684\u98ce\u9669\uff0c\u5305\u62ec\uff1a\u5f71\u54cd<\/span>ADD<\/span>\u7684\u7406\u5316\u56e0\u7d20\u3001\u6070\u5f53\u7684\u57fa\u8d28\u7cfb\u7edf\u548c\u6280\u672f\u7b56\u7565<\/span>\u3002<\/span>
<\/p>\n


<\/p>\n

\u901a\u8fc7\u6bd4\u8f83\u6bcf\u4e2a\u6eb6\u51fa\u53d6\u6837\u70b9\u7684\u76f8\u4f3c\u6027\u53ef\u4ee5\u8bc4\u4ef7\u6eb6\u51fa\u884c\u4e3a\u7684\u76f8\u4f3c\u6027\u3002\u6709\u4e0d\u540c\u65b9\u6cd5\u53ef\u4ee5\u8fdb\u884c\u6eb6\u51fa\u884c\u4e3a\u6bd4\u8f83\uff0c\u4f46\u662f\u4e00\u4e2a\u5728<\/span>FDA<\/span>\u5173\u4e8e<\/span>NDA<\/span>\u548c<\/span>ANDA<\/span>\u7684\u6587\u4ef6\u91cc\uff08<\/span>26-28<\/span>\uff09\u8ba8\u8bba\u6700\u591a\u7684\u5982\u4e0b\uff1a<\/span><\/p>\n


<\/p>\n

\u6a21\u578b\u975e\u4f9d\u8d56\u6cd5\u662f\u4f7f\u7528\u5dee\u5f02\u56e0\u5b50\uff08<\/span>f1<\/span>\uff09\u548c\u76f8\u4f3c\u56e0\u5b50\uff08<\/span>f2<\/span>\uff09\u6765\u6bd4\u8f83\u6eb6\u51fa\u884c\u4e3a\uff08<\/span>29<\/span>\uff09\u3002\u5dee\u5f02\u56e0\u5b50\uff08<\/span>f1<\/span>\uff09\u7528\u6765\u8ba1\u7b97\u4e24\u6761\u66f2\u7ebf\u6bcf\u4e2a\u65f6\u95f4\u70b9\u7684\u6eb6\u51fa\u767e\u5206\u6bd4\u7684\u5dee\u5f02\u3002\u76f8\u4f3c\u56e0\u5b50\uff08<\/span>f2<\/span>\uff09\u7528\u6765\u8861\u91cf\u4e24\u6761\u66f2\u7ebf\u6eb6\u51fa\u767e\u5206\u6bd4\u7684\u76f8\u4f3c\u6027\u3002\u5982\u679c\u4e24\u6761\u66f2\u7ebf\u76f8\u4f3c\uff0c<\/span>f1<\/span>\u503c\u5e94\u63a5\u8fd1<\/span>0<\/span>\u3001<\/span>f2<\/span>\u503c\u5e94\u63a5\u8fd1<\/span>100<\/span>\u3002\u901a\u5e38\uff0c<\/span>f1<\/span>\u503c\u8fbe\u5230<\/span>15<\/span>\uff08<\/span>0-15<\/span>\uff09\u3001<\/span>f2<\/span>\u503c\u5927\u4e8e<\/span>50<\/span>\uff08<\/span>50-100<\/span>\uff09\u8bf4\u660e\u4e24\u6761\u66f2\u7ebf\u76f8\u4f3c\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

\u590d\u6742\u56e0\u7d20<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u6587\u4e2d\u524d\u90e8\u5206\u6240\u63cf\u8ff0\u7684\u6cd5\u89c4\u6307\u5357\u662f\u5173\u4e8e\u4f53\u5916\u6d4b\u8bd5\u7684\uff0c\u8fd9\u4e2a\u8981\u6c42\u662f\u6709\u5fc5\u8981\u7684\uff0c\u56e0\u4e3a\u5982\u679c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u91c7\u7528\u5fd7\u613f\u8005\u6765\u6d4b\u5b9a<\/span>ADD<\/span>\u7684\u98ce\u9669\u53ef\u80fd\u4f1a\u5f15\u8d77\u4e0d\u5fc5\u8981\u7684\u98ce\u9669\uff0c\u8fd9\u88ab\u89c6\u4e3a\u662f\u4e0d\u9053\u5fb7\u7684\u3002\u5904\u65b9\u8bbe\u8ba1\u5e08\u628a\u4e00\u4e2a\u590d\u6742\u7684\u4e8b\u4ef6\u7b80\u5355\u5316\u540e\u4f1a\u5bfc\u81f4\u8fc7\u4e8e\u5f3a\u8c03\u67d0\u4e9b\u56e0\u7d20\uff08\u5982\u7eaf\u805a\u5408\u7269\u5728\u4e59\u9187\u7684\u6eb6\u89e3\u6027\uff09\u800c\u5ffd\u89c6\u4e86\u5176\u4ed6\u56e0\u7d20\uff08\u5982\u5904\u65b9\u8bbe\u8ba1\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u6210\u529f\u5f00\u53d1\u4e00\u4e2a\u5904\u65b9\u9700\u8981\u8003\u8651\u836f\u7269\u548c\u8f85\u6599\u7684\u6027\u80fd\u4ee5\u53ca\u5904\u65b9\u7684\u8bbe\u8ba1\u3002\u4e8b\u5b9e\u4e0a\uff0c\u76d1\u7ba1\u90e8\u95e8\u8981\u6c42\u7684<\/span>40%<\/span>\u4e59\u9187\u4ecb\u8d28\u7684\u4f53\u5916\u7ed3\u679c\u4e0d\u4e00\u5b9a\u80fd\u591f\u9884\u6d4b\u4f53\u5185\u884c\u4e3a\uff0c\u4f53\u5185\u73af\u5883\u7684\u590d\u6742\u6027\u4f7f\u5176\u7f3a\u5c11\u76f8\u5173\u6027\uff0c\u4ee5\u4e0b\u4e24\u4e2a\u4f8b\u5b50\u5c31\u53ef\u4ee5\u5f88\u597d\u8bf4\u660e\uff1a<\/span><\/p>\n


<\/p>\n

\u25cf<\/span>\u901a\u5e38\u8ba4\u4e3a\u7f13\u91ca\u9aa8\u67b6\u7247\u662f\u8010<\/span>ADD<\/span>\u7684\u3002<\/span>Opana<\/span>\u662f\u4e00\u4e2a\u7f9f\u5417\u5561\u916e\u7f13\u91ca\u7247\uff0c\u4e3a\u4eb2\u6c34\u6027\u805a\u5408\u7269\u5904\u65b9\uff08<\/span>TIMERX<\/span>\u836f\u7269\u9012\u9001\u6280\u672f\uff09\uff0c\u91c7\u7528\u7684\u8c03\u91ca\u805a\u5408\u7269<\/span>\u2014\u2014<\/span>\u9ec4\u539f\u80f6\uff08<\/span>30<\/span>\uff09\u548c\u523a\u69d0\u8c46\u80f6\uff08<\/span>31<\/span>\uff09\u90fd\u662f\u9187\u4e0d\u6eb6\u6027\u80f6\u4f53\u3002<\/span>Opana<\/span>\u867d\u7136\u901a\u8fc7\u4e86\u4f53\u5916<\/span>ADD<\/span>\u6eb6\u51fa\u8bd5\u9a8c\uff0c\u4f46\u5728\u4f53\u5185\u5374\u662f\u5931\u8d25\u7684\uff08<\/span>32<\/span>\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u25cf<\/span>\u5c3d\u7ba1\u591a\u9897\u7c92\u5236\u5242\u901a\u8fc7\u80c3\u7684\u8f6c\u8fd0\u65f6\u95f4\u6bd4\u5355\u7247\u8981\u77ed\uff0c\u4f46\u662f\u7ecf\u5305\u8863\u8c03\u91ca\u591a\u5143\u5236\u5242\u901a\u5e38\u8ba4\u4e3a\u4f1a\u4ea7\u751f<\/span>ADD<\/span>\uff0c\u56e0\u4e3a\u5176\u5177\u6709\u8f83\u9ad8\u7684\u6709\u6548\u63a5\u89e6\u8868\u9762\u4f7f\u9178\u6027\u6c34\u9187\u4ecb\u8d28\u8fdb\u5165\u3002\u5361\u7ef4\u5730\u6d1b\u662f\u4e00\u4e2a\u591a\u9897\u7c92\u5236\u5242\uff08\u5fae\u578b\u6cf5\uff09\uff0c\u91c7\u7528\u7532\u57fa\u4e19\u70ef\u9178\u5171\u805a\u7269\u4f5c\u4e3a\u5305\u8863\u6750\u6599\u3002\u7532\u57fa\u4e19\u70ef\u9178\u5171\u805a\u7269\u901a\u5e38\u5728\u4e59\u9187\u4e2d\u6eb6\u89e3\uff0c\u5728\u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u4e2d\u6ca1\u6709\u901a\u8fc7<\/span>ADD<\/span>\u3002\u7136\u800c\uff0c\u5176\u4f53\u5185\u7279\u6027\u5374\u4e0d\u53d7\u4e59\u9187\u7684\u5f71\u54cd\uff08<\/span>33<\/span>\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u4e0a\u9762\u8fd9\u4e24\u4e2a\u4f8b\u5b50\u8bf4\u660e\uff0c\u4f53\u5185\u7684<\/span>ADD<\/span>\u662f\u4e00\u4e2a\u591a\u56e0\u7d20\u4e8b\u4ef6\u3002\u56e0\u6b64\uff0c\u5f53\u524d\u6240\u91c7\u7528\u7684\u6807\u51c6\u4f53\u5916\u8bc4\u4ef7\u65b9\u6cd5\u4e0d\u4e00\u5b9a\u80fd\u591f\u9884\u6d4b\u4f53\u5185\u884c\u4e3a\u3002\u663e\u7136\uff0c\u8fd9\u9700\u8981\u4e00\u4e2a\u7ecf\u8fc7\u7279\u6b8a\u8bbe\u8ba1\u7684\u6d4b\u8bd5\u65b9\u6cd5\uff0c\u5fc5\u987b\u6839\u636e\u5177\u4f53\u60c5\u51b5\u53bb\u9009\u62e9\u6070\u5f53\u7684\u5904\u65b9\u548c\u5de5\u827a\uff0c\u8981\u8003\u8651\u591a\u79cd\u56e0\u7d20\uff0c\u5982\uff1a\u539f\u8f85\u6599\u6027\u8d28\u3001\u5904\u65b9\u8bbe\u8ba1\u3001\u9002\u5e94\u75c7\u3001\u5242\u91cf\u503e\u6cfb\u7684\u98ce\u9669\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

\u603b\u7ed3<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u8c03\u91ca\u5236\u5242\u7684<\/span>ADD<\/span>\u5bf9\u4e8e\u4e00\u90e8\u5206\u60a3\u8005\u53ef\u80fd\u5177\u6709\u98ce\u9669\u3002\u76d1\u7ba1\u90e8\u95e8\u5df2\u7ecf\u5efa\u7acb\u4e86\u6307\u5357\u6765\u6307\u5bfc\u5904\u65b9\u8bbe\u8ba1\u5e08\u964d\u4f4e\u5904\u65b9\u539f\u56e0\u6240\u5f15\u8d77\u7684<\/span>ADD<\/span>\u3002\u7136\u800c\uff0c\u4ec5\u4ec5\u8fdb\u884c\u4f53\u5916\u6d4b\u8bd5\u662f\u4e0d\u80fd\u591f\u4ee3\u8868\u751f\u7406\u73af\u5883\u7684\uff0c\u8fd9\u53ef\u80fd\u5728\u4ee5\u5408\u7406\u7684\u6210\u672c\u5f00\u53d1\u6709\u6548\u5242\u578b\u65b9\u9762\u9020\u6210\u6280\u672f\u969c\u788d\u3002\u5f53\u524d\uff0c\u4e0d\u540c\u5730\u533a\u95f4\u7f3a\u5c11\u7edf\u4e00\u7684\u8981\u6c42\uff0c\u8fd9\u589e\u52a0\u4e86\u7814\u7a76\u5f00\u53d1\u7684\u590d\u6742\u6027\uff0c\u589e\u52a0\u4e86\u5168\u7403\u5316\u4f01\u4e1a\u7684\u6210\u672c\u3002\u9274\u4e8e\u5236\u836f\u884c\u4e1a\u7684\u65e5\u76ca\u5168\u7403\u5316\uff0c<\/span>FDA<\/span>\u548c<\/span>EMA<\/span>\u6307\u5357\u5e94\u8be5\u534f\u8c03\u6709\u5173<\/span>ADD<\/span>\u7684\u4f53\u5916\u8bd5\u9a8c\u6761\u4ef6\uff0c\u4f8b\u5982\u80fd\u53cd\u6620\u751f\u7406\u76f8\u5173\u7684\u4e59\u9187\u6d53\u5ea6\u548c\u66b4\u9732\u7684\u65f6\u95f4\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

\u56fd\u9645\u8981\u7528\u8f85\u6599\u534f\u4f1a\uff08IPEC\uff09\u6b27\u6d32ADD\u5de5\u4f5c\u7ec4
<\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u56fd\u9645\u836f\u7528\u8f85\u6599\u534f\u4f1a\uff08<\/span>IPEC<\/span>\uff09\u6b27\u6d32<\/span>ADD<\/span>\u5de5\u4f5c\u7ec4\u8ba1\u5212\u516c\u5e03\u4e00\u4efd\u610f\u89c1\u4e66\u5f3a\u8c03<\/span>ADD<\/span>\u7684\u6709\u5173\u95ee\u9898\uff0c\u5e76\u5efa\u8bae\u5bf9\u5f53\u524d\u7684\u6307\u5357\u8fdb\u884c\u4fee\u8ba2\uff0c\u4ee5\u4e3a\u914d\u65b9\u8bbe\u8ba1\u5e08\u63d0\u4f9b\u76f8\u5173\u7684\u5efa\u8bae\u3002<\/span><\/span><\/p>\n

\n


<\/p>\n

\u8bd1\u540e\u8bed\uff1a<\/span><\/strong>
<\/p>\n


<\/p>\n

\u5728\u56fd\u5185\uff0c\u8c22\u6c90\u98ce\u8001\u5e08\u66fe\u8bb2\u8fc7\uff0c\u5728\u65e5\u672c\u4e3a\u9632\u6b62\u5242\u91cf\u503e\u6cfb\u73b0\u8c61\u53d1\u751f\uff0c\u8981\u6c42\u5728\u6700\u5177\u533a\u5206\u529b\u7684\u6eb6\u51fa\u4ecb\u8d28\u4e2d\uff0c\u589e\u52a0<\/span>100rpm<\/span>\u6216<\/span>200rpm<\/span>\u6bd4\u8f83\u7814\u7a76\uff0c\u89c2\u6d4b\u4eff\u5236\u5236\u5242\u80fd\u5426\u50cf\u539f\u7814\u5236\u5242\u90a3\u6837\u201c\u6536\u653e\u81ea\u5982\u201d\u3002\u5bf9\u6cbb\u7597\u7a97\u7a84\u7684\u836f\u7269\u5236\u5242\uff0c\u5e94\u540c\u7f13\u63a7\u91ca\u5236\u5242\u90a3\u6837\uff0c\u5728\u5404\u8f6c\u901f\u4e0b\u3001\u5404\u4ecb\u8d28\u4e2d\u8fdb\u884c\u6eb6\u51fa\u884c\u4e3a\u6bd4\u8f83\uff08\u9644\u52a0\u201c\u5242\u91cf\u503e\u6cfb\u8bd5\u9a8c\u201d\uff09\uff0c\u4ee5\u6700\u5927\u9650\u5ea6\u5730\u4fdd\u969c\u4e34\u5e8a\u7528\u836f\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff08<\/span>34<\/span>\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u5f20\u54f2\u5cf0\u8001\u5e08\u6700\u8fd1\u4e5f\u5bf9\u5242\u91cf\u503e\u6cfb\u8bd5\u9a8c\u53d1\u8868\u4e86\u8bba\u8ff0\uff08<\/span>35<\/span>\uff09\uff1a\u201c\u8be5\u9879\u8bd5\u9a8c\u5b9e\u9645\u4e0a\u662f\u4eff\u5236\u836f\u4e0e\u53c2\u6bd4\u5236\u5242\u5728\u9ad8\u5f3a\u5ea6\uff08\u9ad8\u8f6c\u901f\u6216\u6dfb\u52a0\u6709\u673a\u6eb6\u5242\uff09\u4e0b\u7684\u6eb6\u51fa\u66f2\u7ebf\u4e00\u81f4\u6027\u7684\u6bd4\u5bf9\u7814\u7a76\uff0c\u4e3b\u8981\u76ee\u7684\u662f\u9632\u6b62\u53d1\u751f\u5242\u91cf\u503e\u6cfb\u800c\u5bfc\u81f4\u5b89\u5168\u6027\u4e8b\u4ef6\u3002\u5b9e\u9645\u4e0a\uff0c\u8fd9\u4e5f\u662f\u6eb6\u51fa<\/span>\/<\/span>\u91ca\u653e\u884c\u4e3a\u7684\u5168\u65b9\u4f4d\u6bd4\u8f83\uff0c\u66f4\u80fd\u786e\u4fdd\u4e0e\u53c2\u6bd4\u5236\u5242<\/span>CQA<\/span>\u7684\u4e00\u81f4\u6027\u3002\u201d<\/span><\/p>\n


<\/p>\n

\u672c\u6587\u6240\u9644\u7684\u53c2\u8003\u6587\u732e\uff0c\u4e3a\u5927\u5bb6\u63d0\u4f9b\u4e86\u4e86\u89e3\u8be5\u9886\u57df\u5f53\u524d\u7814\u7a76\u8fdb\u5c55\u7684\u5feb\u6377\u9014\u5f84\u3002\u5728\u7814\u7a76\u4e0e\u5f00\u53d1\u4e2d\uff0c\u9664\u4e86\u9700\u8981\u4e86\u89e3\u6b27\u7f8e\u65e5\u7b49\u56fd\u5bf9\u5242\u91cf\u503e\u6cfb\u7684\u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u8981\u6c42\u5916\uff0c\u5242\u91cf\u503e\u6cfb\u5728\u5236\u5242\u5904\u65b9\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4ecd\u9700\u8981\u5173\u6ce8\u539f\u8f85\u6599\u7684\u7406\u5316\u6027\u8d28\u3001\u5904\u65b9\u8bbe\u8ba1\u3001\u751f\u4ea7\u5de5\u827a\u9009\u62e9\u7b49\u5173\u952e\u56e0\u7d20\uff0c\u624d\u80fd\u964d\u4f4e\u540e\u671f\u653e\u5927\u751f\u4ea7\u548c\u6ce8\u518c\u7533\u62a5\u7684\u98ce\u9669\u3002<\/span><\/p>\n


<\/p>\n

\u7531\u4e8e\u672c\u4eba\u6c34\u5e73\u6709\u9650\uff0c\u8bd1\u6587\u4e2d\u9519\u6f0f\u4e4b\u5904\u5728\u6240\u96be\u514d\uff0c\u656c\u8bf7\u5404\u4f4d\u5e08\u957f\u3001\u540c\u884c\u63d0\u51fa\u6279\u8bc4\u548c\u5efa\u8bae\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

\u53c2\u8003\u6587\u732e<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

1.R. J. Meyer et al., FDA\u00b4s ACPD Meeting 2005, Awareness Topic: Mitigating the Risks of Ethanol Induced Dose Dumping from Oral Sustained \/ Controlled Release Dosage Forms.<\/span>
<\/p>\n

2.J.W. Dundee et al., Anesthesia & Analgesia 48 (4) 665\u20139 (1969).<\/span><\/p>\n

3.FDA, Information for Healthcare Professionals: Hydromorphone Hydrochloride Extended-Release Capsules (marketed as Palladone), accessed Aug. 6, 2015.<\/span><\/p>\n

4.H. Lennern\u00e4s, Mol Pharm. 6 (5) 1429\u201340 (2009).<\/span><\/p>\n

5.FDA, Palladone, accessed Aug. 6, 2015.<\/span><\/p>\n

6.FDA ALERT [7\/2005]: Alcohol-Palladone Interaction, accessed Aug. 6,2015.<\/span><\/p>\n

7.EMA, Modified Release Oral and Transdermal Dosage Forms: Section II (EMA\/CHMP\/EWP\/280<\/span><\/p>\n

\/96Rev1), effective January 2000, (London, July 1999).<\/span><\/p>\n

8.EMA, Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms (EMA\/CPMP\/EWP\/280\/96 Corr1), effective June 2015(London, Feb.2013).<\/span><\/p>\n

9.EMA, Quality of medicines questions and answers: Part 2, Subchapter: Specific types of product\u2014Need for in-vitro dissolution studies with alcoholfor modified release oral products including opioid drug products  [15] , accessed Aug. 6, 2015.<\/span><\/p>\n

10. FDA, Quality by Design for ANDAs: An Example for Modified Release Dosage Forms (Rockville, MD, Dec. 2011).<\/span><\/p>\n

11.Health Canada, Draft Guidance Document\u2014Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions(ANDSs), (Ontario, Sept. 2013).<\/span><\/p>\n

12.EMA, Assessment report for authorized modified-release oral medicinal products of the WHO level III scale for the management of pain (intense sustained pain resistant to previous medications) (containing morphine, oxycodone, and hydromorphone) (EMA\/355008 \/ <\/span>2011) <\/span>London, April 2011).<\/span><\/p>\n

13.Barbara M. Davit, Acting Director, Division of Bioequivalence, OGD,FDA, Presentation at the AAPS Annual Meeting, October 27, 2011, Washington Convention Center, Washington, D.C.<\/span><\/p>\n

14.O. Anand et al., AAPS Journal 13 (3) 328-355 (2011).<\/span><\/p>\n

15.FDA, Guidance for Industry ANDA Submissions\u2014Refuse-to-Receive Standards (Rockville, MD, May 2015).<\/span><\/p>\n

16.FDA:Bioequivalence Recommendations for Specific Products, accessed Aug.6, 2015.<\/span><\/p>\n

17.FDA, Draft Guidance on Metoprolol Succinate (Rockville, MD, April2008).<\/span><\/p>\n

18.FDA, Draft Guidance on Clonidine (Rockville, MD, Aug. 2010).<\/span><\/p>\n

19.FDA, Draft Guidance on Memantine Hydrochloride (Rockville, MD, Dec.2014).<\/span><\/p>\n

20.FDA, Draft Guidance on Metformin Hydrochloride; Sitagliptin Phosphate (Rockville, MD, July 2014).<\/span><\/p>\n

21.FDA, Draft Guidance on Trospium Chloride (Rockville, MD, Aug. 2008).<\/span><\/p>\n

22.D.M. Mudie et al., Mol Pharm. 11 (9) 3039-3047 (2014).<\/span><\/p>\n

23.M.D. Levitt et al., Am J Physiol. 273 (4) 951-957 (1997).<\/span><\/p>\n

24.H. Kakish, Bioequivalence Data Submission Requirements.<\/span><\/p>\n

25.N. Jedinger et al., Eur J Pharm Biopharm. 87 (2) 217-226 (2014).<\/span><\/p>\n

26.FDA, CDER Guidance for Industry\u2014Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In-Vitro\/In-Vivo Correlations (Rockville, MDSept. 1997).<\/span><\/p>\n

27.FDA, CDER, Guidance for Industry\u2014Dissolution Testing of Immediate Release Solid Oral Dosage Forms, (Rockville, MD, Aug. 1997).<\/span><\/p>\n

28.FDA, CDER, Guidance for Industry\u2014SUPAC-MR: Modified Release Solid \/Oral Dosage Forms  (Rockville, MD, Sept 1997).<\/span><\/p>\n

29.J. W. Moore and H. H. Flanner, Pharm Tech. 20 (6) 64\u201374 (1996).<\/span><\/p>\n

30.FAO, Xanthan Gum, accessed Aug. 6, 2015.<\/span><\/p>\n

31.FAO, Carob Bean Gum, accessed Aug. 6, 2015.<\/span><\/p>\n

32.D.S. Craig, Pharmacy and Therapeutics, 35 (6) 324\u2013329, 357 (2010).<\/span><\/p>\n

33.L.S. Henderson et al., J ClinPharmacol. 47 (11) 1358\u20131365 (2007).<\/span><\/p>\n

34.<\/span>\u56fd\u5bb6\u4eff\u5236\u836f\u8d28\u91cf\u4e00\u81f4\u6027\u8bc4\u4ef7\u2014\u2014\u8c22\u6c90\u98ce<\/span><\/p>\n

35.<\/span>\u6eb6\u51fa\u5ea6<\/span>\/<\/span>\u91ca\u653e\u5ea6\u7814\u7a76\u4e2d\u4e3a\u4ec0\u4e48\u8981\u505a\u5242\u91cf\u503e\u6cfb\u8bd5\u9a8c\u2014\u2014\u5f20\u54f2\u5cf0<\/span><\/p>\n


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

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