{"id":98495,"date":"2019-03-27T00:00:50","date_gmt":"2019-05-17T08:15:07","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98495\/"},"modified":"2019-05-17T16:15:09","modified_gmt":"2019-05-17T08:15:09","slug":"966dd05986","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98495\/","title":{"rendered":"\u7f8e\u56fdFDA\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u7684\u4fee\u8ba2\u4e0e\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7"},"content":{"rendered":"
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Revision of U. S. FDA bioequivalence guidelines for specific products and <\/span><\/strong>consistency evaluation of generic drugs<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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1.1 \u53d7\u8bd5\u8005<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u76d0\u9178\u6c2f\u4e19\u55ea\u7247\u3001\u76d0\u9178\u666e\u7f57\u5e15\u916e\u7247\u3001\u785d\u9178\u5f02\u5c71\u68a8\u916f\u7247\u3001\u6c1f\u5eb7\u5511\u7247\u3001\u4e59\u9170\u5511\u80fa\u7247\u3001\u786b\u9178\u5417\u5561\u7f13\u91ca\u7247\u7684<\/span>\u5973\u6027\u53d7\u8bd5\u8005\u5747\u7531\u201c\u975e\u5b55\u5973\u6027\u201d\u4fee\u8ba2\u4e3a\u201c\u975e\u5b55\u3001\u975e\u54fa<\/span>\u4e73\u671f\u5973\u6027\u201d\u3002\u901a\u8fc7\u5bf9\u6bd4FDA\u540c\u65f6\u671f\u4fee\u8ba2\u7684\u975e289\u76ee\u5f55<\/span>\u54c1\u79cd\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u53ef\u77e5\uff0c\u591a\u4e2a\u54c1\u79cd\u7684\u5973\u6027\u53d7\u8bd5\u8005\u5747\u4e0e\u4e0a\u8ff06\u4e2a\u54c1\u79cd\u7684\u4fee\u8ba2\u76f8\u540c\uff0c\u8bf4\u660eFDA\u5728\u5973\u6027\u53d7<\/span>\u8bd5\u8005\u7684\u7b5b\u9009\u4e0a\u8f83\u4e4b\u4ee5\u5f80\u66f4\u52a0\u7684\u8c28\u614e\u548c\u4e25\u683c\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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1.2 \u4f53\u5185\u8bd5\u9a8c\u7684\u8c41\u514d\u8bf7\u6c42<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u5728\u6b64\u6b21\u4fee\u8ba2\u4e2d\uff0c\u785d\u9178\u5f02\u5c71\u68a8\u916f\u7247\u5bf95mg\u89c4\u683c\u7b26\u5408\u6761\u4ef6\u7684\u5236\u5242\u589e\u52a0\u4e86\u4f53\u5185\u8bd5\u9a8c\u7684\u8c41\u514d\u8bf7\u6c42\uff1b\u76d0\u9178\u82ef<\/span>\u6d77\u62c9\u660e\u80f6\u56ca\u5bf9\u4f53\u5185\u8bd5\u9a8c\u7684\u8c41\u514d\u8bf7\u6c42\u660e\u786e\u4e86\u201c\u4e0d\u9002<\/span>\u7528\u201d\uff1b\u5730\u9ad8\u8f9b\u7247\u5728\u4fee\u8ba2\u524d\u4ec5\u5141\u8bb80.125mg\u89c4\u683c\u7b26\u5408<\/span>\u6761\u4ef6\u7684\u5236\u5242\u7533\u8bf7\u8c41\u514d\uff0c\u4fee\u8ba2\u540e\u5141\u8bb80.0625\u30010.125\u548c<\/span>0.1875mg 3\u79cd\u89c4\u683c\u7b26\u5408\u6761\u4ef6\u7684\u5236\u5242\u7533\u8bf7\u8c41\u514d\u3002<\/span><\/p>\n

\u7ecf\u67e5\uff0c<\/span>\u785d\u9178\u5f02\u5c71\u68a8\u916f\u7247\u5728289\u76ee\u5f55\u4e2d\u7684\u89c4\u683c\u4e3a5mg\uff0c\u6309\u7167\u4fee<\/span>\u8ba2\u540e\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff0c\u53ef\u4ee5\u7533\u8bf7BE\u8c41\u514d\u3002\u5730\u9ad8<\/span>\u8f9b\u5c5e\u7a84\u6cbb\u7597\u6307\u6570\u836f\u7269\uff0c\u4e34\u5e8a\u4e0a\u5bf9\u4e8e\u809d\u80be\u529f\u80fd\u51cf\u9000\u7684<\/span>\u8001\u5e74\u4eba\uff0c\u63a8\u8350\u4ece\u5c0f\u5242\u91cf(0.0625mg)\u5f00\u59cb\uff0c\u6309\u7167\u808c\u9150<\/span>\u6e05\u9664\u7387\u8c03\u6574\u7ed9\u836f\u5242\u91cf\u3002\u808c\u9150\u6e05\u9664\u7387\u57288~25mL\/min\u65f6<\/span>\u63a8\u83500.125mg\uff0c\u572826~49mL\/min\u65f6\u63a8\u83500.1875mg\uff0c50~79mL\/min\u65f6\u63a8\u83500.25mg[12]\u3002<\/span><\/p>\n

FDA\u5bf9\u8be5\u54c1\u79cd\u589e\u52a0\u5141<\/span>\u8bb8\u7533\u8bf7BE\u8c41\u514d\u7684\u5236\u5242\u89c4\u683c\uff0c\u6709\u52a9\u4e8e\u4fc3\u8fdb\u66f4\u7b26\u5408\u4e34\u5e8a<\/span>\u9700\u8981\u7684\u4ea7\u54c1\u7684\u5f00\u53d1\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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1.3 \u7814\u7a76\u7c7b\u578b<\/span><\/strong>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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\u5728\u4fee\u8ba2\u540e\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u6c1f\u5eb7\u5511\u7247\u3001\u4e59\u9170\u5511\u80fa\u7247\u589e\u52a0\u4e86\u9910\u540e\u8bd5\u9a8c(\u4fee\u8ba2\u524d\u4ec5\u8fdb\u884c\u7a7a\u8179\u8bd5\u9a8c)\uff0c\u786b\u9178\u5417\u5561\u7f13\u91ca\u7247\u8fd8\u589e\u52a0\u4e86\u4f53\u5185\u6ee5\u7528\u5a01\u6151\u7814\u7a76(\u4fee\u8ba2\u524d\u4ec5\u8fdb\u884c\u7a7a\u8179\u8bd5\u9a8c\u548c\u9910\u540e\u8bd5\u9a8c)\u3002<\/span><\/p>\n

\u7b14\u8005\u6ce8\u610f\u5230\uff0c\u4e59\u9170\u5511\u80fa\u7247\u7684FDA\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u7684\u4fee\u8ba2\u53d1\u5e03\u65e5\u671f\u662f2018\u5e749\u6708\uff0c\u800c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u4e8e2018\u5e745\u670825\u65e5\u53d1\u5e03\u4e862018\u5e74\u7b2c32\u53f7\u901a\u544a\uff0c\u9644\u4ef6\u4e2d\u53d1\u5e03\u4e86\u53ef\u8c41\u514d\u6216\u7b80\u5316\u4eba\u4f53BE\u8bd5\u9a8c\u54c1\u79cd\uff0c\u4e59\u9170\u5511\u80fa\u7247\u53ef\u8c41\u514d\u9910\u540eBE\u7814\u7a76[13]\u3002<\/span><\/p>\n

\u4ece\u65f6\u95f4\u4e0a\u770b\uff0c\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u5141\u8bb8\u8c41\u514d\u9910\u540e\u8bd5\u9a8c\u5728\u5148\uff0c\u800cFDA\u589e\u52a0\u9910\u540e\u8bd5\u9a8c\u5728\u540e\uff1b\u4ece\u5408\u7406\u7528\u836f\u4e0a\u770b\uff0c\u4e59\u9170\u5511\u80fa\u7247\u5728\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\u901a\u5e38\u5efa\u8bae\u4e0e\u98df\u7269\u540c\u670d\u4ee5\u51cf\u5c11\u80c3\u80a0\u9053\u53cd\u5e94\uff0c\u56e0\u6b64\u5efa\u8bae\u5728\u4e00\u81f4\u6027\u8bc4\u4ef7\u4e2d\uff0c\u5bf9\u8be5\u54c1\u79cd\u8c41\u514d\u9910\u540eBE\u7814\u7a76\u7684\u5408\u7406\u6027\u518d\u505a\u8bc4\u4f30\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u786b\u9178\u5417\u5561\u7f13\u91ca\u7247\uff0c\u4fee\u8ba2\u540e\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u589e\u52a0\u4e86\u4f53\u5185\u6ee5\u7528\u5a01\u6151\u7814\u7a76(in vivo abuse deterrence study)\u3002\u5417\u5561\u5c5e\u963f\u7247\u7c7b\u836f\u7269\uff0c\u963f\u7247\u7c7b\u836f\u7269\u6ee5\u7528\u5728\u5168\u7403\u5df2\u6210\u4e3a\u4e25\u91cd\u7684\u516c\u5171\u536b\u751f\u95ee\u9898\uff0c\u800c\u9632\u6ee5\u7528\u963f\u7247\u7c7b\u5236\u5242\u53ef\u4e0d\u540c\u7a0b\u5ea6\u5730\u963b\u6b62\u6ee5\u7528\u3002FDA\u4e3a\u9f13\u52b1\u3001\u652f\u6301\u548c\u52a0\u901f\u7814\u53d1\u53ef\u904f\u5236\u6ee5\u7528\u7684\u963f\u7247\u7c7b\u4ea7\u54c1\uff0c\u4e8e2013\u5e741\u67089\u65e5\u516c\u5e03\u4e86\u201c\u9632\u6ee5\u7528\u7684\u963f\u7247\u7c7b\u836f\u7269\u2014\u8bc4\u4ef7\u548c\u8bf4\u660e\u4e66\u201d\u6307\u5bfc\u539f\u5219(\u8349\u6848)\uff0c\u5e76\u4e8e2015\u5e744\u67081\u65e5\u5728\u300a\u8054\u90a6\u8bb0\u4e8b\u300b\u4e2d\u901a\u77e5\u4e86\u6700\u7ec8\u6307\u5357\u7684\u53d1\u5e03[14]\u3002<\/span><\/p>\n

\u7531\u4e8eFDA\u5df2\u7ecf\u786e\u5b9a\u786b\u9178\u5417\u5561\u7f13\u91ca\u7247\u7684\u53c2\u6bd4\u5236\u5242(RLD)\u5177\u6709\u9884\u671f\u80fd\u591f\u963b\u6b62\u6ee5\u7528\u7684\u7279\u6027\uff0c\u4f9d\u636eFDA\u53d1\u5e03\u7684\u201c\u8bc4\u4ef7\u53e3\u670d\u56fa\u4f53\u963f\u7247\u7c7b\u836f\u7269\u4eff\u5236\u836f\u6ee5\u7528\u5a01\u6151\u7684\u4e00\u822c\u6027\u539f\u5219\u201d [15](general principles for evaluating the abuse deterrence of generic solid oral opioid drug products)\u7684\u8981\u6c42\uff0c\u5e94\u8bc1\u660e\u5728\u6240\u6709\u53ef\u80fd\u7684\u6ee5\u7528\u9014\u5f84\u4e0b\uff0c\u4eff\u5236\u5236\u5242\u5177\u6709\u4e0d\u4f4e\u4e8e\u53c2\u6bd4\u5236\u5242\u7684\u9632\u6ee5\u7528\u63aa\u65bd\uff0c\u5c06\u4eff\u5236\u5236\u5242\u6ee5\u7528\u7684\u98ce\u9669\u964d\u5230\u6700\u4f4e\u3002<\/span><\/p>\n

\u63a8\u8350\u8fdb\u884c\u7a7a\u8179\u6761\u4ef6\u4e0b\u4eff\u5236\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u9f3b\u8154\u7ed9\u836f\u836f\u52a8\u5b66(PK)\u6bd4\u8f83\u7814\u7a76\uff0c\u53ef\u4f7f\u7528\u5439\u6c14\u65b9\u5f0f\u8fdb\u884c\u7b2c2\u7ea7(\u836f\u52a8\u5b66)\u6ee5\u7528\u8bc4\u4f30\u3002<\/span><\/p>\n

\u91c7\u7528\u5355\u6b21\u7ed9\u836f\uff0c\u53cc\u5904\u7406\uff0c\u4e24\u5468\u671f\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\uff0c60mg\u7ed9\u836f\u5242\u91cf\uff0c\u9009\u62e9\u975e\u4f9d\u8d56\u6027\u6d88\u9063\u963f\u7247\u7c7b\u836f\u7269\u4f7f\u7528\u8005\u6216\u4e00\u822c\u4eba\u7fa4\u4f5c\u4e3a\u53d7\u8bd5\u8005\u3002\u6d4b\u5b9a\u76f8\u5173\u7684PK\u53c2\u6570\uff0c\u5305\u62ec\u6700\u5927\u5cf0\u6d53\u5ea6(Cmax)\u3001\u66f2\u7ebf\u4e0b\u9762\u79ef(<\/span>AUC0~t<\/sub>\u548c<\/span>AUC0~\u221e<\/sub>)\u3001\u8fbe\u5cf0\u65f6\u95f4(T<\/span>max<\/span>)\uff0c\u4ee5\u53ca\u90e8\u5206\u622a\u53d6\u7684AUC(\u4f8b\u5982<\/span>AUC0~3h<\/sub>\u548c<\/span>AUC0~4h<\/sub>)\u4f5c\u4e3a\u652f\u6301\u6027\u6570\u636e\u3002<\/span><\/p>\n

\u88681 10\u4e2a\u54c1\u79cdFDA\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u7684\u4fee\u8ba2\u60c5\u51b5<\/strong><\/span><\/p>\n

Tab. 1 Revision of U.S. FDA bioequivalence guidelines for 10 specific products<\/strong><\/span><\/p>\n

\"\u7f8e\u56fdFDA\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u7684\u4fee\u8ba2\u4e0e\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\"<\/p>\n

<\/span>*\uff1a149\u53f7\u54c1\u79cd\u4e3a\u4e19\u620a\u9178\u94a0\u7247\uff0c\u7f51\u7ad9\u53d1\u5e03\u7684\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u4e3a\u4e19\u620a\u9178\u80f6\u56ca\uff0c\u56fd\u5916\u6587\u732e\u4e00\u822c\u5bf9\u4e19\u620a\u9178(Valproic Acid)\u53ca\u5176\u94a0\u76d0(Valproate)\u4e0d\u505a\u533a\u5206<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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1.4 \u8bd5\u9a8c\u8bbe\u8ba1<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e19\u620a\u9178\u80f6\u56ca\u3001\u5730\u9ad8\u8f9b\u7247\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u5747\u7531\u201c\u5355\u6b21\u7ed9\u836f\uff0c\u53cc\u5411\u4ea4\u53c9\u4f53\u5185\u8bd5\u9a8c\u201d\u4fee\u8ba2\u4e3a\u201c\u5355\u6b21\u7ed9\u836f\uff0c<\/span>\u53cc\u5904\u7406\uff0c\u4e24\u5e8f\u5217\uff0c\u56db\u5468\u671f\uff0c\u5b8c\u5168\u91cd\u590d\u4ea4\u53c9\u4f53\u5185\u8bd5<\/span>\u9a8c\u201d\uff0c\u7b26\u5408FDA\u4e8e2012\u5e7412\u6708\uff0c\u5728\u4ee5\u534e\u6cd5\u6797\u94a0\u4e3a\u53c2<\/span>\u9605\u6807\u51c6\u53d1\u5e03\u7684\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u5bf9\u7a84\u6cbb\u7597\u6307<\/span>\u6570\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6240\u505a\u7684\u4fee\u8ba2[16]\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u7a84\u6cbb\u7597\u6307\u6570(narrow therapeutic index, NTI)\u836f\u7269\uff0cFDA\u5b9a\u4e49\u4e3a\u201c\u836f\u7269\u5242\u91cf\u6216\u8840\u836f\u6d53\u5ea6\u7684\u5fae\u5c0f\u5dee<\/span>\u5f02\u5c31\u53ef\u4ee5\u80fd\u5bfc\u81f4\u4e25\u91cd\u6cbb\u7597\u5931\u8d25\u548c(\u6216)\u836f\u54c1\u4e0d\u826f\u53cd\u5e94<\/span>\u7684\u836f\u7269\uff0c\u5373\u53ef\u5371\u53ca\u751f\u547d\u6216\u5bfc\u81f4\u6301\u4e45\u7684\u6216\u660e\u663e\u7684\u6b8b\u75be<\/span>\u6216\u5931\u80fd\u201d[17]\u3002<\/span><\/p>\n

\u57282017\u5e748\u6708\u53d1\u5e03\u4fee\u8ba2\u7684\u751f\u7269\u7b49\u6548\u6027\u6307<\/span>\u5bfc\u539f\u5219\u4e2d\uff0c\u4e19\u620a\u9178\u3001\u5730\u9ad8\u8f9b\u5747\u88abFDA\u5b9a\u4e49\u4e3aNTI\u836f<\/span>\u7269\u3002<\/span><\/p>\n

2010\u5e74\u4ee5\u524d\uff0cFDA\u5236\u5b9a\u7684\u7279\u5b9a\u836f\u7269BE\u8bd5\u9a8c\u6307\u5bfc<\/span>\u539f\u5219\uff0c\u5bf9NTI\u836f\u7269\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u751f\u7269\u7b49\u6548\u9650\u8981\u6c42\u4e0e\u975e<\/span>NTI\u836f\u7269\u76f8\u540c\u3002<\/span><\/p>\n

2010\u20142011\u5e74\uff0cFDA\u5bf9NTI\u836f\u7269\u7684\u751f<\/span>\u7269\u7b49\u6548\u9650\u768490%\u7f6e\u4fe1\u533a\u95f4\u5982\u4f55\u8bbe\u7f6e\u66f4\u5408\u7406\u8fdb\u884c\u4e86\u4e00<\/span>\u7cfb\u5217\u7684\u7814\u7a76\uff0c\u5bf9\u6bd4\u4e86\u76f4\u63a5\u6536\u7a84\u751f\u7269\u7b49\u6548\u9650\u6807\u51c6\u7684\u65b9<\/span>\u6cd5\u548c\u6839\u636e\u53c2\u6bd4\u5236\u5242\u7684\u53d8\u5f02\u6027\u6536\u7a84\u751f\u7269\u7b49\u6548\u9650\u6807\u51c6\u7684<\/span>\u65b9\u6cd5\uff0c\u5373\u53c2\u6bd4\u5236\u5242\u6807\u5ea6\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u6cd5(referencescaled average bioequivalence, RSABE)\uff0c\u8ba4\u4e3a\u540e\u8005\u66f4<\/span>\u52a0\u5408\u7406\u3002<\/span><\/p>\n

\u7efc\u5408NTI\u836f\u7269\u7279\u6027\u548c\u4e34\u5e8a\u5e94\u7528\u7684\u98ce\u9669\uff0cFDA<\/span>\u5efa\u8bae\u4f7f\u7528RSABE\u6cd5\uff0c\u4ee5\u5bf9\u6bd4\u4eff\u5236\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684<\/span>\u4e2a\u4f53\u5185\u53d8\u5f02(within-subject variability, WSV)\u60c5\u51b5\uff0c\u5e76<\/span>\u540c\u65f6\u4fdd\u7559\u4e86\u975e\u6807\u5ea6\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u9650\u6765\u786e\u5b9a\u5404\u4e2aPK<\/span>\u53c2\u6570\u7684\u751f\u7269\u7b49\u6548\uff0c\u5373\u6240\u6709\u7684BE\u8bd5\u9a8c\u65e2\u8981\u901a\u8fc7\u53c2\u6bd4\u5236<\/span>\u5242\u6807\u5b9a\u7684\u751f\u7269\u7b49\u6548\u9650\u53c8\u8981\u901a\u8fc7\u5e38\u89c4\u7684\u975e\u6807\u5b9a\u751f\u7269\u7b49<\/span>\u6548\u9650\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u4ece2012\u5e74\u5f00\u59cb\uff0cFDA\u5236\u5b9a\u548c<\/span>\u4fee\u8ba2\u7684\u7279\u5b9a\u836f\u7269BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u5bf9NTI\u836f\u7269\u63a8<\/span>\u8350\u91c7\u7528\u5355\u6b21\u7ed9\u836f\uff0c\u53cc\u5904\u7406\uff0c\u4e24\u5e8f\u5217\uff0c\u56db\u5468\u671f\uff0c\u5b8c\u5168<\/span>\u91cd\u590d\u4ea4\u53c9\u4f53\u5185\u8bd5\u9a8c\uff0c\u4ee5\u51c6\u786e\u4f30\u8ba1\u4e2a\u4f53\u5185\u53d8\u5f02[18]\u3002<\/span><\/p>\n

\u5bf9\u4e8eNTI\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\uff0c\u6211\u56fd\u76ee\u524d\u6682\u65e0\u76f8\u5173\u7684\u6307\u5bfc\u539f\u5219\uff0c\u4e5f\u672a\u89c1\u5b98\u65b9\u516c\u5e03\u7684NTI\u836f\u7269\u76ee<\/span>\u5f55\u3002<\/span><\/p>\n

2015\u7248\u4e2d\u56fd\u836f\u5178\u56db\u90e8\u201c\u836f\u7269\u5236\u5242\u4eba\u4f53\u751f\u7269\u5229\u7528<\/span>\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u201d\u63d0\u51fa\u201c\u5bf9\u4e8e\u6cbb\u7597\u6307<\/span>\u6570\u7a84\u7684\u836f\u54c1\u7684\u7279\u6b8a\u60c5\u51b5\uff0cAUC\u7684\u53ef\u63a5\u53d7\u533a\u95f4\u5e94\u8be5\u88ab<\/span>\u7f29\u7a84\u4e3a90.00%~111.11%\uff0c\u5728Cmax\u5bf9\u5b89\u5168\u6027\u3001\u836f\u6548\u6216<\/span>\u836f\u7269\u6d53\u5ea6\u76d1\u6d4b\u7279\u522b\u91cd\u8981\u7684\u60c5\u51b5\u4e0b\uff0c\u8be5\u53c2\u6570\u4e5f\u9002\u752890.00%~111.11%\u7684\u63a5\u53d7\u9650\u201d[19]\u3002<\/span><\/p>\n

\u4f5c\u4e3a\u5f00\u5c55\u4eff\u5236\u836f\u8d28<\/span>\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u6307\u5bfc\u6027\u6280\u672f\u6587\u4ef6\uff0c\u56fd\u5bb6\u98df\u54c1<\/span>\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u57282016\u5e74\u7b2c61\u53f7\u901a\u544a\u9644\u4ef6\u4e2d\u53d1\u5e03<\/span>\u4e86\u300a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236<\/span>\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff0c\u6307\u51fa\u201c\u5bf9<\/span>\u4e8e\u7a84\u6cbb\u7597\u7a97\u836f\u7269\uff0c\u5e94\u6839\u636e\u836f\u7269\u7684\u7279\u6027\u9002\u5f53\u7f29\u5c0f90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u8303\u56f4\u201d[20]\uff0c\u4f46\u672a\u63a8\u8350NTI\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027<\/span>\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6848\u3002<\/p>\n

\u636e\u7b14\u8005\u7c97\u7565\u7edf\u8ba1\uff0c289\u76ee\u5f55\u5185\u88ab\u7f8e\u56fdFDA\u3001\u52a0\u62ff\u5927\u536b\u751f\u5c40(HC)\u3001\u6b27\u76dfEMA\u3001\u65e5\u672cPMDA\u7b49\u56fd\u9645\u4e0a\u4e3b<\/span>\u8981\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u6536\u5165NTI\u836f\u7269\u76ee\u5f55[18]\u7684\u54c1\u79cd\u5927\u81f4\u670917<\/span>\u79cd\uff0c\u5305\u62ec\u6c28\u8336\u78b1\u3001\u5361\u9a6c\u897f\u5e73\u3001\u514b\u6797\u9709\u7d20\u3001\u7094\u96cc\u9187\u3001<\/span>\u9502\u3001\u82ef\u59a5\u82f1\u3001\u54cc\u5511\u55ea\u3001\u8336\u78b1\u3001\u4e19\u620a\u9178\u3001\u534e\u6cd5\u6797\u3001\u5de6<\/span>\u65cb\u7532\u72b6\u817a\u7d20\u3001\u73af\u5b62\u7d20\u3001\u5730\u9ad8\u8f9b\u3001\u6c2f\u785d\u897f\u6cee\u3001\u7532\u6c28\u8776<\/span>\u5464\u3001\u82ef\u5df4\u6bd4\u59a5\u3001\u683c\u5217\u672c\u8132\u7b49\u3002<\/span><\/p>\n

\u7ecf\u67e5\u8be2\u56fd\u5bb6\u98df\u54c1\u836f\u54c1<\/span>\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u5b98\u65b9\u7f51\u7ad9\u7684\u4e00\u81f4\u6027\u8bc4\u4ef7<\/span>\u4fe1\u606f\u516c\u5f00\uff0c\u622a\u81f32018\u5e7411\u670830\u65e5\uff0c\u4e0a\u8ff017\u4e2a\u54c1\u79cd\u4e2d<\/span>\u4ec5\u514b\u6797\u9709\u7d201\u4e2a\u54c1\u79cd\u67091\u5bb6\u4f01\u4e1a\u76842\u4e2a\u89c4\u683c\u80f6\u56ca\u4ea7\u54c1\u4e8e<\/span>2018\u5e7411\u670820\u65e5\u901a\u8fc7\u4e86\u4e00\u81f4\u6027\u8bc4\u4ef7\uff0c\u8be5\u4f01\u4e1a\u662f\u8be5\u54c1<\/span>\u79cd\u9996\u5bb6\u901a\u8fc7\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u4f01\u4e1a\u3002\u53ef\u89c1\u7edd\u5927\u90e8\u5206NTI\u836f<\/span>\u7269\u7684\u4e00\u81f4\u6027\u8bc4\u4ef7\u76ee\u524d\u4ecd\u5904\u4e8e\u8fdb\u884c\u4e2d\u751a\u81f3\u89c2\u671b\u4e2d\u3002<\/span><\/p>\n

\u8bf4<\/span>\u660e\u4e00\u65b9\u9762\u4e1a\u5185\u4eba\u58eb\u9488\u5bf9NTI\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u4e9f<\/span>\u9700\u5f00\u5c55\u6df1\u5165\u7ec6\u81f4\u7684\u7814\u7a76\u548c\u63a2\u8ba8\uff0c\u53e6\u4e00\u65b9\u9762\u6709\u5173\u90e8\u95e8<\/span>\u4ea6\u5e94\u5c3d\u65e9\u51fa\u53f0\u76f8\u5173\u7684\u6307\u5bfc\u539f\u5219\uff0c\u4ee5\u4fc3\u8fdbNTI\u836f\u7269\u4e00\u81f4<\/span>\u6027\u8bc4\u4ef7\u5de5\u4f5c\u7684\u5f00\u5c55\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

1.5 \u5176\u4ed6\u4fee\u8ba2<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u7b14\u8005\u6ce8\u610f\u5230\uff0c\u5bf9\u4e8e\u76d0\u9178\u666e\u7f57\u5e15\u916e\u7247\u548c\u6c1f\u5eb7\u5511\u7247\u4e24\u4e2a\u54c1\u79cd\uff0c FDA\u5206\u522b\u4e8e2011\u5e7410\u6708\u548c2008\u5e745\u6708\u53d1\u5e03<\/span>\u4e86\u6700\u7ec8\u7248\u672c\u3002\u4f462018\u5e742\u67088\u65e5\uff0cFDA\u5728\u5176\u7f51\u7ad9\u4e0a\u66f4<\/span>\u65b0\u4e86\u6536\u56de\u5df2\u53d1\u5e03\u6700\u7ec8\u7248\u672c\u7684\u54c1\u79cd\u5217\u8868[21]\uff0c\u4e0a\u8ff0\u4e24\u4e2a<\/span>\u54c1\u79cd\u5206\u522b\u4e8e2017\u5e747\u6708\u548c2018\u5e742\u6708\u88ab\u6536\u56de\uff0c\u5e76\u540c\u671f<\/span>\u91cd\u65b0\u53d1\u5e03\u4e86\u4fee\u8ba2\u7a3f\u3002<\/p>\n

\u76d0\u9178\u666e\u7f57\u5e15\u916e\u7247\u5c5e\u9ad8\u53d8\u5f02\u836f\u7269(highly variable drug)\uff0cFDA\u4ece2004\u5e74\u8d77\u5bf9\u9ad8\u53d8\u5f02\u836f\u7269\u5f00\u5c55\u4e86\u5927\u91cf\u7814<\/span>\u7a76\uff0c2008\u5e74\u51b3\u5b9a\u5bf9\u9ad8\u53d8\u5f02\u836f\u7269\u91c7\u7528\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684<\/span>\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u65b9\u6848\u3002\u5728\u5927\u91cf\u7814\u7a76\u7684\u57fa\u7840\u4e0a\uff0c<\/span>FDA\u4e8e2010\u5e744\u6708\u53d1\u5e03\u4e86\u7b2c\u4e00\u4e2a\u9ad8\u53d8\u5f02\u836f\u7269\u5b55\u916e\u80f6\u56ca<\/span>\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff0c\u5e76\u4e8e2011\u5e742\u6708\u5bf9\u5176\u8fdb\u884c\u4e86\u4fee<\/span>\u8ba2\uff0c\u4f5c\u4e3a\u5728\u6b64\u4e4b\u540e\u4fee\u8ba2\u6216\u65b0\u589e\u7684\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u8bc4\u4ef7<\/span>\u65b9\u6cd5\u53c2\u9605\u4fe1\u606f[22]\u3002<\/span><\/p>\n

2017\u5e747\u6708\u88ab\u6536\u56de\u5e76\u91cd\u65b0\u53d1\u5e03\u7684\u76d0<\/span>\u9178\u666e\u7f57\u5e15\u916e\u7247BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff0c\u5373\u4e3a\u201c\u9644\u6ce8\u201d\u4e2d\u8bc4<\/span>\u4ef7\u65b9\u6cd5\u53c2\u9605\u4fe1\u606f\u7684\u53d8\u66f4\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

2<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

\u65b0\u589e\u54c1\u79cd<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

2.1 \u5730\u897f\u6cee\u7247<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2018\u5e749\u6708\uff0cFDA\u65b0\u589e\u4e86\u5730\u897f\u6cee\u7247[23]\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u3002\u63a8\u8350\u5f00\u5c55\u7a7a\u8179\u548c\u9910\u540e\u4e24\u9879\u7814\u7a76\uff0c\u91c7\u7528\u5355<\/span>\u6b21\u7ed9\u836f\uff0c\u53cc\u5411\u4ea4\u53c9\u4f53\u5185\u8bd5\u9a8c\u8bbe\u8ba1\uff0c10mg\u7ed9\u836f\u5242\u91cf\uff0c<\/span>\u9009\u62e9\u5065\u5eb7\u7537\u6027\u548c\u975e\u5b55\u3001\u975e\u54fa\u4e73\u671f\u5973\u6027\u6216\u4e00\u822c\u4eba\u7fa4\u4f5c<\/span>\u4e3a\u53d7\u8bd5\u8005\u3002<\/span><\/p>\n

\u5730\u897f\u6cee\u5c5e\u957f\u534a\u8870\u671f\u836f\u7269\uff0c\u7531\u4e8e\u6e05\u9664\u534a\u8870<\/span>\u671f\u8f83\u957f\uff0c\u7814\u7a76\u4e2d\u5e94\u786e\u4fdd\u4ea4\u53c9\u8bd5\u9a8c\u7684\u6bcf\u6b21\u7ed9\u836f\u95f4\u6709\u5145<\/span>\u5206\u7684\u6d17\u51c0\u671f\u3002\u540c\u65f6\u4e5f\u53ef\u4ee5\u8003\u8651\u91c7\u7528\u5e73\u884c\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span>\u5bf9\u4e8e\u836f\u7269\u5206\u5e03\u548c\u6e05\u9664\u4e2a\u4f53\u5185\u53d8\u5f02\u8f83\u5c0f\u7684\u957f\u534a\u8870\u671f\u836f<\/span>\u7269\uff0c\u53ef\u4ee5\u9009\u62e9\u4f7f\u7528<\/span>AUC0~72h<\/sub>\u6765\u4ee3\u66ff<\/span>AUC0~t<\/sub>\u6216<\/span>AUC0~\u221e<\/sub>\u3002<\/span><\/p>\n

\u65e0\u8bba\u662f\u4ea4\u53c9\u8bd5\u9a8c\u8fd8\u662f\u5e73\u884c\u8bd5\u9a8c\uff0c\u5747\u5e94\u786e\u4fdd\u8db3\u591f\u7684\u6837\u54c1<\/span>\u91c7\u96c6\u65f6\u95f4\u4ee5\u5b8c\u6210\u836f\u7269\u5728\u80a0\u9053\u5185\u7684\u8f6c\u8fd0\u548c\u5438\u6536\u3002\u7814\u7a76\u4e2d<\/span>\u5e94\u91c7\u96c6\u8db3\u91cf\u7684\u8840\u6db2\u6837\u672c\u6765\u5145\u5206\u5730\u63cf\u8ff0Cmax\u548c\u8fbe\u5cf0\u65f6\u95f4<\/span>Tmax\u7684\u7279\u5f81\u3002\u6307\u5bfc\u539f\u5219\u8fd8\u5141\u8bb82\u548c5mg\u89c4\u683c\u7b26\u5408\u6761\u4ef6\u7684<\/span>\u5236\u5242\u63d0\u51fa\u4f53\u5185\u8bd5\u9a8c\u7684\u8c41\u514d\u8bf7\u6c42\u3002<\/span><\/p>\n

\u6839\u636e\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u4e8e2017\u5e748\u670821\u65e5\u53d1\u5e03\u7684\u201c\u5173\u4e8e\u4f01\u4e1a\u5f00\u5c55289\u76ee\u5f55\u5185\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597<\/span>\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u57fa\u672c\u60c5\u51b5\u4fe1\u606f\u201d[24]\u7684\u7edf\u8ba1\u6c47\u603b\uff0c\u622a\u81f3<\/span>2017\u5e745\u670823\u65e5\uff0c\u56fd\u5185\u6301\u6709\u5730\u897f\u6cee\u7247\u6587\u53f7\u7684\u751f\u4ea7\u4f01\u4e1a<\/span>\u603b\u91cf\u4e3a121\u5bb6\uff0c\u7ecf\u6478\u5e95\u8c03\u7814\u786e\u5b9a\u4e0d\u653e\u5f03\u8bc4\u4ef7\u7684\u4f01\u4e1a\u6570<\/span>\u91cf\u4e3a71\u5bb6\uff0c\u7ea6\u536059%\uff0c\u5df2\u5f00\u5c55\u8bc4\u4ef7\u7684\u4f01\u4e1a\u6570\u91cf\u4e3a32<\/span>\u5bb6\uff0c\u5728\u4e0d\u653e\u5f03\u8bc4\u4ef7\u7684\u4f01\u4e1a\u4e2d\u5360\u6bd4\u4e0d\u5230\u4e00\u534a\u3002<\/span><\/p>\n

\u4f46\u7b14\u8005<\/span>\u67e5\u8be2\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u5b98\u65b9<\/span>\u7f51\u7ad9\u7684\u4e00\u81f4\u6027\u8bc4\u4ef7\u4fe1\u606f\u516c\u5f00\u540e\u53d1\u73b0\uff0c\u622a\u81f32018\u5e7411<\/span>\u670830\u65e5\uff0c\u5c1a\u65e0\u4efb\u4f55\u4f01\u4e1a\u7684\u4ea7\u54c1\u901a\u8fc7\u4e00\u81f4\u6027\u8bc4\u4ef7\u3002<\/span><\/p>\n

\u5730\u897f<\/span>\u6cee\u7247\u6536\u8f7d\u4e8e\u6700\u65b0\u7248\u7684\u5404\u56fd\u836f\u5178(\u4e2d\u56fd\u836f\u51782015\u5e74\u7248[25]\u3001<\/span>\u7f8e\u56fd\u836f\u517840\u7248[26]\u3001\u82f1\u56fd\u836f\u51782018\u5e74\u7248[27]\u3001\u65e5\u672c\u836f\u5178<\/span>17\u7248[28])\u4e2d\u3002\u7ecf\u6bd4\u8f83\uff0c\u5404\u56fd\u836f\u5178\u7684\u5206\u6790\u65b9\u6cd5\u53ca\u8d28\u91cf\u6807<\/span>\u51c6\u5b58\u5728\u5dee\u5f02\uff0c\u4e3b\u8981\u8868\u73b0\u5728\u6709\u5173\u7269\u8d28\u3001\u6eb6\u51fa\u5ea6\u3001\u542b\u91cf<\/span>\u7b49\u51e0\u4e2a\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u4e0a\u3002<\/span><\/p>\n

\u8bf4\u660e\u8be5\u54c1\u79cd\u4e00\u81f4\u6027\u8bc4\u4ef7\u8fdb<\/span>\u5c55\u7f13\u6162\uff0c\u4e00\u65b9\u9762\u53d7\u5230\u836f\u5b66\u7814\u7a76\u73af\u8282\u7684\u5236\u7ea6\uff0c\u53e6\u4e00\u65b9\u9762<\/span>\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7279\u522b\u662f\u957f\u534a\u8870\u671f\u836f\u7269BE\u8bd5\u9a8c\u7684\u590d\u6742\u6027<\/span>\u66f4\u589e\u52a0\u4e86\u8be5\u54c1\u79cd\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u96be\u5ea6\u3002<\/span><\/p>\n

FDA\u65b0\u589e\u4e86\u5730\u897f<\/span>\u6cee\u7247\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff0c\u4e3a\u76f8\u5173\u4f01\u4e1a\u5f00\u5c55\u8be5\u54c1\u79cd\u7684\u751f<\/span>\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u63d0\u4f9b\u4e86\u501f\u9274\u548c\u5e2e\u52a9\uff0c\u76f8\u4fe1\u4f1a\u5728\u4e00\u5b9a\u7a0b\u5ea6<\/span>\u4e0a\u52a0\u901f\u8be5\u54c1\u79cd\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u4f5c\u7684\u63a8\u8fdb\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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2.2 \u786b\u9178\u5417\u5561\u7f13\u91ca\u7247<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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2018\u5e749\u6708\uff0cFDA\u4fee\u8ba2\u4e86\u786b\u9178\u5417\u5561\u7f13\u91ca\u7247(100mg)\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff0c\u540c\u65f6\u65b0\u589e\u4e86\u8be5\u54c1\u79cd60mg\u89c4\u683c\u7684<\/span>BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff0c\u7814\u7a76\u65b9\u6848\u3001\u8bd5\u9a8c\u8bbe\u8ba1\u3001\u53d7\u8bd5\u8005\u3001<\/span>\u751f\u7269\u7b49\u6548\u9650\u3001\u6eb6\u51fa\u5ea6\u8bd5\u9a8c\u65b9\u6cd5\u548c\u91c7\u6837\u6b21\u6570\u7b49\u5747\u4e0e<\/span>100mg\u89c4\u683c\u7684\u76f8\u540c\uff0c\u4ec5\u7ed9\u836f\u5242\u91cf\u8c03\u6574\u4e3a60mg[29]\u3002<\/span><\/p>\n

\u786b\u9178\u5417\u5561\u7f13\u91ca\u7247\u4e3a\u5f3a\u6548\u9547\u75db\u836f\uff0c\u4e3b\u8981\u9002\u7528\u4e8e\u665a<\/span>\u671f\u764c\u75c7\u75c5\u4eba\u9547\u75db\u3002\u672c\u54c1\u540c\u65f6\u5177\u6709\u660e\u663e\u7684\u9547\u9759\u4f5c\u7528\u548c<\/span>\u5bf9\u547c\u5438\u4e2d\u67a2\u7684\u6291\u5236\u4f5c\u7528\uff0c\u4f7f\u5176\u5bf9\u4e8c\u6c27\u5316\u78b3\u5f20\u529b\u7684\u53cd<\/span>\u5e94\u6027\u964d\u4f4e\uff0c\u8fc7\u91cf\u53ef\u81f4\u547c\u5438\u8870\u7aed\u800c\u6b7b\u4ea1\u3002\u5728\u4f7f\u7528\u8bf4\u660e<\/span>\u4e66\u4e2d\u6709\u201c\u836f\u7269\u8fc7\u91cf\u201d\u7684\u53d9\u8ff0\u201c\u5417\u5561\u8fc7\u91cf\u53ef\u81f4\u6025\u6027\u4e2d<\/span>\u6bd2\uff0c\u6210\u4eba\u4e2d\u6bd2\u91cf\u4e3a60mg\uff0c\u81f4\u6b7b\u91cf\u4e3a250mg\u201d\u3002<\/span><\/p>\n

\u867d\u7136<\/span>\u8fc4\u4eca\u4e3a\u6b62\u56fd\u5185\u5916\u4e34\u5e8a\u8d44\u6599\u5c1a\u65e0\u5417\u5561\u6700\u9ad8\u9650\u5236\u5242\u91cf\u7684<\/span>\u62a5\u9053\uff0c\u4f46\u53d7\u672c\u54c1\u4e2a\u4f53\u5dee\u5f02\u8f83\u5927\u7684\u5f71\u54cd\uff0c\u5728\u4e34\u5e8a\u4e0a\u5355<\/span>\u6b21\u53e3\u670d\u5417\u5561\u7f13\u91ca\u5236\u5242<100mg\uff0c\u4ecd\u5f15\u8d77\u6025\u6027\u4e2d\u6bd2\u7b49\u4e25<\/span>\u91cd\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7684\u75c5\u4f8b\u5c61\u89c1\u62a5\u9053[30-32]\u3002<\/span><\/p>\n

\u5417\u5561\u5236\u5242\u53e3\u670d<\/span>\u7ed9\u836f\u7684\u4f7f\u7528\u5242\u91cf\u662f30mg\/\u6b21\uff0c100mg\/d[33]\u3002FDA\u5bf9\u8be5<\/span>\u54c1\u79cd\u589e\u52a060mg\u89c4\u683c\u7684BE\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff0c\u6709\u52a9\u4e8e\u964d\u4f4e<\/span>\u5065\u5eb7\u53d7\u8bd5\u8005\u5728\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u7684\u98ce\u9669\u3002<\/span><\/p>\n

\u540c\u65f6\u4e5f\u8981<\/span>\u6c42\u63d0\u524d\u7ed9\u4e88\u7eb3\u66f2\u916e\uff0c\u4ee5\u6700\u5927\u7a0b\u5ea6\u963b\u65ad\u963f\u7247\u53d7\u4f53\uff0c\u6d88<\/span>\u9664\u6240\u6709\u963f\u7247\u836f\u7269\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u7684\u98ce\u9669\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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3<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u53d1\u5e03\u6700\u7ec8\u7248\u672c\u54c1\u79cd<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u9664\u4fee\u8ba2\u4e86\u76d0\u9178\u6c2f\u4e19\u55ea\u7247\u7b4910\u4e2a\u54c1\u79cd\uff0c\u65b0\u589e\u4e86\u5730\u897f\u6cee\u7247\u7b49\u4e24\u4e2a\u54c1\u79cd\u7684\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u5916\uff0cFDA<\/span>\u4e8e2017\u5e748\u6708\u8fd8\u53d1\u5e03\u4e8611\u4e2a\u54c1\u79cd\u7684\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f<\/span>\u5219\u7684\u6700\u7ec8\u7248\u672c\uff0c\u8fd911\u4e2a\u54c1\u79cd\u662f\uff1a\u76d0\u9178\u4e59\u80fa\u4e01\u9187\u7247(28<\/span>\u53f7)\u3001\u76d0\u9178\u514b\u6797\u9709\u7d20\u80f6\u56ca(46\u53f7)\u3001\u963f\u66ff\u6d1b\u5c14\u7247(51\u53f7)\u3001<\/span>\u76d0\u9178\u7ef4\u62c9\u5e15\u7c73\u7247(84\u53f7)\u3001\u6c22\u5316\u53ef\u7684\u677e\u7247(85\u53f7)\u3001\u514b\u62c9<\/span>\u9709\u7d20\u7247(98\u53f7)\u3001\u6c2f\u785d\u897f\u6cee\u7247(131\u53f7)\u3001\u76d0\u9178\u591a\u585e\u5e73\u80f6<\/span>\u56ca(136\u53f7)\u3001\u6c28\u82ef\u781c\u7247(182\u53f7)\u3001\u963f\u83ab\u897f\u6797\u514b\u62c9\u7ef4\u9178\u94be<\/span>\u7247(244\u53f7)\u548c\u918b\u9178\u53bb\u6c28\u52a0\u538b\u7d20\u7247(287\u53f7)\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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4<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u7ed3\u8bed<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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FDA\u4ece2010\u5e746\u6708\u5f00\u59cb\u9646\u7eed\u516c\u5e03\u5e76\u6301\u7eed\u66f4\u65b0\u7684\u300a\u7279\u5b9a\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u300b\uff0c\u662f\u6211\u56fd\u5f00\u5c55\u4eff<\/span>\u5236\u836f\u8d28\u91cf\u4e0e\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u91cd\u8981\u53c2\u8003\u3002\u901a\u8fc7\u5bf9289<\/span>\u76ee\u5f55\u5185\u54c1\u79cd\u4ece2016\u5e746\u6708\u81f3\u4eca\u7684\u66f4\u65b0\u60c5\u51b5\u7684\u7814\u7a76\u548c\u5206<\/span>\u6790\uff0c\u53ef\u4ee5\u770b\u51fa\u7f8e\u56fdFDA\u5728\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u65b9\u9762\u5bf9\u4f53\u5185<\/span>\u8bd5\u9a8c\u7684\u8c41\u514d\u3001\u9910\u540eBE\u7814\u7a76\u7b49\u8d8a\u6765\u8d8a\u5177\u4f53\u5230\u54c1\u79cd\uff0c\u66f4<\/span>\u52a0\u79d1\u5b66\uff1b\u66f4\u5173\u6ce8\u53d7\u8bd5\u8005\u7684\u5065\u5eb7\uff0c\u5982\u589e\u52a0\u66f4\u4e25\u8c28\u7684\u53d7\u8bd5<\/span>\u8005\u5165\u9009\u6761\u4ef6\uff0c\u91c7\u7528\u66f4\u4f4e\u7684\u7ed9\u836f\u5242\u91cf\u7b49\uff1b\u540c\u65f6\u5bf9\u4e8e\u7a84\u6cbb<\/span>\u7597\u6307\u6570\u836f\u7269\u3001\u9ad8\u53d8\u5f02\u836f\u7269\u3001\u957f\u534a\u8870\u671f\u836f\u7269\u7684\u751f\u7269\u7b49\u6548<\/span>\u6027\u8bd5\u9a8c\u65b9\u6848\u8bbe\u8ba1\u3001\u7edf\u8ba1\u5b66\u65b9\u6cd5\u7b49\uff0c\u59cb\u7ec8\u5728\u8fdb\u884c\u7814\u7a76\u548c<\/span>\u63a2\u8ba8\u3002\u8fd9\u4e9b\u90fd\u662f\u503c\u5f97\u6211\u4eec\u5b66\u4e60\u548c\u501f\u9274\u7684\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u7f8e\u56fdFDA\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u7684\u4fee\u8ba2\u4e0e\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\"<\/p>\n
\n

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

\"\u7f8e\u56fdFDA\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u7684\u4fee\u8ba2\u4e0e\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\"<\/section>\n

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<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u8be6\u89c1\u539f\u6587\uff1a\u4e2d\u56fd\u6297\u751f\u7d20\u6742\u5fd7\uff0c2019\u5e743\u6708\u7b2c44\u5377\u7b2c3\u671f<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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<\/section>\n
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<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n
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\u514d\u8d23\u58f0\u660e<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

\u7f8e\u56fdFDA\u751f\u7269\u7b49\u6548\u6027\u6307\u5bfc\u539f\u5219\u7684\u4fee\u8ba2\u4e0e\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7 Revision of U. S. FDA bioequ […]<\/p>\n","protected":false},"author":1,"featured_media":98496,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98495"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=98495"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98495\/revisions"}],"predecessor-version":[{"id":98509,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98495\/revisions\/98509"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/98496"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=98495"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=98495"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=98495"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}