{"id":13224,"date":"2018-07-13T01:00:00","date_gmt":"2018-07-30T04:15:25","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/%e3%80%90%e6%94%b6%e8%97%8f%e8%b4%b4%e3%80%91%e5%9f%ba%e5%9b%a0%e6%af%92%e6%80%a7%e6%9d%82%e8%b4%a8%e9%9d%a2%e4%b8%b4%e5%9b%bd%e9%99%85%e6%b3%95%e8%a7%84%e7%9a%84%e5%b7%a8%e5%a4%a7%e6%8c%91%e6%88%98\/"},"modified":"2018-07-30T12:15:26","modified_gmt":"2018-07-30T04:15:26","slug":"%e3%80%90%e6%94%b6%e8%97%8f%e8%b4%b4%e3%80%91%e5%9f%ba%e5%9b%a0%e6%af%92%e6%80%a7%e6%9d%82%e8%b4%a8%e9%9d%a2%e4%b8%b4%e5%9b%bd%e9%99%85%e6%b3%95%e8%a7%84%e7%9a%84%e5%b7%a8%e5%a4%a7%e6%8c%91%e6%88%98","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/13224\/","title":{"rendered":"\u3010\u6536\u85cf\u8d34\u3011\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u9762\u4e34\u56fd\u9645\u6cd5\u89c4\u7684\u5de8\u5927\u6311\u6218"},"content":{"rendered":"
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\"\u3010\u6536\u85cf\u8d34\u3011\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u9762\u4e34\u56fd\u9645\u6cd5\u89c4\u7684\u5de8\u5927\u6311\u6218\"<\/a><\/p>\n

\uff08\u70b9\u51fb\u56fe\u7247\u67e5\u770b\u8be6\u60c5\uff09<\/span><\/p>\n

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\u6982\u8ff0<\/span><\/strong><\/span><\/strong>
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\u4e2d\u56fd\u52a0\u5165<\/span>ICH<\/span>\u610f\u5473\u7740\u4e2d\u56fd\u7684\u836f\u54c1\u7814\u53d1\u4e0e\u6ce8\u518c\u5728\u56fd\u9645\u5316\u9053\u8def\u4e0a\u8fc8\u51fa\u4e86\u5386\u53f2\u6027\u7684\u4e00\u6b65\uff0c<\/span>CFDA<\/span>\u5728\u56fd\u9645\u836f\u54c1\u7814\u53d1\u548c\u6ce8\u518c\u6280\u672f\u8981\u6c42\u9886\u57df\u6709\u4e86\u53d1\u8a00\u6743\u548c\u53c2\u4e0e\u51b3\u7b56\u6743\uff0c\u4e2d\u56fd\u533b\u836f\u4ea7\u4e1a\u5728\u9762\u4e34\u6311\u6218\u7684\u540c\u65f6\u4e5f\u5c06\u83b7\u5f97\u5de8\u5927\u7684\u53d1\u5c55\u673a\u9047\u3002<\/span><\/span><\/p>\n


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\u6742\u8d28\u4f5c\u4e3a\u5f71\u54cd\u836f\u54c1\u5b89\u5168\u8d28\u91cf\u53ca\u6709\u6548\u6027\u7684\u5173\u952e\u56e0\u7d20\uff0c\u5728\u52a0\u5165<\/span>ICH<\/span>\u540e\uff0c\u65e0\u7591\u5c06\u6210\u4e3a\u7814\u7a76\u53ca\u8bc4\u4ef7\u7684\u91cd\u70b9\u3002\u6839\u636e<\/span>ICH<\/span>\u6307\u5357\uff0c\u539f\u6599\u836f\u6742\u8d28\u53ef\u5206\u4e3a\u4e09\u4e2a\u4e3b\u8981\u7c7b\u522b\uff1a\u6709\u673a\u6742\u8d28\uff08\u6709\u5173\u7269\u8d28\uff09\u3001\u65e0\u673a\u6742\u8d28\u53ca\u6b8b\u7559\u6eb6\u5242\uff0c\u800c\u5927\u90e8\u5206\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u662f\u6709\u5173\u7269\u8d28\u4e2d\u7684\u4e00\u79cd\u7279\u4f8b\uff0c\u5728\u6781\u4f4e\u6d53\u5ea6\u65f6\u5373\u53ef\u4e0e\u4eba\u4f53\u5185\u7684\u9057\u4f20\u5206\u5b50\u8fdb\u884c\u5316\u5b66\u53cd\u5e94\uff0c\u9020\u6210\u4e0d\u53ef\u9006\u7684\u635f\u4f24\uff0c\u8fdb\u800c\u5bfc\u81f4\u57fa\u56e0\u7a81\u53d8\uff0c\u5e76\u53ef\u80fd\u4fc3\u4f7f\u80bf\u7624\u7684\u53d1\u751f\uff0c\u5b58\u5728\u4e25\u91cd\u7684\u5b89\u5168\u98ce\u9669\u3002<\/span><\/span><\/p>\n


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<\/span>\u73b0\u5c06\u56fd\u5916\u4e3b\u8981\u76f8\u5173\u6307\u5bfc\u539f\u5219\u7684\u6709\u5173\u8981\u6c42\u603b\u7ed3\u5982\u4e0b\uff1a<\/span><\/span><\/p>\n


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

EMEA\u6307\u5357<\/strong><\/span><\/p>\n

_______________________________________<\/span><\/strong><\/span><\/p>\n

2006 <\/span>\u5e74\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08<\/span>EMA<\/span>\uff09\u9881\u5e03\u4e86\u300a\u9057\u4f20\u6027\u6742\u8d28\u9650\u5ea6\u6307\u5bfc\u539f\u5219\u300b\u548c\u300a<\/span>CHMP<\/span>\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u9650\u5ea6\u6307\u5bfc\u539f\u5219\u95ee\u7b54\u300b\u3002\u6307\u5357\u8981\u6c42\u65b0\u836f\u5fc5\u987b\u8fdb\u884c\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u5206\u6790\uff1b\u5bf9\u4e8e\u73b0\u6709\u836f\u54c1\uff0c\u4e0d\u5f3a\u5236\u8fdb\u884c\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u5206\u6790\u8bc4\u4f30\uff0c\u4f46\u5bf9\u5df2\u4e0a\u5e02\u54c1\u8fdb\u884c\u5316\u5b66\u5408\u6210\u53d8\u66f4\u6216\u8005\u4eff\u5236\u836f\u54c1\u4e0a\u5e02\u524d\uff0c\u9700\u5bf9\u5176\u5408\u6210\u8def\u7ebf\u3001\u8fc7\u7a0b\u63a7\u5236\u3001\u6742\u8d28\u6982\u51b5\u8bc4\u4ef7\u5e76\u4e0e\u73b0\u6709\u4ea7\u54c1\u5bf9\u6bd4\uff0c\u4ee5\u786e\u5b9a\u672a\u5f15\u5165\u65b0\u7684\u6216\u66f4\u9ad8\u6c34\u5e73\u7684\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u3002<\/span><\/span><\/p>\n


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\u8be5\u6307\u5357\u8fd8\u5f15\u5165\u4e86\u53ef\u63a5\u53d7\u98ce\u9669\u7684\u6444\u5165\u91cf\uff0c\u5373\u6bd2\u7406\u5b66\u9608\u503c\uff08<\/span>TTC<\/span>\uff0c<\/span>Thresholdof Toxicological Concern<\/span>\uff09\u8fd9\u4e2a\u6982\u5ff5\u3002\u6839\u636e\u8be5\u65b9\u6cd5\uff0c\u82e5\u60a3\u8005\u6bcf\u65e5\u6444\u5165\u6d53\u5ea6\u4f4e\u4e8e<\/span>1.5 \u03bcg<\/span>\uff0c\u90a3\u4e48\u60a3\u8005\u56e0\u670d\u836f\u5bfc\u81f4\u764c\u75c7\u53d1\u751f\u7684\u989d\u5916\u98ce\u9669\u53ef\u4ee5\u5ffd\u7565\u4e0d\u8ba1\u3002\u4f46<\/span>TTC<\/span>\u4e0d\u80fd\u88ab\u7406\u89e3\u4e3a\u7edd\u5bf9\u65e0\u98ce\u9669\u7684\u4fdd\u969c\uff0c\u5982\u5bf9\u7c7b\u9ec4\u66f2\u9709\u7d20\u7b49\u4e00\u4e9b\u9ad8\u5ea6\u5371\u9669\u7684\u7269\u8d28\uff0c\u5176\u81f4\u764c\u6027\u660e\u786e\uff0c\u6bd2\u7406\u5b66\u9608\u503c\uff08<\/span>TTC<\/span>\uff09<\/span>1.5 \u03bcg \/d <\/span>\u7684\u9650\u5ea6\u5e76\u4e0d\u9002\u7528\uff0c\u9700\u8fdb\u884c\u7279\u6b8a\u7684\u98ce\u9669\u8bc4\u4ef7\u3002\u4f46\u5728\u77ed\u671f\u66b4\u9732\u3001\u6cbb\u7597\u75c5\u5371\u9884\u671f\u4ec5\u5b58\u6d3b<\/span>5<\/span>\u5e74\u4e14\u6ca1\u6709\u66f4\u5b89\u5168\u7684\u6cbb\u7597\u9009\u62e9\u65f6<\/span>TTC<\/span>\u7684<\/span>1.5 \u03bcg \/d<\/span>\u8fd9\u4e2a\u9650\u5ea6\u53ef\u4ee5\u9002\u5f53\u653e\u5bbd\u3002<\/span><\/span><\/p>\n


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

FDA\u6307\u5357<\/span><\/strong><\/span><\/span><\/p>\n

_______________________________________<\/span><\/strong><\/span><\/p>\n

<\/span><\/strong><\/span>2008<\/span>\u5e74\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08<\/span>FDA<\/span>\uff09\u9881\u5e03\u4e86\u300a\u5de5\u4e1a\u6307\u5357\uff1a\u539f\u6599\u836f\u53ca\u5236\u5242\u4e2d\u7684\u9057\u4f20\u6bd2\u6027\u53ca\u81f4\u764c\u6027\u6742\u8d28\u7814\u7a76\u65b9\u6cd5\u63a8\u8350\u300b\u3002<\/span>FDA <\/span>\u9488\u5bf9\u5df2\u77e5\u6216\u53ef\u7591\u7684\u6f5c\u5728\u57fa\u56e0\u6bd2\u6027\u548c\u81f4\u764c\u6742\u8d28\u7684\u5b89\u5168\u8ba4\u8bc1\u63d0\u51fa\u5177\u4f53\u7684\u5efa\u8bae\u3002\u6307\u5357\u63cf\u8ff0\u4e86\u8bb8\u591a\u7528\u4ee5\u8868\u5f81\u53ca\u51cf\u5c11\u60a3\u8005\u66b4\u9732\u4e8e\u57fa\u56e0\u6bd2\u6027\u548c\u81f4\u764c\u6027\u6742\u8d28\u5bfc\u81f4\u7684\u6f5c\u5728\u764c\u75c7\u98ce\u9669\u7684\u65b9\u6cd5\uff0c\u8fd9\u4e9b\u65b9\u6cd5\u4e0e<\/span>EMA <\/span>\u6307\u5357\u76f8\u4f3c\u3002<\/span>FDA <\/span>\u89c4\u5b9a\u5f53\u6742\u8d28\u542b\u91cf\u8d85\u51fa<\/span>ICH <\/span>\u8d28\u63a7\u9650\u5ea6\u65f6\uff0c\u82e5\u65e0\u5145\u5206\u7684\u6587\u732e\u6216\u7814\u7a76\u6570\u636e\u652f\u6301\uff0c\u5219\u9700\u6309<\/span>ICH <\/span>\u7684\u8bd5\u9a8c\u65b9\u6848\u8fdb\u884c\u57fa\u56e0\u6bd2\u6027\u8bc4\u4ef7\uff1b\u5f53\u6742\u8d28\u542b\u91cf\u4f4e\u4e8e<\/span>ICH <\/span>\u8d28\u63a7\u9650\u5ea6\u65f6\uff0c\u5e94\u91c7\u7528(<\/span>Q<\/span>\uff09<\/span>SAR <\/span>\u65b9\u6cd5\u8fdb\u884c\u6bd2\u6027\u8bc4\u4f30\uff1b\u5bf9\u5177\u6709\u8b66\u6212\u7ed3\u6784\u7684\u6742\u8d28\uff0c\u91c7\u7528<\/span>Ames (<\/span>\u7ec6\u83cc\u8bf1\u53d8\u6d4b\u8bd5<\/span>)<\/span>\u8fdb\u884c\u7814\u7a76\u3002<\/span><\/span>
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ICH\u6307\u5bfc\u539f\u5219<\/span><\/strong><\/span><\/span><\/p>\n

_______________________________________<\/span><\/strong><\/span><\/p>\n

<\/span><\/strong><\/span>2013<\/span>\u5e74\uff0c<\/span>ICH<\/span>\u5728<\/span>EMA<\/span>\u3001<\/span>FDA <\/span>\u7b49\u5173\u4e8e\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u63a7\u5236\u6307\u5bfc\u539f\u5219\u7684\u57fa\u7840\u4e0a\uff0c\u53d1\u5e03\u4e86\u300a<\/span>M7<\/span>\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u6307\u5357\u300b\u7b49\u6280\u672f\u6307\u5bfc\u6587\u4ef6\uff0c\u63d0\u4f9b\u4e86\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u9274\u522b\u3001\u5206\u7c7b\u3001\u5b9a\u91cf\u5206\u6790\u548c\u63a7\u5236\u7684\u57fa\u672c\u601d\u8def\u548c\u7b56\u7565\u3002\u6839\u636e\u8bf1\u53d8\u6027\u548c\u81f4\u764c\u6027\uff0c\u53ef\u5c06\u6742\u8d28\u5206\u4e3a\u4e94\u7c7b\uff0c\u91c7\u7528\u4e0d\u540c\u7684\u63a7\u5236\u63aa\u65bd\uff1a<\/span><\/span><\/span>
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\"\u3010\u6536\u85cf\u8d34\u3011\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u9762\u4e34\u56fd\u9645\u6cd5\u89c4\u7684\u5de8\u5927\u6311\u6218\"<\/span><\/p>\n

\u6ce8\uff1a\u5316\u5408\u7269\u53ef\u63a5\u53d7\u9650\u5ea6\u53c2\u7167ICH M7: Assessment and Controlof DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit PotentialCarcinogenic Risk.<\/span><\/p>\n


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\u8be5\u6307\u5bfc\u539f\u5219\u5438\u6536\u4e86<\/span>TTC<\/span>\u63a7\u5236\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7684\u7406\u5ff5\uff0c\u4f5c\u4e3a\u9ed8\u8ba4\u7684\u8bc4\u4f30\u65b9\u5f0f\uff0c\u7528\u4e8e\u5927\u591a\u6570\u957f\u671f\uff08\u957f\u4e8e<\/span>10<\/span>\u5e74\uff09\u6cbb\u7597\u7528\u7684\u836f\u54c1\uff0c\u5e76\u4e14\u6ca1\u6709\u81f4\u764c\u6027\uff08\u4e8c\u7c7b\u548c\u4e09\u7c7b\uff09\u3002\u540c\u65f6<\/span>M7<\/span>\u4e5f\u8ba4\u53ef\u91c7\u7528\uff08<\/span>Q<\/span>\uff09<\/span>SAR <\/span>\u65b9\u6cd5\u53ca<\/span>Ames<\/span>\u8bd5\u9a8c\uff0c\u4e0d\u540c\u7684\u662f\u8be5\u6307\u5bfc\u539f\u5219\u8981\u6c42\u4f7f\u7528\u4e24\u4e2a\u76f8\u4e92\u8865\u5145\u7684\uff08<\/span>Q<\/span>\uff09<\/span>SAR<\/span>\u65b9\u6cd5\uff08\u4e13\u5bb6\u89c4\u5219\u548c\u7edf\u8ba1\u5b66\uff09\u8fdb\u884c\u8bc4\u4f30\u3002<\/span><\/span><\/span><\/p>\n


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\u672c\u6587\u6839\u636e\u4ee5\u4e0b\u6587\u7ae0\u8fdb\u884c\u7f16\u8f91\u6574\u7406\uff0c\u4ec5\u7528\u4e8e\u5b66\u4e60\u3001\u4ea4\u6d41\uff1a<\/span><\/p>\n

1. Snodin, D. J., Elder, D. P. Genotoxic Impurities Part 1: General Overview.<\/span><\/p>\n

2. FDA: Guidance for industry\u2014Genotoxic and Carcinogenic Impurities in Drug Substances and Products:  Recommended Approaches.<\/span><\/p>\n

3. EMEA: Committee for Medicinal Products for Human Use. Guideline on the Limits of Genotoxic Impurities.<\/span><\/o:p><\/p>\n

4. ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.<\/span><\/p>\n


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\u6587\u7ae0\u6765\u6e90\uff1a\u8bfa\u8861\u5206\u6790<\/span><\/em><\/span><\/p>\n

\u836f\u7814\u7f16\u8f91\u6574\u7406<\/span><\/em><\/span><\/p>\n


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\u5173\u6ce8\u836f\u7814  \u4e00\u8def\u540c\u884c<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5408\u4f5c\u529e\u4f1a<\/span>\uff5c\u4f01\u4e1a\u5185\u8bad\uff5c\u884c\u4e1a\u57f9\u8bad\uff5c\u6295\u7a3f<\/span><\/span><\/span><\/p>\n

\u8bf7\u8054\u7cfb\uff1adiaodiao666666<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u7814 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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