{"id":104914,"date":"2019-03-11T00:00:50","date_gmt":"2019-05-17T09:00:39","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/104914\/"},"modified":"2019-05-17T17:00:41","modified_gmt":"2019-05-17T09:00:41","slug":"768cc984f9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/104914\/","title":{"rendered":"2019\u7248ICH M10\u201c\u751f\u7269\u5206\u6790\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u201d\u6307\u5bfc\u539f\u5219\u89e3\u8bfb"},"content":{"rendered":"
\n

\u5728\u4e4b\u524dADA\u6307\u5bfc\u539f\u5219\u7684\u89e3\u8bfb\u540e\uff0c\u7a81\u7136\u53d1\u73b0\u53ef\u4ee5\u53d1\u6325\u81ea\u5df1\u5de5\u4f5c\u4e0a\u7684\u4f18\u52bf\u53ca\u516c\u4f17\u53f7\u7684\u53ca\u65f6\u6027\u5bf9\u76f8\u5173\u6307\u5bfc\u539f\u5219\u548c\u767d\u76ae\u4e66\u8fdb\u884c\u53ca\u65f6\u7684\u89e3\u8bfb\uff0c\u5e0c\u671b\u80fd\u5e26\u7740\u5927\u5bb6\u5feb\u901f\u4e86\u89e3\u4e1a\u5185\u6700\u65b0\u7684\u6cd5\u89c4\u8981\u6c42\u8d8b\u52bf\u3002\u8981\u662f\u80fd\u987a\u5e26\u591a\u70b9\u7c89\u4e1d\u5c31\u66f4\u597d\u4e86\u3002<\/span><\/p>\n

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\n

\u968f\u7740\u6211\u56fd<\/span>2017<\/span>\u5e74\u6b63\u5f0f\u52a0\u5165<\/span>ICH<\/span>\uff0c\u6211\u56fd\u6b63\u9010\u6b65\u5728<\/span>ICH<\/span>\u7684\u8981\u6c42\u4e0b\u8fdb\u884c\u8fc7\u6e21\u3002\u5bf9\u4e8e\u5206\u6790\u9886\u57df\u800c\u8a00\u7684\u5927\u4e8b\u4ef6\u5c31\u662f<\/span>2019<\/span>\u5e74\u7684<\/span>ICH M10\u201c<\/span>\u751f\u7269\u5206\u6790\u65b9\u6cd5\u5b66\u9a8c\u8bc1<\/span>\u201d<\/span>\u6307\u5bfc\u539f\u5219\u3002<\/span>
<\/p>\n

ICH<\/span>\u7ec8\u4e8e\u5728<\/span>2019\/<\/span>02\/26<\/span>\u53d1\u5e03\u4e86<\/span>M10<\/span>\u7684<\/span>Draft<\/span>\u7248\u3002\u63a5\u4e0b\u6765\u7b14\u8005\u5c31\u5e26\u7740\u5927\u5bb6\u5feb\u901f\u4e86\u89e3<\/span><\/span>ICH <\/span>M10<\/span>\u5c06\u7ed9\u6211\u4eec\u5e26\u6765\u4e9b\u5565\u53d8\u5316\u3002<\/span><\/p>\n

\u5168\u6587\u94fe\u63a5\u5982\u4e0b\uff1a<\/span><\/p>\n

https:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Multidisciplinary\/M10\/M10EWG_Step2_DraftGuideline_2019_0226.pdf<\/span><\/p>\n

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\n


<\/p>\n

\u5199\u5728\u524d\u9762\uff1a<\/span><\/p>\n

\u76ee\u524d<\/span>ICH M10<\/span>\u5df2\u7ecf\u8fdb\u5165\u751f\u6548\u7684\u7b2c\u4e8c\u9636\u6bb5\u4e86\uff0c\u5373\u8349\u7a3f\u7684\u5f81\u6c42\u610f\u89c1\u9636\u6bb5\uff0c\u6309\u7167<\/span>ICH<\/span>\u53d1\u5e03\u7684\u5de5\u4f5c\u9884\u671f\uff0c\u5e94\u8be5\u5728<\/span>2019<\/span>\u7684<\/span>6<\/span>\u6708\u63a8\u51fa\u6700\u7ec8\u7248\u672c\u3002\u5bf9\u4e8e\u751f\u7269\u5206\u6790\u800c\u8a00\uff0c\u53d1\u5c55\u591a\u5e74\uff0c\u4e14\u8981\u6c42\u66f4\u4e3a\u5177\u4f53\u548c\u5b8c\u5584\u3002\u76f8\u8f83\u4e8e\u4e4b\u524d\u89e3\u8bfb\u7684<\/span>ADA<\/span>\u6307\u5bfc\u539f\u5219\u8981\u6c42\u66f4\u4e3a\u660e\u786e\u3002\u56e0\u6b64\u6839\u636e\u751f\u7269\u5206\u6790\u7684\u7279\u70b9\u8fdb\u884c\u89e3\u8bfb\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6574\u4f53\u800c\u8a00\uff1a<\/span><\/p>\n

\u76ee\u524d\u5bf9\u4e8e\u751f\u7269\u5206\u6790\u7684\u4ece\u4e1a\u8005\u6765\u8bf4\u4e3b\u8981\u7684\u53c2\u8003\u8d44\u6599\u53ef\u4ee5\u603b\u7ed3\u4e3a<\/span>4<\/span>\u7c7b\uff1a<\/span>EMA<\/span>\u7684<\/span>2015<\/span>\u7248<\/span>BMV<\/span>\u6307\u5bfc\u539f\u5219\uff1b<\/span>FDA<\/span>\u7684<\/span>2018<\/span>\u7248<\/span>BMV<\/span>\u6307\u5bfc\u539f\u5219\uff1b\u4e2d\u56fd\u836f\u5178\u7684<\/span>2015<\/span>\u7248\u6307\u5bfc\u539f\u5219\uff1b\u6bcf\u4e2a\u5e74\u4efd\u7684<\/span>AAPS<\/span>\u548c<\/span>Bioanalysis<\/span>\u767d\u76ae\u4e66\u3002\u73b0\u5728\u65b0\u52a0\u5165\u7684<\/span>ICH <\/span>\u7684<\/span>2019<\/span>\u7248<\/span>M10<\/span>\u52bf\u5fc5\u662f\u8981\u4e00\u7edf<\/span>EMA<\/span>\uff0c<\/span>FDA<\/span>\u53ca<\/span>NMPA<\/span>\u3002<\/span><\/p>\n

\u7531\u4e8e\u6211\u56fd\u836f\u5178\u7248\u7684\u6307\u5bfc\u539f\u5219\u603b\u4f53\u9075\u5faa<\/span>EMA<\/span>\u7248\uff0c\u56e0\u6b64\u5728\u540e\u7eed\u7684\u89e3\u8bfb\u4e2d\u5c06\u4ec5\u5bf9<\/span>ICH <\/span>\uff0c<\/span>EMA<\/span>\uff0c<\/span>FDA<\/span>\u7248\u672c\u8fdb\u884c\u6bd4\u8f83\u3002<\/span><\/p>\n

\"2019\u7248ICH<\/p>\n

<\/span>\uff08\u516c\u4f17\u53f7\u8868\u683c\u7f16\u8f91\u5b9e\u5728\u592a\u6e23\u4e86\uff0c\u76f4\u63a5\u7528\u56fe\u7247\uff09<\/span><\/p>\n

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

    \u7bc7\u5e45\u65b9\u9762<\/span>ICH<\/span>\u535a\u91c7\u4f17\u957f\uff0c\u8fbe\u5230\u4e86<\/span>60<\/span>\u9875\u3002<\/span>EMA<\/span>\u5219\u662f\u6700\u7cbe\u7b80\u7684\u53ea\u6709<\/span>23<\/span>\u9875\u3002\u4e0d\u8fc7\u8003\u8651\u5230<\/span>ICH<\/span>\u662f\u6700\u65b0\u7248\u672c\uff0c\u4e14\u8fd8\u5904\u4e8e<\/span>draft<\/span>\u7248\uff0c\u6709\u4fee\u6539\u7684\u53ef\u80fd\u3002\u4ece\u6574\u4f53\u7ed3\u6784\u6765\u8bf4<\/span>FDA<\/span>\u548c<\/span>ICH<\/span>\u7248\u672c\u90fd\u5728\u6700\u540e\u91c7\u7528\u4e86\u8868\u683c\u5f62\u5f0f\u8fdb\u884c\u603b\u7ed3\uff0c\u800c<\/span>EMA<\/span>\u7531\u4e8e\u9881\u5e03\u8f83\u65e9\u5e76\u65e0\u603b\u7ed3\u8868\u683c\u3002\u4e0d\u8fc7\u6bd4\u8f83<\/span>FDA<\/span>\u548c<\/span>ICH<\/span>\u7248\u672c\uff0c<\/span>FDA<\/span>\u7684\u603b\u7ed3\u662f\u9488\u5bf9\u6240\u6709\u9a8c\u8bc1\u9879\u548c\u8bd5\u9a8c\u73af\u8282\u7684\uff0c\u4f46<\/span>ICH<\/span>\u4ec5\u9488\u5bf9\u8bd5\u9a8c\u73af\u8282\u3002\u5168\u6587\u63cf\u8ff0\u65b9\u5f0f\u4e2a\u4eba\u66f4\u559c\u6b22<\/span>ICH<\/span>\u7684\uff0c\u6574\u4f53\u903b\u8f91\u5f88\u987a\uff0c\u5927\u5c0f\u5206\u5b50\u63cf\u8ff0\u90fd\u5f88\u5b8c\u6574\u3002\u4f46\u662f\u603b\u7ed3\u8868\u683c\u4e2a\u4eba\u503e\u5411\u4e8e<\/span>FDA<\/span>\u7248\uff0c\u6e05\u6670\u660e\u4e86\uff0c\u8981\u7684\u4fe1\u606f\u8868\u683c\u90fd\u6709\uff0c\u53ef\u4ee5\u5feb\u901f\u67e5\u770b\u3002<\/span>EMA<\/span>\u7248\u53d7\u9650\u4e8e\u53d1\u5e03\u65f6\u95f4\u8f83\u65e9\u7684\u539f\u56e0\u5404\u65b9\u9762\u8868\u8ff0\u5747\u65e0\u7a81\u51fa\u4e4b\u5904\u3002<\/span>
<\/p>\n

 <\/span><\/p>\n

\u6982\u8ff0\u90e8\u5206<\/span><\/p>\n

ICH<\/span>\u7248\u5f00\u7bc7\u5c31\u5c06\u65b9\u6cd5\u5b66\u62c6\u5206\u4e3a\u65b9\u6cd5\u5efa\u7acb\u548c\u65b9\u6cd5\u9a8c\u8bc1<\/span>2<\/span>\u4e2a\u9636\u6bb5\uff0c\u8ba9\u540e\u7eed\u7684\u884c\u6587\u66f4\u6d41\u7545\u3002<\/span>FDA<\/span>\u7248\u672c\u4e2d\u4e5f\u6709\u5f3a\u8c03\u65b9\u6cd5\u5efa\u7acb\u548c\u65b9\u6cd5\u9a8c\u8bc1\u7684\u533a\u522b\uff0c<\/span>EMA<\/span>\u7248\u5219\u672a\u660e\u786e\u533a\u5206\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u5206\u6790\u65b9\u6cd5\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u6765\u8bf4\u65b9\u6cd5\u7684\u5efa\u7acb\u548c\u5177\u4f53\u7684\u9a8c\u8bc1\u662f\u5bc6\u4e0d\u53ef\u5206\u7684\uff0c\u6ca1\u6709\u4e00\u4e2a\u597d\u7684\u65b9\u6cd5\u5efa\u7acb\u8fc7\u7a0b\uff0c\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u53ef\u80fd\u4f1a\u5904\u5904\u78b0\u58c1\u3002\u56e0\u6b64\u5f3a\u8c03\u65b9\u6cd5\u7684\u5efa\u7acb\u8fc7\u7a0b\u4e2a\u4eba\u8ba4\u4e3a\u662f\u5bf9\u4e8e\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u7684\u4e00\u4e2a\u5f88\u597d\u7684\u8865\u5145\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u5177\u4f53\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u53c8\u6839\u636e\u5176\u9a8c\u8bc1\u8303\u56f4\u5206\u4e3a\u5168\u9a8c\u8bc1\uff0c\u90e8\u5206\u9a8c\u8bc1\u548c\u4ea4\u53c9\u9a8c\u8bc1\u3002\u5168\u9a8c\u8bc1\u987e\u540d\u601d\u4e49\u5c31\u662f\u5bf9\u65b9\u6cd5\u5b66\u4e2d\u7684\u6240\u6709\u53c2\u6570\u9010\u4e2a\u8fdb\u884c\u9a8c\u8bc1\u3002\u90e8\u5206\u9a8c\u8bc1\u5219\u662f\u5728\u65b9\u6cd5\u7ecf\u5168\u9a8c\u8bc1\u540e\u51fa\u73b0\u66f4\u6539\u540e\u8fdb\u884c\u7684\u8865\u5145\uff0c\u8fd9\u90e8\u5206\u7684\u53ef\u64cd\u4f5c\u7a7a\u95f4\u5f88\u5927\uff0c\u53ef\u4ee5\u4ec5\u4e00\u4e2a<\/span>A&P run<\/span>\uff0c\u4e5f\u53ef\u80fd\u51e0\u4e4e\u518d\u6765\u4e00\u904d\u5168\u9a8c\u8bc1\u3002\u5bf9\u4e8e\u4ea4\u53c9\u9a8c\u8bc1\u5219\u662f\u5728\u9700\u8981\u8fdb\u884c\u591a\u4e2d\u5fc3\u6570\u636e\u6bd4\u8f83\u65f6\u8fdb\u884c\u7684\uff0c\u5e76\u4e0d\u5c5e\u4e8e\u65e5\u5e38\u64cd\u4f5c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6b63\u6587\u90e8\u5206<\/span><\/p>\n

\"2019\u7248ICH<\/p>\n


<\/span>    3<\/span>\u4e2a\u7248\u672c\u63cf\u8ff0\u65b9\u5f0f\u5404\u6210\u4f53\u7cfb\uff0c\u4f46\u662f\u8003\u8651\u5230\u76ee\u524d\u5927\u5c0f\u5206\u5b50\u751f\u7269\u5206\u6790\u5f80\u5f80\u4e0d\u662f\u540c\u4e00\u56e2\u961f\u6267\u884c\uff0c\u4f3c\u4e4e<\/span>ICH<\/span>\u7684\u63cf\u8ff0\u65b9\u5f0f\u53ef\u8bfb\u6027\u66f4\u597d\uff0c\u4f46\u540c\u65f6\u5e26\u6765\u7684\u95ee\u9898\u5c31\u662f\u7bc7\u5e45\u88ab\u62c9\u957f\u4e86\u3002\u540c\u6837\u662f\u63cf\u8ff0\u9a8c\u8bc1\u548c\u6d4b\u6837\uff0c<\/span>ICH<\/span>\u7248\u7528\u4e86<\/span>22<\/span>\u9875\uff0c\u76f8\u6bd4\u800c\u8a00<\/span>EMA<\/span>\u7248\u662f<\/span>14<\/span>\u9875\uff0c<\/span>FDA<\/span>\u7248\u662f<\/span>8<\/span>\u9875\u3002<\/span>ICH<\/span>\u7248\u4f30\u8ba1\u662f\u9700\u8981\u518d\u7626\u7626\u8eab\u4e86\u3002<\/span>
<\/span><\/p>\n

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 <\/span><\/p>\n

\u5bf9\u4e8e\u9a8c\u8bc1\u9879\u800c\u8a00\uff1a<\/span><\/p>\n

\u8272\u8c31\u6cd5\uff1a<\/span><\/p>\n

\u8272\u8c31\u6cd5\u53d1\u5c55\u591a\u5e74\uff0c\u76f8\u5bf9\u4e8e\u914d\u4f53\u7ed3\u5408\u6cd5\u66f4\u4e3a\u6210\u719f\uff0c\u5927\u6982\u8fc7\u4e86\u4e00\u904d\uff0c\u6b64\u90e8\u5206\u5dee\u5f02\u5e76\u4e0d\u7b97\u5927\uff0c<\/span>ICH<\/span>\u7248\u672c\u5728<\/span>EMA<\/span>\u548c<\/span>FDA<\/span>\u57fa\u7840\u4e0a\u5728\u5404\u4e2a\u73af\u8282\u5747\u6709\u90e8\u5206\u7684\u7ec6\u5316\u3002\u603b\u4f53\u800c\u8a00\uff0c\u53ef\u64cd\u4f5c\u6027\u66f4\u5927\u3002<\/span><\/p>\n

\uff08\u4e0d\u8be6\u7ec6\u5199\u7684\u53e6\u4e00\u4e2a\u539f\u56e0\u662f\u597d\u51e0\u5e74\u6ca1\u5f04\u5c0f\u5206\u5b50\u4e86\uff0c\u9732\u602f\uff09<\/span><\/p>\n

 <\/span><\/p>\n

\u914d\u4f53\u7ed3\u5408\u6cd5\uff1a<\/span><\/p>\n

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

\"2019\u7248ICH<\/p>\n

\"2019\u7248ICH<\/p>\n

        \u5173\u4e8e\u5927\u5206\u5b50\u7a33\u5b9a\u6027\u6e29\u5ea6\u7684\u63cf\u8ff0\u5fc5\u987b\u597d\u8bc4\uff0c\u7ec8\u4e8e\u6709\u636e\u53ef\u5faa\u4e0d\u7528\u4e00\u4e2a\u6e29\u5ea6\u4e00\u4e2a\u6e29\u5ea6\u7684\u8003\u5bdf\u4e86\u3002<\/p>\n

\"2019\u7248ICH<\/p>\n

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

     \u5bf9\u4e8e\u5168\u8840\u7a33\u5b9a\u6027\u8981\u5410\u69fd\u4e00\u70b9\u3002\u4e2a\u4eba\u5bf9\u4e8e\u8840\u6e05\u7684\u5168\u8840\u7a33\u5b9a\u6027\u662f\u5426\u9700\u8981\u8fdb\u884c\u8fd8\u662f\u6301\u4fdd\u7559\u610f\u89c1\u3002\u5982\u679c\u771f\u8981\u505a\u8fd8\u662f\u5e0c\u671b\u80fd\u6709\u4e9b\u8be6\u7ec6\u7684\u8bf4\u660e\u3002<\/span><\/p>\n

\"2019\u7248ICH<\/p>\n

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

\u5bf9\u4e8e\u6837\u54c1\u68c0\u6d4b<\/span><\/p>\n

\"2019\u7248ICH<\/p>\n


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

\u5bf9\u4e8e<\/span>ISR<\/span><\/span><\/p>\n

\"2019\u7248ICH<\/p>\n

 \u5bf9\u4e8e\u8fd9\u90e8\u5206\u7b14\u8005\u6240\u5728\u5355\u4f4d\u7684\u505a\u6cd5\u4e0e\u6b64\u6709\u6240\u4e0d\u540c\uff0c\u6301\u4fdd\u7559\u610f\u89c1\u3002<\/span><\/p>\n

\"2019\u7248ICH<\/p>\n


<\/p>\n

\u5bf9\u4e8e\u7279\u6b8a\u8003\u91cf<\/span><\/p>\n

\"2019\u7248ICH<\/p>\n

 <\/span>
<\/span><\/p>\n

\u5173\u4e8e\u62a5\u544a\u65b9\u5f0f<\/span><\/p>\n

\"2019\u7248ICH<\/p>\n

<\/span>\u603b\u7684\u8bf4\u6765ICH\u7248\u4f5c\u4e3a\u6700\u65b0\u7684\u7248\u672c\uff0c\u5728\u63cf\u8ff0\u4e0a\u548c\u6db5\u76d6\u5185\u5bb9\u65b9\u9762\u5747\u8f83\u5176\u5b83\u7248\u672c\u6709\u7740\u4e00\u5b9a\u7684\u4f18\u52bf\uff0c\u4f46\u662f\u5176\u4e2d\u4e5f\u4e0d\u4e4f\u63cf\u8ff0\u91cd\u590d\uff0c\u6709\u4e89\u8bae\u7684\u4e00\u4e9b\u5730\u65b9\u3002\u7b14\u8005\u5728\u8fd9\u629b\u7816\u5f15\u7389\uff0c\u5f81\u8be2\u610f\u89c1\u65f6\u5927\u5bb6\u591a\u591a\u63d0\u610f\u89c1\u54af\u3002<\/p>\n


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

\u53c2\u8003\u6587\u732e\uff1a<\/p>\n

1\u3001EMA\u76842015\u7248BMV<\/p>\n

\u539f\u6587\u94fe\u63a5\uff1a<\/p>\n

https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-bioanalytical-method-validation_en.pdf<\/p>\n

2\u3001FDA\u76842018\u7248BMV<\/p>\n

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https:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/@fdagov-drugs-gen\/documents\/document\/ucm070107.pdf<\/p>\n

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2019\u75ab\u82d7\u5de5\u827a\u4f18\u5316\u53ca\u521b\u65b0\u7814\u53d1\u8bba\u575b<\/a>
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2019\u7b2c\u4e09\u5c4a\u56fd\u9645\u751f\u7269\u6cbb\u7597\u5927\u4f1a\u66a8\u5c55\u89c8\u4f1a<\/a><\/strong><\/p>\n

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\"2019\u7248ICH<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

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