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\u7f16\u8f91 l \u5c0f\u5352\u5b50<\/span><\/strong><\/p>\n


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 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

\u6839\u636eICH\u6307\u5357Q1E\uff0c\u9700\u8981\u5206\u522b\u5b9a\u91cf\u5730\u8bc4\u4f30\u6bcf\u4e2aCQA\u7684\u7a33\u5b9a\u6027\u6570\u636e\u3002\u7528\u4e8e\u7a33\u5b9a\u6027\u6570\u636e\u7edf\u8ba1\u8bc4\u4f30\u7684\u56de\u5f52\u6a21\u578b\u53ef\u7528\u7ebf\u6027\u6216\u975e\u7ebf\u6027\u51fd\u6570\u6765\u63cf\u8ff0\u3002\u8fd9\u4e9b\u56de\u5f52\u6a21\u578b\u662f\u5426\u5408\u9002\u53d6\u51b3\u4e8e\u5b83\u4eec\u80fd\u63ed\u793a\u7684\u4e0b\u8ff0\u4fe1\u606f\u7684\u7a0b\u5ea6: \u54cd\u5e94\u968f\u65f6\u95f4\u7684\u53d8\u5316\uff0c\u6574\u4f53\u53d8\u5f02\u548c\u8bef\u5dee\u6210\u5206\u3002\u53e6\u5916\uff0c\u53ef\u4ee5\u901a\u8fc7\u5728\u6a21\u578b\u4e2d\u5141\u8bb8\u968f\u673a\u6548\u5e94\u4ee5\u6539\u8fdb\u56de\u5f52\u6a21\u578b\u3002\u8fd9\u79cd\u6a21\u578b\u4e5f\u79f0\u4e3a\u6df7\u5408\u6548\u5e94\u6a21\u578b\uff0c\u5373\u56fa\u5b9a\u6548\u5e94+\u968f\u673a\u6548\u5e94\u3002\u8fd9\u4e9b\u7edf\u8ba1\u65b9\u6cd5\u6700\u7ec8\u901a\u8fc7\u4f30\u7b97\u653e\u884c\u9650\u5236(release limits)\u548c\u9884\u6d4b\u6279\u6b21\u62d2\u7edd\u7387\uff08batch rejection rate\uff09\u6765\u5e2e\u52a9\u7ba1\u7406\u751f\u4ea7\u98ce\u9669\u3002\u653e\u884c\u9650\u5236\u5b9e\u9645\u4e0a\u662f\u5bf9\u5df2\u6ce8\u518c\u836f\u54c1\u89c4\u8303\u7684\u9650\u5236\u3002\u8fd9\u4e2a\u9650\u5236\u662f\u57fa\u4e8e\u4ece\u6a21\u62df\u957f\u671f\u7a33\u5b9a\u6027\u6570\u636e\u548c\u5176\u53d8\u5f02\u90e8\u5206\uff08the variability components\uff09\u5f97\u51fa\u7684\u968f\u65f6\u95f4\u53d8\u5316\u7684\u8d8b\u52bf\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u8fd9\u4e9b\u653e\u884c\u9650\u5236\u786e\u4fdd\u836f\u54c1\u7684CQA\u4fdd\u6301\u5728\u89c4\u683c\u5185\uff0c\u76f4\u5230\u4fdd\u8d28\u671f\u7ed3\u675f\u3002\u8fdd\u53cd\u653e\u884c\u9650\u5236\u7684\u6279\u6b21\uff0c\u5728\u836f\u54c1\u7684\u4fdd\u8d28\u671f\u671f\u95f4\uff0c\u5b9e\u9645\u4e0a\u6709\u66f4\u5927\u7684\u53ef\u80fd\uff08\u4ee5\u767e\u5206\u6bd4\u8ba1\u7b97\uff09\u6709\u67d0\u4e9b\u5173\u952e\u8d28\u91cf\u53c2\u6570\uff08CQA\uff09\u8d85\u51fa\u89c4\u683c\uff08OOS\uff09\u3002\u56e0\u6b64\uff0c\u5efa\u8bae\u62d2\u7edd\u8fd9\u4e9b\u6279\u6b21\u8fdb\u5165\u5e02\u573a\u3002\u5931\u8d25\u6279\u6b21\u76f8\u5bf9\u4e8e\u6240\u6709\u6279\u6b21\u7684\u767e\u5206\u6bd4\u79f0\u4e3a\u5b9e\u9645\u6279\u6b21\u62d2\u7edd\u7387\u3002\u5f97\u81ea\u7a33\u5b9a\u6027\u6570\u636e\u7684\u653e\u884c\u9650\u5236\uff0c\u5982\u679c\u5047\u8bbe\u6b63\u6001\u5206\u5e03\uff0c\u53ef\u7528\u4e8e\u8ba1\u7b97\u6240\u6709\u672a\u751f\u4ea7\u6279\u6b21\u7684\u9884\u6d4b\u62d2\u7edd\u7387\u3002\u8f83\u9ad8\u7684\u9884\u6d4b\u6279\u6b21\u62d2\u7edd\u7387\u8868\u660e\u9700\u8981\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5f15\u5165\u6539\u8fdb\u6216\u91cd\u65b0\u8bbe\u5b9a\u836f\u54c1\u7684\u4fdd\u8d28\u671f\uff0c\u4ee5\u514d\u5728\u4fdd\u8d28\u671f\u95f4\u5931\u6548\u3002<\/span><\/p>\n

 <\/span><\/p>\n

ICH\u6307\u5bfc\u6587\u4ef6Q1A\u548cQ1E\u63d0\u4f9b\u4e86\u7a33\u5b9a\u6027\u6d4b\u8bd5\u8981\u6c42\u4ee5\u8bc4\u4f30\u7a33\u5b9a\u6027\u6570\u636e\u548c\u4f30\u8ba1\u4fdd\u8d28\u671f\u7684\u5efa\u8bae\u3002\u8fd9\u4e9b\u8981\u6c42\u53ef\u7b80\u6d01\u5730\u63cf\u8ff0\u4e3a\uff1a<\/span><\/p>\n

 <\/span><\/p>\n

\u81f3\u5c11\u62bd\u6837\u4e09\u6279\uff0c\u6d4b\u8bd5ICH Q1A\u63a8\u8350\u7684\u5b58\u50a8\u65f6\u95f4\u6bb5\u5185\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff0c\u6309\u7167ICH Q1E\u4e2d\u7684\u63cf\u8ff0\u5bf9\u7a33\u5b9a\u6027\u6570\u636e\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\uff0c\u4fdd\u8d28\u671f\u88ab\u4f30\u7b97\u4e3a95\uff05\u7f6e\u4fe1\u9650\u5ea6\u8d8a\u8fc7\u53ef\u63a5\u53d7\u7684\u8fb9\u754c\u7684\u5b58\u50a8\u65f6\u95f4\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

\u867d\u7136\u6ca1\u6709\u63d0\u4f9b\u660e\u786e\u7684\u8d28\u91cf\u58f0\u660e\uff0cICH Q1E\u7b56\u7565\u7684\u76ee\u7684\u662f\u8981\u786e\u7acb\u4e00\u4e2a\u5b58\u50a8\u65f6\u95f4\uff0c\u5728\u6b64\u671f\u95f4\uff0c\u5bf9\u201c\u5728\u7c7b\u4f3c\u60c5\u51b5\u4e0b\u751f\u4ea7\uff0c\u5305\u88c5\u548c\u5b58\u50a8\u7684\u6240\u6709\u672a\u6765\u6279\u6b21\u201d\uff0c\u5176\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u5c06\u88ab\u89c6\u4e3a\u53ef\u63a5\u53d7\u7684\u3002\u9057\u61be\u7684\u662f\uff0c\u6b63\u5982\u540e\u9762\u5c06\u8be6\u7ec6\u8ba8\u8bba\u7684\u90a3\u6837\uff0c\u8be5\u6307\u5bfc\u6587\u4ef6\u4e2d\u5efa\u8bae\u7684\u7edf\u8ba1\u65b9\u6cd5\u662f\u4e0e\u6b64\u610f\u56fe\u4e0d\u7b26\u3002\u4e00\u4e2a\u4f8b\u5b50\u662f: \u4ece\u7406\u8bba\u4e0a\u8bb2\uff0c\u836f\u54c1\u4fdd\u8d28\u671f\u662f\u5176\u751f\u4ea7\u8fc7\u7a0b\u7684\u56fa\u6709\u7279\u6027\uff0c\u56e0\u6b64\u5176\u5b9a\u4e49\u4e0e\u7528\u4e8e\u4f30\u8ba1\u5b83\u7684\u6837\u672c\u91cf\u65e0\u5173\u3002\u4f46\u662f\uff0c\u4f7f\u7528ICH Q1E\u65b9\u6cd5\u4f30\u7b97\u4fdd\u8d28\u671f\u53d6\u51b3\u4e8e\u6837\u672c\u91cf\uff08\u7279\u522b\u662f\u6279\u6b21\u6570\uff09\u4ee5\u53ca\u7f6e\u4fe1\u6c34\u5e73\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4fdd\u8d28\u671f\u7684\u5b9a\u4e49<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

ICH\u6307\u5bfc\u6587\u4ef6\u4e3a\u786e\u5b9a\u836f\u7269\u4ea7\u54c1\u7684\u4fdd\u8d28\u671f\u63d0\u4f9b\u4e86\u4e00\u4e2a\u72ed\u7a84\u7684\u6846\u67b6\u3002\u5b9e\u9645\u4e0a\uff0c\u9664\u975e\u7f6e\u4e8e\u9002\u5f53\u7684\u4e0a\u4e0b\u6587\u4e2d\uff0c\u5426\u5219\u201c\u4fdd\u8d28\u671f\u201d\u8fd9\u4e2a\u672f\u8bed\u672c\u8eab\u5e76\u6ca1\u6709\u660e\u786e\u7684\u5b9a\u4e49\u3002\u66f4\u5168\u9762\u7684\u7406\u89e3\u9700\u8981\u4e00\u4e2a\u660e\u786e\u7684\u672f\u8bed\uff0c\u4ee5\u533a\u5206\u88ab\u8ba8\u8bba\u7684\u4fdd\u8d28\u671f\u7684\u4e0d\u540c\u6982\u5ff5\u3002\u4e0b\u9762\u8ba8\u8bba\u4e86\u4e94\u4e2a\u76f8\u5173\u672f\u8bed\uff0c\u4ee5\u4fbf\u5728\u5404\u79cd\u60c5\u51b5\u4e0b\u5bf9\u4fdd\u8d28\u671f\u8fdb\u884c\u524d\u540e\u4e00\u81f4\u7684\u8ba8\u8bba\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u771f\u5b9e\u4fdd\u8d28\u671f<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

\u771f\u5b9e\u4fdd\u8d28\u671f<\/span>\u662f\u4e00\u4e2a\u771f\u5b9e\u7684\u4f46\u662f\u672a\u77e5\u7684\u50a8\u5b58\u65f6\u95f4, \u5728\u8fd9\u4e2a\u65f6\u95f4\u5185, \u836f\u7269\u6216\u836f\u54c1\u88ab\u8ba4\u4e3a\u662f\u9002\u5408\u4f7f\u7528\u548c\u6709\u6548\u7684\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c<\/span>\u771f\u5b9e\u4fdd\u8d28\u671f<\/span>\u4e5f\u53ef\u4ee5\u7279\u6307\u4e3a<\/span>\u771f\u5b9e\u4ea7\u54c1\u4fdd\u8d28\u671f<\/span>\u3002\u6b63\u662f\u8fd9\u4e2a\u672a\u77e5\u7684\u50a8\u5b58\u65f6\u95f4\uff0c\u5373<\/span>\u771f\u5b9e\u4ea7\u54c1\u4fdd\u8d28\u671f<\/span>\uff0c\u9700\u8981\u901a\u8fc7\u7a33\u5b9a\u6027\u7814\u7a76\u6765\u4f30\u7b97\u3002\u672c\u6587\u7a0d\u540e\u4f1a\u8fdb\u4e00\u6b65\u8ba8\u8bba\u201c\u836f\u54c1\u201d\u542b\u4e49\u7684\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u8bf7\u6ce8\u610f\uff0c\u7531\u4e8e\u771f\u5b9e\u4ea7\u54c1\u4fdd\u8d28\u671f\u9002\u7528\u4e8e\u5f53\u524d\u548c\u672a\u6765\u7684\u6240\u6709\u6279\u6b21\uff0c\u56e0\u6b64\u53ea\u6709\u5728\u751f\u4ea7\u8fc7\u7a0b\u5904\u4e8e\u7edf\u8ba1\u63a7\u5236\u72b6\u6001\u65f6\u624d\u6709\u610f\u4e49\u3002\u5426\u5219\uff0c\u4eca\u5929\u751f\u4ea7\u7684\u6279\u6b21\u53ef\u80fd\u65e0\u6cd5\u4ee3\u8868\u672a\u6765\u751f\u4ea7\u7684\u6279\u6b21\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4f30\u8ba1\u4fdd\u8d28\u671f<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

\u7a33\u5b9a\u6027\u7814\u7a76\u662f\u4e00\u79cd\u4eba\u4e3a\u8bbe\u8ba1\u7684\u5b9e\u9a8c\u3002\u5176\u4e2d\uff0c\u836f\u7269\u4ea7\u54c1\u50a8\u5b58\u5728\u73af\u5883\u5ba4\u4e2d\u5e76\u9075\u5faa\u7279\u522b\u89c4\u5b9a\u7684\u50a8\u5b58\u65f6\u95f4\u3002\u5b9a\u671f\u5bf9\u4ea7\u54c1\u8fdb\u884c\u53d6\u6837\u4ee5\u6d4b\u91cf\u4e00\u7cfb\u5217\u7a33\u5b9a\u6027\u9650\u5236\u7279\u6027\u3002\u6839\u636e\u8fd9\u4e9b\u6570\u636e\uff0c\u53ef\u4ee5\u83b7\u5f97<\/span>\u771f\u5b9e\u4fdd\u8d28\u671f<\/span>\u7684\u4f30\u7b97\u503c\u3002\u901a\u5e38\uff0c\u8fd9\u79cd\u5bf9\u771f\u5b9e\u4ea7\u54c1\u4fdd\u8d28\u671f\u7684\u4f30\u8ba1\u79f0\u4e3a<\/span>\u4f30\u8ba1\u4fdd\u8d28\u671f<\/span>\u6216<\/span>\u4f30\u8ba1\u4ea7\u54c1\u4fdd\u8d28\u671f<\/span>\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u652f\u6301\u4fdd\u8d28\u671f<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

\u6839\u636e\u7edf\u8ba1\u8ba1\u7b97\u6240\u652f\u6301\u7684\uff0c\u5bf9<\/span>\u771f\u5b9e\u4ea7\u54c1\u4fdd\u8d28\u671f<\/span>\u7684\u4efb\u4f55\u9002\u5f53\u7684\u4fdd\u5b88\u4f30\u8ba1\u79f0\u4e3a<\/span>\u652f\u6301\u4fdd\u8d28\u671f<\/span>\u3002\u5b83\u65e8\u5728\u4fdd\u5b88\u5730\u4f30\u8ba1\u4ea7\u54c1\u4fdd\u8d28\u671f\uff0c\u4ee5\u5e2e\u52a9\u786e\u4fdd\u5927\u90e8\u5206\u4ea7\u54c1\u4fdd\u6301\u5728\u9002\u5408\u4f7f\u7528\u7684\u72b6\u6001\uff0c\u76f4\u81f3\u4f30\u8ba1\u7684\u50a8\u5b58\u65f6\u95f4\u3002\u4f8b\u5982\uff0c\u5728ICH Q1E\u6307\u5357\u4e2d\uff0c<\/span>\u652f\u6301\u4fdd\u8d28\u671f\uff08the supported shelf life\uff09<\/span>\u662f95\uff05\u7f6e\u4fe1\u9650\uff0895% Confidence Interval\uff0c\u5355\u4fa7\u6216\u53cc\u4fa7\uff0c\u53d6\u51b3\u4e8e\u6240\u6d4b\u91cf\u7684\u7a33\u5b9a\u6027\u9650\u5236\u7279\u6027\u7684\u5c5e\u6027\uff09\u4e0e\u63a5\u53d7\u9650\u5ea6\u76f8\u4ea4\u7684\u65f6\u95f4\u70b9\u3002\u5982\u56fe1\u6240\u793a\uff0c\u8be5\u56fe\u63cf\u7ed8\u4e86\u968f\u65f6\u95f4\u589e\u52a0\u7684\u54cd\u5e94\u7684\u60c5\u51b5\u3002<\/span><\/p>\n


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

\"\u7b80\u8bba\u836f\u54c1\u7684\u4fdd\u8d28\u671f\uff08\u4e00\uff09\"<\/p>\n

\u56fe1. ICH\u63a8\u8350\u7684\u7528\u4e8e\u4f30\u7b97<\/span>\u652f\u6301\u4fdd\u8d28\u671f<\/span>\uff08\u4e0d\u80fd\u5408\u5e76\u6279\u6b21\u7684\u72b6\u51b5\uff09\u7684\u65b9\u6cd5\u3002 Y\u8f74\u8868\u793a\u7a33\u5b9a\u6027\u9650\u5236\u7279\u6027\u7684\u5e73\u5747\u54cd\u5e94\u503c\uff0cX\u8f74\u8868\u793a\u4ee5\u6708\u8ba1\u7684\u5b58\u50a8\u65f6\u95f4\u3002 \u865a\u7ebf\u8868\u793a\u4e09\u4e2a\u5047\u8bbe\u6279\u6b21\u968f\u65f6\u95f4\u53d8\u5316\u7684\u4f30\u8ba1\u7684\u56de\u5f52\u7ebf\u3002 \u7531\u4e8e\u6279\u6b21\u8d8b\u52bf\u63cf\u7ed8\u4e86\u968f\u65f6\u95f4\u589e\u52a0\u7684\u7a33\u5b9a\u6027\u9650\u5236\u7279\u6027\uff0c\u56e0\u6b64\u9700\u8981\u63a5\u53d7\u6807\u51c6\u7684\u4e0a\u9650\u3002 \u6b64\u793a\u4f8b\u663e\u793a\u4e86\u5728ICH\u5efa\u8bae\u5206\u6790\u4e4b\u540e\u65e0\u6cd5\u5408\u5e76\u6279\u6b21\u6570\u636e\u7684\u60c5\u51b5\u3002 \u8fd9\u5bfc\u81f4\u4f7f\u7528\u201c\u6700\u574f\u72b6\u51b5\u201d\u6279\u6b21\uff08\u8be5\u6279\u6b21\u9996\u5148\u4e0e\u9a8c\u6536\u6807\u51c6\u76f8\u4ea4\uff09\u4ee5\u4f30\u8ba1<\/span>\u652f\u6301\u4fdd\u8d28\u671f<\/span>\u3002<\/span><\/p>\n


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

\u6700\u957f\u4fdd\u8d28\u671f<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

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

\"\u7b80\u8bba\u836f\u54c1\u7684\u4fdd\u8d28\u671f\uff08\u4e00\uff09\"<\/p>\n

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<\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

ICH\u6307\u5357\u7684\u7edf\u8ba1\u65b9\u6cd5\u8bba<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

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 <\/span><\/p>\n

\u6279\u6b21\u7684\u53ef\u6df7\u5408\u6027\u6d4b\u8bd5<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

\u53ef\u6df7\u5408\u6027\uff08Poolability\uff09\u662f\u4e00\u79cd\u7edf\u8ba1\u6d4b\u8bd5\uff0c\u5b83\u4f7f\u7edf\u8ba1\u5b66\u5bb6\u80fd\u591f\u51b3\u5b9a\u6570\u636e\u9a71\u52a8\u7684\u51b3\u7b56\u662f\u5426\u5c5e\u4e8e\u540c\u4e00population\u3002\u4e3a\u4e86\u5efa\u7acb\u4e0d\u540c\u6279\u6b21\u7684\u53ef\u6df7\u5408\u6027\uff0c\u4e00\u822c\u4f7f\u7528\u534f\u65b9\u5dee\u5206\u6790\uff08ANCOVA\uff09\uff0c\u5176\u4e2d\u65f6\u95f4\u88ab\u8ba4\u4e3a\u662f\u534f\u53d8\u91cf\u4ee5\u6d4b\u8bd5\u659c\u7387\u548c\u622a\u8ddd\u7684\u5dee\u5f02\u3002\u8be5\u65b9\u6cd5\u53ef\u7528\u4e8e\u8bc4\u4f30\u6765\u81ea\u4e24\u4e2a\u4e0d\u540c\u5047\u8bbe\u7fa4\u4f53\u7684\u6279\u6b21\u5728\u7edf\u8ba1\u4e0a\u8fdb\u884c\u6d4b\u8bd5\u7684\u60c5\u666f\u3002\u4f8b\u5982\uff0c\u5bf9\u4e8e\u76f8\u540c\u7684\u836f\u7269\u4ea7\u54c1\uff0c\u53ef\u4ee5\u9488\u5bf9\u4ee5\u4e0b\u60c5\u51b5\u786e\u5b9a\u53ef\u6df7\u5408\u6027\uff1a<\/span><\/p>\n

1.\u4e24\u79cd\u4e0d\u540c\u5305\u88c5\u7684\u7a33\u5b9a\u6027\u6570\u636e; 2.\u4e24\u4e2a\u6c14\u5019\u5e26\u7684\u7a33\u5b9a\u6027\u6570\u636e\u3002<\/span><\/p>\n


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

\u5728\u8fdb\u884c\u4efb\u4f55\u7edf\u8ba1\u5206\u6790\u4e4b\u524d\u5efa\u7acb\u6279\u6b21\u7684\u53ef\u6df7\u5408\u6027\u3002\u53ef\u4ee5\u68c0\u67e5\u659c\u7387\u662f\u5426\u7b49\u4e8e\u659c\u7387\u6216\u622a\u8ddd\u3002\u8003\u8651\u836f\u7269\u4ea7\u54c1\u7684\u6d4b\u5b9a\uff0c\u5176\u968f\u65f6\u95f4\u51cf\u5c11\u3002\u8fd9\u53ef\u4ee5\u901a\u8fc7\u65b9\u7a0b\u5f0f[1]\u7ed9\u51fa\u7684\u7ebf\u6027\u56de\u5f52\u6765\u5efa\u6a21\u3002<\/span><\/p>\n


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

Y<\/span>ij<\/sub> = <\/span>a<\/span>0<\/sub>+ <\/span>a<\/span>i<\/sub> + (<\/span>b<\/span>0<\/sub> + <\/span>b<\/span>i<\/sub>)t<\/span>ij<\/sub> + <\/span>e<\/span>ij         <\/sub>[1]<\/span><\/p>\n

 <\/span><\/p>\n

\u5176\u4e2d<\/span>yij<\/sub><\/span>\u662f\u91c7\u6837\u65f6\u95f4<\/span>tij<\/sub><\/span>\u7684\u7b2c<\/span>i<\/span>\u6279\u7684\u54cd\u5e94<\/span>; <\/span>a<\/span>0<\/sub> = \u6240\u6709\u6279\u6b21\u7684\u5171\u540c\u622a\u8ddd<\/span>; <\/span>a<\/span>i<\/sub> = \u7b2c<\/span>i<\/span>\u6279\u6b21\u7684\u622a\u8ddd\u4e0e<\/span>a<\/span>0<\/sub>\u7684\u504f\u5dee<\/span>; <\/span>b<\/span>0<\/sub> = \u6240\u6709\u6279\u6b21\u7684\u5171\u540c\u659c\u7387<\/span>; <\/span>b<\/span>i<\/sub>= \u7b2c<\/span>i<\/span>\u6279\u4e2a\u522b\u659c\u7387\u4e0e<\/span>b<\/span>0<\/sub>\u7684\u504f\u5dee<\/span>; <\/span>tij <\/sub>= \u91c7\u6837\u65f6\u95f4\uff08\u6708\uff09<\/span>; <\/span>e<\/span>ij<\/sub> = \u8bef\u5dee\u56e0\u5b50\uff0c<\/span>\u03b5 ~N(0, s<\/span>)<\/span><\/p>\n

 <\/span><\/p>\n

\u5bf9\u659c\u7387<\/span>\/\u622a\u8ddd\u76f8\u7b49\u7684\u5047\u8bbe\u6d4b\u8bd5\uff08<\/span>Hypothesis Testing\uff09\u53ef\u4ee5\u544a\u8bc9\u6211\u4eec\u56de\u5f52\u7ebf\u7684\u5747\u5300\u6027<\/span>\/\u540c\u8d28\u6027\u3002\u5728\u6279\u6b21\u4e4b\u95f4\uff0c\u9996\u5148\u505a\u659c\u7387\u6d4b\u8bd5\uff0c\u7136\u540e\u8fdb\u884c\u622a\u8ddd\u6d4b\u8bd5\u3002\u5173\u4e8e\u76f8\u7b49\u659c\u7387\u7684\u68c0\u9a8c\u5047\u8bbe\u6709\u4ee5\u4e0b\u4e24\u79cd\u7c7b\u578b\uff1a<\/span><\/span><\/p>\n


<\/p>\n

\u96f6\u5047\u8bbe<\/span>H0<\/sub>b<\/span><\/sub>:                            b<\/span>i<\/sub> = 0<\/span><\/p>\n

\u66ff\u4ee3\u5047\u8bbe<\/span>Ha<\/sub>b<\/span><\/sub>:                        b<\/span>i<\/sub> \u2260 0<\/span><\/p>\n


<\/p>\n

\u4e00\u65e6\u66ff\u4ee3\u5047\u8bbe\u88ab\u62d2\u7edd\uff0c\u8fd9\u610f\u5473\u7740\u6240\u6709\u88ab\u6d4b\u8bd5\u7684\u6279\u6b21\u90fd\u5177\u6709\u5171\u540c\u7684\u659c\u7387\u3002\u5728\u4e0b\u4e00\u6b65\u4e2d\uff0c\u6211\u4eec\u68c0\u9a8c\u622a\u8ddd\u76f8\u7b49\u7684\u5047\u8bbe\uff0c\u622a\u8ddd\u540c\u6837\u662f\u6709\u4e24\u79cd\u7c7b\u578b\uff1a<\/span><\/p>\n


<\/p>\n

\u96f6\u5047\u8bbe<\/span>H0<\/sub>a<\/span><\/sub>:                            a<\/span>i<\/sub> = 0<\/span><\/p>\n

\u66ff\u4ee3\u5047\u8bbe<\/span>Ha<\/sub>a<\/span><\/sub>:                        a<\/span>i<\/sub> \u2260 0<\/span><\/p>\n


<\/p>\n

\u6839\u636e\u659c\u7387\u6d4b\u8bd5\u4e2d\u96f6\u5047\u8bbe\u662f\u5426\u88ab\u63a5\u53d7\uff0c\u6211\u4eec\u53ef\u4ee5\u786e\u5b9a\u662f\u5426\u53ef\u4ee5\u5408\u5e76\u6279\u6b21\u505a\u7edf\u8ba1\u5206\u6790\u3002\u5982\u679c\u5728\u659c\u7387\u6d4b\u8bd5\u4e2d\u63a5\u53d7\u96f6\u5047\u8bbe\u4f46\u5728\u622a\u8ddd\u6d4b\u8bd5\u4e2d\u62d2\u7edd\u96f6\u5047\u8bbe\uff0c\u5219\u4ecd\u53ef\u4ee5\u7ec4\u5408\u6570\u636e\u4ee5\u4f30\u8ba1\u5171\u540c\u659c\u7387\u3002\u5982\u679c\u4e24\u4e2a\u6d4b\u8bd5\u7684\u96f6\u5047\u8bbe\u90fd\u88ab\u62d2\u7edd\uff0c\u5219\u6570\u636e\u4e0d\u53ef\u6df7\u5408\u4f7f\u7528\uff0c\u5e94\u8be5\u8fdb\u884c\u5355\u72ec\u7684\u5206\u6790\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0cICH\u6307\u5357Q1E\u5efa\u8bae\u6839\u636e\u6700\u5dee\u7684\u6279\u6b21\u786e\u5b9a\u4fdd\u8d28\u671f\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u56e0\u6b64\uff0c\u5728\u5efa\u7acb\u6279\u6b21\u7684\u53ef\u6df7\u5408\u6027\u65f6\uff0c\u53ef\u80fd\u4f1a\u51fa\u73b0\u56db\u79cd\u4e0d\u540c\u7684\u60c5\u51b5\uff1a<\/span><\/p>\n

1. H0<\/sub>b<\/span><\/sub>: b<\/span>i<\/sub> = 0 \u5e76\u4e14<\/span>H0<\/sub>a<\/span><\/sub>: a<\/span>i<\/sub> = 0 \u6570\u636e\u53ef\u6df7\u5408\u3002<\/span><\/span><\/p>\n

2. H0<\/sub>b<\/span><\/sub>: b<\/span>i<\/sub> = 0 \u5e76\u4e14<\/span>H0<\/sub>a<\/span><\/sub>: a<\/span>i<\/sub> \u2260 0\u6570\u636e\u53ef\u6df7\u5408\u4ee5\u4f30\u7b97\u5171\u540c\u659c\u7387\u3002<\/span><\/span><\/p>\n

3. H0<\/sub>b<\/span><\/sub>: b<\/span>i<\/sub> \u2260 0 \u5e76\u4e14<\/span>H0<\/sub>a<\/span><\/sub>: a<\/span>i<\/sub> \u2260 0 \u6570\u636e\u4e0d\u53ef\u6df7\u5408\u3002<\/span><\/span><\/p>\n

4. H0<\/sub>b<\/span><\/sub>: b<\/span>i<\/sub> \u2260 0 \u5e76\u4e14<\/span>H0<\/sub>a<\/span><\/sub>: a<\/span>i<\/sub> = 0 \u6570\u636e\u4e0d\u53ef\u6df7\u5408\u3002<\/span><\/span><\/p>\n

\u5728\u8bc4\u4f30\u6279\u6b21\u7684\u53ef\u6df7\u5408\u6027\u65f6\uff0c\u8003\u8651\u7684\u663e\u8457\u6027\u6c34\u5e73\uff08p\u503c\uff09\u4e3a0.25\u3002\u8fd9\u4e2ap\u503c\u4f3c\u4e4e\u5f88\u9ad8\uff0c\u4f46\u9009\u62e9\u7684\u539f\u56e0\u662f\uff0c\u7531\u4e8e\u7528\u4e8e\u7a33\u5b9a\u6027\u6d4b\u8bd5\u7684\u6279\u6b21\u6570\u8f83\u5c11\uff0c\u6211\u4eec\u5e94\u8be5\u5bf9\u5dee\u522b\u663e\u8457\u6027\u7684\u6709\u8db3\u591f\u7684\u4fe1\u5fc3\u3002<\/span><\/p>\n


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

\u957f\u671f\u7a33\u5b9a\u6027\u6570\u636e\u7684\u7edf\u8ba1\u8bc4\u4f30<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

ICH\u6307\u5357Q1E\u5efa\u8bae\u5bf9\u6bcf\u4e2a\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQA\uff09\u5206\u522b\u8fdb\u884c\u957f\u671f\u7a33\u5b9a\u6027\u6570\u636e\u7684\u7edf\u8ba1\u8bc4\u4f30\u3002\u53ea\u6709\u5728\u52a0\u901f\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u524d3\u4e2a\u6708\u5185\u89c2\u5bdf\u5230\u7684\u65f6\u95f4\u53d1\u751f\u663e\u7740\u53d8\u5316\u65f6\uff0c\u624d\u5e94\u542f\u52a8\u8bc4\u4f30\u3002\u5047\u8bbe\u836f\u7269\u4ea7\u54c1A\u7684\u52a0\u901f\u7a33\u5b9a\u6027\u6570\u636e\u5728CQA1\u7684\u65f6\u95f4\u5185\u663e\u793a\u51fa\u663e\u8457\u53d8\u5316\uff0c\u5219\u5982\u4ee5\u4e0b\u6b65\u9aa4\u4e2d\u7ed9\u51fa\u7684\u90a3\u6837\u8fdb\u884c\u957f\u671f\u7a33\u5b9a\u6027\u6570\u636e\u7684\u7edf\u8ba1\u8bc4\u4f30\u4ee5\u4f30\u8ba1\u653e\u884c\u9650\u5ea6\uff08Release Limit, RL\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6b65\u9aa41. \u6574\u7406\u7a33\u5b9a\u6027\u6570\u636e\u3002<\/span><\/p>\n

\u6b65\u9aa42. \u5efa\u7acb\u56de\u5f52\u6a21\u578b\u4ee5\u5f97\u51fa\u4f30\u8ba1\u4fdd\u503c\u671f\u3002<\/span><\/p>\n

\u6b65\u9aa43. \u4f30\u8ba1\u653e\u884c\u9650\u5236\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e0b\u9762\u53ea\u5c31\u6b65\u9aa42\u4f5c\u7b80\u660e\u7684\u9610\u8ff0\u3002\u540e\u7eed\u6587\u7ae0\u4f1a\u8fdb\u4e00\u6b65\uff0c\u5168\u9762\u4ecb\u7ecd\u6b65\u9aa41-3\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5982\u679c\u88ab\u6d4b\u8bd5\u7684CQA\u662f\u7a33\u5b9a\u6027\u6307\u793a\u7684\uff08\u968f\u65f6\u95f4\u53d8\u5316\uff09\uff0c\u5219\u56de\u5f52\u5206\u6790\u662f\u786e\u5b9a\u7a33\u5b9a\u6027\u7684\u4e3b\u8981\u65b9\u6cd5\uff0c\u56e0\u4e3a\u56e0\u5b50\u662f\u65f6\u95f4\uff0c\u54cd\u5e94\u662f\u836f\u54c1\u6279\u6b21\u91ca\u653e\u7684\u8d28\u91cf\u5c5e\u6027\u548c\u8868\u5f81\u836f\u7269\u7684\u4efb\u4f55\u5176\u4ed6\u5c5e\u6027\u3002\u8bc4\u4f30\u7a33\u5b9a\u6027\u6709\u4e24\u79cd\u65b9\u6cd5\uff0c\u5206\u522b\u57fa\u4e8e\u964d\u89e3\u901f\u7387\u548c\u4e0e\u964d\u89e3\u901f\u7387\u76f8\u5173\u7684\u7f6e\u4fe1\u533a\u95f4\u3002\u5f53\u6837\u672c\u91cf\u8f83\u5c0f\u65f6\uff0c\u5373\u5728\u65e9\u671f\u5f00\u53d1\u65f6\uff0c\u57fa\u4e8e\u964d\u89e3\u901f\u7387\u7684\u65b9\u6cd5\u6700\u5408\u9002\u3002\u5f53\u6837\u672c\u91cf\u548c\u65f6\u95f4\u95f4\u9694\u6709\u66f4\u591a\u6570\u636e\u65f6\uff0c\u5982\u5bf9\u957f\u671f\u7a33\u5b9a\u6027\u7814\u7a76\uff0c\u57fa\u4e8e\u7f6e\u4fe1\u533a\u95f4\u7684\u4fdd\u8d28\u671f\u4f30\u8ba1\u6700\u9002\u5408\u3002\u7b80\u5355\u7ebf\u6027\u56de\u5f52\u63d0\u4f9b\u964d\u89e3\u901f\u7387\uff08\u659c\u7387\uff09\uff0c\u65f6\u95f40\u5904\u7684\u8d77\u59cb\u503c\uff08\u622a\u8ddd\uff09\uff0c\u6bcf\u4e2a\u65f6\u95f4\u70b9\u7684\u5e73\u5747\u4f30\u8ba1\u503c\u7684\u7f6e\u4fe1\u533a\u95f4\u548c\u56de\u5f52\u7ebf\u7684\u6b8b\u5dee\uff08\u56fe2\uff09\u3002\u901a\u5e38\u907f\u514d\u4f7f\u7528\u975e\u7ebf\u6027\u548c\u5176\u4ed6\u7c7b\u578b\u7684\u7279\u6b8a\u7ebf\u6027\u6a21\u578b\uff08sqrt\uff0c1\/x\uff0clog\uff0c\u6307\u6570\uff0c\u591a\u9879\u5f0f\uff0c\u7b49\uff09\uff0c\u9664\u975e\u4ece\u6570\u636e\uff0c\u5386\u53f2\u7ecf\u9a8c\u548c\/\u6216\u6b8b\u5dee\u7684\u4ed4\u7ec6\u5206\u6790\u4e2d\u660e\u786e\u6307\u51fa\u3002\u975e\u7ebf\u6027\u6216\u7279\u6b8a\u62df\u5408\u7684\u5916\u63a8\u53ef\u80fd\u5728\u5916\u63a8\u65f6\u4ea7\u751f\u65e0\u610f\u4e49\u7684\u6216\u4e0d\u53ef\u91cd\u590d\u7684\u4fdd\u8d28\u671f\u4f30\u8ba1\uff0c\u56e0\u6b64\u5fc5\u987b\u5c0f\u5fc3\u4f7f\u7528\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5efa\u7acb\u56de\u5f52\u6a21\u578b\u4ee5\u4f30\u8ba1\u4fdd\u8d28\u671f\u2014\u2014\u56fa\u5b9a\u6279\u6b21\u5904\u7406\u65b9\u6cd5\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u76ee\u524d\u4e1a\u754c\u5728\u8bc4\u4f30\u957f\u671f\u7a33\u5b9a\u6027\u6570\u636e\u65f6\uff0c\u4e00\u822c\u4f9d\u636eICH Q1E\u6307\u5357, \u91c7\u7528\u56fa\u5b9a\u6279\u6b21\u5904\u7406\u65b9\u6cd5\uff08Fixed Batch Approach\uff09\u3002\u56fa\u5b9a\u6279\u6b21\u65b9\u6cd5\u662f\u4e00\u79cd\u7ebf\u6027\u56de\u5f52\uff0c\u5b83\u4f7f\u7528\u6700\u5c0f\u4e8c\u4e58\u7684\u65b9\u6cd5\u6765\u62df\u5408\u56de\u5f52\u7ebf\u3002\u516c\u5f0f[2]\u662f\u56fa\u5b9a\u6279\u6b21\u65b9\u6cd5\u7684\u6a21\u578b\u65b9\u7a0b\u3002<\/span><\/p>\n


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

Y<\/span>kl<\/sub> = <\/span>a<\/span>k<\/sub>+ <\/span>b<\/span>k<\/sub>t <\/span>kl<\/sub> + <\/span>e<\/span>kl                      <\/sub>[2]<\/span>
<\/span><\/p>\n

 <\/span><\/p>\n

\u5176\u4e2d<\/span> Ykl<\/sub> = \u5728\u65f6\u95f4<\/span>tkl<\/sub>\u65f6\u7b2c<\/span>k<\/em>\u6279\u6b21\u7684\u54cd\u5e94<\/span>; tkl<\/sub> =\u7b2c<\/span>k<\/span><\/em>\u6279\u7684\u91c7\u6837\u65f6\u95f4<\/span>; <\/span>b<\/span>k<\/sub> =\u7b2c<\/span>k<\/span><\/em>\u6279\u7684\u659c\u7387<\/span>; <\/span>a<\/span>k <\/sub>=\u7b2c<\/span>k<\/span><\/em>\u6279\u7684\u622a\u8ddd<\/span>; <\/span>e<\/span>ij<\/sub> =\u8bef\u5dee\u56e0\u5b50\uff0c<\/span> \u03b5 ~ N(0, s<\/span>)\u3002<\/span><\/p>\n

 <\/span><\/strong><\/p>\n

\"\u7b80\u8bba\u836f\u54c1\u7684\u4fdd\u8d28\u671f\uff08\u4e00\uff09\"<\/p>\n

\u56fe3. \u56de\u5f52\u7ebf\u56fe\u3002\u57fa\u4e8e\u56de\u5f52\u7ebf\u659c\u7387\u7684\u65b9\u6cd5\u5f97\u51fa\u4fdd\u8d28\u671f\u4e3a52\u4e2a\u6708\uff0c\u800c\u57fa\u4e8e\u7f6e\u4fe1\u533a\u95f4\u7684\u65b9\u6cd5\u5219\u5f97\u51fa35\u4e2a\u6708\u7684\u4fdd\u8d28\u671f\u3002 ICH\u6307\u5357\u5efa\u8bae\u4f7f\u7528\u57fa\u4e8e\u7f6e\u4fe1\u533a\u95f4\u7684\u65b9\u6cd5\u3002USL\u662f\u836f\u54c1\u89c4\u683c\u7684\u4e0a\u9650\u3002LSL\u662f\u836f\u54c1\u89c4\u683c\u7684\u4e0b\u9650\u3002<\/span><\/p>\n

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

\u8ba8\u8bba<\/span><\/span><\/strong><\/p>\n

 <\/span><\/p>\n

\u9700\u8981\u5f3a\u8c03\u4e00\u4e0b\uff0c\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u57fa\u672c\u76ee\u6807\u662f\u8868\u5f81\u836f\u7269\u4ea7\u54c1\u7684\u201c\u5316\u5b66\u7a33\u5b9a\u6027\u201d\u6216\u964d\u89e3\u901f\u7387\uff08\u53d8\u5316\u7387\uff09\u3002\u4ece\u67d0\u79cd\u610f\u4e49\u4e0a\u8bf4\uff0c\u53ef\u4ee5\u5c06\u5176\u89c6\u4e3a\u5728\u7a33\u5b9a\u6027\u65b9\u6848\u4e2d\u89c4\u5b9a\u7684\u5df2\u77e5\u56fa\u5b9a\u6548\u5e94\uff08\u4f8b\u5982\u50a8\u5b58\u6761\u4ef6\u548c\u5305\u88c5\uff09\u6761\u4ef6\u4e0b\u7684\u836f\u7269\u5206\u5b50\u7684\u5316\u5b66\u52a8\u529b\u5b66\u7814\u7a76\u3002\u7814\u7a76\u91cd\u70b9\u662f\u591a\u6279\u6b21\u7684\u5e73\u5747\u7a33\u5b9a\u6027\uff0c\u5176\u91cd\u8981\u6027\u5728\u4f7f\u7528\u6df7\u5408\u6837\u54c1\u4f5c\u7a33\u5b9a\u6027\u8bc4\u4f30\u65f6\u5c24\u5176\u660e\u663e\uff0c\u5e76\u4e14\u4e0e\u4e34\u5e8a\u5f00\u53d1\u8303\u5f0f\u5b8c\u5168\u4e00\u81f4: \u5373\u6bcf\u4e2a\u6279\u6b21\u4e2d\u7684\u5355\u4e2a\u5242\u91cf\u5355\u4f4d\u5728\u7528\u4e8e\u53d7\u8bd5\u8005\u4e4b\u524d\u662f\u4e0d\u80fd\u5355\u72ec\u6d4b\u8bd5\u7684\u3002\u6807\u51c6\u7684\u8d28\u91cf\u58f0\u660e\u5fc5\u987b\u662f\u4f9d\u636e\u6279\u6b21\u5e73\u5747\u503c\u7684\u7ed3\u679c\uff0c\u5e76\u8fdb\u884c\u989d\u5916\u7684\u9075\u5faa\u836f\u5178\u6216\u5176\u4ed6\u542b\u91cf\u5747\u5300\u6027\u6d4b\u8bd5\uff0c\u4ee5\u786e\u4fdd\u5355\u4e2a\u5242\u91cf\u5355\u4f4d\u7684\u836f\u7269\u6548\u529b\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5e94\u8be5\u6307\u51fa\u7684\u662f\uff0c\u8bbe\u8ba1\u7a33\u5b9a\u6027\u7814\u7a76\u65f6\u901a\u5e38\u4e0d\u4f1a\u5bf9\u56fa\u5b9a\u6216\u968f\u673a\u56e0\u7d20\u6709\u7edf\u8ba1\u4e0a\u7684\u8003\u8651\u3002\u76f8\u53cd\uff0c\u91cd\u70b9\u662f\u901a\u8fc7\u5c11\u91cf\u6279\u6b21\u7684\u7814\u7a76\uff0c\u7ecf\u6d4e\u5730\u4f30\u7b97\u591a\u79cd\u50a8\u5b58\u6761\u4ef6\u4e0b\uff0c\u5982\u4f5c\u4e3a\u56fa\u5b9a\u6548\u5e94\u7684\u5305\u88c5\u548c\u5f3a\u5ea6\uff0c\u5bf9\u7a33\u5b9a\u6027\u7684\u5f71\u54cd\u3002\u8fd9\u6837\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u8bbe\u8ba1\u7ecf\u53d7\u4e86\u65f6\u95f4\u7684\u8003\u9a8c\uff0c\u8db3\u4ee5\u7528\u4e8e\u7edf\u8ba1\u6a21\u578b\u7684\u53c2\u6570\u4f30\u8ba1\u3002\u53e6\u4e00\u4e2a\u91cd\u8981\u95ee\u9898\u662f\u5316\u5b66\u5206\u6790\u65b9\u6cd5\u7684\u8bbe\u8ba1\u3002\u8fd9\u5728\u7a33\u5b9a\u6027\u65b9\u6848\u8bbe\u8ba1\u4e2d\u5f88\u5c11\u88ab\u8003\u8651\uff0c\u4f46\u5b83\u6709\u53ef\u80fd\u5bfc\u81f4\u56fa\u5b9a\u6548\u5e94\u4e0e\u5206\u6790\u8fc7\u7a0b\u7684\u590d\u5408\u6548\u5e94\u3002\u8fd9\u4f7f\u5f97\u7a33\u5b9a\u6027\u5206\u5e03\u4f30\u8ba1\u7684\u72ec\u7acb\u6027\u4e4b\u7f3a\u4e4f\u8fdb\u4e00\u6b65\u589e\u52a0\u3002\u5728\u8bc4\u4f30\u7a33\u5b9a\u6027\u6a21\u578b\u53c2\u6570\u7684\u4e0d\u786e\u5b9a\u6027\u65f6\uff0c\u4e5f\u9700\u8981\u6b63\u786e\u5730\u8bc4\u4f30\u5206\u6790\u8fc7\u7a0b\u4e4b\u5185\u548c\u4e4b\u95f4\u7684\u53d8\u5f02\uff08between and within analytical run variance components\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5728\u53e6\u4e00\u65b9\u9762\uff0cICH Q1E\u5efa\u8bae\u7684\u7a33\u5b9a\u6027\u6570\u636e\u7684\u7edf\u8ba1\u8bc4\u4f30\u5b58\u5728\u8bb8\u591a\u7406\u8bba\u548c\u5b9e\u8df5\u4e0a\u7684\u95ee\u9898\u3002\u4e1a\u754c\u5df2\u5145\u5206\u610f\u8bc6\u5230\u8fd9\u4e9b\u95ee\u9898\uff0c\u5e76\u5c55\u5f00\u4e86\u5404\u79cd\u8ba8\u8bba\u4e0e\u63a2\u7d22\uff0c\u5bfb\u6c42\u65b0\u7684\u89e3\u51b3\u529e\u6cd5\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4f8b\u5982\uff0cQ1E\u5bf9\u622a\u8ddd\u662f\u5426\u76f8\u540c\u7684\u6d4b\u8bd5\u7684\u5efa\u8bae\u5c24\u5176\u6210\u95ee\u9898\u3002\u6bcf\u4e2a\u6279\u6b21\u5728\u653e\u884c\u65f6\u6709\u76f8\u540c\u7684\u836f\u54c1\u6548\u529b\u662f\u4e00\u4e2a\u5b8c\u5168\u4e0d\u73b0\u5b9e\u7684\u5047\u8bbe\uff0c\u56e0\u4e3a\u5728\u7269\u7406\u79f0\u91cd\u64cd\u4f5c\u548c\u6df7\u5408\u4e2d\u603b\u4f1a\u5b58\u5728\u5fae\u5c0f\u5dee\u5f02\u3002\u8fd9\u662f\u4e00\u4e2a\u5408\u7406\u7684\u5148\u9a8c\u9884\u671f\uff0c\u56e0\u6b64\u5b83\u4e0e\u5bfb\u6c42\u68c0\u9a8c\u201c\u76f8\u7b49\u622a\u8ddd\u201d\u7684Q1E\u89c4\u5219\u5b8c\u5168\u80cc\u9053\u800c\u9a70\u3002\u5982\u4f55\u8bc1\u660e\u4f7f\u7528\u57fa\u672c\u4e0a\u6765\u81ea\u6d4b\u91cf\u8bef\u5dee\u7684\u5269\u4f59\u8bef\u5dee\u9879\u4f5c\u4e3a\u6279\u6b21\u622a\u8ddd\u7684\u53ef\u6df7\u5408\u6027\u6807\u51c6\u662f\u5408\u7406\u7684\u5462\uff1f\u9884\u8ba1\u751f\u4ea7\u7684\u5404\u6279\u6b21\u7684\u4e0d\u540c\u4f1a\u56e0\u5206\u6790\u6d4b\u91cf\u7684\u8bef\u5dee\u800c\u6076\u5316\u3002\u6b64\u5916\uff0c\u5047\u8bbe\u68c0\u9a8c\u65b9\u6cd5\uff08hypothesis testing approach\uff09\u4e0d\u5229\u4e8e\u6211\u4eec\u8ffd\u6c42\u66f4\u7cbe\u786e\u7684\u6d4b\u91cf\u5de5\u5177\u548c\u5206\u6790\u65b9\u6cd5\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5404\u6279\u6b21\u659c\u7387\u7684\u53ef\u6df7\u6027\u6d4b\u8bd5\u4e5f\u5b58\u5728\u95ee\u9898\u3002\u5b83\u57fa\u672c\u4e0a\u662f\u5728\u8bf4\uff0c\u63a7\u5236\u6279\u6b21\u751f\u4ea7\u8fc7\u7a0b\u7684\u5316\u5b66\u548c\u7269\u7406\u8fc7\u7a0b\u968f\u4e0d\u540c\u6279\u6b21\u800c\u53d8\u5316\u3002\u8fd9\u4e5f\u662f\u4e00\u79cd\u4e0d\u5207\u5b9e\u9645\u7684\u82db\u523b\u89c2\u70b9\uff0c\u56e0\u4e3a\u73b0\u4ee3\u751f\u4ea7\u6280\u672f\u7684\u5de5\u827a\u53c2\u6570\u548c\u6750\u6599\u7684\u63a7\u5236\u901a\u5e38\u4fdd\u6301\u5728\u975e\u5e38\u9ad8\u7684\u6c34\u5e73\u3002\u8003\u8651\u5230\u8fd9\u4e9b\u60c5\u51b5\uff0c\u5316\u5b66\u964d\u89e3\u901f\u7387\u901a\u5e38\u5e94\u4e0e\u751f\u4ea7\u6279\u6b21\u65e0\u5173\uff0c\u56e0\u6b64\uff0c\u6279\u6b21\u95f4\u76f8\u540c\u5e76\u56fa\u5b9a\u901f\u7387\u5e38\u6570\u7684\u5047\u8bbe\u662f\u5408\u7406\u7684\u3002<\/span><\/p>\n

 <\/span><\/p>\n

Stan Altan et al\u63d0\u4f9b\u7ecf\u9a8c\u8bc1\u636e\u652f\u6301\u76f8\u540c\u659c\u7387\u6a21\u578b\u662f\u4e00\u4e2a\u5408\u7406\u5047\u8bbe\u3002\u4ed6\u4eec\u56de\u987e\u4e8633\u9879\u7a33\u5b9a\u6027\u7814\u7a76\uff0c\u8fd9\u4e9b\u7814\u7a76\u4ee3\u8868\u4e86\u5404\u79cd\u5242\u578b\u7684\u5c1a\u5728\u5f00\u53d1\u548c\u5df2\u4e0a\u5e02\u7684\u836f\u7269\u3002\u5728\u5047\u8bbe\u6279\u6b21\u7279\u5b9a\u622a\u8ddd\u7684\u60c5\u51b5\u4e0b\uff0c\u5728\u62df\u5408\u4e86\u56fa\u5b9a\u6279\u6b21\u6a21\u578b\u5e76\u6d4b\u8bd5\u659c\u7387\u7684\u53ef\u6df7\u5408\u6027\u53d1\u73b0\uff0c\u53ef\u6df7\u5408\u6027\u6d4b\u8bd5\u7684\u4e2d\u503cp\u503c= 0.670\uff0c\u5176\u4e2d13\uff05\u7684p\u503c<0.25\uff0c5\uff05\u7684p\u503c<0.10\uff0c70\uff05\u7684p\u503c> 0.50\u3002\u5982\u679c\u6d4b\u8bd5\u7ed3\u679c\u63a5\u8fd1\u5747\u5300\u5206\u5e03\u5e76\u4e14\u5b8c\u5168\u5f52\u56e0\u4e8e\u5076\u7136\u6027\uff0c\u5219p\u503c\u7684\u8fd9\u79cd\u5206\u5e03\u53ef\u80fd\u4e0e\u4eba\u4eec\u9884\u671f\u7684\u5dee\u522b\u4e0d\u5927\u3002\u56e0\u6b64\uff0c\u5728\u8fd9\u9879\u5b9e\u8bc1\u7814\u7a76\u4e2d\uff0c\u6ca1\u6709\u8bc1\u636e\u8868\u660e\u5b58\u5728\u7279\u5b9a\u6279\u6b21\u659c\u7387\u7684\u4e00\u822c\u8d8b\u52bf\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u57fa\u672c\u5047\u8bbe\u662f\u7a33\u5b9a\u6027\u7814\u7a76\u4e2d\u5305\u542b\u7684\u6ce8\u518c\u6279\u6b21\u6765\u81ea\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\u7684\u751f\u4ea7\u8fc7\u7a0b\u3002\u4e00\u4e2a\u826f\u597d\u7684\u53d7\u63a7\u8fc7\u7a0b\u7531\u603b\u4f53\u5e73\u5747\u54cd\u5e94\u5b9a\u4e49\uff0c\u5176\u4e2d\u5355\u4e2a\u6279\u6b21\u54cd\u5e94\u7b49\u4e8e\u8be5\u8fc7\u7a0b\u7684\u5e73\u5747\u503c\u52a0\u4e0a\u968f\u673a\u53d8\u5f02\u3002\u56e0\u6b64\uff0c\u5171\u540c\u622a\u8ddd\u548c\u5171\u540c\u659c\u7387\u7684\u56de\u5f52\u6a21\u578b\u662f\u63cf\u8ff0\u4e00\u4e2a\u53d7\u63a7\u8fc7\u7a0b\u7684\u5e73\u5747\u54cd\u5e94\u7684\u6700\u6709\u610f\u4e49\u7684\u6a21\u578b\u3002\u7136\u540e\uff0c\u4f30\u8ba1\u5171\u540c\u622a\u8ddd\u548c\u659c\u7387\u65f6\uff0c\u5e94\u8be5\u5229\u7528\u6765\u81ea\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u6240\u6709\u53ef\u7528\u6570\u636e\u6765\u63d0\u4f9b\u5bf9\u603b\u4f53\u5e73\u5747\u54cd\u5e94\u968f\u65f6\u95f4\u53d8\u5316\u7684\u6700\u7cbe\u786e\u4f30\u8ba1\u3002<\/span><\/p>\n


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

\u4f46\u662f\uff0c\u589e\u52a0\u4f30\u8ba1\u7684\u7cbe\u786e\u5ea6\u4f1a\u5bfc\u81f4\u5982\u4e0b\u7684\u7ed3\u679c\uff1a\u5373\u4f7f\u5177\u6709\u5171\u540c\u622a\u8ddd\u548c\u6279\u6b21\u95f4\u5171\u540c\u659c\u7387\u7684\u56de\u5f52\u6a21\u578b\u662f\u6700\u5408\u9002\u7684\u6a21\u578b\uff0c\u5982\u679c\u9075\u5faaICH\u7b56\u7565\uff0c\u7edf\u8ba1\u8ba1\u7b97\u5c06\u503e\u5411\u4e8e\u6700\u5c11\u9009\u62e9\u8be5\u6a21\u578b\uff0c\u56e0\u4e3a\u589e\u52a0\u622a\u8ddd\u548c\u659c\u7387\u4f30\u8ba1\u7684\u7cbe\u5ea6\u589e\u52a0\u4e86ICH\u6d4b\u8bd5\u7684\u529f\u6548\uff0c\u4ee5\u81f3\u4e8e\u68c0\u6d4b\u5230\u5b83\u4eec\u4e4b\u95f4\u5fae\u5c0f\u7684\uff0c\u751a\u81f3\u65e0\u5173\u7d27\u8981\u7684\u5dee\u5f02\u3002\u8fd9\u662f\u6709\u95ee\u9898\u7684\uff0c\u56e0\u4e3a\u6df7\u5408\u6279\u6b21\u7a33\u5b9a\u6027\u6570\u636e\u7684\u7406\u7531\u662f\u4e0d\u62d2\u7edd\u5171\u540c\u622a\u8ddd\u548c\u659c\u7387\u6a21\u578b\u4e3a\u9002\u5f53\u7684\u96f6\u5047\u8bbe\u7684\u7ed3\u679c\u3002\u589e\u52a0\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e2d\u5305\u542b\u7684\u6279\u6b21\u6570\u53ea\u4f1a\u5bfc\u81f4\u66f4\u591a\u5730\u62d2\u7edd\u5171\u540c\u622a\u8ddd\u548c\u659c\u7387\u4e3a\u9002\u5f53\u7684\u96f6\u5047\u8bbe\u3002<\/span><\/p>\n

 <\/span><\/p>\n

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 <\/span><\/p>\n

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\u603b\u7ed3\u548c\u524d\u77bb<\/span><\/strong><\/span><\/p>\n

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\u672c\u6587\u5982\u6709\u758f\u6f0f\u548c\u8bef\u8bfb\u76f8\u5173\u6307\u5357\u548c\u6570\u636e\u7684\u5730\u65b9\uff0c\u8bf7\u8bfb\u8005\u8bc4\u8bba\u548c\u6307\u6b63\u3002\u6240\u6709\u5f15\u7528\u7684\u539f\u59cb\u4fe1\u606f\u548c\u8d44\u6599\u5747\u6765\u81ea\u5df2\u7ecf\u53d1\u8868\u5b66\u672f\u671f\u520a\uff0c\u5b98\u65b9\u7f51\u7edc\u62a5\u9053\uff0c\u7b49\u516c\u5f00\u6e20\u9053\uff0c\u4e0d\u6d89\u53ca\u4efb\u4f55\u4fdd\u5bc6\u4fe1\u606f\u3002\u53c2\u8003\u6587\u732e\u7684\u9009\u62e9\uff0c\u8003\u8651\u5230\u591a\u6837\u5316\u4f46\u4e5f\u4e0d\u53ef\u80fd\u5b8c\u5907\u3002\u6b22\u8fce\u8bfb\u8005\u63d0\u4f9b\u6709\u4ef7\u503c\u7684\u6587\u732e\u53ca\u5176\u8bc4\u4f30\u3002<\/span><\/em><\/p>\n

 <\/span><\/p>\n

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

1. InternationalConference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use. Q1A(R2): Stability testing of new drugsubstances and products; 2003.<\/span><\/p>\n

2. InternationalConference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use. Q1E evaluation of stability data; 2004.<\/span><\/p>\n

3. InternationalConference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use. Q6A: specifications: test procedures andacceptance criteria for new drug substances and new drug products: ChemicalSubstances; 1999.<\/span><\/p>\n

4. Larner G, et al.Challenges and opportunities in implementing the FDA default parametrictolerance interval two one-sided test for delivered dose uniformity of orallyinhaled products. AAPS PharmSciTech. 2011;12(4):1144\u201356.<\/span><\/p>\n

5. InternationalConference on Harmonization of Technical Requirements for Registration ofPharmaceuticals for Human Use. Q1E evaluation of stability data; 2004.<\/span><\/p>\n

6. Quinlan M, StroupW, Christopher D, Schwenke J. On the distribution of batch shelf lives. JBiopharm Stat. 2013;23(4):897-920. doi: 10.1080\/10543406.2013.790039.<\/span><\/p>\n

7. Quinlan M, StroupW, Schwenke J, Christopher D. Evaluating the performance of the ICH guidelinesfor shelf life estimation. J Biopharm Stat. 2013;23(4):881-96. doi:10.1080\/10543406.2013.789889.<\/span><\/p>\n

8. Stroup W, Quinlan,M. Alternative shelf life estimation methodologies. In JSM Proceedings,Biopharmaceutical Section. Alexandria, VA: American Statistical Association.2010;2056\u2013x2066.<\/span><\/p>\n

9. Khan et al.Stability challenges not addressed by harmonized guidance \u2013 AAPS workshop of thestability focus group, April 3rd- 4th, 2017 in Rockville, MDAAPS Open (2018)4:2 DOI 10.1186\/s41120-018-0022-4.<\/span><\/p>\n

10.  Robert Capen, etal, On the Shelf Life of Pharmaceutical Products. AAPS PharmSciTech, Vol. 13,No. 3, September 2012 (# 2012) DOI: 10.1208\/s12249-012-9815-2.<\/span><\/p>\n

11.  Stan Altan et al, Perspectiveson Pooling as Described in the ICH Q1E Guidance, Conference: Joint StatisticalMeeting, August 2013.<\/span><\/p>\n


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\u6b22\u8fce\u6295\u7a3f\u5230\u5c0f\u7f16\u90ae\u7bb1\uff1awuwj06@163.com<\/strong><\/span><\/strong><\/span><\/strong><\/span><\/span><\/span><\/strong><\/p>\n

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\u5c0f\u7f16\u56e2\u961f\u73b0\u670921\u4f4d\u6210\u5458\uff1a<\/strong><\/span><\/span><\/p>\n

Armstrong\u3001\u533b\u836f\u5c40\u5916\u4eba\u3001Fairy\u3001<\/span>Jone\u3001\u4e1c\u80dc\u897f\u725b\u3001Alpharesearcher\u3001MT\u3001\u767e\u8349\u3001Irene\u3001<\/span>Self Renew\u3001\u86cb\u767d\u5de5\u4eba\u3001At.Zhou\u3001Julia\u3001\u6e38\u65b9\u548c\u5c1a\u3001Grand\u3001\u5915\u9633\u6b66\u58eb\u3001\u5403\u74dc\u7fa4\u4f17\u3001Nathan\u3001\u795e\u7ecf\u5143\u3001Clear\u516e\u3001\u5357\u5c71\u5357<\/span><\/span><\/p>\n

\u6b22\u8fce\u6709\u5171\u540c\u5174\u8da3\u7684\u670b\u53cb\u52a0\u5165<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n

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