{"id":1805,"date":"2026-06-05T16:07:06","date_gmt":"2026-06-05T08:07:06","guid":{"rendered":"https:\/\/www.millibuff.com\/?p=1805"},"modified":"2026-06-05T16:16:37","modified_gmt":"2026-06-05T08:16:37","slug":"nmpa-%e4%b8%8e-fda-%e6%8c%87%e5%8d%97%e4%b8%8b%e7%be%a4%e4%bd%93%e8%8d%af%e4%bb%a3%e5%8a%a8%e5%8a%9b%e5%ad%a6%ef%bc%88poppk%ef%bc%89%e6%a8%a1%e5%9e%8b%e8%af%84%e4%bb%b7%e8%a7%84%e8%8c%83%e7%a0%94","status":"publish","type":"post","link":"https:\/\/www.millibuff.com\/?p=1805","title":{"rendered":"NMPA \u4e0e FDA \u6307\u5357\u4e0b\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\uff08popPK\uff09\u6a21\u578b\u8bc4\u4ef7\u89c4\u8303\u7814\u7a76"},"content":{"rendered":"\n<p class=\"has-medium-font-size wp-block-paragraph\">1\u3001<strong>\u5f15\u8a00<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u4ee5\u975e\u7ebf\u6027\u6df7\u5408\u6548\u5e94\u6a21\u578b\uff08NLMEM\uff09\u4e3a\u6838\u5fc3\uff0c\u53ef\u6574\u5408\u5bc6\u96c6 \/ \u7a00\u758f\u91c7\u6837\u6570\u636e\u3001\u91cf\u5316\u4e2a\u4f53\u95f4\u53d8\u5f02\u4e0e\u534f\u53d8\u91cf\u6548\u5e94\uff0c\u5728\u7ed9\u836f\u65b9\u6848\u4f18\u5316\u3001\u7279\u6b8a\u4eba\u7fa4\u7528\u836f\u3001\u79cd\u65cf\u5dee\u5f02\u5206\u6790\u3001\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u8bc4\u4ef7\u4e2d\u53d1\u6325\u5173\u952e\u4f5c\u7528\u3002\u6a21\u578b\u8bc4\u4ef7\u662f PopPK \u5206\u6790\u7684\u8d28\u63a7\u6838\u5fc3\uff0c\u7528\u4e8e\u9a8c\u8bc1\u7ed3\u6784\u5408\u7406\u6027\u3001\u53c2\u6570\u53ef\u9760\u6027\u3001\u9884\u6d4b\u6027\u80fd\u4e0e\u7a33\u5065\u6027\uff0c\u662f\u76d1\u7ba1\u5ba1\u8bc4\u7684\u91cd\u70b9\u5ba1\u67e5\u5185\u5bb9\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u4e8e 2020 \u5e74 12 \u6708\u53d1\u5e03\u6b63\u5f0f\u7248\u6307\u5bfc\u539f\u5219\uff0c\u5168\u9762\u8986\u76d6\u7814\u7a76\u8bbe\u8ba1\u3001\u6570\u636e\u5206\u6790\u3001\u6a21\u578b\u5efa\u7acb\u4e0e\u8bc4\u4ef7\u3001\u8d28\u91cf\u63a7\u5236\u5168\u6d41\u7a0b\uff0c\u8d34\u5408\u56fd\u5185\u521b\u65b0\u836f\u7814\u53d1\u4e0e\u7533\u62a5\u5b9e\u8df5\u3002FDA \u5219\u5728 1999 \u7248\u6307\u5357\u57fa\u7840\u4e0a\uff0c\u4e8e 2022 \u5e74 2 \u6708\u53d1\u5e03\u7ec8\u7248\u6307\u5357\uff0c\u5f3a\u5316\u751f\u7269\u5236\u54c1\u3001\u65f6\u53d8\u534f\u53d8\u91cf\u3001\u6a21\u578b\u4e0d\u786e\u5b9a\u6027\u4e0e\u63d0\u4ea4\u89c4\u8303\uff0c\u6280\u672f\u4f53\u7cfb\u66f4\u8d8b\u5b8c\u5584\u3002\u4e24\u4efd\u6307\u5357\u5728\u79d1\u5b66\u5185\u6838\u4e0a\u9ad8\u5ea6\u4e00\u81f4\uff0c\u4f46\u5728\u672f\u8bed\u5b9a\u4e49\u3001\u65b9\u6cd5\u5c42\u7ea7\u3001\u7279\u6b8a\u95ee\u9898\u5904\u7f6e\u4e0e\u9a8c\u8bc1\u6743\u91cd\u4e0a\u5b58\u5728\u663e\u8457\u5dee\u5f02\u3002\u672c\u6587\u805a\u7126\u6a21\u578b\u8bc4\u4ef7\u89c4\u8303\uff0c\u5f00\u5c55\u7cfb\u7edf\u6027\u5bf9\u6bd4\u7814\u7a76\uff0c\u4e3a\u884c\u4e1a\u5b9e\u8df5\u63d0\u4f9b\u6e05\u6670\u6307\u5f15\u3002<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">2\u3001<strong>PopPK \u6a21\u578b\u8bc4\u4ef7\u7684\u6838\u5fc3\u5b9a\u4f4d\u4e0e\u6846\u67b6\u5bf9\u6bd4<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2.1\u6838\u5fc3\u5b9a\u4f4d\u4e0e\u672f\u8bed\u4f53\u7cfb<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u6307\u5357\u91c7\u7528\u6a21\u578b\u8bc4\u4ef7\u6982\u5ff5\uff0c\u5f3a\u8c03\u8d2f\u7a7f\u5efa\u6a21\u5168\u5468\u671f\uff08\u57fa\u7840\u6a21\u578b\u2192\u7ed3\u6784\u6a21\u578b\u2192\u534f\u53d8\u91cf\u6a21\u578b\u2192\u6700\u7ec8\u6a21\u578b\uff09\u7684\u6301\u7eed\u8bc4\u4f30\uff0c\u76ee\u6807\u662f\u751f\u7269\u5b66\u5408\u7406\u3001\u53c2\u6570\u53ef\u9760\u3001\u9884\u6d4b\u6ee1\u8db3\u7814\u7a76\u76ee\u7684\u3002FDA \u6307\u5357\u4ee5\u6a21\u578b\u9a8c\u8bc1\u4e3a\u6838\u5fc3\uff0c\u805a\u7126\u9884\u6d4b\u6027\u80fd\uff0c\u5f3a\u8c03\u6a21\u578b\u5bf9\u72ec\u7acb\u6570\u636e\u96c6\u7684\u5916\u63a8\u80fd\u529b\uff0c\u66f4\u8d34\u5408\u4e0a\u5e02\u7533\u62a5\u4e0e\u8bf4\u660e\u4e66\u652f\u6491\u573a\u666f\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u7ef4\u5ea6<\/strong><strong><\/strong><\/td><td><strong>NMPA<\/strong><strong>\uff08<\/strong><strong>2020<\/strong><strong>\uff09<\/strong><strong><\/strong><\/td><td><strong>FDA<\/strong><strong>\uff08<\/strong><strong>1999\/2022<\/strong><strong>\uff09<\/strong><strong><\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u6838\u5fc3\u76ee\u6807<\/td><td>\u7efc\u5408\u5408\u7406\u6027 + \u53c2\u6570\u7cbe\u5ea6 + \u9884\u6d4b\u6027\u80fd + \u7a33\u5b9a\u6027<\/td><td>\u9884\u6d4b\u51c6\u786e\u6027 + \u7cbe\u786e\u6027 + \u4e34\u5e8a\u9002\u7528\u6027<\/td><\/tr><tr><td>\u5b9e\u65bd\u9636\u6bb5<\/td><td>\u5efa\u6a21\u5404\u9636\u6bb5\u540c\u6b65\u5f00\u5c55<\/td><td>\u6a21\u578b\u6784\u5efa\u5b8c\u6210\u540e\u4e13\u9879\u9a8c\u8bc1<\/td><\/tr><tr><td>\u76d1\u7ba1\u5bfc\u5411<\/td><td>\u79d1\u5b66\u89c4\u8303 + \u7533\u62a5\u5b9e\u64cd + \u56fd\u5185\u9002\u914d<\/td><td>\u9884\u6d4b\u6027\u80fd + \u8bf4\u660e\u4e66\u652f\u6491 + \u56fd\u9645\u5316\u7edf\u4e00<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">2.2\u5206\u7c7b\u4f53\u7cfb\u5dee\u5f02<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u6309<strong>\u6570\u636e\u6765\u6e90<\/strong>\u4e0e<strong>\u5b9e\u65bd\u624b\u6bb5<\/strong>\u53cc\u91cd\u5206\u7c7b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6309\u6570\u636e\u6765\u6e90\uff1a<strong>\u5185\u90e8\u8bc4\u4ef7<\/strong>\uff08\u5efa\u6a21\u6570\u636e\u96c6\uff09\u3001<strong>\u5916\u90e8\u8bc4\u4ef7<\/strong>\uff08\u72ec\u7acb\u6570\u636e\u96c6\uff09\uff1b<\/li>\n\n\n\n<li>\u6309\u624b\u6bb5\uff1a<strong>\u8bca\u65ad\u56fe\u8bc4\u4ef7<\/strong>+<strong>\u7edf\u8ba1\u5b66\u68c0\u9a8c<\/strong>\uff0c\u5f3a\u8c03\u591a\u65b9\u6cd5\u7efc\u5408\u9a8c\u8bc1\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u6309<strong>\u9a8c\u8bc1\u7c7b\u578b<\/strong>\u5206\u7c7b\uff0c\u66f4\u4fa7\u91cd\u7edf\u8ba1\u91cd\u62bd\u6837\u6280\u672f\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5916\u90e8\u9a8c\u8bc1\uff1a\u72ec\u7acb\u6570\u636e\u96c6\uff0c\u89c6\u4e3a<strong>\u6700\u4e25\u683c\u9a8c\u8bc1\u65b9\u5f0f<\/strong>\uff1b<\/li>\n\n\n\n<li>\u5185\u90e8\u9a8c\u8bc1\uff1a\u6570\u636e\u62c6\u5206\u3001\u4ea4\u53c9\u9a8c\u8bc1\u3001Bootstrap\uff0c\u9002\u914d\u6837\u672c\u53d7\u9650\u573a\u666f\uff08\u5982\u513f\u79d1\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">3\u3001<strong>\u6a21\u578b\u8bc4\u4ef7\u65b9\u6cd5\u4e0e\u6280\u672f\u89c4\u8303\u5bf9\u6bd4<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">3.1\u8bca\u65ad\u56fe\u8bc4\u4ef7\uff08NMPA \u66f4\u7cfb\u7edf\u3001FDA \u66f4\u7b80\u6d01\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u6307\u5357\u5c06\u8bca\u65ad\u56fe\u5206\u4e3a 4 \u5927\u7c7b\uff0c\u8986\u76d6\u5168\u7ef4\u5ea6\u8bca\u65ad\uff0c\u660e\u786e\u7eb3\u5165\u73b0\u4ee3\u5de5\u5177\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u57fa\u4e8e\u9884\u6d4b\uff1aDV vs PRED\u3001DV vs IPRED\u3001\u4e2a\u4f53\u836f\u2011\u65f6\u66f2\u7ebf\uff1b<\/li>\n\n\n\n<li>\u57fa\u4e8e\u6b8b\u5dee\uff1aCWRES\u3001IWRES \u6563\u70b9\u56fe \/ \u76f4\u65b9\u56fe \/ Q\u2011Q \u56fe\uff1b<\/li>\n\n\n\n<li>\u57fa\u4e8e\u968f\u673a\u6548\u5e94\uff1a\u5206\u5e03\u3001\u76f8\u5173\u6027\u3001\u534f\u53d8\u91cf\u5173\u8054\u56fe\uff1b<\/li>\n\n\n\n<li>\u57fa\u4e8e\u6a21\u62df\uff1a<strong>VPC<\/strong><strong>\u3001<\/strong><strong>pcVPC<\/strong><strong>\u3001<\/strong><strong>NPC<\/strong><strong>\u3001<\/strong><strong>NPDE<\/strong>\uff0c\u9ad8\u6536\u7f29\u573a\u666f\u4f18\u5148\u4f7f\u7528\u3002<\/li>\n\n\n\n<li>FDA \u6307\u5357\u4ec5\u63d0\u53ca\u5b9e\u6d4b\u2011\u9884\u6d4b\u56fe\u3001\u6b8b\u5dee\u2011\u534f\u53d8\u91cf\u56fe\uff0c2022 \u7248\u65b0\u589e\u9884\u6d4b\u6821\u6b63\u53ef\u89c6\u5316\u68c0\u9a8c\uff0c\u4f46<strong>\u672a\u7cfb\u7edf\u5206\u7c7b<\/strong>\uff0c\u66f4\u4fa7\u91cd\u4e34\u5e8a\u76f4\u89c2\u89e3\u8bfb\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">3.2 \u7edf\u8ba1\u5b66\u68c0\u9a8c\u4e0e\u53c2\u6570\u8bc4\u4ef7<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\"><strong>NMPA <\/strong><strong>\u5f3a\u8c03\uff1a<\/strong><strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bootstrap \u6cd5\u8bc4\u4f30\u53c2\u6570\u5206\u5e03\u4e0e\u7a33\u5065\u6027\uff1b<\/li>\n\n\n\n<li>\u53c2\u6570\u7cbe\u5bc6\u5ea6\uff08RSE%\u300195% CI\uff09\u3001\u53c2\u6570\u76f8\u5173\u6027\u3001\u6761\u4ef6\u6570\u7efc\u5408\u8bc4\u4ef7\uff1b<\/li>\n\n\n\n<li>\u654f\u611f\u6027\u5206\u6790\uff1a\u79bb\u7fa4\u503c\u3001\u6a21\u578b\u5047\u8bbe\u3001\u56fa\u5b9a \/ \u968f\u673a\u6548\u5e94\u7684\u5f71\u54cd\u91cf\u5316\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA <\/strong><strong>\u4fa7\u91cd\uff1a<\/strong><strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9884\u6d4b\u8bef\u5dee\u91cf\u5316\uff1a\u5e73\u5747\u9884\u6d4b\u8bef\u5dee\uff08\u51c6\u786e\u6027\uff09\u3001\u5747\u65b9\u6839\u8bef\u5dee\uff08\u7cbe\u786e\u6027\uff09\uff1b<\/li>\n\n\n\n<li>\u6807\u51c6\u5316\u9884\u6d4b\u8bef\u5dee\uff08z \u68c0\u9a8c\uff09\u3001\u53c2\u6570\u9a8c\u8bc1\u3001\u540e\u9a8c\u9884\u6d4b\u68c0\u9a8c\uff1b<\/li>\n\n\n\n<li>\u75c5\u4f8b\u5220\u9664\u8bca\u65ad\uff0c\u8bc4\u4f30\u6a21\u578b\u7a33\u5b9a\u6027\u4e0e\u5f02\u5e38\u503c\u5f71\u54cd\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">3.3 \u7279\u6b8a\u95ee\u9898\u5904\u7f6e\uff08\u6838\u5fc3\u5dee\u5f02\u70b9\uff09<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6536\u7f29\u73b0\u8c61\uff08<\/strong><strong>Shrinkage<\/strong><strong>\uff09<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u660e\u786e\u754c\u5b9a \u03b7\u2011\u6536\u7f29\u4e0e \u03b5\u2011\u6536\u7f29\uff0c\u6307\u51fa\u9ad8\u6536\u7f29\u65f6 EBE \u4f30\u7b97\u4e0d\u53ef\u9760\uff0c<strong>\u4f18\u5148\u91c7\u7528<\/strong><strong> VPC\/NPC <\/strong><strong>\u7b49\u6a21\u62df\u7c7b\u8bca\u65ad<\/strong>\uff0c\u4e0d\u5f71\u54cd\u534f\u53d8\u91cf\u5206\u6790\uff1bFDA \u6307\u5357<strong>\u672a\u63d0\u53ca\u6536\u7f29<\/strong>\uff0c\u66f4\u5173\u6ce8\u7a33\u5065\u6027\u4e0e\u9884\u6d4b\u504f\u5dee\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u7f3a\u5931\u503c<\/strong><strong> \/ <\/strong><strong>\u79bb\u7fa4\u503c<\/strong><strong> \/ <\/strong><strong>\u4f4e\u4e8e\u5b9a\u91cf\u4e0b\u9650\uff08<\/strong><strong>LLOQ<\/strong><strong>\uff09\u6570\u636e<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e24\u4efd\u6307\u5357\u5747\u8981\u6c42\u9884\u5148\u5236\u5b9a\u5904\u7406\u89c4\u5219\uff0c\u4f46 NMPA \u66f4\u5f3a\u8c03<strong>\u6570\u636e\u53ef\u6eaf\u6e90\u3001\u654f\u611f\u6027\u5206\u6790<\/strong>\uff0cFDA \u4fa7\u91cd<strong>\u504f\u501a\u63a7\u5236\u4e0e\u4e34\u5e8a\u89e3\u91ca<\/strong>\uff0c\u4e0d\u5efa\u8bae\u968f\u610f\u5254\u9664\u5f02\u5e38\u53d7\u8bd5\u8005\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u573a\u666f\u95f4\u53d8\u5f02\uff08<\/strong><strong>IOV<\/strong><strong>\uff09<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u660e\u786e\u8981\u6c42\u8bc4\u4f30 IOV\uff0c\u9700\u6709\u8db3\u591f\u53d7\u8bd5\u8005\u591a\u573a\u666f\u91c7\u6837\uff1bFDA \u5c06 IOV \u7eb3\u5165\u53d7\u8bd5\u8005\u5185\u53d8\u5f02\uff0c\u5f3a\u8c03\u591a\u6b21\u91c7\u6837\u4ee5\u533a\u5206\u4e2a\u4f53\u95f4 \/ \u4e2a\u4f53\u5185\u53d8\u5f02\uff0c\u63d0\u5347\u9884\u6d4b\u53ef\u9760\u6027\u3002<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong>4\u3001\u6a21\u578b\u9a8c\u8bc1\u903b\u8f91\u4e0e\u5fc5\u8981\u6027\u8981\u6c42<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4.1 \u9a8c\u8bc1\u5fc5\u8981\u6027<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>NMPA\uff1a\u4e0d\u5f3a\u5236\u6240\u6709\u6a21\u578b\uff0c\u7528\u4e8e\u652f\u6301\u8bf4\u660e\u4e66\u3001\u7ed9\u836f\u65b9\u6848\u4f18\u5316\u65f6\u9700\u5145\u5206\u8bc4\u4ef7\uff0c\u4ec5\u63a2\u7d22\u6027\u5206\u6790\u53ef\u7b80\u5316\uff1b<\/li>\n\n\n\n<li>FDA\uff1a\u7ed3\u679c\u7528\u4e8e\u836f\u54c1\u8bf4\u660e\u4e66\u5f3a\u70c8\u5efa\u8bae\u9a8c\u8bc1\uff0c\u4ec5\u89e3\u91ca\u53d8\u5f02\u53ef\u4ec5\u8bc4\u4f30\u7a33\u5b9a\u6027\uff0c\u4e0a\u5e02\u7533\u62a5\u63a8\u8350\u5916\u90e8\u9a8c\u8bc1\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">4.2 \u5916\u90e8\u9a8c\u8bc1\u6743\u91cd<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>NMPA\uff1a\u8ba4\u53ef\u5916\u90e8\u9a8c\u8bc1\u4ef7\u503c\uff0c<strong>\u4e0d\u5f3a\u5236\u9996\u9009<\/strong>\uff0c\u5141\u8bb8\u5185\u90e8\u8bc4\u4ef7 + \u654f\u611f\u6027\u5206\u6790\u66ff\u4ee3\uff1b<\/li>\n\n\n\n<li>FDA\uff1a<strong>\u5916\u90e8\u9a8c\u8bc1\u4e3a\u9996\u9009<\/strong>\uff0c\u662f\u9884\u6d4b\u6027\u80fd\u6700\u4e25\u683c\u8bc1\u660e\uff0c\u5185\u90e8\u9a8c\u8bc1\u4ec5\u7528\u4e8e\u6837\u672c\u53d7\u9650\u573a\u666f\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">4.3 \u5185\u90e8\u9a8c\u8bc1\u6280\u672f\u7ec6\u8282<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u7075\u6d3b\u91c7\u7528\u5185\u90e8\u8bc4\u4ef7\uff0c\u805a\u7126\u6570\u636e\u6765\u6e90\u4e00\u81f4\u6027\uff1bFDA \u660e\u786e\u5185\u90e8\u9a8c\u8bc1\u6d41\u7a0b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6570\u636e\u62c6\u5206\uff1a2\/3 \u5efa\u6a21\u30011\/3 \u9a8c\u8bc1\uff1b<\/li>\n\n\n\n<li>\u4ea4\u53c9\u9a8c\u8bc1\uff1a\u53cd\u590d\u62c6\u5206\u964d\u4f4e\u53d8\u5f02\uff1b<\/li>\n\n\n\n<li>Bootstrap\uff1a\u81f3\u5c11 200 \u6b21\u91cd\u590d\uff0c\u9002\u914d\u513f\u79d1\u7b49\u5c0f\u6837\u672c\u573a\u666f\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">5\u3001<strong>\u6a21\u578b\u6a21\u62df\u4e0e\u8bc4\u4ef7\u7684\u5173\u8054\u89c4\u8303<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6a21\u578b\u6a21\u62df\u662f\u8bc4\u4ef7\u5ef6\u4f38\uff0c\u4e24\u4efd\u6307\u5357\u5747\u8981\u6c42\u57fa\u4e8e\u6700\u7ec8\u6a21\u578b\u3001\u6309\u9884\u8bbe\u65b9\u6848\u5f00\u5c55\uff0c\u4f46\u4fa7\u91cd\u70b9\u4e0d\u540c\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>NMPA\uff1a\u5206 3 \u5c42\u7ea7\u6a21\u62df\uff08\u56fa\u5b9a\u6548\u5e94\u2192\u53c2\u6570\u4e0d\u786e\u5b9a\u6027\u2192\u5b8c\u6574\u53d8\u5f02\uff09\uff0c\u5f3a\u8c03\u968f\u673a\u6548\u5e94\u76f8\u5173\u6027\uff0c\u7528\u4e8e\u7ed9\u836f\u65b9\u6848\u6a21\u62df\u4e0e\u534f\u53d8\u91cf\u6548\u5e94\u53ef\u89c6\u5316\uff08\u68ee\u6797\u56fe\uff09\uff1b<\/li>\n\n\n\n<li>FDA\uff1a2022 \u7248\u65b0\u589e<strong>BSV <\/strong><strong>\u4e0d\u786e\u5b9a\u6027<\/strong>\uff0c\u533a\u5206\u7814\u7a76\u4eba\u7fa4\u4e0e\u672a\u6765\u4eba\u7fa4\u9884\u6d4b\uff0c\u660e\u786e\u6b8b\u5dee\u4ec5\u7528\u4e8e\u89c2\u6d4b\u503c\u6a21\u62df\uff0c\u903b\u8f91\u66f4\u4e25\u8c28\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">6\u3001<strong>\u62a5\u544a\u63d0\u4ea4\u4e0e\u5ba1\u8bc4\u8981\u70b9\u5bf9\u6bd4<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">6.1\u62a5\u544a\u5185\u5bb9\u8981\u6c42<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u8981\u6c42\u63d0\u4ea4\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5efa\u6a21\u6d41\u7a0b\u3001\u5173\u952e\u6a21\u578b\u5bf9\u6bd4\uff08OFV \u53d8\u5316\uff09\u3001\u53c2\u6570\u7cbe\u5ea6\u3001\u6536\u7f29\u503c\uff1b<\/li>\n\n\n\n<li>\u5206\u5c42\u8bca\u65ad\u56fe\uff08GOF\u3001VPC\/pcVPC\uff09\u3001\u654f\u611f\u6027\u5206\u6790\u7ed3\u679c\uff1b<\/li>\n\n\n\n<li>\u5206\u6790\u8ba1\u5212\u3001\u63a7\u5236\u6587\u4ef6\u3001\u5254\u9664\u6570\u636e\u8bf4\u660e\uff0c\u786e\u4fdd\u53ef\u91cd\u73b0\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u8981\u6c42\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9a8c\u8bc1\u65b9\u6cd5\u9009\u62e9\u4f9d\u636e\u3001\u521b\u65b0\u65b9\u6cd5\u8bf4\u660e\uff1b<\/li>\n\n\n\n<li>\u7535\u5b50\u6570\u636e\u96c6 + \u4ee3\u7801 + \u8bf4\u660e\u6587\u4ef6\uff0c\u652f\u6301\u5ba1\u8bc4\u91cd\u73b0\uff1b<\/li>\n\n\n\n<li>\u660e\u786e\u7ed3\u679c\u5bf9\u8bf4\u660e\u4e66\u7684\u652f\u6491\u4ef7\u503c\uff0c\u5f3a\u8c03\u4e34\u5e8a\u610f\u4e49\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">6.2\u76d1\u7ba1\u5ba1\u67e5\u91cd\u70b9<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA\uff1a<strong>\u65b9\u6cd5\u5408\u89c4\u6027\u3001\u53c2\u6570\u53ef\u9760\u6027\u3001\u534f\u53d8\u91cf\u79d1\u5b66\u6027\u3001\u7279\u6b8a\u95ee\u9898\u5904\u7f6e<\/strong>\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\uff1a<strong>\u9884\u6d4b\u6027\u80fd\u3001\u5916\u63a8\u5408\u7406\u6027\u3001\u504f\u501a\u63a7\u5236\u3001\u7533\u62a5\u6750\u6599\u5b8c\u6574\u6027<\/strong>\u3002<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">7\u3001<strong>\u5dee\u5f02\u6839\u6e90\u4e0e\u76d1\u7ba1\u5bfc\u5411\u89e3\u6790<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6280\u672f\u8fed\u4ee3\u5dee\u5f02<\/strong>NMPA \u6307\u5357\u6574\u5408\u8fd1\u5e74\u5b9a\u91cf\u836f\u7406\u5b66\u8fdb\u5c55\uff0c\u7eb3\u5165\u6536\u7f29\u3001pcVPC\u3001NPDE \u7b49\u73b0\u4ee3\u65b9\u6cd5\uff0c\u6846\u67b6\u66f4<strong>\u5168\u9762\u3001\u7cfb\u7edf<\/strong>\uff1bFDA \u6307\u5357\u5386\u7ecf 20 \u4f59\u5e74\u8fed\u4ee3\uff0c2022 \u7248\u8865\u9f50\u751f\u7269\u5236\u54c1\u3001\u65f6\u53d8\u534f\u53d8\u91cf\u7b49\u5185\u5bb9\uff0c\u66f4<strong>\u6210\u719f\u3001\u56fd\u9645\u5316<\/strong>\u3002<\/li>\n\n\n\n<li><strong>\u4e34\u5e8a\u5b9e\u8df5\u9002\u914d<\/strong>NMPA \u517c\u987e\u56fd\u5185\u7814\u53d1\u9636\u6bb5\uff0c\u5141\u8bb8\u7a00\u758f\u91c7\u6837\u3001\u5408\u5e76\u7814\u7a76\u6570\u636e\uff0c\u964d\u4f4e\u5b9e\u64cd\u95e8\u69db\uff1bFDA \u5f3a\u8c03<strong>\u9884\u6d4b\u6027\u80fd\u4e0e\u4e34\u5e8a\u8f6c\u5316<\/strong>\uff0c\u4e25\u683c\u63a7\u5236\u504f\u501a\uff0c\u9002\u914d\u5168\u7403\u591a\u4e2d\u5fc3\u7533\u62a5\u3002<\/li>\n\n\n\n<li><strong>\u7533\u62a5\u5bfc\u5411\u5dee\u5f02<\/strong>NMPA \u8d34\u5408\u56fd\u5185\u6ce8\u518c\u6d41\u7a0b\uff0c\u5f3a\u5316\u8d28\u91cf\u63a7\u5236\u4e0e\u53ef\u8ffd\u6eaf\uff1bFDA \u805a\u7126<strong>\u4e0a\u5e02\u83b7\u76ca\u2011\u98ce\u9669\u8bc4\u4f30<\/strong>\uff0c\u6a21\u578b\u7ed3\u679c\u76f4\u63a5\u652f\u6491\u8bf4\u660e\u4e66\u5242\u91cf\u8c03\u6574\uff0c\u9a8c\u8bc1\u8981\u6c42\u66f4\u4e25\u683c\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">8\u3001<strong>\u7ed3\u8bba\u4e0e\u884c\u4e1a\u5efa\u8bae<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">8.1 \u6838\u5fc3\u7ed3\u8bba<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NMPA \u4e0e FDA \u6307\u5357\u5728 PopPK \u6a21\u578b\u8bc4\u4ef7\u7684<strong>\u79d1\u5b66\u5185\u6838\u4e00\u81f4<\/strong>\uff0c\u5747\u4ee5\u7ed3\u6784\u5408\u7406\u3001\u53c2\u6570\u53ef\u9760\u3001\u9884\u6d4b\u51c6\u786e\u4e3a\u6838\u5fc3\uff0c\u4f46\u5b58\u5728\u4e09\u5927\u5173\u952e\u5dee\u5f02\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6846\u67b6\uff1aNMPA\u300c\u5168\u5468\u671f\u6a21\u578b\u8bc4\u4ef7\u300dvs FDA\u300c\u4e8b\u540e\u6a21\u578b\u9a8c\u8bc1\u300d\uff1b<\/li>\n\n\n\n<li>\u6280\u672f\uff1aNMPA \u7cfb\u7edf\u7eb3\u5165\u6536\u7f29\u3001\u73b0\u4ee3\u6a21\u62df\u8bca\u65ad\uff0cFDA \u4fa7\u91cd\u4f20\u7edf\u9884\u6d4b\u6027\u80fd\u4e0e\u91cd\u62bd\u6837\uff1b<\/li>\n\n\n\n<li>\u76d1\u7ba1\uff1aNMPA \u517c\u987e\u5b9e\u64cd\u4e0e\u7533\u62a5\uff0cFDA \u5f3a\u5316\u5916\u90e8\u9a8c\u8bc1\u4e0e\u8bf4\u660e\u4e66\u652f\u6491\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">8.2 \u884c\u4e1a\u5b9e\u8df5\u5efa\u8bae<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u4e2d\u7f8e\u53cc\u62a5\u9879\u76ee<\/strong>\uff1a\u4f18\u5148\u91c7\u7528 NMPA+FDA \u517c\u5bb9\u65b9\u6848\uff0c\u4ee5 VPC\/pcVPC\u3001Bootstrap \u4e3a\u6838\u5fc3\uff0c\u540c\u6b65\u5f00\u5c55\u5185\u90e8\u8bc4\u4ef7 + \u5916\u90e8\u9a8c\u8bc1\uff0c\u63a7\u5236\u6536\u7f29\u4e0e\u504f\u501a\uff1b<\/li>\n\n\n\n<li><strong>\u6a21\u578b\u5efa\u7acb<\/strong>\uff1a\u9884\u5148\u5236\u5b9a\u8bc4\u4ef7\u8ba1\u5212\uff0c\u89c4\u8303\u7f3a\u5931\u503c \/ \u79bb\u7fa4\u503c \/ LLOQ \u5904\u7406\uff0c\u5b8c\u6574\u7559\u5b58\u8bca\u65ad\u56fe\u4e0e\u53c2\u6570\u6570\u636e\uff1b<\/li>\n\n\n\n<li><strong>\u7533\u62a5\u63d0\u4ea4<\/strong>\uff1a\u6309 NMPA \u8981\u6c42\u5448\u73b0\u5168\u6d41\u7a0b\u8bc1\u636e\uff0c\u6309 FDA \u5f3a\u8c03\u9884\u6d4b\u6027\u80fd\u4e0e\u9a8c\u8bc1\u4f9d\u636e\uff0c\u786e\u4fdd\u6750\u6599\u53ef\u91cd\u73b0\u3001\u53ef\u5ba1\u8bc4\uff1b<\/li>\n\n\n\n<li><strong>\u7279\u6b8a\u573a\u666f<\/strong>\uff1a\u513f\u79d1\u3001\u809d\u80be\u529f\u80fd\u635f\u5bb3\u4eba\u7fa4\u4f18\u5148 NMPA \u7a00\u758f\u91c7\u6837\u89c4\u8303\uff0c\u540c\u65f6\u6ee1\u8db3 FDA \u5c0f\u6837\u672c\u9a8c\u8bc1\u8981\u6c42\u3002<\/li>\n\n\n\n<li>PopPK \u6a21\u578b\u8bc4\u4ef7\u6b63\u8d70\u5411<strong>\u5168\u7403\u7edf\u4e00\u3001\u89c4\u8303\u91cf\u5316<\/strong>\uff0c\u4f01\u4e1a\u5e94\u9075\u5faa\u4e24\u4efd\u6307\u5357\u6838\u5fc3\u8981\u6c42\uff0c\u5efa\u7acb\u6807\u51c6\u5316\u8bc4\u4ef7\u6d41\u7a0b\uff0c\u63d0\u5347\u6a21\u578b\u53ef\u9760\u6027\u4e0e\u56fd\u9645\u8ba4\u53ef\u5ea6\uff0c\u52a9\u529b\u521b\u65b0\u836f\u9ad8\u6548\u7814\u53d1\u4e0e\u5168\u7403\u4e0a\u5e02\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u53c2\u8003\u6587\u732e<\/strong><strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219[S]. 2020.<\/li>\n\n\n\n<li>U.S. FDA. Population Pharmacokinetics Guidance for Industry[S]. 2022.<\/li>\n\n\n\n<li>\u9a6c\u5e7f\u7acb, \u8bb8\u7f9a, \u9648\u9510, \u7b49. \u65b0\u836f\u7814\u53d1\u4e2d\u7fa4\u4f53\u836f\u52a8\u5b66\/\u836f\u6548\u5b66\u7814\u7a76\u7684\u4e00\u822c\u8003\u8651[J].\u4e2d\u56fd\u4e34\u5e8a\u836f\u7406\u5b66\u4e0e\u6cbb\u7597\u5b66, 2019, 24(11):1201-1220.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">\u64b0\u7a3f\u4eba\uff1a\u8042\u8339\u4f73<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">\u5ba1\u6838\uff1a\u9648\u4e9a\u7ea2<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">\u6da6\u8272\u6392\u7248\uff1a\u5434\u534e\u82b3<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\uff08Population Pharmacokinetics, PopPK\uff09\u5df2\u6210\u4e3a\u65b0\u836f\u7814\u53d1\u3001\u4e2a\u4f53\u5316\u7ed9\u836f\u4e0e\u76d1\u7ba1\u7533\u62a5\u7684\u6838\u5fc3\u5b9a\u91cf\u5de5\u5177\uff0c\u5176\u6a21\u578b\u8bc4\u4ef7\u76f4\u63a5\u51b3\u5b9a\u7ed3\u679c\u53ef\u9760\u6027\u4e0e\u7533\u62a5\u8ba4\u53ef\u5ea6\u3002\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff092020 \u5e74\u53d1\u5e03\u300a\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5386\u7ecf 1999 \u7248\u4e0e 2022 \u7ec8\u7248\u6307\u5357\u8fed\u4ee3\uff0c\u4e8c\u8005\u5747\u6784\u5efa\u4e86\u7cfb\u7edf\u7684 PopPK \u6a21\u578b\u8bc4\u4ef7\u4f53\u7cfb\u3002\u672c\u6587\u4ee5\u6a21\u578b\u8bc4\u4ef7\u4e3a\u6838\u5fc3\uff0c\u4ece\u6846\u67b6\u5b9a\u4f4d\u3001\u5206\u7c7b\u4f53\u7cfb\u3001\u8bc4\u4ef7\u65b9\u6cd5\u3001\u7279\u6b8a\u95ee\u9898\u5904\u7f6e\u3001\u9a8c\u8bc1\u903b\u8f91\u4e0e\u7533\u62a5\u8981\u6c42\u516d\u5927\u7ef4\u5ea6\uff0c\u7cfb\u7edf\u5bf9\u6bd4 NMPA \u4e0e FDA \u6307\u5357\u7684\u89c4\u8303\u8981\u70b9\u3001\u6280\u672f\u5dee\u5f02\u4e0e\u76d1\u7ba1\u5bfc\u5411\uff0c\u89e3\u6790\u6536\u7f29\u73b0\u8c61\u3001\u53ef\u89c6\u5316\u9884\u6d4b\u68c0\u9a8c\uff08VPC\uff09\u3001\u81ea\u4e3e\u6cd5\uff08Bootstrap\uff09\u7b49\u5173\u952e\u6280\u672f\u7684\u76d1\u7ba1\u8981\u6c42\uff0c\u4e3a\u4e2d\u7f8e\u53cc\u62a5\u3001\u6a21\u578b\u89c4\u8303\u5316\u5efa\u7acb\u4e0e\u5ba1\u8bc4\u63d0\u4ea4\u63d0\u4f9b\u53c2\u8003\uff0c\u63a8\u52a8 PopPK \u6a21\u578b\u8bc4\u4ef7\u4ece\u7ecf\u9a8c\u5316\u8d70\u5411\u6807\u51c6\u5316\u3001\u56fd\u9645\u5316\u7edf\u4e00\u3002<\/p>\n<p>\u5173\u952e\u8bcd\uff1apopPK\uff1b\u6a21\u578b\u8bc4\u4ef7\uff1bFDA\uff1bNMPA\uff1b\u6307\u5bfc\u539f\u5219<\/p>\n","protected":false},"author":1,"featured_media":1806,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[115],"tags":[44,35,15,32],"class_list":["post-1805","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-115","tag-44","tag-35","tag-15","tag-32"],"_links":{"self":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1805","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1805"}],"version-history":[{"count":4,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1805\/revisions"}],"predecessor-version":[{"id":1811,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1805\/revisions\/1811"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/media\/1806"}],"wp:attachment":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1805"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1805"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1805"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}