{"id":1537,"date":"2025-11-25T16:39:46","date_gmt":"2025-11-25T08:39:46","guid":{"rendered":"https:\/\/www.millibuff.com\/?p=1537"},"modified":"2025-11-25T16:40:50","modified_gmt":"2025-11-25T08:40:50","slug":"%e5%b0%8f%e7%89%9b%e4%b8%b4%e7%a0%94-%e8%82%9d%e8%82%be%e5%8a%9f%e8%83%bd%e4%b8%8d%e5%85%a8%e6%82%a3%e8%80%85pk%e7%a0%94%e7%a9%b6%ef%bc%9a%e5%a6%82%e4%bd%95%e6%94%bb%e5%85%8b%e6%96%b0%e8%8d%af","status":"publish","type":"post","link":"https:\/\/www.millibuff.com\/?p=1537","title":{"rendered":"\u5c0f\u725b\u4e34\u7814 | \u809d\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005PK\u7814\u7a76\uff1a\u5982\u4f55\u653b\u514b\u65b0\u836f\u7814\u53d1\u201c\u7279\u201d\u79cd\u96be\u9898"},"content":{"rendered":"\n<p>\u672c\u7bc7\u6587\u7ae0\u63a2\u8ba8\u7684\u4e09\u4e2a\u95ee\u9898\uff1a<\/p>\n\n\n\n<p>\u2460\u3000\u4e3a\u4f55\u809d\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\u5bf9\u65b0\u836f\u81f3\u5173\u91cd\u8981\uff1f<\/p>\n\n\n\n<p>\u2461\u3000\u54ea\u4e9b\u60c5\u51b5\u4e0b\u9700\u8981\u8fdb\u884c\u809d\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\uff1f<\/p>\n\n\n\n<p>\u2462\u3000\u5982\u4f55\u89e3\u51b3\u809d\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\u8fd9\u9053\u96be\u9898\uff1f<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"436\" src=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/\u7a3f\u5b9a\u8bbe\u8ba1-1-1024x436.jpg\" alt=\"\" class=\"wp-image-1545\" srcset=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/\u7a3f\u5b9a\u8bbe\u8ba1-1-1024x436.jpg 1024w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/\u7a3f\u5b9a\u8bbe\u8ba1-1-300x128.jpg 300w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/\u7a3f\u5b9a\u8bbe\u8ba1-1-768x327.jpg 768w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/\u7a3f\u5b9a\u8bbe\u8ba1-1-1536x654.jpg 1536w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/\u7a3f\u5b9a\u8bbe\u8ba1-1.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">PART 01 <\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">\u5f15\u8a00\uff1a\u7279\u6b8a\u4eba\u7fa4\u8bc4\u4f30\u4e0e\u7814\u7a76\uff0c\u8d62\u53d6\u5e02\u573a\u7684\u9ad8\u96be\u5ea6\u201c\u5fc5\u7b54\u9898\u201d<\/h2>\n\n\n\n<p>\u5728\u65b0\u836f\u7814\u53d1\u8fd9\u573a\u9ad8\u98ce\u9669\u3001\u9ad8\u6295\u5165\u7684\u9a6c\u62c9\u677e\u7ade\u8d5b\u4e2d\uff0c\u5982\u4f55\u7cbe\u51c6\u3001\u9ad8\u6548\u5730\u5b8c\u6210\u7279\u6b8a\u4eba\u7fa4\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ece\u800c\u52a0\u901f\u4ea7\u54c1\u4e0a\u5e02\u8fdb\u7a0b\uff0c\u65e0\u7591\u662f\u836f\u7269\u7814\u53d1\u51b3\u7b56\u8005\u6700\u4e3a\u5173\u5207\u7684\u6838\u5fc3\u8bae\u9898\u4e4b\u4e00\u3002<\/p>\n\n\n\n<p>\u5728\u8fd9\u5176\u4e2d\uff0c\u809d\u80be\u529f\u80fd\u4e0d\u5168\uff08Hepatic\/Renal Impairment,HI\/RI\uff09\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\uff08Pharmacokinetics,PK\uff09\u8bc4\u4f30\u4e0e\u7814\u7a76\uff0c\u65e2\u662f\u5f88\u591a\u65b0\u836f\u7ed5\u4e0d\u5f00\u7684\u201c\u5408\u89c4\u5fc5\u7b54\u9898\u201d\uff0c\u4e5f\u662f\u4e00\u9053\u8003\u9a8c\u7814\u53d1\u7efc\u5408\u5b9e\u529b\u7684\u201c\u96be\u9898\u201d\u3002<\/p>\n\n\n\n<p>\u800c\u8981\u5728\u8fd9\u9053\u96be\u9898\u4e0a\u53d6\u5f97\u9ad8\u5206,\u4e0d\u4ec5\u8981\u6ee1\u8db3\u6307\u5357\u548c\u6cd5\u89c4\u7684\u57fa\u672c\u8981\u6c42,\u66f4\u9700\u8981\u6df1\u523b\u7406\u89e3\u5176\u80cc\u540e\u7684\u79d1\u5b66\u590d\u6742\u6027,\u5e76\u5728\u6267\u884c\u5c42\u9762\u653b\u514b\u5de8\u5927\u6311\u6218\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PART 02<br>\u4e3a\u4f55\u809d\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\u5bf9\u65b0\u836f\u81f3\u5173\u91cd\u8981\uff1f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">2.1 \u89c4\u907f\u5b89\u5168\u6027\u98ce\u9669<\/h3>\n\n\n\n<p>\u4ece\u751f\u7406\u5b66\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u7684\u89c6\u89d2\u6765\u770b\uff0c\u809d\u80be\u529f\u80fd\u7684\u53d7\u635f\u8fdc\u4e0d\u6b62\u662f\u5668\u5b98\u6307\u6807\u7684\u5f02\u5e38\uff0c\u5b83\u4f1a\u5f15\u53d1\u836f\u7269\u5728\u4f53\u5185\u5438\u6536\u3001\u5206\u5e03\u3001\u4ee3\u8c22\u548c\u6392\u6cc4\uff08ADME\uff09\u5168\u8fc7\u7a0b\u7684\u201c\u8fde\u9501\u53cd\u5e94\u201d\u3002<\/p>\n\n\n\n<p>\u809d\u810f\u662f\u673a\u4f53\u6700\u91cd\u8981\u7684\u836f\u7269\u4ee3\u8c22\u548c\u6e05\u9664\u5668\u5b98\uff0c\u5176\u529f\u80fd\u4e0d\u5168\uff08HI\uff09\u5bf9\u836f\u7269\u5904\u7f6e\u7684\u5f71\u54cd\u662f\u591a\u7ef4\u4e14\u590d\u6742\u7684\uff0c\u5f80\u5f80\u7275\u4e00\u53d1\u800c\u52a8\u5168\u8eab\uff0c\u53ef\u80fd\u5bfc\u81f4\u836f\u7269\u66b4\u9732\u91cf\u5267\u589e\uff0c\u5f15\u53d1\u975e\u9884\u671f\u7684\u6bd2\u6027\uff1b\u5bf9\u4e8e\u9700\u7ecf\u809d\u810f\u6d3b\u5316\u7684\u524d\u836f\uff0c\u5219\u53ef\u80fd\u56e0\u8f6c\u5316\u53d7\u963b\u800c\u5bfc\u81f4\u7597\u6548\u201c\u6253\u6298\u201d\u3002\u800c\u80be\u810f\u901a\u8fc7\u6ee4\u8fc7\u3001\u5206\u6ccc\u548c\u91cd\u5438\u6536\u7ef4\u6301\u4f53\u5185\u5e73\u8861\u3002<\/p>\n\n\n\n<p>\u7531\u4e8e\u80be\u529f\u80fd\u4e0d\u5168\uff08RI\uff09\u53ef\u80fd\u5bfc\u81f4\u836f\u7269\u66b4\u9732\u91cf\u53d1\u751f\u6570\u500d\u7684\u53d8\u5316\uff0c\u552f\u6709\u901a\u8fc7\u7cbe\u51c6\u7684PK\u7814\u7a76\u91cf\u5316RI\u7684\u5f71\u54cd\uff0c\u624d\u80fd\u4e3a\u8bf4\u660e\u4e66\u63d0\u4f9b\u79d1\u5b66\u7684\u5242\u91cf\u8c03\u6574\u65b9\u6848\uff08\u5982\u964d\u4f4e\u5242\u91cf\u6216\u5ef6\u957f\u7ed9\u836f\u95f4\u9694\uff09\uff0c\u786e\u4fdd\u60a3\u8005\u7528\u836f\u5b89\u5168\u3002\u540c\u65f6\uff0c\u5bf9RI\u7684\u5f71\u54cd\u4e5f\u4e0d\u4ec5\u5c40\u9650\u4e8e\u80be\u810f\u672c\u8eab\uff0c\u66f4\u5177\u6709\u9690\u853d\u7684\u7cfb\u7edf\u6027\u5f71\u54cd\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"830\" height=\"244\" src=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-2.png\" alt=\"\" class=\"wp-image-1544\" srcset=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-2.png 830w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-2-300x88.png 300w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-2-768x226.png 768w\" sizes=\"(max-width: 830px) 100vw, 830px\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-center\">\u56fe1 \u529f\u80fd\u4e0d\u5168\u60a3\u8005\u7684\u836f\u7269\u66b4\u9732\u4e0e\u5242\u91cf\u8c03\u6574\u793a\u610f\u56fe\uff08AI\u751f\u6210\uff0c\u4ec5\u4f9b\u53c2\u8003\uff09<\/p>\n\n\n\n<p>\u6df1\u5ea6\u7406\u89e3\u5e76\u8fd0\u7528\u8fd9\u4e9b\u6838\u5fc3\u673a\u7406\uff0c\u662f\u5236\u5b9a\u79d1\u5b66\u4e34\u5e8a\u7814\u7a76\u65b9\u6848\u3001\u89c4\u907f\u65b0\u836f\u4e34\u5e8a\u5f00\u53d1\u98ce\u9669\u7684\u57fa\u77f3\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2.2 \u76d1\u7ba1\u5408\u89c4\u8981\u6c42<\/h3>\n\n\n\n<p>\u9996\u5148\uff0c\u4ece\u76d1\u7ba1\u5c42\u9762\u770b\uff0c\u5168\u7403\u4e3b\u6d41\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff08\u5982FDA\u3001EMA\u3001NMPA\uff09\u5747\u5efa\u8bae\u5728\u836f\u7269\u7814\u53d1\u4e2d\u5e94\u5c3d\u65e9\u8bc4\u4f30\u80be\u529f\u80fd\u4e0d\u5168\u5bf9\u836f\u4ee3\u52a8\u529b\u5b66\u7684\u5f71\u54cd\uff0c\u4ee5\u4fbf\u901a\u8fc7\u65e9\u671f\u524d\u77bb\u6027\u5242\u91cf\u8c03\u6574\uff0c\u5c06\u6b64\u7c7b\u60a3\u8005\u4ee5\u9002\u5f53\u5242\u91cf\u7eb3\u5165\u540e\u671f\u5173\u952e\u4e34\u5e8a\u7814\u7a76\u3002<\/p>\n\n\n\n<p>\u8fd9\u4f7f\u5f97\u809d\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005PK\u7684\u8bc4\u4f30\u4e0e\u7814\u7a76\u6210\u4e3a\u5f88\u591a\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u6750\u6599\u4e2d\u7684\u5173\u952e\u73af\u8282\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2.3 \u8d62\u5f97\u5e02\u573a\u4f18\u52bf<\/h3>\n\n\n\n<p>\u901a\u8fc7\u5b8c\u6210\u6b64\u7c7b\u7814\u7a76\uff0c\u4e0d\u4ec5\u53ef\u4ee5\u4e3a\u7279\u6b8a\u60a3\u8005\u7fa4\u4f53\u63d0\u4f9b\u79d1\u5b66\u7684\u7528\u836f\u6307\u5bfc\uff0c\u66f4\u662f\u8d62\u5f97\u5e02\u573a\u5148\u673a\u7684\u201c\u9ad8\u5206\u8868\u73b0\u201d\u3002\u4e00\u4efd\u9ad8\u8d28\u91cf\u7684\u809d\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005PK\u7814\u7a76\u6210\u679c\u80fd\u591f\u8f6c\u5316\u4e3a\u6e05\u6670\u3001\u6709\u5229\u7684\u836f\u54c1\u8bf4\u660e\u4e66\uff0c\u4e3a\u7279\u6b8a\u4eba\u7fa4\u63d0\u4f9b\u7cbe\u51c6\u7684\u5242\u91cf\u6307\u5bfc\uff0c\u4ece\u800c\u6781\u5927\u52a0\u901f\u533b\u751f\u5904\u65b9\u91c7\u7eb3\uff0c\u62d3\u5bbd\u4ea7\u54c1\u7684\u5e02\u573a\u8986\u76d6\u4eba\u7fa4\uff0c\u6700\u7ec8\u5728\u4e0e\u8bf4\u660e\u4e66\u4fe1\u606f\u6a21\u7cca\u6216\u7528\u6cd5\u53d7\u9650\u7684\u7ade\u54c1\u89d2\u9010\u4e2d\uff0c\u5efa\u7acb\u8d77\u51b3\u5b9a\u6027\u7684\u7ade\u4e89\u4f18\u52bf\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PART 03<br>\u72ec\u7acb\u7684\u809d\/\u80be\u529f\u80fd\u635f\u5bb3\u60a3\u8005PK\u7814\u7a76\u542f\u52a8\u6807\u51c6<\/h2>\n\n\n\n<p>\u76d1\u7ba1\u673a\u6784\u5bf9\u4f55\u65f6\u9700\u8981\u5f00\u5c55\u809d\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\uff08PK\uff09\u7814\u7a76\uff0c\u8bbe\u5b9a\u4e86\u660e\u786e\u7684\u5b9a\u91cf\u89e6\u53d1\u6807\u51c6\u3002\u4f8b\u5982\uff0c\u7f8e\u56fdFDA\u6307\u5357\u89c4\u5b9a\u4e86\u4ee5\u4e0b\u4e24\u4e2a\u6838\u5fc3\u8bc4\u4f30\u8d77\u70b9\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u809d\u529f\u80fd\u4e0d\u5168\u7814\u7a76\uff1a\u5f53\u809d\u810f\u4ee3\u8c22\u5bf9\u836f\u7269\u6d88\u9664\u7684\u8d21\u732e\u8d85\u8fc720%\u65f6\uff0c\u901a\u5e38\u5efa\u8bae\u5f00\u5c55\u809d\u529f\u80fd\u4e0d\u5168\u7814\u7a76\u3002<\/li>\n\n\n\n<li>\u80be\u529f\u80fd\u4e0d\u5168\u7814\u7a76\uff1a\u5f53\u836f\u7269\u4e3b\u8981\u7ecf\u80be\u810f\u6392\u6cc4\u65f6\uff08\u5f53\u836f\u7269\u6216\u6d3b\u6027\u4ee3\u8c22\u7269\u4ee5\u539f\u5f62\u7ecf\u80be\u810f\u6392\u6cc4\u7684\u5206\u6570\uff08fe\uff09\u22650.3\u65f6\uff09\uff0c\u80be\u529f\u80fd\u4e0d\u5168\u7814\u7a76\u540c\u6837\u662f\u8bc4\u4f30\u7684\u91cd\u70b9\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u7136\u800c,\u8fd9\u4e9b\u5b9a\u91cf\u6807\u51c6\u53ea\u662f\u8bc4\u4f30\u8fc7\u7a0b\u7684\u8d77\u70b9\u3002\u5728\u5b9e\u9645\u51b3\u7b56\u4e2d\uff0c\u8fd8\u9700\u8981\u7ed3\u5408\u836f\u7269\u7684\u5242\u578b\u3001\u6cbb\u7597\u7a97\u3001\u4ee3\u8c22\u9014\u5f84\u7b49\u56e0\u7d20\u8fdb\u884c\u7efc\u5408\u5224\u65ad\u3002\u5c0f\u725b\u533b\u836f\u56e2\u961f\u5728\u4e4b\u524d\u5206\u4eab\u8fc7\u7684\u4e24\u7bc7\u6587\u7ae0\u4e2d\u5206\u522b\u5bf9\u809d\u80be\u529f\u80fd\u4e0d\u5168\u7684\u60c5\u5f62\u6709\u8fc7\u8be6\u7ec6\u4ecb\u7ecd\uff0c\u6b22\u8fce\u5927\u5bb6\u8fdb\u884c\u70b9\u51fb\u4e0b\u6587\u9605\u8bfb\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=Mzg3NDUyMDg2OA==&amp;mid=2247485280&amp;idx=1&amp;sn=da704e94558cd7855dbd6a0bdfe40c9a&amp;scene=21#wechat_redirect\" target=\"_blank\" rel=\"noreferrer noopener\">\u63a2\u8ba8\u809d\u529f\u80fd\u4e0d\u5168\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=Mzg3NDUyMDg2OA==&amp;mid=2247485215&amp;idx=3&amp;sn=fe37600149f9685188d95335bc683cec&amp;scene=21#wechat_redirect\" target=\"_blank\" rel=\"noreferrer noopener\">\u63a2\u8ba8\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\uff082\uff09<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"has-text-align-center\"><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"831\" height=\"468\" src=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image.png\" alt=\"\" class=\"wp-image-1542\" srcset=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image.png 831w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-300x169.png 300w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-768x433.png 768w\" sizes=\"(max-width: 831px) 100vw, 831px\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-center\">\u56fe2 \u8fdb\u884c\u809d\u635f\u4f24\u7814\u7a76\u53ca\u5bf9\u6807\u7b7e\u5f71\u54cd\u7684\u51b3\u7b56\u6811\uff08Ravenstijn P, Chetty M, Manchandani P, et al. Design and conduct considerations for studies in patients with hepatic impairment[J]. Clinical and Translational Science, 2023, 16(1): 50-61.\uff09<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"831\" height=\"440\" src=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-1.png\" alt=\"\" class=\"wp-image-1543\" srcset=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-1.png 831w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-1-300x159.png 300w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2025\/11\/image-1-768x407.png 768w\" sizes=\"(max-width: 831px) 100vw, 831px\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-center\"><\/p>\n\n\n\n<p class=\"has-text-align-center\">\u56fe3 \u80be\u529f\u80fd\u4e0d\u5168\uff08RI\uff09\u7814\u7a76\u5728\u4f55\u79cd\u6807\u51c6\/\u6761\u4ef6\u4e0b\u53ef\u80fd\u88ab\u63a8\u8350\u6216\u4e0d\u88ab\u63a8\u8350\u8fdb\u884c\uff08Ravenstijn P, Chetty M, Manchandani P. Design and conduct considerations for studies in patients with impaired renal function[J]. Clinical and Translational Science, 2021, 14(5): 1689-1704.\uff09<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u76d1\u7ba1\u673a\u6784\u4e5f\u5728\u79ef\u6781\u5173\u6ce8\u90a3\u4e9b\u6613\u88ab\u5ffd\u89c6\u7684\u201c\u9690\u853d\u98ce\u9669\u201d\uff1a\u4f8b\u5982FDA\u660e\u786e\u6307\u51fa\uff0c\u5373\u4fbf\u662f\u4e3b\u8981\u7ecf\u809d\u810f\u4ee3\u8c22\u3001\u975e\u80be\u810f\u6392\u6cc4\u7684\u836f\u7269\uff0c\u5728\u4e25\u91cd\u80be\u529f\u80fd\u4e0d\u5168\u7684\u60c5\u51b5\u4e0b\uff0c\u5176\u4ee3\u8c22\u7279\u5f81\u4e5f\u53ef\u80fd\u56e0\u4f53\u5185\u5fae\u73af\u5883\u6539\u53d8\u800c\u53d7\u5230\u6ce2\u53ca\u3002\u8fd9\u79cd\u5bf9\u201c\u975e\u5178\u578b\u201d\u98ce\u9669\u7684\u79d1\u5b66\u9884\u5224\u4e0e\u8bc4\u4f30\uff0c\u5f80\u5f80\u66f4\u80fd\u4f53\u73b0\u65b0\u836f\u7814\u53d1\u7b56\u7565\u7684\u6df1\u5ea6\u4e0e\u4e25\u8c28\u6027\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PART 04<br>\u6311\u6218\u91cd\u91cd\uff1a\u6a2a\u4e98\u5728\u809d\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\u9053\u8def\u4e0a\u7684\u4e09\u5927\u6280\u672f\u201c\u96be\u9898\u201d<\/h2>\n\n\n\n<p>\u809d\u80be\u529f\u80fd\u4e0d\u5168 PK \u7814\u7a76\u7684\u590d\u6742\u6027\u8fdc\u8d85\u5e38\u89c4\u4e34\u5e8a\u8bd5\u9a8c\u3002\u8fd9\u4e0d\u4ec5\u662f\u4e00\u573a\u5bf9\u7a00\u7f3a\u4e34\u5e8a\u8d44\u6e90\u7cbe\u7ec6\u5316\u90e8\u7f72\u7684\u6311\u6218\uff0c\u66f4\u662f\u4e00\u6b21\u5bf9\u65b9\u6848\u79d1\u5b66\u6027\u4e0e\u6267\u884c\u5408\u89c4\u6027\u7684\u6781\u9650\u5927\u8003\u3002\u4efb\u4f55\u4e00\u4e2a\u73af\u8282\u7684\u758f\u6f0f\uff0c\u90fd\u53ef\u80fd\u89e6\u53d1\u8fde\u9501\u53cd\u5e94\uff0c\u5bfc\u81f4\u9879\u76ee\u9677\u5165\u50f5\u5c40\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4.1 \u6311\u6218\u4e00\uff1a\u65b9\u6848\u8bbe\u8ba1 \u2014 \u79d1\u5b66\u6027\u7684\u57fa\u77f3<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8bc4\u4f30\u65b9\u6cd5\u7684\u9009\u62e9\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u5728\u809d\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005\u7684PK\u7814\u7a76\u4e2d\uff0c\u8bc4\u4f30\u65b9\u6cd5\u7684\u9009\u62e9\u76f4\u63a5\u5173\u7cfb\u5230\u6570\u636e\u7684\u6709\u6548\u6027\u4e0e\u76d1\u7ba1\u63a5\u53d7\u5ea6\u3002\u809d\u529f\u80fd\u8bc4\u4f30\u5e94\u4f18\u5148\u91c7\u7528\u76d1\u7ba1\u5171\u8bc6\u7684Child-Pugh\u5206\u7ea7\uff0c\u80bf\u7624\u836f\u7269\u53ef\u57fa\u4e8e\u5408\u7406\u6027\u8bba\u8bc1\u9009\u7528NCI\u6807\u51c6\u3002\u80be\u529f\u80fd\u8bc4\u4f30\u5219\u9ed8\u8ba4\u63a8\u8350Cockcroft-Gault\u516c\u5f0f\uff08C-G\u516c\u5f0f\uff09\uff0c\u91c7\u7528CKD-EPI\u7b49eGFR\u516c\u5f0f\u9700\u63d0\u4f9b\u5145\u5206\u79d1\u5b66\u4f9d\u636e\u3002\u6070\u5f53\u7684\u8bc4\u4f30\u65b9\u6cd5\u9009\u62e9\u662f\u786e\u4fdd\u60a3\u8005\u5206\u5c42\u51c6\u786e\u3001PK\u7ed3\u679c\u53ef\u9760\u53ca\u540e\u7eed\u5242\u91cf\u5efa\u8bae\u5408\u7406\u7684\u57fa\u7840\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7814\u7a76\u7b56\u7565\u7684\u6743\u8861\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u9700\u6839\u636e\u836f\u7269\u98ce\u9669\u7279\u6027\uff0c\u6743\u8861\u662f\u91c7\u7528\u8986\u76d6\u6240\u6709\u53d7\u635f\u7b49\u7ea7\u7684\u201c\u5b8c\u6574\u8bbe\u8ba1\uff08Full Design\uff09\u201d\uff0c\u8fd8\u662f\u91c7\u7528\u4ec5\u5bf9\u6bd4\u91cd\u5ea6\u53d7\u635f\u4e0e\u6b63\u5e38\u4eba\u7fa4\u7684\u201c\u7b80\u5316\u8bbe\u8ba1\uff08Reduced Design\uff09\u201d\uff08\u5373 Worst-case scenario\uff09\u3002\u7b56\u7565\u5931\u8bef\u5c06\u76f4\u63a5\u5f71\u54cd\u76d1\u7ba1\u673a\u6784\u7684\u8ba4\u53ef\u548c\u6700\u7ec8\u4ea7\u54c1\u6807\u7b7e\u4fe1\u606f\u7684\u5168\u9762\u6027\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8bbe\u8ba1\u7f3a\u9677\u5bf9\u9879\u76ee\u7684\u5f71\u54cd\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u8bbe\u8ba1\u7f3a\u9677\u53ef\u80fd\u5bfc\u81f4\u5173\u952e\u6570\u636e\u65e0\u6548\uff0c\u8feb\u4f7f\u8bd5\u9a8c\u63a8\u5012\u91cd\u6765\uff0c\u9020\u6210\u957f\u65f6\u95f4\u4e0a\u5e02\u5ef6\u8bef\uff0c\u751a\u81f3\u4f7f\u83b7\u6279\u7684\u8bf4\u660e\u4e66\u7f3a\u4e4f\u5242\u91cf\u6307\u5bfc\uff0c\u75db\u5931\u5e02\u573a\u4efd\u989d\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4.2 \u6311\u6218\u4e8c\uff1a\u8bd5\u9a8c\u53c2\u4e0e\u8005\u62db\u52df \u2014 \u53ef\u884c\u6027\u7684\u74f6\u9888<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6781\u5ea6\u7a00\u7f3a\u7684\u5408\u683c\u60a3\u8005\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u6cd5\u89c4\u8981\u6c42\u8bd5\u9a8c\u53c2\u4e0e\u8005\u5fc5\u987b\u5904\u4e8e\u201c\u75c5\u60c5\u7a33\u5b9a\u671f\u201d\uff0c\u4e14\u9700\u5c3d\u53ef\u80fd\u7684\u4e25\u683c\u6392\u9664\u53ef\u80fd\u5e72\u6270\u4ee3\u8c22\u7684\u5408\u5e76\u7528\u836f\u3002\u5728\u8001\u9f84\u5316\u4e14\u5171\u75c5\u590d\u6742\u7684\u809d\u80be\u529f\u80fd\u4e0d\u5168\u7fa4\u4f53\u4e2d\uff0c\u7b5b\u9009\u5408\u683c\u60a3\u8005\u5982\u540c\u201c\u5927\u6d77\u635e\u9488\u201d\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e25\u82db\u7684\u5bf9\u7167\u5339\u914d\u96be\u5ea6\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u7814\u7a76\u4e0d\u4ec5\u8981\u62db\u52df\u60a3\u8005\uff0c\u76d1\u7ba1\u673a\u6784\u8fd8\u5efa\u8bae\u62db\u52df\u5728\u5e74\u9f84\u3001\u6027\u522b\u3001\u4f53\u91cd\u7b49\u4eba\u53e3\u5b66\u7279\u5f81\u4e0a\u7cbe\u786e\u5339\u914d\u7684\u5065\u5eb7\u5bf9\u7167\u7ec4\u3002\u5728\u591a\u4e2d\u5fc3\u540c\u6b65\u534f\u8c03\u4e2d\uff0c\u5176\u6267\u884c\u96be\u5ea6\u5448\u6307\u6570\u7ea7\u4e0a\u5347\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u62db\u52df\u5ef6\u8bef\u5bf9\u9879\u76ee\u7684\u5f71\u54cd\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u62db\u52df\u5ef6\u8bef\u662f\u7814\u7a76\u4e2d\u6700\u6602\u8d35\u7684\u201c\u9690\u5f62\u6210\u672c\u201d\u3002\u6bcf\u62d6\u5ef6\u4e00\u4e2a\u6708\uff0c\u90fd\u610f\u5473\u7740\u9ad8\u6602\u7684\u8fd0\u8425\u6d88\u8017\uff0c\u66f4\u4ee3\u8868\u7740\u4e13\u5229\u4fdd\u62a4\u671f\u7684\u7f29\u77ed\u548c\u7ade\u54c1\u62a2\u5360\u5148\u673a\u7684\u6f5c\u5728\u5e02\u573a\u635f\u5931\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4.3 \u6311\u6218\u4e09\uff1a\u8d28\u91cf\u4e0e\u5408\u89c4 \u2014 \u5b89\u5168\u6027\u7684\u5e95\u7ebf<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8106\u5f31\u4eba\u7fa4\u7684\u98ce\u9669\u7ba1\u7406\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u8bd5\u9a8c\u53c2\u4e0e\u8005\u751f\u7406\u72b6\u6001\u4e0d\u7a33\u5b9a\u3001\u50a8\u5907\u80fd\u529b\u5dee\uff0c\u8fd9\u8981\u6c42\u7814\u7a76\u56e2\u961f\u5177\u5907\u5f3a\u5927\u7684\u98ce\u9669\u7ba1\u7406\u80fd\u529b,\u80fd\u591f\u5728\u786e\u4fdd\u60a3\u8005\u5b89\u5168\u7684\u524d\u63d0\u4e0b,\u7cbe\u51c6\u6267\u884c\u5bc6\u96c6\u7684PK\u91c7\u6837(\u5305\u62ec\u900f\u6790\u6db2\u6536\u96c6\u7b49\u590d\u6742\u64cd\u4f5c)\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6cd5\u89c4\u8981\u6c42\u7684\u7cbe\u51c6\u9002\u914d\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u82e5\u7814\u7a76\u65e8\u5728\u652f\u6301\u4e2d\u56fd\u6ce8\u518c\u7533\u62a5\uff0c\u5e94\u4ee5 NMPA \u6307\u5bfc\u539f\u5219\u4e3a\u6838\u5fc3\u4f9d\u636e\uff1b\u82e5\u89c4\u5212\u5168\u7403\u5f00\u53d1\uff0c\u5219\u9700\u5728\u65b9\u6848\u8bbe\u8ba1\u9636\u6bb5\u524d\u77bb\u6027\u534f\u8c03 FDA\u3001EMA \u4e0e NMPA \u5728\u5173\u952e\u53c2\u6570\uff08\u5982\u80be\u529f\u80fd\u8bc4\u4f30\u65b9\u6cd5\u3001\u91c7\u6837\u65f6\u95f4\u70b9\u3001\u5206\u6790\u7b56\u7565\uff09\u4e0a\u7684\u5dee\u5f02\uff0c\u907f\u514d\u540e\u671f\u6570\u636e\u65e0\u6cd5\u4e92\u8ba4\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8d28\u91cf\u95ee\u9898\u5bf9\u9879\u76ee\u7684\u5f71\u54cd\uff1a<\/li>\n<\/ul>\n\n\n\n<p>\u4e25\u91cd\u7684 GCP \u8fdd\u89c4\u6216\u7cfb\u7edf\u6027\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\uff0c\u53ef\u80fd\u5bfc\u81f4\u5173\u952e\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u5728\u6ce8\u518c\u6838\u67e5\u4e2d\u4e0d\u88ab\u76d1\u7ba1\u673a\u6784\u63a5\u53d7\uff0c\u8fdb\u800c\u5f71\u54cd\u836f\u54c1\u7684\u83b7\u76ca-\u98ce\u9669\u8bc4\u4f30\u7ed3\u8bba\u3002\u5728\u6781\u7aef\u60c5\u51b5\u4e0b\uff0c\u6b64\u7c7b\u7f3a\u9677\u53ef\u6784\u6210\u62d2\u7edd\u6279\u51c6\u7684\u7406\u7531\uff0c\u4f7f\u524d\u671f\u5de8\u989d\u7814\u53d1\u6295\u5165\u65e0\u6cd5\u8f6c\u5316\u4e3a\u4e0a\u5e02\u4ea7\u54c1\uff0c\u9020\u6210\u91cd\u5927\u7ecf\u6d4e\u635f\u5931\u3002<\/p>\n\n\n\n<p>\u9762\u5bf9\u8fd9\u4e9b\u9ad8\u98ce\u9669\u3001\u9ad8\u96be\u5ea6\u7684\u809d\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\u96be\u9898\uff0c\u7814\u53d1\u6210\u8d25\u7684\u5173\u952e\uff0c\u5728\u4e8e\u9009\u62e9\u80fd\u63d0\u4f9b<strong>\u79d1\u5b66\u65b9\u6848\u8bbe\u8ba1\u3001\u9ad8\u6548<\/strong><strong>\u8bd5\u9a8c\u53c2\u4e0e\u8005<\/strong><strong>\u62db\u52df<\/strong><strong>\u3001<\/strong><strong>\u7cbe\u51c6\u98ce\u9669<\/strong><strong>\u4e0e\u8d28\u91cf<\/strong><strong>\u7ba1\u7406<\/strong>\u7684\u5408\u4f5c\u4f19\u4f34\u4e0e\u6267\u884c\u56e2\u961f\uff0c\u5c06\u590d\u6742\u7684\u75c5\u7406\u751f\u7406\u5b66\u77e5\u8bc6\u901a\u8fc7\u4e13\u4e1a\u80fd\u529b\u8f6c\u5316\u4e3a\u9ad8\u8d28\u91cf\u7684\u4e34\u5e8a\u6570\u636e\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PART 05<br>\u5c0f\u725b\u533b\u836f\uff1a\u4ee5\u4e13\u4e1a\u514b\u96be\u70b9\uff0c\u5316\u6311\u6218\u4e3a\u5766\u9014<\/h2>\n\n\n\n<p>\u5c0f\u725b\u533b\u836f\u6df1\u8c19\u809d\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\u7684\u6bcf\u4e00\u4e2a\u96be\u70b9\u4e0e\u75db\u70b9\uff0c\u4e00\u5982\u65e2\u5f80\u575a\u6301\u7ed9\u6bcf\u4e00\u4f4d\u5ba2\u6237\u63d0\u4f9b\u4e00\u5957\u8d34\u5fc3\u3001\u5b8c\u6574\u3001\u9ad8\u6548\u7684\u201c\u966a\u4f34\u5f0f\u7efc\u5408\u89e3\u51b3\u65b9\u6848\u201d\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u4e13\u4e1a\u56e2\u961f\u4e0e\u4e13\u5bb6\u8d44\u6e90\uff1a<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u5c0f\u725b\u533b\u836f\u6838\u5fc3\u8fd0\u8425\u56e2\u961f\u6210\u5458<strong>100%\u83b7\u5f97GCP\u8ba4\u8bc1<\/strong>\uff0c\u4eba\u5747\u62e5\u6709<strong>15\u5e74\u4ee5\u4e0a<\/strong>\u7684\u4e34\u5e8a\u7814\u7a76\u7ecf\u9a8c\u3002\u540c\u65f6\uff0c\u6211\u4eec\u62e5\u6709\u56fd\u5185\u5916\u521b\u65b0\u836f\u7814\u53d1\u9886\u57df\u7684<strong>\u4e00\u6d41\u4e13\u5bb6\u987e\u95ee\u56e2\u961f<\/strong>\uff0c\u80fd\u591f\u4ece\u6e90\u5934\u4e0a\u786e\u4fdd\u7814\u7a76\u65b9\u6848\u7684\u79d1\u5b66\u6027\u3001\u5408\u89c4\u6027\u4e0e\u524d\u77bb\u6027\uff0c\u7cbe\u51c6\u5e94\u5bf9\u201c\u65b9\u6848\u8bbe\u8ba1\u96be\u201d\u7684\u75db\u70b9\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u7cbe\u51c6\u62db\u52df\u4e0e\u5e7f\u6cdb\u8986\u76d6\uff1a<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u5c0f\u725b\u533b\u836f\u4e0e\u5168\u56fd\u591a\u5bb6\u5728\u809d\u635f\u3001\u80be\u635f\u6cbb\u7597\u9886\u57df\u5904\u4e8e\u9886\u5148\u5730\u4f4d\u7684\u4e34\u5e8a\u673a\u6784<strong>\u6df1\u5ea6\u5171\u5efa\u4e34\u5e8a\u5e73\u53f0<\/strong>\uff0c\u5f62\u6210\u4e86\u5f3a\u5927\u7684\u7814\u7a76\u4e2d\u5fc3\u7f51\u7edc\u3002\u901a\u8fc7\u591a\u4e2d\u5fc3\u9ad8\u6548\u534f\u540c\u673a\u5236\u548c\u8d44\u6e90\u4e30\u5bcc\u7684<strong>\u53d7\u8bd5\u8005<\/strong><strong>\u5e93<\/strong>\uff0c\u5b9e\u73b0\u809d\u80be\u529f\u80fd\u4e0d\u5168\u8bd5\u9a8c\u53c2\u4e0e\u7684\u9ad8\u6548\u62db\u52df\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u5408\u89c4\u9ad8\u8d28\u4e0e\u98ce\u9669\u7ba1\u7406\uff1a<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u5c0f\u725b\u533b\u836f\u62e5\u6709\u5065\u5168\u7684SOP\u4f53\u7cfb\u548c\u6210\u719f\u7684\u6a21\u677f\u5316\u6d41\u7a0b\uff0c\u786e\u4fdd\u7814\u7a76\u7684\u6bcf\u4e00\u4e2a\u73af\u8282\u90fd\u4e25\u683c\u9075\u5faa\u56fd\u9645\u4e0e\u56fd\u5185\u89c4\u8303\u3002\u901a\u8fc7<strong>\u5168\u5468\u671f\u7684\u98ce\u9669\u7ba1\u7406<\/strong>\uff0c\u4e3b\u52a8\u8bc6\u522b\u5e76\u89c4\u907f\u6f5c\u5728\u98ce\u9669\uff0c\u5168\u529b\u4fdd\u969c\u6570\u636e\u7684\u5b8c\u6574\u3001\u53ef\u9760\u4e0e\u60a3\u8005\u7684\u5b89\u5168\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u9ad8\u6548\u6267\u884c\u4e0e\u6210\u672c\u4f18\u5316\uff1a<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u6241\u5e73\u5316\u7684\u7ba1\u7406\u67b6\u6784\u4e0e\u51b3\u7b56\u673a\u5236\u5e26\u6765\u4e86\u5c0f\u725b\u533b\u836f\u56e2\u961f\u9ad8\u6548\u7684\u6c9f\u901a\u901f\u5ea6\uff0c\u786e\u4fdd\u9879\u76ee\u4fe1\u606f\u540c\u9891\uff0c\u5b9e\u73b0<strong>\u5feb<\/strong><strong>\u901f\u4ea4\u4ed8<\/strong>\u3002\u8fd9\u4e0d\u4ec5\u80fd\u4e3a\u7533\u529e\u65b9\u62a2\u56de\u5b9d\u8d35\u7684\u7814\u53d1\u65f6\u95f4\uff0c\u66f4\u80fd\u6709\u6548\u63a7\u5236\u7ecf\u6d4e\u6210\u672c\uff0c\u5e2e\u52a9\u5ba2\u6237\u5728\u6fc0\u70c8\u7684\u5e02\u573a\u7ade\u4e89\u4e2d\u201c\u8dd1\u8d62\u5bf9\u624b\u201d\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PART 06<br>\u5c0f\u725b\u7ecf\u9a8c\uff1a\u52a9\u529b\u56fd\u4ea71\u7c7b\u65b0\u836f\u51b2\u523a\u201c\u56fd\u5185\u9996\u4e2a\uff0c\u5168\u7403\u552f\u4e8c\u201d<\/h2>\n\n\n\n<p><strong>\u5c0f\u725b\u533b\u836f\u6df1\u8015\u809d\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005PK\u7814\u7a76\u9886\u57df\u591a\u5e74,\u5df2\u6210\u529f\u4ea4\u4ed8\u591a\u4e2a\u9ad8\u96be\u5ea6\u9879\u76ee\u3002<\/strong>\u4ee5\u4e0b\u662f\u4e00\u4e2a\u771f\u5b9e\u7684\u6210\u529f\u6848\u4f8b\uff0c\u5177\u4f53\u5c55\u793a\u4e86\u5c0f\u725b\u533b\u836f\u7684\u7efc\u5408\u6027\u966a\u4f34\u670d\u52a1\u5982\u4f55\u5c06\u4e13\u4e1a\u80fd\u529b\u8f6c\u5316\u4e3a\u5b9e\u5b9e\u5728\u5728\u7684\u7814\u53d1\u52a0\u901f\u6210\u679c\u3002<strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u9879\u76ee\u80cc\u666f\uff1a<\/strong>\u67d0\u9776\u5411\u808c\u677e\u62ee\u6297\u5242\u7684\u80be\u529f\u80fd\u4e0d\u5168PK\u7814\u7a76\uff0c\u662f\u5176\u51b2\u523a\u201c\u56fd\u5185\u9996\u4e2a\uff0c\u5168\u7403\u552f\u4e8c\u201d\u4e0a\u5e02\u76ee\u6807\u7684\u5173\u952e\u4e00\u6b65\u3002<\/li>\n\n\n\n<li><strong>\u6838\u5fc3\u6311\u6218\uff1a<\/strong>\u9879\u76ee\u7684\u62db\u52df\u7a97\u53e3\u671f\u6781\u77ed\uff0c\u4e14\u6070\u9022\u6cd5\u5b9a\u957f\u5047\uff0c\u65f6\u95f4\u538b\u529b\u5de8\u5927\uff0c\u4efb\u4f55\u5ef6\u8bef\u90fd\u53ef\u80fd\u5f71\u54cd\u6574\u4f53\u4e0a\u5e02\u8ba1\u5212\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u9762\u5bf9\u8fd9\u4e00\u8270\u5de8\u4efb\u52a1\uff0c\u5c0f\u725b\u533b\u836f\u56e2\u961f\u8fc5\u901f\u54cd\u5e94\uff0c\u51ed\u501f\u5f3a\u5927\u7684\u8d44\u6e90\u7f51\u7edc\u548c\u9ad8\u6548\u7684\u8fd0\u8425\u4f53\u7cfb\uff0c\u53d6\u5f97\u4e86<strong>\u5982\u4e0b\u5173\u952e\u6210\u679c<\/strong>\uff1a<strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u5316\u89e3\u62db\u52df\u5371\u673a\uff0c\u62a2\u5360\u65f6\u95f4\u7a97\u53e3\uff1a<\/strong>\u9762\u5bf9\u957f\u5047\u4e0e\u7a97\u53e3\u671f\u77ed\u7684\u53cc\u91cd\u538b\u529b\uff0c\u5c0f\u725b\u533b\u836f\u56e2\u961f\u51ed\u501f\u5353\u8d8a\u7684\u8d44\u6e90\u8c03\u52a8\u80fd\u529b\uff0c\u4ec5\u7528\u65f6<strong>1\u4e2a\u591a\u6708<\/strong>\u5c31\u9ad8\u8d28\u91cf\u5b8c\u6210\u4e86\u5168\u90e8\u8f7b\/\u4e2d\u5ea6\u80be\u635f\u60a3\u8005\u53ca\u5339\u914d\u5065\u5eb7\u5bf9\u7167\u7ec4\u7684\u5165\u7ec4\uff0c\u4e3a\u9879\u76ee\u8d62\u5f97\u4e86\u5148\u673a\u3002<\/li>\n\n\n\n<li><strong>\u4fdd\u969c\u5173\u952e\u8282\u70b9\uff0c\u52a0\u901f\u4e0a\u5e02\u8fdb\u7a0b\uff1a<\/strong>\u9ad8\u6548\u7684\u9879\u76ee\u8fd0\u8425\u786e\u4fdd\u4e86\u7814\u53d1\u5468\u671f\u4e0d\u88ab\u5ef6\u8bef\uff0c\u6700\u7ec8\u6709\u529b\u652f\u6301\u5ba2\u6237\u987a\u5229\u9012\u4ea4\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\uff0c\u5411\u201c\u56fd\u5185\u9996\u4e2a\uff0c\u5168\u7403\u552f\u4e8c\u201d\u7684\u76ee\u6807\u8fc8\u51fa\u51b3\u5b9a\u6027\u4e00\u6b65\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u8ba9\u65b0\u836f\u7814\u53d1\u5c11\u8d70\u5f2f\u8def\uff0c\u4ece\u9009\u62e9\u4e13\u4e1a\u7684\u5408\u4f5c\u4f19\u4f34\u5f00\u59cb\u3002<\/p>\n\n\n\n<p>\u5c0f\u725b\u533b\u836f\u4e13\u6ce8\u65b0\u836f\u4e0e\u9ad8\u96be\u5ea6\u4eff\u5236\u836f\u4e34\u5e8a\u7814\u7a76\uff0c\u6b63\u5982\u5c0f\u725b\u7ecf\u9a8c\u6848\u4f8b\u6240\u793a\uff1a\u771f\u6b63\u7684\u4e13\u4e1a\u9ad8\u6548\uff0c\u6e90\u4e8e\u5bf9\u836f\u7269\u7279\u6027\u7684\u6df1\u5ea6\u7406\u89e3\u548c\u5bf9\u8d28\u91cf\u98ce\u9669\u7684\u7cbe\u51c6\u628a\u63a7\u3002<\/p>\n\n\n\n<p>\u5982\u679c\u60a8\u6b63\u5728\u4e3a\u7279\u6b8a\u4eba\u7fa4\u4e34\u5e8a\u7814\u7a76\u7684\u6311\u6218\u800c\u56f0\u6270\uff0c\u6b22\u8fce\u968f\u65f6\u8054\u7cfb\u6211\u4eec\uff0c\u8ba9\u5c0f\u725b\u533b\u836f\u7684\u4e13\u4e1a\u56e2\u961f\u4e3a\u60a8\u7684\u9879\u76ee\u4fdd\u9a7e\u62a4\u822a\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u53c2\u8003\u8d44\u6599\uff1a<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3. \u5173\u4e8e\u53d1\u5e03\u300a\u521b\u65b0\u836f\u4e34\u5e8a\u836f\u7406\u5b66\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\u7684\u901a\u544a\uff082021\u5e74\u7b2c55\u53f7\uff09[EB\/OL]. (2021-12-20) [2025-11-24].<\/li>\n\n\n\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3. \u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09[EB\/OL]. (2022-01-06) [2025-11-24].<\/li>\n\n\n\n<li>U.S. Food and Drug Administration. Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function\u2014Study Design, Data Analysis, and Impact on Dosing and Labeling [EB\/OL]. Silver Spring, MD: FDA, 2003[2025-11-24].<\/li>\n\n\n\n<li>U.S. Food and Drug Administration. Pharmacokinetics in Patients with Impaired Renal Function\u2014Study Design, Data Analysis, and Impact on Dosing: Guidance for Industry [EB\/OL]. Silver Spring, MD: FDA, 2022[2025-11-24].<\/li>\n\n\n\n<li>European Medicines Agency. Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function [EB\/OL]. Amsterdam: EMA, 2014[2025-11-24].<\/li>\n\n\n\n<li>Ravenstijn P, Chetty M, Manchandani P, et al. Design and conduct considerations for studies in patients with hepatic impairment[J]. Clinical and Translational Science, 2023, 16(1): 50-61.<\/li>\n\n\n\n<li>Ravenstijn P, Chetty M, Manchandani P. Design and conduct considerations for studies in patients with impaired renal function[J]. Clinical and Translational Science, 2021, 14(5): 1689-1704.<\/li>\n<\/ol>\n\n\n\n<p><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><\/p>\n\n\n\n<p>\u7f16\u8f91\uff1a\u5468\u5b89\u6960<\/p>\n\n\n\n<p>\u5ba1\u6838\uff1a\u9648\u4e9a\u7ea2 \u90d1\u53f6\u654f<\/p>\n\n\n\n<p>\u6821\u5bf9\u6392\u7248\uff1a\u5468\u5b89\u6960<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u672c\u6587\u63a2\u8ba8\u4e86\u809d\u80be\u529f\u80fd\u4e0d\u5168\u60a3\u8005\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\uff08PK\u7814\u7a76\uff09\u5728\u65b0\u836f\u7814\u53d1\u4e2d\u7684\u5173\u952e\u4f5c\u7528\u3002\u540c\u65f6\u89e3\u6790\u4e86\u7814\u7a76\u542f\u52a8\u7684\u5b9a\u91cf\u6807\u51c6\uff0c\u4ee5\u53ca\u6267\u884c\u4e2d\u5b58\u5728\u7684\u4e09\u5927\u6280\u672f\u96be\u9898\uff0c\u5e76\u901a\u8fc7\u771f\u5b9e\u6848\u4f8b\u5c55\u793a\u5c0f\u725b\u533b\u836f\u56e2\u961f\u5982\u4f55\u653b\u514b\u96be\u9898\uff0c\u52a0\u901f\u4ea7\u54c1\u4e0a\u5e02\u8fdb\u7a0b\u3002<\/p>\n","protected":false},"author":1,"featured_media":1539,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[62,35,15,32,34,61],"class_list":["post-1537","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-pk","tag-35","tag-15","tag-32","tag-34","tag-61"],"_links":{"self":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1537","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=1537"}],"version-history":[{"count":5,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1537\/revisions"}],"predecessor-version":[{"id":1548,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1537\/revisions\/1548"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/media\/1539"}],"wp:attachment":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1537"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1537"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1537"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}