{"id":31963,"date":"2019-02-25T11:33:17","date_gmt":"2019-02-25T10:33:17","guid":{"rendered":"https:\/\/www.unither-pharma.com\/?post_type=publication&#038;p=31963"},"modified":"2026-03-18T15:11:40","modified_gmt":"2026-03-18T14:11:40","slug":"%e6%96%b0%e5%9e%8b%e7%bb%99%e8%8d%af%e5%bd%a2%e5%bc%8f%ef%bc%9a%e6%8f%90%e5%8d%87%e8%8d%af%e7%89%a9%e4%bd%bf%e7%94%a8%e4%b8%8e%e7%ab%9e%e4%ba%89%e5%8a%9b%e7%9a%84%e6%88%98%e7%95%a5%e6%9d%a0%e6%9d%86","status":"publish","type":"publication","link":"https:\/\/www.unither-pharma.com\/zh-hans\/publication\/%e6%96%b0%e5%9e%8b%e7%bb%99%e8%8d%af%e5%bd%a2%e5%bc%8f%ef%bc%9a%e6%8f%90%e5%8d%87%e8%8d%af%e7%89%a9%e4%bd%bf%e7%94%a8%e4%b8%8e%e7%ab%9e%e4%ba%89%e5%8a%9b%e7%9a%84%e6%88%98%e7%95%a5%e6%9d%a0%e6%9d%86\/","title":{"rendered":"\u65b0\u578b\u7ed9\u836f\u5f62\u5f0f\uff1a\u63d0\u5347\u836f\u7269\u4f7f\u7528\u4e0e\u7ade\u4e89\u529b\u7684\u6218\u7565\u6760\u6746"},"content":{"rendered":"<p><strong>\u836f\u7269\u9012\u9001\u6280\u672f\uff08\u836f\u5242\u5f62\u5f0f\uff09\u4e3a\u5236\u836f\u4f01\u4e1a\u5e26\u6765\u7ade\u4e89\u4f18\u52bf\u3002<\/strong><\/p>\n<div>\n<p>\u8fd9\u4e9b\u6280\u672f\u80fd\u591f\u66f4\u597d\u5730\u6ee1\u8db3\u60a3\u8005\u3001\u533b\u751f\u3001\u62a4\u58eb\u548c\u836f\u5242\u5e08\u7684\u9700\u6c42\uff0c\u540c\u65f6\u4e3a\u66f4\u5e7f\u6cdb\u7684\u533b\u7597\u4f53\u7cfb\u521b\u9020\u4ef7\u503c\u3002<\/p>\n<p>\u901a\u8fc7\u5c06\u73b0\u6709\u6d3b\u6027\u6210\u5206\u91cd\u65b0\u5236\u6210\u66f4\u4fbf\u5229\u7684\u7ed9\u836f\u5f62\u5f0f\uff0c\u539f\u7814\u836f\u4f01\u4e1a\u80fd\u591f\u5de9\u56fa\u5176\u4ea7\u54c1\u7cfb\u5217\uff1b\u4eff\u5236\u836f\u4f01\u4e1a\u80fd\u591f\u63d0\u5347\u6210\u719f\u4ea7\u54c1\uff1bOTC \u4f01\u4e1a\u5219\u80fd\u5728\u7ade\u4e89\u6fc0\u70c8\u7684\u5e02\u573a\u4e2d\u5b9e\u73b0\u5dee\u5f02\u5316\u2014\u2014\u8fd9\u4e9b\u90fd\u540c\u65f6\u6709\u52a9\u4e8e\u63d0\u9ad8\u4f9d\u4ece\u6027\u5e76\u6539\u5584\u60a3\u8005\u4f53\u9a8c\u3002<\/p>\n<h2><\/h2>\n<h2><strong>1\uff09\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u5236\u5242\uff1a\u4e34\u5e8a\u4e0e\u5e02\u573a\u4ef7\u503c<\/strong><\/h2>\n<h3><strong>1.1. \u6539\u5584\u4f7f\u7528\u4f53\u9a8c\u7684\u836f\u5242\u521b\u65b0<\/strong><\/h3>\n<ul>\n<li><strong>\u9884\u5148\u91cf\u597d\u7684\u5242\u91cf\uff1a<\/strong> \u6db2\u4f53\u68d2\u72b6\u5305\u88c5\uff08liquid stick packs\uff09\u53ca\u4fbf\u643a\u5f0f\u201con\u2011the\u2011go\u201d\u5f62\u5f0f\uff0c\u53ef\u8f7b\u677e\u878d\u5165\u65e5\u5e38\u751f\u6d3b\u3002<\/li>\n<li><strong>\u53e3\u670d\u7c89\u672b \/ \u7c89\u5242\u68d2\u72b6\u5305\u88c5\uff1a<\/strong> \u6613\u4e8e\u643a\u5e26\uff0c\u5feb\u901f\u91cd\u914d\u3002<\/li>\n<li><strong>\u53e3\u6eb6\u7247\uff08ODT\uff09\uff1a<\/strong> \u9002\u7528\u4e8e\u541e\u54bd\u56f0\u96be\u7684\u60a3\u8005\uff08\u513f\u79d1\u3001\u8001\u5e74\u79d1\uff09\u3002<\/li>\n<li><strong>\u63a9\u5473 \/ \u9897\u7c92\u5305\u8863\uff1a<\/strong> \u63d0\u9ad8\u63a5\u53d7\u5ea6\uff0c\u652f\u6301\u957f\u671f\u4f9d\u4ece\u6027\u3002<\/li>\n<li><strong>\u7f13\u91ca\uff08ER\/LP\uff09\uff1a<\/strong> \u51cf\u5c11\u7ed9\u836f\u6b21\u6570\uff0c\u63d0\u5347\u8010\u53d7\u6027\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><\/h3>\n<h3><strong>1.2. \u5dee\u5f02\u5316\u4e0e\u4ea7\u54c1\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\uff08LCM\uff09<\/strong><\/h3>\n<ul>\n<li><strong>\u4eff\u5236\u836f\uff1a<\/strong> \u5728\u9971\u548c\u5e02\u573a\u4e2d\u901a\u8fc7\u589e\u503c\u5236\u5242\u5b9e\u73b0\u5dee\u5f02\u5316\u3002<\/li>\n<li><strong>OTC\uff1a<\/strong> \u901a\u8fc7\u4fbf\u5229\u3001\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u5242\u578b\u5b9e\u73b0\u201c\u9ad8\u7aef\u5316\u201d\uff0c\u907f\u514d\u9677\u5165\u4ef7\u683c\u6218\u3002<\/li>\n<li><strong>\u5904\u65b9\u836f\uff08\u539f\u7814\uff09\uff1a<\/strong> \u5728\u4e13\u5229\u5230\u671f\u524d\uff0f\u671f\u95f4\uff0f\u4e4b\u540e\u8fdb\u884c\u751f\u547d\u5468\u671f\u7ba1\u7406\uff08\u989d\u5916\u7684\u77e5\u8bc6\u4ea7\u6743\u4fdd\u62a4\u3001\u6539\u5584\u60a3\u8005\u4f53\u9a8c\uff09\u3002<\/li>\n<\/ul>\n<blockquote><p>\u201c\u589e\u503c\u836f\u7269\u662f\u533a\u5206\u6211\u4eec\u4ea7\u54c1\u7ec4\u5408\u7684\u91cd\u8981\u673a\u4f1a\u3002\u201d<br \/>\n\u2014\u2014 <em>Robert Knerr\uff08Stada\uff09<\/em><\/p><\/blockquote>\n<h2><\/h2>\n<h2><strong>2\uff09\u8bc6\u522b\u673a\u4f1a\uff1a\u503e\u542c\u4e00\u7ebf\u5e76\u5206\u6790\u771f\u5b9e\u4f7f\u7528\u60c5\u51b5<\/strong><\/h2>\n<h3><strong>2.1. \u4e34\u5e8a\u63a5\u89e6\u70b9\uff08Point\u2011of\u2011Care\uff09\u6d1e\u5bdf<\/strong><\/h3>\n<ul>\n<li>\u6765\u81ea\u533b\u751f\u3001\u62a4\u58eb\u3001\u836f\u5242\u5e08\u548c\u60a3\u8005\u7684\u4e00\u7ebf\u53cd\u9988\u3002<\/li>\n<li>\u4e13\u5bb6\u4e0e\u60a3\u8005\u54a8\u8be2\u59d4\u5458\u4f1a\uff0c\u7528\u4e8e\u660e\u786e\u611f\u77e5\u4ef7\u503c\u4e0e\u771f\u5b9e\u4ef7\u503c\u3002<\/li>\n<li>\u672c\u5730\u5316\u5206\u6790\uff1a\u9700\u6c42\u56e0\u56fd\u5bb6\u548c\u4e34\u5e8a\u5b9e\u8df5\u800c\u5f02\u3002<\/li>\n<\/ul>\n<blockquote><p>Markus Weigandt\uff08Merck KGaA\uff09\uff1a<br \/>\n\u201c\u4f60\u7684\u521b\u65b0\u662f\u5426\u771f\u6b63\u6ee1\u8db3\u4e86\u91cd\u8981\u9700\u6c42\uff1f\u201d<\/p><\/blockquote>\n<h3><\/h3>\n<h3><strong>2.2. \u9002\u5408\u201con\u2011the\u2011go\u201d\u5f62\u5f0f\u7684\u9002\u5e94\u75c7<\/strong><\/h3>\n<ul>\n<li>\u9547\u75db\u836f\u3001\u6297\u7ec4\u80fa\u836f\u3001\u6297\u9178\u836f \u2192 \u75c7\u72b6\u7a81\u53d1\uff0c\u9700\u8981\u5feb\u901f\u3001\u9690\u853d\u7684\u7ed9\u836f\u65b9\u5f0f\u3002<\/li>\n<li>\u7c89\u5242\u4e0e\u6db2\u4f53\u5f62\u5f0f = \u968f\u65f6\u53ef\u7528 + \u4f7f\u7528\u4fbf\u5229\u3002<\/li>\n<\/ul>\n<h3><strong>2.3. \u521b\u610f\u6765\u6e90\uff1a\u4e13\u5229\u3001CDMO\u3001\u5f00\u653e\u5f0f\u521b\u65b0<\/strong><\/h3>\n<ul>\n<li>\u4e13\u5229\u76d1\u6d4b\uff08\u4e13\u5229\u5230\u671f\uff09\u2192 \u91cd\u914d\u673a\u4f1a\u3002<\/li>\n<li>\u5236\u836f CDMO\uff1a\u591a\u6280\u672f\u5e73\u53f0\u3001\u901f\u5ea6\u5feb\u3001\u6210\u672c\u4f18\u5316\u3002<\/li>\n<li>\u5f00\u653e\u5f0f\u65b9\u6cd5\uff08\u5185\u90e8 \/ \u5916\u90e8\uff09\uff1a<br \/>\n<blockquote><p>\u201c\u6211\u4eec\u5173\u6ce8\u7684\u662f\u521b\u610f\u7684\u8d28\u91cf\u3002\u201d<\/p><\/blockquote>\n<\/li>\n<\/ul>\n<h2><\/h2>\n<h2><strong>3\uff09CDMO\uff1a\u836f\u5242\u521b\u65b0\u7684\u5173\u952e\u5408\u4f5c\u4f19\u4f34<\/strong><\/h2>\n<h3><strong>3.1. \u4e3a\u4ec0\u4e48\u8981\u5916\u5305\uff1f<\/strong><\/h3>\n<ul>\n<li>\u5f25\u8865\u5185\u90e8\u6280\u672f\u7f3a\u53e3\u3002<\/li>\n<li>\u83b7\u53d6\u4e13\u4e1a\u5e73\u53f0\uff08ODT\u3001\u7f13\u91ca\u3001\u5fae\u56ca\u5316\u3001\u63a9\u5473\u7b49\uff09\u3002<\/li>\n<li>\u66f4\u5feb\u4e0a\u5e02\u901f\u5ea6\uff0c\u66f4\u4f4e\u8d44\u672c\u6295\u5165\uff08CAPEX\uff09\u3002<\/li>\n<\/ul>\n<blockquote><p>Sandoz\uff1a<br \/>\n\u201c\u6211\u4eec\u4e0d\u53ef\u80fd\u5728\u6240\u6709\u9886\u57df\u90fd\u505a\u5230\u6700\u597d\u3002\u201d<\/p><\/blockquote>\n<h3><\/h3>\n<h3><strong>3.2. \u5982\u4f55\u9009\u62e9\u5408\u9002\u7684 CDMO<\/strong><\/h3>\n<ul>\n<li>\u53ef\u9760\u6027\u3001\u8d28\u91cf\u3001\u5408\u89c4\u6027\uff08GxP\u3001\u6ce8\u518c\u8d44\u6599\uff09\u3002<\/li>\n<li>\u5177\u5907\u9a8c\u8bc1\u53c2\u8003\u7684\u6280\u672f\u80fd\u529b\uff08\u4e34\u5e8a \/ \u5546\u4e1a\u6279\u6b21\uff09\u3002<\/li>\n<li>\u5de5\u4e1a\u80fd\u529b\uff08\u4e2d\u8bd5\u3001\u9a8c\u8bc1\u3001\u4f9b\u5e94\u94fe\uff09\u3002<\/li>\n<li>\u5f3a\u5927\u7684\u5171\u540c\u5f00\u53d1\u6587\u5316\u3002<\/li>\n<\/ul>\n<h2><\/h2>\n<h2><strong>4\uff09\u4ece\u6982\u5ff5\u5230\u5e02\u573a\u6210\u529f\uff1a\u4ef7\u503c\u4e0e\u91c7\u7528\u5ea6\u7684\u5bf9\u9f50<\/strong><\/h2>\n<h3><strong>4.1. \u5904\u65b9\u836f\uff08Rx\uff09\uff1a\u8bf4\u670d\u591a\u4e2a\u51b3\u7b56\u8005<\/strong><\/h3>\n<ul>\n<li>\u96c6\u4e2d\u5f0f\u4ed8\u8d39\u65b9 \u2192 \u6210\u672c\u9650\u5236\u53ef\u80fd\u4f18\u5148\u4e8e\u4f7f\u7528\u76ca\u5904\u3002<\/li>\n<li>\u6fc0\u52b1\u4e0d\u4e00\u81f4\uff08\u4f8b\u5982\uff1a\u6ce8\u5c04\u7ed9\u836f vs. \u66f4\u4fbf\u5229\u7684\u7ed9\u836f\u5f62\u5f0f\uff09\u3002<\/li>\n<li>\u9700\u8981\u624e\u5b9e\u7684\u4ef7\u503c\u8bc1\u636e\u5305\uff1a\u4f9d\u4ece\u6027\u3001\u751f\u6d3b\u8d28\u91cf\u3001\u4e34\u5e8a\u7ed3\u679c\u3001\u603b\u4f53\u533b\u7597\u6210\u672c\u3002<\/li>\n<\/ul>\n<h3><strong>4.2. OTC \u5e02\u573a\uff1a\u6559\u80b2\u4e0e\u54c1\u724c\u8ba4\u77e5<\/strong><\/h3>\n<ul>\n<li>\u6d88\u8d39\u8005\u505a\u51fa\u51b3\u5b9a\u2026\u2026\u524d\u63d0\u662f\u77e5\u9053\u8fd9\u79cd\u5242\u578b\u7684\u5b58\u5728\u3002<\/li>\n<li>\u68d2\u72b6\u5305\u88c5\uff1a\u8ba4\u77e5\u5ea6\u4ecd\u4f4e \u2192 \u9700\u8981\u836f\u623f\u6559\u80b2\u3001\u4f7f\u7528\u53ef\u89c6\u5316\u3001\u8bd5\u7528\u6837\u54c1\u3002<\/li>\n<li>\u54c1\u724c\u529b\u91cf\u5bf9\u63a8\u52a8\u589e\u91cf\u521b\u65b0\u81f3\u5173\u91cd\u8981\u3002<\/li>\n<\/ul>\n<h2><\/h2>\n<h2><strong>5\uff09\u8d8b\u52bf\u4e0e\u524d\u666f\uff1a\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u5242\u578b\u5d1b\u8d77<\/strong><\/h2>\n<h3><strong>5.1. \u533b\u7597\u4f53\u7cfb\u66f4\u91cd\u89c6\u201c\u4f7f\u7528\u4ef7\u503c\u201d<\/strong><\/h3>\n<ul>\n<li>\u5317\u6b27\u56fd\u5bb6\uff1a\u5c06\u60a3\u8005\u548c\u4e34\u5e8a\u4f7f\u7528\u4f53\u9a8c\u7eb3\u5165\u91c7\u8d2d\u51b3\u7b56\u3002<\/li>\n<li>\u66f4\u613f\u610f\u91c7\u7528\u80fd\u6539\u5584\u4fbf\u5229\u6027\u548c\u751f\u6d3b\u8d28\u91cf\u7684\u5242\u578b\u3002<\/li>\n<\/ul>\n<h3><strong>5.2. \u4f9d\u4ece\u6027 = \u66f4\u4f73\u7ed3\u679c<\/strong><\/h3>\n<ul>\n<li>\u7b80\u5355\u3001\u4fbf\u6377\u7684\u5242\u578b\u80fd\u63d0\u9ad8\u4f9d\u4ece\u6027 \u2192 \u5e26\u6765\u66f4\u597d\u7684\u4e34\u5e8a\u6548\u679c\u548c\u66f4\u4f4e\u6210\u672c\u3002<\/li>\n<li>\u8fd9\u662f\u836f\u7269\u7ecf\u6d4e\u5b66\u6587\u4ef6\u4e2d\u7684\u6838\u5fc3\u8bba\u70b9\u3002<\/li>\n<\/ul>\n<h3><strong>5.3. \u52a0\u901f\u56e0\u7d20<\/strong><\/h3>\n<ul>\n<li>\u7ade\u4e89\u538b\u529b \u2192 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