{"id":42862,"date":"2018-08-08T13:29:02","date_gmt":"2018-08-08T11:29:02","guid":{"rendered":"https:\/\/kymos.com\/news\/%e5%b1%80%e9%83%a8%e5%a4%96%e7%94%a8%e4%bb%bf%e5%88%b6%e8%8d%af%e7%9a%84%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7\/"},"modified":"2026-07-07T12:58:48","modified_gmt":"2026-07-07T10:58:48","slug":"%e5%b1%80%e9%83%a8%e5%a4%96%e7%94%a8%e4%bb%bf%e5%88%b6%e8%8d%af%e7%9a%84%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e5%b1%80%e9%83%a8%e5%a4%96%e7%94%a8%e4%bb%bf%e5%88%b6%e8%8d%af%e7%9a%84%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7\/","title":{"rendered":"\u5c40\u90e8\u5916\u7528\u4eff\u5236\u836f\u7684\u751f\u7269\u7b49\u6548\u6027"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\">2018 \u5e74 9 \u6708\uff0cFDA \u5728\u4e3a\u671f\u4e24\u5929\u7684\u590d\u6742\u4eff\u5236\u836f\u5f00\u53d1<a href=\"https:\/\/www.fda.gov\/drugs\/cder-small-business-industry-assistance-sbia\/regulatory-education-industry-redi-complex-generic-drug-product-development-workshop-september-12-13\" data-wpel-link=\"external\">\u7814\u8ba8\u4f1a<\/a>\u4e0a\uff0c\u4fee\u8ba2\u4e86\u5c40\u90e8\u5916\u7528\u4eff\u5236\u836f\u7684\u72b6\u6001\u53ca\u5176\u672a\u6765\u524d\u666f\u3002<\/span><\/p>\n<div class=\"blog-content\">\n<div class=\"field field-name-body field-type-text-with-summary field-label-hidden\">\n<div class=\"field-items\">\n<div class=\"field-item even\">\n<p><span style=\"font-size: 14pt;\">\u4e00\u5e74\u524d\uff0c\u5373 2017 \u5e74 10 \u6708\uff0cFDA \u4e3e\u529e\u4e86\u4e0a\u4e00\u6b21\u5c40\u90e8\u76ae\u80a4\u79d1\u4eff\u5236\u836f\u7814\u8ba8\u4f1a\u3002\u4ee5\u4e0b\u662f\u4f1a\u8bae\u671f\u95f4\u8ba8\u8bba\u7684\u5173\u4e8e\u4f7f\u7528 Franz \u6269\u6563\u6c60\u8fdb\u884c<i>\u4f53\u5916<\/i>\u6027\u80fd\u6d4b\u8bd5\u7684\u4e3b\u8981\u89c2\u70b9\u3002 <\/span><\/p>\n<h4 class=\"\" style=\"--fontsize: 16; line-height: 1.43; --minfontsize: 16;\" data-fontsize=\"16\" data-lineheight=\"22.88px\"><span style=\"font-size: 14pt;\"><span class=\"fusion-tooltip tooltip-shortcode\" data-animation=\"\" data-delay=\"0\" data-placement=\"top\" data-title=\"none\" title=\"none\" data-toggle=\"tooltip\" data-trigger=\"hover\">\u5bf9\u7167\u836f\u54c1\u4e2d\u5305\u542b\u54ea\u4e9b\u5fc5\u987b\u5728\u4eff\u5236\u836f\u4e2d\u590d\u5236\u7684\u5185\u5bb9\uff0c\u624d\u80fd\u4f7f\u5176\u771f\u6b63\u7b49\u6548\uff1f<\/span><\/span><\/h4>\n<p><span style=\"font-size: 14pt;\"><strong>\u4eff\u5236\u836f\u4e0e\u54c1\u724c\u836f\u4e4b\u95f4\u552f\u4e00\u7684\u533a\u522b\u5e94\u8be5\u662f\u4ef7\u683c<\/strong>\uff1b\u56e0\u6b64\uff0c\u4eff\u5236\u836f\u5fc5\u987b\u8bc1\u660e\u4e0e\u5bf9\u7167\u836f\u54c1\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002\u751f\u7269\u7b49\u6548\u6027\u662f\u6307\u6d3b\u6027\u6210\u5206\u5230\u8fbe\u4f5c\u7528\u90e8\u4f4d\u7684\u901f\u7387\u548c\u7a0b\u5ea6\u6ca1\u6709\u663e\u8457\u5dee\u5f02\u3002 <\/span><\/p>\n<h2 style=\"--fontsize: 16; line-height: 1.43; --minfontsize: 16;\" data-fontsize=\"16\" data-lineheight=\"22.88px\"><span style=\"font-size: 18pt;\">\u76d1\u7ba1\u673a\u6784\u5bf9\u4eff\u5236\u836f\u5173\u6ce8\u4ec0\u4e48\uff1f<\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u76d1\u7ba1\u673a\u6784\u5173\u6ce8\u4e24\u70b9\uff1a<b>\u751f\u7269\u7b49\u6548\u6027<\/b>\uff08\u4ee5\u8bc1\u660e\u6027\u80fd\u548c\u751f\u7406\u7cfb\u7edf\u5c06\u4e0e\u5bf9\u7167\u836f\u54c1\u76f8\u540c\uff09\uff1b\u4ee5\u53ca<b>\u836f\u7269\u7b49\u6548\u6027<\/b>\uff08\u76f8\u540c\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7279\u5f81\uff09\u3002\u4eff\u5236\u836f\u7684\u53ef\u66ff\u4ee3\u6027\u57fa\u4e8e\u76f8\u4f3c\u6027\uff0c\u5176\u6807\u51c6\u662f\u8bc1\u660e\u4e0e\u5bf9\u7167\u836f\u54c1\u5177\u6709\u5171\u540c\u7684\u8eab\u4efd\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u751f\u7269\u7b49\u6548\u6027\u53ef\u4ee5\u901a\u8fc7\u4e34\u5e8a\u7ec8\u70b9\u7814\u7a76\u6765\u8bc1\u660e\uff1b\u7136\u800c\uff0c\u8fd9\u79cd\u65b9\u6cd5\u4e0d\u654f\u611f\u4e14\u9700\u8981\u5927\u91cf\u53d7\u8bd5\u8005\u3002\u5bf9\u4e8e\u5c40\u90e8\u5916\u7528\u4ea7\u54c1\uff0c\u836f\u4ee3\u52a8\u529b\u5b66\u96be\u4ee5\u6d4b\u91cf\u3002\u5168\u8eab\u8870\u51cf\uff08\u836f\u4ee3\u52a8\u529b\u5b66\uff09\u5e76\u4e0d\u603b\u662f\u4ee3\u8868\u4f5c\u7528\u90e8\u4f4d\u7684\u60c5\u51b5\u3002   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u7531\u4e8e\u4ea7\u54c1\u7684\u590d\u6742\u6027\uff0c\u5373\u4f7f\u5b58\u5728\u663e\u8457\u7684\u5168\u8eab\u5438\u6536\uff0c\u4e5f\u65e0\u6cd5\u4fdd\u8bc1\u836f\u4ee3\u52a8\u529b\u5b66\u4e0e\u5c40\u90e8\u90e8\u4f4d\u7684\u6cbb\u7597\u6548\u679c\u76f8\u5173\u3002\u5177\u6709\u76f8\u540c\u5b9a\u6027\u7ec4\u6210\u7684\u914d\u65b9\u53ef\u80fd\u4f1a\u5bfc\u81f4\u529f\u80fd\u4e0d\u540c\u7684\u4ea7\u54c1\u3002 <\/span><\/p>\n<h2 style=\"--fontsize: 16; line-height: 1.43; --minfontsize: 16;\" data-fontsize=\"16\" data-lineheight=\"22.88px\"><span style=\"font-size: 18pt;\">\u662f\u5426\u6709\u4efb\u4f55\u66ff\u4ee3\u65b9\u6cd5\uff1f<\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u65b0\u6280\u672f\u53ef\u4e3a\u5c40\u90e8\u5916\u7528\u4eff\u5236\u836f\u7b49\u6548\u6027\u63d0\u4f9b\u6709\u6548\u7684\u65b9\u6cd5\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u5fae\u900f\u6790<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u5f00\u653e\u5f0f\u5fae\u704c\u6ce8<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><i>\u4f53\u5916<\/i>\u91ca\u653e\u6d4b\u8bd5 (IVRT) \u548c<i>\u4f53\u5916<\/i>\u6e17\u900f\u6d4b\u8bd5 (IVPT)\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u673a\u6784\u5bfb\u6c42\u5236\u5b9a\u7ecf\u8fc7\u5145\u5206\u7814\u7a76\u3001\u5177\u6709\u79d1\u5b66\u4f9d\u636e\u7684\u76d1\u7ba1\u6807\u51c6\u3002<b><i>\u4f53\u5916<\/i><\/b>\u9014\u5f84\u6db5\u76d6\u4e86 Q1\u3001Q2 \u548c Q3 \u7684\u4e00\u81f4\u6027\u3002\u636e\u63a8\u6d4b\uff0c\u5f53\u4ea7\u54c1\u7684 Q1\/Q2 \u76f8\u540c\u4e14 Q3 \u4e5f\u76f8\u540c\u65f6\uff0c\u5176\u8868\u73b0\u51e0\u4e4e\u4e0d\u53ef\u80fd\u6709\u6240\u4e0d\u540c\u3002\u56e0\u6b64\uff0c\u5b83\u5f88\u53ef\u80fd\u88ab\u8ba4\u4e3a\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5728\u8fd9\u65b9\u9762\uff0c\u8fc7\u53bb\u51e0\u5e74\u4e2d\uff0c\u591a\u4e2a\u7814\u7a76\u5c0f\u7ec4\u4e00\u76f4\u5728\u5408\u4f5c\u7814\u7a76\u901a\u8fc7\u66ff\u4ee3\u65b9\u6cd5\u8fdb\u884c\u7684\u963f\u6614\u6d1b\u97e6\u4e73\u818f\u7684\u751f\u7269\u7b49\u6548\u6027\uff0c\u5e76\u6700\u7ec8\u5f62\u6210\u4e86\u963f\u6614\u6d1b\u97e6\u6307\u5357\u8349\u6848\uff08FDA\uff0c2016 \u5e74\u4fee\u8ba2\u7248\uff09\u3002\u8fd9\u4e9b\u5c0f\u7ec4\u83b7\u5f97\u7684\u65b9\u6cd5\u548c\u7ed3\u679c\u5728\u7814\u8ba8\u4f1a\u4e0a\u8fdb\u884c\u4e86\u5206\u4eab\u548c\u8ba8\u8bba\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u7b80\u800c\u8a00\u4e4b\uff0cIVPT \u5177\u6709\u7075\u654f\u3001\u8fa8\u522b\u529b\u5f3a\u548c\u53ef\u91cd\u590d\u7684\u7279\u70b9\u3002\u7136\u800c\uff0c\u9700\u8981\u5efa\u7acb\u751f\u7269\u7b49\u6548\u6027\u6807\u51c6\u3002\u5e76\u4e14\u6709\u5fc5\u8981\u89c4\u8303 IVPT \u65b9\u6cd5\u5f00\u53d1\u548c\u9a8c\u8bc1\u7684\u6807\u51c6\u7a0b\u5e8f\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u521d\u6b65\u7814\u7a76\u65e8\u5728\u786e\u5b9a\u5173\u952e\u7814\u7a76\u7684\u4f9b\u4f53\u6570\u91cf\u3002\u5e94\u663e\u793a\u6bcf\u4e2a\u76ae\u80a4\u5207\u7247\u7684\u76ae\u80a4\u5b8c\u6574\u6027\uff1b\u5e76\u4e14\u5e94\u5305\u62ec\u6765\u81ea\u591a\u4e2a\u4f9b\u4f53\u7684\u76ae\u80a4\uff08\u6bcf\u4e2a\u4f9b\u4f53\u548c\u6cbb\u7597\u7ec4\u81f3\u5c11\u56db\u4e2a\u91cd\u590d\u6837\u672c\uff09\u3002\u5e94\u4f7f\u7528\u4e0e RLD \u4e0d\u540c\u7684\u7b2c 3 <sup>\u79cd<\/sup>\u5236\u5242\u8fdb\u884c\u5e73\u884c\u8bc4\u4f30\uff0c\u4ee5\u663e\u793a\u9009\u62e9\u6027\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">IVPT \u7684\u6301\u7eed\u65f6\u95f4\u5e94\u8db3\u4ee5\u8bc6\u522b\u6700\u5927\u901a\u91cf\u4ee5\u53ca\u968f\u540e\u540e\u7eed\u65f6\u95f4\u70b9\u7684\u901a\u91cf\u4e0b\u964d\u3002\u5173\u952e\u7814\u7a76\u4e2d\u5e94\u5305\u62ec\u6765\u81ea\u6bcf\u4e2a\u4f9b\u4f53\u7684\u4e00\u4e2a\u672a\u7ed9\u836f\u5bf9\u7167\u76ae\u80a4\u5207\u7247\u3002\u4ee5\u53ca\u6765\u81ea\u6bcf\u4e2a\u6269\u6563\u6c60\u7684\u7ed9\u836f\u524d\u96f6\u70b9\u6837\u54c1\u3002  <\/span><\/p>\n<h2 style=\"--fontsize: 16; line-height: 1.43; --minfontsize: 16;\" data-fontsize=\"16\" data-lineheight=\"22.88px\"><span style=\"font-size: 18pt;\">\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4f53\u5916\u6d4b\u8bd5\u7684\u5173\u952e\u70b9\uff1a<\/span><\/h2>\n<table style=\"width: 59.5139%;\" border=\"1\" cellspacing=\"1\" cellpadding=\"1\">\n<tbody>\n<tr>\n<td class=\"rtecenter\" style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"><strong>IVRT<\/strong><\/span><\/td>\n<td class=\"rtecenter\" style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"><strong>IVPT<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"> \u5408\u6210\u819c<\/span><\/td>\n<td style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"> \u4eba\u7c7b\u76ae\u80a4<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"> \u65e0\u9650\u5242\u91cf<\/span><\/td>\n<td style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"> \u6709\u9650\u5242\u91cf<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"> \u95ed\u585e\u6761\u4ef6<\/span><\/td>\n<td style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"> \u975e\u95ed\u585e\u6761\u4ef6<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"> \u91ca\u653e\u7387<\/span><\/td>\n<td style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"> \u901a\u91cf\u56fe\u8c31<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"> \u76f8\u5bf9\u4e00\u81f4\u6027<\/span><\/td>\n<td style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"> \u4f9b\u4f53\u53d8\u5f02\u6027<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"> \u9152\u7cbe\u4ecb\u8d28<\/span><\/td>\n<td style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"> \u751f\u7406\u4ecb\u8d28<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 36.3431%;\"><span style=\"font-size: 14pt;\"> \u57fa\u4e8e\u7ebf\u6027\u548c\u836f\u7269\u7a33\u5b9a\u6027\u7684\u63a5\u6536\u6db2\u4ecb\u8d28<\/span><\/td>\n<td style=\"width: 37.5839%;\"><span style=\"font-size: 14pt;\"> \u57fa\u4e8e\u836f\u7269\u5728\u4ecb\u8d28\u4e2d\u6eb6\u89e3\u5ea6\u7684\u9009\u62e9<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 data-fontsize=\"16\" data-lineheight=\"22.88px\"><\/h2>\n<h2 style=\"--fontsize: 16; line-height: 1.43; --minfontsize: 16;\" data-fontsize=\"16\" data-lineheight=\"22.88px\"><span style=\"font-size: 18pt;\">\u8981\u70b9\u603b\u7ed3\uff1a<\/span><\/h2>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u76ee\u524d\uff0c\u901a\u5e38\u8fdb\u884c\u4e34\u5e8a\u7ec8\u70b9\u7814\u7a76\u6765\u8bc1\u660e\u751f\u7269\u7b49\u6548\u6027\uff1b\u4f46\u8fd9\u4e9b\u7814\u7a76\u8017\u65f6\u957f\u4e14\u6210\u672c\u9ad8\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u5fae\u89c2\u7ed3\u6784\u7279\u5f81\u53ef\u80fd\u663e\u8457\u5f71\u54cd\u5236\u5242\u7684\u6027\u80fd\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">IVPT \u662f\u8f85\u52a9\u8bc4\u4f30\u4ea7\u54c1\u53ef\u884c\u6027\u548c\u751f\u7269\u7b49\u6548\u6027\u7684\u7edd\u4f73\u5de5\u5177\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 18.6667px;\">&gt;  \u4e86\u89e3\u66f4\u591a\u5173\u4e8e\u6211\u4eec\u7684<a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/%e4%b8%b4%e5%ba%8a%e5%89%8d%e5%92%8c%e4%b8%b4%e5%ba%8a%e6%9c%8d%e5%8a%a1\/%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e7%a0%94%e7%a9%b6\/\" data-wpel-link=\"internal\">\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u670d\u52a1<\/a><a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/%e4%b8%b4%e5%ba%8a%e5%89%8d%e5%92%8c%e4%b8%b4%e5%ba%8a%e6%9c%8d%e5%8a%a1\/%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e7%a0%94%e7%a9%b6\/\" 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