{"id":1302,"date":"2021-03-10T22:03:29","date_gmt":"2021-03-10T22:03:29","guid":{"rendered":"http:\/\/www.validant.com\/%e4%b8%b4%e5%ba%8a%e5%89%8d\/"},"modified":"2021-04-13T21:51:39","modified_gmt":"2021-04-13T21:51:39","slug":"%e4%b8%b4%e5%ba%8a%e5%89%8d","status":"publish","type":"page","link":"https:\/\/www.validant.com\/zh-hans\/%e4%b8%b4%e5%ba%8a%e5%89%8d\/","title":{"rendered":"\u4e34\u5e8a\u524d"},"content":{"rendered":"\n<section class=\"wp-block-mkl-section-block\"><div class=\"section-bg bg__stretched\" style=\"background-image:url(https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/preclinical-header-img.jpg);opacity:1\"><\/div>\n<div class=\"wp-block-mkl-section-block container pt-xl\">\n<p><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block transparent\">\n<div class=\"wp-block-mkl-section-block has-white-background-color container panel pb-s ot-l\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column pr-s is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:65%\">\n<p class=\"has-text-align-left large has-olive-color has-text-color\"><strong>\u4e34\u5e8a\u524d\u54a8\u8be2<\/strong><\/p>\n\n\n\n<h1 class=\"wp-block-heading\">\u4f18\u5316<strong><span class=\"has-inline-color has-green-color\">\u524d\u671f\u6b65\u9aa4\uff0c\u4ee5\u6700\u7ec8\u83b7\u5f97\u4ea7\u54c1\u6279\u51c6<\/span><\/strong><\/h1>\n\n\n\n<p class=\"large pt-xxs\"><strong>\u5b9a\u4e49\u660e\u786e\u7684\u76d1\u7ba1\u7b56\u7565\u662f\u786e\u5b9a\u6700\u4f73\u4ea7\u54c1\u5f00\u53d1\u8ba1\u5212\u7684\u7b2c\u4e00\u6b65\uff0c\u5305\u62ec\u4e34\u5e8a\u548c\u5546\u4e1a\u8003\u8651\u3002<\/strong><\/p>\n\n\n\n<p>Validant 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class=\"wp-block-list\"><li>\u6ce8\u518c\u7b56\u7565\u64cd\u4f5c<\/li><li>\u6ce8\u518c\u4e0e\u4e34\u5e8a\u7b56\u7565<\/li><li>\u751f\u547d\u5468\u671f\u7ba1\u7406<\/li><li>FDA\/\u673a\u6784\u4f1a\u8bae\u51c6\u5907<\/li><li>IND\u3001NDA\/BLA\u3001ANDA\u3001IDE\u3001510(K)\u3001PMA \u51c6\u5907<\/li><li>\u63d0\u4ea4\u3001\u53d1\u5e03\u548c eCTD<\/li><li>\u836f\u5b66\u7b56\u7565<\/li><li>\u5e7f\u544a\u4e0e\u63a8\u5e7f<\/li><li>\u836f\u54c1\u4e0e\u8bbe\u5907\u8d34\u6807<\/li><li>\u6cd5\u89c4\u4e8b\u52a1 IT \u7cfb\u7edf<\/li><li>\u8fdb\u7a0b\u6539\u8fdb\u4e0e\u5b9e\u65bd<\/li><li>\u5b9e\u9a8c\u5ba4\u63a7\u5236\u4e0e\u6570\u636e\u5b8c\u6574\u6027<\/li><li>\u6570\u636e\u5b8c\u6574\u6027\u4fee\u590d<\/li><li>\u4e34\u65f6\u884c\u4e1a\u4e13\u5bb6\u4e0e\u4eba\u5458\u914d\u7f6e<\/li><\/ul><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\"><li>\u5458\u5de5\u57f9\u8bad<\/li><li>\u9879\u76ee\u7ba1\u7406<\/li><li>\u8d28\u91cf\u7cfb\u7edf\u8bbe\u8ba1\u3001\u7b56\u7565\u4e0e\u90e8\u7f72<\/li><li>\u8d28\u91cf\u7cfb\u7edf\u5f00\u53d1<\/li><li>\u6570\u636e\u5b8c\u6574\u6027<\/li><li>\u98ce\u9669\u7ba1\u7406<\/li><li>\u8bbe\u8ba1\u63a7\u5236<\/li><li>\u652f\u6301\u5b9e\u65bd\u65b0\u7684\/\u4fee\u8ba2\u7684\u6807\u51c6\u4e0e\u6cd5\u89c4<\/li><li>FDA\/EMA\/\u536b\u751f\u5f53\u5c40\u673a\u6784\u60c5\u62a5<\/li><li>\u4e0e\u76d1\u7ba1\u5f8b\u5e08\u534f\u8c03<\/li><li>\u7b2c\u4e09\u65b9\u652f\u6301<\/li><li>\u5ba1\u8ba1\u4e0e\u8bc4\u4f30<\/li><li>\u4f9b\u5e94\u5546\u8bc4\u4f30<\/li><\/ul><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:35%\">\n<div class=\"wp-block-mkl-section-block panel-small bg-greengrad mb-xs\">\n<ul class=\"strategy-list wp-block-list\"><li>\u6cd5\u89c4\u4e8b\u52a1<\/li><li><strong>\u7b56\u7565\u6307\u5bfc\u4e0e\u6f0f\u6d1e\u8bc4\u4f30<\/strong><\/li><li><strong>\u4e34\u5e8a\u524d\u7b56\u7565\/\u7a0b\u5e8f\u8bbe\u8ba1<\/strong>\uff08<strong>GLP \u6bd2\u7406\u5b66\u7814\u7a76<\/strong>\uff1b<strong>GLP PK \u7814\u7a76<\/strong>\uff1b<strong>\u975e GLP \u836f\u6548\u5b66\u7814\u7a76<\/strong>\uff09<\/li><li><strong>PK\/PD\/\u6bd2\u7406\u5b66\u534f\u8bae\u4e0e\u62a5\u544a\u5ba1\u67e5<\/strong><\/li><li><strong>\u7814\u7a76\u62a5\u544a\u7684\u64b0\u5199\u3001\u5ba1\u8bc4\u3001\u6388\u6743\u548c\u7ed3\u679c\u89e3\u91ca<\/strong><\/li><li><strong>PK\/PD \u5efa\u6a21<\/strong><\/li><li><strong>IB \u64b0\u5199\u4e0e\u51c6\u5907<\/strong><\/li><li><strong>\u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\u7ffb\u8bd1\uff08\u4e2d\u6587\/\u82f1\u6587\uff09<\/strong><\/li><\/ul>\n\n\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-mkl-section-block has-grey-background-color panel-small mb-xs\">\n<p class=\"mb-z\"><strong><span class=\"has-inline-color has-olive-color\">\u6848\u4f8b\u7814\u7a76<\/span><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u8ba9\u63d0\u4ea4\u7684 IND <strong>\u6210\u529f\u901a\u8fc7 FDA \u5ba1\u67e5<\/strong><\/h3>\n\n\n\n<p>\u4e86\u89e3 DataRevive \u5982\u4f55\u5728\u4e00\u5e74\u65f6\u95f4\u5185\u5b9e\u73b0 32 \u9879 IND \u7533\u8bf7 100% \u901a\u8fc7\u3002<\/p>\n\n\n\n<p class=\"more\"><a href=\"#\">\u67e5\u770b\u6848\u4f8b\u7814\u7a76<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block cta-panel mb-m\">\n<div class=\"wp-block-mkl-section-block container panel bg-greengrad\">\n<div class=\"wp-block-mkl-section-block has-green-background-color bg-greengrad panel\">\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-columns relative is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:45%\">\n<h2 class=\"has-white-color has-text-color wp-block-heading\">\u9700\u8981<strong><span class=\"has-inline-color has-lightblue-color\">\u6211\u4eec\u6548\u52b3\u5417\uff1f<\/span><\/strong><\/h2>\n<\/div>\n\n\n\n<div class=\"wp-block-column pl-xs is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"large has-white-color has-text-color\">\u544a\u8bc9\u6211\u4eec\u60a8\u7684\u76ee\u6807\u3002<br\/><strong>\u6211\u4eec\u5c06\u7aed\u5c3d\u6240\u80fd\u6765\u89e3\u51b3\u60a8\u7684\u5177\u4f53\u95ee\u9898\u3002<\/strong><\/p>\n\n\n\n<p class=\"btn white\"><a 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