{"id":1647,"date":"2021-03-11T18:16:04","date_gmt":"2021-03-11T18:16:04","guid":{"rendered":"http:\/\/www.validant.com\/%e5%89%8d%e8%87%a8%e5%ba%8a\/"},"modified":"2021-04-14T20:44:59","modified_gmt":"2021-04-14T20:44:59","slug":"%e5%89%8d%e8%87%a8%e5%ba%8a","status":"publish","type":"page","link":"https:\/\/www.validant.com\/ja\/%e5%89%8d%e8%87%a8%e5%ba%8a\/","title":{"rendered":"\u524d\u81e8\u5e8a"},"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 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class=\"wp-block-list\"><li>\u85ac\u4e8b\u6226\u7565\u306e\u5b9f\u884c<\/li><li>\u85ac\u4e8b\u304a\u3088\u3073\u81e8\u5e8a\u6226\u7565<\/li><li>\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406<\/li><li>FDA\/\u5f53\u5c40\u3068\u306e\u4f1a\u5408\u306e\u6e96\u5099<\/li><li>IND\u3001NDA\/BLA\u3001ANDA\u3001IDE\u3001510(K)\u3001PMA\u306e\u6e96\u5099<\/li><li>\u7533\u8acb\u3001\u767a\u8868\u3001\u304a\u3088\u3073eCTD<\/li><li>CMC\u6226\u7565<\/li><li>\u5ba3\u4f1d\u304a\u3088\u3073\u30d7\u30ed\u30e2\u30fc\u30b7\u30e7\u30f3<\/li><li>\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30d9\u30eb\u8868\u793a<\/li><li>\u85ac\u4e8bIT\u30b7\u30b9\u30c6\u30e0<\/li><li>\u30d7\u30ed\u30bb\u30b9\u306e\u6539\u5584\u304a\u3088\u3073\u5b9f\u65bd<\/li><li>\u30e9\u30dc\u306e\u7ba1\u7406\u3068\u30c7\u30fc\u30bf\u5b8c\u5168\u6027<\/li><li>\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u306e\u5fa9\u65e7<\/li><li>\u66ab\u5b9a\u7684\u306a\u7279\u5b9a\u5206\u91ce\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3001\u304a\u3088\u3073\u4eba\u6750\u914d\u7f6e<\/li><\/ul><\/div>\n\n\n\n<div 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class=\"wp-block-list\"><li>\u5f93\u696d\u54e1\u306e\u7814\u4fee<\/li><li>\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406<\/li><li>\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u8a2d\u8a08\u3001\u6226\u7565\u3001\u304a\u3088\u3073\u5b9f\u88c5<\/li><li>\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u958b\u767a<\/li><li>\u30c7\u30fc\u30bf\u5b8c\u5168\u6027<\/li><li>\u30ea\u30b9\u30af\u7ba1\u7406<\/li><li>\u8a2d\u8a08\u7ba1\u7406<\/li><li>\u65b0\u898f\u307e\u305f\u306f\u6539\u8a02\u3055\u308c\u305f\u898f\u683c\u304a\u3088\u3073\u6cd5\u898f\u5236\u3078\u306e\u9069\u5408\u30b5\u30dd\u30fc\u30c8<\/li><li>FDA\/EMA\/\u4fdd\u5065\u5f53\u5c40\u306b\u95a2\u3059\u308b\u60c5\u5831<\/li><li>\u898f\u5236\u5f53\u5c40\u306e\u9867\u554f\u5b98\u3068\u306e\u8abf\u6574<\/li><li>\u7b2c\u4e09\u8005\u306b\u3088\u308b\u30b5\u30dd\u30fc\u30c8<\/li><li>\u76e3\u67fb\u304a\u3088\u3073\u8a55\u4fa1<\/li><li>\u7d0d\u5165\u696d\u8005\u306e\u8a55\u4fa1<\/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>\u85ac\u4e8b<\/li><li><strong>\u6226\u7565\u30ac\u30a4\u30c0\u30f3\u30b9\u304a\u3088\u3073\u30ae\u30e3\u30c3\u30d7\u8a55\u4fa1<\/strong><\/li><li><strong>\u524d\u81e8\u5e8a\u6226\u7565\/\u30d7\u30ed\u30b0\u30e9\u30e0\u8a2d\u8a08<\/strong>(<strong>GLP\u6bd2\u7269\u5b66\u7814\u7a76<\/strong>\u3001<strong>GLP PK\u7814\u7a76<\/strong>\u3001<strong>\u975eGLP\u85ac\u52b9\u8a66\u9a13<\/strong>)<\/li><li><strong>PK\/PD\/\u6bd2\u6027\u5b66\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u5831\u544a\u66f8\u306e\u691c\u67fb<\/strong><\/li><li><strong>\u7814\u7a76\u5831\u544a\u66f8\u306e\u4f5c\u6210\u3001\u78ba\u8a8d\u3001\u627f\u8a8d\u304a\u3088\u3073\u7d50\u679c\u306e\u89e3\u91c8<\/strong><\/li><li><strong>PK\/PD\u30e2\u30c7\u30ea\u30f3\u30b0<\/strong><\/li><li><strong>IB\u66f8\u985e\u4f5c\u6210\u304a\u3088\u3073\u6e96\u5099<\/strong><\/li><li><strong>\u975e\u81e8\u5e8a\u7814\u7a76\u5831\u544a\u66f8\u306e\u7ffb\u8a33(\u4e2d\u56fd\u8a9e\/\u82f1\u8a9e)<\/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\">\u4e8b\u4f8b<\/span><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u7533\u8acb\u3057\u305fIND\u306b\u95a2\u3059\u308b<strong>FDA\u304b\u3089\u306e\u53d7\u7406\u901a\u77e5<\/strong>\u3092\u53ef\u80fd\u306b<\/h3>\n\n\n\n<p>DataRevive\u304c\u3069\u306e\u3088\u3046\u306b\u3057\u30661\u5e74\u9593\u306732\u4ef6\u306eIND\u7533\u8acb\u3092100%\u5408\u683c\u3055\u305b\u305f\u304b\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p class=\"more\"><a href=\"#\">\u4e8b\u4f8b\u3092\u898b\u308b<\/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\">\u3069\u306e\u3088\u3046\u306a<strong><span class=\"has-inline-color has-lightblue-color\">\u5f53\u793e\u306e\u30b5\u30fc\u30d3\u30b9<\/span><\/strong>\u304c\u3054\u5e0c\u671b\u3067\u3059\u304b\uff1f<\/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\">\u5b9f\u73fe\u3055\u305b\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u304a\u77e5\u3089\u305b\u304f\u3060\u3055\u3044\u3002<br\/><strong>\u5f53\u793e\u306e\u7d4c\u9a13\u3092\u6ce8\u304e\u8fbc\u3093\u3067\u3001\u304a\u5ba2\u69d8\u306e\u5177\u4f53\u7684\u306a\u554f\u984c\u306b\u53d6\u308a\u7d44\u307f\u307e\u3059\u3002<\/strong><\/p>\n\n\n\n<p class=\"btn white\"><a 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