{"id":7149,"date":"2020-03-17T08:20:55","date_gmt":"2020-03-17T08:20:55","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7149"},"modified":"2020-12-04T11:08:40","modified_gmt":"2020-12-04T11:08:40","slug":"5-applications-of-biomarkers-in-drug-discovery-and-development","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/","title":{"rendered":"5 \u5275\u85ac\u30fb\u958b\u767a\u306b\u304a\u3051\u308b\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u5fdc\u7528"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f1d71895152\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f1d71895152\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/#Current_applications_of_biomarkers\" title=\"\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u5fdc\u7528\u4f8b\">\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u5fdc\u7528\u4f8b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/#1_The_development_of_therapeutic_agents_for_Alzheimers_disease\" title=\"1.\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u578b\u8a8d\u77e5\u75c7\u6cbb\u7642\u85ac\u306e\u958b\u767a\u306b\u3064\u3044\u3066\">1.\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u578b\u8a8d\u77e5\u75c7\u6cbb\u7642\u85ac\u306e\u958b\u767a\u306b\u3064\u3044\u3066<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/#2_Predicting_Disease_Progression_in_Polycystic_Kidney_Disease\" title=\"2.\u591a\u56a2\u80de\u6027\u814e\u81d3\u75c5\u306e\u75c5\u72b6\u9032\u884c\u3092\u4e88\u6e2c\u3059\u308b\">2.\u591a\u56a2\u80de\u6027\u814e\u81d3\u75c5\u306e\u75c5\u72b6\u9032\u884c\u3092\u4e88\u6e2c\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/#3_Novel_Immuno-oncology_Biomarkers_for_Personalizing_Cancer_Therapy\" title=\"3.\u304c\u3093\u6cbb\u7642\u306e\u500b\u5225\u5316\u306b\u5411\u3051\u305f\u65b0\u3057\u3044\u514d\u75ab\u816b\u760d\u5b66\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\">3.\u304c\u3093\u6cbb\u7642\u306e\u500b\u5225\u5316\u306b\u5411\u3051\u305f\u65b0\u3057\u3044\u514d\u75ab\u816b\u760d\u5b66\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/#4_Identifying_Diagnostic_Prognostic_Biomarkers_for_Drug_Discovery_of_Cystic_Fibrosis\" title=\"4.\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306e\u5275\u85ac\u306e\u305f\u3081\u306e\u8a3a\u65ad\u30fb\u4e88\u5f8c\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u540c\u5b9a\">4.\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306e\u5275\u85ac\u306e\u305f\u3081\u306e\u8a3a\u65ad\u30fb\u4e88\u5f8c\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u540c\u5b9a<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/#5_Detecting_Cardiovascular_Biomarkers_to_Re-evaluate_treatments_for_CVD\" title=\"5.\u5fc3\u8840\u7ba1\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u691c\u51fa\u306b\u3088\u308bCVD\u6cbb\u7642\u306e\u518d\u8a55\u4fa1\">5.\u5fc3\u8840\u7ba1\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u691c\u51fa\u306b\u3088\u308bCVD\u6cbb\u7642\u306e\u518d\u8a55\u4fa1<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>\u30de\u30cf\u30b9\u30a6\u30a7\u30fc\u30bf\u30fb\u30d1\u30eb <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biomarkers-Applications\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> Kolabtree\u3067\u306f\u3001\u5275\u85ac\u3084\u958b\u767a\u3092\u9032\u3081\u308b\u4e0a\u3067\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u65b0\u3057\u3044\u5fdc\u7528\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/em><\/p>\n<p>\u533b\u85ac\u54c1\u958b\u767a <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> drives the biopharma industry outlook. A milestone for drug discovery was the establishment of the Precision Medicine initiative by the USFDA, which shaped the industry&#8217;s transformation. This regulation not only formalizes the qualification of<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biomarkers?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biomarkers-Applications\"> \u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc<\/a> \u3053\u306e\u3088\u3046\u306b\u3001\u672c\u88fd\u54c1\u306f\u81e8\u5e8a\u8a66\u9a13\u306e\u52b9\u7387\u5316\u306b\u8ca2\u732e\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u60a3\u8005\u306e\u63a1\u5426\u5224\u5b9a\u3084\u6cbb\u7642\u5f8c\u306e\u751f\u4f53\u53cd\u5fdc\u306e\u5224\u5b9a\u306b\u3082\u5fdc\u7528\u3067\u304d\u307e\u3059\u3002\u3055\u3089\u306b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/analytical-chemistry\">\u5206\u6790\u7684<\/a> \u307e\u305f\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u6709\u52b9\u6027\u3084\u9069\u683c\u6027\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3084\u526f\u6b21\u8a55\u4fa1\u9805\u76ee\u3092\u6c7a\u5b9a\u3059\u308b\u969b\u306e\u6709\u7528\u6027\u306b\u3082\u3064\u306a\u304c\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306b\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306f\u3001\u533b\u85ac\u54c1\u3084\u65b0\u3057\u3044\u6cbb\u7642\u6cd5\u306e\u767a\u898b\u3001\u958b\u767a\u3001\u691c\u8a3c\u306b\u304a\u3044\u3066\u3001\u3069\u3053\u306b\u3067\u3082\u3042\u308b\u3082\u306e\u306b\u306a\u308a\u3064\u3064\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u6700\u8fd1\u306e\u5927\u304d\u306a\u5909\u5316\u306f\u3001\u4f55\u767e\u4e07\u4eba\u3082\u306e\u60a3\u8005\u304c\u7f79\u60a3\u3059\u308b\u75c5\u6c17\u306e\u6cbb\u7642\u85ac\u304b\u3089\u3001\u30aa\u30fc\u30d5\u30a1\u30f3\u30c9\u30e9\u30c3\u30b0\uff08\u3054\u304f\u5c11\u6570\u306e\u60a3\u8005\u304c\u7f79\u60a3\u3059\u308b\u75c5\u6c17\u306e\u6cbb\u7642\u85ac\uff09\u3078\u306e\u79fb\u884c\u3067\u3059\u3002\u4e00\u65b9\u3067\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u5411\u4e0a\u306f\u3001\u65e9\u671f\u5e02\u5834\u5316\u306b\u5411\u3051\u305f\u7af6\u4e89\u304c\u6fc0\u5316\u3059\u308b\u4e2d\u3067\u3001\u81e8\u5e8a\u958b\u767a\u30b5\u30a4\u30af\u30eb\u306e\u4e2d\u5fc3\u306b\u636e\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\u3084\u30ca\u30ce\u30bb\u30f3\u30b7\u30f3\u30b0\u6280\u8853\u304c\u3001\u4f4e\u5206\u5b50\u3084\u96fb\u89e3\u8cea\uff08\u30a4\u30aa\u30f3\uff09\u306a\u3069\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u81e8\u5e8a\u5fdc\u7528\u3084\u5b9a\u91cf\u5316\u306b\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u304b\u3089\u3001\u30d0\u30a4\u30aa\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30bb\u30f3\u30b5\u30fc\u306e\u30e1\u30fc\u30ab\u30fc\u3082\u3053\u306e\u6d41\u308c\u306b\u4e57\u3063\u3066\u3044\u307e\u3059\u3002<a href=\"https:\/\/xsensio.com\/lab-on-skin-technology\/\">Xsensio<\/a> \u304c\u826f\u3044\u4f8b\u3067\u3059\uff09\u3001\u4ee3\u8b1d\u7269\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u3053\u3067\u3001\u3053\u3053\u3067\u306f\u3001\u533b\u85ac\u54c1\u3084\u65b0\u898f\u6cbb\u7642\u85ac\u306e\u81e8\u5e8a\u958b\u767a\u306b\u304a\u3051\u308b\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u6709\u52b9\u6027\u3092\u4f8b\u793a\u3059\u308b\u3001\u73fe\u5728\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u5fdc\u7528\u4f8b\u3092\u3044\u304f\u3064\u304b\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Current_applications_of_biomarkers\"><\/span>\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u5fdc\u7528\u4f8b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_The_development_of_therapeutic_agents_for_Alzheimers_disease\"><\/span>1.\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u578b\u8a8d\u77e5\u75c7\u6cbb\u7642\u85ac\u306e\u958b\u767a\u306b\u3064\u3044\u3066<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5\u306f\u4f9d\u7136\u3068\u3057\u3066\u6cbb\u7642\u4e0d\u53ef\u80fd\u306a\u75c5\u6c17\u3067\u3042\u308a\u3001\u69d8\u3005\u306a\u85ac\u5264\u958b\u767a\u304c\u5931\u6557\u306b\u7d42\u308f\u3063\u3066\u3044\u307e\u3059\u3002\u306e\u81e8\u5e8a\u958b\u767a\u304c\u9032\u3093\u3067\u3044\u307e\u3059\u304c <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6617248\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u3092\u6e1b\u3089\u3059\u305f\u3081\u306e\u85ac<\/a> \u3053\u306e\u75c5\u6c17\u306e\u7f79\u60a3\u7387\u3084\u75c7\u72b6\u3078\u306e\u5bfe\u7b56\u304c\u9032\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306f\u305d\u308c\u3092\u53ef\u80fd\u306b\u3059\u308b\u3082\u306e\u3067\u3059\u3002 <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/30488277\" target=\"_blank\" rel=\"noopener noreferrer\">\u7406\u89e3\u5ea6\u5411\u4e0a<\/a> AD\u306e\u69d8\u3005\u306a\u75c7\u72b6\u3001\u7570\u306a\u308b\u30bf\u30a4\u30d7\u3001\u9032\u5316\u3059\u308b\u30e1\u30ab\u30cb\u30ba\u30e0\u3092\u7406\u89e3\u3057\u3001\u52b9\u679c\u7684\u306b\u30bf\u30fc\u30b2\u30c3\u30c8\u3092\u7d5e\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/28077397\">\u30bf\u30a6<\/a> \u3068\u30a2\u30df\u30ed\u30a4\u30c9\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u52b9\u679c\u306e\u305f\u3081\u306b\u3001\u3055\u3089\u306b <a href=\"https:\/\/www.fda.gov\/media\/110903\/download\" target=\"_blank\" rel=\"noopener noreferrer\">USFDA\u304c\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868<\/a> \u306f\u3001\u524d\u99c6\u75c7\u72b6\u306e\u3042\u308bAD\u3092\u542b\u3080\u75be\u60a3\u306e\u30b9\u30c6\u30fc\u30b8\u30f3\u30b0\u306b\u304a\u3051\u308b\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u5f79\u5272\u306b\u3064\u3044\u3066\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5958625\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u30ea\u30b5\u30fc\u30c1\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u78ba\u7acb<\/a> \u7c73\u56fd\u56fd\u7acb\u8001\u5316\u7814\u7a76\u6240\uff08NIA\uff09\u3068\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5\u5354\u4f1a\u304c\u5c0e\u5165\u3057\u305f\u30a2\u30df\u30ed\u30a4\u30c9\u3001\u30bf\u30a6\u3001\u795e\u7d4c\u5909\u6027\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306b\u57fa\u3065\u304fAD\u306e\u8a3a\u65ad\u52b9\u7387\u3092\u9ad8\u3081\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>2019\u5e74\u73fe\u5728\u3001\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u958b\u767a\u3067\u306f <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/core\/lw\/2.0\/html\/tileshop_pmc\/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&amp;p=PMC3&amp;id=6617248_gr1.jpg\" target=\"_blank\" rel=\"noopener noreferrer\">\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u578b\u8a8d\u77e5\u75c7<\/a>\u8133\u810a\u9ac4\u6db2\u4e2d\u306e\u30a2\u30df\u30ed\u30a4\u30c9\u304a\u3088\u3073\u30bf\u30a6\uff0827 \u4ef6\u306e\u81e8\u5e8a\u8a66\u9a13\uff09\u3001\u30d5\u30eb\u30aa\u30ed\u30c7\u30aa\u30ad\u30b7\u30b0\u30eb\u30b3\u30fc\u30b9-PET\uff081 \u4ef6\u306e\u81e8\u5e8a\u8a66\u9a13\uff09\u3001\u5bb9\u7a4d\u578b\u78c1\u6c17\u5171\u9cf4\u753b\u50cf\uff0810 \u4ef6\u306e\u81e8\u5e8a\u8a66\u9a13\uff09\u3001\u307e\u305f\u306f\u30a2\u30df\u30ed\u30a4\u30c9 PET\uff0810 \u4ef6\u306e\u81e8\u5e8a\u8a66\u9a13\uff09\u3067\u3059\u3002\u30a2\u30df\u30ed\u30a4\u30c9PET\u3068\u9ac4\u6db2\u30a2\u30df\u30ed\u30a4\u30c9\u306f\u3001\u75c5\u671f\u5206\u985e\u3084\u60a3\u8005\u306e\u7d44\u307f\u5165\u308c\u306b\u6700\u3082\u3088\u304f\u7528\u3044\u3089\u308c\u308b\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3067\u3042\u3063\u305f\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Predicting_Disease_Progression_in_Polycystic_Kidney_Disease\"><\/span>2.\u591a\u56a2\u80de\u6027\u814e\u81d3\u75c5\u306e\u75c5\u72b6\u9032\u884c\u3092\u4e88\u6e2c\u3059\u308b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6ccc\u5c3f\u5668\u7cfb\u306e\u75be\u60a3\u3067\u306f\u3001\u7279\u306b\u814e\u75be\u60a3\u3092\u4e2d\u5fc3\u306b\u69d8\u3005\u306a\u30ec\u30d9\u30eb\u3084\u7a2e\u985e\u306e\u6bd2\u6027\u304c\u898b\u3089\u308c\u307e\u3059\u3002\u85ac\u5264\u3084\u65b0\u3057\u3044\u6cbb\u7642\u6cd5\u306b\u3088\u308b\u7d30\u80de\u6bd2\u6027\u306e\u6570\u3092\u6e1b\u3089\u3059\u305f\u3081\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u3067\u306f\u3001\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u306e\u7279\u6027\u3084\u75be\u60a3\u7279\u6709\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306b\u57fa\u3065\u3044\u305f\u7d44\u307f\u5165\u308c\u57fa\u6e96\u3092\u53d6\u308a\u5165\u308c\u3066\u3044\u307e\u3059\u3002\u4ee5\u524d\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u6bd2\u6027\u306f43%\u306b\u3082\u4e0a\u308a\u3001\u524d\u81e8\u5e8a\u8a66\u9a13\u3067\u306f71%\u306b\u3082\u4e0a\u308a\u307e\u3057\u305f\u3002<\/p>\n<p>\u6700\u8fd1\u306e <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5932128\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u7814\u7a76<\/a> \u5e38\u67d3\u8272\u4f53\u512a\u6027PKD\u60a3\u8005104\u540d\u3092\u5bfe\u8c61\u306b\u3001\u4ee5\u4e0b\u306e\u708e\u75c7\u30de\u30fc\u30ab\u30fc\u3001\u7cf8\u7403\u4f53\u969c\u5bb3\u30de\u30fc\u30ab\u30fc\u3001\u5c3f\u7d30\u7ba1\u969c\u5bb3\u30de\u30fc\u30ab\u30fc\u3092\u7528\u3044\u3066\u60a3\u8005\u3092\u5206\u96e2\u3057\u307e\u3057\u305f\u3002\u30a2\u30eb\u30d6\u30df\u30f3\u3001IgG\u3001\u814e\u50b7\u5bb3\u5206\u5b501\uff08KIM-1\uff09\u3001N-\u30a2\u30bb\u30c1\u30eb-\u03b2-d-\u30b0\u30eb\u30b3\u30b5\u30df\u30cb\u30c0\u30fc\u30bc\uff08NAG\uff09\u3001\u03b22\u30df\u30af\u30ed\u30b0\u30ed\u30d6\u30ea\u30f3\uff08\u03b22MG\uff09\u3001\u5fc3\u81d3\u578b\u8102\u80aa\u9178\u7d50\u5408\u86cb\u767d\uff08HFABP\uff09\u3001\u30de\u30af\u30ed\u30d5\u30a1\u30fc\u30b8\u904a\u8d70\u963b\u6b62\u56e0\u5b50\uff08MIF\uff09\u3002MIF\u3001NGAL\u3001MCP-1\u3001\u7cf8\u7403\u4f53\u6ffe\u904e\u7387\uff08mGFR\uff09\u3001\u8eab\u9577\u8abf\u6574\u6e08\u307f\u7dcf\u814e\u5bb9\u7a4d\uff08htTKV\uff09\u3092\u6e2c\u5b9a\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306f\u3001\u60a3\u8005\u306e\u8a3a\u65ad\u3001\u533b\u85ac\u54c1\u306b\u5bfe\u3059\u308b\u85ac\u7406\u907a\u4f1d\u5b66\u7684\u306a\u8010\u6027\u306e\u5224\u5b9a\uff08therapeutic drug monitoring\uff09\u3001\u75be\u60a3\u306e\u9032\u884c\u5ea6\u306e\u5b9a\u91cf\u5316\u3001\u672b\u671f\u814e\u4e0d\u5168\u306e\u5404\u60a3\u8005\u306b\u304a\u3051\u308b\u4e88\u5f8c\u6307\u6a19\u306e\u7279\u5b9a\uff08\u7dcf\u814e\u5bb9\u7a4d\u306b\u57fa\u3065\u304f\uff09\u306b\u5f79\u7acb\u3063\u305f\u3002<\/p>\n<p>\u4e00\u65b9\u3001\u907a\u4f1d\u5b50\u578b\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306f\u3001\u75be\u60a3\u306e\u9032\u884c\u50be\u5411\u3084\u672b\u671f\u814e\u4e0d\u5168\u306e\u767a\u75c7\u306b\u95a2\u9023\u3059\u308b\u5371\u967a\u56e0\u5b50\u3092\u628a\u63e1\u3059\u308b\u305f\u3081\u306b\u7528\u3044\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u30b8\u30a7\u30ce\u30bf\u30a4\u30d7\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3068\u708e\u75c7\u6027\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\uff08\u30de\u30af\u30ed\u30d5\u30a1\u30fc\u30b8\u904a\u8d70\u963b\u6b62\u56e0\u5b50\u3084MCP-1\u306a\u3069\uff09\u3092\u5b9a\u6027\u7684\u306b\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3067\u3001\u591a\u56a2\u80de\u6027\u814e\u81d3\u75c5\u306e\u5c3f\u7d30\u7ba1\u969c\u5bb3\u3092\u793a\u3057\u3001\u60a3\u8005\u306e\u814e\u81d3\u7f6e\u63db\u8853\u306e\u9069\u683c\u6027\u3092\u4e88\u6e2c\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u306b\u3001\u5c0f\u3055\u306a <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02936791\" target=\"_blank\" rel=\"noopener noreferrer\">\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13<\/a> PKD\u306b\u95a2\u3059\u308b\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u8a66\u9a13\uff08PKD Biomarkers Study\uff09\u3067\u306f\u3001PKD\u306e\u5c3f\u4e2d\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u30d0\u30a4\u30aa\u30ea\u30dd\u30b8\u30c8\u30ea\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u8a66\u9a13\u3067\u306f\u3001PKD\u306e\u65e2\u5f80\u306e\u3042\u308b\u60a3\u8005\u3060\u3051\u3067\u306a\u304f\u3001PKD\u306e\u5bb6\u65cf\u6b74\u306e\u3042\u308b\u60a3\u8005\u3084\u5065\u5e38\u5bfe\u7167\u8005\u3082\u767b\u9332\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Novel_Immuno-oncology_Biomarkers_for_Personalizing_Cancer_Therapy\"><\/span>3.\u304c\u3093\u6cbb\u7642\u306e\u500b\u5225\u5316\u306b\u5411\u3051\u305f\u65b0\u3057\u3044\u514d\u75ab\u816b\u760d\u5b66\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u3060\u3051\u3067\u3042\u308b\u3053\u3068\u306f\u3082\u306f\u3084\u79d8\u5bc6\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-get-fda-approval-4-expert-tips\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biomarkers-Applications\">\u65b0\u85ac\u7533\u8acb\u306e12-14%<\/a> \u306f\u3001USFDA\u306b\u3088\u308b\u5e02\u5834\u5316\u306e\u627f\u8a8d\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u5c11\u306a\u304f\u3068\u30822,000\u7a2e\u985e\u4ee5\u4e0a\u306e\u6cbb\u7642\u85ac\u304c\u3001\u304c\u3093\u6cbb\u7642\u306e\u305f\u3081\u3060\u3051\u306b\u81e8\u5e8a\u958b\u767a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u4f01\u696d\u306f\u304c\u3093\u6cbb\u7642\u306e\u7126\u70b9\u3092\u500b\u5225\u5316\u533b\u7642\u3084\u7cbe\u5bc6\u533b\u7642\u306b\u79fb\u3057\u3066\u304a\u308a\u3001\u7279\u5b9a\u306e\u5909\u7570\u3084\u514d\u75ab\u30fb\u304c\u3093\u5b66\u7684\u7279\u6027\u3092\u6301\u3064\u30bf\u30fc\u30b2\u30c3\u30c8\u30b0\u30eb\u30fc\u30d7\u306b\u306e\u307f\u6cbb\u7642\u85ac\u3092\u6295\u4e0e\u3059\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a <a href=\"https:\/\/www.nature.com\/articles\/s41586-019-1671-8\" target=\"_blank\" rel=\"noopener noreferrer\">\u514d\u75ab\u7642\u6cd5\u306e\u6539\u5584<\/a> \u3068\u3001\u65b0\u3057\u3044\u514d\u75ab\u816b\u760d\u5b66\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u30af\u30e9\u30b9\u3092\u751f\u307f\u51fa\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u514d\u75ab\u816b\u760d\u5b66\u30de\u30fc\u30ab\u30fc\uff08\u5909\u7570\u30bf\u30f3\u30d1\u30af\u8cea\u3084\u6297\u539f\uff09\u306f\u3001\u4e3b\u306b\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5c0f\u898f\u6a21\u306a\u5f8c\u671f\u81e8\u5e8a\u8a66\u9a13\u3067\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6503740\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u30ad\u30e9\u30fcT\u7d30\u80de\u3068\u30d8\u30eb\u30d1\u30fcT\u7d30\u80de\u306e\u514d\u75ab\u7642\u6cd5<\/a>.\u6700\u8fd1\u3067\u306f\u3001\u514d\u75ab\u30c1\u30a7\u30c3\u30af\u30dd\u30a4\u30f3\u30c8\u963b\u5bb3\u5264\u306e\u52b9\u679c\u3092\u5b9a\u91cf\u5316\u3057\u3001\u514d\u75ab\u7642\u6cd5\u306e\u6a19\u7684\u7279\u7570\u7684\u306a\u5019\u88dc\u3092\u898b\u3064\u3051\u308b\u305f\u3081\u306b\u3001\u514d\u75ab\u816b\u760d\u5b66\u7684\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u4f7f\u7528\u304c\u62e1\u5927\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>\u6700\u8fd1\u3067\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u304c\u3093\u306e\u907a\u4f1d\u5b50\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u304c <a href=\"https:\/\/www.eurekalert.org\/pub_releases\/2020-03\/fda-sch030320.php\" target=\"_blank\" rel=\"noopener noreferrer\">\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u5229\u7528\u3055\u308c\u307e\u3059\u3002<\/a> \u306f\u3001\u5316\u5b66\u7642\u6cd5\u5f8c\u306e\u526f\u4f5c\u7528\u306e\u5927\u304d\u3055\u3092\u8868\u3057\u3066\u3044\u307e\u3059\u3002\u3042\u308b\u7814\u7a76\u3067\u306f\u3001\u7279\u306b\u5316\u5b66\u7642\u6cd5\u306b\u8d77\u56e0\u3059\u308b <a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/full\/10.1002\/jcsm.12565\" target=\"_blank\" rel=\"noopener noreferrer\">\u60aa\u6db2\u8cea\u75c7\u5019\u7fa4<\/a> \u3067\u3001\u5316\u5b66\u7642\u6cd5\u3092\u53d7\u3051\u3066\u3044\u308b\u3059\u3079\u3066\u306e\u60a3\u8005\u304c\u7570\u306a\u308b\u816b\u760d\u7279\u7570\u7684\u306a\u30bf\u30f3\u30d1\u30af\u8cea\u306e\u5206\u6ccc\u3092\u3057\u3066\u304a\u308a\u3001\u305d\u308c\u304c\u30bf\u30a4\u30d7\u3054\u3068\u306e\u60aa\u6db2\u8cea\u306e\u6709\u75c5\u7387\u3084\u5e73\u5747\u4f53\u91cd\u6e1b\u5c11\u91cf\u3068\u76f8\u95a2\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u660e\u3089\u304b\u306b\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u5316\u5b66\u7642\u6cd5\u306e\u6295\u4e0e\u91cf\u3092\u8abf\u6574\u3057\u3001\u60a3\u8005\u306e\u751f\u7406\u7684\u53cd\u5fdc\u3092\u500b\u3005\u306e\u907a\u4f1d\u5b50\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3068\u5408\u308f\u305b\u3066\u7814\u7a76\u3059\u308b\u3053\u3068\u306f\u3001\u304c\u3093\u306b\u3088\u308b\u6b7b\u4ea1\u7387\u3092\u6e1b\u3089\u3059\u305f\u3081\u306e\u6709\u671b\u306a\u624b\u6bb5\u3068\u3057\u3066\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7814\u7a76\u8005\u305f\u3061\u306f\u3001\u3053\u306e\u65b9\u6cd5\u3092\u524d\u7acb\u817a\u304c\u3093\u306b\u62e1\u5927\u3057\u3066\u3001\u767a\u304c\u3093\u7d30\u80de\u306e\u907a\u4f1d\u5b50\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u5909\u5316\u3092\u7814\u7a76\u3057\u3001\u3088\u308a\u5b89\u5168\u3067\u6a19\u7684\u3068\u306a\u308b\u6cbb\u7642\u6cd5\u3092\u958b\u767a\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u764c\u3084\u5316\u5b66\u7642\u6cd5\u306b\u3088\u308b\u60aa\u6db2\u8cea-\u98df\u6b32\u4e0d\u632f\u306f\u8907\u96d1\u306a\u591a\u56e0\u5b50\u75c7\u5019\u7fa4\u3067\u3042\u308b\u305f\u3081\u3001\u816b\u760d\u306e\u907a\u4f1d\u5b50\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u57fa\u3065\u3044\u3066\u3001\u4f4e\u5206\u5b50\u3068\u514d\u75ab\u7642\u6cd5\u3092\u4f75\u7528\u3057\u305f\u8907\u5408\u7684\u306a\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u884c\u3046 <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5733020\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u306f\u4e88\u5099\u8a55\u4fa1\u4e2d<\/a> \u3092\u30de\u30a6\u30b9\u30e2\u30c7\u30eb\u3067\u518d\u73fe\u3057\u307e\u3057\u305f\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Identifying_Diagnostic_Prognostic_Biomarkers_for_Drug_Discovery_of_Cystic_Fibrosis\"><\/span>4.\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306e\u5275\u85ac\u306e\u305f\u3081\u306e\u8a3a\u65ad\u30fb\u4e88\u5f8c\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u540c\u5b9a<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306f\u3001\u80ba\u3084\u81b5\u81d3\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u5e0c\u5c11\u306a\u907a\u4f1d\u6027\u75be\u60a3\u3067\u3001\u30a2\u30f3\u30e1\u30c3\u30c8\u30e1\u30c7\u30a3\u30ab\u30eb\u30cb\u30fc\u30ba\u306e\u3042\u308b\u75be\u60a3\u3068\u3057\u3066\u6b8b\u3063\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u3053\u3053\u6570\u5e74\u3067USFDA\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6cd5\u304c\u6539\u6b63\u3055\u308c\u3001\u4e3b\u6d41\u306e\u533b\u85ac\u54c1\u7814\u7a76\u958b\u767a\u306b\u5c0e\u5165\u3055\u308c\u305f\u3053\u3068\u3067\u3001\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u60a3\u8005\u306e\u904b\u547d\u304c\u5909\u308f\u308a\u3001\u6cbb\u7642\u3078\u306e\u671f\u5f85\u304c\u73fe\u5b9f\u306e\u3082\u306e\u3068\u306a\u308a\u307e\u3057\u305f\u3002CFTR\u907a\u4f1d\u5b50\u306e\u5909\u7570\u306b\u3088\u308a\u767a\u75c7\u3059\u308b\u907a\u4f1d\u6027\u75be\u60a3\u3067\u3042\u308b\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306f\u3001\u907a\u4f1d\u7684\u3001\u751f\u5316\u5b66\u7684\u3001\u751f\u7406\u5b66\u7684\u306b\u69d8\u3005\u306a\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3092\u793a\u3057\u307e\u3059\u3002<\/p>\n<p>\u3044\u304f\u3064\u304b\u306e <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5321565\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u8a3a\u65ad\u3068\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0<\/a> \u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306f\u3001\u305d\u306e\u65e9\u671f\u8a3a\u65ad\u3092\u53ef\u80fd\u306b\u3059\u308b\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u304c\u540c\u5b9a\u3055\u308c\u3001\u751f\u547d\u3092\u8105\u304b\u3059\u75c7\u72b6\u306e\u4e88\u9632\u306b\u9ad8\u3044\u6210\u529f\u7387\u3067\u7528\u3044\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3092\u5bfe\u8c61\u3068\u3057\u305f\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u691c\u8a3c\u30fb\u9069\u683c\u6027\u8a66\u9a13\u3067\u306f\u3001\u65b0\u3057\u3044\u6cbb\u7642\u6cd5\u306e\u751f\u7269\u5b66\u7684\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3057\u3001\u4f5c\u7528\u6a5f\u5e8f\u3092\u78ba\u8a8d\u3057\u3001\u6295\u4e0e\u91cf\u3092\u9078\u629e\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u7279\u7570\u6027\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u305d\u306e <a href=\"https:\/\/www.rarediseasereview.org\/publications\/2018\/4\/30\/shifting-biomarkers-the-future-of-expediting-and-refining-drug-delivery\" target=\"_blank\" rel=\"noopener noreferrer\">G551D\u907a\u4f1d\u5b50\u5909\u7570<\/a> \u306f\u3001Ivacaftor\u306e\u6709\u52b9\u6027\u3092\u81e8\u5e8a\u7684\u306b\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u4e88\u6e2c\u7684\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3068\u3057\u3066\u4f7f\u7528\u3055\u308c\u3001FEV1\u306e8\u9031\u9593\u5909\u5316\u306f\u3001Ivacaftor\u306e\u6295\u4e0e\u306b\u3088\u308b\u8eab\u4f53\u306e\u52d5\u7684\u5909\u5316\u3092\u6e2c\u5b9a\u3059\u308b\u85ac\u7406\u5b66\u7684\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3068\u3057\u3066\u6ce8\u76ee\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>\u6c57-\u5869\u5316\u7269\u6fc3\u5ea6\u3001\u9f3b\u8154\u5185\u96fb\u4f4d\u5dee\u3001\u8178\u7ba1\u96fb\u6d41\u3092\u691c\u51fa\u3057\u3066 <em>in vivo<\/em> \u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3068\u3057\u3066\u3001\u500b\u4eba\u306e\u56a2\u80de\u6027\u7dda\u7dad\u75c7\u306e\u75c7\u72b6\u3084CFTR\u907a\u4f1d\u5b50\u306e\u907a\u4f1d\u7684\u6a5f\u80fd\u306e\u7279\u5fb4\u3092\u660e\u3089\u304b\u306b\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u307e\u305f\u3001R117H\u3001F508del CFTR\u3001G551D CFTR\u907a\u4f1d\u5b50\u306e\u30d7\u30ed\u30d5\u30a1\u30a4\u30ea\u30f3\u30b0\u306b\u3088\u308a\u3001\u3053\u308c\u3089\u306e\u5909\u7570\u3092\u6301\u3064\u60a3\u8005\u306b\u304a\u3051\u308b\u30a4\u30d0\u30ab\u30d5\u30c8\u30fc\u30eb\u306e\u7528\u91cf\u4f9d\u5b58\u6027\u306e\u751f\u7269\u6d3b\u6027\u3092\u89e3\u660e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u540c\u69d8\u306b\u3001\u30e1\u30c1\u30b7\u30ea\u30f3\u8010\u6027\u306a\u3069\u306e\u75c5\u539f\u6027\u7d30\u83cc\u306b\u3088\u308b\u611f\u67d3\u75c7\u306f <em>\u9ec4\u8272\u30d6\u30c9\u30a6\u7403\u83cc\uff08Staphylococcus aureus<\/em>, <em>\u7dd1\u81bf\u83cc\uff08Pseudomonas aeruginosa<\/em>\u3068\u3057\u3066\u3044\u307e\u3059\u3002 <em>Burkholderia cepacia<\/em> \u306e\u8907\u5408\u4f53\u3084\u7d30\u83cc\u5bc6\u5ea6\u304c\u611f\u67d3\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3068\u3057\u3066\u60f3\u5b9a\u3055\u308c\u3066\u3044\u305f\u3002\u305d\u306e\u305f\u3081\u3001\u3053\u308c\u3089\u306e\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306f\u3001tezacaftor\uff0bivacaftor\uff0belexacaftor\u306a\u3069\u306e\u4f75\u7528\u7642\u6cd5\u306e\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u7121\u4f5c\u70ba\u5316\u81e8\u5e8a\u8a66\u9a13\u306b\u591a\u304f\u7528\u3044\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"5_Detecting_Cardiovascular_Biomarkers_to_Re-evaluate_treatments_for_CVD\"><\/span>5.\u5fc3\u8840\u7ba1\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u306e\u691c\u51fa\u306b\u3088\u308bCVD\u6cbb\u7642\u306e\u518d\u8a55\u4fa1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5fc3\u8840\u7ba1\u75be\u60a3\u306f\u3001\u4f9d\u7136\u3068\u3057\u3066\u4e16\u754c\u7684\u306b\u6b7b\u4ea1\u7387\u306e\u9ad8\u3044\u539f\u56e0\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002CETP\u963b\u5bb3\u5264\u3067\u3042\u308borcetrapib\u3084Dalcetrapib\u306e\u3088\u3046\u306b\u3001\u52d5\u8108\u786c\u5316\u306e\u4e88\u9632\u3084\u6291\u5236\u304c\u671f\u5f85\u3055\u308c\u305f\u5b9f\u9a13\u7684\u306a\u6cbb\u7642\u6cd5\u304c\u5931\u6557\u306b\u7d42\u308f\u3063\u305f\u3053\u3068\u3067\u3001\u72b6\u6cc1\u306f\u8907\u96d1\u306b\u306a\u3063\u3066\u3044\u308b\u3002CETP\u306f\u3001\u9ad8\u5bc6\u5ea6\u30ea\u30dd\u30bf\u30f3\u30d1\u30af\u8cea\uff08HDL\uff09\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\u304b\u3089\u3001\u52d5\u8108\u786c\u5316\u306e\u539f\u56e0\u3068\u306a\u308b\u8d85\u4f4e\u5bc6\u5ea6\u30ea\u30dd\u30bf\u30f3\u30d1\u30af\u8cea\uff08VLDL\uff09\u304a\u3088\u3073\u4f4e\u5bc6\u5ea6\u30ea\u30dd\u30bf\u30f3\u30d1\u30af\u8cea\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\uff08LDL-C\uff09\u3078\u306e\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\u30a8\u30b9\u30c6\u30eb\u306e\u79fb\u884c\u3092\u4ef2\u4ecb\u3059\u308b\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\u30a8\u30b9\u30c6\u30eb\u79fb\u884c\u30d7\u30e9\u30ba\u30de\u30bf\u30f3\u30d1\u30af\u8cea\u3067\u3042\u308b\u3002<\/p>\n<p>\u30b9\u30bf\u30c1\u30f3\u3068\u306f\u7570\u306a\u308a\u3001LDL-C\u3092\u52b9\u679c\u7684\u306b\u6e1b\u5c11\u3055\u305b\u308b\u4e00\u65b9\u3067\u3001\u6b8b\u5b58\u3059\u308b\u5fc3\u8840\u7ba1\u30ea\u30b9\u30af\u306b\u306f\u5f71\u97ff\u3092\u4e0e\u3048\u306a\u3044\u3002 <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1206797\">CETP\u963b\u5bb3\u5264\u306fHDL-C\u3092\u4e0a\u6607\u3055\u305b\u308b<\/a> 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<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/genetics-and-genomics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biomarkers-Applications\">\u907a\u4f1d\u5b66\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>?Kolabtree\u3067\u306f\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u79d1\u5b66\u8005\u306b\u76f4\u63a5\u76f8\u8ac7\u3057\u305f\u308a\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u7121\u6599\u3067\u898b\u7a4d\u3082\u308a\u3092\u3082\u3089\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Mahasweta Pal, freelance medical writer on Kolabtree, describes novel applications of biomarkers in advancing drug discovery and development.\u00a0 Drug development research drives the biopharma industry outlook. A milestone for drug discovery was the establishment of the Precision Medicine initiative by the USFDA, which shaped the industry&#8217;s transformation. This regulation not only formalizes the qualification of biomarkers but also encourages clinical trial efficiency by application in the evaluation of patient inclusion\/exclusion and determining the biological responses of patients after therapeutic administration. Moreover, the analytical validation and qualification of biomarkers also link their usability in determining the primary and secondary endpoints of clinical trials. Thus, biomarkers are becoming ubiquitous in the discovery,<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":32,"featured_media":7210,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,247,443,653,435],"tags":[551,550,379,527,347,552],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>5 Applications of Biomarkers in Drug Discovery and Development<\/title>\n<meta name=\"description\" content=\"Applications of biomarkers in drug development, including personalized medicine, cancer therapy, drug discovery for cystic fibrosis, and more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"5 Applications of Biomarkers in Drug Discovery and Development\" \/>\n<meta property=\"og:description\" content=\"Applications of biomarkers in drug development, including personalized medicine, cancer therapy, drug discovery for cystic fibrosis, and more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/5-applications-of-biomarkers-in-drug-discovery-and-development\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-03-17T08:20:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-12-04T11:08:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/03\/applications-biomarkers-drug-discovery.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1350\" \/>\n\t<meta property=\"og:image:height\" content=\"900\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mahasweta Pal\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mahasweta Pal\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"8\u5206\" \/>\n<!-- \/ Yoast SEO 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She is a biotechnologist at heart with research experience in Tissue Engineering, Medical Imaging Devices and Industrial Microbiology. She majored in Biomedical Engineering from Vellore Institute of Technology and has served as an editor for journal publications from Elsevier, Wolters Kluwer Health and the Royal Society for Chemistry.","url":"https:\/\/www.kolabtree.com\/blog\/ja\/author\/mahasweta-pal\/"}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7149"}],"collection":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/comments?post=7149"}],"version-history":[{"count":22,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7149\/revisions"}],"predecessor-version":[{"id":7212,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7149\/revisions\/7212"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media\/7210"}],"wp:attachment":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media?parent=7149"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/categories?post=7149"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/tags?post=7149"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}