{"id":28120,"date":"2023-09-14T13:49:01","date_gmt":"2023-09-14T11:49:01","guid":{"rendered":"https:\/\/kymos.com\/news\/fda-%ec%83%88%eb%a1%9c%ec%9a%b4-%ec%a7%80%ec%b9%a8-ndsri-%ea%b6%8c%ec%9e%a5-%ed%97%88%ec%9a%a9-%ec%84%ad%ec%b7%a8-%ed%95%9c%eb%8f%84\/"},"modified":"2023-09-14T13:49:01","modified_gmt":"2023-09-14T11:49:01","slug":"fda-%ec%83%88%eb%a1%9c%ec%9a%b4-%ec%a7%80%ec%b9%a8-ndsri-%ea%b6%8c%ec%9e%a5-%ed%97%88%ec%9a%a9-%ec%84%ad%ec%b7%a8-%ed%95%9c%eb%8f%84","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/fda-%ec%83%88%eb%a1%9c%ec%9a%b4-%ec%a7%80%ec%b9%a8-ndsri-%ea%b6%8c%ec%9e%a5-%ed%97%88%ec%9a%a9-%ec%84%ad%ec%b7%a8-%ed%95%9c%eb%8f%84\/","title":{"rendered":"FDA \uc0c8\ub85c\uc6b4 \uc9c0\uce68: NDSRI \uad8c\uc7a5 \ud5c8\uc6a9 \uc12d\ucde8 \ud55c\ub3c4"},"content":{"rendered":"<p>\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc740 \ub2c8\ud2b8\ub85c\uc0ac\ubbfc \uc57d\ubb3c \ubb3c\uc9c8 \uad00\ub828 \ubd88\uc21c\ubb3c(NDSRI)\uacfc \uad00\ub828\ub41c \ub3cc\uc5f0\ubcc0\uc774 \uc720\ubc1c \ubc0f \ubc1c\uc554 \uc704\ud5d8\uc5d0 \ub300\ucc98\ud558\uae30 \uc704\ud574 \uc911\uc694\ud55c \uc870\uce58\ub97c \ucde8\ud588\uc2b5\ub2c8\ub2e4. \uc9c0\ub09c 8\uc6d4, FDA\ub294 \uc758\uc57d\ud488 \ubc0f \ud65c\uc131 \uc758\uc57d\ud488 \uc131\ubd84(API)\uc5d0 \ud568\uc720\ub41c NDSRI\uc758 \uc704\ud5d8\uc131\uc744 \uc608\uce21\ud560 \ubfd0\ub9cc \uc544\ub2c8\ub77c \uad8c\uc7a5 \uc12d\ucde8 \ud5c8\uc6a9\ub7c9(AI)\uc744 \uc124\uc815\ud558\ub294 <g id=\"gid_0\">\ucd5c\uc885 \uc9c0\uce68<\/g> \ud504\ub808\uc784\uc6cc\ud06c\ub97c \ubc1c\ud45c\ud588\uc2b5\ub2c8\ub2e4. \uc774 \uc911\uc694\ud55c \uac1c\ubc1c\uc740 \uc720\ub7fd \uc758\uc57d\ud488\uccad(EMA)\uc758 \uad8c\uace0\uc5d0 \ubd80\ud569\ud558\uba70, \uc81c\uc57d \uc0b0\uc5c5\uc758 \uc548\uc804\uc131\uc744 \uac15\ud654\ud558\ub294 \uac83\uc744 \ubaa9\ud45c\ub85c \ud569\ub2c8\ub2e4.  <\/p>\n<p>\ub2c8\ud2b8\ub85c\uc0ac\ubbfc, \ud2b9\ud788 NDSRI\ub294 \uc7a0\uc7ac\uc801\uc778 \uac74\uac15 \uc704\ud5d8\uc73c\ub85c \uc778\ud574 \uc81c\uc57d \uc5c5\uacc4\uc5d0\uc11c \uc6b0\ub824\uac00 \ucee4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubd88\uc21c\ubb3c\uc740 2\ucc28 \uc544\ubbfc\uc774\ub098 \ub514\uba54\ud2f8 3\ucc28 \uc544\ubbfc\uc744 \ud568\uc720\ud55c \uc758\uc57d\ud488 \ubc0f \uc6d0\ub8cc\uc758\uc57d\ud488(API)\uc5d0\uc11c \uc0dd\uc131\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. FDA\uc758 \uc801\uadf9\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc740 NDSRI\uc640 \uad00\ub828\ub41c \uc704\ud5d8\uc744 \uc644\ud654\ud558\uace0 \uc758\uc57d\ud488\uc758 \uc548\uc804\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \uac83\uc744 \ubaa9\ud45c\ub85c \ud569\ub2c8\ub2e4.  <\/p>\n<h3><strong>NDSRI\uc5d0 \ub300\ud55c FDA\uc758 \ud655\uc815 \uc9c0\uce68<\/strong><\/h3>\n<p>&#8220;\ub2c8\ud2b8\ub85c\uc0ac\ubbfc \uc57d\ubb3c \uad00\ub828 \ubd88\uc21c\ubb3c(NDSRI)\uc758 \uad8c\uc7a5 \uc12d\ucde8 \ud5c8\uc6a9 \ud55c\ub3c4&#8221;\ub77c\ub294 \uc81c\ubaa9\uc758 \ucd5c\uadfc \uc0b0\uc5c5 \uc9c0\uce68(GFI)\uc740 \uc911\uc694\ud55c \ubc1c\uc804\uc785\ub2c8\ub2e4. \uc774 \uc9c0\uce68\uc740 API, \uc77c\ubc18 \uc758\uc57d\ud488(OTC), \ucc98\ubc29\uc57d\uc744 \ud3ec\ud568\ud55c \uad11\ubc94\uc704\ud55c \uc758\uc57d\ud488\uc5d0 \uc801\uc6a9\ub429\ub2c8\ub2e4. \ub610\ud55c AI \ud55c\ub3c4\ub97c \uacb0\uc815\ud558\uace0 \ubc1c\uc554 \uac00\ub2a5\uc131 \ubd84\ub958\ub97c \uc608\uce21\ud558\uae30 \uc704\ud55c \uccb4\uacc4\uc801\uc778 \ubc29\ubc95\ub860\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.  <\/p>\n<p>\uc55e\uc11c \uc18c\uac1c\ud588\ub4ef\uc774 \ub2c8\ud2b8\ub85c\uc0ac\ubbfc \ubd88\uc21c\ubb3c\uc744 \ucc98\ub9ac\ud558\ub294 \uc774\ub7ec\ud55c \uc811\uadfc \ubc29\uc2dd\uc740 \uc720\ub7fd \uc758\uc57d\ud488\uccad(EMA)\uc758 \uaddc\uc815\uacfc \uc644\ubcbd\ud558\uac8c \uc77c\uce58\ud558\uba70, NDSRI\uc640 \uad00\ub828\ub41c \uc704\ud5d8\uc744 \uc644\ud654\ud558\ub294 \ub370 \uc788\uc5b4 \uc804 \uc138\uacc4\uc801\uc778 \uc77c\uad00\uc131\uacfc \uc870\uc815\uc744 \ubcf4\uc7a5\ud558\uace0 \uad6d\uc81c\uc801 \ucc28\uc6d0\uc5d0\uc11c \ud658\uc790 \uc548\uc804\uc5d0 \uae30\uc5ec\ud569\ub2c8\ub2e4.<\/p>\n<h3><strong>3\ub2e8\uacc4 \uc644\ud654 \uc804\ub7b5<\/strong><\/h3>\n<p>\uc774 \uc9c0\uce68\uc740 FDA\uac00 \uc81c\uc870\uc5c5\uccb4\uc640 \uc2e0\uccad\uc790\uac00 NDSRI\ub97c \ud3c9\uac00\ud560 \ub54c \uc0ac\uc6a9\ud560 \uac83\uc73c\ub85c \uae30\ub300\ud558\ub294 3\ub2e8\uacc4 \uc644\ud654 \uc804\ub7b5\uc744 \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n<ul>\n<li>API \ubc0f \uc758\uc57d\ud488\uc5d0 \ud568\uc720\ub41c \ub2c8\ud2b8\ub85c\uc0ac\ubbfc\uc5d0 \ub300\ud55c \uc704\ud5d8\uc131 \ud3c9\uac00\ub97c \uc2e4\uc2dc\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc704\ud5d8\uc774 \ud655\uc778\ub418\uba74 \ud655\uc778 \ud14c\uc2a4\ud2b8\ub97c \uc2e4\uc2dc\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc2b9\uc778 \ubc0f \ubcf4\ub958 \uc911\uc778 \uc2e0\uc57d \uc2e0\uccad(NDA)\uacfc \uc57d\uc2dd \uc2e0\uc57d \uc2e0\uccad(ANDA)\uc5d0 \ud3ec\ud568\ub41c API \ubc0f \uc758\uc57d\ud488\uc5d0\uc11c \uc774\ub7ec\ud55c \ubd88\uc21c\ubb3c\uc774 \uc874\uc7ac\ud558\uc9c0 \uc54a\ub3c4\ub85d \ud558\uae30 \uc704\ud574 \uc2dc\ud589\ub41c \ubcc0\uacbd \uc0ac\ud56d\uc744 \ubcf4\uace0\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<h3><strong>\ubc1c\uc554\uc131 \ubc0f AI \ud55c\uacc4 \uc608\uce21<\/strong><\/h3>\n<p>\ubcf8 \uc9c0\uce68\uc740 \uc608\uce21 \ubc1c\uc554\ub825 \ubd84\ub958\ub97c \ud65c\uc6a9\ud558\uc5ec NDSRI\uc5d0 \uad8c\uc7a5\ub418\ub294 AI \ud55c\ub3c4\ub97c \ud560\ub2f9\ud558\ub294 \ubc29\ubc95\ub860\uc744 \uc81c\uc2dc\ud569\ub2c8\ub2e4. \uc774 \uc811\uadfc\ubc95\uc740 \uad6c\uc870-\ud65c\uc131 \uad00\uacc4(SAR) \uac1c\ub150\uc758 \uc0ac\uc6a9\uc744 \uac15\uc870\ud558\ub294 ICH M7(R2) \uc9c0\uce68\uacfc \uc77c\uce58\ud569\ub2c8\ub2e4. AI \ud55c\ub3c4\ub294 \ud3c9\uc0dd 10\ub9cc \uba85\ub2f9 1\uac74\uc758 \ucd94\uac00 \uc554 \ubc1c\uc0dd \uc704\ud5d8 \uc99d\uac00\ub97c \uadfc\uc0ac\uce58\ub85c \uc124\uc815\ud569\ub2c8\ub2e4. \ubcf8 \uc9c0\uce68\uc758 \ud45c 1\uc740 \uc608\uce21 \ubc1c\uc554\ub825 \ubc94\uc8fc\uc640 \uad00\ub828 \uad8c\uc7a5 AI \ud55c\ub3c4\ub97c \ub098\ud0c0\ub0b4\uba70, \ubc94\uc704\ub294 26.5ng\/\uc77c(EMA \uc9c0\uce68\uc758 18ng\/\uc77c \ub300\ube44)\uc5d0\uc11c 1500ng\/\uc77c\uc785\ub2c8\ub2e4.   <\/p>\n<p>FDA\ub294 \ub610\ud55c NDSRI\uc5d0 \ub300\ud55c \ud654\ud569\ubb3c\ubcc4 \ub370\uc774\ud130\uac00 \uc81c\ud55c\uc801\uc774\ub77c\ub294 \uc810\uc744 \uc778\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ub370\uc774\ud130 \ubd80\uc871\uc73c\ub85c \uc778\ud574 \uc2e0\uccad\uc790\ub4e4\uc740 \ubd88\ud544\uc694\ud55c \uc5f0\uad6c\ub97c \uc218\ud589\ud558\uac70\ub098 \uc2ec\uc9c0\uc5b4 \uc758\uc57d\ud488 \ud310\ub9e4\ub97c \uc911\ub2e8\ud558\uae30\ub3c4 \ud588\uc2b5\ub2c8\ub2e4. \uc774\ub85c \uc778\ud574 \uc758\uc57d\ud488 \ubd80\uc871 \ud604\uc0c1\uc774 \ubc1c\uc0dd\ud558\uc5ec \ud658\uc790\uc758 \uc758\uc57d\ud488 \uc811\uadfc\uc131\uc5d0 \uc601\ud5a5\uc744 \ubbf8\ucce4\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc774\uc720\ub85c \ubcf8 \uc9c0\uce68\uc11c\ub294 \uc774\ub7ec\ud55c \uacfc\uc81c\ub97c \ud574\uacb0\ud558\uace0 \uc548\uc804\uc131 \ud3c9\uac00\uc640 \uc6d0\ud65c\ud55c \uc758\uc57d\ud488 \uacf5\uae09 \uac04\uc758 \uade0\ud615\uc744 \ub9de\ucd94\ub294 \uac83\uc744 \ubaa9\ud45c\ub85c \ud569\ub2c8\ub2e4.   <\/p>\n<h3><strong>\uc5c5\uacc4 \uc758\ubb34 \ubc0f \ud0c0\uc784\ub77c\uc778<\/strong><\/h3>\n<p>FDA \uc9c0\uce68\uc740 \uc758\uc57d\ud488 \uc81c\uc870\uc5c5\uccb4\uc758 \uad6c\uccb4\uc801\uc778 \uc758\ubb34 \uc0ac\ud56d\uc744 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc2b9\uc778\ub41c \uc81c\ud488 \uc81c\uc870\uc5c5\uccb4\ub294 \uc9c0\uce68 \ubc1c\ud45c \ud6c4(2023\ub144 8\uc6d4) 3\uac1c\uc6d4 \uc774\ub0b4\uc5d0 \ub2c8\ud2b8\ub85c\uc0ac\ubbfc \uc704\ud5d8\uc131\uc744 \ud3c9\uac00\ud574\uc57c \ud558\uba70, 2023\ub144 11\uc6d4 1\uc77c\uae4c\uc9c0 \ud3c9\uac00\ub97c \uc644\ub8cc\ud560 \uac83\uc744 \uad8c\uc7a5\ud569\ub2c8\ub2e4. <\/p>\n<p>\ub610\ud55c \uc81c\uc870\uc5c5\uccb4\uc640 \uc2e0\uccad\uc790\ub294 2025\ub144 8\uc6d4 1\uc77c\uae4c\uc9c0 \uc790\uc0ac \uc758\uc57d\ud488\uc5d0 \ud568\uc720\ub41c \ubaa8\ub4e0 NDSRI\uac00 FDA\uac00 \uad8c\uc7a5\ud558\ub294 AI \ud55c\ub3c4\uc640 \ud574\ub2f9 \ubc1c\uc554 \uac00\ub2a5\uc131 \ubc94\uc8fc\ub97c \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h3><strong>\uc2e4\uc2dc\uac04 \uc5c5\ub370\uc774\ud2b8\ub97c \uc704\ud55c \uc804\uc6a9 \uc6f9\ud398\uc774\uc9c0<\/strong><\/h3>\n<p>FDA\ub294 \uac15\ub825\ud55c \uc2dc\uc791\uacfc \ud568\uaed8 \uc9c0\uce68\uc5d0 \uc57d 250\uac1c\uc758 \uad8c\uc7a5 AI \ud55c\ub3c4\ub97c \uc81c\uc2dc\ud558\ub294 \uac83 \uc678\uc5d0\ub3c4, \uc778\uccb4 \uc57d\ubb3c\uc5d0\uc11c \uc0dd\uc131 \uc704\ud5d8\uc774 \uc788\ub294 NDSRI\uc758 \ud5c8\uc6a9 \uc12d\ucde8 \ud55c\ub3c4\uc5d0 \ub300\ud55c \uc2e4\uc2dc\uac04 \uc815\ubcf4\ub97c \uc81c\uacf5\ud558\ub294 \uc804\uc6a9 \uc6f9\ud398\uc774\uc9c0\ub97c \uac1c\uc124\ud588\uc2b5\ub2c8\ub2e4. FDA\ub294 \uc774\ud574\uad00\uacc4\uc790\ub4e4\uc774 \ucd5c\uc2e0 \ub370\uc774\ud130\uc5d0 \uc811\uadfc\ud560 \uc218 \uc788\ub3c4\ub85d \uc774 \uc815\ubcf4\ub97c \uc8fc\uae30\uc801\uc73c\ub85c \uc5c5\ub370\uc774\ud2b8\ud560 \uacc4\ud68d\uc785\ub2c8\ub2e4. <\/p>\n<h3><strong>\uacb0\ub860<\/strong><\/h3>\n<p>FDA\uc758 \ub2c8\ud2b8\ub85c\uc0ac\ubbfc \ubd88\uc21c\ubb3c\uc5d0 \ub300\ud55c \ucd5c\uc885 \uc9c0\uce68\uc740 \uc81c\uc57d \uc5c5\uacc4\uac00 \uc548\uc804\uc131\uacfc \ud658\uc790 \uce58\ub8cc \uac15\ud654\ub97c \ud5a5\ud55c \uc5ec\uc815\uc5d0\uc11c \uc911\uc694\ud55c \uc774\uc815\ud45c\uc785\ub2c8\ub2e4. FDA\uc640 EMA\ub294 NDSRI \uad00\ub828 \uacfc\uc81c\ub97c \ud574\uacb0\ud558\uace0 AI \ud55c\uacc4\ub97c \uc124\uc815\ud568\uc73c\ub85c\uc368 \uacf5\uc911 \ubcf4\uac74\uc744 \ubcf4\ud638\ud558\uae30 \uc704\ud55c \uc911\uc694\ud55c \uc870\uce58\ub97c \ucde8\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc81c\uc57d \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uc774\uc81c \uaddc\uc81c \uae30\uad00\uacfc \ud611\ub825\ud558\uc5ec \uc774\ub7ec\ud55c \ubcc0\ud654\uc5d0 \ub300\uc751\ud558\uace0 \uc804 \uc138\uacc4 \ud658\uc790\ub4e4\uc5d0\uac8c \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \uc758\uc57d\ud488\uc744 \uc81c\uacf5\ud560 \uc900\ube44\ub97c \uac16\ucd94\uac8c \ub418\uc5c8\uc2b5\ub2c8\ub2e4.  <\/p>\n<p>\ub2c8\ud2b8\ub85c\uc0ac\ubbfc \ubd88\uc21c\ubb3c \ubd84\uc11d\uc5d0 \ub3c4\uc6c0\uc774 \ud544\uc694\ud558\uba74 \uc5b8\uc81c\ub4e0\uc9c0 \ubb38\uc758\ud574 \uc8fc\uc138\uc694: <a href=\"https:\/\/kymos.com\/ko\/%ec%97%b0%eb%9d%bd%ed%95%98%eb%8b%a4\/\" data-wpel-link=\"internal\">https:\/\/kymos.com\/contact\/<\/a> .<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc740 \ub2c8\ud2b8\ub85c\uc0ac\ubbfc \uc57d\ubb3c \ubb3c\uc9c8 \uad00\ub828 \ubd88\uc21c\ubb3c(NDSRI)\uacfc \uad00\ub828\ub41c \ub3cc\uc5f0\ubcc0\uc774 \uc720\ubc1c  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":28122,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[261],"tags":[67],"class_list":["post-28120","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-261","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA \uc9c0\uce68: NDSRI \uad8c\uc7a5 \ud5c8\uc6a9 \uc12d\ucde8 \ud55c\ub3c4<\/title>\n<meta name=\"description\" content=\"FDA\uc758 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