{"id":28206,"date":"2024-11-15T09:19:20","date_gmt":"2024-11-15T08:19:20","guid":{"rendered":"https:\/\/kymos.com\/news\/%ea%b5%ad%ec%86%8c-%ec%a0%9c%ed%92%88%ec%97%90-%eb%8c%80%ed%95%9c-%ec%83%88%eb%a1%9c%ec%9a%b4-ema-%ec%a7%80%ec%b9%a8-ivrt-%eb%b0%8f-ivpt%ec%97%90-%eb%af%b8%ec%b9%98%eb%8a%94-%ec%98%81%ed%96%a5\/"},"modified":"2024-11-15T09:19:20","modified_gmt":"2024-11-15T08:19:20","slug":"%ea%b5%ad%ec%86%8c-%ec%a0%9c%ed%92%88%ec%97%90-%eb%8c%80%ed%95%9c-%ec%83%88%eb%a1%9c%ec%9a%b4-ema-%ec%a7%80%ec%b9%a8-ivrt-%eb%b0%8f-ivpt%ec%97%90-%eb%af%b8%ec%b9%98%eb%8a%94-%ec%98%81%ed%96%a5","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%ea%b5%ad%ec%86%8c-%ec%a0%9c%ed%92%88%ec%97%90-%eb%8c%80%ed%95%9c-%ec%83%88%eb%a1%9c%ec%9a%b4-ema-%ec%a7%80%ec%b9%a8-ivrt-%eb%b0%8f-ivpt%ec%97%90-%eb%af%b8%ec%b9%98%eb%8a%94-%ec%98%81%ed%96%a5\/","title":{"rendered":"\uad6d\uc18c \uc81c\ud488\uc5d0 \ub300\ud55c \uc0c8\ub85c\uc6b4 EMA \uc9c0\uce68: IVRT \ubc0f IVPT\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\uc720\ub7fd\uc758\uc57d\ud488\uccad(EMA)\uc740 2024\ub144 10\uc6d4, \uc624\ub7ab\ub3d9\uc548 \uae30\ub2e4\ub824\uc628 \uad6d\uc18c \uc81c\ud488\uc758 \ud488\uc9c8 \ubc0f \ub3d9\ub4f1\uc131 \uac00\uc774\ub4dc\ub77c\uc778 \ucc44\ud0dd\uc744 \ubc1c\ud45c\ud588\uc2b5\ub2c8\ub2e4. \ucd5c\uc885 \ubb38\uc11c\ub294 2018\ub144\uc5d0 \ucd08\uc548\ub418\uc5c8\uc73c\uba70, 2025\ub144 4\uc6d4\ubd80\ud130 &#8221; <a href=\"https:\/\/www.ema.europa.eu\/en\/quality-equivalence-locally-applied-locally-acting-cutaneous-products-scientific-guideline#current-version-8664\" data-wpel-link=\"external\">\uad6d\uc18c \ub3c4\ud3ec \ubc0f \uad6d\uc18c \uc791\uc6a9 \ud53c\ubd80 \uc81c\ud488\uc758 \ud488\uc9c8 \ubc0f \ub3d9\ub4f1\uc131 \uac00\uc774\ub4dc\ub77c\uc778<\/a> &#8220;\uc774\ub77c\ub294 \uacf5\uc2dd \uba85\uce6d\uc73c\ub85c \uc2dc\ud589\ub420 \uc608\uc815\uc785\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">IVRT &amp; IVPT \ubd80\uc11c\uc640 \ud488\uc9c8 \ubcf4\uc99d \ubd80\uc11c\ub294 IVRT \ubc0f IVPT\uc640 \uad00\ub828\ud558\uc5ec EMA \uc9c0\uce68\uc758 \uac00\uc7a5 \uad00\ub828\uc131 \ub192\uc740 \ubd80\ubd84\uc744 \uc694\uc57d\ud558\uc5ec \ud488\uc9c8 \uad8c\uc7a5 \uc0ac\ud56d\uacfc \uce58\ub8cc \ub3d9\ub4f1\uc131 \uc139\uc158\uc73c\ub85c \uad6c\ubd84\ud588\uc2b5\ub2c8\ub2e4. \ub9c8\uc9c0\ub9c9\uc73c\ub85c, 2018\ub144 \uc774\uc804 \ucd08\uc548 \ubb38\uc11c \uc774\ud6c4 Kymos Group\uc774 \uc774 \uc9c0\uce68\uc744 \uc900\uc218\ud558\uc5ec \uc791\uc5c5\ud55c \uacbd\ud5d8\uc744 \uacf5\uc720\ud588\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<h2><strong>2024\ub144 EMA\uc758 \uad6d\uc18c \uc81c\ud488\uc5d0 \ub300\ud55c \uc0c8\ub85c\uc6b4 \uc9c0\uce68\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc81c\ubaa9\uc5d0\uc11c \uc54c \uc218 \uc788\ub4ef\uc774, \ubcf8 \uc9c0\uce68\uc740 \uad6d\uc18c \ub3c4\ud3ec \ubc0f \uad6d\uc18c \uc791\uc6a9 \ud53c\ubd80\uc6a9 \uc758\uc57d\ud488\uc5d0 \uad00\ud55c \uac83\uc774\uc9c0\ub9cc, \uadc0 \ub610\ub294 \uc548\uad6c\uc6a9 \uc81c\uc81c, \uad6d\uc18c \uc791\uc6a9 \uc9c8\uc6a9 \uc81c\ud488 \ub4f1 \ub2e4\ub978 \uc81c\ud488\uc5d0\ub3c4 \uc801\uc6a9\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \uc0c8\ub85c\uc6b4 \uaddc\uc815\uc740 \ud488\uc9c8 \ubc0f \ub3d9\ub4f1\uc131 \uad8c\uace0 \uc0ac\ud56d\uc73c\ub85c \uad6c\ubd84\ub418\uc5b4 \uc788\uc73c\uba70, \ud53c\ubd80\uc6a9 \uc81c\ud488 \ud3c9\uac00\uc5d0 \ub300\ud55c \ubcf4\ub2e4 \uccb4\uacc4\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \uc81c\uc2dc\ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub3d9\ub4f1\uc131\uc5d0 \uad00\ud55c \ub450 \ubc88\uc9f8 \uc870\ud56d\uc740 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c, \uc0dd\uc57d \uc81c\uc81c, \uc784\uc0c1\uc2dc\ud5d8\uc744 \ud1b5\ud574 \ud6a8\ub2a5\uc758 \ub3d9\ub4f1\uc131\uc774 \uc785\uc99d\ub41c \uc81c\uc81c, \uadf8\ub9ac\uace0 \uc2dc\ud5d8\uc57d\uacfc \ub300\uc870\uc57d\uc758 \uc81c\ud615\uc774 \ub3d9\uc77c\ud558\uc9c0 \uc54a\uc740 \uc81c\uc81c\uc5d0\ub294 \uc801\uc6a9\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ud2b9\ud788 <a href=\"https:\/\/kymos.com\/ko\/%ec%84%9c%eb%b9%84%ec%8a%a4\/cmc-%eb%b6%84%ec%84%9d-%eb%b0%8f-%ed%92%88%ec%a7%88-%ea%b4%80%eb%a6%ac\/%ea%b2%bd%ed%94%bc-%ed%85%8c%ec%8a%a4%ed%8a%b8\/\" data-wpel-link=\"internal\">\uacbd\ud53c \ud328\uce58\uc640 \uac19\uc740 \uc804\uc2e0 \ud761\uc218 \uc81c\ud615\uc744 \ub2e4\ub8f0 \ub54c \uc774\ub7ec\ud55c \uc81c\uc678 \uc0ac\ud56d\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/a> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">EMA\ub294 \ucd5c\uadfc \uc5c5\ub370\uc774\ud2b8\ub97c \ud1b5\ud574 \uce58\ub8cc\uc801 \ub3d9\ub4f1\uc131\uc744 \uc785\uc99d\ud558\ub294 \uacfc\uc815\uc744 \ub2e8\uc21c\ud654\ud558\ub294 \ubcf4\ub2e4 \uccb4\uacc4\uc801\uc774\uace0 \ub2e8\uacc4\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \uac15\uc870\ud569\ub2c8\ub2e4. \uc774 \uc811\uadfc \ubc29\uc2dd\uc740 \uc784\uc0c1 \uc5f0\uad6c\uc5d0 \ube44\ud574 \ube44\uc6a9 \uc808\uac10 \ubc0f \uc2dc\uac04 \ud6a8\uc728\uc801\uc778 \ub300\uc548\uc744 \uc81c\uc2dc\ud558\ub294 \uc2dc\ud5d8\uad00 \ub0b4(\uc2dc\ud5d8\uad00 \ub0b4 \ubc29\ucd9c \uc2dc\ud5d8 \ub610\ub294 IVRT, \uc2dc\ud5d8\uad00 \ub0b4 \ud22c\uacfc \uc2dc\ud5d8 \ub610\ub294 IVPT) \ubc0f \uc57d\ub3d9\ud559(PK) \ubc29\ubc95\uc5d0 \uc911\uc810\uc744 \ub461\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>\uad6d\uc18c \uc81c\ud488\uc5d0 \ub300\ud55c \ud488\uc9c8 \uad8c\uc7a5 \uc0ac\ud56d<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\ubcf8 \uc9c0\uce68\uc758 \ud488\uc9c8 \uad8c\uace0 \uc0ac\ud56d\uc740 \ub2e4\ub978 \uc9c0\uce68\uc774\ub098 \uad00\ub828 \uc57d\uc804 \uae30\uc900\uc774 \uc801\uc6a9\ub418\uc9c0 \uc54a\ub294 \uc81c\ud488\uc758 \uc2e0\uaddc \uc2dc\ud310 \ud5c8\uac00 \uc2e0\uccad \ubc0f \uc2b9\uc778 \ud6c4 \ubcc0\uacbd\uc5d0 \uc801\uc6a9\ub429\ub2c8\ub2e4. IVRT \ubc0f IVPT\uc640 \uad00\ub828\ud558\uc5ec \ubcf8 \uc9c0\uce68\uc5d0\uc11c \uac00\uc7a5 \uad00\ub828\uc131\uc774 \ub192\uc740 \uce21\uba74\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<h4><span style=\"text-decoration: underline;\"><span style=\"font-size: 14pt;\"><strong>\uc81c\uc57d \uac1c\ubc1c<\/strong><\/span><\/span><\/h4>\n<ul>\n<li>\n<h4><strong><span style=\"font-size: 14pt;\">\uc81c\ud615 \uac1c\ubc1c<\/span><\/strong><\/h4>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc81c\ud615 \uac1c\ubc1c\uc740 QTTP(\ud488\uc9c8 \ubaa9\ud45c \uc81c\ud488 \ud504\ub85c\ud544)\uc5d0 \ub9de\ucdb0\uc57c \ud558\uba70, \ud22c\uc5ec \uc6a9\uc774\uc131, \uc0ac\uc6a9 \uae30\uac04, \uc6a9\ucd9c, IVRT \ubc0f \ud544\uc694\ud55c \uacbd\uc6b0 IVPT\uc640 \uac19\uc740 \uc81c\ud488 \uc131\ub2a5\uacfc \uac19\uc740 CQA(\uc8fc\uc694 \ud488\uc9c8 \uc18d\uc131)\ub97c \ud2b9\uc131\ud654\ud558\uace0 \uc81c\uc5b4\ud558\uae30 \uc704\ud55c \uc801\uc808\ud55c \ud14c\uc2a4\ud2b8\ub97c \uc2e4\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li>\n<h4><strong><span style=\"font-size: 14pt;\">\uc81c\ud488 \ud2b9\uc131\ud654<\/span><\/strong><\/h4>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\ud2b9\uc131 \ubd84\uc11d\uc740 \uc218\uba85 \uc8fc\uae30 \uad00\ub9ac\ub97c \uc6a9\uc774\ud558\uac8c \ud558\uace0, \ud544\uc694\ud55c \uacbd\uc6b0 \uc81c\ud488 \ub3d9\ub4f1\uc131\uc744 \ud655\ubcf4\ud558\ub294 \ub370 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. \uc8fc\uc694 \uc131\ub2a5 \uc2dc\ud5d8\uc5d0\ub294 \ud604\ud0c1\uc561 \uc6a9\ud574, IVRT(\uccb4\uc678\ucda9\uaca9\ud30c\uce58\ub8cc), \uadf8\ub9ac\uace0 \ud544\uc694\ud55c \uacbd\uc6b0 IVPT(\uccb4\uc678\ucda9\uaca9\ud30c\uce58\ub8cc)\uac00 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc81c\ud488 \uc131\ub2a5\uc740 \ubcf4\uad00 \uae30\uac04 \ub3d9\uc548 \uc548\uc815\uc801\uc784\uc744 \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4.  <\/span><\/p>\n<h4><span style=\"font-size: 14pt;\"><strong><span style=\"text-decoration: underline;\">\ud1b5\uc81c \uc804\ub7b5<\/span><\/strong><\/span><\/h4>\n<p><span style=\"font-size: 14pt;\">\uc57d\ubb3c \ubc29\ucd9c \uc81c\uc5b4\uc5d0 \uc911\uc694\ud55c CQA\ub294 IVRT \ubc0f IVPT(\ud574\ub2f9\ud558\ub294 \uacbd\uc6b0)\uc640 \uac19\uc740 \uc2dc\ud5d8\uc744 \ud1b5\ud574 \uc2e0\uc911\ud558\uac8c \uad00\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4. \uc57d\ubb3c \ubc29\ucd9c \uc81c\uc5b4 \uc2dc \ub354 \ub6f0\uc5b4\ub09c \ud310\ubcc4\ub825\uc744 \ubcf4\uc774\ub294 \uac83\uc73c\ub85c \uc785\uc99d\ub41c \uacbd\uc6b0, \ub2e4\ub978 \ub9e4\uac1c\ubcc0\uc218(\uc608: \ud604\ubbf8\uacbd, DSC, \uc720\ubcc0\ud559)\ub97c \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c, \uaddc\uaca9\uc5d0 \ud3ec\ud568\ub41c \ubaa8\ub4e0 \uc131\ub2a5 \uc2dc\ud5d8 \ud55c\uacc4(\uc608: \uc6a9\ucd9c, IVRT)\ub294 \uc720\ud6a8\uc131\uacfc \uc548\uc804\uc131\uc774 \uc785\uc99d\ub41c \uc784\uc0c1 \ubc30\uce58\ub97c \ucc38\uc870\ud558\uc5ec \ud0c0\ub2f9\uc131\uc744 \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4.  <\/span><\/p>\n<h4><span style=\"font-size: 14pt;\"><strong><span style=\"text-decoration: underline;\">\uc548\uc815\uc131 \ud504\ub85c\uadf8\ub7a8<\/span><\/strong><\/span><\/h4>\n<p><span style=\"font-size: 14pt;\">\uc548\uc815\uc131 \ud14c\uc2a4\ud2b8\ub97c \ud1b5\ud574 \uc2dc\uac04\uc774 \uc9c0\ub098\ub3c4 \uc81c\ud488\uc758 \ud488\uc9c8\uacfc \ud6a8\uacfc\ub97c \ubcf4\uc7a5\ud574\uc57c \ud558\uba70, IVRT\ub098 \uae30\ud0c0 \uc131\ub2a5 \ud14c\uc2a4\ud2b8\ub97c \ud1b5\ud574 \uc720\ud1b5\uae30\ud55c\uc758 \uc77c\uad00\uc131\uc744 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>\uad6d\uc18c \uc81c\ud488\uc5d0 \ub300\ud55c \ub3d9\ub4f1\uc131 \uad8c\uc7a5 \uc0ac\ud56d  <\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\ubcf8 \uc9c0\uce68\uc758 \uc774 \ubd80\ubd84\uc740 \uae30\uc874 \uc758\uc57d\ud488\uacfc\uc758 \uce58\ub8cc\uc801 \ub3d9\ub4f1\uc131\uc744 \uc785\uc99d\ud558\uace0\uc790 \ud558\ub294 \uc0c8\ub85c\uc6b4 \ud53c\ubd80 \uc81c\ud488\uc5d0 \uc801\uc6a9\ub429\ub2c8\ub2e4. \ub610\ud55c, \uc704\ud5d8 \ud3c9\uac00 \ud6c4 \ud488\uc9c8, \uc548\uc804\uc131 \ub610\ub294 \ud6a8\ub2a5\uc5d0 \uc7a0\uc7ac\uc801 \uc601\ud5a5\uc774 \uc608\uc0c1\ub418\ub294 \uc2b9\uc778 \ud6c4 \ubcc0\uacbd\uc5d0\ub3c4 \uc801\uc6a9\ub429\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uac00\uc774\ub4dc\uc5d0\uc11c\ub294 \ub610\ud55c &#8220;\uc758\uc57d\ud488\uc758 \uc548\uc804\uc131\uacfc \ud6a8\ub2a5\uc744 \uc785\uc99d\ud558\uae30 \uc704\ud574 \ubb38\ud5cc\uc5d0 \uc758\uc874\ud558\ub294 \uc2e0\uccad\uc758 \uacbd\uc6b0, \ubb38\ud5cc\uc758 \uad00\ub828\uc131\uc740 \ubb38\ud5cc\uc5d0 \uc124\uba85\ub41c \uc81c\ud488\uacfc\uc758 \ub3d9\ub4f1\uc131 \uc5f0\uacb0 \ub370\uc774\ud130\ub85c \ub4b7\ubc1b\uce68\ub418\uc5b4\uc57c \ud55c\ub2e4&#8221;\uace0 \uad6c\uccb4\uc801\uc73c\ub85c \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc55e\uc11c \uc5b8\uae09\ud588\ub4ef\uc774, EMA\ub294 \ub3d9\ub4f1\uc131 \uc785\uc99d\uc744 \uc704\ud574 \ub2e8\uacc4\uc801 \uc811\uadfc\ubc95\uc744 \uad8c\uc7a5\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc81c\uc57d \ud68c\uc0ac\ub294 \uc790\uc0ac \uc81c\ud488\uc5d0 \ub300\ud574 \uc5b4\ub5a4 \uc2dc\ud5d8\uc744 \uc218\ud589\ud574\uc57c \ud560\uc9c0(\uc6a9\uc561\uc774\ub098 \uac94\uacfc \uac19\uc740 \ub2e8\uc21c \uc81c\ud615 \ub610\ub294 \uc5d0\uba40\uc83c\uacfc \uac19\uc740 \ubcf5\uc7a1\ud55c \uc81c\ud615) \ubbf8\ub9ac \uc54c \uc218 \uc788\uc73c\uba70, \uc8fc\uc694 \ubaa9\ud45c\ub294 \uc804\uccb4 \uc784\uc0c1 \uc5f0\uad6c\ub97c \uac74\ub108\ub6f0\ub294 \uac83\uc785\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">EMA\ub294 \uc5b4\ub5a4 \uc811\uadfc \ubc29\uc2dd\uacfc \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac\ub97c \uc120\ud0dd\ud560\uc9c0 \uacb0\uc815\ud560 \ub54c \ud53c\ubd80 \uc81c\ud488\uc758 \uc9c8\uc801 \uad6c\uc131, \uc591\uc801 \uad6c\uc131, \ubb3c\ub9ac\ud654\ud559\uc801 \ubc0f \uad6c\uc870\uc801 \ud2b9\uc131\uc744 \uace0\ub824\ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17702\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline.png\" alt=\"EMA \uac00\uc774\ub4dc\ub77c\uc778\uc5d0\uc11c \ucc44\ud0dd\ud55c \ub2e8\uacc4\ubcc4 \uc811\uadfc \ubc29\uc2dd\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac \uc120\ud0dd\" width=\"579\" height=\"407\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27579%27%20height%3D%27407%27%20viewBox%3D%270%200%20579%20407%27%3E%3Crect%20width%3D%27579%27%20height%3D%27407%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-200x141.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-300x211.png 300w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-400x282.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-600x423.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-768x541.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-800x563.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline-1024x721.png 1024w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Selection-of-decision-tree-in-the-stepwise-approach-adapted-from-EMAs-guideline.png 1200w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 579px) 100vw, 579px\" \/><\/p>\n<p style=\"text-align: center;\"><em>\uadf8\ub9bc 1) EMA \uac00\uc774\ub4dc\ub77c\uc778\uc5d0\uc11c \ucc44\ud0dd\ud55c \ub2e8\uacc4\ubcc4 \uc811\uadfc \ubc29\uc2dd\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac \uc120\ud0dd<\/em><\/p>\n<p><span style=\"font-size: 14pt;\">\uadf8\ub7f0 \ub2e4\uc74c, \uc774\ub7ec\ud55c \uace0\ub824 \uc0ac\ud56d\uc5d0 \ub530\ub77c \ud5c8\uc6a9 \uac00\ub2a5\ud55c \ube0c\ub9ac\uc9c0 \ub610\ub294 \uac70\ubd80\ub85c \uc774\uc5b4\uc9c0\ub294 \ub2e4\uc74c \uacb0\uc815 \ud2b8\ub9ac\uc5d0 \ub300\ud55c \ub2e8\uacc4\uc801 \uc811\uadfc \ubc29\uc2dd\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 1: \ub3d9\uc77c\ud55c \uc9c8\uc801 \ubc0f \uc591\uc801 \uad6c\uc131, \ub3d9\uc77c\ud55c \ubb3c\ub9ac\ud654\ud559\uc801 \ubc0f \uad6c\uc870\uc801 \ud2b9\uc131<\/strong><\/span><\/p>\n<p><strong><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17712\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1.png\" alt=\"EMA \uac00\uc774\ub4dc\ub77c\uc778\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 1\" width=\"618\" height=\"579\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27618%27%20height%3D%27579%27%20viewBox%3D%270%200%20618%20579%27%3E%3Crect%20width%3D%27618%27%20height%3D%27579%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-200x187.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-300x281.png 300w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-400x375.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-600x562.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-768x719.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-800x749.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1-1024x959.png 1024w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-1-from-EMAs-Guideline-1.png 1169w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 618px) 100vw, 618px\" \/><\/strong><\/p>\n<p style=\"text-align: center;\"><em>\uadf8\ub9bc 2) EMA \uac00\uc774\ub4dc\ub77c\uc778\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 1<\/em><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 2: \uc815\uc131\uc801 \ubc0f \uc815\ub7c9\uc801 \uad6c\uc131\uc758 \uc791\uc740 \ucc28\uc774 \ubc0f\/\ub610\ub294 \ubb3c\ub9ac\ud654\ud559\uc801 \ubc0f \uad6c\uc870\uc801 \ud2b9\uc131<\/strong><\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17704\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline.png\" alt=\"EMA \uac00\uc774\ub4dc\ub77c\uc778\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 2\" width=\"610\" height=\"344\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27610%27%20height%3D%27344%27%20viewBox%3D%270%200%20610%20344%27%3E%3Crect%20width%3D%27610%27%20height%3D%27344%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-200x113.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-300x169.png 300w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-400x225.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-600x338.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-768x433.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-800x451.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline-1024x577.png 1024w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-2-from-EMAs-Guideline.png 1194w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 610px) 100vw, 610px\" \/><\/p>\n<p style=\"text-align: center;\"><em>\uadf8\ub9bc 3) EMA \uac00\uc774\ub4dc\ub77c\uc778\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 2<\/em><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 3: \ub2e4\uc591\ud55c \uc815\uc131\uc801, \uc815\ub7c9\uc801 \uad6c\uc131\uacfc \ub2e4\uc591\ud55c \ubb3c\ub9ac\ud654\ud559\uc801, \uad6c\uc870\uc801 \ud2b9\uc131<\/strong><\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload aligncenter wp-image-17708\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline.png\" alt=\"EMA \uac00\uc774\ub4dc\ub77c\uc778\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 3\" width=\"357\" height=\"377\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27357%27%20height%3D%27377%27%20viewBox%3D%270%200%20357%20377%27%3E%3Crect%20width%3D%27357%27%20height%3D%27377%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-200x211.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-284x300.png 284w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-400x422.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-600x634.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline-768x811.png 768w, https:\/\/kymos.com\/wp-content\/uploads\/2024\/11\/Decision-Tree-3-from-EMAs-Guideline.png 786w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 357px) 100vw, 357px\" \/><\/p>\n<p style=\"text-align: center;\"><em>\uadf8\ub9bc 4) EMA \uac00\uc774\ub4dc\ub77c\uc778\uc758 \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac 3<\/em><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uc758\uc0ac\uacb0\uc815 \ud2b8\ub9ac\uc5d0\uc11c \ubcfc \uc218 \uc788\ub4ef\uc774, EMA\ub294 \uc81c\ud488 \uac04 \uc720\uc0ac\uc131\uc5d0 \ub530\ub77c \uc81c\uc870\uc5c5\uccb4\uac00 \uace0\ub824\ud574\uc57c \ud560 \ub2e4\uc591\ud55c \ub2e8\uacc4\ubcc4 \uc811\uadfc \ubc29\uc2dd\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>IVRT \ubc0f IVPT \uc5f0\uad6c\uc5d0 \ub300\ud55c Kymos \uadf8\ub8f9\uc758 \uacbd\ud5d8<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Kymos Group\uc740 2017\ub144\ubd80\ud130 \uad6d\uc18c \uc81c\ud488\uc758 \uc57d\ubb3c \ubc29\ucd9c \ubc0f \uae30\uc220 \uc5f0\uad6c\ub97c \ub2f4\ub2f9\ud558\ub294 \uc804\ubb38\ud300\uc744 \uc6b4\uc601\ud558\uace0 \uc788\uc73c\uba70, IVRT \ubc0f IVPT \uc5f0\uad6c\uc5d0 \ub300\ud55c \ud48d\ubd80\ud55c \uacbd\ud5d8\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ub2f9\uc0ac\uc758 \ubc29\ubc95\uc740 2018\ub144\uc5d0 \ubc1c\ud45c\ub41c \ub3d9\uc77c\ud55c \uc9c0\uce68\uc758 \ucd08\uc548 \ubc84\uc804\uc744 \uc900\uc218\ud558\uc5ec \uac1c\ubc1c\ub418\uc5c8\uc73c\uba70, \ub2f9\uc0ac \uacfc\ud559\uc790\ub4e4\uc740 \uc774\ubbf8 \uc774 \ucd5c\uc885 \ubc84\uc804\uc5d0 \ub300\ud574 \uc798 \uc54c\uace0 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc6b0\ub9ac\ub294 \uc57d\ubb3c \ubc29\ucd9c \ubc0f \uacbd\ud53c \ud761\uc218 \uc11c\ube44\uc2a4 \uce74\ud0c8\ub85c\uadf8\ub97c \ub450 \uac00\uc9c0 \uc8fc\uc694 \uadf8\ub8f9\uc73c\ub85c \ub098\ub204\uc5c8\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>IVRT:<\/strong> \uc778\uacf5 \ub9c9\uc744 \uc774\uc6a9\ud558\uc5ec \uc57d\ubb3c \ubc29\ucd9c\ub7c9\uacfc \ubc29\ucd9c \uc18d\ub3c4\ub97c \uce21\uc815\ud558\uc5ec \ub2e4\uc591\ud55c \uc81c\ud615\uc5d0 \ub300\ud55c \ubd84\uc11d\ubc95\uc744 \uac1c\ubc1c\ud558\uace0 \uac80\uc99d\ud569\ub2c8\ub2e4.<\/span> <span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \ubd84\uc11d\ubc95\uc740 \ube44\uad50 \uc5f0\uad6c\uc5d0 \ud65c\uc6a9\ub418\uc5b4 \ub3d9\ub4f1\uc131\uc744 \ud3c9\uac00\ud558\uace0 \uc81c\uc870 \ubc30\uce58\uc758 \ud488\uc9c8 \uad00\ub9ac\ub97c \uc218\ud589\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>IVPT:<\/strong> \uc0dd\ubb3c\ud559\uc801 \ub3d9\ub4f1\uc131 \uc5f0\uad6c\ub97c \uc704\ud574 \ud53c\ubd80 \uc0d8\ud50c\uc744 \uc774\uc6a9\ud558\uc5ec \uacbd\ud53c \ud22c\uacfc\ub7c9, \ud50c\ub7ed\uc2a4 \uc18d\ub3c4, \uadf8\ub9ac\uace0 \uce35 \ubd84\ud3ec\ub97c \uce21\uc815\ud569\ub2c8\ub2e4.<\/span> <span style=\"font-size: 14pt;\">\ub610\ud55c, \uacbd\ud53c \ud761\uc218 \uc5f0\uad6c\ub97c \ud1b5\ud574 \uc81c\ud615 \ucd5c\uc801\ud654 \ubc0f \ube44\uad50\ub97c \uc9c0\uc6d0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc800\ud76c \uc5f0\uad6c\uc2e4\uc740 \ucd5c\uc2e0 \uc790\ub3d9\ud654\ub41c Hanson \uc218\uc9c1 \ud655\uc0b0 Phoenix \uc7a5\ube44(Franz \uc138\ud3ec \uac80\uc0ac)\ub97c \uc0ac\uc6a9\ud558\uc5ec \ud53c\ubd80 \uc81c\ud488\uc5d0 \ub300\ud55c GLP \ubc0f GMP \uc778\uc99d \uacbd\ud53c \ud761\uc218 \uac80\uc0ac\ub97c \uc81c\uacf5\ud558\ub294 \uba87 \uc548 \ub418\ub294 \uc720\ub7fd \uc2dc\uc124 \uc911 \ud558\ub098\uc785\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc0c8\ub85c\uc6b4 \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \ub300\ud55c \uc2ec\uce35\uc801\uc778 \uc774\ud574\ub97c \ubc14\ud0d5\uc73c\ub85c, \ub2f9\uc0ac\uc758 \uacfc\ud559\ud300\uc740 \uc81c\ud615 \uac1c\ubc1c\ubd80\ud130 \uc2e0\uaddc \ub9c8\ucf00\ud305 \uc2e0\uccad\uc758 \uaddc\uc81c \uc81c\ucd9c\uae4c\uc9c0, \uadf8\ub9ac\uace0 EMA\uc758 \ub2e8\uacc4\uc801 \uc811\uadfc \ubc29\uc2dd\uc5d0 \ub530\ub77c \uae30\uc874 \uc758\uc57d\ud488\uacfc\uc758 \ub3d9\ub4f1\uc131\uc744 \uc785\uc99d\ud558\uace0\uc790 \ud558\ub294 \ud53c\ubd80 \uc81c\ud488\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0 \uace0\uac1d\uc744 \uc9c0\uc6d0\ud560 \uc900\ube44\uac00 \ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>\uacb0\ub860<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\uad6d\uc18c \uc81c\ud488\uc758 \ud488\uc9c8 \ubc0f \ub3d9\ub4f1\uc131\uc5d0 \ub300\ud55c \uc0c8\ub85c\uc6b4 EMA \uac00\uc774\ub4dc\ub77c\uc778 \ucc44\ud0dd\uc740 \uc774\ub7ec\ud55c \uc720\ud615\uc758 \uc758\uc57d\ud488 \ubd84\uc11d\uc5d0 \uc788\uc5b4 \ub354\uc6b1 \uc870\ud654\ub86d\uace0 \uccb4\uacc4\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \ud5a5\ud55c \ud070 \uc9c4\uc804\uc785\ub2c8\ub2e4. IVRT(\uccb4\uc678\ucda9\uaca9\ud30c\uce58\ub8cc) \ubc0f IVPT(\uccb4\uc678\ucda9\uaca9\ud30c\uce58\ub8cc)\uc640 \uac19\uc740 \uae30\ubc95\uc744 \uc0ac\uc6a9\ud558\uc5ec \ub3d9\ub4f1\uc131\uc744 \uc785\uc99d\ud558\uae30 \uc704\ud55c \ub2e8\uacc4\ubcc4 \uad8c\uace0\uc548\uc740 \ube44\uc6a9\uacfc \uc2dc\uac04\uc774 \ub9ce\uc774 \uc18c\uc694\ub418\ub294 \uc784\uc0c1 \uc5f0\uad6c \uc5c6\uc774\ub3c4 \uc0c8\ub85c\uc6b4 \uc81c\ub124\ub9ad \uc758\uc57d\ud488\uc758 \uc2dc\uc7a5 \ucd9c\uc2dc \uacfc\uc815\uc744 \uac04\uc18c\ud654\ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">IVRT \ubc0f IVPT \ubd84\uc57c\uc758 \uc120\ub3c4\uc801 CRO\uc778 Kymos Group\uacfc \uadf8 \ud300\uc740 \ucd5c\uc2e0 \uc9c0\uce68\uc5d0 \ub530\ub77c \uc720\ub7fd\uc5d0\uc11c\uc758 \uc2dc\uc7a5 \uc2b9\uc778\uc744 \uc6d0\ud65c\ud558\uac8c \uc9c4\ud589\ud560 \uc218 \uc788\ub3c4\ub85d \ubaa8\ub4e0 \ub2e8\uacc4\uc5d0\uc11c \uace0\uac1d\uacfc \ud30c\ud2b8\ub108\ub97c \uc9c0\uc6d0\ud560 \uc900\ube44\uac00 \ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">EMA \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \uc815\ubcf4\ub098 \uacbd\ud53c \ud761\uc218 \ud504\ub85c\uc81d\ud2b8 \uad00\ub828 \uc9c0\uc6d0\uc774 \ud544\uc694\ud558\uc2dc\uba74 <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a> \uc73c\ub85c \ubb38\uc758\ud574 \uc8fc\uc138\uc694. \uc790\uc138\ud55c \ucee8\uc124\ud305\uacfc \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud574 \ub4dc\ub9ac\uaca0\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc720\ub7fd\uc758\uc57d\ud488\uccad(EMA)\uc740 2024\ub144 10\uc6d4, \uc624\ub7ab\ub3d9\uc548 \uae30\ub2e4\ub824\uc628 \uad6d\uc18c \uc81c\ud488\uc758 \ud488\uc9c8 \ubc0f \ub3d9\ub4f1\uc131  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