{"id":28171,"date":"2024-05-31T11:19:59","date_gmt":"2024-05-31T09:19:59","guid":{"rendered":"https:\/\/kymos.com\/news\/%ea%b2%bd%ed%94%bc-%ec%8b%9c%ed%97%98-%ea%b2%bd%ed%94%bc-%ed%8c%a8%ec%b9%98%ec%9d%98-%eb%b6%84%ec%84%9d-%eb%b0%8f-%ed%92%88%ec%a7%88-%ea%b4%80%eb%a6%ac\/"},"modified":"2024-05-31T11:19:59","modified_gmt":"2024-05-31T09:19:59","slug":"%ea%b2%bd%ed%94%bc-%ec%8b%9c%ed%97%98-%ea%b2%bd%ed%94%bc-%ed%8c%a8%ec%b9%98%ec%9d%98-%eb%b6%84%ec%84%9d-%eb%b0%8f-%ed%92%88%ec%a7%88-%ea%b4%80%eb%a6%ac","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%ea%b2%bd%ed%94%bc-%ec%8b%9c%ed%97%98-%ea%b2%bd%ed%94%bc-%ed%8c%a8%ec%b9%98%ec%9d%98-%eb%b6%84%ec%84%9d-%eb%b0%8f-%ed%92%88%ec%a7%88-%ea%b4%80%eb%a6%ac\/","title":{"rendered":"\uacbd\ud53c \uc2dc\ud5d8: \uacbd\ud53c \ud328\uce58\uc758 \ubd84\uc11d \ubc0f \ud488\uc9c8 \uad00\ub9ac"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\uacbd\ud53c \ud328\uce58 \ub610\ub294 \uacbd\ud53c \uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c(TDDS)\uc740 \ud65c\uc131 \uc131\ubd84\uc744 \ud53c\ubd80\ub97c \ud1b5\ud574 \ud608\ub958\ub85c \uc7a5\uc2dc\uac04 \uc77c\uc815\ud55c \uc18d\ub3c4\ub85c \uc9c1\uc811 \uc804\ub2ec\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uace0\uc720\ud55c \ud2b9\uc131\uc73c\ub85c \uc778\ud574 \ud488\uc9c8, \ud6a8\ub2a5 \ubc0f \uc548\uc804\uc131 \uad00\ub9ac\uc5d0 \uc788\uc5b4 \uc5ec\ub7ec \uac00\uc9c0 \uc5b4\ub824\uc6c0\uc774 \ub530\ub985\ub2c8\ub2e4. \uc774 \uae00\uc5d0\uc11c\ub294 \uacbd\ud53c \ud328\uce58\uc758 \uc791\uc6a9 \uae30\uc804, \uaddc\uc81c \uc694\uac74, \uadf8\ub9ac\uace0 Kymos Group\uc774 \ud488\uc9c8 \uad00\ub9ac \ubc0f \ubd84\uc11d\uc5d0 \uc5b4\ub5bb\uac8c \ub3c4\uc6c0\uc744 \uc904 \uc218 \uc788\ub294\uc9c0 \uc0b4\ud3b4\ubcf4\uaca0\uc2b5\ub2c8\ub2e4.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uacbd\ud53c \ud328\uce58\ub294 \ub2e4\uce35 \uad6c\uc870\ub85c \ub418\uc5b4 \uc788\uc73c\uba70, \uc77c\ubc18\uc801\uc73c\ub85c \uc57d\ubb3c \uc800\uc7a5\uace0, \uc81c\uc5b4\ub9c9, \uc811\ucc29\uce35, \uadf8\ub9ac\uace0 \ubcf4\ud638 \ub77c\uc774\ub108\ub85c \uad6c\uc131\ub429\ub2c8\ub2e4. \ud328\uce58\ub97c \ud53c\ubd80\uc5d0 \ubd80\ucc29\ud558\uba74 \ud558\ub098 \uc774\uc0c1\uc758 \ud65c\uc131 \uc131\ubd84\uc774 \uc800\uc7a5\uace0\uc5d0\uc11c \ubc29\ucd9c\ub418\uc5b4 \uc81c\uc5b4\ub9c9\uacfc \uc811\ucc29\uce35\uc744 \ud1b5\uacfc\ud55c \ud6c4, \uc190\uc0c1\ub418\uc9c0 \uc54a\uc740 \ud53c\ubd80\ub85c \uce68\ud22c\ud558\uc5ec \uc804\uc2e0 \uc21c\ud658\uacc4\uc5d0 \ub3c4\ub2ec\ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc801\uc6a9 \ubd80\uc704\uc5d0\ub9cc \uc601\ud5a5\uc744 \ubbf8\uce58\ub3c4\ub85d \uc124\uacc4\ub41c \uad6d\uc18c \uc81c\ud488\uacfc \ub2ec\ub9ac, \uacbd\ud53c \ud328\uce58\ub294 \uc804\uc2e0 \ud6a8\uacfc\ub97c \ubaa9\uc801\uc73c\ub85c \ud558\uae30 \ub54c\ubb38\uc5d0 \ubaa9\uc801, \uc791\uc6a9 \uae30\uc804, \uadf8\ub9ac\uace0 \uc81c\ud615\uc758 \ubcf5\uc7a1\uc131\uc774 \uc11c\ub85c \ub2e4\ub985\ub2c8\ub2e4. \ubc14\ub85c \uc774\ub7ec\ud55c \uc774\uc720\ub85c \uad6d\uc18c \uc81c\ud488 \ubd84\uc11d \uc2dc, \uccb4\uc678 \ubc29\ucd9c \uc2dc\ud5d8(IVRT)\uacfc \uccb4\uc678 \ud22c\uacfc \uc2dc\ud5d8(IVPT)\uc744 \ud1b5\ud574 \uc784\uc0c1 \uc5f0\uad6c\ub97c \uc0dd\ub7b5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4( <a href=\"https:\/\/www.ema.europa.eu\/en\/quality-equivalence-topical-products-scientific-guideline\" data-wpel-link=\"external\">2018\ub144 EMA\uc758 &#8220;\uad6d\uc18c \uc81c\ud488\uc758 \ud488\uc9c8 \ubc0f \ub3d9\ub4f1\uc131&#8221; \uc9c0\uce68 \ucd08\uc548<\/a> ). \ud558\uc9c0\ub9cc \uacbd\ud53c \ud328\uce58\uc758 \uacbd\uc6b0, IVRT\uc640 IVPT\uac00 \uc784\uc0c1\uc801 \ubd80\ubd84\uc744 \ub300\uccb4\ud560 \uc218\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uacbd\ud53c \ud328\uce58\uc758 \uaddc\uc81c \uac1c\uc694 \ubc0f \ud14c\uc2a4\ud2b8<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc55e\uc11c \uc5b8\uae09\ud588\ub4ef\uc774, \uc774\ub7ec\ud55c \ud2b9\uc131\uc73c\ub85c \uc778\ud574 \uaddc\uc81c \uae30\uad00\uc5d0\uc11c\ub294 \uacbd\ud53c \ud328\uce58\uc758 \uc8fc\uc694 \ud488\uc9c8 \uc18d\uc131(CQA)\uc744 \ud2b9\uc131\ud654\ud558\uace0 \uad00\ub9ac\ud558\uae30 \uc704\ud55c \uc801\ud569\ud55c \uc2dc\ud5d8\uc744 \uc815\uc758\ud588\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc8fc\uc694 \ucc38\uace0 \ud504\ub808\uc784\uc6cc\ud06c\ub294 \uc720\ub7fd\uc758\uc57d\ud488\uccad(EMA)\uc5d0\uc11c 2014\ub144\uc5d0 \ubc1c\ud45c\ud55c <em><a href=\"https:\/\/www.ema.europa.eu\/en\/quality-transdermal-patches-scientific-guideline\" data-wpel-link=\"external\">&#8220;\uacbd\ud53c \ud328\uce58 \ud488\uc9c8 \uac00\uc774\ub4dc\ub77c\uc778(EMA\/CHMP\/608924\/2014)<\/a> &#8220;<\/em> \uc785\ub2c8\ub2e4. \uc774 \ubb38\uc11c\ub294 \uacbd\ud53c \uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c(DDS)\uc5d0 \ub300\ud55c \uc0c8\ub85c\uc6b4 \uc2dc\ud310 \ud5c8\uac00 \uc2e0\uccad\uc744 \ub2e4\ub8e8\uace0, \uc548\uc804\uc131, \uc720\ud6a8\uc131 \ubc0f \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \ud3c9\uac00\ud574\uc57c \ud558\ub294 \ud544\uc218 \uc2dc\ud5d8 \ubc0f CQA(\ud575\uc0b0\ud488\uc9c8\ubcf4\uc99d\uae30\uc900)\ub97c \uc124\uba85\ud569\ub2c8\ub2e4. \uc774 \ubb38\uc11c\ub294 \uad00\ub828 \uc57d\uc804 \ubaa8\ub178\uadf8\ub798\ud504, ICH \ubc0f CHMP\/CVMP \uac00\uc774\ub4dc\ub77c\uc778\uacfc \ud568\uaed8 \ub2f9\uc0ac\uc758 \uacbd\ud53c \ud328\uce58 \uc11c\ube44\uc2a4 \uce74\ud0c8\ub85c\uadf8\ub97c \uad6c\uc131\ud558\ub294 \uae30\ubc18 \uc790\ub8cc\uc785\ub2c8\ub2e4.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Kymos Group\uc740 \uacbd\ud53c \ud328\uce58 \uc758\uc57d\ud488\uc758 \uc81c\ud615, \uac1c\ubc1c, \uc548\uc815\uc131\ubd80\ud130 \uc77c\uc0c1\uc801\uc778 \ubd84\uc11d \ubc0f \uc81c\ud615 \ubcc0\uacbd\uae4c\uc9c0 \uc804\uccb4 \uc218\uba85 \uc8fc\uae30 \ub3d9\uc548 \uc644\ubcbd\ud55c \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. EMA \uc9c0\uce68\uc5d0 \uc5b8\uae09\ub41c \uc8fc\uc694 \ud488\uc9c8 \uad00\ub9ac \uae30\uc900(CQA) \ubd84\uc11d \uacbd\ud5d8\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc73c\uba70, \uc5ec\uae30\uc5d0\ub294 \uc77c\ubc18\uc801\uc778 \ud488\uc9c8 \uad00\ub9ac \ubd84\uc11d(\uc815\ub7c9 \ubd84\uc11d, \uc720\uc5f0 \ubb3c\uc9c8, \uc678\uad00 \ub4f1), \uc794\ub958 \uc6a9\ub9e4 \uce21\uc815, \ud65c\uc131 \ubb3c\uc9c8 \uacb0\uc815\ud654, \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c \uc2dc\ud5d8, IVRT \ubc0f IVPT, \uadf8\ub9ac\uace0 \uc811\ucc29 \ud2b9\uc131\uacfc \uac19\uc740 \ud2b9\uc815 \uacbd\ud53c \ud328\uce58 \uc2dc\ud5d8\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uacbd\ud53c \ud328\uce58\uc758 CMC \ubc0f \ud488\uc9c8 \uad00\ub9ac \ud14c\uc2a4\ud2b8<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\ud488\uc9c8 \uad00\ub9ac \ubc0f CMC \ubd84\uc11d\uc740 \uacbd\ud53c \ud328\uce58\uc758 \uc548\uc804\uc131\uacfc \ud6a8\ub2a5\uc744 \ubcf4\uc7a5\ud558\ub294 \ub370 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. TDDS\ub97c \ud3ec\ud568\ud55c \ubaa8\ub4e0 \uc81c\ud615\uc5d0 \ub300\ud574 \uc218\ud589\ud574\uc57c \ud558\ub294 \uc801\ud569\ud55c \uc2dc\ud5d8\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\uac80\uc815:<\/strong> \uacbd\ud53c \ud328\uce58\uc5d0 \ud568\uc720\ub41c \uc57d\ubb3c\uc758 \ud568\ub7c9\uc744 \uce21\uc815\ud558\uc5ec \ud65c\uc131 \ubb3c\uc9c8\uc758 \ud2b9\uc815 \ub18d\ub3c4\ub97c \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc678\uad00:<\/strong> \uacbd\ud53c \ud328\uce58\uc758 \uc2dc\uac01\uc801 \ubc0f \ubb3c\ub9ac\uc801 \ud2b9\uc131\uc744 \ud3c9\uac00\ud558\uc5ec \uc694\uad6c\ub418\ub294 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. TDDS\uc758 \uacbd\uc6b0, \uc0c9\uc0c1\uc774\ub098 \ubaa8\uc591\uacfc \uac19\uc740 \uc77c\ubc18\uc801\uc778 \ud2b9\uc131\ubfd0 \uc544\ub2c8\ub77c \uc811\ucc29\uc131 \ub9e4\ud2b8\ub9ad\uc2a4\ub098 \uc774\ud615\uc9c0\uc758 \ubc15\ub9ac \uc5ec\ubd80\uc640 \uac19\uc740 \uad6c\uccb4\uc801\uc778 \ud2b9\uc131\ub3c4 \ud3ec\ud568\ud569\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uad00\ub828 \ubb3c\uc9c8:<\/strong> \ubd88\uc21c\ubb3c\uacfc \ubd84\ud574\uc0b0\ubb3c\uc744 \uc2dd\ubcc4\ud558\uace0 \uadf8 \uc218\uc900\uc774 \ud5c8\uc6a9 \ud55c\ub3c4 \ub0b4\uc5d0 \uc788\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\ub2e4\uc74c\uc73c\ub85c, \uacbd\ud53c \ud328\uce58\ub97c \ub2e4\ub8f0 \ub54c \ud2b9\uc815\ud558\uac70\ub098 \ub9e4\uc6b0 \uc911\uc694\ud55c \ud2b9\uc815 QC \ubd84\uc11d\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\ud65c\uc131 \uc131\ubd84\uc758 \uacb0\uc815\ud654:<\/strong> \uacb0\uc815 \ud615\uc131\uc740 \ud53c\ubd80\uc5d0\uc11c \ubc29\ucd9c\ub418\uace0 \ud761\uc218\ub418\ub294 \ud65c\uc131 \uc131\ubd84\uc758 \uc591\uc744 \uac10\uc18c\uc2dc\ucf1c \ud328\uce58\uc758 \ud6a8\ub2a5\uacfc \uc548\uc804\uc131\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc73c\ubbc0\ub85c \ud488\uc9c8 \uacb0\ud568\uc785\ub2c8\ub2e4. \uacb0\uc815\uc744 \ud655\uc778\ud558\uae30 \uc704\ud55c \uc815\uc131 \ubd84\uc11d\uc774 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc794\ub958 \uc6a9\ub9e4:<\/strong> \uacbd\ud53c \ud328\uce58\uc5d0\uc11c \uc794\ub958 \uc6a9\ub9e4\ub97c \uac80\ucd9c\ud558\uace0 \uc815\ub7c9\ud654\ud558\ub294 \uac83\uc740 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. \uc794\ub958 \uc6a9\ub9e4\ub294 \uc811\ucc29\ub825\uacfc \ud22c\uacfc\uc131 \ud5a5\uc0c1\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc73c\uba70, ICH Q3C\uc5d0\uc11c \uc81c\uc2dc\ud55c \uac83\ubcf4\ub2e4 \ub354 \uc5c4\uaca9\ud55c \ud55c\uacc4\uac00 \ud544\uc694\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c:<\/strong> \uacbd\ud53c \ud328\uce58 \uc81c\ud615\uc758 \ud2b9\uc131\uc0c1 \uc6a9\ub9e4\uac00 \uc874\uc7ac\ud560 \ub54c \ub2e4\uce35 \uad6c\uc870, \uc57d\ubb3c \uc800\uc7a5\uc18c \ubc0f 1\ucc28 \ud3ec\uc7a5\uc5d0\uc11c \ucd94\ucd9c\ub420 \uc218 \uc788\ub294 \ucd94\ucd9c\ubb3c\uacfc \uc57d\ubb3c \uc81c\ud488\uc73c\ub85c \uc6a9\ucd9c\ub418\ub294 \uc624\uc5fc \ubb3c\uc9c8\uc744 \uac10\uc9c0\ud558\ub294 \uac83\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc811\ucc29\ub825:<\/strong> \uacbd\ud53c \ud328\uce58\uc758 \uacbd\uc6b0, \ud328\uce58\uac00 \ud544\uc694\ud55c \uae30\uac04 \ub3d9\uc548 \ud53c\ubd80\uc5d0 \ubd80\ucc29\ub41c \uc0c1\ud0dc\ub97c \uc720\uc9c0\ud558\ub3c4\ub85d \uc811\ucc29\ub825\/\uc751\uc9d1\ub825\uc744 \ud2b9\uc131\ud654\ud558\uace0 \ub9cc\uc871\uc2a4\ub7fd\uac8c \uad00\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 Kymos\uc5d0\uc11c \uc801\uc6a9 \ubc0f \uad6c\ud604 \uac00\ub2a5\ud55c \uc7a5\ube44\ub97c \uc0ac\uc6a9\ud558\uc5ec \ubc15\ub9ac\ub825 \uc2dc\ud5d8, \uc811\ucc29\ub825 \uc2dc\ud5d8, \uc810\ucc29\ub825 \uc2dc\ud5d8 \ub4f1\uc758 \ubd84\uc11d\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ubbf8\uc0dd\ubb3c\ud559:<\/strong> \uc801\uc6a9 \ubd84\uc57c\uc5d0 \ub530\ub77c \ubb34\uade0 \ud14c\uc2a4\ud2b8\ub294 \ub9e4\uc6b0 \uc911\uc694\ud558\uba70, \ubbf8\uc0dd\ubb3c \ubd84\uc11d\uacfc \ud2b9\uc815 \ubcd1\uc6d0\uade0 \uc870\uc0ac\uac00 \ud544\uc694\ud560 \uc218\ub3c4 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uccb4\uc678 \ubc29\ucd9c \uc2dc\ud5d8(IVRT)\/\uc6a9\ucd9c \uc2dc\ud5d8:<\/strong> \uc77c\uad00\ub418\uace0 \uc870\uc808\ub41c \uc57d\ubb3c \uc804\ub2ec\uc5d0 \ud544\uc694\ud55c \uaddc\uaca9\uc744 \ucda9\uc871\ud558\ub824\uba74 \ud328\uce58\uc5d0\uc11c \uc57d\ubb3c \ubc29\ucd9c \uc18d\ub3c4\ub97c \uce21\uc815\ud558\ub294 \uac83\uc774 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. EMA \uc9c0\uce68\uc5d0 \uba85\uc2dc\ub41c \ubc14\uc640 \uac19\uc774, \uccb4\uc678 \ubc29\ucd9c \ubc0f \uc6a9\ucd9c \uc2dc\ud5d8\uc740 TDDS(\uc720\ud574\uc131 \uc57d\ubb3c \ubc29\ucd9c)\ub97c \ub2e4\ub8f0 \ub54c \ub3d9\uc77c\ud55c \ubd84\uc11d \ubc29\ubc95\uc73c\ub85c \uc124\uba85\ub429\ub2c8\ub2e4. \uc774 \uc2dc\ud5d8\uc740 Kymos\uc758 \ud328\ub4e4 \ud074\ub798\uc2a4 2 \uc6a9\ucd9c \uc2dc\ud5d8 \uc7a5\uce58\ub97c \uc0ac\uc6a9\ud558\uc5ec \uc218\ud589\ub418\ub294\ub370, \uc774 \uc7a5\uce58\ub294 \ud328\uce58\uac00 \uc6a9\ucd9c \ub9e4\uccb4\uc5d0 \ub5a0\ub2e4\ub2c8\ub294 \uac83\uc744 \ubc29\uc9c0\ud558\ub294 \ud2b9\uc218 \uba64\ube0c\ub808\uc778\uc744 \uc0ac\uc6a9\ud569\ub2c8\ub2e4. \ud2b9\uc815 \uc6a9\ub3c4\ub97c \uc704\ud574 \uc218\uc9c1 \ud655\uc0b0 \ud504\ub780\uce20 \uc138\ud3ec(Vertical Diffusion Franz Cell)\ub3c4 \uc81c\uacf5\ub429\ub2c8\ub2e4.   <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uccb4\uc678 \ud22c\uacfc \uc2dc\ud5d8(IVPT):<\/strong> \uc774 \uc2dc\ud5d8\uc740 \ud569\uc131 \ub610\ub294 \uc0dd\ubb3c\ud559\uc801 \ub9c9\uc5d0 \ud328\uce58\ub97c \ubd80\ucc29\ud558\uc5ec \ud53c\ubd80\ub97c \ud1b5\ud55c \uc57d\ubb3c \ud22c\uacfc\uc728\uc744 \uce21\uc815\ud558\ub294 \uac83\uc73c\ub85c, \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \ub530\ub77c \uc81c\ud615 \uac1c\ubc1c \ub2e8\uacc4, \uc548\uc815\uc131 \uc2dc\ud5d8, \uadf8\ub9ac\uace0 \uc758\uc57d\ud488 \ubd80\ud615\uc81c \ubcc0\uacbd \uc2dc \uc218\ud589\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. Kymos\uc5d0\uc11c\ub294 \uc774 \uc2dc\ud5d8\uc744 \uc758\uc57d\ud488\uc758 \uc131\ub2a5 \uc9c0\ud45c\ub85c \ud65c\uc6a9\ud558\uba70, \uc218\uc9c1 \ud655\uc0b0 \ud504\ub780\uce20 \uc138\ud3ec\ub97c \uc0ac\uc6a9\ud558\uace0 2018\ub144 EMA \uac00\uc774\ub4dc\ub77c\uc778 \ucd08\uc548\uc5d0 \uc5c5\ub370\uc774\ud2b8\ub41c \ubc29\ubc95\ub860\uc744 \ub530\ub985\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc548\uc815\uc131 \uc2dc\ud5d8:<\/strong> EMA \uc9c0\uce68\uc740 \uacbd\ud53c \ud328\uce58 \uc548\uc815\uc131 \uc2dc\ud5d8\uc5d0 \uc6a9\ucd9c, \uc57d\ubb3c \ubc29\ucd9c, \ud53c\ubd80 \ud22c\uacfc \uc2dc\ud5d8 \ubc0f \ubd80\ucc29\uc5d0 \ub300\ud55c \uc131\ub2a5 \uc2dc\ud5d8\uc744 \ud3ec\ud568\ud574\uc57c \ud55c\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. Kymos\uc5d0\uc11c\ub294 ICH \uc548\uc815\uc131 \uc2dc\ud5d8, \uc9c4\ud589 \uc911 \ubc0f \uc0ac\uc6a9 \uc911 \uc2dc\ud5d8, \uc2e4\uc2dc\uac04 \ubcf4\uad00 \uc870\uac74(\uc628\ub3c4 \uc0ac\uc774\ud074\ub9c1 \ud3ec\ud568), \uadf8\ub9ac\uace0 \uc2a4\ud2b8\ub808\uc2a4 \uc2dc\ud5d8\uc744 \uc218\ud589\ud569\ub2c8\ub2e4. <\/span><\/li>\n<\/ul>\n<h2><\/h2>\n<h2><span style=\"font-size: 18pt;\"><strong>\uacb0\ub860<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\uacbd\ud53c \ud328\uce58\ub294 \ud53c\ubd80\ub97c \ud1b5\ud574 \ud65c\uc131 \uc131\ubd84\uc744 \ud608\ub958\ub85c \uc9c1\uc811 \ubc29\ucd9c\ud558\ub294 \ub3c5\ud2b9\ud558\uace0 \ud6a8\uc728\uc801\uc778 \ubc29\ubc95\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc57d\ubb3c \ubc29\ucd9c \ubc0f \uc804\uc2e0 \ud761\uc218 \uc870\uc808\uc740 \ud488\uc9c8, \ud6a8\ub2a5 \ubc0f \uc548\uc804\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \ub370 \uc788\uc5b4 \uace0\uc720\ud55c \uacfc\uc81c\ub97c \uc548\uaca8\uc8fc\uba70, \uc774\ub7ec\ud55c \uc774\uc720\ub85c EMA\uc640 \uac19\uc740 \uaddc\uc81c \uae30\uad00\uc740 \uacbd\ud53c \ud328\uce58\uc5d0 \ub300\ud55c \uc5c4\uaca9\ud55c \uae30\uc900\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud55c \uad6c\uccb4\uc801\uc778 \uc9c0\uce68\uc744 \uc218\ub9bd\ud588\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Kymos Group\uc740 \uc81c\ud615 \uac1c\ubc1c \ubc0f \uc548\uc815\uc131\ubd80\ud130 \uc77c\uc0c1\uc801\uc778 \ubd84\uc11d \ubc0f \uc81c\ud615 \ubcc0\uacbd\uae4c\uc9c0 TDDS \uc758\uc57d\ud488\uc758 \uc804\uccb4 \uc218\uba85 \uc8fc\uae30 \ub3d9\uc548 \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc800\ud76c\ub294 \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \uc5b8\uae09\ub41c CQA \ubd84\uc11d \ubc0f IVRT\/IVPT \uc5f0\uad6c \uacbd\ud5d8\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc73c\uba70, \uacbd\ud53c \ud328\uce58 \uad00\ub828 GLP \ubc0f GMP \uc778\uc99d\uc744 \ubaa8\ub450 \uc81c\uacf5\ud558\ub294 \uc18c\uc218\uc758 CRO \uc911 \ud558\ub098\uc785\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc6b0\ub9ac\ub294 \uc774\uc804\uc5d0 \ub9cc\uc131 \ud1b5\uc99d(\ud39c\ud0c0\ub2d0)\uacfc \uc554(\uc774\ub9ac\ub178\ud14c\uce78) \uce58\ub8cc\ub97c \uc704\ud55c \uacbd\ud53c \ud328\uce58\ub97c \ubd84\uc11d\ud588\uc73c\uba70, \ub2e4\uc74c\uacfc \uac19\uc740 \ub2e4\ub978 \ub9cc\uc131 \ub610\ub294 \uc7a5\uae30 \uce58\ub8cc TDDS\uc5d0 \ub300\ud55c \ubd84\uc11d\uc744 \uc218\ud589\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uc54c\uce20\ud558\uc774\uba38\ubcd1, \ud30c\ud0a8\uc2a8\ubcd1, \ud1f4\ud589\uc131 \uc9c8\ud658 \ub4f1\uc744 \uce58\ub8cc\ud558\ub294 \uc57d\ubb3c<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud5a5\uc815\uc2e0\uc131 \uc57d\ubb3c<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud1b5\uc99d \uce58\ub8cc\uc81c<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud53c\uc784\uc57d<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uae08\uc5f0\uc744 \uc704\ud55c \ub2c8\ucf54\ud2f4<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud638\ub974\ubaac \uce58\ub8cc<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uba40\ubbf8(\uc2a4\ucf54\ud3f4\ub77c\ubbfc)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">CMC \ub610\ub294 \uc0dd\ubb3c\ubd84\uc11d \ud504\ub85c\uc81d\ud2b8\uc5d0 \ub3c4\uc6c0\uc774 \ud544\uc694\ud558\uba74 \uc800\ud76c\uc5d0\uac8c \uc5f0\ub77d\ud558\uc2dc\uac70\ub098 <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a> \uc73c\ub85c \uc774\uba54\uc77c\uc744 \ubcf4\ub0b4\uc8fc\uc138\uc694.  <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uacbd\ud53c \ud328\uce58 \ub610\ub294 \uacbd\ud53c \uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c(TDDS)\uc740 \ud65c\uc131 \uc131\ubd84\uc744 \ud53c\ubd80\ub97c  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":28173,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[259,261],"tags":[67],"class_list":["post-28171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-259","category-261","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\uacbd\ud53c \uc2dc\ud5d8: \uacbd\ud53c \ud328\uce58\uc758 \ud488\uc9c8 \uad00\ub9ac<\/title>\n<meta name=\"description\" content=\"\uacbd\ud53c \ud328\uce58\uc758 \uc791\ub3d9 \uba54\ucee4\ub2c8\uc998, \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \ubc0f Kymos Group\uc774 \ubd84\uc11d\uc744 \uc9c0\uc6d0\ud558\ub294 \ubc29\ubc95\uc5d0 \ub300\ud574 \uc54c\uc544\ubcf4\uc138\uc694.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/ko\/news\/%ea%b2%bd%ed%94%bc-%ec%8b%9c%ed%97%98-%ea%b2%bd%ed%94%bc-%ed%8c%a8%ec%b9%98%ec%9d%98-%eb%b6%84%ec%84%9d-%eb%b0%8f-%ed%92%88%ec%a7%88-%ea%b4%80%eb%a6%ac\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\uacbd\ud53c \uc2dc\ud5d8: \uacbd\ud53c \ud328\uce58\uc758 \ud488\uc9c8 \uad00\ub9ac\" \/>\n<meta property=\"og:description\" content=\"\uacbd\ud53c \ud328\uce58\uc758 \uc791\ub3d9 \uba54\ucee4\ub2c8\uc998, \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \ubc0f Kymos Group\uc774 \ubd84\uc11d\uc744 \uc9c0\uc6d0\ud558\ub294 \ubc29\ubc95\uc5d0 \ub300\ud574 \uc54c\uc544\ubcf4\uc138\uc694.\" \/>\n<meta property=\"og:url\" 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