{"id":28182,"date":"2024-09-04T09:00:00","date_gmt":"2024-09-04T07:00:00","guid":{"rendered":"https:\/\/kymos.com\/news\/ich-m10-%ec%83%9d%eb%ac%bc%eb%b6%84%ec%84%9d-%eb%b0%a9%eb%b2%95-%ea%b2%80%ec%a6%9d%ec%97%90-%eb%8c%80%ed%95%9c-ema-%eb%b0%8f-fda-%ea%b3%bc%ea%b1%b0-%ec%a7%80%ec%b9%a8-%eb%b9%84%ea%b5%90\/"},"modified":"2024-09-04T09:00:00","modified_gmt":"2024-09-04T07:00:00","slug":"ich-m10-%ec%83%9d%eb%ac%bc%eb%b6%84%ec%84%9d-%eb%b0%a9%eb%b2%95-%ea%b2%80%ec%a6%9d%ec%97%90-%eb%8c%80%ed%95%9c-ema-%eb%b0%8f-fda-%ea%b3%bc%ea%b1%b0-%ec%a7%80%ec%b9%a8-%eb%b9%84%ea%b5%90","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/ich-m10-%ec%83%9d%eb%ac%bc%eb%b6%84%ec%84%9d-%eb%b0%a9%eb%b2%95-%ea%b2%80%ec%a6%9d%ec%97%90-%eb%8c%80%ed%95%9c-ema-%eb%b0%8f-fda-%ea%b3%bc%ea%b1%b0-%ec%a7%80%ec%b9%a8-%eb%b9%84%ea%b5%90\/","title":{"rendered":"ICH M10 \uc0dd\ubb3c\ubd84\uc11d \ubc29\ubc95 \uac80\uc99d\uc5d0 \ub300\ud55c EMA \ubc0f FDA \uacfc\uac70 \uc9c0\uce68 \ube44\uad50"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">ICH\ub294 25\ub144 \uc774\uc0c1 \uc57d\ubb3c \ubc0f \ud65c\uc131 \ubb3c\uc9c8\uc758 \ud488\uc9c8 \ud3c9\uac00\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubd84\uc11d \ubc29\ubc95\uc758 \uac80\uc99d\uc5d0 \ub300\ud55c \uad8c\uc7a5 \uc0ac\ud56d(ICH Q2)\uc744 \ubc1c\ud45c\ud574 \uc654\uc9c0\ub9cc, \uc0dd\ubb3c\ud559\uc801 \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0\uc11c \uc57d\ubb3c \ubc0f \ubd84\uc11d\ubb3c\uc758 \uac80\uc99d \ubc0f \ubd84\uc11d\uc744 \ud3ec\uad04\ud558\ub294 \uc870\ud654\ub41c \uc9c0\uce68\uc774 \ub098\uc628 \uac83\uc740 \ucd5c\uadfc(2022-2023\ub144)\uc774\uc5c8\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \ub9e4\ud2b8\ub9ad\uc2a4\ub294 \uc758\uc57d\ud488\uc774\ub098 \uc644\uc81c \uc758\uc57d\ud488\uc5d0\uc11c \ubc1c\uacac\ub418\ub294 \uac83\uacfc\ub294 \ub2ec\ub9ac \ub9e4\uc6b0 \ub192\uc740 \ubcf5\uc7a1\uc131\uacfc \ub354\ubd88\uc5b4 \uac1c\uc778 \uac04 \ub610\ub294 \uac1c\uc778 \uac04 \ubcc0\ub3d9\uc131\uc744 \ub098\ud0c0\ub0c5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc774\uc720\ub85c ICH M10\uc740 FDA\uc640 EMA\uc5d0\uc11c \uc774\ubbf8 \ucc44\ud0dd \ubc0f \uc2dc\ud589 \uc911\uc778 \ub9e4\uc6b0 \uc911\uc694\ud55c \uc870\ud654 \ub178\ub825\uc774\uba70, \ub2e4\ub978 \uaddc\uc81c \uae30\uad00 \ubc0f \ud589\uc815\ubd80\uc5d0\uc11c\ub3c4 \uc2dc\ud589 \uc911\uc785\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uc810\uc744 \uace0\ub824\ud558\uc5ec \ub2f9\uc0ac\uc758 \uc0dd\ubb3c\ubd84\uc11d \ubd80\uc11c\ub294 \ud488\uc9c8 \ubcf4\uc99d \ubd80\uc11c\uc640 \ud611\ub825\ud558\uc5ec \uc0dd\ubb3c\ubd84\uc11d \uc5f0\uad6c\uc5d0 \uac00\uc7a5 \ud070 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uae30\uc874 \uc9c0\uce68\uacfc\uc758 \uc8fc\uc694 \ud575\uc2ec \uc0ac\ud56d\uacfc \ucc28\uc774\uc810\uc744 \uc694\uc57d\ud558\uace0 \uc885\ud569\ud588\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2>\uc18c\uac1c \ubc0f \ubc94\uc704<\/h2>\n<p><span style=\"font-size: 14pt;\">ICH M10\uc740 \uaddc\uc81c \uacb0\uc815\uc744 \ub4b7\ubc1b\uce68\ud558\ub294 \ub370 \ud544\uc694\ud55c \uc0dd\ubb3c\ubd84\uc11d\ubc95 \uac80\uc99d\uc744 \uae30\uc220\ud558\uba70, \uc774\ub97c \uc704\ud574 \ubcf8 \uc9c0\uce68\uc774 \uc801\uc6a9\ub418\ub294 \uad6c\uccb4\uc801\uc778 \ubc94\uc704\ub97c \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud574\ub2f9 \uc5f0\uad6c\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uc784\uc0c1 \uc5f0\uad6c\ub97c \ub300\uc2e0\ud558\uc5ec \uc218\ud589\ub418\ub294 \ube44\uc784\uc0c1 \ub3c5\uc131\ub3d9\ud0dc\ud559(TK) \uc5f0\uad6c \ubc0f \uc57d\ub3d9\ud559(PK) \uc5f0\uad6c<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uaddc\uc81c \uc81c\ucd9c\uc5d0 \ud3ec\ud568\ub41c \uc784\uc0c1 \uc2dc\ud5d8\uc758 \ubaa8\ub4e0 \ub2e8\uacc4(\ube44\uad50 \uc0dd\ubb3c\ud559\uc801 \uc774\uc6a9 \uac00\ub2a5\uc131\/\uc0dd\ubb3c\ud559\uc801 \ub3d9\ub4f1\uc131(BA\/BE) \uc5f0\uad6c \ud3ec\ud568).<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc77c\ubc18\uc801\uc73c\ub85c GLP \ub610\ub294 GCP\ub97c \uc801\uc6a9\ud55c \uc5f0\uad6c<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\ubc14\uc774\uc624\ub9c8\ucee4\ub294 \uc5f0\uad6c\uc758 \uc8fc\uc694 \ud3c9\uac00\ubcc0\uc218\uac00 \uc544\ub2cc \ud55c \ubc94\uc704\uc5d0\uc11c \uc81c\uc678\ub429\ub2c8\ub2e4. \uc0dd\ubb3c\ud559\uc801 \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0\ub294 \ud608\uc561, \ud608\uccad, \ud608\uc7a5 \ubc0f \uae30\ud0c0 \uccb4\uc561\uc774\ub098 \uc870\uc9c1\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. <\/span><\/p>\n<h2>\uc77c\ubc18 \uc6d0\uce59<\/h2>\n<h3><strong><span style=\"font-size: 14pt;\">\ubc29\ubc95 \uac1c\ubc1c<\/span><\/strong><\/h3>\n<p><span style=\"font-size: 14pt;\">\ubd84\uc11d\ubc95 \uac1c\ubc1c\uacfc \uad00\ub828\ud558\uc5ec, \uc0c8\ub85c\uc6b4 ICH M10\uc740 \uae30\uc874 FDA \uc9c0\uce68\uc758 \ub300\ubd80\ubd84\uc744 \ucc28\uc6a9\ud588\uc2b5\ub2c8\ub2e4. \ubd84\uc11d\ubc95 \uac1c\ubc1c\uc740 \ubd84\uc11d\ubc95\uc758 \uc124\uacc4, \uc791\ub3d9 \uc870\uac74, \ud55c\uacc4 \ubc0f \uc758\ub3c4\ub41c \ubaa9\uc801\uc5d0 \ub300\ud55c \uc801\ud569\uc131\uc744 \uc815\uc758\ud558\uace0, \uac80\uc99d\uc744 \uc704\ud55c \uc900\ube44\uac00 \ub418\uc5b4 \uc788\ub294\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4. <\/span><\/p>\n<h3><strong><span style=\"font-size: 14pt;\">\uc804\uccb4 \uac80\uc99d<\/span><\/strong><\/h3>\n<p><span style=\"font-size: 14pt;\">ICH M10\uc740 \uc0dd\ubb3c\ud559\uc801 \ubd84\uc11d \ubc29\ubc95\uc5d0 \ub300\ud55c \uc644\uc804\ud55c \uac80\uc99d\uc774 \ud544\uc694\ud55c \uacbd\uc6b0\uc5d0 \ub300\ud55c EMA\uc640 FDA\uc758 \uc774\uc804 \uac00\uc774\ub4dc\ub97c \ub354\uc6b1 \ud655\uc7a5\ud558\uc5ec \uc124\uba85\ud569\ub2c8\ub2e4<\/span> .<\/p>\n<h2>\ud06c\ub85c\ub9c8\ud1a0\uadf8\ub798\ud53c \ubd84\uc11d<\/h2>\n<h3><span style=\"font-size: 14pt;\"><strong>\ud655\uc778<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">ICH M10\uc740 \ud06c\ub85c\ub9c8\ud1a0\uadf8\ub798\ud53c \ubd84\uc11d\ubc95\uc758 \ubd84\uc11d\ubc95 \uac80\uc99d\uc5d0 \ud544\uc694\ud55c \ubaa8\ub4e0 \uc694\uc18c\uc5d0 \ub300\ud55c \ucd94\uac00 \uc138\ubd80 \uc815\ubcf4\uc640 \uc9c0\uce68\uc744 \uc81c\uacf5\ud558\uba70, \uc0c8\ub85c\uc6b4 \uac00\uc774\ub4dc\uc5d0\uc11c\ub294 \uc77c\ubd80 \uc694\uc18c\uc5d0 \ub300\ud55c \ub0b4\uc6a9\uc744 \ud655\uc7a5\ud558\uace0 \uc0c8\ub85c\uc6b4 \uc7a5\uc744 \ucd94\uac00\ud558\uae30\ub3c4 \ud569\ub2c8\ub2e4. \uc800\ud76c \ud300\uc740 EMA\/FDA\uc758 \uae30\uc874 \uc9c0\uce68\uacfc\uc758 \uc8fc\uc694 \ub0b4\uc6a9\uacfc \ucc28\uc774\uc810\uc744 \ub2e4\uc74c\uacfc \uac19\uc774 \uc694\uc57d\ud588\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uc0c8\ub85c\uc6b4 ICH M10\uc5d0\uc11c\ub294 <strong>\uc120\ud0dd\uc131\uc774<\/strong> \ud2b9\uc774\uc131\uacfc \ubd84\ub9ac\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ub9e4\ud2b8\ub9ad\uc2a4 \ud6a8\uacfc(ME):<\/strong> \ub9e4\ud2b8\ub9ad\uc2a4 \ud6a8\uacfc\uc640 \uad00\ub828\ud558\uc5ec ICH M10\uc740 \uacfc\uac70 EMA \ubc0f FDA\ubcf4\ub2e4 \ub354 \uc815\ud655\ud55c \uc9c0\uce68\uc744 \uc81c\uacf5\ud558\uba70 \ud3c9\uac00\ub41c \uac01 \uac1c\ubcc4 \ub9e4\ud2b8\ub9ad\uc2a4 \uc18c\uc2a4\/\ub85c\ud2b8\uc5d0 \ub300\ud55c \uc815\ud655\ub3c4 \ubc0f \uc815\ubc00\ub3c4\ub97c \uacb0\uc815\ud558\ub3c4\ub85d \uc870\uc5b8\ud569\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>A&amp;P<\/strong> \uc640 \uad00\ub828\ud558\uc5ec ICH M10\uc740 EMA\uc640 FDA\uc758 \uae30\uc900\uc744 \ud655\uc7a5\ud558\uace0 \uc77c\ubd80 \uad8c\uc7a5 \uc0ac\ud56d\uc744 \ud1b5\ud569\ud588\uc2b5\ub2c8\ub2e4. \uac00\uc7a5 \uc911\uc694\ud55c \uc810\uc740 \uc774\ub7ec\ud55c \ud3c9\uac00\ub97c \uc704\ud55c \uac80\ub7c9\uc120\uc740 \ucd5c\uc18c \ud55c \ubc88\uc758 \uc2e4\ud5d8\uc5d0\uc11c \uc0c8\ub85c \ucca8\uac00\ud55c \uac80\ub7c9 \ud45c\uc900\ubb3c\uc9c8\uc744 \uc0ac\uc6a9\ud558\uc5ec \uc791\uc131\ud574\uc57c \ud55c\ub2e4\ub294 \uac83\uc785\ub2c8\ub2e4. \ub9cc\uc57d \uc0c8\ub85c \ucca8\uac00\ud55c \uac80\ub7c9 \ud45c\uc900\ubb3c\uc9c8\uc744 \ub2e4\ub978 \uc2e4\ud5d8\uc5d0\uc11c \uc0ac\uc6a9\ud558\uc9c0 \uc54a\ub294 \uacbd\uc6b0, \ub3d9\uacb0\ub41c \uac80\ub7c9 \ud45c\uc900\ubb3c\uc9c8\uc758 \uc548\uc815\uc131\uc744 \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4.  <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc548\uc815\uc131:<\/strong> ICH M10\uc740 EMA\/FDA\uc758 \uc774\uc804 \uac00\uc774\ub4dc\ub77c\uc778\uc744 \ub354\uc6b1 \uc790\uc138\ud788 \uc124\uba85\ud558\uace0 \uc0dd\ubb3c\ud559\uc801 \ub9e4\ud2b8\ub9ad\uc2a4, \uac00\uacf5\ub41c \uc0d8\ud50c, \uc7ac\uace0 \ubc0f \uc791\uc5c5 \uc6a9\uc561\uc5d0\uc11c \ubd84\uc11d\ubb3c\uc758 \uc548\uc815\uc131\uc5d0 \ub300\ud55c \uad8c\uc7a5 \uc0ac\ud56d\uc744 \uba85\uc2dc\ud569\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<h3><strong><span style=\"font-size: 14pt;\">\uc5f0\uad6c \uc0d8\ud50c \ubd84\uc11d<\/span><\/strong><\/h3>\n<p><span style=\"font-size: 14pt;\">ICH M10\uc740 \uac80\uc99d\uc774 \uc644\ub8cc\ub41c \ud6c4(\uc774 \uc2dc\uc810\uae4c\uc9c0 \ub370\uc774\ud130\uac00 \uaddc\uc81c \uae30\uad00\uc5d0 \uc81c\ucd9c\ub428) \uc5f0\uad6c \uc2dc\ub8cc \ubd84\uc11d\uc744 \uc218\ud589\ud560 \uc218 \uc788\ub2e4\uace0 \uaddc\uc815\ud558\uace0 \uc788\uc9c0\ub9cc, \uc77c\ubd80 \ub9e4\uac1c\ubcc0\uc218\ub294 \uc774\ud6c4 \ub2e8\uacc4\uc5d0\uc11c \uc644\ub8cc\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. ICH M10\uc740 \ub9e4\uac1c\ubcc0\uc218\uc640 \uc808\ucc28 \uce21\uba74\uc5d0\uc11c \uac70\uc758 \ub3d9\uc77c\ud558\uac8c \uc720\uc9c0\ub418\uba70, \uc0ac\uc18c\ud55c \ubcc0\uacbd\uacfc \uc77c\ubd80 \ucd94\uac00 \uc0ac\ud56d\uc774 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<h2>\ub9ac\uac04\ub4dc \uacb0\ud569 \ubd84\uc11d<\/h2>\n<h3><span style=\"font-size: 14pt;\"><strong>\uc8fc\uc694 \uc2dc\uc57d<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\uc800\ud76c \ud300\uc740 \ub9ac\uac04\ub4dc \uacb0\ud569 \uac80\uc815\uc744 \uc704\ud55c \uc8fc\uc694 \uc2dc\uc57d\uc5d0 \uad00\ud55c EMA\/FDA\uc758 \uacfc\uac70 \uac00\uc774\ub4dc\ub77c\uc778\uacfc \uc8fc\uc694 \ubd80\ubd84 \ubc0f \ucc28\uc774\uc810\uc744 \uc694\uc57d\ud588\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\ucc38\uc870 \ud45c\uc900\ud488:<\/strong> EMA\/FDA\uc640 \ub9c8\ucc2c\uac00\uc9c0\ub85c ICH M10\uc740 1\ucc28 \ud45c\uc900\ud488\uc744 \uc694\uad6c\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. CoA \ubc0f \ucc38\uc870 \ud45c\uc900\ud488 \uc720\ud6a8\uae30\uac04, \uac80\ub7c9\uc120\uc5d0 \ub3d9\uc77c\ud55c \ubc30\uce58 \uc0ac\uc6a9, \ubc30\uce58 \ubcc0\uacbd \ub4f1\uc5d0 \uad00\ud55c \uc815\ubcf4 \ubc0f \uad8c\uc7a5 \uc0ac\ud56d\uc740 \uc774\uc804 \uc9c0\uce68\uacfc \ub3d9\uc77c\ud569\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc911\uc694 \uc2dc\uc57d:<\/strong> \uad8c\uc7a5 \uc0ac\ud56d\uc740 EMA\/FDA\ub97c \uae30\ubc18\uc73c\ub85c \ud558\uc9c0\ub9cc, \uc774\ub7ec\ud55c \uc911\uc694 \uc2dc\uc57d\uc758 \uc548\uc815\uc131 \ud14c\uc2a4\ud2b8\ub294 \uc0dd\ubb3c \ubd84\uc11d \ubd84\uc11d\uc758 \uc131\ub2a5\uc5d0 \uae30\ubc18\ud574\uc57c \ud558\uba70 \uc2dc\uc57d \ubcf4\uad00 \uc870\uac74\uc5d0 \ub300\ud55c \uc77c\ubc18\uc801\uc778 \uc9c0\uce68\uc744 \uae30\ubc18\uc73c\ub85c \ud574\uc57c \ud558\uba70 \uacf5\uae09\uc5c5\uccb4\uc758 \uc720\ud6a8\uae30\uac04\uc744 \ub118\uc5b4 \uc5f0\uc7a5\ub420 \uc218 \uc788\ub2e4\ub294 \uc810\uc5d0 \uc720\uc758\ud558\ub294 \uac83\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<h3><strong><span style=\"font-size: 14pt;\">\ud655\uc778<\/span><\/strong><\/h3>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\ud2b9\uc774\uc131:<\/strong> ICH M10\uc740 \ud2b9\uc774\uc131\uc758 \uc808\ucc28 \ubc0f \ud5c8\uc6a9 \uae30\uc900\uacfc \uad00\ub828\ud558\uc5ec EMA\/FDA\uc640 \ub3d9\uc77c\ud55c \uad8c\uc7a5 \uc0ac\ud56d\uc744 \uc720\uc9c0\ud558\uc9c0\ub9cc \uad50\ucc28 \ubc18\uc751\uc131\uc774 \uc788\ub294 \uacbd\uc6b0 \uc601\ud5a5\uc744 \ud3c9\uac00\ud574\uc57c \ud55c\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.  <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc120\ud0dd\uc131:<\/strong> ICH M10\uc740 \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0 \ubd84\uc11d \ub300\uc0c1 \ubb3c\uc9c8\uc5d0 \uac04\uc12d\uc744 \uc77c\uc73c\ud0ac \uc218 \uc788\ub294 \ube44\ud2b9\uc774\uc801 \ub9e4\ud2b8\ub9ad\uc2a4 \uc131\ubd84\uc774 \ud3ec\ud568\ub420 \uc218 \uc788\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uae30\uc874\uc5d0 \ud655\ub300\ub41c \uad8c\uc7a5 \uc0ac\ud56d\uc73c\ub85c\ub294 \ubd84\uc11d \ucd5c\uc800 \ub18d\ub3c4\uc5d0\uc11c\uc758 \uc120\ud0dd\uc131, \uc2a4\ud30c\uc774\ud06c \ub18d\ub3c4, \uadf8\ub9ac\uace0 \uad00\ub828 \uc9d1\ub2e8\uc758 \uacbd\uc6b0 \ucd5c\uc18c \ud658\uc790 \uc218 \ub4f1\uc774 \uc788\uc2b5\ub2c8\ub2e4. \ud5c8\uc6a9 \uae30\uc900\uc740 \ub3d9\uc77c\ud569\ub2c8\ub2e4.  <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uac80\ub7c9\uc120 \ubc0f \ubc94\uc704:<\/strong> \uac80\ub7c9\uc120 \ubc0f \ubc94\uc704\uc640 \uad00\ub828\ud558\uc5ec ICH M10\uc740 \uc774\uc804 \uc9c0\uce68\uacfc \uac70\uc758 \ub3d9\uc77c\ud558\uc9c0\ub9cc, \uc0c8\ub85c \ucca8\uac00\ud55c \uac80\ub7c9 \ud45c\uc900\ubb3c\uc9c8\uc744 \uc0ac\uc6a9\ud558\uc5ec \uc791\uc131\ud558\ub294 \uac83\uc774 \ubc14\ub78c\uc9c1\ud558\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud5c8\uc6a9 \uae30\uc900\uc740 \uc0ac\uc18c\ud55c \ud655\uc7a5\uc810\uc744 \uc81c\uc678\ud558\uace0\ub294 \ub3d9\uc77c\ud569\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc815\ud655\ub3c4 \ubc0f \uc815\ubc00\ub3c4:<\/strong> \uc774\ub7ec\ud55c \ub9e4\uac1c\ubcc0\uc218\uc758 \uc8fc\uc694 \ucc28\uc774\uc810\uc740 ICH M10\uc5d0\uc11c QCs\ub97c \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0 \uc2a4\ud30c\uc774\ud0b9\ud558\uc5ec \uc81c\uc870\ud558\uace0 \uc5f0\uad6c \uc2dc\ub8cc\uc5d0 \uc608\uc0c1\ub418\ub294 \uc870\uac74\uc5d0\uc11c \ubcf4\uad00\ud558\ub3c4\ub85d \uad8c\uc7a5\ud55c\ub2e4\ub294 \uac83\uc785\ub2c8\ub2e4. \ub610\ud55c QCs \uc81c\uc870\ub97c \uc704\ud55c \uc0c8\ub85c\uc6b4 \ub18d\ub3c4 \uc218\uc900(\uae30\ud558 \ud3c9\uade0 \uadfc\ucc98\uc758 \uc911\uac04 \ub18d\ub3c4)\uc744 \ucd94\uac00\ud558\uace0, \ub3d9\uc77c\ud55c \uc2e4\ud5d8 \ubc0f \ub370\uc774\ud130\ub97c \uc0ac\uc6a9\ud558\uc5ec \uc815\ud655\ub3c4\uc640 \uc815\ubc00\ub3c4\ub97c \ud3c9\uac00\ud558\ub3c4\ub85d \uad8c\uc7a5\ud569\ub2c8\ub2e4. \ud5c8\uc6a9 \uae30\uc900\uc740 EMA\uc640 FDA\ub97c \uae30\ubc18\uc73c\ub85c \ud569\ub2c8\ub2e4.  <\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\ud76c\uc11d \uc120\ud615\uc131 \ubc0f \ud6c4\ud06c \ud6a8\uacfc:<\/strong> EMA\/FDA(\uc591\ucabd \ubaa8\ub450\uc758 \uc870\ud654)\uc640 \ub3d9\uc77c\ud55c \uad8c\uc7a5 \uc0ac\ud56d\uc744 \ucc3e\uc744 \uc218 \uc788\uc73c\uba70, \uc57d\uac04\uc758 \ucd94\uac00 \uc0ac\ud56d\uc774 \uc788\uc2b5\ub2c8\ub2e4. \ud5c8\uc6a9 \uae30\uc900\uc5d0 \ub300\ud574 ICH M10\uc740 \uc5f0\uad6c \uc2dc\ub8cc \ubd84\uc11d \uc2dc \uc801\uc6a9\ub418\ub294 \ud76c\uc11d \ubc30\uc218\uac00 \ubc38\ub9ac\ub370\uc774\uc158 \uc2dc \ud3c9\uac00\ub41c \ud76c\uc11d \ubc30\uc218 \ubc94\uc704 \ub0b4\uc5d0 \uc788\uc5b4\uc57c \ud55c\ub2e4\uace0 \uad8c\uc7a5\ud569\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc548\uc815\uc131:<\/strong> ICH M10\uc740 \uc548\uc815\uc131\uc774 \uac00\uacf5 \ubc0f \ubcf4\uad00 \uc870\uac74\uc744 \ud3ec\uad04\ud574\uc57c \ud558\uba70, \uc548\uc815\uc131 \uc2dc\ub8cc\ub294 \uc5f0\uad6c \uc2dc\ub8cc\uc758 \uc804\uccb4 \ub18d\ub3c4 \ubc94\uc704\ub97c \ud3ec\uad04\ud574\uc57c \ud55c\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc0dd\ubb3c\uc758\uc57d\ud488\uc758 \uacbd\uc6b0, \uc0c8\ub85c\uc6b4 \uc9c0\uce68\uc740 \ube0c\ub798\ucf00\ud305 \uc811\uadfc\ubc95(\ub450 \uc628\ub3c4 \uc0ac\uc774\uc758 \uc628\ub3c4)\uc744 \uc801\uc6a9\ud558\ub294 \uac83\uc774 \ud5c8\uc6a9\ub418\uba70, \uc808\ucc28 \ubc0f \ud5c8\uc6a9 \uae30\uc900\uacfc \uad00\ub828\ud558\uc5ec \uad8c\uace0 \uc0ac\ud56d\uc740 \ub3d9\uc77c\ud558\uac8c \uc870\ud654\ub418\uc5c8\ub2e4\uace0 \ub367\ubd99\uc600\uc2b5\ub2c8\ub2e4. <\/span><\/li>\n<\/ul>\n<h3><span style=\"font-size: 14pt;\"><strong>\uc5f0\uad6c \uc0d8\ud50c \ubd84\uc11d<\/strong><\/span><\/h3>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\ubd84\uc11d \uc2e4\ud589<\/strong> : \uc2e4\ud589 \uad6c\uc131 \ubc0f \uc2e4\ud589 \ub0b4 QC \ubc30\uce58\ub294 EMA\/FDA\uc640 \ub3d9\uc77c\ud558\uba70, \ub450 \uac1c \uc774\uc0c1\uc758 \ud50c\ub808\uc774\ud2b8\ub97c \ubd84\uc11d\ud560 \ub54c \uac01 \ud50c\ub808\uc774\ud2b8\uc5d0\ub294 \uac1c\ubcc4\uc801\uc778 \uad50\uc815 \ud45c\uc900 \ubc0f QC \uc138\ud2b8\uac00 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<p style=\"padding-left: 40px;\"><span style=\"font-size: 14pt;\">ICH M10\uc758 \ud575\uc2ec \uc0ac\ud56d \uc911 \ud558\ub098\ub294 QC\uac00 \uc608\uc0c1 \uc5f0\uad6c \uc2dc\ub8cc \ub18d\ub3c4 \ubc94\uc704\ub97c \ud3ec\uad04\ud574\uc57c \ud55c\ub2e4\ub294 \uac83\uc785\ub2c8\ub2e4. \ub610\ud55c, \ub2e8\uc77c \uc6f0 \ubd84\uc11d(\uac80\uc99d \ubc0f \uc5f0\uad6c \uc2dc\ub8cc \ubaa8\ub450)\ub3c4 \ud5c8\uc6a9\ub41c\ub2e4\ub294 \uc810\uc5d0 \uc720\uc758\ud574\uc57c \ud569\ub2c8\ub2e4. <\/span><\/p>\n<p style=\"padding-left: 40px;\"><span style=\"font-size: 14pt;\">\uac80\ub7c9\uc120 \ubc0f \ud5c8\uc6a9 \uae30\uc900\uacfc \uad00\ub828\ud558\uc5ec ICH M10\uc740 EMA\uc640 FDA\uc758 \uc870\ud654\ub97c \uc774\ub8e8\uc5c8\uc73c\uba70, \ubaa8\ub4e0 \uc2b9\uc778\ub41c \uc2e4\ud5d8\uc758 QC\uc5d0 \ub300\ud55c \uc804\ubc18\uc801\uc778 \ud3c9\uade0 \uc815\ud655\ub3c4\uc640 \uc815\ubc00\ub3c4\ub294 \uac01 \ub18d\ub3c4 \uc218\uc900\uc5d0\uc11c \uacc4\uc0b0\ub418\uc5b4\uc57c \ud558\uba70 \ubd84\uc11d \ubcf4\uace0\uc11c\uc5d0 \ubcf4\uace0\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\uc5f0\uad6c \uc2dc\ub8cc \uc7ac\ubd84\uc11d<\/strong> : \uc7ac\ubd84\uc11d \uc0ac\uc720, \uae30\uc900 \ubc0f \uc2dc\ub8cc \uc218\uc5d0 \ub300\ud55c \uad8c\uc7a5 \uc0ac\ud56d\uc740 EMA\/FDA\uc640 \ub3d9\uc77c\ud569\ub2c8\ub2e4. ICH M10\uc740 \uc2dc\ub8cc \ubd84\uc11d \uc2dc \ucd08\uae30 \ubd84\uc11d\uacfc \ub3d9\uc77c\ud55c \uc5f0\uad6c \uc2dc\ub8cc\ub2f9 \uc6f0 \uc218\ub97c \uae30\uc900\uc73c\ub85c \ud574\uc57c \ud55c\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/li>\n<\/ul>\n<h2><strong>\ubc1c\uc0dd \uc0d8\ud50c \uc7ac\ubd84\uc11d(ISR)<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">ICH M10\uc5d0 \ub530\ub77c, ISR\uc740 \ubcf4\uace0\ub41c \uc2dc\ub8cc \ubd84\uc11d\ubb3c\uc9c8 \ub18d\ub3c4\uc758 \uc2e0\ub8b0\uc131\uc744 \uac80\uc99d\ud558\uae30 \uc704\ud55c \uac83\uc774\uba70, EMA\uc640 FDA\uc5d0\uc11c \uba85\uc2dc\ud558\uace0 \uc0c8\ub85c\uc6b4 \uc9c0\uce68\uc5d0\uc11c \ud1b5\ud569 \ubc0f \uc870\ud654\ub97c \uc774\ub8ec \uc0c1\ud669\uc5d0\uc11c \uc218\ud589\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc5f0\uad6c, \uc218\uce58, \uc2dc\ub8cc \uc120\ud0dd \ubc0f \uacc4\uc0b0 \ubc29\uc2dd\uc740 \ubcc0\uacbd\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<h2>\uacb0\ub860<\/h2>\n<p><span style=\"font-size: 14pt;\">\uc774 \uc694\uc57d\ub41c \ud14d\uc2a4\ud2b8\uc5d0\uc11c \ubcfc \uc218 \uc788\ub4ef\uc774 ICH M10\uc740 FDA\uc640 EMA\uc5d0\uc11c \uc774\ubbf8 \uc2dc\ud589 \uc911\uc778 \uc0dd\ubb3c\ubd84\uc11d \uc5f0\uad6c\ub97c \uc704\ud55c \uc870\ud654\ub85c\uc6b4 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uc2dc\ud558\uba70, \uc0dd\ubb3c\ud559\uc801 \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0\uc11c \uc57d\ubb3c\uacfc \ubd84\uc11d\ubb3c\uc744 \ubd84\uc11d\ud560 \ub54c \ud45c\uc900\uc774 \ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uc0c8\ub85c\uc6b4 \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \ub9de\ucdb0 \uc801\uc6a9\ud55c \uc774\ud6c4, \uc6b0\ub9ac\ub294 \uace0\uac1d\uc73c\ub85c\ubd80\ud130 \uc774 \uc0c8\ub85c\uc6b4 \ubc84\uc804\uc758 \uac80\uc99d \ud504\ub85c\ud1a0\ucf5c\uacfc \uc0d8\ud50c \ubd84\uc11d \ud504\ub85c\ud1a0\ucf5c\uc5d0 \ub300\ud574 \ub9e4\uc6b0 \uae0d\uc815\uc801\uc778 \ud53c\ub4dc\ubc31\uc744 \ubc1b\uc558\uc2b5\ub2c8\ub2e4. \uc774\ub294 \uc6b0\ub9ac\uc758 \ubc29\ubc95\uacfc \uc808\ucc28\uac00 ICH M10\uc744 \uc900\uc218\ud55c\ub2e4\ub294 \uac83\uc744 \ud655\uc778\ud574\uc8fc\uc5c8\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc0c8\ub85c\uc6b4 \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \uc815\ubcf4\ub098 \ud504\ub85c\uc81d\ud2b8 \uad00\ub828 \uc9c0\uc6d0\uc774 \ud544\uc694\ud558\uc2dc\uba74 <a href=\"mailto:quotes@kymos.com\" data-wpel-link=\"internal\">quotes@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>ICH\ub294 25\ub144 \uc774\uc0c1 \uc57d\ubb3c \ubc0f \ud65c\uc131 \ubb3c\uc9c8\uc758 \ud488\uc9c8 \ud3c9\uac00\uc5d0 \uc0ac\uc6a9\ub418\ub294  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":28189,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[259],"tags":[62],"class_list":["post-28182","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-259","tag-joan"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ICH M10 \uac00\uc774\ub4dc\ub77c\uc778: \uc0dd\ubb3c\ubd84\uc11d \ubc29\ubc95\uc758 \uac80\uc99d<\/title>\n<meta name=\"description\" content=\"\ucd5c\uadfc ICH \uc870\ud654 \uc9c0\uce68 M10 \uc0dd\ubb3c\ubd84\uc11d \ubc29\ubc95 \uac80\uc99d \ubc0f \uc5f0\uad6c \uc0d8\ud50c \ubd84\uc11d\uc774 Kymos Group\uc5d0\uc11c \ucc44\ud0dd\ub418\uc5c8\uc2b5\ub2c8\ub2e4.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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