{"id":48383,"date":"2026-10-14T11:42:41","date_gmt":"2026-10-14T09:42:41","guid":{"rendered":"https:\/\/kymos.com\/news\/%eb%b6%84%ec%84%9d%eb%b2%95-%ea%b0%9c%eb%b0%9c-aqbd-%ec%a0%91%ea%b7%bc%eb%b2%95\/"},"modified":"2026-10-14T11:42:41","modified_gmt":"2026-10-14T09:42:41","slug":"%eb%b6%84%ec%84%9d%eb%b2%95-%ea%b0%9c%eb%b0%9c-aqbd-%ec%a0%91%ea%b7%bc%eb%b2%95","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%eb%b6%84%ec%84%9d%eb%b2%95-%ea%b0%9c%eb%b0%9c-aqbd-%ec%a0%91%ea%b7%bc%eb%b2%95\/","title":{"rendered":"\ubd84\uc11d\ubc95 \uac1c\ubc1c: AQbD \uc811\uadfc\ubc95"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\ubd84\uc11d\ubc95\uc740 \uc758\ub3c4\ub41c \ubaa9\uc801\uc5d0 \ub300\ud574 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uacb0\uacfc\ub97c \uc81c\uacf5\ud574\uc57c \ud558\uc9c0\ub9cc, \uc815\uc758\ub41c \uc870\uac74 \uc138\ud2b8\uc5d0\uc11c \uc791\ub3d9\ud558\ub294 \ubc29\ubc95\uc744 \uac1c\ubc1c\ud558\ub294 \uac83\uc774 \uadf8 \uc870\uac74\uc774 \ubcc0\ud560 \ub54c \ud574\ub2f9 \ubc29\ubc95\uc774 \uc5b4\ub5bb\uac8c \uac70\ub3d9\ud558\ub294\uc9c0 \uc774\ud574\ud558\ub294 \uac83\uacfc \ubc18\ub4dc\uc2dc \ub3d9\uc77c\ud55c \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uad6c\ubd84\uc740 <strong>ICH Q14<\/strong>\uc5d0 \uc124\uba85\ub41c \ubd84\uc11d \uc808\ucc28 \uac1c\ubc1c\uc758 \uac15\ud654\ub41c \uc811\uadfc\ubc95\uc758 \ud575\uc2ec\uc785\ub2c8\ub2e4. 2024\ub144 6\uc6d4\ubd80\ud130 \uc720\ub7fd\uc5f0\ud569\uc5d0\uc11c \ud6a8\ub825\uc774 \ubc1c\uc0dd\ud55c \uc774 \uac00\uc774\ub4dc\ub77c\uc778\uc740 \ubd84\uc11d \uc808\ucc28\uc758 \uac1c\ubc1c \ubc0f \uc720\uc9c0\ub97c \uc704\ud55c \uacfc\ud559 \ubc0f \ub9ac\uc2a4\ud06c \uae30\ubc18 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud558\uba70, \ubc38\ub9ac\ub370\uc774\uc158\uc744 \ub2e4\ub8e8\ub294 <strong>ICH Q2(R2)<\/strong>\ub97c \ubcf4\uc644\ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Analytical Quality by Design (AQbD)<\/strong>\ub294 \uc77c\ubc18\uc801\uc73c\ub85c <strong>\ubd84\uc11d \uc808\ucc28 \uac1c\ubc1c\uc5d0 Quality by Design \uc6d0\uce59\uc744 \uc801\uc6a9\ud558\ub294 \uac83<\/strong>\uc744 \uc124\uba85\ud558\ub294 \ub370 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \uc801\ud569\ud55c \ubd84\uc11d \uc870\uac74\uc744 \ud655\ubcf4\ud558\ub294 \ub370\ub9cc \ucd08\uc810\uc744 \ub9de\ucd94\uae30\ubcf4\ub2e4\ub294, AQbD \uae30\ubc18 \uc811\uadfc\ubc95\uc740 \ubc29\ubc95 \uc131\ub2a5\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uc694\uc778\uc5d0 \ub300\ud55c \uad6c\uc870\ud654\ub41c \uc774\ud574\ub97c \uad6c\ucd95\ud558\uace0, \uadf8 \uc9c0\uc2dd\uc744 \ucd5c\uc801\ud654, \uad00\ub9ac(control) \ubc0f \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac\uc5d0 \ud65c\uc6a9\ud558\ub294 \uac83\uc744 \ubaa9\ud45c\ub85c \ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><em>\ucc38\uace0:<\/em> <em>\ubcf8 \ubb38\uc11c\uc5d0\uc11c\ub294 \uac00\ub3c5\uc131\uc744 \uc704\ud574 \u201canalytical method\u201d\uc640 \u201canalytical procedure\u201d\ub97c \uc0c1\ud638 \uad50\ucc28\uc801\uc73c\ub85c \uc0ac\uc6a9\ud558\uc9c0\ub9cc, ICH Q14\uc5d0\uc11c\ub294 \uacf5\uc2dd\uc801\uc73c\ub85c analytical procedure\ub77c\ub294 \uc6a9\uc5b4\ub97c \uc0ac\uc6a9\ud569\ub2c8\ub2e4.<\/em><\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\ubd84\uc11d\ubc95 \uac1c\ubc1c\uc5d0\uc11c AQbD\ub780 \ubb34\uc5c7\uc778\uac00\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>ICH Q14<\/strong>\ub294 \ubd84\uc11d \uc808\ucc28 \uac1c\ubc1c\uc5d0\uc11c <strong>minimal \uc811\uadfc\ubc95\uacfc enhanced \uc811\uadfc\ubc95<\/strong>\uc744 \uad6c\ubd84\ud569\ub2c8\ub2e4. minimal \uc811\uadfc\ubc95\uc740 \ubd84\uc11d\ubc95\uc744 \uac1c\ubc1c\ud558\ub294 \ub370 \uc5ec\uc804\ud788 \uc218\uc6a9\ub418\ub294 \ubc29\uc2dd\uc785\ub2c8\ub2e4. enhanced \uc811\uadfc\ubc95\uc740 \ubd84\uc11d \uc808\ucc28 \ud30c\ub77c\ubbf8\ud130\uc640 \ubd84\uc11d \uc131\ub2a5 \uac04\uc758 \uad00\uacc4\uc5d0 \ub300\ud55c \ub354 \ud070 \uc774\ud574\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \uc694\uc18c\ub97c \ucd94\uac00\ud569\ub2c8\ub2e4.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uad6c\ubd84\uc740 \uc911\uc694\ud569\ub2c8\ub2e4. <strong>AQbD<\/strong>\ub294 \uae30\uc874\uc758 \ubd84\uc11d \uac1c\ubc1c\uc744 \ub300\uccb4\ud558\ub294 \uac83\uc774 \uc544\ub2c8\uba70, <strong>ICH Q14<\/strong> \ub610\ud55c \ubaa8\ub4e0 \ubd84\uc11d \uc808\ucc28\ub97c enhanced \uc811\uadfc\ubc95\uc73c\ub85c \uac1c\ubc1c\ud560 \uac83\uc744 \uc694\uad6c\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub300\uc2e0 <strong>enhanced \uc811\uadfc\ubc95\uc740 \uc808\ucc28\uc758 \ud544\uc694, \uc774\uc6a9 \uac00\ub2a5\ud55c \uc0ac\uc804 \uc9c0\uc2dd, \uc758\ub3c4\ub41c \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uc804\ub7b5\uc5d0 \ub530\ub77c \uc801\uc6a9\ud560 \uc218 \uc788\ub294 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc2e4\ubb34\uc801\uc73c\ub85c\ub294 \ucd08\uc810\uc774 \ub2e8\uc21c\ud788 \ub2e4\uc74c\uc744 \ubb3b\ub294 \uac83\uc5d0\uc11c<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u201c\uc774 \ubc29\ubc95\uc774 \uc791\ub3d9\ud558\ub098\uc694?\u201d<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub2e4\uc74c\ub3c4 \ud568\uaed8 \ubb3b\ub294 \uac83\uc73c\ub85c \uc774\ub3d9\ud569\ub2c8\ub2e4:<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u201c\uc774 \ubc29\ubc95\uc774 \ub2ec\uc131\ud574\uc57c \ud558\ub294 \uac83\uc740 \ubb34\uc5c7\uc774\uba70, \uc5b4\ub5a4 \uc694\uc778\uc774 \uc131\ub2a5\uc5d0 \uc601\ud5a5\uc744 \uc904 \uc218 \uc788\uace0, \uc5b4\ub5a4 \uc870\uac74 \ubc94\uc704 \ub0b4\uc5d0\uc11c \uc694\uad6c\uc0ac\ud56d\uc744 \uc77c\uad00\ub418\uac8c \ucda9\uc871\ud568\uc744 \uc785\uc99d\ud560 \uc218 \uc788\ub098\uc694?\u201d<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \ucd94\uac00\uc801\uc778 \uc774\ud574\ub294 \uc774\ud6c4 \uc801\uc808\ud55c \uc6b4\uc6a9 \ubc94\uc704\ub97c \uc124\uc815\ud558\uace0, \uad00\ub9ac \uc804\ub7b5(control strategy)\uc744 \uc9c0\uc6d0\ud558\uba70, \ubd84\uc11d \uc808\ucc28 \ub77c\uc774\ud504\uc0ac\uc774\ud074\uc758 \ud6c4\uc18d \ub2e8\uacc4\uc5d0 \ub300\ud574 \ub354 \uac15\ud55c \uc9c0\uc2dd \uae30\ubc18\uc744 \uc81c\uacf5\ud558\ub294 \ub370 \ud65c\uc6a9\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\ubc29\ubc95 \uc131\ub2a5\uc5d0 \ub300\ud55c \ub354 \ub098\uc740 \uc774\ud574 \uad6c\ucd95<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>AQbD \uae30\ubc18 \uac1c\ubc1c<\/strong>\uc740 \ubd84\uc11d \uc808\ucc28\uac00 \ub2ec\uc131\ud574\uc57c \ud558\ub294 \ubc14\ub97c \uc815\uc758\ud558\ub294 \uac83\uc5d0\uc11c \uc2dc\uc791\ud569\ub2c8\ub2e4.<\/span><\/p>\n<ol>\n<li><span style=\"font-size: 14pt;\"><strong> \ubd84\uc11d \ud0c0\uae43 \ud504\ub85c\ud30c\uc77c<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\"><strong>Analytical Target Profile (ATP)<\/strong>\ub294 \ubd84\uc11d \uc808\ucc28\uc758 \uc758\ub3c4\ub41c \ubaa9\uc801, \uce21\uc815\ud560 \uc81c\ud488 \ud2b9\uc131, \uadf8\ub9ac\uace0 \uae30\ub300\ub418\ub294 \uc131\ub2a5 \uae30\uc900\uc744 \uc815\uc758\ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 \uac1c\ubc1c \uc758\uc0ac\uacb0\uc815\uc744 \ud3c9\uac00\ud560 \uc218 \uc788\ub294 \ud0c0\uae43\uc744 \uc124\uc815\ud568\uc73c\ub85c\uc368 \uac1c\ubc1c\uc758 \uae30\ubc18\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n<ol start=\"2\">\n<li><span style=\"font-size: 14pt;\"><strong> \uc9c0\uc2dd \ubc0f \ub9ac\uc2a4\ud06c \ud3c9\uac00<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\uc758\ub3c4\ub41c \uc131\ub2a5\uc774 \ud655\ub9bd\ub418\uba74, <strong>\uc0ac\uc804 \uc9c0\uc2dd\uacfc \ub9ac\uc2a4\ud06c \ud3c9\uac00\ub97c \uc0ac\uc6a9\ud558\uc5ec \uc131\ub2a5\uc5d0 \uc601\ud5a5\uc744 \uc904 \uc218 \uc788\ub294 \ubd84\uc11d \uc808\ucc28 \ud30c\ub77c\ubbf8\ud130\ub97c \uc2dd\ubcc4\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 \uc808\ucc28\uc5d0 \ub530\ub77c \ubd84\uc11d \uc870\uac74, \uc790\uc7ac, \uc7a5\ube44(instrumentation) \ub610\ub294 \uc2dc\ub8cc \uc804\ucc98\ub9ac\uc640 \uad00\ub828\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubaa9\uc801\uc740 \uac00\ub2a5\ud55c \ud55c \ub9ce\uc740 \ubcc0\uc218\ub97c \ub2e8\uc21c\ud788 \uc2dd\ubcc4\ud558\ub294 \uac83\uc774 \uc544\ub2c8\ub77c, <strong>\ubd84\uc11d \uc131\ub2a5\uc5d0 \ub300\ud55c \uc7a0\uc7ac\uc801 \uc601\ud5a5\uc5d0 \uadfc\uac70\ud574 \ucd94\uac00 \uc870\uc0ac\uac00 \ud544\uc694\ud55c \ud30c\ub77c\ubbf8\ud130\uac00 \ubb34\uc5c7\uc778\uc9c0 \uacb0\uc815\ud558\ub294 \uac83<\/strong>\uc785\ub2c8\ub2e4.<\/span><\/p>\n<ol start=\"3\">\n<li><span style=\"font-size: 14pt;\"><strong> \uc608\ube44 \uac1c\ubc1c<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\uadf8\ub2e4\uc74c \ucd08\uae30 \uc2e4\ud5d8\uc2e4 \uc5f0\uad6c\ub97c \ud1b5\ud574 <strong>\uc801\uc808\ud55c \ubd84\uc11d \uc870\uac74\uc744 \ud655\ub9bd\ud558\uace0 \uc608\ube44 \ubc29\ubc95\uc744 \uac1c\ubc1c<\/strong>\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 \ubcf4\ub2e4 \uccb4\uacc4\uc801\uc778 \uc870\uc0ac\uc640 \ucd5c\uc801\ud654\ub97c \uc704\ud55c \ucd9c\ubc1c\uc810\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n<ol start=\"4\">\n<li><span style=\"font-size: 14pt;\"><strong> \uc120\ud0dd\uc131 \ubc0f \uac15\uc81c \ubd84\ud574<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\uc548\uc815\uc131 \uc9c0\uc2dc(stability-indicating) \ub2a5\ub825\uc774 \uc694\uad6c\ub418\ub294 \uc808\ucc28\uc758 \uacbd\uc6b0, \uc801\uc808\ud55c \uac15\uc81c \ubd84\ud574(forced degradation) \uc5f0\uad6c\ub97c \uac1c\ubc1c\uc5d0 \ud3ec\ud568\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc2a4\ud2b8\ub808\uc2a4(stress) \uc5f0\uad6c\ub294 \uc120\ud0dd\uc131\uc744 \ud3c9\uac00\ud558\uace0 \ucd94\uac00 \ucd5c\uc801\ud654\uac00 \ud544\uc694\ud560 \uc218 \uc788\ub294 \ubd84\ud574 \uad00\ub828 \ubd84\ub9ac<\/strong>\ub97c \uc2dd\ubcc4\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 \ubaa8\ub4e0 \ubd84\uc11d \uc808\ucc28\uc5d0 \ud544\uc218 \ub2e8\uacc4\ub294 \uc544\ub2d9\ub2c8\ub2e4. \uad00\ub828\uc131\uc740 \ubc29\ubc95\uc758 \uc758\ub3c4\ub41c \ubaa9\uc801\uacfc \uc81c\ud488\uc758 \ud2b9\uc131\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4. <\/span><\/p>\n<ol start=\"5\">\n<li><span style=\"font-size: 14pt;\"><strong> \uc2e4\ud5d8\uacc4\ud68d\ubc95 \ubc0f \ubc29\ubc95 \ucd5c\uc801\ud654<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">enhanced \uc811\uadfc\ubc95\uc744 \uc9c0\uc6d0\ud560 \uc218 \uc788\ub294 \ub3c4\uad6c \uc911 \ud558\ub098\ub294 <strong>Design of Experiments (DoE)<\/strong>\uc785\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ud55c \ubc88\uc5d0 \ud558\ub098\uc758 \ud30c\ub77c\ubbf8\ud130\ub9cc \uc870\uc0ac\ud558\ub294 \ub300\uc2e0, \uc801\uc808\ud788 \uc124\uacc4\ub41c \uc2e4\ud5d8\uc744 \ud1b5\ud574 \uad00\ub828 \ubd84\uc11d \uc808\ucc28 \ud30c\ub77c\ubbf8\ud130\uc758 \uc601\ud5a5\uacfc, \ud574\ub2f9\ub418\ub294 \uacbd\uc6b0 \uadf8 \uc0c1\ud638\uc791\uc6a9\uc744 \uc5f0\uad6c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uadf8 \uacb0\uacfc \ub370\uc774\ud130\ub294 <strong>\ucd5c\uc801\ud654\ub97c \uc704\ud55c \ubcf4\ub2e4 \uccb4\uacc4\uc801\uc778 \uadfc\uac70\uc640, \uc11c\ub85c \ub2e4\ub978 \uc870\uac74\uc774 \ubd84\uc11d \uc131\ub2a5\uc5d0 \uc5b4\ub5bb\uac8c \uc601\ud5a5\uc744 \ubbf8\uce58\ub294\uc9c0 \uc774\ud574\ud558\uae30 \uc704\ud55c \uae30\ubc18<\/strong>\uc744 \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc911\uc694\ud558\uac8c\ub3c4 <strong>ICH Q14<\/strong>\ub294 \ubaa8\ub4e0 enhanced \ubd84\uc11d \uc808\ucc28\uc5d0 DoE\ub97c \uc758\ubb34\ud654\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uc801\uc808\ud55c \uacbd\uc6b0 \uc0ac\uc6a9\ud560 \uc218 \uc788\ub294 \uc694\uc18c\ub85c\uc11c \ub2e8\ubcc0\ub7c9 \ub610\ub294 \ub2e4\ubcc0\ub7c9 \uc2e4\ud5d8 \ubc0f \ubaa8\ub378\ub9c1\uc744 \uc124\uba85\ud569\ub2c8\ub2e4. <\/span><\/p>\n<ol start=\"6\">\n<li><span style=\"font-size: 14pt;\"><strong> Method Operable Design Region<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\uc2e4\ud5d8\uc744 \ud1b5\ud574 \uc0dd\uc131\ub41c \uc9c0\uc2dd\uc740 \uc801\uc808\ud55c \ud30c\ub77c\ubbf8\ud130 \ubc94\uc704\ub97c \uc124\uc815\ud558\ub294 \ub370 \ud65c\uc6a9\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ud574\ub2f9\ub418\ub294 \uacbd\uc6b0, \uc774\ub294 <strong>Method Operable Design Region (MODR)<\/strong>\uc744 \ud3ec\ud568\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc989, \uc808\ucc28\uac00 \uc0ac\uc804\uc5d0 \uc815\uc758\ub41c \uc131\ub2a5 \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud568\uc774 \uc785\uc99d\ub418\ub294 \uad00\ub828 \ubd84\uc11d \uc808\ucc28 \ud30c\ub77c\ubbf8\ud130 \ubc94\uc704\ub4e4\uc758 \uc870\ud569\uc785\ub2c8\ub2e4.<\/span><\/p>\n<ol start=\"7\">\n<li><span style=\"font-size: 14pt;\"><strong> \ubd84\uc11d \uc808\ucc28 \uad00\ub9ac \uc804\ub7b5<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\uadf8\ub2e4\uc74c <strong>\uac1c\ubc1c \uc9c0\uc2dd\uc744 \ubd84\uc11d \uc808\ucc28 \uad00\ub9ac \uc804\ub7b5(analytical procedure control strategy)\uc73c\ub85c \uc804\ud658<\/strong>\ud560 \uc218 \uc788\uc73c\uba70, \uc5ec\uae30\uc5d0\ub294 \uc801\uc808\ud55c \ud30c\ub77c\ubbf8\ud130 \uc124\uc815\uac12(set-point) \ub610\ub294 \ubc94\uc704\uc640 \uad00\ub828 \uc2dc\uc2a4\ud15c \uc801\ud569\uc131(system suitability) \uae30\uc900\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 \uac1c\ubc1c \uc911 \uc0dd\uc131\ub41c \uc9c0\uc2dd\uacfc, \ubd84\uc11d \uc808\ucc28\uac00 \uc77c\uc0c1\uc801\uc73c\ub85c \uc0ac\uc6a9\ub420 \ub54c \uc801\uc6a9\ub420 \uc870\uac74\uc744 \uc5f0\uacb0\ud569\ub2c8\ub2e4.<\/span><\/p>\n<ol start=\"8\">\n<li><span style=\"font-size: 14pt;\"><strong> \uac1c\ubc1c \uc9c0\uc2dd \ubb38\uc11c\ud654<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\ub9c8\uc9c0\ub9c9\uc73c\ub85c \uac1c\ubc1c \uc791\uc5c5\uc740 \ucd5c\uc885 \ubc29\ubc95\ubfd0 \uc544\ub2c8\ub77c \uadf8 \ubc30\uacbd\uc774 \ub418\ub294 \uacfc\ud559\uc801 \uadfc\uac70\uae4c\uc9c0 \ud3ec\ucc29\ud560 \uc218 \uc788\ub294 \ubc29\uc2dd\uc73c\ub85c \ubb38\uc11c\ud654\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ud3ec\uad04\uc801\uc778 \uac1c\ubc1c \ubcf4\uace0\uc11c\ub294 \uac1c\ubc1c \ub370\uc774\ud130, \ud1b5\uacc4\uc801 \ud3c9\uac00, \ud575\uc2ec \uae30\uc220\uc801 \uc758\uc0ac\uacb0\uc815, \uadf8\ub9ac\uace0 \ucd5c\uc885 \ubd84\uc11d \uc808\ucc28 \ubc0f \uadf8 \uc6b4\uc6a9 \uc870\uac74\uc5d0 \ub300\ud55c \uc815\ub2f9\ud654\ub97c \ud568\uaed8 \uc815\ub9ac\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc774\ub294 Kymos\uac00 \ub0b4\ubd80 AQbD \uac1c\ubc1c \uc6cc\ud06c\ud50c\ub85c\uc6b0\uc5d0\uc11c \ucc44\ud0dd\ud55c \uad6c\uc870\uc785\ub2c8\ub2e4.<\/strong> \uadf8 \uacb0\uacfc \uac1c\ubc1c \ud328\ud0a4\uc9c0\ub294 \ud6c4\uc18d \ubc38\ub9ac\ub370\uc774\uc158, \ubc29\ubc95 \uc774\uc804 \ubc0f \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac\ub97c \uc9c0\uc6d0\ud558\uae30 \uc704\ud55c \uac83\uc785\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>ICH Q14\uc640 \ubd84\uc11d \uc808\ucc28 \ub77c\uc774\ud504\uc0ac\uc774\ud074<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>ICH Q14<\/strong>\uc758 \ud575\uc2ec \uac1c\ub150 \uc911 \ud558\ub098\ub294 <strong>\ubd84\uc11d \uc808\ucc28 \ub77c\uc774\ud504\uc0ac\uc774\ud074<\/strong>\uc785\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc774 \uac00\uc774\ub4dc\ub77c\uc778\uc740 \ubd84\uc11d \uc808\ucc28 \uac1c\ubc1c\uacfc \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac\uac00 \uc5f0\uacb0\ub418\uc5b4 \uc788\uc74c\uc744 \uc778\uc815<\/strong>\ud558\uba70, \uac1c\ubcc4 \ud65c\ub3d9\uc758 \uc21c\uc11c\uc640 \ubc94\uc704\ub294 \uc758\ub3c4\ub41c \ubaa9\uc801\uacfc \uac1c\ubc1c \uc811\uadfc\ubc95\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc74c\uc744 \uba85\uc2dc\ud569\ub2c8\ub2e4. \ub610\ud55c \uc5ec\ub7ec \ud65c\ub3d9\uc774 \ub3d9\uc2dc\uc5d0 \uc9c4\ud589\ub420 \uc218\ub3c4 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 <strong>\uac1c\ubc1c \uc791\uc5c5\uc758 \uac00\uce58\uac00 \ucd5c\uc885 \ubd84\uc11d \uc870\uac74\uc774 \ud655\ub9bd\ub418\ub294 \uc2dc\uc810\uc5d0\ub9cc \uad6d\ud55c\ub418\uc9c0 \uc54a\ub294\ub2e4<\/strong>\ub294 \uac83\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uac1c\ubc1c \uc911 \uc0dd\uc131\ub41c \uc9c0\uc2dd\uc740 \ub2e4\uc74c\uc5d0 \ub300\ud55c \ub354 \ub098\uc740 \uc774\ud574\uc5d0 \uae30\uc5ec\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uc5b4\ub5a4 \ud30c\ub77c\ubbf8\ud130\uac00 \ubc29\ubc95 \uc131\ub2a5\uc5d0 \uac00\uc7a5 \ud070 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294\uc9c0<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud574\ub2f9 \ud30c\ub77c\ubbf8\ud130\uc758 \ubcc0\ub3d9\uc774 \ubd84\uc11d \uc808\ucc28\uc5d0 \uc5b4\ub5a4 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294\uc9c0<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc5b4\ub5a4 \uc6b4\uc6a9 \ubc94\uc704\ub97c \uacfc\ud559\uc801\uc73c\ub85c \uc815\ub2f9\ud654\ud560 \uc218 \uc788\ub294\uc9c0<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc77c\uc0c1\uc801 \uc0ac\uc6a9 \uc911 \uc5b4\ub5a4 \uad00\ub9ac(control)\uac00 \uad00\ub828\ub418\ub294\uc9c0<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ubcc0\uacbd\uc774 \ud544\uc694\ud560 \ub54c \uc808\ucc28\ub97c \uc5b4\ub5bb\uac8c \uad00\ub9ac\ud560 \uc218 \uc788\ub294\uc9c0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uc9c0\uc2dd\uc758 \ucd95\uc801\uc740 \ubc38\ub9ac\ub370\uc774\uc158, \uc774\uc804, \uc77c\uc0c1\uc801 \uc0ac\uc6a9 \ubc0f \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac\ub97c \ud3ec\ud568\ud558\uc5ec <strong>\ubc29\ubc95 \ub77c\uc774\ud504\uc0ac\uc774\ud074\uc758 \ud6c4\uc18d \ub2e8\uacc4\uc5d0 \ub300\ud55c \ub354 \uac15\ud55c \uae30\ubc18<\/strong>\uc744 \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>AQbD\uc640 \ubd84\uc11d\ubc95 \ubc38\ub9ac\ub370\uc774\uc158<\/strong><\/span><\/h2>\n<p><strong><span style=\"font-size: 14pt;\">AQbD\ub294 \ubd84\uc11d \uc808\ucc28 \ubc38\ub9ac\ub370\uc774\uc158\uc744 \ub300\uccb4\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>ICH Q14\ub294 \ubd84\uc11d \uc808\ucc28 \uac1c\ubc1c\uc744 \ub2e4\ub8e8\ub294 \ubc18\uba74, ICH Q2(R2)\ub294 \ubc38\ub9ac\ub370\uc774\uc158\uc744 \uc704\ud55c \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4<\/strong>. \ub450 \uac00\uc774\ub4dc\ub77c\uc778\uc740 \uc0c1\ud638 \ubcf4\uc644\uc801\uc785\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub3d9\uc2dc\uc5d0, \uac1c\ubc1c \uc911 \uc0dd\uc131\ub41c \ub370\uc774\ud130\ub294 \ubc38\ub9ac\ub370\uc774\uc158 \uc804\ub7b5\uc5d0 \uae30\uc5ec\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<strong> ICH Q14<\/strong>\ub294 DoE \uc5f0\uad6c\uc5d0\uc11c\uc758 \uacac\uace0\uc131(robustness) \ub370\uc774\ud130\uc640 \uac19\uc740 \uac1c\ubc1c \ub370\uc774\ud130\uac00 \uad00\ub828 \ubd84\uc11d \uc808\ucc28 \uc131\ub2a5 \ud2b9\uc131\uc5d0 \ub300\ud55c \ubc38\ub9ac\ub370\uc774\uc158 \ub370\uc774\ud130\uc758 \uc77c\ubd80\ub85c \uc0ac\uc6a9\ub420 \uc218 \uc788\uc74c\uc744 \uc5b8\uae09\ud558\uba70, \uc774\ub294 \ud2b9\uc815 \uc5f0\uad6c\ub97c \ubc18\ub4dc\uc2dc \ubc18\ubcf5\ud560 \ud544\uc694\uac00 \uc5c6\uc744 \uc218 \uc788\uc74c\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 \ub354 \uc5f0\uacb0\ub41c \ud504\ub85c\uc138\uc2a4\ub97c \ub9cc\ub4ed\ub2c8\ub2e4. \uc989, <strong>\uac1c\ubc1c \uc911 \uc0dd\uc131\ub41c \uacfc\ud559\uc801 \uc774\ud574\uac00 \ubc38\ub9ac\ub370\uc774\uc158 \uc804\ub7b5\uc744 \ud615\uc131<\/strong>\ud560 \uc218 \uc788\uc73c\uba70, \uac1c\ubc1c \ub2e8\uacc4\uac00 \uc644\ub8cc\ub41c \ud6c4\uc5d0 \ub2e8\uc808\ub418\uc5b4 \ub0a8\uaca8\uc9c0\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\ubd84\uc11d \uc808\ucc28 \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac \uc9c0\uc6d0<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>\ubd84\uc11d \uc808\ucc28 \ud30c\ub77c\ubbf8\ud130\uc5d0 \ub300\ud55c \ub354 \ub098\uc740 \uc774\ud574\ub294<\/strong> \uc81c\ud488 \ub77c\uc774\ud504\uc0ac\uc774\ud074 \ud6c4\ubc18\uc5d0 \ubcc0\uacbd\uc774 \ud544\uc694\ud560 \ub54c\ub3c4 \uac00\uce58 \uc788\uac8c \uc791\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc608\ub97c \ub4e4\uc5b4, enhanced \uac1c\ubc1c \uc811\uadfc\ubc95\uc740 \uacfc\ud559\uc801\uc73c\ub85c \uc815\ub2f9\ud654\ub41c \uc6b4\uc6a9 \ubc94\uc704\uc758 \uc815\uc758\uc640 \ubd84\uc11d \uc808\ucc28\uc5d0 \ub300\ud55c \uc801\uc808\ud55c \uc870\uac74\uc758 \ud655\ub9bd\uc744 \uc9c0\uc6d0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <strong>ICH Q14\ub294 \uc774\ub7ec\ud55c \uac15\ud654\ub41c \uc774\ud574\ub97c \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac\uc5d0\uc11c\uc758 \ub354 \ud070 \uc720\uc5f0\uc131 \ubc0f \ud2b9\uc815 \ud5c8\uac00 \ud6c4 \ubcc0\uacbd(post-approval changes)\uc758 \uad00\ub9ac\uc640 \uc5f0\uacb0\ud569\ub2c8\ub2e4.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 AQbD\ub85c \uac1c\ubc1c\ub41c \ubc29\ubc95\uc774 \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d\uc744 \uc790\ub3d9\uc73c\ub85c \uc81c\uac70\ud558\uac70\ub098 \ud5a5\ud6c4 \ubcc0\uacbd\uc744 \ud68c\ud53c\ud55c\ub2e4\ub294 \uc758\ubbf8\ub294 \uc544\ub2d9\ub2c8\ub2e4. \uc624\ud788\ub824 \uac1c\ubc1c \uc9c0\uc2dd\uacfc \uacfc\ud559\uc801\uc73c\ub85c \uc815\ub2f9\ud654\ub41c \ubc94\uc704\ub294 \uadf8\ub7ec\ud55c \ubcc0\uacbd\uc744 \ud3c9\uac00\ud558\uace0 \uad00\ub9ac\ud558\ub294 \ub370 \ub354 \uac15\ud55c \uadfc\uac70\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\ub3d9\uc77c\ud55c \uc6d0\uce59\uc740 \ubd84\uc11d \uc808\ucc28 \uc774\uc804\uc5d0\ub3c4 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/strong> \uad00\ub828 \ud30c\ub77c\ubbf8\ud130, \uc131\ub2a5 \uc694\uad6c\uc0ac\ud56d \ubc0f \uc6b4\uc6a9 \ubc94\uc704\uac00 \uc798 \uc774\ud574\ub41c \ubc29\ubc95\uc740, \uc808\ucc28\ub97c \ub2e4\ub978 \uc2e4\ud5d8\uc2e4\uc5d0\uc11c \uad6c\ud604\ud558\uac70\ub098 \ub2e4\ub978 \uc6b4\uc6a9 \uc870\uac74 \ud558\uc5d0\uc11c \uc801\uc6a9\ud574\uc57c \ud560 \ub54c \ub354 \uc644\uc804\ud55c \uc9c0\uc2dd \uae30\ubc18\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uac1c\ubc1c \uc911 \uacfc\ud559\uc801 \uc774\ud574 \uad6c\ucd95<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>enhanced \ubd84\uc11d \uac1c\ubc1c\uc758 \uacb0\uacfc\ub294 \uc131\ub2a5\uc5d0 \ub300\ud55c \ub354 \uae4a\uc740 \uc774\ud574\ub85c \ub4b7\ubc1b\uce68\ub418\ub294 \ubc29\ubc95\uc785\ub2c8\ub2e4.<\/strong> \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4\ub294 \uc65c \ud2b9\uc815 \uc870\uac74\uc774 \uc120\ud0dd\ub418\uc5c8\ub294\uc9c0, \uc5b4\ub5a4 \ubcc0\uc218\uac00 \ubc29\ubc95\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294\uc9c0, \uadf8\uac83\ub4e4\uc774 \uc5b4\ub5bb\uac8c \uc0c1\ud638\uc791\uc6a9\ud558\ub294\uc9c0, \uadf8\ub9ac\uace0 \uc808\ucc28\uac00 \uc5b4\ub514\uc5d0\uc11c \uc2e0\ub8b0\uc131 \uc788\uac8c \uc6b4\uc6a9\ub420 \uc218 \uc788\ub294\uc9c0\uc5d0 \ub300\ud55c \uc9c0\uc2dd\uc744 \uc0dd\uc131\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uc9c0\uc2dd\uc740 \uac1c\ubc1c\uc774 \uc644\ub8cc\ub41c \uc774\ud6c4\uc5d0\ub3c4 \uc720\uc6a9\ud558\uac8c \ub0a8\uc2b5\ub2c8\ub2e4. <strong>\ubd84\uc11d \uc808\ucc28\ub294 \ubc38\ub9ac\ub370\uc774\uc158, \uc774\uc804 \ubc0f \uc77c\uc0c1\uc801 \uc0ac\uc6a9 \ub3d9\uc548\ubfd0 \uc544\ub2c8\ub77c, \ub77c\uc774\ud504\uc0ac\uc774\ud074 \ud6c4\ubc18\uc5d0 \ubcc0\uacbd\uc774 \ub3c4\uc785\ub420 \ub54c\uc5d0\ub3c4 \uc758\ub3c4\ub41c \ubaa9\uc801\uc5d0 \uc801\ud569\ud55c \uc0c1\ud0dc\ub97c \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uac1c\ubc1c \uc911 \uc218\ud589\ub418\ub294 \ub9ac\uc2a4\ud06c \ud3c9\uac00, \uc2e4\ud5d8 \uc5f0\uad6c, \ud1b5\uacc4\uc801 \ud3c9\uac00 \ubc0f \uc6b4\uc6a9 \ubc94\uc704 \uc815\uc758\ub294 \uc774\ub7ec\ud55c \ub2e8\uacc4 \uc804\ubc18\uc5d0\uc11c \ubc29\ubc95\uc744 \uad00\ub9ac\ud558\uae30 \uc704\ud55c \uacfc\ud559\uc801 \uadfc\uac70\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \ub610\ud55c \uc0dd\uc131\ub41c \uc9c0\uc2dd\uc740 \uad00\ub9ac \uc804\ub7b5(control strategy)\uc5d0 \uc815\ubcf4\ub97c \uc81c\uacf5\ud558\uace0, \ubd84\uc11d \uc808\ucc28\uac00 \uc9c4\ud654\ud574\uc57c \ud560 \ub54c \ubcc0\uacbd\uc744 \ud3c9\uac00\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc81c\uc57d \uac1c\ubc1c \ubc0f \ud488\uc9c8 \uad00\ub9ac\ub97c \uc9c0\uc6d0\ud558\ub294 \ubd84\uc11d \uc808\ucc28\uc758 \uacbd\uc6b0, \uc774\ub7ec\ud55c \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\uc810\uc740 ICH Q14\uc5d0 \uc124\uba85\ub41c enhanced \uc811\uadfc\ubc95\uc758 \uc911\uc694\ud55c \uc694\uc18c\uc785\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Kymos\uc5d0\uc11c\uc758 AQbD \uad6c\ud604<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>Kymos\uc5d0\uc11c\ub294 AQbD \uc6d0\uce59\uc758 \uad6c\ud604\uc774 \ud604\uc7ac\uc758 \ubd84\uc11d \uac1c\ubc1c \ud504\ub808\uc784\uc6cc\ud06c, \ud2b9\ud788 ICH Q14 \ubc0f ICH Q2(R2)\uc5d0 \ub300\ud55c \uac80\ud1a0<\/strong>\uc640 \uad00\ub828 \uacfc\ud559 \ubc0f \uc0b0\uc5c5 \uc790\ub8cc\ub97c \ud568\uaed8 \uc0b4\ud3b4\ubcf4\ub294 \uac83\uc5d0\uc11c \uc2dc\uc791\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ud6c4 Kymos Italy\uc758 Lab Efficiency \ud300\uc740 \uc774 \uc9c0\uc2dd\uc744 \ub0b4\ubd80 \uad50\uc721 \uc790\ub8cc\uc640 \uadf8\ub8f9 \uc804\uccb4\ub97c \uc704\ud55c \uc81c\uc548 \uac1c\ubc1c \uc6cc\ud06c\ud50c\ub85c\uc6b0\ub85c \uc804\ud658\ud588\uc2b5\ub2c8\ub2e4. \uc811\uadfc\ubc95\uc774 \uc2e4\uc81c\ub85c \uc5b4\ub5bb\uac8c \uc791\ub3d9\ud558\ub294\uc9c0 \ud3c9\uac00\ud558\uae30 \uc704\ud574 <strong>\uae30\uc874 \ubc29\ubc95 \uac1c\ubc1c \ud504\ub85c\uc81d\ud2b8\ub97c \ub0b4\ubd80 \ud30c\uc77c\ub7ff\uc73c\ub85c \uc120\uc815<\/strong>\ud588\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \ud30c\uc77c\ub7ff\uc758 \ubaa9\uc801\uc740 \uace0\uac1d\uc758 \ud504\ub85c\uc81d\ud2b8\ub97c \ubcc0\uacbd\ud558\uac70\ub098 \uace0\uac1d\uc5d0\uac8c \ucd94\uac00 AQbD \ud328\ud0a4\uc9c0\ub97c \uc81c\uacf5\ud558\ub294 \uac83\uc774 \uc544\ub2c8\uc5c8\uc2b5\ub2c8\ub2e4. \ub300\uc2e0 \uc81c\uc548\ub41c \uc811\uadfc\ubc95\uc744 \ud14c\uc2a4\ud2b8\ud558\uace0, \ud3ec\ud568\ub418\ub294 \ud65c\ub3d9\uc744 \uc2dd\ubcc4\ud558\uba70, \ucd94\uac00\ub85c \ud544\uc694\ud55c \uac1c\ubc1c \ub178\ub825 \uc218\uc900\uc744 \uc774\ud574\ud558\uae30 \uc704\ud574 AQbD \uc6d0\uce59\uc744 \uc0ac\uc6a9\ud558\uc5ec \ub0b4\ubd80\uc801\uc73c\ub85c \ubc29\ubc95 \uac1c\ubc1c\uc744 \uc218\ud589\ud588\uc2b5\ub2c8\ub2e4.  <strong>\uadf8 \uacb0\uacfc \ubcf4\uace0\uc11c\ub294 \uc774 \uc0c8\ub85c\uc6b4 \uc811\uadfc\ubc95\uc758 \uae30\ubc18\uc774 \ub418\ub294 \ub0b4\ubd80 \uac1c\ubc1c \ubb38\uc11c\uc600\uc2b5\ub2c8\ub2e4.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc774\ub7ec\ud55c \uc2e4\ubb34 \uacbd\ud5d8\uc740 \uc774\uc81c \ud504\ub85c\uc81d\ud2b8\ubcc4 \uc694\uad6c\uc0ac\ud56d\uacfc \uace0\uac1d\uc758 \ub2c8\uc988\uc5d0 \ub9de\uac8c \uc870\uc815\ub41c AQbD \uae30\ubc18 \ubd84\uc11d\ubc95 \uac1c\ubc1c\uc758 Kymos \uc804\uc0ac\uc801 \uad6c\ud604\uc744 \uc9c0\uc6d0<\/strong>\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>AQbD\ub294 \ubc29\ubc95 \uc131\ub2a5\uacfc \uadf8\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uc694\uc778\uc744 \uc774\ud574\ud558\uae30 \uc704\ud55c \ubcf4\ub2e4 \uad6c\uc870\ud654\ub41c \uc811\uadfc\ubc95\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/strong> \uac1c\ubc1c \uc911 \ud655\ubcf4\ub41c \uc9c0\uc2dd\uc740 \uacac\uace0\ud55c \uc6b4\uc6a9 \uc870\uac74\uc744 \ud655\ub9bd\ud558\uace0, \ubc29\ubc95 \uc774\uc804\uc744 \uc9c0\uc6d0\ud558\uba70, \uacfc\ud559\uc801\uc73c\ub85c \uc815\ub2f9\ud654\ub418\ub294 \ubc94\uc704 \ub0b4\uc5d0\uc11c \ubd84\uc11d \uc808\ucc28 \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uc804\ubc18\uc758 \ubcc0\uacbd \uad00\ub9ac\ub97c \ub4b7\ubc1b\uce68\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Kymos\ub294 \uac01 \ud504\ub85c\uc81d\ud2b8\uc5d0 \uac00\uc7a5 \uc801\ud569\ud55c \uc811\uadfc\ubc95\uc744 \uc0ac\uc6a9\ud55c \ubd84\uc11d\ubc95 \uac1c\ubc1c\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/strong> \uace0\uac1d\uc740 \uae30\uc874 \uac1c\ubc1c \uc804\ub7b5 \ub610\ub294 <strong>\ubc29\ubc95\uc5d0 \ub300\ud55c \ubcf4\ub2e4 \uc0c1\uc138\ud55c \uc774\ud574\ub97c \uad6c\ucd95\ud558\uae30 \uc704\ud574 \ucd94\uac00 \uac1c\ubc1c \ud65c\ub3d9\uacfc \ubb38\uc11c\ud654\ub97c \ud3ec\ud568\ud558\ub294 AQbD \uae30\ubc18 \uc811\uadfc\ubc95<\/strong>\uc744 \uc120\ud0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud6c4\uc790\ub294 \uacac\uace0\uc131, \uc2e4\ud5d8\uc2e4 \uac04 \uc774\uc804 \ub610\ub294 \ud5a5\ud6c4 \ub77c\uc774\ud504\uc0ac\uc774\ud074 \ubcc0\uacbd\uc774 \uc911\uc694\ud55c \uace0\ub824\uc0ac\ud56d\uc77c \ub54c \ud2b9\ud788 \uac00\uce58\uac00 \uc788\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Kymos\ub294 \uc18c\ubd84\uc790, \ubc14\uc774\uc624\uc758\uc57d\ud488(biologics), \uc62c\ub9ac\uace0\ub274\ud074\ub808\uc624\ud0c0\uc774\ub4dc \ubc0f \ud3a9\ud0c0\uc774\ub4dc, \uadf8\ub9ac\uace0 \uc138\ud3ec\u00b7\uc720\uc804\uc790 \uce58\ub8cc\uc81c\uc5d0 \ub300\ud55c \ubd84\uc11d\ubc95 \uac1c\ubc1c, \ubc38\ub9ac\ub370\uc774\uc158 \ubc0f \uc774\uc804\uc744 \ud1b5\ud574 \uc81c\uc57d \ubc0f \ubc14\uc774\uc624\ud14d \uae30\uc5c5\uc744 \uc9c0\uc6d0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubd84\uc11d\ubc95 \uac1c\ubc1c \ud504\ub85c\uc81d\ud2b8\uc5d0 \ub300\ud574 \ub17c\uc758\ud558\uace0 \uc2f6\uc73c\uc2e0\uac00\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> \ub610\ub294 <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a>\uc73c\ub85c \uc800\ud76c \ud300\uc5d0 \ubb38\uc758\ud574 \uc8fc\uc138\uc694. <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\ubd84\uc11d\ubc95\uc740 \uc758\ub3c4\ub41c \ubaa9\uc801\uc5d0 \ub300\ud574 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uacb0\uacfc\ub97c \uc81c\uacf5\ud574\uc57c \ud558\uc9c0\ub9cc,  [&#8230;]<\/p>\n","protected":false},"author":8,"featured_media":48369,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[261],"tags":[],"class_list":["post-48383","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-261"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\ubd84\uc11d\ubc95 \uac1c\ubc1c: AQbD \uc811\uadfc\ubc95 | Kymos<\/title>\n<meta name=\"description\" content=\"AQbD\uac00 ICH Q14 \ud558\uc5d0\uc11c \ubd84\uc11d\ubc95 \uac1c\ubc1c\uc744 \uc5b4\ub5bb\uac8c \uc9c0\uc6d0\ud558\uba70, \ubc29\ubc95 \uacac\uace0\uc131, \ubc38\ub9ac\ub370\uc774\uc158, \uc774\uc804 \ubc0f \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac\ub97c \uc5b4\ub5bb\uac8c \uac1c\uc120\ud558\ub294\uc9c0 \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\/%eb%b6%84%ec%84%9d%eb%b2%95-%ea%b0%9c%eb%b0%9c-aqbd-%ec%a0%91%ea%b7%bc%eb%b2%95\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\ubd84\uc11d\ubc95 \uac1c\ubc1c: AQbD \uc811\uadfc\ubc95 | Kymos\" \/>\n<meta property=\"og:description\" content=\"AQbD\uac00 ICH Q14 \ud558\uc5d0\uc11c \ubd84\uc11d\ubc95 \uac1c\ubc1c\uc744 \uc5b4\ub5bb\uac8c \uc9c0\uc6d0\ud558\uba70, \ubc29\ubc95 \uacac\uace0\uc131, \ubc38\ub9ac\ub370\uc774\uc158, \uc774\uc804 \ubc0f \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uad00\ub9ac\ub97c \uc5b4\ub5bb\uac8c \uac1c\uc120\ud558\ub294\uc9c0 \uc54c\uc544\ubcf4\uc138\uc694.\" \/>\n<meta property=\"og:url\" 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\ub418\ub294 \ud310\ub3c5 \uc2dc\uac04\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\ubd84\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/kymos.com\\\/ko\\\/news\\\/%eb%b6%84%ec%84%9d%eb%b2%95-%ea%b0%9c%eb%b0%9c-aqbd-%ec%a0%91%ea%b7%bc%eb%b2%95\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kymos.com\\\/ko\\\/news\\\/%eb%b6%84%ec%84%9d%eb%b2%95-%ea%b0%9c%eb%b0%9c-aqbd-%ec%a0%91%ea%b7%bc%eb%b2%95\\\/\"},\"author\":{\"name\":\"Sandra Magdaleno\",\"@id\":\"https:\\\/\\\/kymos.com\\\/ko\\\/#\\\/schema\\\/person\\\/b0ed444c71c4c8afa6f4ae674967c999\"},\"headline\":\"\ubd84\uc11d\ubc95 \uac1c\ubc1c: AQbD 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