{"id":30504,"date":"2026-01-22T10:11:54","date_gmt":"2026-01-22T09:11:54","guid":{"rendered":"https:\/\/kymos.com\/news\/%eb%af%b8%ea%b5%ad-%ed%8a%b9%ed%97%88-%ec%9d%bc%ed%9a%8c%ec%9a%a9-%ec%8b%9c%ec%8a%a4%ed%85%9c%ec%9d%98-%ec%b6%94%ec%b6%9c%eb%ac%bc-%eb%b0%8f-%ec%9a%a9%ec%b6%9c%eb%ac%bc\/"},"modified":"2026-01-22T10:11:54","modified_gmt":"2026-01-22T09:11:54","slug":"%eb%af%b8%ea%b5%ad-%ed%8a%b9%ed%97%88-%ec%9d%bc%ed%9a%8c%ec%9a%a9-%ec%8b%9c%ec%8a%a4%ed%85%9c%ec%9d%98-%ec%b6%94%ec%b6%9c%eb%ac%bc-%eb%b0%8f-%ec%9a%a9%ec%b6%9c%eb%ac%bc","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%eb%af%b8%ea%b5%ad-%ed%8a%b9%ed%97%88-%ec%9d%bc%ed%9a%8c%ec%9a%a9-%ec%8b%9c%ec%8a%a4%ed%85%9c%ec%9d%98-%ec%b6%94%ec%b6%9c%eb%ac%bc-%eb%b0%8f-%ec%9a%a9%ec%b6%9c%eb%ac%bc\/","title":{"rendered":"\ubbf8\uad6d \ud2b9\ud5c8<665> \/<1665> \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc758 \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c(SUS)\uc740 \ud604\ub300 \ubc14\uc774\uc624\uc758\uc57d\ud488 \uc81c\uc870\uc5d0\uc11c \ud544\uc218\uc801\uc778 \uc694\uc18c\uac00 \ub418\uc5c8\uc2b5\ub2c8\ub2e4. \ud3f4\ub9ac\uba38 \uae30\ubc18 \uad6c\uc131 \uc694\uc18c\ub294 \uc720\uc5f0\uc131, \uc138\ucc99 \uc694\uad6c \uc0ac\ud56d \uac10\uc18c, \uacf5\uc815 \uc804\ud658 \uc18d\ub3c4 \ud5a5\uc0c1 \ub4f1\uc758 \uc774\uc810\uc744 \uc81c\uacf5\ud558\uba70, \uc0c1\ub958 \uc0dd\ubb3c\ubc18\uc751\uae30, \ud558\ub958 \uc5ec\uacfc \ub610\ub294 \ucda9\uc804 \uc7a5\uce58\uc640 \uac19\uc740 \ub2e4\uc591\ud55c \ubd84\uc57c\uc5d0\uc11c \uc0ac\uc6a9\ub429\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub3d9\uc2dc\uc5d0, \uc774\ub7ec\ud55c \uc81c\ud488\uc758 \uad11\ubc94\uc704\ud55c \uc0ac\uc6a9\uc740 <strong>\ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c(E&amp;L)<\/strong> \ud3c9\uac00\uc758 \uc911\uc694\uc131\uc744 \ub354\uc6b1 \uac15\uc870\ud574 \uc654\uc2b5\ub2c8\ub2e4. \uc81c\ud488 \ud488\uc9c8, \ud658\uc790 \uc548\uc804 \ubc0f \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uae30 \uc704\ud574\uc11c\ub294 \uc77c\ud68c\uc6a9 \uc81c\ud488\uacfc \uc0dd\uc0b0 \uacf5\uc815 \uac04\uc758 \ud654\ud559\uc801 \uc0c1\ud638\uc791\uc6a9\uc744 \uc774\ud574\ud558\uace0 \uad00\ub9ac\ud558\ub294 \uac83\uc774 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc0c8\ub85c\uc6b4 \uc77c\ubc18 USP \uc7a5\uc774 \ub3c4\uc785\ub428\uc5d0 \ub530\ub77c <strong>&lt;665&gt;<\/strong> \uadf8\ub9ac\uace0 <strong>&lt;1665&gt;<\/strong> \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \ud6a8\ub2a5 \ubc0f \uc218\uba85(E&amp;L) \uc5f0\uad6c\uc5d0 \ub300\ud55c \uae30\ub300\uce58\uac00 \uc810\ucc28 \uba85\ud655\ud574\uc9c0\uace0 \uccb4\uacc4\ud654\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c \uc774\ub294 \uaddc\uc81c\uc0c1\uc758 \uc911\uc694\ud55c \uc774\uc815\ud45c\uc778 \ub3d9\uc2dc\uc5d0 \uc704\ud5d8 \uae30\ubc18\uc758 CMC \uc804\ub7b5\uc744 \uac15\ud654\ud560 \uc218 \uc788\ub294 \uae30\ud68c\uc785\ub2c8\ub2e4. <\/span><\/p>\n<h2><strong>\ubc14\uc774\uc624\uc81c\uc57d \ubd84\uc57c\uc758 \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c: \uc774\uc810 \ubc0f \ud6a8\uc728\uc131\/\ube44\uc6a9 \uce21\uba74\uc5d0\uc11c\uc758 \uacfc\uc81c<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc77c\ud68c\uc6a9 \uae30\uc220\uc740 \uc774\uc81c \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870\uc5d0 \ub110\ub9ac \ub3c4\uc785\ub418\uc5b4 \uc720\uc5f0\ud55c \uc2dc\uc124 \uc124\uacc4, \uc138\ucc99 \ubc0f \uad50\ucc28 \uc624\uc5fc \uc704\ud5d8 \uac10\uc18c, \uc2e0\uc18d\ud55c \uaddc\ubaa8 \ud655\uc7a5 \ub610\ub294 \ub2e4\ud488\ubaa9 \uc0dd\uc0b0\uc744 \uac00\ub2a5\ud558\uac8c \ud569\ub2c8\ub2e4. \uc0c1\ub958 \ubc0f \ud558\ub958 \uacf5\uc815 \uc804\ubc18\uc5d0 \uac78\uccd0 \ubc31, \ud29c\ube59, \ucee4\ub125\ud130, \ud544\ud130 \ubc0f \uc77c\ud68c\uc6a9 \uc0dd\ubb3c\ubc18\uc751\uae30\uc640 \uac19\uc740 \uad6c\uc131 \uc694\uc18c\uac00 \uc81c\uc870 \uc6cc\ud06c\ud50c\ub85c\uc5d0 \uc77c\uc0c1\uc801\uc73c\ub85c \ud1b5\ud569\ub429\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ud558\uc9c0\ub9cc \uae30\uc874\uc758 \uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15\uc774\ub098 \uc720\ub9ac \uc7a5\ube44\uc640\ub294 \ub2ec\ub9ac, \uc77c\ud68c\uc6a9 \ubd80\ud488\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uc0b0\ud654\ubc29\uc9c0\uc81c, \uac00\uc18c\uc81c, \uc548\uc815\uc81c, \uc548\ub8cc \ub610\ub294 \uac00\uacf5 \ubcf4\uc870\uc81c\uc640 \uac19\uc740 \ucca8\uac00\uc81c\ub97c \ud3ec\ud568\ud558\ub294 <strong>\ubcf5\ud569 \uace0\ubd84\uc790 \uc7ac\ub8cc<\/strong> \ub85c \ub9cc\ub4e4\uc5b4\uc9d1\ub2c8\ub2e4. \uc0ac\uc6a9 \uc870\uac74\uc5d0 \ub530\ub77c \ud2b9\uc815 \ubb3c\uc9c8\uc774 \uc7ac\ub8cc\uc5d0\uc11c \uacf5\uc815 \ud750\ub984\uc73c\ub85c \uc6a9\ucd9c\ub420 \uc218 \uc788\uc73c\uba70, \uc801\uc808\ud558\uac8c \ud3c9\uac00\ud558\uc9c0 \uc54a\uc73c\uba74 \uc81c\ud488 \ud488\uc9c8\uc774\ub098 \uc548\uc804\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uac00\ub2a5\uc131\uc774 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uc7a0\uc7ac\uc801\uc778 \uc774\ub3d9\uc740 <strong>\ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c\uc5d0<\/strong> \ub300\ud55c \uc6b0\ub824\uc758 \uadfc\uac70\uac00 \ub429\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\ucd94\ucd9c\ubb3c\uc740<\/strong> \uacfc\ub3c4\ud558\uac70\ub098 \uac15\uc81c\uc801\uc778 \uc870\uac74\uc5d0\uc11c \ubb3c\uc9c8\ub85c\ubd80\ud130 \ubc29\ucd9c\ub420 \uc218 \uc788\ub294 \ud654\ud569\ubb3c\uc785\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc6a9\ucd9c\ubb3c\uc9c8\uc740<\/strong> <span style=\"text-decoration: line-through;\">\uc2e4\uc81c<\/span> \uacf5\uc815 \ub610\ub294 \ubcf4\uad00 \uc870\uac74\uc5d0\uc11c \uc758\uc57d\ud488 \uc6d0\ub8cc \ub610\ub294 \uc644\uc81c\ud488\uc73c\ub85c \uc774\ub3d9\ud558\ub294 \ud654\ud569\ubb3c\uc785\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c\uc758 \uacbd\uc6b0, \ubbf8\ub7c9\uc758 \ubd88\uc21c\ubb3c\uc870\ucc28\ub3c4 \uc548\uc815\uc131, \uc548\uc804\uc131, \ud6a8\ub2a5\uc744 \ud3ec\ud568\ud55c <strong>\uc911\uc694\ud55c \ud488\uc9c8 \ud2b9\uc131<\/strong> \uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc73c\ubbc0\ub85c, E&amp;L \ud3c9\uac00\ub294 \uacf5\uc815 \uc774\ud574 \ubc0f \uad00\ub9ac\uc5d0 \uc788\uc5b4 \ud575\uc2ec\uc801\uc778 \ubd80\ubd84\uc785\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>USP\ub780 \ubb34\uc5c7\uc778\uac00\uc694?&lt; 665&gt; \uadf8\ub9ac\uace0&lt; 1665&gt; ?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">USP \ucc55\ud130&lt; 665&gt; \uadf8\ub9ac\uace0&lt; 1665&gt; <strong>\uc774\ub7ec\ud55c \uae30\uc220\uc740 \uc81c\uc57d \ubc0f \ubc14\uc774\uc624 \uc81c\uc57d \uc81c\uc870\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ud50c\ub77c\uc2a4\ud2f1 \ubd80\ud488 \ubc0f \uc2dc\uc2a4\ud15c<\/strong> \uacfc \uad00\ub828\ub41c E&amp;L \uc704\ud5d8\uc744 \ud574\uacb0\ud558\uae30 \uc704\ud574 \uac1c\ubc1c\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\ubbf8\uad6d \ud2b9\ud5c8&lt; 665&gt;<\/strong> \uc774 \uc7a5\uc740 \ud50c\ub77c\uc2a4\ud2f1 \ubd80\ud488 \ubc0f \uc2dc\uc2a4\ud15c\uc5d0\uc11c \ucd94\ucd9c\ub418\ub294 \ubb3c\uc9c8\uc744 \ud3c9\uac00\ud558\uae30 \uc704\ud55c \ud45c\uc900\ud654\ub41c \uc811\uadfc \ubc29\uc2dd\uc744 \uc815\uc758\ud558\ub294 <strong>\ud544\uc218 \uc77c\ubc18 \uc7a5<\/strong> \uc785\ub2c8\ub2e4. \uacf5\uc2dd \uc2dc\ud589\uc77c\uc740 <strong>2026\ub144 5\uc6d4<\/strong> 1\uc77c\uc785\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ubbf8\uad6d \ud2b9\ud5c8&lt; 1665&gt;<\/strong> \uc774 \uc7a5\uc740 E&amp;L \ud3c9\uac00\ub97c \uc9c0\uc6d0\ud558\ub294 \uc704\ud5d8 \ud3c9\uac00 \ubc0f \uc5f0\uad6c \uc124\uacc4 \uc6d0\uce59\uc744 \uc124\uba85\ud558\ub294 <strong>\uc9c0\uce68 \uc7a5<\/strong> \uc785\ub2c8\ub2e4.&lt; 665&gt; .<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc2e4\uc81c\ub85c\ub294,&lt; 665&gt; \ud574\uc57c \ud560 <em>\uc77c<\/em> \uc744 \uc815\uc758\ud558\ub294 \ubc18\uba74&lt; 1665&gt; \ubcf8 \ubb38\uc11c\uc5d0\uc11c\ub294 \uacfc\ud559\uc801\uc73c\ub85c \ud0c0\ub2f9\ud558\uace0 \uc704\ud5d8 \uae30\ubc18\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \ud1b5\ud574 \uc774\ub7ec\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc801\uc6a9\ud558\ub294 <em>\ubc29\ubc95\uc744<\/em> \uc124\uba85\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>USP\uc758 \ubc94\uc704&lt; 665&gt; \uadf8\ub9ac\uace0&lt; 1665&gt;<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\ubbf8\uad6d \ud2b9\ud5c8&lt; 665&gt; \uc774\ub294 <strong>\uacf5\uc815 \ud750\ub984, \uc911\uac04\uccb4, \uc758\uc57d\ud488 \uc6d0\ub8cc \ub610\ub294 \uc644\uc81c\ud488\uacfc \uc9c1\uc811 \uc811\ucd09<\/strong> \ud558\ub294 \ud50c\ub77c\uc2a4\ud2f1 \ubd80\ud488 \ubc0f \uc2dc\uc2a4\ud15c\uc5d0 \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc77c\ubc18\uc801\uc778 \uc608\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uc77c\ud68c\uc6a9 \ubd09\ud22c \ubc0f \ub77c\uc774\ub108<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud544\ud130 \ubc0f \uc5ec\uacfc \uc7a5\uce58<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud29c\ube59 \ubc0f \ucee4\ub125\ud130<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ucda9\uc804\uc6a9 \ubc14\ub298 \ubc0f \uc720\uccb4 \uc774\uc1a1 \ubd80\ud488<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud63c\ud569 \uc2dc\uc2a4\ud15c \ubc0f \uc77c\ud68c\uc6a9 \uc0dd\ubb3c\ubc18\uc751\uae30<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc720\uccb4 \uc811\ucd09\uc774 \uc5c6\uac70\ub098 \ub178\ucd9c \uc815\ub3c4\uac00 \ubbf8\ubbf8\ud55c \ud488\ubaa9\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ud3c9\uac00 \ubc94\uc704\uc5d0\uc11c \uc81c\uc678\ub418\ubbc0\ub85c, \uc77c\ubc18\uc801\uc774\uac70\ub098 &#8220;\uc77c\uad04\uc801\uc778&#8221; \ud14c\uc2a4\ud2b8\ubcf4\ub2e4\ub294 <strong>\uacf5\uc815\ubcc4 \ud3c9\uac00\uac00<\/strong> \uc911\uc694\ud558\ub2e4\ub294 \uc810\uc744 \uac15\uc870\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong><span style=\"font-size: 18pt;\">\uc9c0\uae08 \uc774\uac83\uc774 \uc911\uc694\ud55c \uc774\uc720<\/span><\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\uacf5\uc2dd \uc2dc\ud589\uc77c\uc774 \ub2e4\uac00\uc634\uc5d0 \ub530\ub77c \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uc774\ubbf8 \uc0c8\ub85c\uc6b4 \uc7a5\uc5d0 \ub9de\ucdb0 \uac80\uc0ac \ubc0f \uac10\uc0ac\ub97c \uc900\ube44\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\uc640 \ub3d9\uc2dc\uc5d0 <strong>ICH Q3E<\/strong> \uc640 \uac19\uc740 \uae00\ub85c\ubc8c \uc870\ud654 \ub178\ub825\uc740 E&amp;L\uc5d0 \ub300\ud55c \ud5a5\ud6c4 \uaddc\uc81c \uae30\ub300\uce58\ub97c \ud615\uc131\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc0c8\ub85c\uc6b4 \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \ub0b4\uc6a9\uc740 <a href=\"https:\/\/kymos.com\/ko\/news\/%ec%b6%94%ec%b6%9c%eb%ac%bc-%eb%b0%8f-%ec%9a%a9%ec%b6%9c%eb%ac%bc-%eb%b6%84%ec%84%9d-%ec%97%b0%ea%b5%ac-%ec%84%a4%ea%b3%84-%eb%b0%8f-ich-q3e-%ec%a7%80%ec%b9%a8\/\" data-wpel-link=\"internal\">\ubd84\uc11d, \uc5f0\uad6c \uc124\uacc4 \ubc0f ICH Q3E \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \uad00\ud55c \uc774\uc804 \uae30\uc0ac\uc5d0\uc11c \ud655\uc778\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/a>  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \ubcd1\ud589\uc801\uc778 \ubc1c\uc804\uc740 \ub3d9\uc77c\ud55c \ubc29\ud5a5\uc744 \uac00\ub9ac\ud0b5\ub2c8\ub2e4. \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c E&amp;L \ud3c9\uac00\ub294 \uc120\ud0dd \uc0ac\ud56d\uc774\ub098 \uac1c\ubcc4 \uc0ac\ub840\ubcc4 \ud3c9\uac00\ub97c \ub118\uc5b4 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c CMC \uc804\ub7b5\uc758 \ud45c\uc900 \uc694\uc18c\ub85c \uc810\ucc28 \ud1b5\ud569\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>\ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c \uc5f0\uad6c\uc5d0\uc11c \uc704\ud5d8 \uae30\ubc18 \uc811\uadfc\ubc95<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\ucd94\ucd9c\ubb3c \uc5f0\uad6c\ub294 \ud1b5\uc81c\ub41c \uc870\uac74, \ub54c\ub85c\ub294 \uacfc\uc7a5\ub41c \uc870\uac74\uc5d0\uc11c \ud2b9\uc815 \uc6a9\ub9e4\uc5d0 \ubb3c\uc9c8\uc744 \ub178\ucd9c\uc2dc\ucf1c \uc7a0\uc7ac\uc801 \uc6a9\ucd9c \ubb3c\uc9c8\uc758 <strong>\ud654\ud559\uc801 \ud504\ub85c\ud544\uc744<\/strong> \uc0dd\uc131\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc5f0\uad6c\ub294 \uc6a9\ucd9c\ub420 <em>\uc218 \uc788\ub294<\/em> \ud654\ud569\ubb3c\uc744 \uc2dd\ubcc4\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubc18\uba74, \uc6a9\ucd9c\ubb3c\uc9c8\uc740 <strong>\uc2e4\uc81c \uacf5\uc815 \ub610\ub294 \uc81c\ud488 \uc870\uac74<\/strong> \uc5d0\uc11c \ud3c9\uac00\ub418\uba70, <em>\uc2e4\uc81c\ub85c<\/em> \uc81c\ud488\uc73c\ub85c \uc774\ub3d9\ud558\ub294 \ud654\ud569\ubb3c\uc744 \ub098\ud0c0\ub0c5\ub2c8\ub2e4. \ub530\ub77c\uc11c \ud658\uc790\uc5d0\uac8c \uad00\ub828\ub41c \ub178\ucd9c\uc5d0 \ub300\ud55c \uc9c1\uc811\uc801\uc778 \uc815\ubcf4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubbf8\uad6d \ud2b9\ud5c8&lt; 665&gt; \uadf8\ub9ac\uace0&lt; 1665&gt; \ucd94\ucd9c \uac00\ub2a5\ud55c \ub370\uc774\ud130\ub294 <strong>\uc704\ud5d8 \ud3c9\uac00\ub97c \uc704\ud55c \ub3c4\uad6c\uc77c<\/strong> \ubfd0, \uadf8 \uc790\uccb4\uac00 \ubaa9\uc801\uc774 \uc544\ub2c8\ub77c\ub294 \uc810\uc744 \uac15\uc870\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>USP\uc5d0 \ub530\ub978 \uc704\ud5d8 \ubd84\ub958&lt; 665&gt; \/&lt; 1665&gt;<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">USP \ud504\ub808\uc784\uc6cc\ud06c\uc758 \ud575\uc2ec \uc694\uc18c\ub294 <strong>\uc704\ud5d8 \ubd84\ub958<\/strong> \uc774\uba70, \uc774\ub294 \ub2e4\uc74c \uc0ac\ud56d\ub4e4\uc744 \uace0\ub824\ud569\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uc7ac\ub8cc \ubc0f \ucca8\uac00\uc81c\uc758 \ud2b9\uc131<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud504\ub85c\uc138\uc2a4 \ud750\ub984\uc758 \uad6c\uc131<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc0ac\uc6a9 \ub2e8\uacc4(\uc0c1\ub958, \ud558\ub958, \ucda9\uc804)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc811\ucd09 \uc2dc\uac04 \ubc0f \uc628\ub3c4<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud558\ub958 \uc815\uc81c \ub2e8\uacc4\uc5d0\uc11c \uc7a0\uc7ac\uc801 \uc6a9\ucd9c \ubb3c\uc9c8\uc744 \uc81c\uac70\ud558\ub294 \ub2a5\ub825<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \ud3c9\uac00\ub97c \ubc14\ud0d5\uc73c\ub85c \uad6c\uc131 \uc694\uc18c\ub294 \uc800\uc704\ud5d8, \uc911\uc704\ud5d8 \ub610\ub294 \uace0\uc704\ud5d8\uc73c\ub85c \ubd84\ub958\ub420 \uc218 \uc788\uc73c\uba70, \uc774\ub294 \ud544\uc694\ud55c <strong>\ubd84\uc11d \ud14c\uc2a4\ud2b8\uc758 \ubc94\uc704\uc640 \ubcf5\uc7a1\uc131\uc5d0<\/strong> \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">USP \uc811\uadfc \ubc29\uc2dd\uc740 \ubaa8\ub4e0 \uad6c\uc131 \uc694\uc18c\uc5d0 \ucd5c\uc545\uc758 \uc0c1\ud669\uc744 \uac00\uc815\ud55c \ud14c\uc2a4\ud2b8\ub97c \uc801\uc6a9\ud558\ub294 \ub300\uc2e0 <strong>, \uacfc\ud559\uc5d0 \uae30\ubc18\ud55c \ubaa9\ud45c \uc9c0\ud5a5\uc801\uc778 \uc5f0\uad6c\ub97c<\/strong> \uc7a5\ub824\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc81c\uc870\uc5c5\uccb4\ub294 \uc81c\ud488 \ud488\uc9c8\uc774\ub098 \ud658\uc790 \uc548\uc804\uc5d0 \ubbf8\uce60 \uc218 \uc788\ub294 \uc7a0\uc7ac\uc801 \uc601\ud5a5\uc774 \uac00\uc7a5 \ud070 \ubd80\ubd84\uc5d0 \uc790\uc6d0\uc744 \uc9d1\uc911\ud560 \uc218 \uc788\uc73c\uba70, \uc774\ub294 \ubcf5\uc7a1\ud55c \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870 \uacf5\uc815\uc5d0\uc11c \ud2b9\ud788 \uc911\uc694\ud55c \uace0\ub824 \uc0ac\ud56d\uc785\ub2c8\ub2e4. <\/span><\/p>\n<h2><strong>\uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc744 \uc704\ud55c E&amp;L \uc5f0\uad6c \uc124\uacc4<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">SUS\ub97c \uc704\ud55c \uacac\uace0\ud55c E&amp;L \ud504\ub85c\uadf8\ub7a8\uc740 \uc77c\ubc18\uc801\uc73c\ub85c <strong>\ub2e8\uacc4\ubcc4 \uc811\uadfc \ubc29\uc2dd\uc744<\/strong> \ub530\ub985\ub2c8\ub2e4.<\/span><\/p>\n<ol>\n<li><span style=\"font-size: 14pt;\"><strong>\uc7ac\ub8cc \ubc0f \uacf5\uc815 \ud3c9\uac00<\/strong><\/span><br \/>\n <span style=\"font-size: 14pt;\">\uc81c\uc870\uc5c5\uccb4\uac00 \uc81c\uacf5\ud558\ub294 \uc815\ubcf4\ub97c \ubc14\ud0d5\uc73c\ub85c \uace0\ubd84\uc790 \uad6c\uc131, \uc81c\uc870 \uacf5\uc815 \ubc0f \uc0ac\uc6a9 \uc870\uac74\uc744 \uc774\ud574\ud569\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ucd94\ucd9c\ubb3c \ud14c\uc2a4\ud2b8<\/strong><\/span><br \/>\n <span style=\"font-size: 14pt;\">USP\uc5d0 \ubd80\ud569\ud558\ub294 \ud2b9\uc815 \uc6a9\ub9e4 \ubc0f \uc870\uac74\uc744 \uc0ac\uc6a9\ud558\uc5ec&lt; 665&gt; \ub300\ud45c\uc801\uc778 \ud654\ud559\uc801 \ud504\ub85c\ud544\uc744 \uc0dd\uc131\ud558\uae30 \uc704\ud574.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ubd84\uc11d\uc801 \uc2a4\ud06c\ub9ac\ub2dd<\/strong><\/span><br \/>\n <span style=\"font-size: 14pt;\">GC-MS, LC-MS, ICP-MS\uc640 \uac19\uc740 \uc9c1\uad50 \ubd84\uc11d \uae30\ubc95\uc744 \uc801\uc6a9\ud558\uc5ec \ud718\ubc1c\uc131, \ubc18\ud718\ubc1c\uc131, \ube44\ud718\ubc1c\uc131 \ubc0f \uc6d0\uc18c \ubd88\uc21c\ubb3c\uc744 \uc2dd\ubcc4\ud569\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ub370\uc774\ud130 \ud574\uc11d \ubc0f \uc704\ud5d8 \ud3c9\uac00<\/strong><\/span><br \/>\n <span style=\"font-size: 14pt;\">\uacf5\uc815 \ub178\ucd9c, \uc815\ud654 \ub2a5\ub825 \ubc0f \ub3c5\uc131\ud559\uc801 \uad00\ub828\uc131\uc744 \uace0\ub824\ud558\uc5ec \uacb0\uacfc\ub97c \ud3c9\uac00\ud569\ub2c8\ub2e4.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">\ud544\uc694\ud55c \uacbd\uc6b0, \ucd94\ucd9c\ubb3c \ub370\uc774\ud130\ub294 \uacf5\uc815\ubcc4 \uc870\uac74\uc5d0\uc11c\uc758 <strong>\uc2dc\ubbac\ub808\uc774\uc158 \ub610\ub294 \uc6a9\ucd9c\ubb3c \uc5f0\uad6c\ub97c<\/strong> \ub4b7\ubc1b\uce68\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong><span style=\"font-size: 18pt;\">\ubd84\uc11d\uc801 \ud3c9\uac00 \uc784\uacc4\uac12(AET)<\/span><\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\ubd84\uc11d \ud3c9\uac00 \uc784\uacc4\uac12(AET)\uc740 \uace0\uc815\ub41c \uac12\uc774 \uc544\ub2c8\ub77c \uacf5\uc815 \ub178\ucd9c, \uc6a9\ub7c9, \ud22c\uc5ec \uacbd\ub85c \ubc0f \ud658\uc790 \uc548\uc804 \uace0\ub824 \uc0ac\ud56d\uacfc \uac19\uc740 \uc694\uc18c\ub97c \uae30\ubc18\uc73c\ub85c \ud569\ub2c8\ub2e4. \ub530\ub77c\uc11c AET <span style=\"text-decoration: line-through;\">\ub294<\/span> \ud2b9\uc815 \uc81c\uc870 \uacf5\uc815 \ubc0f \uac1c\ubc1c \uc911\uc778 \uc81c\ud488\uc758 \ub9e5\ub77d\uc5d0\uc11c \ud574\uc11d\ud574\uc57c \ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub294 \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc758 \uc0ac\uc6a9 \ubaa9\uc801\uc5d0 \ub9de\ucd98 E&amp;L \uc5f0\uad6c \uc124\uacc4\uac00 \uc911\uc694\ud558\ub2e4\ub294 \uc810\uc744 \ub2e4\uc2dc \ud55c\ubc88 \uac15\uc870\ud558\uba70, \uc2e4\uc81c \uacf5\uc815 \uc870\uac74\uc744 \uc801\uc808\ud788 \ubc18\uc601\ud558\uc9c0 \ubabb\ud560 \uc218 \uc788\ub294 \uc77c\ubc18\uc801\uc778 \ud5c8\uc6a9 \uae30\uc900\uc5d0\ub9cc \uc758\uc874\ud574\uc11c\ub294 \uc548 \ub41c\ub2e4\ub294 \uac83\uc744 \uc2dc\uc0ac\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>\uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870\uc5c5\uccb4\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5\uc740 \ubb34\uc5c7\uc77c\uae4c\uc694?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uac1c\ubc1c\uc5c5\uccb4 \ubc0f \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c \uc788\uc5b4 \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc758 \ud6a8\ub2a5 \ubc0f \uc218\uba85 \ud3c9\uac00(E&amp;L \ud3c9\uac00)\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \uc0ac\ud56d\uc5d0 \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\ud504\ub85c\uc138\uc2a4\uc758 \uacac\uace0\uc131 \ubc0f \uc77c\uad00\uc131<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uacf5\uae09\uc5c5\uccb4 \uc790\uaca9 \uc2ec\uc0ac \ubc0f \uc790\uc7ac \uc120\uc815<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uaddc\uc81c \uc81c\ucd9c \ubc0f \uac10\uc0ac \uc900\ube44<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc7a5\uae30 \uc81c\ud488 \uc218\uba85\uc8fc\uae30 \uad00\ub9ac<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uac1c\ubc1c \ucd08\uae30 \ub2e8\uacc4\uc5d0\uc11c E&amp;L(\ud6a8\uacfc \ubc0f \uc190\uc2e4) \uace0\ub824 \uc0ac\ud56d\uc744 \ud1b5\ud569\ud558\uba74 \ud6c4\uae30 \ub2e8\uacc4\uc5d0\uc11c \ubc1c\uacac\ub420 \uc704\ud5d8\uc744 \uc904\uc774\uace0, \ubcf4\ub2e4 \uc815\ubcf4\uc5d0 \uc785\uac01\ud55c \uc758\uc0ac \uacb0\uc815\uc744 \uc9c0\uc6d0\ud558\uba70, \ud504\ub85c\uc138\uc2a4\uac00 \ubc1c\uc804\ud568\uc5d0 \ub530\ub77c \uaddc\uc81c \ub2f9\uad6d\uacfc\uc758 \uc6d0\ud65c\ud55c \uc0c1\ud638 \uc791\uc6a9\uc744 \ucd09\uc9c4\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>Kymos\ub294 \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c E&amp;L \uc811\uadfc \ubc29\uc2dd\uc744 \uc5b4\ub5bb\uac8c \ub9c8\ub828\ud588\uc744\uae4c\uc694?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\ud0a4\ubaa8\uc2a4\uc5d0\uc11c\ub294 \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c E&amp;L \uc5f0\uad6c\ub97c <strong>\uacfc\ud559\uc801 \uadfc\uac70\ub97c \ucd5c\uc6b0\uc120\uc73c\ub85c \ud558\uace0 \uc704\ud5d8 \uae30\ubc18 \uc0ac\uace0\ubc29\uc2dd\uc744<\/strong> \ubc14\ud0d5\uc73c\ub85c \uc124\uacc4\ud569\ub2c8\ub2e4. \uac01 \ud504\ub85c\uadf8\ub7a8\uc740 \uc77c\ubc18\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \ub530\ub974\ub294 \ub300\uc2e0 \ud2b9\uc815 \uacf5\uc815, \uc7ac\ub8cc \ubc0f \uaddc\uc81c \ud658\uacbd\uc5d0 \ub9de\ucdb0 \uac1c\uc778\ud654\ub429\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub2f9\uc0ac\ub294 \ucca8\ub2e8 \ubd84\uc11d \uae30\uc220\uc744 \ud65c\uc6a9\ud55c \ud3ec\uad04\uc801\uc778 \ucd94\ucd9c\ubb3c \ud504\ub85c\ud30c\uc77c\ub9c1\uacfc \ud604\ud589 \uaddc\uc81c \uae30\uc900\uc5d0 \ubd80\ud569\ud558\ub294 \uccb4\uacc4\uc801\uc778 \ub370\uc774\ud130 \ud574\uc11d\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \ucd94\ucd9c\ubb3c \ubc0f \uc561\uccb4 \ud568\ub7c9(E&amp;L) \uc5f0\uad6c\ub97c \ubcf4\ub2e4 \uad11\ubc94\uc704\ud55c CMC \uc804\ub7b5\uc5d0 \ud1b5\ud569\ud568\uc73c\ub85c\uc368, \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870\uc5c5\uccb4\uac00 \uaddc\uc81c \uae30\uad00\uc758 \uae30\ub300\uc5d0 \ubd80\uc751\ud558\ub294 <strong>\uc2e0\ub8b0\ud560 \uc218 \uc788\uace0 \uc2e4\ud589 \uac00\ub2a5\ud55c \ub370\uc774\ud130\ub97c<\/strong> \uc0dd\uc131\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4. <\/span><\/p>\n<h2><strong>\uacb0\ub860<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870\uc5d0\uc11c \uc77c\ud68c\uc6a9 \uc2dc\uc2a4\ud15c\uc758 \uc5ed\ud560\uc774 \ucee4\uc9d0\uc5d0 \ub530\ub77c \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c \ud3c9\uac00\uac00 \ud488\uc9c8 \ubc0f \uaddc\uc815 \uc900\uc218\uc758 \ud575\uc2ec \uc694\uc18c\uac00 \ub418\uc5c8\uc2b5\ub2c8\ub2e4. (USP)&lt; 665&gt; \uadf8\ub9ac\uace0&lt; 1665&gt; \uad6c\uc870\ud654\ub41c \uc704\ud5d8 \uae30\ubc18 \ubc29\ubc95\uc744 \ud1b5\ud574 \uc774\ub7ec\ud55c \uc704\ud5d8\uc744 \uad00\ub9ac\ud558\uae30 \uc704\ud55c \uba85\ud655\ud55c \uc9c0\uce68\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc81c\uc870\uc5c5\uccb4\ub294 \uaddc\uc81c \uae30\uad00\uc758 \uae30\ub300\uce58\ub97c \ud30c\uc545\ud558\uace0 \uacfc\ud559\uc5d0 \uae30\ubc18\ud55c E&amp;L \uc804\ub7b5\uc744 \ud65c\uc6a9\ud568\uc73c\ub85c\uc368 \uacf5\uc815 \uc81c\uc5b4\ub97c \uac1c\uc120\ud558\uace0 \uaddc\uc81c \uc81c\ucd9c\uc744 \uc9c0\uc6d0\ud558\uba70 \uad81\uadf9\uc801\uc73c\ub85c \uc81c\ud488\uc758 \uc548\uc804\uc131\uacfc \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c \uc5f0\uad6c, \ub610\ub294 CMC\ub098 \uc0dd\ubb3c \ubd84\uc11d \uc5f0\uad6c\uc640 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