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[\uc774\ub370\uc77c\ub9ac \uae40\uc0c8\ubbf8 \uae30\uc790] \u201c\uc608\uc804\ubcf4\ub2e4 \uc694\uc998 \uc5d0\ubca0\ub808\uc2a4\ud2b8\uc0b0\uc744 \uc815\ubcf5\ud558\ub294 \uc0ac\ub78c\ub4e4\uc774 \ub9ce\uc544\uc9c4 \uc774\uc720\ub294 \ubca0\uc774\uc2a4\ucea0\ud504\uac00 \uc815\uc0c1 \uadfc\ucc98\ub85c \ub9ce\uc774 \uc62c\ub77c\uc654\uae30 \ub54c\ubb38\uc774\ub77c\uace0 \ud569\ub2c8\ub2e4. \ubca0\uc774\uc2a4\ucea0\ud504 \uc704\uce58\uac00 \ub192\uc544\uc9c0\ub2c8 \uc815\uc0c1\uae4c\uc9c0 \uc624\ub97c \ud655\ub960\uc774 \ub192\uc544\uc9c4 \uac70\uc8e0. \uc800\ud76c\ub294 (\uc2e0\uc57d\uac1c\ubc1c\uc0ac\ub4e4\uc758) \ubca0\uc774\uc2a4\ucea0\ud504\ub97c \ub192\uc774\ub294 \uc5ed\ud560\uc744 \ud558\uace0 \uc2f6\uc2b5\ub2c8\ub2e4. \uc800\uae30\uae4c\uc9c0\ub9cc \ub354 \uac00\uba74 \ub41c\ub2e4\uace0 \uc54c\ub824\uc8fc\ub294 \uac70\uc8e0.\u201d<\/p>\n

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\uc870\ubbfc\uadfc \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8 \ub300\ud45c\ub294 4\uc77c \uc11c\uc6b8 \uc131\uc218\ub3d9\uc5d0 \uc704\uce58\ud55c \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\uc5d0\uc11c \uc774\ub370\uc77c\ub9ac\uc640 \ub9cc\ub098 \uc774\uac19\uc774 \ub9d0\ud588\ub2e4. \uadf8\ub294 \uac19\uc774 \ub300\uc6c5\uc81c\uc57d(069620)\uc5d0\uc11c \uc77c\ud55c \uacbd\ud5d8\uc774 \uc788\ub294 \uae40\ud76c\uc120 \ub300\ud45c\uc640 \uc758\uae30\ud22c\ud569\ud574 \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\ub97c \uc9c0\ub09c 1\uc6d4 \uacf5\ub3d9 \ucc3d\uc5c5\ud588\ub2e4. \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\ub294 \uc2e0\uc57d\uac1c\ubc1c \uc804\uc8fc\uae30 \ucee8\uc124\ud305\uc740 \ubb3c\ub860, \uc784\uc0c1, \uc0ac\uc5c5\ubaa8\ub378 \uac1c\ubc1c, \ud22c\uc790, \uc624\ud508\uc774\ub178\ubca0\uc774\uc158 \ub4f1 \uac01\uc885 \ub178\ud558\uc6b0\ub97c \uc81c\uacf5\ud574 \ubc14\uc774\uc624\ubca4\ucc98\uc758 \uc131\uc7a5\uc744 \uc9c0\uc6d0\ud558\uae30 \uc704\ud574 \uc124\ub9bd\ub410\ub2e4.<\/p>\n

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\ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\ub294 \uc2e0\uc57d\uac1c\ubc1c \uc804\uc8fc\uae30 \uc804\ub7b5 \ucee8\uc124\ud305\ubd80\ud130 \uc778\ud5c8\uac00 \uc11c\ube44\uc2a4, \uc2dc\ud310\ud6c4 \uad00\ub9ac\uae4c\uc9c0 \uc9c0\uc6d0\ud55c\ub2e4. \ud2b9\ud788 \uc784\uc0c1\uac1c\ubc1c\u00b7\uc5f0\uad6c\uc870\uc9c1(CDRO) \uc804\ubb38\uae30\uc5c5\uc73c\ub85c\uc11c \uc5f0\uad6c\uac1c\ubc1c(R&D) \uc804\ub7b5\uc744 \uc218\ub9bd\ud558\uace0 \uc784\uc0c1\uc744 \uc6b4\uc601\ud55c\ub2e4.<\/p>\n

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CDRO\ub780 \uae30\uc874 \uc784\uc0c1\uc2dc\ud5d8\uc218\ud0c1\uae30\uad00(CRO) \uc5c5\ubb34\uc5d0 \uc784\uc0c1\uac1c\ubc1c\u00b7\uc6b4\uc601 \ub4f1 \uc804\ub7b5\uc801 \uc784\uc0c1\uac1c\ubc1c(Clinical Development)\uc744 \uc811\ubaa9\ud55c \uc0ac\uc5c5\uc774\ub2e4. CRO \uc0ac\uc5c5 \uc601\uc5ed\uc774 \uc758\ub8b0\uc0ac \uc694\uccad\uc5d0 \uc758\ud55c \uc784\uc0c1 \uc704\ud0c1 \uc11c\ube44\uc2a4\uc5d0 \uadf8\uce5c\ub2e4\uba74, CDRO\ub294 \uc784\uc0c1 \uc804 \ub2e8\uacc4\uc778 \uc5f0\uad6c\u00b7\ube44\uc784\uc0c1 \ub2e8\uacc4\ubd80\ud130 \uc758\ub8b0\uc0ac\uc640 \ud638\ud761\uc744 \ub9de\ucd98\ub2e4. \uc778\ud5c8\uac00(RA), \uc81c\uc870\uacf5\uc815(CMC), \ube44\uc784\uc0c1 \ub3c5\uc131\uc2dc\ud5d8\uc740 \ubb3c\ub860\uc774\uace0 \uc784\uc0c1 1\uc0c1~4\uc0c1\uae4c\uc9c0\ub3c4 \uc11c\ube44\uc2a4\ud55c\ub2e4.<\/p>\n

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\uc77c\ubc18\uc801\uc73c\ub85c \uc81c\uc57d\uc0ac\ub294 \uc5f0\uad6c\uc18c, \uac1c\ubc1c\ubcf8\ubd80, \uc784\uc0c1\ubcf8\ubd80 \ub4f1\uc744 \ud1b5\ud574 R&D \uc804\ub7b5\uc744 \uc218\ud589\ud55c\ub2e4. \ubcf4\ud1b5 \ubc14\uc774\uc624\ubca4\ucc98\ub294 \uc5f0\uad6c\uc18c \uc5ed\ud560\ub9cc \ud558\uace0 \ube44\uc784\uc0c1 \ub2e8\uacc4\ubd80\ud130\ub294 CRO\uc5d0 \uc704\ud0c1\uc744 \ub9e1\uae30\uac8c \ub41c\ub2e4. \uc5f0\uad6c\uc5d0\uc11c \uac1c\ubc1c\ub85c \ub118\uc5b4\uac00\ub294 \uacfc\uc815\uc5d0\uc11c R&D \uc804\ub7b5\uc758 \uc5f0\uacc4\uc131\uc774 \ub04a\uae30\uace0, \uc784\uc0c1\uac1c\ubc1c \uc804\ub7b5 \uc218\ub9bd\uc744 \uc678\ubd80\uc5d0 \uc758\uc874\ud558\uac8c \ub418\ub294 \ubb38\uc81c\uac00 \uc0dd\uae34\ub2e4.<\/p>\n

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\uc870 \ub300\ud45c\ub294 \u201c\ube44\uc784\uc0c1 \ub2e8\uacc4\uc5d0\uc11c \uc784\uc0c1 \uc804\ub7b5\uc744 \uac16\uace0 \ube44\uc784\uc0c1\ub3c5\uc131\uc2dc\ud5d8\uc744 \ud574\uc57c \uc784\uc0c1\uc2dc\ud5d8\uacc4\ud68d(IND)\uc744 \ucc28\uc9c8\uc5c6\uc774 \uc2b9\uc778\ubc1b\uc744 \uc218 \uc788\ub294\ub370 \uc774 \ub2e8\uacc4\uc5d0\uc11c\ubd80\ud130 \uc798 \uc548\ub3fc\uc11c \uc7ac\uc2dc\ud5d8\ud558\uac70\ub098 \uc2b9\uc778\uc744 \ubabb \ubc1b\uc544\uc11c \ud22c\uc790\uac00 \ub04a\uae30\ub294 \uacbd\uc6b0\ub3c4 \uc788\ub2e4\u201d\uace0 \uc5b8\uae09\ud588\ub2e4. \uc81c\uc57d\uc0ac \ucd9c\uc2e0\uc778 \uc870 \ub300\ud45c\uc640 \uae40 \ub300\ud45c\ub294 \uc774\ub7ec\ud55c \ub2e8\uc808 \uad6c\uac04 \ubb38\uc81c\ub97c \ud574\uacb0\ud55c\ub2e4\uba74 \ubc14\uc774\uc624\ubca4\ucc98\ub4e4\uc774 \ubc14\uc774\uc624\ud14d\uc73c\ub85c \uc2a4\ucf00\uc77c\uc5c5\ud560 \uc218 \uc788\ub2e4\uace0 \ud310\ub2e8\ud588\ub2e4.<\/p>\n

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\uc870 \ub300\ud45c\ub294 \u201c\uc6b0\ub9ac\uac00 \uc8fc\ubaa9\ud588\ub358 \uac74 CRO\ub294 \ub9ce\uc740\ub370 \uc784\uc0c1 \uac1c\ubc1c\uc744 \ud574\uc8fc\ub294 \ub370\uac00 \uc5c6\ub2e4\ub294 \uac83\uc774\uc5c8\ub2e4\u201d\uba70 \u201c\uc784\uc0c1\uac1c\ubc1c\uc744 \ub204\uad70\uac00\ub294 \ud574\uc918\uc57c \ud55c\ub2e4\uace0 \uc0dd\uac01\ud574 \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\ub97c \ub9cc\ub4e4\uc5c8\ub2e4\u201d\uace0 \uac15\uc870\ud588\ub2e4. \uc774\uc5b4 \u201c\ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\uac00 \ubc14\uc774\uc624\ubca4\ucc98\ub97c \ub300\uc0c1\uc73c\ub85c \uc81c\uc57d\uc0ac\uc758 \uac1c\ubc1c\u00b7\uc784\uc0c1\ubcf8\ubd80 \uac19\uc740 \uc5ed\ud560\uc744 \uc218\ud589\ud558\uace0\uc790 \ud55c\ub2e4\u201d\uba70 \u201cR&D \ube0c\ub9bf\uc9c0(bridge)\uac00 \uc6b0\ub9ac\uc758 \uc8fc\uc694 \uc0ac\uc5c5\u201d\uc774\ub77c\uace0 \ub367\ubd99\uc600\ub2e4.<\/p>\n

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\ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\uc758 CDRO \uc11c\ube44\uc2a4 \ub300\uc0c1\uc740 \uc758\uc57d\ud488\uc5d0\ub9cc \ud55c\uc815\ub418\ub294 \uac8c \uc544\ub2c8\ub77c \ub514\uc9c0\ud138\uce58\ub8cc\uc81c(DTx), \uc758\uc57d\uc678\ud488, \uc758\ub8cc\uae30\uae30 \ub4f1\ub3c4 \ud3ec\ud568\ub41c\ub2e4. \uc870 \ub300\ud45c\ub294 \u201c\ub514\uc9c0\ud138\uce58\ub8cc\uc81c \ucabd\uc73c\ub85c \uacac\uc801\uc774\ub098 \uc758\ub8b0\ub3c4 \ub4e4\uc5b4\uc624\uace0 \uc788\ub2e4\u201d\uace0 \uadc0\ub754\ud588\ub2e4.<\/p>\n

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\uc774\uc640 \ud568\uaed8 \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\ub294 \ubc14\uc774\uc624\u00b7\ud5ec\uc2a4\ucf00\uc5b4 \ubd84\uc57c \uc720\ub9dd \uc2a4\ud0c0\ud2b8\uc5c5\uc744 \ubc1c\uad74\ud574 \ubc14\uc774\uc624\ud14d\uc73c\ub85c \uc721\uc131\ud558\ub294 \uc2a4\ucf00\uc77c\ub7ec\ub808\uc774\ud130(Scalerator) \uc5ed\ud560\ub3c4 \uc218\ud589\ud558\uace0\uc790 \ud55c\ub2e4. \uc5d1\uc140\ub7ec\ub808\uc774\ud130\uac00 \uc2e0\uc0dd \uc2a4\ud0c0\ud2b8\uc5c5\uc744 \ubc1c\uad74\ud574 \ub2e4\uc591\ud55c \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud55c\ub2e4\uba74 \uc2a4\ucf00\uc77c\ub7ec\ub808\uc774\ud130\ub294 \uc2a4\ud0c0\ud2b8\uc5c5\uc774 \uc131\uc219\ud560 \uc218 \uc788\uac8c \ub3d5\ub294\ub2e4\ub294 \uc810\uc5d0\uc11c \ucc28\uc774\uac00 \uc788\ub2e4.<\/p>\n

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\uc870 \ub300\ud45c\ub294 \u201c\ubc14\uc774\uc624 \uc2a4\ud0c0\ud2b8\uc5c5\uacfc \ubc14\uc774\uc624\ud14d\uc758 \ucc28\uc774\ub294 \ud30c\uc774\ud504\ub77c\uc778 \ud655\ubcf4 \uc720\ubb34\uc5d0 \uc788\ub294 \uac83 \uac19\ub2e4\u201d\uba70 \u201c\uc2a4\ud0c0\ud2b8\uc5c5\uc758 \uacbd\uc6b0 R&D\uac00 \uc57d\ud55c \uce21\uba74\uc774 \uc788\uc9c0\ub9cc R&D \uc804\ub7b5\uc758 \ub2e8\uc808 \uad6c\uac04\uc744 \ucc44\uc6cc\uc8fc\uba74 \ucda9\ubd84\ud788 \ubc14\uc774\uc624\ud14d\uc73c\ub85c \uc131\uc7a5\ud560 \uc218 \uc788\uc744 \uac83\u201d\uc774\ub77c\uace0 \uc9c4\ub2e8\ud588\ub2e4. \uae40 \ub300\ud45c\ub294 \u201c\ube44\uc784\uc0c1\uc5d0\uc11c \ucd08\uae30 \uc784\uc0c1\uc73c\ub85c \ub118\uc5b4\uac00\ub294 \ub2e8\uacc4\uac00 \uc2e0\uc57d\uac1c\ubc1c\uc0ac\uc758 \ubc38\ub958(\uae30\uc5c5\uac00\uce58)\uac00 \uae30\ud558\uae09\uc218\uc801\uc73c\ub85c \uc62c\ub77c\uac00\ub294 \ub2e8\uacc4\u201d\ub77c\uba70 \u201c\uc774 \ub2e8\uacc4\uac00 \uc2a4\ucf00\uc77c\uc5c5\uc774\uba74 \uadf8 \uc804 \ub2e8\uacc4\ub294 \ubd80\uc2a4\ud305\u201d\uc774\ub77c\uace0 \ubd80\uc5f0\ud588\ub2e4.<\/p>\n

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\uc870 \ub300\ud45c\ub294 \uad6d\ub0b4 \ubc14\uc774\uc624\uae30\uc5c5\ub4e4\uc774 \uae30\uc220\uc774\uc804 \uc774\ud6c4 \uc804\ub7b5\uc774 \ubd80\uc7ac\ud55c \uacbd\uc6b0\uac00 \ub9ce\ub2e4\uace0 \uc9c0\uc801\ud588\ub2e4. \uc2e4\uc81c\ub85c \uad6d\ub0b4 \ubc14\uc774\uc624\uae30\uc5c5\ub4e4\uc758 \uae30\uc220\uc774\uc804 \uc774\ud6c4 \ud574\ub2f9 \uc2e0\uc57d\ud6c4\ubcf4\ubb3c\uc9c8\uc758 \uc784\uc0c1 \uacb0\uacfc\uac00 \uc88b\uc9c0 \uc54a\uac70\ub098 \ud30c\ud2b8\ub108\uc0ac\uc758 \uc804\ub7b5\uc774 \ubc14\ub00c\uba74\uc11c \uad8c\ub9ac \ubc18\ud658\ub418\ub294 \uc0ac\ub840\ub3c4 \uc801\uc9c0 \uc54a\ub2e4. \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\ub294 \uc2e0\uc57d\uc744 \uc0c1\uc6a9\ud654\ud560\uc9c0, \uae30\uc220\uc774\uc804\ud560\uc9c0\uc5d0 \ub530\ub77c \ub2e4\ub978 \uc804\ub7b5\uc744 \uc81c\uacf5\ud55c\ub2e4.<\/p>\n

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\uae40 \ub300\ud45c\ub294 \u201c\uc778\ud5c8\uac00\ub97c \ubc1b\uc744 \uac83\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uace0 \uc2e0\uc57d\uc744 \uac1c\ubc1c\ud558\ub294 \uac83\uacfc \uc911\uac04\uc5d0 \ud314 \uac83(\uae30\uc220\uc774\uc804)\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uace0 \uac1c\ubc1c\ud558\ub294 \uac74 (\uc784\uc0c1\uac1c\ubc1c \uc804\ub7b5\uc774) \ub2e4\ub97c \uc218 \uc788\ub2e4\u201d\uba70 \u201c\uc2dc\ud310\uae4c\uc9c0 \ub05d\uae4c\uc9c0 \uc9c4\ud589\ud55c\ub2e4\uba74 \ud658\uc790\ub098 \uc2dc\uc7a5\uc744 \uc0dd\uac01\ud558\ub294\ub370 \ucd08\uae30 \ub2e8\uacc4\uc5d0\uc11c \uae30\uc220\uc774\uc804\uc744 \uc5fc\ub450\uc5d0 \ub454\ub2e4\uba74 \ubc14\uc774\uc624\ub9c8\ucee4\ub098 \uc784\uc0c1 \ub514\uc790\uc778\uc744 \ud1b5\ud574 \uadfc\uac70\ub97c \uba85\ud655\ud558\uac8c \ud574\ub458 \ud544\uc694\uac00 \uc788\ub2e4\u201d\uace0 \uc124\uba85\ud588\ub2e4.<\/p>\n

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\ub2e4\ub9cc \uc2e0\uc57d\uac1c\ubc1c\uc0ac\ub4e4\uc774 \ub300\ubd80\ubd84 \uc790\uae08\ub09c\uc5d0 \ud5c8\ub355\uc774\uace0 \uc788\ub2e4\ub294 \uc810\uc740 \ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8 \uc0ac\uc5c5\uc5d0 \uac78\ub9bc\ub3cc\uc774 \ub420 \uc218 \uc788\ub294 \uc694\uc778\uc774\ub2e4. \uc774\ub7ec\ud55c \uc6b0\ub824\uc5d0 \ub300\ud574 \uae40 \ub300\ud45c\ub294 \uc624\ud788\ub824 \uc704\uae30\uac00 \uae30\ud68c\uac00 \ub420 \uc218 \uc788\ub2e4\ub294 \uc9c4\ub2e8\uc744 \ub0b4\ub1a8\ub2e4.<\/p>\n

\uae40 \ub300\ud45c\ub294 \u201c\ubc14\uc774\uc624\ubca4\ucc98\ub4e4\uc774 \uc774\uc81c \uc815\ub9d0 \uc790\uae08\uc774 \ubd80\uc871\ud558\uae30 \ub54c\ubb38\uc5d0 \ub354\uc6b1 \uc2e0\uc911\ud558\uac8c \uc784\uc0c1\uc5d0 \uc9c4\uc785\ud560 \uac83\u201d\uc774\ub77c\uba70 \u201c\uadf8\ub0e5 \uc784\uc0c1 1\uc0c1 \ub4e4\uc5b4\uac00\ub294 \uac8c \uc544\ub2c8\ub77c \uc804\ub7b5\uc744 \uc138\uc6cc\uc11c \ud6a8\uc728\uc801\uc73c\ub85c \ube44\uc6a9\uc744 \uc808\uac10\ud558\uba74\uc11c \ub370\uc774\ud130\ub97c \uc5bb\ub294 \ubc29\ud5a5\uc73c\ub85c \uc804\ud658\ub420 \uac83\u201d\uc774\ub77c\uace0 \uc5ed\uc124\ud588\ub2e4. \uc774\uc5b4 \u201c\uc5f0\uad6c\ub3c4 \uc5b4\ub824\uc6b4\ub370 \uac1c\ubc1c\uae4c\uc9c0 \ud558\ub824\uba74 \uc784\uc0c1 \uac00\uc774\ub4dc\ub77c\uc778\uc774\ub098 \uaddc\uc81c \ub4f1 \uccb4\ud06c\ud560 \uac8c \ub9ce\uc740\ub370 \uc9c1\uc811 \ub2e4 \ud560 \uc218\ub294 \uc5c6\ub2e4\u201d\uba70 \u201c\ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\uac00 \ubc14\uc774\uc624\ubca4\ucc98\uc5d0\uc11c \uc0dd\uac01\ud558\ub294 \uc758\ub3c4\ub97c \uc798 \uc774\ud574\ud574\uc11c \uc815\ud655\ud558\uac8c \uadf8\uc5d0 \ub9de\ub294 \uc804\ub7b5\uc744 \ucc3e\uc544\ub4dc\ub9b4 \uac83\u201d\uc774\ub77c\uace0 \ud588\ub2e4.<\/p>\n

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