{"id":28381,"date":"2025-11-07T08:38:16","date_gmt":"2025-11-07T07:38:16","guid":{"rendered":"https:\/\/kymos.com\/news\/%eb%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b0%9c%eb%b0%9c-3%ec%83%81%eb%b6%80%ed%84%b0-%eb%b6%84%ec%84%9d-%eb%b9%84%ea%b5%90%ec%84%b1-%eb%b0%8f-pk-pd%ea%b9%8c%ec%a7%80\/"},"modified":"2025-12-03T19:05:15","modified_gmt":"2025-12-03T18:05:15","slug":"%eb%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b0%9c%eb%b0%9c-3%ec%83%81%eb%b6%80%ed%84%b0-%eb%b6%84%ec%84%9d-%eb%b9%84%ea%b5%90%ec%84%b1-%eb%b0%8f-pk-pd%ea%b9%8c%ec%a7%80","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%eb%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b0%9c%eb%b0%9c-3%ec%83%81%eb%b6%80%ed%84%b0-%eb%b6%84%ec%84%9d-%eb%b9%84%ea%b5%90%ec%84%b1-%eb%b0%8f-pk-pd%ea%b9%8c%ec%a7%80\/","title":{"rendered":"\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c: 3\uc0c1\ubd80\ud130 \ubd84\uc11d \ube44\uad50\uc131 \ubc0f PK\/PD\uae4c\uc9c0"},"content":{"rendered":"

\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc740 \uc5ed\uc0ac\uc801\uc73c\ub85c \uc5b4\ub835\uace0 \ube44\uc6a9\uacfc \uc2dc\uac04\uc774 \ub9ce\uc774 \uc18c\uc694\ub418\uc5c8\uc9c0\ub9cc, \uc0dd\uba85\uc744 \uad6c\ud558\ub294 \uc0dd\ubb3c\ud559\uc801 \uce58\ub8cc\uc81c\uc5d0 \ub300\ud55c \ud658\uc790\uc758 \uc811\uadfc\uc131\uc744 \uac1c\uc120\ud558\ub294 \ud574\uacb0\ucc45\uc785\ub2c8\ub2e4. \uc804\ud1b5\uc801\uc73c\ub85c \ud655\uc99d\uc801 3\uc0c1 \ube44\uad50 \ud6a8\ub2a5 \ubc0f \uc548\uc804\uc131(CES) \uc5f0\uad6c\ub294 \uc2b9\uc778\uc758 \ud45c\uc900 \uc694\uac74\uc73c\ub85c \uc5ec\uaca8\uc84c\uc9c0\ub9cc, \ucd5c\uadfc \uc774\ub7ec\ud55c \uc0c1\ud669\uc774 \ubc14\ub00c\uc5c8\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n

2025\ub144, \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uacfc \uc720\ub7fd \uc758\uc57d\ud488\uccad(EMA)\uc740 \ub300\ubd80\ubd84\uc758 \uacbd\uc6b0 \ud655\uc99d\uc801 3\uc0c1 \uc784\uc0c1\uc2dc\ud5d8\uc774 \ub354 \uc774\uc0c1 \ud544\uc694\ud558\uc9c0 \uc54a\ub2e4\ub294 \uc8fc\uc694 \uc5c5\ub370\uc774\ud2b8\ub97c \ubc1c\ud45c\ud588\uc2b5\ub2c8\ub2e4. \ub300\uc2e0, \uc57d\ub3d9\ud559(PK) \uc5f0\uad6c \ubc0f \ud544\uc694\ud55c \uacbd\uc6b0 \uc57d\ub825\ud559(PD) \uc5f0\uad6c\ub85c \ub4b7\ubc1b\uce68\ub418\ub294 \uac15\ub825\ud55c \ubd84\uc11d\uc801 \ube44\uad50\ub3d9\ub4f1\uc131 \ub370\uc774\ud130\uac00 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc81c\ucd9c\uc5d0 \ud544\uc694\ud55c \uae30\uc900\uc774 \ub420 \uac83\uc785\ub2c8\ub2e4. <\/span><\/p>\n

\uc8fc\uc694 \ub0b4\uc6a9 <\/strong><\/h2>\n
    \n
  • EMA\uc640 FDA\ub294 \ub354 \uc774\uc0c1 \ub300\ubd80\ubd84\uc758 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uc5d0 \ub300\ud574 \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 3\uc0c1 \ud6a8\ub2a5 \uc2dc\ud5d8\uc744 \uc694\uad6c\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n
  • \ubd84\uc11d\uc801 \ube44\uad50\uc131, PK\/PD \uc5f0\uad6c \ubc0f \uba74\uc5ed\uc6d0\uc131 \ud14c\uc2a4\ud2b8\ub294 \uc774\uc81c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc758 \ud575\uc2ec\uc785\ub2c8\ub2e4.<\/span><\/li>\n
  • \uc804 \uc138\uacc4 \uaddc\uc81c \uae30\uad00\uc740 \ud658\uc790\uc758 \uc811\uadfc\uc131\uc744 \ub192\uc774\uace0 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc744 \uac00\uc18d\ud654\ud558\uae30 \uc704\ud574 \ud611\ub825\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n
  • \uc774\ub97c \ud1b5\ud574 \uac1c\ubc1c\uc790\ub294 \ube44\uc6a9\uacfc \uc77c\uc815\uc744 \uc904\uc77c \uc218 \uc788\ub294 \uae30\ud68c\ub97c \uc5bb\uc9c0\ub9cc, \uac15\ub825\ud55c \ubd84\uc11d\uacfc \uc2a4\ub9c8\ud2b8\ud558\uace0 \ube60\ub978 \uac1c\ubc1c \uacc4\ud68d\uc774 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n

    \uc774 \uae30\uc0ac\uc5d0\uc11c\ub294 \uc774\ub7ec\ud55c \uaddc\uc81c \ubcc0\ud654\uac00 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc790\ub4e4\uc5d0\uac8c \uc5b4\ub5a4 \uc758\ubbf8\ub97c \uac16\ub294\uc9c0, \ubd84\uc11d\uc801 \ube44\uad50 \uac00\ub2a5\uc131\uacfc PK\/PD \uc5f0\uad6c\uac00 \uc774\uc81c \uc65c \uc8fc\ubaa9\uc744 \ubc1b\uace0 \uc788\ub294\uc9c0, \uadf8\ub9ac\uace0 Kymos Group\uc774 \uae30\uc5c5\ub4e4\uc774 \uc774 \uc0c8\ub85c\uc6b4 \uac1c\ubc1c \uacbd\ub85c\ub97c \ud0d0\uc0c9\ud558\ub294 \ub370 \uc5b4\ub5bb\uac8c \ub3c4\uc6c0\uc744 \uc904 \uc218 \uc788\ub294\uc9c0 \uac04\ub7b5\ud558\uac8c \uc0b4\ud3b4\ubd05\ub2c8\ub2e4.<\/p>\n

    <\/span><\/p>\n

    \uaddc\uc81c \ubcc0\ud654: EMA\uc640 FDA\uc758 \ud611\ub825<\/strong><\/h2>\n

    EMA\uc758 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc5d0 \ub300\ud55c \ub9de\ucda4\ud615 \uc784\uc0c1 \uc811\uadfc\ubc95\uc5d0 \ub300\ud55c \uc131\ucc30 \ubcf4\uace0\uc11c \ucd08\uc548<\/em> \uc5d0 \ub530\ub974\uba74, \ucca0\uc800\ud55c \uc5f0\uad6c\ub97c \ud1b5\ud574 \uad6c\uc870, \uae30\ub2a5 \ubc0f \uc57d\ub3d9\ud559(PK)\uc758 \ub192\uc740 \uc720\uc0ac\uc131\uc744 \uc785\uc99d\ud558\uba74 \uc784\uc0c1 \ud6a8\ub2a5\uc744 \ucd94\ub860\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub530\ub77c\uc11c \uad6c\uc870, \uae30\ub2a5 \ubc0f \uc57d\ub3d9\ud559\uc5d0 \ub300\ud55c \ube44\uad50\ub3d9\ub4f1\uc131 \ub370\uc774\ud130\ub294 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc2b9\uc778\uc758 \uc8fc\uc694 \uc694\uac74\uc785\ub2c8\ub2e4. \ube44\uad50 \uc784\uc0c1 \ud6a8\ub2a5 \uc5f0\uad6c(CES)\ub294 \ud654\ud569\ubb3c\uc758 \uc791\uc6a9 \uae30\uc804\uc774 \uc81c\ub300\ub85c \uc774\ud574\ub418\uc9c0 \uc54a\uc558\uac70\ub098, \ud655\uc778\ub41c \uad6c\uc870\uc801 \ubc0f \uae30\ub2a5\uc801 \ucc28\uc774\uac00 \uc784\uc0c1 \uacb0\uacfc\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\ub294 \uacbd\uc6b0\uc5d0\ub9cc \ud544\uc694\ud569\ub2c8\ub2e4. <\/span><\/p>\n

    \ub9c8\ucc2c\uac00\uc9c0\ub85c, FDA\ub294 \ucd5c\uadfc \ub2e8\uc77c\ud074\ub860 \ud56d\uccb4 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uc5d0 \ub300\ud55c \uc784\uc0c1 \ud6a8\ub2a5 \uc5f0\uad6c \uba74\uc81c \uc2e0\uccad\uc744 \ucd5c\ucd08\ub85c \uc811\uc218\ud588\uc2b5\ub2c8\ub2e4. \uc774\ub294 FDA\uc758 \ube44\uad50 \ubd84\uc11d \ud3c9\uac00 \ubc0f \uae30\ud0c0 \ud488\uc9c8 \uad00\ub828 \uace0\ub824 \uc0ac\ud56d<\/em> \uc5d0 \ub300\ud55c \uc9c0\uce68 \ubc1c\ud45c\uc640 \ub3d9\uc2dc\uc5d0 \uc774\ub8e8\uc5b4\uc84c\ub294\ub370, \uc774 \uc9c0\uce68\uc740 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uc640 \ub300\uc870\uc57d \uac04\uc758 \uc6d0\ud65c\ud55c \ube44\uad50\uac00\ub2a5\uc131\uc744 \uc785\uc99d\ud558\uae30 \uc704\ud55c \ubd84\uc11d \uc694\uac74\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801\uc774\uace0 \uc0c1\uc138\ud55c \uc124\uba85\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. <\/span><\/p>\n

    \uc2e4\uc81c\ub85c \uc774\ub294 CES \uc5f0\uad6c\uac00 \ub354 \uc774\uc0c1 \uae30\ubcf8 \uc694\uac74\uc774 \uc544\ub2d8\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \ub300\uc2e0, \uc774\uc81c \uaddc\uc81c \uae30\uad00\ub4e4\uc740 \uac1c\ubc1c\uc790\ub4e4\uc774 \uc0dd\ubb3c\ud559\uc801 \ub3d9\ub4f1\uc131\uc744 \ud655\ub9bd\ud558\uae30 \uc704\ud574 \ubd84\uc11d \ub370\uc774\ud130, \uae30\ub2a5 \ubd84\uc11d, \uc57d\ub3d9\ud559\/\uc57d\ub825\ud559 \uc5f0\uad6c, \uba74\uc5ed\uc6d0\uc131 \uc2dc\ud5d8 \ub4f1\uc5d0\uc11c \ub3c4\ucd9c\ub418\ub294 “\ucd1d\uccb4\uc801 \uc99d\uac70(totality of evidence)” \uc811\uadfc\ubc95\uc5d0 \uc758\uc874\ud558\uae30\ub97c \uae30\ub300\ud569\ub2c8\ub2e4. EMA\uc640 FDA \uc678\uc5d0\ub3c4 WHO\ub098 \uce90\ub098\ub2e4 \ubcf4\uac74\ubd80 \ub4f1 \ub2e4\ub978 \uaddc\uc81c \uae30\uad00\ub4e4\ub3c4 \ubd88\ud544\uc694\ud55c \uc784\uc0c1\uc2dc\ud5d8\uc744 \uc904\uc774\uae30 \uc704\ud574 \uc9c0\uce68\uc744 \uac1c\uc815\ud558\uc5ec \uc870\ud654\ub85c\uc6b4 \uad6d\uc81c\uc801 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uad6c\ucd95\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n

    <\/span><\/p>\n

    3\uc0c1\ubd80\ud130 \ubd84\uc11d \ubc0f PK\/PD\uae4c\uc9c0
    <\/strong><\/h2>\n

    3\uc0c1 \uc5f0\uad6c\uac00 \uc7ac\uace0\ub418\ub294 \uc774\uc720<\/p>\n

    <\/strong><\/h3>\n

    \ub300\uaddc\ubaa8 CES \uc5f0\uad6c\ub294 \uc5ed\uc0ac\uc801\uc73c\ub85c \uc2dc\uac04\uacfc \uc790\uc6d0\uc774 \ub9ce\uc774 \uc18c\uc694\ub418\uc5b4 \uc218\ubc31 \uba85\uc758 \ud658\uc790, \uac12\ube44\uc2fc \ube44\uad50 \uc57d\ubb3c \uc870\ub2ec, \uadf8\ub9ac\uace0 \uae34 \ucd94\uc801 \uad00\ucc30 \uae30\uac04\uc774 \ud544\uc694\ud588\uc2b5\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uaddc\uc81c \uacbd\ud5d8\uc5d0 \ub530\ub974\uba74 \uc0dd\ubb3c\ud559\uc801 \ub3d9\ub4f1\uc131 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 \uc81c\ud488\uc774\ub77c\ub3c4 3\uc0c1\uc5d0\uc11c \uc784\uc0c1\uc801\uc73c\ub85c \uc720\uc758\ubbf8\ud55c \ucc28\uc774\ub97c \ubcf4\uc774\ub294 \uacbd\uc6b0\ub294 \ub4dc\ubb45\ub2c8\ub2e4. <\/span><\/p>\n

    \uc774\ub7ec\ud55c \uc774\uc720\ub85c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc5d0 \ub300\ud55c \uc0c8\ub85c\uc6b4 \ud45c\uc900\uc740 \ub2e4\uc74c\uacfc \uac19\uc774 \ud615\uc131\ub429\ub2c8\ub2e4.<\/span><\/p>\n

    <\/h3>\n

    \ubd84\uc11d\uc801 \ube44\uad50\uc131<\/strong><\/span><\/p>\n

    \ud3ec\uad04\uc801\uc778 \ubb3c\ub9ac\ud654\ud559\uc801 \ubc0f \uae30\ub2a5\uc801 \ud2b9\uc131 \ubd84\uc11d\uc774 \uae30\ubc18\uc774 \ub429\ub2c8\ub2e4. \uac1c\ubc1c\uc790\ub294 \ub2e4\uc74c\uc744 \uc218\ud589\ud574\uc57c \ud569\ub2c8\ub2e4. <\/span><\/p>\n

      \n
    • 1\ucc28 \uad6c\uc870\ubd80\ud130 4\ucc28 \uad6c\uc870, \ubc88\uc5ed \ud6c4 \ubcc0\ud615, \uc81c\ud488 \uad00\ub828 \ubcc0\ud615\uae4c\uc9c0 \ud3c9\uac00\ud569\ub2c8\ub2e4.<\/span><\/li>\n
    • \uc9c1\uad50\uc801\uc774\uace0 \ucd5c\ucca8\ub2e8 \ubd84\uc11d \ubc29\ubc95\uc744 \uc0ac\uc6a9\ud569\ub2c8\ub2e4.<\/span><\/li>\n
    • \ubcc0\ub3d9\uc131\uc744 \ud30c\uc545\ud558\uae30 \uc704\ud574 \uae30\uc900 \uc81c\ud488\uacfc \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \ubaa8\ub450\uc5d0 \ub300\ud574 \uc5ec\ub7ec \ub85c\ud2b8\ub97c \ud14c\uc2a4\ud2b8\ud569\ub2c8\ub2e4.<\/span><\/li>\n
    • \uc704\ud5d8 \uae30\ubc18 \uc811\uadfc \ubc29\uc2dd\uc744 \uc801\uc6a9\ud558\uc5ec \uc8fc\uc694 \ud488\uc9c8 \uc18d\uc131(CQA)\uc744 \uc2dd\ubcc4\ud558\uace0 \uc774\ub97c \uc784\uc0c1 \uc131\uacfc\uc640 \uc5f0\uacb0\ud569\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n

      PK \ubc0f PD \uc5f0\uad6c<\/p>\n

      <\/strong><\/span><\/h3>\n

      \uc778\uccb4 \uc57d\ub3d9\ud559(PK) \uc5f0\uad6c\ub294 \uc5ec\uc804\ud788 \ud544\uc218\uc801\uc774\uba70, \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uc640 \ub300\uc870\uc57d \uac04\uc758 \ud761\uc218 \ubc0f \uc18c\uc2e4\uc744 \ube44\uad50\ud558\uae30 \uc704\ud574 \ub2e8\ud68c \ud22c\uc5ec \uad50\ucc28 \uc5f0\uad6c\ub85c \uc124\uacc4\ub418\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4. \uac80\uc99d\ub41c \ub300\ub9ac \ud45c\uc9c0\uc790\uac00 \uc788\ub294 \uacbd\uc6b0 \uc57d\ub825\ud559(PD) \ud3c9\uac00\ubcc0\uc218\ub97c \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uba74\uc5ed\uc6d0\uc131 \ub370\uc774\ud130\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc57d\ub3d9\ud559(PK)\uacfc \ud568\uaed8 \uc218\uc9d1\ub429\ub2c8\ub2e4. <\/span><\/p>\n

      \uba74\uc5ed\uc6d0\uc131 \ud3c9\uac00<\/p>\n

      <\/strong><\/span><\/h3>\n

      \uacb0\ud569 \ubc0f \uc911\ud654 \ud56d\uc57d\ubb3c \ud56d\uccb4(ADA, NAb)\ub294 \ud6a8\ub2a5\uc774\ub098 \uc548\uc804\uc131\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\ub294 \uba74\uc5ed \ubc18\uc751\uc744 \ubc30\uc81c\ud558\uae30 \uc704\ud574 \uce21\uc815\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ud604\uc7ac \uc9c0\uce68\uc5d0\uc11c\ub294 \uacb0\ud569 \ud56d\uccb4 \uc2a4\ud06c\ub9ac\ub2dd, \ud655\uc9c4 \uac80\uc0ac, \uadf8\ub9ac\uace0 \ud544\uc694\ud55c \uacbd\uc6b0 \uc911\ud654 \ud65c\uc131 \ud2b9\uc131 \ubd84\uc11d\uc744 \ud3ec\ud568\ud558\ub294 \ub2e8\uacc4\uc801 \uc811\uadfc\ubc95\uc744 \uad8c\uc7a5\ud569\ub2c8\ub2e4. <\/span><\/p>\n

      \uc774 \uc138 \uac00\uc9c0 \ubd80\ubd84\uc744 \ud569\uce58\uba74 \ub300\uaddc\ubaa8 \ud6a8\ub2a5 \uc2dc\ud5d8 \uc5c6\uc774\ub3c4 \uc0dd\ubb3c\ud559\uc801 \uc720\uc0ac\uc131\uc744 \uc785\uc99d\ud558\ub294 \ub370 \ud544\uc694\ud55c “\ucd1d\uccb4\uc801\uc778 \uc99d\uac70”\ub97c \uc5bb\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

      <\/span><\/p>\n

      \uc774\uac83\uc774 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc790\uc5d0\uac8c \uc758\ubbf8\ud558\ub294 \ubc14<\/strong><\/h2>\n

      \uc774\ub7ec\ud55c \uaddc\uc81c \ubcc0\ud654\ub294 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc790\ub4e4\uc5d0\uac8c \uc0c8\ub85c\uc6b4 \uac00\ub2a5\uc131\uc744 \uc5f4\uc5b4\uc8fc\uace0 \uae30\ud68c\ub97c \uc81c\uacf5\ud558\uc9c0\ub9cc, \ud2b9\uc815 \ubd84\uc57c\uc5d0\uc11c\ub294 \uae30\ub300\uce58\ub97c \ub192\uc774\uae30\ub3c4 \ud569\ub2c8\ub2e4. \ud55c\ud3b8\uc73c\ub85c\ub294 \uc758\ubb34\uc801\uc778 3\uc0c1 \uc784\uc0c1\uc2dc\ud5d8\uc5d0\uc11c \ubc97\uc5b4\ub098\ub294 \uc804\ud658\uc740 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc2dc\uc7a5 \uac1c\ubc1c\uc744 \uac00\uc18d\ud654\ud558\uace0 \ucc38\uc5ec\ub97c \ud655\ub300\ud560 \uac83\uc785\ub2c8\ub2e4. \ub2e4\ub978 \ud55c\ud3b8\uc73c\ub85c\ub294 \ub354 \ub192\uc740 \ubd84\uc11d \uae30\ub300\uce58, \uc2e0\uc911\ud55c \uacc4\ud68d \uc218\ub9bd, \uadf8\ub9ac\uace0 \uaddc\uc81c \uae30\uad00\uacfc\uc758 \uae34\ubc00\ud55c \ud611\ub825\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. <\/span><\/p>\n

      \uae30\ud68c<\/strong><\/h3>\n
        \n
      • \ube44\uc6a9 \uc808\uac10 \ubc0f \ud0c0\uc784\ub77c\uc778 \ub2e8\ucd95:<\/strong> 3\uc0c1 \uc5f0\uad6c\ub97c \uc5c6\uc560\uba74 \uac1c\ubc1c \uae30\uac04\uc744 \uc218\ub144 \ub2e8\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n
      • \uc2dc\uc7a5 \ucc38\uc5ec \ud655\ub300:<\/strong> \uc911\uc18c \uaddc\ubaa8\uc758 \uc0dd\ubb3c\uc81c\uc57d \ud68c\uc0ac\ub3c4 \uc774\uc81c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \ubd84\uc57c\uc5d0\uc11c \uacbd\uc7c1\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n
      • \uaddc\uc81c\uc758 \uba85\ud655\uc131:<\/strong> \uae00\ub85c\ubc8c \uac00\uc774\ub4dc\ub77c\uc778\uc758 \uc870\ud654\ub85c \uc778\ud574 \uac1c\ubc1c \uacbd\ub85c\uac00 \ub354 \uc608\uce21 \uac00\ub2a5\ud574\uc84c\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n
      • \uc2e4\uc81c \uc0ac\ub840:<\/strong> \ucd5c\uadfc \uba87\uba87 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\ub294 \uc774\ubbf8 3\uc0c1 \uc784\uc0c1 \uc2dc\ud5d8 \uc5c6\uc774 \uc2b9\uc778\ub418\uc5c8\uc73c\uba70, \uc774\ub294 \uac04\uc18c\ud654\ub41c \uacbd\ub85c\uac00 \uc774\ub860\uc801\uc778 \uac83\uc5d0 \uadf8\uce58\uc9c0 \uc54a\uace0 \uc774\ubbf8 \uaddc\uc81c \uae30\uad00\uc5d0\uc11c \uad6c\ud604\ub418\uace0 \uc788\uc74c\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n

        \uc0c8\ub85c\uc6b4 \uc694\uad6c<\/strong><\/h3>\n
          \n
        • \ub354 \ub192\uc740 \ubd84\uc11d \uae30\uc900:<\/strong> \ubbfc\uac10\ud558\uace0 \uc9c1\uad50\uc801\uc778 \ubc29\ubc95\uacfc \ud3ec\uad04\uc801\uc778 \uc704\ud5d8 \ud3c9\uac00\uac00 \ud544\uc218\uc785\ub2c8\ub2e4.<\/span><\/li>\n
        • \uc870\uae30 \uacc4\ud68d:<\/strong> \ud575\uc2ec \uc5f0\uad6c\ub97c \uc2dc\uc791\ud558\uae30 \uc804\uc5d0 \uc0ac\uc804 \ud569\uc758\ub41c \uc720\uc0ac\uc131 \ud3c9\uac00 \ud504\ub85c\ud1a0\ucf5c\uc744 \uc218\ub9bd\ud558\ub294 \uac83\uc774 \uc88b\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n
        • \uacac\uace0\ud55c \uc81c\uc870 \uad00\ub9ac:<\/strong> \uc0c1\uc5c5\uc6a9 \ubc30\uce58\uc758 \uc77c\uad00\uc131\uc740 \uc720\uc0ac\uc131 \uc8fc\uc7a5\uc744 \ub4b7\ubc1b\uce68\ud558\ub294 \ub370 \uc911\uc694\ud569\ub2c8\ub2e4.<\/span><\/li>\n
        • \uaddc\uc81c \ucc38\uc5ec:<\/strong> \uc5f0\uad6c \uc124\uacc4\uc5d0 \ub300\ud55c \uc758\uacac\uc744 \uc870\uc728\ud558\uace0 \uc608\uc0c1\uce58 \ubabb\ud55c \uc0c1\ud669\uc744 \ud53c\ud558\uae30 \uc704\ud574 EMA \ub610\ub294 FDA\uc640 \uc870\uae30\uc5d0 \uacfc\ud559\uc801 \uc790\ubb38 \ud68c\uc758\ub97c \uac16\ub294 \uac83\uc774 \uc88b\uc2b5\ub2c8\ub2e4.\n

          <\/span><\/li>\n<\/ul>\n

          3\ub2e8\uacc4\uac00 \uc5ec\uc804\ud788 \ud544\uc694\ud560 \uc218 \uc788\ub294 \uacbd\uc6b0<\/strong><\/h2>\n

          \ud604\uc7ac \uae30\ubcf8 \uae30\ub300\uce58\ub294 “CES \uc5c6\uc74c”\uc774\uc9c0\ub9cc, \uc784\uc0c1 \ud6a8\ub2a5 \uc2dc\ud5d8\uc774 \uc694\uccad\ub420 \uc218 \uc788\ub294 \uc0c1\ud669\uc774 \uc5ec\uc804\ud788 \uc874\uc7ac\ud569\ub2c8\ub2e4. \uc791\uc6a9 \uae30\uc804\uc774 \ubd88\ubd84\uba85\ud558\uac70\ub098 \ubcf5\uc7a1\ud55c \uc81c\ud488\uc758 \uacbd\uc6b0, \ub610\ub294 \ubd84\uc11d \ub370\uc774\ud130\uc640 \uae30\ub2a5 \ubd84\uc11d\ub9cc\uc73c\ub85c \uc784\uc0c1\uc801 \ud6a8\ub2a5\uc744 \ucda9\ubd84\ud788 \uc608\uce21\ud560 \uc218 \uc5c6\ub294 \uacbd\uc6b0\uc5d0\ub294 3\uc0c1 \uc784\uc0c1\uc2dc\ud5d8\uc774 \uc5ec\uc804\ud788 \ud544\uc694\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub9c8\ucc2c\uac00\uc9c0\ub85c, \uc57d\ub3d9\ud559(PK) \uc5f0\uad6c \uc911 \uc608\uc0c1\uce58 \ubabb\ud55c \uba74\uc5ed\uc6d0\uc131 \uc2e0\ud638\uac00 \ubc1c\uacac\ub418\uba74 \ucd94\uac00\uc801\uc778 \ud6a8\ub2a5 \ubc0f \uc548\uc804\uc131 \ub370\uc774\ud130\uac00 \ud544\uc694\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/p>\n

          <\/span><\/p>\n

          Kymos Group\uc774 \uc5b4\ub5bb\uac8c \ub3c4\uc6c0\uc744 \uc904 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/strong><\/h2>\n

          Kymos Group\uc740 \uc774 \uc0c8\ub85c\uc6b4 \uaddc\uc81c \uc0c1\ud669\uc744 \uadf9\ubcf5\ud558\uae30 \uc704\ud574 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc790\ub97c \uc9c0\uc6d0\ud558\uae30 \uc704\ud574 \ub2e4\uc591\ud55c \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n

            \n
          • \ubd84\uc11d \ube44\uad50\uc131:<\/strong> GMP \uae30\uc900\uc5d0 \ub530\ub978 \ubb3c\ub9ac\ud654\ud559\uc801, \uae30\ub2a5\uc801, \ud6a8\ub2a5 \ubd84\uc11d\uc744 \ud3ec\ud568\ud55c \ud3ec\uad04\uc801\uc778 CMC \ud2b9\uc131 \ubd84\uc11d. CMC \ubd84\uc11d \uc11c\ube44\uc2a4\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uc138\uc694. <\/span><\/li>\n
          • \uc0dd\uccb4 \ubd84\uc11d \ubc0f \uc57d\ub3d9\ud559(PK) \uc5f0\uad6c:<\/strong> \uc2a4\ud398\uc778\uacfc \ub3c5\uc77c\uc5d0 \uc704\uce58\ud55c \uc800\ud76c \uc2e4\ud5d8\uc2e4\uc5d0\uc11c GLP \uaddc\uc815\uc744 \uc900\uc218\ud558\ub294 \uc57d\ub3d9\ud559(PK) \ubc0f \uba74\uc5ed\uc6d0\uc131 \uac80\uc0ac(ADA, NAb)\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc800\ud76c\uc758 \uba74\uc5ed\uc6d0\uc131 \uac80\uc0ac \uc5ed\ub7c9\uc744 \uc0b4\ud3b4\ubcf4\uc138\uc694. <\/span><\/li>\n
          • \ud1b5\ud569 \uc194\ub8e8\uc158:<\/strong> \uc804\ubb38 \uc784\uc0c1 \ubd80\uc11c\uc640\uc758 \ud30c\ud2b8\ub108\uc2ed\uc744 \ud1b5\ud574 \uc784\uc0c1 \uc2e4\ud589\uacfc \uc0ac\ub0b4 \uc0dd\ubb3c\ud559\uc801 \ubd84\uc11d\uc744 \uacb0\ud569\ud558\uc5ec \uc644\uc804\ud55c PK\/PD \uc5f0\uad6c\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/li>\n
          • \uaddc\uc81c \uc804\ubb38\uc131:<\/strong> \ub2f9\uc0ac \ud300\uc740 EMA, FDA, ICH \uac00\uc774\ub4dc\ub77c\uc778\uc5d0 \ub9de\ucdb0 \ubaa9\uc801\uc5d0 \ub9de\ub294 \uc5f0\uad6c\ub97c \uc124\uacc4\ud558\uc5ec \uadc0\ud558\uc758 \uacb0\uacfc\uac00 \uc81c\ucd9c \uc900\ube44\uac00 \ub418\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4.\n

            <\/span><\/li>\n<\/ul>\n

            \uacb0\ub860<\/strong><\/h2>\n

            \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc2dc\uc7a5\uc740 \ucd5c\uadfc \uba87 \ub144 \ub3d9\uc548 \ube60\ub974\uac8c \ubc1c\uc804\ud574 \uc654\uc73c\uba70, \uc774\ub7ec\ud55c \ubcc0\ud654\ub294 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc758 \ud328\ub7ec\ub2e4\uc784 \uc804\ud658\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \uae30\uad00\ub4e4\uc740 \ub300\uaddc\ubaa8 3\uc0c1 \uc784\uc0c1\uc2dc\ud5d8\uc758 \uc911\uc694\uc131\uc744 \uc904\uc784\uc73c\ub85c\uc368, \uac15\ub825\ud55c \ubd84\uc11d\uacfc \uc2a4\ub9c8\ud2b8\ud55c \uac1c\ubc1c \uacc4\ud68d\uc5d0 \uc911\uc810\uc744 \ub454 \uacfc\ud559 \uc911\uc2ec\uc801\uc774\uace0 \ud6a8\uc728\uc131 \uc911\uc2ec\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \uac15\uc870\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n

            \uc774\ub7ec\ud55c \uc0c8\ub85c\uc6b4 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \ud658\uacbd\uc740 \uac1c\ubc1c\uc790\ub4e4\uc5d0\uac8c \uae30\ud68c\ub97c \uc81c\uacf5\ud558\uba70, Kymos\uc640 \uac19\uc740 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \ubd84\uc11d \ud30c\ud2b8\ub108\uc640\uc758 \ud611\ub825\uc758 \uc911\uc694\uc131\uc744 \uac15\uc870\ud569\ub2c8\ub2e4. \ub2f9\uc0ac\uc758 \uc720\ub7fd \uc5f0\uad6c\uc18c\ub294 \ud544\uc218 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 \uc5d4\ub4dc \ud22c \uc5d4\ub4dc \ubd84\uc11d \ube44\uad50\uc131, \uc0dd\uccb4 \ubd84\uc11d, \uadf8\ub9ac\uace0 \uc57d\ub3d9\ud559\/\uc57d\ub825\ud559(PK\/PD) \uc5ed\ub7c9\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. <\/span><\/p>\n

            \uc774\ub7ec\ud55c \uac15\uc810\uc744 \ubc14\ud0d5\uc73c\ub85c \uc6b0\ub9ac\ub294 \uaddc\uc81c \uc900\uc218\ub97c \uc720\uc9c0\ud558\uba74\uc11c\ub3c4 \uc0c8\ub85c\uc6b4 \uae30\ub300\uc5d0 \ubd80\uc751\ud558\uace0 \ucd9c\uc2dc \uae30\uac04\uc744 \ub2e8\ucd95\ud574\uc57c \ud558\ub294 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc790\ub97c \uc9c0\uc6d0\ud560 \uc218 \uc788\ub294 \uc785\uc9c0\ub97c \ud655\ubcf4\ud588\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n

            \uc624\ub298 \uc5f0\ub77d\ud558\uc5ec \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \ud504\ub85c\uadf8\ub7a8\uc744 \uc9c0\uc6d0\ud558\uace0 \ucd5c\uc2e0 \uaddc\uc81c \uc5c5\ub370\uc774\ud2b8\ub97c \ud65c\uc6a9\ud558\ub294 \ub370 \ub3c4\uc6c0\uc744 \ub4dc\ub9b4 \uc218 \uc788\ub294 \ubc29\ubc95\uc5d0 \ub300\ud574 \ub17c\uc758\ud574 \ubcf4\uc138\uc694.<\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":8,"featured_media":28383,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[259,261],"tags":[67],"class_list":["post-28381","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-259","category-261","tag-carles"],"acf":[],"yoast_head":"\n\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c: 3\uc0c1\ubd80\ud130 \ubd84\uc11d \ube44\uad50\uae4c\uc9c0<\/title>\n<meta name=\"description\" content=\"\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc758 \ucd5c\uadfc \ubcc0\ud654\uc640 \ubd84\uc11d\uc801 \ube44\uad50\uc131\uacfc PK\/PD\uac00 \uc0c8\ub85c\uc6b4 \ud45c\uc900\uc774 \ub41c \uc774\uc720\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \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%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b0%9c%eb%b0%9c-3%ec%83%81%eb%b6%80%ed%84%b0-%eb%b6%84%ec%84%9d-%eb%b9%84%ea%b5%90%ec%84%b1-%eb%b0%8f-pk-pd%ea%b9%8c%ec%a7%80\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c: 3\uc0c1\ubd80\ud130 \ubd84\uc11d \ube44\uad50\uae4c\uc9c0\" \/>\n<meta property=\"og:description\" content=\"\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc758 \ucd5c\uadfc \ubcc0\ud654\uc640 \ubd84\uc11d\uc801 \ube44\uad50\uc131\uacfc PK\/PD\uac00 \uc0c8\ub85c\uc6b4 \ud45c\uc900\uc774 \ub41c \uc774\uc720\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uc138\uc694.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kymos.com\/ko\/news\/%eb%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b0%9c%eb%b0%9c-3%ec%83%81%eb%b6%80%ed%84%b0-%eb%b6%84%ec%84%9d-%eb%b9%84%ea%b5%90%ec%84%b1-%eb%b0%8f-pk-pd%ea%b9%8c%ec%a7%80\/\" \/>\n<meta property=\"og:site_name\" content=\"Kymos\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-07T07:38:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-03T18:05:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kymos.com\/wp-content\/uploads\/2025\/11\/Biosimilar-Development-Article-Header.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"900\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Sandra Magdaleno\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@KymosGroup\" \/>\n<meta name=\"twitter:site\" content=\"@KymosGroup\" \/>\n<meta name=\"twitter:label1\" content=\"\uae00\uc4f4\uc774\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sandra Magdaleno\" \/>\n\t<meta name=\"twitter:label2\" content=\"\uc608\uc0c1 \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%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b0%9c%eb%b0%9c-3%ec%83%81%eb%b6%80%ed%84%b0-%eb%b6%84%ec%84%9d-%eb%b9%84%ea%b5%90%ec%84%b1-%eb%b0%8f-pk-pd%ea%b9%8c%ec%a7%80\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kymos.com\\\/ko\\\/news\\\/%eb%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b0%9c%eb%b0%9c-3%ec%83%81%eb%b6%80%ed%84%b0-%eb%b6%84%ec%84%9d-%eb%b9%84%ea%b5%90%ec%84%b1-%eb%b0%8f-pk-pd%ea%b9%8c%ec%a7%80\\\/\"},\"author\":{\"name\":\"Sandra Magdaleno\",\"@id\":\"https:\\\/\\\/kymos.com\\\/ko\\\/#\\\/schema\\\/person\\\/b0ed444c71c4c8afa6f4ae674967c999\"},\"headline\":\"\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c: 3\uc0c1\ubd80\ud130 \ubd84\uc11d \ube44\uad50\uc131 \ubc0f 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