{"id":3734,"date":"2024-06-03T10:43:15","date_gmt":"2024-06-03T01:43:15","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&#038;p=3734"},"modified":"2024-06-12T12:39:58","modified_gmt":"2024-06-12T03:39:58","slug":"%ed%95%9c%ec%83%98%ea%b8%80%eb%a1%9c%eb%b2%8c%ec%9d%98-%ec%97%ad%eb%b2%88%ec%97%ad-back-translation-%ec%84%9c%eb%b9%84%ec%8a%a4-%ec%97%ad%ed%95%a0%ea%b3%bc-%ec%a4%91%ec%9a%94%ec%84%b1","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/%ed%95%9c%ec%83%98%ea%b8%80%eb%a1%9c%eb%b2%8c%ec%9d%98-%ec%97%ad%eb%b2%88%ec%97%ad-back-translation-%ec%84%9c%eb%b9%84%ec%8a%a4-%ec%97%ad%ed%95%a0%ea%b3%bc-%ec%a4%91%ec%9a%94%ec%84%b1\/","title":{"rendered":"\ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \uc5ed\ubc88\uc5ed (Back Translation) \uc11c\ube44\uc2a4: \uc5ed\ud560\uacfc \uc911\uc694\uc131"},"content":{"rendered":"\n<p>\uc5ed\ubc88\uc5ed \ud504\ub85c\uc138\uc2a4\ub294 \uc758\ub8cc\uae30 \uc124\uba85\uc11c, \uc784\uc0c1 \uc2dc\ud5d8, \uc81c\uc57d \ubd84\uc57c \ub4f1\uc758 \uc911\uc694 \ubb38\uc11c \ubc88\uc5ed\uc5d0\uc11c \ube60\uc9c8 \uc218 \uc5c6\ub294 \ud575\uc2ec \uae30\uc220\uc785\ub2c8\ub2e4. \uc774\ub4e4 \ubb38\uc11c\uc758 \uc815\ud655\ud55c \ubc88\uc5ed\uc740 \ud658\uc790\uc758 \uc548\uc804\uacfc \uaddc\uc81c \uc900\uc218\uc5d0 \uc911\uc694\ud55c \uc694\uc18c\uc774\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4. \ud55c\uc0d8\uae00\ub85c\ubc8c\uc774 \uc218\ud589\ud558\uace0 \uc788\ub294 \uc5ed\ubc88\uc5ed \uc11c\ube44\uc2a4\uc5d0 \ub300\ud574\uc11c \uc18c\uac1c\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\uc5ed\ubc88\uc5ed\uc774 \uc65c \ud544\uc694\ud55c\uac00?<\/h3>\n\n\n\n<p>\uc5ed\ubc88\uc5ed\uc774\ub780 \uc774\ubbf8 \ubc88\uc5ed\ub41c \ubb38\uc11c\ub97c \uc6d0\ub798 \uc5b8\uc5b4\ub85c \ub2e4\uc2dc \ubc88\uc5ed\ud558\ub294 \uac83\uc744 \ub9d0\ud569\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4, \uc601\uc5b4\uc5d0\uc11c \uc911\uad6d\uc5b4\ub85c \ubc88\uc5ed\ub41c \ubb38\uc11c\ub97c \ub2e4\uc2dc \uc601\uc5b4\ub85c \ubc88\uc5ed\ud558\uc5ec \ubc88\uc5ed\uc774 \uc815\ud655\ud55c\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. \uc5ed\ubc88\uc5ed\uc740 \uc6d0\ubcf8 \ubc88\uc5ed\uacfc \ubb34\uad00\ud55c, \uc81c3\uc758 \ub3c5\ub9bd\uc801\uc778 \ubc88\uc5ed\uac00\uac00 \ubc88\uc5ed\ub41c \ubb38\uc11c\ub97c \ub2e4\uc2dc \uc6d0\ubcf8 \uc5b8\uc5b4\ub85c \ub2e4\uc2dc \ubc88\uc5ed\ud574\uc57c \ud569\ub2c8\ub2e4. \uadf8\ub9ac\uace0, \uc911\uc694\ud55c \uc808\ucc28\ub85c, \uc5ed\ubc88\uc5ed\ub41c \ubc84\uc804\uc744 \uc6d0\ubcf8\uacfc \ube44\uad50\ud558\uc5ec \ubd88\uc77c\uce58\ub098 \uc624\ub958\ub97c \ud655\uc778\ud558\uace0 \uc218\uc815\ud558\ub294 \uc808\ucc28\uc785\ub2c8\ub2e4.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"420\" height=\"195\" src=\"http:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/01-image1026_240508-34.png\" alt=\"\" class=\"wp-image-3819\" srcset=\"https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/01-image1026_240508-34.png 420w, https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/01-image1026_240508-34-300x139.png 300w\" sizes=\"auto, (max-width: 420px) 100vw, 420px\" \/><\/figure><\/div>\n\n\n<p>\uc5ed\ubc88\uc5ed\uc740 \uc758\ub8cc\uae30 \uc81c\uc870, \uc81c\uc57d \uc0b0\uc5c5\uc5d0\uc11c \ud544\uc218\uc801\uc778 \ubc88\uc5ed \ub3c4\uad6c\uc785\ub2c8\ub2e4. \uc758\ub8cc\uae30 \uc0ac\uc6a9\uc124\uba85\uc11c\ub294 \uc758\ub8cc \uc804\ubb38\uac00\uc640 \ud658\uc790\uac00 \uae30\uae30\ub97c \uc62c\ubc14\ub974\uac8c \uc0ac\uc6a9\ud558\uace0 \uc720\uc9c0 \ubcf4\uc218\ud558\ub294 \ub370 \ud544\uc694\ud55c \uc815\ubcf4\ub97c \ub2f4\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc0ac\uc18c\ud55c \uc624\uc5ed\uc774\ub098 \uc560\ub9e4\ud55c \ud45c\ud604\uc870\ucc28\ub3c4 \ud658\uc790\uc758 \uc548\uc804\uc744 \uc704\ud611\ud558\uac70\ub098 \uaddc\uc81c \uc704\ubc18\uc73c\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.&nbsp; \uadf8\ub798\uc11c \uc758\ub8cc\uae30 \uc0ac\uc6a9\uc124\uba85\uc11c\uc758 \ubc88\uc5ed\uc740 \ub2e8\uc21c\ud55c \uc5b8\uc5b4 \ubcc0\ud658 \ucc28\uc6d0\uc744 \ub118\uc5b4, \uae30\uc220, \uaddc\uc81c \uae30\uc900, \ubb38\ud654\uc801 \uace0\ub824\uc0ac\ud56d \ub4f1 \ub2e4\ubc29\uba74\uc758 \uc694\uc18c\ub97c \ud3ec\ud568\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc81c\uc57d\uc0ac\uc758 \uc784\uc0c1 \uc2dc\ud5d8 \ubb38\uc11c\ub3c4 \ub9c8\ucc2c\uac00\uc9c0\uc785\ub2c8\ub2e4. \uc784\uc0c1 \uc2dc\ud5d8 \ubb38\uc11c\uc758 \uc624\uc5ed\uc740 \ud658\uc790\uc758 \uc548\uc804\uc5d0 \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc5ed\ubc88\uc5ed\uc744 \ud1b5\ud574 \uc815\ud655\ud55c \uc815\ubcf4\ub97c \uc804\ub2ec\ud558\uc5ec \uc624\uc5ed\uc73c\ub85c \uc778\ud55c \uc704\ud5d8\uc744 \ucd5c\uc18c\ud654\ud558\uc9c0 \uc54a\uc73c\uba74 \uc548\ub429\ub2c8\ub2e4. \uae00\ub85c\ubc8c \uc784\uc0c1 \uc2dc\ud5d8\uc758 \uaddc\uc81c\ub3c4 \uc788\uc2b5\ub2c8\ub2e4. \uc5ed\ubc88\uc5ed\uc744 \ud1b5\ud574 \ubb38\uc11c\uc758 \uc815\ud655\uc131\uacfc \uc77c\uad00\uc131\uc744 \ud655\ubcf4\ud568\uc73c\ub85c\uc368 \uad6d\uc81c \uaddc\uc81c\ub97c \uc900\uc218\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\uc5ed\ubc88\uc5ed\uc758 \ubaa9\ud45c<\/h3>\n\n\n\n<p>\uc5ed\ubc88\uc5ed\uc740 \ubc88\uc5ed\ub41c \uc124\uba85\uc11c\ub098 \uc784\uc0c1 \uc2dc\ud5d8 \ubb38\uc11c\uc5d0 \uc7a0\uc7ac\ud55c \ubd80\uc815\ud655\uc131\uacfc \ubd88\uc77c\uce58\ub97c \uc2dd\ubcc4\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \uc774 \uacfc\uc815\uc744 \uac70\uccd0 \uc81c\uc870\uc0ac\ub294 \uc6d0\ubcf8 \ud14d\uc2a4\ud2b8\uc5d0 \ubb38\uc81c\uac00 \uc5c6\uc5c8\ub294\uc9c0\ub97c \uc0ac\uc804\uc5d0 \uc2dd\ubcc4\ud558\uace0 \uc218\uc815\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc758\ub8cc\uae30 \uc124\uba85\uc11c\uc758 \uc624\ub958\ub098 \uc624\uc5ed\uc740 \uc2ec\uac01\ud558\uace0 \uad11\ubc94\uc704\ud55c \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc0ac\uc6a9 \ubc29\ubc95\uc5d0 \ub300\ud55c \uc798\ubabb\ub41c \uc774\ud574\ub098 \uc798\ubabb\ub41c \ubcf5\uc6a9\ub7c9 \uc815\ubcf4\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0, \uc798\ubabb \ubc88\uc5ed\ub41c IFU (Instruction for Use, Information for Use. \uc0ac\uc6a9\uc790 \ubb38\uc11c\ub97c \ud1b5\uce6d\ud558\ub294 \uad6d\uc81c \ud45c\uc900 \uc6a9\uc5b4) \uc758 \uc624\ub958\ub294 \ud658\uc790 \uc548\uc804\uc5d0 \uc9c1\uc811\uc801\uc778 \uc704\ud611\uc774 \ub418\uba70, \uc81c\uc870\uc0ac\uc5d0\ub294 \ubc95\uc801 \ucc45\uc784\uc744 \ucd08\ub798\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc5c4\uaca9\ud55c \uc5ed\ubc88\uc5ed \ud504\ub85c\ud1a0\ucf5c\uc744 \uad6c\ud604\ud568\uc73c\ub85c\uc368, \uc758\ub8cc\uae30 \uc81c\uc870\uc0ac\ub294 \uc7a0\uc7ac\uc801\uc778 \uc624\ub958\ub97c \uc0ac\uc804\uc5d0 \uc2dd\ubcc4\ud558\uace0 \uc218\uc815\ud558\uc5ec \uc704\ud5d8\uc744 \uc644\ud654\ud558\uace0 \ud658\uc790\uc758 \uc548\uc804\uc744 \uc9c0\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uc758\ub8cc\uae30\ub098 \uae00\ub85c\ubc8c \uc784\uc0c1\uc2dc\ud5d8\uc740 \ub300\uc0c1 \uc9c0\uc5ed\uc758 \uc5c4\uaca9\ud55c \uaddc\uc81c \uc694\uac74\uc744 \ub530\ub77c\uc57c \ud569\ub2c8\ub2e4. <a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">FDA<\/a>\uc640 <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\" target=\"_blank\" rel=\"noreferrer noopener\">EMA<\/a>\uc640 \uac19\uc740 \uaddc\uc81c \uae30\uad00\uc740 \uc2dc\uc7a5 \uc2b9\uc778 \uc870\uac74\uc73c\ub85c \ud310\ub9e4 \ub300\uc0c1 \uc9c0\uc5ed\uc758 \uc5b8\uc5b4\ub85c \ubc88\uc5ed\ub41c \uc124\uba85\uc11c\uc640 \ubb38\uc11c\ub97c \uc694\uad6c\ud569\ub2c8\ub2e4. \uc5ed\ubc88\uc5ed\uc744 \ubc88\uc5ed \uacfc\uc815\uc5d0 \ud3ec\ud568\ud558\uba74 \ubc88\uc5ed\ub41c \ub0b4\uc6a9\uc758 \uc815\ud655\uc131\uacfc \uc2e0\ub8b0\uc131\uc744 \uc785\uc99d\ud558\ub294 \uac15\ub825\ud55c \uc99d\uac70\uac00 \ub418\uc5b4 \uaddc\uc81c \uc900\uc218\uc640 \uc2dc\uc7a5 \uc811\uadfc\uc131\uc744 \uc6a9\uc774\ud558\uac8c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\uc5ed\ubc88\uc5ed\uc758 \uc808\ucc28<\/h3>\n\n\n\n<p>\uac00\uc7a5 \ud45c\uc900\uc801\uc778 \uc5ed\ubc88\uc5ed\uc758 \uc808\ucc28\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\ubc88\uc5ed \ub2e8\uacc4<\/strong>: \uc6d0\ubcf8 \ubb38\uc11c\ub97c \ubaa9\ud45c \uc5b8\uc5b4\ub85c \ubc88\uc5ed. \uc758\ub8cc \ubd84\uc57c\uc758 \uacbd\ud5d8\uc774 \ub9ce\uc740 \ubc88\uc5ed\uac00\uac00 \uc218\ud589\ud569\ub2c8\ub2e4. \uc6d0\ubcf8\uc744 \uc815\ud655\ud558\uac8c \ubc88\uc5ed\ud558\ub294 \uac83\uc744 \ubaa9\ud45c\ub85c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc5ed\ubc88\uc5ed \ub2e8\uacc4<\/strong>: \ubaa9\ud45c \uc5b8\uc5b4\ub85c \ubc88\uc5ed\ub41c \ubb38\uc11c\ub97c \uc6d0\ubcf8 \uc5b8\uc5b4\ub85c \ub2e4\uc2dc \ubc88\uc5ed. \uc6d0\ubcf8 \ubb38\uc11c \ubc88\uc5ed\uacfc \ubb34\uad00\ud55c \ub3c5\ub9bd\ub41c \ubc88\uc5ed\uac00\uac00 \uc218\ud589\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ube44\uad50 \ubc0f \uac80\ud1a0<\/strong>: \uc6d0\ubcf8 \ubb38\uc11c\uc640 \uc5ed\ubc88\uc5ed\ub41c \ubb38\uc11c\ub97c \ube44\uad50\ud558\uc5ec \uc624\ub958 \ud655\uc778. \uc774 \uc791\uc5c5\uc744 \uad00\ub9ac\ud558\ub294 \ud504\ub85c\uc81d\ud2b8 \ub9e4\ub2c8\uc800\uac00 \uc218\ud589\ud569\ub2c8\ub2e4. \uc6d0\ubcf8\uacfc \uc5ed\ubc88\uc5ed\ub41c \ubb38\uc11c\ub97c \ube44\uad50\ud558\uc5ec \ubd88\uc77c\uce58\ub098 \uc624\ub958\ub97c \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc218\uc815 \ub2e8\uacc4<\/strong>: \ubc1c\uacac\ub41c \uc624\ub958\ub97c \uc218\uc815\ud558\uace0 \uc7ac\uac80\ud1a0. \ucd08\uae30 \ubc88\uc5ed\uac00\uac00 \uc5ed\ubc88\uc5ed\uac00\uac00 \uac01\uc790 \uc218\ud589\ud569\ub2c8\ub2e4. \ubc1c\uacac\ub41c \uc624\ub958\ub97c \uc218\uc815\ud558\uace0 \uc218\uc815\ub41c \ubd80\ubd84\uc744 \uc7ac\uac80\ud1a0\ud558\uc5ec \uc815\ud655\uc131\uc744 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ucd5c\uc885 \uac80\ud1a0 \ubc0f \uc2b9\uc778<\/strong>: \ucd5c\uc885 \ubb38\uc11c\uc758 \ud488\uc9c8\uc744 \ud655\uc778\ud558\uace0 \uc2b9\uc778. \ud504\ub85c\uc81d\ud2b8 \ub9e4\ub2c8\uc800\uac00 \uc9c4\ud589\ud569\ub2c8\ub2e4. \uc18c\uc2a4 \ubb38\uc11c \uc790\uccb4\uc5d0 \uc624\ub958\uac00 \uc788\ub2e4\uace0 \ud310\ub2e8\ub41c \uacbd\uc6b0\ub77c\uba74 \uace0\uac1d\uc5d0\uac8c \ubcf4\uace0\ud558\uc5ec \uc6d0\ubcf8\uc774 \uac1c\uc120\ub420 \uc218 \uc788\ub3c4\ub85d \ud569\ub2c8\ub2e4.<\/li>\n<\/ol>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"471\" height=\"604\" src=\"http:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/02-image1026_240508-19.png\" alt=\"\" class=\"wp-image-3817\" srcset=\"https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/02-image1026_240508-19.png 471w, https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/02-image1026_240508-19-234x300.png 234w\" sizes=\"auto, (max-width: 471px) 100vw, 471px\" \/><\/figure><\/div>\n\n\n<h3 class=\"wp-block-heading\">\uacb0\ub860<\/h3>\n\n\n\n<p>\uc5ed\ubc88\uc5ed \uacfc\uc815\uc740 \uc7a0\uc7ac\uc801\uc778 \ubd80\uc815\ud655\uc131\uacfc \ubd88\uc77c\uce58\ub97c \ubc29\uc9c0\ud558\ub294 \ud544\uc218\uc801\uc778 \uc548\uc804 \uc7a5\uce58\ub85c \ub4f1\uc7a5\ud569\ub2c8\ub2e4. \uc81c\uc57d\uc0ac\uc5d0 \ud544\uc218\uc801\uc778 <a href=\"https:\/\/www.ich.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">ICH<\/a> (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) <a href=\"https:\/\/www.ich.org\/page\/ich-guidelines\" target=\"_blank\" rel=\"noreferrer noopener\">\uac00\uc774\ub4dc\ub77c\uc778<\/a>\uc740 \uc784\uc0c1 \uc2dc\ud5d8 \ubb38\uc11c \ubc88\uc5ed\uc758 \ud45c\uc900 \uc808\ucc28\uc5d0 \uc5ed\ubc88\uc5ed\uc744 \ud3ec\ud568\uc2dc\ucf1c 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