\uc81c\uc57d \uc911\uac04\uccb4\uc640 API\uc758 \ucc28\uc774\uc810<\/p>\n
\uc81c\uc57d \uc911\uac04\uccb4\uc640 API\ub294 \ubaa8\ub450 \uc815\ubc00\ud654\ud559\ubb3c\uc9c8 \uce74\ud14c\uace0\ub9ac\uc5d0 \uc18d\ud569\ub2c8\ub2e4. \uc911\uac04\uccb4\ub294 API\uac00 \ub418\uae30 \uc704\ud574 \ucd94\uac00\uc801\uc778 \ubd84\uc790 \ubcc0\ud654\ub098 \uc815\uc81c \uacfc\uc815\uc744 \uac70\uccd0\uc57c \ud558\ub294 API \uacf5\uc815 \ub2e8\uacc4\uc5d0\uc11c \uc0dd\uc0b0\ub41c \ubb3c\uc9c8\uc785\ub2c8\ub2e4. \uc911\uac04\uccb4\ub294 \ubd84\ub9ac\ub420 \uc218\ub3c4 \uc788\uace0 \ubd84\ub9ac\ub418\uc9c0 \uc54a\uc744 \uc218\ub3c4 \uc788\uc2b5\ub2c8\ub2e4. (\ucc38\uace0: \uc774 \uac00\uc774\ub4dc\uc5d0\uc11c\ub294 API \uc81c\uc870 \uc2dc\uc791 \uc2dc\uc810 \uc774\ud6c4\uc5d0 \uc81c\uc870\ub418\ub294 \uac83\uc73c\ub85c \ud68c\uc0ac\uc5d0\uc11c \uc815\uc758\ud55c \uc911\uac04\uccb4\ub9cc \ub2e4\ub8f9\ub2c8\ub2e4.)<\/p>\n
\ud65c\uc131 \uc758\uc57d\ud488 \uc131\ubd84(API): \uc758\uc57d\ud488 \uc81c\uc870\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubaa8\ub4e0 \ubb3c\uc9c8 \ub610\ub294 \ubb3c\uc9c8\uc758 \ud63c\ud569\ubb3c. \uc758\uc57d\ud488\uc5d0 \uc0ac\uc6a9\ub418\uba74 \uc758\uc57d\ud488\uc758 \ud65c\uc131 \uc131\ubd84\uc774 \ub429\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubb3c\uc9c8\uc740 \uc9c8\ubcd1\uc758 \uc9c4\ub2e8, \uce58\ub8cc, \uc99d\uc0c1 \uc644\ud654, \uad00\ub9ac \ub610\ub294 \uc608\ubc29\uc5d0 \uc57d\ub9ac\ud559\uc801 \ud65c\uc131\uc774\ub098 \uae30\ud0c0 \uc9c1\uc811\uc801\uc778 \ud6a8\uacfc\uac00 \uc788\uac70\ub098 \uc2e0\uccb4\uc758 \uae30\ub2a5\uacfc \uad6c\uc870\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud65c\uc131 \uc57d\ubb3c\uc740 \ud569\uc131 \uacbd\ub85c\ub97c \uc644\ub8cc\ud55c \ud65c\uc131 \uc81c\ud488\uc774\uace0, \uc911\uac04\uccb4\ub294 \ud569\uc131 \uacbd\ub85c \uc5b4\ub518\uac00\uc5d0 \uc788\ub294 \uc81c\ud488\uc785\ub2c8\ub2e4. API\ub294 \uc9c1\uc811 \uc81c\uc870\ud560 \uc218 \uc788\uace0 \uc911\uac04\uccb4\ub294 \ub2e4\uc74c \uc81c\ud488\uc744 \ud569\uc131\ud558\ub294 \ub370\ub9cc \uc0ac\uc6a9\ud560 \uc218 \uc788\uc73c\uba70 \uc911\uac04\uccb4\ub97c \ud1b5\ud574\uc11c\ub9cc API\ub97c \uc81c\uc870\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n
\uc815\uc758\uc5d0\uc11c \uc54c \uc218 \uc788\ub4ef\uc774 \uc911\uac04\uccb4\ub294 API\ub97c \uc81c\uc870\ud558\ub294 \uc774\uc804 \uacf5\uc815\uc758 \ud575\uc2ec \uc81c\ud488\uc73c\ub85c API\uc640 \uad6c\uc870\uac00 \ub2e4\ub985\ub2c8\ub2e4. \ub610\ud55c, \uc57d\uc804\uc5d0\ub294 \uc6d0\uc561\uc758 \uac80\ucd9c\ubc29\ubc95\uc774 \uc788\uc73c\ub098 \uc911\uac04\uccb4\uac00 \uc5c6\ub2e4. \uc778\uc99d\uc5d0 \uad00\ud574 \ub9d0\ud558\uc790\uba74, \ud604\uc7ac FDA\ub294 \uc911\uac04\uccb4 \ub4f1\ub85d\uc744 \uc694\uad6c\ud558\uace0 \uc788\uc9c0\ub9cc COS\ub294 \uadf8\ub807\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uadf8\ub7ec\ub098 CTD \ubb38\uc11c\uc5d0\ub294 \uc911\uac04\uccb4\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \uacf5\uc815 \uc124\uba85\uc774 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc911\uad6d\uc5d0\uc11c\ub294 \uc911\uac04\uccb4\uc5d0 \ub300\ud55c \ud544\uc218 GMP \uc694\uad6c \uc0ac\ud56d\uc774 \uc5c6\uc2b5\ub2c8\ub2e4.<\/p>\n
\uc758\uc57d\ud488 \uc911\uac04\uccb4\ub294 API\ucc98\ub7fc \uc0dd\uc0b0 \ud5c8\uac00\uac00 \ud544\uc694\ud558\uc9c0 \uc54a\uc73c\uba70, \uc9c4\uc785 \uc7a5\ubcbd\uc774 \uc0c1\ub300\uc801\uc73c\ub85c \ub0ae\uace0 \uacbd\uc7c1\ub3c4 \uce58\uc5f4\ud569\ub2c8\ub2e4. \ub530\ub77c\uc11c \ud488\uc9c8, \uaddc\ubaa8 \ubc0f \uad00\ub9ac \uc218\uc900\uc740 \uae30\uc5c5\uc758 \uc0dd\uc874\uacfc \ubc1c\uc804\uc5d0 \uae30\ubcf8\uc774 \ub418\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc73c\uba70, \ud658\uacbd \ubcf4\ud638\uc5d0 \ub300\ud55c \uc555\ub825\uc774 \ub192\uc544\uc9d0\uc5d0 \ub530\ub77c \ub9ce\uc740 \uc911\uc18c\uae30\uc5c5\uc774 \uc810\ucc28 \uacbd\uc7c1 \ub2e8\uacc4\uc5d0\uc11c \ubb3c\ub7ec\ub098\uace0 \uc0b0\uc5c5 \uc9d1\uc911\ub3c4\uac00 \uae09\uaca9\ud788 \ud5a5\uc0c1\ub420 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc77c\ubc18\uc801\uc73c\ub85c \uad00\ub828 \uae30\uc5c5\uc774 \uc218\uc775\uc131\uc744 \uac1c\uc120\ud558\uace0 \ubd80\uac00\uac00\uce58\ub97c \ub192\uc774\uba70 \uc9c0\uc18d\uc801\uc73c\ub85c \uc131\uc7a5\ud558\uae30 \uc704\ud574\uc11c\ub294 \ub2e4\uc74c \uc138 \uac00\uc9c0 \ubc29\ud5a5\uc774 \ud575\uc2ec\uc774 \ub420 \uac83\uc774\ub77c\uace0 \ubbff\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n
(1) \uad11\ubc94\uc704\ud55c \uc800\uac00 \uc911\uac04\uccb4 \uc0dd\uc0b0\uc5d0\uc11c \uace0\uae09 \uace0\uae09 \uc911\uac04\uccb4\uae4c\uc9c0 \uc81c\ud488 \ub2e4\uc591\ud654 \ubc0f \uace0\uae09\ud654;<\/p>\n
(2) \uc804\ubb38 \uc544\uc6c3\uc18c\uc2f1 \uc11c\ube44\uc2a4\uc758 \uae38\uc744 \ud0dd\ud558\uace0 \uc544\uc6c3\uc18c\uc2f1 \uc11c\ube44\uc2a4 \uc0b0\uc5c5 \uccb4\uc778\uc744 \uc9c0\uc18d\uc801\uc73c\ub85c \ud655\uc7a5\ud558\uba70 R&D \uc544\uc6c3\uc18c\uc2f1 \uc11c\ube44\uc2a4\ub97c \uc218\ud589\ud569\ub2c8\ub2e4.<\/p>\n
(3) \uc758\uc57d\ud488\uc5d0 \uc911\uc810\uc744 \ub450\uace0 \uc911\uac04\uccb4 \ub2e4\uc6b4\uc2a4\ud2b8\ub9bc\uc758 \uc6d0\ub8cc \ubc0f \uc81c\uc81c\ub97c \uacf5\uaca9\ud569\ub2c8\ub2e4.<\/p>\n
\uc81c\uc57d\uc911\uac04\uccb4 \uc0b0\uc5c5 \ub9de\ucda4\ud615 \uc0dd\uc0b0\uacf5\uc815<\/p>\n
\uc911\uac04\uccb4\ub294 \ud654\ud569\ubb3c \ud569\uc131 \uacfc\uc815\uc758 \uc911\uac04 \uc0dd\uc131\ubb3c\uc744 \ub9d0\ud558\uba70, \uc758\uc57d\ud488 \uc911\uac04\uccb4\ub294 api\uc758 \ud569\uc131 \uacfc\uc815\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc77c\ubd80 \ud654\ud559 \uc6d0\ub8cc \ub610\ub294 \ud654\ud559 \uc81c\ud488\uc774\uba70 api\uc758 \uc0dd\uc0b0 \ub77c\uc774\uc13c\uc2a4\uac00 \ud544\uc694\ud558\uc9c0 \uc54a\uc73c\uba70 \uc77c\ubc18 \ud654\ud559 \uacf5\uc7a5\uc5d0\uc11c \uc0dd\uc0b0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc77c\uc815 \uc218\uc900\uc5d0 \ub3c4\ub2ec\ud558\uba74 API \ud569\uc131\uc5d0 \uc0ac\uc6a9\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc81c\uc57d \uc911\uac04\uccb4 \uc0b0\uc5c5\uc740 \uace0\uac1d\uc758 \uc694\uad6c\uc5d0 \ub530\ub77c \ub9de\ucda4\ud615 \uc911\uac04\uccb4 \ud569\uc131 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n
\ub9de\ucda4\ud615 \uc81c\ud488\uc740 \uace0\uac1d\uacfc\uc758 \uae34\ubc00\ud55c \ud611\ub825 \uc815\ub3c4\uc5d0 \ub530\ub77c 3\ub2e8\uacc4\ub85c \uad6c\ubd84\ub429\ub2c8\ub2e4.<\/p>\n
(1) \ud68c\uc0ac\uc758 R&D \uc13c\ud130\uc5d0 \uac15\ub825\ud55c \ud601\uc2e0 \ub2a5\ub825\uc774 \uc694\uad6c\ub418\ub294 \uace0\uac1d \uc5f0\uad6c \ubc0f \uc2e0\uc57d \uac1c\ubc1c \ub2e8\uacc4\uc5d0 \ucc38\uc5ec\ud569\ub2c8\ub2e4.<\/p>\n
(2) \ub300\ub7c9 \uc0dd\uc0b0 \uacf5\uc815 \uacbd\ub85c\uc5d0 \ub9de\ucdb0 \uace0\uac1d\uc758 \uc2dc\uc81c\ud488\uc744 \uaddc\ubaa8 \ud655\ub300\ud558\uae30 \uc704\ud574 \ud68c\uc0ac\uc758 \uc81c\ud488 \uaddc\ubaa8 \ud655\ub300 \ub2a5\ub825\uacfc \uc774\ud6c4 \ub2e8\uacc4\uc5d0\uc11c \ub9de\ucda4\ud615 \uc81c\ud488 \uae30\uc220 \ud504\ub85c\uc138\uc2a4\ub97c \uc9c0\uc18d\uc801\uc73c\ub85c \uac1c\uc120\ud560 \uc218 \uc788\ub294 \ub2a5\ub825\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc81c\ud488\uc758 \ub300\uaddc\ubaa8 \uc0dd\uc0b0 \uc694\uad6c\ub97c \ucda9\uc871\ud558\uace0, \uc9c0\uc18d\uc801\uc73c\ub85c \uc0dd\uc0b0 \ube44\uc6a9\uc744 \uc808\uac10\ud558\uba70, \uc81c\ud488 \uacbd\uc7c1\ub825\uc744 \ud5a5\uc0c1\uc2dc\ud0b5\ub2c8\ub2e4.<\/p>\n
(3) \uc678\uad6d \uae30\uc5c5\uc758 \ud488\uc9c8 \uae30\uc900\uc744 \ucda9\uc871\uc2dc\ud0a4\uae30 \uc704\ud574 \uc8fc\uc694 \uc0dd\uc0b0 \ub2e8\uacc4\uc5d0\uc11c \uace0\uac1d \uc81c\ud488\uc758 \uc18c\ud654 \ubc0f \uac1c\uc120\uc744 \ucc98\ub9ac\ud569\ub2c8\ub2e4.<\/p>\n
\ub9de\ucda4\ud615 \ud569\uc131 \uc11c\ube44\uc2a4\ub294 \uace0\uac1d\uc758 \ud45c\uc801 \ubd84\uc790\uc5d0 \ub300\ud55c \ud569\uc131 \uacbd\ub85c\ub97c \uc124\uacc4\ud558\uace0 \uc81c\uc5b4 \ud654\ud569\ubb3c, \ub300\uc0ac\uc0b0\ubb3c, \uc2dc\uc57d, \uc911\uac04\uccb4, \ubd84\uc790 \ub2e8\ud3b8 \ubc0f \ubd88\uc21c\ubb3c\uc744 \ud3ec\ud568\ud55c \ud654\ud569\ubb3c\uc758 \ud569\uc131 \ubc0f \uc804\ub2ec\uc744 \uc801\uc2dc\uc5d0 \ub300\ub7c9\uc73c\ub85c \uc644\ub8cc\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>","protected":false},"excerpt":{"rendered":"
The difference between pharmaceutical intermediates and apis Pharmaceutical intermediates and apis both belong to the category of fine chemicals. Intermediates are materials produced in the process steps of apis that must undergo further molecular changes or refining to become apis. Intermediates can be separated or not separated. (Note: This guide covers only intermediates that the company defines as being manufactured after the start point of manufacturing for the API.) Active pharmaceutical ingredient (API) : Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical product and, when used in a pharmaceutical product, becomes an active ingredient of the pharmaceutical product. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function and structure of the body. An active drug is an active product that has completed the synthetic path, and\u2026<\/p>","protected":false},"author":1,"featured_media":1889,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"attr":[],"class_list":["post-2042","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-trends"],"_links":{"self":[{"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/posts\/2042","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/comments?post=2042"}],"version-history":[{"count":1,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/posts\/2042\/revisions"}],"predecessor-version":[{"id":2043,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/posts\/2042\/revisions\/2043"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/media\/1889"}],"wp:attachment":[{"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/media?parent=2042"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/categories?post=2042"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/tags?post=2042"},{"taxonomy":"attr","embeddable":true,"href":"https:\/\/www.yearnintl.com\/ko\/wp-json\/wp\/v2\/attr?post=2042"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}