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KMID : 1142220100050010051
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Regulatory Research on Food, Drug & Cosmetic
2010 Volume.5 No. 1 p.51 ~ p.56
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Combination of The Standards for Antibiotics to The Korean Pharmacopoeia and The Korean Pharmaceutical Codex
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Kim Young-Ok
Sohn Kyung-Hee
Um So-Young
Kim Hye-Ji
Kim Dong-Hwan
Lee Eun-Sun
Park So-Ra
Lim Sang-Mi
Ryu Heui-Young
Kim Hee-Sung
Kim Hye-Soo
Kim Dong-Sub
Kim Seung-Hee
Lee Su-Jung
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Abstract
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The Standards for Antibiotics is a collection of specifications such as manufacture, appearance, and storage conditions for the antibiotics that are approved in Korea. With the similar composition as The Korean Pharmacopoeia, the specification of every antibiotics that were approved by Korea Food and Drug Administration was to meet the specifications in The Standards for Antibiotics. However, with the revision of the approval process in 2008, different specifications other than The Standards for Antibiotics were acknowledged as one of the specifications. With the revision of the process, the effective management of the various official standards was in need. In order to manage the various official standards, the study in combination of The Standards for Antibiotics into The Korean Pharmacopoeia and The Korean Pharmaceutical Codex was conducted. Therefore, with the combined standards of the pharmaceutical products, the official standards would be effectively managed and meet the international harmonization requirements.
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KEYWORD
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Antibiotics, The Standards for Antibiotics, The Korean Pharmacopoeia, The Korean Pharmaceutical Codex
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