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KMID : 0369820070370060403
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 6 p.403 ~ p.411
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Reconstruction on Application Category of Pharmaceutical Additives and Boundaries of Pharmaceutical Additives according to the Dosage Forms
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Cho Cheong-Weon
Kim Seung-Soo
Cho Won-Kyung
Park Hyo-Min
Park In-Sook
Jung Joo-Yeon
Chung Sang-Jeon
Lee Sun-Hee
Hwang Sung-Joo
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Abstract
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The importance of pharmaceutical additives is increasing and the sorts and application categories are being classified in detail. International pharmaceutical council based on IPEC-America, IPEC-Europe and JPEC was established for specifications, safety and efficacy, approval regulations of pharmaceutical additives in 1992. Therefore, scrutinized examination of pharmaceutical additives used for already approved domestic drug was performed under the supervision of KFDA and nomenclature on application categories of pharmaceutical additives was summarized and endowed their glossary. Additionally, the boundaries of pharmaceutical additives according to the dosage forms based on the principle of the dosage forms of Korean pharmacopoeia were classified. These informations could be available for standards & experimental methods, approval, evaluation, audit of drug and contribution for national welfare.
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KEYWORD
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Pharmaceutical additives, Excipients, Application category, Glossary, Dosage form
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