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http://dx.doi.org/10.4333/KPS.2007.37.6.403

Reconstruction on Application Category of Pharmaceutical Additives and Boundaries of Pharmaceutical Additives according to the Dosage Forms  

Cho, Cheong-Weon (College of Pharmacy, Chungnam National University)
Kim, Seung-Soo (College of Pharmacy, Chungnam National University)
Cho, Won-Kyung (College of Pharmacy, Chungnam National University)
Park, Hyo-Min (Drug Evaluation Department, Korea Food and Drug Administration)
Park, In-Sook (Drug Evaluation Department, Korea Food and Drug Administration)
Jung, Joo-Yeon (Drug Evaluation Department, Korea Food and Drug Administration)
Chung, Sang-J. (Bionanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology)
Lee, Sun-Hee (Drug Evaluation Department, Korea Food and Drug Administration)
Hwang, Sung-Joo (College of Pharmacy, Chungnam National University)
Publication Information
Journal of Pharmaceutical Investigation / v.37, no.6, 2007 , pp. 403-411 More about this Journal
Abstract
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.
Keywords
Pharmaceutical additives; Excipients; Application category; Glossary; Dosage form;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
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