Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Reconstruction on Application Category of Pharmaceutical Additives and Boundaries of Pharmaceutical Additives according to the Dosage Forms

첨가제의 배합목적 재정비와 제형에 따른 첨가제의 범위

  • 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)
  • Published : 2007.12.21
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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.

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References

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