A Collaborative Study to Establish a Korea National Biological Standard for Antithrombin III Concentrate

  • Kang, Hye-Na (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration) ;
  • Oh, Ho-Jung (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Kim, Soon-Nam (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Hong, Choong-Man (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Lee, Ki-Hong (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Yoo, Si-Hyung (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Shin, In-Soo (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Choi, Seung-Eun (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Lee, Seok-Ho (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration)
  • Published : 2003.04.01

Abstract

We have carried out a collaborative study to evaluate a candidate preparation of antithrombin III concentrate whether it is suitable to serve as a Korea National Biological Standard. Three National Control Laboratories and three manufacturers participated in this study. The potency of this candidate preparation was determined by using a heparin cofactor chromogenic method described in the Minimum Requirements for Biological Products and the European Phamacopoeia. (omitted)

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