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Suggestion for Good Manufacturing Practice of Radiopharmaceuticals

우수방사성의약품 제조관리를 위한 제언

  • Shin, Byungchul (Nuclear Training & Education Center, Korea Atomic Energy Research Institute) ;
  • Lee, Sangbock (Dept. of Radiology Nambu University)
  • 신병철 (한국원자력연구원 원자력교육센터) ;
  • 이상복 (남부대학교 방사선학과)
  • Received : 2013.10.26
  • Accepted : 2013.12.25
  • Published : 2013.12.25

Abstract

This study suggests considerations for legislation of radiopharmaceutical manufacturing practice according as the Korea Pharmaceutical Affairs Act and guidelines on foreign radiopharmaceutical manufacturing practice. Pharmaceuticals should be verified safety, effectiveness, and uniformity. Therefore, it is expected that the efficiency of the administration of radiopharmaceuticals increase and nation's health promote if rational manufacturing management to consider of radiopharmaceutical properties is legislated.

우리나라 약사법과 외국의 방사성의약품 제조관리기준 가이드라인을 참고하여 방사성의약품 제조관리기준 제정 시 고려해야할 사항들에 대해 의견을 제시하였다. 의약품은 안전성, 유효성과 더불어 제품의 균일성이 검증되어야 한다. 따라서 방사성의약품의 특성을 충분히 고려한 합리적인 제조관리기준을 제정하면 방사성의약품 관리의 효율성을 증대시키고 국민건강 증진에 기여할 수 있을 것으로 기대된다.

Keywords

References

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