Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Strategic Plans for the Implementation of Pharmacometric Methodology in Drug Regulatory Review Decisions

효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안

  • Lee, Sang-Min (Market Access Team, Pfizer Korea) ;
  • Choi, Bo-Yoon (College of Pharmacy, Seoul National University) ;
  • Yun, Hwi-Yeol (Drug Discovery Lab, Central Research Institute, Choongwae Pharma Corporation) ;
  • Jun, Da-Hae (College of Pharmacy, Seoul National University) ;
  • Kim, Myung-Gou (College of Pharmacy, Seoul National University) ;
  • Ha, Ji-Hye (Clinical Research Department, National Institute of Food and Drug Safety Evaluation, KFDA, Osong Health Technology Administration Complex) ;
  • Kim, Young-Hoon (Clinical Research Department, National Institute of Food and Drug Safety Evaluation, KFDA, Osong Health Technology Administration Complex) ;
  • Ji, Eun-Hee (College of Pharmacy, Seoul National University) ;
  • Kang, Won-Ku (College of Pharmacy, Yeungnam University) ;
  • Han, Na-Young (College of Pharmacy, Seoul National University) ;
  • Shin, Wan-Gyoon (College of Pharmacy, Seoul National University) ;
  • Oh, Jung-Mi (College of Pharmacy, Seoul National University)
  • 이상민 (한국화이자제약 Market Access 부서 Outcomes Research 팀) ;
  • 최보윤 (서울대학교 약학대학) ;
  • 윤휘열 (중외제약 중앙연구소 신약연구실) ;
  • 전다혜 (서울대학교 약학대학) ;
  • 김명규 (서울대학교 약학대학) ;
  • 하지혜 (식품의약품안전청 식품의약품안전평가원 임상연구과) ;
  • 김영훈 (식품의약품안전청 식품의약품안전평가원 임상연구과) ;
  • 지은희 (서울대학교 약학대학) ;
  • 강원구 (영남대학교 약학대학) ;
  • 한나영 (서울대학교 약학대학) ;
  • 신완균 (서울대학교 약학대학) ;
  • 오정미 (서울대학교 약학대학)
  • Received : 2011.11.01
  • Accepted : 2011.12.06
  • Published : 2011.12.31
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Abstract

Over the past few decades, drug regulatory agencies in advanced countries have been emphasizing pharmacometrics as a tool for an effective and efficient drug evaluation. Despite this international movement, the value of pharmacometrics is still poorly recognized by the Korean drug evaluation system. This study aimed to analyze the current state of utilization of pharmacometrics by foreign drug regulatory agencies and develop a road map to guide the implementation pharmacometrics into the Korean drug evaluation system. MEDLINE and foreign drug regulatory agency database were extensively searched to obtain scientific research articles, guidance, regulations and pharmacometric review reports on foreign pharmacometric drug evaluation system. A systematic roadmap comprised of 3 stages to implement pharmacometrics in Korean drug evaluation system was formulated after analyzing the collected data in tune with the current evaluation system. Pharmacometrics is an urgently required tool to achieve an efficient drug evaluation and review in Korea. The road map developed by this study is expected to aid in setting up a policy to implement and utilize pharmacometrics in Korea.

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