Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Development of Guidance on the Pharmacokinetic Studies of Therapeutic Biologics

생명공학의약품의 약동학 시험 지침 개발 연구

  • Lee, Hae-Won (Department of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and Hospital) ;
  • Lim, Mi-Sun (Department of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and Hospital) ;
  • Seong, Sook-Jin (Department of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and Hospital) ;
  • Lee, Joo-Mi (Department of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and Hospital) ;
  • Park, Sung-Min (Department of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and Hospital) ;
  • Noh, Keum-Han (College of Pharmacy, Yeungnam University) ;
  • Park, Sung-Ho (College of Pharmacy, Yeungnam University) ;
  • Kim, Eun-Jung (Pharmacological Research Division, Korea Food & Drug Administration) ;
  • Kang, Won-Ku (College of Pharmacy, Yeungnam University) ;
  • Yoon, Young-Ran (Department of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and Hospital)
  • 이혜원 (경북대학교 일반대학원 의과학과 및 경북대학교병원 임상시험센터) ;
  • 임미선 (경북대학교 일반대학원 의과학과 및 경북대학교병원 임상시험센터) ;
  • 성숙진 (경북대학교 일반대학원 의과학과 및 경북대학교병원 임상시험센터) ;
  • 이주미 (경북대학교 일반대학원 의과학과 및 경북대학교병원 임상시험센터) ;
  • 박성민 (경북대학교 일반대학원 의과학과 및 경북대학교병원 임상시험센터) ;
  • 노금한 (영남대학교 약학대학) ;
  • 박성호 (영남대학교 약학대학) ;
  • 김은정 (식품의약품안전청 약리연구과) ;
  • 강원구 (영남대학교 약학대학) ;
  • 윤영란 (경북대학교 일반대학원 의과학과 및 경북대학교병원 임상시험센터)
  • Received : 2011.11.18
  • Accepted : 2012.01.17
  • Published : 2012.03.31
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Abstract

Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.

Keywords

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