Pharmacokinetic Studies and Drug-drug Interactions of Herbal Medicine

생약제제의 약물동태 연구 및 상호작용

  • Jung, Won-Pill (College of Pharmacy, Catholic University of Daegu) ;
  • Noh, Keum-Han (College of Pharmacy, Catholic University of Daegu) ;
  • Lim, Mi-Sun (School of Medicine, Kyungpook National University) ;
  • Lee, Hae-Won (School of Medicine, Kyungpook National University) ;
  • Kim, Eun-Jung (Pharmacological Research Division, Korea Food & Drug Administration) ;
  • Yoon, Young-Ran (School of Medicine, Kyungpook National University) ;
  • Kang, Won-Ku (College of Pharmacy, Yeungnam University)
  • 정원필 (대구가톨릭대학교 약학대학) ;
  • 노금한 (대구가톨릭대학교 약학대학) ;
  • 임미선 (경북대학교 의학전문대학원) ;
  • 이혜원 (경북대학교 의학전문대학원) ;
  • 김은정 (식품의약품안전청, 약리연구과) ;
  • 윤영란 (경북대학교 의학전문대학원) ;
  • 강원구 (영남대학교 약학대학)
  • Received : 2010.08.27
  • Accepted : 2010.09.15
  • Published : 2010.09.30

Abstract

Drugs mostly represent an efficacy or an adverse effect according to their dosage and/or plasma concentrations. Therefore, to investigate the pharmacokinetic behavior of drugs including herbal medicines is necessary both to maximize the drug action and to minimize the adverse effect. To date, pharmacokinetic studies of herbal medicines have been conducted by some experts in this field on the bases of science and knowledge in Korea. On the other hand, in advanced countries, a typical series of pharmacokinetic studies has been conducted by using a harmonized guidance established. Consequently, an administrative support on these studies has to be needed in Korea as well. This study aimed to establish a draft guidance on pharmacokinetic studies of herbal medicines in non-clinical and clinical studies. Literatures previously published as well as guidances in the US, Europe and Japan were summarized for the present guidance. Effect of herbal medicines was listed on the proteins in charge of drug metabolism and transportation, as well as on the pharmacokinetics of chemical drugs. The present suggestion might be helpful to proceed pharmacokinetic studies of herbal medicines efficiently, and further polish should be needed in terms of an administrative point of view.

Keywords

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