Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Food-Effect Bioavailability and Fed Bioequivalence Studies

생체이용률에 미치는 음식물의 영향 및 식후 생물학적동등성시험

  • Choi, Sun-Ok (Drug Metabolism Team, Pharmacological Research Department, Department of Pharmacology, National Institute of Toxicological Research, KFDA) ;
  • Kwon, Kwang-Il (College of Pharmacy, Chungnam National University) ;
  • Jung, Sung-Hee (Drug Metabolism Team, Pharmacological Research Department, Department of Pharmacology, National Institute of Toxicological Research, KFDA) ;
  • Um, So-Young (Drug Metabolism Team, Pharmacological Research Department, Department of Pharmacology, National Institute of Toxicological Research, KFDA) ;
  • Jung, Seo-Jeong (Drug Metabolism Team, Pharmacological Research Department, Department of Pharmacology, National Institute of Toxicological Research, KFDA) ;
  • Kim, Joo-Il (Drug Metabolism Team, Pharmacological Research Department, Department of Pharmacology, National Institute of Toxicological Research, KFDA) ;
  • Chung, Soo-Youn (Drug Metabolism Team, Pharmacological Research Department, Department of Pharmacology, National Institute of Toxicological Research, KFDA) ;
  • Kim, Ok-Hee (Drug Metabolism Team, Pharmacological Research Department, Department of Pharmacology, National Institute of Toxicological Research, KFDA)
  • 최선옥 (국립독성연구원 약리연구부 대사약물팀) ;
  • 권광일 (충남대학교 약학대학) ;
  • 정성희 (국립독성연구원 약리연구부 대사약물팀) ;
  • 엄소영 (국립독성연구원 약리연구부 대사약물팀) ;
  • 정서정 (국립독성연구원 약리연구부 대사약물팀) ;
  • 김주일 (국립독성연구원 약리연구부 대사약물팀) ;
  • 정수연 (국립독성연구원 약리연구부 대사약물팀) ;
  • 김옥희 (국립독성연구원 약리연구부 대사약물팀)
  • Published : 2005.12.30
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Abstract

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

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