Journal of Pharmaceutical Investigation

  • 제34권3호
  • /
  • Pages.223-228
  • /
  • 2004
  • /
  • 2093-5552(pISSN)
  • /
  • 2093-6214(eISSN)
한국약제학회 (The Korean Society of Pharmaceutical Sciences and Technology)
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생체이용률에 미치는 음식물의 영향 및 식후 생물학적동등성시험

Food-Effect Bioavailability and Fed Bioequivalence Studies

  • 최선옥 (국립독성연구원 유효성연구부 생물측정과) ;
  • 정성희 (국립독성연구원 유효성연구부 생물측정과) ;
  • 엄소영 (국립독성연구원 유효성연구부 생물측정과) ;
  • 정서정 (국립독성연구원 유효성연구부 생물측정과) ;
  • 김주일 (국립독성연구원 유효성연구부 생물측정과) ;
  • 정수연 (국립독성연구원 유효성연구부 생물측정과)
  • Choi, Sun-Ok (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Jung, Sung-Hee (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Um, So-Young (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Jung, Seo-Jeong (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Kim, Joo-Il (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Chung, Soo-Youn (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
  • 발행 : 2004.06.20
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초록

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 the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.

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참고문헌

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