Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Guideline for Extended Release Oral Dosage Forms : Development, Evaluation, and Application of In Vitro/In Vivo Correlations

서방성 경구제형의 개발과 평가 및 생체내.외 상관성 연구를 위한 가이드라인

  • Choi, Sun-Ok (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Jeong, Sung-Hee (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Um, So-Young (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Jung, Seo-Jeong (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Kim, Joo-Il (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Kim, Ok-Hee (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
  • 최선옥 (국립독성연구원 약리연구부 대사약리팀) ;
  • 정성희 (국립독성연구원 약리연구부 대사약리팀) ;
  • 엄소영 (국립독성연구원 약리연구부 대사약리팀) ;
  • 정서정 (국립독성연구원 약리연구부 대사약리팀) ;
  • 김주일 (국립독성연구원 약리연구부 대사약리팀) ;
  • 김옥희 (국립독성연구원 약리연구부 대사약리팀)
  • Published : 2005.12.20
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Abstract

In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.

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References

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