Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Guideline for Bioequivalence Studies of Generic Products for Topical Use

국소용 후발의약품의 생물학적동등성시험을 위한 가이드라인

  • 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)
  • 최선옥 (국립독성연구원 유효성연구부 생물측정과) ;
  • 정성희 (국립독성연구원 유효성연구부 생물측정과) ;
  • 엄소영 (국립독성연구원 유효성연구부 생물측정과) ;
  • 정서정 (국립독성연구원 유효성연구부 생물측정과) ;
  • 김주일 (국립독성연구원 유효성연구부 생물측정과) ;
  • 정수연 (국립독성연구원 유효성연구부 생물측정과)
  • Published : 2004.08.20
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Abstract

A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

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References

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