Proceedings of the PSK Conference (대한약학회:학술대회논문집)

The Pharmaceutical Society of Korea (대한약학회)
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Studies on the Standard Protocols of Bioequivalence Test

  • Yoon, Kyung-Eun (Division of Bioequivalence, Department of Pharmacology, National Institute of Toxicology Research) ;
  • Chung, Soo-Youn (Division of Bioequivalence, Department of Pharmacology, National Institute of Toxicology Researc) ;
  • Park, Ki-Sook (Division of Bioequivalence, Department of Pharmacology, National Institute of Toxicology Researc) ;
  • Choi, Hong-Suk (Division of Bioequivalence, Department of Pharmacology, National Institute of Toxicology Researc) ;
  • Baek, Min-Sun (Division of Bioequivalence, Department of Pharmacology, National Institute of Toxicology Researc) ;
  • Jung, Sung-Hee (Division of Bioequivalence, Department of Pharmacology, National Institute of Toxicology Researc) ;
  • Choi, Sun-Ok (Division of Bioequivalence, Department of Pharmacology, National Institute of Toxicology Research)
  • Published : 2003.04.01
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Abstract

After beginning the new medical system separating the prescription from the drug dispensary, the demand of bioequivalence test significantly increases to show the equivalence between the test and reference drugs as a result of amendment of the pharmaceutical affairs law which allows a generic substitution. Accordingly the standard protocols provided by the government are required for reducing the period andthe cost to perform the bioequivalence study. (omitted)

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