Strategy for Bioequivalence of Doxifluridine

항암제 doxifluridine의 생물학적동등성 연구방안

  • Jin, Qing Ri (Pharmacokinetics/Toxicokinetics, Korea Research Institute of Chemical Technology, Korea Institute of Toxicology(KIT)) ;
  • Kwon, Kwang-Il (Clinical pharmacy, College of Pharmacy, Chungnam National University) ;
  • Kang, Wonku (Pharmacokinetics/Toxicokinetics, Korea Research Institute of Chemical Technology, Korea Institute of Toxicology(KIT))
  • 김경일 (약물/독성동태 연구실, 한국화학연구원 부설 안전성평가연구소) ;
  • 권광일 (충남대학교 약학대학 임상약학실) ;
  • 강원구 (약물/독성동태 연구실, 한국화학연구원 부설 안전성평가연구소)
  • Published : 2005.06.01

Abstract

This study was designed to establish a strategy for the bioequivalence study of doxifluridine, an anticancer drug, in dogs instead of cancer patients. Although the results from animals may not occur in the same manner from human, those would be worth enough in terns of the bioequivalence. As for critically ill population such as cancer patients, bioequivalence studies in animals bring many advantages. Six healthy Beagle dogs were selected on the basis of hematology and blood chemistry test. After an over night fast, 200 mg of doxifluridine was orally administered, and blood was serially taken up to 12 hours. Plasma concentration of doxifluridine was measured using a newly validated bioanalytical method by a HPLC coupled tandem mass spectrometry. Time course of plasma doxifluridine concentration was analyzed with non-compartmental and compartmental approaches. Consequently, we represented hematology and blood chemistry database for the selection of healthy Beagle dogs, and suggested a sensitive and validated analytical method of doxifluridine, as well as a study design for the bioequivalence of doxifluridine in dogs.

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