임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

가교자료 생성을 위한 약동학 시험

Pharmacokinetic Study for Bridging Data Package

  • 정재용 (연세대학교 의과대학 약리학교실 및 세브란스병원 임상약리학과)
  • Chung, Jae-Yong (Department of Pharmacology College of Medicine Yonsei University)
  • 투고 : 2009.05.14
  • 심사 : 2009.06.04
  • 발행 : 2009.06.30

⟨ 이전 논문 다음 논문 ⟩

초록

키워드

과제정보

연구 과제 주관 기관 : 연세대학교

참고문헌

  1. Uchida E. [History of the discussion on ethnic difference at ICH]. Yakugaku Zasshi 2009;129:213-221 https://doi.org/10.1248/yakushi.129.213
  2. Uyama Y, Shibata T, Nagai N, Hanaoka H, Toyoshima S, Mori K. Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin Pharmacol Ther 2005;78:102-113. https://doi.org/10.1016/j.clpt.2005.04.001
  3. 식품의약품안전청. 가교자료평가가이드라인. 2008.
  4. 김보형. 약물의 특성이 민족간 약동학 차이에 미치는 영향-한국인과 타민족 약동학 결과 비교연구. 약리학, Vol 의학석사. 서울: 서울대학교 대학원 2008.
  5. Myrand SP, Sekiguchi K, Man MZ, Lin X, Tzeng RY, Teng CH, Hee B, Garrett M, Kikkawa H, Lin CY, Eddy SM, Dostalik J, Mount J, Azuma J, Fujio Y, Jang IJ, Shin SG, Bleavins MR, Williams JA, Paulauskis JD, Wilner KD. Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and thirdgeneration Japanese populations: comparison with Korean, Chinese, and Caucasian populations. Clin Pharmacol Ther 2008;84:347-361. https://doi.org/10.1038/sj.clpt.6100482
  6. A haplotype map of the human genome. Nature 2005;437:1299-1320. https://doi.org/10.1038/nature04226
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  9. Latz JE, Schneck KL, Nakagawa K, Miller MA, Takimoto CH. Population pharmacokinetic/pharmacodynamic analyses of pemetrexed and neutropenia: effect of vitamin supplementation and differences between Japanese and Western patients. Clin Cancer Res 2009;15:346-354. https://doi.org/10.1158/1078-0432.CCR-08-0791
  10. Pigeolet E, Jacqmin P, Sargentini-Maier ML, Stockis A. Population pharmacokinetics of levetiracetam in Japanese and Western adults. Clin Pharmacokinet 2007;46:503-512. https://doi.org/10.2165/00003088-200746060-00004
  11. Shin JG, Kang WK, Shon JH, Arefayene M, Yoon YR, Kim KA, Kim DI, Kim DS, Cho KH, Woosley RL, Flockhart DA. Possible interethnic differences in quinidine-induced QT prolongation between healthy Caucasian and Korean subjects. Br J Clin Pharmacol 2007;63:206-215. https://doi.org/10.1111/j.1365-2125.2006.02793.x
  12. Rohatagi S, Kastrissios H, Gao Y, Zhang N, Xu J, Moberly J, Wada R, Yoshihara K, Takahashi M, Truitt K, Salazar D. Predictive population pharmacokinetic/pharmacodynamic model for a novel COX-2 inhibitor. J Clin Pharmacol 2007;47:358-370. https://doi.org/10.1177/0091270006296152
  13. Liu JP. Bridging bioequivalence studies. J Biopharm Stat 2004;14:857-867. https://doi.org/10.1081/BIP-200035418
  14. Nakajima K. [From ethnic difference to ethnic similarity]. Yakugaku Zasshi 2009;129:223-229. https://doi.org/10.1248/yakushi.129.223