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药物临床研究的计算机模拟 被引量:13

Clinical trial simulation
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摘要 药物临床研究的计算机模拟是近年来刚兴起的一门交叉学科。该技术的成功运用,可大大降低新药开发费用、缩短研发时间,有广泛的应用前景。本文从药动学和药效学的角度对其发展历史、内容、方法和应用作一综述。 Clinical trial simulation is a newly evolved interdiscipline with pr o mising future. Its appropriate and successful implementation helps to reduce the cost and time of the new drug development process. In this paper, the history, application and general methodology of the technique was reviewed from the pharm acokinetics and pharmacology point of view.
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2005年第6期491-496,共6页 Chinese Journal of New Drugs and Clinical Remedies
关键词 药学 研究 计算机模拟 药动学/药效 学模型 pharmacy research computer simulation pharmacokinetics/ pharmaco dynamics model
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参考文献29

  • 1CRAWFORD LM. Speech before R&D Leaders'Forum[EB/OL].http://www. fda. gov/oc/speeches/ 2004/leaders1005. html,2005-1-14 last visited.
  • 2HOLFORD NH, KIMKO HC, MONTELEONE JP, et al. Simulation of clinical trials[J]. Annu Rev Pharmacol Toxicol, 2000,40:209-234.
  • 3SHEINER LB, STEIMER JL. Pharmacokinetic/pharmacodynamic modeling in drug development[J]. Annu Rev Pharmacol Toxicol,2000,40:67-95.
  • 4HOLFORD NH, HALE M, KO HC, et al. Simulation in drug development: good practices. Draft publication of the Center for Drug Development Science.[DB/OL] http://www. health. auckland.ac. nz/pharmacology/staff/nholford/pkpd/ sddgp619. htm, 2005-1-14 last visited.
  • 5SUN H, FADIRAN EO, JONES CD, et al. Population pharmacokinetics. A regulatory perspective [J]. Clin Pharmacokinet,1999 ;37 ( 1 ) :41-58.
  • 6KIMKO HC, DUFFUL SB. Simulation for designing clinical trials.1st ed[M]. New York, USA: Marcel Dekker Inc, 2003. 1-173.
  • 7BLESCH KS, GIESCHKE R, TSUKAMOTO Y, et al. Clinical pharmacokinetic/ pharmacodynamic and physiologically based pharmacokinetic modeling in new drug development: the capecitabine experience[J]. Invest New Drugs, 2003, 21 (2) :195-223.
  • 8REIGNER BG, WILLIAMS PE, PATEL IH, et al. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche[J]. Clin Pharmacokinet, 1997,33(2): 142-152.
  • 9AARONS L, KARLSSON MO, MENTRE F, et al. Role of modelling and simulation in Phase I drug development[J]. Eur J Pharm Sci, 2001, 13(2):115-122.
  • 10PFISTER M, MARTIN NE, HASKELL LP, et al. Optimizing dose selection with modeling and simulation: application to the vasopeptidase inhibitor M100240[J]. J Clin Pharmacol, 2004,44(6):621-631.

二级参考文献9

  • 1[1]Johnston A, Holt DW. Therapeutic drug monitoring of immunosuppressant drugs. Br J Clin Pharmacol, 1999, 47(4) :339-350.
  • 2[2]Johnston A, Sketris I, Marsden JT, et al. A limited sampling strategy for the measurement of cyclosporine AUC. Transplant Proc, 1990, 22(3):1345-1346.
  • 3[3]Efron B. Bootstrap methods: another look at the jackknife. Ann Statist,1979, 7(1):1-26.
  • 4[5]Serafinowicz A, Gaciong Z, Baczkowska T, et al. Limited sampling strategy to estimate exposure to cyclosporine A in renal allograft recipient treated with Sandimmune-Neoral. Transplant Proc, 1996, 28 (6): 3138-9.
  • 5[6]Chantal LG, Matthias B, Bruno G, et al. Simultaneous estimation of cyclosporin and mycophenolic acid areas under curve in stable renal transplant patients using a limited sampling strategy. Eur J Clin Pharmacol,2002, 57(11) :805-811.
  • 6[9]Efron B. The jackknife, the bootstrap and resampling plans. Philadelphia: Society for Industrial and Applied Methematics, 1982, 33-34.
  • 7张毕奎,李焕德,贾彩,彭文兴,王峰,刘燕相.单步萃取高效液相色谱法测定全血环孢素A浓度及在肝、肾移植患者中的应用[J].中国临床药学杂志,1999,8(6):357-359. 被引量:23
  • 8金从凯,蔡志华,董时富.药物溶解参数的Bootstrap方法估计[J].中国卫生统计,2001,18(5):313-315. 被引量:3
  • 9蔡雪亚,金丕焕,曹素华.用Bootstrap方法计算中位数的可信区间[J].中国卫生统计,2002,19(3):185-186. 被引量:13

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