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    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/87307


    Title: 藥劑生體可用及相等性在兩個單尾檢定下樣本數之研究
    Sample Size Determination for the Two One-Sided Tests Procedure in Bioavailability/Bioequivalence
    Authors: 吳嘉翰
    Wu, Chia-Han
    Contributors: 林慧
    Lin, Huey
    吳嘉翰
    Wu, Chia-Han
    Keywords: 樣本數
    檢測能力
    生體可用
    生體相等
    交叉實驗設計
    Sample size
    Power
    Bioavailability
    Bioequivalence
    Crossover
    Date: 1996
    Issue Date: 2016-04-28 11:48:40 (UTC+8)
    Abstract: 藥劑生體可用及相等試驗,對於藥品的研發佔有非常重要之地位.如何在各種交叉實驗設計中選取適當的樣本,以達到我們要求的檢測能力,是本文的主要目的.Liu and chow(1992a)根據Schuirmann(1987)的區間假設檢定以正負20決策準則,針對二乘二交叉實驗設計,提出了一個簡易的樣本數計算方法.本文將對高階交叉實驗設計之樣本數計算方法,做進一步的研究.
    Reference: 1.林慧. 淺談統計與臨床試驗，數學傳播，l 9 卷第2 期，民國八十四年六月， 22-28 。
    2. 周賢忠，林慧. 藥劑生體互用:回顧與展望，中國統計學報，32 卷第2期，民國八十三年六月，179-196.
    3. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm stat.
    Theory Methods. 12:2663-2692, 1983.
    4. Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequiva-lence Studies. New York: Marcel Dekker; 1992.
    5. Chow SC, Shao J. An alternative approach for assessment of bioequivalence between two formulations of a drug. Biometrical J.
    32:969-976, 1990.
    6. Chow SC, Liu JP.Recent statistical developments in bioequivalence trials - a review of the FDA Guidance.Drug Information J. 28:851-
    864,l994.
    7. Cornell R G. The evaluation of bioequivalence using nonparametric procedures. Comm Stat. Theory Methods. 19:4153-4165,1990.
    8. FDA. Guidance on Statistical Procedures for Bioequivalence Studies Using a Standard Two-treatment Crossover Design. Division of
    Bioequivalence,Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, July 1,1992.
    9. Grieve AP. A Bayesian analysis of the two-period crossover design for clinical trails. Biometrics. 41 :979-990, 1985.
    10. Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analyses of bioequivalence studies. Int J Clin
    Pharmacol, Ther, Toxicol. 28:72-78,1990.
    11. Jones B, Kenward MG. Design and Analysis of Cross-Over Trials. New York and London: Chapman and Hall; 1989.
    12. Kershner RP, Federer, WT. Two-treatment crossover design for estimating a variety of effects. J Amer Statist Assoc 76:612-618, 1981.
    13. Phillips KF. Power of the two one-sided tests procedtrre in bioequivalence. J Pharmacokin Biopharm. 18:137-144,1990.
    14. Lasserre V. Determination of optimal designs using linear models in crossover trials. Statistics in Medicine.lO:909-924,1991.
    15. Laska EM,Meisner M, Kuslmer HB. Optimal crossover designs in the presence of carryover effects. Biometrics. 39:1087-1091, 1983.
    16. Liu JP. Bioequivalence and intrasubject variability. J Biopharm Stat. 1:205-219, 1991.
    17. Liu JP, Chow SC.On power calculation of Schuinnann`s two onesided tests procedure in bioequivalence. J Pharmacokin Biopharm.
    20: 10 1-104,1992a.
    18. Liu JP, Chow SC. On assessment of bioequivalence under a higherorder crossover design. J Biopharma Stat. 2:239-256, 1992c.
    19. Mandallaz D, Mau J. Comparison of different methods for decisiommaking in bioequivalence assessment. Biometrics. 37:213-222,1981.
    20. Rodda BE, Davis RL. Determining the probability of an important difference in bioavailability. Clin Pharmacol Ther. 28:247-252,1980.
    21. Schuinnann DJ.On hypothesis testing to determine if the mean of a normal distribution is continued in a known interval. Biometrics,37:617,1981.
    22. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability. J pharmacokin Biopharm.l5:657-680,1987.
    23. Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics. 32:741-774,1976.
    Description: 碩士
    國立政治大學
    統計學系
    83354006
    Source URI: http://thesis.lib.nccu.edu.tw/record/#B2002002793
    Data Type: thesis
    Appears in Collections:[Department of Statistics] Theses

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