Loading...
|
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: | [統計學系] 學位論文
|
Files in This Item:
There are no files associated with this item.
|
All items in 政大典藏 are protected by copyright, with all rights reserved.
|
