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題名 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
作者 吳嘉翰
Wu, Chia-Han
貢獻者 林慧
Lin, Huey
吳嘉翰
Wu, Chia-Han
關鍵詞 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
日期 1996
上傳時間 28-四月-2016 11:48:40 (UTC+8)
摘要 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.
參考文獻 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.
描述 碩士
國立政治大學
統計學系
83354006
資料來源 http://thesis.lib.nccu.edu.tw/record/#B2002002793
資料類型 thesis
dc.contributor.advisor 林慧zh_TW
dc.contributor.advisor Lin, Hueyen_US
dc.contributor.author (作者) 吳嘉翰zh_TW
dc.contributor.author (作者) Wu, Chia-Hanen_US
dc.creator (作者) 吳嘉翰zh_TW
dc.creator (作者) Wu, Chia-Hanen_US
dc.date (日期) 1996en_US
dc.date.accessioned 28-四月-2016 11:48:40 (UTC+8)-
dc.date.available 28-四月-2016 11:48:40 (UTC+8)-
dc.date.issued (上傳時間) 28-四月-2016 11:48:40 (UTC+8)-
dc.identifier (其他 識別碼) B2002002793en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/87307-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 統計學系zh_TW
dc.description (描述) 83354006zh_TW
dc.description.abstract (摘要) 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.zh_TW
dc.description.tableofcontents 第一章 緒論..........1
第一節 前言..........1
第二節 藥劑生體可用及相等之評估..........2
第三節 藥劑生體相等性試驗之實驗設計及參數..........3
第四節 研究動機及目的..........3
第二章 二乘二交叉實驗設樣本數之探討..........5
第一節 二乘二交叉實驗設計..........5
第二節 區間假設檢定..........7
第三節 SCHUIRMANN兩個單位檢定..........8
第四節 二乘二交叉實驗設計之樣本個數..........10
第三章 高階交叉實驗設計..........16
第一節 四乘二交叉實驗設計..........17
第二節 二乘三交叉實驗設計..........20
第三節 二乘四交叉實驗設計..........23
第四節 四乘四交叉實驗設計..........26
第五節 WILLIAM六乘三交叉實驗設計..........29
第六節 WILLIAM四乘四交叉實驗設計..........31
第四章 高階交叉實驗設計之樣本個數..........35
第一節 樣本計算公式..........35
第二節 檢測能力與樣本個數..........38
第五章 模擬驗證..........55
第一節 電腦模擬的目的..........55
第二節 電腦模擬過程..........55
第三節 模擬結果..........56
第六章 結論..........62
附錄..........63
參考文獻..........72		zh_TW
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#B2002002793en_US
dc.subject (關鍵詞) 樣本數zh_TW
dc.subject (關鍵詞) 檢測能力zh_TW
dc.subject (關鍵詞) 生體可用zh_TW
dc.subject (關鍵詞) 生體相等zh_TW
dc.subject (關鍵詞) 交叉實驗設計zh_TW
dc.subject (關鍵詞) Sample sizeen_US
dc.subject (關鍵詞) Poweren_US
dc.subject (關鍵詞) Bioavailabilityen_US
dc.subject (關鍵詞) Bioequivalenceen_US
dc.subject (關鍵詞) Crossoveren_US
dc.title (題名) 藥劑生體可用及相等性在兩個單尾檢定下樣本數之研究zh_TW
dc.title (題名) Sample Size Determination for the Two One-Sided Tests Procedure in Bioavailability/Bioequivalenceen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (參考文獻) 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.		zh_TW