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| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 劉仁沛(Jen-Pei Liu),蔡政安(Chen-An Tsai) | |
| dc.contributor.author | Chih-Yang Huang | en |
| dc.contributor.author | 黃智揚 | zh_TW |
| dc.date.accessioned | 2021-06-16T13:41:56Z | - |
| dc.date.available | 2016-07-26 | |
| dc.date.copyright | 2013-07-26 | |
| dc.date.issued | 2013 | |
| dc.date.submitted | 2013-07-11 | |
| dc.identifier.citation | Berger R.L. (1982) Multiparametric hypothesis testing and acceptance sampling, Technometrics, 24, 433-440.
Berger R.L. ,Hsu J.C.(1996) Bioequivalence trials, intersection union tests and equivalence confidence sets. Statistical Science,4, 283-319. Chow S.C., Liu J.P. (2004) Design and Analysis of Clinical Trials, 3rd Ed, John Wiley and Sons ,New York. Chow S.C., Liu J.P. (2010) Design and Analysis of Bioavailability and Bioequivalence, 3rd Ed ,CRC/Chapman & Hall ,New York. Chow S.C., Wang H. (2001) On sample size calculation in bioequivalence trials, Journal of Pharmacokinetics and Pharmaceutics, 28, 155-169. Chow S.C., Shao J., Wang H. (2002) A note on sample size calculation for mean comparisons based on noncentral t-statistics, Journal of Biopharmaceutical Statistics, 12, 441-456. Chow S.C., Shao J., Wang H. (2008) Sample Size Calculation in Clinical Research, CRC/Chpman &Hall,New York. FDA (2003). Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products—General Considerations, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD. Fuhr U., Tuculanu D., Berghout A., Balser S., Schwebig A., Saenger P.. (2010) Bioequivalence between novel ready-to-use liquid formulations of the recombinant human GH Omnitrope and the original lyophilized formulations for reconstitution of Omnitrope and Genotropin. Europe Journal Endocrinol,162(6):1051-8. Hauschke D., Steinjans V.W., Diletti E., Burke M. (1992) Sample size determination for bioequivalence assessment using a multiplicative model, Journal of Pharmacokinetics and Pharmaceutics, 20, 557-561. Hsieh C.Y. (2010) A geometric mean approach to sampling size determination for the equivalence hypothesis ,Master Thesis ,National Taiwan University. Hsieh C.Y. ,Liu J.P.(2013)An approximate approach to sample size determination for the equivalence hypothesis. Journal of Biopharmaceutical Statistics, 23,526–538. Julious S.A., McIntyre N.E.(2012) Sample sizes for trials involving multiple correlated must-win comparisons. Pharmaceutial Statistics, 11 177–185 Liu J.P., Chow S.C. (1992) Sample size determination for the two one-sided tests procedure in bioequivalence, Journal of Pharmacokinetics and Pharmaceutics, 20, 101-104. Moral A., Bolibar I., Seguranyes G., et al. (2010) Mechanics of sucking: comparison between bottle feeding and breastfeeding, BMC Pediatrics, 10:6. Mukhopadhyay S. and Bolognese J.A. (2000) Determining average bioequivalence and corresponding sample sizes in general asymmetric settings. The Indian Journal of Statistics, 62, 162-174. Papi A., Canonica G.W., Maestrelli P., et al. (2007) Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma. New England Journal of Medicine, 356, 2040-2052. Schuirmann D.J. (1987) A comparison of the two one-sided tests procedure and power approach for assessing the bioequivalence in average bioavailability. Journal of Pharmacokinetics and Pharmaceutics, 15, 657-680. Sozu T., Sugimoto T., Hamasaki T.(2011) Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints. Journal of Biopharmaceutical Statistics, 21,650–668 Sozu T., Sugimoto T., Hamasaki T.(2012) A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints. Pharmaceutial Statistics,11,118–128. Westlake W.J. (1986) Bioavailability and bioequivalence of pharmaceutical formulations. In Biopharmaceutical Statistics for Drug Development, Peace, K. (Ed.), Marcel Dekker, New York, 329–352. Zhang P. (2003) A simple formula for sample size calculation in equivalence studies Journal of Biopharmaceutical Statistics, 13, 529-538. | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/62336 | - |
| dc.description.abstract | 對等性假設檢定(Equivalence hypothesis)在評估學名藥與專利藥間的差異扮演著很重要的角色。常使用雙單尾檢定(Two one-sided tests procedure, TOST)來檢定對等性假設上的兩種處理的對等性，而當兩處理之間的差異不為0時，其檢定力函數(Power function)並非對稱型分配，故沒有確切公式可算出樣本數，而一般近似的樣本數公式，其計算出來的檢定力(power)常產生不足或是過多的現象，雖然後來有幾何平均的方式來推估所需樣本數。但由於是採用迭代方法，故計算方式較為複雜，為了改善此點，本論文採取較簡單的迭代方法，也採用多重主要端點樣本數方法的概念來推導出所需的樣本數。並將本論文及其他方法所算出的樣本數進行比較。並以實例說明生物對等性的對數尺度及臨床相等性的原始尺度之應用。 | zh_TW |
| dc.description.abstract | The equivalence hypothesis plays an important role on assessing the differences between the generic drugs and original patented drugs. The two-one-sided test ( TOST) procedure is usually applied to test the equivalence hypothesis based on average of two treatments. When the difference in population between the two treatments is not 0 but still within the equivalence limits, the power function is not symmetric. There is no exact formula to calculate the sample sizes. Hence the approximate formulas are proposed to determine the sample size for the equivalence hypothesis. Consequently the sample sizes may provide either insufficient power or unnecessarily high power. Geometric approach to the sample size determination for the equivalence hypothesis has been proposed. However , it requires a complicated iterative procedure. In this thesis, we suggest an iterative method in conjunction of the ideal of multiple co-primary endpoints sample size method for determination of the sample size for equivalence hypothesis. A numerical study was conducted to compare the performance of our proposed method with the current methods. Numerical examples are used to illustrate the applications to bioequivalence on the logarithmic scale and to clinical equivalence on the original scale. | en |
| dc.description.provenance | Made available in DSpace on 2021-06-16T13:41:56Z (GMT). No. of bitstreams: 1 ntu-102-R00621208-1.pdf: 638053 bytes, checksum: d64768e5da8a9def03147705d8ff4d3e (MD5) Previous issue date: 2013 | en |
| dc.description.tableofcontents | Chapter 1 Introduction 1
Chapter 2 Review of the Current Methods 4 2.1 The geometric mean method 7 2.2 A sample size for correlated must-win continuous endpoints 13 Chapter 3 The Proposed Methods 27 3.1 Sample size on the original scale 27 3.2 Sample size on the logarithmic scale 29 Chapter 4 Numerical Studies 31 4.1 Simulation study 31 4.2 Numerical Examples 32 Chapter 5 Discussions and Conclusion 44 References 46 Appendix A. R Program Codes for sample size Determination 49 Appendix B. Fortran Codes for Empirical Power 52 | |
| dc.language.iso | en | |
| dc.subject | 對等性假說 | zh_TW |
| dc.subject | 雙單尾檢定 | zh_TW |
| dc.subject | 樣本數 | zh_TW |
| dc.subject | 檢定力 | zh_TW |
| dc.subject | 生物對等性 | zh_TW |
| dc.subject | Power | en |
| dc.subject | Two one-sided tests | en |
| dc.subject | Sample size | en |
| dc.subject | Equivalence hypothesis | en |
| dc.subject | Bioequivalence. | en |
| dc.title | 以簡易方法決定對等性假說樣本數之研究 | zh_TW |
| dc.title | A study on a Simplified Approach to the Sample Size Determination in Bioequivalence Testing | en |
| dc.type | Thesis | |
| dc.date.schoolyear | 101-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 季瑋珠(Wei-Chu Chie),林志榮(Jr-Rung Lin) | |
| dc.subject.keyword | 對等性假說,雙單尾檢定,樣本數,檢定力,生物對等性, | zh_TW |
| dc.subject.keyword | Equivalence hypothesis,Two one-sided tests,Sample size,Power,Bioequivalence., | en |
| dc.relation.page | 55 | |
| dc.rights.note | 有償授權 | |
| dc.date.accepted | 2013-07-12 | |
| dc.contributor.author-college | 生物資源暨農學院 | zh_TW |
| dc.contributor.author-dept | 農藝學研究所 | zh_TW |
| 顯示於系所單位： | 農藝學系 | |
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