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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
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dc.contributor.advisor | 劉仁沛(Jen-Pei Liu) | |
dc.contributor.author | Yu-Ching Yang | en |
dc.contributor.author | 楊宇晴 | zh_TW |
dc.date.accessioned | 2021-06-16T08:05:00Z | - |
dc.date.available | 2019-07-16 | |
dc.date.copyright | 2014-07-16 | |
dc.date.issued | 2014 | |
dc.date.submitted | 2014-06-26 | |
dc.identifier.citation | Altnam, D. G. and Bland, J.M. (1995). Absence of evidence is nor evidence of absence. British Medical Journal, 311:485.
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EMEA/ CPMP/ 3097/ 02/ Final8. EMA.(2005) Guideline on Similar Biological Medicinal Products. The European Medicines Agency Evaluation of Medicines for Human Use; EMA: London, UK, 2005; EMEA/CHMP/437/04. FDA (2012) Scientific considerations in demonstrating biosimilarity to a reference Product, The United States Food and Drug Administration, Silver Spring, Maryland, USA. 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. FDA (2012) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, The United States Food and Drug Administration, Silver Spring, Maryland, USA. FDA. (2012) Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; FDA: Silver Spring, Maryland, USA. FDA. (2012) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; FDA: Silver Spring, Maryland, USA. FDA. (2012) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; FDA: Silver Spring, Maryland, USA. Giani, G. and Finner, H. (1991). Some general results on least favorable parameter configurations with special reference to equivalence testing and the range statistics. Journal of Statistical Planning and Inference, 28(1):33-47. Health Canada. (2010) Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs); Health Canada: Ottawa, Canada. Intercontinental Marketing Services Health (2011) Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape; IMS Health: Danbury, Connecticut, USA. Joseph A. Levitt (1977) Notices and radiological health for general information, or arrow down for specific topics. Federal Register, Vol. 62, No. 242. Lehmann, E. L. and Casella, G. (1998). Theory of Point Estimation. Springer texts in statistics. Springer, New York. Moore, J.W. and Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharnaceutical Technology, 20:64-74. Munk, A. and Pfluger, R. (1999). 1-α equivariant confidence rules for convex alternatives are α/2 level tests – with applications to the multivariate assessment of bioequivalence. Journal of the American Statistical Association, 94(448):1311-1319. Reiser, B. (2001). Confidence intervals for the mahalanobis distance. Communications in Statistics – Simulation and Computation, 30, 37-45. Saranadasa, H. (2011). Defining similarity of dissolution profiles through Hotelling’s T2 statistics. Pharmaceutical Technology, 25 (2), 46–54. Saranadasa, H. and Krishnamoorthy, K. (2005). A multivariate test for similarity of two dissolution profiles. Journal of Biopharmaceutical Statistics, 15, 265–278. Senn S. 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(2000). Design and analysis of three treatment equivalence trials. Controlled Clinical Trials, 21(2):127-137. Williams, E. J. (1949): Experimental designs balanced for the estimation of residual effects of treatments. Australian Journal of Scientific Research, Ser. A 2, 149-168. WHO. (2009) Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs); WHO: Geneva, Switzerland, 2009. | |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/58043 | - |
dc.description.abstract | 隨著生物製劑的專利期即將到期,生物相似性產品的發展愈來愈受到重視。生物相似性藥品的製程與傳統小分子藥物 (學名藥) 非常不同,因其製程、分子結構複雜且可能有嚴重的免疫反應。
目前已有一些標準可用以評估生物相似性藥品與對照生物製劑之間的相似性,其中一個重要的標準是生物相似性藥品與其對照的生物製劑必須符合可互換性。以生物相似性藥品替代原參考之生物製劑後,不須經過醫療人員的特別介入。可互換性的概念為受試者服用原廠生物製劑(R)轉換為生物相似性藥品(T)再轉換為原廠生物製劑(R),或是由生物相似性藥品(T)轉換為原廠生物製劑(R)再轉換為生物相似性藥品(R)。因此,由T轉換為R或由R轉換為T的差異是我們在評估可互換性時需要考量的條件。而這樣的概念與側面圖分析(profile analysis)相似。我們提出一個多變量相等性檢定的方法,利用兩序列、三個時期 (2 3) 交叉設計評估可互換性。我們利用模擬研究驗證此方法的樣本數及檢定力,而實際的例子也在本論文中呈現。並提出在2 3交叉設計下評估可互換性所需樣本數的方法。 | zh_TW |
dc.description.abstract | As more biological products are going off patent protection, the development of biosimilar products has received much attention. Unlike traditional small-molecule chemical drug products, which called generic drug, the development of biologic products is very different from the small-molecule drug products due to the complexity of the molecular structure, complicated manufacturing process and severe immunogenicity reactions.
Several criteria are proposed to evaluate the similarity between the biosimilar product and its reference product. One of these criteria is the alternating ability. Alternative ability means that the biosimilar product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The concept of alternating is referred to as either the switch from test product (T) to its corresponding reference drug (R) and then switch back to T or the switch from R to T and then switch back to R. Thus, the difference between “the switch from T to R” or “the switch from R to T” and “the switch from R to T” or “the switch from T to R” needs to be assessed for addressing the concept of alternating. The concept of alternating ability was formulated as the hypotheses for profile analysis. Then we proposed a multivariate equivalence testing procedure under two sequences and three periods (2 3) crossover design to assess the alternating ability. Simulation studies were conducted to evaluate performance of the proposed procedure in terms of size and power. Numerical example illustrates the proposed procedure. Methods of sample size determination for evaluation of alternating ability under 2 3 crossover design were also proposed. | en |
dc.description.provenance | Made available in DSpace on 2021-06-16T08:05:00Z (GMT). No. of bitstreams: 1 ntu-103-R01621201-1.pdf: 1090471 bytes, checksum: 47c96694a8de7799f707f093d2cfa062 (MD5) Previous issue date: 2014 | en |
dc.description.tableofcontents | Chapter 1 Introduction 1
1.1 Global Development of Biosimilar products 1 1.2 Biosimilarity, Interchangeability and Alternating Ability 3 1.3 Objectives 5 Chapter 2 Assessment for Alternating Ability 10 2.1 Bioequivalence and Regulations 10 2.2 Study Design 14 2.3 Hypothesis testing 17 2.4 Multivariate Equivalence Tests 19 Chapter 3 The Proposed Methods 23 3.1 Testing Procedure 23 3.2 Power function and sample size determination 27 Chapter 4 Numerical Studies 31 4.1 Simulation study 31 4.2 Numerical Examples 34 Chapter 5 Discussions and Conclusion 52 Appendix A. R Program Codes for drawing power curve 62 Appendix B. R Program Codes for sample size Determination 69 Appendix C. R Codes for Empirical Power and Emporical Size 71 | |
dc.language.iso | en | |
dc.title | 生物相似產品交替性之統計評估 | zh_TW |
dc.title | Statistical Evaluation of Alternating Ability of Biosimilar Drug Products | en |
dc.type | Thesis | |
dc.date.schoolyear | 102-2 | |
dc.description.degree | 碩士 | |
dc.contributor.oralexamcommittee | 季瑋珠(Wei-Chu Chie),林志榮(Jr-Rung Lin) | |
dc.subject.keyword | 生物製劑,生物製劑相似性藥品,曼哈頓距離,交叉設計,多變量對等性假說, | zh_TW |
dc.subject.keyword | Biosimilars,Mahalanobis distance,cross-over design,Multivariate equivalence test, | en |
dc.relation.page | 72 | |
dc.rights.note | 有償授權 | |
dc.date.accepted | 2014-06-27 | |
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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