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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 劉仁沛(Jen-Pei Liu) | |
dc.contributor.author | Chih-Hsi Chang | en |
dc.contributor.author | 張志熙 | zh_TW |
dc.date.accessioned | 2021-06-15T06:43:49Z | - |
dc.date.available | 2016-07-26 | |
dc.date.copyright | 2011-07-26 | |
dc.date.issued | 2011 | |
dc.date.submitted | 2011-07-04 | |
dc.identifier.citation | 中文文獻:
沈明來(2000) , 生物檢定統計法 第一版, 九州圖書文物有限公司 台北市 台灣 行政院衛生署 食品藥物管理局(2009) 藥品生體可用率及生體相等性試驗準則 林亞靚碩士論文(2010) 平行檢定法於生物製劑學名藥對等性評估之應用 台灣大學 林治華、李元鳳、王蓉君(2011) 生物相似性藥品 Biosimilar財團法人醫藥品查驗中心 當代醫藥法規 RegMed Vol.3 英文文獻(按字母排序): Agreti, A. (2002). Categorical Data Analysis. 2nd ed. John Wiley & Sons, Inc. Hoboken, New Jersey. Chow, S. C. and Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd ed. Marcel Dekker, Inc. New York, USA Chow, S. C. and Liu, J. P. (2010). Statistical Assessment of Biosimilar Products. Journal of Biopharmaceutical Statistics, 20:10-30 FDA 2001. Guidance on Statistical Approaches to Establishing Bioequivalence, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD. FDA 2003. Guidance on Food-Effect Bioavailability and Fed Bio equivalence Studies, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD. ICH (2005). Q5E Guideline on Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the US Food and Drug Administration, Rockville, Maryland, USA Keith O. Webber (2007). Biosimilars: Are we there yet? Presented at Biosimilars 2007, George Washington University, Washington DC, USA. Lachin, J. M. (2000). Biostatistical Methods. The Assessment of Relative Risks. John Wiley & Sons, Inc. Schellekens, H. (2004). How similar do ‘biosimilar’ need to be? Nat Biotechnol, 22, 1357-1359. Schuirmann, D. J. (1987). A Comparison of the Two One-Sided Tests Procedure and the Power Approach for Assessing the Equivalence of Average Bioavailability. Journal of Pharmacokinetics and Biopharmaceutics, Vol. 15, No. 6, 1987 The European Agency for the Evaluation of Medicinal Products (EMEA) 2001. Note for Guidance on the Investigation of Bioavailability and Bioequivalence, London, UK. http://en.wikipedia.org/wiki/ “Biosimilar” and “Biologic” (2011.04) | |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/47978 | - |
dc.description.abstract | 生物製劑的市場近年來逐漸增加,但是所需的開發成本仍然很高,所以在生物製劑的專利到期以後,許多藥廠紛紛投入生物相似性藥品的研發。不同於一般的化學分子學名藥,生物製劑具有製程專一的特性,所以評估生物相似性藥品必須與化學分子學名藥有所不同。現行法規中,生物相似性藥品需依個案,適度的減免臨床試驗,才能被核准上市,成本並不小於開發新的生物製劑,無法降低成本,達到造福病患之目的。
當療效指標為二元變數時,本篇論文以羅吉斯回歸檢定法評估生物製劑相似性藥品與原廠生物製劑是否有差異,以評估是否需要執行完整臨床試驗,模擬所提出方法之第一型錯誤機率、檢定力和覆蓋率,並以數值例子來介紹方法之應用。 | zh_TW |
dc.description.abstract | In recent years, biologics market increases rapidly, but the development costs are also very high. Therefore, after the patent of biological products expires, many pharmaceutical companies have invested in the development of biosimilar products. But, biological products, with process specificity, are different from traditional small molecule drug products. Thought the methods for assessment of biosimilar products are also different. Current regulations indicate that the clinical trials for assessment can be waived on a case-by-case basis, but a pharmacovigilance is necessary. However, if the requirement for clinical trials cannot be waived, the development cost of biosimilar products will be the same as that of the innovators, and it cannot achieve the goal of cost reduction.
In this thesis, we try to apply the logistic regression to test whether the approval of the biosimilar should require clinical trials and to evaluate the similarity between the biosimilar products and innovator’s biological products when the primary endpoint as a binary variable. The results of size and power from the simulation studies are presented. A numerical example is used to illustrate the application of the proposed method. | en |
dc.description.provenance | Made available in DSpace on 2021-06-15T06:43:49Z (GMT). No. of bitstreams: 1 ntu-100-R98621205-1.pdf: 1115811 bytes, checksum: 2a2ee5a5c041dc8f9970ca80fcb419ec (MD5) Previous issue date: 2011 | en |
dc.description.tableofcontents | Chapter 1 Introduction 1
1.1 Background and Motivation 1 1.2 Bioequivalence and Regulations 3 Chapter 2 Literature Review 9 2.1 Interval Hypotheses 9 2.2 Biological Assay 11 2.3 Parallel Line Assay to Evaluation of the Similarity of Biosimilar Products 13 2.4 Logistic Regression 15 2.5 Newton-Raphson Method 18 Chapter 3 Proposed Methods 21 3.1 Design 21 3.2 The Procedure and Methods Based on Relative Potency of Product Characteristics 24 3.2.1 Test for Parallel Lines of Logistic Regressions 26 3.2.2 Estimate Relative Potency and Its Confidence Interval 29 Chapter 4 Numerical Example 33 Chapter 5 Simulation Study 39 5.1 Selection of Dose Levels 39 5.2 Simulation Process 40 5.3 Simulation Results 41 Chapter 6 Discussion and Conclusion 57 References 61 Appendix A.1 63 Appendix A.2 75 Appendix A.3 89 | |
dc.language.iso | en | |
dc.title | 羅吉斯回歸於生物相似性藥品對等性評估之應用 | zh_TW |
dc.title | On Study of Applications of the Logistic Regression to Evaluation of Equivalence of Similar Biological Medicinal Products | en |
dc.type | Thesis | |
dc.date.schoolyear | 99-2 | |
dc.description.degree | 碩士 | |
dc.contributor.oralexamcommittee | 林志榮,謝宗成,李子奇 | |
dc.subject.keyword | Biological products,Biosimilar,Logistic regression, | zh_TW |
dc.subject.keyword | 生物製劑,生物製劑相似性藥品,羅吉斯回歸, | en |
dc.relation.page | 103 | |
dc.rights.note | 有償授權 | |
dc.date.accepted | 2011-07-04 | |
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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