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http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/40983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 | Huei-Jyuan Wu | en |
| dc.contributor.author | 吳惠娟 | zh_TW |
| dc.date.accessioned | 2021-06-14T17:10:08Z | - |
| dc.date.available | 2013-07-30 | |
| dc.date.copyright | 2008-07-30 | |
| dc.date.issued | 2008 | |
| dc.date.submitted | 2008-07-26 | |
| dc.identifier.citation | Reference
[1] Chow, S.C. and Liu, J.P. (2000) Design and Analysis of Bioavailability and Bioequivalence Studies, 2nd Ed, Marcel Dekker, Inc. New York. Basel. [2] NCCLS document EP6-A. (2003) Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. Wayne, Pennsylvania 19807-1898 USA. [3] International Conference on Harmonisation. (1994) ICH harmonised tripartite guideline, Q2A. Text on validation of analytical procedures. International Conference on Harmonisation, Geneva, Switzerland. [4] International Conference on Harmonisation. (1996) ICH harmonised tripartite guideline, Q2B. Validation of analytical procedures: methodology. International Conference on Harmonisation, Geneva, Switzerland. [5] Martin H. Kroll, Jens Prastgaard, Ellen Michaliszyn, and Patricia E. Styer. (2000) Evaluation of the Extent of Nonlinearity in Reportable Range Studies. Archives of Pathology and Laboratory Medicine: Vol. 124, No. 9, pp. 1331-1338. [6] Timothy L. Schofield. (2000) Assay validation. In: Chow, S.C., Editor. Encyclopedia of biopharmaceutical statistics. Marcel Dekker, Inc. New York. [7] Timothy L. Schofield. (2003) Assay validation. In: Chow, S.C., Editor. Encyclopedia of biopharmaceutical statistics. Marcel Dekker, Inc. New York, pp. 63-71. [8] Bob Zhong, Chunfu Qiu, and Dejun Tang. (2003) Validation of Quantitative and Qualitative Assays. In: Chow, S.C., Editor. Encyclopedia of biopharmaceutical statistics. Marcel Dekker, Inc. New York. [9] Weerahandi, S. (2004) Generalized Inference in Repeated Measures. John Wiley & Sons Inc. [10] Hsieh, E., Hsiao, C.F., and Liu, J.P. (2008) Statistical Inference for Evaluating the Linearity in Assay Validation. [11] Hanning J, Iyer H, and Patterson P. (2006) Fiducial Generalized Confidence Intervals. Journal of the American Statistical Association. 101:254-69. [12] Robert V. Hogg, Allen Craig, and Joseph W. McKean.(2005) Introduction to Mathematical Statistics, 6th Ed, Prentice Hall. | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/40983 | - |
| dc.description.abstract | Abstract
Linearity is one of the most important characteristics for evaluation of the accuracy in assay validation. The current statistical method for evaluation of the linearity recommended by the Clinical Laboratory Standard Institute (CLSI) guideline EP6-A was reviewed. The method directly compares the point estimates with the pre-specified allowable limit and completely ignores the sampling error of the point estimates. An alternative method for evaluation of linearity proposed by Kroll, et al. (2000) considers the statistical test procedure based on the average deviation from linearity (ADL). However this procedure is based on the inappropriate formulation of hypothesis for evaluation of the linearity. Consequently, the type I error rates of both current methods may be inflated for inference of linearity. Because any procedures for assessment of linearity should be based on the sampling distributions of the proposed test statistics, we propose a generalized pivotal quantity (GPQ) procedure. The method does not involve in any nuisance parameters. The simulation studies were conducted to empirically compare the size and power between current and proposed methods. The simulation results show that the proposed methods not only adequately control size but also provide sufficient power. A numeric example illustrates the proposed methods. | en |
| dc.description.provenance | Made available in DSpace on 2021-06-14T17:10:08Z (GMT). No. of bitstreams: 1 ntu-97-R95621209-1.pdf: 469443 bytes, checksum: 4a53459be751159f7d6c226da6818b4b (MD5) Previous issue date: 2008 | en |
| dc.description.tableofcontents | Contents
1 Introduction 1 2 Literature Review 4 2.1 Experiment Design 4 2.2 Current Test Procedures 5 2.2.1 The Average Deviation from Linearity (ADL) 5 2.2.2 Corrected Kroll's Method 6 2.2.3 The Approved CLSI EP6-A Method 8 2.2.4 Hsieh's Method 9 3 Proposed Methods 11 3.1 Type I and Type II Errors in Evaluation of Linearity 11 3.2 Testing Hypothesis 12 3.3 The Multivariate Normal Distribution 13 3.4 Generalized Pivotal Quantity(GPQ) 15 4 Simulation Study 19 4.1 Parameter Combinations 19 4.2 Simulation Process 19 4.3 Simulation Results 20 5 Numerical Example 23 6 Summary and Discussion 25 6.1 Summary 25 6.2 Why We Have the Proposed Method 25 6.3 Why Linearity Is Important 26 Reference 27 Appendices 29 | |
| dc.language.iso | en | |
| dc.subject | 量化分析的實驗方法 | zh_TW |
| dc.subject | 允許區間 | zh_TW |
| dc.subject | 線性 | zh_TW |
| dc.subject | Quantitative analytical laboratory | en |
| dc.subject | Linearity | en |
| dc.subject | Allowable Limit | en |
| dc.title | 線性確效評估之統計方法的研究 | zh_TW |
| dc.title | A Study on Statistical Methods for Evaluation of Linearity in Assay Validation | en |
| dc.type | Thesis | |
| dc.date.schoolyear | 96-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 季瑋珠(Wei-Chu Chie),廖振鐸(Chen-Tuo Liao) | |
| dc.subject.keyword | 允許區間,線性,量化分析的實驗方法, | zh_TW |
| dc.subject.keyword | Allowable Limit,Linearity,Quantitative analytical laboratory, | en |
| dc.relation.page | 40 | |
| dc.rights.note | 有償授權 | |
| dc.date.accepted | 2008-07-29 | |
| 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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