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| 研究生： |
廖淑真 Liaw, Shu-Jean |
|---|---|
| 論文名稱： |
藥劑溶離率比對方法之應用與研究 The Application and Research of Comparative in-Vitro Dissolution Data |
| 指導教授： |
林慧
Lin, Huey |
| 學位類別： |
碩士
Master |
| 系所名稱： |
商學院 - 統計學系 Department of Statistics |
| 論文出版年： | 1996 |
| 畢業學年度： | 84 |
| 語文別： | 中文 |
| 論文頁數： | 102 |
| 中文關鍵詞： | 溶離度試驗 、體外溶離 、體內生體相等 |
| 外文關鍵詞： | Dissolution testing, Inin-vitro dissolution, In-vivo bioequivalence |
| 相關次數： | 點閱：243 下載：0 |
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目前在國內外藥界對比對溶離資料之處理方法有很多種.在本文以常用之二維隨機集區實驗設計,共變異數分析法,單變量分裂區集變異析法,Chow(1995)所提出之時間數列分析法,及美國食品藥物管理局在1995年11月所提出的方法,比較此五種方法並以電腦模擬不同情形之資料再對其結果予以分析.
There are various ways of comparing dissolution profiles between two drug products. In this thesis, we compare five statistical methods often used,namely, two-way randomized block design, analysis of covariance, split-plot,time-series analysis method proposed by Chow (1995), and the method proposed by Food and Drug Administration (FDA) in November, 1995. The five methods are compared via simulation studies under different conditions, analyses arealso provided.
第一章緒論..........1
1.1研究動機與目的..........1
1.2本文架構..........2
第二章比對溶離資料之方法與設計..........3
2.1二維隨機集區實驗設計..........3
2.2共變異數分析法..........5
2.3單變量分裂區集變異數分析法..........8
2.4時間數列分析法..........10
2.5FDA分析法..........17
第三章時間數列分析法AR(2)模式之探討..........19
3.1AR(2)模式之全部相似性..........19
3.2AR(1)和AR(2)模式之比較..........24
第四章模擬結果與分析..........27
4.1模擬過程..........27
4.2模擬線性資料之結果分析..........28
4.3模擬二次曲線資料之結果分析..........31
4.4問題與討論..........35
第五章結論..........91
參考文獻..........93
附錄
附錄一溶離率資料..........95
附錄二模擬之程式..........96
行政院衛生署科技研究發展計畫成果報告，「溶離率試驗比對基準之探討」，台北醫學院，民國八十四年.
吳柏林，「時間數列分析導論」，華泰，民國八十四年.
許興智、陳甘霖、陳朝洋，「藥劑的安定性及配方的篩選」，華榮，民國八十年.
Chow, S. C., (1995). Statistical comparison between dissolution profiles of drug products. Submitted to J of Biopharm.
Cochran, w. G., (1957). Analysis of covariance: its nature and uses. Biometrics, Vol. 13, No.3, 261-281.
Duncan, A. l, (1974). Quality Control and Industrial Statistics, 4th edition. Richard D. Irwin, Inc. Homewood, III.
FDA, (1995). Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In-Vitro Dissolution Testing, and In-Vivo Bioequivalence Documentation, Food and Drug Administration, Rockville, Mayrland.
Federer, W. T., (1957). Variance and covariance analysis for unbalanced cIassifications. Biometrics, Vol. 13, No.3, 333-362.
Gill, J. L., (1988). Repeated measurement: split-plot trend analysis versus analysis of first differences. Biometrics, 44, 289-297.
Mauger, J. W., Chilko, D., Howard, S., (1986). On the analysis of dissolution data. Drug Development and Industrial Pharmacy, 12(7), 969-992.
Minitab, Minitab Inc. ,. State College Pennsylvania, USA, (1993).
Montgomery, D. c., (1991). Design and Analysis of Experiments, 3rd edition. John Wiley and Sons, Inc. New York.
Ronald D. Snee, (1972). On the analysis of response curve data. Technometrics,14(1), 47-62.
Tsong, Y. and Hammerstrom, T. (1992). Statistical issues in drug quality control based on dissolution testing. Proceedings the Biopharmaceutical Section of the American Statistical Association, 295-300.
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