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研究生:蘇緯珊
研究生(外文):Wei-Shan Su
論文名稱:利用P-值評估體外試驗非曲線型資料生體相等性
論文名稱(外文):A p-value approach to assessing In-vitro nonprofile bioequivalence
指導教授:馬瀰嘉馬瀰嘉引用關係劉仁沛劉仁沛引用關係
指導教授(外文):Mi-chia MaJen-pei Liu
學位類別:碩士
校院名稱:國立成功大學
系所名稱:統計學系碩博士班
學門:數學及統計學門
學類:統計學類
論文種類:學術論文
論文出版年:2002
畢業學年度:90
語文別:英文
論文頁數:149
中文關鍵詞:體外試驗非曲線型資料生體相等性P-值模擬95%信賴上限
外文關鍵詞:In-vitro nonprofile bioequivalenceP-valueSimulationupper 95% confidence limit.
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1999年,美國食品與藥物管理局,簡稱FDA,提出「鼻藥噴劑(Nasal aerosols)與噴霧劑(Nasal sprays)局部作用之藥劑生體可用率與生體相等性」的評估基準。就個體藥劑生體相等性(individual bioequivalence)而言, FDA針對平行設計之體外試驗所得非曲線型資料提出95%信賴上限方法作為判定生體相等性的準則。該方法是由Hyslop, Hsuan 和 Holder於2000年所提出的統計檢定方法,在2001年時FDA提出此方法亦可利用在藥劑族群生體相等性方面。本論文中,利用假設中測度量之P-值評估體外試驗非曲線型資料的生體相等性,並且與Hyslop等人於2000年所提出之檢定方法,在一定的顯著水準下,比較檢定力的大小,另外,再給定之檢定力之下決定樣本大小。最後利用各種樣本數及參數下之模擬資料,以經驗型I誤差(empirical size)和經驗檢定力(empirical power)來證實以P-值對生體相等性做檢定較Hyslop等人所提出之檢定方法佳。
In 1999, the U.S. Food and Drug Administration(FDA)issue a graft guidance on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action. For individual bioequivalence(IBE), the FDA provided a method of determining an upper 95﹪confidence limit for in vitro bioequivalence data based on nonprofile analyses using parallel designs. This method was based on statistic test procedure proposed by Hyslop, Hsuan and Holder(2000)and the same method is also recommended in FDA 2001 guidance for assessment of population bioequivalence(PBE). In this paper, we provide a P-value method to assess in-vitro nonprofile bioequivalence and compare this method with the test procedure of Hyslop et al. (2000). Sample size determination for bioequivalence test is also proposed. Empirical size and empirical power from simulation results are provided to examine the performance between the P-value method and Hyslop, Hsuan and Holder’s procedure.
List of Tables II
List of Figures IX
Chapter 1 Introduction 1
1.1 Bioavailability(BA)and bioequivalence(BE) 1
1.2 Average bioequivalence(ABE), population
bioequivalence(PBE)and individual bioequivalence(IBE) 1
1.3 In vitro BA/BE test and nonprofile 2
1.4 Bioequivalence study protocol with nasal sprays and nasal aerosols 3
Chapter 2 Population Bioequivalence 5
2.1 FDA’S PBE test 5
2.2 Confidence interval method 8
Chapter 3 Statistical Procedure 14
3.1 The P-value method 14
3.1.1 Statistical model and criterion 14
3.1.2 P-value construction 15
3.2 The Asymptotic normality method 19
3.3 The Bootstrap method 23
3.4 The determination of sample size 24
Chapter 4 Simulation Studies 27
4.1 Simulation Process 27
4.2 Simulation Results 31
4.2.1 The descriptive statistics for 31
4.2.2 The probability of concluding BE 33
Chapter 5 Discussion 39
Reference 41
Appendix 42
References
1.Chinchilli V, Esinhar J. Design and analysis of intra-subject variability in cross-over experiments. Statistics in Medicine, 15:1619-1634, 1996.
2.Howe W.G., “Approximate confidence limits on the mean of X+Y where X and Y are two tabled independent random variables”. J Amer Statist Assoc, 69:789-794, 1974.
3.Hsu J.C., J.T.G.Hwang, H.-K. Liu, and S.J. Ruberg, “Confidence intervals associated withtests for bioequivalence”. Biometrika, 81:103-114, 1994.
4.Hyslop T., F. Hsuan, D.J. Holder, "A small-sample confidence interval approach to assess individual bioequivalence". Statistic in Medicine, 19:2885-2897, 2000.
5.U.S.FDA. Guidance for Industry: Bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action. Center for Drug Evaluation and Research (CDER), Food and Drug Administration, US Department of Health and Human Services, June, 1999.
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