Comparison of Three Methods for Power and Sample Size Determination in Bioequivalence Test
Bioequivalence test is becoming more frequently used in clinical trials. Investigators are now asking statisticians for advice on how to plan and analyze studies using bioequivalence test, which includes questions on sample size determination (SSD). SSD is a crucial aspect of experimental design. Here, three methods were discussed for evaluating power and sample size in bioequivalence test with two-independent samples design and two-period crossover design. Based on summarizing the factors which affected power and sample size in traditional significance test and bioequivalence test such as α, β,θ,Δ,δ and σ, especially introduced the meaning ofαandβin detail, we explore some of the questions surrounding SSD for bioequivalence test in this paper. We found that the power will be negative calculated by simplified Jen-pei Liu and Shein-Chung Chow’s method when n is small or CV is large, which is undoubtedly unreasonable. What’s more, we confirmed computer simulation is a great way to work out sample size and it can make up for the defections of the other two methods.
Sample Size Power Bioequivalence
WANG Jiu YU Lili
Department of Health Statistics and Epidemology, Binzhou Medical University, China, 264003 Department of Information, Genernal Hospital of Jinan Millity Command, P.R.China, 250031
国际会议
2009 International Institute of Applied Statistics Studies(2009 国际应用统计学术研讨会)
青岛
英文
1-7
2009-07-25（万方平台首次上网日期，不代表论文的发表时间）