ABE {TrialSize} | R Documentation |
The most commonly used design for ABE is a standard two-sequence and two-period crossover design. Ft is the fixed effect of the test formulation and Fr is the fixed effect of the reference formulation.
Ho: Ft-Fr ≤ δ_{L} or Ft-Fr ≤ δ_{U}
Ha: δ_{L} < Ft-Fr < δ_{U}
ABE(alpha, beta, sigma1.1, delta, epsilon)
alpha |
significance level |
beta |
power = 1- beta |
sigma1.1 |
σ_{a.b} with a=1 and b=1. |
delta |
delta is the bioequivalence limit. here delta=0.223 |
epsilon |
epsilon=Ft-Fr |
σ_{a.b}^{2}=σ_{D}^{2}+a*σ_{WT}^{2}+b*σ_{WR}^{2}
.
Chow SC, Shao J, Wang H. Sample Size Calculation in Clinical Research. New York: Marcel Dekker, 2003
Example.10.2<-ABE(0.05,0.2,0.4,0.223,0.05) Example.10.2 # 21