ABE {TrialSize} | R Documentation |
Average Bioequivalence
Description
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 \le \delta_{L}
or Ft-Fr \le \delta_{U}
Ha: \delta_{L}
< Ft-Fr < \delta_{U}
Usage
ABE(alpha, beta, sigma1.1, delta, epsilon)
Arguments
alpha |
significance level |
beta |
power = 1- beta |
sigma1.1 |
|
delta |
delta is the bioequivalence limit. here delta=0.223 |
epsilon |
epsilon=Ft-Fr |
Value
\sigma_{a.b}^{2}=\sigma_{D}^{2}+a*\sigma_{WT}^{2}+b*\sigma_{WR}^{2}
.
References
Chow SC, Shao J, Wang H. Sample Size Calculation in Clinical Research. New York: Marcel Dekker, 2003
Examples
Example.10.2<-ABE(0.05,0.2,0.4,0.223,0.05)
Example.10.2
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[Package TrialSize version 1.4 Index]