Usage
power.scABEL(alpha = 0.05, theta1, theta2, theta0, CV, n,
design = c("2x3x3", "2x2x4", "2x2x3"),
regulator = c("EMA", "ANVISA", "FDA"),
nsims = 1e+05, details = FALSE, setseed = TRUE)Arguments
alpha
Type I error probability, significance level. Conventionally mostly set to 0.05.
theta1
Conventional lower ABE limit to be applied in the mixed procedure if
CVsWR
theta2
Conventional upper ABE limit to be applied in the mixed procedure if
CVsWR
theta0
'True' or assumed bioequivalence ratio.
Defaults to 0.95 if not given explicitly.
CV
Coefficient(s) of variation as ratio.
If length(CV) = 1 the same CV is assumed for Test and Reference.
If length(CV) = 2 the CV for Test must be given in CV[1] and for
Reference in CV[2].
n
Number of subjects under study.
May be given as vector. In that case it is assumed that n contains the number
of subjects in the sequence groups.
If n is given as single number (total sample size) and this number is not
divisible by the number of seque
design
Design of the study to be planned.
2x3x3 is the partial replicate design (TRR/RTR/RRT).
2x2x4 is the full replicate design with 2 sequences and 4 periods.
2x2x3 is the 3-period design with sequences TRT|RTR.
Defaults to design="2x3x3".
regulator
Regulatory body settings for the widening of the BE acceptance limits.
Defaults to regulator="EMA"
This argument may be given also in lower case.
nsims
Number of simulations to be performed to obtain the empirical power.
Defaults to 100 000 = 1e+05.
If simulations are aimed for empirical alpha nsims=1e+06 is recommended.
details
If set to TRUE the computational time is shown as well as the components
for the BE decision.
p(BE-wABEL) is the probability that the CI is within (widened) limits.
p(BE-PE) is the probability that the point estimate is within theta1 ... the
setseed
Simulations are dependent on the starting point of the (pseudo) random number
generator. To avoid differences in power for different runs a set.seed()
is issued if setseed=TRUE, the default.