Usage
power.NTIDFDA(alpha = 0.05, theta1, theta2, theta0, CV, n, design=c("2x2x4", "2x2x3"),
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 FDA procedure.
Defaults to 0.8 if not given explicitly.
theta2
Conventional upper ABE limit to be applied in the FDA procedure.
Defaults to 1.25 if not given explicitly.
theta0
'True' or assumed bioequivalence ratio.
Attention! Defaults here to 0.975 if not given explicitly. The value was chosen
nearer to 1 because the potency (contents) settings for NTID's are tightened
by the FDA.
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 per sequence groups.
Attention! In case of the 2x2x3 (TRT|RTR) design the order of n's important
if given as vector. n[1] is for s
design
Design of the study to be planned.
2x2x4 is the full replicate design with 2 sequences and 4 periods.
2x2x3 is the 3-period replicate design with sequences TRT|RTR.
Defaults to design="2x2x4".
nsims
Number of simulations to be performed to obtain the empirical power.
Defaults to 100 000 = 1e+5.
details
If set to TRUE the computational time is shown as well as the components
for the BE decision.
p(BE-ABE) is the simulated probability for the conventional ABE test.
p(BE-SABEc) is the probability that the 95% CI of the ABE criterion is
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(123456)
is issued if setseed=TRUE, the default.