Power and Sample-Size Distribution of 2-Stage Bioequivalence
Studies
Functions to obtain the operational characteristics of
bioequivalence studies with 2-stage designs via simulations
- Contains a function to calculate power and sample-size distribution
of 2-stage bioequivalence (BE) studies with a 2x2 crossover design
according to Potvin et al. / Montague et al. modified to include a
futility Nmax and modified to do the sample size estimation step
with PE and mse of stage 1.
- Contains further a function with the modifications according to
Karalis & Macheras which use both point estimate (PE) and mse from stage 1
also for the power monitoring steps.
- The third function power.2stage.fC() calculates power and sample-size
distribution of 2-stage BE studies with a futility criterion
for the PE or CI of T/R from stage 1.
- The fourth function power.2stage.GS() calculates power of non-adaptive
group sequential (2-stage) BE studies.
- The fifth function power.2stage.p() calculates power and sample size
distribution of 2-stage BE studies with 2 parallel groups.
This function has a sibling power.2stage.pAF(), which performs exactly as
described in A.Fuglsang 2014
- Another function power.2stage.ssr() allows the power calculation
for 2-stage studies with (blinded) interim sample size re-estimation.

Contains functions to obtain the operational characteristics of
bioequivalence studies with 2-stage designs (TSD) via simulations.

c(person("Detlew", "Labes", role = c("aut","cre"),
email = "DetlewLabes@gmx.de"),
person("Benjamin", "Lang", role = c("aut", "ctb"),
email = "BenjaminL@gmx.de"),
person("Helmut", "Schuetz", role = c("aut", "ctb"), email =
"helmut.schuetz@bebac.at"))
Detlew Labes [aut, cre],
Benjamin Lang [aut, ctb],
Helmut Schuetz [aut, ctb]

c(person("Detlew", "Labes", role = c("aut","cre"),
email = "DetlewLabes@gmx.de"),
person("Benjamin", "Lang", role = c("aut", "ctb"),
email = "BenjaminL@gmx.de"),
person("Helmut", "Schütz", role = c("aut", "ctb"), email =
"helmut.schuetz@bebac.at"))
Detlew Labes [aut, cre],
Benjamin Lang [aut, ctb],
Helmut Schütz [aut, ctb]