be_design() inspects the treatment-by-period pattern of a crossover study
and reports the design type, the replication of the reference and test
formulations, and which regulatory frameworks are feasible. Reference
scaling (EMA/HC/GCC/FDA) requires the reference to be replicated; the narrow
therapeutic index frameworks additionally require the test to be replicated.
Arguments
- data
A long data.frame with one row per concentration-derived observation (subject, period, treatment).
- subject, sequence, period, treatment
Column names (length-1 character) identifying the subject, randomization sequence, period, and treatment.
sequencemay beNAto derive it from the treatment-by-period pattern.- reference_value
The value of
treatmentthat is the reference formulation.
Value
An object of class be_design: a list with elements design (one
of "parallel", "2x2x2", "full_replicate", "partial_replicate",
"other"),
n_sequences, n_periods, n_treatments, n_subjects, sequences,
treatments, reference, replicate_reference, replicate_test,
reps_reference, reps_test, balanced, and feasible (a named logical
vector for abe, abel, rsabe, ntid, hvntid).
See also
Other Bioequivalence:
be_assess(),
be_compare(),
be_dataset(),
be_expand_limits(),
be_extract_param(),
be_fit_model_single(),
be_fit_models(),
be_regulator(),
be_table(),
be_within_var()
Examples
d <- data.frame(
subject = rep(1:4, each = 4),
period = rep(1:4, times = 4),
sequence = rep(c("TRTR", "RTRT"), each = 8),
treatment = c("T", "R", "T", "R", "R", "T", "R", "T",
"T", "R", "T", "R", "R", "T", "R", "T")
)
be_design(d, "subject", "sequence", "period", "treatment", reference_value = "R")
#> Bioequivalence design: full_replicate
#> 2 sequence(s) (RTRT, TRTR), 4 period(s), 2 treatment(s), 4 subject(s), balanced
#> Reference "R" replicated: TRUE (2/subject); test replicated: TRUE (2/subject)
#> Feasible frameworks: ABE, ABEL, RSABE, NTID, HVNTID