Reference-scaled acceptance limits for bioequivalence

be_expand_limits() computes the (possibly widened) bioequivalence acceptance limits for a scaled-ABE framework given the within-reference standard deviation. The limits widen geometrically with swR as exp(+/- k * swR) and are capped; below the switching variability they remain the conventional 80.00-125.00%. They apply to the endpoints the framework widens (Cmax for the EMA and GCC, AUC for Health Canada; see be_regulator() for the sources); be_assess() keeps the other endpoints at 80.00-125.00%.

Usage

be_expand_limits(swR, regulator)

Arguments

swR

The within-reference standard deviation of the log-transformed endpoint (for example from be_within_var()).

regulator

A regulator name (see be_regulator()) or a be_regulator object. Only the ABEL frameworks ("EMA", "HC", "GCC") widen; "ABE" always returns 80.00-125.00%, and "descriptive" (which has no limits) is an error.

Value

A named numeric vector c(lower, upper) of acceptance limits as percentages.

See also

be_regulator(), be_assess()

Other Bioequivalence: be_assess(), be_compare(), be_dataset(), be_design(), be_extract_param(), be_fit_model_single(), be_fit_models(), be_regulator(), be_table(), be_within_var()

Examples

be_expand_limits(0.485, "EMA") # capped expansion (69.84-143.19%)
#>     lower     upper 
#>  69.83678 143.19102 
be_expand_limits(0.20, "EMA")  # below the switch: 80-125%
#> lower upper 
#>    80   125 
be_expand_limits(0.60, "HC")   # Health Canada cap (66.7-150.0%)
#>     lower     upper 
#>  66.66666 150.00000