Build the regulatory bioequivalence table

be_table() takes the parameters from be_extract_param() and a regulatory framework and produces the final per-endpoint pass/fail table. It selects the regulator-appropriate statistic (the model contrast for the expanding-limits frameworks; for the FDA family, intra-subject contrasts for the reference-scaled criterion and the model contrast for the unscaled 80.00-125.00% criterion) and calls the per-framework decision functions; it is the only place regulator decisions are made. Each row shows the ratio and confidence interval that its decision used. The expanding-limits frameworks decide each endpoint by its own rule (see be_regulator()); an endpoint that is neither a PKNCA parameter nor a CDISC code cannot be classified, so it keeps 80.00-125.00% with a warning unless it is named in widen_endpoints.

Usage

be_table(
  params,
  regulator,
  alpha = 0.1,
  design = NA_character_,
  model_type = NA_character_,
  widen_endpoints = NULL,
  widen_default = TRUE
)

Arguments

params

A data.frame of parameters from be_extract_param() (with an endpoint column added per endpoint).

regulator

A regulator name or a be_regulator object.

alpha

The significance level.

design

The design label (character) for the design column.

model_type

The model type label for the model_type column.

widen_endpoints

For the expanding-limits frameworks ("EMA", "HC", and "GCC"), endpoints whose acceptance limits widen in addition to the framework's own choice (the endpoints judged like Cmax for the EMA and GCC, like AUC for Health Canada; see be_regulator()). Use it for an endpoint that the guidance widens but PKNCA cannot recognize from its name, such as a partial AUC of a modified-release product (EMA), or an endpoint that is neither a PKNCA parameter nor a CDISC code. Naming an endpoint for another framework is an error; be_compare() passes it to the expanding-limits frameworks only, and each adds it to its own choice.

widen_default

For the expanding-limits frameworks, whether the framework's own choice of endpoints widens (the default, TRUE). With FALSE only the endpoints in widen_endpoints widen, for example none when the protocol did not specify widening in advance; Health Canada still judges Cmax by its point estimate. FALSE for another framework is an error; be_compare() applies it to the expanding-limits frameworks only.

Value

A data.frame with one row per endpoint and test formulation and the pass/fail decision columns, including rule, the criterion each row's decision used. For the "descriptive" framework the decision columns (rule, limit_lower, limit_upper, criterion, and pass) are omitted.

See also

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