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Build and validate a bioequivalence dataset

Source: R/bioequivalence.R
be_dataset.Rd

be_dataset() prepares a noncompartmental result for bioequivalence calculation: it accepts a PKNCAresults object or a tidy long data.frame, resolves the value column, drops excluded/invalid rows, detects the subject/sequence/period columns, validates the reference, and sets the reference formulation as the first factor level. It standardizes the modeling columns (.subject, .sequence, .period, .trt, .logval) used by the downstream fitters.

Usage

be_dataset(
  object,
  reference_col,
  reference_value,
  endpoints = c("cmax", "aucinf.obs", "aucinf.pred", "auclast"),
  subject = NULL,
  sequence = NULL,
  period = NULL
)

Arguments

object

A PKNCAresults object or a tidy long data.frame with a PPTESTCD column of parameter names, a PPORRES/PPSTRES column of values, and subject/sequence/period/treatment columns.

reference_col

The column identifying the formulation/treatment.

reference_value

The value of reference_col that is the reference formulation.

endpoints

Character vector of NCA parameters (matched against PPTESTCD) to assess.

subject, sequence, period

Column names for the subject, randomization sequence, and period. When NULL they are taken from the PKNCAresults object or detected from common column names. sequence may be absent.

Value

An object of class be_dataset: a list with data (the standardized long frame, including a .units column), columns (the resolved column names, including units), reference_value, test_levels, and endpoints (those present).

Details

The endpoint value is taken from the PPSTRES column when present, otherwise PPORRES. The measurement units are read from the matching units column – PPSTRESU for PPSTRES, or PPORRESU for PPORRES – which a PKNCAresults object provides automatically; a plain data.frame supplies units the same way by including the corresponding PPSTRESU/PPORRESU column. When no units column is present, units are unavailable and the units column is omitted from the assessment table.

See also

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