Modify or add columns (PK parameters) to the NCA result

The function allows to overwrite or derive new PK parameters based on the existing parameters, e.g., transforming the result to a different unit, or deriving per body weight parameters. Alternatively, if the computation of additional PK parameters requires more than just an algebraic relationship, the function can be used to "register" manually added columns of custom PK parameters.

mutate_IQnca(
  data,
  name,
  based_on = NULL,
  formula,
  name_short = NULL,
  name_long = NULL,
  description = NULL,
  unit = NULL,
  sd = NULL,
  fd = NULL,
  ss = NULL,
  bolus = NULL,
  infusion = NULL,
  extravascular = NULL,
  reporting = NULL,
  reporting_across_dose = NULL
)

Arguments

data

IQnca object, i.e., the output of nca_IQdataNCA.

name

Character of length 1. The column name to be generated (corresponds to PKPARAMCD).

based_on

Character of length 1 or NULL (default). An existing column from which the new parameter inherits all the attributes which are not explicitly provided by other argument of this function.

formula

One-sided formula of the form "~expression". Here expression is an algebraic expression by which the new parameter is computed based on existing columns in data. See details for more information.

name_short

Character of length 1 or NULL (default). A short, humanly readable name of the added parameter. If NULL, the value proposed by based_on will be used. If also based_on is NULL, name will be used.

name_long

Character of length 1 or NULL (default). A slightly longer, humanly readable name of the added parameter. This name will appear in tables and listings. If NULL, the value proposed by based_on will be used. If also based_on is NULL, name will be used.

description

Character of length 1 or NULL (default). A longer description of the added parameter. If NULL, the value proposed by based_on will be used. If also based_on is NULL, name will be used.

unit

Character of length 1 or NULL (default). The unit can be provided explicitly, e.g., mg, mL, kg, etc., or using keywords recognized by IQnca, see details. If NULL, the value proposed by based_on will be used. If also based_on is NULL, "-" will be used.

sd

Logical or NULL (default). Indicates whether the param should be reported for single dose profiles. If NULL, the value proposed by based_on will be used. If also based_on is NULL, TRUE will be assumed.

fd

Logical or NULL (default). Indicates whether the param should be reported for first dose profiles. If NULL, the value proposed by based_on will be used. If also based_on is NULL, TRUE will be assumed.

ss

Logical or NULL (default). Indicates whether the param should be reported for steady-state profiles. If NULL, the value proposed by based_on will be used. If also based_on is NULL, TRUE will be assumed.

bolus

Logical or NULL (default). Indicates whether the param should be reported for administration type "BOLUS". If NULL, the value proposed by based_on will be used. If also based_on is NULL, TRUE will be assumed.

infusion

Logical or NULL (default). Indicates whether the param should be reported for administration type "INFUSION". If NULL, the value proposed by based_on will be used. If also based_on is NULL, TRUE will be assumed.

extravascular

Logical or NULL (default). Indicates whether the param should be reported for administration type "EXTRAVASCULAR". If NULL, the value proposed by based_on will be used. If also based_on is NULL, TRUE will be assumed.

reporting

"standard", "slope", "other", or NULL (default). See details. If NULL, the value proposed by based_on will be used. If also based_on is NULL, "standard" will be assumed.

reporting_across_dose

Logical or NULL (default). Indicates whether the parameter should appear in summary tables for which PK parameters were summarized across doses. See details. If NULL, the value proposed by based_on will be used. If also based_on is NULL, FALSE will be assumed.

Value

IQnca object including the new or modified column, an updated units attribute and an updated parameter specification table (paramspec) attribute.

Details

For the interpretation of formula, the right-hand side of the formula is parsed to an R expression which is then evaluated in a local environment generated by data using the with function.

Units can be stated explicitly or using key words recognized by IQnca. Valid keywords are CONCUNIT, TIMEUNIT, DOSEUNIT, CLROUTINE, and VOLROUTINE. Here, CLROUTINE and VOLROUTINE refer to clearance and volume routines. These units are computed by internal routines.

Reporting of values is categorized by "standard", "slope", and "other". Here, "standard" indicates parameters which are reported by default, "slope" indicates parameters related to slope determination, and "other" are the remaining PK parameters. Which parameters are acutally reported in tables and listings can be fine-tuned by the table and listings functions if IQnca.

Reporting across dose means that PK parameters summarized across different dose groups are reported. Summarizing across doses can be valid for parameters which are expected to be independent of dose, e.g., TMAX, clearance, terminal half-life. Summarizing across doses is usually not valid for parameters such as Cmax and AUC.

See also

Other NCA Parameter Tables: reliabilityTable_IQnca(), table_summary_acrossGROUP_pkparameters_IQnca(), table_summary_byGROUP_pkparameters_IQnca()

Other NCA Parameter Listings: listing_pkparameter_IQnca()

Other NCA Parameter Export: exportCDISC_IQnca(), export_IQnca()

Author

Daniel Kaschek, IntiQuan