Constructor of an IQRdataNCA object

The IQRdataNCA object will contain the information needed for the NCA analysis, using the IQRnca functionality. Different source data formats can be used. The data should contain the following columns:

COLUMN REQUIRED DEFAULT DESCRIPTION
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USUBJID YES - Unique subject identifier
STUDY - "Unknown" Study identifier
GROUP If GROUPN in data DOSE + unit Defines groups of subjects to consider together for plot and summary tables. E.g. the mg/kg based dose could be used a GROUP
GROUPN If GROUP in data DOSE Defines groups in a numeric way to be used for plotting NCA results over these groups. Useful, e.g., for weight-based dosing
INFO - GROUP Used to annotate each subject with this information in plots and tables
PROFNR - 1 Dataset can contain multiple profiles to analyze independently. 1 could be an IV single dose profile and 2 an SC single dose profile, 3 an IV steady-state profile, etc.
PROFTIME YES - Time of the concentration measurement relative to previous dose
DV YES - Value of concentration measurement (same unit for all). Currently supported units: "mg/mL","ug/mL","ng/mL","pg/mL"
DOSE YES - Value of absolute dose (same unit for all). Currently supported units: "g", "mg", "ug", "ng", "pg"
DURATION YES, if infusion data Error if not provided for Infusion Infusion duration. Only used if type of administration is "INFUSION".
NOSLOPE - FALSE for DV>=LLOQ, TRUE for DV<LLOQ Logical entries, defining if points are eligible for bestslope calculation
IQRdataNCA(data, PROFNR = NULL, ADM = "Extravascular", STUDY = NULL,
  NAME = "Concentration", CONCUNIT = "ng/ml", TIMEUNIT = "Hour",
  DOSEUNIT = "mg", LLOQ = NA, GROUPN_label = NULL, ADDCOLS = NULL)

Arguments

data

data.frame as specified in the table above

PROFNR

Profile number as in the data argument to consider for analysis. Numeric or character names can be used as PROFNR. For a single unique PROFNR in the dataset this argument does not need to be provided

ADM

"Extravascular", "Bolus", or "Infusion"

STUDY

Study name to use for display purposes. If not defined the STUDY column from the dataset will be used. If not present "unknown" will be used.

NAME

String with name of analyte

CONCUNIT

String with unit of concentration measurement

TIMEUNIT

String with unit of time

DOSEUNIT

String with unit of dose

LLOQ

LLOQ value for concentration measurements. Observations<LLOQ will not be considered for slope calculation but the values (if not NA) will be used for AUC calculation.

GROUPN_label

If a GROUPN column is defined in the data then this argument needs to be defined. Useful for mg/kg based dosing. This label will be used as xlabel in the result plots of the NCA.

ADDCOLS

Character vector with column names in data to add to IQRdataNCA dataset. Useful for additional covariates that might be interesting for grouping NCA results

Value

IQRdataNCA object with results

See also