Output

When the Submit button is pressed in the Analysis Preparation page, the following output is generated:

In the Data/PK Worksheets folder:

These will be used as input for the NCA execution.

NCA_DOSING

NCA_PLASMA: Excludes all records where the matrix is Urine.

NCA_URINE: Excludes all records where the matrix is Plasma.

“_SERIAL” will be appended to the NCA_PLASMA and NCA_URINE name if the study was designated as a serial study, (“_SPARSE” will be appended to the name if the study was designated as a sparse study.)

PartialArea: For studies with both sparse and serial data, three worksheets are generated (sparse data – PartialAreaSparse, serial data – PartialAreaSerial, and a reference containing both – PartialArea).

For sparse data only, two worksheets are generated (a reference – PartialArea and the source worksheet for the sparse NCA object – PartialAreaSparse).

For serial data only, two worksheets are generated (a reference – PartialArea and the source worksheet for the serial NCA object – PartialAreaSerial).

In the Data folder:

MasterConcentration: Contains all of the input data, including any converted concentrations and flags for concentration exclusions.

MasterCO: Contains any comments that were specified.

In the Documents/json folder:

ProjectSettings: Contains all of the Analysis Wizard settings used when creating the NCA object(s).

In the Documents/log folder:

log: Record of the values entered at each step in the Analysis Wizard.

In the Workflow:

NCA objects: One object for each model type (URINE, PLASMA) specified in the Analysis Wizard and ready for execution. “_SERIAL” will be appended to the NCA object name if the study was designated as a serial study, “_SPARSE” will be appended if the study was designated as a sparse study.

After the NCA execution has completed, you may notice that there are no units in the Final Parameters worksheet’s Units column. Some parameters (such as clearance and volume) need to be corrected with the dose, and the dose needs to match the concentration units. The Units column will be filled as part of the PK data finalizing process. Note that the PK Assist Core output file contains these units and can be used to verify them, if needed.