PK data

This page describes what data you visualise in VA HUB and describes some key things to note when mapping dosing and exposure (PK) data for visualisation of the three different plots.

As with other data the PK data also has mandatory and non-mandatory fields to populate

These must be mapped to the correct source data file column

The data visualised in the dosing and exposure view in VA HUB will be dependent upon the data which has been mapped into ADMIN UI

If all three plots in the dosing and exposure view are required for study analysis, then three data types (source data files) are required to be mapped and loaded into ADMIN UI:

1. PK Concentration

2. Specimen Collection

3. Stacked PK Results

In addition, oncology package permissions in VA Security need to be granted to enable an authorised user or user group to access the PK-Response Exploration plot, as this is generated using RECIST data

The dosing and exposure view is not available in VA HUB if only PK Concentration data has been mapped and loaded in ADMIN UI

To generate the dosing and exposure view both the PK Concentration and Specimen Collection data must be mapped, this will then also generate the Analyte Concentration Over Time plot

The specific dosing and exposure plots visualised in VA HUB are dependent on the data types that have been mapped and loaded into ADMIN UI

Analyte concentration over time

Data types required to visualise plot:

• PK Concentration

• Specimen Collection

Dose Proportionality Exploration

Data types required to visualise plot:

• PK Concentration

• Specimen Collection

• Stacked PK Results

PK-Response Exploration

Data types required to visualise plot:

• PK Concentration

• Specimen Collection

• Stacked PK Results

• Recist target lesion assessments (recist1)

• Recist assessment summarised (recist2)