Write Quicker PBPK Reports with the Simcyp Report Assistant

Instead of creating figures and tables manually with data from different documents, multiple results from Simcyp simulations can be uploaded into Word via the Report Assistant to populate different predefined graphical and tabular templates. In addition, the Report Assistant provides the flexibility to include a fully referenced description for each prediction method or model used in your Simcyp compound.

The Report Assistant was first released alongside version 16 of the Simcyp Simulator and has been updated in each subsequent version of the simulator.

Although the Report Assistant cannot write a report by itself, it is a user-friendly tool that can produce tables with all the relevant simulation information described within the FDA guidance^[1]:

• Route, dose, formulation of the drug product (either substrate or modulator), time of administration, and fasting or fed conditions
• Dosing regimen of the drug product
• Duration of the simulated trials
• Demographics of the virtual population and distribution of demographic information
• Number of simulation studies for a specific scenario (simulated trials)
• Number of virtual subjects in each simulated trial (..)

The Report Assistant allows a table of input parameters, dosing regimen and study design for each compound to be quickly populated.

The Report Assistant’s results section contains all the PK parameters listed below alongside the selected descriptive statistics such as range, standard deviation and confidence intervals to populate graphical and tabular templates. This is in line with the reporting requirements listed in the EMA guidance^[2].

‘The relevant simulated pharmacokinetic parameters (e.g., AUC, Cmax, t1/2, Cmin, V, CL, accumulation / interaction ratios, and inter-individual variability) should be tabulated and presented visually using figures and graphs. The parameter values should be reported with descriptive statistics such as geometric mean and standard deviation and/or range.’

A strength of the Simcyp Simulator is predicting DDI (drug-drug interactions). To best display how a model performs in DDI prediction against observed values, we have developed an automated table found in the report assistant that will create a table that displays observed Cmax, AUC and Clearance ratios against results from simulations.