In silico and PBPK modelling
Working with your full project team, Sygnature’s experienced modelling and simulation team provides guidance throughout the lifetime of your project, helping to:
- define early discovery screening cascades, interpret in vitro data and recommend options for progression to in vivo studies.
- make recommendations of dose and dosing regimen for pharmacodynamic (PD) studies through PK and PK/PD modelling and simulation.
- predict human PK using allometric and PBPK approaches.
- predict efficacious pharmacological dose (integrate PK prediction with PK/PD hypothesis).
- assess drug-drug interaction risks [metabolising enzymes (CYPs, UGTs, non-hepatic) and transporters].
- due diligence (in-licensing evaluation or out-licensing support).
Gold standard modelling and simulation
Sygnature uses the GastroPlusTM software package that simulates absorption, distribution, metabolism and elimination in humans and animals from a range of dose routes including oral, intravenous, inhaled, ocular and dermal. This enables data integration within the context of a virtual animal or human model. Having this in silico understanding can help us make faster and more informed development decisions. It has been identified as the number one commercially ranked program for in vitro-in vivo extrapolation and has been the focus of several publications from the FDA.