Working with your broader project team, XenoGesis provides guidance throughout the lifetime of your project through our consultancy support.
Areas of expertise include:
- Defining early discovery screening cascades, interpretation of in vitro data and recommendations for progression to in vivo studies
- PK and PK-PD modelling and simulation including recommendations of dose selection and frequency for PD studies
- Prediction of human PK using allometric and physiologically based pharmacokinetic (PBPK) approaches
- Prediction of efficacious human dose (integrating human PK prediction with PK-PD hypothesis)
- Assessment of drug-drug interaction risks (CYPs and transporters)
- Due diligence (in-licensing evaluation or out-licensing support)
Gold standard modelling and simulation
XenoGesis has invested in GastroPlusTM, a 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 to be integrated within the context of a virtual animal or a human model. Having this in-silico understanding can help 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.
For more information, contact a member of the team.