Pre-clinical PK & Dose Prediction
XenoGesis has developed a series of ADME packages which are designed to help clients answer key questions on how their drug discovery compounds behave in key areas such as absorption, clearance, distribution and oral bioavailability. The packages build sequentially to predict oral exposure in pre-clinical species and ultimately the likely efficacious pharmacokinetics and dose in man.
They are designed to be part of a robust iterative screening cascade during drug discovery ultimately leading to better informed decisions with an understanding of drug exposure with respect to efficacy and safety.
For more information on each of these packages, please click on the buttons below.
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.