DMPK Consultancy

DMPK Consultancy

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.

 

Graham Trevitt

Richard Weaver