Population PK and PK/PD Modelling

Accelera has the know-how and experience to develop, assess and validate population PK and PK/PD models through:
  • analysis planning (study and sampling design)
  • dataset construction (e.g. handling outliers and missing data)
  • base model building
  • covariates analysis
  • model validation
  • parameter estimation
  • predictions
  • sensitivity analysis and parameter stability.
Possible applications include:
  • PD and PK/PD for supporting pharmacology studies and clinical development.
  • Parametric and non-parametric PD and PK/PD models, using novel mathematical-statistical approaches such as non-linear and non-linear mixed modeling techniques, for estimating drug potency.
  • Simulation of different scenarios for optimizing preclinical and clinical experimental designs.
  • Software development for specific data analysis (PK, PD, PK/PD modelling and application of population approaches).
Dedicated software systems include: Nonmem (ICON Development Solutions), SAS (SAS Institute, Inc.), WinNonMix Pro (Pharsight Corporation) and WinBUGS for Bayesian analysis using Markov chain Monte Carlo (MCMC) methods. These applications are validated in accordance with requirements stipulated by regulatory bodies.