Translational Sciences

Accelera provides expertise and services to bridge pre-clinical and clinical development using a model based drug development (MBDD) approach to test drug candidates in humans with reduced cost, time, and resources. Accelera's translational sciences include:
  • Pharmacokinetic and PK/PD modelling to determine the first dose in man and associated safety margin, as well as predict oral bioavailability.
  • Pharmacokinetic and PK/PD data analysis to support regulatory requirements.
  • Data analysis and interpretation to optimize selection of patients and dosing regimens.
We have extensive experience of the application to drug development programmes of pharmacokinetic and population pharmacokinetic modelling, PK/PD analysis, Monte Carlo simulations.

Our dedicated software systems include: Nonmem (ICON Development Solutions), SAS (SAS Institute, Inc.), WinNonlin Pro and WinNonMix Pro (Pharsight Corporation), MatLab (MathWorks), R and WinBUGS for Bayesian analysis using Markov chain Monte Carlo (MCMC) methods. These applications are validated in accordance with requirements stipulated by regulatory bodies.