Pharmacokinetic/Pharmacodynamic analysis

An understanding of the relationship between drug concentration and clinical effect can aid you in the choice of a safe and effective dose.  Using our extensive experience we can design, analyse and report your pharmacokinetic studies so that they provide clarity around their impact on future drug development. We use industry standard software (Phoenix™, WinNonlin®) to aid our non-compartmentalnand PK/PD analyses.  SOPs along with independent QC checks ensure the quality of all our analyses and reports.  We have contributed to the success of our clients’s projects through work in the following areas:
  • Interim PK and PD analysis and reporting for input into safety review meetings during dose escalation  studies
  • Non-compartmental analysis of data from clinical pharmacology studies
  • PK/PD modelling of drug plasma concentration data against surrogate markers  of efficacy in animals and humans
  • Modelling and simulation to justify dose selection in clinical pharmacology studies
  • Writing PK/PD sections for clinical study reports
  • Stand alone PK reports