Typical PK/PD studies are experimental and most often performed in healthy volunteers or in some cases in narrowly defined patient population to minimize inter-individual variability. Our expert PK/PD data analysis services are available for non-clinical and clinical studies. Our experienced pharmacokineticists provide high-quality PK/PD reports using either our standard format or client’s template.

Population PK and population PD studies assess the variability in drug concentrations and PD markers between individuals (healthy volunteers or patients). PD modelling aims to create a framework for quantifying and predicting drug-body system interactions (therapeutic and adverse drug responses as well). PK/PD relationship is also modelled within these studies, providing a better understanding of the underlying biological process. Our PK team is highly experienced in non-linear mixed effect modelling and simulations.

WE ARE CONSCIOUS OF THE IMPORTANCE OF:

• Integration of the time-course of IMP concentrations, PD markers and/or clinical responses in a mechanism-based PK/PD model
• Understand the benefits of different dosing intervals and difference of investigational product formulations

• Decrease drug development time & cost by:
  • Exploring doses and dosing intervals via Monte Carlo simulation
  • Rational selection of optimized dosage regimens for human clinical trials
  • Fewer blood sampling at optimized time points in human trials (ethical benefit and cost saving; e.g. 6 instead of 12 samples per patient)
• Increased value of drug development program due to a modelling supported understanding of key product properties
• Estimate and account for potentially large inter-patient variability
• Predict the median response and distribution of responses via Monte Carlo simulation for the patient population
• Test and account for influential covariate effects (such as baseline, age, sex or other parameters)
• Integrate data from various species and translate from animal to human, as well as a bridge between adults and children (while accounting for literature data!)
• Ability to individualize dosage regimen of an individual patient using Bayesian methods.

PK / PD MODELLING SERVICES

• Development of PK/PD strategy as part of the drug development plan
• Design of standalone PK studies and sub-studies
• Sample size and power calculations
• Generation of randomization codes
• Preparation of analysis plans

• Compartmental and non-compartmental pharmacokinetic analysis
• Pharmacodynamic analysis
• Assessment of PK/PD relationship
• Assessment of Bioequivalence/Bioavailability
• Drug interaction evaluations
• Reporting

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