Typical pharmacokinetic (PK)/pharmacodynamic (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 pharmacokinetic and pharmacodynamic 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 producing these in client-guided formats.
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 CONSIOUS 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;
- 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 patient population;
- Understand the benefits of different dosing intervals and difference of investigational product formulations;
- 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 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.