The pharmacokinetics of drugs and their active metabolites define the time-course over which a drug can affect biological targets. Understanding pharmacokinetics is a crucial first step in developing pharmacodynamic models and hence optimizing dose and schedule. Formulation changes are common in modern drug development, and pharmacokinetic information is essential in bridging knowledge across formulations. Subpopulations with altered pharmacokinetics (for example due to hepatic impairment or genetic polymorphisms) can be correctly dosed if we understand both the change in kinetics and the impact of plasma drug concentrations on pharmacodynamics, safety and efficacy.
Wright Dose Ltd build pharmacokinetic models to accurately characterize the behaviour of a drug, including the impact of critical covariates and an understanding of the magnitude of variability in pharmacokinetic processes. As well as standard pharmacokinetic models, we are experts at analyzing more complex pharmacokinetic datasets including:-
- Meta-models of multi-trial databases
- Models incorporating nonlinear clearance and distribution, including saturation of first-pass metabolism and nonlinear protein binding
- Models for multiple formulations and complex absorption
- Characterization of one or more metabolites, including first-pass formation
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