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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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