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Pharmacokinetics (PK) and Pharmacodynamics (PD) modelling and simulation techniques are used to understand drug properties and their behaviour in diverse patient populations. Our qualified experts meticulously assess the appropriate PK research designs needed for a successful clinical drug development plan, eliminating the need for unnecessary and costly studies.

All of our clinical PK/PD services strictly adhere to ICH, EMA, FDA, and Health Canada regulations and guidelines. We provide precise data analysis regardless of your pharmacokinetic study’s purpose. PK parameter calculations are performed according to standard international definitions, followed by in-depth interpretation to ensure accurate and reliable results.

We provide PK/PD modelling and simulation services including, but not limited to, the following areas:

  • PK/PD modeling and simulation
  • Trial design evaluation, optimization and data analysis
  • Interpretation of PK and PD outcomes
  • PK/PD input into the protocol design and Clinical Study Report
  • Statistical analyses including bioequivalence, bioavailability, drug-drug interactions, dose-proportionality and special populations
  • PD analyses using various graphical and statistical approaches
  • PK/PD linear and non-linear mixed modeling techniques
  • NON-COMPARTMENTAL PK – A standard, efficient, and effective method for estimating PK parameters by relying almost exclusively on simple algebraic equations to estimate PK parameters, making the analysis less complex than compartmental methods. Parameters from NCAs are also routinely used by regulatory authorities to inform their decision making both during development and during the approval process.
  • COMPARTMENTAL PK – Relies more on the model specifically used for each analysis. Predicts how a PK profile changes with altered doses or dose regimens. There is more complexity in this type of analysis due to the potential for variability in the output of the analysis
  • POPULATION PK – popPK models are helpful in explaining the variability in PK data. It is a powerful tool to understand the PK in all patients and to assess covariates and vulnerable populations
  • DOSE SELECTION – Optimization and selection of optimal dosing regimen.
  • EXPOSURE-RESPONSE MODELING – Developing empirical models to characterize the relationship between drug exposure vs. drug response.

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