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Quantitative Pharmacology and Pharmacometrics

Delivering real impact in clinical development

ICON offers expert clinical and nonclinical pharmacokinetic, pharmacodynamic, and exposure response data analysis services.

Pharmacometrics play a crucial role in optimising clinical development by integrating mathematical models and statistical techniques to analyse and interpret pharmacological data. Application of pharmacometric principles help design efficient studies and interpret their results in the context of all available data and knowledge to enable effective decision-making for the clinical drug development process.

ICON provides a comprehensive range of pharmacokinetic and pharmacodynamic modelling and simulation services that are available either as individual components or as part of an integrated package. We leverage the latest quantitative pharmacology & pharmacometrics approaches, together with strategic consulting, analysis, model development and simulation to support Model Informed Drug Development (MIDD).

We have expertise in the application and presentation of pharmacokinetic (PK) and pharmacodynamic (PD) principles for successful drug development and approval. Our experience covers a wide range of clinical and nonclinical development of small molecules, large molecules, and biologics.

Our services include:

  • Model-informed drug development consulting
  • PopPK, PK/PD and ER modelling and simulation
  • Optimal design analysis and clinical trial simulation
  • Modelling to support FIH and phase2/3 dose selection
  • PK and PK/PD study design
  • Optimal PK and PD sample scheduling
  • Exposure-based target selection and lead optimisation
  • Nonclinical PK (including toxicokinetics), PD, and ER using NCA and model‑based methods
  • Allometry and model‑based prediction of human PK and dose selection First-In-Human studies.
  • In Vitro/In Vivo correlation and deconvolution analyses to support formulation development
  • Clinical PK, PD, and ER using NCA and model‑based methods
  • Expert review of data
  • Due diligence assessments
  • Authoring of QP&PMx‑related sections of protocols, analysis plans, study reports, and regulatory documents

Whether you are looking for consultancy, support for single studies, or contribution to programs of work, ICON’s QP&PMx specialists can help to advance your project and save you time and expense.

Pharmacometric software can vary depending on specific needs, such as the type of modelling, user experience, and budget. NONMEM is the best option, offering advanced modelling capabilities and a variety of statistical algorithms for population analysis. As the gold standard for population analysis, NONMEM has a long history of serving the pharmacometrics community in providing both classic and contemporary approaches to non-linear mixed effects modelling, and Bayesian analysis. The graphical user interface companion software PDx-Pop provides additional versatility in project maintenance, NONMEM launching procedures, rendering post-analysis diagnostics and graphing NONMEM output results.

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