Transforming Data into Drug Development Success
Expert clinical pharmacokinetic, pharmacodynamic, and exposure response analysis services. We leverage quantitative pharmacology to support Model Informed Drug Development.
Optimising Clinical Development Through Pharmacometrics
Pharmacometrics Solutions integrates mathematical models and statistical techniques to analyse and interpret pharmacological data. Our approach helps design efficient studies and interpret results in the context of all available data and knowledge.
We provide comprehensive pharmacokinetic and pharmacodynamic modelling and simulation services—available as individual components or as part of an integrated package—to enable effective decision-making throughout the clinical drug development process.
Comprehensive PK/PD Analysis Services
From first-in-human studies to regulatory submissions, we provide end-to-end support for all your pharmacometric needs across all phases of clinical development.
Clinical Pharmacology Program
Structured approach to designing, analysing, and interpreting clinical trials with comprehensive data analysis plans.
PK Analysis
Standard non-compartmental and compartmental PK analysis with population pharmacokinetic modelling.
PK/PD Modelling
Semi-mechanistic and mechanistic pharmacodynamic models including target mediated drug disposition.
Exposure/Response Modelling
Time to event/survival models, logistic models, categorical endpoints, and safety/tolerability modelling.
Special Populations
Modelling and prediction of pharmacokinetics in special populations, including paediatric studies.
Clinical Trial Simulations
Study design and dose selection from first-in-human (Phase I) through Phase IV with full simulation support.
Regulatory Support
Full support for regulatory interactions, submissions, PIP/PSP, and authoring of protocols and regulatory documents.
Analysis Reports
Comprehensive PK/PD analysis reports for interim decision making and final analysis for regulatory submissions.
Strategic Consulting
Expert guidance on MIDD strategy, study design, and interpretation of results in context of all available data.
Decades of Drug Development Excellence
With over 35 years of expertise in the application and presentation of pharmacokinetic and pharmacodynamic principles, we have supported successful drug development and regulatory approval across a wide range of therapeutic areas.
Our experience spans small molecules, large molecules, and biologics—ensuring you have access to comprehensive expertise regardless of your drug modality.
Phase I-IV
All clinical development stages
FDA & EMA
Regulatory expertise
35+ Years
Proven track record
MIDD
Model-Informed Development
- Population PK/PD modelling
- Paediatric plans (PIP/PSP)
- TMDD modelling
- Regulatory documentation
- Clinical trial simulation
- Dose optimization
Ready to Accelerate Your Development?
Whether you're planning a first-in-human study or preparing a regulatory submission, we're here to help. Let's discuss how Pharmacometrics Solutions can optimize your clinical development program.