Modeling and Simulation
With modeling and simulation, your existing data can answer important questions and result in significant savings in future studies. Model-based drug development consists of the use of mathematical and statistical methods to:
- Understand how various dosing choices (e.g., dose, dose frequency, dosing duration) affect drug concentrations
- Clarify the relationship between drug concentration and desired or undesired pharmacodynamic responses
- Characterize the PK/PD variability of drugs and assist in understanding the clinically relevant factors contributing to variability
Nuventra has an expert team of pharmacometricians who build models to guide your future drug development decisions. Our team creates tailored model-based drug development plans, including rational selection of the most salient model for a given investigational compound and disease area.
Our Modeling and Simulation Services:
- Population pharmacokinetics (Population PK)
- Candidate selection
- Allometric scaling
- Dose selection and justification
- Clinical study design simulations
- Exposure-response analysis
- Identify & confirm predictive covariates
- Comparator PK/PD analysis
- Concentration QT (cQT) modeling
- TQT waiver
- Model risk
- Large-scale NONMEM
- Darwin – automated model selection
