Pharmacometrics

What we do

Modeling & simulation expertise

We provide a wide variety of expertise in Modeling & Simulation, including:

Development of Population PK model building in animals and humans

Extrapolation of animal PK to humans (allometric scaling)

PK-efficacy and PK–side effects relationships

Covariates and predictors of exposure (e.g., demographics)

Risk-benefit analysis for selection and justification of optimized dose

Exposure-QT relationship using Phase I/II data for regulatory waiver

End of Phase I/II Population PK and PK-PD to guide dose selection and optimal dose-ranging studies

PK-efficacy and PK–adverse event relationship to justify dosing regimen for NDAs

Pediatric population PK modeling and extrapolation from adults for first pediatric studies and NDA submissions

Benchmarking and competitor analysis

Design, analysis and reporting of studies in animal species (exposure and toxicity, NOEL/NOAEL, exposure-efficacy, biomarkers)

Optimized PK sampling schemes

Prediction of safety margins in humans for first-in-human study