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

Development of Population PK model building in animal

Development of Population PK model building in humans

Extrapolation of animal PK to humans (allometric scaling)

PK-efficacy, PK-side effects relationship

Identify covariates and predictors of exposure (e.g., demographics)

Risk-benefit analysis supporting the selection and justification of optimized dose

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

End of Phase I/II Population PK and PK-PD to guide dose selection and for design of 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 to determine the optimal dose for first pediatric studies and for NDA submissions​

Benchmarking and competitor analysis

Design, analysis and reporting of studies in different animal species to characterize PK in pre-clinical species and determine the relationship between exposure and toxicity end points (NOEL and NOAEL) or determine the exposure-efficacy or biomarkers. The expertise we provide include:

Optimized PK sampling scheme

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

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