Population Modeling

Pharmacokinetic

We develop population pharmacokinetic models for drugs and drug candidates from single study or multiple studies data using the state of the art pharmacometric knowledge discovery techniques. In the latter case an integrated knowledge of the population pharmacokinetics of the drug is developed.

Pharmacokinetic / Pharmacodynamic

Using the state of the art pharmacometric knowledge discovery methodologies we develop Pharmacokinetic / Pharmacodynamic (PK/PD) models that provide our clients with enhanced knowledge about exposure-response relationships for their drugs, where the response could be a biomarker, efficacy/outcome measure, or safety.

Integrated Population Analyses

We specialize in performing population PK or PK/PD analyses based on the integration of data obtained from multiple clinical studies. Such analyses provide a broader characterization of the PKand PD of a drug candidate and allow a more comprehensive evaluation of intrinsic and extrinsic factors that may influence PK and PD. More generally, our pharmacometric methods can be applied to efficacy and/or safety variables as well as PK and PD.

Dose Selection and Optimization

Knowing the appropriate doses of a drug candidate to study during the course of the development of a drug is crucial to the success of the development program since dose choice is one of the leading causes of attrition in drug development. Thus, being able to define the utility window for a drug is critical to the progression of a drug candidate in the clinic.

We apply our pharmacometric knowledge discovery and creation methodologies to the modeling of clinical trial data coupled with simulation to define the utility window for a drug or drug candidate and select optimal dosage regimens with the highest benefit/risk ratio.