Clinical Pharmacokinetic Studies

We assist in the identification of optimal sampling time points, provide regulatory justification for dose selection, help to design case report forms, identify the optimal sample matrix and collection tubes, sample processing, storage and handling of samples prior to bioanalysis.

Non-compartmental analyses permit no model-based assumptions for intensive sample data. We also use non-linear mixed effects modeling on sparse sampling sets to characterize systemic exposure and co-model the PK/PD effect or safety of the lead compound.

We provide Population-PK analyses, and employ a parametric or non-parametrics approach based on the data. This approach permits the identification of covariates predictive of system parameters.

The right dose at the right time for the right patient requires precise mathematical approaches. We can design a drug specific Bayesian approach to help you select the right dosage for your patients.