Pharmacokinetic (PK) Evaluations
An integral part of any Phase I program is the PK data analysis. Frontage statisticians can offer non-compartmental, compartmental and, if needed, population PK analyses using industry recognized, state-of-the-art software. These analyses can be coupled to statistical analyses performed following FDA guidance to demonstrate bioavailability or bioequivalence of drugs. Frontage has a great deal of experience incorporating pharmacodynamic endpoints, including biomarkers, into Phase I studies to generate proof-of-concept data.