Pharmacometric Analyses

Pharmacometric analyses, which are advanced applications of pharmacokinetic-pharmacodynamic (PK-PD) systems analysis, sits at the core of what we do at ICPD. We stress the system analysis approach because it facilitates robust, relevant models informed by our best understanding of the pertinent biology. We learn, confirm, and succeed through advanced methods of PK and PK-PD system analysis. From glassware to mice to man, we strive to learn, and when necessary, to re-conceive convention in an effort to help our sponsors help patients.

Typical pharmacometric analyses and tools utilized by ICPD include:

Individual and population PK study design
• ADAPT
• Optimal Sampling Theory
• Monte Carlo simulation

Individual PK and PK-PD model development
• ADAPT
• WinNonLin®
• S-ADAPT

Population PK and PK-PD model development
• ADAPT
• S-ADAPT
• NONMEM®
• IT2S
• NPAG

Development of dosing guidelines, based upon PK-PD principles
• Development and validation of optimal adaptive feedback control algorithms

Monte Carlo simulation, including clinical trial simulation, PK-PD target attainment analyses, and more.
• ADAPT
• Crystal Ball®
• S-ADAPT
• SYSTAT®/SAS®/R