The San Diego PPRU faculty are recognized internationally for leadership in pharmacokinetic and pharmacodynamic modeling. The group has extensive experience in sparse data collection techniques and population analysis methodologies that enable the characterization of variability and identification of appropriate dosing in pediatric subpopulations. The PPRU has expertise using a wide variety of software for statistical (SAS and S-Plus), pharmacokinetic (WinNonlin, InnaPhase, Adapt II) and population pharmacokinetic (NONMEM, NPEM, and P-Pharm) analysis. The faculty and staff at the PPRU continue to develop, validate, use and sponsor new technology in the area of laboratory assays for drugs, pharmacokinetic and pharmacodynamic modeling and simulation, in particular for answering pediatric therapeutic and developmental questions.
Use of Monte Carlo Simulation in Drug Development
The San Diego PPRU has applied Monte Carlo (MC) simulation to population pharmacokinetic, pharmacodynamic and disease-state models to project distributions of outcomes of proposed studies. This unit was the first to utilize Computer-Assisted Trial Designer (CATD) by Pharsight. The benefits of MC simulation include:
- Integrates existing knowledge into study design
- Fosters communication among study team and can enhance translational research efforts
- Prevents moving forward with studies that are likely to fail
- Promotes rational development of dosing recommendations.
Data Processing and Clinical Management
The San Diego PPRU contains a fully functional data analysis and clinical management system with experience in designing and validating databases. The data center can collect, validate, and maintain clinical trials data and export it electronically, if desired.