Use of Monte Carlo Simulation in Drug Development 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. 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 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 San Diego PPRU faculty are recognized internationally for leadership in pharmacokinetic and pharmacodynamic modeling.
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