Implementing Population Pharmacokinetic Modeling Algorithm in Physiologically-based Pharmacokinetic Models to Allow Parameter Estimation at Individual Data Level (U01)

The purpose of this project is to develop and implement a robust optimization algorithm that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models so that knowledge of parameter distributions in the population(s) of interest can be derived. The models developed will be used to generate predictions that can inform bioequivalence assessments and regulatory decisions relating to generic drug development.