Pharmacokinetic/Pharmacodynamic Modeling in Support of Drug Development

Alan Hartford
Merck Research Laboratories, Inc.

Systems of differential equations with random parameters are used to model pharmacokinetic behavior of a drug and to model how the pharmacokinetics are intertwined with the pharmacodynamics. The solutions to the system of differential equations are generally nonlinear in the PK/PD parameters. So when intra- and inter-subject variability are included in models, sophisticated maximum likelihood algorithms are required. This talk will explain how PK/PD models are set-up and how they are fitted in practice using maximum likelihood approaches. Examples from literature will be given to show the complexity of both the models and of the methods used to fit them.

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