**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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