DAE

Abstract

In all stages of contemporary drug development, the use of mixed effects ("population") models has become crucial to the understanding of pharmacokinetic (PK) and pharmacodynamic (PD) data. Population PK/PD models allow for the use of sparse sampling (i.e., fewer samples per subject), and they can be used to explain different sources of variability, ultimately leading to the possibility of dose optimisation for special populations or even individuals.

The design of trials involving population PK/PD models is often assessed via simulation, although the use of optimal design is gaining prominence. In recent years there have been a number of methodological advances in this area, but this talk will focus on more practical considerations of optimal design in the setting of a pharmaceutical company, from time and cost constraints to awareness and acceptance of optimal design methods. Several examples will be presented for illustration.