Population Pharmacokinetics - An Overview

Abstract: Population pharmacokinetics is the study of the sources and correlates of variability in drug concentrations in patient population receiving standard dosage regimen of a drug of interest. Certain patient demographical, pathophysiological, and therapeutical features, such as body weight, excretory and metabolic functions, and the presence of other therapies, can regularly alter dose-concentration relationships. Population pharmacokinetics seeks to identify the measurable pathophysiologic factors that cause changes in the dose-concentration relationship and the extent of these changes so that dosage can be appropriately modified. This approach considers the population study sample which may be sparse, unbalanced, and fragmentary, in comparison to dense data obtained in traditional pharmacokinetic studies. A population PK analysis gives estimates of the population parameters, i.e. the values of the parameters that describe the typical individual in the population (the fixed effects) as well as their variability ( the random effects). Several software packages for population pk/pd analysis are available today among which NONMEM is the most widely used. Analysis according to nonlinear mixed effects model (NONMEM) provides estimates of population characteristics that define population distribution of the PK and/or PD parameters.

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