Software for population pharmacokinetics and pharmacodynamics

Abstract

Pharmacokinetic-pharmacodynamic modelling is being used increasingly as a tool in drug development because often in phase III clinical trials only sparse data are available for analysis and so a nonlinear mixed effects modelling approach has to be adopted. Specialist data analytical techniques and software are required to analyse such data. This article reviews some of the software currently available for performing nonlinear mixed effects modelling. A questionnaire was devised and sent to a number of software producers and the findings are presented and discussed in this paper. The programs could be grouped into 3 main categories: parametric and nonparametric maximum likelihood and Bayesian. It was apparent from the questionnaire that software development for population data analysis is a very active area of investigation. The implementation of methodologies varied widely between the packages: some were self-contained programs, whereas others were written within another application, usually a statistical package. They also varied with respect to their ease of use and level of support offered by the software producers. Although robustness and reliability are important concerns, they were not addressed in the present review. Most of the programs surveyed are in continual development.