Modelling and simulation in clinical drug development.

Pharmaceutical companies are under greater pressure than ever before to improve the R&D process (1). There is a growing need to increase productivity in R&D, and to use technologies that can both increase and more efficiently facilitate the flow of products through the development pipeline. This article describes how the twin processes of modelling and simulation are being used to improve the efficiency of the clinical drug-development process, and consequently how these methodologies have delivered significant benefits in the drive to save time, money (and additionally assisted in ensuring an 'optimal quality' drug label) in the development of novel therapeutic agents.