"Virtual trials" could improve drug development

New techniques for creating virtual early-stage clinical trials using advanced modelling techniques will improve the process of drug development, according to Amin Rostami, from the University of Sheffield and director of R&D at Simcyp, a firm focussed on the mechanistic in vitro-in vivo extrapolation (IVIVE) of pharmacokinetics (see also Marketletter November 26, 2007).

Speaking at the British Pharmacological Society conference in Brighton, on December 18, Dr Rostami described the importance of new pharmacokinetic modelling techniques and how these can help drug development researchers to select the best candidates for human investigations, avoiding inconclusive outcomes caused by poor study design.

Dr Rostami commented on several recent clinical studies which had failed to properly assess the impact of genetic differences in the expression of the metabolic enzyme CYP2C9 on patients' responses to warfarin - the most widely-prescribed anticoagulant in North America and most European countries. Referring to the recent findings of his research team, he said: "if modelling and simulation using the Simcyp platform had been employed before these studies began, the researchers could have optimally designed their investigations, avoiding costly inconclusive outcomes using human volunteers."