The Simcyp Simulator allows preclinical data to be used to maximum advantage in drug development; informing the design of human studies and allowing ‘what if’ questions to be explored in the safety of a computer.
Executive Director of Simcyp, Dr Steve Toon said: “It is estimated that in the near future up to 15% of drug development budgets will be spent on modelling and simulation, and the benefits to the industry are rapidly becoming apparent. For example, complex multiple drug-drug interactions involving various enzyme inhibition or induction mechanisms can now be simulated using the Simcyp platform as a prelude to undertaking a clinical study. This not only helps optimise the study design but minimises the risk to the clinical study subjects.”
Simcyp simulations incorporate known population variability; this produces relevant ‘real world’ predictions which are more informative than simulations performed in a single ‘average’ reference man. In addition to modelling the fate of drugs in Caucasian and Japanese populations, the Simcyp Simulator can also predict drug-fate in patients with liver cirrhosis, renal impairment or obesity. On top of this, a ‘healthy volunteer’ library within the platform allows drug companies to carry out virtual Phase I studies, which can help improve the design of real studies in humans.
Commenting on the new release, Professor Amin Rostami-Hodjegan, Director of Research and Development at Simcyp said: “The recent enhancements to the Simcyp Simulator will prove particularly useful to scientists working in pharmaceutics, as the Simcyp absorption model can now accommodate a variety of different drug formulations. Many factors which affect the subsequent bioavailability of a drug, including food intake, variability in pH and concentration-dependent effects of efflux transporters in the gut, can now also be simulated using Simcyp.”