Report in the British Journal of Clinical Pharmacology shows how modelling and simulation can predict clinically significant drug-drug interactions before undertaking human studies
Scientists at Pfizer Global Research and Development (Sandwich, Kent) have used the Simcyp Simulator to predict the extent of drug-drug interactions for maraviroc, which is used in combination with other medications in the treatment of HIV.
The research group used the Simcyp Simulator, together with in vitro data, to predict in vivo outcomes.
The results of this 'virtual' study were then compared with observed clinical data.
The simulations were found to be in good agreement with the clinical results, which led to the conclusion that validated models of drug-drug interactions within Simcyp allow for the prediction of other metabolic drug-drug interactions without the need for a clinical study.
The report stated: "Simcyp has successfully simulated the extent of clinical interactions with CYP3A4 inhibitors, further validating this software as a good predictor of CYP-based drug-drug interactions".
Professor Amin Rostami-Hodjegan, director of research and development at Simcyp, commented: "We are very pleased that Pfizer, the world's largest pharmaceutical company, is taking full advantage of its routine in vitro data by successfully using the Simcyp Simulator to accurately predict drug-drug interactions.
"Clearly, the combination of high quality modelling and simulation plus high quality in vitro data is a powerful tool for streamlining drug development.
"Simcyp simulations, which draw from unique databases of biological information, are increasingly being used to improve the design of human studies, identify the characteristics of individuals most at risk from adverse drug reaction, and even avoid unnecessary and costly clinical studies."
