Simcyp Limited, the leader in predictive pharmacokinetics, has released Version 8.0 of the ‘Simcyp Population-based ADME Simulator’, an advanced platform for the modelling and simulation of drug absorption, distribution, metabolism and elimination (ADME) in virtual populations.
The new features incorporated into Version 8.0 were determined in consultation with the Simcyp Consortium, which currently includes nine out of the top ten pharmaceutical companies worldwide.
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 optimize the study design but minimizes 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.”