Company launches version 18 of the popular software behind more than 90% FDA-approved drugs
In modern drug development, modelling and simulation are a key part of the process. Certara’s Simcyp platform is used to simulate drug effects and is used on more than 90% of FDA drug approvals.
2018 was a record-breaking year for drug approvals with 59 new drugs, almost all had been simulated in some form. The new update features several major modelling and simulation advances to help improve the safety and efficacy of these new drugs.
Commenting on the launch, Steve Toon, Certara’s Simcyp President and Managing Director, said: “I am delighted to introduce Simcyp Simulator v18, which includes several major modelling and simulation advances to help improve the safety and efficacy of new drugs – both small molecules and biologics – under development.”
V18 advances include:
- New Tumor Models
- The new update helps to quantify how much drug is getting to the target site within the tumor.
- Enhanced ADAM Model to Predict Back-conversion of Metabolites in the Gut Lumen
- This model, which simulates drug disposition in the gut, has been enhanced to simulate back-conversion of metabolites in the gut lumen. Updates also permit simultaneous modelling of the inter-conversion of the parent compound to metabolite, entero-hepatic re-circulation, and efflux to the gut lumen, as well as metabolism- and/or transporter-mediated DDIs in the gut.
- Expansion of Trial Design to Allow Food and Fluid Staggering
- The Simcyp Simulator now offers a “food-staggering” simulation capability to help investigate and determine the optimal time for patients to consume food and fluids with their medication.
- Mechanistic Absorption Models
- The new model enables simulating two different solid states of a drug to be handled simultaneously.
- New Reverse Translation Tool (RTT)
- The retrograde model allows researchers to take an in vivo value, such as an observed clearance, and work backwards to determine the original in-vitro values.
- Expanded Compound Library
- Certara has continued to expand its compound database to provide background on compound parameters and demonstrate the Simcyp Simulator’s ability to mimic clinical studies.
Certara has reported that this was the fourth consecutive year that it was part of more than 90% of FDA novel new drug approvals. Headquartered in Princeton, the company partners with 17,000 bodies in 60 countries.
The updates will further expand the range and type of drug effects simulatable, improving the product. As a result of its popularity in FDA new drug approvals, improvements to the simulator will have an impact on many other companies.