Certara Expands Simcyp® Simulator to Streamline Regulatory Submissions and Internal Efficiencies

The Simcyp Simulator has been developed for over 25 years in collaboration with a consortium of more than 30 leading pharmaceutical companies worldwide. Version 25 reflects client demand to support faster, more confident decision-making and regulatory submissions, including expanded compound and population libraries. Some of the highlights in features and capabilities in Version 25 of the Simcyp Simulator are described below.

• Transporter-Mediated DDI Expansion: An analysis of applications of PBPK models of novel drug approved by the FDA showed that assessing transporter-mediated DDIs was the second most popular application of this technology. Building on Simcyp’s existing EMA qualification for enzyme-mediated DDIs, additional compounds, case studies, model development and documentation continue to expand support for transporter-mediated DDI modeling and future qualification to enable better prediction and risk assessment.
• Enhanced Biopharmaceutics Capabilities: Bioequivalence is a critical concept in the development of generic drugs. The traditional methods of assessing bioequivalence often involve extensive clinical trials, which can be time-consuming and costly. Furthering support for enabling formulations (e.g. Amorphous Solid Dispersion and lipid-based formulations) and expanding the virtual bioequivalence module will help accelerate this workflow.
• Improved Usability and Efficiency: Streamlining PBPK model development and analysis through refined user interfaces, intuitive parameter sensitivity analysis to highlight which inputs matter most, integrated fitting and diagnostic tools, within tissues drug binding, and AI-enabled chat support will help modelers use the software quicker and more efficiently.

The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs. It has also supported clinical trial waivers in many areas, including DDI and pediatric trials. Learn more about Simcyp Simulator Version 25 and its latest advancements in regulatory-accepted PBPK modeling in our recent webinar.