Core Insights - Certara, Inc. has launched a new version of the Simcyp™ Simulator, enhancing its capabilities for physiologically-based pharmacokinetic (PBPK) modeling to support data-driven decision-making in drug development [1][2] Company Developments - The Simcyp Simulator Version 24 has been developed with input from a consortium of over 30 leading pharmaceutical companies, reflecting the evolving needs of pharmaceutical collaborators and regulators [2] - The simulator has been instrumental in the approval of over 120 novel drugs by the FDA and has facilitated clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] Technological Advancements - The latest version includes features for predicting food effects on drug absorption, expanded libraries for drug-drug interactions, and improved modeling for special populations such as pediatrics, pregnancy, and lactation [4] - Enhancements in performance and usability include a modernized user interface, cloud computing capabilities, and AI-enabled help chat [4] Market Impact - Currently, 80% of drugs utilizing PBPK for FDA approval in recent years have employed the Simcyp Simulator, indicating its significant role in the industry [2]

Core Insights - Certara, Inc. has released a new version of the Simcyp™ Simulator, enhancing its position as a leader in physiologically-based pharmacokinetic (PBPK) modeling for drug development [1][2] - The latest version, Simcyp Version 24, addresses the evolving needs of pharmaceutical collaborators and regulators, supporting the growing adoption of PBPK in drug development and regulatory decision-making [2] Company Developments - The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs and has supported clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] - A consortium of over 30 leading pharmaceutical companies guides the development of the Simcyp Simulator, ensuring that the latest version incorporates their feedback to enhance capabilities and databases [2] Features of Simcyp Version 24 - The new version includes features for predicting food effects, improving drug absorption simulations under various meal conditions [4] - An expanded library for drug-drug interactions now covers a broader range of capabilities, providing qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney [4] - Enhanced modeling for special populations, including pediatric, pregnancy, and lactation groups, has been incorporated [4] - The user interface has been modernized, and new functionalities such as cloud computing and AI-enabled help chat have been added to improve performance and usability [4]