Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, announced the launch of version 18 of its Simcyp® Population-based Simulator.
“I am delighted to introduce Simcyp Simulator v18, which includes several major modeling and simulation advances to help improve the safety and efficacy of new drugs—both small molecules and biologics—under development,” said Certara’s Simcyp President and Managing Director Steve Toon, PhD.
“When we began developing the Simcyp Simulator 20 years ago, we could not have foreseen the major impact the Simulator would have upon the entire drug development process and how it would serve as the catalyst for 35 leading global pharmaceutical companies coming together in a pre-competitive environment to move the mechanistic modeling and simulation field forward through the sharing of open-science. I am very proud of the Simcyp Consortium and that movement, which has helped spur the widespread adoption of model-informed drug development by pharma, academic institutions and global regulators.
The Simcyp Simulator has now been used to inform drug label claims, removing the need for specific clinical investigation, for more than 50 new drugs approved by US FDA. As our technology advances, so will its impact upon regulatory decision making,” added Dr. Toon.
Certara’s Simcyp Simulator is the most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating and advancing new drug formulations, predicting drug-drug interactions (DDIs) and PK outcomes in numerous virtual clinical populations. These include vulnerable populations, such as pediatric patients, pregnant women, and patients with impaired organ function.
Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com