Certara Releases Enhanced Simcyp™ Simulator for Drug Development
In a significant move to enhance model-informed drug development, Certara, Inc. has unveiled a new version of its highly regarded Simcyp™ Simulator, now optimized for physiologically-based pharmacokinetic (PBPK) modeling. This update is designed to better aid pharmaceutical developers in understanding how drugs behave within the body, accommodating emerging needs from both industry partners and regulatory bodies.
Advancements in the Latest Version of Simcyp
The Simcyp Simulator Version 24 incorporates feedback from a consortium made up of over 30 leading pharmaceutical companies, ensuring that the latest updates reflect real-world requirements and challenges. Dr. Masoud Jamei, Senior Vice President of Simcyp R&D at Certara, emphasized the continuous enhancements and innovative technology that have led to the simulator's significant impact in the drug development space. Notably, around 80% of drugs leveraging PBPK modeling for regulatory approval in recent years have utilized this advanced tool.
New Features of Simcyp Version 24
The updated simulator introduces a range of new capabilities:
Biopharmaceutical Modeling Enhancements
One groundbreaking feature includes an upgraded Virtual Bioequivalence (VBE) module that allows for the prediction of food effects on drug absorption, enabling more accurate simulations under various dietary conditions. This improvement aims to refine the predictive power of the simulator in real-world scenarios.
Expanded Drug-Drug Interaction (DDI) Library
Certara has also expanded its library of drug-drug interactions, introducing new and upgraded compound files for enzymes and transporters. This expansion broadens the simulator's DDI capabilities, providing vital evidence for interactions in critical bodily systems such as the gut, liver, and kidney.
Increased Precision in Biologics Models
With a focus on membrane-bound targets in biologics, the latest version enhances the characterization of drug behavior and interaction with targets throughout various tissues. It includes refined models that track soluble target movement and drug-target complex dynamics, thereby providing finer insights into drug disposition.
Clinical Trial Design Support
Simcyp Version 24 enhances trial design features, significantly improving the speed and usability of clinical trial simulations. This is crucial for researchers and developers striving for efficient drug approval processes.
Support for Special Populations
Recognizing the necessity for inclusive trial modeling, the updated simulator also offers enhanced capabilities for special populations, including pediatric, pregnant, and lactating individuals. This ensures that all segments of the population are appropriately considered during drug development stages.
Usability Enhancements
Modernized user interfaces and integration of cloud computing facilitate a better user experience. Users can now access AI-enabled help through the 'Ask Simcyp' feature, making it easier to navigate complex modeling processes. Furthermore, improvements have been made in predicting parameters based on chemical structures.
The Impact of Simcyp Simulator in Drug Approvals
The Simcyp Simulator boasts a remarkable track record, having contributed to the development of over 120 FDA-approved novel drugs. Its influence extends to supporting clinical trial waivers in various contexts, including DDI assessments and trials involving pediatric patients. As the pharmaceutical industry continues to embrace PBPK modeling, Simcyp stands at the forefront, facilitating innovation in drug discovery and development.
Get Involved with Simcyp
For those interested in diving deeper into these advancements, Certara invites professionals to participate in a webinar focusing on the release of Simcyp Version 24, where insights and practical applications will be further discussed.
About Certara
Certara is dedicated to accelerating drug development through its innovative biosimulation software and services. With approximately 2,400 clients globally, including biopharmaceutical companies, academic institutions, and regulatory agencies, Certara is transforming traditional practices in drug discovery. Their commitment to advancing science through technology is evident in their comprehensive approach to enhancing drug development pipelines.
Contact Information for Certara
Certara Contact:
Sheila Rocchio
Email: sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
Email: certara@pancomm.com
Frequently Asked Questions
What is the Simcyp Simulator?
The Simcyp Simulator is a biopharmaceutical modeling platform that predicts drug behavior in the body, facilitating more effective drug development and regulatory decision-making.
What are the new features of Simcyp Version 24?
New features include enhanced biopharmaceutical modeling, expanded DDI libraries, increased precision in biologics models, and improved clinical trial design support.
How does Simcyp support drug approval processes?
Simcyp has been instrumental in the approval of numerous novel drugs and provides evidence for clinical trial waivers, streamlining the regulatory approval process.
Who can benefit from using the Simcyp Simulator?
Pharmaceutical companies, research institutions, and regulatory agencies can all benefit from the advanced modeling capabilities and insights provided by the Simcyp Simulator.
How can I learn more about the latest Simcyp advancements?
Interested individuals can register for webinars and events hosted by Certara to gain insights into the latest developments in Simcyp technology.
