In the ever-evolving pharmaceutical landscape, advancing drug development requires innovative tools that seamlessly integrate science and regulatory standards. The release of Simcyp™ PBPK Simulator Version 23 provides an even more comprehensive platform for all stages of drug development.
Physiologically Based Pharmacokinetic (PBPK) modeling is a cornerstone in drug development, providing predictive insights into drug behavior within the human body. With Version 23 of the Simcyp Simulator, pharmaceutical researchers gain access to a robust platform for predicting dosing strategies and evaluating complex drug-drug interactions (DDIs) with precision.
A standout feature of this release is its alignment with regulatory best practices, notably FDA guidelines. Guided by inputs from leading pharmaceutical companies, this version meets industry demands while upholding regulatory standards.
Version 23 introduces enhancements in four key areas:
- Regulatory Best Practices: Aligned with FDA guidelines, ensuring compliance and bolstering confidence in predictive capabilities for smoother regulatory approvals.
- Innovative DDI Prediction: Incorporating advanced biomarker assessments for enhanced accuracy in predicting and mitigating DDI risks, thus improving patient safety and efficacy. This approach can inform trial design and sometimes support clinical trial waivers.
- Increased Biologics Support: Extending support to predict outcomes in emerging modalities like biologics and oligonucleotides, enabling confident assessment of novel therapies’ pharmacokinetics. These insights are key to optimizing drug safety and efficacy and optimizing the drug label.
- Expanded Biopharmaceutics Capabilities: Now simulating oral, dermal, and inhaled formulations, demonstrating virtual bioequivalence and providing insights into formulation optimization and effectiveness.
The Simcyp™ PBPK Simulator underscores our commitment to advancing drug development through state-of-the-art predictive modeling technology. By integrating the latest scientific advancements with regulatory standards we’ve empowered pharmaceutical researchers to make informed decisions, accelerate drug development timelines, and ultimately bring safer and more effective therapies to patients worldwide.
製品・サービスの詳細は、The release webinar and the Simcyp Simulator webpage offer invaluable insights into the capabilities and applications of Version 23. As the pharmaceutical landscape continues to evolve, tools like the Simcyp Simulator will continue to play a pivotal role in driving innovation and transforming the future of healthcare. Begin your journey today.
