The FDA’s plan to phase out animal testing is a transformative step that paves the way for innovative, human-relevant preclinical approaches that are more predictive, efficient, and ethical. There is a long history at the FDA of using validated new approach methodologies (NAMs), including in silico tools and computational modeling as a framework for regulatory decision-making to support this transition effectively.
As a global leader in Model-Informed Drug Development (MIDD) strategies, Certara is ready to support the industry with a comprehensive offering of advanced modeling tools and development expertise that directly align with the FDA’s vision for the future of drug development.
Watch this webinar to learn how:
- Use of NAMs can be integrated into your development programs. Learn the opportunities and considerations for the reduction in animal testing in pre-clinical safety studies made possible by the FDA’s roadmap.
- PBPK and QSP models simulate monoclonal antibody behavior across diverse populations and disease states without relying on preclinical animal models.
- Pharmacometric and PK/PD analyses inform dose selection, optimize trial design, and reduce uncertainty in first-in-human studies thru late-stage development.
- Real-world evidence strategies complement modeling and simulation by providing context-rich insights into patient safety and efficacy, disease progression, and treatment outcomes.
