FDA’s Roadmap to Replace Animal Testing
How Certara’s Non-Animal Navigator™ is Shaping the Future of Drug Development
The FDA Modernization Act 2.0 and the FDA Roadmap to Reducing Animal Testing mark a turning point in preclinical drug development. For the first time, animal studies are no longer required before clinical trials.
By adopting advanced, human-relevant alternatives, drug developers can improve translational accuracy while meeting these regulatory and ethical standards.
Why the traditional animal testing paradigm for investigational drugs must change
Over 90% of drugs that pass animal studies fail in human trials.
Traditional animal models often fall short in predicting human safety and efficacy. Human-relevant methods like biosimulation, microphysiological systems, and advanced in vitro assays (New Approach Methodologies; NAMs) can provide more reliable insights into drug safety and efficacy.
Phasing out your animal studies to comply with these regulations
Certara’s Non-Animal Navigator is a platform supporting transition to non-animal testing models. Our framework combines biosimulation tools and our experts’ services to build scientifically robust, regulator-ready evidence packages.
Download the Guide
A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs explains what this shift means for pharmaceutical development and how to prepare your organization.
By reading this it, you’ll learn:
- The global regulatory landscape for non-animal studies
- Practical steps to build confidence with regulators
- How Certara provides guidance tools for integrating NAMs into pre-clinical pipelines
Download the free guide today.
