Gaining regulatory approval for drugs targeting conditions that cannot ethically be studied in humans presents a unique challenge for drug developers. Without traditional clinical trial pathways, teams must rely on alternative methods to demonstrate efficacy and support approval.
This webinar will explore how modeling and simulation are used to meet the requirements of the FDA Animal Rule, a regulatory mechanism that enables drug approval based on animal efficacy data. The featured speakers will provide practical insights into navigating this pathway using real-world examples.
The Animal Rule permits approval when human trials are unethical or infeasible. In these cases, preclinical data are quantified using mathematical models, and simulations inform clinical dose selection, trial design, and the bridging of efficacy between animal models and human exposure data. These tools also guide broader program development and regulatory decision-making.
Attendees will learn
- When the Animal Rule is appropriate to use for drug approval
- How modeling and simulation is used to navigate the Animal Rule
- How to apply the concepts in a real-world example
For more information on the requirements of the FDA’s Animal Rule and how modeling & simulation can help successfully navigate the complex requirements, explore our infographic, Advancing Drug Development Under the Animal Rule with Modeling and Simulation
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