Publication: STAT
The article, written by Prof. Amin Rostami-Hodjegan, explores the transition from animal testing to alternative methods in drug development. It highlights the limitations of traditional animal models, such as their inability to reliably predict human outcomes, and the ethical and logistical challenges they pose. Rostami-Hodjegan also discusses the FDA’s roadmap to reduce animal testing and emphasizes the potential of in vitro assays, modeling, and organ-on-chip technologies. However, he also warns that fully replacing animal testing takes time and requires collaboration among sponsors, regulators, and technology pioneers.
Author: Amin Rostami-Hodjegan
Year: July 15, 2025
Are you prepared for the FDA’s phase out of animal tests?
The FDA’s plan to phase out animal testing paves the way for innovative, human-relevant preclinical approaches that are more predictive, efficient, and ethical. The FDA has long used validated new approach methodologies (NAMs), including in silico tools and computational modeling 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 advanced modeling tools and development expertise that align with the agency’s vision for the future of drug development.
