How Do Regulatory Agencies Address Species Differences?
Regulatory agencies like the FDA and EMA require comprehensive toxicology testing to assess the safety of new drugs. They consider species differences by demanding studies in multiple animal species. Agencies evaluate the relevance of animal data to human risk and often require clinical trials to confirm findings. They also encourage the use of advanced models and 3Rs principles (Replacement, Reduction, and Refinement) to minimize animal use.
