B. Carlsson

State of the industry: integration of 3Rs principles and new approach methodologies in non-clinical product development through fit-for-purpose

Regulators, such as the FDA and EMA, are increasingly signaling expectations for broader and earlier adoption of New Approach Methodologies (NAMs) to reduce, refine, and, where justified, replace animal studies (3Rs principle)—particularly where NAMs can deliver improved human relevance, clearer mechanistic insight, or...