01734nas a2200253 4500000000100000008004100001260003100042653004200073653002000115653001900135653001900154653002200173653000900195653002100204653002200225100002300247700002300270700002300293245011300316856007500429300001000504520094400514020002201458 2027 d c2027-01-01bAcademic Press10aAlternative methods to animal testing10aanimal research10aAnimal science10aanimal testing10aClinical research10aDrug10aNonanimal models10aResearch activity1 aNirva Kapasi Patel1 aCatharine E. Krebs1 aGail A. Van Norman00aChapter 2 - Legislative history of animal-based research and implications for the shift to nonanimal methods uhttps://www.sciencedirect.com/science/article/pii/B9780443265143000151 a19-373 aAnimal research in the United States has witnessed an increasing emphasis on nonanimal models. The existing legislations have been critiqued for insufficient species coverage, lack of rigorous enforcement, and inadequate transparency. Ethical concerns, coupled with scientific progress, have accelerated the development of alternative research methods. Internationally, legislative frameworks are evolving to support nonanimal testing, with milestones such as the European Union’s Directive 2010/63/EU, which prioritizes alternative methods. Countries like Japan and India have also enacted guidelines and bans to limit animal testing. These initiatives reflect the principles of the 3Rs—replacement, reduction, and refinement—and promote innovative technologies like in vitro testing and organ-on-chip systems. Despite advancements, significant challenges remain in achieving widespread adoption of nonanimal research methodologies. a978-0-443-26514-3