01645nas a2200265   4500000000100000008004100001260003100042653002200073653001100095653001000106653001800116653001700134653005000151653003400201653003100235653001500266100002300281700002300304700002300327245011500350856007500465300001200540520080500552020002201357       2027                            d  c2027-01-01bAcademic Press10a(Complement-ARIE)10a(NAMs)10a(NIH)10aanimal models10aBenchmarking10aComplement Animal Research in Experimentation10aNational institutes of health10anew approach methodologies10aValidation1 aKristifor Sunderic1 aCatharine E. Krebs1 aGail A. Van Norman00aChapter 17 - Building confidence in new approach methodologies through reporting, validation, and benchmarking  uhttps://www.sciencedirect.com/science/article/pii/B9780443265143000011  a277-2883 aThis chapter explores building trust and confidence in new approach methodologies (NAMs) through standardization, validation, benchmarking, and transparent reporting. It discusses the limitations of animal models in terms of predictivity and reproducibility, and the drive to develop human-relevant NAMs for safety and efficacy testing. It then outlines validation frameworks and benchmarking methods to compare NAM performance against traditional models. The different regulatory approaches in the United States and European Union are compared, illustrating how legislation, policy, and collaboration influence NAM adoption. Lastly, it discusses key initiatives such as the NIH Complement-ARIE program and public–private partnerships, and their roles in accelerating regulatory acceptance of NAMs.  a978-0-443-26514-3