@inbook{bibcite_9306,
  keywords = {(Complement-ARIE), (NAMs), (NIH), animal models, Benchmarking, Complement Animal Research in Experimentation, National institutes of health, new approach methodologies, Validation},
  author = {Kristifor Sunderic},
  editor = {Catharine E. Krebs and Gail A. Van Norman},
  title = {Chapter 17 - Building confidence in new approach methodologies through reporting, validation, and benchmarking},
  abstract = {This 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{\textendash}private partnerships, and their roles in accelerating regulatory acceptance of NAMs.},
  year = {2027},
  journal = {Moving Toward Nonanimal Approaches in Medical Research and Testing},
  pages = {277-288},
  month = {2027-01-01},
  publisher = {Academic Press},
  isbn = {978-0-443-26514-3},
  url = {https://www.sciencedirect.com/science/article/pii/B9780443265143000011},
}