TY - ECHAP
KW - (Complement-ARIE)
KW - (NAMs)
KW - (NIH)
KW - animal models
KW - Benchmarking
KW - Complement Animal Research in Experimentation
KW - National institutes of health
KW - new approach methodologies
KW - Validation
AU - Kristifor Sunderic
AU - Catharine E. Krebs
AU - Gail A. Van Norman
AB - 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–private partnerships, and their roles in accelerating regulatory acceptance of NAMs.
BT - Moving Toward Nonanimal Approaches in Medical Research and Testing
DA - 2027-01-01
N2 - 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–private partnerships, and their roles in accelerating regulatory acceptance of NAMs.
PB - Academic Press
PY - 2027
SN - 978-0-443-26514-3
SP - 277
EP - 288
T2 - Moving Toward Nonanimal Approaches in Medical Research and Testing
TI - Chapter 17 - Building confidence in new approach methodologies through reporting, validation, and benchmarking
UR - https://www.sciencedirect.com/science/article/pii/B9780443265143000011
Y2 - 2026-10-05
ER -