FDA DEFINITION
New Approach Methodologies (NAMs) is the regulatory term encompassing any technology, methodology, approach, or combination thereof that can provide information on drug safety and/or effectiveness that historically has been derived from animal testing. NAMs include organoids, organ-on-chip, in silico modeling, AI/ML, and computational approaches.
NAMs CATEGORIES
IN VITRO
Cell-Based Systems
Organoids, organ-chips, MPS, 3D cultures, spheroids—human cell-based models.
IN SILICO
Computational
PBPK modeling, QSAR, digital twins, AI/ML prediction models.
HYBRID
Integrated Approaches
Combinations of in vitro and in silico methods for comprehensive assessment.
BIOMARKERS
Translational
Human-relevant biomarkers that bridge preclinical to clinical prediction.