From application‐first to science‐first: A two‐phase validation framework for complex in vitro NAMs
Abstract
Validation of new approach methodologies increasingly requires developers to define a context of use (CoU) before establishing scientific credibility, constraining complex in vitro models. This CoU first strategy can impose a structural limitation on validation. We propose a two-phase framework that separates scientific validation from context-specific qualification, bridged by a shared data repository. Under this structure, the model's scientific capabilities and limitations inform the range of potential applications, rather than being constricted to the first CoU selected.
Fields of Study & Subjects
3D Printing in Biomedical Research
Cell Image Analysis Techniques
HER2/EGFR in Cancer Research
Publication details
- Journal / source
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Volume
- 120
- Issue
- 5
- Pages
- 1173-1177
- Publication date
- 3 August 2026
- Language
- EN