Promise of Quantitative Proteomics in the Qualification of New Approach Methodologies.

Abstract

The shift from animal models to new approach methodologies (NAMs) in drug development requires experimental models that accurately reflect human biology. Characterizing protein abundance and composition in NAMs like microphysiological systems (MPS), enabling comparison with human tissues, allows identification of physiological differences, development of scaling factors for in silico models, monitoring of biomarkers, cellular heterogeneity, and interindividual variability. Thus, characterization of NAMs by quantitative proteomics is important for enhancing their translational and regulatory relevance.