Comment from Biomarker Solutions LLC
AnonymousSupportIndividual
Summary: The commenter suggests updating the BEST (Biomarkers, EndpointS, and other Tools) Resource to include a specific definition for "NAM-based biomarker." They provide draft verbiage to ensure terminology consistency with the proposed guidance.
It would be beneficial to update the BEST (Biomarkers, EndpointS, and other Tools) Resource to include "NAM-based biomarker" in its glossary. Below, I have proposed draft verbiage for consideration, aligned with terminology used in the referenced draft guidance document.
NAM-based biomarker – A New Approach Methodology (NAM)-based biomarker is a type of biomarker whose value, when considered in a specified way, provide an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions. NAMs include a broad range of methods such as complex in vitro, 2D in vitro, in chemico and in silico studies. see also chapter on fit-for-purpose