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Everything is a Biomarker: Insights on Integrated Bioanalysis
Everything Is a Biomarker A biomarker is a definition, not a category of assay. PK and immunogenicity both meet that definition, and that has real consequences for how we develop assays and interpret the data. In most labs, “biomarker” is treated as a category of work. It is a service line, a box on the…
Biomarker Assay Validation
Biomarker Assay Validation: Scientific Considerations As defined by the BeST glossary, a biomarker is a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions. Bioanalytical method validation of biomarker assays ensures that the method reliably measures the biomarker of interest…