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Biomarker Validation Strategy

Meaning

Biomarker Validation Strategy is a rigorous, multi-stage clinical and analytical process used to confirm that a specific biological marker reliably and accurately measures a defined physiological state, disease progression, or therapeutic response. This strategy ensures the biomarker possesses the necessary sensitivity, specificity, and predictive value for clinical utility in hormonal health assessments. The successful validation of a biomarker is essential for its trustworthy application in personalized diagnostics and treatment monitoring.