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Special consideration: commentary on the 2025 FDA Bioanalytical Method Validation for Biomarkers

Special consideration: commentary on the 2025 FDA Bioanalytical Method Validation for Biomarkers

Karen J Quadrini ¹, Jiri Aubrecht ¹, Nicholas M P King ², Carmen Fernandez-Metzler ³, Yan G Ni ⁴, John-Michael Sauer ⁵, Lauren Stevenson ⁶, Steven P Piccoli ^2,7

Karen J Quadrini ¹, Jiri Aubrecht ¹, Nicholas M P King ²

¹Clinical Biomarkers, Prothena Biosciences, Inc, Brisbane, CA, USA.
²Critical Path Institute, Tucson, AZ, USA.
³PharmaCadence Analytical Services, LLC, Hatfield, PA, USA.
⁴Biomarkers and Precision Medicine, Passage Bio, Inc, Philadelphia, PA, USA.
⁵Denali Therapeutics Institution, South San Francisco, CA, USA.
⁶Immunologix Laboratories, Tampa, FL, USA.
⁷Clinical Sciences, Sun Pharma Advanced Research Company Ltd, Princeton, NJ, USA.

⁰Clinical Biomarkers, Prothena Biosciences, Inc, Brisbane, CA, USA.

Bioanalysis +

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August 12, 2025

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Summary

No abstract available on PubMed

Keywords:

Biomarkers clinical method development regulatory validation

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Data Validation

Data Validation

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:

Specificity: The ability of the method to accurately measure the target analyte without...

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