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

Karen J Quadrini1, Jiri Aubrecht1, Nicholas M P King2

  • 1Clinical Biomarkers, Prothena Biosciences, Inc, Brisbane, CA, USA.

Bioanalysis
|August 12, 2025
PubMed
Summary

No abstract available in PubMed .

Keywords:
Biomarkersclinicalmethod developmentregulatoryvalidation

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Data Validation01:15

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:
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