Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019

Developed by the Biomarker Assay Collaborative Evidentiary Considerations Writing Group, Critical Path Institute (C-Path)

This Points to Consider document was originally designed to establish consensus on the expectations for the validation of assays used in the regulatory qualification of fluid biomarkers. The scope of this document was to define the scientific and regulatory considerations for the analytical validation of assays for fluid-based (any protein, peptide, lipid or other chemical entity soluble in plasma, urine, saliva, etc.) biomarkers used in the regulatory qualification of drug development tools (DDT’s).

However, the scope quickly expanded, and the document is now a comprehensive user guide to the analysis of biomarkers in drug development. At its core, this document contains a complete description of necessary approaches that can be applied to nearly every analytical situation that will be encountered in fluid-based biomarker qualification.

Download the full consensus document that outlines best practice approaches that can be applied to the development, characterization, and validation of assays to support fluid biomarker qualification.

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