1. US FDA Critical Path Initiative. www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ucm076689.htm.
2. US FDA. List of Qualified Biomarkers. www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/BiomarkerQualificationProgram/ucm535383.htm.
3. Piccoli SP, Sauer JM. Critical Path Institute “Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices”. https://healthpolicy.duke.edu/sites/default/files/atoms/files/cpath_ptc_biomarker_qualification_assays_20170623.pdf.
4. The Duke-Margolis Center for Health Policy. Public Workshop. Scientific and regulatory considerations for the analytical validation of assays used in the qualification of biomarkers in biological matrices. https://healthpolicy.duke.edu/events/public-workshop-scientific-and-regulatory-considerations-analytical-validation-assays-used.