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Table 1 Categories for considerations when establishing context of use. Multiple factors need to be considered when establishing the biomarker assay context of use

From: Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report

Drug development phase	Discovery
	Pre-clinical
	Clinical development
	Post-marketing
Assay context	Analyte
	Technology
	Critical reagents
	Pre-analytical factors
Biomarker type	Pharmacodynamic
	Safety
	Enrollment
	Monitoring
	Susceptibility/risk
	Predictive
	Prognostic
	Diagnostic

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