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Biomarker Characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or pharmacologic responses to a therapeutic intervention Bioanalytical validation Procedure that demonstrates that a method will successfully meet or exceed the minimum standards recommended in the US FDA guidance for accuracy, precision, selectivity, sensitivity, reproducibility and stability Stable isotope analog Compound of identical structure in which ideally three or more atoms have been replaced with 13 C, 15 N or a combination of both DNA adduct Covalent attachment of a reactive intermediate to a DNA base SID methodology Normally involves the use of a stable isotope-labeled internal standard, which is spiked into a sample at a known concentration