Biomarkers
FDA Bioanalytical Method Validation for Industry. Assays were rigidly validated based on sensitivity, specificity, robustness, accuracy, precision, linearity, working range and analyte stability. Furthermore, these parameters were defined in the context of the biological matrix and potential interference effects from urinary components were assessed. The development of additional toxicity bio- markers for other major target organs has also been described (reviewed by Marrer and Dieterle8). Hepatotoxicity is a major clinical challenge and a common cause of adverse events in drug develop- ment. While serum levels of alanine aminotrans- ferase (ALT) and aspartate aminotransferase (AST) continue to be accepted measures of liver injury, combination with other leakage biomarkers may improve sensitivity and specificity for this applica- tion. For example, glutathione-S-transferase is an early inducible detoxification enzyme in liver, and serum levels of this enzyme are a useful marker of organ histopathology. However, significant varia- tion in baseline liver expression levels of this
enzyme may limit establishment of a universal threshold for clinical application. Cardiac troponin I and T are established leakage markers for damage to the heart muscle, however NT-proBNP, the N- terminal cleavage product generated as a result B- type natriuretic peptide processing, may offer advantages such as improved stability and ease of measurement as a biomarker for ischaemic heart disease and ventricular dysfunction.
Measurement of protein biomarkers Genome-wide analytical technologies continue to be applied to identify potential biomarkers of rele- vance to pathobiology and therapeutic interven- tion. Over the past decade, gene expression microarray technology has been well established and offers the ability to measure the transcriptome under a variety of biological conditions at either the single gene level or collectively in multiple genes9. Proteome analysis offers the additional advantage to evaluate changes at the protein level that may be overlooked by transcriptomics. High-throughput
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