ABSTRACT
The regulatory use of genomic biomarkers of toxicity is an important goal for the pharmaceutical industry as well as for the US Food and Drug Administration (FDA) and corresponding regulatory agencies. This chapter focuses on genomic biomarkers as an example of the current approaches and issues relevant to biomarker validation in general. Genomic biomarkers are subject to the same definitions and requirements for qualification as are biomarkers defined by any other metrics or technological platforms. Validation of genomic biomarkers of toxicity generate exploratory data that accelerate development of genomic science at the FDA and in the pharmaceutical industry, but the main regulatory thrust of the Pharmacogenomics Guidance is in the application of valid genomic biomarkers. The development of a process for validation of genomic biomarkers of toxicity requires a partnership between the FDA and the pharmaceutical industry.
