Pharmacogenomic approaches in clinical studies to identify biomarkers of safety and efficacy

Although toxicogenomics originated as a field of primarily preclinical investigation, a variety of genomic approaches can also be employed during or after clinical development to identify biomarkers linked to drug exposure and/or drug safety. Comparing and contrasting the different pharmacogenomic approaches according to their scale (targeted, focused or exploratory) illustrates the potential utility of each type of strategy in characterizing the genetic determinants that may play roles in various aspects of drug activity. Examples of targeted ADME genotyping, focused SNP panels, and exploratory whole genome association studies are briefly reviewed to provide an overview of the range of pharmacogenetic options available to the research community to support the ongoing efforts to identify biomarkers predictive of drug exposure and/or safety in human subjects.