ABSTRACT

THE PROMISE OF PHARMACOGENOMICS Pharmacogenomics (Pgx) may be defined as the application of genomic or genetic biomarkers to predict patient-specific responses to a therapeutic intervention (1). No longer solely concerned with individual differences in drug metabolism and pharmacokinetics (PK), Pgx inquiry now addresses the use of biomarkers associated with variability in drug targets and pharmacodynamic (PD) responses. In addition, protein biomarkers and diagnostics have been developed to identify patient subsets for specialized treatment. The introduction of Pgx-based tools to assist in clinical decision-making has been publicly anticipated by multiple stakeholders: clinicians, patients, insurers, and regulatory agencies. Thus, Pgx strategies are increasingly integrated into drug development paradigms.