chapter  10
22 Pages


WithLawrence J. Lesko, Janet Woodcock

Regulatory perspectives on pharmacogenomics (PGx) have been presented in the literature over the past several years to focus attention on an emerging technology that has the potential to make targeted treatments more widely available to physicians and patients (1,2). In this chapter, PGx will be used broadly to collectively describe all of the interindividual variations in the whole genome or candidate gene single-nucleotide polymorphism (SNP) maps, haplotype markers and alterations in gene expression or inactivation that may be correlated with clinical response. We intend that PGx encompass the more narrow science of pharmacogenetics (PGt), which refers to the study of interindividual variations in DNA sequence related to drug absorption and disposition (pharmacokinetics) or drug action (pharmacodynamics) including polymorphic variation in genes that encode the functions of transporters, metabolizing enzymes, receptors, and other proteins. We will use the term PGx tests to refer to an assay to study these interindividual variations in conjunction with drug development and therapeutics.