RT Journal Article SR Electronic T1 Pharmacogenetic Application in Drug Development and Clinical Trials JF Drug Metabolism and Disposition JO Drug Metab Dispos FD American Society for Pharmacology and Experimental Therapeutics SP 591 OP 595 VO 29 IS 4 A1 Michael M. Shi A1 Michael R. Bleavins A1 Felix A. de la Iglesia YR 2001 UL http://dmd.aspetjournals.org/content/29/4/591.abstract AB Pharmacogenetics examines the genetic characteristics of individuals to understand variations in response to therapeutics. This approach has the potential to significantly affect the development of new medicines. The application of pharmacogenetic principles could yield significant time and resource savings within the drug development process. In preclinical drug development, pharmacogenetics could be applied to compound screening and identifying potential side effects before entering full clinical testing. Subpopulations of patients with different drug responses and underlying genetic markers could be stratified in clinical trials by analyzing their genotype. These data can improve clinical trial design and offer the possibility of optimized drug prescription based on patient genotype. Pharmacogenetics can guide the development of therapeutic interventions by identifying nonresponder patient groups. Advances in high-throughput genotyping technologies have added potential by facilitating the technical hurdles and improving drug development strategies, clinical trial design, and postmarket pharmaco-vigilance. Pharmacogenetics, thus, impacts all phases of drug development and will fundamentally change the practice of medicine in the near future. The American Society for Pharmacology and Experimental Therapeutics