Vol. 29, Issue 4, 591-595, April 2001

Pharmacogenetic Application in Drug Development and Clinical Trials

Michael M. Shi, Michael R. Bleavins, and Felix A. de la Iglesia

Genomic Pathology Laboratory, Drug Safety Evaluation, Pfizer Global Research and Development, Ann Arbor, Michigan; and Department of Pathology, The University of Michigan Medical School, Ann Arbor, Michigan

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.