Pharmacogenetic application in drug development and clinical trials

Pharmacogenetics examines the genetic characteristics of individuals to und erstand variations in response to therapeutics. This approach has the poten tial to significantly affect the development of new medicines. The applicat ion of pharmacogenetic principles could yield significant time and resource savings within the drug development process. In preclinical drug developme nt, pharmacogenetics could be applied to compound screening and identifying potential side effects before entering full clinical testing. Subpopulatio ns 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 optimiz ed drug prescription based on patient genotype. Pharmacogenetics can guide the development of therapeutic interventions by identifying nonresponder pa tient groups. Advances in high-throughput genotyping technologies have adde d potential by facilitating the technical hurdles and improving drug develo pment strategies, clinical trial design, and postmarket pharmaco-vigilance. Pharmacogenetics, thus, impacts all phases of drug development and will fu ndamentally change the practice of medicine in the near future.