Application of Pharmacogenomics in Drug Discovery and Development

Abstract

Pharmacogenomics research aims to investigate the causes at genome level for the individual variability of drug efficacy or safety. Application of pharmacogenomics is to identify the genetic polymorphisms affecting diseases to determine the likelihood of the disease and it is influencing the drug therapy in the past decades. It is commonly applied to achieve personalized care by determining the genotype of patients in the clinical drug therapy. With the rapid progress in pharmacogenomics technologies and methods, the application has been broadened to the drug efficacy and safety studies in drug discovery and development. Pharmacogenomics can contribute to the two major determinants of the success of drug discovery and development, namely, safety and efficacy, which are more predictable by the identification of the susceptibility polymorphism of possible target and thus increase the success rate of drug development by stratifying subjects and adjusting dosage regimen in clinical trials. As there are more and more drug labels with pharmacogenomics information, global regulatory agencies have laid down the guidelines on the application of pharmacogenomics in drug development and clinical therapy. The guidance further facilitates the application of pharmacogenomics in the drug discovery and development.