Current trends and strategic directions in the use of pharmacogenomics to identify translational biomarkers.
The development of new drugs is hampered by the quality and usefulness of currently available biomarkers, which are unable to correlate human and animal responses, and in vivo and in vitro testing within one species. Furthermore, new translational (or bridging) biomarkers are required to improve the prediction of adverse events, whether they are related to drug toxicity or disease processes. The discipline of pharmacogenomics has been proposed by the FDA as a means to spur the discovery of new biomarkers for use in drug discovery and development, and although its guidance has addressed some of the issues associated with the use of this new technology, many remain to be solved. The existing controversies and unresolved issues in the field of pharmacogenomics will be the focus of this review and illustrative case studies will be presented.
Mendrick
Donna L
DL
Gene Logic Inc, Toxicogenomics, 610 Professional Drive, Gaithersburg, MD 20879, USA. dmendrick@genelogic.com
D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D015195:Drug Design; D017408:Guidelines as Topic / Q000592:standards; D000072596:Hepatitis A Virus Cellular Receptor 1; D006801:Humans; D007684:Kidney Tubules / Q000378:metabolism / Q000473:pathology; D008562:Membrane Glycoproteins / Q000032:analysis / Q000235:genetics; D010597:Pharmacogenetics / Q000379:methods* / Q000639:trends; D011991:Receptors, Virus / Q000032:analysis / Q000235:genetics; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards / Q000639:trends
D015415:Biomarkers; C491143:HAVCR1 protein, human; D000072596:Hepatitis A Virus Cellular Receptor 1; D008562:Membrane Glycoproteins; D011991:Receptors, Virus