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Toxicol Mech Methods. 2006;16(2-3):89-99. doi: 10.1080/15376520600558333.

Application of pharmacogenomics in clinical pharmacology.

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Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.


Many factors can affect a patient's response to a drug. These include intrinsic factors such as age, gender, race/ethnicity, genetics, disease states, organ dysfunctions, and other physiological changes, including pregnancy, lactation, and extrinsic factors such as smoking, diet (food, juice, dietary supplements), and concomitant medications (ICH E5, 1998 and 2004). The interplay of genotypes of the enzymes, transporters and receptors, among other factors (such as concomitant medications and disease states), can affect the risk/benefit ratio for individual patients. This commentary discusses when the genomic information should be obtained during drug development and when it is to be assimilated into labeling and standards of care that can be used to "individualize" drug therapy and become one of the pillars of "personalized medicine."

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