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About the Authors:
Lun Yang
Current address: GlaxoSmithKline, Philadelphia, Pennsylvania, United States of America
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Elvin T. Price
Affiliation: Department of Pharmaceutical Sciences, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America
Ching-Wei Chang
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Yan Li
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Ying Huang
Affiliation: Department of Pharmaceutical Sciences, College of Pharmacy, Western University of Health Sciences, Pomona, California, United States of America
Li-Wu Guo
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Yongli Guo
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Jim Kaput
Current address: Nestle Institute of Health Sciences, Lausanne, Switzerland
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Leming Shi
* E-mail: [email protected] (BN); [email protected] (LS)
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Baitang Ning
* E-mail: [email protected] (BN); [email protected] (LS)
Affiliation: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, United States of America
Introduction
Drugs are usually approved based on safety and efficacy data in a limited number of patients that are thought to represent the entire population. However, individuals in a population show differences in drug sensitivity, efficacy, toxicity, and dosing [1], [2], [3]. For the majority of drugs used in treating common diseases, only 25% to 60% of patients respond to a specific medication [2]. A widely cited article [4] stated that more than 2 million adverse drug reaction cases were reported annually in the United States, including approximately 100,000 instances of death.
The variability of drug responses among individuals in the population occurs because of complex, multifactorial contributions of genetic factors (such as single nucleotide polymorphisms and copy number variations), environmental factors (such as...