Biomarkers in Drug Development#

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The Needs and Challenges in Assessing Genetic Variants for Drug Efficacy and Safety

The Needs and Challenges in Assessing Genetic Variants for Drug Efficacy and Safety

The views presented in this paper are those of the authors and do not necessarily represent those of the U.S. Food and Drug Administration.Genetic variation, environmental stimulation, and their interaction introduce significant interindividual variability in disease susceptibility, drug efficacy and adverse drug reactions.

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