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Updated: Apr 25, 2026

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
Published on: June 21, 2018
A question-based approach to adopting pharmacogenetics to understand risk for clinical variability in
R Evers1, R L Blanchard2, A W Warner3
1Department of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism, Merck & Co., Rahway, New Jersey, USA.
Abstract:
Understanding genetic variations that influence pharmacokinetics (PK) in humans is important for optimal clinical use of drugs. Guidances for making decisions on when to conduct pharmacogenetic research during drug development have been proposed by regulatory agencies, but their uniform adoption presents problems due to an inherent lack of flexibility. A questions-based approach (QBA) was developed to enable drug development teams at Merck to iteratively and flexibly evaluate the potential impact of pharmacogenetics (PGx) on clinical pharmacokinetic variability.
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