A question-based approach to adopting pharmacogenetics to understand risk for clinical variability in pharmacokinetics in early drug development

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 pre...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 96; no. 3; p. 291
Main Authors Evers, R, Blanchard, R L, Warner, A W, Cutler, D, Agrawal, N G B, Shaw, P M
Format Journal Article
LanguageEnglish
Published United States 01.09.2014
Subjects
Algorithms
Animals
Biological Transport - genetics
Biotransformation - genetics
Drug Discovery - methods
Genetic Variation
Genotype
Humans
Pharmacogenetics
Pharmacokinetics
Phenotype
Risk Assessment
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Summary: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.
ISSN:1532-6535
DOI:10.1038/clpt.2014.98