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A Question‐Based Approach to Adopting Pharmacogenetics to Understand Risk for Clinical Variability in Pharmacokinetics in Early Drug Development
Author(s) -
Evers R,
Blanchard R L,
Warner A W,
Cutler D,
Agrawal N G B,
Shaw P M
Publication year - 2014
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2014.98
Subject(s) - pharmacogenetics , pharmacokinetics , drug development , drug , medicine , pharmacology , intensive care medicine , biology , genotype , genetics , gene
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. Clinical Pharmacology & Therapeutics (2014); 96 3, 291–295. doi: 10.1038/clpt.2014.98