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Assessment of Drug Metabolism Enzyme and Transporter Pharmacogenetics in Drug Discovery and Early Development: Perspectives of the I-PWG

Brian, William and Tremaine, Larry M. and Arefayene, Million and de Kanter, Ruben and Evers, Raymond and Guo, Yingying and Kalabus, James and Lin, Wen and Loi, Cho-Ming and Xiao, Guangqing (2016) Assessment of Drug Metabolism Enzyme and Transporter Pharmacogenetics in Drug Discovery and Early Development: Perspectives of the I-PWG. Pharmacogenomics, 17. pp. 615-631. ISSN 1744-8042

Abstract

Genetic variants of drug metabolism enzymes and transporters can result in high pharmacokinetic and pharmacodynamics variability, unwanted characteristics of efficacious and safe drugs. Ideally, the contributions of these enzymes and transporters to drug disposition can be predicted from in vitro experiments and in silico modeling in discovery or early development, and then be utilized during clinical development. Recently, regulatory agencies have provided guidance on the preclinical investigation of pharmacogenetics, for application to clinical drug development. This white paper summarizes the results of an industry survey on current practice and challenges with using in vitro systems and in silico models to understand pharmacogenetic causes of variability in drug disposition.

Item Type: Article
Date Deposited: 12 Oct 2016 00:45
Last Modified: 12 Oct 2016 00:45
URI: https://oak.novartis.com/id/eprint/26950

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