Regulatory qualification and applications of new translational kidney safety biomarkers in drug development

Abstract

New translational kidney safety biomarkers are now enabling drug development by: 1) enhancing safety monitoring of patients in early clinical trials for toxicities seen in animal studies that are of questionable human relevance, 2) providing early insights to pathogenic mechanisms leading to drug induced kidney injury in early drug development toxicology… (More)

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@inproceedings{Tice2017RegulatoryQA, title={Regulatory qualification and applications of new translational kidney safety biomarkers in drug development}, author={Raymond Richard Tice and Tuula Heinonen and Frank Sistare and Elizabeth Walker and L. N. Smirnova and Xiali Zhong and David Pamies and Helena T. Hogberg and Herbert M. Lachman and Thomas Hartung}, year={2017} }