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- W2489277534 abstract "Depending on the type of injury, preclinical drug-induced kidney injury (DIKI) findings help to define safety margins for clinical studies. The margins are defined in part based on case-by-case evaluations of preclinical data including nephron-specific kidney histopathology findings and associated changes in traditional DIKI biomarkers as well as reversibility. This chapter presents a case study highlighting options to consider when implementing DIKI assessment strategies. Traditional renal biomarkers, including sCr, BUN, and total protein in urine lack the sensitivity and specificity needed to diagnose and monitor nephron-specific toxicities. To overcome the limitations of traditional markers, Burt et al. explored the utility of several emerging biomarkers of kidney injury for monitoring nephrotoxicity of polymyxin analogues in preclinical toxicity studies. The chapter also explains the applications of emerging renal safety biomarkers for compound selection and managing risk of DIKI, including the translational potentials for novel DIKI biomarkers to the clinic setting." @default.
- W2489277534 created "2016-08-23" @default.
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- W2489277534 date "2016-03-24" @default.
- W2489277534 modified "2023-09-23" @default.
- W2489277534 title "Case Study" @default.
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- W2489277534 doi "https://doi.org/10.1002/9781119053248.ch37" @default.
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