Introduction: Kidney Safety Science
Section snippets
PREDICT
Current approaches to conduct kidney safety assessments of compounds rely on animal studies and these results are extrapolated to dose effects in human beings despite knowledge that the typical responses of animal models and human beings can differ greatly owing to species differences in anatomy, physiology, and metabolic responses. The lack of adequate models to accurately predict human toxicity contributes to an underestimation of the potential for kidney toxicity of therapeutic candidates,
DETECT
A second drug development tool that is essential to determine kidney safety as promising therapeutics advance closer to patients is robust translational biomarkers that apply to nonclinical and clinical studies.6 In the past 2 decades we have made considerable progress identifying, confirming, validating, and qualifying biomarkers to detect kidney proximal tubular toxicity as a result of a concerted effort by pharmaceutical companies, academia, governments, and consortia. In 2008, the US Food
TREAT
The most challenging tenet remains developing targeted safe and effective therapeutics for kidney damage, specifically for AKI, for which we have no therapy that has been shown to improve clinical outcomes.8 There were at least 59 interventional studies with candidate therapeutics in phase 2 clinical trials and approximately 45 in phase 3 to counteract AKI that are either active, recruiting, or were completed in 2018 (listed in clinicaltrials.gov). It is possible that one of these may offer a
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