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The ideal characteristics of translational safety biomarkers of organ injury are that they provide more sensitive and specific information than current clinical chemistry biomarkers, can be detected through robust analytical assays in relevant translational species (rat, dog, mouse or monkey) and in humans, can be measured noninvasively or in accessible fluids like blood or urine, can predict or monitor severity of histopathology in nonclinical species, are specific for organ injury or mechanisms of toxicity that lead to organ injury, are specific to tissue location and are insensitive to nontoxic perturbations (exercise, diet, age, and other diseases and toxicities to other organs) (Amacher 2010
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