| Challenge |
Testing Approach |
| Inflammation and oxidative stress |
Immunohistochemistry for TNF-a and MDA in kidneys, myocardium, vasculature, and brain |
| Cardiac Toxicity |
Electrocardiograms, clinical chemistry including Troponin, histopathology, and full cardiovascular and pulmonary assessment in telemetered monkeys |
| Nephrotoxicity |
Renal glomerular filtration rate and renal blood flow study; clinical chemistry; urinalysis; histopathology; measured presence of hemoglobin in urine |
| Safety Margin |
High dose/high volume groups included to maximize dosing levels |
| Clinical Pathology Interference |
Interference assessment and correction for affected parameters |
