A new tool for in vivo detection of liver toxicity could represent a significant improvement over routine methods that only work in vitro or on tissue slices.1 The litmus test for the Stanford University inventors will be to show that the nanoparticle-based method can detect toxicity in compounds that previously eluded standard analysis and later failed in the clinic.
Current preclinical toxicity testing methods are clearly suboptimal, as more than 20% of compounds end up failing clinical trials because of toxicity issues.2
Standard toxicology analysis involves early stage screening using in vitro microsomes, hepatocytes and liver slices followed by IND-enabling histopathology and plasma biomarker studies on animals treated for two weeks or longer.
IND submissions also require additional assessments such as genotoxicity and immunotoxicity.
Multiple tools have been tried in discovery research, but few have been incorporated into routine preclinical toxicology assessment.
Michael Taylor, founder and principal of NonClinical Safety Assessment, told SciBX that the field often is resistant to disruptive innovation. Companies prefer to focus resources on techniques currently accepted by the FDA, and toxicologists want