Zafalon RVA, Risolia LW, Vendramini THA, et al
Full safety profile Multiple species 96-well Service outputs aProximate TM Evaluation of KIM-1, NGAL, and clusterin, three FDA-approved biomarkers of kidney toxicity Cell viability: ATP, LDH, and TEER measurements Assays Kidney toxicity assays Assessment of renal drug safety Models aProximate TM kidney proximal tubule cells (from human, mouse, rat, and dog) Timeline 2-3 months How can Newcells kidney tissue models be used to assess renal toxicity
Request for CommentsBulk Drug Substances Nominated for Inclusion on the Section 503A Bulks List
The Regents of the University of Michigan.
In the body, about 95% of the total choline pool is converted to phosphatidylcholine, an essential component of the phospholipid bilayer and the predominant phospholipid in most mammalian cells
Safety doesn't translate into humans necessarily," said Brubaker