RENAL DRUG SAFETY
As leading experts in kidney transport, we design and conduct customised experimental protocols to generate the most relevant data for regulatory submissions and assessment of pre-clinical renal safety and efficacy.
The most advanced near-physiological high throughput kidney proximal tubule model
Determine relative IC50 values and assist decisions on lead compound selection
Accurately predict renal drug safety profiles
Bridge the gap between simple in vitro and expensive animal models
The aProximateTM human, rat, mouse, canine and non-human primate (NHP) assay expresses and measures levels of the FDA qualified clinical renal safety biomarkers, KIM-1, NGAL and clusterin, along with TEER, LDH and ATP.
These biomarkers have been selected by the FDA based on data that shows their accumulation in the urine of patients suffering renal damage.
We believe aProximateTM to be the most well-characterised and most predictive assay available.
Drug induced kidney injury (DIKI) is a frequent adverse event, which accounts for approximately 5-9% of drug attrition during product development. In order to evaluate the risk of drug nephrotoxicity or the mechanism by which this occurs based on known pharmacology, it is crucial to use a robust, validated, in vitro model, which closely recapitulates physiological conditions.
Our kidney model, aProximate™, is the most advanced, validated kidney proximal tubule cell (PTC) model for drug safety studies, allowing the evaluation of key renal specific biomarkers for accurate safety predictions giving confidence in the safety profile of new drugs for ADMET-Tox.
Preventing drug induced kidney injury: Validated in vitro model.