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Here we present the characterization and verification of an in vitro assay using plated human cryopreserved hepatocytes with incubation conditions supplemented with HepExtend^TM media. Incorporating a mathematical regression offset approach the assay is capable of characterizing and predicting human metabolic clearance over a wide dynamic range including compounds with low metabolic clearance.
Verified using a range of clinical marker compounds this assay can be used for metabolic IVIVE, human PK predictions and modelling.