Cytochrome P450 and UGT induction studies to predict drug-drug interaction.
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Reproducible Induction Response in Gentest® Inducible-qualified Human Cryo-hepatocytes
Omeprazole-induced CYP1A2 catalytic activity in Gentest® Inducible-qualified human cryo-hepatocytes on 7 independent days
Highly reproducible, robust data. Phenacetin O-deethylase activity in a single donor (lot 246) of Gentest® Inducible-qualified human cryopreserved hepatocytes in 7 independent experiments conducted over the span of 18 weeks. Cells were treated with 50 μM omeprazole (OME) for 2 days prior to determination of enzyme activity. The amount of acet- aminophen metabolite formation was determined by incubating cells with 100 μM phenacetin for 30 minutes.
Understanding how a drug candidate is metabolized, transported, and cleared is an essential part of the drug development process. Discovery Life Sciences’ (Discovery’s) Gentest® ADME & Custom Services have provided IND-enabling in vitro ADME and bioanalytical services for more than two decades, helping countless drug developers get the answers they needed to make critical go/no-go decisions.
Zhang JG, et al (2014). Evaluation of calibration curve-based approaches to predict clinical inducers and non-inducers of CYP3A4 with plated human hepatocytes. Drug Metab. Dispos. 42:1379-1391.
Wong, S.G. et al (2021). Considerations from the innovation and quality induction working group in response to drug-drug interaction guidance from regulatory agencies: Guidelines on model fitting and recommendations on time course for in vitro cytochrome P450 induction studies including impact on drug interaction risk assessment. Drug Metab. Dispos. 49:94-110.
