We recommend implementing CYP induction studies using TRANSPORTER CERTIFIED™ hepatocytes in sandwich culture. This model can show better IVIVE correlations Vs. conventional, transporter-deficient models because it incorporates biliary efflux whereas conventional models do not. Compared to conventional systems, the model better maintains physiologically-relevant intracellular concentrations (ICC) of drug candidates, which is critical for preventing cytotoxicity at the higher concentrations suggested by the FDA. The latest Guidance recommends testing compounds to the limit of solubility or until cytotoxicity is observed. If efflux transporter function is deficient, compounds can accumulate in hepatocytes and cause toxicity. If the hepatocytes have complete transporter function and are able to clear the compound as in vivo, higher concentrations of compound may be tested.
CYP Enzyme Induction Services
Our support for CYP450 research includes the following programs:
- Screening Assays: Used for lead selection and early determination of DDI potential.
- Regulatory Submission Packages: Assay programs that meet FDA and EMA requirements for regulatory submissions.
- Customized Research Programs: Studies designed to address specific needs
Improve Clinical Predictions with a Physiologically-Relevant Model
Our clients reply on our induction study data to guide decision-making throughout their drug discovery and development programs
- Lead selection
- Clinical study design, relating to DDI concerns
- Regulatory submissions
- Response to regulators’ questions