Using Relative Induction Score to Improve Risk Assessment of Clinical CYP3A4 Induction

Cytochrome (CYP) P450 induction is a well-established mechanism for increased prevalence of DDIs. Whilst its study in vitro has been described in regulatory guidance for over 20 years, data interpretation methods and details for study design have evolved and the best approaches for study of small molecules and other therapeutics are still being discussed within CROs, pharma and biotechs.

In this webinar our expert, Katie Plant, describes the most recent updates in CYP induction. By reviewing and consolidating literature and recent perspectives from Innovation and Quality Induction Working Group (IQ IWG) alongside the regulatory guidance, this provides a comprehensive overview and outlines the recommended approach to assess CYP induction in vitro. When supported by well-designed in vitro assays and batch qualification using a known set of CYP3A4 inducers, relative induction score (RIS) correlation analysis serves as a useful tool enabling the magnitude of clinical CYP3A4 induction to be predicted and used to support decision-making for investigating potential DDI risk.

Stream the Webinar

 

Stream on demand

Stream the Webinar

Learn More About Our Speaker

Katie Plant

Katie Plant,
Principal Scientist, Drug Metabolism at Cyprotex

Katie Plant is a Principal Scientist in the Drug Metabolism group at Cyprotex, UK, responsible for operational delivery of high-throughput screening assays covering metabolic stability, enzyme inhibition and induction, alongside supporting clients in designing and interpreting DDI studies to support regulatory submission, supporting R&D and bespoke studies and driving continuous improvement projects.
 

Katie joined Cyprotex in 2007 and has played an important part in improving Cyprotex’s capabilities to assess DDIs with projects including, introduction of the cytochrome P450 IC50 shift assay, multiple investigations into non-CYP and extra-hepatic metabolism, and recently the introduction of relative induction score (RIS) analysis for CYP3A4 induction.