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2C or Not 2C: CYP2C Induction Studies for Successful Preclinical Risk Assessment

  • Webinar

As a part of IND-enabling preclinical drug development studies companies are required to meet regulatory expectations to evaluate the induction potential of their compound for the cytochrome P450 (CYP) enzymes CYP1A2, 2B6, 2C8, 2C19 and 3A4.  While only CYP1A2, 2B6 and 3A4 must be assessed in the initial induction panel, any observed induction of CYP3A4 requires further investigation of induction potential for enzymes in the CYP2C family due to shared activation by the PXR nuclear receptor pathway. This webinar will focus on CYP2C induction and will emphasize when to include CYP2C induction in a study, how to design the study to generate meaningful data and meet the regulatory requirements, what endpoints to measure, and how to interpret results… View Details

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