Considerations from the IQ Induction WG_Part 2 of 2_CYP3A4 mRNA In Vitro Response Thresholds скачать в хорошем качестве

Considerations from the IQ Induction WG_Part 2 of 2_CYP3A4 mRNA In Vitro Response Thresholds

Webinar presented on December 6, 2018. The IQ Consortium’s Induction Working Group is presenting two webinars with the intent of sharing and discussing the data driven recommendations made in two recently published manuscripts. The first webinar focused on downregulation, CYP2C induction, and CYP2B6 positive control. This second webinar will focus on the collation and review of a large set of in vitro and clinical CYP3A induction data aimed at understanding drug drug interaction interpretation and risk assessment as they relate to the current guidelines from Regulatory agencies. This webinar will take the audience through the data that lead to key recommendations with respect to donor number, criteria for characterizing positive and negative in vitro induction including the 2-fold cut-off, the value of negative controls, and finally indexing response to prototypical inducers. The intent of this webinar series is to promote discussion and collaboration among industry peers. This is a public forum so we encourage you to share this information with interested parties, you do not need to be an IQ member to register for these webinars. IQ Consortium Translational & ADME Sciences Leadership Group Induction Working Group Learn more at iqconsortium.org