Induction Working Group

Mission

To move towards a better understanding of the overall regulatory approach to induction-based DDIs in the guidance from the EMA (+FDA and PMDA)
To take a data driven approach to influence the EMA (and other regulatory agencies) to make changes to the requirements for assessing induction

Activities

We intend to publish 3 white papers as follows:

First white paper prepared with following areas of focus
- In vitro assessment of CYP2C induction
- Assessment of down regulation
- Use of CITCO as CYP2B6 positive control
Second white paper to focus on data interpretation
- Single point variability for positive, negative and vehicle control data
- Collation of in vitro and in vivo data for proprietary and non-proprietary compounds
- Translation of in vitro induction to clinical relevance
Third white paper to focus on induction time course
- Primarily to address issue of 72 vs 48h for mRNA
- Limited data received from survey within IQ. Additional data being generated within WG

Expected outcomes

Leadership
Groups