Best Practices for In Vitro enzyme (CYP, UGTs) and Clinical Study Design (encompasses PBPK) to Support DDI Studies & Product Labeling | An ISSX 2023 Short Course

This short course, featured during the 25th North American ISSX Meeting in September 2023, covers current best practices and regulatory guidance around in vitro studies assessing inhibition and induction of CYPs  and UGTs, the use of the in vitro data to project DDIs using static and PBPK modeling, as well as the use of the data to design clinical DDI studies and inform product labels. The lectures discuss fundamental mechanisms of enzyme inhibition and induction with examples of classic DDIs from the literature for CYPs and UGTs. Successes around prediction accuracy using various models are highlighted.

Assessing Victim Drug-drug Interaction – Reaction Phenotyping of CYP and non-CYP
Li Di, Pfizer, Groton, Connecticut, USA

CYP and UGT Inhibition to Assess Perpetrator Drug-drug Interaction Potential
Mike Zientek, Takeda, San Diego, California, USA

Enzyme Induction Fundamentals, Assays, Data Interpretation and in vivo Translation
Diane Ramsden, AstraZeneca, Waltham, Massachusetts, USA

Clinical DDI Trial Design and Impact on Product Labels
Fatemeh Akhlaghi, Pfizer, San Diego, California, USA

Chairs: Li Di, Pfizer, Groton, Connecticut, USA and Fatemeh Akhlaghi, Pfizer, San Diego, California, USA