The FDA released a revised version of its Guidance for Industry on metabolism and transporter-mediated drug-drug interactions, dividing its 2012 document into two parts: one on in vitro studies and one on clinical drug interaction studies.
Drs. Andrew Parkinson, XPD Consulting, and Ron Laethem, Qualyst, offer their expert opinion on how the Guidance has changed and how it will impact drug development strategies.
By attending you will learn:
- Why the changes were made
- How they impact the design and interpretation of in vitro studies
- How to translate the latest FDA in vitro DDI Guidance into an effective action plan for getting your IND enabling studies done right