What’s New in Clinical Drug-drug Interaction Studies: Recommendations from Regulatory Authorities and Scientific Consortia
Pharmacokinetic drug-drug interaction studies are in a state of transition—and there is often confusion around requirements and timing. They have transformed from studies of empirically-selected narrow therapeutic window and concomitantly-prescribed medications to systematic and mechanistic evaluations of a compound’s potential for interaction with key drug-metabolizing enzymes and transporters. This paradigm shift offers improved safety for participants in clinical trials and for patients after drug approval. An attractive incentive of these efforts for the industry is the development of robust in vitro systems and modelling approaches that eliminate the need for clinical drug-drug interaction studies in many cases.
Implementing these advances has been a daunting task for industry, academics and regulatory authorities. Regulators recognize the need for flexibility to accommodate an ever-expanding knowledge base in a timely manner. The US Food and Drug Administration (FDA) has released several draft guidances that reflected their current thinking on best practices for in vitro and clinical evaluations with the latest documents released in October 2017. Other regulatory authorities from around the world are actively focused on this issue and new regulatory guidance from the European Medicines Agency (EMA) is expected at any time.
This webinar focuses on recent scientific and regulatory developments impacting the design of clinical drug-drug interaction studies. Talking points range from general concepts targeted towards scientists in drug development to specific recommendations from recent publications aimed at researchers directly involved in the design of clinical drug-drug interaction studies.
Key points that are discussed include:
- Timing of drug-drug interaction studies
- Which enzymes and transporters should be evaluated
- The potential role of cocktail and microdosing drug-drug interaction studies
- Selection of probe drugs and duration of dosing