These studies 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.
TORONTO (PRWEB) October 11, 2019
Join Senior Clinical Pharmacologist from Medpace, Carol Collins, MD in a live webinar on Thursday, October 24, 2019 at 11am EDT (4pm BST/UK) to learn about changes in pharmacokinetic drug-drug interaction studies.
These studies 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.
This webinar will focus on recent scientific and regulatory developments impacting the design of clinical drug-drug interaction studies. Talking points will 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 to be 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
For more information or to register for this event, visit What’s New in Clinical Drug-drug Interaction Studies: Recommendations from Regulatory Authorities and Scientific Consortia.
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