Recorded webinar: What’s All the Flux About? Transporter Webinar by Joseph Polli
September 26, 2011
Interpretation and Application of the ITC Whitepaper and Draft EMA Guidance
Presenter: Joseph Polli, GlaxoSmithKline (USA)
In case you would like to watch the presentation again or you have missed it, you can find the recorded webinar HERE.
There has been a surge of research and regulatory activity in the area of drug transporter over the past 12 months.
In March 2010, the International Transporter Consortium published a position paper entitled "Membrane transporters in drug development" (Nature Rev. Drug Discov. 9, 215–236, 2010) that provided recommendations on which transporters are clinically important in drug absorption and disposition, which in vitro
and nonclinical methods are suitable to study drug interactions, what criteria should trigger follow-up clinical studies and which clinical studies should be conducted to assess the drug interaction risk. As well, the ITC whitepaper include decision trees intended to help guide clinical studies on the most important drug transporter interactions.
Also in March of 2010, the FDA Clinical Pharmacology Advisory Committee reviewed scientific considerations and recent developments in transporter-mediated drug–drug interactions and voted in favor of recommendations to routinely study drug transporters prior to formal regulatory submission.
Finally, in May of 2010, the European Medicines Agency (EMA) released the draft guidance around drug interactions that included recommendations on when and how to assess for interactions with drug transporters.
The objective of this presentation is to briefly review the decision trees and regulatory guidances, give an update on their evolution since the publication of the ITC whitepaper, and to provide case studies from drug development illustrating how the decision trees have been applied to address project team and/or regulatory queries on drug transporters.
The International Transporter Consortium Workshop Two (ITCW2)
on membrane transporters in drug development will be held on March 12-13, 2012 at National Harbor, Maryland in conjunction with ASCPT. The meeting will cover new topics in the area of drug transporters and drug interactions.
FDA CP Advisor Committee
EMA Draft Drug Interaction Guidance
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