Drug Transporters Regulatory Guidance Update
Posted on Thu, Aug 18, 2011 @ 07:50 AM
Drug Transporters – 2nd meeting of the ITC Announced
The date of the second meeting of the International Transporter Consortium (ITC) has been announced – March 12/13, 2012 (as a pre-conference to the 2012 ASCPT Annual Meeting, March 14-17, 2012, National Harbor, Maryland). It will be interesting to see the current view of DDI risk concerning Transporters and if they recommend any major changes to their 2010 white paper. Will they recommend the addition of BSEP for example?
Drug Transporter Regulatory Guidance 2010 White Paper
In their 2010 White Paper, the ITC recommended that interactions be assessed using in vitro methods for seven specific transporters, and this recommendation was subsequently endorsed by the FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee.
Further details on the transporters it recommended to be assessed can be found in a poster presented at ADMET, Munich, 28-29 June 2011.
Drug Transporter Testing Strategy Development
This second meeting is perhaps timely, as it’s becoming increasingly clear from discussions with our clients that the Regulators (both FDA and EMEA) are requesting that all clearance mechanisms of a new drug are fully understood – both metabolic and transporter related.
To increase understanding of transporter based interactions, we have developed a comprehensive GLP-compliant drug efflux and uptake Transporter testing strategy, which includes all the recommended ITC (and EMEA) Transporters. Some of our recent assay developments have involved validating the use of novel in vitro systems (cell line(s) and/or well format).
To find out more about the development of higher throughput in vitro models to assess transporter based Interactions and see some of our results for P-gp and BCRP please download the poster: “Transporters in Focus: New targets for ADMETox optimisation”
Author: Guy Webber, Chief Scientist (In Vitro Sciences), Quotient Bioresearch