RESEARCH TRIANGLE PARK, N.C., June 26, 2012 /PRNewswire-iReach/ -- Qualyst Transporter Solutions, LLC has launched a contract service offering using a clinically-relevant model to assess FDA concerns on drug transporter related hepatic drug-drug interactions. The newest FDA draft guidance on drug interactions (February, 2012) specifies six hepatic drug transporters of interest, which include three uptake and three efflux transport proteins.
"What is missing in the market is a way to address FDA concerns around transporter-based drug interactions that is predictive of an in vivo outcome." said Dr. Christopher Black, CEO for Qualyst Transporter Solutions. "Utilizing the gold-standard sandwich-culture hepatocyte model, we have applied our clinically-relevant B-CLEAR® technology in order to produce a cost-effective answer to the FDA's concerns," said Dr. Black.
Many of the ways that current technologies try to address the FDA concerns involve in vitro transfected systems. Data from these systems are difficult to translate into reliable in vivo knowledge. An integrated in vitro system, like hepatocytes, with multiple localized, functioning, and expressed uptake and efflux transporters, is required to accurately predict and describe in vivo transporter-based drug interactions.
Experiments can be performed in hepatocytes from multiple species, including humans, and the streamlined results are provided as a percent change from control. Clinically relevant positive controls are included in order to gauge the relative inhibitory potency of the tested compounds. Qualyst Transporter Solutions has a large historical data base which can help provide clinical perspective on the effects of your compound for an FDA submission. This can be important since many models overestimate inhibitory interactions or there may be inhibitory effects on a single transporter that ca
|SOURCE Qualyst Transporter Solutions, LLC|
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