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4/28/09 Xceleron Launches Solution to FDA MIST
Date Posted: |
28 Apr 2009 |
Summary: |
April 28, 2009 GERMANTOWN, MD – XCELERON, a global leader of translational science in clinical research, today announced the launch of its fast and cost-effective solution to the FDA ‘Safety Testing of Drug Metabolites’ guidance (also known as MIST: ‘Metabolites in Safety Testing’). |
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April 28, 2009: GERMANTOWN, MD – XCELERON, a global leader of translational science in clinical research, today announced the launch of its fast and cost-effective solution to the FDA ‘Safety Testing of Drug Metabolites’ guidance (also known as MIST: ‘Metabolites in Safety Testing’). The guidance, issued in February 2008, highlights the importance of obtaining human drug metabolite information in humans as early as possible. Xceleron’s microtracer approach generates quantitative metabolism data from an existing Phase I study.
“Our MIST solution has been developed in collaboration with major drug developers. It cost-effectively provides a quantitative metabolite profile from a scheduled clinical Phase I study to determine if there are disproportionate human metabolites that need to be investigated further” commented Dr. Mike Butler, CEO, Xceleron.
The guidance states “metabolites that can raise a safety concern are those formed at greater than 10 percent of parent drug systemic exposure at steady state”. It is recommended that in vivo metabolic evaluation in humans be performed as early as possible.
By incorporating a 14C microtracer in an existing Phase I study, Xceleron can obtain an uncomplicated first view of human metabolism which addresses MIST. The ability to compare this early human clinical information with existing profiles from preclinical studies enables the drug developer to make important decisions on the development of promising drug candidates much earlier.
“The feedback we have so far confirms our clients’ interest in the early investigation of human metabolism. We are very pleased that once again, the combination of sensitive analysis and drug development expertise is helping our clients’ drug development efforts.” said Dr. Butler.
About Xceleron
Founded in 1997 in York, UK, Xceleron provides bioanalytical Accelerator Mass Spectrometry (AMS) services for accelerated early drug development. The company uses ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I and Phase II/III clinical trials.
Xceleron pioneered human microtracer techniques and has unmatched robust processes and knowledge of experimental design. There are currently 6 drugs on the market that have used Xceleron AMS data in filing, and another 3 in late stages of development. In 2008, the company opened its US facility in Maryland.
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