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XCELERON Launches Solution to FDA MIST
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XCELERON has announced the launch of its 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.
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.
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