Drug Metabolism LIMS in Demand for Clinical Studies
News Jun 24, 2009
LabLogic Systems reports a rapid rise in the number of clinical studies being performed using its drug metabolism LIMS Debra.
The increase is apparently a response to the MIST* guidance document 'Safety Testing of Drug Metabolites' released by the FDA in February 2008, which clarifies the Administration’s position on when metabolites should be identified and characterized.
The document, which applies to small molecule drug candidates only, states that the FDA "strongly recommend in vivo metabolic evaluation in humans be performed as early as possible.” Metabolites that raise a safety concern are those produced in humans at greater than 10% of parent drug systemic exposure at steady state.
Huw Loaring, LabLogic’s systems director, said “Some of our pharmaceutical and contract research customers have always used Debra to collect data from human mass balance studies, but we have seen a marked increase in enquiries relating to this work recently.
“Debra facilitates the collation of patient data and calculates cumulative recovery immediately, so users find it easier to make decisions about the duration of sample collection and to report validated data.”
As well as Debra, LabLogic offers the B-RAM Model 5 RHPLC flow-through detector with SoFie stop flow for low level sample analysis - all the tools laboratories performing human radio-labelled studies need to detect and characterize metabolites derived from the parent drug.
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