Lablogic Systems has reported a rapid rise in the number of clinical studies being performed using its LIMS Debra drug metabolism.
The increase is said to be a response to a MIST guidance document - entitled 'Safety Testing of Drug Metabolites' - released by the Food and Drug Administration (FDA) in February 2008, which clarifies its position on when metabolites should be identified and characterised.
The document, which only applies to small-molecule drug candidates, states that the FDA 'strongly recommends [that] 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 per cent of parent drug systemic exposure at a 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,' he added.
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 that laboratories performing human radio-labelled studies need in order to detect and characterise metabolites derived from the parent drug.
