430. significant human metabolite A metabolite seen in humans that is either greater than 10% of all drug-related material in circulation or a metabolite whose exposure in humans is greater than that seen in animal species. A significant human metabolite typically requires additional monitoring or studies to demonstrate its safety.
431. single-dose administration Administration of a single dose of drug by the selected route.
432. size-exclusion chromatography Chromatographic separation mode based on the relative sizes of the analytes.
433. solid-phase analytical derivatization A technique whereby analytes are derivatized while being retained on solid phase analytical extraction support.
434. solid-phase extraction (SPE) A sample preparation procedure using packed solid sorbent and a defined protocol of conditioning, equilibration, sample pretreatment, loading and elution to provide a separation of analytes from other biological components.
