The Bioanalysis Glossary • 171 instrument qualification (IQ/OQ/PQ)


A process that tests the suitability of the given instrument(s) and associated software/hardware for their intended usage by following a predefined protocol.


• 172 inter-assay accuracy


Accuracy as it pertains to within multiple analytical occasions, typically from a mean of 18 replicates over three analytical occasions (six or more replicates on three occasions) and a corresponding nominal concentration.


• 173 inter-assay precision


Precision of the replicate measurement of an analyte between separate analytical occasions, typically measured in terms of CV for each nominal concentration.


• 174 interference


The effect of substances present in samples on the accuracy of measurement of analytes.


• 175 interim data


A report of results and their evaluation based on analyses performed during the course of a trial or experiment prior to their completion.


• 176 intermediate precision


A measure of precision that reflects within-laboratory variations: different days, different analysts, different equipment, among others.


• 177 internal standard


Test substance(s) (e.g., a physicochemically similar analogue, or stable iso- tope-labeled compound) added to calibration standards, quality control samples (QCs) and study samples at a known and constant concentration to correct for experimental variability during sample preparation and analysis.


S44 Bioanalysis (2016) 8(21) Suppl. 1 future science group


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