Definitions


323. outlier A result that differs unreasonably from the others in a set of data, and is therefore a suspect measurement. Outliers may be verified as such using statistical approaches.


324. over-curve concentration A sample with concentration above the validated range of the analytical method (>upper limit of quantitation [ULOQ]).


325. PandA (precipitation and acid dissociation) An immunoassay that uses precipitation and acid dissociation to overcome drug interference in immunogenicity assays.


326. parallel-line analysis (PLA) A statistical method for the comparison of potency between a reference product and test product. It is used to calculate relative potency by comparing the dose–response curves of products.


the two


327. parallel reaction monitoring (PRM) In PRM, the third quadrupole of the mass spectrometer is substituted with a high-resolution mass analyzer to permit the parallel detection of all target product ions in one analysis.


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