The Bioanalysis Glossary • 12 analyte


A specific chemical moiety being determined, which can be an intact drug, biomolecule or its derivative, metabolite and/or degradation product in a biologic matrix.


• 13 analyte fortification


Addition of the compound of interest to the biological matrix for preparation of calibration standard or quality control samples (QCs). A common informal term is ‘spiking’.


• 14 analytical procedure


The sequence of steps necessary to perform a complete analysis described in adequate detail to permit the procedure to be reliably and reproducibly performed by someone knowledgeable in the field. See also “method”.


• 15 analytical range


The range of concentration or other quantity values (units) in the specimen over which the method is applicable without modification.


• 16 analytical run


A complete set of analytical and study samples including an appropriate number of standards and quality control samples (QCs).


• 17 anchor calibrator


Standard point outside of the range of quantification, used to assist in fitting the nonlinear regression (e.g., 4-parameter or 5-parameter logistic) of the standard (calibration) curve in ligand-binding assays (LBA).


• 18 antibody


A protein molecule elicited in response to treatment with an antigen that is capable of binding to a specific determinant on the antigen. Also used as biotherapeutics.


S10 Bioanalysis (2016) 8(21) Suppl. 1 future science group


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