The Bioanalysis Glossary • 382 therapeutic drug monitoring


Clinical monitoring of patient drug concentrations in plasma, serum or blood in order to enhance treatment efficacy, or reduce toxicity. Typically used to treat patients taking marketed drugs with a narrow therapeutic range (those which can be easily under- or overdosed).


• 383 tiered approach


A science-driven, fit-for-purpose strategy for scientific validation applying a predefined appropriate level of bioanalytical quality, for the analysis of biological samples originating from preclinical and clinical studies. Level of pre- or in-study validation, acceptance criteria and documentation depend on the intended use of the concentration data, and consider the type of study (assay-appropriate scientific validation), and/or the stage of drug development (stage- appropriate scientific validation and regulatory validation) in which the study data are generated.


• 384 time-of-flight mass spectrometry (TOF-MS)


Mass analyzer that utilizes a field-free vacuum chamber to separate ions by their velocity (heavier ions of the same charge reach lower speeds). The time-of-flight is then converted into the accurate mass of the observed ion.


• 385 tissue distribution


The extent of accumulation of a therapeutic agent or chemical substance in various organs.


• 386 top down proteomics


Top down approach is identifying proteins in mixtures without prior proteolytic digestion into corresponding peptides.


• 387 total drug The sum of the bound and free drug within a biological system.


S86


Bioanalysis (2016) 8(21) Suppl. 1


future science group


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