Terms & Definitions • 420 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.


• 421 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.


• 422 tissue distribution


The extent of penetration of the adinistered agent into in various tissues of the body.


• 423 top-down proteomics


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


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


• 425 total error


Sum of the absolute value of the errors in accuracy and precision, and reported as percentage error.


future science group


www.future-science.com


S101


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