472. 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.
473. 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.
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474. tissue distribution The extent of penetration of the administered agent into various tissues of the body.
