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Mass balance studies in humans are also known as absorption, distribution, metabolism, and excretion (ADME) studies. In general, they are carried out using a radiolabeled version of the medical product to be evaluated [1].
Mass balance excretion studies/human radiolabeled mass balance studies in laboratory animals and humans using radiolabeled compounds constitute a standard part of the drug development process. From them, the fate of drug-related materials is assessed, including routes of excretion and, with additional analyses, metabolic pathways. In these studies, the total mass balance of drug-related material (represented by radiolabeled molecules) in excreta is quantified, as is the time course of excretion of total drug-related materials. The systemic pharmacokinetics (PK) of total radioactivity are assessed, and, lastly, the excreta and blood samples gathered in such studies are used for identification and quantitative profiling of the...
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Quiroga, P.A.M. (2022). Bioavailability: Mass Balance Studies. In: Talevi, A. (eds) The ADME Encyclopedia. Springer, Cham. https://doi.org/10.1007/978-3-030-84860-6_134
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DOI: https://doi.org/10.1007/978-3-030-84860-6_134
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