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In vivo metabolite identification and safety evaluation of human metabolites

7 December 2021

To support understanding whether the drug metabolites can be considered safe, Admescope provides numerous assays for metabolite identification (MetID) and profiling starting from in vitro cross-species comparison of the metabolic pathways in preclinical tox-species and human. The assays can be performed either using cold or radiolabelled compounds.

After the in vitro assays, an important step on the path of metabolites in safety testing (MIST) evaluation is in vivo MetID. The initial in vivo MetID should be performed as soon as the first in vivo samples are available to gain initial understanding for potential risk of having a disproportionate or unique human metabolite.

When the repeated dose samples are available from both human and tox-species, a MIST analysis is recommended to be performed. In this step, it is confirmed if adequate exposures to human metabolites are observed in preclinical tox-species according to FDA and EMA/ICH guidelines.

The final picture can be established, when samples from radiolabelled human ADME study are investigated for their metabolite profiles.

To discuss more about in vitro or in vivo MetID, please contact us at: info@admescope.com

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