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Can I use
the in vitro micronucleus test as part of the standard battery?
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Yes. ICH states, “Several in vitro mammalian cell systems are widely used and can be considered sufficiently validated: The in vitro metaphase chromosome aberration assay, the in vitro micronucleus assay and the mouse lymphoma L5178Y cell Tk (thymidine kinase) gene mutation assay (MLA). These three assays are currently considered equally appropriate and therefore interchangeable for measurement of chromosomal damage...”
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MicroFlow In Vitro Kits use flow cytometry to analyze hundreds of samples in just a few hours. This method supports both attachment and suspension cell lines. Contact us for more information on how In Vitro MicroFlow kits can support your regulatory submissions.
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