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The component-resolved HPLC panel, the multi-target LC-MS run, the ICP copper measurement, and the LAL endotoxin assay all have to clear against pre-locked criteria before the lot is signed off, with a partial pass on any single assay triggering a hold rather than conditional release

This impairs Notch2 degradation and sustains oncogenic Notch2 signaling, which upregulates c-Myc and Cyclin D3 expression

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Kolodny et al., 2020)

Some clinicians start at 250 mcg and increase to 500 mcg if no response is seen after 2-3 weeks