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FIGURE 8 The aforementioned abnormalities at the molecular level (downregulation of the Nrf2/HO-1 axis and GPX4) and subcellular structural level (neuronal somata and mitochondrial impairment) were consistent with the GSH metabolism perturbations identified by multi-omics analyses, collectively reflecting oxidative stress-associated damage in the hippocampus during SAE

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In the warning letter, FDA includes several repeat observations from 2022, including discoloration on equipment in the ISO 5 area, monitoring environmental conditions in aseptic processing areas, and failure to establish and follow appropriate written procedures to prevent microbiological contamination

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This process also produces NADH