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Hepatotoxicity caused by APAP overdose is one of the leading causes of acute liver failure (ALF) in the US and in some parts of Europe, limiting its clinical application

doi: 10.1089/ars.2013.5593 31 DixonS

Although strategies such as iron chelators (e.g., deferoxamine), antioxidants (e.g., N-acetylcysteine), and GPX4 activation demonstrate neuroprotective potential in animal and cellular models, their safety, tolerability, blood-brain barrier permeability, and ability to modulate disease progression in humans have not been systematically validated

Pfizer/Hospira and Fresenius Kabi set the documentation benchmark through FDA-registered cGMP manufacturing with per-lot COAs

doi: 10.3390/app11083590 18 AnuradhaKumariM.ZintaG.ChauhanR.KumarA.SinghS.et al