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In practice, this means specified and unspecified impurity thresholds, identity and immunogenicity justification for new impurities, and orthogonal methods to confirm impurity sameness against a reference listed drug
N-acetylcysteine, glycine and combinations described as GlyNAC provide substrates or precursors
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This explains a higher incidence of long-term effects in neonatal sepsis survivors but also underlines the importance of different strategies for sepsis treatment both with antioxidant administration and pharmacologic inhibition of pro-oxidant pathways in addition to antibiotics
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