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Proteomic analyses have revealed that, although many of the same mouse liver proteins are modified covalently by metabolites of the two compounds in vivo, that acetaminophen selectively forms adducts with various mitochondrial proteins (Myers et al
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Consistent with the role of KG in de novo carnitine synthesis through TMLHE, we observed an increase in H2AX foci following TMLHE knockdown, which was rescued by l-carnitine and acetylcarnitine, but was not markedly rescued by KG, propionylcarnitine or butyrylcarnitine (Fig
Unlike domestic FDA guidance, ICH E6(R3) carries harmonized weight across FDA, EMA, PMDA, and MHRA-regulated trial submissions, enabling sponsors to design global protocols against a single set of GCP principles rather than navigating jurisdiction-specific interpretations
