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In: Handbook on the Toxicology of Metals

Water-soluble allyl sulfones for dual site-specific labelling of proteins and cyclic peptides

Safety, tolerability, and exploratory indicators of mitochondrial functioning were included among the secondary objectives ( Another 2021 open-label, single-center Phase I trial NCT04976127 looked at the safety, tolerability, and pharmacokinetics of intravenous TalineurenTM (TLN), a liposomal GM1 ganglioside for PD

PMID: 26586667

This is done both for the overall and, because 12 of the warning letters were solely for registration deficiencies without appearing to have evaluated other potential deficiencies, with those 12 removed