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FDA consumer context worth knowing: The FDA has published consumer guidance expressing concerns about unapproved GLP-1 products marketed for weight loss, including quality and dosing concerns and, in some cases, products that may use semaglutide salt forms that are not the same active ingredient as the FDA-approved reference drug

10.3389/fmicb.2018.01478 Front

10.1016/j.jff.2019.01.011 [DOI] [Google Scholar] 97.Liu A, Lin L, Xu W, Gong Z, Liu Z, Xiao W

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Detailed structural confirmation for regulatory filing: Peptide Sequencing and Mapping for Sameness Studies LC-MS Characterization of GLP-1 Peptides in Biosimilar and Follow-On Products LC-MS Characterization of GLP-1 Peptides is especially important during biosimilar development and comparability studies

Feb 2020