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As part of its defense, Novo Nordisk points to its compliance with regulatory agencies, including the FDA

Topics include structural and functional equivalence demonstration, comprehensive analytical characterization strategies (including higher-order structure analysis and mass spectrometry), peptide-specific stability challenges and shelf-life determinations, impurity profiling and characterization, and an update on peptide impurity qualification

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Wang S, He G, Chen M, Zuo T, Xu W, Liu X