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Lda-Rgo G, Studart-Bott P, Abbade P, Rabelo-Da-Ponte FD, Casqueiro JS, Sarmento S, et al

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

The dataset spans a time period from September 1, 2002, to December 1, 2022