GDUFA Research Outcomes
Peptide APIs
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are peptides, including associated impurities in generic products.
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Innate Immune Response Modulating Impurities Assay for Assessing Synthetic Semaglutide and Liraglutide
Lee, Jennifer K; Holley, Claire K; Dobrovolskaia, Marina A; Pang, Eric
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In Vitro Assays for the Evaluation of Innate Immunogenicity in Generic Peptide Drug Products
Lee, Jennifer K; Manangeeswaran, Mohanraj; Verthelyi, Daniela; Pang, Eric
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Semi-Validation of the LC-MS/MS Method for Identification and Comparative Quantification of Host Cell Protein (HCP) Impurities in Teriparatide Drug Products
Thawng, Cung; Sommers, Cynthia; Pang, Eric; Keire, David; Zhu, Hongbin
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In-Vitro Assessment of Comparative Immunogenicity for Generic Synthetic Peptide Drug Products
Pang, Eric; Liao, Kuo-Tang; Holley, Claire K; Dobrovolskaia, Marina A; Verthelyi, Daniela
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Evaluation of Quantitative Capsule Rupture Test Methods and Data Variability in Generic Omega-3 Capsule Applications
Liu, Hao; Suh, Min Sung; Kozak, Darby; Pang, Eric
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Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin
Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui