GDUFA Research Outcomes
Peptide APIs
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Immunogenicity Risk Assessment of Synthetic Peptide Drugs and their Impurities
De Groot, Anne S; Roberts, Brian J; Mattei, Aimee; Lalias, Sandra; Boyle, Christine; Martin, William
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Direct Assessment of Oligomerization of Chemically Modified Peptides and Proteins in Formulations using DLS and DOSY-NMR
Wang, Kai; Chen, Kang
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A Precise qNMR Method for the Rapid Quantification of Lot-to-Lot Variations in Multiple Quality Attributes of Pentosan Polysulfate Sodium
Wang, Kai; Dai, Weixiang; Qian, Keduo; Scott, Barbara; Chen, Kang
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Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs
Chen, Kang; Smith, Cameron
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Liquid Chromatography-High Resolution Mass Spectrometry for Peptide Drug Quality Control
Zeng, Kui; Geerlof Vidavisky, Ilan; Gucinski, Ashley; Jiang, Xiaohui; Boyne II, Michael
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Scientific Considerations for Generic Synthetic Salmon Calcitonin Nasal Spray Products
Lee, Sau; Yu, Lawrence; Cai, Bing; Johnsons, Gibbes; Rosenberg, Amy; Cherney, Barry; Guo, Wei; Raw, Andre
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Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi
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Considerations in Developing Generic Peptide and Oligonucleotide Drug Products
Zhang, Deyi
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Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness
Zhang, Deyi
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Considerations in Demonstrating Complex API Sameness
Zhang, Deyi