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.

• All(30)
• Posters(6)
• Presentations(18)
• Papers(6)

• 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

• Direct Assessment of Oligomerization of Chemically Modified Peptides and Proteins in Formulations using DLS and DOSY-NMR

  Wang, Kai; Chen, Kang

• 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

• Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs

  Chen, Kang; Smith, Cameron

• Liquid Chromatography-High Resolution Mass Spectrometry for Peptide Drug Quality Control

  Zeng, Kui; Geerlof Vidavisky, Ilan; Gucinski, Ashley; Jiang, Xiaohui; Boyne II, Michael

• 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

• Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products

  Zhang, Deyi

• Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness

  Zhang, Deyi

• Considerations in Developing Generic Peptide and Oligonucleotide Drug Products

  Zhang, Deyi

• Considerations in Demonstrating Complex API Sameness

  Zhang, Deyi