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(18)
• Posters(3)
• Presentations(13)
• Papers(2)

• 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 in Developing Generic Peptide and Oligonucleotide Drug Products

  Zhang, Deyi

• Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness

  Zhang, Deyi

• Considerations in Demonstrating Complex API Sameness

  Zhang, Deyi

• Demonstrating Complex API Sameness

  Zhang, Deyi

• Guidance for Peptide Products and Assessing Immunogenicity Risk

  Pang, Eric

• Resolving Peptide Drug Challenges Through Pre-ANDA Processes

  Pang, Eric

• An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• Non-clinical Evaluation of Comparative Immunogenicity Risk of Complex Peptide Products

  Pang, Eric