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)

• Follow up Discussion on FDA Peptide Guidance after Public Comments

  Jiang, Jeff

• Current Thinking on Synthetic Peptides in Abbreviated New Drug Applications

  Jiang, Jeff

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

  Jiang, Jeff

• Introduction to complex products and FDA considerations

  Jiang, Jeff

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

  Zhang, Deyi

• 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

• 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

• Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin

  Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui