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)

• 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