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(32)
• Posters(6)
• Presentations(20)
• Papers(6)

• Generic Drug User Fee Amendments (GDUFA) Research and the Product-Specific Guidance (PSG) Program for Complex Products: Challenges and Notable Advances

  Kozak, Darby

• 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

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

  Jiang, Xiaohui

• Introduction to complex products and FDA considerations

  Jiang, Jeff

• Innate Immune Response Modulating Impurities Assay for Assessing Synthetic Semaglutide and Liraglutide

  Lee, Jennifer K; Holley, Claire K; Dobrovolskaia, Marina A; Pang, Eric

• In Vitro Assays for the Evaluation of Innate Immunogenicity in Generic Peptide Drug Products

  Lee, Jennifer K; Manangeeswaran, Mohanraj; Verthelyi, Daniela; Pang, Eric

• Semi-Validation of the LC-MS/MS Method for Identification and Comparative Quantification of Host Cell Protein (HCP) Impurities in Teriparatide Drug Products

  Thawng, Cung; Sommers, Cynthia; Pang, Eric; Keire, David; Zhu, Hongbin

• 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