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)

• 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

• Demonstrating Complex API Sameness

  Zhang, Deyi

• Assessing Immunogenicity Risk of Peptide Drugs: Generic Drug Perspective

  Pang, Eric

• Regulations, Guidances, and Sameness Assessment for Generic GLP-1 Products

  Pang, Eric

• In Vitro, In Silico Immunogenicity Assessments (IVISIA) of Generic Peptide Drug Products

  Pang, Eric

• PSG Recommendations for Risk-based Comparative Immunogenicity and Impurity Profile Assessment

  Pang, Eric

• Guidance for Peptide Products and Assessing Immunogenicity Risk

  Pang, Eric