GDUFA Research Outcomes

Mixture APIs

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are comprised of a mixtures (e.g., polymers) in generic products.

• All(66)
• Posters(22)
• Presentations(29)
• Papers(15)

• Overview: Non-clinical Immunogenicity Assessment of Generic Peptide Products

  Pang, Eric; Vertheryi, Daniela

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

  Pang, Eric

• Resolving Peptide Drug Challenges Through Pre-ANDA Processes

  Pang, Eric

• Scientific and Regulatory Considerations for Synthetic Peptides Referencing Peptide Drug Products of rDNA Origin

  Pang, Eric

• Introductory Remarks

  Lionberger, Robert

• Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods

  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