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(58)
• Posters(20)
• Presentations(27)
• Papers(11)

• Comparative Characterization of Highly Heterogeneous Drugs

  Sasisekharan, Ram

• Use of Data Analytics Approaches to Support Regulatory Assessment – from FDA Perspective

  Hu, Meng

• Guidance for Peptide Products and Assessing Immunogenicity Risk

  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

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

  Kozak, Darby

• Introductory Remarks

  Lionberger, Robert

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

  Jiang, Xiaohui

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

  Pang, Eric

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

  Pang, Eric; Vertheryi, Daniela