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)

• 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

• Introduction to complex products and FDA considerations

  Jiang, Jeff

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

  Hu, Meng

• Complex Nasal Suspension PSGs: Utilization of Newly Recommended In Vitro Only Bioequivalence Option

  Boc, Susan

• Q1 and Q2 Recommendations: Sucralfate Oral Suspension

  Al Ghabeish, Manar