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)

• 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

• Introduction to complex products and FDA considerations

  Jiang, Jeff

• Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development

  Zhang, Deyi

• Developing Product-Specific Guidances on Oligonucleotides for Generic Drug Development

  Zhang, Deyi

• Considerations in Submitting Abbreviated New Drug Application of Generic Peptide Drug Products

  Zhang, Deyi

• Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products

  Zhang, Deyi

• Solid State 13C NMR Analysis of Patiromer

  Zhang, Deyi; Li, Shaohua; Jarrells, Travis; Munson, Eric; Kozak, Darby; Jiang, Xiaohui

• Therapeutic Teriparatide Peptides Quality Control by Liquid Chromatography Mass Spectrometry

  Zeng, Kui; Geerlof-Vidavsky, Ilan; Wang, Xiaoshi; Rogstad, Sarah; Pang, Eric; Keire, David