GDUFA Research Outcomes

Oligonucleotide APIs

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are oligonucleotides, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), and associated impurities in generic products.

• All(36)
• Posters(8)
• Presentations(21)
• Papers(7)

• 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

• High-Resolution Ion Mobility Mass Spectrometry for Oligonucleotide Impurity Analysis

  Dieke, Nnenna; Shipman, Joshua; Sommers, Cynthia; Rodriguez, Jason; Zhang, Deyi; Kozak, Darby; Yang, Kui

• Comprehensive Impurity Profiling of Synthetic Oligonucleotides by High-Resolution Mass Spectrometry Intact Mass Data Processing

  Abdullah, A M; Sommers, Cynthia; Rodriguez, Jason; Zhang, Deyi; Kozak, Darby; Yang, Kui

• FDA’s Efforts in Facilitating Generic Oligonucleotide Drug Development

  Zhang, Deyi; Yang, Kui; Liang, Likan; Zhang, Li; Kozak, Darby

• Semi-Validation of the LC-MS/MS Method for Identification and Comparative Quantification of Host Cell Protein (HCP) Impurities in Teriparatide Drug Products

  Thawng, Cung; Sommers, Cynthia; Pang, Eric; Keire, David; Zhu, Hongbin