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)

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

  Zhang, Deyi

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

  Zhang, Deyi

• Considerations in Developing Generic Peptide and Oligonucleotide Drug Products

  Zhang, Deyi

• Considerations in Demonstrating Complex API Sameness

  Zhang, Deyi

• Demonstrating Complex API Sameness

  Zhang, Deyi

• LC-HRMS-based Multi-attribute Method for Oligonucleotides (MAMO): Characterization and Impurity Profiling

  Yang, Kui

• LC-HRMS-based Multi-Attribute Method for Oligonucleotides (MAMO)

  Yang, Kui; Abdhullah, Alm; Islam, Rabiul; Dieke, Nnenna; Sommers, Cynthia; Rodriguez, Jason; Zhang, Deyi; Kozak, Darby; Keire, David

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

  Pang, Eric

• Resolving Peptide Drug Challenges Through Pre-ANDA Processes

  Pang, Eric

• Opportunities and Challenges: Generic Oligonucleotide Drugs

  Luke, Markham