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(44)
• Posters(10)
• Presentations(21)
• Papers(13)

• Multinuclear 1H/13C/15N Chemical Shift Assignment of Therapeutic Octreotide Acetate Performed at Natural Abundance

  Menke, Alexander; Chen, Fu; Chen, Kang

• Anti-drug Antibody Sample Testing and Reporting Harmonization

  Jani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura Schild; Ward, Bethany; Cowan, Kyra J; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R; Coble, Kelly; Dholakiya, Sanjay L; Dusseault, J; Hays, Amanda; Herl, Carina; Hodson, Michael E; Irvin, Susan C; Kirshner, Susan; Kolaitis, Gerry; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D; Moldovan, Ioana R; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary-Lehmann, Magdalena; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Williams, William T; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don

• Immunogenicity Risk Assessment of Synthetic Peptide Drugs and their Impurities

  De Groot, Anne S; Roberts, Brian J; Mattei, Aimee; Lalias, Sandra; Boyle, Christine; Martin, William

• Direct Assessment of Oligomerization of Chemically Modified Peptides and Proteins in Formulations using DLS and DOSY-NMR

  Wang, Kai; Chen, Kang

• Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs

  Chen, Kang; Smith, Cameron

• Comparability in Generic Oligonucleotide Drug Development: Regulatory Considerations and Case Studies

  Zhang, Deyi

• Product-Specific Guidance Development for Patisiran Sodium Intravenous Solution

  Zhang, Deyi; Bin, Qin; Wang, Yan

• 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 for Abbreviated New Drug Application of Generic Peptide Drug Products

  Zhang, Deyi