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)

• 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

• Effect of Process Parameters and Buffer Exchange on the Critical Quality Attributes of siRNA Loaded Lipid Nanoparticles

  Ranjbar, Sheyda; O’Reilly Beringhs, Andre; Bin, Qin; Wang, Yan; Lu, Xiuling

• Validation of HILIC-HRMS Method for Oligonucleotide Analysis

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

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

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

• Validation of HILIC-HRMS Method for Quantitative Oligonucleotide Analysis

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

• Evaluation of Quantitative Capsule Rupture Test Methods and Data Variability in Generic Omega-3 Capsule Applications

  Liu, Hao; Suh, Min Sung; Kozak, Darby; Pang, Eric

• Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin

  Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui