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.
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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
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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
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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
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Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin
Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui