GDUFA Research Outcomes
Mixture APIs
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are comprised of a mixtures (e.g., polymers) in generic products.
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Physicochemical Characterization of Complex Drug Substances: Evaluation of Structural Similarities and Differences of Protamine Sulfate from Various Sources
Awotwe Otoo, David; Agarabi, Cyrus; Keire, David; Lee, Sau; Raw, Andre; Yu, Lawrence; Habib, Muhammad; Khan, Mansoor; Shah, Rakhi
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Detection of Innate Immune Response Modulating Impurities (IIRMI) in Therapeutic Peptides and Proteins: Impact of Excipients
Thacker, Seth G; Her, Cheng; Kelley Baker, Logan; Ireland, Derek D C; Manangeeswaran, Mohanraj; Pang, Eric S; Verthelyi, Daniela
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Effect of Formulation and Peptide Folding on the Fibrillar Aggregation, Gelation, and Oxidation of a Therapeutic Peptide
Korang-Yeboah, Maxwell; Ketcham, Stephanie; Shih, Mack; Ako-Adounvo, Ann-Marie; Zhang, Jinhui; Bandaranayake, Bandaranayake; Abbey-Berko, Yvonne; Faustino, Patrick; Ashraf, Muhammed
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Scientific Considerations in the Review and Approval of Generic Enoxaparin in the United States
Lee, Sau; Raw, Andre; Yu, Lawrence; Lionberger, Robert; Ya, Naiqi; Verthelyi, Daniela; Rosenberg, Amy; Kozlowski, Steve; Webber, Keith; Woodcock, Janet
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An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide
Holley, Claire; Cedrone, Edward; Donohue, Duncan; Neun, Barry; Verthelyi, Daniela; Pang, Eric; Dobrovolskaia, Marina
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Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development
Zhang, Deyi
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Developing Product-Specific Guidances on Oligonucleotides for Generic Drug Development
Zhang, Deyi
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Considerations in Submitting Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi
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Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi
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Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness
Zhang, Deyi