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.

• All(66)
• Posters(22)
• Presentations(29)
• Papers(15)

• 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

• 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

• 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

• 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

• 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

• 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 in Submitting Abbreviated New Drug Application of Generic Peptide Drug Products

  Zhang, Deyi

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

  Zhang, Deyi

• Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness

  Zhang, Deyi