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(58)
• Posters(20)
• Presentations(27)
• Papers(11)

• The Role of Mass Spectrometry in the Characterization of Biologic Protein Products

  Rathore, Deepali; Faustino, Anneliese; Schiel, John; Pang, Eric; Boyne, Michael; Rogstad, Sarah

• Bioequivalence Approaches for Highly Variable Drugs and Drug Products

  Haidar, Sam; Davit, Barbara; Chen, Meiling; Conner, Dale; Lee, Laiming; Li, Qian; Lionberger, Robert; Makhlouf, Fairouz; Patel, Devvrat; Schuirmann, Donald; Yu, Lawrence

• 2D NMR Peak Profiling to Compare Chemical Differences between Batches of Pentosan Polysulfate Sodium

  Chen, Kang

• Quantification of Monomer Units in Insoluble Polymeric Active Pharmaceutical Ingredients Using Solid-State NMR Spectroscopy I: Patiromer

  Jarrells, Travis; Zhang, Deyi; Li, Shaohua; Munson, Eric

• Tandem Mass Spectrometric Sequence Characterization of Synthetic Thymidine-Rich Oligonucleotides

  Abdullah, A M; Sommers, Cynthia; Hawes, Jessica; Rodriguez, Jason D; Yang, Kui

• Marketplace Analysis of Conjugated Estrogens: Determining the Consistently Present Steroidal Content with LC-MS

  Levy, Michaella; Boyne II, Michael; Rogstad, Sarah; Skanchy, David; Jiang, Xiaohui; Geerlof Vidavsky, Ilan

• 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