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)

• Assessing the Immunogenicity Risk of Salmon Calcitonin Peptide Impurities Using In Silico and In Vitro Methods

  Roberts, Brian J; Mattei, Aimee; Howard, Kristina E; Weaver, James L; Liu, Hao; Lelias, Sandra; Martin, William D; Verthelyi, Daniela; Pang, Eric; Edwards, Katie J; De Groot, Anne S

• Immunogenicity Risk Assessment of Synthetic Peptide Drugs and their Impurities

  De Groot, Anne S; Roberts, Brian J; Mattei, Aimee; Lalias, Sandra; Boyle, Christine; Martin, William

• Direct Assessment of Oligomerization of Chemically Modified Peptides and Proteins in Formulations using DLS and DOSY-NMR

  Wang, Kai; Chen, Kang

• Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs

  Chen, Kang; Smith, Cameron

• 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