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)

• In Vitro Immunogenicity Assays for Evaluating Generic Peptide Drug Products

  Pang, Eric

• 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

• Review of Advanced Analytical Methods in Complex Polymeric Drug Substance Characterization

  Li, Shaohua; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui

• Universal Open-source Software for Detecting Metabolites in Complex Mixtures by Scanning Precursors with Predetermined Neutral Lossed from MS/MS

  Kedia, Komal; Bilbao, Aivett; Zhou, Mowei; Payne, Samuel; Cort, John

• Mass Spectrometry Profiling of Pentosan Polysulfate Sodium (PPS)

  Kedia, Komal; Zheng, Xueyun; Zhou, Mowei; Ansong, Charles; Baker, Erin; Cort, John

• Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin

  Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui

• Development of an in-Vitro Protein Binding Method for the Evaluation of Bioequivalence of Sucralfate Suspension

  Feng, Xin; Al-Ghabeish, Manar; Lionberger, Robert; Cruz, Celia; Ashraf, Muhammad

• In Vitro Evaluation of the Performance of a Locally-acting Gastrointestinal Drug, Sucralfate

  Al-Ghabeish, Manar; Manar; Feng, Xin; Mohammad, Adil; Lionberger, Robert; Robert; Faustino, Patrick; Ashraf, Muhammad