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)

• Introduction to complex products and FDA considerations

  Jiang, Jeff

• Use of Data Analytics Approaches to Support Regulatory Assessment – from FDA Perspective

  Hu, Meng

• Complex Nasal Suspension PSGs: Utilization of Newly Recommended In Vitro Only Bioequivalence Option

  Boc, Susan

• Q1 and Q2 Recommendations: Sucralfate Oral Suspension

  Al Ghabeish, Manar

• Characterization of Intravenous Iron Supplements: Injectafer

  Zhang, Tianyun; Shamim, Md Abdullah; Tower, Cole; Sapkota, Rachana; Munson, Eric J; Liu, Dahui; Chen, Kang; Jiang, Wenlei; Wang, Yan; Zhang, Deyi

• Scanning Analysis of Semi-solvent Vapor Impact (SAVI): Microstructural and Compositional Analysis of Leuprolide-loaded Poly(lactide-co-glycolide) Microparticles

  Garner, J; Hadar, J; Skidmore, S; Jessmon, F; Park, H; Park, K; Otte, A; Xu, X; Jhon, Y K; Qin, B; Wang, Y

• Solid State 13C NMR Analysis of Patiromer

  Zhang, Deyi; Li, Shaohua; Jarrells, Travis; Munson, Eric; Kozak, Darby; Jiang, Xiaohui

• Therapeutic Teriparatide Peptides Quality Control by Liquid Chromatography Mass Spectrometry

  Zeng, Kui; Geerlof-Vidavsky, Ilan; Wang, Xiaoshi; Rogstad, Sarah; Pang, Eric; Keire, David

• Therapeutic Teriparatide Peptides Quality Control by Liquid Chromatography Mass Spectrometry

  Zeng, K; Pang, E; Keire, D; Geerlof-Vidavsky, Ilan

• Develop and Validate a LC-MS Method to Establish Impurity Profile in the RLD for Teriparatide

  Zeng, Kui; Pang, Eric; Keire, David