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)

• Rapid Screening of Peptide Impurities in Calcitonin-Salmon Nasal Spray Using Data-Dependent LC-MS-MS and Data-Independent LC-MS

  Yang, Jingyue; Chitranshi, Priyanka; Zeng, Kui; Keire, David; Trehy, Michael; Jiang, Wenlei; Zhang, Deyi; Jiang, Xiaohui; Verthelyi, Daniela; Geerlof-Vidavsky, Ilan

• Quantitative comparison of peptide impurities in teriparatide from biological and synthetic origin using LC-MS/MS

  Weisz, Daniel; Geerlof-Vidavsky, Ilan; Zeng, Kui; Rogstad, Sarah

• Quantitative comparison of peptide impurities in teriparatide from biological and synthetic origin using LC-MS/MS

  Weisz, Daniel; Geerlof-Vidavsky, Ilan; Zeng, Kui; Jiang, Xiaohui; Pang, Eric

• Identification and Quantitation of Host Cell Protein Impurities in Peptide Biotherapeutics using Liquid Chromatography-Mass Spectrometry

  Wang, Xiaoshi; Pang, Eric; Jiang, Xiaohui; Rogstad, Sarah

• Exploring Factors Affecting Nifedipine Biphasic Dissolution Profile Using an inForm Platform

  Tian, Li; Box, Karl; Swoboda, Moriah; Tang, Fuxing; Lin, Ho-Pi; Jiang, Wenlei; Ruzicka, Connie; Rodriguez, Jason; Gao, Zongming

• A humanized mouse model to predict immunogenicity of impurities in generic peptide drugs

  Sung, Jungeun; Becker, Robyn; Knapton, Alan; Pang, Eric; Howard, Kristina

• A non-Clinical Animal Model to Predict Therapeutic Peptide and Biological Drug Product Immunogenicity

  Sung, Jungeun; San Emeterio, Cheryl; Hosain, Salman; Knapton, Alan; Pang, Eric; Howard, Kristina

• Quantification of Lysophosphatidylcholines (LPCs) and Free Fatty Acids (FFAs) in Parenteral Liposomal Formulations by Liquid Chromatography – Mass Spectrometry (LC-MS)

  Siriwardane, Dumindika; Wang, Changguang; Ansar, Siyam; Jiang, Wenlei; Mudalige, Thilak

• 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