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.
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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
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A humanized mouse model to predict immunogenicity of impurities in generic peptide drugs
Sung, Jungeun; Becker, Robyn; Knapton, Alan; Pang, Eric; Howard, Kristina
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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
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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
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In Vitro Immunogenicity Assays for Evaluating Generic Peptide Drug Products
Pang, Eric
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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
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Review of Advanced Analytical Methods in Complex Polymeric Drug Substance Characterization
Li, Shaohua; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui
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Mass Spectrometry Profiling of Pentosan Polysulfate Sodium (PPS)
Kedia, Komal; Zheng, Xueyun; Zhou, Mowei; Ansong, Charles; Baker, Erin; Cort, John
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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
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Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin
Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui