GDUFA Research Outcomes
Peptide APIs
-
Current Thinking on Synthetic Peptides in Abbreviated New Drug Applications
Jiang, Jeff
-
Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Jeff
-
An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Xiaohui
-
Introduction to complex products and FDA considerations
Jiang, Jeff
-
Innate Immune Response Modulating Impurities Assay for Assessing Synthetic Semaglutide and Liraglutide
Lee, Jennifer K; Holley, Claire K; Dobrovolskaia, Marina A; Pang, Eric
-
In Vitro Assays for the Evaluation of Innate Immunogenicity in Generic Peptide Drug Products
Lee, Jennifer K; Manangeeswaran, Mohanraj; Verthelyi, Daniela; Pang, Eric
-
Semi-Validation of the LC-MS/MS Method for Identification and Comparative Quantification of Host Cell Protein (HCP) Impurities in Teriparatide Drug Products
Thawng, Cung; Sommers, Cynthia; Pang, Eric; Keire, David; Zhu, Hongbin
-
In-Vitro Assessment of Comparative Immunogenicity for Generic Synthetic Peptide Drug Products
Pang, Eric; Liao, Kuo-Tang; Holley, Claire K; Dobrovolskaia, Marina A; Verthelyi, Daniela
-
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
-
Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin
Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui