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)

• An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide

  Holley, Claire; Cedrone, Edward; Donohue, Duncan; Neun, Barry; Verthelyi, Daniela; Pang, Eric; Dobrovolskaia, Marina

• Considerations in Developing Generic Peptide and Oligonucleotide Drug Products

  Zhang, Deyi

• Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness

  Zhang, Deyi

• Considerations in Demonstrating Complex API Sameness

  Zhang, Deyi

• Demonstrating Complex API Sameness

  Zhang, Deyi

• Scientific Considerations in Submitting Synthetic Peptide Drug Products as ANDAs Referencing Peptide Drug products of rDNA origin

  Zhang, Deyi

• Developing a Statistical Approach to Facilitate Sameness Assessment of Complex Heterogenous Active Pharmaceutical Ingredients

  Weng, Yu Ting; Hu, Meng; Zhao, Liang; Wang, Chao; Shen, Meiyu; Gong, Xiajing

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

  Wang, Xiaoshi

• Scientific Considerations for the Assessment Immunogenicity Risk of Generic Synthetic Peptide Products

  Verthelyi, Daniela

• In Vitro Binding Studies for Bioequivalence Demonstration

  Sun, Wei-Jhe