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)

• 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

• Comparative Characterization of Highly Heterogeneous Drugs

  Sasisekharan, Ram

• Guidance for Peptide Products and Assessing Immunogenicity Risk

  Pang, Eric

• Non-clinical Evaluation of Comparative Immunogenicity Risk of Complex Peptide Products

  Pang, Eric

• Overview: Non-clinical Immunogenicity Assessment of Generic Peptide Products

  Pang, Eric; Vertheryi, Daniela

• Scientific and Regulatory Considerations for Synthetic Peptides Referencing Peptide Drug Products of rDNA Origin

  Pang, Eric

• Resolving Peptide Drug Challenges Through Pre-ANDA Processes

  Pang, Eric

• Introductory Remarks

  Lionberger, Robert