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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Use of Data Analytics Approaches to Support Regulatory Assessment – from FDA Perspective
Hu, Meng
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Guidance for Peptide Products and Assessing Immunogenicity Risk
Pang, Eric
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Resolving Peptide Drug Challenges Through Pre-ANDA Processes
Pang, Eric
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Scientific and Regulatory Considerations for Synthetic Peptides Referencing Peptide Drug Products of rDNA Origin
Pang, Eric
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Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods
Kozak, Darby
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Introductory Remarks
Lionberger, Robert
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An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Xiaohui
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Non-clinical Evaluation of Comparative Immunogenicity Risk of Complex Peptide Products
Pang, Eric
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Overview: Non-clinical Immunogenicity Assessment of Generic Peptide Products
Pang, Eric; Vertheryi, Daniela
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Follow up Discussion on FDA Peptide Guidance after Public Comments
Jiang, Jeff