GDUFA Research Outcomes
Peptide APIs
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Demonstrating Complex API Sameness
Zhang, Deyi
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Regulations, Guidances, and Sameness Assessment for Generic GLP-1 Products
Pang, Eric
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In Vitro, In Silico Immunogenicity Assessments (IVISIA) of Generic Peptide Drug Products
Pang, Eric
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Assessing Immunogenicity Risk of Peptide Drugs: Generic Drug Perspective
Pang, Eric
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PSG Recommendations for Risk-based Comparative Immunogenicity and Impurity Profile Assessment
Pang, Eric
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Guidance for Peptide Products and Assessing Immunogenicity Risk
Pang, Eric
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Non-clinical Evaluation of Comparative Immunogenicity Risk of Complex Peptide Products
Pang, Eric
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Resolving Peptide Drug Challenges Through Pre-ANDA Processes
Pang, Eric
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Generic Drug User Fee Amendments (GDUFA) Research and the Product-Specific Guidance (PSG) Program for Complex Products: Challenges and Notable Advances
Kozak, Darby
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Follow up Discussion on FDA Peptide Guidance after Public Comments
Jiang, Jeff