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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Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development
Zhang, Deyi
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Developing Product-Specific Guidances on Oligonucleotides for Generic Drug Development
Zhang, Deyi
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Considerations in Submitting Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi
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Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi
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Characterization and Comparative Evaluation Strategies to Demonstrate Complex API Sameness
Zhang, Deyi
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Considerations in Developing Generic Peptide and Oligonucleotide Drug Products
Zhang, Deyi
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Considerations in Demonstrating Complex API Sameness
Zhang, Deyi
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Scientific Considerations in Submitting Synthetic Peptide Drug Products as ANDAs Referencing Peptide Drug products of rDNA origin
Zhang, Deyi
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Demonstrating Complex API Sameness
Zhang, Deyi
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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