GDUFA Research Outcomes
Complex Oral Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the oral route, including buccal and locally-acting gastrointestinal products.
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Characterization of Complex Excipients and Formulations
Wang, Yan
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Long Acting Injectable and Implantable Drug Product Development Regulatory Challenges and Considerations_GSK-CRS Conference
Wang, Yan
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Challenges Associated with Development of Generic PLGAPLA Based Drug Products
Wang, Yan
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Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling
Tan, Ming-Liang
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In Vitro Binding Studies for Bioequivalence Demonstration
Sun, Wei-Jhe
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Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing
Manna, Soumyarwit
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Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
Kozak, Darby
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Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment
Mousa, Youssef
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Development of Model-Informed Bioequivalence Evaluation Strategies for Long-Acting Injectable Products (LAI)
Karlsson, Matt; Chen, Xiaomei; Hooker, Andrew
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An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Xiaohui