GDUFA Research Outcomes
LAI Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to long-acting injectable, insertable or implantable (collectively, LAI) generic products.
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Stochastic and Deterministic Analysis of Reactivity Ratios in the Partially Reversible Copolymerization of Lactide and Glycolide
Kuehster, Louise
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A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges
Kozak, Darby
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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
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Current Thinking and Research On In Vitro Only Approaches for Injectable Drug Substance Suspensions-A Scientific Discussion
Qin, Bin
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Bioequivalence of Long Acting Injectable (LAI) Suspensions: Current Perspective and Future Directions
Qin, Bin
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Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives
Jiang, Wenlei
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Correlating The In Vitro Dissolution Behavior Of Inhalation And Nasal Drug Products With In Vivo Performance: Pitfalls And Potential Solutions Using The Transwell System
Hochhaus, Guenther
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Model-Informed and Model-Integrated Approaches in BE Assessment of Long Acting Injectable Products
Sharan, Satish
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In Vitro Release Testing Of Complex Parenteral Dosage Forms
Shen, Jie