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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Correlation between Polymer Properties, Extrusion Process Parameters and Permeability of Etonogestrel in Ethylene Vinyl Acetate Films
Zhong, Ziyue; Ren, Angela; Arbilo, Lance; Zhang, Qiangnan; Smith, William; Qin, Bin; Wang, Yan; Zhang, Feng
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Impact of Agglomeration on In Vitro Performance of Long-Acting Injectable Suspensions
Malavia, Nilesh; Bao, Quanying; Silva, Daniela Amaral; Wang, Yan; Alam, Khondoker; Lukacova, Viera; Burgess, Diane J
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Leveraging Model Master Files for Long-Acting Injectables
Gong, Yuqing; Hopefl, Robert; Li, Tonglei; Hooker, Andrew C; Silva, Daniela Amaral; Alam, Khondoker; Ducharme, Murray; Moody, Rebecca; Saha, Pratik; Babiskin, Andrew
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In Vitro-In Vivo Correlation (IVIVC) Development for Long-Acting Injectable Drug Products based on Poly(lactide-co-glycolide)
Wang, Yan; Otte, Andrew; Park, Haesun; Park, Kinam
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Manufacture, Characterization, and Elucidation of Drug Release Mechanisms of Etonogestrel Implants based on Ethylene Vinyl Acetate
Ren, Angela; Zhong, Ziyue; Wang, Yan; Qin, Bin; Smith, William; Xu, Xiaoming; Listro, Tony; Zhang, Feng
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Predicting Drug Release from Long-Acting Implants: Mechanisms, Modeling, and Simulation
Zhong, Ziyue
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Compositional Sameness for Complex Polymeric Excipients: Progress and Remaining Challenges
Qin, Bin
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Considerations of Bioequivalence Studies for Long-Acting Injectables and the Application of Model-Integrated Evidence Approaches
Gong, Yuqing
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Navigating Formulation Assessment: Considerations When Preparing the Q1/Q2 Sameness Inquiry
Zhang, Qiangnan
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Predicting Drug Release from EVA-Based Long-Acting Implants: Mechanisms, Modeling, and Simulation of Drug Release
Zhong, Ziyue; Ren, Angela; Smith, William; Qin, Bin; Wang, Yan; Zhang, Feng