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.

• All(300)
• Posters(133)
• Presentations(76)
• Papers(91)

• In Situ Forming Implants: The Effect of Drug-Polymer-Solvent Interplay on Depot Behavior

  Roy, McKenzie; Wang, Yan; Li, Qi; Burgess, Diane J

• Revolutionizing Women’s Health by Enabling the Rational Development of Long-Acting Contraceptive Levonorgestrel Intrauterine Systems

  Abhang, Ashwin; Fanse, Suraj; Zou, Yuan; Wang, Yan; Burgess, Diane J

• Beyond Particle Size: Impact of Milling Techniques on Agglomeration Behavior and In Vitro Performance of Long-Acting Injectable Suspensions

  Bhorkade, Saurabh; Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Wang, Yan; Burgess, Diane J

• Impact of Polyethylene Glycol Polymer in the Development of Long-Acting Injectable Suspensions

  Malavia, Nilesh; Bao, Quanying; Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Wang, Yan; Burgess, Diane J

• Population Balance Modeling of Aggregation in Long-Acting Injectable Formulations Integrated with PBPK Modeling

  Mullin, James M; Silva, Daniela; Alam, Khondoker; Al Shoyaib, Abdullah

• Physiologically Based Pharmacokinetic Modeling and Mechanistic In Vitro-In Vivo Correlation for Long-Acting Injectable Suspension

  Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Tsakalozou, Eleftheria; Al Shoyaib, Abdullah

• In Vitro Release Testing System Development for Buprenorphine In Situ Forming Implant

  Poudel, Surendra; Pangeni, Rudra; Zhang, Qiangnan; Wang, Yan; Qin, Bin; Halquist, Matthew S; Xu, Qingguo

• Microstructural and Compositional Analysis of Dexamethasone-Loaded Poly(Lactide-Co-Glycolide) Rods

  Garner, J; Hadar, Justin; Skidmore, S; Park, H; Park, K; Wang, Y; Jhou, Y; Smith, W; Zhang, D; Zou, Y

• A New Analytical Method for Quantifying Acid-End-Cap PLGA inSub-Milligram Quantities

  Garner, John; Skidmore, Sarah; Overdorf, Gary; Hadar, Justin; Park, Haesun; Park, Kinam; Wang, Yan; Jhon, Young Kuk; Smith, William C; Zhang, Deyi; Zou, Yuan

• Analysis of Copolymerization with Simultaneous Reversibility and Transesterification by Stochastic Model Regression

  Kuehster, Louise; Dai, Jingyi; Thompson, Avery; Jhon, Young Kuk; Wang, Yan; Bin, Qin; Smith, William; Xu, Xiaoming; Zhang, Feng; Lynd, Nathaniel