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(272)
• Posters(124)
• Presentations(72)
• Papers(76)

• Model-informed Drug Development for Long-acting Injectable Products

  Fang, Lanyan (Lucy)

• Applications of AI in Manufacturing of Pharmaceutical Products: Challenges and Opportunities

  Das, Jayanti

• Correlating Microstructure to Performance of PLGA Microspheres Using X ray Microscopy and AI Based Image Analysis

  Clark, Andrew

• Generic Drug Regulatory Research: In Vitro Equivalence Testing

  Choi, Stephanie

• Understanding In Situ Forming Implants and Development of Appropriate In Vitro Testing Methods

  Burgess, D

• IVRT Method Development for API Suspension Products and Validation with In Vivo Models

  Burgess, Diane J

• In Vitro Drug Release from Complex Parenterals and Development of IVIVCs

  Burgess, D

• Regulatory Utility of MMF for Development of Long-Acting Injectable Drug Products

  Babiskin, Andrew

• Mechanistic Modeling of Intramuscular Administration of Long-acting Injectable Suspensions Accounting for Fibrosis at the Depot Site

  Silva, Daniela Amaral; Malavia, Nilesh; Burgess, Daine J; Khondoker, Alam; Wang, Yan; Lukacova, Viera

• Understanding the Impact of Accelerated Release Testing Conditions on Transport Properties and Release Mechanisms of Drug from Long-acting Ethylene Vinyl Acetate Implants

  Ren, Angela; Zhong, Ziyue; Arbilo, Lance; Wang, Yan; Smith, William; Qin, Bin; Listro, Tony; Zhang, Feng