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(202)
• Posters(97)
• Presentations(51)
• Papers(54)

• Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives

  Jiang, Wenlei

• 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

• Model-Informed and Model-Integrated Approaches in BE Assessment of Long Acting Injectable Products

  Sharan, Satish

• In Vitro Release Testing Of Complex Parenteral Dosage Forms

  Shen, Jie

• Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why

  Smith, William C

• Advanced Imaging and Data Analysis to Support Structure Similarity of Polymeric Formulations

  Wang, Yan

• Application of Quantitative Modeling and Simulations to Bioequivalence Determination for Long-Acting Injectables – Sharing Research Progress and Regulatory Experience

  Feng, Kairui

• Bioequivalence of Intravaginal Rings and Intrauterine Systems: Current Perspective and Future Directions

  Wang, Yan

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

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

  Fang, Lanyan (Lucy)