GDUFA Research Outcomes

Other Generics Research

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.

• All(57)
• Posters(10)
• Presentations(44)
• Papers(3)

• Post-Approval Impact of Generic Fluticasone Propionate & Salmeterol Inhalation Powder (RLD: Advair Diskus)

  Clerman, Andrew

• Scientific Challenges Related to Establishing Q1/Q2 Sameness-An Industry Perspective

  Bhattad, Nitin

• Ask us about Pre-ANDA Communication Pathways!

  Bengtson, Karen

• GDUFA III Redesigned Pre-Submission (PSUB) Meetings

  Bengtson, Karen

• Oral PBPK to Support BE Evaluation for Pediatric Drugs

  Batchelor, Hannah

• Challenges in Demonstrating API Sameness for Drug Products with Complex APIs

  Barretto, Francis Xavier

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

  Babiskin, Andrew

• Method Development for the Evaluation of Orally Inhaled Drug Products Containing Spray-Dried Phospholipid Porous Particles

  Sonju, Jafrin; Wanasathop, Apipa; Mohan, Abhinav; Dhapare, Sneha; Bielski, Elizabeth; Boc, Susan

• Regulatory Perspective of Considerations in Endogenous Therapeutic Analyte Bioanalysis

  Yu, Chongwoo; Jiang, Wenlei; Matta, Murali K; Wang, Rong; Haidar, Sam; Seo, Hyeonglim

• Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions

  Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaofei; Babiskin, Andrew; Yoon, Miyoung; Zhao, Liang; Fang, Lanyan