GDUFA Research Outcomes

Nasal Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the nasal route, including nasal sprays.

• All(103)
• Posters(15)
• Presentations(53)
• Papers(35)

• Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA

  Witzmann, Kimberly

• Generic Drug Development For Respiratory Products, US Food And Drug Administration Update

  Witzmann, Kimberly

• The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA

  Witzmann, Kimberly

• Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products

  Witzmann, Kimberly

• Predictive Dissolution Methods fro OINDPs

  Witzmann, Kimberly

• Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products

  Walenga, Ross

• Modeling of CNS Delivery for Nose-to-Brain Targeted Drug Products

  Walenga, Ross

• In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development

  Walenga, Ross

• Credibility Establishment for Computational Fluid Dynamics Models of Complex Generic Drug Delivery

  Walenga, Ross

• Computational Fluid Dynamics (CFD) Modeling for Product Development of Generic OINDPs and for Supporting Novel BE Approaches

  Walenga, Ross