GDUFA Research Outcomes

Inhalation Products

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

• All(217)
• Posters(37)
• Presentations(91)
• Papers(89)

• Generic Drug Development for Respiratory Products: US Food and Drug Administration Update

  Witzmann, Kimberly

• Critical Importance of Excipients in Generic Product Development- Now and in the Future

  Witzmann, Kimberly

• 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

• Impact of Excipients on Inhalation Products

  Witzmann, Kimberly

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

  Walenga, Ross

• Impact of Orally Inhaled and Nasal Drug Product PBPK Models on Product Development and Regulatory Decision Making

  Walenga, Ross