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)

• PSG Recommendations and Updates for OINDPs

  Newman, Bryan

• Bioequivalence Considerations for Conducting Bridging Studies with Orally Inhaled and Nasal Drug Products

  Ma, Tian

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

  Luke, Markham; Witzmann, Kimberly; Conti, Denise

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

  Luke, Markham; Witzmann, Kimberly; Conti, Denise

• Session 3: Realistic Models for Prediction of Regional Drug Deposition from Orally Inhaled and Nasal Drug Products (OINDPs)

  Luke, Markham

• Bioequivalence Testing: Can Systemic Pharmacokinetic Profiles From Corticosteroid Nasal Sprays Be Used To Elucidate Local Drug Deposition Within The Nose?

  Longest, Worth; Rygg, Alex; Hindle, Michael

• New Tools for Generic OIDPs to Maximize Prospects of FDA Approval

  Lionberger, Robert

• Session 4: Computational Models to Understand In Vivo Performance of OINDPs

  Liang, Zhao

• Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products

  Li, Matt (Zhichuan)

• Session 2: Novel Analytical Tools for Characterization of Nasal Suspensions

  Jiang, Xiaohui