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(136)
• Posters(22)
• Presentations(67)
• Papers(47)

• Considerations for Pre-ANDA Meeting Requests for Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products

  Conti, Denise

• Current Product-specific Guidances and Common Questions in Pre-ANDA Communications

  Conti, Denise

• Emerging Technologies for Bioequivalence of Generic Complex Drug-Device Combination Products

  Conti, Denise

• Post-Approval Impact of Generic Fluticasone Propionate & Salmeterol Inhalation Powder

  Clerman, Andrew

• Physiologically Based Pharmacokinetic Modeling of Naloxone Hydrochloride Nasal Sprays

  Chopski, Steven; Al Ghabeish, Manar; Babiskin, Andrew; Zhao, Liang; Walenga, Ross

• Feasibility of Predicting Regional Lung Exposure from Systemic Pharmacokinetic (PK) Data of Generic OIDPs via Population PK

  Bulitta, J

• Complex Nasal Suspension PSGs: Utilization of Newly Recommended In Vitro Only Bioequivalence Option

  Boc, Susan

• The Current Status and Considerations for Dissolution Testing of Orally Inhaled Drug Products (OIDPs)

  Bielski, E