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.
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Patient-Specific Aerosol Deposition Assessment – Technology and Validation
De Backer, J
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Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products
Conti, Denise
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Considerations for Pre-ANDA Meeting Requests for Orally Inhaled and Nasal Drug Products
Conti, Denise
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Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products
Conti, Denise
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Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products
Conti, Denise
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Current Product-specific Guidances and Common Questions in Pre-ANDA Communications
Conti, Denise
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Emerging Technologies for Bioequivalence of Generic Complex Drug-Device Combination Products
Conti, Denise
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Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled Drug Products
Clerman, Andrew
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Post-Approval Impact of Generic Fluticasone Propionate & Salmeterol Inhalation Powder
Clerman, Andrew
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Novel Method for Aerodynamic Particle Size Distribution Measurements from Respimat Inhalers
Chopski, Steven; Hu, Meng; Walenga, Ross; Boc, Susan; Newman, Bryan; Kakhi, Maziar; Zhao, Liang; Guha, Suvajyoti