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(283)
• Posters(52)
• Presentations(126)
• Papers(105)

• Generic MDI LGWP Propellant Transition: OGD Framework and Data Submission Considerations

  Bielski, Elizabeth

• FDA Recommendations for Alternative Bioequivalence Approaches: Design and Rationale for In Vitro and In Vivo Studies

  Bielski, Elizabeth; Boc, Susan

• Recent Updates for the Use of Alternative Approaches for Demonstrating Bioequivalence with OIDPs

  Bielski, Elizabeth

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

  Bielski, E

• Loxapine Inhalation Powder: OTR Research Conducted to Inform the PSG Recommendations

  Bielski, Elizabeth; Reed, Nathan

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

  Bielski, Elizabeth

• Considerations and Challenges for Dissolution Testing of Orally Inhaled Drug Products (OIDPs)

  Bielski, Elizabeth

• Scientific Careers at FDA: Where Science Meets Regulations and Public Health

  Bielski, Elizabeth

• Advancements in In Vitro Studies for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies

  Bielski, Elizabeth

• The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance

  Bielski, Elizabeth