GDUFA Research Outcomes

Drug-Device Combo Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to considerations impacting the device constituent of generic drug-device combination products.

• All(38)
• Posters(2)
• Presentations(36)
• Papers(0)

• The Impact of Actuator Device Design on Metered Dose Inhaler (MDI) In Vitro Performance

  Bielski, Elizabeth

• Drug-Device Combination Products: A New Methodology for Evaluation – Part 2

  Ballard, Betsy

• Drug-Device Combination Product Development Simulation

  Ballard, Betsy

• Future Challenges: Electronic Devices, Drug Use Related Software, and Impacts on Generic Development and Substitution

  Ballard, Betsy

• Pre – ANDA Evaluation of Drug Delivery Device Constituents

  Zhao, Liang

• Device Considerations from User Interface Perspective: Comparative Analyses

  Zhao, Liang

• Effect of Collagen Source on the In-vitro Performance of Collagen Implant

  Srinivasan, Priyanka; Korang-Yeboah, Maxwell; Xu, Xiaoming; Ashraf, Muhammad; Wang, Yan; Qin, Bin; Kamal, Nahid

• Investigation of Cholesterol Oxidation Products (COPs) in Liposomal Drug Products

  Wang, Changguang; Siriwardane, Dumindika; Jiang, Wenlei; Mudalige, Thilak