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(25)
• Posters(1)
• Presentations(24)
• Papers(0)

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

  Conti, Denise

• Mechanistic Drug Delivery Models

  Zhao, Liang

• Pre – ANDA Evaluation of Drug Delivery Device Constituents

  Zhao, Liang

• Device Considerations from User Interface Perspective: Comparative Analyses

  Zhao, Liang

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

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