GDUFA Research Outcomes

Human Factors

Research in this area is related to human factors and interactions with the user interface of generic drug-device combination products.

• All(21)
• Posters(2)
• Presentations(16)
• Papers(3)

• Development of Drug-Device Combination Products and Generic Substitution in the United States: An Overview

  Srivastava, Ila; Lee, YoonJung; Feibus, Katharine; Bielski, Elizabeth; Sterrett, Lolita; Harris, Danielle; Luke, Markham

• Ophthalmic Drug-Device Combination Products – Comparative Analyses

  Kim, Shinae

• Generic substitution of epinephrine autoinjectors: Patient and caregiver perceptions and attitudes

  Ray, Sarah E; Boudewyns, Vanessa; Oguntimein, Murewa; Conti, Denise; Malik, Raahina; Srivastava, Ila; B, Katharine

• Patient Perceptions of Switching to a Generic Dry Powder Inhaler���Increased Understanding Through Journey Mapping

  Ray, Sarah E; Boudewyns, Vanessa; Davis, Christine; Tzeng, Janice P; Srivastava, Ila; Oguntimein, Oluwamurewa; Conti, Denise S; Feibus, Karen B

• Complex Generic Drug-Device Inhalation Products and User Interface Sameness: Successful Outcomes

  Witzmann, Kimberly

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly

• Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA

  Witzmann, Kimberly

• The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA

  Witzmann, Kimberly

• Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products

  Witzmann, Kimberly

• Approaches to Analyzing Comparative Use Human Factors Studies

  Wang, Jing