GDUFA Research Outcomes

Topical Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.

• All(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• Microstructural Characterization and In Vitro Permeation Testing of Topical Products

  Murthy, Narasimha

• Advanced Characterization Approaches for Topical Formulations

  Murthy, Narasimha

• Characterizing the Critical Quality Attributes and In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products

  Murthy, Narasimha

• Beyond Q1/Q2-Comparing the Arrangement of Matter (Q3) and Performance

  Murthy, Narasimha

• Topical Semisolid Drug Product Critical Quality Attributes (Q3 Characterization) with Relevance to Topical Bioequivalence

  Murthy, Narasimha

• Characterizing Failure Modes And Critical Quality (Q3) Attributes Of Semi-Solid Topical Drug Products

  Murthy, Narasimha

• Evaluating Quality (Q3) Attributes And Potential Failure Modes For Topical Semisolid Drug Products

  Murthy, Narasimha

• “No Difference” Standard vs. Q1/Q2 Sameness for Topical Drug Products

  Kelchen, Megan

• An FDA Perspective on the Comparative Analyses of Critical Material, Quality, and Design Attributes for Topical, Transdermal, Rectal, and Vaginal Drug-Device Combination Products

  Kelchen, Megan

• Locally Acting Drug Update

  Luke,Markham