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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• Considerations Relating To Product Quality Characterization For Topical Semisolid Dosage Forms

  Raney, Sam

• Developing Regulatory Standards for Characterizing Critical Quality Attributes and Performance Attributes for Topical Semisolid Dosage Forms

  Raney, Sam

• Approaches for Evaluation of Formulation Differences on Performance of Topical Products

  Ramezanli, Tannaz

• A Case Study to Evaluate the Performance of Dermal Open Flow Microperfusion and Dermal Microdialysis for Assessing the Cutaneous Pharmacokinetics of Topical Lidocaine and Prilocaine Cream

  Ramezanli, Tannaz

• Characterizing In Vivo Cutaneous Pharmacokinetics of Topical Lidocaine Prilocaine Cream Using Dermal Open Flow Microperfusion and Dermal Microdialysis

  Ramezanli, Tannaz

• Translating Science to Regulatory Tools: Novel Approaches for characterizing and Evaluating the Performance of Topical Drug Products

  Ramezanli, Tannaz

• Novel Approaches for Evaluating Bioavailability and Bioequivalence (BE) of Topical Drug Products

  Ramezanli, Tannaz

• Therapeutic Equivalence of Compositionally Different Topical Products: Correlation of Product Characteristics with Sensorial Attributes

  Ramezanli, Tannaz

• Practical Considerations for IVRT Studies with Topical Drug Products Submitted in ANDAs

  Ramezanli, Tannaz

• Development of Efficient Alternative Bioequivalence Approaches for Topical Dermatological Drug Products

  Ramezanli, Tannaz