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)

• In Vitro Data Analysis Issues: IVPT Analyses and Other Challenges

  Ghosh, Priyanka

• Product Development Considerations for Generic Topical Products

  Ghosh, Priyanka

• Understanding the Complexity of Topical (Dermatological) Semisolids

  Ghosh, Priyanka

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

• Symposium 14: Applying Pharmacometrics to Precision Dosing in the Lifecycle of Long-acting Injectable Products: Drug Development, Regulatory Approval & Clinical Practice

  Fang, Lanyan

• Advanced Techniques for Measuring Cutaneous Pharmacokinetics Using Pharmacokinetic Tomography

  Evans, Conor

• In Vitro Bioequivalence Data for a Topical Product:Bioequivalence Review Perspective

  Dandamudi, Suman

• Evidence from In Vivo Skin Stripping Studies: Utility for Evaluating Topical Bioavailability

  Bunge, Annette; Guy, Richard

• Improved Stratum Corneum Sampling In vivo Delivers Obvious Value for Topical Bioequivalence Assessment

  Bunge, A

• Correlation of Physicochemical Characteristics and in Vitro Permeation Test (IVPT) Results for Acyclovir Topical Products

  Zhao, Liang