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)

• FDA and Dermatology – Topical Drug Products: New Paradigm for Generics

  Luke, Markham

• General Considerations for the “No Significant Difference” Evaluation of a Proposed Generic Formulation

  Kelchen, Megan

• The Development And Application Of Surrogate Methods To Assess Bioequivalence Of Topical Generic Products Intended For Local Action

  Kanfer,Isadore

• Role of Excipients in Dermal and Transdermal Delivery of Drugs

  Murthy, Narasimha

• Bioequivalence Evaluation of Narrow Therapeutic Index Drugs – Rationales for the Current Regulatory Approach by U.S. FDA

  Jiang, Wenlei

• U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products

  Jiang, Wenlei

• 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

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei