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)

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

  Jiang, Wenlei

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

  Jiang, Wenlei

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

  Jiang, Wenlei

• SRS Microscopy and Deep Learning: Novel Approach for Evaluation of Topical Bioequivalence

  Iliopoulos, Fotis

• Precilinical Models for Pulmonary Delivery

  Hochhaus, Guenther

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Parameter Sensitivity Analysis of a Two-Dimensional Skin Diffusion Model

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Drug Permeation through Skin: A Challenging Application for High Performance Scientific Computing

  Heisig, M; Nagel, A; Wittum, G

• Dermatopharmacokinetics: Modelling, Assessment and Optimization

  Guy, Richard