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)

• Influence Of The Method Of Dose Application On The In Vitro Permeation Profile Of Acyclovir From Topical Creams

  Srinatha, A; Maurya, A; Ghosh, P; Raney, S G; Murthy, S N

• Clinical Relevance Of Rheological Characteristics Of Topical Creams: Relationship Between Yield Stress And Dose Spreading Area

  Srinatha, A; Hashemnejad, S M; Kundu, S; Ghosh, P; Raney, S G; Murthy, S N

• Steps Towards Microscopic Simulations Of Skin Penetration

  Sontak, E; Holmes, A; Pastore, M; Studier, H; Abd, E; Grice, J; Roberts, M; Brandner, J; Heisig, M; Nagel, A; Wittum, G

• In-Silico and Experimental Investigation of the Thermodynamic Change of Topical Formulations due to Evaporation and the Impact on Skin Permeation

  Silva, Samadhi R; Mohammad, Yousuf; Roberts, Michael; Ramezanli, Tannaz; Lian, Guoping; Chen, Tao

• Quantitative Analysis to Discriminate Cutaneous Pharmacokinetic Profiles for Topical Drug Products

  Shukla, Sagar; Ramezanli, Tannaz; Rantou, Elena; Tiffner, Katrin; Birngruber, Thomas; Sinner, Frank; Raney, Sam G.

• Quantitative Discrimination of Cutaneous Pharmacokinetic Profiles for Topical Drug Products

  Shukla, Sagar; Ramezanli, Tannaz; Rantou, Eleni; Tiffner, Katrin; Birngruber, Thomas; Sinner, Frank; Raney, Sam G

• Impact of Operator Variability on the Reproducibility of Tape Stripping Results

  Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra

• Assessment of Bioavailabilty of Diclofenac from Two Topical Drug Products using Pharmacokinetic and Skin (Tape) Stripping Analyses

  Shukla, Sagar; Thomas, Sherin; Yu, Mingming; Shin, Soohyeon; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra

• Assessment of Local and Systemic Bioavailability of Lidocaine from Two Lidocaine Topical Delivery Systems using Pharmacokinetic and Skin (Tape) Stripping Analyses

  Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra

• In Vivo Evaluation of Lidocaine Bioavailability from Two Topical Patch Products by Pharmacokinetic and Skin (Tape) Stripping Analyses

  Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra