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(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• Does Vehicle Evaporation Affect Drug Distribution within Different Phases of Topically Applied Emulsion? A Modeling Case Study with Clindamycin Phosphate Lotion

  Alam, Khondoker; Tsakalozou, Eleftheria; Babiskin, Andrew; Ghosh, Priyanka; Ramezanli, Tannaz; Jiang, Ying; Niu, Mengmeng; Zhao, Liang

• Development of an In Vitro Release Method for Mechlorethamine Hydrochloride Topical Gel

  Ako Adounvo, Ann Marie; Niu, Mengmeng; Ghosh, Priyanka; Ashraf, Muhammad; Zidan, Ahmed

• A Mechanistic Evaluation of How Metamorphosis of a Topical Dosage Form Impacts Permeation

  Ajjarapu, S; Rangappa, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Urena-Benavides, EE; Maibach, H; Narasimha Murthy, S

• A Mechanistic Evaluation of the Impact of Formulation Viscosity and Fractional Solubility on Drug Release and Permeation

  Ajjarapu, S; Rangappa, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Urena-Benavides, EE; Maibach, H; Narasimha Murthy, S

• The Impact of the Metamorphosis of Topical Formulations on Bioavailability

  Ajjarapu, S; Rangappa, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Repka, M A; Maibach, H; Narasimha Murthy, S

• Method Development and Optimization of an In Vitro Permeation Test (IVPT) to Compare the Rate and Extent of Drug Permeation from Topical Drug Products

  Ajjarapu, S; Rangappa, S; Raney, S G; Repka, M A; Murthy, S N

• A Novel Strategy for the Efficient Modulation of Topical Drug Delivery to Validate the Sensitivity of an In Vitro Permeation Test (IVPT)

  Ajjarapu, S; Rangappa, S; Ghosh, P; Raney, S G; Murthy, S N

• Metronidazole Crystal Patterns formed during the Metamorphosis of Topical Carbopol Gels

  Ajjarapu, S; Rangappa, S; Deboyace, K; Wildfong, P; Murthy, S N

• Predicting the Pharmacokinetics of Topically Applied Ketoprofen using Mechanistic Physiologically-based Pharmacokinetics Modelling

  Abdulla, Tariq; Patel, Nikunjumar; Martins, Federico; Salem, Farzaneh; Clarke, James; Jamei, Masoud; Polak, Sebastian

• Quantitative Prediction of Dermal Drug Absorption using MPML-MechDermA model: Relative Effects of Application Site on Rivastigmine Pharmacokinetics from a Transdermal Delivery System

  Abdulla, T; Patel, N; Polak, S; Martins, F; Rostami-Hodjegan, A; Jamei, M