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)

• Investigator Impact on Reproducibility of Drug Bioavailability in Stratum Corneum Sampling by Tape Stripping

  Shukla, Sagar; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra

• Near Infrared Spectrometry for the Quantification of Human Dermal Absorption of Econazole Nitrate and Estradiol

  Medendorp, Josph; Paudel, Kalpana; Lodder, Robert; Stinchcomb, Audra

• A Comprehensive Approach to Qualify and Validate the Essential Parameters of an In Vitro Release test (IVRT) Method for Acyclovir Cream, 5

  Tiffner, Katrin; Kanfer, Isadore; Augustin, Thomas; Raml, Reingard; Raney, Sam; Sinner, Frank

• Physiologically-based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

  Tsakalozou, Eleftheria; Babiskin, Andrew; Zhao, Liang

• Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products

  Raney, Sam; Franz, Thomas; Lehman, Paul; Lionberger, Robert; Chen, Meiling

• Cutaneous Pharmacokinetics of Acyclovir Cream 5% Products: Evaluating Bioequivalence with an In Vitro Permeation Test and an Adaptation of Scaled Average Bioequivalence

  Shin, Soo Hyeon; Rantou, Eleni; Raney, Sam; Ghosh, Priyanka; Hassan, Hazem; Stinchcomb, Audra

• The relationship between the Number of Available Therapeutic Options and Government Payer (Medicare part D) Spending on Topical Drug Products

  Kwa, Michael; Tegtmeyer, Kyle; Welty, Leah; Raney, Sam; Luke, Markham; Xu, Shuai; Kong, Betty

• Diffusion Modelling of Percutaneous Absorption Kinetics. Predicting Urinary Excretion from In Vitro Skin Permeation Tests (IVPT) for an Infinite Dose

  Liu, Xin; Yousef, Shereen; Anissimov, Yuri; Van Der Hoek, John; Hoek, John; Tsakalozou, Eleftheria; Ni, Zhanglin; Grice, Jeffrey; Roberts, Michael

• Drug Recrystallization in Drug-in-adhesive Transdermal Delivery System: A Case Study of Deteriorating the Mechanical and Rheological Characteristics of Testosterone TDS

  Mohamed, Loqman; Kamal, Nahid; Elfakhri, Khaled; Willett, Daniel; Wokovich, Anna; Strasinger, Caroline; Curz, Celia; Raney, Sam; Ashraf, Muhammad; Zidan, Ahmed

• In Vivo Predictive Dissolution: Transport Analysis of the CO2 , Bicarbonate in Vivo Buffer System

  Krieg, Brian; Taghavi, Seyed; Amidon, Gordon; Amidon, Gregory