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)

• 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

• Evaluation Of Two Lidocaine Topical Patch 5% Products By Cutaneous Pharmacokinetic Methods: In Vitro Tape Stripping And In Vitro Permeation Testing

  Shukla, Sagar; Raney, Sam; Ghosh, Priyanka; Hassan, Hazem; Bunge, Annette; Stinchcomb, Audra

• Evaluation Of Flector And Lidoderm Topical Formulations By Dermal Pharmacokinetic Methods: In Vitro Tape Stripping And In Vitro Permeation Testing (Ivpt)

  Shukla, Sagar; Hassan, Hazem; Raney, Sam; Newman, Bryan; Ghosh, Priyanka; Bunge, Annette; Stinchcomb, Audra

• Assessing Bioavailability And Estimating Bioequivalence Of Acyclovir Creams By In Vitro Permeation Tests With Excised Human Skin

  Shin, Soohyeon; Raney, Sam; Rantou, Elena; Newman, Bryan; Ghosh, Priyanka; Hassan, Hazem; Stinchcomb, Audra

• Low Volume And High Shear Rheology On A Conventional Rheometer: A Tool For Characterising Pharmaceutical Skin Creams

  Shewan, Heather; Boehm, Michael; Suvanmani, Vilaiwan; Mohammed, Yousuf; Namjoshi, Sarika; Raney, Sam; Roberts, Michael; Stokes, Jason

• The Systematic Influence of Changes in Manufacturing Process Variables on the Microstructure and Performance of Topical Emulsions

  Sharma, Purnendukumar; Srinatha, Anegundha; Raney, Sam; Ghosh, Priyanka; Hashemnejad, Seyed-Meysam; Kundu, Santanu; Repka, Michael; Murthy, Narasimha

• Determination Of Ph For An Oil-In-Water Based Semisolid Cream: Method Development And Standardization

  Sharma, Purnendukumar; Srinatha, Anegundha; Angamuthu, Muralikrishnan; Raney, Sam; Ghosh, Priyanka; Repka, Michael; Murthy, Narasimha

• Investigation of the Relationship Between Product-Dose and Dermal Exposure of Lidocaine and Prilocaine from a Topical Cream Product Using Dermal Microdialysis

  Senemar, Sharareh; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Kuzma, Benjamin; Stagni, Grazia

• Dermal Clearance, Elimination Half-life, and Apparent Volume of Distribution of Lidocaine And Prilocaine Are Independent of the Dose Delivered Directly in Dermis Using a Dermal Infusion Technique

  Senemar, S; Kuzma, B A; Ramezanli, T; Ghosh, P; Raney, S G; Stagni, G

• A Cross-Species Retrospective Percutaneous IVIVR for Topical Dermatological Products Containing Metronidazole

  Senemar, Sharareh; Kuzma, Benjamin; Stagni, Grazia