Use of an in vitro human skin permeation assay to assess bioequivalence of two topical cream formulations containing butenafine hydrochloride (1%, w/w)

详细信息    查看全文

• 作者：Amitava Mitra^a ; ^{mitraamitava11@gmail.com} ; Nanhye Kim^b ; Darren Spark^c ; Frank Toner^c ; Susan Craig^c ; Clive Roper^c ; Thomas A. Meyer^b ; ^{thomas.meyer3@bayer.com}
• 关键词：Topical ; Skin permeation ; Bioequivalence ; Dermal ; Flux ; Butenafine
• 刊名：Regulatory Toxicology and Pharmacology
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：82
• 期：Complete
• 页码：14-19
• 全文大小：234 K
• 卷排序：82

文摘

In vitro skin permeation assay conducted to compare 2 butenafine cream formulations. Goal of the assay was to use it as surrogate for BE study between the formulations. No statistically significant permeation difference was observed between the creams. The results were accepted by USFDA and led to authorization to market the new cream.