Reconstructed Human Epidermis: An Alternative Approach for In Vitro Bioequivalence Testing of Topical Products.

ABSTRACT: The use of in vitro human skin permeation tests is of value when addressing the quality and equivalence of topical drug products in Europe and the US. Human skin is the membrane of choice for these studies. The use of human skin as a membrane is hindered by limited access, high variability of results, and limited applicability for drugs with low skin permeability. Reconstructed human epidermis (RhE) models are validated as skin surrogates for safety tests and have been explored for percutaneous absorption testing. Clotrimazole poorly permeates human skin and is widely available for topical treatments. In this study, clotrimazole creams were used to test the ability of RhE to be used as biological membrane for bioequivalence testing, based on the Draft Guideline on Quality and Equivalence o

SUBMITTER: Agonia AS 

PROVIDER: S-EPMC9331624 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature