Clinical Considerations of Bioequivalence for Topical Dermatologic Drugs

This chapter reviewed various methods used to assess bioequivalence (BE) of topical dermatologic drugs, highlighting the limitations of current techniques and the lack of a standardized method. The vasoconstrictor assay was used for steroids, but it was not applicable to other drug classes. Alternative methods like the blister technique, dermal microdialysis, skin stripping, and in vitro release analysis were explored, each with its own limitations. The chapter emphasized the potential of percutaneous penetration research and visual inspection methods, such as those used for retinoids and acne grading, in developing a standardized BE assessment for topical drugs.