This guidance provides recommendations for the study design, method qualification, data analysis, and data reporting for the pilot dose-duration vasoconstrictor response study and pivotal vasoconstrictor bioequivalence study used to demonstrate bioequivalence of topical corticosteroids. The guidance also discusses considerations and approaches for estimating key study parameters (e.g., dose corresponding to half the maximal vasoconstrictor response (ED50)) and sample size for the pivotal vasoconstrictor bioequivalence study).