TOPICAL CORTICOSTEROID DOSE DURATION-RESPONSE CURVE SHOULD BE DETERMINED USING POOLED DATA FROM PILOT VASOCONSTRICTOR STUDY -- FDA FINAL GUIDANCE
Executive Summary
The dose duration-response curve of a dermatological corticosteroid should be calculated using pooled data obtained during a pilot vasoconstrictor assay study, FDA's final guidance for determining in vivo bioequivalence of topical corticosteroids recommends.