Revisiting FDA's 1995 Guidance on Bioequivalence Establishment of Topical Dermatologic Corticosteroids: New Research Based Recommendations

• Main Authors: Deniz Ozdin (Author), Naveen Sharma (Author), Jorge Lujan-Zilbermann (Author), Philippe Colucci (Author), Isadore Kanfer (Author), Murray P. Ducharme (Author)
• Format: Book
• Published: Frontiers Media S.A., 2018-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Purpose: As per the US FDA guidance issued on June 2, 1995, the establishment of bioequivalence for topical dermatologic corticosteroids is based on comparing the pharmacodynamic (PD) effects of Test and Reference products at the dose duration corresponding to the population ED50, determined either...