A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay.
Six generic formulations of five topical steroids were compared for bioequivalence with their trade-name counterparts using an in vivo vasoconstriction assay. Two of six generic formulations were found to show significantly less vasoconstriction than the respective trade-name topical steroids. The issue of generic equivalence of topical steroids is discussed, with particular emphasis on the vagaries of the vasoconstriction assay.
Olsen
E A
EA
Department of Medicine, Duke University Medical Center, Durham, NC 27710.
D000287:Administration, Topical; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005938:Glucocorticoids; D006801:Humans; D008875:Middle Aged; D013810:Therapeutic Equivalency; D014661:Vasoconstriction
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone