Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.
Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
In summary, the three bioequivalence approaches that are currently consistently accepted by regulatory authorities are bioequivalence studies with clinical endpoints, in-vivo pharmacodynamic studies (in particular VCA for topical corticosteroid products), and waivers for topical solutions. Also, most require pharmacokinetic studies if there are safety concerns relating to systemic exposure. However, it is refreshing to see that the regulatory authorities are giving credence to alternative science-based methods for demonstration of bioequivalence, rather than insistence on clinical endpoint studies.