Topical corticosteroid cream for face

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.

Topical corticosteroid cream for face

topical corticosteroid cream for face

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