Eleftheria Tsakalozou from the Office of Generic Drugs illustrates how modeling and simulation approaches such as physiologically-based pharmacokinetic (PBPK) modeling can be used to advance drug product development and support alternative bioequivalence approaches for generic dermatological drug products. Model-informed dose selection for dermal-open flow microperfusion studies assessing the cutaneous pharmacokinetics of test and reference products and justifying acceptable differences in physical and structural composition between test and reference products by utilizing in silico in vitro permeation testing methodologies are highlighted.
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