Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches

Sam Raney from the Office of Generic Drugs discusses recent results from GDUFA-funded research into the influence of differences in the composition of topical products on the resulting dermal pharmacokinetics and bioavailability. The potential implications of these results for bioequivalence approaches (based on topical formulation “similarity” or “no difference”) will be explored.

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