The approval of topical generic products is essentially governed by clinical endpoint studies. Is this the most efficient approach to document bioequivalence in these particular dosage forms? This issue has sparked multiple discussions among different stakeholders - academia, industry and several regulatory agencies - in the active pursuit for new and robust surrogate methodologies. This mini review attempts to critically discuss this topic in light of the recently issued European regulatory requirements within the proposed modular framework for bioequivalence assessment.
Keywords: Bioequivalence; EMA guideline; Extended pharmaceutical equivalence; Generic topical products.
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