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Updated: Jan 5, 2026

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging
Published on: November 24, 2021
Quality and equivalence of topical products: A critical appraisal
Margarida Miranda1, Catarina Cardoso2, Carla Vitorino3
1Faculty of Pharmacy, University of Coimbra, Portugal, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Coimbra Chemistry Center, Department of Chemistry, University of Coimbra, Rua Larga, 3004-535 Coimbra, Portugal.
Abstract:
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.
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