Quality and equivalence of topical products: A critical appraisal

Margarida Miranda; Catarina Cardoso; Carla Vitorino

doi:10.1016/j.ejps.2019.105082

Quality and equivalence of topical products: A critical appraisal

Margarida Miranda, Catarina Cardoso, Carla Vitorino

Research output: Contribution to journal › Review article › peer-review

15 Citations (Scopus)

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.

Original language	English
Article number	105082
Journal	European Journal of Pharmaceutical Sciences
Volume	148
DOIs	https://doi.org/10.1016/j.ejps.2019.105082
Publication status	Published - 30 May 2020
Externally published	Yes

Keywords

Bioequivalence
EMA guideline
Extended pharmaceutical equivalence
Generic topical products

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10.1016/j.ejps.2019.105082

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Quality and equivalence of topical products: A critical appraisal

Abstract

Keywords

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