Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union

Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union

The development of second-entry topical products is hampered by several factors. The excipient composition should be similar to the reference product because excipients may also contribute to efficacy. Conventional pharmacokinetic bioequivalence studies were not considered acceptable because drug co...

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Bibliographic Details
Main Authors: Alfredo García-Arieta, John Gordon, Luther Gwaza, Virginia Merino, Víctor Mangas-Sanjuan
Format: Article
Language:English
Published: MDPI AG 2023-02-01
Series:Pharmaceutics
Subjects:
topical
cutaneous
stepwise approach
qualitative sameness
quantitative similarity
microstructure
Online Access:https://www.mdpi.com/1999-4923/15/2/601

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