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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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Detalles Bibliográficos
Autores principales:	García-Arieta, Alfredo, Gordon, John, Gwaza, Luther, Merino, Virginia, Mangas-Sanjuan, Víctor
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2023
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9961670/ https://www.ncbi.nlm.nih.gov/pubmed/36839924 http://dx.doi.org/10.3390/pharmaceutics15020601

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