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Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences. Quantitative methods and modeling, such as physiologically‐based pharmacok...

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Detalles Bibliográficos
Autores principales:	Tsakalozou, Eleftheria, Babiskin, Andrew, Zhao, Liang
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Reviews
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129718/ https://www.ncbi.nlm.nih.gov/pubmed/33547863 http://dx.doi.org/10.1002/psp4.12600

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