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The Implications of Regulatory Framework for Topical Semisolid Drug Products: From Critical Quality and Performance Attributes towards Establishing Bioequivalence

Due to complex interdependent relationships affecting their microstructure, topical semisolid drug formulations face unique obstacles to the development of generics compared to other drug products. Traditionally, establishing bioequivalence is based on comparative clinical trials, which are expensiv...

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Detalles Bibliográficos
Autores principales: Ilić, Tanja, Pantelić, Ivana, Savić, Snežana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8152494/
https://www.ncbi.nlm.nih.gov/pubmed/34068036
http://dx.doi.org/10.3390/pharmaceutics13050710