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A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

A drug dissolution profile is one of the most critical dosage form characteristics with immediate and controlled drug release. Comparing the dissolution profiles of different pharmaceutical products plays a key role before starting the bioequivalence or stability studies. General recommendations for...

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Detalles Bibliográficos
Autores principales:	Muselík, Jan, Komersová, Alena, Kubová, Kateřina, Matzick, Kevin, Skalická, Barbora
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2021
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8539859/ https://www.ncbi.nlm.nih.gov/pubmed/34683995 http://dx.doi.org/10.3390/pharmaceutics13101703

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