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

Internet

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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