Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established for the development of drug products/substanc...

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Detalles Bibliográficos
Autores principales: Almeida, Juan, Bezerra, Mariana, Markl, Daniel, Berghaus, Andreas, Borman, Phil, Schlindwein, Walkiria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076712/
https://www.ncbi.nlm.nih.gov/pubmed/32059445
http://dx.doi.org/10.3390/pharmaceutics12020150

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076712/
https://www.ncbi.nlm.nih.gov/pubmed/32059445
http://dx.doi.org/10.3390/pharmaceutics12020150

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