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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...
Autores principales: | Almeida, Juan, Bezerra, Mariana, Markl, Daniel, Berghaus, Andreas, Borman, Phil, Schlindwein, Walkiria |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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Materias: | |
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 |
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