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Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
The objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous retro...
Autores principales: | Galí, Albert, Ascaso, Magda, Nardi-Ricart, Anna, Suñé-Pou, Marc, Pérez-Lozano, Pilar, Suñé-Negre, Josep M., García-Montoya, Encarna |
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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/PMC7465942/ https://www.ncbi.nlm.nih.gov/pubmed/32784621 http://dx.doi.org/10.3390/pharmaceutics12080743 |
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