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Working within the Design Space: Do Our Static Process Characterization Methods Suffice?
The Process Analytical Technology initiative and Quality by Design paradigm have led to changes in the guidelines and views of how to develop drug manufacturing processes. On this occasion the concept of the design space, which describes the impact of process parameters and material attributes on th...
Autores principales: | von Stosch, Moritz, Schenkendorf, René, Geldhof, Geoffroy, Varsakelis, Christos, Mariti, Marco, Dessoy, Sandrine, Vandercammen, Annick, Pysik, Alexander, Sanders, Matthew |
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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/PMC7356980/ https://www.ncbi.nlm.nih.gov/pubmed/32560435 http://dx.doi.org/10.3390/pharmaceutics12060562 |
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