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Workflow for Criticality Assessment Applied in Biopharmaceutical Process Validation Stage 1
Identification of critical process parameters that impact product quality is a central task during regulatory requested process validation. Commonly, this is done via design of experiments and identification of parameters significantly impacting product quality (rejection of the null hypothesis that...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5746752/ https://www.ncbi.nlm.nih.gov/pubmed/29023375 http://dx.doi.org/10.3390/bioengineering4040085 |