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Assessment of Performance of Manufacturing Procedures in a Unit for Production of Investigational Anticancer Agents, Using a Mixed Effects Analysis
PURPOSE: To identify the magnitude and sources of variability of a generic, aseptic manufacturing process for experimental anticancer agents employed at our facility, and to estimate the effects on product quality. MATERIALS AND METHODS: In-process and quality control data of all products manufactur...
| Autores principales: | , , , |
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| Formato: | Texto |
| Lenguaje: | English |
| Publicado: |
Kluwer Academic Publishers-Plenum Publishers
2007
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1915623/ https://www.ncbi.nlm.nih.gov/pubmed/17245647 http://dx.doi.org/10.1007/s11095-006-9179-y |