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...

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Detalles Bibliográficos
Autores principales: van der Schoot, S. C., Nuijen, B., Huitema, A. D. R., Beijnen, J. H.
Formato: Texto
Lenguaje:English
Publicado: Kluwer Academic Publishers-Plenum Publishers 2007
Materias:
Research Paper
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

Internet

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

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