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Resumen de Statistics in Pharmaceutical Development and Manufacturing

John J. Peterson, Ronald D. Snee, Paul R. McAllister

  • An overview is given of the use of statistical thinking and methods in the research and development and manufacturing functions in the pharmaceutical industry. Four case studies illustrate how these issues work in real life settings. A synopsis of these issues concludes that the technical nature of pharmaceutical development and manufacturing offers opportunities for the effective use of statistical methods leading to both process-development understanding and product-quality improvement.


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