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Statistics in Pharmaceutical Development and Manufacturing

Summary: [This abstract is based on the authors' abstract.] 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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  • Topics: Problem Solving, Statistics, Process Capability
  • Keywords: Pharmaceutical industry, Statistical methods, Design quality, Research and development (R&D), Statistical quality control (SQC), Product development, Food and Drug Administration (FDA), Case study
  • Author: Peterson; John J.; Snee, Ronald D.; McCallister, Paul R.; Schoefield, Timothy L.; Carella, Anthony J.
  • Journal: Journal of Quality Technology