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QICID: 30056
Title: Discussion on Statistics in Pharmaceutical Development and Manufacturing
Copyright:
Author: Peterson; John J.; Snee, Ronald D.; McCallister, Paul R.; Schoefield, Timothy L.; Carella, Anthony J.
Organization:
Subject: Pharmaceutical industry; Statistical methods; Design quality; Research and development (R&D); Statistical quality control (SQC); Product development; Food and Drug Administration (FDA);
Series: Journal of Quality Technology, Vol. 41, No. 2, April 2009, pp. 135-147
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Abstract: Prominent researchers in the pharmaceutical industry and biometrics comment on issues discussed in the article Statistics in Pharmaceutical Development and Manufacturing by Peterson, et al. Discussants lend their support to ideas expressed and expand on many issues. In a rejoinder, the original authors thank the discussants for their contributions and summarize some of the important issues raised.
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