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"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
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Shein-Chung Chow is Director of the Biostatistics and Data Management Department at Bristol-Myers Squibb Company, Plainsboro, New Jersey, and an Affiliate Professor in the Statistics Department at Temple University, Philadelphia, Pennsylvania.Review:
. . .comprehensive. . ..a useful reference for practitioners as well as a good source for statisticians wishing to understand some of the key issues in these aspects of drug development.
---Publication of the International Statistical Institute
. . .Particularly appealing in this book are the extensive explanations of technical concepts, beginning with a fine overview. . .and continuing as concepts such as assay validation, process validation, quality assurance, and stability studies are introduced subsequently.
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