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Burdick, Richard K., Leblond, David J., Pfahler, Lori B., Quiroz, Jorge, Sidor, Leslie, Vukovinsky, Kimberly, Zhang, Lanju - Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (Statistics for Biology and Health) - 9783319501840 - V9783319501840
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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (Statistics for Biology and Health)

€ 140.56
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Description for Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (Statistics for Biology and Health) Hardcover. Series: Statistics for Biology and Health. Num Pages: 379 pages, 33 black & white illustrations, 80 colour illustrations, 68 colour tables, biography. BIC Classification: MQP; PBT; TDCW. Category: (P) Professional & Vocational. Dimension: 235 x 155. Weight in Grams: 748.

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry.  

The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods.  The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value ... Read more

The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors.  One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995).  We agreed that a more recent book would serve a need in our industry.  

Since we began this project, an edited book has been published on the same topic by Zhang (2016).  The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development.  We believe our book complements Zhang by providing more detailed statistical analyses and examples.

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Product Details

Format
Hardback
Publication date
2017
Publisher
Springer
Condition
New
Series
Statistics for Biology and Health
Number of Pages
379
Place of Publication
Cham, Switzerland
ISBN
9783319501840
SKU
V9783319501840
Shipping Time
Usually ships in 15 to 20 working days
Ref
99-15

About Burdick, Richard K., Leblond, David J., Pfahler, Lori B., Quiroz, Jorge, Sidor, Leslie, Vukovinsky, Kimberly, Zhang, Lanju
Richard K. Burdick is an Emeritus Professor of Statistics, Arizona State University and served as Quality Engineering Director for Amgen, Inc. for 10 years.  He presently serves as Chief Statistician for Elion Labs, an analytical testing company in Colorado.  He has written articles and consulted in several areas of CMC statistics including comparability, stability data analysis, analytical method validation, quality ... Read more

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