Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry

Nonfiction, Health & Well Being, Medical, Reference, Biostatistics, Specialties, Pharmacy, Science & Nature, Mathematics
Cover of the book Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry by Richard K. Burdick, Jorge Quiroz, Lori B. Pfahler, Lanju Zhang, Leslie Sidor, Kimberly Vukovinsky, David J. LeBlond, Springer International Publishing
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Author: Richard K. Burdick, Jorge Quiroz, Lori B. Pfahler, Lanju Zhang, Leslie Sidor, Kimberly Vukovinsky, David J. LeBlond ISBN: 9783319501864
Publisher: Springer International Publishing Publication: February 14, 2017
Imprint: Springer Language: English
Author: Richard K. Burdick, Jorge Quiroz, Lori B. Pfahler, Lanju Zhang, Leslie Sidor, Kimberly Vukovinsky, David J. LeBlond
ISBN: 9783319501864
Publisher: Springer International Publishing
Publication: February 14, 2017
Imprint: Springer
Language: English

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 to the reader.

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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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 to the reader.

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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