Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (Paperback, Softcover reprint of the original 1st ed. 2017)

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.

General

Imprint:	Springer International Publishing AG
Country of origin:	Switzerland
Series:	Statistics for Biology and Health
Release date:	May 2018
First published:	2017
Authors:	Richard K. Burdick • David J Leblond • Lori B Pfahler • Jorge Quiroz • Leslie Sidor • Kimberly Vukovinsky • Lanju Zhang
Dimensions:	235 x 155 x 21mm (L x W x T)
Format:	Paperback
Pages:	379
Edition:	Softcover reprint of the original 1st ed. 2017
ISBN-13:	978-3-319-84338-4
Categories:	Books > Medicine > Nursing & ancillary services > Pharmacy / dispensing Books > Science & Mathematics > Mathematics > Probability & statistics Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	3-319-84338-9
Barcode:	9783319843384

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