书目名称 | Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Indus | 编辑 | Richard K. Burdick,David J. LeBlond,Lanju Zhang | 视频video | | 概述 | Offers an indispensable guide for statisticians supporting pharmaceutical development and manufacturing, as well as non-statisticians requiring an analysis of their data.Covers a range of applications | 丛书名称 | Statistics for Biology and Health | 图书封面 |  | 描述 | .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 | 出版日期 | Book 2017 | 关键词 | Analytical Methods; Biosimilarity; CMC Statistics; Chemistry, Manufacturing and Controls; FDA Guidance; P | 版次 | 1 | doi | https://doi.org/10.1007/978-3-319-50186-4 | isbn_softcover | 978-3-319-84338-4 | isbn_ebook | 978-3-319-50186-4Series ISSN 1431-8776 Series E-ISSN 2197-5671 | issn_series | 1431-8776 | copyright | Springer International Publishing AG 2017 |
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