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Titlebook: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Indus; Richard K. Burdick,David J. LeBlond,

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发表于 2025-3-21 18:04:56 | 显示全部楼层 |阅读模式
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
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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Titlebook: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Indus;  Richard K. Burdick,David J. LeBlond,
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
doihttps://doi.org/10.1007/978-3-319-50186-4
isbn_softcover978-3-319-84338-4
isbn_ebook978-3-319-50186-4Series ISSN 1431-8776 Series E-ISSN 2197-5671
issn_series 1431-8776
copyrightSpringer International Publishing AG 2017
The information of publication is updating

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Analytical Comparability and Similarity,es performed when changes are made to the process include demonstration of comparability in product parameters. The actual timing of each activity and the statistical rigor required for the evaluation of pre- and post-change product is linked to the stage of the product development (e.g., clinical v
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Book 2017ns 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
发表于 2025-3-22 08:04:16 | 显示全部楼层
Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lag high-risk individuals in whom this deadly disease can be prevented. An understanding of the etiological and molecular events leading to the development of pancreatic carcinoma may provide a basis for the development of effective strategies for the prevention, early diagnosis, and treatment of this disease.
发表于 2025-3-22 11:13:36 | 显示全部楼层
Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,La their concerns into print actually promoted the practice. Both actions reflect not only the effective influence pamphlets were believed to exert, but again the growing political importance of winning the hearts of the ..
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1431-8776 eference 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 edited978-3-319-84338-4978-3-319-50186-4Series ISSN 1431-8776 Series E-ISSN 2197-5671
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Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Laay confer an increased risk for this disease. When this research is coupled with work aimed at understanding the mechanism by which the currently known genes contribute to pancreatic carcinogenesis, we hope to make a significant impact on the mortality of this disease.
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