Lanju Zhang's Books

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

By: Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang

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

By: Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang

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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Page Count

383

Publisher

Springer

Published Date

ISBN 10

3319501860

ISBN 13

9783319501864

Contemporary Biostatistics with Biopharmaceutical Applications

By: Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan

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Contemporary Biostatistics with Biopharmaceutical Applications

By: Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan

This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for A New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications. Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.

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Page Count

336

Published Date

ISBN 10

3030153118

ISBN 13

9783030153113

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

By: Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang

Write a review Read reviews Take a Quiz Solve Book Puzzle

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

By: Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang

Average ratings

N/A

Write a review

Solve jigsaw puzzle

Age

Page Count

383

Publisher

Springer

Published Date

ISBN 10

3319501860

ISBN 13

9783319501864

Book's by Lanju Zhang

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

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

Contemporary Biostatistics with Biopharmaceutical Applications

Contemporary Biostatistics with Biopharmaceutical Applications

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

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

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