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Encyclopedia of Biopharmaceutical Statistics, Second Edition

Encyclopedia of Biopharmaceutical Statistics, Second Edition
Author: Shein-Chung Chow
Publisher: CRC Press
Total Pages: 1000
Release: 2003-06-04
Genre: Mathematics
ISBN: 9780824742614

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The only encyclopedia that specifically focuses on biopharmaceutical statistics, the 3rd Edition provides a well-balanced summary of current regulatory requirements, along with a comprehensive and unified presentation of designs and analyses used at different stages of biopharmaceutical and clinical research and development. This is the definitive statistical guide for the entire pipeline of drug/pharmaceutical product development: from non-clinical and pre-clinical assessments and manufacturing processes through to clinical trials, regulatory processes and postmarketing surveillence. Thoroughly exploring emerging technologies, concepts, and trends, this edition incorporates 89 brand new chapters on subjects such as biomarker development, target clinical trials and follow-on biologics. Previous contents of this title have been revised and updated, and cover topics ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials and medical devices. The encyclopedia also includes popular topics that are currently under discussion within regulatory agencies and the pharmaceutical/biotech industry, such as pharmacoeconomics, reproducibility and probability in clinical research. Available in hard copy and online formats, this highly specialised book is a must-have resource for pharmaceutical R&D departments as well as for statisticians and researchers who work on clinical trials regulated by the FDA.


Encyclopedia of Biopharmaceutical Statistics

Encyclopedia of Biopharmaceutical Statistics
Author: Shein-Chung Chow
Publisher:
Total Pages:
Release: 2010
Genre: MATHEMATICS
ISBN: 9781351237116

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In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230 Updated information on changes in regulatory requirements for drug review/approval processes Recent developments in statistical design and methodology Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine Also Available OnlineThis Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages.US: (Tel) 1.888.318.2367; (E-mail) [email protected]: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]


Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set
Author: Shein-Chung Chow
Publisher: CRC Press
Total Pages: 2434
Release: 2018-09-03
Genre: Medical
ISBN: 1351110268

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Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.


Encyclopedia of Biopharmaceutical Statistics, Third Edition

Encyclopedia of Biopharmaceutical Statistics, Third Edition
Author: Shein-Chung Chow
Publisher: CRC Press
Total Pages: 0
Release: 2010-05-20
Genre: Mathematics
ISBN: 9781439822456

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In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230 Updated information on changes in regulatory requirements for drug review/approval processes Recent developments in statistical design and methodology Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine


Encyclopedia Of Biopharma- Ceutical Statistics

Encyclopedia Of Biopharma- Ceutical Statistics
Author: Shein-Chung Chow
Publisher: CRC Press
Total Pages: 562
Release: 2000
Genre: Medical
ISBN:

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"This reference covers all key topics for evaluation of data at critical stages in the pharmaceutical research and development process - highlighting the vital areas of statistical design and regulatory requirements." "Each entry of the Encyclopedia includes: self-contained, self-explanatory, and accessible data to nonbiostatisticians; "real-world" examples of statistical design and practice in the pharmaceutical industry; thoroughly up-to-date standards on good laboratory practice (GLP), good clinical practice (GCP), current good manufacturing practice (cGMP), and good statistics practice (GSP)." "Written by over 75 acclaimed international experts, the Encyclopedia of Biopharmaceutical Statistics explores interrelations among physiochemical properties of drugs in dosage form and their pharmacological, toxicological, and clinical effects; elucidates new applications of computer telephony technology; surveys the crucial relationship of the Food and Drug Administration (FDA) to pharmaceutical development, clinical trials and testing, and marketing; showcases monoclonal antibodies, cytokines, hematopoietic growth factors, tumor vaccines, xenotherapies, and cell-selection devices; describes one-sided equivalence and noninferiority trials; investigates genetic toxicology tests and other animal studies; illustrates assay technologies measuring gravimetric mass, potency, and physical or biological properties of analytes; discusses proposals for internationally standardized systems of data collection and analysis; and supplies vital economic data on factors such as reference-based pricing, burden-of-illness studies, cost-utility analysis, and cost-benefit analysis." "Containing over 2200 references, equations, tables, and drawings, the Encyclopedia of Biopharmaceutical Statistics serves as a reference for biostatisticians, chemists, pharmaceutical scientists, clinical researchers, and development pharmacists in the pharmaceutical industry and regulatory agencies, as well as upper-level undergraduate and graduate students in these disciplines."--BOOK JACKET.Title Summary field provided by Blackwell North America, Inc. All Rights Reserved


Biopharmaceutical Statistics

Biopharmaceutical Statistics
Author: Shein-Chung Chow
Publisher:
Total Pages: 0
Release: 2018
Genre: Drug development
ISBN: 9780815363200

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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set
Author: Shein-Chung Chow
Publisher: CRC Press
Total Pages: 4057
Release: 2018-09-03
Genre: Medical
ISBN: 135111025X

Download Encyclopedia of Biopharmaceutical Statistics - Four Volume Set Book in PDF, ePub and Kindle

Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.


The Role of Statistics in Business and Industry

The Role of Statistics in Business and Industry
Author: Gerald J. Hahn
Publisher: John Wiley & Sons
Total Pages: 302
Release: 2011-09-20
Genre: Mathematics
ISBN: 1118211464

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An insightful guide to the use of statistics for solving key problems in modern-day business and industry This book has been awarded the Technometrics Ziegel Prize for the best book reviewed by the journal in 2010. Technometrics is a journal of statistics for the physical, chemical and engineering sciences, published jointly by the American Society for Quality and the American Statistical Association. Criteria for the award include that the book brings together in one volume a body of material previously only available in scattered research articles and having the potential to significantly improve practice in engineering and science. Highlighting the relevance of statistical methods in everyday applications, The Role of Statistics in Business and Industry bridges the gap between the tools of statistics and their use in today's business world. This one-of-a-kind resource encourages the proactive use of statistics in three well-organized and succinct parts: Setting the Stage provides an introduction to statistics, with a general overview of its uses in business and industry Manufactured Product Applications explains how statistical techniques assist in designing, building, improving, and ensuring the reliability of a wide variety of manufactured products such as appliances, plastic materials, aircraft engines, and locomotives Other Applications describe the role of statistics in pharmaceuticals, finance, and business services, as well as more specialized areas including the food, semiconductor, and communications industries This book is truly unique in that it first describes case studies and key business problems, and then shows how statistics is used to address them, while most literature on the topic does the reverse. This approach provides a comprehensive understanding of common issues and the most effective methods for their treatment. Each chapter concludes with general questions that allow the reader to test their understanding of the presented statistical concepts as well as technical questions that raise more complex issues. An extensive FTP site provides additional material, including solutions to some of the applications. With its accessible style and real-world examples, The Role of Statistics in Business and Industry is a valuable supplement for courses on applied statistics and statistical consulting at the upper-undergraduate and graduate levels. It is also an ideal resource for early-career statisticians and practitioners who would like to learn the value of applying statistics to their everyday work.