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Design and Analysis of Clinical Trials(3rd Edition)
Concepts and Methodologies (Wiley Series in Probability and Statistics)
by Shein-Chung Chow, Jen-Pei Liu
Hardcover, 892 Pages, Published 2013 by Wiley
ISBN-13: 978-0-470-88765-3, ISBN: 0-470-88765-6

"Praise for the "Second Edition: " .".".a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." --Journal of Clinical Research Best Practices" The "Third Edition" of "Design and Analysis of Clinical Trials" provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the ..."

Controversial Statistical Issues in Clinical Trials(1st Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow
Paperback, 612 Pages, Published 2017 by Chapman And Hall/Crc
ISBN-13: 978-0-367-57693-6, ISBN: 0-367-57693-7

Statistical Design and Analysis of Stability Studies(1st Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow
Hardcover, 352 Pages, Published 2007 by Chapman And Hall/Crc
ISBN-13: 978-1-58488-905-2, ISBN: 1-58488-905-5

"The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical De ..."

Innovative Methods for Rare Disease Drug Development(1st Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow, Shein-Chung
Paperback, 306 Pages, Published 2022 by Chapman And Hall/Crc
ISBN-13: 978-0-367-50290-4, ISBN: 0-367-50290-9

"Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives."

Statistical Design and Analysis in Pharmaceutical Science(1st Edition)
Validation, Process Controls, and Stability (Statistics: Textbooks and Monographs)
by Shein-Chung Chow, Jen-Pei Liu
Paperback, 580 Pages, Published 2019 by Taylor & Francis Ltd, United Kingdom
ISBN-13: 978-0-367-40187-0, ISBN: 0-367-40187-8

Biosimilars(1st Edition)
Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow
Hardcover, 444 Pages, Published 2013 by Chapman And Hall/Crc
ISBN-13: 978-1-4665-7969-9, ISBN: 1-4665-7969-2

"As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products. ..."

Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition(3rd Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow, Jen-Pei Liu
Hardcover, 760 Pages, Published 2008 by Chapman And Hall/Crc
ISBN-13: 978-1-58488-668-6, ISBN: 1-58488-668-4

"Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical method ..."

Translational Medicine(1st Edition)
Strategies and Statistical Methods (Chapman & Hall/CRC Biostatistics Series)
by Dennis Cosmatos, Shein-Chung Chow
Hardcover, 224 Pages, Published 2008 by Chapman And Hall/Crc
ISBN-13: 978-1-58488-872-7, ISBN: 1-58488-872-5

"Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information c ..."

Innovative Statistics in Regulatory Science(1st Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow
Paperback, 552 Pages, Published 2021 by Taylor & Francis Ltd, United Kingdom, London
ISBN-13: 978-1-03-208653-8, ISBN: 1-03-208653-X

Biosimilars(1st Edition)
Design and Analysis of Follow-on Biologics
by Shein-Chung Chow
Paperback, 444 Pages, Published 2019 by Chapman And Hall/Crc
ISBN-13: 978-0-367-37972-8, ISBN: 0-367-37972-4

"As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products.Written by a top biostatistics ..."

Sample Size Calculations in Clinical Research, Third Edition(3rd Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow, Jun Shao, Hansheng Wang, Yuliya Lokhnygina
Hardcover, 522 Pages, Published 2017 by Chapman And Hall/Crc
ISBN-13: 978-1-138-74098-3, ISBN: 1-138-74098-5

"Praise for the Second Edition: "… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered ..."

Sample Size Calculations in Clinical Research, Second Edition(2nd Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow, Hansheng Wang, Jun Shao
Hardcover, 480 Pages, Published 2007 by Chapman And Hall/Crc
ISBN-13: 978-1-58488-982-3, ISBN: 1-58488-982-9

"Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence. A comprehensive and unified presentation of statistical concepts and ..."

Adaptive Design Methods in Clinical Trials(1st Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow, Mark Chang
Hardcover, 296 Pages, Published 2006 by Chapman And Hall/Crc
Kindle Ebook
ISBN-13: 978-1-58488-776-8, ISBN: 1-58488-776-1

"Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures that are based on accrued data of ongoing clinical trials. The book also offers a well-ba ..."

Design and Analysis of Clinical Trials(2nd Edition)
Concepts and Methodologies (Wiley Series in Probability and Statistics)
by Shein-Chung Chow, Jen-Pei Liu
Hardcover, 752 Pages, Published 2003 by Wiley-Interscience
ISBN-13: 978-0-471-24985-6, ISBN: 0-471-24985-8

"Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." -Statistical Methods in Medicine A complete and balanced presentation now revised, updated ..."

Statistical Design and Analysis in Pharmaceutical Science(1st Edition)
Validation, Process Controls, and Stability (Statistics: A Series of Textbooks and Monographs)
by Shein-Chung Chow, Jen-Pei Liu, Chowc Shein-Chung
Hardcover, 580 Pages, Published 1995 by Crc Press
International Edition
ISBN-13: 978-0-8247-9336-4, ISBN: 0-8247-9336-6

""Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples.""

Design and Analysis of Animal Studies in Pharmaceutical Development(1st Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow, Jen-Pei Liu
Hardcover, 424 Pages, Published 1998 by Chapman And Hall/Crc
International Edition
ISBN-13: 978-0-8247-0130-7, ISBN: 0-8247-0130-5

"In: Peace K, ed. Biopharmaceutical Statistics for Drug Development. New York: Marcel Dekker, 1988, pp 1–20. Jonckheere AR. A distribution free k-sample test against ordered alternatives. Biometrika 41:133-145, 1954. Keene JH, Sansone EG. Airborne transfer of contaminants in ventilated spaces. Lab Anim Sci 34:453- 457, 1984. Krewski D, Bickis M. Statistical issues in toxicological research. In: Krewski D, Franklin C, eds. Statistics ..."

Design and Analysis of Bridging Studies
by Jen-Pei Liu, Shein-Chung Chow, Chin-Fu Hsiao
Paperback, Published 2020 by Chapman & Hall
ISBN-13: 978-0-367-57674-5, ISBN: 0-367-57674-0

Quantitative Methods for Traditional Chinese Medicine Development(1st Edition)
by Shein-Chung Chow
Paperback, 456 Pages, Published 2019 by Chapman And Hall/Crc
ISBN-13: 978-0-367-37738-0, ISBN: 0-367-37738-1

"A Western-Based Approach to Analyzing TCMsIn recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine.Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and an ..."

Adaptive Design Methods in Clinical Trials, Second Edition(2nd Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow, Mark Chang
Hardcover, 374 Pages, Published 2011 by Chapman And Hall/Crc
ISBN-13: 978-1-4398-3987-4, ISBN: 1-4398-3987-5

"With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activitie ..."

Controversial Statistical Issues in Clinical Trials(1st Edition)
(Chapman & Hall/CRC Biostatistics Series)
by Shein-Chung Chow
Hardcover, 611 Pages, Published 2011 by Chapman And Hall/Crc
ISBN-13: 978-1-4398-4961-3, ISBN: 1-4398-4961-7

"In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever ..."

Books by Shein-Chung Chow