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1. Design and Analysis of Bridging Studies

   Edited by Jen-pei Liu, Shein-Chung Chow, Chin-Fu Hsiao

   Series: Chapman & Hall/CRC Biostatistics Series

   This book provides a comprehensive and unified summary of the growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology pertaining to the design and evaluation of bridging studies, which provide pharmacodynamic or clinical...

   To Be Published July 11th 2012 by Chapman and Hall/CRC
2. Adaptive Design Methods in Clinical Trials, Second Edition

   By Shein-Chung Chow, Mark Chang

   Series: Chapman & Hall/CRC Biostatistics Series

   With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed.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...

   Published November 30th 2011 by Chapman and Hall/CRC
3. Controversial Statistical Issues in Clinical Trials

   By Shein-Chung Chow

   Series: Chapman & Hall/CRC Biostatistics Series

   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....

   Published June 14th 2011 by Chapman and Hall/CRC
4. Adaptive Design Methods in Clinical Trials

   By Shein-Chung Chow, Mark Chang

   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...

   Published December 11th 2010 by Chapman and Hall/CRC
5. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

   Edited by Annpey Pong, Shein-Chung Chow

   In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a...

   Published October 24th 2010 by CRC Press
6. Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition BABE-Solution bundle version

   Edited by Shein-Chung Chow, Jen-pei Liu

   Series: Chapman & Hall/CRC Biostatistics Series

   Containing four new chapters, along with several new and updated sections, this third edition reviews the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. It presents the current...

   Published March 22nd 2009 by CRC Press
7. Sample Size Calculations in Clinical Research, Second Edition N-Solution bundle version

   Edited by Shein-Chung Chow, Jun Shao

   Series: Chapman & Hall/CRC Biostatistics Series

   This book explains how the formulas and procedures for sample size calculations can be used in a variety of clinical research and development stages. It presents real-world examples from several therapeutic areas and explores emerging topics in pharmaceutical research and development. This edition...

   Published March 22nd 2009 by Chapman and Hall/CRC
8. Translational Medicine

   Strategies and Statistical Methods

   Edited by Dennis Cosmatos, Shein-Chung Chow

   Series: Chapman & Hall/CRC Biostatistics Series

   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...

   Published December 16th 2008 by Chapman and Hall/CRC
9. Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition

   By Shein-Chung Chow, Jen-pei Liu

   Series: Chapman & Hall/CRC Biostatistics Series

   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...

   Published October 14th 2008 by Chapman and Hall/CRC
10. Sample Size Calculations in Clinical Research, Second Edition

    By Shein-Chung Chow, Hansheng Wang, Jun Shao

    Series: Chapman & Hall/CRC Biostatistics Series

    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...

    Published August 21st 2007 by Chapman and Hall/CRC