Book Search

1. Biosimilars

   Design and Analysis of Follow-on Biologics

   By Shein-Chung Chow

   Series: Chapman & Hall/CRC Biostatistics Series

   This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies...

   To Be Published August 1st 2013 by Chapman and Hall/CRC
2. Encyclopedia of Biopharmaceutical Statistics, Third Edition

   Edited by Shein-Chung Chow

   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...

   Published May 15th 2013 by CRC Press
3. Encyclopedia of Biopharmaceutical Statistics, Third Edition

   Edited by Shein-Chung Chow

   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...

   Published December 26th 2012 by CRC Press
4. Design and Analysis of Bridging Studies

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

   Series: Chapman & Hall/CRC Biostatistics Series

   As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that...

   Published July 25th 2012 by Chapman and Hall/CRC
5. 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  With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed.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
6. 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
7. Adaptive Design Methods in Clinical Trials

   By Shein-Chung Chow, Mark Chang

   Series: Chapman & Hall/CRC Biostatistics Series

   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
8. 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
9. 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
10. 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