Design and Analysis of Follow-on Biologics
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...
Published July 28th 2013 by Chapman and Hall/CRC
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
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed.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
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
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
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 19th 2010 by CRC Press
Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition BABE-Solution bundle version
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
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
Strategies and Statistical Methods
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