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9781439849613

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This volume deals with an important area-issues in clinical trials research which are perhaps not fully resolved. ... it is wide ranging, covering all aspects of clinical trials, and has excellent links and references to regulatory aspects. It will therefore provide a useful reference work for clinical trials researchers. -David J. Hand, International Statistical Review, 2012 I would recommend this book since it covers a number of areas that have not been covered in as much detail elsewhere. In particular, I thought the chapters on molecularly targeted therapies, follow-on biologics, multiregional clinical trials and good statistical practices were well written and useful. -William Mietlowski, Journal of Biopharmaceutical Statistics, Issue 5, 2012

I would recommend this book since it covers a number of areas that have not been covered in as much detail elsewhere. In particular, I thought the chapters on molecularly targeted therapies, follow-on biologics, multiregional clinical trials and good statistical practices were well written and useful. --William Mietlowski, Journal of Biopharmaceutical Statistics, Issue 5, 2012

Author Information

Shein-Chung Chow, Ph.D., is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also an adjunct professor of clinical sciences at Duke--National University of Singapore Graduate Medical School and the editor-in-chief of the Journal of Biopharmaceutical Statistics. He has authored or co-authored more than 200 papers and 19 books, including the recently published Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. He earned his Ph.D. in statistics from the University of Wisconsin--Madison.

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