Shein-Chung Chow

Gebundenes Buch

Innovative Methods for Rare Disease Drug Development

Beschreibung

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.

Autor

Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Produktdetails

• Chapman & Hall/CRC Biostatistics Series
• Verlag: Taylor & Francis Ltd
• Seitenzahl: 322
• Erscheinungstermin: 12. November 2020
• Englisch
• Abmessung: 240mm x 161mm x 22mm
• Gewicht: 626g
• ISBN-13: 9780367502102
• ISBN-10: 0367502100
• Artikelnr.: 60002338

Rezensionen

The very limited sample size of patients with rare disease brings a lot of challenges in both design and analysis of clinical trials as compared to the other common disease. To promote rare diseases drug development, innovative thinking is not only encouraged by FDA but also needed for the pharmaceutical companies. This book is published in a very timely manner that enable the promoting of these innovative design and analysis. I believe that it will certainly not only inspire the statisticians working in rare disease, but also could shed some light on the solutions of unique situation for clinical trials with common disease. Therefore, I strongly recommend this book to all the statisticians who work on clinical trials, not only those in rare disease but also on other indications.

- Meijing Wu, Journal of Biopharmaceutical Statistics, August 2021

"I recommend this book to researchers who want to delve into the world of rare-disease trials, and in the meanwhile would encourage them to actively think about the problems also from a Bayesian perspective."

- Haiyan Zheng, International Society for Clinical Biostatistics, 72, 2021