Overview
- First comprehensive book on the design and analysis of Phase II clinical trials
- Provides step-by-step illustrations for data analysis using statistical software R and SAS
- Serves as a reference book for clinical research statisticians, physicians, drug regulatory affairs experts, pharmacokineticists, project managers, and other health care professionals
- Includes supplementary material: sn.pub/extras
Part of the book series: ICSA Book Series in Statistics (ICSABSS)
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Table of contents (12 chapters)
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Front Matter
Keywords
About this book
Reviews
Authors and Affiliations
About the authors
Professor Ding-Geng Chen is a fellow of the American Statistical Association and currently the Wallace Kuralt distinguished professor at the University of North Carolina at Chapel Hill, USA, and an extraordinary professor at University of Pretoria, South Africa. He was a professor at the University of Rochester and the Karl E. Peace endowed eminent scholar chair in biostatistics at Georgia Southern University. He is also a senior consultant for biopharmaceuticals and government agencies with extensive expertise in clinical trial biostatistics and public health statistics. Professor Chen has written more than 150 referred publications and co-authored/co-edited twelve books on clinical trial methodology with R and SAS, meta-analysis using R, advanced statistical causal-inference modeling, Monte-Carlo simulations, advanced public health statistics and statistical models in data science.
Shuyen Ho received his PhD in Statistics from University of Wisconsin – Madison, and his Bachelor in Applied Mathematics from Taiwan. Dr. Ho is a Biostatistics Director at PAREXEL International in Durham, North Carolina and has worked in the pharmaceutical industry for over 25 years. Prior to PAREXEL, he was a Clinical Statistics Director at GlaxoSmithKline (GSK) and Group Leader at Merck. He specializes in Phase II & III clinical development and has helped developed widely used respiratory medicines such as Claritin, Advair and Veramyst.
Joseph C. Cappelleri earned his MS in statistics from the City University of New York (Baruch College), PhD in psychometrics from Cornell University, and MPH in epidemiology from Harvard University. Dr. Cappelleri is a senior director of biostatistics at Pfizer Inc. He has also served on the adjunct faculties at Brown University, Tufts Medical Center, and the University of Connecticut. A Fellow of the American Statistical Association, he has delivered numerous conference presentations and published extensively on clinical and methodological topics, including regression-discontinuity designs, meta-analysis, and health measurement scales. Dr. Cappelleri is the lead author of the book “Patient-Reported Outcomes: Measurement, Implementation and Interpretation.”
Bibliographic Information
Book Title: Phase II Clinical Development of New Drugs
Authors: Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
Series Title: ICSA Book Series in Statistics
DOI: https://doi.org/10.1007/978-981-10-4194-5
Publisher: Springer Singapore
eBook Packages: Mathematics and Statistics, Mathematics and Statistics (R0)
Copyright Information: Springer Nature Singapore Pte Ltd. 2017
Hardcover ISBN: 978-981-10-4192-1Published: 24 April 2017
Softcover ISBN: 978-981-13-5074-0Published: 12 December 2018
eBook ISBN: 978-981-10-4194-5Published: 08 April 2017
Series ISSN: 2199-0980
Series E-ISSN: 2199-0999
Edition Number: 1
Number of Pages: XVII, 241
Number of Illustrations: 8 b/w illustrations, 17 illustrations in colour
Topics: Statistics for Life Sciences, Medicine, Health Sciences, Pharmaceutical Sciences/Technology, Management