Pharmaceutical Statistics Using SAS: A Practical Guide
Author(s): Alex Dmitrienko (Author), Christy Chuang-Stein (Author), Ralph D'Agostino (Author)
Publisher: SAS Institute
Publication Date: 7 Feb. 2007
Language: English
Print length: 460 pages
ISBN-10: 159047886X
ISBN-13: 9781590478868
Book Description
Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.
Editorial Reviews
Review
“Pharmaceutical Statistics Using SAS contains applications of cutting-edge statistical techniques using cutting-edge software tools provided by SAS. The theory is presented in down-to-earth ways, with copious examples, for simple understanding. For pharmaceutical statisticians, connections with appropriate guidance documents are made; the connections between the document and the data analysis techniques make ‘standard practice’ easy to implement. In addition, the included references make it easy to find these guidance documents that are often obscure. Specialized procedures, such as easy calculation of the power of nonparametric and survival analysis tests, are made transparent, and this should be a delight to the statistician working in the pharmaceutical industry, who typically spends long hours on such calculations. However, non-pharmaceutical statisticians and scientists will also appreciate the treatment of problems that are more generally common, such as how to handle dropouts and missing values, assessing reliability and validity of psychometric scales, and decision theory in experimental design. I heartily recommend this book to all.” — Peter H. Westfall, Professor of Statistics “Texas Tech University”
About the Author
Alex Dmitrienko, Ph.D., is Principal Research Scientist, Eli Lilly and Company. He has been actively involved in biostatistical research and has published papers on multiple testing, group sequential inferences, and analysis of categorical data with clinical trial applications. Alex co-authored a recently published SAS Press book, Analysis of Clinical Trials Using SAS: A Practical Guide. His other interests include software implementation of new and existing statistical methods.
Christy Chuang-Stein, Ph.D., Senior Director of the Statistical Research and Consulting Center at Pfizer, has more than 20 years of experience in the pharmaceutical industry. She has more than 80 publications in statistical and medical journals. In addition to technical subjects dealing with statistical theory and applications, she is also interested in the development of pharmaceutical statisticians and the statistics profession in general.
Ralph B. D’Agostino, Sr., Ph.D., is Professor of Mathematics/Statistics and Public Health at Boston University. Ralph has published over 400 papers on clinical trials, epidemiology, health services, and statistical methods, and he is coauthor/editor of 7 books. He has been an advisor to the FDA since 1974 and has consulted extensively with pharmaceutical companies around the world.
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