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People (3 results)
Activities & events
| Title & Speakers | Event |
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Pharmaceutical Statistics Using SAS
2007-02-07
Sr. Ralph B. D'Agostino
– author
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Ph. D. Christy Chuang-Stein
– author
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Ph. D. Alex Dmitrienko
– author
Pharmaceutical Statistics Using SAS: A Practical Guide offers extensive coverage of cutting-edge biostatistical methodology used in drug development and the practical problems facing today's drug developers. Written by well-known experts in the pharmaceutical industry Alex Dmitrienko, Christy Chuang-Stein, and Ralph D'Agostino, it provides relevant tutorial material and SAS examples to help readers new to a certain area of drug development quickly understand and learn popular data analysis methods and apply them to real-life problems. Step-by-step, the book introduces a wide range of data analysis problems encountered in drug development and illustrates them using a wealth of case studies from actual pre-clinical experiments and clinical studies. The book also provides SAS code for solving the problems. Among the topics addressed are these: drug discovery experiments to identify promising chemical compounds animal studies to assess the toxicological profile of these compounds clinical pharmacology studies to examine the properties of new drugs in healthy human subjects Phase II and Phase III clinical trials to establish therapeutic benefits of experimental drugs. Additional features include a discussion of methodological issues, practical advice from subject-matter experts, and review of relevant regulatory guidelines. Most chapters are self-contained and include a fair amount of high-level introductory material to make them accessible to a broad audience of pharmaceutical scientists. This book will also serve as a useful reference for regulatory scientists as well as academic researchers and graduate students. This book is part of the SAS Press program. |
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Analysis of Clinical Trials Using SAS
2005-02-18
Geert Molenberghs
– author
,
Christy Chuang-Stein
– author
,
Walter W. Offen
– author
,
Alex Dmitrienko
– author
In Analysis of Clinical Trials Using SAS: A Practical Guide, Alex Dmitrienko, Geert Molenberghs, Christy Chuang-Stein, and Walter Offen bridge the gap between modern statistical methodology and real-world clinical trial applications. Step-by-step instructions illustrated with examples from actual trials and case studies serve to define a statistical method and its relevance in a clinical trials setting and to illustrate how to implement the method rapidly and efficiently using the power of SAS software. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials, including analysis of stratified data, incomplete data, multiple inferences, issues arising in safety and efficacy monitoring, and reference intervals for extreme safety and diagnostic measurements. Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience compiled in this book. Numerous ready-to-use SAS macros and example code are included. This book is part of the SAS Press program. |
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