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ceutical Statistics Using SAS: A Practical Guide (SAS Press)

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ceutical 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 ceutical 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 compounds, animal studies to assess the toxicological profile of these compounds, clinical cology studies to examine the properties of new drugs in y 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 a of high-level introductory material to make them accessible to a broad audience of ceutical scientists. This book will also serve as a useful reference for regulatory scientists as well as academic researchers and graduate students.

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