E-raamat: Pharmaceutical Statistics Using SAS: A Practical Guide

This volume covers statistical methods used in drug discovery, animal toxicology studies, and clinical trials, for use by biostatisticians, pharmaceutical researchers, regulatory scientists, academic researchers, and graduate students. The 14 chapters, written by scientists from pharmaceutical companies from Europe and the US, discuss methodological issues, traditional and recently developed approaches to data analysis, and reviews of regulatory guidelines. They demonstrate how to implement the algorithms presented using built-in SAS procedures or custom SAS macros, illustrated using case studies from pre-clinical experiments and clinical trials. Focus is on methods to support research and early drug development activities, and not much emphasis is placed on technical details. Dmitrienko is a research scientist, and Chuang-Stein works in the pharmaceutical industry. D'Agostino is professor of mathematics, statistics, and public health at Boston U. Annotation ©2007 Book News, Inc., Portland, OR (booknews.com)

This essential new book 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, 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, and 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.