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Applied Statistics in the Pharmaceutical Industry - With Case Studies Using S-Plus (Paperback, Softcover reprint of the original 1st ed. 2001)
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Applied Statistics in the Pharmaceutical Industry - With Case Studies Using S-Plus (Paperback, Softcover reprint of the original 1st ed. 2001)
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Each year hundreds of new drugs are approved for the marketplace.
The approval of a single new drug is the result of years of
screening tens of thousands of compounds, performing pre-clinical
research on their effects, and designing, implementing, and
analyzing the results of clinical trials. This book provides a
general guide to statistical methods used in the pharmaceutical
industry, and is aimed at graduate students and researchers who
want to know more about statistical applications in all phases of
the drug development process. The 19 chapters authored by over 30
statisticians working in the industry follow the general sequence
of drug development, from pre-clinical research and saftey
assessment to dose finding, safety studies, large clinical trials,
analysis of health economic data, and fianlly manufacturing and
production. Special topics such as single patient analysis and the
impact of patient compliance show the broad spectrum of
applications of data analysis methods. Each chapter illustrates a
practical problem using data from actual studies by describing the
study, the data, the methods, and the results. All of the analyses
are done with S-PLUS, and the data and code are provided both in
appendices to the chapters and on the companion Springer-Verlag web
site, making it possible to reproduce the results and extend the
analyses. Prior knowledge of the software is not required to follow
the analyses. Steven P. Millard is a statistical consultant and
also Manager of Consulting Services for MathSoft, Inc. (Data
Analysis Products Division.) He has applied statistical methods to
projects ranging from quality control in bioassay to measuring
water quality to automating home appraisal, and has taught courses
in S-PLUS for over 10 years. He is the author of the book
Environmental Statistics with S-PLUS (CRC Press) as well as the
S-PLUS add-in module ENVIRONMENTALSTATS for S-PLUS. Andreas Krause
is a statistical consultant in the pharmaceutical industry and
works for Novartis Pharma AG. He has extensive experience in
graphical and numerical data analysis as well as programming, has
taught numerous classes with and on S-PLUS, and is an S_PLUS user
from the early days on. He is also author of the book The Basics of
S and S-PLUS (Springer).
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