Steve Millard, Andreas Krause (Editors)

Applied Statistics in the Pharmaceutical Industry
with case studies using S-Plus

Springer-Verlag, New York
ISBN 0-387-988149

The volume comprises contributions from more than 20 statisticians working in the pharmaceutical industry. The drug development process is described from the viewpoint of statistical applications. The authors describe studies, data, methods, and results that finally lead to a new drug.

The focus is on illustrating the practical problems and the statistical approaches to tackle them. Real-world studies form the basis for applying the methods.

The topics cover all stages of drug development from pre-clinical safety assessment to dose finding, safety studies, and large clinical trials, from analysis of health economic data to production and quality assessment. Special topics such as single patient analysis and the impact of patient compliance show the broad spectrum of applications of data analysis methods.

All analyses were done in S-PLUS and the program code is provided on the Springer web pages. S-PLUS serves as the tool for analyzing data and generating graphs. Prior knowledge of the system is not required to follow the analyses.

The intended readership comprises students, practitioners, and everybody interested in drug development and the application of statistical methods in clinical trials.


Hongshik Ahn State University of NY   Darel Allen Eli Lilly
Dhammika Amaratunga The R.W. Johnson Pharmaceutical Research Institute   Axel Benner German Cancer Research Center (DKFZ)
Vance Berger National Cancer Institute   Jürgen Bock Hoffmann-LaRoche
Thomas Bradstreet Merck   George Carides Merck
David Carlin Medimmune   James Chou Eli Lilly
John Cook Merck   Erik Dasbach Merck
Lutz Edler German Cancer Research Center (DKFZ)   Jeffrey Eisele Novartis Pharma
Ene Ette Vertex Pharmaceuticals   Mauro Gasparini Politecnico di Torino
Gernot Hartung German Cancer Research Center (DKFZ)   Michael Heathman Eli Lilly
Wherly Hoffman Eli Lilly   Anastasia Ivanova University of North Carolina
Michaela Jahn Hoffmann-LaRoche   Ralph Kodell Food and Drug Administration (FDA)
Andreas Krause Novartis Pharma   Peter Lockwood Parke Davis
Jaap Mandema PharSight   Steve Millard Probability, Statistics, & Information
Raymond Miller Parke Davis   Ha Nguyen Merck (now at Aventis)
Keith O'Rourke University of Ottawa   Melvin Olson Allergan
Bill Pikounis Merck   Amy Racine Novartis Pharma
Bruce Rodda Southwest Texas State University   Beverly Shea University of Ottawa
Wenping Wang PharSight   George Wells University of Ottawa
Harry Yang Medimmune


Chapter titles and corresponding authors are given here.
The code presented in the book is available for download. Please follow this link.


List of known errors

Further references related to this book

The Springer-Verlag site for this book
The site for this book

Further S-Plus resources

S-News mailing list
The S-Plus FAQ (ETH Zuerich)
Books on S-Plus (Insightful)

Other references by Steve Millard and Andreas Krause

Steve's PSI server
The Basics of S-Plus by Krause and Olson