Steve Millard, Andreas Krause (Editors)
Applied Statistics in the Pharmaceutical Industry
Springer-Verlag, New York
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|
|The Springer-Verlag site for this book|
|The amazon.com site for this book|
|S-News mailing list|
|The S-Plus FAQ (ETH Zuerich)|
|Books on S-Plus (Insightful)|
|Steve's PSI server|
|The Basics of S-Plus by Krause and Olson|