Steve Millard, Andreas Krause (Editors)

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


Download Page

The program code presented in the book is available for download. Programs and data are organized by chapter. Click on the individual chapter to download the corresponding material - after having read the following.

General Disclaimer

These programs are free software; you can redistribute them and/or modify them under the terms of the GNU General Public License (GPL) as published by the Free Software Foundation.

This program is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY; without even the implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE.

See the GNU General Public License for more details.

Organization of Code

The ways the programs were written varies. The program code therefore comes in one of 3 ways:
.ssc files
An ssc (S-Plus script) file contains S-Plus code, either commands that will be run or declarations of functions that need to be called to run. Under S-Plus for Windows Version 2000 and 6.0, double-click on the ssc file to start up S-Plus and have the code available in the script window. Code can be selected and run from there.
SSC files contain S-Plus expressions in a human readable format.
Under S-Plus for Unix (including Linux), use source("filename.ssc") to read in the file, or use an editor and copy/ paste to execute selected commands.
.sdd files
An sdd (S-Plus data dump) file can contain one or more S-Plus objects, even an entire working directory's contents. Using data.restore("filename.sdd") will read in all objects. No code will be executed, but objects will be created that might overwrite existing objects of the same name.
SDD files are not easily read by a human being

It is a good idea to look at the code first before you read it in and run commands.


Download Section

Introduction
1 Rodda, Millard, and Krause
  Statistics and the Drug Development Process
Basic Research and Preclinical Studies
2 Pikounis
  One-Factor Comparative Studies
Pre-Clinical Safety Assessment
3 Ahn and Kodell
  Analysis of Animal Carcinogenicity Data
4 Hoffman, Heathman, Chou, and Allen
  Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies
Phase I
5 Nguyen and Amaratunga
  Analysis of Pharmacokinetic Studies
6 Bock
  Graphical Presentation of Single Patient Results
7 Pikounis, Bradstreet, and Millard
  Graphical Insight and Data Analysis for the 2, 2, 2 Crossover Design
8 Benner, Edler, and Hartung
  Design and Analysis of Phase I Cancer Treatment Trials
9 Wang
  Patient Compliance and Its Impact on Steady State Pharmacokinetics
10 Ette, Lockwood, Miller, Mandema
  Analysis of Analgesic Trials
Phase II and III
11 Bock
  Power and Sample Size Calculations
12 Jahn
  Comparing Two Treatments in a Large Phase III Trial
13 Olson
  Using S-Plus and SAS for ANOVA and Contrasts
14 Berger and Ivanova
  Permutation Tests in S-PLUS for in Phase III Clinical Trials
15 Wang and Krause
  Sample Size Re-Estimation in Clinical Trials
16 O'Rourke, Shea, and Wells
  Meta Analysis in Clinical Trials
Phase IV
17 Cook, Carides, and Dasbach
  Analysis of Health Economic Data
Manufacturing and Production
18 Eisele, Gasparini, and Racine
  Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production
19 Yang and Carlin
  Acceptance Sampling Plans By Attributes


Back to the main page.