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  • Book
  • © 2001

Applied Statistics in the Pharmaceutical Industry

With Case Studies Using S-Plus

  • Each chapter illustrates a practical problem using data from actual studies
  • No competing book has this pharmaceutical focus or use S-PLUS in this manner
  • Includes supplementary material: sn.pub/extras

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Table of contents (19 chapters)

  1. Front Matter

    Pages i-xviii
  2. Introduction

    1. Front Matter

      Pages 1-1
    2. Statistics and the Drug Development Process

      • Bruce Rodda, Steven P. Millard, Andreas Krause
      Pages 3-14
  3. Basic Research and Preclinical Studies

    1. Front Matter

      Pages 15-15
    2. One-Factor Comparative Studies

      • Bill Pikounis
      Pages 17-40
  4. Pre-Clinical Safety Assessment

    1. Front Matter

      Pages 41-41
    2. Analysis of Animal Carcinogenicity Data

      • Hongshik Ahn, Ralph L. Kodell
      Pages 43-73
    3. Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies

      • Wherly P. Hoffman, Michael A. Heathman, James Z. Chou, Darrel L. Allen
      Pages 75-106
  5. Phase I Studies

    1. Front Matter

      Pages 107-107
    2. Analysis of Pharmacokinetic Data

      • Ha Nguyen, Dhammika Amaratunga
      Pages 109-133
    3. Graphical Insight and Data Analysis for the 2,2,2 Crossover Design

      • Bill Pikounis, Thomas E. Bradstreet, Steven P. Millard
      Pages 153-188
    4. Design and Analysis of Phase I Trials in Clinical Oncology

      • Axel Benner, Lutz Edler, Gernot Hartung
      Pages 189-216
    5. Analysis of Analgesic Trials

      • Ene I. Ette, Peter Lockwood, Raymond Miller, Jaap Mandema
      Pages 237-266
  6. Phase II and Phase III Clinical Trials

    1. Front Matter

      Pages 267-267
    2. Power and Sample Size Calculations

      • Jürgen Bock
      Pages 269-297
    3. Permutation Tests for Phase III Clinical Trials

      • Vance Berger, Anastasia Ivanova
      Pages 349-374

About this book

The purpose of this book is to provide a general guide to statistical methods used in the pharmaceutical industry, and to illustrate how to use S-PLUS to implement these methods. Specifically, the goal is to: *Illustrate statistical applications in the pharmaceutical industry; *Illustrate how the statistical applications can be carried out using S-PLUS; *Illustrate why S-PLUS is a useful software package for carrying out these applications; *Discuss the results and implications of a particular application; The target audience for this book is very broad, including: *Graduate students in biostatistics; *Statisticians who are involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the indsutry that they may not be familiar with; *Statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.

Reviews

From the reviews:

STATISTICAL METHODS IN MEDICAL RESEARCH AN INTERNATIONAL REVIEW JOURNAL

"...this book is extremely good and highly recommended to statisticians involved in the drug development process."

"The book has a dual purpose. First, it contains examples of statistics in practice and includes interesting real-life examples … . The second purpose of the book is to promote the use of S-Plus, by showing what can be done with this software, and illustrating its use … . this is a very valuable book of case studies. Managers of Biometrics groups should ensure their staff have access to a copy and statistics consultants will need a copy of their own." (Tim Auton, Journal of Applied Statistics, Vol. 30 (1), 2003)

"Most of the chapters are written from a procedural perspective, describing the task to be done, showing the S-PLUS code required to conduct the task, and then displaying the S-PLUS results. … For a reader already sold on S-PLUS and looking for ways to apply it in his or her work, this book will be appealing. … The book will help pharmaceutical statisticians implement S-PLUS in their work if they are new to S-PLUS." (Brian J. Eastwood, Journal of the American Statistical Association, Issue March, 2003)

"Each one of the chapters begins with a short introduction to the subject, followed by background information on each source of data. ... and finishes with related references and an appendix with S-PLUS code. The latter is of major benefit to readers. It is very clearly set out with macros that cover a wide range of graphics and aspects of statistical analysis. … this book is extremely good and highly recommended to statisticians involved in the drug development process." (Vasilis Nikolaou, Statistical Methods in Medical Research, Vol. 11 (2), 2002)

Editors and Affiliations

  • Probability, Statistics & Information, Seattle, USA

    Steven P. Millard

  • Biostatistics, Novartis Pharma AG, Basel, Switzerland

    Andreas Krause

Bibliographic Information

  • Book Title: Applied Statistics in the Pharmaceutical Industry

  • Book Subtitle: With Case Studies Using S-Plus

  • Editors: Steven P. Millard, Andreas Krause

  • DOI: https://doi.org/10.1007/978-1-4757-3466-9

  • Publisher: Springer New York, NY

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer Science+Business Media New York 2001

  • Hardcover ISBN: 978-0-387-98814-6

  • Softcover ISBN: 978-1-4419-3166-5

  • eBook ISBN: 978-1-4757-3466-9

  • Edition Number: 1

  • Number of Pages: XVIII, 514

  • Topics: Statistics for Life Sciences, Medicine, Health Sciences, Computer Appl. in Life Sciences

Buy it now

Buying options

eBook USD 84.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 109.00
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access