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Applied Statistics in the Pharmaceutical Industry

With Case Studies Using S-Plus

  • Steven P. Millard
  • Andreas Krause

Table of contents

  1. Front Matter
    Pages i-xviii
  2. Introduction

    1. Front Matter
      Pages 1-1
    2. Bruce Rodda, Steven P. Millard, Andreas Krause
      Pages 3-14
  3. Basic Research and Preclinical Studies

    1. Front Matter
      Pages 15-15
    2. Bill Pikounis
      Pages 17-40
  4. Pre-Clinical Safety Assessment

    1. Front Matter
      Pages 41-41
    2. Hongshik Ahn, Ralph L. Kodell
      Pages 43-73
    3. 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. Ha Nguyen, Dhammika Amaratunga
      Pages 109-133
    3. Bill Pikounis, Thomas E. Bradstreet, Steven P. Millard
      Pages 153-188
    4. Axel Benner, Lutz Edler, Gernot Hartung
      Pages 189-216
    5. 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. Jürgen Bock
      Pages 269-297
    3. Vance Berger, Anastasia Ivanova
      Pages 349-374
    4. Wenping Wang, Andreas Krause
      Pages 375-396
    5. Keith O’Rourke, Beverley Shea, George A. Wells
      Pages 397-424
  7. Phase IV Studies

    1. Front Matter
      Pages 425-425
    2. John R. Cook, George W. Carides, Erik J. Dasbach
      Pages 427-454
  8. Manufacturing and Production

    1. Front Matter
      Pages 455-455
    2. Harry Yang, David Carlin
      Pages 475-502
  9. Back Matter
    Pages 503-515

About this book

Introduction

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.

Keywords

Biostatistics S-Plus applied statistics clinical trial data analysis development drug drug development evaluation pharmaceutical pharmaceutical industry pharmacokinetics quality control research statistical methods statistics Variance

Editors and affiliations

  • Steven P. Millard
    • 1
  • Andreas Krause
    • 2
  1. 1.Probability, Statistics & InformationSeattleUSA
  2. 2.BiostatisticsNovartis Pharma AGBaselSwitzerland

Bibliographic information