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　　分類: 图书,进口原版书,科学与技术 Science & Techology ,

作者： Steven P. Millard， Andreas Krause著

出 版 社：

出版时间： 2001-6-1字数：版次： 1页数： 513印刷时间： 2001/06/01开本： 16开印次： 1纸张： 胶版纸I S B N ： 9780387988146包装： 精装内容简介

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。

目录

Preface

A Note About S-PLUS Versions

Typographic Conventions

Companion Web Site for This Book

Information on S-PLUS

Acknowledgments

List of Contributors

Part 1 Introduction

1 Statistics and the Drug Development Process

Part 2 Basic Research and Preclinical Studies

2 One-Factor Comparative Studies

Part 3 Pre-Clinical Safety Assessment

3 Analysis of Animal Carcinogenicity Data

4 Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies

Part 4 Phase I Studies

5 Analysis of Pharmacokinetic Data

6 Graphical Presentation of Single Patient Results

7 Graphical Insight and Data Analysis for the 2,2,2 Crossover Design

8 Design and Analysis of Phase I Trials in Clinical Oncology

9 Patient Compliance and its Impact on Steady State Pharmacokinetics

10 Analysis of Analgesic Trials

Part 5 Phase II and Phase III Clinical Trials

11 Power and Sample Size Calculations

12 Comparing Two Treatments in a Large Phase III Clinical Trial

13 Analysis of Variance: A Comparison Between SAS and S-PLUS

14 Permutation Tests for Phase III Clinical Trials

15 Sample Size Reestimation

16 Meta-Analysis of Clinical Trials

Part 6 Phase IV Studies

17 Analysis of Health Economic Data

Part 7 Manufacturing and Production

18 Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production

19 Acceptance Sampling Plans by Attributes

Index

 

 

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