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Table Of Contents

Introduction
1.1 DRUG DEVELOPMENT
1.2 THE ROLE OF STATISTICS IN DRUG DEVELOPMENT
1.3 THE OBJECT OF THIS BOOK
1.4 THE AUTHOR’S KNOWLEDGE OF STATISTICS IN DRUG DEVELOPMENT
1.5 THE READER AND HIS OR HER KNOWLEDGE OF STATISTICS
1.6 HOW TO USE THE BOOK
References
A Brief and Superficial History of Statistics for Drug Developers
2.1 INTRODUCTION
2.2 EARLY PROBABILISTS
2.3 JAMES BERNOULLI (1654–1705)
2.4 JOHN ARBUTHNOTT (1667–1753)
2.6 THOMAS BAYES (1701–1761)
2.7 ADOLPHE QUETELET (1796–1874)
2.8 FRANCIS GALTON (1822–1911)
2.9 KARL PEARSON (1857–1936)
2.10 ‘STUDENT’ (1876–1937)
2.11 R.A. FISHER (1890–1962)
2.12 MODERN MATHEMATICAL STATISTICS
2.13 MEDICAL STATISTICS
2.14 STATISTICS IN CLINICAL TRIALS TODAY
2.15 THE CURRENT DEBATE
2.16 A LIVING SCIENCE
2.17 FURTHER READING
Design and Interpretation of Clinical Trials as Seen by a Statistician
3.1 PREFATORY WARNING
3.2 INTRODUCTION
3.3 DEFINING EFFECTS
3.4 PRACTICAL PROBLEMS IN USING THE COUNTERFACTUAL ARGUMENT
3.5 REGRESSION TO THE MEAN
3.6 CONTROL IN CLINICAL TRIALS
3.7 RANDOMIZATION
3.8 BLINDING
3.9 USING CONCOMITANT OBSERVATIONS
3.10 MEASURING TREATMENT EFFECTS
3.11 DATA GENERATION MODELS
3.12 IN CONCLUSION
3.13 FURTHER READING
4.1 INTRODUCTION
4.2 AN EXAMPLE
4.3 ODDS AND SODS
4.4 THE BAYESIAN SOLUTION TO THE EXAMPLE
4.6 A FREQUENTIST APPROACH
4.7 HYPOTHESIS TESTING IN CONTROLLED CLINICAL TRIALS
4.8 SIGNIFICANCE TESTS AND P-VALUES
4.9 CONFIDENCE INTERVALS AND LIMITS AND CREDIBLE INTERVALS
4.10 SOME BAYESIAN CRITICISM OF THE FREQUENTIST APPROACH
4.11 DECISION THEORY
4.12 CONCLUSION
4.13 FURTHER READING
The Work of the Pharmaceutical Statistician
5.1 PREFATORY REMARKS
5.2 INTRODUCTION
5.3 IN THE BEGINNING
5.4 THE TRIAL PROTOCOL
5.5 THE STATISTICIAN’S ROLE IN PLANNING THE PROTOCOL
5.6 SAMPLE SIZE DETERMINATION
5.7 OTHER IMPORTANT DESIGN ISSUES
5.8 RANDOMIZATION
5.9 DATA COLLECTION PREVIEW
5.10 PERFORMING THE TRIAL
5.11 DATA ANALYSIS PREVIEW
5.12 ANALYSIS AND REPORTING
5.13 OTHER ACTIVITIES
5.14 STATISTICAL RESEARCH
5.15 FURTHER READING
Allocating Treatments to Patients in Clinical Trials
6.1 BACKGROUND
6.2 ISSUES
6.A TECHNICAL APPENDIX
Baselines and Covariate Information
7.1 BACKGROUND
7.2 ISSUES
7.A TECHNICAL APPENDIX
The Measurement of Treatment Effects
8.1 BACKGROUND
8.2 ISSUES
8.A TECHNICAL APPENDIX
Demographic Subgroups: Representation and Analysis
9.1 BACKGROUND
9.2 ISSUES
9.A TECHNICAL APPENDIX
10.1 BACKGROUND
10.2 ISSUES
10.A TECHNICAL APPENDIX
Intention to Treat, Missing Data and Related Matters
11.1 BACKGROUND
11.2 ISSUES
11.A TECHNICAL APPENDIX
12.1 BACKGROUND
12.2 ISSUES
Determining the Sample Size
13.1 BACKGROUND
13.2 ISSUES
Multicentre Trials
14.1 BACKGROUND
14.2 ISSUES
14.A TECHNICAL APPENDIX
Active Control Equivalence Studies
15.1 BACKGROUND
15.2 ISSUES
15.A TECHNICAL APPENDIX
16.1 BACKGROUND
16.2 ISSUES
16.A TECHNICAL APPENDIX
Cross-over Trials
17.1 BACKGROUND
17.2 ISSUES
18.1 BACKGROUND
18.2 ISSUES
Sequential Trials
19.1 BACKGROUND
19.2 ISSUES
20.1 BACKGROUND
20.2 ISSUES
Concerning Pharmacokinetics and Pharmacodynamics
21.1 BACKGROUND
21.2 ISSUES
Bioequivalence Studies
22.1 BACKGROUND
22.2 ISSUES
Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology
23.1 BACKGROUND
23.2 ISSUES
Pharmaco-economics and Portfolio Management
24.1 BACKGROUND
24.2 ISSUES
25.1 BACKGROUND
25.2 ISSUES
25.A TECHNICAL APPENDIX
Glossary
Index
P. 1
Statistical Issues in Drug Development

Statistical Issues in Drug Development

Ratings: (0)|Views: 33|Likes:
Published by Wiley
Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes.

Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. 

This highly readable second edition has been updated to include:

Comprehensive coverage of the design and interpretation of clinical trials. Expanded sections on missing data, equivalence, meta-analysis and dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials.

It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.

Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes.

Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. 

This highly readable second edition has been updated to include:

Comprehensive coverage of the design and interpretation of clinical trials. Expanded sections on missing data, equivalence, meta-analysis and dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials.

It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.

More info:

Publish date: Feb 28, 2008
Added to Scribd: Jun 04, 2013
Copyright:Traditional Copyright: All rights reservedISBN:9780470723579
List Price: $141.00 Buy Now

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