Introduction to Statistics in Pharmaceutical Clinical Trials
Ref. 12-9780853697145
| 1u | 45.00 € |
Product Information
Durham, Todd A; Turner, J Rick
First edition
Scheduled closure of pharmpress.com
Todd A Durham - Senior Director, Biostatistics and Data Management, Inspire Pharmaceuticals and J Rick Turner - Associate Professor of Clinical Research
ISBN 978 0 85369 714 5
Published Mar 2008
Paperback 246 x 189mm (240pp)
DESCRIPTION:
Introduction to Statistics in Pharmaceutical Clinical Trials is presented in the context of clinical trials conducted during pharmaceutical drug development.
This novel approach teaches the computational steps needed to conduct analyses. It also provides a conceptual understanding of how these analyses provide information that forms the basis for decision making throughout the drug development process.
This textbook conveys:
- why, and how data are collected in clinical studies
- how these data are summarized and analyzed
- what the results mean in the context of the clinical research question
- how the results are communicated to regulatory agencies and to the scientific and medical communities.
All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics. Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to professionals entering the pharmaceutical, biotechnology, and contract research organization industries who wish to gain a broader understanding of study design, research methodology, and statistical analysis and interpretation in clinical trials.
CONTENTS:
1. The Discipline of Statistics: Introduction and Terminology
2. The Role of Clinical Trials in New Drug Development
3. Research Questions and Research Hypotheses
4. Study Design and Experimental Methodology
5. Data, Central Tendency and Variation
6. Probability, Hypothesis Testing and Estimation
7. Early-phase Clinical Trials
8. Confirmatory Clinical Trials: Safety Data I
9. Confirmatory Clinical Trials: Safety Data II
10. Confirmatory Trials: Analysis of Categorical Efficacy Data
11. Confirmatory Clinical Trials of Analysis of Continuous Efficacy Data
12. Additional Statistical Considerations in Clinical Trials
13. Concluding Comments: Appendix: References
REVIEWS:
01-Aug-08, Doody Enterprises, Inc
'It fills the gap that exists between books that focus on research design and those that address statistical methods. The authors have clearly met this worthy objective. This book fills a unique position and uses innovative method.'
Michael R Jacobs, BS, PharmD (Temple University of Pharmacy) Doody Enterprises July 2008
Chemical properties
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