New Drug Development: Design, Methodology, and Analysis

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John Wiley & Sons, 27 Tem 2007 - 270 sayfa
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This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
 

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İçindekiler

PARTI INTRODUCTION
3
The Regulatory Environment for New Drug Development
17
Drug Discovery
31
Nonclinical Research
47
Design and Methodology in Clinical Trials
61
Statistical Analysis
83
Employment of Hypothesis Testing
101
Employment of Confidence Intervals
121
SampleSize Estimation
127
Safety Assessment in Clinical Trials
139
Efficacy Assessment in Clinical Trials
165
Pharmaceutical and Biopharmaceutical Drug Manufacturing
191
Unifying Themes and Concluding Comments
217
APPENDIX Additional Resources For Training Executives and Professors
241
Index
259
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Yazar hakkında (2007)

J. Rick Turner, PhD, is Chairman of the Department of Clinical Research at Campbell University School of Pharmacy in Morrisville, North Carolina. A Fellow of the Society of Behavioral Medicine, his areas of interest include cardiovascular behavioral medicine, drug development, and clinical submissions. Dr. Turner has authored several books as well as more than fifty articles in professional journals, and he received a Commit to Product Development Award from GlaxoSmithKline in 2005.

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