New Drug Development - Design, Methodology, and Analysis

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.Table of ContentForeword. Preface. PART I: INTRODUCTION. Chapter 1. New Drug Development. Chapter 2. The Regulatory Environment for New Drug Development. PART II: DRUG DISCOVERY AND NONCLINICAL RESEARCH. Chapter 3. Drug Discovery. Chapter 4. Nonclinical Research. PART III: DESIGN, METHODOLOGY, AND ANALYSIS. Chapter 5. Design and Methodology in Clinical Trials. Chapter 6. Statistical Analysis. Chapter 7. Statistical Significance: Employment of Hypothesis testing. Chapter 8. Clinical Significance: Employment of Confidence Intervals. Chapter 9. Sample-Size Estimation. PART IV: LIFECYCLE CLINICAL DEVELOPMENT. Chapter 10. Safety Assessment in Clinical Trials. Chapter 11. Efficacy Assessment in Clinical Trials. Chapter 12. Pharmaceutical and Biopharmaceutical Drug Manufacturing. Chapter 13. Postmarketing Surveillance and Evidence-Based Medicine. PART V: INTEGRATIVE DISCUSSION. Chapter 14. Unifying Themes and Concluding Comments. Appendix. Additional Resource For Training Executives and Professors. References. Index. About the Author.Review Quote"This volume would provide an excellent introduction for anyone entering the pharmaceutical industry. It would also make superb background reading for medical statistics for MSc students." (International Statistical Review Aug 2008) "The book gives a refreshing run through of the drug discovery and development process and it is probably the book you need to have to learn about this fascinating field." (Journal of Applied Statistics, January 2008) "The author has the uncanny ability to reveal the essence of a complex topic without bogging down in superficialities." (Journal of Clinical Research Practices, September 2007)Biographical NoteJ. 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.