New Drug Development

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.

Foreword. 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.