 New Drug Development: Design, Methodology, and Analysis
ISBN: 978-0-470-07373-5
Hardcover
270 pages
July 2007
US $99.95
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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.
