New drug development: Design, methodology & analysis (Statistics in practice)

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.

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.