New Drug Development 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.

New Drug Development provides an indispensable overview of an otherwise confusing and fragmented set of topics.

Contents

1. New Drug Development
2. The Regulatory Environment for New Drug Development

Drug Discovery and Nonclinical Research

3. Drug Discovery
4. Nonclinical Research

Design, Methodology, and Analysis

5. Design and Methodology in Clinical Trials
6. Statistical Analysis
7. Statistical Significance: Employment of Hypothesis testing
8. Clinical Significance: Employment of Confidence Intervals
9. Sample-Size Estimation

Lifecycle Clinical Development

10. Safety Assessment in Clinical Trials
11. Efficacy Assessment in Clinical Trials
12. Pharmaceutical and Biopharmaceutical Drug Manufacturing
13. Postmarketing Surveillance and Evidence-Based Medicine

Intergrative Discussion

14. Unifying Themes and Concluding Comments

Index

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