Turner J.R. New Drug Development. Design, Methodology, and Analysis

Wiley, 2007. — 298 p.New Drug Development
The Regulatory Environment for New Drug Development
Drug Discovery and Nonclinical Research
Drug Discovery
Nonclinical Research
Design, Methodology, and Analysis
Design and Methodology in Clinical Trials
Statistical Analysis
Statistical Significance: Employment of Hypothesis Testing
Clinical Significance: Employment of Confidence Intervals
Sample-Size Estimation
Lifecycle Clinical Development
Safety Assessment in Clinical Trials
Efficacy Assessment in Clinical Trials
Pharmaceutical and Biopharmaceutical Drug Manufacturing
Postmarceting Surveillance and Evidence-based Medicine
Integrative Discussion
Unifiyng Themes and Concluding Comments