New Drug Development

1. New Drug Development
J. Rick Turner

2. The Regulatory Environment
J. Rick Turner

3. Drug Discovery
J. Rick Turner

4. Nonclinical Research
J. Rick Turner

5. Designing Clinical Trials
J. Rick Turner

6. Conducting Clinical Trials I: Experimental Methodology
J. Rick Turner

7. Conducting Clinical Trials II: Operational Execution
J. Rick Turner

8. Statistical Analysis
J. Rick Turner

9. Statistical Significance
J. Rick Turner

10. Clinical Significance
J. Rick Turner

11. Sample Size Estimation
J. Rick Turner

12. General Safety Assessments
J. Rick Turner

13. Efficacy Assessment
J. Rick Turner

14. Cardiac and Cardiovascular Safety Assessments
J. Rick Turner

15. Manufacturing Small Molecule Drugs and Biologicals
J. Rick Turner

16. Postmarketing Surveillance
J. Rick Turner

17. Main Themes and Concluding Comments
J. Rick Turner

Keywords: Biomedicine, Pharmaceutical Sciences/Technology