Here’s an essential guide for drugmakers looking to streamline the trials process for faster FDA approvals and major cost savings. You’ll find loads of expert advice plus case studies — actual experiences of manufacturers like you who brought products to market successfully once they learned the right way to plan and manage clinical trials.

The book helps readers:

• Discover how to cut waste;
• Identify which trials are "must do" and which can be delayed;
• Choose the most powerful clinical endpoints to optimize product usage;
• Register products worldwide;
• Manage patient safety;
• and much more.

"This is a 'must read' book for those who want to gain a solid foundation on the basics of strategies involved in clinical trial design and clinical development," according to Kevin L. Skare, Ph.D, Adjunct Professor of Pharmaceutical Sciences for the University of Cincinnati’s College of Pharmacy, and Senior Director of Global Clinical Operations for Procter & Gamble Pharmaceuticals.

Table of Contents

Foreword
1. Introduction
2. Overview of Clinical Development Process
3. Strategic Planning
4. Market Research and Focus Groups
5. Package Insert
6. Phase 1 Studies
7. Proof-of-Concept Studies
8. Choosing Clinical Endpoints
9. Phase 2 Studies
10. Phase 3 Studies
11. Drug-Drug Interaction Studies
12. Organ Impairment Studies
13. Special Populations
14. Pharmacokinetics, Metabolism, and Bioavailability
15. Phase 3b Studies
16. Phase 4 Studies
17. Health Care Utilization and Pharmacoeconomic Studies
18. Rx to OTC Switches
19. Blinding Clinical Studies
20. Ethics, IRBs and IECs, and the Informed Consent Process
21. Estimating Program Timing and Costs
22. Life Cycle Management
23. Glossary
24. References