Preface Contributors

1. Current Challenges and Future Directions of Drug Development Allen Cato, Lynda Sutton, and Allen Cato III

2. Preclinical Drug Discovery and Development David S. Duch and Robert M. Ferris

3. The IND Process for New Drug Products David M. Cocchetto

4. Performance and Interpretation of Laboratory Tests

W. Leigh Thompson, Rocco L. Brunelle, and Michael G. Wilson

5. Issues in Endpoint Selection

Karen D. Weiss and Jay Philip Siegel

6. Dix, Cent, Mille: Proof of Principle with $10 Million, 100 Patients, and 1000 Days

W. Leigh Thompson

7. Clinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric Populations

Allen Cato and Myron B. Peterson

8. Electronic Capture of Clinical Trial Information Daniel C. Cato and David B. Thomas

9. Providing Patient Access to Promising Investigational Drugs Peggy J. Berry and Allen Cato

10. Issues in the Review of Clinical Drug Trials by IRBs Dale H. Cowan

11. Personal Care and Randomized Clinical Trials: Understanding the Ethical Conflicts

Paul J. Reitemeier

12. Informed Consent in Clinical Trials: Emerging Issues Cheryl K. Fiedler and H. Russell Searight

13. Orphan Drug Development: David and Goliath

Allen Cato, Susan L. Watts, Lynda Sutton, and Marlene E. Haffner

14. Single-Event Adverse Drug Reactions: Tribulations in Ascribing Causality

Nelson S. Irey

15. How to Deal with a Sudden, Unexpected Death in Clinical Studies

Allen Cato and Lynda Sutton

16. Clinical Trial Material—The Fuel for Clinical Research David F. Bernstein

17. The Role of Pharmacokinetics in Drug Development Allen Cato III and Richard Granneman

18. Building an NDA/BLA

Diana E. Fordyce and Angela Cahill

19. International Planning of Drug Clinical Trials David L. Horwitz

20. Uncertainty in Drug Development: Approval Success Rates for New Drugs

Joseph A. DiMasi

21. Contract Clinical Research: Value to In-House Drug Development

F. Richard Nichol

22. Package Inserts as Viewed by the Busy Private Practitioner Jean M. Findlay

23. New Directions in Pharmaceutical Promotion: Regulatory Concerns and Contrivances

Louis A. Morris and Peter H. Rheinstein

24. The Campus Researcher and Industry: Issues of Intellectual Property and Technology Transfer

Todd S. Keiller

25. Anatomy of Drug Withdrawals in the United States Marion J. Finkel

Appendices: Routine Clinical Analyte Test Results

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