Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations 2nd Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies.

Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management.

New to the Second Edition:

• international regulation and deregulation
• venture capitalist investment
• the IND process
• informed consent
• changes in manufacturing

and updated and extended coverage of:

• pediatric drug trial design
• the advantages and disadvantages of orphan drug designations
• the maximization of package inserts for marketing
• post approval safety surveillance
• withdrawals from the drug market

Clinical Drug Trials and Tribulations will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Contents

1. Current Challenges and Future Directions of Drug Development
2. Preclinical Drug Discovery and Development
3. The IND Process for New Drug Products
4. Performance and Interpretation of Laboratory Tests
5. Issues in Endpoint Selection
6. Dix, Cent, Mille: Proof of Principle with $10 Million, 100 Patients, and 1000 Days
7. Clinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric Populations
8. Electronic Capture of Clinical Trial Information
9. Providing Patient Access to Promising Investigational Drugs
10. Issues in the Review of Clinical Drug Trials by IRBs
11. Personal Care and Randomized Clinical Trials: Understanding the Ethical Conflicts
12. Informed Consent in Clinical Trials: Emerging Issues
13. Orphan Drug Development: David and Goliath
14. Single-Event Adverse Drug Reactions: Tribulations in Ascribing Causality
15. How to Deal with a Sudden, Unexpected Death in Clinical Studies
16. Clinical Trial Material—The Fuel for Clinical Research
17. The Role of Pharmacokinetics in Drug Development
18. Building an NDA/BLA
19. International Planning of Drug Clinical Trials
20. Uncertainty in Drug Development: Approval Success Rates for New Drugs
21. Contract Clinical Research: Value to In-House Drug Development
22. Package Inserts as Viewed by the Busy Private Practitioner
23. New Directions in Pharmaceutical Promotion: Regulatory Concerns and Contrivances
24. The Campus Researcher and Industry: Issues of Intellectual Property and Technology Transfer
25. Anatomy of Drug Withdrawals in the United States

Appendices: Routine Clinical Analyte Test Results
Index

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