1st Edition

The Clinical Research Process in the Pharmaceutical Industry

Edited By

Gary M. Matoren





ISBN 9780824719142
Published December 13, 1983 by CRC Press
572 Pages

USD $220.00

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Book Description

This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.

Table of Contents

1. Pharmogenology: The Industrial New Drug Development Process 2. Research Planning and Development Perspectives 3. Historical Review 4. Legal and Ethical Problems in Clinical Research 5. Social Psychological Implications of Clinical Research 6. Clinical Project Coordination 7. The Protocol and Case Report Form 8. Clinical Data Management and Statistical Design in the Clinical Research Process 9. Document Preparation 10. Clinical Pharmacology 11. Clinical Research 12. The Monitoring Process 13. Drug Safety Evaluation and Implications for Clinical Investigation 14. Special Considerations of Drug Disposition 15. Product Development 16. Over-the-Counter Drug Research 17. Postmarketing Surveillance of Drugs 18. Research Quality Assurance 19. Role of Contract Research Organizations 20. Drug Regulatory Affairs 21. Relationship of Marketing to Clinical Research 22. Impact of the Pharmaceutical Industry on Health Care and Health Care Economics 23. Role of the FDA in the Clinical Research Process 24. Clinical Pharmacy and its Relationship to Clinical Research William 25. Career Opportunities in Industrial Clinical Research Martin 26. Recent Trends: The Impact of the Enviroment on Research Strategies and Productivity 27. A Futuristic View

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Editor(s)

Biography

Matoren\, Gary M.