Clinical trials handbook /

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Bibliographic Details
Imprint:Hoboken, N.J. : Wiley, c2009.
Description:xix, 1225 p. : ill. ; 26 cm.
Language:English
Subject:Drugs -- Testing -- Handbooks, manuals, etc.
Clinical trials -- Handbooks, manuals, etc.
Clinical Trials as Topic -- Handbooks.
Clinical trials.
Drugs -- Testing.
Handbooks and manuals.
Format: Print Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/7788791
Hidden Bibliographic Details
Other authors / contributors:Gad, Shayne C., 1948-
ISBN:9780471213888 (cloth)
0471213888 (cloth)
Notes:Includes bibliographical references and index.
Table of Contents:
  • Preface
  • Contributors
  • 1. Introduction to Clinical Trials
  • 2. Regulatory Requirements for Investigational New Drug
  • 3. Preclinical Assessment of Safety in Human Subjects
  • 4. Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies
  • 5.1. History of Clinical Trial Development and the Pharmaceutical Industry
  • 5.2. Adaptive Research
  • 6. Organization and Planning
  • 7. Process of Data Management
  • 8. Clinical Trials Data Management
  • 9.1. Clinical Trials and the Food and Drug Administration
  • 9.2. Phase I Clinical Trials
  • 9.3. Phase II Clinical Trials
  • 9.4. Designing and Conducting Phase III Studies
  • 9.5. Phase IV: Postmarketing Trials
  • 9.6. Phase IV and Postmarketing Clinical Trials
  • 9.7. Regulatory Approval
  • 9.8. New Paradigm for Analyzing Adverse Drug Events
  • 10.1. Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent
  • 10.2. Clinical Trials Involving Oral Diseases
  • 10.3. Dermatology Clinical Trials
  • 10.4. Emergency Clinical Trials
  • 10.5. Gastroenterology Lise Lotte Gluud and J┬┐rgen Rask-Madsen
  • 10.6. Gynecology Randomized Control Trials Khalid S. Khan, Tara Selman, and Jane Daniels
  • 10.7. Special Population Studies (Healthy Patient Studies)
  • 10.8. Musculoskeletal Disorders
  • 10.9. Oncology
  • 10.10. Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration
  • 10.11. Paediatrics
  • 10.12. Clinical Trials in Dementia
  • 10.13. Clinical Trials in Urology
  • 10.14. Clinical Trials on Cognitive Drugs
  • 10.15. Bridging Studies in Pharmaceutical Safety Assessment
  • 10.16. Brief History of Clinical Trials on Viral Vaccines
  • 11. Methods of Randomization
  • 12. Randomized Controlled Trials
  • 13. Cross-Over Designs
  • 14.1. Biomarkers
  • 14.2. Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis
  • 15. Review Boards
  • 16. Size of Clinical Trials
  • 17. Blinding and Placebo
  • 18. Pharmacology
  • 19. Modeling and Simulation in Clinical Drug Development
  • 20. Monitoring
  • 21. Inference Following Sequential Clinical Trials
  • 22. Statistical Methods for Analysis of Clinical Trials
  • 23. Explanatory and Pragmatic Clinical Trials
  • 24.1. Ethics of Clinical Research in Durg Trials
  • 24.2. Ethical Issues in Clinical Research
  • 25. Regulations
  • 26. Future Challenges in Design and Ethics of Clinical Trials
  • 27. Proof-of-Principle/Proof-of-Concept Trials in Drug Development
  • Index