Clinical trials handbook /
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| Imprint: | Hoboken, N.J. : Wiley, c2009. |
|---|---|
| Description: | xix, 1225 p. : ill. ; 26 cm. |
| Language: | English |
| Subject: | |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/7788791 |
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
