Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /
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Author / Creator: | Brody, Tom, author. |
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Edition: | Second edition. |
Imprint: | London : Academic Press is an imprint of Elsevier, 2016. |
Description: | 1 online resource |
Language: | English |
Subject: | |
Format: | E-Resource Book |
URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/11253892 |
Table of Contents:
- 1. Origins of drugs
- 2. Clinical trial design
- 3. Run-in period
- 4. Inclusion/exclusion criteria, stratification, and subgroups
- part I
- 5. Inclusion/exclusion criteria, stratification, and subgroups
- part II
- 6. Blinding, randomization, and allocation
- 7. Placebo arm as part of clinical trial design
- 8. Intent-to-treat analysis versus per protocol analysis
- 9. Biostatistics
- part I
- 10. Biostatistics
- part II
- 11. Introduction to endpoints
- 12. Oncology endpoint
- objective response
- 13. Oncology endpoints : overall survival and progression-free survival
- 14. Oncology endpoints : time to progression
- 15. Oncology endpoint : disease-free survival
- 16. Oncology endpoint : time to distant metastasis
- 17. Neoadjuvant therapy versus adjuvant therapy
- 18. Hematological cancers
- 19. Biomarkers
- 20. Endpoints for immune diseases
- 21. Endpoints for infections
- 22. Health-related quality of life tools
- oncology
- 23. Health-related quality-of-life tools
- immune disorders
- 24. Health-related quality-of-life tools
- infections
- 25. Drug safety
- 26. Mechanism of action of diseases and drugs
- part I
- 27. Mechanism of action
- part II (cancer)
- 28. Mechanism of action
- part III (immune disorders)
- 29. Mechanisms of action
- part IV (infections)
- 30. Consent forms
- 31. Package inserts
- 32. Warning letters
- 33. Regulatory approval
- 34. Patents.