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Clinical Trials
Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
- 2nd Edition - February 19, 2016
- Author: Tom Brody
- Language: English
- Hardback ISBN:9 7 8 - 0 - 1 2 - 8 0 4 2 1 7 - 5
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 0 4 2 5 8 - 8
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomed… Read more
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Request a sales quote- Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more
- Extensively covers the "study schema" and related features of study design
- Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials
- Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
1. The Origins of Drugs
2. Introduction to Clinical Trial Design
3. Run-in Period
4. Inclusion/Exclusion Criteria, Stratification and Subgroups – Part I
5. Inclusion and Stratification Criteria – Part II
6. Randomization, Allocation, and Binding
7. Intent to Treat Analysis vs. Per Protocol Analysis
8. Biostatistics – Part I
9. Biostatistics – Part II
10. Introduction to Endpoints for Clinical Trials in Pharmacology
11. Endpoints in Clinical Trials on Solid Tumors – Objective Response
12. Oncology Endpoints: Overall Survival and Profession-Free Survival
13. Oncology Endpoints: Time to Progression
14. Oncology Endpoint: Disease-Free Survival
15. Oncology Endpoint: Time to Distant Metastasis
16. Neoadjuvant Therapy vs. Adjuvant Therapy
17. Hematological Cancers
18. Biomarkers and Personalized Medicine
19. Endpoints in Immune Diseases
20. Endpoints in Clinical Trials on Infections
21. Health-Related Quality of Life
22. Health-Related Quality of Life Instruments for Immune Disorders
23. Health-Related Quality of Life Instruments and Infections
24. Drug Safety
25. Mechanisms of Action, Part I
26. Mechanisms of Action, Part II – Cancer
27. Mechanisms of Action, Part III – Immune Disorders
28. Mechanisms of Action, Part IV- Infections
29. Consent Forms
30. Package Inserts
31. Regulatory Approval
32. Patents
- No. of pages: 896
- Language: English
- Edition: 2
- Published: February 19, 2016
- Imprint: Academic Press
- Hardback ISBN: 9780128042175
- eBook ISBN: 9780128042588
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