Phase I Cancer Clinical Trials

A Practical Guide (Revised)
Herausgeber: Eisenhauer, Elizabeth A; Buyse, Marc; Twelves, Christopher

• Broschiertes Buch

Produktbeschreibung

Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it is a useful resource for oncology trainees or specialists interested in understanding cancer drug development.

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Produktdetails

• Verlag: Oxford University Press
• 2nd Revised edition
• Seitenzahl: 368
• Erscheinungstermin: 17. April 2015
• Englisch
• Abmessung: 231mm x 155mm x 23mm
• Gewicht: 517g
• ISBN-13: 9780199359011
• ISBN-10: 0199359016
• Artikelnr.: 47871104

Autorenporträt

EAE: Head, Department of Oncology, Queen's University, Medical Director, Oncology Program, Kingston General Hospital, Cancer Centre of Southeastern Ontario, Kingston, Canada; CT: Professor of Clinical Pharmacology and Oncology, Head, Section of Clinical Cancer Research Groups, Leeds Institute of Cancer Studies and Pathology, St. James's Institute of Oncology Leeds, UK; MB: Founder and Chairman, International Drug Development Institute, Louvain-la-Neuve, Belgium, Associate Professor of Biostatistics, Universiteit Hasselt Diepenbeek, Belgium

Inhaltsangabe

1. Introduction
2. Preclinical Data and Requirements
3. Phase 0 Clinical Trials
4. Basics of Phase I Design: First-in-man Studies
5. Ethical Issues in First-in-human Phase I Cancer Trials
6. Phase I Trials in Special Populations and Circumstances
7. Phase I Trials of Immunotherapeutics
8. Statistical Designs for First-in-human Phase I Trials
9. Writing the Protocol
10. Practical Aspects of Pharmacokinetics and Pharmacodynamics
11. Process, Pitfalls, and Logistics of Phase I Trials
12. Reporting and Interpreting Results
Appendix: Useful Web Resources