Read more
Zusatztext This is a well-written, well-structured book that comprehensively covers the unique aspects of phase I clinical trials in cancer patients. This may be the only book of its kind and will be appropriate for a wide audience. Informationen zum Autor 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 Klappentext 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. Zusammenfassung 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. Inhaltsverzeichnis 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 ...
