Phase 1 Cancer Clinical Trials (Paperback)

Language: English

Published by Oxford University Press, Oxford, 2006

0198567197 / 9780198567196

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Seller: CitiRetail, Stevenage, United KingdomCitiRetail

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Paperback. Phase I trials are a critical first step in the study of novel therapeutic approaches. They follow years of development in the laboratory, and precede Phase II and III trials where testing of the drug becomes more focused yet is conducted on a wider scale.The primary goals of Phase I trials are to identify the recommended dose, schedule and pharmacologic behaviour of new agents or new combinations of agents, and to describe the adverseeffects of treatment. In cancer therapeutics, such studies have particular challenges. In general, because of the nature of the effects of treatment, most studies are conducted in patients with advancedmalignancy, rather than in healthy volunteers. Furthermore, the endpoints of these trials are usually measures of adverse effects, but increasingly investigators are interested in assessment of the effects of new drugs on their molecular target. These factors render the design, conduct, analysis and ethical aspects of Phase I cancer clinical trials unique.This book provides a practical guide to Phase I cancer trials and is appropriate for oncology trainees or specialistsinterested in understanding cancer drug development. Topics covered include preclinical requirements needed for first-in-man investigation of new agents, principles and statistical design, ethicalconsiderations of Phase I studies, pharmacokinetics, pharmacodynamics, and studies in special populations. Practical information on protocol development, study activation and conduct, as well as how to write reports of the results, are incorporated. Numerous appendices offer document templates to use in Phase I study development, and examples from actual Phase I trials are interspersed throughout, making this a true 'hands-on' guide.In an exciting time in cancer research,as the number and type of new potential anti-cancer drugs is increasing dramatically, this book provides much needed information on the first stage in getting a drug approved. Phase I trials are the first step in the study of novel therapeutic approaches. They aim to identify the recommended dose, schedule and pharamcologic behaviour of new drugs, and to describe the adverse effects of treatment. This practical guide discusses the design, conduct, analysis and ethical aspects of Phase I cancer trials. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.…

Seller Inventory # 9780198567196

Title
Phase 1 Cancer Clinical Trials (Paperback)
Author
Elizabeth A. Eisenhauer
Publisher
Oxford University Press, Oxford
Publication year
2006
Condition
new
Binding
Paperback
Language
English
ISBN 10
0198567197
ISBN 13
9780198567196
Edition
1st Edition

CitiRetail

Stevenage, United Kingdom

5-star seller

AbeBooks seller since June 29, 2022

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