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Books > Medicine > Clinical & internal medicine > Haematology
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Phase 1 Cancer Clinical Trials - A Practical Guide (Paperback, New)
Loot Price: R2,224
Discovery Miles 22 240
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Phase 1 Cancer Clinical Trials - A Practical Guide (Paperback, New)
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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 adverse effects 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 advanced
malignancy, 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 specialists interested in understanding cancer drug development.
Topics covered include preclinical requirements needed for
first-in-man investigation of new agents, principles and
statistical design, ethical considerations 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.
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