An Introduction to Clinical Trials: Second Edition
Turner, J. Rick
The First Edition was published by Wiley, 2007
2nd ed. 2010, XXV, 256 p.
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Discusses the latest developments in the realm of drug safety, and expands its coverage of clinical trials considerably
Provides a conceptual introduction to statistics and illustrates its important role in the new drug development process
Adopts a conceptual approach, not a computational one, explaining the statistical thinking that goes into the successful planning of clinical trials
New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions.
While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions.
This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries.
Content Level »Research
Keywords »Clinical - Development - Drug - Introduction - Trial - Turner - methodology