ECU Libraries Catalog

The design and management of medical device clinical trials : strategies and challenges / Salah Abdel-aleem.

Author/creator Abdel-aleem, Salah
Format Book and Print
Publication InfoHoboken, N.J. : John Wiley, ©2010.
Descriptionxvii, 250 pages ; 25 cm
Subject(s)
Medical instruments and apparatus--Research.
Clinical trials.
Clinical Trials as Topic--methods.
Equipment and Supplies.
Device Approval.
Contents Challenges to the design of clinical study -- Challenges to managing the study -- Selection of historic controls -- Fraud and misconduct in clinical trials -- Challenges to the regulation of medical device -- Challenges of global clinical studies and the CE mark process -- Challenging FDA PMA cases -- Bioethics in clinincal research.
Local noteLaupus-WCP
Bibliography noteIncludes bibliographical references and index.
LCCN 2009045887
ISBN9780470602256 (cloth)
ISBN0470602252 (cloth)

Available Items

Library Location Call Number Status Item Actions
Laupus Books - Stacks W 26 A135D 2010 ✔ Available Place Hold
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