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Design and management of medical device clinical trials : strategies and challenges

By: Abdel-aleem, Salah.
Material type: materialTypeLabelBookPublisher: Hoboken, N.J. : Wiley, ©2010Description: xvii, 250 p. ; 25 cm.ISBN: 9780470602256.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.
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Reference
Science REF 610.28 ABD-D (Browse shelf) Not For Loan 006920
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REF 522.1954 MUK-J Jantar mantar : REF 541.369 HAN-I Introduction to molecular thermodynamics REF 591.188 JOH-F Foundations of cellular neurophysiology REF 610.28 ABD-D Design and management of medical device clinical trials : REF 610.28 YI-N Nanobiomaterials : REF 610.284 WEB-P Principles of biomedical instrumentation REF 612.8 BIC-o The Oxford handbook of philosophy and neuroscience

Includes bibliographical references and index.

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.

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