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

By: Material type: TextTextPublication details: Hoboken, N.J. : Wiley, ©2010.Description: xvii, 250 p. ; 25 cmISBN:
  • 9780470602256
Subject(s): DDC classification:
  • 610.28 22 ABD-D
LOC classification:
  • R856.4 .A22 2010
NLM classification:
  • 2010 J-282
  • W 26
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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Holdings
Item type Current library Collection Call number Status Date due Barcode Item holds
Books Books IIITD Reference Science REF 610.28 ABD-D (Browse shelf(Opens below)) Loan on demand 006920
Total holds: 0

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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