Franklin

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

Author/Creator:
Abdel-aleem, Salah.
Publication:
Hoboken, N.J. : John Wiley, c2010.
Format/Description:
Book
xvii, 250 p. ; 25 cm.
Subjects:
Medical instruments and apparatus -- Research.
Clinical trials.
Medical subjects:
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.
Notes:
Includes bibliographical references and index.
ISBN:
9780470602256 (cloth)
0470602252 (cloth)
OCLC:
465378651
Publisher Number:
99941843790
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