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" The design and management of medical device clinical trials : "


Document Type : BL
Record Number : 657473
Doc. No : dltt
Main Entry : Abdel-aleem, Salah
Title & Author : The design and management of medical device clinical trials : : strategies and challenges /\ Salah Abdel-aleem
Publication Statement : Hoboken, N.J. :: John Wiley,, c2010
Page. NO : xvii, 250 p. ;; 25 cm
ISBN : 9780470602256 (cloth)
: : 0470602252 (cloth)
Bibliographies/Indexes : Includes bibliographical references and index
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
Subject : Medical instruments and apparatus-- Research
Subject : Clinical trials
Subject : Clinical Trials as Topic-- methods
Subject : Equipment and Supplies
Subject : Device Approval
Dewey Classification : ‭610.28/4072‬
LC Classification : ‭R856.4‬‭.A22 2010‬
NLM classification : ‭W 26‬‭A135d 2010‬
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