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" Clinical evaluation of medical devices "
edited by Karen M. Becker, John J. Whyte.
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BL
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| Record Number
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602522
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| Doc. No
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b431741
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| Title & Author
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Clinical evaluation of medical devices\ edited by Karen M. Becker, John J. Whyte.
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| Edition Statement
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2nd ed.
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| Publication Statement
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Totowa, N.J. :: Humana Press,, c2006.
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| Page. NO
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x, 346 p. :: ill. ;; 24 cm.
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| ISBN
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1588294226 (alk. paper)
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: 1597450049 (e-ISBN)
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: 9781588294227 (alk. paper)
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: 9781597450041 (e-ISBN)
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Clinical trials in development and marketing of medical devices / Karen M. Becker -- Regulatory requirements for clinical studies of medical devices and diagnostics / Daniel A. Kracov and Lisa M. Dwyer -- Requirements for medicare coverage and reimbursement for medical devices / Esther R. Scherb and Stuart S. Kurlander -- Postmarket requirements for significant risk devices / Suzan Onel -- Applications of bayesian methods to medical device trials / Richard Simon and Telba Z. Irony -- Intellectual property protection for medical devices / Faffi Moazzam and Michael D. Bednarek -- HIPAA compliance in clinical research / Peter M. Kazon and Sharon D. Brooks --
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Clinical trials of an anti-adhesion adjuvant / Michael P. Diamond -- Use of multiple imputation models in medical device trials / Donald B. Rubin and Samantha R. Cook -- Case studies on local coverage process / Michael I. Burken -- Reimbursement analysis: from concept to coverage / Robin Bostic -- Polyurethane pacemaker leads: the contribution of clinical experience to the elucidation of failure modes and biodegradation mechanism / Ken Strokes -- Role of device retrieval and analysis in the evaluation of substitute heart valves / Frederick J. Shoen -- Home prothromin monitoring: evidence-based medicine exemplified in the medicare coverage process / John J. Whyte.
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Overview of medicare coverage of clinical trials / Julie K. Taitsman -- Developing drug-device combination products with unapproved components / Guy Chamberland -- Wall Street's perspective on medical device evaluation / Adam K. Galeon -- Challenges in conducting implantable device trials: left ventricular assist device in destination therapy / Davis Ascheim, Michael Parides, and Alan J. Moskowitz -- BELIEF: a randomized, sham-procedure-controlled trial of percutaneous myocardial laser therapy / Jan Eric Nordrehaug --
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| Subject
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Clinical trials.
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| Subject
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Medical instruments and apparatus-- Evaluation.
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| Added Entry
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Becker, Karen M.
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Whyte, John J.,1966-
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