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008    050420s2006    njua    ob    001 0 eng c 
010    2005011142 
020    1588294226 
020    9781588294227 
020    1597450049 
020    9781597450041 
024 8  9786610358618 
024 7  10.1007/978-1-59745-004-1 
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035    Springer Chemistry and Materials Science eBooks 2006 
       English+International 
035    All EBSCO eBooks 
035    skip4alma 
037    978-1-58829-422-7|bSpringer|nhttp://www.springerlink.com 
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245 00 Clinical evaluation of medical devices /|cedited by Karen 
       M. Becker, John J. Whyte. 
246 3  Clinical evaluation of medical devices: principles and 
       case studies 
250    2nd ed. 
260    Totowa, N.J. :|bHumana Press,|c©2006. 
300    1 online resource (x, 346 pages) :|billustrations 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
347    text file|bPDF|2rda 
504    Includes bibliographical references and index. 
505 0  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. 
505 0  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. 
505 0  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. 
506    Available only to authorized UTEP users. 
520    Summarizes the key principles and approaches employed in 
       medical device clinical trials and illustrate their uses. 
       This book includes information on the requirements and 
       process for gaining reimbursement from Medicare and 
       private insurers on new products, including case studies 
       of research designed for this purpose. 
650  0 Medical instruments and apparatus|xEvaluation. 
650  0 Clinical trials. 
650 12 Equipment and Supplies|xstandards. 
650 22 Clinical Trials|xstandards 
650 22 Device Approval|xstandards. 
650 22 Evaluation Studies 
700 1  Becker, Karen M. 
700 1  Whyte, John J.,|d1966- 
776 08 |iPrint version:|tClinical evaluation of medical devices.
       |b2nd ed.|dTotowa, N.J. : Humana Press, ©2006|z1588294226
       |z1597450049|w(DLC)  2005011142|w(OCoLC)59711774 
856 40 |uhttp://0-link.springer.com.lib.utep.edu/10.1007/978-1-
       59745-004-1|zTo access this resource 
856 40 |uhttp://0-search.ebscohost.com.lib.utep.edu/
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