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LEADER 03287cam a2200409Ia 4500

005 20141212020700.0;

008 050420s2006 njua b 001 0 eng ;

010 a| 2005011142;

020 a| 1588294226 :c| $116.00;

035 a| (Sirsi) H1036799;

035 a| (OCoLC)59711774;

049 a| NEHH;

245 00 a| Clinical evaluation of medical devices :b| principles and case studies /c| edited by Karen M. Becker, John J. Whyte.;

250 a| 2nd ed.;

300 a| x, 346 pages :b| illustrations ;c| 24 cm;

336 a| text2| rdacontent;

337 a| unmediated2| rdamedia;

338 a| volume2| rdacarrier;

504 a| Includes bibliographical references and index.;

505 0 a| 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 a| 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 a| 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.;

650 12 a| Equipment and Suppliesx| standards.=| ^A923321;

650 22 a| Clinical Trials as Topicx| standards.=| ^A933177;

650 22 a| Device Approvalx| standards.=| ^A945318;

650 22 a| Evaluation Studies.?| UNAUTHORIZED;

700 1 a| Becker, Karen M.=| ^A945319;

700 1 a| Whyte, John J.,d| 1966-=| ^A945320;

994 a| C0b| NEH;

919 a| BOOK;

959 a| 1036799;

096 a| W 26 C641 2006;

596 a| 4;

998 a| 1571449;

999 a| W 26 C641 2006w| NLMc| 1i| 31740008351557d| 6/25/2018e| 4/26/2018f| 2/15/2011g| 1l| HSLBKm| HSLn| 2p| $116.00r| Ys| Yt| HBKu| 2/7/2006x| BOOKz| HSTACKSo| .STAFF. 0;

Clinical evaluation of medical devices : principles and case studies / edited by Karen M. Becker, John J. Whyte.

Other author	Becker, Karen M.
Other author	Whyte, John J., 1966-
Format	Book
Edition	2nd ed.
Publication Info	Totowa, N.J. : Humana Press, ©2006.
Description	x, 346 pages : illustrations ; 24 cm
Subjects	Equipment and Supplies--standards. Clinical Trials as Topic--standards. Device Approval--standards. Evaluation Studies.

Contents	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 --
Contents	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 --
Contents	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.
Bibliography note	Includes bibliographical references and index.
LCCN	2005011142
ISBN	1588294226 :

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Clinical evaluation of medical devices : principles and case studies / edited by Karen M. Becker, John J. Whyte.

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