| 000 -LEADER |
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| fixed length control field |
04104nam a22004575i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-1-59745-004-1 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20161121231100.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
100301s2006 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781597450041 |
| -- |
978-1-59745-004-1 |
| 024 7# - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1007/978-1-59745-004-1 |
| Source of number or code |
doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
R857.M3 |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
TGM |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
TCB |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
TEC021000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
SCI009000 |
| Source |
bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
620.11 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Clinical Evaluation of Medical Devices |
| Medium |
[electronic resource] : |
| Remainder of title |
Principles and Case Studies / |
| Statement of responsibility, etc. |
edited by Karen M. Becker, John J. Whyte. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
Second Edition. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Totowa, NJ : |
| Name of producer, publisher, distributor, manufacturer |
Humana Press, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2006. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
360 p. 53 illus. |
| Other physical details |
online resource. |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
|---|
| File type |
text file |
| Encoding format |
PDF |
| Source |
rda |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Fundamentals of Clinical Study Design and Evaluation -- Clinical Trials in Development and Marketing of Medical Devices -- Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics -- Requirements for Medicare Coverage and Reimbursement for Medical Devices -- Postmarket Requirements for Significant Risk Devices -- Applications of Bayesian Methods to Medical Device Trials -- Intellectual Property Protection for Medical Devices -- HIPAA Compliance in Clinical Research -- Overview of Medicare Coverage of Clinical Trials -- Developing Drug-Device Combination Products With Unapproved Components -- Wall Street’s Perspective on Medical Device Evaluation -- Case Studies -- Challenges in Conducting Implantable Device Trials -- BELIEF -- Clinical Trials of an Anti-Adhesion Adjuvant -- Use of Multiple Imputation Models in Medical Device Trials -- Case Studies on the Local Coverage Process -- Reimbursement Analysis -- Polyurethane Pacemaker Leads -- Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves -- The Use of Surrogate Outcome Measures. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
Highly praised in its first edition, Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition has been expanded and updated to include the many innovations and clinical research methods that have developed since the first edition, as well as current information on the regulatory, legal, and reimbursement environment for medical devices. The book's deeply experienced authors summarize the key principles and approaches employed in medical device clinical trials and illustrate their uses in a revealing series of detailed, real-world case studies. Highlights include new information on the requirements and process for gaining reimbursement from Medicare and private insurers on new products-including case studies of research specifically designed for this purpose-and new statistical methods applied to medical device trials. Additional case studies provide examples of combination products, three-phase development models (i.e., feasibility, FDA approval, and Medicare reimbursement), and novel study designs. The cases demonstrate a wide range of designs that have been successfully applied to many different research problems, as well as to a variety of therapeutic or diagnostic products. Authoritative and highly practical, Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition, provides a gold-standard resource for clinical professionals and regulatory specialists working at the forefront of new therapeutics, diagnostics, and medical device development and marketing today. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Materials science. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biomaterials. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Materials Science. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biomaterials. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Becker, Karen M. |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Whyte, John J. |
| Relator term |
editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9781588294227 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
http://dx.doi.org/10.1007/978-1-59745-004-1 |
| 912 ## - |
|---|
| -- |
ZDB-2-CMS |
