MARC details
| 000 -LEADER |
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| fixed length control field |
06833cam a2200577 i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
on1105899155 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20240726104811.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
190902s2019 dcua obt 100 0 eng |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
NLM |
| Language of cataloging |
eng |
| Description conventions |
rda |
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pn |
| Transcribing agency |
NLM |
| Modifying agency |
NT |
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EBLCP |
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IUL |
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OCLCF |
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YDX |
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OCLCO |
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NLM |
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OCLCO |
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OCLCQ |
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OCLCO |
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OCLCA |
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UKAHL |
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OCLCA |
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OCLCO |
| 016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER |
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| Record control number |
101753591 |
| Source |
DNLM |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9780309489096 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9780309489102 |
| Qualifying information |
|
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9780309489126 |
| Qualifying information |
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| 042 ## - AUTHENTICATION CODE |
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| Authentication code |
pcc |
| 043 ## - GEOGRAPHIC AREA CODE |
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| Geographic area code |
n-us--- |
| 050 04 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
QH499 |
| Item number |
.E975 2019 |
| 049 ## - LOCAL HOLDINGS (OCLC) |
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| Holding library |
MAIN |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
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| Personal name |
Hackmann, Meredith, |
| Relator term |
Author |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Exploring sources of variability related to the clinical translation of regenerative engineering products : |
| Remainder of title |
proceedings of a workshop / |
| Statement of responsibility, etc. |
Meredith Hackmann, Theresa Wizemann, and Sarah H. Beachy, rapporteurs ; Forum on Regenerative Medicine, Board on Health Sciences Policy, National Academies of Sciences, Engineering, Medicine. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
Washington, DC : |
| Name of publisher, distributor, etc. |
National Academies Press, |
| Date of publication, distribution, etc. |
(c)2019. |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
1 online resource (1 PDF file (xx, 111 pages)) : |
| Other physical details |
illustration |
| 336 ## - CONTENT TYPE |
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| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
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| 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 |
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| File type |
data file |
| Source |
rda |
| 490 1# - SERIES STATEMENT |
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| Series statement |
A consensus study report of the National Academies of Sciences, Engineering, Medicine |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
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| Bibliography, etc. note |
Includes bibliographical references. |
| 520 3# - SUMMARY, ETC. |
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| Summary, etc. |
The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results. The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop. |
| 530 ## - COPYRIGHT INFORMATION: |
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| COPYRIGHT INFORMATION |
COPYRIGHT NOT covered - Click this link to request copyright permission: |
| Uniform Resource Identifier |
<a href="b">b</a> |
| 536 ## - FUNDING INFORMATION NOTE |
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| Text of note |
This activity was supported by contracts between the National Academy of Sciences and Advanced Regenerative Manufacturing Institute (unnumbered contract); Akron Biotech (unnumbered contract); Alliance for Regenerative Medicine (unnumbered contract); ALS Association (unnumbered contract); American Society of Gene and Cell Therapy (unnumbered contract); Burroughs Wellcome Fund (unnumbered contract); California Institute for Regenerative Medicine (unnumbered contract); Centre for Commercialization of Regenerative Medicine (unnumbered contract); Department of Veterans Affairs (Contract No. VA268-16-C-0051); Food and Drug Administration (Grant #1R13FD0066--14-01); GE Healthcare (unnumbered contract); GlaxoSmithKline (unnumbered contract); International Society for Cellular Therapy (unnumbered contract); International Society for Stem Cell Research (unnumbered contract); Johnson and Johnson (unnumbered contract); Juno Therapeutics (unnumbered contract); The Michael J. Fox Foundation for Parkinson's Research (unnumbered contract); National Institute of Standards and Technology (unnumbered contract); National Institutes of Health (Contract No. HHSN263201200074I, Order No. HHSN23600075: National Heart, Lung, and Blood Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; and National Institute of Neurological Disorders and Stroke); The New York Stem Cell Foundation (unnumbered contract); Parkinson's Foundation (unnumbered contract); Takeda Development Center Americas (unnumbered contract); and United Therapeutics Corporation (#10003921). Any opinions, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. |
| 505 00 - FORMATTED CONTENTS NOTE |
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| Formatted contents note |
Introduction and overview -- |
| Title |
Sources of variability associated with regenerative therapies : lessons from case studies -- |
| -- |
Factors contributing to patient variability -- |
| -- |
Addressing variability in donor tissues and cells -- |
| -- |
Addressing variability and meeting quality expectations in the manufacturing setting -- |
| -- |
Exploring variability and its impact on product regulation and outcomes -- |
| -- |
Potential next steps to consider for addressing variability -- |
| -- |
References -- |
| -- |
Appendixes |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Regenerative medicine |
| Form subdivision |
Congresses. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Regenerative medicine |
| General subdivision |
Standards |
| Form subdivision |
Congresses. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Quality control |
| Form subdivision |
Congresses. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Tissue engineering. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Quality control. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Tissue Engineering |
| General subdivision |
standards |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Regenerative Medicine |
| General subdivision |
standards |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Quality Control |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Translational Research, Biomedical |
| 655 #1 - INDEX TERM--GENRE/FORM |
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| Genre/form data or focus term |
Electronic Books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
National Academies of Sciences, Engineering, and Medicine (U.S.). |
| Relator term |
|
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Wizemann, Theresa M., |
| Relator term |
|
| 700 1# - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
Beachy, Sarah H., |
| Relator term |
|
| 711 2# - ADDED ENTRY--MEETING NAME |
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| Meeting name or jurisdiction name as entry element |
Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products (Workshop) |
| Location of meeting |
Washington, D.C.) |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
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| -- |
Click to access digital title | log in using your CIU ID number and my.ciu.edu password. |
| Uniform Resource Identifier |
<a href="httpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2219053&site=eds-live&custid=s3260518">httpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2219053&site=eds-live&custid=s3260518</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Online Book (LOGIN USING YOUR MY CIU LOGIN AND PASSWORD) |
| DONATED BY: |
|
| VENDOR |
EBSCO |
| Classification part |
QH |
| PUBLICATION YEAR |
2019 |
| LOCATION |
ONLINE |
| REQUESTED BY: |
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| -- |
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| -- |
NFIC |
| Source of classification or shelving scheme |
|
| 994 ## - |
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| -- |
92 |
| -- |
NT |
| 902 ## - LOCAL DATA ELEMENT B, LDB (RLIN) |
|---|
| a |
1 |
| b |
Cynthia Snell |
| c |
1 |
| d |
Cynthia Snell |