MARC details
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08076cam a2201033 i 4500 |
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ocn741650502 |
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OCoLC |
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20220713071348.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION |
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m o d |
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cr un||||||||| |
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140702s2011 dcua obt 000 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
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| LC control number |
2011283692 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
NLM |
| Language of cataloging |
eng |
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rda |
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pn |
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NLM |
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OCLCO |
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OCLCO |
| 016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER |
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| Record control number |
101638901 |
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DNLM |
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742515383 |
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743413565 |
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816844562 |
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923283476 |
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1021265268 |
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1062919609 |
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1156389155 |
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1228530382 |
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1229860501 |
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1249216073 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9780309212816 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
0309212812 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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1283135167 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9781283135160 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| Cancelled/invalid ISBN |
9780309212809 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| Cancelled/invalid ISBN |
0309212804 |
| 029 0# - (OCLC) |
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| OCLC library identifier |
NLM |
| System control number |
101638901 |
| 029 1# - (OCLC) |
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AU@ |
| System control number |
000051598503 |
| 029 1# - (OCLC) |
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DEBBG |
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BV043033783 |
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DEBBG |
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BV044109219 |
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DEBSZ |
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372699588 |
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DEBSZ |
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421588497 |
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DEBSZ |
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452578191 |
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GBVCP |
| System control number |
803607997 |
| 035 ## - SYSTEM CONTROL NUMBER |
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| System control number |
(OCoLC)741650502 |
| Canceled/invalid control number |
(OCoLC)742515383 |
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(OCoLC)743413565 |
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(OCoLC)816844562 |
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(OCoLC)923283476 |
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(OCoLC)1021265268 |
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(OCoLC)1062919609 |
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(OCoLC)1081249833 |
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(OCoLC)1156389155 |
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(OCoLC)1228530382 |
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(OCoLC)1229860501 |
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(OCoLC)1249216073 |
| 042 ## - AUTHENTICATION CODE |
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| Authentication code |
pcc |
| 043 ## - GEOGRAPHIC AREA CODE |
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| Geographic area code |
n-us--- |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RA401.A3 |
| Item number |
R57 2011eb |
| 060 00 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
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| Classification number |
WA 289 |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
POL |
| Subject category code subdivision |
020000 |
| Source |
bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
353.9/970973 |
| Edition number |
23 |
| 049 ## - LOCAL HOLDINGS (OCLC) |
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| Holding library |
MAIN |
| 110 2# - MAIN ENTRY--CORPORATE NAME |
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| Corporate name or jurisdiction name as entry element |
National Academies (U.S.). |
| Subordinate unit |
Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, |
| Relator term |
author. |
| 9 (RLIN) |
1514028 |
| 245 12 - TITLE STATEMENT |
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| Title |
A risk-characterization framework for decision-making at the Food and Drug Administration / |
| Statement of responsibility, etc |
Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicolgoy, Division on Earth and Life Studies, National Research Council, Institute of Medicine, National Research Council of the National Academies. |
| 264 #1 - |
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| -- |
Washington D.C. : |
| -- |
National Academies Press, |
| -- |
[2011] |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
1 online resource (1 PDF file (xiv, 192 pages)) : |
| Other physical details |
illustrations |
| 336 ## - |
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| -- |
text |
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txt |
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rdacontent |
| 337 ## - |
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computer |
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c |
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rdamedia |
| 338 ## - |
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online resource |
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cr |
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rdacarrier |
| 500 ## - GENERAL NOTE |
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| General note |
Title from PDF title page. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
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| Bibliography, etc |
Includes bibliographical references. |
| 520 3# - SUMMARY, ETC. |
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| Summary, etc |
With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations. |
| 536 ## - FUNDING INFORMATION NOTE |
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| Text of note |
This project was supported by Contract HHSP23320042509XI/HHSP233200800001T between the National Academy of Sciences and the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. |
| 588 0# - |
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| -- |
Version viewed October 3, 2014. |
| 505 00 - FORMATTED CONTENTS NOTE |
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| Title |
Introduction -- |
| -- |
A Risk-Characterization Framework -- |
| -- |
Case Study of a Mitigation-Selection Decision -- |
| -- |
Case Study of a Targeting Decision -- |
| -- |
Case Study of a Strategic-Investment Decision -- |
| -- |
Case Study of a Targeting Decision That Spans Food and Drug Administration Centers -- |
| -- |
Conclusions and Future Directions -- |
| Miscellaneous information |
A: |
| Title |
Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks -- |
| Miscellaneous information |
B: |
| Title |
Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |
| Miscellaneous information |
C: |
| Title |
Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |
| Miscellaneous information |
D: |
| Title |
Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |
| Miscellaneous information |
E: |
| Title |
Factors Hypothesized as Important in Understanding Risk. |
| 590 ## - LOCAL NOTE (RLIN) |
|---|
| Local note |
eBooks on EBSCOhost |
| Provenance (VM) [OBSOLETE] |
EBSCO eBook Subscription Academic Collection - Worldwide |
| 610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
United States. |
| Subordinate unit |
Food and Drug Administration |
| Form subdivision |
Case studies. |
| 9 (RLIN) |
1514029 |
| 610 12 - SUBJECT ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
United States. |
| Subordinate unit |
Food and Drug Administration. |
| 9 (RLIN) |
9402 |
| 610 17 - SUBJECT ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
United States. |
| Subordinate unit |
Food and Drug Administration. |
| Source of heading or term |
fast |
| -- |
(OCoLC)fst00549734 |
| 9 (RLIN) |
9402 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Decision making |
| Geographic subdivision |
United States |
| Form subdivision |
Case studies. |
| 9 (RLIN) |
307752 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Product safety |
| Geographic subdivision |
United States |
| General subdivision |
Decision making |
| Form subdivision |
Case studies. |
| 9 (RLIN) |
1514030 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Risk assessment |
| Geographic subdivision |
United States |
| Form subdivision |
Case studies. |
| 9 (RLIN) |
1514031 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Decision making. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
Risk Assessment |
| General subdivision |
methods |
| 9 (RLIN) |
932252 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Consumer Product Safety |
| 9 (RLIN) |
1085921 |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
Drug Approval |
| 9 (RLIN) |
342421 |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
Decision Making |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
United States Government Agencies |
| 9 (RLIN) |
1034190 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Prise de décision |
| Geographic subdivision |
États-Unis |
| Form subdivision |
Études de cas. |
| 9 (RLIN) |
873057 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Produits commerciaux |
| General subdivision |
Sécurité |
| Geographic subdivision |
États-Unis |
| General subdivision |
Prise de décision |
| Form subdivision |
Études de cas. |
| 9 (RLIN) |
1514032 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Évaluation du risque |
| Geographic subdivision |
États-Unis |
| Form subdivision |
Études de cas. |
| 9 (RLIN) |
1514033 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Prise de décision. |
| 9 (RLIN) |
874731 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
decision making. |
| Source of heading or term |
aat |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
POLITICAL SCIENCE |
| General subdivision |
Government |
| -- |
State & Provincial. |
| Source of heading or term |
bisacsh |
| 9 (RLIN) |
849788 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Decision making. |
| Source of heading or term |
fast |
| -- |
(OCoLC)fst00889035 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Risk assessment. |
| Source of heading or term |
fast |
| -- |
(OCoLC)fst01098146 |
| 9 (RLIN) |
35942 |
| 651 #7 - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Geographic name |
United States. |
| Source of heading or term |
fast |
| -- |
(OCoLC)fst01204155 |
| 655 #0 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic books. |
| 655 #4 - INDEX TERM--GENRE/FORM |
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| Genre/form data or focus term |
Electronic books. |
| 655 #7 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Case studies. |
| Source of term |
fast |
| -- |
(OCoLC)fst01423765 |
| 9 (RLIN) |
59979 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Display text |
Print version: |
| Title |
Risk-characterization framework for decision-making at the Food and Drug Administration. |
| Place, publisher, and date of publication |
Washington, D.C. : National Academies Press, ©2011 |
| International Standard Book Number |
9780309212809 |
| Record control number |
(OCoLC)741786294 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Online access: National Academy of Sciences National Academies Press. |
| 9 (RLIN) |
875383 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Online access: NCBI NCBI Bookshelf. |
| 9 (RLIN) |
875384 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=372484">https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=372484</a> |
| 938 ## - |
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Askews and Holts Library Services |
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ASKH |
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AH36617393 |
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Askews and Holts Library Services |
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ASKH |
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AH36559613 |
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Coutts Information Services |
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COUT |
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18019345 |
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EBL - Ebook Library |
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EBLB |
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EBL3378782 |
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ebrary |
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EBRY |
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ebr10478232 |
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EBSCOhost |
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EBSC |
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372484 |
| 938 ## - |
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ProQuest MyiLibrary Digital eBook Collection |
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IDEB |
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313516 |
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YBP Library Services |
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YANK |
| -- |
7082344 |
| 994 ## - |
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92 |
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INOPJ |
