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008 140702s2011 dcua obt 100 0 eng
016 7 101638949|2DNLM
019 732282307|a764551283|a816637050
020 9780309163248
020 0309163242
020 9780309163255
020 0309163250
020 1282976052
020 9781282976054
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100 1 Mack, Alison,|0https://id.loc.gov/authorities/names/
n88194541|eauthor.
245 10 Perspectives on biomarker and surrogate endpoint
evaluation :|bdiscussion forum summary /|cAlison Mack,
Erin Balogh, and Christine M. Micheel, rapporteurs ;
Committee on Qualification of Biomarkers and Surrogate
Endpoints in Chronic Disease, Board on Health Care
Services, Board on Health Sciences Policy, Food and
Nutrition Board, Institute of Medicine of the National
Academies.
264 1 Washington, D.C. :|bThe National Academies Press,|c[2011]
300 1 online resource (1 PDF file (ix, 129 pages)) :
|billustrations
336 text|btxt|2rdacontent
337 computer|bc|2rdamedia
338 online resource|bcr|2rdacarrier
347 text file|2rdaft
500 Title from PDF title page.
504 Includes bibliographical references.
505 00 |tIntroduction --|tCommittee findings and recommendations
--|tFDA perspectives --|tNational institutes of health
perspectives --|tIndustry perspectives --|tPublic health,
consumer, and consulting organization perspectives --
|tPresentation by Thomas Fleming: biomarkers and surrogate
endpoints in chronic disease --|tKey themes, challenges,
and opportunities --|tImportance of the biomarker
discussion forum.
520 3 In 2010 the Institute of Medicine (IOM) recommended a
framework for the evaluation of biomarkers in the chronic
disease setting. Published in the book Evaluation of
Biomarkers and Surrogate Endpoints in Chronic Disease, the
framework is intended to bring consistency and
transparency to the previously disparate process of
biomarker evaluation. Following the book's release, the
IOM convened a 2-day discussion forum in Washington, DC,
in order to provide an opportunity for stakeholders to
learn about, react to, and discuss the book. Presentations
reviewed the authoring committee's work process,
recommendations, and provided perspectives on the book
from the point of view of participants. Thomas Fleming,
professor of biostatistics and statistics at the
University of Washington, gave a keynote presentation on
the critical issues in the validation of surrogate
endpoints, a specific use of a biomarker. The present
volume recounts the discussion forum proceedings, focusing
in turn on each represented sector. A summary of Dr.
Fleming's presentation then sets the committee's
recommendations within the context of biomarker
utilization. Lastly, this summary examines the main themes
raised by stakeholders, and the challenges and
opportunities presented to stakeholders by the book's
recommendations.
536 This study was supported by Contract No. HHSF223200810020I
between the National Academy of Sciences and the Food and
Drug Administration. Any opinions, findings, conclusions,
or recommendations expressed in this publication are those
of the author(s) and do not necessarily reflect the view
of the organizations or agencies that provided support for
this project.
588 0 Version viewed Sept. 10, 2014.
590 eBooks on EBSCOhost|bEBSCO eBook Subscription Academic
Collection - North America
630 02 Evaluation of biomarkers and surrogate endpoints in
chronic disease.
650 0 Biochemical markers|0https://id.loc.gov/authorities/
subjects/sh85014122|xEvaluation|0https://id.loc.gov/
authorities/subjects/sh00005674|vCongresses.|0https://
id.loc.gov/authorities/subjects/sh99001533
650 0 Drugs|zUnited States|xTesting|0https://id.loc.gov/
authorities/subjects/sh2009123883|vCongresses.|0https://
id.loc.gov/authorities/subjects/sh99001533
650 0 Clinical trials|0https://id.loc.gov/authorities/subjects/
sh85027069|vCongresses.|0https://id.loc.gov/authorities/
subjects/sh99001533
650 0 Chronic diseases|0https://id.loc.gov/authorities/subjects/
sh85025392|vCongresses.|0https://id.loc.gov/authorities/
subjects/sh99001533
650 7 Biochemical markers|xEvaluation.|2fast|0https://
id.worldcat.org/fast/831951
650 7 Biochemical markers.|2fast|0https://id.worldcat.org/fast/
831950
650 7 Drugs.|2fast|0https://id.worldcat.org/fast/898761
650 7 Testing.|2fast|0https://id.worldcat.org/fast/1148240
650 7 Clinical trials.|2fast|0https://id.worldcat.org/fast/
864429
650 7 Chronic diseases.|2fast|0https://id.worldcat.org/fast/
860072
650 7 Medication.|2homoit|0https://homosaurus.org/v3/
homoit0001007
650 12 Biomarkers.|0https://id.nlm.nih.gov/mesh/D015415
650 22 Chronic Disease.|0https://id.nlm.nih.gov/mesh/D002908
650 22 Evidence-Based Practice.|0https://id.nlm.nih.gov/mesh/
D055317
651 7 United States.|2fast|0https://id.worldcat.org/fast/1204155
655 2 Congress.|0https://id.nlm.nih.gov/mesh/D016423
655 4 Electronic books.
655 7 Conference papers and proceedings.|2fast|0https://
id.worldcat.org/fast/1423772
655 7 Technical reports.|2lcgft|0https://id.loc.gov/authorities/
genreForms/gf2015026093
655 7 Technical reports.|2fast|0https://id.worldcat.org/fast/
1941336
655 7 Conference papers and proceedings.|2lcgft|0https://
id.loc.gov/authorities/genreForms/gf2014026068
700 1 Balogh, Erin,|0https://id.loc.gov/authorities/names/
no2010170659|eauthor.
700 1 Micheel, Christine,|0https://id.loc.gov/authorities/names/
no2009004337|eauthor.
710 2 Institute of Medicine (U.S.).|bCommittee on Qualification
of Biomarkers and Surrogate Endpoints in Chronic Disease,
|0https://id.loc.gov/authorities/names/n2010182021
|eauthor.
711 2 Evaluation of Biomarkers and Surrogate Endpoints in
Chronic Disease (Discussion forum)|d(2010 :|cWashington,
D.C.)|0https://id.loc.gov/authorities/names/n2014188419
730 02 Evaluation of biomarkers and surrogate endpoints in
chronic disease.
776 08 |iPrint version:|tPerspectives on biomarker and surrogate
endpoint evaluation.|dWashington, D.C. : National
Academies Press, ©2011|z9780309163248|w(OCoLC)707494250
856 40 |uhttps://rider.idm.oclc.org/login?url=http://
search.ebscohost.com/login.aspx?direct=true&scope=site&
db=nlebk&AN=354514|zOnline eBook. Access restricted to
current Rider University students, faculty, and staff.
856 42 |3Instructions for reading/downloading this eBook|uhttp://
guides.rider.edu/ebooks/ebsco
901 MARCIVE 20231220
948 |d20160616|cEBSCO|tebscoebooksacademic|lridw
994 92|bRID
