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Record W2772924770 · doi:10.1111/trf.14435

Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016

2017· article· en· W2772924770 on OpenAlexaff
Jaroslav G. Vostal, Paul W. Buehler, Monique P. Gelderman, Abdu I. Alayash, Alan Doctor, James C. Zimring, Simone A. Glynn, John R. Hess, Harvey G. Klein, Jason P. Acker, Philip C. Spinella, Angelo D’Alessandro, Bernhard Ø. Palsson, Thomas J. Raife, Michael P. Busch, T. McMahon, Marcos Intaglietta, Harold M. Swartz, Michael A. Dubick, Sylvain Cardin, Rakesh P. Patel, Charles Natanson, John W. Weisel, Jennifer A. Muszynski, Philip J. Norris, Paul M. Ness

Bibliographic record

VenueTransfusion · 2017
Typearticle
Languageen
FieldMedicine
TopicBlood transfusion and management
Canadian institutionsCanadian Blood Services
FundersNational Institute of General Medical SciencesU.S. Food and Drug AdministrationU.S. Department of Health and Human ServicesNational Institutes of HealthU.S. Department of Veterans AffairsNational Heart, Lung, and Blood InstituteU.S. Department of Defense
KeywordsFood and drug administrationRegulatory scienceAgency (philosophy)Human servicesMedicineProduct (mathematics)Public healthHealth scienceAdministration (probate law)Regulatory agencyResearch centerLibrary sciencePolitical scienceFamily medicineMedical educationEnvironmental healthPublic administrationNursingPathologySociologyComputer scienceLaw

Abstract

fetched live from OpenAlex

The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory science on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported by the National Heart, Lung, and Blood Institute, NIH; the Department of Defense; the Office of the Assistant Secretary for Health, Department of Health and Human Services; and the Center for Biologics Evaluation and Research, FDA. The workshop reviewed the status and scientific basis of the current regulatory framework and the available scientific tools to expand it to evaluate innovative and future RBC transfusion products. A full record of the proceedings is available on the FDA website (http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm). The contents of the summary are the authors' opinions and do not represent agency policy.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Bench or experimental · Consensus signal: Bench or experimental
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.196
Threshold uncertainty score0.440

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0010.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.022
GPT teacher head0.250
Teacher spread0.228 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designBench or experimental
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations34
Published2017
Admission routes1
Has abstractyes

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