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Record W2614636769 · doi:10.1002/cpt.676

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

2017· review· en· W2614636769 on OpenAlexaff
J Wang, Tamara Johnson, Leyla Şahin, MS Tassinari, PO Anderson, TE Baker, Christina Bucci‐Rechtweg, GJ Burckart, Christina Chambers, TW Hale, D Johnson‐Lyles, Nelson Rm, Christine Nguyen, Denise Pica-Branco, Zhaoxia Ren, Hari Cheryl Sachs, Jason Sauberan, Anne Zajicek, Shinya Ito, LP Yao

Bibliographic record

VenueClinical Pharmacology & Therapeutics · 2017
Typereview
Languageen
FieldMedicine
TopicBreastfeeding Practices and Influences
Canadian institutionsHospital for Sick Children
FundersNational Institutes of Health
KeywordsLactationFood and drug administrationMedicineBreastfeedingEnvironmental healthPregnancyPediatricsBiology

Abstract

fetched live from OpenAlex

This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.

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)0.004
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.992
Threshold uncertainty score0.565

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0040.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.001
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 head0.513
GPT teacher head0.560
Teacher spread0.047 · 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 designOther design
Domainnot available
GenreReview

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

Citations96
Published2017
Admission routes1
Has abstractyes

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