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Medicamentos na gravidez e na lactação: novas normas da FDA

2015· article· pt· W3177534585 on OpenAlexaff
Renan Rocha, Joel Rennó, Hewdy Lobo Ribeiro, Juliana Pires Cavalsan, Amaury Cantilino, Jerônimo de Almeida Mendes Ribeiro, Gislene Valadares, Antônio Geraldo da Silva

Bibliographic record

VenueDebates em Psiquiatria · 2015
Typearticle
Languagept
FieldMedicine
TopicPregnancy and Medication Impact
Canadian institutionsSt. Joseph’s Healthcare Hamilton
Fundersnot available
KeywordsFood and drug administrationPregnancyMedical prescriptionMedicineGynecologyDrugFamily medicinePharmacologyBiology

Abstract

fetched live from OpenAlex

New rules set forth by the Food and Drug Administration (FDA) for the use of drugs during pregnancy and lactation take effect this year (2015). They reshape the content and format of labeling and concomitantly remove any reference to the A, B, C, D,and X categories. The latter are replaced by a summary of the perinatal risks associated with the drug, discussion of related evidence, and a summary of the most relevant data for prescription decision-making. Also, the new rules include essential information on the identificati on of pregnancy, contraception, and infertility. The ultimate goal of the new rules is to facilitate the process of prescribing drugs by offering consistent, well-structuredinformation about the use of drugs during pregnancy and lactation.

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)0.003
metaresearch head score (Gemma)0.004
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow), Insufficient payload (model declined to judge)
Consensus categoriesInsufficient payload (model declined to judge)
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.273
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0030.004
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0010.001
Science and technology studies0.0000.000
Scholarly communication0.0000.001
Open science0.0010.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0020.004

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 head0.068
GPT teacher head0.335
Teacher spread0.267 · 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; both teacher heads agree on what is shown here.

Study designNot applicable
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

Citations0
Published2015
Admission routes1
Has abstractyes

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