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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 machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.028
metaresearch head score (Gemma)0.057
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Commentary · Consensus signal: Commentary
Teacher disagreement score0.028
Threshold uncertainty score0.150

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0280.057
Meta-epidemiology (narrow)0.0000.001
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0020.002
Science and technology studies0.0030.011
Scholarly communication0.0100.005
Open science0.0020.003
Research integrity0.0100.013
Insufficient payload (model declined to judge)0.0030.002

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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreCommentary

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".

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Citations0
Published2015
Admission routes1
Has abstractyes

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