Medicamentos na gravidez e na lactação: novas normas da FDA
Bibliographic record
Abstract
As novas normas da Food and Drug Administration (FDA) para o uso de medicamentos na gravidez e na lactação entram em vigor este ano (2015). Elas reformulam o conteúdo e o formato das bulas e, concomitantemente, removem quaisquer referências às categorias A, B, C, D e X. Estas são substituídas por um resumo dos riscos perinatais do medicamento, discussão das evidências pertinentes e uma síntese dos dados mais relevantes para a tomada de decisões na prescrição. Também constam nas novas normas informações essenciais sobre identificação de gravidez, contracepção e infertilidade. O objetivo final das novas normas é facilitar o processo de prescrição por meio do oferecimento de um conjunto de informações consistentes e bem estruturadas a respeito do uso de medicamentos nos períodos da gravidez e lactação.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot 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.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.069 | 0.160 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.002 |
| Science and technology studies | 0.005 | 0.023 |
| Scholarly communication | 0.015 | 0.008 |
| Open science | 0.003 | 0.006 |
| Research integrity | 0.010 | 0.017 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".