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Record W1981415974 · doi:10.3899/jrheum.130875

Dosing of Biologics in Juvenile Idiopathic Arthritis: Is the Sky the Limit?

2013· letter· en· W1981415974 on OpenAlexvenueno aff
Femke H. M. Prince, Daniel H. Solomon

Bibliographic record

VenueThe Journal of Rheumatology · 2013
Typeletter
Languageen
FieldMedicine
TopicPharmaceutical studies and practices
Canadian institutionsnot available
FundersBrigham and Women's Hospital
KeywordsMedicineDosingOff-label useIntensive care medicineEuropean unionOrphan drugAdverse effectDrugPediatricsPharmacologyBioinformatics

Abstract

fetched live from OpenAlex

In the past decade, biologic therapy has been a valuable new option in the treatment of both adult and pediatric rheumatic diseases. Many patients previously refractory to anti-rheumatic drugs have shown excellent responses to biologic therapy. However, there remains a significant minority of patients who do not respond to these drugs or who lose efficacy after a period of successful treatment. Why are some patients with inflammatory arthritis primary or secondary nonresponders? Part of the problem is likely due to the heterogeneous nature of the disease. But insufficient dosing might be an issue for some patients. In drug research, dosing is evaluated by pharmaco-dynamic and pharmacokinetic (PK) models and then tested in humans for a safe dosage range and possible side effects before a drug is tested for its efficacy1,2. Unfortunately, a large proportion of medicines (50–90%) used in children are prescribed outside the terms of the drug license, i.e., off-label, which can place children at a direct risk of under- or overdosing and a delayed risk of longterm adverse effects3. The US Food and Drug Administration (FDA) has provided an incentive to US pharmaceutical companies since 1997 to study products that could be beneficial for the pediatric population3,4. The European Union (EU) enforced the Paediatric Regulation in 20075. The goals of the EU legislation are similar to those of US pediatric legislation: to improve children’s health through advancements in research and to provide a new framework for evaluating the efficacy and safety of medicines for children3,6. However, in the EU, … Address correspondence to Dr. F.H.M. Prince, Academic Medical Centre, Emma Children’s Hospital, Department of Pediatrics, H7-270, Meibergdreet 9, Amsterdam, 1105 A2, the Netherlands. E-mail: femkeprince{at}gmail.com

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)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesResearch integrity
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Commentary · Consensus signal: none
Teacher disagreement score0.504
Threshold uncertainty score0.998

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0030.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0000.004
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 head0.055
GPT teacher head0.324
Teacher spread0.269 · 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.

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".

Quick stats

Citations0
Published2013
Admission routes1
Has abstractyes

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