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Record W6930893789 · doi:10.5281/zenodo.16574827

Perspectives and Insights on Anti-Psoriatic Drugs (D05): From Development to New Drug Submission (NDS) Application to Health Canada

2025· article· en· W6930893789 on OpenAlexaboutno aff

Bibliographic record

VenueZenodo (CERN European Organization for Nuclear Research) · 2025
Typearticle
Languageen
FieldMedicine
TopicOsteoarthritis Treatment and Mechanisms
Canadian institutionsnot available
Fundersnot available
KeywordsReimbursementDrugBiosimilarDrug developmentQuality (philosophy)Drug approvalBiological drugsAccess to medicines

Abstract

fetched live from OpenAlex

Psoriasis, a chronic autoimmune skin disorder, affects millions in Canada, causing erythematous plaques, reduced quality of life, and comorbidities like psoriatic arthritis. Anti-psoriatic drugs (ATC code D05) encompass topical, oral, and biologic therapies targeting inflammatory pathways, such as IL-23/Th17, to manage moderate-to-severe disease. These include traditional systemic agents, targeted small molecules, and biologics, offering diverse mechanisms to balance efficacy and safety. This article reviews the D05 class’s clinical applications, chemical properties, container closure systems, safety profiles, and emerging technologies, such as nanomedicines and precision medicine. It also outlines the regulatory pathway for New Drug Submission (NDS) in Canada, aligning with the Food and Drugs Act, Health Canada regulations, and International Council for Harmonisation (ICH) guidelines. Recommendations address reimbursement barriers, emphasizing early regulatory engagement, robust pharmacovigilance, and equitable access strategies to ensure patient access to innovative therapies.

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)0.016
metaresearch head score (Gemma)0.029
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: Not applicable
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.286
Threshold uncertainty score0.576

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0160.029
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0010.002
Bibliometrics0.0030.004
Science and technology studies0.0050.007
Scholarly communication0.0160.005
Open science0.0030.004
Research integrity0.0070.009
Insufficient payload (model declined to judge)0.0270.004

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 head0.012
GPT teacher head0.246
Teacher spread0.234 · 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
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
Published2025
Admission routes1
Has abstractyes

Explore more

Same venueZenodo (CERN European Organization for Nuclear Research)→Same topicOsteoarthritis Treatment and Mechanisms→French-language works237,207→