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Record W4399571906 · doi:10.1007/s13346-024-01646-2

Toward an international standardisation roadmap for nanomedicine

2024· article· en· W4399571906 on OpenAlexaffabout
Fanny Caputo, Georges Favre, Gerrit Borchard, Luigi Calzolai, Paola Fisicaro, Emeric Fréjafon, Nazende Günday-Türeli, Denis Koltsov, Caterina Minelli, Bryant C. Nelson, Jérémie Parot, Adriele Prina‐Mello, Shan Zou, F. X. Ouf

Bibliographic record

VenueDrug Delivery and Translational Research · 2024
Typearticle
Languageen
FieldImmunology and Microbiology
TopicBiosimilars and Bioanalytical Methods
Canadian institutionsNational Research Council Canada
FundersHORIZON EUROPE Framework ProgrammeConseil Régional, Île-de-FranceEuropean CommissionEuropean Partnership on MetrologyBpifrance
KeywordsEuropean commissionCommissionNanomedicineTest (biology)Political scienceEngineering managementEngineeringMember statesBusinessEuropean union

Abstract

fetched live from OpenAlex

The French National Metrology Institute (LNE) initiated a series of events to identify priorities for test methods and their harmonisation that directly address regulatory needs in Nanomedicine. One of these workshops entitled "The International Standardisation Roadmap for Nanomedicine" held in October 2023 (Paris, France) brought together key experts in the characterisation of nanomedicines and medical products containing nanomaterials, including the Joint Research Centre of the European Commission, SINTEF Industry and the metrology institutes of France, the UK, the USA and Canada, two flagship initiatives of the European Commission (PHOENIX and SAFE-n-MEDTECH Open Innovation Test Beds), representatives of a working party on mRNA vaccines at the European Directorate for the Quality of Medicines (EDQM) and members of international standardisation and pre-normative organisations (including CEN, ISO, ASTM, VAMAS). Two take-home message came out from the discussion. First, developing standard test methods and Reference Materials (RMs) for nanomedicines is a key priority for the European Commission and various stakeholders. Furthermore, there was a unanimous recognition of the need for a unified approach between standardisation committees, regulators and the nanomedicine community. At the USA, Canadian and European level, examples of success stories and of future initiative have been discussed. Future perspectives include the creation of a dedicated Working Group under CEN/TC 352 to consolidate efforts and develop a nanomedicine standardisation roadmap.

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)0.130
metaresearch head score (Gemma)0.072
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: Theoretical or conceptual
GenreCandidate signal: Methods · Consensus signal: none
Teacher disagreement score0.870
Threshold uncertainty score0.685

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.1300.072
Meta-epidemiology (narrow)0.0030.002
Meta-epidemiology (broad)0.0020.003
Bibliometrics0.0080.006
Science and technology studies0.0040.006
Scholarly communication0.0160.019
Open science0.0070.013
Research integrity0.0140.019
Insufficient payload (model declined to judge)0.0100.008

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 head0.129
GPT teacher head0.430
Teacher spread0.301 · 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.

Study designTheoretical or conceptual
DomainMethods
GenreMethods

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

Citations50
Published2024
Admission routes2
Has abstractyes

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