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Record W4315567348 · doi:10.1017/s0962728600029705

The Three Rs in the pharmaceutical industry: perspectives of scientists and regulators

2005· article· en· W4315567348 on OpenAlex
NP Fenwick, David Fraser

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.

Bibliographic record

VenueAnimal Welfare · 2005
Typearticle
Languageen
FieldVeterinary
TopicAnimal testing and alternatives
Canadian institutionsUniversity of British Columbia
Fundersnot available
KeywordsAnimal welfarePharmaceutical industryAnimal testingDrug developmentRegulatory scienceSafety pharmacologyTest (biology)BiotechnologyBusinessRisk analysis (engineering)DrugMedicinePharmacologyBiologyPathology

Abstract

fetched live from OpenAlex

Abstract Six drug regulatory reviewers and 11 pharmaceutical industry scientists were interviewed to explore their perspectives on the obstacles and opportunities for greater implementation of the Three Rs (replacement, reduction, refinement) in drug research and development. Participants generally supported the current level of animal use in the pharmaceutical industry and viewed in vitro methods as supporting, but not replacing, the use of animals. Obstacles to greater use of the Three Rs cited by participants included the lack of non-animal alternatives; requirements for statistical validity; reluctance by industry and regulators to depart from established patterns of animal use; the priority of commercial objectives ahead of the Three Rs; and concern that less animal testing could jeopardise human safety. Opportunities identified for the Three Rs included the development of better animal models including genetically modified (GM) animals; pursuit of more basic knowledge, notably drug action on gene expression; re-use of animals; greater use of pilot studies; using sufficient numbers of animals per test to avoid repeating inconclusive studies; regular review of animal data in regulatory requirements; and following the regulatory option of combining segments of reproductive toxicology studies into one study. In some areas, greater implementation of the Three Rs seemed well aligned with industry priorities, for example, phenotypic characterisation of GM animals and validation of alternative methods. In other areas, wider use of the Three Rs may require building consensus on areas of disagreement including the usefulness of death as an endpoint; the suitability of re-using animals; and whether GM animals and the use of pilot studies contribute to reduction.

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.

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)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.554
Threshold uncertainty score0.236

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
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 head0.111
GPT teacher head0.406
Teacher spread0.295 · 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