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Record W2905469602 · doi:10.4324/9781351278409-14

The global drug development process

2017· book-chapter· en· W2905469602 on OpenAlexaboutno aff
Sharon F. Terry, Jayson Swanson

Bibliographic record

VenueRare Diseases · 2017
Typebook-chapter
Languageen
FieldMedicine
TopicBiotechnology and Related Fields
Canadian institutionsnot available
Fundersnot available
KeywordsDrug developmentDrugProcess (computing)Computer scienceMedicinePharmacology

Abstract

fetched live from OpenAlex

Culture in the biomedical research arena plays an enormous role in both the lack of productivity and the focus on common conditions as well. Rare disease drug discovery resides in this difficult morass, and is then only further complicated by small cohorts that make it difficult to characterise the disease and create adequate trial size. Heterogeneity in disease pathophysiology plagues rare conditions, although it affects common ones as well. Regulatory agencies such as United States Food and Drug Administration, Health Canada and the European Medicines Agency examine the safety and efficacy of potential therapies. Even if a validated biomarker is available, it is difficult to get a large enough pool of people for studies to have high enough &s;power&s;. Stratified medicine challenges the traditional drug development paradigm because it creates smaller cohorts and reduces the power of studies. Potential therapies often fail during the clinical trial process. This is part of what adds to the enormous costs of drug development.

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)0.004
metaresearch head score (Gemma)0.006
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: none
GenreCandidate signal: Review · Consensus signal: none
Teacher disagreement score0.053
Threshold uncertainty score0.176

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0040.006
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0010.002
Science and technology studies0.0020.005
Scholarly communication0.0100.011
Open science0.0010.006
Research integrity0.0030.007
Insufficient payload (model declined to judge)0.0530.030

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 head0.010
GPT teacher head0.263
Teacher spread0.254 · 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
GenreReview

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
Published2017
Admission routes1
Has abstractyes

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