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Record W6984775900

The European Union

2010· book-chapter· en· W6984775900 on OpenAlexaboutno aff

Bibliographic record

VenueDIAL (Catholic University of Leuven) · 2010
Typebook-chapter
Languageen
FieldSocial Sciences
TopicHistorical Legal Studies and Society
Canadian institutionsnot available
Fundersnot available
KeywordsEuropean unionMarketing authorizationAuthorizationAgency (philosophy)Food and drug administrationProduct (mathematics)European marketPharmaceutical industry
DOInot available

Abstract

fetched live from OpenAlex

The generic drug product market is projected to grow from US $15 billion in 2004 to US $27 billion in 2009 in the United States, and from US $9 billion to US $14 billion in Western Europe (1). Moreover, the growth opportunities for generic drug products in the near future are significant with an estimated US $100 billion worth of branded pharmaceutical products to go off patent by 2010 (1). The substantial growth of the world generics drug market has been driven by a number of factors, but in particular the need to contain public health care spending, including the expenditure on drug products. In response to the important growth of the generic pharmaceutical industry during the last 10 to 15 years, regulatory agencies in countries all over the world, such as the Food and Drug Administration (FDA) in the United States, Canada's Health Products and Food Branch (HPFB), and the European Medicines Agency (EMEA) in the European Union (EU), have established requirements which must be met by a generic drug product to receive marketing authorization (2,3)\n\n\nRead More: http://informahealthcare.com/doi/abs/10.3109/9781420020021.005

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)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesScience and technology studies
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Other · Consensus signal: Other
Teacher disagreement score0.979
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0020.001
Scholarly communication0.0000.000
Open science0.0010.000
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 head0.016
GPT teacher head0.210
Teacher spread0.194 · 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
GenreOther

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
Published2010
Admission routes1
Has abstractyes

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