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Record W2262409806 · doi:10.1159/000381581

Potential Concerns and Questions

2015· book-chapter· en· W2262409806 on OpenAlexaboutno aff
Gerhard Rogler

Bibliographic record

VenueFrontiers of gastrointestinal research · 2015
Typebook-chapter
Languageen
FieldImmunology and Microbiology
TopicBiosimilars and Bioanalytical Methods
Canadian institutionsnot available
Fundersnot available
KeywordsPsychology

Abstract

fetched live from OpenAlex

Biosimilars are biological products that are very similar, but not identical, to an originator product. For anti-TNF biosimilars for inflammatory bowel disease treatment, a number of concerns have been raised by pharmacologists and gastroenterologists with respect to the evaluation of biosimilarity, product stability, production condition stability, biosimilar name, extrapolation of indications, traceability, interchangeability and pharmacovigilance. These points will be discussed in this review. There are several questions that have not been satisfactorily answered so far, leading to different regulatory guidelines in Europe (European Medicines Agency), the USA (Food and Drug Administration), Canada and other countries. For clinicians, it will be important to have knowledge about these concerns to make reasonable patient-oriented decisions in the upcoming confusing market of biosimilars for established anti-TNF antibodies.

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)0.002
metaresearch head score (Gemma)0.001
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: Not applicable
GenreCandidate signal: Other · Consensus signal: Other
Teacher disagreement score0.071
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.003
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.002
Insufficient payload (model declined to judge)0.0010.000

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 head0.112
GPT teacher head0.380
Teacher spread0.268 · 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
Published2015
Admission routes1
Has abstractyes

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