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Record W1996277995 · doi:10.1177/0091270009347871

Does Therapeutic Equivalence Follow Bioequivalence? A Randomized Trial to Assess Clinical Effects After Switching From Clozaril to Generic Clozapine (Gen‐Clozapine)

2010· article· en· W1996277995 on OpenAlexaff
Oloruntoba Oluboka, Sandra C. Stewart, Suzette Landry, Susan Adams

Bibliographic record

VenueThe Journal of Clinical Pharmacology · 2010
Typearticle
Languageen
FieldMedicine
TopicSchizophrenia research and treatment
Canadian institutionsInnovation Initiatives Ontario NorthNortheast Cancer CentreUniversity of Calgary
Fundersnot available
KeywordsClozapineBioequivalenceMedicineRandomized controlled trialClinical trialRating scaleBrief Psychiatric Rating ScaleInternal medicinePsychologySchizophrenia (object-oriented programming)PsychosisPsychiatryPharmacokinetics

Abstract

fetched live from OpenAlex

This study prospectively assessed outcomes in a group of patients who were randomly switched from Clozaril to generic clozapine (Gen-Clozapine). The authors examined data from rating scales administered before the switch and at points after the switch. There were no statistically significant differences between the groups on any baseline measures, including psychiatric status and dose of medication. In the group of patients who were switched to the generic formulation, there was a significant increase in Global Assessment Scale scores by the end of the 6-month monitoring period. In the group of patients who remained on Clozaril, a significant decrease in the 32-item Behavior and Symptom Identification Scale scores was found at the end of the monitoring period. The results of this study suggest that clinical equivalence indeed followed bioequivalence when switching from Clozaril to Gen-Clozapine.

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)0.016
metaresearch head score (Gemma)0.008
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Research integrity, Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.071
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0160.008
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0030.002
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0000.003
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 head0.123
GPT teacher head0.488
Teacher spread0.365 · 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 designRandomized trial
Domainnot available
GenreEmpirical

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

Citations11
Published2010
Admission routes1
Has abstractyes

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