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Record W2067306560 · doi:10.1002/qaj.294

Conducting portions of GLP studies in GMP laboratories

2004· article· en· W2067306560 on OpenAlexaff
Kristin Roberge

Bibliographic record

VenueThe Quality Assurance Journal · 2004
Typearticle
Languageen
FieldMathematics
TopicStatistical Methods in Clinical Trials
Canadian institutionsEli Lilly (Canada)Purdue Pharma (Canada)
Fundersnot available
KeywordsGood laboratory practiceGood manufacturing practiceClinical PracticeOverhead (engineering)Risk analysis (engineering)EngineeringComputer scienceEngineering ethicsManagement scienceMedicineOperations managementNursingElectrical engineering

Abstract

fetched live from OpenAlex

Abstract Good manufacturing practice (GMP) analytical laboratories are routinely used to conduct stability and concentration analyses of dose formulations for non‐clinical laboratory studies. There are many reasons for using GMP analytical laboratories including saving the overhead required for two or more separate laboratories. There are also several challenges that need to be addressed, however, to make this a successful transition. This paper discusses the challenges resulting from the differences in the GMP and good laboratory practice (GLP) regulations and some of the cultural challenges associated with such a major change. Some challenges are common to most major changes and some are specific to this situation. Finally, this paper will discuss some simple strategies to prepare the GMP analytical laboratory for conducting GLP studies. Copyright © 2004 John Wiley & Sons, Ltd.

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)0.020
metaresearch head score (Gemma)0.242
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: Theoretical or conceptual
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.271
Threshold uncertainty score0.764

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0200.242
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
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 head0.896
GPT teacher head0.692
Teacher spread0.204 · 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 designTheoretical or conceptual
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

Citations0
Published2004
Admission routes1
Has abstractyes

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