Evidence map›Paper›PMID 39317677›Full record

ArticlePharmaceutical statistics

Quality by Design for Preclinical In Vitro Assay Development.

Jonathan Jones, Bairu Zhang, Xiang Zhang, Peter Konings, Pia Hansson, Anna Backmark, Alessia Serrano, Ulrike Künzel, Steven Novick

Abstract read
In one paragraph

Article in Pharmaceutical statistics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jonathan JonesData Sciences and Quantitative Biology, Discovery Sciences, R&D, AstraZeneca, Cambridge, UK.ORCID 0000-0003-0333-5212
Bairu ZhangData Sciences and Quantitative Biology, Discovery Sciences, R&D, AstraZeneca, Cambridge, UK.
Xiang ZhangData Sciences and Quantitative Biology, Discovery Sciences, R&D, AstraZeneca, Gothenburg, Sweden.
Peter KoningsData Sciences and Quantitative Biology, Discovery Sciences, R&D, AstraZeneca, Gothenburg, Sweden.ORCID 0000-0002-8637-5916
Pia HanssonBioscience Cardiovascular, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Anna BackmarkBioscience Cardiovascular, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Alessia SerranoFunctional Genomics, Discovery Sciences, R&D, AstraZeneca, Cambridge, UK.
Ulrike KünzelFunctional Genomics, Discovery Sciences, R&D, AstraZeneca, Cambridge, UK.
Steven NovickData Sciences and Quantitative Biology, Discovery Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, USA.ORCID 0000-0001-8760-1519

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Quality by Design (QbD) is an approach to assay development to determine the design space, which is the range of assay variable settings that should result in satisfactory assay quality. Typically, QbD is applied in manufacturing, but it works just as well in the preclinical space. Through three examples, we illustrate the QbD approach with experimental design and associated data analysis to determine the design space for preclinical assays.

Indexed as

Biological AssayDrug DevelopmentResearch DesignAnimalsDrug Evaluation, PreclinicalHumansQuality Controlassay optimizationCRISPRdesign of experimentsdesign spaceJMPscreening

Identifiers

PMID39317677
PMCPMC11788254

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.