Evidence map›Paper›PMID 39985138›Full record

ArticleBioanalysis2025

Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for

Philip Timmerman, Steve White, Neil Adcock, Cecilia Arfvidsson, Matthew Barfield, Kyra Cowan, Luca Ferrari, Michaela Golob, Lee Goodwin, Richard Hughes and 7 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioanalysis, 2025. 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. Article
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

17 authors.

Philip TimmermanEuropean Bioanalysis Forum, Brussels, Belgium.
Steve WhiteGSK, Precision Medicine Design Assurance, Stevenage, UK.
Neil AdcockPharmaron-UK, Metabolism, Rushden, UK.
Cecilia ArfvidssonAstraZeneca, Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, R&D, Gothenburg, Sweden.
Matthew BarfieldRoche Innovation Center Welwyn, Roche Pharma Research and Early Development, Welwyn Garden City, UK.
Kyra CowanMerck KGaA, Research and Development, Drug Metabolism and Pharmacokinetics New Biological Entities, Darmstadt, Germany.
Luca FerrariRoche Pharma Research & Early Development (pRED), F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Michaela GolobBioanalysis, Nuvisan GmbH, Neu-Ulm, Germany.
Lee GoodwinLabcorp, Bioanalytical Services, Harrogate, UK.
Richard HughesResolian Bioanalytics, Fordham, Ely, UK.
Tsvetelina IvanovaQuality and Compliance, Comac Medical, Sofia, Bulgaria.
Anna LaurénMinervaX, Lund, Sweden.
Stuart McDougallQuotient Sciences, Bioanalytical Department, Alnwick, Northumberland, UK.
Robert NelsonBioAgilytix Laboratories, Hamburg, Germany.
Nico van de MerbelICON, Bioanalytical Laboratories, Assen, The Netherlands.
Tom VerhaegheBDDS, J&J Innovative Medicine, Beerse, Belgium.
Michael WrightGSK, Biomarker & Bioanalytical Platforms, Precision Medicine, Stevenage, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The release of the ICH M12 Guideline on Drug Interaction Studies has reignited discussions around assay validation requirements for

Indexed as

Biological AssayGuidelines as TopicEuropeHumansValidation Studies as Topiccontext of useICH M12plasma protein binding assays

Identifiers

PMID39985138
PMCPMC11959917

What OpenQuestion holds

Textmetadata
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.