Evidence map›Paper›PMID 38864397›Full record

ArticleBioanalysis2024

16

Jennifer Zimmer, Amanda Hays, Todd Lester, Manisha Diaz, Eric Thomas, Mark O'Dell, Elizabeth Hyer, Shabnam Tangri, Naveen Dakappagari, Moucun Yuan and 32 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioanalysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

42 authors.

Jennifer ZimmerAlturas Analytics, Moscow, Idaho, USA.
Amanda HaysBioAgilytix, Durham, North Carolina, USA.
Todd LesterBioAgilytix, Durham, North Carolina, USA.
Manisha DiazEurofins Viracor, BioPharma Services, Lenexa, Kansas, USA.
Eric ThomasLabcorp, Indianapolis, Indiana, USA.
Mark O'DellLabcorp, Indianapolis, Indiana, USA.
Elizabeth HyerLabcorp, Madison, Wisconsin, USA.
Shabnam TangriNavigate Biopharma, San Diego, California, USA.
Naveen DakappagariNavigate Biopharma, San Diego, California, USA.
Moucun YuanPPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
Amy LavellePPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
Shane KarnikAliri Bioanalysis, Colorado Springs, Colorado, USA.
Aihua LiuResolian (Formally Alliance Pharma), Malvern, Pennsylvania, USA.
Bin XuAccurant Biotech, Cranbury, New Jersey, USA.
Kurt SalesAgilex Biolabs, Adelaide, Australia.
Shashank GorityalaBioAgilytix, Durham, North Carolina, USA.
Gregory ReynoldsBioAgilytix, San Diego, California, USA.
Tim SangsterCelerion, Lincoln, Nebraska, USA.
Dean FranckaertCellCarta Biosciences, Montreal, Canada.
Iain LoveCharles River Laboratories, Edinburgh, Tranent, UK.
Vimal PatelCharles River Laboratories, Reno, Nevada, USA.
Martin RobergeCIRION BioPharma Research (a Cerba Research Company), Laval, Quebec, Canada.
Jenny LinCMIC, Hoffman Estates, Illinois, USA.
Erik JerksEurofins Pharma Bioanalytics, Lake St. Louis, Missouri, USA.
Tao XuFrontage Laboratory, Exton, Pennsylvania, USA.
Wei GarofoloGCC, Toronto, Ontario, Canada.
Sankeetha NadarajahGCC, Toronto, Ontario, Canada.
Robert KernstockICON plc, Whitesboro, New York, USA.
Dawn DufieldKCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA.
David AmbroseKCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA.
Dominic WarrinoKCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA.
Marsha LunaKCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA.
Chantal Di MarcoPharma Medica Research, Mississauga, Ontario, Canada.
Ariana TudoroniuPharma Serv International, Bucharest, Romania.
Adriana IordachescuPharma Serv International, Bucharest, Romania.
Mitesh SanghviPharmaron, Germantown, Maryland, USA.
Hollie BartonPPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
Michael BrownQ2 Solutions Durham, North Carolina, USA.
Brian HoffpauirSmithers, Gaithersburg, Maryland, USA.
Agostinho RochaSmithers, Ewing, New Jersey, USA.
Kelly DongUnited-Power Pharma Tech Co., Beijing, China.
Jim YamashitaWuXi AppTec, Plainsboro, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.

Indexed as

BiomarkersFlow CytometryHigh-Throughput Nucleotide SequencingHumansReal-Time Polymerase Chain ReactionBiomarkersbioanalysisbiomarker assayCROdPCR validationflow cytometryICH M10immunogenicity harmonizationIS responseNGS assay

Identifiers

PMID38864397
PMCPMC11299793

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.