Evidence map›Paper›PMID 38389403›Full record

ArticleBioanalysis2024

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard

Johanna Mora, Rachel Palmer, Leslie Wagner, Bonnie Wu, Michael Partridge, Meena, Ivo Sonderegger, John Smeraglia, Nicoletta Bivi, Naveen Dakappagari and 48 more

Open access · greenAbstract readConsensus Statement
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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.8field-weighted citation impact, top 6% of its field
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

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
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  10. 16Bioanalysis · 2024
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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

58 authors at 20 institutions in 12 countries.

Johanna MoraBristol Myers Squibb, Lawrenceville, NJ, USA.
Rachel PalmerSanofi, Cambridge, MA, USA.
Leslie WagnerUS FDA, Silver Spring, MD, USA.
Bonnie WuJanssen R&D, Spring House, PA, USA.
Michael PartridgeRegeneron, Tarrytown, NY, USA.
MeenaStoke, Cambridge, MA, USA.
Ivo SondereggerTakeda, Opfikon, Switzerland.
John SmeragliaAstraZeneca, Cambridge, UK.
Nicoletta BiviEli Lilly & Company, Indianapolis, IN, USA.
Naveen DakappagariNavigate, a Novartis Subsidiary, San Diego, CA, USA.
Sandra DieboldUK MHRA, London, UK.
Fabio GarofoloBRI Frontage, Vancouver, BC, Canada.
Christine GrimaldiRegeneron, Tarrytown, NY, USA.
Warren KalinaPfizer, Groton, CT, USA.
John KamerudPfizer, Groton, CT, USA.
Sumit KarWRIB, Toronto, ON, Canada.
Jean-Claude MarshallModerna, Mystic, CT, USA.
Christian MayerAustria AGES, Vienna, Austria.
Andrew MeltonBioMarin, Novato, CA, USA.
Keith MerdekBristol Myers Squibb, Lawrenceville, NJ, USA.
Katrina NolanMerck, West Point, PA, USA.
Serge PicardBristol Myers Squibb, Lawrenceville, NJ, USA.
Weiping ShaoAstraZeneca, Cambridge, UK.
Jessica SeitzerIntellia, Cambridge, MA, USA.
Yoichi TanakaJapan MHLW, Tokyo, Japan.
Omar TounektiHealth Canada, Ottawa, ON, Canada.
Adam VigilBoehringer Ingelheim, Danbury, CT, USA.
Karl WalravensGlaxoSmithKline, Rixensart, Belgium.
Joshua XuUS FDA, Jefferson, AR, USA.
Weifeng XuMerck, West Point, PA, USA.
Yuanxin XuIntellia, Cambridge, MA, USA.
Lin YangUS FDA, Jefferson, AR, USA.
Liang ZhuModerna, Mystic, CT, USA.
Daniela VerthelyiUS FDA, Silver Spring, MD, USA.
Robert J KubiakAstraZeneca, Gaithersburg, MD, USA.
Kelly CobleBoehringer Ingelheim, Danbury, CT, USA.
Swati GuptaAbbVie, Irvine, CA, USA.
Mohsen Rajabi AbhariUS FDA, Silver Spring, MD, USA.
Susan RichardsSanofi, Cambridge, MA, USA.
Yuan SongGenentech, South San Francisco, CA, USA.
Martin UllmannFresenius Kabi, Bad Homburg, Germany.
Boris CalderonEli Lilly & Company, Indianapolis, IN, USA.
Isabelle CludtsUK MHRA, London, UK.
George R GunnGlaxoSmithKline, Collegeville, PA, USA.
Shalini GuptaAmgen, Thousand Oaks, CA, USA.
Akiko Ishii-WatabeJapan MHLW, Tokyo, Japan.
Mohanraj ManangeeswaranUS FDA, Silver Spring, MD, USA.
Kimberly MaxfieldUS FDA, Silver Spring, MD, USA.
Fred McCushPfizer, Groton, CT, USA.
Christine O'DaySeattle Genetics, Bothell, WA, USA.
Kate PengGenentech, South San Francisco, CA, USA.
Johann PoetzlSandoz, Oberhaching, Germany.
Michele RasamoelisoloSandoz, Oberhaching, Germany.
Ola M SaadGenentech, South San Francisco, CA, USA.
Kara ScheibnerUS FDA, Silver Spring, MD, USA.
Sophie ShubowUS FDA, Silver Spring, MD, USA.
Sam SongTakeda, Cambridge, MA, USA.
Seth ThackerUS FDA, Silver Spring, MD, USA.
United States Food and Drug Administration · USPfizer (United States) · USAmgen (United States) · USBoehringer Ingelheim (Egypt) · EGBristol-Myers Squibb (Germany) · DEEli Lilly (United States) · USIntellia Therapeutics (United States) · USMercy Willard Hospital · USModerna Therapeutics (United States) · USMontana Health Research Institute · USRegeneron (United States) · USSanofi (United States) · USTakeda (France) · FRAstraZeneca (Brazil) · BRAstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USAustrian Agency for Health and Food Safety · ATBioMarin (United States) · USBristol-Myers Squibb (United States) · USFresenius Kabi (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The 17

Indexed as

Biological AssayTechnologyBiomarkersCell- and Tissue-Based TherapyImmunotherapy, ActiveBiomarkersbioanalysisbiomarkerscell therapygene therapyimmunogenicityvaccineWRIB

Identifiers

PMID38389403
PMCPMC11849449
OpenAlexW4392107106

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.