Evidence map›Paper›PMID 41028689›Full record

ArticleThe AAPS journal2025

Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays?

Yan G Ni, Lauren F Stevenson, Lakshmi Amaravadi, Carmen Fernández-Metzler, Lindsay King, Steven P Piccoli, Amanda Hays, Dhiman Ghosh, Sarah Mitchell Bean, Stephanie Cape and 13 more

Abstract readEditorial
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

23 authors.

Yan G NiPassage Bio, Inc, 1835 Market Street, Philadelphia, PA, 19103, USA. yni@passagebio.com.ORCID http://orcid.org/0009-0004-7498-9197
Lauren F StevensonImmunologix Laboratories, Tampa, FL, USA.ORCID http://orcid.org/0009-0001-3103-3150
Lakshmi AmaravadiAstra Zeneca, Waltham, MA, USA.ORCID http://orcid.org/0009-0008-1720-3249
Carmen Fernández-MetzlerPharmaCadence Analytical Services, LLC, Hatfield, PA, USA.ORCID http://orcid.org/0009-0006-8077-842X
Lindsay KingPfizer Inc, Cambridge, MA, USA.ORCID http://orcid.org/0009-0005-3749-1522
Steven P PiccoliSun Pharma Advanced Research Company Ltd, Princeton, NJ, USA.ORCID http://orcid.org/0000-0002-9355-6651
Amanda HaysBioAgilytix, Durham, NC, USA.ORCID http://orcid.org/0000-0002-3429-4727
Dhiman GhoshWave Life Sciences, Inc, Lexington, MA, USA.ORCID http://orcid.org/0000-0002-3965-9887
Sarah Mitchell BeanCharles River Laboratories, Shrewsbury, MA, USA.ORCID http://orcid.org/0009-0006-6033-0564
Stephanie CapeLabcorp, Madison, WI, USA.ORCID http://orcid.org/0009-0000-9545-0933
Enrique A DalmassoUS Pharmacopeia, Rockville, MD, USA.ORCID http://orcid.org/0009-0007-9708-2725
Shashank GorityalaBioAgilytix, Durham, NC, USA.ORCID http://orcid.org/0000-0002-2514-6589
Jennifer GreenTakeda Development Center Americas, Inc, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-4279-5476
Michele GunsiorAstria Therapeutics, Inc, Boston, MA, USA.ORCID http://orcid.org/0000-0002-6086-5968
Mohamed HassaneinPfizer Inc, Pearl River, NY, USA.ORCID http://orcid.org/0009-0009-5503-7330
Sreenivas LaxmananBioAgilytix, Boston, MA, USA.ORCID http://orcid.org/0009-0005-9524-5960
Robert J NeelyImmunologix Laboratories, Tampa, FL, USA.ORCID http://orcid.org/0009-0000-5619-0163
Alok PandeyPBL Assay Science, Piscataway, NJ, USA.ORCID http://orcid.org/0009-0006-5703-4094
Xiazi QiuNovartis Biomedical Research, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-8397-2168
Chunyan TinderBio-Rad Laboratories Inc, Seattle, WA, USA.ORCID http://orcid.org/0009-0007-6389-2148
Jianing ZengModerna Therapeutics, Inc, Boston, MA, USA.ORCID http://orcid.org/0009-0002-4292-6832
Jad ZoghbiBiogen, Cambridge, MA, USA.ORCID http://orcid.org/0000-0001-7481-6692
Karen J QuadriniProthena Biosciences Inc, 1800 Sierra Point Parkway, Brisbane, CA, 94005, USA. Karen.Quadrini@prothena.com.ORCID http://orcid.org/0009-0001-3113-5800

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Biomarker assay validationBiomarkersContext of useFDA guidanceFit-for-purpose

Identifiers

PMID41028689

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.