Evidence map›Paper›PMID 40069400›Full record

ArticleThe AAPS journal2025

Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis.

Faye Vazvaei-Smith, Wenkui Li, Omar S Barnaby, Sanjeev Bhardwaj, Juyao Dong, Carolyne Dumont, Carmen Fernández-Metzler, Brian Geist, Mohamed Hassanein, Amanda Hays and 13 more

Abstract read
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 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

23 authors.

Faye Vazvaei-SmithMerck & Co., Inc., West Point, Pennsylvania, 19486, USA. fataneh.vazvaei-smith@merck.com.ORCID 0000-0002-8181-8335
Wenkui LiNovartis Biomedical Research, East Hanover, New Jersey, 07936, USA. wenkui.li@novartis.com.
Omar S BarnabyAmgen, Thousand Oaks, California, 91320, USA.
Sanjeev BhardwajModerna Therapeutics, Cambridge, MA, 02142, USA.
Juyao DongIntellia Therapeutics, Cambridge, Massachusetts, 02139, USA.
Carolyne DumontCharles River Laboratories, Senneville, Canada.
Carmen Fernández-MetzlerPharmaCadence Analytical Services, LLC, Hatfield, Pennsylvania, 19440, USA.
Brian GeistJohnson & Johnson Innovative Medicine, Spring House, PA, 19477, USA.
Mohamed HassaneinPfizer Inc., Cambridge, Massachusetts, 02139, USA.
Amanda HaysBioAgilytix Labs, Durham, North Carolina, 27713, USA.
Anna IlinskayaSmithers, Gaithersburg, Maryland, 20878, USA.
Eugene P KadarPfizer Inc., Groton, CT, 06340, USA.
Kris KingValo Health, Lexington, Massachusetts, 02421, USA.
Nadia KulaginaSmithers, Gaithersburg, Maryland, 20878, USA.
Murali K MattaMerck & Co., Inc., West Point, Pennsylvania, 19486, USA.
Krishna MiddePPD Labs, Richmond, Virginia, 23230, USA.
Rina PanIncyte Research Institute, Wilmington, Delaware, 19803, USA.
Divya PathaniaAbbVie Inc., Irvine, CA, 92612, USA.
Thomas TarnowskiGilead Sciences, Inc., Foster City, California, 94404, USA.
Eric TewaltPPD, part of Thermo Fisher Scientific, Richmond, Virginia, 23230, USA.
Eric ThomasLabcorp, Indianapolis, Indiana, 46214, USA.
Enaksha WickremsinheGates Medical Research Institute, Cambridge, Massachusetts, 02139, USA.
Deqing XiaoGilead Sciences, Inc., Foster City, California, 94404, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The analysis of Non-Liquid Matrices (NLMs) can provide key information on many aspects in drug discovery and development. These include but are not limited to drug uptake and distribution, engagement and modulation, and target exposure. A thorough understanding of these aspects is fundamental to the progression of drug development. In many cases, such an understanding can only be achieved through quantitative analysis of NLMs. Such dependence can lead to bottlenecks in the drug development process-as the practices and regulations that govern bioanalysis of conventional liquid matrices typically cannot be directly applied to NLMs. This paper strives to fill this crucial gap. To this end, subject matter experts from across the industry, through the auspices of the AAPS Bioanalytical Community, have combined their collective best practices for NLM bioanalysis in this paper. Certainly, this endeavor came with challenges, the most prominent of which also serves as the impetus for this project, the lack of literature on NLM bioanalysis dealing with different types of NLM, analysis rigor, and best practices to draw from. This paper aims to serve as a comprehensive set of best practices drawn from the experiences of leading scientists across the industry-for NLM bioanalysis in drug development.

Indexed as

Drug DevelopmentDrug DiscoveryDrug IndustryHumansPharmaceutical PreparationsPharmaceutical Preparationsbioanalysisbiomarkerscellsfit-for-purpose validationlysatesnon-liquid matricespharmacokineticsPK/PDtissue

Identifiers

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.