Evidence map›Paper›PMID 40849915›Full record

ArticleClinical pharmacology and therapeutics2025

New Approach Methodologies: What Clinical Pharmacologists Should Prepare For.

Yanguang Cao, William Polacheck

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 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. New approach methodologies (NAMs) for preclinical and translational evaluation of mRNA-lipid nanoparticle (LNP) therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2026
    Review
  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

2 authors.

Yanguang CaoDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0002-3974-9073
William PolacheckLampe Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Chapel Hill, North Carolina, USA.ORCID 0000-0003-2728-0746

Funding

Integrative Approaches for the Study of the Fluidic Cellular MicroenvironmentR35GM142944 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI William J Polacheck · 2021 to 2026
$2.3M
Quantitative Systems Pharmacology of Antibody Therapeutics across Diverse Biological ContextsR35GM152449 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Yanguang Cao · 2024 to 2026
$1.2M
NIGMS NIH HHS R35 GM142944NIGMS NIH HHS R35 GM152449
6 · The paper itself

Abstract

As new approach methodologies (NAMs) gain regulatory momentum for Investigational new drug (IND) applications, clinical pharmacologists are uniquely positioned to collaborate with preclinical and translational teams in the development, quantification, and implementation of these methodologies. Their involvement is critical to ensuring a reduction in animal use to support early-phase drug development.

Indexed as

Drug DevelopmentDrugs, InvestigationalPharmacology, ClinicalAnimalsDrug Evaluation, PreclinicalHumansTranslational Research, BiomedicalDrugs, Investigational

Identifiers

PMID40849915
PMCPMC12404678

What OpenQuestion holds

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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.