Evidence map›Paper›PMID 42021917›Full record

ReviewToxicology reports2026

Regulatory integration of new approach methodologies for human-relevant developmental and reproductive toxicity (DART) assessment: A systematic cross-sector review.

Smita Kumbhar, Shrikant Borude, Rahil Deshmukh

Abstract readReview
In one paragraph

Review in Toxicology reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

3 authors.

Smita KumbharDepartment of Drug Regulatory Affairs, Sanjivani College of Pharmaceutical Education and Research (Autonomous), Kopargaon, Maharashtra 423603, India.
Shrikant BorudeDepartment of Drug Regulatory Affairs, Sanjivani College of Pharmaceutical Education and Research (Autonomous), Kopargaon, Maharashtra 423603, India.
Rahil DeshmukhDepartment of Drug Regulatory Affairs, Sanjivani College of Pharmaceutical Education and Research (Autonomous), Kopargaon, Maharashtra 423603, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Developmental and reproductive toxicity (DART) assessment is a critical component of regulatory safety evaluation across pharmaceutical, chemical, environmental, and consumer product sectors. Traditionally, DART testing has relied on animal-based studies designed to detect adverse effects on fertility, embryonic development, and postnatal growth. However, these conventional approaches present increasing scientific and ethical challenges, including high costs, extended study durations, limited mechanistic insight, and interspecies differences that may reduce their predictive value for human health outcomes. Concurrently, regulatory frameworks increasingly emphasize the principles of Replacement, Reduction, and Refinement (3Rs), driving the development of alternative testing strategies. This systematic review examines the evolving regulatory landscape for DART assessment and evaluates the scientific and regulatory progress associated with emerging New Approach Methodologies (NAMs). A structured literature search was conducted across major scientific databases following PRISMA 2020 guidelines, identifying relevant scientific and regulatory publications from

Indexed as

Adverse outcome pathwaysDevelopmental and reproductive toxicityIntegrated approaches to testing and assessmentNew approach methodologiesNon-animal testingRegulatory toxicology

Identifiers

PMID42021917
PMCPMC13098335

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.