Evidence map›Paper›PMID 26168280›Full record

ArticleALTEX2015

Toxicity testing in the 21st century beyond environmental chemicals.

Costanza Rovida, Shoji Asakura, Mardas Daneshian, Hana Hofman-Huether, Marcel Leist, Leo Meunier, David Reif, Anna Rossi, Markus Schmutz, Jean-Pierre Valentin and 2 more

Open access · goldAbstract read
In one paragraph

Article in ALTEX, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
25.1field-weighted citation impact, top 1% 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

25 citing papers in PubMed, 104 citations in OpenAlex.

  1. AI/ML-based computational models for toxicity prediction.Environmental science and pollution research international · 2026
    Review
  2. Article
  3. Application ofFrontiers in toxicology · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Advancing human health risk assessment.EFSA journal. European Food Safety Authority · 2019
    Article
  18. Article
  19. Article
  20. 21st Century Cell Culture for 21st Century Toxicology.Chemical research in toxicology · 2017
    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

12 authors at 1 institution in 1 country.

Costanza RovidaCAAT-Europe, University of Konstanz, Konstanz, Germany.
Shoji AsakuraTsukuba Drug Safety, Biopharmaceutical Assessment Core Function Unit, Eisai Co., Ltd., Ibaraki, Japan.
Mardas DaneshianCAAT-Europe, University of Konstanz, Konstanz, Germany.
Hana Hofman-HuetherEurofins BioPharma Product Testing Munich GmbH, Planegg, Germany.
Marcel LeistCAAT-Europe, University of Konstanz, Konstanz, Germany.
Leo MeunierDanone Food Safety Center, Utrecht, The Netherlands.
David ReifBioinformatics Research Center, Department of Biological Sciences, North Carolina State University, Raleigh, NC, USA.
Anna RossiEuropean Food Safety Authority (EFSA), Parma, Italy.
Markus SchmutzConsultant, Basel, Switzerland.
Jean-Pierre ValentinNon-Clinical Development, UCB-Biopharma, Belgium.
Joanne ZurloCAAT, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, US.
Thomas HartungCAAT, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, US.
University of Konstanz · DE

Funding

STOCHASTIC ANALYSIS OF FLOW AND TRANSPORT PHENOMENAP42ES005948 · NIEHS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRY, REBECCA · 1992 to 2017
$45.4M
NIEHS NIH HHS P42 ES005948
6 · The paper itself

Abstract

After the publication of the report titled Toxicity Testing in the 21st Century - A Vision and a Strategy, many initiatives started to foster a major paradigm shift for toxicity testing - from apical endpoints in animal-based tests to mechanistic endpoints through delineation of pathways of toxicity (PoT) in human cell based systems. The US EPA has funded an important project to develop new high throughput technologies based on human cell based in vitro technologies. These methods are currently being incorporated into the chemical risk assessment process. In the pharmaceutical industry, the efficacy and toxicity of new drugs are evaluated during preclinical investigations that include drug metabolism, pharmacokinetics, pharmacodynamics and safety toxicology studies. The results of these studies are analyzed and extrapolated to predict efficacy and potential adverse effects in humans. However, due to the high failure rate of drugs during the clinical phases, a new approach for a more predictive assessment of drugs both in terms of efficacy and adverse effects is getting urgent. The food industry faces the challenge of assessing novel foods and food ingredients for the general population, while using animal safety testing for extrapolation purposes is often of limited relevance. The question is whether the latest paradigm shift proposed by the Tox21c report for chemicals may provide a useful tool to improve the risk assessment approach also for drugs and food ingredients.

Indexed as

Risk AssessmentAnimalsAnimal Testing AlternativesDrug ApprovalDrug EvaluationDrug IndustryHumansIn Vitro TechniquesSafetyToxicity TestsUnited StatesUnited States Environmental Protection Agencydrugsfood ingredientssafety assessmentTox21c

Identifiers

PMID26168280
PMCPMC5986181
OpenAlexW902455282

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.