Evidence map›Paper›PMID 23338803›Full record

ArticleALTEX2013

Integrated testing strategies for safety assessments.

Thomas Hartung, Tom Luechtefeld, Alexandra Maertens, Andre Kleensang

Abstract read
In one paragraph

Article in ALTEX, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing 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

50 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Toxicity testing is evolving!Toxicology research · 2020
    Review
  17. Article
  18. Article
  19. Article
  20. Perspectives onApplied in vitro toxicology · 2018
    Review
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

4 authors.

Thomas HartungJohns Hopkins University, Bloomberg School of Public Health, CAAT, Baltimore, MD 21205, USA. thartung@jhsph.edu
Tom Luechtefeld
Alexandra Maertens
Andre Kleensang

Funding

Traning Program in Environmental Health SciencesT32ES007141 · NIEHS · JOHNS HOPKINS UNIVERSITY · PI Marsha Wills-Karp · 1985 to 2026
$22.2M
Mapping the Human Toxome by Systems ToxicologyR01ES020750 · NIEHS · JOHNS HOPKINS UNIVERSITY · PI HARTUNG, THOMAS · 2011 to 2015
$6.0M
Developmental neurotoxicity pathways for high throughput testing by metabolomicsU01FD004230 · FDA · JOHNS HOPKINS UNIVERSITY · PI HARTUNG, THOMAS · 2011 to 2012
$815k
FDA HHS U01 FD004230FDA HHS U01FD004230NIEHS NIH HHS R01 ES020750NIEHS NIH HHS R01ES020750NIEHS NIH HHS T32 ES007141
6 · The paper itself

Abstract

Despite the fact that toxicology uses many stand-alone tests, a systematic combination of several information sources very often is required: Examples include: when not all possible outcomes of interest (e.g., modes of action), classes of test substances (applicability domains), or severity classes of effect are covered in a single test; when the positive test result is rare (low prevalence leading to excessive false-positive results); when the gold standard test is too costly or uses too many animals, creating a need for prioritization by screening. Similarly, tests are combined when the human predictivity of a single test is not satisfactory or when existing data and evidence from various tests will be integrated. Increasingly, kinetic information also will be integrated to make an in vivo extrapolation from in vitro data. Integrated Testing Strategies (ITS) offer the solution to these problems. ITS have been discussed for more than a decade, and some attempts have been made in test guidance for regulations. Despite their obvious potential for revamping regulatory toxicology, however, we still have little guidance on the composition, validation, and adaptation of ITS for different purposes. Similarly, Weight of Evidence and Evidence-based Toxicology approaches require different pieces of evidence and test data to be weighed and combined. ITS also represent the logical way of combining pathway-based tests, as suggested in Toxicology for the 21st Century. This paper describes the state of the art of ITS and makes suggestions as to the definition, systematic combination, and quality assurance of ITS.

Indexed as

AnimalsAnimal Testing AlternativesHumansReproducibility of ResultsToxicity Tests

Identifiers

PMID23338803
PMCPMC3800026

What OpenQuestion holds

Textmetadata
LicenceTDM
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.