Evidence map›Paper›PMID 27689095›Full record

ReviewBioMed research international

Key Challenges and Opportunities Associated with the Use of In Vitro Models to Detect Human DILI: Integrated Risk Assessment and Mitigation Plans.

Franck A Atienzar, Eric A Blomme, Minjun Chen, Philip Hewitt, J Gerry Kenna, Gilles Labbe, Frederic Moulin, Francois Pognan, Adrian B Roth, Laura Suter-Dick and 4 more

Abstract readReview
In one paragraph

Review in BioMed research international. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

23 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Characterization of primary mouse hepatocyte spheroids as a model system to support investigations of drug-induced liver injury.Toxicology in vitro : an international journal published in association with BIBRA · 2021
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. CXCL9 regulates acetaminophen-induced liver injury via CXCR3.Experimental and therapeutic medicine · 2019
    Article
  16. Article
  17. Advances in Engineered Human Liver Platforms for Drug Metabolism Studies.Drug metabolism and disposition: the biological fate of chemicals · 2018
    Article
  18. Population-based dose-response analysis of liver transcriptional response to trichloroethylene in mouse.Mammalian genome : official journal of the International Mammalian Genome Society · 2018
    Article
  19. Article
  20. 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

14 authors.

Franck A AtienzarUCB BioPharma SPRL, Chemin du Foriest, R9 Building, 1420 Braine-l'Alleud, Belgium.ORCID 0000-0003-3436-3830
Eric A BlommeAbbVie, 1 North Waukegan Road, North Chicago, IL 60064, USA.
Minjun ChenDivision of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration (FDA), Jefferson, AR 72079, USA.ORCID 0000-0002-6453-2351
Philip HewittMerck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.
J Gerry KennaDrug Safety Consultant, Macclesfield, Cheshire SK11, UK.
Gilles LabbeSanofi, Bâtiment C. Bernard, 13 Quai Jules Guesdes, Zone B, BP14, 94403 Vitry-sur-Seine Cedex, France.
Frederic MoulinU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, USA.
Francois PognanNovartis Pharma AG, Klybeckstrasse 141, 4057 Basel, Switzerland.
Adrian B RothHoffmann La-Roche Inc., 4000 Basel, Switzerland.
Laura Suter-DickSchool of Life Sciences, University of Applied Sciences Northwestern Switzerland, Gründenstrasse 40, 4132 Muttenz, Switzerland.
Okechukwu UkairoIpsen Biosciences Inc., 650 E Kendall Street, Cambridge, MA 02142, USA.
Richard J WeaverInstitut de Recherches Internationales Servier (IRIS), 50 rue Carnot, 92284 Suresnes Cedex, France.
Yvonne WillPfizer R&D, Drug Safety Research and Development, Eastern Point Road, Groton, CT 06340, USA.
Donna M DambachGenentech, 1 DNA Way, South San Francisco, CA 94080, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug-induced liver injury (DILI) is a major cause of late-stage clinical drug attrition, market withdrawal, black-box warnings, and acute liver failure. Consequently, it has been an area of focus for toxicologists and clinicians for several decades. In spite of considerable efforts, limited improvements in DILI prediction have been made and efforts to improve existing preclinical models or develop new test systems remain a high priority. While prediction of intrinsic DILI has improved, identifying compounds with a risk for idiosyncratic DILI (iDILI) remains extremely challenging because of the lack of a clear mechanistic understanding and the multifactorial pathogenesis of idiosyncratic drug reactions. Well-defined clinical diagnostic criteria and risk factors are also missing. This paper summarizes key data interpretation challenges, practical considerations, model limitations, and the need for an integrated risk assessment. As demonstrated through selected initiatives to address other types of toxicities, opportunities exist however for improvement, especially through better concerted efforts at harmonization of current, emerging and novel in vitro systems or through the establishment of strategies for implementation of preclinical DILI models across the pharmaceutical industry. Perspectives on the incorporation of newer technologies and the value of precompetitive consortia to identify useful practices are also discussed.

Identifiers

PMID27689095
PMCPMC5027328

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.