Evidence map›Paper›PMID 31195068›Full record

ArticleRegulatory toxicology and pharmacology : RTP2019

Genetic toxicology in silico protocol.

Catrin Hasselgren, Ernst Ahlberg, Yumi Akahori, Alexander Amberg, Lennart T Anger, Franck Atienzar, Scott Auerbach, Lisa Beilke, Phillip Bellion, Romualdo Benigni and 64 more

Abstract read
In one paragraph

Article in Regulatory toxicology and pharmacology : RTP, 2019. 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. Review
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Frontiers in toxicology · 2023
    Article
  11. Principles and Procedures for Assessment of Acute Toxicity IncorporatingComputational toxicology (Amsterdam, Netherlands) · 2022
    Article
  12. Article
  13. Evaluating Confidence in Toxicity Assessments Based on Experimental Data andComputational toxicology (Amsterdam, Netherlands) · 2022
    Article
  14. Implementation ofComputational toxicology (Amsterdam, Netherlands) · 2022
    Article
  15. Implementation of In Silico Toxicology Protocols in Leadscope.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  16. Article
  17. Computational toxicology (Amsterdam, Netherlands) · 2021
    Article
  18. Computational toxicology (Amsterdam, Netherlands) · 2021
    Article
  19. Computational toxicology (Amsterdam, Netherlands) · 2021
    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

74 authors.

Catrin HasselgrenGenentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA. Electronic address: hasselgren.catrin@gene.com.
Ernst AhlbergPredictive Compound ADME & Safety, Drug Safety & Metabolism, AstraZeneca IMED Biotech Unit, Mölndal, Sweden.
Yumi AkahoriChemicals Evaluation and Research Institute, 1-4-25 Kouraku, Bunkyo-ku, Tokyo, 112-0004, Japan.
Alexander AmbergSanofi, R&D Preclinical Safety Frankfurt, Industriepark Hoechst, D-65926, Frankfurt am Main, Germany.
Lennart T AngerSanofi, R&D Preclinical Safety Frankfurt, Industriepark Hoechst, D-65926, Frankfurt am Main, Germany.
Franck AtienzarUCB BioPharma SPRL, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Scott AuerbachThe National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Research Triangle Park, NC, 27709, USA.
Lisa BeilkeToxicology Solutions Inc., San Diego, CA, USA.
Phillip BellionDSM Nutritional Products, Kaiseraugst, Switzerland.
Romualdo BenigniAlpha-PreTox, via G.Pascoli 1, 00184, Roma, Italy.
Joel BercuGilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Ewan D BoothSyngenta, Product Safety Department, Jealott's Hill International Research Centre, Bracknell, Berkshire, RG42 6EY, UK.
Dave BowerLeadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Alessandro BrigoRoche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Zoryana CammererJanssen Research & Development, 1400 McKean Road, Spring House, PA, 19477, USA.
Mark T D CroninSchool of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.
Ian CrooksBritish American Tobacco, Research and Development, Regents Park Road, Southampton, Hampshire, SO15 8TL, UK.
Kevin P CrossLeadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Laura CusterBristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Krista DoboPfizer Global Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA.
Tatyana DoktorovaDouglas Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, CH-4057, Basel / Basel-Stadt, Switzerland.
David FaulknerLawrence Berkeley National Laboratory, One Cyclotron Road, MS 70A-1161A, Berkeley, CA, 947020, USA.
Kevin A FordGlobal Blood Therapeutics, 171 Oyster Point Boulevard, South San Francisco, CA, 94080, USA.
Marie C FortinJazz Pharmaceuticals, Inc., 200 Princeton South Corporate Center, Suite 180, Ewing, NJ, 08628, USA; Department of Pharmacology and Toxicology, Ernest Mario School of Pharmacy, Rutgers University, 170 Frelinghuysen Rd, Piscataway, NJ, 08855, USA.
Markus FrericksBASF SE, 67056, Ludwigshafen, Germany.
Samantha E Gad-McDonaldGad Consulting Services, 4008 Barrett Drive, Suite 201, Raleigh, NC, 27609, USA.
Nichola GellatlyNational Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UK.
Helga GeretsUCB BioPharma SPRL, Chemin du Foriest, B-1420, Braine-l'Alleud, Belgium.
Véronique GervaisServier Group, 905 route de Saran, 45520, Gidy, France.
Susanne GlowienkeNovartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH, 4057, Basel, Switzerland.
Jacky Van GompelJanssen Pharmaceutical Companies of Johnson & Johnson, 2340, Beerse, Belgium.
James S HarveyGlaxoSmithKline Pre-Clinical Development, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
Jedd HillegassBristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Masamitsu HonmaDivision of Genetics and Mutagenesis, National Institute of Health Sciences, Kanagawa, 210-9501, Japan.
Jui-Hua HsiehKelly Government Solutions, Research Triangle Park, NC, 27709, USA.
Chia-Wen HsuFDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Tara S Barton-MaclarenExisting Substances Risk Assessment Bureau, Health Canada, Ottawa, ON, K1A 0K9, Canada.
Candice JohnsonLeadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Robert JollyToxicology Division, Eli Lilly and Company, Indianapolis, IN, USA.
David JonesMedicines and Healthcare Products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Ray KemperVertex Pharmaceuticals Inc., Predictive and Investigative Safety Assessment, 50 Northern Ave, Boston, MA, USA.
Michelle O KenyonPfizer Global Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA.
Naomi L KruhlakFDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Sunil A KulkarniExisting Substances Risk Assessment Bureau, Health Canada, Ottawa, ON, K1A 0K9, Canada.
Klaus KümmererInstitute for Sustainable and Environmental Chemistry, Leuphana University Lüneburg, Scharnhorststraße 1/C13.311b, 21335, Lüneburg, Germany.
Penny LeavittBristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Scott MastenThe National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Research Triangle Park, NC, 27709, USA.
Scott MillerLeadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Chandrika MoudgalGenentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Wolfgang MusterRoche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Alexandre PaulinoOro Agri Setúbal, Portugal.
Elena Lo PiparoNestlé Research Vers-chez-les-Blanc, Lausanne, Switzerland.
Mark PowleyMerck Research Laboratories, West Point, PA, 19486, USA.
Donald P QuigleyLeadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
M Vijayaray ReddyMerck Research Laboratories, West Point, PA, 19486, USA.
Andrea-Nicole RicharzEuropean Commission, Joint Research Centre (JRC), Ispra, Italy.
Benoit SchilterNestlé Research Vers-chez-les-Blanc, Lausanne, Switzerland.
Ronald D SnyderRDS Consulting Services, 2936 Wooded Vista Ct, Mason, OH, 45040, USA.
Lidiya StavitskayaFDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Reinhard StidlSafetree Consulting e.U, Vienna, Austria.
David T SzaboPPG Industries, Pittsburgh, PA, 15146, USA.
Andrew TeasdaleAstraZeneca, Macclesfield, Cheshire, UK.
Raymond R TiceRTice Consulting, Hillsborough, NC, USA.
Alejandra Trejo-MartinGilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Anna VuorinenDSM Nutritional Products, Kaiseraugst, Switzerland.
Brian A WallColgate-Palmolive Company, Piscataway, NJ, 08854, USA.
Pete WattsBibra, Cantium House, Railway Approach, Wallington, Surrey, SM6 0DZ, UK.
Angela T WhiteGlaxoSmithKline Pre-Clinical Development, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
Joerg WichardBayer AG, Pharmaceuticals Division, Investigational Toxicology, Muellerstr. 178, D-13353, Berlin, Germany.
Kristine L WittThe National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Research Triangle Park, NC, 27709, USA.
Adam WoolleyForthTox Limited, PO Box 13550, Linlithgow, EH49 7YU, UK.
David WoolleyForthTox Limited, PO Box 13550, Linlithgow, EH49 7YU, UK.
Craig ZwicklTransendix LLC, 1407 Moores Manor, Indianapolis, IN, 46229, USA.
Glenn J MyattLeadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.

Funding

Biomolecular Screening and Alternative Approaches for the National Toxicology ProgramZIAES103318 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI CASEY, WARREN · 2016 to 2021
$25.0M
Rapid response toxicology prediction platformR44ES026909 · NIEHS · LEADSCOPE, INC. · PI MYATT, GLENN JOHN · 2018 to 2019
$1000k
Rapid response toxicology prediction platformR43ES026909 · NIEHS · LEADSCOPE, INC. · PI MYATT, GLENN JOHN · 2016 to 2016
$149k
NIEHS NIH HHS R43 ES026909NIEHS NIH HHS R44 ES026909
6 · The paper itself

Abstract

In silico toxicology (IST) approaches to rapidly assess chemical hazard, and usage of such methods is increasing in all applications but especially for regulatory submissions, such as for assessing chemicals under REACH as well as the ICH M7 guideline for drug impurities. There are a number of obstacles to performing an IST assessment, including uncertainty in how such an assessment and associated expert review should be performed or what is fit for purpose, as well as a lack of confidence that the results will be accepted by colleagues, collaborators and regulatory authorities. To address this, a project to develop a series of IST protocols for different hazard endpoints has been initiated and this paper describes the genetic toxicity in silico (GIST) protocol. The protocol outlines a hazard assessment framework including key effects/mechanisms and their relationships to endpoints such as gene mutation and clastogenicity. IST models and data are reviewed that support the assessment of these effects/mechanisms along with defined approaches for combining the information and evaluating the confidence in the assessment. This protocol has been developed through a consortium of toxicologists, computational scientists, and regulatory scientists across several industries to support the implementation and acceptance of in silico approaches.

Indexed as

Models, TheoreticalResearch DesignAnimalsComputer SimulationHumansMutagenicity TestsMutagensRisk AssessmentToxicologyMutagensComputational toxicology protocolsExpert alertsExpert reviewGenetic toxicologyIn silicoIn silico toxicology(Q)SAR

Identifiers

PMID31195068
PMCPMC7485926

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.