Evidence map›Paper›PMID 29203341›Full record

ReviewToxicology in vitro : an international journal published in association with BIBRA2018

In vitro to in vivo extrapolation for high throughput prioritization and decision making.

Shannon M Bell, Xiaoqing Chang, John F Wambaugh, David G Allen, Mike Bartels, Kim L R Brouwer, Warren M Casey, Neepa Choksi, Stephen S Ferguson, Grazyna Fraczkiewicz and 14 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Toxicology in vitro : an international journal published in association with BIBRA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 101 papers.

0numbers the graph read from it
0cells of the map it votes in
101citing 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

101 citing papers in PubMed.

  1. Article
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  10. Cross-species comparisons of plasma binding and considerations for data evaluation.Toxicology in vitro : an international journal published in association with BIBRA · 2025
    Article
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  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article

41 more citing papers are in PubMed but not listed here.

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

24 authors.

Shannon M BellIntegrated Laboratory Systems, Inc., P.O. Box 13501, Research Triangle Park, NC 27709, USA. Electronic address: SBell@ils-inc.com.
Xiaoqing ChangIntegrated Laboratory Systems, Inc., P.O. Box 13501, Research Triangle Park, NC 27709, USA. Electronic address: XChang@ils-inc.com.
John F WambaughU.S. Environmental Protection Agency, 109 T.W. Alexander Dr., Research Triangle Park, NC 27709, USA. Electronic address: wambaugh.john@epa.gov.
David G AllenIntegrated Laboratory Systems, Inc., P.O. Box 13501, Research Triangle Park, NC 27709, USA. Electronic address: DAllen@ils-inc.com.
Mike BartelsDow Chemical Company, Saginaw, MI 48603, USA. Electronic address: mjbartels@toxmetrics.com.
Kim L R BrouwerUNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Campus Box 7569, Chapel Hill, NC 27599, USA. Electronic address: kbrouwer@unc.edu.
Warren M CaseyNational Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, P.O. Box 12233, Research Triangle Park, NC 27709, USA. Electronic address: warren.casey@nih.gov.
Neepa ChoksiIntegrated Laboratory Systems, Inc., P.O. Box 13501, Research Triangle Park, NC 27709, USA. Electronic address: NChoksi@ils-inc.com.
Stephen S FergusonNational Toxicology Program, National Institute of Environmental Health Sciences, P.O. Box 12233, Research Triangle Park, NC 27709, USA. Electronic address: Stephen.ferguson@nih.gov.
Grazyna FraczkiewiczSimulations Plus, Inc., 42505 10th St. West, Lancaster, CA 93534, USA. Electronic address: grace@simulations-plus.com.
Annie M JarabekU.S. Environmental Protection Agency, 109 T.W. Alexander Dr., Research Triangle Park, NC 27709, USA. Electronic address: jarabek.annie@epa.gov.
Alice KeSimcyp Limited (a Certara company), John Street, Sheffield, S2 4SU, United Kingdom. Electronic address: alice.ke@certara.com.
Annie LumenNational Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA. Electronic address: annie.lumen@fda.hhs.gov.
Scott G LynnU.S. Environmental Protection Agency, William Jefferson Clinton Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, USA. Electronic address: lynn.scott@epa.gov.
Alicia PainiEuropean Commission, Joint Research Centre, Directorate Health, Consumers and Reference Materials, Chemical Safety and Alternative Methods Unit incorporating EURL ECVAM, Via E. Fermi 2749, Ispra, Varese 20127, Italy. Electronic address: Alicia.paini@ec.europa.eu.
Paul S PriceU.S. Environmental Protection Agency, 109 T.W. Alexander Dr., Research Triangle Park, NC 27709, USA. Electronic address: price.pauls@epa.gov.
Caroline RingOak Ridge Institute for Science and Education, P.O. Box 2008, Oak Ridge, TN 37831, USA. Electronic address: cring@toxstrategies.com.
Ted W SimonTed Simon LLC, 4184 Johnston Road, Winston, GA 30187, USA. Electronic address: ted@tedsimon-toxicology.com.
Nisha S SipesNational Toxicology Program, National Institute of Environmental Health Sciences, P.O. Box 12233, Research Triangle Park, NC 27709, USA. Electronic address: Nisha.sipes@nih.gov.
Catherine S SprankleIntegrated Laboratory Systems, Inc., P.O. Box 13501, Research Triangle Park, NC 27709, USA. Electronic address: CSprankle@ils-inc.com.
Judy StricklandIntegrated Laboratory Systems, Inc., P.O. Box 13501, Research Triangle Park, NC 27709, USA. Electronic address: JStrickland@ils-inc.com.
John TroutmanCentral Product Safety, The Procter & Gamble Company, Cincinnati, OH 45202, USA. Electronic address: troutman.ja@pg.com.
Barbara A WetmoreScitoVation LLC, 6 Davis Drive, Research Triangle Park, NC 27709, USA. Electronic address: Wetmore.barbara@epa.gov.
Nicole C KleinstreuerNational Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, P.O. Box 12233, Research Triangle Park, NC 27709, USA. Electronic address: nicole.kleinstreuer@nih.gov.

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
ALTERED HEPATIC DISPOSITION OF ANIONIC DRUGS-MECHANISMSR01GM041935 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BROUWER, KIM L.R. · 1997 to 2016
$6.5M
Mechanisms of Altered Hepatic Transport: Impact on Drug TherapyR35GM122576 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER · 2017 to 2026
$5.7M
Intramural NIH HHS Z99 ES999999NIEHS NIH HHS HHSN273201500010CNIGMS NIH HHS R01 GM041935NIGMS NIH HHS R35 GM122576
6 · The paper itself

Abstract

In vitro chemical safety testing methods offer the potential for efficient and economical tools to provide relevant assessments of human health risk. To realize this potential, methods are needed to relate in vitro effects to in vivo responses, i.e., in vitro to in vivo extrapolation (IVIVE). Currently available IVIVE approaches need to be refined before they can be utilized for regulatory decision-making. To explore the capabilities and limitations of IVIVE within this context, the U.S. Environmental Protection Agency Office of Research and Development and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods co-organized a workshop and webinar series. Here, we integrate content from the webinars and workshop to discuss activities and resources that would promote inclusion of IVIVE in regulatory decision-making. We discuss properties of models that successfully generate predictions of in vivo doses from effective in vitro concentration, including the experimental systems that provide input parameters for these models, areas of success, and areas for improvement to reduce model uncertainty. Finally, we provide case studies on the uses of IVIVE in safety assessments, which highlight the respective differences, information requirements, and outcomes across various approaches when applied for decision-making.

Indexed as

Decision Making, Computer-AssistedDecision Making, OrganizationalHealth PrioritiesHigh-Throughput Screening AssaysModels, BiologicalAnimalsAnimal Use AlternativesChemical SafetyComputational BiologyComputer SimulationExpert SystemsGuidelines as TopicHumansNational Institute of Environmental Health Sciences (U.S.)Toxicity TestsUnited StatesComputational toxicologyHigh throughput testingIVIVERisk assessmentToxicity testingToxicokinetic

Identifiers

PMID29203341
PMCPMC7393693

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.