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Principles and proc...
Principles and procedures for assessment of acute toxicity incorporating in silico methods
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- Zwickl, Craig M. (författare)
- Transendix LLC, Indianapolis, IN 46229 USA.
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- Graham, Jessica C. (författare)
- Genentech Inc, 1 DNA way, South San Francisco, CA 94080 USA.
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- Jolly, Robert A. (författare)
- Eli Lilly & Co, Indianapolis, IN 46285 USA.
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- Bassan, Arianna (författare)
- Innovatune, Via Giulio Zanon 130-D, I-35129 Padua, Italy.
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- Ahlberg, Ernst (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap,Universal Predict AB, Gothenburg, Sweden.
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- Amberg, Alexander (författare)
- Sanofi, R&D Preclin Safety Frankfurt, Ind Pk Hoechst, D-65926 Frankfurt, Germany.
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- Anger, Lennart T. (författare)
- Genentech Inc, 1 DNA way, South San Francisco, CA 94080 USA.
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- Beilke, Lisa (författare)
- Toxicol Solut Inc, Marana, AZ 85658 USA.
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- Bellion, Phillip (författare)
- Boehringer Ingelheim Vetmed GmbH, Binger Str 173, D-55216 Ingelheim, Germany.
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- Brigo, Alessandro (författare)
- Roche Innovat Ctr Basel, Roche Pharmaceut Res & Early Dev, Grenzacherstr 124, CH-4070 Basel, Switzerland.
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- Burleigh-Flayer, Heather (författare)
- PPG Ind Inc, Monroeville, PA 15146 USA.
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- Cronin, Mark T. D. (författare)
- Liverpool John Moores Univ, Liverpool L3 3AF, England.
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- Devlin, Amy A. (författare)
- FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
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- Fish, Trevor (författare)
- Nelson Labs, Salt Lake City, UT USA.
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- Glowienke, Susanne (författare)
- Novartis, Basel, Switzerland.
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- Gromek, Kamila (författare)
- GlaxoSmithKline, Munich, Germany.
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- Karmaus, Agnes L. (författare)
- Integrated Lab Syst LLC, Morrisville, NC USA.
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- Kemper, Ray (författare)
- Nuvalent, Cambridge, MA 02142 USA.
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- Kulkarni, Sunil (författare)
- Hlth Canada, Hlth Environm & Consumer Safety Branch, Existing Subst Risk Assessment Bur, Ottawa, ON K1A 0K9, Canada.
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- Lo Piparo, Elena (författare)
- Nestle Res, Chem Food Safety Grp, Lausanne, Switzerland.
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- Madia, Federica (författare)
- European Commiss, Joint Res Ctr JRC, Ispra, Italy.
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- Martin, Matthew (författare)
- Pfizer Worldwide Res & Dev, Groton, CT 06340 USA.
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- Masuda-Herrera, Melisa (författare)
- Gilead Sci, 333 Lakeside Dr, Foster City, CA 94404 USA.
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- Mcatee, Britt L. (författare)
- PPG Ind Inc, Monroeville, PA 15146 USA.
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- Mestres, Jordi (författare)
- IMIM Inst Hosp del Mar Invest Med, IULA, Doctor Aiguader 88,Parc Recerca Biomed, Barcelona 08003, Spain.;Univ Pompeu Fabra, Doctor Aiguader 88,Parc Recerca Biomed, Barcelona 08003, Spain.;Chemotargets SL, Baldiri Reixac 4,Parc Cient Barcelona, Barcelona 08028, Spain.
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- Milchak, Lawrence (författare)
- 3M Co, St Paul, MN USA.
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- Moudgal, Chandrika (författare)
- Genentech Inc, 1 DNA way, South San Francisco, CA 94080 USA.
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- Mumtaz, Moiz (författare)
- Ctr Dis Control & Prevent CDC, Off Associate Director Sci OADS, Agcy Tox Subst & Dis Registry ATSDR, 1600 Clifton Rd,S102-2, Atlanta, GA 30333 USA.
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- Muster, Wolfgang (författare)
- Roche Innovat Ctr Basel, Roche Pharmaceut Res & Early Dev, Grenzacherstr 124, CH-4070 Basel, Switzerland.
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- Neilson, Louise (författare)
- JT Int SA, Geneva, Switzerland.
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- Patlewicz, Grace (författare)
- US EPA, Ctr Computat Toxicol & Exposure CCTE, Res Triangle Pk, NC 27711 USA.
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- Paulino, Alexandre (författare)
- Oro Agri Europe SA, Estr Municipal 533,Estr Lau, P-2950401 Palmela, Portugal.
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- Roncaglioni, Alessandra (författare)
- Ist Ric Farmacol Mario Negri IRCCS, Dept Environm Hlth Sci, Lab Environm Chem & Toxicol, Milan, Italy.
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- Ruiz, Patricia (författare)
- Ctr Dis Control & Prevent CDC, Off Innovat & Analyt OIA, Agcy Tox Subst & Dis Registry ATSDR, Atlanta, GA 30333 USA.
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- Szabo, David T. (författare)
- PPG Ind Inc, Monroeville, PA 15146 USA.
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- Valentin, Jean-Pierre (författare)
- UCB Biopharm SRL, Dev Sci, Ave Ind, Braine Lalleud, Wallonia, Belgium.
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- Vardakou, Ioanna (författare)
- BAT Investments Ltd, Regents Pk Rd, Southampton SO15 8TL, England.
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- Woolley, David (författare)
- ForthTox Ltd, Linlithgow EH49 7YU, Scotland.
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- Myatt, Glenn J. (författare)
- Instem, 1393 Dublin Rd, Columbus, OH 43215 USA.
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Transendix LLC, Indianapolis, IN 46229 USA Genentech Inc, 1 DNA way, South San Francisco, CA 94080 USA. (creator_code:org_t)
- Elsevier, 2022
- 2022
- Engelska.
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Ingår i: COMPUTATIONAL TOXICOLOGY. - : Elsevier. - 2468-1113. ; 24
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Acute toxicity in silico models are being used to support an increasing number of application areas including (1) product research and development, (2) product approval and registration as well as (3) the transport, storage and handling of chemicals. The adoption of such models is being hindered, in part, because of a lack of guidance describing how to perform and document an in silico analysis. To address this issue, a framework for an acute toxicity hazard assessment is proposed. This framework combines results from different sources including in silico methods and in vitro or in vivo experiments. In silico methods that can assist the prediction of in vivo outcomes (i.e., LD50) are analyzed concluding that predictions obtained using in silico approaches are now well-suited for reliably supporting assessment of LD50- based acute toxicity for the purpose of the Globally Harmonized System (GHS) classification. A general overview is provided of the endpoints from in vitro studies commonly evaluated for predicting acute toxicity (e.g., cytotoxicity/cytolethality as well as assays targeting specific mechanisms). The increased understanding of pathways and key triggering mechanisms underlying toxicity and the increased availability of in vitro data allow for a shift away from assessments solely based on endpoints such as LD50, to mechanism-based endpoints that can be accurately assessed in vitro or by using in silico prediction models. This paper also highlights the importance of an expert review of all available information using weight-of-evidence considerations and illustrates, using a series of diverse practical use cases, how in silico approaches support the assessment of acute toxicity.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
- NATURVETENSKAP -- Biologi -- Biokemi och molekylärbiologi (hsv//swe)
- NATURAL SCIENCES -- Biological Sciences -- Biochemistry and Molecular Biology (hsv//eng)
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Zwickl, Craig M.
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Graham, Jessica ...
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Jolly, Robert A.
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Bassan, Arianna
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Ahlberg, Ernst
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Amberg, Alexande ...
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visa fler...
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Anger, Lennart T ...
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Beilke, Lisa
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Bellion, Phillip
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Brigo, Alessandr ...
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Burleigh-Flayer, ...
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Cronin, Mark T. ...
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Devlin, Amy A.
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Fish, Trevor
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Glowienke, Susan ...
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Gromek, Kamila
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Karmaus, Agnes L ...
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Kemper, Ray
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Kulkarni, Sunil
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Lo Piparo, Elena
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Madia, Federica
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Martin, Matthew
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Masuda-Herrera, ...
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Mcatee, Britt L.
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Mestres, Jordi
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Milchak, Lawrenc ...
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Moudgal, Chandri ...
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Mumtaz, Moiz
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Muster, Wolfgang
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Neilson, Louise
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Patlewicz, Grace
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Paulino, Alexand ...
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Roncaglioni, Ale ...
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Ruiz, Patricia
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Szabo, David T.
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Valentin, Jean-P ...
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Vardakou, Ioanna
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Woolley, David
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Myatt, Glenn J.
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Uppsala universitet