Journal ArticleDOI
Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions.
Tewes Tralau,Michael Oelgeschläger,Rainer Gürtler,Gerhard Heinemeyer,Matthias Herzler,Thomas Höfer,Heike Itter,Thomas Kuhl,Nikola Lange,Nicole Lorenz,Christine Müller-Graf,Ulrike Pabel,Ralph Pirow,Vera Ritz,Helmut Schafft,Heiko Schneider,Thomas G. Schulz,David M. Schumacher,S. Zellmer,Gaby Fleur-Böl,Matthias Greiner,Monika Lahrssen-Wiederholt,Alfonso Lampen,Andreas Luch,Gilbert Schönfelder,Roland Solecki,Reiner Wittkowski,Andreas Hensel +27 more
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TLDR
This document summarizes key aspects of this debate in the light of the European “regulatory status quo”, while elucidating new perspectives for regulatory toxicity testing.Abstract:
The advent of new testing systems and "omics"-technologies has left regulatory toxicology facing one of the biggest challenges for decades. That is the question whether and how these methods can be used for regulatory purposes. The new methods undoubtedly enable regulators to address important open questions of toxicology such as species-specific toxicity, mixture toxicity, low-dose effects, endocrine effects or nanotoxicology, while promising faster and more efficient toxicity testing with the use of less animals. Consequently, the respective assays, methods and testing strategies are subject of several research programs worldwide. On the other hand, the practical application of such tests for regulatory purposes is a matter of ongoing debate. This document summarizes key aspects of this debate in the light of the European "regulatory status quo", while elucidating new perspectives for regulatory toxicity testing.read more
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Biology-inspired microphysiological system approaches to solve the prediction dilemma of substance testing.
Uwe Marx,Tommy B. Andersson,Anthony Bahinski,Mario Beilmann,Sonja Beken,Flemming R. Cassee,Murat Cirit,Mardas Daneshian,Susan Fitzpatrick,Olivier Frey,Claudia Gaertner,Christoph Giese,Linda G. Griffith,Thomas Hartung,Minne B. Heringa,Julia Hoeng,Wim H. de Jong,Hajime Kojima,Jochen Kuehnl,Marcel Leist,Andreas Luch,Ilka Maschmeyer,D. A. Sakharov,Adriënne J.A.M. Sips,Thomas Steger-Hartmann,Danilo A. Tagle,Alexander G. Tonevitsky,Tewes Tralau,Sergej Tsyb,Anja van de Stolpe,Rob J. Vandebriel,Paul Vulto,Jufeng Wang,Joachim Wiest,Marleen Rodenburg,Adrian Roth +35 more
TL;DR: The status quo of microphysiological systems available today against industry needs is reviewed, and the broad variety of approaches with fit-for-purpose potential in the drug development cycle are assessed, and feasibility solutions to reach the next levels of human biology in vitro are proposed.
Journal ArticleDOI
Synthesis and characterization of silver nanoparticles using Gelidium amansii and its antimicrobial property against various pathogenic bacteria
Arivalagan Pugazhendhi,Desika Prabakar,Jaya Mary Jacob,Indira Karuppusamy,Rijuta Ganesh Saratale +4 more
TL;DR: It is suggested that Ag NPs synthesized using a green approach effectively reduce the bacterial growth by eliciting a bactericidal activity against the Gram Negative and Gram Positive biofilm forming pathogens.
Journal ArticleDOI
Screening Chemicals for Estrogen Receptor Bioactivity Using a Computational Model
TL;DR: A multistep, performance-based validation of new methods is described and it is demonstrated that these new tools are sufficiently robust to be used in the Endocrine Disruptor Screening Program (EDSP).
Journal ArticleDOI
Air–Liquid Interface In Vitro Models for Respiratory Toxicology Research: Consensus Workshop and Recommendations
Ghislaine Lacroix,Wolfgang Koch,Detlef Ritter,Arno C. Gutleb,Søren Thor Larsen,Thomas Loret,Filippo Zanetti,Samuel Constant,Savvina Chortarea,Savvina Chortarea,Barbara Rothen-Rutishauser,Pieter S. Hiemstra,Emeric Frejafon,Philippe Hubert,Laura Gribaldo,Peter Kearns,Jean-Marc Aublant,Silvia Diabaté,Carsten Weiss,Antoinette de Groot,Ingeborg M. Kooter +20 more
TL;DR: A 1-day workshop on ALI in vitro models for respiratory toxicology research was organized in Paris in March 2016 to assess the situation and to discuss what might be possible in terms of validation studies.
Journal ArticleDOI
Prospects and challenges of multi-omics data integration in toxicology
Sebastian Canzler,Jana Schor,Wibke Busch,Kristin Schubert,Ulrike Rolle-Kampczyk,Hervé Seitz,Hennicke Kamp,Martin von Bergen,Martin von Bergen,Roland Buesen,Jörg Hackermüller +10 more
TL;DR: It is argued that more data need to be generated from studies with a multi-omics-focused design, to define which omics layers contribute most to the identification of a pathway response to a toxicant.
References
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GRADE guidelines: 3. Rating the quality of evidence
Howard Balshem,Mark Helfand,Mark Helfand,Holger J. Schünemann,Andrew D Oxman,Regina Kunz,Jan Brozek,Gunn Elisabeth Vist,Yngve Falck-Ytter,Joerg J Meerpohl,Susan L Norris,Gordon H. Guyatt +11 more
TL;DR: The approach of GRADE to rating quality of evidence specifies four categories-high, moderate, low, and very low-that are applied to a body of evidence, not to individual studies.
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Can the pharmaceutical industry reduce attrition rates
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